AACIS Hospital

I n t e r n a t I o n a l S t a n d a r d f o r

Version 1January 2013

AMERICAN

COUNCIL

The mark of excellence and safety

ACCREDITATION

american accreditation council (AAC)

The over lying mission of AAC is to improve the safety, well-being and quality of life and quality of care throughout the world. AAC recognizes the necessity for collaborative efforts and will assist all those working to improve global healthcare outcomes. AAC believes that all people are equally entitled to superior healthcare.

© 2013 American Accreditation Council All rights reserved. No part of this publication may be reproduced in any

form or by any means without written permission from the publisher. www.americanaccreditationcouncil.com

Table of Contents

Acronyms/AbbreviationsINTERNATIONAL STANDARDS 4

regulatory compliance 5

governing body 6

organizational ethics 9

quality management and performance improvement program 10

composition of the medical staff 15

patient’s rights 22

nursing services 50

medical record services 55

infection prevention 69

surgical services 76

anesthesia services 86

emergency services 94

outpatient services 97

medication use 99

laboratory services 126

radiologic services 129

nuclear medicine services 133

rehabilitation services 137

respiratory care 141

food and dietetic services 144

utilization review 148

discharge planning 152

organ, tissue and eye procurement 159

physical environment 165

human resources/staff administration 175

Acronyms/Abbreviations INTERNATIONAL STANDARDS

ADR Adverse Drug Reaction

BBP Bloodborne Pathogens

BID Latin word meaning “twice daily”

BSI Blood Stream Infections

CDC Center for Disease Control

DON Director of Nursing

ECP Exposure Control Plan

EKG Electrocardiogram

H&P History and Physical

HACCP Hazard Analysis and Critical Control Points

HAI Hospital Acquired Infections

HAZMAT Hazardous Materials

HIV Human Immunodeficiency Virus

HNOC Hazard Not Otherwise Classified

HVAC Heating, Ventilation, Air-Conditioning

ICU Intensive Care Unit

IUPAC International Union of Pure and Applied Chemistry

IV Intravenous

MAC Monitored Anesthesia Care

MD Medical Doctor

MDR - Multi-Drug Resistant Organisms

MSDS Material Safety Data Sheet

OP - Organ Procurement Organization

PACU Post Anesthesia Care Unit

PE Physical Environment

PIM Potentially Infectious Materials

PPE Personal Protective Equipment

PRN Pro re nata (Latin phrase meaning “as needed”

QMS Quality Management System

RN Registered Nurse

SARS Severe Acute Respiratory Syndrome

SDS Safety Data Sheet

SNF Skilled Nursing Facility

SSI Surgical Site Infection

UR Utilization Review

UV Ultra Violet

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regulatory compliance

rG-1 Compliance with applicable laws and regulations

rG-1.1 The organization must be in compliance with applicable laws and regulations related to the health and safety of patients.

rG-1.2 The organization must be licensed; or

rG-1.3 Approved as meeting standards for licensing established by the Ministry of Health or locality responsible for licensing healthcare organizations.

rG-1.4 The organization must ensure that all applicable laws and regulations are met.

rG-2 licensure and Certification

rG-2.1 The organization must have a policy in place to assure that personnel are licensed or meet other applicable standards that are required by applicable laws and regulations.

rG-2.2 All staff that are required by the Ministry of Health, Medical Chamber, Nursing Chamber or any other regulatory body to be licensed or certified must possess a current license or certification. The organization must assure that these personnel are in compliance with the applicable licensure and certification laws.

rG-2.3 All staff must meet all applicable standards required by applicable laws and regulations for hospital/organization personnel. This would include at a minimum:

RG-2.3.1 Certification requirements; RG-2.3.2 Minimum qualifications; RG-2.3.3 Training/education requirements; and RG-2.3.4 Permits (such as food handlers).

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governing body

GB-1 The organization must have an effective governing body responsible for the conduct of the hospital as an institution. If a hospital does not have an organized governing body, the persons legally responsible for the conduct of the hospital must carry out the functions specified in this part that pertain to the governing body.

GB-2 In the absence of an organized governing body, there must be written docu-mentation that identifies the individual or individuals that are responsible for the conduct of the hospital operations.

GB-3 Medical Staff: Categories of Practitioners

GB-3.1 The governing body must ensure the medical staff requirements are met. The governing body must determine, in accordance with applicable laws and regulations and Medical Chamber, which categories of practitioners are eligible candidates for appointment to the medical staff:

GB-3.1.1 Doctor of Medicine; GB-3.1.2 Doctor of Dental Surgery or of Dental Medicine; GB-3.1.3 Doctor of Podiatric Medicine; and

GB-3.2 Furthermore, the governing body has the authority, in accordance with applicable laws and regulations, to appoint some types of non-physician practitioners to the medical staff.

GB-3.2.1 Certified Nurse-Midwife; GB-3.2.2 Clinical Social Worker; and GB-3.2.3 Clinical Psychologist.

GB-4 The governing body determines whether to grant, deny, continue, revise, discontinue, limit, or revoke specified privileges, including medical staff membership, or a specific practitioner after considering the recommendation of the medical staff. In all instances, the governing body’s determination must be consistent with established hospital medical staff criteria, as well as with applicable laws and regulations. Only the hospital’s governing body has the authority to grant a practitioner privileges to provide care in the healthcare organization.

GB-5 Chief Executive Officer: The governing body must appoint one Chief Execu-tive Officer/Director/ Manager who is responsible for managing the entire hospital.

GB-5.1 The governing board must appoint only one person responsible for managing the entire healthcare organization.

GB-5.2 Physician on-Duty/On-Call: The Governing Board must ensure that a doctor/physician is on duty or on call at all times.

GB-6 The organization must have an overall organizational plan that meets the following conditions:

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GB-6.1 The plan must include an annual operating budget that is prepared according to generally accepted accounting principles.

GB-6.2 The budget must include all anticipated income and expenses. This provision does not require that the budget identify the components of each anticipated income or expense item by item.

GB-6.3 The plan must provide for capital expenditures for at least a 3-year period, including and identifying the anticipated sources of financing for capital expenditure that relates to the following:

GB-6.3.1 Acquisition of land GB-6.3.2 Improvement of land, buildings, and equipment; or GB-6.3.3 Replacement, modernization, and expansion of buildings and equipment.

GB-6.4 The plan must be prepared under the direction of the governing board and by a committee consisting of representatives of the governing board, the administrative staff, and the medical staff of the healthcare organization.

Interpretive Guidelines: • Reviewandverifydocumentationalongwiththeplanandbudgetarereviewedandupdatedannually.Alsoverifythegoverningbody,administrativestaff,andmedicalstaffhasparticipatedinthedevelopmentoftheplanandbudget.

GB-7 Contracted Services

GB-7.1 The governing body must be responsible for services furnished in the healthcare organization. The governing body must ensure that a contracted service will comply with all regulations required by applicable laws and regulations, Ministry of Health and Medical Chamber requirements.

Interpretive Guidelines: • Thegoverningbodyhastheresponsibilityforassuringthathospitalservicesarepro-videdincompliancewithregulationsoftheMinistryofHealthandMedicalChamber.

GB-7.2 The governing body must ensure that the services performed under a contract are provided in a safe and effective manner.

GB-7.2.1 Determine if the healthcare organization has a mechanism in place to evaluate the quality of each contracted service and ensures that each contracted service is provided in a safe and effective manner. Review the Quality Management System minutes to ensure every contracted service is evaluated.

GB-7.3 The healthcare organization must maintain a list of all contracted services, including the scope and nature of the services provided.

GB-8 tobacco free Workplace

GB-8.1 The organization shall ensure a tobacco-free campus. This applies to all forms of tobacco smoking products (e.g., cigarettes, cigars, pipes, and herbal tobacco products), as well as smokeless tobacco products (e.g., chewing tobacco, snuff), none of which shall be used on the campus or at any facility owned, leased or operated by the organization.

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GB-8.2 Tobacco use is prohibited in all facilities owned and used by the hospital including: leased buildings, parking lots and garages, ramps, plazas, sidewalks adjacent to campus, personal vehicles parked on hospital property, as well as hospital owned, leased or operated vehicles.

GB-8.3 There shall be no designated smoking areas on the campus.

GB-8.4 This requirement applies to all hospital employees, medical staff, auxiliary staff, patients, students, contracted personnel, vendors, volunteers, visitors, and tenants of the hospital.

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organizational ethics

oe-1 The organization establishes a framework for ethical management that ensures that patient care is provided within business, financial, ethical and legal norms and that protects patients and their rights.

oe-1.1 The organization’s framework for ethical management includes marking, admissions, transfer, discharge, and disclosure of ownership and any business and professional conflicts that may not be in patients’ best interests.

oe-1.2 The organization’s framework for ethical management supports ethical decision-making in clinical care and non-clinical services.

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QM

quality management and performance improvement program

QM-1 The hospital must develop, implement, and maintain an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement program. The hospital’s governing body must ensure that the program reflects the complexity of the hospital’s organization and services; involves all hospital departments and services (including those services furnished under contract or arrangement); and focuses on indicators related to improved health outcomes and the prevention and reduction of medical errors. The hospital must maintain and demonstrate evidence of its Quality Management System.

QM -2 Quality Plan

QM -2.1 The hospital must ensure that the Quality Plan/ Scope requirements are met.

QM -2.2 The Quality Plan must include, but not be limited to, an ongoing program that shows measurable improvement in indicators for which there is evidence that it will improve health outcomes and identify and reduce medical errors.

QM -2.3 The hospital must measure, analyze, and track quality indicators, including adverse patient events, and other aspects of performance that assess processes of care, hospital service and operations.

QM-3 Quality Data

QM-3.1 The hospital must ensure that the Quality Data requirements are met.

QM-3.2 Quality indicators including patient care data, and other relevant data, for example, information submitted to, or received from, the hospital’s Quality Management System.

QM-3.3 The hospital must use the data collected to monitor the effectiveness and safety of services and quality of care; and identify opportunities for improvement and changes that will lead to improvement.

QM-3.4 The frequency and detail of data collection must be specified by the hospital’s governing body.

Interpretive Guidelines: • Theorganizationwillprovidedocumentationthatdefinesqualityandperformanceimprovementandhowtheyaremeasured,monitored,analyzedandcontinuallyimproved.

QM-4 Measurement, Monitoring, and Analysis: The organization shall evaluate all organ-ized services and processes, both direct and supportive, including services pro-vided by any contracted service. The monitoring shall include the use of internal reviews (audits) of each department or service at scheduled intervals, not to exceed one year and data related to these processes. Individual(s) not assigned to that department or service shall conduct the internal review (audit). Measure-ment, monitoring and analysis of processes throughout the organization require established measures that have the ability to detect variation, identify problem processes, identify both positive and negative outcomes, and effectiveness of actions taken to improve performance and/or reduce risks. The governing body of the organization must define the frequency and detail of the measurement. Those functions to be measured at a minimum must include the following:

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QM-4.1 Threats to patient safety (i.e. falls, patient identification, injuries,);

QM-4.2 Medication therapy/medication use; to include medication reconciliation, look alike-sound alike medications and the use of dangerous abbreviations;

QM-4.3 Operative and invasive procedures; to include wrong site/wrong patient/wrong procedure surgery;

QM-4.4 Anesthesia/moderate sedation;

QM-4.5 Blood and blood components;

QM-4.6 Restraint use/seclusion;

QM-4.7 Effectiveness of pain management system;

QM-4.8 Infection control system, including hospital acquired infections (HAI);

QM-4.9 Utilization Management System;

QM-4.10 Patient flow issues, to include reporting of patients held in the Emergency Department or the PACU for extended periods of time (as defined by the organization);

QM-4.11 Customer satisfaction, both clinical and support areas;

QM-4.12 Discrepant pathology reports;

QM-4.13 Unanticipated deaths, adverse and/or sentinel events;

QM-4.14 Near misses;

QM-4.15 Other adverse events;

QM-4.16 Critical and/or pertinent processes, both clinical and supportive;

QM-4.17 Medical record delinquency; and

QM-4.18 Physical Environment Management Systems.

QM-5 Patient Safety Systems

QM-5.1 The organization shall have a means for established clear expectations for identifying and detecting the prevalence and severity of incidents that impact or threaten patient safety. This shall include medical errors and adverse patient events.

QM-5.2 The organization’s Patient Safety System shall be documented and shall address the following:

QM-5.2.1 Detections; QM-5.2.2 Preventative and corrective action; QM-5.2.3 Defined processes to reduce risk; QM-5.2.4 Implementation of action plans;

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QM QM-5.2.5 On-going measurement to ensure action effectiveness; QM-5.2.6 Management review of response and resource allocation utilizing the results

of patient adverse events and other data analysis; and, QM-5.2.7 Quality Management System policy and procedure of informing patients and/

or their families about unexpected adverse events.

QM-6 The hospital must ensure that the program activities requirements are met.

QM-6.1 The hospital must set priorities for its performance improvement activities that:

QM-6.1.1 Focus on high-risk, high-volume, or problem-prone areas; QM-6.1.2 Consider the incidence, prevalence, and severity of problems in those areas; and QM-6.1.3 Affect health outcomes, patient safety, and quality of care.

QM-7 Performance improvement activities must track medical errors and adverse patient events, analyze their causes, and implement preventive actions and mechanisms that include feedback and learning throughout the hospital.

QM-8 The hospital must take actions aimed at performance improvement and, after implementing those actions, the hospital must measure its success, and track performance to ensure that improvements are sustained.

QM-9 Performance Improvement Projects: As part of its quality assessment and performance improvement program, the hospital must conduct perfor-mance improvement projects. The number and scope of distinct improvement projects conducted annually must be proportional to the scope and com-plexity of the hospital’s services and operations.

QM-10 A hospital may, as one of its projects, develop and implement an information technology system explicitly designed to improve patient safety and quality of care. This project, in its initial stage of development, does not need to demonstrate measurable improvement in indicators related to health outcomes.

QM-11 The hospital must document what quality improvement projects are being conducted, the reasons for conducting these projects, and the measurable progress achieved on these projects.

QM-12 A hospital is not required to participate in a performance improvement coop-erative project, but its own projects are required to be of comparable effort.

QM-13 Executive Responsibilities: The hospital’s governing body (or organized group or individual who assumes full legal authority and responsibility for operations of the hospital), medical staff, and administrative officials are responsible and accountable for ensuring the hospital-wide quality assess-ment and performance improvement efforts address priorities for improved and patient safety and that all improvement actions are evaluated.

QM-13.1 That clear expectations for safety are established.

QM-13.2 That adequate resources are allocated for measuring, assessing, improving, and sustaining the hospital’s performance and

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QM-13.3 That adequate resources are allocated for reducing risk to patients.

QM-13.4 That the determination of the number of distinct improvement projects is conducted annually.

QM-14 Risk Management: An ongoing program of risk management is used to identify and to reduce unanticipated adverse events and other safety risks to patients and staff.

QM-14.1 Organizations need to adopt a proactive approach to risk management. One such way is a formalized risk management program whose essential compo-nents include:

QM-14.1.1 Risk identification QM-14.1.2 Risk prioritization; QM-14.1.3 Risk reporting; QM-14.1.4 Risk management; QM-14.1.5 Investigation of adverse events; and QM-14.1.6 Management of related claims.

QM-14.2 An important element of risk management is risk analysis, such as process to evaluate near misses and other high-risk processes for which a failure would result in a sentinel event. One tool that provides such a proactive analysis of the consequences of an event that could occur in a critical, high-risk process is failure mode and effects analysis. The organization can also identify and use similar tools to identify and to reduce risks, such as a hazard vulnerability analysis.

QM-14.3 To use this or similar tools effectively, the organization’s leaders need to adopt and to learn the approach, to agree on a list of high-risk processes in terms of patient and staff safety, and then to use the tool on a priority risk process. Following analysis of the results, the organization’s leaders take action to redesign the process or similar actions to reduce the risk in the process. This risk-reduction process is carried out at least once per year and documented.

Surveyor Guidance: • Theorganization’sleadersadoptariskmanagementframeworktoincludeintheintent. • Theorganizationconductsanddocumentsuseofproactiverisk-reductiontoolatleast

annuallyononeofthepriorityriskprocesses. • Theorganization’sleaderstakeactiontoredesignhigh-riskprocessesbasedontheanalysis.

QM-15 Quality Management Representative: A Quality Management Representative shall be appointed. The Quality Management Representative shall have the authority and responsibility to ensure the requirements of the Quality Management System are implemented and maintained.

Interpretive Guidelines: • TheQualityManagementRepresentativeisresponsibleforInternalAuditsandManagementReviewactivitiesandmustensurethatcorrectiveandpreventiveactionsarecarriedoutandmeasuredforeffectiveness.TheseniorleadershipisrequiredtoappointtheQualityManagementRepresentativeanddefinetheirroleasrequiredbyISO9001.

QM-16 Management Reviews and Documentation: Management Reviews must be performed at regular intervals and at a minimum of once annually. The organi-

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zation must be able to demonstrate that planned review activities were measured through the internal audit process. The results of these activities are communicated to Senior Leadership and conducted as part of Management Review. Any variation, non-conformity, or deficiency in the organization process must be addressed by Senior Management.

Interpretive Guidelines: • ManagementReviewisaformalevaluationbySeniorLeadershipoftheeffectiveness,adequacy,andcomplianceoftheQualityManagementSystem.Resultsfromtheinternalaudits,customer/patientsatisfaction,dataanalysisorotherprocessimprovementactivitiesmustbereviewedasapartoftheManagementReviewProcess.TheresultsoftheauditsmustbedemonstratedtobeeffectivebyquantifiablemeasuresandcommunicatedtoSeniorLeadership.DocumentationcantaketheformofRootCauseAnalysis(RCA),PerformanceImprovement(PI)Report,Non-ConformityReport,SpecificPerformance(PI)Projectsand/oranalysisorFailure,ModeandEffectAnalysis(FMEA).

QM-17 Quality Management System Requirements: The organization is required to have the following as part of the Quality Management System:

QM-17.1 Multi-disciplinary committee will oversee the Quality Management System with membership consisting of CEO, Senior Leadership, Nursing, Quality Management System Representative, Medical Staff, Pharmacy, Information Technology (IT), Risk Management, Physical Environment and other ancillary departments as identified.

QM-17.2 A written document including all clinical and nonclinical service areas defining their involvement in the Quality Management System.

QM-17.3 Quality Policy Statement

QM-17.4 Quantifiable quality objectives

QM-17.5 Establishment of goals and activities

QM-17.5.1 High Risk, Problem Prone processes or functions. QM-17.5.2 Severity, prevalence, incidence, or problems in the processes or functions. QM-17.5.3 Improve quality of care, patient safety, and effect healthy outcomes.

Interpretive Guidelines: • TheQualityManagementSystemwillbedocumentedinaplan,manual,orotherdocumentasdefinedbytheorganization.ThisdocumentwillincludeorreferencetheQualityPolicy,GoalsandObjectives,andhowservicesandprocessesaremonitoredandmeasuredthroughouttheorganization.

Surveyor Guidance: • ReviewtheQualityManagementSystemdocumentsi.e.QualityManual,QualityPolicy,QualityPlan,GoalsandObjectivesandhowservicesandprocessesaremonitoredandmeasuredthroughouttheorganization.

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MS

composition of the medical staff

MS-1 The medical staff must be composed of doctors of medicine and, in accordance with applicable laws and regulations and Medical Chamber and Ministry of Health, may also be composed of other practitioners appointed by the governing body.

MS-1.1 The medical staff must at a minimum be composed of physicians who are doctors of medicine. In addition, the medical staff may include other health-care professionals:

Interpretive Guidelines: • Doctorofmedicine; • Doctorofdentalsurgeryorofdentalmedicine; • Doctorofpodiatricmedicine;and • Doctorofoptometry.

MS-1.2 In all cases the healthcare professional included in the definition of a physician must be legally authorized to practice within the locality where the hospital is located and providing services within their authorized scope of practice.

MS-1.3 The governing body has the flexibility to determine whether healthcare professionals included in the definition of a physician other than a doctor of medicine are eligible for appointment to the medical staff.

MS-1.4 Furthermore, the governing body has the authority, in accordance with applicable laws and regulations, to appoint non-physician practitioners to the medical staff.

Interpretive Guidelines: • Certifiednurse-midwife; • Clinicalsocialworker; • Clinicalpsychologist;or • Registereddieticianornutritionprofessional.

MS-1.5 Physicians and non-physician practitioners may be granted medical staff privileges to practice at the hospital by the governing body for practice activities authorized within the applicable laws and regulations scope of practice without being appointed a member of the medical staff.

MS -2 The medical staff must periodically conduct appraisals of its members.

MS-2.1 The medical staff must at regular intervals appraise the qualifications of all practitioners appointed to the medical staff/granted medical staff privileges. In the absence of applicable laws and regulations that establishes a timeframe for periodic reappraisal, a hospital’s medical staff must conduct a periodic appraisal of each practitioner. It is recommended that an appraisal be conducted at least every 24 months for each practitioner.

MS-2.2 The purpose of the appraisal is for the medical staff to determine the suitability of continuing the medical staff membership or privileges of each individual practitioner, to determine if that individual practitioner’s membership or privileges should be continued, discontinued, revised, or otherwise changed.

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MSMS-2.3 The medical staff appraisal procedures must evaluate each individual practitioner’s applicable scope of practice or privileges for that type of practitioner for which he/she has been granted privileges. Components of practitioner qualifications and demonstrated competencies would include at least: current work practice, special training, quality of specific work, patient outcomes, education, and maintenance of continuing education, adherence to medical staff rules, certifications, appropriate licensure, and currency of compliance with licensure requirements.

MS-2.4 In addition to the periodic appraisal of members, any procedure/task/activity/privilege requested by a practitioner that goes beyond the specified list of privileges for that particular category of practitioner requires an appraisal by the medical staff and approval by the governing body. The appraisal must consider evidence of qualifications and competencies specific to the nature of the request. It must also consider whether the activity/task/procedure is one that the hospital can support when it is conducted within the hospital. Privileges cannot be granted for tasks/procedures/activities that are not conducted within the hospital, regardless of the individual practitioner’s ability to perform them.

MS-2.5 After the medical staff conducts its reappraisal of individual members, the medical staff makes recommendations to the governing body to continue, revise, discontinue, limit, or revoke some or all of the practitioner’s privileges, and the governing body takes final appropriate action.

MS-2.6 A separate credentials file must be maintained for each medical staff member. The hospital must ensure that the practitioner and appropriate hospital patient care areas/departments are informed of the privileges granted to the practitioner, as well as of any revisions or revocations of the practitioner’s privileges. Further-more, whenever a practitioner’s privileges are limited, revoked, or in any way constrained, the hospital must, in accordance with Medical Chamber and Ministry of Health laws or regulations, report those constraints to the appropriate local authorities, registries, and/or data bases.

Surveyor Guidance: • Determinewhetherthemedicalstaffhasasysteminplacethatisusedtoreappraiseeachofitscurrentmembersandtheirqualificationsatregularintervals,or,ifapplicable,asprescribedbyapplicablelawsandregulations.

• Determinewhetherthemedicalstaffdocumentationidentifiestheprocessandcriteriatobeusedfortheperiodicappraisal.

• Determinewhetherthecriteriausedforreevaluationcomplywiththerequirementsofthissection,applicablelawsandregulationsandhospitalrules,andregulations.

• Determinewhetherthemedicalstaffhasasystemtoensurethatpractitionersseekapprovaltoexpandtheirprivilegesfortasks/activities/proceduresthatgobeyondthespecifiedlistofprivilegesfortheircategoryofpractitioner.

• Determinehowthemedicalstaffconductstheperiodicappraisalsofanycurrentmemberofthemedicalstaffwhohasnotprovidedpatientcareatthehospitalorwhohasnotprovidedcareforwhichhe/sheisprivilegedtopatientsatthehospitalduringtheappropriateevaluationtimeframes.Isthismethodinaccordancewithapplicablelawsandregulationsandthehospital’s/MedicalChamber’swrittencriteriaformedicalstaffmembershipandforgrantingprivileges?

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MS-3 The medical staff must examine credentials of candidates for medical staff membership and make recommendations to the governing body on the appointment of the candidates.

MS-3.1 There must be a mechanism established to examine credentials of individual prospective members (new appointments or reappointments) by the Hospital Director. The individual’s credentials to be examined must include at least:

MS-3.1.1 A request for clinical privileges; MS-3.1.2 Evidence of current licensure; MS-3.1.3 Evidence of training and professional education; MS-3.1.4 Documented experience; and MS-3.1.5 Supporting references of competence.

MS-3.2 The medical staff may not make its recommendation solely on the basis of the presence or absence of board certification, but must consider all of the elements above. However, this does not mean that the medical staff is prohibited from requiring in its laws board certification when considering a MD for medical staff membership or privileges; only that such certification may not be the only factor that the medical staff considers.

MS-3.3 The medical staff makes recommendations to the governing body for each candidate for medical staff membership/privileges that are specific to the type of appointment and extent of the individual practitioner’s specific clinical privileges, and then the governing body takes final appropriate action.

MS-3.4 A separate credentials file must be maintained for each individual medical staff member or applicant. The hospital must ensure that the practitioner and appropriate hospital patient care areas/departments are informed of the privileges granted to the practitioner.

Surveyor Guidance: • Determinewhetherthemedicalstaffdocumentationidentifiestheprocessandcriteriatobeusedfortheevaluationofcandidatesformedicalstaffmembership/privileges.

• Determinewhetherthecriteriausedforevaluationcomplywiththerequirementsofthissection,applicablelawsandregulations,andhospitalrules,andregulations.

• Determinewhetherthemedicalstaffhasasystemtoensurethatpractitionersseekapprovaltoexpandtheirprivilegesfortasks/activities/proceduresthatgobeyondthespecifiedlistofprivilegesfortheircategoryofpractitioner.

MS-4 When telemedicine services are furnished to the hospital’s patients through an agreement with a distant-site hospital, the governing body of the hospital whose patients are receiving the telemedicine services may choose to have its medical staff rely upon the credentialing and privileging decisions made by the distant-site hospital when making recommendations on privileges for the individual distant-site physicians and practitioners providing such services, if the hospital’s governing body ensures, through its written agreement with the distant-site hospital, that all of the following provisions are met:

MS-4.1 The individual distant-site physician or practitioner is privileged at the distant-site hospital providing the telemedicine services, which provides a current list of the distant-site physician’s or practitioner’s privileges at the distant-site hospital.

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MSMS-4.2 The individual distant-site physician or practitioner holds a license issued or recognized by the applicable laws and regulations in which the hospital whose patients are receiving the telemedicine services is located.

MS-4.3 With respect to a distant-site physician or practitioner, who holds current privileges at the hospital whose patients are receiving the telemedicine services, the hospital has evidence of an internal review of the distant-site physician’s or practitioner’s performance of these privileges and sends the distant-site hospital such performance information for use in the periodic appraisal of the distant-site physician or practitioner. At a minimum, this information must include all adverse events that result from the telemedicine services provided by the distant-site physician or practitioner to the hospital’s patients and all complaints the hospital has received about the distant-site physician or practitioner.

MS-4.4 The hospital’s governing body has the option, when considering granting privileges to telemedicine physicians and practitioners, to have the hospital’s medical staff rely upon the credentialing and privileging decisions of the distant-site hospital for these physicians and practitioners.

MS-4.5 In order to exercise this alternative credentialing and privileging option, the hospital’s governing body must ensure through its written agreement with the distant-site hospital that all of the following requirements are met:

MS-4.5.1 The distant-site hospital provides to the hospital a list of all its physicians and practitioners covered by the agreement, including their privileges at the distant-site hospital. The list may not include any physician or practitioner who does not hold privileges at the distant-site hospital. The list must be current, so the agreement must address how the distant-site hospital will keep the list current;

MS-4.5.2 Each physician or practitioner who provides telemedicine services to the hospital’s patients under the agreement holds a license issued or recognized by the applicable laws and regulations where the hospital (not the distant-site hospital) is located. Applicable laws and regulations may have varying requirements as to whether they will recognize an out-of-locality license for purposes of practicing within their applicable laws and regulations, and they may also vary as to whether they establish different standards for telemedi-cine services. The licensure requirements governing applicable laws and regulations where the hospital whose patients are receiving the telemedi-cine services is located must be satisfied, whatever they may be;

MS-4.5.3 The hospital has evidence that it reviews the telemedicine services provided to its patients and provides feedback based on this review to the distant-site hospital for the latter’s use in its periodic appraisal of each physician and practi-tioner providing telemedicine services under the agreement. At a minimum, the hospital must review and send information to the distant-site hospital on all adverse events that result from a physician or practitioner’s provision of tel-emedicine services under the agreement and on all complaints it has received about a telemedicine physician or practitioner covered by the agreement.

Surveyor Guidance: • Ifthehospitalprovidestelemedicineservicestoitspatientsunderanagreementwithadistant-sitehospital,askwhetherthehospital'sgoverningbodyhasexercisedtheoptiontohavethemedicalstaffrelyuponthecredentialingandprivilegingdecisionsofthedistant-sitehospitalinmakingprivilegingrecommendationsontelemedicinephysiciansandpractitioners.Ifyes,asktosee:

- Thewrittenagreementwiththedistant-sitehospital.Doestheagreementaddresstherequiredelementsconcerningthedistant-sitehospital’slicensureoftelemedicine

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physiciansandpractitioners,currentlistoftelemedicinephysiciansandpractitionerswithprivileges,andreviewbythehospitalofthetelemedicinephysicians’andpractitioners’servicesandprovisionofinformationbasedonitsreviewtothedistant-sitehospital?

- Thelistprovidedbythedistant-sitehospitalofthetelemedicinephysiciansandpractitioners,includingtheircurrentprivilegesandpertinentlicensureinformation.

• Evidencethatthehospitalreviewstheservicesprovidedbythetelemedicinephysi-ciansandpractitioners,includinganyadverseeventsandcomplaints,andprovidesfeedbacktothedistant-sitehospital.

MS-5 Medical Staff Organization and Accountability

MS-5.1 The medical staff must be well organized and accountable to the governing body for the quality of the medical care provided to the patients. The medical staff must be organized in a manner approved by the governing body. The responsibil-ity for organization and conduct of the medical staff must be assigned to the Hospital Director.

MS-5.2 The medical staff must be accountable to the hospital’s governing body for the quality of medical care provided to the patients. The organization of the medical staff must comply with these requirements.

Surveyor Guidance: • Verifythatthemedicalstaffhasaformalizedorganizationalstructure,thatlinesoffunctionandresponsibilityaredelineatedbetweenthegoverningbodyandotherpartsoftheorganization,andthatthegoverningbodyhassanctioneditsapprovalontheorganizationalstructureandrelationships.

• Ifthereisanactiveexecutivecommittee,verifythatamajorityofthemembersaredoctorsofmedicine.

• Verifythatanindividualdoctorofmedicineisresponsiblefortheconductandorgani-zationofthemedicalstaffthroughreviewoftheorganizationalstructureandinter-viewswithmembersofthemedicalstaff.

MS-6 Describe the organization of the medical staff.

MS-6.1 Describe the qualifications to be met by a candidate in order for the medical staff to recommend that the candidate be appointed by the governing body.

MS-6.2 Documentation must describe the qualifications to be met by a candidate for medical staff membership/privileges in order for the medical staff to recom-mend the candidate be approved by the governing body. The documentation must describe the privileging process to be used in the hospital. The process articulated in the documentation must include criteria for determining the privileges that may be granted to individual practitioners and a procedure for applying the criteria to individual practitioners that considers:

MS-6.1.1 Individual character; MS-6.1.2 Individual competence; MS-6.1.3 Individual training; MS-6.1.4 Individual experience; and MS-6.1.5 Individual judgment.

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MS-6.3 Documentation laws must apply equally to all practitioners in each profes-sional category of practitioners. The medical staff then recommends indi-vidual candidates that meet those requirements to the governing body for appointment to the medical staff.

Surveyor Guidance: • Verifythattherearewrittencriteriaforappointmentstothemedicalstaffandgrant-ingofmedicalstaffprivileges.

• Verifythatgrantingofmedicalstaffmembershiporprivilegesisbaseduponanindividualpractitioner’smeetingthemedicalstaff’smembership/privilegingcriteria.

• Verifythatataminimum,criteriaforappointmenttothemedicalstaff/grantingofmedicalstaffprivilegesareindividualcharacter,competence,training,experience,andjudgment.

MS-6.4 The documentation must include a requirement that an updated examination of the patient, including any changes in the patient’s condition, be completed and documented within 24 hours after admission or registration, but prior to surgery or a procedure requiring anesthesia services, when the medical history and physical examination are completed within 30 days before admission or regis-tration. The updated examination of the patient, including any changes in the patient’s condition, must be completed and documented by a physician, an or maxillofacial surgeon, or other qualified licensed individual in accordance with applicable laws and regulations and hospital policy.

MS-6.5 Hospital Policy must include a requirement that when a medical history and physical examination has been completed within 30 days before admission or registration, an updated medical record entry must be completed and docu-mented in the patient’s medical record within 24 hours after admission or registration. A licensed practitioner who is credentialed and privileged by hospital’s policy to perform an H&P must conduct the examination. In all cases, the update must take place prior to surgery or a procedure requiring anesthesia services. The update note must document an examination for any changes in the patient’s condition since the patient’s H&P was performed that might be significant for the planned course of treatment. The physician or qualified licensed individual uses his/her clinical judgment, based upon his/her assess-ment of the patient’s condition and co-morbidities, if any, in relation to the patient’s planned course of treatment to decide the extent of the update assessment needed as well as the information to be included in the update note in the patient’s medical record.

MS-6.6 If, upon examination, the licensed practitioner finds no change in the patient’s condition since the H&P was completed, he/she may indicate in the patient’s medical record that the H&P was reviewed, the patient was examined, and that “no change” has occurred in the patient’s condition since the H&P was completed. Any changes in the patient’s condition must be documented by the practitioner in the update note and placed in the patient’s medical record within 24 hours of admission or registration, but prior to surgery or a proce-dure requirement anesthesia services. Additionally, if the practitioner finds that the H&P done before admission is incomplete, inaccurate, or otherwise unacceptable, the practitioner reviewing the H&P, examining the patient, and completing the update may disregard the existing H&P, and conduct and document in the medical record a new H&P within 24 hours after admission or registration, but prior to surgery or a procedure requiring anesthesia.

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Surveyor Guidance: • Reviewthemedicalstaffdocumentationtodeterminewhethertheyincludeprovisionsrequiringthat,whenthemedicalhistoryandphysicalexaminationwascompletedwithin30daysbeforeadmissionorregistration,anupdatedmedicalrecordentrydocu-mentinganexaminationforchangesinthepatient'sconditionwascompletedanddocu-mentedinthepatient'smedicalrecordwithin24hoursafteradmissionorregistration.

• Determinewhetherthedocumentationrequiresthat,inallcasesinvolvingsurgeryoraprocedurerequiringanesthesiaservices,theupdatetotheH&Pmustbecompletedanddocumentedpriortothesurgeryorprocedure.

• Inthesampleofmedicalrecordsselectedforreview,lookforcaseswherethemedicalhistoryandphysicalexaminationwascompletedwithin30daysbeforeadmissionorregistration.Verifythatanupdatedmedicalrecordentrydocumentinganexamina-tionforanychangesinthepatient'sconditionwascompletedanddocumentedinthepatient'smedicalrecordwithin24hoursafteradmissionorregistration.Verifythatinallcasesinvolvingsurgeryoraprocedurerequiringanesthesiaservices,theupdatewascompletedanddocumentedpriortothesurgeryorprocedure.

MS-6.7 The medical staff must include criteria for determining the privileges to be granted to individual practitioners and a procedure for applying the criteria to individuals requesting privileges.

MS-6.8 All patient care is provided by or in accordance with the orders of a physician or practitioner who meets the hospital policy criteria and procedures for the privileges granted, who has been granted privileges in accordance with those criteria by the governing body, and who is working within the scope of those granted privileges.

Surveyor Guidance: • Verifythatthemedicalstaffdocumentationcontainscriteriaforgranting,withdraw-ing,andmodifyingclinicalprivilegestoindividualphysiciansandpractitionersofthemedicalstaffandthataprocedureexistsforapplyingthesecriteria.

• Inthecaseoftelemedicinephysiciansandpractitionersprovidingtelemedicineservicesunderanagreementwiththehospitalwherethehospital’sgoverningbodyhasoptedtohavethemedicalstaffrelyuponthecredentialingandprivilegingdeci-sionsofthedistant-sitehospitalortelemedicineentity,verifythatthebylawsincludeaprovisionpermittingsuchreliance.

• Verifythatphysiciansandpractitionerswhoprovidecaretopatientsareworkingwithinthescopeoftheprivilegesgrantedbythegoverningbody.

MS-7 Autopsies

MS-7.1 The medical staff should attempt to secure autopsies in all cases of unusual deaths and of medical-legal and educational interest. The mechanism for documenting permission to perform an autopsy must be defined. There must be a system for notifying the medical staff, and specifically the at-tending practitioner, when an autopsy is being performed.

Surveyor Guidance: • Verifythatthemedicalstaffhaspoliciesrequiringthepractitionerstoattempttosecurepermissiontoperformautopsies,thatthemechanismfordocumentingpermis-siontoperformanautopsyisdefined,andthatthereisasystemfornotifyingthemedi-calstaff,specificallytheattendingpractitioner,whenanautopsyisperformed.

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patient’s rights

Pr-1 A healthcare organization must protect and promote each patient’s rights.

Pr-2 The healthcare organization must display and ensure notice of patient rights are met.

Pr-3 Advance Directives: The healthcare organization must inform each patient, or when appropriate, the patient’s representative of the patient’s rights, in advance of furnishing or discontinuing patient care whenever possible.

Pr-3.1 The healthcare organization must inform each patient, or when appropriate, the patient’s representative as allowed by applicable laws and regulations, of the patient’s rights.

Interpretive Guidelines: • Wheneverpossible,thisnoticemustbeprovidedbeforeprovidingorstoppingcare. • Allpatients,inpatientoroutpatients,mustbeinformedoftheirrightsaspatients. • Thepatient’srightsshouldbeprovidedandexplainedinalanguageormannerthat

thepatientorthepatient’srepresentativecanunderstand. • Thehealthcareorganizationisexpectedtotakereasonablestepstodeterminethe

patient’swishesconcerningdesignationofarepresentativeunlessprohibitedbyapplicablelawsandregulations.

Pr-3.2 When a patient who is not incapacitated has designated, either orally to hospital staff or in writing, another individual to be his/her representative, the hospital must provide the designated individual with the required pa-tients’ rights notice in addition to the patient.

Interpretive Guidelines: • Theexplicitdesignationofarepresentativetakesprecedenceoveranynon-designatedrelationshipandcontinuesthroughoutthepatient’sinpatientstayoroutpatientvisit,unlessexpresslywithdrawn,eitherorallyorinwriting,bythepatient.

Pr-3.3 In the case of a patient who is incapacitated, when an individual presents to the hospital with an advance directive, medical power of attorney or similar document executed by the patient and designating an individual to make medical decisions for the patient when incapacitated, then the hospital must, when presented with the document, provide the required notice of its policies to the designated representative.

Interpretive Guidelines: • Theexplicitdesignationofarepresentativetakesprecedenceoveranynon-designatedrelationshipandcontinuesthroughoutthepatient’sinpatientstayoroutpatient’svisit,unlessthepatientceasestobeincapacitatedandexpresslywithdrawsthedesignation,eitherorallyorinwriting.

Pr-3.4 When a patient is incapacitated or otherwise unable to communicate his or her wishes, there is no written advance directive on file or presented, and an indi-vidual asserts that he or she is the patient’s spouse, domestic partner (whether or not formally established and including same-sex domestic partner), patient (including someone who has stood in loco parentis for the patient who is a minor child), or other family member and thus is the patient’s representative, the hospital is expected to accept this patient’s transfer to an appropriate facility and to provide the necessary medical information along with the patient.

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Pr-3.5 Advance Directives Compliance: The patient has the right to formulate advance directives and to have the organization’s staff and practitioners who provide care in the healthcare organization comply with these directives.

Interpretive Guidelines: • Anadvancedirectiveisdefinedasa‘writteninstruction’,suchasalivingwillordurablepowerofattorneyforhealthcarerecognizedbyapplicablelawsandregula-tions,relatingtotheprovisionofhealthcarewhentheindividualisincapacitated.

• Thepatienthastherighttoformulateadvancedirectives,andtohavehospitalstaffimplementandcomplywiththeiradvancedirective.

Pr-3.6 In the advance directive, the patient may provide guidance as to his/her wishes concerning provision of care in certain situations; alternatively the patient may delegate decision-making authority to another individual, as permitted by applicable laws and regulations.

Pr-4 Patient Grievance: The hospital must establish a process for prompt resolution of patient grievances and must inform each patient whom to contact to file a grievance.

Pr-4.1 The patient should have reasonable expectations of care and services and the healthcare organization should address those expectations in a timely, reasonable, and consistent manner. The hospital must inform the patient and/or the patient’s representative of the internal grievance process, includ-ing whom to contact to file a grievance (complaint).

PR-4.1.1 As part of its notification of patient rights, the hospital must provide the patient or the patient’s representative a phone number and address for lodging a grievance with the Ministry of Health or Medical Chamber.

PR-4.1.2 The healthcare organization must inform the patient that he/she may lodge a grievance with local authority, regardless of whether he/she has first used the healthcare organization’s grievance process.

Pr-4.2 A ‘patient grievance’ is a formal or informal written or verbal complaint that is made to the hospital by a patient, or the patient’s representative, regarding the patient’s care when the complaint is not resolved at the time of the complaint by staff present, abuse or neglect, issues related to the healthcare organizations compliance with the applicable laws and regulations, Ministry of Health or Medical Chamber.

Pr-4.3 If a patient care complaint cannot be resolved at the time of the complaint by staff present, is postponed for later resolution, is referred to other staff or later resolution, requires investigation, and/or requires further actions for resolution, then the complaint is a grievance for the purposes of these re-quirements. A complaint is considered resolved when the patient is satisfied with the actions taken on their behalf.

Pr-4.4 Billing issues are not usually considered grievances for the purposes of these requirements.

Pr-4.5 A written complaint is always considered a grievance. This includes written complaints from an inpatient, an outpatient, a released/discharge patient, or a patient’s representative regarding the patient care provided, abuse or neglect, or the hospital’s compliance with applicable laws and regulations. For the purposes of this requirement, an email or fax is considered ‘written’.

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Pr-4.6 Information obtained from patient satisfaction surveys usually does not meet the definition of a grievance.

Interpretive Guidelines: • Ifanidentifiedpatientwritesorattachesawrittencomplaintonthesurveyandrequestsresolution,thenthecomplaintmeetsthedefinitionofagrievance.

• Ifanidentifiedpatientwritesorattachesacomplainttothesurveybuthasnotrequestedresolution;thehealthcareorganizationmusttreatthisasagrievanceifthehealthcareorganizationwouldusuallytreatsuchacomplaintasagrievance.

• Patientcomplaintsthatareconsideredgrievancesalsoincludesituationswhereapatientorapatient’srepresentativetelephonesthehealthcareorganizationwithacomplaintregardingthepatient’scareorwithanallegationofabuseorneglect,orfailureofthehealthcareorganizationtocomplywithapplicablelawsandregulations,MinistryofHealthorMedicalChamberrequirements.

• Thosepost-healthcareorganizationverbalcommunicationsregardingpatientcarethatwouldroutinelyhavebeenhandledbystaffpresentifthecommunicationhadoccurredduringthestay/visitarenotrequiredtobedefinedasagrievance.

• Allverbalorwrittencomplaintsregardingabuse,neglect,patientharm,orhealthcareorganizationcompliancewithapplicablelawsandregulations,MinistryofHealthandMedicalChamberareconsideredagrievanceandalltherequirementsapply.

• Wheneverthepatientorthepatient’srepresentativerequeststhathisorhercomplaintbehandledasaformalcomplaintorgrievanceorwhenthepatientrequestsaresponsefromthehealthcareorganization,thecomplaintisconsideredagrievanceandalltherequirementsapply.

• Datacollectedregardingpatientgrievances,aswellasothercomplaintsthatarenotdefinedasgrievances(asdeterminedbythehealthcareorganization),mustbeincor-poratedintheorganization’sQualityManagementSystem.

Pr-5 Grievance Review: The governing body must approve and be responsible for the effective operation of the grievance process, and must review and resolve griev-ances, unless it delegates the responsibility in writing to a grievance committee.

Pr-5.1 The healthcare organization’s grievance process must be approved by the governing body. The organization’s governing body is responsible for the effective operation of the grievance process.

PR-5.1.1 This includes the organizations compliance with all of the applicable laws and regulations, Ministry of Health and Medical Chamber requirements.

PR-5.1.2 The organization’s governing body must review and resolve grievances, unless it delegates this responsibility in writing to a grievance committee. A commit-tee is more than one person.

PR-5.1.3 The committee membership should have adequate numbers of qualified members to review and resolve the grievances the organization receives in a manner that complies with applicable laws and regulations.

Pr-6 Utilization and Quality Control: The grievance process must include a mecha-nism for timely referral of patient concerns regarding quality of care or prema-ture discharge to the appropriate Utilization and Quality Management system.

Pr-7 Grievance Submission: The healthcare organization must establish a clearly defined procedure for the submission of a patient’s written or verbal griev-ance to the healthcare organization.

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PRInterpretive Guidelines: • Theorganization’sprocedureforapatientorthepatient’srepresentativetosubmit

writtenorverbalgrievancesmustbeclearlyexplained.Thepatientorpatient’srepresentativeshouldbeabletoclearlyunderstandtheprocedure.

Pr-8 Grievance Timeframe: The grievance process must specify time frames for review of the grievance and the provision of a response.

Pr-8.1 The organization must review, investigate, and resolve each patient’s grievance within a reasonable time frame.

Interpretive Guidelines: • Documentwhenagrievanceissocomplicatedthatitmayrequireanextensiveinvestigation.Onaverage,atimeframeof7daysfortheprovisionofawrittenresponsewouldbeconsideredappropriate.

• Ifthegrievancewillnotberesolved,oriftheinvestigationisnotorwillnotbecom-pletedwithin7days,theorganizationshouldinformthepatientorthepatient’srepresentativethattheorganizationisstillworkingtoresolvethegrievanceandthattheorganizationwillfollow-upwithawrittenresponsewithinastatednumberofdaysinaccordancewiththeorganization’sgrievancepolicy.

• Theorganizationmustattempttoresolveallgrievancesassoonaspossible.

Pr-9 Grievance Resolution Notice

Pr-9.1 In the resolution of the grievance, the hospital must provide the patient with a written notice of its decision that contains;

PR-9.1.1 Healthcare organization contact person PR-9.1.2 Steps taken on behalf of patient to investigate the grievance PR-9.1.3 Results of the grievance process PR-9.1.4 Date of Completion

Pr-9.2 The written notice of the organization’s determination regarding the grievance must be communicated to the patent or the patient’s representative in a lan-guage and manner the patient or the patient’s legal representative understands.

Pr-10 Plan of Care: The patient has the right to participate in the development and implementation of his or her plan of care.

Interpretive Guidelines: • Thepatient’srightsincludebeinginformedofhisorherhealthstatus,beinginvolvedincareplanningandtreatment,andbeingabletorequestorrefusetreatment.

• Thisrightmustnotbeconstruedasamechanismtodemandtheprovisionoftreatmentorservicesdeemedmedicallyunnecessaryorinappropriate.

• Thisstandardrequirestheorganizationtoplanthepatient’scare,withpatientpartici-pationtomeetthepatient’spsychologicalandmedicalneeds.

• Thepatient’s(orpatient’srepresentatives,asallowedbyapplicablelawsandregula-tions)righttoparticipateinthedevelopmentandimplementationofhisorherplanofcareincludes,ataminimum,therighttoparticipateinthedevelopmentandimple-mentationofhis/herinpatienttreatment/careplan,outpatienttreatment/careplan,participateinthedevelopmentandimplementationofhis/herdischargeplan,andparticipateinthedevelopmentandimplementationofhis/herpainmanagementplan.

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PRPr-11 Family Member Notification: The patient has the right to have a family member or representative of his or her choice and his or her own physician notified promptly of his or her admission to a healthcare organization.

Pr-11.1 For every inpatient admission, the organization must ask the patient wheth-er the organization should notify a family member or representative about the admission. If the patient requests such notice and identifies the family member or representative to be notified the hospital must provide such notice promptly to the designated individual.

Pr-11.2 The explicit designation of a family member or representative by the patient takes precedence over any non-designated relationship.

Pr-11.3 The organization must also ask the patient whether the organization should notify his/her own physician. In the case of scheduled admissions, the patient’s own physician likely is already aware of the admission. However, if the patient requests notice to and identifies the physician, the hospital must provide such notice promptly to the designated physician, regardless of whether the admission was scheduled in advance or emergent.

Pr-12 Right to Personal Privacy: The patient has the right to personal privacy.

Pr-12.1 The patient has a basic right to respect, dignity, and comfort. “The right to personal privacy” includes at a minimum, that patients have privacy during personal hygiene activities, during medical/nursing treatments, and when requested as appropriate.

Pr-12.2 The right to personal privacy would also include limiting the release or disclosure of patient information such as the patient’s presence in the facility or location in the hospital, or personal information such as name, age, address, income, health information without prior consent from the patient.

Pr-13 Safety: The patient has the right to receive care in a safe setting.

Pr-13.1 Each patient should receive care in an environment that a reasonable person would consider to be safe.

Pr-13.2 The hospital must protect vulnerable patients, including newborns and children.

Pr-13.3 Additionally, this standard is intended to provide protection for the patient’s emotional health and safety as well as his/her physical safety.

Pr-13.4 Respect, dignity and comfort would be components of an emotionally safe environment.

Pr-14 Abuse, Harassment and Mobbing: The patient has the right to be free from all forms of abuse, harassment and mobbing.

Pr-14.1 This standard is to prohibit all forms of abuse, neglect, harassment and mobbing whether from staff, other patients or visitors.

Pr-14.2 The hospital must ensure that patients are free from all forms of abuse, neglect, harassment or mobbing.

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Pr-14.3 The hospital must have mechanisms/methods in place that ensure patients are free of all forms of abuse, neglect harassment and mobbing.

Pr-15 Confidentiality of Patient Records: The healthcare organization must ensure the confidentiality of patient records requirements are met.

Pr-15.1 The organization has sufficient safeguards to ensure that access to all information regarding patients is limited to those individuals designated by law, regulation, and policy; or duly authorized as having a need to know.

Interpretive Guidelines: • Nounauthorizedaccessordisseminationofclinicalrecordsispermitted. • Clinicalrecordsarekeptsecureandareonlyviewedwhennecessarybythosepersons

whohaveapartinthepatient’scare.

Pr-15.2 The right to confidentiality means safeguarding the content of information, including patient paper records, video, audio, and/or computer stored infor-mation from unauthorized disclosure without the informed consent of the individual, parent of a minor child, or legal guardian.

Pr-15.3 Hospital staff and consultants, hired to provide services to the individual, should have access to only that portion of information that is necessary to provide effective responsive services to that individual.

Pr-15.4 Confidentiality applies to both central records and clinical record information that may be kept at other locations in the organization, such as patient units, radiology, laboratories, patient clinics, record storage area, and data systems.

Pr-16 Restraint and/or Seclusion: All patients have the right to be free from physical or mental abuse, and corporal punishment. All patients have the right to be free from restraint or seclusion, of any form, imposed as a means of coercion, discipline, convenience, or retaliation by staff. Restraint or seclusion may only be imposed to ensure the immediate physical safety of the patient, a staff member, or others and must be discontinued at the earliest possible time.

Pr-16.1 The patient protections contained in this standard apply to all hospital patients when the use of restraint or seclusion becomes necessary, regard-less of patient location. The requirements contained in this standard are not specific to any treatment setting within the hospital. They are not targeted only to patients on psychiatric units or those with behavioral/mental health care needs. Instead, the requirements are specific to the patient behavior that the restraint or seclusion intervention is being used to address. In summary, these restraint and seclusion regulations apply to:

Interpretive Guidelines: • Allhospitals(acutecare,long-termcare,psychiatric,children's,andcancer); • Alllocationswithinthehospital(includingmedical/surgicalunits,criticalcareunits,

forensicunits,emergencydepartment,psychiatricunits,etc.);and • Allhospitalpatients,regardlessofage,whoarerestrainedorsecluded(includingboth

inpatientsandoutpatients).

Pr-16.2 The decision to use a restraint or seclusion is not driven by diagnosis, but by a comprehensive individual patient assessment. For a given patient at a

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particular point in time, this comprehensive individualized patient assess-ment is used to determine whether the use of less restrictive measures poses a greater risk than the risk of using a restraint or seclusion.

Interpretive Guidelines: • Thecomprehensiveassessmentshouldincludeaphysicalassessmenttoidentifymedicalproblemsthatmaybecausingbehaviorchangesinthepatient.Forexample,temperatureelevations,hypoxia,hypoglycemia,electrolyteimbalances,druginterac-tions,anddrugsideeffectsmaycauseconfusion,agitation,andcombativebehaviors.

• Addressingthesemedicalissuesmayeliminateorminimizetheneedfortheuseofrestraintsorseclusion.

• Staffmustassessandmonitorapatient’sconditiononanongoingbasistoensurethatthepatientisreleasedfromrestraintorseclusionattheearliestpossibletime.

• Restraintorseclusionmayonlybeemployedwhiletheunsafesituationcontinues. • Oncetheunsafesituationends,theuseofrestraintorseclusionshouldbediscontinued.

Pr-16.3 Hospital leadership is responsible for creating a culture that supports a patient’s right to be free from restraint or seclusion. Through their Quality Management System , hospital leadership should:

Interpretive Guidelines: • Assessandmonitortheuseofrestraintorseclusionintheirfacility; • Implementactionstoensurethatrestraintorseclusionisusedonlytoensurethe

physicalsafetyofthepatient,staffandothers;and • Ensurethatthehospitalcomplieswiththerequirementssetforthinthisstandardas

wellasthosesetforthapplicablelawsandregulationswhentheuseofrestraintorseclusionisnecessary.

Pr-16.4 An individualized patient assessment is critical. In this example, an assess-ment should minimally address the following questions:

PR-16.4.1 Are there safety interventions or precautions (other than restraint) that can be taken to reduce the risk of the patient slipping, tripping, or falling if the patient gets out of bed?

PR-16.4.2 Is there a way to enable the patient to safely ambulate? PR-16.4.3 Is there some assistive device that will improve the patient’s ability to self-

ambulate? PR-16.4.4 Is a medication or a reversible condition causing the unsteady gait? Would the

patient be content to walk with a staff person? PR-16.4.5 Could the patient be brought closer to the nurse’s station where he or she

could be supervised?

Pr-16.5 Patient care staff must demonstrate through their documentation in the patient’s medical record that the restraint intervention used is the least restrictive intervention that protects the patient’s safety, and that the use of restraint is based on individual assessments of the patient.

Interpretive Guidelines: • Theassessmentsanddocumentationofthoseassessmentsmustbeongoinginordertodemonstrateacontinuedneedforrestraint.

Surveyor Guidance: • Reviewhospitalrestraintandseclusionpoliciesandprocedurestodetermineiftheyaddress,ataminimum,whohastheauthoritytodiscontinuetheuseofrestraintorseclusion(basedonapplicablelawsandregulations).

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PR • Reviewasampleofmedicalrecordsofpatientsforwhomrestraintswereusedtomanagenon-violent,non-self-destructivebehavior,aswellasasampleofmedicalrecordsofpatientsforwhomrestraintorseclusionwasusedtomanageviolentorself-destructivebehavior;

• Includeinthereviewpatientswhoarecurrentlyinrestraintorseclusion,aswellasthosewhohavebeeninrestraintorseclusionduringtheirhospitalstay(includebothviolentorself-destructivepatientsaswellasnon-violent,non-self-destructivepatients).

• Whatevidenceistherethathospitalstaffidentifiedthereasonfortherestraintorseclusion,anddeterminedthatotherlessrestrictivemeasureswouldnotbeeffectivebeforeapplyingtherestraint?

• Interviewstaffthatworkdirectlywithpatientstodeterminetheirunderstandingoftherestraintandseclusionpolicies.Ifanypatientsarecurrentlyinrestraintorseclusion,ascertaintherationaleforuseandwhenthepatientwaslastmonitoredandassessed.

• Istheactualuseofrestraintsorseclusionconsistentwithhospitalrestraintandseclusionpoliciesandprocedures?

• Obtaindataontheuseofrestraintandseclusionforaspecifiedtimeperiod(e.g.,3months)todetermineanypatternsintheiruseforspecificunits,shifts,daysoftheweek,etc.

Pr-16.6 Restraint - Any manual method, physical or mechanical device, material, or equip-ment that immobilizes or reduces the ability of a patient to move his or her arms, legs, body, or head freely. This restraint definition applies to all uses of restraint in all hospital care settings. Under this definition, commonly used hospital devices and other practices could meet the definition of a restraint, such as:

PR-16.6.1 Tucking a patient’s sheets in so tightly that the patient cannot move; PR-16.6.2 Use of a “net bed” or an “enclosed bed” that prevents the patient from freely

exiting the bed. EXCEPTION: Placement of a toddler in an “enclosed” or “domed” crib;

PR-16.6.3 Use of “Freedom” splints that immobilize a patient’s limb; PR-16.6.4 Using side rails to prevent a patient from voluntarily getting out of bed; or PR-16.6.5 Geri chairs or recliners, only if the patient cannot easily remove the restraint

appliance and get out of the chair on his or her own.

Pr-16.7 Generally, if a patient can easily remove a device, the device would not be considered a restraint. In this context, easily remove means that the manual method, device, material, or equipment can be removed intentionally by the patient in the same manner as it was applied by the staff (e.g., side rails are put down, not climbed over; buckles are intentionally unbuckled; ties or knots are intentionally untied; etc.) considering the patient’s physical condition and ability to accomplish objective (e.g., transfer to a chair, get to the bathroom in time).

Surveyor Guidance: • Determinewhetherthehospital’spolicyandproceduresemployadefinitionordescriptionofwhatconstitutesarestraintthatisconsistentwiththeregulation.

• Whiletouringhospitalunitslookforrestraintsinuse.Wherearestraintisinuse,checkthemedicalrecordforappropriatedocumentation.

• Interviewhospitalstafftodeterminewhethertheyknowthedefinitionofarestraint.

Pr-16.8 A restraint is a drug or medication when it is used as a restriction to manage the patient’s behavior or restrict the patient’s freedom of movement and is not a standard treatment or dosage for the patient’s condition.

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PRInterpretive Guidelines: • Drugsormedicationsthatareusedaspartofapatient'sstandardmedicalorpsychi-

atrictreatment,andareadministeredwithinthestandarddosageforthepatient’scondition,wouldnotbesubjecttotherequirementsofthestandard.

• Theseregulationsarenotintendedtointerferewiththeclinicaltreatmentofpatientswhoaresufferingfromseriousmentalillnessandwhoneedtherapeuticdosesofmedicationtoimprovetheirleveloffunctioningsothattheycanmoreactivelypartici-pateintheirtreatment.

• Similarly,theseregulationsarenotintendedtointerferewithappropriatedosesofsleepingmedicationprescribedforpatientswithinsomnia,anti-anxietymedicationprescribedtocalmapatientwhoisanxious,oranalgesicsprescribedforpainman-agement.

• Theregulatorylanguageisintendedtoprovideflexibilityandrecognizethevariationsinpatientconditions.

• WhetherornotanorderforadrugormedicationisPRN(Latinabbreviationforprorenata-asneeded;ascircumstancesrequire)orastandingorderdoesnotdeterminewhetherornottheuseofthatdrugormedicationisconsideredarestraint.

• TheuseofPRNorstandingorderdrugsormedicationsisonlyprohibitedifthedrugormedicationmeetsthedefinitionofadrugormedicationusedasarestraint.

Pr-16.9 Criteria used to determine whether the use of a drug or medication, or combination of drugs or medications is a standard treatment or dosage for the patient’s condition includes all of the following:

PR-16.9.1 The drug or medication is used within the pharmaceutical parameters ap-proved by the manufacturer for the indications that it is manufactured and labeled to address, including listed dosage parameters;

PR-16.9.2 The use of the drug or medication to treat a specific patient’s clinical condi-tion is based on that patient’s symptoms, overall clinical situation, and on the knowledge of that patient’s expected and actual response to the medication.

Pr-16.10 As with any use of restraint or seclusion, staff must conduct a comprehen-sive patient assessment to determine the need for other types of interven-tions before using a drug or medication as a restraint. For example, a patient may be agitated due to pain, an adverse reaction to an existing drug or medication, or other unmet care need or concern.

Surveyor Guidance: • Determinewhetherthehospital’spoliciesandproceduresemployadefinitionordescriptionofwhatconstitutestheuseofdrugsormedicationsasarestraintthatisconsistentwiththeregulation.

• Interviewhospitalstafftodeterminewhethertheycanidentifywhentheuseofadrugormedicationisconsideredachemicalrestraint.

Pr-16.11 A restraint does not include devices, such as orthopedically prescribed devices, surgical dressings or bandages, protective helmets, or other meth-ods that involve the physical holding of a patient for the purpose of con-ducting routine physical examinations or tests, or to protect the patient from falling out of bed, or to permit the patient to participate in activities without the risk of physical harm (this does not include a physical escort). The devices and methods listed here would not be considered restraints, and, therefore, not subject to these requirements. These devices and meth-ods are typically used in medical-surgical care.

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PRInterpretive Guidelines: • UseofanIVarmboardtostabilizeanIVlineisgenerallynotconsideredarestraint.

However,ifthearmboardistieddown(orotherwiseattachedtothebed),ortheentirelimbisimmobilizedsuchthatthepatientcannotaccesshisorherbody,theuseofthearmboardwouldbeconsideredarestraint.

• Amechanicalsupportusedtoachieveproperbodyposition,balance,oralignmentsoastoallowgreaterfreedomofmobilitythanwouldbepossiblewithouttheuseofsuchame-chanicalsupportisnotconsideredarestraint.Forexample,somepatientslacktheabilitytowalkwithouttheuseoflegbraces,ortosituprightwithoutneck,head,orbackbraces.

• Amedicallynecessarypositioningorsecuringdeviceusedtomaintaintheposition,limitmobility,ortemporarilyimmobilizethepatientduringmedical,dental,diagnos-tic,orsurgicalproceduresisnotconsideredarestraint.Recoveryfromanesthesiathatoccurswhenthepatientisinacriticalcareorpost-anesthesiacareunitisconsideredpartofthesurgicalprocedure;therefore,medicallynecessaryrestraintuseinthissettingwouldnotneedtomeettherequirementsoftheregulation.However,iftheinterventionismaintainedwhenthepatientistransferredtoanotherunit,orrecoversfromtheeffectsoftheanesthesia(whicheveroccursfirst),arestraintorderwouldbenecessaryandtherequirementsofthestandardwouldapply.

• Manytypesofhandmittswouldnotbeconsideredrestraint.However,pinningorotherwiseattachingthosesamemittstobeddingorusingawristrestraintinconjunctionwiththehandmittswouldmeetthedefinitionofrestraintandtherequirementswouldapply.Inaddition,ifthemittsareappliedsotightlythatthepatient'shandorfingersareimmobilized,thiswouldbeconsideredrestraintandtherequirementswouldapply.Likewise,ifthemittsaresobulkythatthepatient’sabilitytousetheirhandsissignifi-cantlyreduced,thiswouldbeconsideredrestraintandtherequirementswouldapply.

• Inaddition,ifapatientcaneasilyremoveadevice,thedevicewouldnotbeconsid-eredarestraint.Inthiscontext,easilyremove"meansthatthemanualmethod,device,material,orequipmentcanberemovedintentionallybythepatientinthesamemannerasitwasappliedbythestaff(e.g.,siderailsareputdown,notclimbedover;bucklesareintentionallyunbuckled;tiesorknotsareintentionallyuntied;etc.)consideringthepatient’sphysicalconditionandabilitytoaccomplishtheobjective(e.g.,transfertoachair,gettothebathroomintime).

• Ageordevelopmentallyappropriateprotectivesafetyinterventions(suchasstrollersafetybelts,swingsafetybelts,highchairlapbelts,raisedcribrails,andcribcovers)thatasafety-consciouschildcareprovideroutsideahealthcaresettingwouldutilizetoprotectaninfant,toddler,orpreschool-agedchildwouldnotbeconsideredrestraintorseclusionforthepurposesofthisregulation.Theuseofthesesafetyinterventionsneedstobeaddressedinthehospital’spoliciesorprocedures.

• PhysicalEscort:Aphysicalescortwouldincludealight‖grasptoescortthepatienttoadesiredlocation.Ifthepatientcaneasilyremoveorescapethegrasp,thiswouldnotbeconsideredphysicalrestraint.However,ifthepatientcannoteasilyremoveorescapethegrasp,thiswouldbeconsideredphysicalrestraintandalltherequirementswouldapply.

• Physicalholding:Theregulationpermitsthephysicalholdingofapatientforthepurposeofconductingroutinephysicalexaminationsortests.However,patientsdohavetherighttorefusetreatment.Thisincludestherighttorefusephysicalexamina-tionsortests.Holdingapatientinamannerthatrestrictsthepatient’smovementagainstthepatient’swillisconsideredrestraint.Thisincludesholdsthatsomemem-berofthemedicalcommunitymayterm“therapeuticholds.”Manydeathshaveoccurredwhileemployingthesepractices.Physicallyholdingapatientcanbejustasrestrictive,andjustasdangerous,asrestrainingmethodsthatinvolvedevices.Physicallyholdingapatientduringaforcedpsychotropicmedicationprocedureisconsideredarestraintandisnotincludedinthisexception.

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PR • Forthepurposeofthisregulation,astaffmemberpickingup,redirecting,orholdinganinfant,toddler,orpreschool-agedchildtocomfortthepatientisnotconsideredrestraint.

Pr-16.12 Side rails: A restraint does not include methods that protect the patient from falling out of bed. Examples include raising the side rails when a patient is: on a stretcher, recovering from anesthesia, sedated, experiencing involuntary movement, or on certain types of therapeutic beds to prevent the patient from falling out of the bed. The use of side rails in these situations protects the patient from falling out of bed and, therefore, would not be subject to the requirements of the standard.

Interpretive Guidelines: • However,siderailsarefrequentlynotusedasamethodtopreventthepatientfromfallingoutofbed,butinstead,usedtorestrictthepatient’sfreedomtoexitthebed.Theuseofsiderailstopreventthepatientfromexitingthebedwouldbeconsideredarestraintandwouldbesubjecttotherequirementsofthestandard.Theuseofsiderailsisinherentlyrisky,particularlyifthepatientiselderlyordisoriented.Frailelderlypatientsmaybeatriskforentrapmentbetweenthemattressorbedframeandthesiderail.Disorientedpatientsmayviewaraisedsiderailasabarriertoclimbover,mayslidebetweenraised,segmentedsiderails,ormayscoottotheendofthebedtogetaroundaraisedsiderailandexitthebed.Whenattemptingtoleavethebedbyanyoftheseroutes,thepatientisatriskforentrapment,entanglement,orfallingfromagreaterheightposedbytheraisedsiderail,withapossibilityforsustaininggreaterinjuryordeaththanifthepatienthadfallenfromtheheightofaloweredbedwithoutraisedsiderails.Inshort,thepatientmayhaveanincreasedriskforafallorotherinjurybyattemptingtoexitthebedwiththesiderailsraised.Theriskpresentedbysiderailuseshouldbeweighedagainsttheriskpresentedbythepatient’sbehaviorasascertainedthroughindividualizedassessment.

• Whentheclinicianraisesallfoursiderailsinordertorestrainapatient,definedinthisregulationasimmobilizingorreducingtheabilityofapatienttomovehisorherarms,legs,body,orheadfreelytoensuretheimmediatephysicalsafetyofthepatient,thentherequirementsofthisruleapply.Raisingfewerthanfoursiderailswhenthebedhassegmentedsiderailswouldnotnecessarilyimmobilizeorreducetheabilityofapatienttomovefreelyasdefinedintheregulation.Forexample,ifthesiderailsaresegmentedandallbutonesegmentareraisedtoallowthepatienttofreelyexitthebed,thesiderailisnotactingasarestraintandtherequirementsofthisrulewouldnotapply.Conversely,ifapatientisnotphysicallyabletogetoutofbedregardlessofwhetherthesiderailsareraisedornot,raisingallfoursiderailsforthispatientwouldnotbeconsideredrestraintbecausethesiderailshavenoimpactonthepatient’sfreedomofmovement.Inthisexample,theuseofallfoursiderailswouldnotbeconsideredrestraint.Therefore,therequirementsofthisrulewouldnotapply.

• Whenapatientisonabedthatconstantlymovestoimprovecirculationorpreventsskinbreakdown,raisedsiderailsareasafetyinterventiontopreventthepatientfromfallingoutofbedandarenotviewedasrestraint.Whenapatientisplacedonseizureprecau-tionsandallsiderailsareraised,theuseofsiderailswouldnotbeconsideredrestraint.Theuseofpaddedsiderailsinthissituationshouldprotectthepatientfromharm;includingfallingoutofbedshouldthepatienthaveaseizure.Placementinacribwithraisedrailsisanage-appropriatestandardsafetypracticeforeveryinfantortoddler.Therefore,placementofaninfantortoddlerinthecribwithraisedrailswouldnotbeconsideredrestraint.Ifthepatientisonastretcher(anarrow,elevated,andhighlymobilecartusedtotransportpatientsandtoevaluateortreatpatients),thereisanincreasedriskoffallingfromastretcherwithoutraisedsiderailsduetoitsnarrowwidthandmobility.Inaddition,becausestretchersareelevatedplatforms,theriskofpatient

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PRinjuryduetoafallissignificant.Therefore,theuseofraisedsiderailsonstretchersisnotconsideredrestraintbutaprudentsafetyintervention.Likewise,theuseofaseatbeltwhentransportingapatientinawheelchairisnotconsideredrestraint.

• Determinewhetherthehospital’spoliciesandproceduresemployadefinitionordescriptionofwhatconstitutesarestraintthatisconsistentwiththeregulation.

• Whiletouringhospitalunitslookforbedsiderailusetodeterminewhetheritisconsistentwiththedefinitionofarestraint.Wherebedsiderailsarebeingusedasarestraint,checkthemedicalrecordforappropriatedocumentation.

• Interviewhospitalstafftodeterminewhethertheyknowthedefinitionofarestraint,particularlywithrespecttouseofbedsiderails.

Pr-16.13 Seclusion is the involuntary confinement of a patient alone in a room or area from which the patient is physically prevented from leaving. Seclusion may only be used for the management of violent or self-destructive behavior.

Interpretive Guidelines: • Seclusionmayonlybeusedforthemanagementofviolentorself-destructivebehaviorthatjeopardizestheimmediatephysicalsafetyofthepatient,astaffmember,orothers.Seclusionisnotjustconfiningapatienttoanarea,butalsoinvoluntarilyconfiningthepatientaloneinaroomorareawherethepatientisphysicallypreventedfromleaving.Ifapatientisrestrictedtoaroomaloneandstaffarephysicallyinterveningtopreventthepatientfromleavingtheroomorgivingtheperceptionthatthreatensthepatientwithphysicalinterventionifthepatientattemptstoleavetheroom,theroomisconsideredlocked,whetherthedoorisactuallylockedornot.Inthissituation,thepatientisbeingsecluded.

• Apatientphysicallyrestrainedaloneinanunlockedroomdoesnotconstituteseclusion. • Confinementonalockedunitorwardwherethepatientiswithothersdoesnot

constituteseclusion. • Timeoutisnotconsideredseclusion.Timeoutisaninterventioninwhichthepatient

consentstobeingaloneinadesignatedareaforanagreedupontimeframefromwhichthepatientisnotphysicallypreventedfromleaving.Therefore,thepatientcanleavethedesignatedareawhenthepatientchooses.

• Determinewhetherthehospital’spolicyandproceduresemployadefinitionor descriptionofwhatconstitutesseclusionthatisconsistentwiththeregulation.

• Whiletouringhospitalunitslookforcaseswhereapatientisinseclusion. • Interviewhospitalstafftodeterminewhethertheyknowthedefinitionofseclusion. • Theuseofrestraintorseclusionmustbeimplementedinaccordancewithsafeand

appropriaterestraintandseclusiontechniquesasdeterminedbyhospitalpolicyinaccordancewithapplicablelawsandregulations.

• Theuseofrestraintorseclusionmustbeinaccordancewiththeorderofaphysicianwhoisresponsibleforthecareofthepatientandauthorizedtoorderrestraintorseclusionbyhospitalpolicyinaccordancewithapplicablelawsandregulations.

Surveyor Guidance: • Dophysician’sordersspecifythereasonforrestraintorseclusion,thetypeofre-straint,andthedurationofrestraintorseclusion?

• Doestheseverityofthebehaviorjustifyseclusionorrestraintusagebyidentifyinganimmediateandseriousdangertothephysicalsafetyofthepatientorothers?

• Isthereevidencethatthehospitalconsidersfactorsotherthantheindividualpatientindeterminingcausesfortheneedforrestraintsorseclusion(i.e.,environmentalfactors)?

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PR • Doesthemedicalrecordincludedocumentationofanindividualpatientassessmentandarevisionoftheplanofcare?

• Doesthemedicalrecordreflectchangesinbehaviorandstaffconcernsregardingsafetyriskstothepatient,staff,orotherspromptinguseofseclusionorrestraints?

• Didthepatient’sbehaviorplacethepatientorothersatriskforharm?Wasthepatient’sbehaviorviolentorself-destructive?

• Wereother,lessrestrictiveinterventionstriedanddocumented,oristhereevidencethatalternativeswereconsideredanddeterminedtobeinsufficient?

• Theregulationrequiresthataphysicianresponsibleforthecareofthepatienttoorderrestraintorseclusionpriortotheapplicationofrestraintorseclusion.Insomesitua-tions,however,theneedforarestraintorseclusioninterventionmayoccursoquicklythatanordercannotbeobtainedpriortotheapplicationoftherestraintorseclusion.Intheseemergencyapplicationsituations,theordermustbeobtainedeitherduringtheemergencyapplicationoftherestraintorseclusion,orimmediately(withinafewminutes)aftertherestraintorseclusionhasbeenapplied.Thefailuretoimmediatelyobtainanorderisviewedastheapplicationofrestraintorseclusionwithoutanorder.Thehospitalshouldaddressthisprocessinitsrestraintandseclusionpoliciesandprocedures.Thepoliciesandproceduresshouldspecifywhocaninitiatetheemergencyapplicationofrestraintorseclusionpriortoobtaininganorderfromaphysician.

Pr-16.14 Protocols: A protocol cannot serve as a substitute for obtaining a physician’s order prior to initiating each episode of restraint or seclusion use. If a hospital uses protocols that include the use of restraint or seclusion, a specific physi-cian order is still required for each episode of restraint or seclusion use. The philosophy that serves as a foundation for the regulation is that restraint or seclusion use is an exceptional event, not a routine response to a certain patient condition or behavior. Each patient must be assessed, and interven-tions should be tailored to meet the individual patient’s needs. The creation of a protocol can run counter to this philosophy if it sets up the expectation that restraint or seclusion will be used as a routine part of care. The use of restraint or seclusion is a last resort when less restrictive measures have been determined ineffective to ensure the safety of the patient, staff or others, should not be a standard response to a behavior or patient need.

Surveyor Guidance: • Reviewhospitalpoliciesandmedicalstaffregulationstoascertainclinicalpracticeguidelinesthatdescribetheresponsibilitiesofmedicalstaffandclinicianswhoareprivilegedtoorderrestraintandseclusion.

• Dothehospital’swrittenpoliciesconformtoapplicablelawsandregulations? • Doesthehospitalhaveestablishedpoliciesforthosewhocaninitiaterestraintor

seclusion? • Dothemedicalrecordsreviewedidentifythephysicianwhoorderedeachuseof

restraintorseclusion? • Duringthemedicalrecordreview,verifythataphysicianorderwasobtainedpriorto

theinitiationofrestraintorseclusion.Whenemergencyapplicationofrestraintorseclusionwasnecessary,verifythataphysicianororderwasobtainedimmediately(withinafewminutes)afterapplicationoftherestraintorseclusion.

Pr-16.15 Orders for the use of restraint or seclusion must never be written as a standing order or on an as needed basis (PRN).

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PRInterpretive Guidelines: • ThisregulationprohibitstheuseofstandingorPRN(Latinabbreviationforprorenata

-asneeded;ascircumstancesrequire)ordersfortheuseofrestraintorseclusion. • Theongoingauthorizationofrestraintorseclusionisnotpermitted.Eachepisodeof

restraintorseclusionmustbeinitiatedinaccordancewiththeorderofaphysician. • Ifapatientwasrecentlyreleasedfromrestraintorseclusion,andexhibitsbehaviorthat

canonlybehandledthroughthereapplicationofrestraintorseclusion,aneworderwouldberequired.

• Staffcannotdiscontinuearestraintorseclusionintervention,andthenre-startitunderthesameorder.ThiswouldconstituteaPRNorder.AtrialreleaseconstitutesaPRNuseofrestraintorseclusion,and,therefore,isnotpermittedbythisregulation.

• Whenastaffmemberendsanorderedrestraintorseclusionintervention,thestaffmemberhasnoauthoritytoreinstitutetheinterventionwithoutaneworder.Forexample,apatientisreleasedfromrestraintorseclusionbasedonthestaff’sassess-mentofthepatient’scondition.Ifthispatientlaterexhibitsbehaviorthatjeopardizestheimmediatephysicalsafetyofthepatient,astaffmember,orothersthatcanonlybehandledthroughtheuseofrestraintorseclusion,aneworderwouldberequired.

• Atemporary,directlysupervisedrelease,however,thatoccursforthepurposeofcaringforapatient'sneeds(e.g.,toileting,feeding,orrangeofmotionexercises)isnotconsideredadiscontinuationoftherestraintorseclusionintervention.

• TheuseofPRNordersfordrugsormedicationsisonlyprohibitedwhenadrugormedicationisbeingusedasarestraint.Adrugormedicationisdeemedtobearestraintonlyifitisnotastandardtreatmentordosageforthepatient’scondition,andthedrugormedicationisarestrictiontomanagethepatient’sbehaviororrestrictsthepatient’sfreedomofmovementUsingadrugtorestrainthepatientforstaffconvenienceisexpresslyprohibited.

Surveyor Guidance: • Reviewarandomsampleofmedicalrecordsforpatientsthathavebeenrestrainedorsecluded.Revieworders,progressnotes,flowsheets,andnursingnotesto:

- Verifythatthereisaphysicianorderforeachepisodeofrestraintorseclusion; - Evaluatepatternsofuseandverifythatorderswereobtainedwhennecessary; - Verifythatthedocumentationspecificallyaddressesthepatients’behaviorsor

symptoms;and, - DetermineifrestraintorseclusionisbeingimproperlyimplementedonaPRNbasis.

Pr-16.16 Unless superseded by applicable laws and regulations that is more restric-tive: Each order for restraint or seclusion used for the management of violent or self-destructive behavior that jeopardizes the immediate physical safety of the patient, a staff member, or others may only be renewed in accordance with the following limits for up to a total of 24 hours:

PR-16.16.1 4 hours for adults 18 years of age or older; PR-16.16.2 2 hours for children and adolescents 9 to 17 years of age; PR-16.16.3 1 hour for children under 9 years of age.

Pr-16.17 Patients of all ages are vulnerable and at risk when restrained or secluded to man-age violent or self-destructive behavior. Therefore, time limits have been estab-lished for each order for restraint or seclusion used to manage violent or self-de-structive behavior. Applicable laws and regulations may require more restrictive time limits. These time limits do not apply to orders for restraint used to manage non-violent or non-self-destructive behavior. However, the requirement that restraint use be ended at the earliest possible time applies to all uses of restraint.

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Pr-16.18 In the final rule on the use of restraint or seclusion, the standard did not include specific criteria for differentiating between emergency situations where the patient’s behavior is violent or self-destructive and jeopardizes the immediate physical safety of the patient, a staff member, or others, and non-emergency use of restraint. Clinicians are adept at identifying various behaviors and symptoms, and can readily recognize violent and self-de-structive behavior that jeopardizes the immediate physical safety of the patient, a staff member, or others. Asking clinicians to act based on an evaluation of the patient’s behavior is no different than relying on the clinical judgment that they use daily in assessing the needs of each patient and taking actions to meet those individual needs.

Pr-16.19 The regulation identifies maximum time limits on the length of each order for restraint or seclusion based on age.

Interpretive Guidelines: • Thephysicianhasthediscretiontowritetheorderforashorterlengthoftime.Thelength-of-orderrequirementidentifiescriticalpointsatwhichthereismandatorycontactwithaphysicianresponsibleforthecareofthepatient.Inaddition,thetimelimitsdonotdictatehowlongapatientshouldremaininrestraintorseclusion.

• Staffisexpectedtocontinuallyassessandmonitorthepatienttoensurethatthepatientisreleasedfromrestraintorseclusionattheearliestpossibletime.Re-straintorseclusionmayonlybeemployedwhiletheunsafesituationcontinues.Oncetheunsafesituationends,theuseofrestraintorseclusionshouldbediscon-tinued.

• Theregulationexplicitlystatesthattheinterventionmustbediscontinuedattheearliestpossibletime,regardlessofthelengthoftimeidentifiedintheorder.Forexample,ifapatient’sbehaviorisnolongerviolentorself-destructive20minutesaftertheinterventionisinitiated,thentherestraintorseclusionshouldbediscon-tinued,eveniftheorderwasgivenforupto4hours.

• Ifrestraintorseclusionisdiscontinuedpriortotheexpirationoftheoriginalorder,anewordermustbeobtainedpriortoreinitiatingtheuseofrestraintorseclusion.

• Attheendofthetimeframe,ifthecontinueduseofrestraintorseclusiontomanageviolentorself-destructivebehaviorisdeemednecessarybasedonanindividualizedpatientassessment,anotherorderisrequired.

• Whentheoriginalorderisabouttoexpire,anRNmustcontactthephysician,reporttheresultsofhisorhermostrecentassessmentandrequestthattheoriginalorderberenewed(nottoexceedthetimelimitsestablishedintheregulation).

• WhetherornotanonsiteassessmentisnecessarypriortorenewingtheorderislefttothediscretionofthephysicianinconjunctionwithadiscussionwiththeRNwhoisover-seeingthecareofthepatient.Another1-hourface-to-facepatientevalua-tionandtherelatedinterpretiveguidanceisnotrequiredwhentheoriginalorderisrenewed.

• Theoriginalrestraintorseclusionordermayonlyberenewedwithintherequiredtimelimitsforuptoatotalof24hours.Aftertheoriginalorderexpires,aphysi-cianmustseeandassessthepatientbeforeissuinganeworder.

Surveyor Guidance: • Whenrestraintorseclusionisusedtomanageviolentorself-destructivebehavior,doorderscontaintheappropriatetimeframesbasedonthepatient’sage?Doesthetotalnumberofhourscoveredbyanorderoritsrenewalexceed24hours?

• Ifmorerestrictiveapplicablelawsorregulationsapply,aretheybeingfollowed?

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PR • Istherenewalorderforrestraintorseclusionbasedonacomprehensiveindividualpatientassessment?

• Isthereevidenceinthepatient’smedicalrecordthatthesymptomsnecessitatingthecontinueduseofrestraintorseclusionhavepersisted?

Pr-16.20 Unless superseded by applicable laws and regulations that is more restrictive after 24 hours, before writing a new order for the use of restraint or seclu-sion for the management of violent or self-destructive behavior, a physician who is responsible for the care of the patient and authorized to order re-straint or seclusion by hospital policy in accordance with applicable laws or regulations must see and assess the patient.

Interpretive Guidelines: • Ataminimum,ifapatientremainsinrestraintorseclusionforthemanagementofviolentorself-destructivebehavior24hoursaftertheoriginalorder,thephysicianmustseethepatientandconductaface-to-facere-evaluationbeforewritinganeworderforthecontinueduseofrestraintorseclusion.

• Twenty-fourhoursofrestraintorseclusionforthemanagementofviolentorself-destruc-tivebehaviorisanextrememeasurewiththepotentialforseriousharmtothepatient.

• Applicablelawsandregulationsmaybemorerestrictiveandrequirethephysiciantoconductaface-to-facere-evaluationwithinashortertimeframe.

• Whenthephysicianrenewsanorderorwritesaneworderauthorizingthecontinueduseofrestraintorseclusion,theremustbedocumentationinthepatient’smedicalrecordthatdescribesthefindingsofthephysician'sre-evaluationsupportingthecontinueduseofrestraintorseclusion.

Surveyor Guidance: • Ifrestraintorseclusionisusedtomanageviolentorself-destructivebehaviorforlongerthan24hours,istheredocumentationofanewwrittenorder,patientassess-ments,andare-evaluationbyaphysicianinthemedicalrecord?Doesthedocumen-tationprovidesufficientevidencetosupporttheneedtocontinuetheuseofrestraintorseclusion?Isthereevidenceinthemedicalrecordthatthesymptomsnecessitatingthecontinueduseofrestraintorseclusionhavepersisted?

• Doesthepatient’splanofcareortreatmentplanaddresstheuseofrestraintorseclusion? • Whatisthepatient’sdocumentedclinicalresponsetothecontinuedneedforrestraint

orseclusion?

Pr-16.21 Each order for restraint used to ensure the physical safety of the non-violent or non-self-destructive patient may be renewed as authorized by hospital policy.

PR-16.21.1 Hospitals have the flexibility to determine time frames for the renewal of orders for restraint of the non-violent, non-self-destructive patient. These time frames should be addressed in hospital policies and procedures.

Interpretive Guidelines: • Restraintorseclusionmayonlybeemployedwhiletheunsafesituationcontinues.Oncetheunsafesituationends,theuseofrestraintorseclusionmustbediscontinued.

• Staffmembersareexpectedtoassessandmonitorthepatient’sconditiononanongoingbasistodeterminewhetherrestraintorseclusioncansafelybediscontinued.Theregulationrequiresthattheseinterventionsbeendedasquicklyaspossible.However,thedecisiontodiscontinuetheinterventionshouldbebasedonthedetermi-nationthatthepatient’sbehaviorisnolongerathreattoself,staffmembers,orothers.Whenthephysicianrenewsanorderorwritesaneworderauthorizingthecontinueduseofrestraintorseclusion,theremustbedocumentationinthemedicalrecordthat

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PRdescribesthepatient’sclinicalneedsandsupportsthecontinueduseofrestraintorseclusion.

• Thehospitalpoliciesandproceduresshouldaddress,ataminimum,categoriesofstaffthatthehospitalauthorizestodiscontinuerestraintorseclusioninaccordancewithapplicablelawsandregulationsandthecircumstancesunderwhichrestraintorseclusionistobediscontinued.

Surveyor Guidance: • Reviewthehospitalpolicyonrenewalofrestraintordersforthemanagementofnon-violent,non-self-destructivepatientbehavior.

• Interviewstaffandreviewthemedicalrecorddocumentationtoensurethatpracticeisconsistentwiththehospitalpolicy.

• Doesthehospitalhavepoliciesandproceduresforendingrestraintorseclusion?Dothepoliciesincludearequirementtoendtherestraintorseclusionassoonasissafelypossible?

• Doesthemedicalrecordcontainevidencethatthedecisiontocontinueordiscontinuetheuseofrestraintorseclusionwasbasedonanassessmentandreevaluationofthepatient’scondition?

• Interviewstafftodeterminewhethertheyareawarethatuseofarestraintorseclusionmustbediscontinuedassoonasissafelypossible.

Pr-16.22 The condition of the patient who is restrained or secluded must be moni-tored by a physician or trained staff that has completed the training criteria determined by hospital policy.

Interpretive Guidelines: • Ongoingassessmentandmonitoringofthepatient'sconditionbyaphysicianortrainedstaffiscrucialforpreventionofpatientinjuryordeath,aswellasensuringthattheuseofrestraintorseclusionisdiscontinuedattheearliestpossibletime.Hospitalpoliciesareexpectedtoguidestaffindeterminingappropriateintervalsforassessmentandmonitoringbasedontheindividualneedsofthepatient,thepatient'scondition,andthetypeofrestraintorseclusionused.

• Theselectionofaninterventionanddeterminationofthenecessaryfrequencyofassessmentandmonitoringshouldbeindividualized,takingintoconsiderationvari-ablessuchasthepatient’scondition,cognitivestatus,risksassociatedwiththeuseofthechosenintervention,andotherrelevantfactors.Insomecases,checksevery15minutesorvitalsignstakenevery2hoursmaynotbesufficienttoensurethepatient’ssafety.Inothers,itmaybeexcessiveordisruptivetopatientcare(e.g.,itmaybeunnecessarytomandatethatapatientwithwristrestraints,andwhoisasleep,becheckedevery15minutesandawakenedevery2hourstotakethepatient’svitalsigns).

• Similarly,dependingonthepatient’sneedsandsituationalfactors,theuseofrestraintorseclusionmayrequireeitherperiodic(e.g.,every15minutes,every30minutes,etc.)orcontinual(i.e.,momenttomoment)monitoringandassessment.

• Hospitalpoliciesshouldaddress:frequenciesofmonitoringandassessment;assess-mentcontent(e.g.,vitalsigns,circulation,hydrationneeds,eliminationneeds,levelofdistressandagitation,mentalstatus,cognitivefunctioning,skinintegrity,etc.);providingfornutritionalneeds,rangeofmotionexercises,andeliminationneeds;andmentalstatusandneurologicalevaluations.

• Withtheexceptionofthesimultaneoususeofrestraintandseclusion,one-to-oneunlessdeemednecessarybasedonapractitioner’sclinicaljudgment.Forexample,placingstaffatthebedsideofapatientwithwristrestraintsmaybeunnecessary.However,foramorerestrictiveorriskyinterventionand/orapatientwhoissuicidal,

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self-injurious,orcombative,staffmaydeterminethatcontinualface-to-facemonitor-ingisneeded.Thehospitalisresponsibleforprovidingthelevelofmonitoringandfrequencyofreassessmentthatwillprotectthepatient'ssafety.

• Hospitalshaveflexibilityindeterminingwhichstaffperformsthepatientassessmentandmonitoring.Thisdeterminationmustbeinaccordancewiththepractitioner’sscopeofclinicalpracticeandapplicablelawsandregulations.Forexample,assess-mentandmonitoringareactivitieswithinaregisterednurse’sscopeofpractice.

• However,sometrained,unlicensedstaffmayperformcomponentsofmonitoring(e.g.,checkingthepatient'svitalsigns,hydrationandcirculation;thepatient’slevelofdistressandagitation;orskinintegrity),andmayalsoprovideforgeneralcareneeds(e.g.,eating,hydration,toileting,andrangeofmotionexercises).

• Beforeapplyingrestraints,implementingseclusion,orperformingassociatedmonitor-ingandcaretasks,staffmustbetrainedandabletodemonstratecompetencyintheperformanceoftheseactions.

• Reviewhospitalpoliciesregardingassessmentandmonitoringofapatientinrestraintorseclusion.

- Whatevidencedoyoufindthatthehospital’smonitoringpoliciesareputintopracticeforallrestrainedorsecludedpatients?

- Dohospitalpoliciesidentifywhichcategoriesofstaffareresponsibleforassessingandmonitoringthepatient?

- Dohospitalpoliciesincludetimeframesforofferingfluidsandnourishment,toileting/elimination,rangeofmotion,exerciseoflimbsandsystematicreleaseofrestrainedlimbs?Isthisdocumentedinthepatient’smedicalrecord?

• Reviewpatientmedicalrecords: - Wasthereavalidrationaleforthedecisionregardingthefrequencyofpatient

assessmentandmonitoringdocumentedinthemedicalrecord? - Wasdocumentationconsistent,relevant,andreflectiveofthepatient’scondition? - Aretimeframesdescribedforhowoftenapatientismonitoredforvitalsigns,

respiratoryandcardiacstatus,andskinintegritychecks? - Istheredocumentationofongoingpatientmonitoringandassessment(e.g.,skin

integrity,circulation,respiration,intakeandoutput,hygiene,injury,etc.)? - Isthepatient’smentalstatusassessed?Isthisdocumentedinthemedicalrecord? - Isthepatientassessedregardingcontinuedneedfortheuseofseclusionorrestraint? - Isthereadequatejustificationforcontinueduseandisthisdocumented? - Isthelevelofsupervisionappropriatetomeetthesafetyneedsofthepatientwhois

atahigherriskforinjury(e.g.,self-injurious,suicidal)?

Pr-16.23 Physician training requirements must be specified in hospital policy. At a minimum, physicians authorized to order restraint or seclusion by hospital policy in accordance with applicable laws and regulations must have a work-ing knowledge of hospital policy regarding the use of restraint or seclusion.

Interpretative Guidelines: • Ataminimum,physiciansauthorizedtoorderrestraintandseclusionmusthaveaworkingknowledgeofhospitalpolicyregardingtheuseofrestraintandseclusion.

• Hospitalshavetheflexibilitytoidentifytrainingrequirementsabovethisminimumrequirementbasedonthecompetencyleveloftheirphysicians,andtheneedsofthepatientpopulation(s)thattheyserve.

• Physiciansreceivetrainingintheassessment,monitoring,andevaluationofapatient’sconditionaspartoftheirmedicalschooleducation.However,physiciansgenerallydo

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notreceivetrainingregardingapplicationofrestraintorimplementationofseclusionaspartoftheirbasiceducation.Dependingonthelevelandfrequencyofinvolvementthataphysicianhasintheperformanceoftheseactivities,additionaltrainingmayormaynotbenecessarytoensurethecompetencyoftheseindividualsinthisarea.

• Thehospitalisinthebestpositiontodetermineifadditionalphysiciantrainingisnecessarybasedonthemodelofcare,levelofphysiciancompetency,andtheneedsofthepatientpopulation(s)thatthehospitalserves.

Surveyor Guidance: • Reviewthehospitalpolicyregardingrestraintandseclusiontrainingrequirementsforphysicians.Aretheminimumtrainingrequirementsaddressed?

• Reviewmedicalstaffcredentialingandprivilegingfilestodetermineifphysiciansinvolvedinrestraintandseclusionactivitieshavecompletedtherequiredtraining.

Pr-16.24 When restraint or seclusion is used for the management of violent or self-destructive behavior that jeopardizes the immediate physical safety of the patient, a staff member, or others, the patient must be seen face-to-face within 1 hour after the initiation of the intervention by a physician or regis-tered nurse who has been trained in accordance with the requirements.

Interpretive Guidelines: • Whenrestraintorseclusionisusedtomanageviolentorself-destructivebehavior,aphysician,oraregisterednurse(RN)mustseethepatientface-to-facewithin1-houraftertheinitiationoftheintervention.

• Thisrequirementalsoapplieswhenadrugormedicationisusedasarestrainttomanageviolentorself-destructivebehavior.

• AphysicianortrainedRNmustconductthe1-hourface-to-facepatientevaluationinperson.Atelephonecallortelemedicinemethodologyisnotpermitted.

• Ifapatient’sviolentorself-destructivebehaviorresolvesandtherestraintorseclusioninterventionisdiscontinuedbeforethepractitionerarrivestoperformthe1-hourface-to-faceevaluation,thepractitionerisstillrequiredtoseethepatientface-to-faceandconducttheevaluationwithin1houraftertheinitiationofthisintervention.

• Thefactthatthepatient’sbehaviorwarrantedtheuseofarestraintorseclusionindicatesaseriousmedicalorpsychologicalneedforpromptevaluationofthepatientbehaviorthatledtotheintervention.Theevaluationwouldalsodeterminewhetherthereisacontinuedneedfortheintervention,factorsthatmayhavecontributedtotheviolentorself-destructivebehavior,andwhethertheinterventionwasappropriatetoaddresstheviolentorself-destructivebehavior.

Surveyor Guidance: • Reviewthehospitalpolicyregardingthe1-hourface-to-faceevaluation. • Whatcategoriesofpractitionersdoesthehospitalpolicyauthorizetoconductthe

1-hourface-to-faceevaluation? • Interviewstafftodetermineifpracticeisconsistentwithhospitalpolicy. • Thepatientmustbeseenface-to-facewithin1houraftertheinitiationoftheintervention. • Toevaluate: - Thepatient’simmediatesituation; - Thepatient’sreactiontotheintervention; - Thepatient’smedicalandbehavioralcondition;and - Theneedtocontinueorterminatetherestraintorseclusion. • The1-hourface-to-faceevaluationincludesbothaphysicalandbehavioralassess-

mentofthepatientthatmustbeconductedbyaqualifiedpractitionerwithinthe

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PRscopeoftheirpractice.Anevaluationofthepatient’smedicalconditionwouldincludeacompletereviewofthepatient’ssystemsassessment,behavioralassess-ment,aswellasreviewandassessmentofthepatient’shistory,drugsandmedica-tions,mostrecentlabresults,etc.Thepurposeistocompleteacomprehensivereviewofthepatient’sconditiontodetermineifotherfactors,suchasdrugormedicationinteractions,electrolyteimbalances,hypoxia,sepsis,etc.,arecontribut-ingtothepatient’sviolentorself-destructivebehavior.

• TrainingforanRNtoconductthe1-hourface-to-faceevaluationwouldincludeallofthetrainingrequirementsataswellascontenttoevaluatethepatient'simmediatesituation,thepatient'sreactiontotheintervention,thepatient'smedicalandbehavio-ralcondition(documentedtraininginconductingphysicalandbehavioralassess-ment);andtheneedtocontinueorterminatetherestraintorseclusion.

• Wasthe1-hourface-to-faceevaluationconductedbyapractitionerauthorizedbyhospitalpolicyinaccordancewithapplicablelawsandregulationstoconductthisevaluation?

• Ifthe1-hourface-to-faceevaluationsareconductedbyRNs,verifythatthoseRNshavedocumentedtrainingthatdemonstratestheyarequalifiedtoconductaphysicalandbehavioralassessmentofthepatientthataddresses:thepatient’simmediatesituation,thepatient’sreactiontotheintervention,thepatient’smedicalandbehavio-ralcondition,andtheneedtocontinueorterminatetherestraintorseclusion.

• Doesdocumentationofthe1-hourface-to-faceevaluationinthepatient’smedicalrecordincludeallthelistedelementsofthisrequirement?

• Didtheevaluationindicatewhetherchangesinthepatient’scarewererequired,and,ifso,werethechangesmade?

• Ispracticeconsistentwithlawsandregulations? • Ifatrainedregisterednurseconductstheface-to-faceevaluation,thetrainedregis-

terednursemustconsulttheattendingphysicianwhoisresponsibleforthecareofthepatientassoonaspossibleafterthecompletionofthe1-hourface-to-faceevaluation.

• Hospitalpolicyshouldaddresstheexpectedtimeframeforandthecomponentsoftheconsultationwiththeattendingphysicianconsistentwith"assoonaspossible."Thisconsultationshouldinclude,ataminimum,adiscussionofthefindingsofthe1-hourface-to-faceevaluation,theneedforotherinterventionsortreatments,andtheneedtocontinueordiscontinuetheuseofrestraintorseclusion.

• Aconsultationthatisnotconductedpriortoarenewaloftheorderwouldnotbeconsistentwiththerequirement,"assoonaspossible."

Surveyor Guidance: • Reviewtherelevanthospitalrestraintandseclusionpolicy. • Doesthehospitalpolicyclarifyexpectationsregardingtherequirement,"assoonaspos-

sible"? • Doesdocumentationinthepatient’smedicalrecordindicateconsultationwiththe

attendingphysicianwhenatrainedRNconductedthe1-hourface-to-faceevaluation? • Ispracticeconsistentwithhospitalpolicy? • Allrequirementsspecifiedunderthisparagraphareapplicabletothesimultaneous

useofrestraintandseclusion.Simultaneousrestraintandseclusionuseisonlypermittedifthepatientiscontinuallymonitored:

- Face-to-facebyanassigned,trainedstaffmember;or - Bytrainedstaffusingbothvideoandaudioequipment.Thismonitoringmustbein

closeproximitytothepatient.

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PRPr-16.25 Simultaneous Use of Restraint & Seclusion: When the simultaneous use of restraint and seclusion is employed, there must be adequate documentation that justifies the decision for simultaneous use as well as vigilance in con-tinuously monitoring the patient so that the patient’s care needs are met.

Interpretive Guidelines: • Allrequirementsspecifiedunderthestandardapplytothesimultaneoususeofrestraintandseclusion.Thesimultaneoususeofrestraintandseclusionisnotpermit-tedunlesstrainedstaff,eitherthroughface-to-faceobservationorthroughtheuseofbothvideoandaudioequipment,continuallymonitorsthepatient.

• Monitoringwithvideoandaudioequipmentfurtherrequiresthatstaffperformthemonitoringincloseproximitytothepatient.Forthepurposesofthisrequirement,continuallymeansongoingwithoutinterruption.Theuseofvideoandaudioequipmentdoesnoteliminatetheneedforfrequentmonitoringandassessmentofthepatient.

• Anindividualwhoisphysicallyrestrainedaloneinhisorherroomisnotnecessarilybeingsimultaneouslysecluded.Theindividual’sprivacyanddignityshouldbepro-tectedtotheextentpossibleduringanyintervention.Infact,thepurposeofrestrainingapatientaloneinhisorherroommaybetopromoteprivacyanddignityversussimultaneouslyusingseclusionandrestraint.Whilethisdistinctionmaybedifficulttomake,itishelpfultoconsiderwhetherthepatientwould,intheabsenceofthephysicalrestraint,beabletovoluntarilyleavetheroom.Ifso,thenthepatientisnotalsobeingsecluded.However,ifthephysicalrestraintwasremovedandthepatientwasstillunabletoleavetheroombecausethedoorwaslockedorstaffwasotherwisephysi-callypreventingthepatientfromdoingso,thenthepatientisalsobeingsecluded.

• Staffmusttakeextracaretoprotectthesafetyofthepatientwheninterventionsthataremorerestrictiveareused.Monitoringmustbeappropriatetotheinterventionchosen,sothatthepatientisprotectedfrompossibleabuse,assault,orself-injuryduringtheintervention.

• Reviewthehospital’spolicyregardingsimultaneoususeofrestraintandseclusiontodeterminewhetheritprovidesforcontinualmonitoring.

• Conductdocumentreviewandstaffinterviewstodetermineifpracticeisconsistentwiththehospitalpolicyandrequireduninterruptedaudioandvisualmonitoringisprovidedasrequired.

• Isthestaffmembermonitoringthepatientwithvideoandaudioequipmenttrainedandincloseproximitytoensurepromptemergencyinterventionifaproblemarises?

• Doesthevideoequipmentcoverallareasoftheroomorlocationwherethepatientisrestrainedorsecluded?

• Istheaudioandvideoequipmentlocatedinanareathatassurespatientprivacy? • Istheequipmentappropriatelymaintainedandinworkingcondition?

Pr-16.26 When restraint or seclusion is used to manage violent or self-destructive behavior, the 1-hour face-to-face medical and behavioral evaluation must be documented in the patient’s medical record. When restraint or seclusion is used, there must be documentation in the patient’s medical record of a description of the patient’s behavior and the intervention used.

Interpretive Guidelines: • Thepatient’sbehaviorshouldbedocumentedindescriptivetermstoevaluatetheappropriatenessoftheinterventionsused.

• Thedocumentationshouldincludeadetaileddescriptionofthepatient’sphysicalandmentalstatusassessments,andofanyenvironmentalfactors(e.g.,physical,activities,etc.)thatmayhavecontributedtothesituationatthetimeoftheintervention.

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PR • Doesthepatient’smedicalrecordincludeacleardescriptionofthepatient’sbehaviorthatwarrantedtheuseofrestraintorseclusion?

• Wastheinterventionemployedappropriatefortheidentifiedbehavior?Whatwasthepatient’sclinicalresponsetotheintervention(s)?

Pr-16.27 When restraint or seclusion is used, there must be documentation in the patient’s medical record of alternatives or other less restrictive interventions attempted (as applicable).

Interpretive Guidelines: • Theuseofrestraintorseclusionmustbeselectedonlywhenlessrestrictivemeasureshavebeenjudgedtobeineffectivetoprotectthepatientorothersfromharm.

• Itisnotalwaysappropriateforlessrestrictivealternativestobeattemptedpriortotheuseofrestraintorseclusion.Whenapatient’sbehaviorpresentsanimmediateandseriousdangertohisorherself,orothers,immediateactionisneeded.Forexample,whenapatientphysicallyattackssomeone,immediateactionisneeded.

• Whilestaffshouldbemindfulofusingtheleastintrusiveintervention,itiscriticalthattheinterventionselectedbeeffectiveinprotectingthepatientorothersfromharm.

Surveyor Guidance: • Doesthepatient’smedicalrecorddocumentanyalternativesorlessrestrictiveinterventionsattemptedbystaff,ifappropriate?

• Whatwastheeffectoflessrestrictiveinterventions,ifattemptedbystaff? • Weretheinterventionsselectedappropriatetothetargetedpatientbehaviors? • Whenanimmediateandseriousdangertothepatientorothersoccurred,wasthe

morerestrictiveintervention(s)effective?Couldalessrestrictiveinterventionhavebeenusedtoensurethesafetyofthepatient,stafforothers?

Pr-16.28 When restraint or seclusion is used, there must be documentation in the patient’s medical record of the patient’s condition or symptom(s) that warranted the use of the restraint or seclusion.

Interpretive Guidelines: • Acomprehensive,individualizedpatientassessmentisnecessarytoidentifythemostappropriateinterventiontoeffectivelymanageapatient’sconditionorsymptom(s).Whenusingarestraintorseclusionintervention,thepatient’sconditionorsymptom(s)mustbeidentifiedanddocumentedinthepatient’smedicalrecord.

• Doesthepatient’smedicalrecordincludedescriptionsofthepatient’sconditionorsymptom(s)thatwarrantedtheuseofrestraintorseclusion?

• Whenrestraintorseclusionisused,theremustbedocumentationinthepatient'smedicalrecordofthepatient'sresponsetotheintervention(s)used,includingtherationaleforcontinueduseoftheintervention.

• Doesthepatient’smedicalrecordincludedescriptionsoftheimpactoftheinterven-tiononthepatientbehaviorthatresultedintheuseofrestraintorseclusion?

• Doesthepatient'smedicalrecordincludeadetailedassessmentofthepatient'sresponsetotheinterventionandawell-reasonedplanforthecontinueduseofre-straintorseclusion?

Pr-16.29 Staff Training: Restraint or seclusion: Staff training requirements. The patient has the right to safe implementation of restraint or seclusion by trained staff.

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PRSurveyor Guidance: • Determinewhetherthehospitalhasstafftrainingandaneducationprogramthat

protectsthepatient’srighttosafeimplementationofrestraintorseclusion. • Observepatientsinrestraintorseclusiontoverifysafeapplicationoftherestraintor

seclusion.

Interpretive Guidelines: • TrainingIntervals-Staffmustbetrainedandabletodemonstratecompetencyintheapplicationofrestraints,implementationofseclusion,monitoring,assessment,andprovidingcareforapatientinrestraintorseclusionbeforeperforminganyoftheactionsspecifiedinthisparagraph;aspartoforientation;andsubsequentlyonaperiodicbasisconsistentwithhospitalpolicy.

• Allstaffdesignatedbythehospitalashavingdirectpatientcareresponsibilities,includingcontractoragencypersonnel,mustdemonstratethecompetenciesspecifiedpriortoparticipatingintheapplicationofrestraints,implementationofseclusion,monitoring,assessment,orcareofapatientinrestraintorseclusion.

• Thesecompetenciesmustbedemonstratedinitiallyaspartoforientationandsubse-quentlyonaperiodicbasisconsistentwithhospitalpolicy.

• Hospitalshavetheflexibilitytoidentifyatimeframeforongoingtrainingbasedonthelevelofstaffcompetency,andtheneedsofthepatientpopulation(s)served.

• TrainingforanRNtoconductthe1-hourface-to-faceevaluationwouldincludeallofthetrainingrequirementsaswellascontenttoevaluatethepatient'simmediatesituation,thepatient'sreactiontotheintervention,thepatient'smedicalandbehavio-ralcondition,andtheneedtocontinueorterminatetherestraintorseclusion.

• Anevaluationofthepatient’smedicalconditionwouldincludeacompletereviewofthepatient’ssystemsassessment,behavioralassessment,aswellasreviewandassessmentofthepatient’shistory,medications,mostrecentlabresults,etc.Thepurposeofthe1-hourface-to-faceevaluationistocompleteacomprehensivereviewofthepatient’sconditionanddetermineifotherfactors,suchasdrugormedicationinteractions,electrolyteimbalances,hypoxia,sepsis,etc.,arecontributingtothepatient’sviolentorself-destructivebehavior.

• Onceinitialtrainingtakesplace,trainingmustbeprovidedfrequentlyenoughtoensurethatstaffpossessestherequisiteknowledgeandskillstosafelycareforre-strainedorsecludedpatientsinaccordancewiththeregulations.

• Theresultsofskillsandknowledgeassessments,newequipment,orqualitydatamayindicateaneedfortargetedtrainingormorefrequentorrevisedtraining.

• Hospitalsarerequiredtohaveappropriatelytrainedstafffortheproperandsafeuseofseclusionandrestraintinterventions.Itwouldnotbeappropriateforahospitaltoroutinelycalluponalawenforcementagencyoragenciesasameansofapplyingrestraintorinitiatingseclusion.

• Ifhospitalsecurityguards,orothernon-healthcarestaff,aspartofhospitalpolicy,mayassistdirectcarestaff,whenrequested,intheapplicationofrestraintorseclu-sion,thesecurityguards,orothernon-healthcarestaff,arealsoexpectedtobetrainedandabletodemonstratecompetencyinthesafeapplicationofrestraintandseclusion.

Surveyor Guidance: • Doesthehospitalhaveadocumentedtrainingprogramfortheuseofrestraintandseclusioninterventionsemployedbythehospital?

• Doesthehospitalhavedocumentedevidencethatalllevelsofstaff,includingagencyorcontractstaff,thathavedirectpatientcareresponsibilitiesandanyotherindividu-alswhomaybeinvolvedintheapplicationofrestraints(e.g.,securityguards)havebeentrainedandareabletodemonstratecompetencyinthesafeuseofseclusionandthesafeapplicationanduseofrestraints?

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PR • Reviewandverifyrestraintandseclusioneducationstafftrainingdocumentationforallnewemployeesandcontractstaff.

• Doesthetrainingincludedemonstrationofrequiredcompetencies?Whatareaswereincludedinthistrainingprogram?

Pr-16.30 Training Content. - The hospital must require appropriate staff to have education, training, and demonstrated knowledge based on the specific needs of the patient population in at least the following techniques to identify staff and patient behaviors, events, and environmental factors that may trigger circumstances that require the use of a restraint or seclusion.

Interpretive Guidelines: • Thetermappropriatestaffincludesallstaffthatappliesrestraintorseclusion,monitor,assess,orotherwiseprovidecareforpatientsinrestraintorseclusion.

• Allstaff,includingcontractoragencypersonnel,designatedbythehospitalashavingdirectpatientcareresponsibilitiesarerequiredtoreceivetrainingintheareasofclinicaltechniquesusedtoidentifypatientandstaffbehaviors,eventsandenvironmentalfactorsthatmaytriggercircumstancesthatrequiretheuseofre-straintorseclusion.Thistrainingshouldbetargetedtothespecificneedsofthepatientpopulationsbeingserved,andtothecompetencylevelofstaff.

• Staffneedstobeabletoemployabroadrangeofclinicalinterventionstomaintainthesafetyofthepatientandothers.Thehospitalisexpectedtoprovideeducationandtrainingattheappropriateleveltotheappropriatestaffbaseduponthespecificneedsofthepatientpopulationbeingserved.Forexample,staffroutinelyprovidingcareforpatientswhoexhibitviolentorself-destructivebehaviorthatjeopardizestheimmediatephysicalsafetyofthepatient,astaffmember,orothers(suchasinanemergencydepartmentoronapsychiatricunit)generallyrequiremorein-depthtrainingintheareasincludedintheregulationthanstaffroutinelyprovidingmedical/surgicalcare.Hospitalsmaydevelopandimplementtheirowntrainingprogramsoruseanoutsidetrainingprogram.However,thestandardspecifiesthatindividualsprovidingstafftrainingmustbequalifiedasevidencedbyeducation,training,andexperience.

• Hospitalshavetheflexibilitytodeveloptheirowntrainingprogramtomeetthestafftrainingrequirementsorpurchaseatrainingprogramfromtheoutside.Eachhospitalmustassessthelearningneedsandcompetencyoftheirstafftodeterminehowextensiveperiodictrainingandstaffcompetencydemonstrationmustbesubsequenttoinitialtraining.Thetrainingprogrammustbeprovidedtoallappro-priatestaff.Anypersonmonitoringorprovidingcaretoarestrainedpatientmustdemonstratetheknowledgeandabilitiesrequiredbytheregulations.

• Ataminimum,physiciansauthorizedtoorderrestraintorseclusionbyhospitalpolicyinaccordancewithapplicablelawsandregulationsmusthaveaworkingknowledgeofhospitalpolicyregardingtheuseofrestraintandseclusion.Hospitalshavetheflexibilitytoidentifytrainingrequirementsabovethisminimumbasedonthecompetencyleveloftheirphysiciansandtheneedsofthepatientpopulationthattheyserve.

Surveyor Guidance: • Doesthehospitaleducationalprogramincludetechniquesrelatedtothespecificpatientpopulationsbeingserved?

• Doesthehospitaleducationalprogramincludetechniquestoidentifystaffandpatientbehaviors,events,andenvironmentalfactorsthatmaytriggercircumstancesthatrequiretheuseofrestraintorseclusion?

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PR • Doesthehospitaleducationalprogramprovidemorein-depthtrainingintheareasincludedintheregulationforstaffmemberswhoroutinelyprovidecaretopatientswhoexhibitviolentorself-destructivebehavior(e.g.,staffwhoworkintheemergencydepartmentorpsychiatricunit)?

• Interviewstafftoassesstheirknowledgeoftherestraintandseclusiontechniquesaddressedinthisrequirement.

Pr-16.31 The hospital must require appropriate staff to have education, training, and demonstrated knowledge based on the specific needs of the patient popu-lation in the use of nonphysical intervention skills.

Interpretive Guidelines: • Althoughwerecognizethattheremaybecircumstancesinwhichtheuseofrestraintorseclusionmaybenecessarytopreventapatientsituationfromescalating,staffoftenskillfullyinterveneswithalternativetechniquestoredirectapatient,engagethepatientinconstructivediscussionoractivity,orotherwisehelpthepatientmaintainself-controlandavertescalation.

• Theuseofnonphysicalinterventionskillsdoesnotmeanattemptingacomplexseriesofinterventionsoralengthychecklistofstepstoinitiatebeforerestrainingorseclud-ingapatient.Rather,awholetoolboxofpossibleinterventionscanbeimplementedduringthecourseofapatient’streatmentbasedupontheassessmentofanindividualpatient’sresponses.

Surveyor Guidance: • Doesthehospitaleducationalprogramaddresstheuseofnonphysicalinterventionskills? • Doesthehospital’strainingprogramcomplywiththeregulatoryrequirements? • Interviewstafftoassesstheirnon-physicalinterventionskills.

Pr-16.32 The hospital must require appropriate staff to have education, training, and demonstrated knowledge based on the specific needs of the patient popu-lation in choosing the least restrictive intervention based on an individual-ized assessment of the patient’s medical, or behavioral status or condition.

Interpretive Guidelines: • Theunderpinningofthisregulationistheconceptthatsafepatientcarehingesonlookingatthepatientasanindividualandassessingthepatient’scondition,needs,strengths,weaknesses,andpreferences.Suchanapproachreliesoncaregiverswhoareskilledinindividualizedassessmentandintailoringinterventionstoindividualpatient’sneedsafterweighingfactorssuchasthepatient’scondition,behaviors,history,andenvironmentalfactors.

Surveyor Guidance: • Doesthehospitaleducationalprogramaddresschoosingtheleastrestrictiveinterven-tionbasedonanindividualizedassessmentofthepatient’smedicalorbehavioralstatusorcondition?

• Doesthehospitaleducationalprogramaddresshowtoconductanassessmentofapatient’smedicalandbehavioralconditions?

• Doesthehospitaleducationalprogramaddresstypesofinterventionsappropriatetothespecificneedsofthepatientpopulation(s)servedandrangingfromlesstomorerestrictive?

• Interviewstafftodetermineiftheyareabletodemonstratetheabilitiesaddressedinthisrequirement.

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PRPr-16.33 The hospital must require appropriate staff to have education, training, and demonstrated knowledge based on the specific needs of the patient popu-lation in safe application and use of all types of restraint or seclusion used in the hospital, including training in how to recognize and respond to signs of physical and psychological distress (for example, positional asphyxia). Pa-tients have a right to the safe application of restraint or seclusion by trained and competent staff.

Surveyor Guidance: • Isallstaff,includingcontractoragencypersonnel,identifiedbythehospitalasdirectcaregiverstrainedandabletodemonstratecompetencyinthesafeuseofalltypesofrestraintsorseclusionusedinthehospital?

• Doesthehospitaleducationalprogramaddressrecognitionandresponsetopatientsignsofphysicalandpsychologicaldistress?

• Isstaffabletoidentifysignsofphysicalandpsychologicaldistressinatimelymanner? • Isstaffabletorespondtoandappropriatelytreatsignsofphysicalandpsychological

distress? • Reviewhospitaldata(i.e.,incidentreports,patientinjuryordeathreports,etc.)toidentify

anypatternsofpatientinjuriesordeaththatmayindicatethatstaffisnotadequatelytrainedtorecognizeandrespondtopatientsignsofphysicalandpsychologicaldistress.

Pr-16.34 The hospital must require appropriate staff to have education, training, and demonstrated knowledge based on the specific needs of the patient popu-lation in clinical identification of specific behavioral changes that indicate that restraint or seclusion is no longer necessary.

Interpretive Guidelines: • Theuseofrestraintorseclusionmustbeendedattheearliestpossibletimeregardlessofthelengthoftimeidentifiedintheorder.Staffmustbetrainedanddemonstratecompe-tencyintheirabilitytoidentifyspecificpatientbehavioralchangesthatmayindicatethatrestraintorseclusionisnolongernecessaryandcanbesafelydiscontinued.

Surveyor Guidance: • Doesthehospitaleducationalprogramaddressidentificationofspecificbehavioralchangesthatmayindicatethatrestraintorseclusionisnolongernecessary?

• Interviewstafftodetermineiftheyareabletodemonstratetheabilitiesaddressedinthisrequirement.

Pr-16.35 The hospital must require appropriate staff to have education, training, and demonstrated knowledge based on the specific needs of the patient popula-tion in monitoring the physical and psychological well-being of the patient who is restrained or secluded, including but not limited to, respiratory and circulatory status, skin integrity, vital signs, and any special requirements specified by hospital policy associated with the 1-hour face-to-face evaluation.

Interpretive Guidelines: • Staffmustbetrainedanddemonstratecompetencyinmonitoringthephysicalandpsychologicalwell-beingofapatientwhoisrestrainedorsecluded,includingbutnotlimitedto,respiratoryandcirculatorystatus,skinintegrity,vitalsigns,andaswellasanyspecialrequirementsspecifiedbyhospitalpolicyassociatedwiththe1-hourface-to-faceevaluation.

Surveyor Guidance: • Doesthehospitaleducationalprogramaddressmonitoringthephysicalandpsycho-logicalneedsofpatientswhoarerestrainedorsecluded,includingbutnotlimitedto,

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PRrespiratoryandcirculatorystatus,skinintegrity,vitalsigns,andanyspecialrequire-mentsspecifiedbyhospitalpolicyassociatedwiththe1-hourface-to-faceevaluation?

• DoesthehospitaleducationalprogramaddressthespecificrequirementsforthetrainingofRNsthatthehospitalauthorizestoconductthe1-hourface-to-faceevaluation?

• Interviewstafftodetermineiftheyareabletodemonstratethecompetenciesad-dressedinthisregulation.

Pr-16.36 The hospital must require appropriate staff to have education, training, and demonstrated knowledge based on the specific needs of the patient popu-lation in the use of first aid techniques and certification in the use of cardio-pulmonary resuscitation, including required periodic recertification.

Interpretive Guidelines: • Hospitalsarerequiredtoprovideasafeenvironmentforthepatientsintheircare.Whenrestraintorseclusiontechniquesareused,patientsareplacedatahigherriskforinjuriesorevendeath.Hospitalsmustrequireappropriatestaff(allstaffwhoapplyrestraintorseclusion,monitor,accessorprovidecareforapatientinrestraintorseclusion)toreceiveeducationandtrainingintheuseoffirstaidtechniquesaswellastrainingandcertificationintheuseofcardiopulmonaryresuscitation.

• Hospitalsarenotrequiredtouseanyparticularrecognizedfirstaidcourse.Addition-ally,suchcoursesmaynotadequatelyaddresstheimmediateinterventions,the“ firstaid",thatneedstoberenderedtoarestrainedorsecludedpatientwhoisindistressorinjured.Thegoalisforstafftobeabletorendertheappropriate“ firstaid"requiredifarestrainedorsecludedpatientisindistressorinjured.Forexample,apatientisfoundhanginginavestrestraint,arestrainedpatientischokingonfood,asecludedsuicidalpatientisfoundhanging,asecludedsuicidalpatienthascuthimself,etc.Hospitalstaffneedtoassesstheirpatientpopulationandidentifylikelyscenarios,developa“ firstaid”trainingthataddressesthosescenarios,andprovidethat“ firstaid”trainingtoallstaffthatcareforrestrainedorsecludedpatients.

Surveyor Guidance: • Doesthehospitaleducationalprogramaddressfirstaidtechniques?Isappropriatestaffcertifiedincardiopulmonaryresuscitation?

• Doesthehospitaleducationalprograminclude,orprovidefor,stafftrainingandcertificationincardiopulmonaryresuscitation(includingprovisionsforrecertification)?

Pr-16.37 Trainer Requirements. - Individuals providing staff training must be qualified as evidenced by education, training, and experience in techniques used to address patients’ behaviors.

Interpretive Guidelines: • Hospitalsmaydevelopandimplementtheirowntrainingprogramsoruseanoutsidetrainingprogram.

• However,individualsprovidingthetrainingmustbequalifiedasevidencedbyeduca-tion,trainingandexperienceintechniquesusedtoaddresspatients’behaviorsforthepatientpopulationsbeingserved.

• Trainersshoulddemonstrateahighlevelofknowledgeregardingalltherequirementsoftheseregulationsaswellasthehospital’spoliciesandproceduresthataddresstheserequirements.

Surveyor Guidance: • Reviewpersonnelfilesofindividualsresponsibleforprovidingstaffeducationandtraining. • Dotheindividualsprovidingtheeducationandtrainingpossesseducation,training,

andexperiencetoqualifythemtoteachthestaff?Aretheyqualifiedtoidentifyandmeettheneedsofthepatientpopulation(s)beingserved?

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• Doesthehospitalhaveasystemfordocumentingandensuringthattheindividualsprovidingeducationandtraininghavetheappropriatequalificationsrequiredbythisregulation?

Pr-16.38 Training Documentation: The hospital must document in the staff personnel records that the training and demonstration of competency were success-fully completed.

PR-16.38.1 Staff personnel records must contain documentation that the training and demonstration of competency were successfully completed initially during orientation and on a periodic basis consistent with hospital policy.

Surveyor Guidance: • Reviewasampleofstaffpersonnelrecords,includingcontractoragencystaff,todetermineifthetraininganddemonstrationofcompetencyhavebeencompletedduringorientationandonaperiodicbasisconsistentwithhospitalpolicy.

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nursing services

nS-1 The hospital must have an organized nursing service that provides 24-hour nursing services. The nursing services must be furnished or supervised by a registered nurse.

nS-2 The hospital must have an organized nursing service and must provide on premise nursing services 24 hours a day, 7 days a week with at least 1 registered nurse (RN) furnishing or supervising the service 24 hours a day, 7 days a week.

nS-3 The nursing service must be integrated into the hospital-wide Quality Management System.

Surveyor Guidance: • Determineifthenursingserviceisintegratedintothehospital-wideQualityManage-mentSystem.

• Interviewthedirectoroftheservice.Requestthefollowingitems: - Organizationalchart(s)fornursingservicesforalllocationswherethehospital

providesnursingservices; - Joborpositiondescriptionsforallnursingpersonnelincludingthedirector’s

positiondescription. • Selectatleastonepatientfromeveryinpatientcareunit.Observethenursingcarein

progresstodeterminetheadequacyofstaffingandtoassessthedeliveryofcare.Othersourcesofinformationtouseintheevaluationofthenursingservicesare:nursingcareplans,medicalrecords,patients,familymembers,accidentandinvestiga-tivereports,staffingschedules,nursingpoliciesandprocedures,andQualityManage-mentSystemactivitiesandreports.Interviewpatientsforinformationrelativetothedeliveryofnursingservices.

nS-4 The hospital must have a well-organized service with a plan of administrative authority and delineation of responsibilities for patient care. The director of the nursing service must be a licensed registered nurse. He or she is responsible for the operation of the service, including determining the types and numbers of nursing personnel and staff necessary to provide nursing care for all areas of the hospital.

nS-4.1 The hospital may have only one nursing service hospital-wide and the single nursing service must be under the direction of one RN.

nS-4.2 The director of the nursing service must be a currently licensed RN and he/she is responsible for the operation of the nursing service. The operation of the nursing service would include the quality of the patient care provided by the nursing service.

nS-4.3 The director of the nursing service must determine and provide the types and numbers of nursing care personnel necessary to provide nursing care to all areas of the hospital.

Surveyor Guidance: • Reviewtheorganizationalchartorplanfornursingservices.Determinethattheorganizationalchart(s)displayslinesofauthoritythatdelegatesresponsibilitywithinthedepartment.

• Readthepositiondescriptionforthedirectorofnursing(DON)todeterminethatitdelegatestotheDONspecificdutiesandresponsibilitiesforoperationoftheservice.

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• Verifythatthedirectoriscurrentlylicensedinaccordancewithlicensurerequirements. • VerifythattheDONisinvolvedwithorapprovedthedevelopmentofthenursing

servicestaffingpoliciesandprocedures. • VerifythattheDONapprovesthenursingservicepatientcarepoliciesandprocedures.

nS-5 Staffing and Delivery of Care

nS-5.1 The nursing service must have adequate numbers of licensed registered nurses, and other personnel to provide nursing care to all patients as need-ed. There must be supervisory and staff personnel for each department or nursing unit to ensure, when needed, the immediate availability of a regis-tered nurse for bedside care of any patient.

nS-5.2 The nursing service must ensure that patient needs are met by ongoing assessments of patients’ needs and provides nursing staff to meet those needs. There must be sufficient numbers, types and qualifications of supervi-sory and staff nursing personnel to respond to the appropriate nursing needs and care of the patient population of each department or nursing unit.

nS-5.3 There must be a RN physically present on the premises and on duty at all times. Every inpatient unit/department/location within the hospital-wide nursing service must have adequate numbers of RNs physically present at each location to ensure the immediate availability of a RN for the bedside care of any patient.

nS-5.4 A RN would not be considered immediately available if the RN were working on more than one unit, building, floor in a building, or provider at the same time.

nS-5.5 Staffing schedules must be reviewed and revised as necessary to meet the patient care needs and to make adjustments for nursing staff absenteeism.

Surveyor Guidance: • Determinethattherearewrittenstaffingscheduleswhichcorrelatetothenumberandacuityofpatients.Verifythatthereissupervisionofpersonnelperformanceandnursingcareforeachdepartmentornursingunit.Todetermineifthereareadequatenumbersofnursestoprovidenursingcaretoallpatientsasneeded,takeintoconsideration:

- Physicallayoutandsizeofthehospital; - Numberofpatients; - Intensityofillnessandnursingneeds; - Availabilityofnurses’aidesandorderliesandotherresourcesfornurses,e.g.,

housekeepingservices,wardclerksetc.; - Trainingandexperienceofpersonnel; - Donotcountpersonnelassignedtoareasotherthanbedsidepatientcare. • Reviewmedicalrecordstodetermineifpatientcarethatistobeprovidedbynursesis

beingprovidedasordered.

nS-6 The nursing service must have a procedure to ensure that hospital nursing personnel for whom licensure is required have valid and current licensure.

nS-6.1 The hospital’s procedure must ensure that all nursing personnel have valid and current licensure that complies with applicable laws and regulations/ licensure laws.

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Surveyor Guidance: • ReviewhospitalpersonnelrecordsorrecordskeptbythenursingservicetodeterminethatRNs,andothernursingpersonnelforwhomlicensureisrequiredhavecurrentvalidlicenses.

• Reviewthenursingservicelicensureverificationpoliciesandprocedures.Islicensureverifiedforeachindividualnursingservicesstaffpersonforwhomlicensureisrequired?

nS-7 A registered nurse must supervise and evaluate the nursing care for each patient.

nS-7.1 A RN must supervise the nursing care for each patient. A RN must evaluate the care for each patient upon admission and when appropriate on an ongoing basis in accordance with accepted standards of nursing practice and hospital policy. Evaluation would include assessing the patient’s care needs, patient’s health status/conditioning, as well as the patient’s response to interventions.

Surveyor Guidance: • Reviewstaffingschedulesandassignments. • DeterminethataRNisassignedtosuperviseandevaluatethenursingcarefurnished

toeachpatient.

nS-8 The hospital must ensure that the nursing staff develops, and keeps current, a nursing care plan for each patient.

nS-8.1 Nursing care planning starts upon admission. It includes planning the pa-tient’s care while in the hospital as well as planning for discharge to meet post-hospital needs. A nursing care plan is based on assessing the patient’s nursing care needs (not solely those needs related to the admitting diagnosis) and developing appropriate nursing interventions in response to those needs. The nursing care plan is kept current by ongoing assessments of the patient’s needs and the patient’s response to interventions, and updating or revising the patient’s nursing care plan in response to assessments. The nursing care plan is part of the patient’s medical record and must comply with the re-quirements for patient records and other patient information.

Surveyor Guidance: • Selectasampleofnursingcareplans.Approximately6-12plansshouldbereviewed. • Aretheyinitiatedassoonaspossibleafteradmissionforeachpatient? • Dotheydescribepatientgoalsandasappropriatephysiologicalandpsychosocial

factorsandpatientdischargeplanning? • IseachplanconsistentwiththeattendingMD’splanformedicalcare?Arethey

revisedastheneedsofthepatientchanges? • Arenursingcareplansimplementedinatimelymanner?

nS-9 A registered nurse must assign the nursing care of each patient to other nursing personnel in accordance with the patient’s needs and the special-ized qualifications and competence of the nursing staff available.

nS-9.1 A RN must make all patient care assignments. The director of the nursing service and the hospital are to ensure that nursing personnel with the appropriate education, experience, licensure, competence and specialized qualifications are assigned to provide nursing care for each patient in ac-cordance with the individual needs of each patient.

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Surveyor Guidance: • Reviewthenursingassignments.DidanRNmaketheassignments?Determinethattheassignmentstakeintoconsiderationthecomplexityofpatientcareneedsandthecompetenceandspecializedqualificationsofthenursingstaff.

• Askaregisterednursewhatconsiderationsarenecessarywhenmakingstaffassign-ments.Answersshouldinclude:

- Patientneeds; - Complexityofpatients; - Anyspecialneedsofindividualpatients; - Competenceofnursingpersonnel; - Qualificationsofnursingpersonnel; - Educationofnursingpersonnel;and - Experienceofnursingpersonnel.

nS-10 Non-employee licensed nurses who are working in the hospital must adhere to the policies and procedures of the hospital. The director of nursing ser-vice must provide for the adequate supervision and evaluation of the clinical activities of non-employee nursing personnel, which occur within the responsibility of the nursing services.

nS-10.1 The hospital must ensure that there are adequate numbers of clinical nursing personnel to meet its patient nursing care needs. In order to meet their patient needs the hospital may supplement their hospital employed licensed nurses with volunteer and or contract non-employee licensed nurses.

nS-10.2 The hospital and the director of the nursing service are responsible for the clinical activities of all nursing personnel. This would include the clinical activities of all non-employee nursing personnel (contract or volunteer).

nS-10.3 Non-employee licensed nurses who are working at the hospital must adhere to the policies and procedures of the hospital. The hospital and the director of the nursing service are responsible for ensuring that non-employee nursing personnel know the hospital’s policies and procedures in order to adhere to those policies and procedures.

nS-10.4 The hospital and the director of the nursing service ensure that each non-employee nursing care staff person is adequately supervised and that their clinical activities are evaluated. This supervision and evaluation of the clinical activities of each non-employee nursing staff person must be conducted by an appropriately qualified hospital-employed RN.

Surveyor Guidance: • Reviewthemethodfororientingnon-employeelicensednursestohospitalpoliciesandprocedures.Theorientationshouldincludeatleastthefollowing:

- Thehospitalandtheunit; - Emergencyprocedures; - Nursingservicespoliciesandprocedures;and - Safetypoliciesandprocedures. • Determineifnon-employeenursingpersonnelareappropriatelyorientedpriorto

providingcare.Ifthehospitalusesnon-employeelicensednurses,doesaRNwhoisa

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NSregularemployeeofthehospitalsupervisethem?Observethecareprovidedbynon-employeenursingpersonnel.

- Dotheyknowandadheretohospitalpolicies? - Dotheyknowappropriateemergencyprocedures? - AretheyadequatelysupervisedbyanappropriatelyexperiencedhospitalemployedRN? - Aretheirclinicalactivitiesbeingevaluatedadequately? - Aretheylicensedinaccordancewithapplicablelawsandregulationslaw? • Confirmwiththedirectorofnursesthatanon-employeenurse’sperformanceis

evaluatedbythehospitalatleastonceayear.Iftheperformanceevaluationisnotconsideredconfidential,reviewtwoevaluations.

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medical record services

Mr-1 The hospital must have a medical record service that has administrative responsibility for medical records. A medical record must be maintained for every individual evaluated or treated in the hospital.

Interpretive Guidelines: • Theterm"hospital"includesalllocationsofthehospital. • Thehospitalmusthaveoneunifiedmedicalrecordservicethathasadministrative

responsibilityforallmedicalrecords,bothinpatientandoutpatientrecords.Thehospitalmustcreateandmaintainamedicalrecordforeveryindividual,bothinpa-tientandoutpatientevaluatedortreatedinthehospital.

• Theterm"medicalrecords"includesatleastwrittendocuments,computerizedelectronicinformation,radiologyfilmandscans,laboratoryreportsandpathologyslides,videos,audiorecordings,andotherformsofinformationregardingtheconditionofapatient.

Surveyor Guidance: • Reviewtheorganizationalstructureandpolicystatementsandinterviewthepersonresponsibleforthemedicalrecordsservicetoascertainthattheserviceisstructuredappropriatelytomeettheneedsofthehospitalandthepatients.

• Reviewasampleofactiveandclosedmedicalrecordsforcompletenessandaccuracyinaccordancewithapplicablelawsandregulationsandhospitalpolicy.Thesampleshouldbe10percentoftheaveragedailycensusandbenolessthan30records.Additionally,selectasampleofoutpatientrecordsinordertodeterminecomplianceinoutpatientdepartments,services,andlocations.

Mr-2 Organization and Staffing: The organization of the medical record service must be appropriate to the scope and complexity of the services performed. The hospital must employ adequate personnel to ensure prompt comple-tion, filing, and retrieval of records.

Interpretive Guidelines: • Themedicalrecordsservicemustbeorganized,equipped,andstaffedinaccordancewiththescopeandcomplexityofthehospital’sservicesandinsuchamannerastocomplywiththerequirementsofthisregulationandotherapplicablelawsandregula-tionsandregulations.Theremustbeanestablishedmedicalrecordsystemthatisorganizedandemploysadequatepersonneltoensureprompt:

- Completionofmedicalrecords; - Filingofmedicalrecords;and - Retrievalofmedicalrecords. - Theterm“employsadequatepersonnel”includes: ◦ Thatmedicalrecordpersonnelareemployeesofthehospital; ◦ Thatthehospitalemploysanadequatenumberofmedicalrecordpersonnel,

employsadequatetypesofmedicalrecordpersonnel,andemployspersonnelwhopossessadequateeducation,skills,qualificationsandexperiencetoensurethehospitalcomplieswithrequirementsofthisregulationandotherapplicablelawsandregulationsandregulations.

Surveyor Guidance: • Verifythatthereisanestablishedsystemthataddressesatleastthefollowingactivitiesofthemedicalrecordsservices:

- Timelyprocessingofrecords; - Coding/indexingofrecords; - Retrievalofrecords;

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- Compilingandretrievalofdataofqualityassuranceactivities.Verifythatthesystemisreviewedandrevisedasneeded.

- Interviewstaff,ifneeded,reviewwrittenjobdescriptionsandstaffingschedulestodetermineifstaffiscarryingoutalldesignatedresponsibilities.

- Verifythatthehospitalemploysadequatemedicalrecordpersonnelaspreviouslydescribed.

- Aremedicalrecordspromptlycompletedinaccordancewithapplicablelawsandregulationsandhospitalpolicy?

- Selectasampleofpastpatientsofthehospital(inpatientand/oroutpatient).Requestthosepatients’medicalrecords.Canthehospitalpromptlyretrievethoserecords?

Mr-3 Form and Retention of Record: The hospital must maintain a medical record for each inpatient and outpatient. Medical records must be accurately written, promptly completed, properly filed and retained, and accessible. The hospital must use a system of author identification and record mainte-nance that ensures the integrity of the authentication and protects the security of all record entries.

Mr-3.1 The hospital must maintain a medical record for each inpatient and outpa-tient evaluated or treated in any part or location of the hospital.

Mr-3.2 All medical records must be accurately written. The hospital must ensure that all medical records accurately and completely document all orders, test results, evaluations, care plans, treatments, interventions, care provided and the patient’s response to those treatments, interventions and care.

Mr-3.3 All medical records must be promptly completed. Every medical record must be complete with all documentation of orders, diagnosis, evaluations, treat-ments, test results, care plans, discharge plans, consents, interventions, discharge summary, and care provided along with the patient’s response to those treatments, interventions, and care. The record must be completed promptly after discharge in accordance with applicable laws and regulations and hospital policy but no later than 30 days after discharge.

Mr-3.4 The medical record must be properly filed and retained. The hospital must have a medical record system that ensures the prompt retrieval of any medical record, of any patient evaluated or treated at any location of the hospital within the past 5 years.

Mr.3.5 The medical record must be accessible. The hospital must have a medical record system that allows the medical record of any patient, inpatient or outpatient, evaluated and/or treated at any location of the hospital within the past 5 years to be accessible by appropriate staff, 24 hours a day, 7 days a week, whenever that medical record may be needed.

Mr-3.6 Medical records must be properly stored in secure locations where they are protected from fire, water damage and other threats.

Mr-3.7 Medical information such as consultations, orders, practitioner notes, x-ray interpretations, lab test results, diagnostic test results, patient assessments and other patient information must be accurately written, promptly com-pleted and properly filed in the patients’ medical record, and accessible to

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the physicians or other care providers when needed for use in making assessments of the patient’s condition, decisions on the provision of care to the patient, and in planning the patient’s care. This requirement applies to the medical records of current inpatients and outpatients of the hospital.

Mr-3.8 The hospital must have a system of author identification and record mainte-nance that ensures the integrity of the authentication and protects the security of all record entries. The medical record system must correctly iden-tify the author of every medical record entry and must protect the security of all medical record entries. The medial record system must ensure that medical record entries are not lost, stolen, destroyed, altered, or reproduced in an unauthorized manner. Locations where medical records are stored or main-tained must ensure the integrity, security and protection of the records. These requirements apply to both manual and electronic medical record systems.

Surveyor Guidance: • Determinethelocation(s)wheremedicalrecordsaremaintained. • Verifythatamedicalrecordismaintainedforeachpersontreatedorreceivingcare.The

hospitalmayhaveaseparaterecordforbothinpatientsandoutpatients.However,whentwodifferentsystemsareusedtheymustbeappropriatelycross-referencedandaccessible.

• Verifythatproceduresensuretheintegrityofauthenticationandprotectthesecurityofpatientrecords.

• Verifythatmedicalrecordsarestoredandmaintainedinlocationswheretherecordsaresecure,thatprotectsthemfromdamage,flood,fire,etc.,andlimitsaccesstoonlyauthorizedindividuals.

• Verifythatrecordsareaccurate,completedpromptly,easilyretrievedandreadilyaccessible,asneeded,inalllocationswheremedicalrecordsaremaintained.

Mr-4 Medical records must be retained in their original or legally reproduced form for a period of at least 5 years.

Interpretive Guidelines: • Medicalrecordsareretainedintheiroriginalorlegallyreproducedforminhardcopy,microfilm,computermemory,orotherelectronicstoragemedia.Thehospitalmustbeabletopromptlyretrievethecompletemedicalrecordofeveryindividualevaluatedortreatedinanypartorlocationofthehospitalwithinthelast5years.

• Inaccordancewithapplicablelawsandregulationsandregulations,certainmedicalrecordsmayhaveretentionrequirementsthatexceed5years.

Surveyor Guidance: • Determinethatrecordsareretainedforatleast5years,ormoreifrequiredbyapplicablelawsandregulations.

• Selectasampleofpatients,bothinpatientandoutpatientwhowerepatientsofthehospitalbetweentheprevious48-60months.Requesttheirmedicalrecord.Isitpromptlyretrieved?Isitcomplete?Isitinoriginalorinalegallyreproducedform?

Mr-5 The hospital must have a system of coding and indexing medical records. The system must allow for timely retrieval by diagnosis and procedure, in order to support medical care evaluation studies.

Interpretive Guidelines: • Verifythatthehospitalusesacodingandindexingsystemthatpermitstimelyretrievalofpatientrecordsbydiagnosisandprocedures.

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MRMr-6 The hospital must have a procedure for ensuring the confidentiality of patient records. Information from or copies of records may be released only to authorized individuals.

Mr-6.1 The hospital has sufficient safeguards to ensure that access to all informa-tion regarding patients is limited to those individuals designated by law, regulation, and policy; or duly authorized as having a need to know. No unauthorized access or dissemination of clinical records is permitted. Clinical records are kept secure and are only viewed when necessary by those persons having a part in the patient’s care.

Mr-6.2 The right to confidentiality means safeguarding the content of information, including patient paper records, video, audio, and/or computer stored infor-mation from unauthorized disclosure without the specific informed consent of the individual, parent of a minor child, or legal guardian. Hospital staff and consultants, hired to provide services to the individual, should have access to only that portion of information that is necessary to provide effective responsive services to that individual.

Mr-6.3 Confidentiality applies to both central records and clinical record information that may be kept at dispersed locations.

Surveyor Guidance: • Verifythatonlyauthorizedpersonsarepermittedaccesstorecordsmaintainedbythemedicalrecordsdepartment.

• Verifythatthehospitalhasapolicytograntpatientsdirectaccesstohis/hermedicalrecordiftheresponsibleofficial(e.g.,MDresponsibleforpatient’scare)determinesthatdirectaccessisnotlikelytohaveanadverseeffectonthepatient.

• Verifythatmedicalrecordsandotherconfidentialpatientinformationarereleasedonlyforpatientcareevaluation,utilizationreview,treatment,qualityassuranceprograms,in-houseeducationalpurposes,orinaccordancewithapplicablelawsandregulations,courtorders,orsubpoenas.

• Verifythatcopiesofmedicalrecordsandotherconfidentialpatientinformationarereleasedoutsidethehospitalonlyuponwrittenauthorizationofthepatient,legalguardian,orpersonwithanappropriatepowerofattorneytoactonthepatient’sbehalf,oronlyifthereisaproperlyexecutedsubpoenaorcourtorder,orasmandatedbyapplicablelawsandregulations.

• Verifythatprecautionsaretakentopreventunauthorizedpersonsfromgainingphysicalaccessorelectronicaccesstoinformationinpatientrecords.

Mr-7 Information from or copies of records may be released only to authorized individuals, and the hospital must ensure that unauthorized individuals cannot gain access to or alter patient records.

Interpretive Guidelines: • Thehospital’spatientrecordsystemmustensurethesecurityofpatientrecords.Thehospitalmustensurethatunauthorizedindividualscannotgainaccesstopatientrecordsandthatindividualscannotalterpatientrecords.Patientrecordsmustbesecureatalltimesandinalllocations.Thisincludesopenpatientrecordsforpatientswhoarecurrentlyinpatientsinthehospitalandoutpatientsinoutpatientclinics.

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MRSurveyor Guidance: • Observethehospital’ssecuritypracticesforpatientrecords.Arepatientrecordsleft

unsecuredorunattended?Arepatientrecordsunsecuredorunattendedinhallways,patientrooms,nurse'sstations,oroncounterswhereanunauthorizedpersoncouldgainaccesstopatientrecords?

• Verifythatthereisanestablishedsysteminplacethataddressesprotectingtheconfidentialityofmedicalinformation.

• Ifthehospitaluseselectronicpatientrecords,areappropriatesecuritysafeguardsinplace?Isaccesstopatientrecordscontrolled?

• Verifythatadequateprecautionsaretakentopreventphysicalorelectronicaltering,damagingordeletion/destructionofpatientrecordsorinformationinpatientrecords.

Mr-8 Original medical records must be released by the hospital only in accord-ance with applicable laws and regulations, court orders, or subpoenas.

Mr-9 Content of Record: The medical record must contain information to justify admission and continued hospitalization, support the diagnosis, and de-scribe the patient’s progress and response to medications and services.

Mr-9.1 The medical record must contain information such as notes, documentation, records, reports, recordings, test results, assessments etc. to:

Interpretive Guidelines: • Justifyadmission; • Justifycontinuedhospitalization; • Supportthediagnosis; • Describethepatient’sprogress; • Describethepatient’sresponsetomedications;and • Describethepatient’sresponsetoservicessuchasinterventions,care,treatments,etc.

Mr-9.2 The medical record must contain complete information/documentation regarding evaluations, interventions, care provided, services, care plans, discharge plans, and the patient’s response to those activities.

Mr-9.3 Patient medical record information, such as, laboratory reports, test results, consults, assessments, radiology reports, dictated notes, etc. must be promptly filed in the patient’s medical record in order to be available to the physician and other care providers to use in making assessments of the patient’s condition, to justify continued hospitalization, to support the diagnosis, to describe the patient’s progress, and to describe the patient’s response to medications, interventions, and services, in planning the pa-tient’s care, and in making decisions on the provision of care to the patient.

Mr-10 All patient medical record entries must be legible, complete, dated, timed, and authenticated in written or electronic form by the person responsible for providing or evaluating the service provided, consistent with hospital policies and procedures.

Mr-10.1 All entries in the medical record must be legible. Orders, progress notes, nursing notes, or other entries in the medical record that are not legible may be mis-read or misinterpreted and may lead to medical errors or other adverse patient events. All entries in the medical record must be complete. A medical record is

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MRconsidered complete if it contains sufficient information to identify the patient; support the diagnosis/condition; justify the care, treatment, and services; document the course and results of care, treatment, and services; and promote continuity of care among providers. With these criteria in mind, an individual entry into the medical record must contain sufficient information on the matter that is the subject of the entry to permit the medical record to satisfy the completeness standard. All entries in the medical record must be dated, timed, and authenticated, in written or electronic form, by the person responsi-ble for providing or evaluating the service provided.

Interpretive Guidelines: • Thetimeanddateofeachentry(orders,reports,notes,etc.)mustbeaccuratelydocu-mented.Timingestablisheswhenanorderwasgiven,whenanactivityhappenedorwhenanactivityistotakeplace.Timinganddatingentriesisnecessaryforpatientsafetyandqualityofcare.Timinganddatingofentriesestablishesabaselineforfutureactionsorassessmentsandestablishesatimelineofevents.Manypatientinterventionsorassess-mentsarebasedontimeintervalsortimelinesofvarioussigns,symptoms,orevents.

• Thehospitalmusthaveamethodtoestablishtheidentityoftheauthorofeachentry.Thiswouldincludeverificationoftheauthoroffaxedorders/entriesorcomputerentries.

• Thehospitalmusthaveamethodtorequirethateachauthortakesaspecificactiontoverifythattheentrybeingauthenticatedishis/herentryorthathe/sheisresponsiblefortheentry,andthattheentryisaccurate.

Mr-10.2 The requirements for dating and timing do not apply to orders or prescriptions that are generated outside of the hospital until they are presented to the hospital at the time of service. Once the hospital begins processing such an order or prescription, it is responsible for ensuring that the implementation of the order or prescription by the hospital is promptly dated, and timed in the patient’s medical record.

Mr-10.3 When a practitioner is using a preprinted order set, the ordering practitioner may be in compliance with the requirement standard to date, time, and authenticate an order if the practitioner accomplishes the following:

MR-10.3.1 Last page: Sign, date, and time the last page of the orders, with the last page also identifying the total number of pages in the order set.

MR-10.3.2 Pages with Internal Selections: Sign or initial any other (internal) pages of the order set where selections or changes have been made.

Interpretive Guidelines: • Thepractitionershouldinitial/signthetoporbottomofthepertinentpage(s);and • Thepractitionershouldalsoinitialeachplaceinthepreprintedordersetwhere

changes,suchasadditions,deletions,orstrikeoutsofcomponentsthatdonotapply,havebeenmade.

• Itisnotnecessarytoinitialeverypreprintedboxthatischeckedtoindicateselectionofanorderoption,solongastherearenochangesmadetotheoption(s)selected.

Mr-10.4 In the case of a pre-established electronic order set, the same principles would apply, so that the practitioner would date, time and authenticate the final order that resulted from the electronic selection/annotation process, with the exception that pages with internal changes would not need to be initialed or signed if they are part of an integrated single electronic document.

Mr-10.5 Authentication of medical record entries may include written signatures, initials, computer key, or other code. For authentication, in written or elec-

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tronic form, a method must be established to identify the author. When rubber stamps or electronic authorizations are used for authentication, the hospital must have policies and procedures to ensure that such stamps or authorizations are used only by the individuals whose signature they repre-sent. There shall be no delegation of stamps or authentication codes to another individual.

Mr-10.6 Where an electronic medical record is in use, the hospital must demonstrate how it prevents alterations of record entries after they have been authenti-cated. Information needed to review an electronic medical record, including pertinent codes and security features, must be readily available to surveyors to permit their review of sampled medical records while on-site in the hospital.

Mr-10.7 When applicable laws and regulations and hospital policy requires that entries in the medical record made by residents or non-physicians be coun-tersigned by supervisory or attending medical staff members, then the medical staff rules and regulations must address counter-signature require-ments and processes.

Mr-10.8 A system of auto-authentication in which a physician or other practitioner authenticates an entry that he or she cannot review, e.g., because it has not yet been transcribed, or the electronic entry cannot be displayed, is not consistent with these requirements. There must be a method of determining that the practitioner did, in fact, authenticate the entry after it was created. In addition, failure to disapprove an entry within a specific time period is not acceptable as authentication.

Mr-10.9 The practitioner must separately date and time his/her signature authenti-cating an entry, even though there may already be a date and time on the document, since the latter may not reflect when the entry was authenticat-ed. For certain electronically generated documents, where the date and time that the physician reviewed the electronic transcription is automatically printed on the document, the requirements of this section would be satis-fied. However, if the electronically generated document only prints the date and time that an event occurred (e.g., EKG printouts, lab results, etc.) and does not print the date and time that the practitioner actually reviewed the document, then the practitioner must either authenticate, date, and time this document itself or incorporate an acknowledgment that the document was reviewed into another document (such as the H&P, a progress note, etc.), which would then be authenticated, dated, and timed by the practitioner.

Surveyor Guidance: • Reviewasampleofopenandclosedmedicalrecords. • Determinewhetherallmedicalrecordentriesarelegible.Aretheyclearlywrittenin

suchawaythattheyarenotlikelytobemisreadormisinterpreted? • Determinewhetherorders,progressnotes,nursingnotes,orotherentriesinthe

medicalrecordarecomplete.Doesthemedicalrecordcontainsufficientinformationtoidentifythepatient;supportthediagnosis/condition;justifythecare,treatment,andservices;documentthecourseandresultsofcare,treatment,andservices;andpromotecontinuityofcareamongproviders?

• Determinewhethermedicalrecordentriesaredated,timed,andappropriatelyauthenticatedbythepersonwhoisresponsibleforordering,providing,orevaluatingtheserviceprovided.

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MR • Determinewhetherallorders,includingverbalorders,arewritteninthemedicalrecordandsignedbythepractitionerwhoiscaringforthepatientandwhoisauthorizedbyhospitalpolicyandinaccordancewithapplicablelawsandregulationstowriteorders.

• Determinewhetherthehospitalhasameansforverifyingsignatures,bothwrittenandelectronic,writteninitials,codes,andstampswhensuchareusedforauthorshipidentification.Forelectronicmedicalrecords,askthehospitaltodemonstratethesecurityfeaturesthatmaintaintheintegrityofentriesandverificationofelectronicsignaturesandauthorizations.Examinethehospital’spoliciesandproceduresforusingthesystem,anddetermineifdocumentsarebeingauthenticatedaftertheyarecreated.

Mr-11 All orders, including verbal orders, must be dated, timed, and authenticated promptly by the ordering practitioner.

Interpretive Guidelines: • Thehospitalmustensurethatallorders,includingverbalorders,aredated,timed,andauthenticatedpromptly.

• Verbalordersareordersformedications,treatments,interventionsorotherpatientcarethataretransmittedasoral,spokencommunicationsbetweensendersandreceivers,deliveredeitherface-to-faceorviatelephone.

• Thereceiverofaverbalordermustdate,time,andsigntheverbalorderinaccord-ancewithhospitalpolicy.

• Theprescribingpractitionermustverify,sign,dateandtimetheorderassoonaspossibleafterissuingtheorder,inaccordancewithhospitalpolicy,andapplicablelawsandregulations.

• Authenticationofaverbalordermaybewritten,electronic,orfaxed.Thehospitalmusthaveamethodforestablishingtheidentityofthepractitionerwhohasgivenaverbalorder,includingverificationoftheauthoroffaxedverbalordersorcomputerentries.

• Insomeinstances,theorderingpractitionermaynotbeabletoauthenticatehisorherverbalorder(e.g.,theorderingpractitionergivesaverbalorderwhichiswrittenandtranscribed,andthenisoffdutyfortheweekendoranextendedperiodoftime).Insuchcases,anexamplewouldbe-foratemporaryperiodexpiringonJanuary26,2012,itisacceptableforanotherpractitionerwhoisresponsibleforthepatient’scaretoauthenticatetheverbalorderoftheorderingpractitioner.

• Allpractitionersresponsibleforthepatient’scareareexpectedtohaveknowledgeofthepatient’shospitalcourse,medicalplanofcare,condition,andcurrentstatus.

• Whenapractitionerotherthantheorderingpractitionersignsaverbalorder,thatpractitionerassumesresponsibilityfortheorderasbeingcomplete,accurateandfinal.

• Ifapplicablelawandregulationsrequirethattheprescribingpractitionerauthenti-catetheverbalorders,apractitionerotherthantheprescribingpractitionerwouldnotbepermittedtoauthenticatetheverbalorderinthatgoverningbody.

Surveyor Procedures: • Doesthehospitalhavepoliciesandproceduresrequiringpromptauthenticationofallorders,includingverbalorders,bytheprescribingpractitioneror,ifpermittedunderapplicablelawsandregulations,anotherpractitionerresponsibleforthecareofthepatient?

• Dothehospital'spoliciesandproceduresforverbalordersincludea"readbackandverify"processwherethereceiveroftheorderreadsbacktheordertotheorderingpractitionertoverifyitsaccuracy?

• Revieworders,includingverbalorders,inasampleofmedicalrecords.Haveordersbeendated,timed,andauthenticatedpromptlybytheorderingpractitioneroranotherpractitionerwhoisresponsibleforthecareofthepatientandwhoisauthorizedtowriteordersbyhospitalpolicyinaccordancewithapplicablelawsandregulations?

• Hasthereceiverofanorder,includingverbalorders,dated,timed,andsignedtheorderaccordingtohospitalpolicy?

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MRMr-12 All verbal orders must be authenticated based upon applicable laws and regulations. If there are no applicable laws and regulations that designate a specific time frame for the authentication of verbal orders, verbal orders must be authenticated within 48 hours.

Interpretive Guidelines: • Thisregulationprovidesthat,iftherearenoapplicablelawsandregulationsdesig-natingaspecifictimeframeforauthenticationofverbalorders,andthensuchordersmustbeauthenticatedwithin48hours.

• Authenticationofaverbalorderrepresentsanopportunitytoidentifyatranscriptionerrorandpotentialrisktopatientsafety.Promptauthenticationofaverbalorderenablesearlyidentificationandcorrectionofanerror.

Mr-13 All records must document the following, as appropriate evidence of a medical history and physical examination completed and documented no more than 30 days before or 24 hours after admission or registration, but prior to surgery or a procedure requiring anesthesia services. The medical history and physical examination must be placed in the patient’s medical record within 24 hours after admission or registration, but prior to surgery or a procedure requiring anesthesia services.

Interpretive Guidelines: • Themedicalrecordmustincludedocumentationthatamedicalhistoryandphysicalexamination(H&P)wascompletedanddocumentedforeachpatientnomorethan30dayspriortohospitaladmissionorregistration,or24hoursafterhospitaladmissionorregis-tration,butinallcasespriortosurgeryoraprocedurerequiringanesthesiaservices.

• ThepurposeofanH&Pistodeterminewhetherthereisanythinginthepatient'soverallconditionthatwouldaffecttheplannedcourseofthepatient'streatment,suchasanallergytoamedicationthatmustbeavoided,oraco-morbiditythatrequirescertainadditionalinterventionstoreducerisktothepatient.

• TheH&Pdocumentationmustbeplacedinthemedicalrecordwithin24hoursofadmissionorregistration,butinallcasespriortosurgeryoraprocedurerequiringanesthesiaservices,includingallinpatient,outpatient,orsame-daysurgeriesorprocedures.TheH&Pmaybehandwrittenortranscribed.AnH&Pthatiscompletedwithin24hoursofthepatient’sadmissionorregistration,butaftersurgeryoraproce-durerequiringanesthesiawouldnotbeincompliance.

• TheH&Pmustbecompletedanddocumentedbyaphysician,ormaxillofacialsur-geon,orotherqualifiedlicensedindividualinaccordancewithapplicablelawsandregulationsandhospitalpolicy.

• Inallcasesthepractitionersincludedinthedefinitionofaphysicianmustbelegallyauthorizedtopracticewithintheapplicablelawsandregulationswherethehospitalislocatedandprovidingserviceswithintheirauthorizedscopeofpractice.

• Otherqualifiedindividualsarethoselicensedpractitioners(suchasnursepractitionersandphysicianassistants)whoarepermittedbytheirapplicablelawsandregulationsandscopeofpracticelawsorregulationstoconductahistoryandphysicalexamina-tion,andwhoarealsoformallyauthorizedbythehospitaltoconductanH&P.

• Morethanonequalifiedlicensedpractitionercanparticipateinperforming,docu-menting,andauthenticatinganH&Pforasinglepatient.Whenperformance,docu-mentation,andauthenticationaresplitamongqualifiedpractitioners,thepractitionerwhoauthenticatestheH&Pwillbeheldresponsibleforitscontents.

• AhospitalmayadoptapolicyallowingsubmissionofanH&Ppriortothepatient’shospitaladmissionorregistrationbyaphysicianwhomaynotbeamemberofthehospi-

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MRtal'smedicalstafforwhodoesnothaveadmittingprivilegesbythathospital,orbyaqualifiedlicensedindividualwhodoesnotpracticeatthathospitalbutisactingwithinhis/herscopeofpracticeunderapplicablelawsandregulationsorregulation.GenerallythisoccurswheretheH&Piscompletedinadvancebythepatient’sprimarycarephysician.

• WhentheH&Pisconductedwithin30daysbeforeadmissionorregistration,anupdatemustbecompletedanddocumentedbyalicensedpractitionerwhoiscreden-tialedandprivilegedbythehospital’smedicalstafftoperformanH&P.

Surveyor Guidance: • Reviewasampleofinpatientmedicalrecordsforvarioustypesofpatientsandoutpatientmedicalrecordsforpatientshavingsamedaysurgeryoraprocedurerequiringanesthesiatodeterminewhether:

• ThereisanH&Pthatwasdonenomorethan30daysbeforeor24hoursafteradmis-sionorregistration,but,forallcasesinvolvingsurgeryoraprocedurerequiringanesthesiaservices,priortothesurgeryorprocedure;

• TheH&Pdocumentationwasplacedinthemedicalrecordwithin24hoursafteradmissionorregistration,but,forallcasesinvolvingsurgeryoraprocedurerequir-inganesthesiaservices,priortothesurgeryorprocedure;

• AphysicianperformedtheH&P,ormaxillofacialsurgeonorotherqualifiedlicensedindi-vidualauthorizedinaccordancewithapplicablelawsandregulationsandhospitalpolicy.

Mr-14 All records must document the following, as appropriate evidence of an updated examination of the patient, including any changes in the patient’s condition, when the medical history and physical examination are complet-ed within 30 days before admission or registration. Documentation of the updated examination must be placed in the patient’s medical record within 24 hours after admission or registration, but prior to surgery or a procedure requiring anesthesia services.

Interpretive Guidelines: • WhenanH&Piscompletedwithinthe30daysbeforeadmissionorregistration,thehospitalmustensurethatanupdatedmedicalrecordentrydocumentinganexamina-tionforanychangesinthepatient'sconditionisplacedinthepatient'smedicalrecordwithin24hoursafteradmissionorregistration,but,inallcasesinvolvingsurgeryoraprocedurerequiringanesthesiaservices,priortothesurgeryorprocedure.Theexaminationmustbeconductedbyapractitionerwhoiscredentialedandprivilegedbythehospital’smedicalstafftoperformanH&P.

• Theupdatenotemustdocumentanexaminationforanychangesinthepatient'scondi-tionsincethetimethatthepatient'sH&Pwasperformedthatmightbesignificantfortheplannedcourseoftreatment.Thephysician,ormaxillofacialsurgeon,orqualifiedlicensedindividualuseshis/herclinicaljudgment,baseduponhis/herassessmentofthepatient’sconditionandco-morbidities,ifany,inrelationtothepatient’splannedcourseoftreatmenttodecidetheextentoftheupdateassessmentneededaswellastheinforma-tiontobeincludedintheupdatenoteinthepatient’smedicalrecord.

• If,uponexamination,thelicensedpractitionerfindsnochangeinthepatient'scondi-tionsincetheH&Pwascompleted,he/shemayindicateinthepatient'smedicalrecordthattheH&Pwasreviewed,thepatientwasexamined,andthat"nochange"hasoccurredinthepatient'sconditionsincetheH&Pwascompleted.Anychangesinthepatient’sconditionmustbedocumentedbythepractitionerintheupdatenoteandplacedinthepatient’smedicalrecordwithin24hoursofadmissionorregistration,butpriortosurgeryoraprocedurerequiringanesthesiaservices.Additionally,ifthepractitionerfindsthattheH&Pdonebeforeadmissionisincomplete,inaccurate,orotherwiseunacceptable,thepractitionerreviewingtheH&P,examiningthepatient,

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MRandcompletingtheupdatemaydisregardtheexistingH&P,andconductanddocu-mentinthemedicalrecordanewH&Pwithin24hoursafteradmissionorregistra-tion,butpriortosurgeryoraprocedurerequiringanesthesia.

Surveyor Guidance: • Inthesampleofmedicalrecordsselectedforreview,lookforcaseswherethemedicalhistoryandphysicalexaminationwascompletedwithin30daysbeforeadmissionorregistration.

• Determinewhetheranupdatedmedicalrecordentrydocumentinganexaminationforchangesinthepatient'sconditionwascompletedanddocumentedinthepatient'smedicalrecordwithin24hoursafteradmissionorregistration.

• Determinewhether,inallcasesinvolvingsurgeryoraprocedurerequiringanesthesiaservices,theupdatewascompletedanddocumentedpriortothesurgeryorprocedure.

Mr-15 All records must document the admitting diagnosis.

Surveyor Guidance: • Verifyinasampleofmedicalrecordsthatthepatient’sadmittingdiagnosisisdocu-mentedineachmedicalrecord.

Mr-16 All records must document the results of all consultative evaluations of the patient and appropriate findings by clinical and other staff involved in the care of the patient.

Mr-16.1 All patient records, both inpatient and outpatient, must contain the results of all consultative evaluations of the patient and appropriate findings by clinical and other staff involved in the care of the patient. This information must be promptly filed in the patient’s medical record in order to be avail-able to the physician or other care providers to use in making assessments of the patient’s condition, to justify treatment or continued hospitalization, to support or revise the patient’s diagnosis, to support or revise the plan of care, to describe the patient’s progress and to describe the patient’s re-sponse to medications, treatments, and services.

Surveyor Guidance: • Reviewasampleofmedicalrecordsofpatientswhohaveordersforconsultativeevaluations.Aretheresults/reportsandotherclinicalfindingsofthoseconsultativeevaluationsincludedinthepatient’smedicalrecord?

Mr-17 All records must document the documentation of complications, hospital acquired infections, and unfavorable reactions to drugs and anesthesia.

Interpretive Guidelines: • Allpatientmedicalrecords,bothinpatientandoutpatient,mustdocument: - Complication; - Hospital-acquiredinfections; - Unfavorablereactionstodrugs;and - Unfavorablereactionstoanesthesia.

Surveyor Guidance: • Throughobservations,interviews,andreviewsofhospitalreportsanddocumentation,determineifpatientcomplications,hospital-acquiredinfections,unfavorablereactionstodrugs/anesthesiahavebeendocumentedintheapplicablepatient’smedicalrecord.

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MRMr-18 All records must document the properly executed informed consent forms for procedures and treatments specified by the medical staff, or by applica-ble laws and regulations if applicable, to require written patient consent.

Interpretive Guidelines: • Themedicalrecordmustcontainadocumentrecordingthepatient’sinformedconsentforthoseproceduresandtreatmentsthathavebeenspecifiedasrequiringinformedconsent.Hospitalpoliciesshouldaddresswhichproceduresandtreatmentsrequirewritteninformedconsent.Theremayalsobeapplicablelawsandregulationsrequir-inginformedconsent.Theinformedconsentformcontainedinthemedicalrecordshouldprovideevidencethatitwasproperlyexecuted.

Mr-19 Informed Consent Forms: A properly executed informed consent form should reflect the patient consent process. Except as specified for emergency situa-tions in the hospital’s informed consent policies, all inpatient and outpatient medical records must contain a properly executed informed consent form prior to conducting any procedure or other type of treatment that requires informed consent. An informed consent form, in order to be properly executed, must be consistent with hospital policies as well as applicable laws and regulations.

Interpretive Guidelines: • Aproperlyexecutedinformedconsentformcontainsthefollowingminimumelements: - Nameofthehospitalwheretheprocedureorothertypeofmedicaltreatmentisto

takeplace; - Nameofthespecificprocedure,orothertypeofmedicaltreatmentforwhich

consentisbeinggiven; - Nameoftheresponsiblepractitionerwhoisperformingtheprocedureoradminis-

teringthemedicaltreatment; - Statementthattheprocedureortreatment,includingtheanticipatedbenefits,

materialrisks,andalternativetherapies,wasexplainedtothepatientorthepa-tient’slegalrepresentative;(Materialriskscouldincluderiskswithahighdegreeoflikelihoodbutalowdegreeofseverity,aswellasthosewithaverylowdegreeoflikelihoodbuthighdegreeofseverity.Hospitalsarefreetodelegatetotheresponsi-blepractitioner,whousestheavailableclinicalevidenceasinformedbythepracti-tioner’sprofessionaljudgment,thedeterminationofwhichmaterialrisks,benefitsandalternativeswillbediscussedwiththepatient.)

- Signatureofthepatientorthepatient’slegalrepresentative;and - Dateandtimetheinformedconsentformissignedbythepatientorthepatient’s

legalrepresentative.

Mr-19.1 If there are applicable laws and regulations governing the content of the informed consent form, then the hospital’s form must comply with those requirements.

Mr-19.2 A well-designed informed consent form might also include the following additional information:

Interpretive Guidelines: • Nameofthepractitionerwhoconductedtheinformedconsentdiscussionwiththepatientorthepatient’srepresentative.

• Date,time,andsignatureofthepersonwitnessingthepatientorthepatient’slegalrepresentativesigningtheconsentform.

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MR • Indicationorlistingofthematerialrisksoftheprocedureortreatmentthatwerediscussedwiththepatientorthepatient’srepresentative;

• Statement,ifapplicable,thatphysiciansotherthantheoperatingpractitioner,includ-ingbutnotlimitedtoresidents,willbeperformingimportanttasksrelatedtothesurgery,inaccordancewiththehospital’spoliciesand,inthecaseofresidents,basedontheirskillsetandunderthesupervisionoftheresponsiblepractitioner.

• Statement,ifapplicable,thatqualifiedmedicalpractitionerswhoarenotphysicianswhowillperformimportantpartsofthesurgeryoradministrationofanesthesiawillbeperformingonlytasksthatarewithintheirscopeofpractice,asdeterminedunderapplicablelawsandregulationsandregulation,andforwhichtheyhavebeengrantedprivilegesbythehospital.

Surveyor Guidance: • Verifythatthehospitalhasassuredthatthemedicalstaffhasspecifiedwhichproce-duresandtreatmentsrequirewrittenpatientconsent.

• Verifythatthehospital’sstandardinformedconsentformcontainstheelementslistedaboveastheminimumelementsofaproperlyexecutedinformedconsent.

• Comparethehospital’sstandardinformedconsentformtothehospital’spoliciesoninformedconsent,toverifythattheformisconsistentwiththepolicies.Ifthereareapplicablelawsandregulations,verifythattheformisconsistentwiththerequire-mentsofthatlaw.

• Reviewaminimumofsixrandommedicalrecordsofpatientswhohave,areundergo-ing,orareabouttoundergoaprocedureortreatmentthatrequiresinformedconsent.Verifythateachmedicalrecordcontainsinformedconsentforms.

• Verifythateachcompletedinformedconsentformcontainstheinformationforeachoftheelementslistedaboveastheminimumelementsofaproperlyexecutedinformedconsent,aswellasanyadditionalelementsrequiredbyapplicablelawsandregula-tionsand/orthehospital’spolicy.

Mr-20 All records must document all practitioners’ orders, nursing notes, reports of treatment, medication records, radiology, and laboratory reports, and vital signs and other information necessary to monitor the patient’s condition.

Interpretive Guidelines: • Therequirementmeansthatthestatedinformationisnecessarytomonitorthepa-tient’sconditionandthatthisandothernecessaryinformationmustbeinthepatient’smedicalrecord.Inorderfornecessaryinformationtobeuseditmustbepromptlyfiledinthemedicalrecordsothathealthcarestaffinvolvedinthepatient’scarecanaccess/retrievethisinformationinordertomonitorthepatient’sconditionandprovideappropriatecare.Themedicalrecordmustcontain:

- Allpractitioner’sorders(properlyauthenticated);Allnursingnotes(includingnursingcareplans);

- Allreportsoftreatment(includingcomplicationsandhospital-acquiredinfections); - Allmedicationrecords(includingunfavorablereactionstodrugs); - Allradiologyreports;Alllaboratoryreports; - Allvitalsigns;and - Allotherinformationnecessarytomonitorthepatient’scondition.

Surveyor Guidance: • Verifythatthepatientrecordscontainappropriatedocumentationofpractitioners’orders,interventions,findings,assessments,records,notes,reportsandotherinfor-mationnecessarytomonitorthepatient’scondition.

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MR • Isnecessaryinformationincludedinpatientrecordsinapromptmannersothathealthcarestaffinvolvedinthecareofthepatienthasaccesstotheinformationnecessarytomonitorthepatient’scondition?

Mr-21 All records must document the discharge summary with outcome of hospi-talization, disposition of case, and provisions for follow-up care.

Interpretive Guidelines: • Allpatientmedicalrecordsmustcontainadischargesummary.Adischargesummarydiscussestheoutcomeofthehospitalization,thedispositionofthepatient,andprovi-sionsforfollow-upcare.Follow-upcareprovisionsincludeanyposthospitalappoint-ments,howposthospitalpatientcareneedsaretobemet,andanyplansforpost-hospi-talcarebyproviderssuchashomehealth,hospice,nursinghomes,orassistedliving.

• TheMDorotherqualifiedpractitionerwithadmittingprivilegesinaccordancewithapplicablelawsandregulationsandhospitalpolicy,whoadmittedthepatient,isresponsibleforthepatientduringthepatient’sstayinthehospital.Thisresponsibilitywouldincludedevelopingandenteringthedischargesummary.

• OtherMDswhoworkwiththepatient’sMDandwhoarecoveringforthepatient’sMDandwhoareknowledgeableaboutthepatient’scondition,thepatient’scareduringthehospitalization,andthepatient’sdischargeplansmaywritethedischargesummaryattheresponsibleMD’srequest.Inaccordancewithhospitalpolicy,theMDmaydelegatewritingthedischargesummarytootherqualifiedhealthcarepersonnelandMDassistantstotheextentrecognizedunderapplicablelawsandregulationsoranotherregulatorymechanism.

• Whetherdelegatedornon-delegated,wewouldexpectthepersonwhowritesthedis-chargesummarytoauthenticate,date,andtimetheirentryandadditionallyfordelegateddischargesummarieswewouldexpecttheMDresponsibleforthepatientduringhis/herhospitalstaytoco-authenticateanddatethedischargesummarytoverifyitscontent.

• Thedischargesummaryrequirementwouldincludeoutpatientrecords.Forexample: - Theoutcomeofthetreatment,procedures,orsurgery; - Thedispositionofthecase; - Provisionsforfollow-upcareforanoutpatientsurgerypatientoranemergency

departmentpatientwhowasnotadmittedortransferredtoanotherhospital.

Surveyor Guidance: • Verifythatadischargesummaryisincludedtoassurethatpropercontinuityofcareisrequired.

• Forpatientstaysunder48hours,thefinalprogressnotesmayserveasthedischargesummaryandmustcontaintheoutcomeofhospitalization,thecasedisposition,andanyprovisionsforfollow-upcare.

• Verifythatafinaldiagnosisisincludedinthedischargesummary.

Mr-22 All records must document the final diagnosis with completion of medical records within 30 days following discharge.

Interpretive Guidelines: • Allmedicalrecordsmustcontainafinaldiagnosis.Allmedicalrecordsmustbecompletewithin30daysofdischargeoroutpatientcare.

Surveyor Guidance: • Selectasampleofpatientswhohavebeendischargedformorethan30days.Requesttheirmedicalrecords.Arethoserecordscomplete?Doeseachrecordhavethepatient’sfinaldiagnosis?

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IP

infection prevention

IP-1 Organization Policies: A person or persons must be designated as infection control officer or officers to develop and implement policies governing control of infections and communicable diseases.

IP-1.1 The hospital must designate in writing an individual or group of individuals as its infection control officer or officers. In designating infection control officers hospitals should assure that the individuals so designated are quali-fied through education, training, experience, or certification.

IP-1.2 The infection control officer(s) must develop and implement policies gov-erning the control of infections and communicable diseases. Infection control policies should address the roles and responsibilities for infection control within the hospital; how the various hospital committees and de-partments interface with the infection control program; and how to prevent infectious/communicable diseases; and how to report infectious/communi-cable diseases to the infection control program.

Surveyor Guidance: • Determinewhetheraninfectioncontrolofficer(s)isdesignatedandhastheresponsi-bilityfortheinfectionpreventionandcontrolprogram.

• Reviewthepersonnelfileoftheinfectioncontrolofficer(s)todeterminewhetherhe/sheisqualifiedthroughongoingeducation,training,experience,orcertificationtooverseetheinfectioncontrolprogram.

• Determinewhethertheinfectioncontrolofficer(s)havedevelopedandimplementedhospitalinfectioncontrolpolicies.

IP-2 The infection control officer or officers must develop a system for identify-ing, reporting, investigating, and controlling infections and communicable diseases of patients and personnel.

IP-2.1 The infection control officer or officers must develop, implement and evalu-ate measures governing the identification, investigation, reporting, preven-tion and control of infections and communicable diseases within the hospi-tal, including both healthcare–associated infections and community-acquired infections.

IP-2.1.2 Infection control policies should be specific to each department, service, and location, including off-site locations, and be evaluated and revised when indicated.

IP-2.1.3 The successful development, implementation and evaluation of a hospital-wide infection prevention and control program requires frequent collabora-tion with persons administratively and clinically responsible for inpatient and outpatient departments and services, as well as, non-patient-care support staff, such as maintenance and housekeeping staff.

IP-3 Implicit in the infection control officer(s)’ responsibility for measures to identify, investigate, report, prevent and control infections and communica-ble diseases are the following activities:

IP-3.1 Maintenance of a sanitary hospital environment;

IP-3.2 Development and implementation of infection control measures related to hospital personnel; hospital staff, for infection control purposes, includes all

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hospital staff, contract workers (e.g., agency nurses, housekeeping staff, etc.), and volunteers;

IP-3.3 Mitigation of risks associated with patient infections present upon admission;

IP-3.4 Mitigation of risks contributing to healthcare-associated infections;

IP-3.5 Active surveillance;

IP-3.6 Monitoring compliance with all policies, procedures, protocols and other infection control program requirements;

IP-3.7 Program evaluation and revision of the program, when indicated;

IP-3.8 Coordination as required by law with locality emergency preparedness and health authorities to address communicable disease threats, bioterrorism, and outbreaks;

IP-3.9 Complying with the reportable disease requirements of the local health authority; For example, a hospital with a comprehensive hospital-wide infec-tion control program should have and implement policies and procedures, based as much as possible on national guidelines, that address the following:

IP-3.10 Maintenance of a sanitary physical environment:

IP-3.10.1 Ventilation and water quality control issues, including measures taken to maintain a safe environment during internal or external construction/renovation;

IP-3.10.2 Maintaining safe air handling systems in areas of special ventilation, such as operating rooms, intensive care units, and airborne infection isolation rooms;

IP-3.10.3 Techniques for food sanitation; IP-3.10.4 Techniques for cleaning and disinfecting environmental surfaces, carpeting

and furniture; IP-3.10.5 Techniques for textiles reprocessing, storage and distribution; Techniques

for disposal of regulated and non-regulated waste; and Techniques for pest control.

IP-3.11 Hospital staff-related measures:

IP-3.11.1 Measures and authority for evaluating hospital staff immunization status for designated infectious diseases, as recommended by the CDC and its Advisory Committee on Immunization Practices (ACIP);

IP-3.11.2 Policies articulating the authority and circumstances under which the hospital screens hospital staff for infections likely to cause significant infec-tious disease or other risk to the exposed individual, and for reportable diseases, as required under applicable public health authority;

IP-3.11.3 Policies articulating when infected hospital staff are restricted from provid-ing direct patient care and/or are required to remain away from the health-care facility entirely;

IP-3.11.4 New employee and regular update training in preventing and controlling healthcare-associated infections and methods to prevent exposure to and transmission of infections and communicable diseases;

IP-3.11.5 Measures to evaluate staff and volunteers exposed to patients with infec-tions and communicable disease;

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IPIP-3.12 Mitigation of risks associated with patient infections present upon admission:

IP-3.12.1 Measures for the early identification of patients who require isolation in accordance with CDC guidelines;

IP-3.12.2 Appropriate use of personal protective equipment including gowns, gloves, masks and eye protection devices;

IP-3.12.3 Use and techniques for isolation precautions as recommended by the CDC.

IP-3.13 Mitigation of risks contributing to healthcare-associated infections:

Interpretive Guidelines: • Surgery-relatedinfectionriskmitigationmeasures: - Implementingappropriateprophylaxistopreventsurgicalsiteinfection(SSI),such

asaprotocoltoassurethatantibioticprophylaxistopreventsurgicalsiteinfectionforappropriateproceduresisadministeredattheappropriatetime,donewithanappropriateantibiotic,anddiscontinuedappropriatelyaftersurgery;

- Addressingaseptictechniquepracticesusedinsurgeryandinvasiveproceduresperformedoutsidetheoperatingtheater,includingsterilizationofinstruments;

• Otherhospitalhealthcare-associatedinfectionriskmitigationmeasures: - Promotionofhandwashinghygieneamongstaffandemployees,includingutiliza-

tionofalcohol-basedhandsanitizers; - Measuresspecifictopreventionofinfectionscausedbyorganismsthatareantibiot-

ic-resistant; - Measuresspecifictopreventionofdevice-associatedbloodstreaminfection(BSI),

suchasaprotocolforreducinginfectionsofcentralvenouscathetersspecifyingasepticprecautionsforlineinsertions,careofinsertedlines,andpromptremovalwhenalineisnolongerneeded;

- Measuresspecifictopreventionofotherdevice-associatedinfections,e.g.,thoseassociatedwithventilators,tubefeeding,indwellingurinarycatheters,etc.;

- Isolationproceduresandrequirementsforhighlyimmuno-suppressedpatientswhorequireaprotectiveenvironment.

- Caretechniquesfortracheostomycare,respiratorytherapy,burnsandothersituationsthatreduceapatient’sresistancetoinfection;

- Requiringdisinfectants,antiseptics,andgermicidestobeusedinaccordancewiththemanufacturers’instructions;

- Appropriateuseoffacilityandmedicalequipment,includingnegativeandpositivepressureisolationroomequipment,portableairfiltrationequipment,treatmentboothsandenclosedbeds,UVlights,andotherequipmentusedtocontrolthespreadofinfectiousagents;

- Adherencetonationallyrecognizedinfectionpreventionandcontrolprecautions,suchascurrentCDCguidelinesandrecommendations,forinfections/communica-blediseasesidentifiedaspresentinthehospital;and

- Educatingpatients,visitors,caregivers,andstaff,asappropriate,aboutinfectionsandcommunicablediseasesandmethodstoreducetransmissioninthehospitalandinthecommunity.

IP-4 Active surveillance:

Interpretive Guidelines: • Methodsforobtainingandreviewingdataoninfections/communicablediseasesselectedformonitoring;

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IP • Methodsformonitoringandevaluatingpracticesofasepsis; • Authorityandindicationsforobtainingmicrobiologicalculturesfrompatientsandthe

environmentasindicated.

IP-4.1 Provisions to monitor compliance with all policies, procedures, protocols and other infection control program requirements;

IP-4.2 Provision for program evaluation and revision of the program, when indicated;

IP-4.3 Policies and procedures developed in coordination with applicable emergen-cy preparedness and health authorities to address communicable disease threats, bioterrorism, and outbreaks; and

IP-4.4 Procedures for meeting the reporting requirements of the local health authority.

Surveyor Guidance: • Determinewhetherthehospitalhasanactive,hospital-wideinfectioncontrolprogramreflectingtheinfectioncontrolofficerresponsibilitiesspecifiedintheinterpretiveguidelines.Specifically,surveyorsshoulddeterminewhetherthehospital:

- Maintainsasanitaryenvironment; - Developsandimplementsinfectioncontrolmeasuresrelatedtohospitalpersonnel; - Mitigatesrisksassociatedwithpatientinfectionspresentuponadmission; - Mitigatesriskscontributingtohealthcare-associatedinfections(forexample,

observewhetherstaffexhibitgoodhandwashinghygiene); - Conductsactivesurveillance; - Monitorscompliancewithallinfectioncontrolprogramrequirements; - Evaluatestheinfectioncontrolprogramregularlyandrevisesit,whenindicated; - Coordinatesasrequiredbylawwithapplicableandlocalemergencypreparedness

andhealthauthoritiestoaddresscommunicablediseasethreats,bioterrorism,andoutbreaks;and

- Complieswiththereportablediseaserequirementsofthelocalhealthauthority.

IP-5 The infection control officer or officers must maintain a log of incidents related to infections and communicable diseases.

Interpretation Guidelines: • Theinfectioncontrolofficer(s)mustmaintainalogofincidentsrelatedtoinfectionsandcommunicablediseases,includinghealthcare-associatedinfections(HAI)andinfectionsidentifiedthroughemployeehealthservices.Thelogidentifiesincidentsofinfectionandcommunicablediseasethroughoutthehospitalanddocumentsinfectionsandcommunicablediseasesinpatientsandstaff(patientcarestaffandnon-patientcarestaff,includingemployees,contractstaffandvolunteers).Sincehospitalsmayberequiredbylaworcontracttoprotecthealthcareinformationrelatedtoitsemployeesasconfidential,thehospitalmaytakeappropriatesteps,suchasusingcodesinsteadofnamesinthelog,withaseparatedocumentthatenableslinkingcodesandnames,toaddressincidentsassociatedwithcommunicablediseaseoccurrenceamongthestaff.

• "Incidentsrelatedtoinfectionsandcommunicablediseases”wouldincludeeventsfallingintoanyofthefollowingcategories.Hospitalsarenotrequiredtoorganizetheirlogsaccordingtothesecategories,buttheyareencouragedtocaptureallofthetypesofincidentsdescribedbelow.Multipleentriesforanincidentthatfallsintoseveralcategoriesisnotrequired,e.g.,apatientrecordedasareportablecaseoftuberculosisneednotbelistedagainasapatientrequiringairborneinfectionisolation.

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IP - Healthcare-associatedinfectionsidentifiedbythehospital,includingsurgicalsiteinfections(SSI)followingeitherinpatientoroutpatientprocedures;

- Patientsorstaffwithidentifiedcommunicablediseasesthatlocalagenciesrequiredbereported;

- Patientsorstaffidentifiedbylaboratorycultureascolonizedorinfectedwithmultidrug-resistantorganisms(MDROs),asdefinedbytheorganization’sInfectionPreventionandControlProgram;

- Patientsorstaffwithsignsandsymptomsthathavebeenrequestedbereportedorrecordedbyapplicablelawsandregulations;and

- Stafforpatientswhoareknownorsuspectedtobeinfectedwithepidemiologically-significantpathogensthatareidentifiedbythehospitalorlocalagencies.

• Thelogmaybeapaperlogorinelectronicformat,butregardlessoftheformat,theinformationmustatalltimesbesafe/securefromunauthorizedaccess,up-to-date,andaccessibleandreadilyretrievablebyauthorizedpersonnel.

Surveyor Guidance: • Determinewhethertheinfectioncontrolofficer(s)maintainsalogofincidentsrelatedtoinfectionsandcommunicablediseases,includingthoseidentifiedthroughemployeehealthservices.

• Determinewhetherthelogcapturesthetypesofincidentsdiscussedabove.Failuretotrackincidentsinoneormoreoftheabovecategoriesisnot,initself,evidenceofadeficiency,butmaybecitedtosupportadocumentedfailureininfectioncontrolpracticesifthefailuretologincidentswaspertinenttothedocumentedfailure.

• Determinewhetherthelogiscurrentandcanbereadilyaccessedandinformationreadilyretrievedbythehospital’sinfectioncontrolofficer(s)andotherappropriatestaff,asrequiredbydesignatedagenciesconsistentwithexistingapplicablelawsandregula-tionsregardingtheconfidentialityofandaccesstoprivilegedmedicalinformation.

IP-5.1 Responsibilities of Chief Executive Officer, Medical Staff, and Director of Nursing Services, The Chief Executive Officer, the Medical Staff, and the Director of Nursing must ensure that the hospital-wide quality assurance program and training programs address problems identified by the infection control officer or officers; and be responsible for the implementation of successful corrective action plans in affected problem areas.

IP-5.1.1 The chief executive officer (CEO), the medical staff and the director of nursing (DON) must ensure that the hospital-wide Quality Management System and staff in-service training programs address problems identified through the infection prevention and control program.

IP-5.1.2 To reflect the importance of infection control the regulations specifically require that the hospital’s Quality Management System and training programs must be involved in addressing problems identified by the infection control program, and hold the CEO, medical staff and DON jointly responsible for linking the infection control program with the Quality Management System and training programs.

IP-5.1.3 These hospital leaders are also held explicitly responsible for implementing suc-cessful corrective action plans. In order to accomplish this, hospital leaders must monitor adherence to corrective action plans, as well as assess the effectiveness of actions taken, with implementation of revised corrective actions as needed.

IP-5.1.4 Education on the principles and practices for preventing transmission of infectious agents within the hospital should be provided to anyone who has an opportunity for contact with patients or medical equipment, e.g., nursing and physicians; therapists and technicians, such as those involved in respira-

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tory, physical, and occupational therapy and radiology and cardiology services; phlebotomists; housekeeping and maintenance staff; volunteers; and all students and trainees in healthcare professions.

Surveyor Guidance: • Determinewhetherthehospital’sQualityManagementSystemandstaffin-servicetrainingprogramsaddressproblemsidentifiedbytheinfectioncontrolofficer(s).

• DeterminewhetherinfectioncontrolproblemsidentifiedarereportedtotheMedicalStaff,CEOandDON.Verifythathospitalleadershiptakesstepstoassurethatcorrec-tiveactionsareimplementedandsuccessful.

IP-5.2 Communicable Disease Outbreaks: Community-wide outbreaks of commu-nicable diseases (such as measles, SARS, or influenza) present many of the same issues and require many of the same considerations and strategies as other hospital infectious disease threats. If a communicable disease out-break occurs, an understanding of the epidemiology, likely modes of trans-mission, and clinical course of the disease is essential for responding to and managing the event. Among the infection control issues that may need to be addressed are:

Interpretive Guidelines: • Preventingtransmissionamongpatients,healthcarepersonnel,andvisitors; • Identifyingpersonswhomaybeinfectedandexposed; • Providingtreatmentorprophylaxistolargenumbersofpeople;and • Logisticsissues(staff,medicalsupplies,resupply,continuedoperations,andcapacity).

IP-5.3 Pandemics, or very widespread and clinically serious outbreaks of an infec-tion, present additional challenges due to the widespread effect on the availability of back-up resources that would typically be available to address an outbreak confined to a smaller geographic area. Additionally, the duration of a pandemic may present special challenges for staffing, supplies, resupply, etc. Hospitals should work with applicable public health agencies to identify likely communicable disease threats and develop appropriate preparedness and response strategies.

IP-6 Bioterrorism: Healthcare facilities would confront a set of issues similar to naturally occurring communicable disease threats when dealing with a suspected bioterrorism event. The required response is likely to differ based on whether exposure is a result of a biological release or person-to-person transmission.

IP-6.1 The hospital must be in compliance with the Bloodborne Pathogens AAC Standard P.E 24.1-24.21.

Surveyor Guidance: • Determinewhethertherearehospital-widepoliciesandproceduresforpreventing,identifying,reporting,investigating,andcontrollinginfectionsandcommunicablediseasesofpatientsandhospitalpersonnel,includingcontractworkersandvolunteers.Determinewhethertheinfectioncontrolprogramcanidentifyallhospitallocationsandthatthepoliciesandprocedurestakethevarioushospitallocationsintoaccount.

• Determinewhetherthepoliciesandproceduresareimplementedcorrectlyinanactiveinfectioncontrolprogram.

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• Determinewhethertheprogramishospital-wideandprogramspecificingatheringandassessinginfectionandcommunicablediseasedata.Reviewtheparametersoftheactivesurveillanceprogramtodeterminewhetheritisconsistentwithinfectioncontrolstandardsofpracticeandsuitabletothescopeandcomplexityofthehospi-tal’sservices.

• Throughoutthehospital,observethesanitaryconditionoftheenvironmentofcare,notingthecleanlinessofpatientrooms,floors,horizontalsurfaces,patientequipment,airinlets,mechanicalrooms,foodserviceactivities,treatmentandprocedureareas,surgicalareas,centralsupply,storageareas,etc.

• Determinewhetherthehospital’sinfectionpreventionandcontrolprogramisinte-gratedintoitshospital-wideQualityManagementSystem.

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SS

surgical services

SS-1 If the hospital provides surgical services, the services must be well organized and provided in accordance with acceptable standards of practice. If outpa-tient surgical services are offered the services must be consistent in quality with inpatient care in accordance with the complexity of services offered.

SS.1.1 The provision of surgical services is an optional hospital service. However, if a hospital provides any degree of surgical services to its patients, the hospital must comply with all the requirements of the Medical Chamber and Ministry of Health.

Interpretive Guidelines: • Surgeryisperformedforthepurposeofstructurallyalteringthehumanbodybytheincisionordestructionoftissuesandispartofthepracticeofmedicine.Surgeryalsoisthediagnosticortherapeutictreatmentofconditionsordiseaseprocessesbyanyinstrumentscausinglocalizedalterationortranspositionoflivehumantissuewhichincludelasers,ultrasound,ionizingradiation,scalpels,probes,andneedles.

• Thetissuecanbecut,burned,vaporized,frozen,sutured,probed,ormanipulatedbyclosedreductionsformajordislocationsorfractures,orotherwisealteredbymechan-ical,thermal,light-based,electromagnetic,orchemicalmeans.Injectionofdiagnosticortherapeuticsubstancesintobodycavities,internalorgans,joints,sensoryorgans,andthecentralnervoussystemalsoisconsideredtobesurgery(thisdoesnotincludetheadministrationbynursingpersonnelofsomeinjections,subcutaneous,intramus-cular,andintravenous,whenorderedbyaphysician).

• Allofthesesurgicalproceduresareinvasive,includingthosethatareperformedwithlasers,andtherisksofanysurgicalprocedurearenoteliminatedbyusingalightknifeorlaserinplaceofametalknife,orscalpel.

• Patientsafetyandqualityofcareareparamountand,therefore,patientsshouldbeassuredthatindividualswhoperformthesetypesofsurgeryarelicensedphysicianswhoareworkingwithintheirscopeofpractice,hospitalprivileges,andwhomeetappropriateprofessionalstandards.

SS-1.2 If surgical services are provided, they must be organized and staffed in such a manner to ensure the health and safety of patients.

Interpretive Guidelines: • Acceptablestandardsofpracticeincludemaintainingcompliancewithapplicablelaws,regulationsandguidelinesgoverningsurgicalservicesorsurgicalservicelocations,aswellas,anystandardsandrecommendationspromotedbyorestablishedbynationallyrecognizedprofessionalorganizations.

• Outpatientsurgicalservicesmustbeincompliancewithallhospitalstandardsincludingthesurgicalservicesstandards.Outpatientsurgicalservicesmustbeprovidedinaccordancewithacceptablestandardsofpractice.Additionally,thehospital’soutpatientsurgicalservicesmustbeconsistentinqualitywiththehospital’sinpatientsurgicalservices.Postoperativecareplanning,coordinationfortheprovi-sionofneededpost-operativecareandappropriateprovisionsforfollow-upcareofoutpatientsurgerypatientsmustbeconsistentinqualitywithinpatientcareinaccord-ancewiththecomplexityoftheservicesofferedandtheneedsofthepatient.

• Thehospital’sinpatientandoutpatientsurgicalservicesmustbeintegratedintoitshospital-wideQualityManagementSystems.

Surveyor Guidance: • Inspectallinpatientandoutpatientoperativetheatres.Requesttheuseofproperattirefortheinspection.Observethepracticestodetermineiftheservicesareprovidedinaccordancewithacceptablestandardsofpractice.Observe:

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• Thataccesstotheoperativeandrecoveryareaislimitedtoauthorizedpersonnelandthatthetrafficflowpatternadherestoacceptedstandardsofpractice;

• Theconformancetoasepticandsteriletechniquebyallindividualsinthesurgicalarea; • Thatthereisappropriatecleaningbetweensurgicalcasesandappropriateterminal

cleaningapplied; • Thatoperatingtheatreattireissuitableforthekindofsurgicalcaseperformed,that

personsworkingintheoperatingtheatremustwearonlycleansurgicalcostumes,thatsurgicalcostumesaredesignedformaximumskinandhaircoverage;

• Thatequipmentisavailableforrapidandroutinesterilizationofoperatingroommaterials; • Thatequipmentismonitored,inspected,tested,andmaintainedbythehospital’s

biomedicalequipmentprogramandinaccordancewithapplicablelaws,regulations,andguidelinesandmanufacturer’srecommendations;

• Thatsterilizedmaterialsarepackaged,handled,labeled,andstoredinamannerthatensuressterilitye.g.,inamoistureanddustcontrolledenvironmentandpoliciesandproceduresforexpirationdateshavebeendevelopedandarefollowedinaccordancewithacceptedstandardsofpractice.

• Thattemperatureandhumidityaremonitoredandmaintainedwithinacceptedstandardsofpractice;

• Thatmedical/surgicaldevicesandequipmentarecheckedandmaintainedroutinelybyclinical/biomedicalengineers.

• Verifythatallsurgicalserviceactivitiesandlocationsareintegratedintothehospital-wideQualityManagementSystem.

SS-2 Organization and Staffing: The organization of the surgical services must be appropriate to the scope of the services offered.

SS-2.1 When the hospital offers surgical services, the hospital must provide the appropriate equipment and the appropriate types and numbers of qualified personnel necessary to furnish the surgical services offered by the hospital in accordance with acceptable standards of practice.

SS-2.2 The scope of surgical services provided by the hospital should be defined in writing and approved by the medical staff.

Surveyor Guidance: • Reviewthehospital’sorganizationalchartdisplayingtherelationshipoftheoperatingtheatreservicetootherservices.Confirmthattheoperatingtheatreorganizationchartindicateslinesofauthorityanddelegationofresponsibilitywithinthedepart-mentorservice.

SS-3 The operating theatre must be supervised by an experienced registered nurse or a doctor of medicine.

Interpretive Guidelines: • Theoperatingtheatre(inpatientandoutpatient)mustbesupervisedbyanexperiencedRNorMD.

• TheRNorMDsupervisingtheoperatingtheatremustdemonstrateappropriateeducation,backgroundworkinginsurgicalservices,andspecializedtrainingintheprovisionofsurgicalservices/managementofsurgicalserviceoperations.

• Thehospitalshouldaddressitsrequiredqualificationsforthesupervisorofthehospi-tal’soperatingtheatreinitspoliciesandthesupervisor’spersonnelfileshouldcontaininformationdemonstratingcompliancewiththehospital’sestablishedqualifications.

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Surveyor Guidance: • VerifythatanRNoradoctorofmedicineisassignedresponsibilityforsupervisionoftheoperatingtheatre.

• Requestacopyofthesupervisor’spositiondescriptiontodeterminethatitspecifiesqualifications,dutiesandresponsibilitiesoftheposition.Verifythatthesupervisorisexperiencedandcompetentinthemanagementofsurgicalservices.

SS-4 Licensed practical nurses (LPNs) may serve as “scrub nurses” under the supervision of a registered nurse.

Interpretive Guidelines: • IfthehospitalutilizesLPNs,thosepersonnelmustbeunderthesupervisionofanRNwhoisimmediatelyavailabletophysicallyinterveneandprovidecare.

Surveyor Guidance: • DeterminethatanRNisavailableforsupervisioninthedepartmentorservice.Validatetheavailabilitybyrequestingandreviewingastaffingschedulefortheoperatingtheatre.

• ReviewstaffingschedulestodetermineadequacyofstaffandRNsupervision.

SS-5 Qualified registered nurses may perform circulating duties in the operating theatre. In accordance with applicable laws and regulations and approved medical staff policies and procedures, LPNs may assist in circulatory duties under the supervision of a qualified registered nurse who is immediately available to respond to emergencies.

Interpretative Guidelines: • ThecirculatingnursemustbeanRN.AnLPNmayassistanRNincarryingoutcirculatoryduties(inaccordancewithapplicablelawsandregulationsandmedical-staffapprovedhospitalpolicy)buttheLPNmustbeunderthesupervisionofthecirculatingRNwhoisintheoperatingtheatreandwhoisavailabletoimmediatelyandphysicallyrespond/intervenetoprovidenecessaryinterventionsinemergencies.ThesupervisingRNwouldnotbeconsideredimmediatelyavailableiftheRNwaslocatedoutsidetheoperatingtheatreorengagedinotheractivities/dutiesthatpreventtheRNfromimmediatelyinterveningandassumingwhatevercirculatingactivities/dutieswerebeingprovidedbytheLPN.

• Thehospital,inaccordancewithapplicablelawsandregulationsandacceptablestandardsofpractice,mustestablishthequalificationsrequiredforRNswhoperformcirculatingdutiesandLPNswhoassistwithcirculatingduties.

Surveyor Guidance: • IfLPNsareassistingwithcirculatingduties,verifythattheydosoinaccordancewithapplicablelawsandregulationsandmedical-staffapprovedpoliciesandprocedures.

• VerifyinsituationswhereLPNsandSTsarepermittedtoassistwithcirculatingdutiesthataqualifiedRNsupervisorisimmediatelyavailabletorespondtoemergencies.

• VerifythatRNsworkingascirculatingnursesareworkinginaccordancewithappli-cablelawsandregulationsandmedical-staffapprovedpoliciesandprocedures.

SS-6 Surgical privileges must be delineated for all practitioners performing sur-gery in accordance with the competencies of each practitioner. The surgical service must maintain a roster of practitioners specifying the surgical privi-leges of each practitioner.

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SSInterpretive Guidelines: • Surgicalprivilegesshouldbereviewedandupdatedatleastevery2years. • Acurrentrosterlistingeachpractitioner’sspecificsurgicalprivilegesmustbeavail-

ableinthesurgicaltheatreandarea/locationwheretheschedulingofsurgicalproceduresisdone.

• Acurrentlistofsurgeonssuspendedfromsurgicalprivilegesorwhosesurgicalprivilegeshavebeenrestrictedmustalsoberetainedintheseareas/locations.

• Thehospitalmustdelineatethesurgicalprivilegesofallpractitionersperformingsurgeryandsurgicalprocedures.

• Themedicalstaffisaccountabletothegoverningbodyforthequalityofcareprovidedtopatients.Themedicalstaffdocumentationmustincludecriteriafordeterminingtheprivilegestobegrantedtoanindividualpractitionerandaprocedureforapplyingthecriteriatoindividualsrequestingprivileges.

• Surgicalprivilegesaregrantedinaccordancewiththecompetenciesofeachpractitioner. • Themedicalstaffappraisalproceduresmustevaluateeachindividualpractitioner’s

training,education,experience,anddemonstratedcompetenceasestablishedbythehospital’sQualityManagementSystem,credentialingprocess,thepractitioner’sadherencetohospitalpoliciesandprocedures,andinaccordancewithscopeofpracticeandotherapplicablelawsandregulations.

• Thehospitalmustspecifythesurgicalprivilegesforeachpractitionerthatperformssurgi-caltasks.ThiswouldincludepractitionerssuchasMD,dentists,oralsurgeons,etc.

• Whenapractitionermayperformcertainsurgicalproceduresundersupervision,thespecifictasks/proceduresandthedegreeofsupervision(toincludewhetherornotthesupervisingpractitionerisphysicallypresentinthesameoperatingtheatre,inlineofsightofthepractitionerbeingsupervised)bedelineatedinthatpractitioner’ssurgicalprivilegesandincludedonthesurgicalroster.

• WhenpractitionerswhosescopeofpracticeforconductingsurgicalproceduresrequiresthedirectsupervisionofanMDsurgeon,theterm“supervision”wouldmeanthesuper-visingMDsurgeonispresentinthesameroom,workingwiththesamepatient.

• Surgeryandallsurgicalproceduresmustbeconductedbyapractitionerwhomeetsthemedicalstaffcriteriaandproceduresfortheprivilegesgranted,whohasbeengrantedspecificsurgicalprivilegesbythegoverningbodyinaccordancewiththosecriteria,andwhoisworkingwithinthescopeofthosegrantedanddocumentedprivileges.

Surveyor Guidance: • Reviewthehospital’smethodforreviewingthesurgicalprivilegesofpractitioners.Thismethodshouldrequireawrittenassessmentofthepractitioner’straining,experience,healthstatus,andperformance.

• Determinethatacurrentrosterlistingeachpractitioner’sspecificsurgicalprivilegesisavailableinthesurgicaltheatreandtheareawheretheschedulingofsurgicalproceduresisdone.

• Determinethatacurrentlistofsurgeonssuspendedfromsurgicalprivilegesorwhohaverestrictedsurgicalprivilegesisretainedintheseareas/locations.

SS-7 Delivery of Service: Surgical services must be consistent with needs and resourc-es. Policies governing surgical care must be designed to assure the achievement and maintenance of high standards of medical practice and patient care.

Interpretative Guidelines: • Policiesgoverningsurgicalcareshouldcontain: - Asepticandsterilesurveillanceandpractice,includingscrubtechniques; - Identificationofinfectedandnon-infectedcases;

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- Housekeepingrequirements/procedures; - Patientcarerequirements: ◦ Preoperativework-up; ◦ Patientconsentsandreleases; ◦ Clinicalprocedures; ◦ Safetypractices; ◦ Patientidentificationprocedures; - Dutiesofscrubandcirculatingnurse. - Safetypractices; - Therequirementtoconductsurgicalcountsinaccordancewithacceptedstandards

ofpractice; - Schedulingofpatientsforsurgery; - Personnelpoliciesuniquetotheoperatingtheatre; - Resuscitativetechniques; - DoNotResuscitate(DNR)status; - Careofsurgicalspecimens;Malignanthyperthermia; - Appropriateprotocolsforallsurgicalproceduresperformed.Thesemaybeproce-

dure-specificorgeneralinnatureandwillincludealistofequipment,materials,andsuppliesnecessarytoproperlycarryoutjobassignment;

- Sterilizationanddisinfectionprocedures; - Acceptableoperatingroomattire; - Handlinginfectionsandbiomedical/medicalwaste;and - Outpatientsurgerypost-operativecareplanningandcoordination,andprovisions

forfollow-upcare.

SS-8 Policies and procedures must be written, implemented and enforced. Surgi-cal services’ policies must be in accordance with acceptable standards of medical practice and surgical patient care.

SS-9 The use of an alcohol-based skin preparation in inpatient or outpatient anes-thetizing locations is not considered safe, unless appropriate fire risk-reduc-tion measures are taken, preferably as part of a systematic approach by the hospital to preventing surgery-related fires. A review of recommendations produced by various expert organizations concerning use of alcohol-based skin preparations in anesthetizing locations indicates there is general consen-sus that the following risk reduction measures are appropriate:

Interpretative Guidelines: • Usingskinprepsolutionsthatare:1)packagedtoensurecontrolleddeliverytothepatientinunitdoseapplicators,swabs,orothersimilarapplicators;and2)provideclearandexplicitmanufacturer/supplierinstructionsandwarnings.Theseinstruc-tionsforuseshouldbecarefullyfollowed.

• Ensuringthatthealcohol-basedskinprepsolutiondoesnotsoakintothepatient’shairorlinens.Steriletowelsshouldbeplacedtoabsorbdripsandrunsduringapplicationandshouldthenberemovedfromtheanesthetizinglocationpriortodrapingthepatient.

• Ensuringthatthealcohol-basedskinprepsolutioniscompletelydrypriortodraping.Thismaytakeafewminutesormore,dependingontheamountandlocationofthesolution.Thepreppedareashouldbeinspectedtoconfirmitisdrypriortodraping.

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SS • Verifyingthatalloftheabovehasoccurredpriortoinitiatingthesurgicalprocedure.Thiscanbedone,forexample,aspartofastandardizedpre-operative“timeout”usedtoverifyotheressentialinformationtominimizetheriskofmedicalerrorsduringtheprocedure.

• Hospitalsthatemployalcohol-basedskinpreparationsinanesthetizinglocationsshouldestablishappropriatepoliciesandprocedurestoreducetheassociatedriskoffire.Theyshouldalsodocumenttheimplementationofthesepoliciesandproceduresinthepatient’smedicalrecord.

• Failurebyahospitaltodevelopandimplementappropriatemeasurestoreducetheriskoffiresassociatedwiththeuseofalcohol-basedskinpreparationsinanesthetiz-inglocationsshouldbecitedascondition-levelnoncompliance.

Surveyor Guidance: • Reviewpoliciesandprocedurestodeterminewhethertheyaddresstheelementsspecifiedintheinterpretiveguidelines.Ifthehospitalusesalcohol-basedskinprepa-rationsinanesthetizinglocations,determinewhetherithasadoptedpoliciesandprocedurestominimizetheriskofsurgicalfires.

• Interviewsurgicalservicesstafftodeterminewhethertheyareawareofandfollowhospitalpoliciesandprocedures.

SS-10 Prior to surgery or a procedure requiring anesthesia services and except in the case of emergencies a medical history and physical examination must be completed and documented no more than 30 days before or 24 hours after admission or registration. An updated examination of the patient, including any changes in the patient’s condition, must be completed and documented within 24 hours after admission or registration when the medical history and physical examination are completed within 30 days before admission or registration.

Interpretive Guidelines: • Theremustbeacompletehistoryandphysicalexamination(H&P),andanupdate,ifapplicable,inthemedicalrecordofeverypatientpriortosurgery,oraprocedurerequiringanesthesiaservices,exceptinemergencies.

- TheH&Pmustbeconducted. - TheH&Pmustbecompletedanddocumentednomorethan30daysbeforeor24hours

afteradmissionorregistration.Inallcases,exceptforemergencies,theH&Pmustbecompletedanddocumentedbeforethesurgeryorproceduretakesplace,evenifthatsurgeryorprocedureoccurslessthan24hoursafteradmissionorregistration.

- IftheH&Pwascompletedwithin30daysbeforeadmissionorregistration,thenanupdatedexaminationmustbecompletedanddocumentedwithin24hoursafteradmissionorregistration.Inallcases,exceptforemergencies,theupdatemustbecompletedanddocumentedbeforethesurgeryorproceduretakesplace,evenifthatsurgeryorprocedureoccurslessthan24hoursafteradmissionorregistration.

Surveyor Guidance: • Reviewasampleofopenandclosedmedicalrecordsofpatients(bothinpatientandoutpatient)whohavehadsurgeryoraprocedurerequiringanesthesia.

• DeterminewhetheranH&Pwasconductedanddocumentedinatimelymanner. • DeterminewhethertheH&Pwasconducted. • DeterminewhethertherecordsofpatientswhodidnothaveatimelyH&Porupdate

indicatethatthesurgeryorprocedurewasconductedonanemergencybasis.

SS-11 A properly executed informed consent form for the operation must be in the patient’s chart before surgery, except in emergencies.

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Interpretative Guidelines: • Theprimarypurposeoftheinformedconsentprocessforsurgicalservicesistoensurethatthepatient,orthepatient’srepresentative,isprovidedinformationnecessarytoenablehim/hertoevaluateaproposedsurgerybeforeagreeingtothesurgery.Typi-cally,thisinformationwouldincludepotentialshort-andlonger-termrisksandbenefitstothepatientoftheproposedintervention,includingthelikelihoodofeach,basedontheavailableclinicalevidence,asinformedbytheresponsiblepractitioner’sprofessionaljudgment.Informedconsentmustbeobtained,andtheinformedconsentformmustbeplacedinthepatient’smedicalrecord,priortosurgery,exceptinthecaseofemergencysurgery.

• Hospitalsmustassurethatthepractitioner(s)responsibleforthesurgeryobtaininformedconsentfrompatientsinamannerconsistentwiththehospital’spoliciesgoverningtheinformedconsentprocess.

• SurgicalInformedConsentPolicy:Thehospital’ssurgicalinformedconsentpolicyshoulddescribethefollowing:

- Whomayobtainthepatient’sinformedconsent; - Whichproceduresrequireinformedconsent; - Thecircumstancesunderwhichsurgeryisconsideredanemergency,andmaybe

undertakenwithoutaninformedconsent; - Thecircumstanceswhenapatient’srepresentative,ratherthanthepatient,may

giveinformedconsentforasurgery; - Thecontentoftheinformedconsentformandinstructionsforcompletingit; - Theprocessusedtoobtaininformedconsent,includinghowinformedconsentisto

bedocumentedinthemedicalrecord; - Mechanismsthatensurethattheinformedconsentformisproperlyexecutedandis

inthepatient’smedicalrecordpriortothesurgery(exceptinthecaseofemergencysurgery);and

- Iftheinformedconsentprocessandinformedconsentformareobtainedoutsidethehospital,howtheproperlyexecutedinformedconsentformisincorporatedintothepatient’smedicalrecordpriortothesurgery.

- Ifthereareadditionalrequirementsunderapplicablelawsandregulationsforinformedconsent,thehospitalmustcomplywiththoserequirements.

SS-12 A well-designed informed consent process would include discussion of the following elements:

SS-12.1 A description of the proposed surgery, including the anesthesia to be used; the indications for the proposed surgery;

SS-12.2 Material risks and benefits for the patient related to the surgery and anes-thesia, including the likelihood of each, based on the available clinical evi-dence, as informed by the responsible practitioner’s clinical judgment. Material risks could include risks with a high degree of likelihood but a low degree of severity, as well as those with a very low degree of likelihood but high degree of severity;

SS-12.3 Treatment alternatives, including the attendant material risks and benefits;

SS-12.4 The probable consequences of declining recommended or alternative thera-pies; who will conduct the surgical intervention and administer the anesthesia;

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SSSS-12.5 Whether physicians other than the operating practitioner, including but not limited to residents, will be performing important tasks related to the surgery, in accordance with the hospital’s policies. Important surgical tasks include: opening and closing, dissecting tissue, removing tissue, harvesting grafts, transplanting tissue, administering anesthesia, implanting devices and placing invasive lines.

SS-12.5.1 For surgeries in which residents will perform important parts of the surgery, discussion is encouraged to include the following:

SS-12.5.1.1 That it is anticipated that physicians who are in approved post graduate residency training programs will perform portions of the surgery, based on their availability and level of competence;

SS-12.5.1.2 That it will be decided at the time of the surgery which residents will partici-pate and their manner or participation, and that this will depend on the availability of residents with the necessary competence; the knowledge the operating practitioner/teaching surgeon has of the resident’s skill set; and the patient’s condition;

SS-12.5.1.3 That residents performing surgical tasks will be under the supervision of the operating practitioner/teaching surgeon; and

SS-12.5.1.4 Whether, based on the resident’s level of competence, the operating practi-tioner/teaching surgeon will not be physically present in the same operating room for some or all of the surgical tasks performed by residents.

SS-12.5.1.5 Whether, as permitted by applicable laws and regulations, qualified medical practi-tioners who are not physicians will perform important parts of the surgery or administer the anesthesia, and if so, the types of tasks each type of practitioner will carry out; and that such practitioners will be performing only tasks within their scope of practice for which they have been granted privileges by the hospital.

Surveyor Guidance: • Verifythatthehospitalhasassuredthatthemedicalstaffhasspecifiedwhichproce-duresareconsideredsurgeryand,thus,arethosethatrequireaproperlyexecutedinformedconsentform.

• Verifythatthehospital’sinformedconsentpoliciesaddressthecircumstanceswhenasurgerywouldbeconsideredanemergencyandthusnotrequireaninformedconsentformbeplacedinthemedicalrecordpriortosurgery.

• Reviewaminimumofsixmedicalrecordsofsurgicalpatientsandverifythattheydidnotinvolveemergencysurgeryandthattheycontaininformedconsentformsthatwereexecutedpriortothesurgery.Whenpossible,reviewmedicalrecordsofpatientswhoareabouttoundergosurgery,orwhoarelocatedinasurgicalrecoveryarea.

• Interviewtwoorthreepost-surgicalpatients,asappropriatebasedontheirabilitytoprovideacogentresponse,orthepatients’representativestoseehowsatisfiedtheyarewiththeinformedconsentdiscussionpriortotheirsurgery.

SS-13 The following equipment must be available to the operating theatre: call-in system, cardiac monitor, resuscitator, defibrillator, aspirator, and tracheotomy set.

Surveyor Guidance: • Checktodeterminethattheoperatingtheatrehasavailabletheitemslisted: - On-callsystem; - Cardiacmonitor; - Resuscitator; - Defibrillator; - Aspirator(suctionequipment);and - Tracheotomyset(acricothyroidotomysetisnotasubstitute).

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SSSS-14 Verify that all equipment is working and, as applicable, in compliance with the hospital’s biomedical equipment inspection, testing, and maintenance program.

Interpretative Guidelines: • Theremustbeadequateprovisionsforimmediatepost-operativecare.Adequateprovisionsforimmediatepost-operativecaremeans:

- Post-operativecaremustbeinaccordancewithacceptablestandardsofpractice. - Thepost-operativecareareaorrecoveryroomisaseparateareaofthehospital.

Accessislimitedtoauthorizedpersonnel. - Policiesandproceduresspecifytransferrequirementstoandfromtherecovery

room.Dependingonthetypeofanesthesiaandlengthofsurgery,thepostoperativecheckbeforetransferringthepatientfromtherecoveryroomshouldincludesomeofthefollowing:

◦ Levelofactivity; ◦ Respirations; ◦ Bloodpressure; ◦ Levelofconsciousness; ◦ Patientcolor - Ifthepatientsarenottransferredtotherecoveryroom,determinethatprovisions

aremadeforcloseobservationuntiltheyhaveregainedconsciousness,e.g.,directobservationbyaqualifiedRNinthepatient’sroom.

Surveyor Guidance: • Verifythatthehospitalhasprovisionsforpost-operativecare. • Determinethattherearepoliciesandproceduresthatgoverntherecoveryroomarea.

SS-15 The operating room register must be complete and up-to-date. The register includes at least the following information:

SS-15.1 Patient’s name;

SS-15.2 Patient’s hospital identification number;

SS-15.3 Date of the operation;

SS-15.4 Inclusive or total time of the operation;

SS-15.5 Name of the surgeon and any assistant(s);

SS-15.6 Name of nursing personnel (scrub and circulating);

SS-15.7 Type of anesthesia used and name of person administering it;

SS-15.8 Operation performed;

SS-15.9 Pre and post-op diagnosis; and

SS-15.10 Age of patient.

Surveyor Guidance: • Examinetheoperatingtheatreregisterorequivalentrecordwhichlistsallsurgeryperformedbythesurgeryservice.Determinethattheregisterincludesitemsspecifiedintheinterpretiveguidelines.

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SS-16 An operative report describing techniques, findings, and tissues removed or altered must be written or dictated immediately following surgery and signed by the surgeon. The operative report includes at least:

SS-16.1 Name and hospital identification number of the patient;

SS-16.2 Date and times of the surgery;

SS-16.3 Name(s) of the surgeon(s) and assistants or other practitioners who performed surgical tasks (even when performing those tasks under supervision);

SS-16.4 Pre-operative and post-operative diagnosis;

SS-16.5 Name of the specific surgical procedure(s) performed;

SS-16.6 Type of anesthesia administered;

SS-16.7 Complications, if any;

SS-16.8 A description of techniques, findings, and tissues removed or altered;

SS-16.9 Surgeons or practitioners name(s) and a description of the specific signifi-cant surgical tasks that were conducted by practitioners other than the primary surgeon/practitioner (significant surgical procedures include: open-ing and closing, harvesting grafts, dissecting tissue, removing tissue, im-planting devices, altering tissues); and

SS-16.10 Prosthetic devices, grafts, tissues, transplants, or devices implanted, if any.

Surveyor Guidance: • Reviewaminimumofsixrandommedicalrecordsofpatientswhohadasurgicalencounter.Verifythattheycontainasurgicalreportthatisdatedandsignedbytheresponsiblesurgeonandincludestheinformationspecifiedintheinterpretiveguidelines.

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anesthesia services

If the hospital furnishes anesthesia services, they must be provided in a well-organized manner under the direction of a qualified doctor of medicine. The service is responsible for all anesthesia administered in the hospital.

aS-1 The provision of anesthesia services is an optional hospital service. However, if a hospital provides any degree of anesthesia service to its patients, the hospital must comply with all the requirements of this standard. “Anesthesia” involves the administration of a medication to produce a blunting or loss of:

aS-1.1 pain perception (analgesia);

aS-1.2 voluntary and involuntary movements;

aS-1.3 autonomic function; and

aS-1.4 memory and/or consciousness, depending on where along the central neuraxial (brain and spinal cord) the medication is delivered.

aS-2 In contrast, “analgesia” involves the use of a medication to provide relief of pain through the blocking of pain receptors in the peripheral and/or central nervous system. The patient does not lose consciousness, but does not perceive pain to the extent that may otherwise prevail. Anesthesia exists along a continuum. For some medications there is no bright line that distin-guishes when their pharmacological properties bring about the physiologic transition from the analgesic to the anesthetic effects. Furthermore, each individual patient may respond differently to different types of medications.

aS-3 The additional definitions below illustrate distinctions among the various types of “anesthesia services” that may be offered by a hospital.

aS-3.1 General anesthesia: a drug-induced loss of consciousness during which patients are not arousable, even by painful stimulation. The ability to inde-pendently maintain ventilatory support is often impaired. Patients often require assistance in maintaining a patent airway, and positive pressure ventilation may be required because of depressed spontaneous ventilation or drug-induced depression of neuromuscular function. Cardiovascular function may be impaired. For example, a patient undergoing major abdominal surgery involving the removal of a portion or all of an organ would require general anesthesia in order to tolerate such an extensive surgical procedure. General anesthesia is used for those procedures when loss of consciousness is re-quired for the safe and effective delivery of surgical services.

aS-3.2 Regional anesthesia: the delivery of anesthetic medication at a specific level of the spinal cord and/or to peripheral nerves, including epidurals and spinals and other central neuraxial nerve blocks, is used when loss of consciousness is not desired but sufficient analgesia and loss of voluntary and involuntary movement is required. Given the potential for the conversion and extension of regional to general anesthesia in certain procedures, it is necessary that the administration of regional and general anesthesia be delivered or supervised by a practitioner.

aS-3.3 Monitored anesthesia care (MAC): anesthesia care that includes the moni-toring of the patient by a practitioner who is qualified to administer anes-thesia. Indications for MAC depend on the nature of the procedure, the

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patient’s clinical condition, and/or the potential need to convert to a general or regional anesthetic. Deep sedation/analgesia is included in MAC.

aS-3.4 Deep sedation/analgesia: a drug-induced depression of consciousness during which patients cannot be easily aroused but respond purposefully following repeated or painful stimulation. The ability to independently maintain ventilatory function may be impaired. Patients may require assistance in maintaining a patent airway, and spontaneous ventilation may be inadequate. Cardiovascular function is usually maintained. Because of the potential for the inadvertent progression to general anesthesia in certain procedures, it is necessary that the administration of deep sedation/analgesia be delivered or supervised by a practitioner.

aS-3.5 Moderate sedation/analgesia: (“Conscious Sedation”): a drug-induced de-pression of consciousness during which patients respond purposefully to verbal commands, either alone or accompanied by light tactile stimulation. No interventions are required to maintain a patent airway, and spontaneous ventilation is adequate. Cardiovascular function is usually maintained.

aS-3.6 Minimal sedation: a drug-induced state during which patients respond normally to verbal commands. Although cognitive function and coordination may be impaired, ventilator and cardiovascular functions are unaffected. This is also not anesthesia.

aS-3.7 Topical or local anesthesia: the application or injection of a drug or combina-tion of drugs to stop or prevent a painful sensation to a circumscribed area of the body where a painful procedure is to be performed. There are generally no systemic effects of these medications, which also are not anesthesia, despite the name.

aS-4 Rescue Capacity: Hospitals must ensure that procedures are in place to rescue patients whose level of sedation becomes deeper than initially intended, for example, patients who inadvertently enter a state of Deep Sedation/Analgesia when Moderate Sedation was intended.

aS-4.1 Rescue from a deeper level of sedation than intended requires an interven-tion by a practitioner with expertise in airway management and advanced life support. The qualified practitioner corrects adverse physiologic conse-quences of the deeper-than-intended level of sedation and returns the patient to the originally intended level of sedation.

aS-4.2 Rescue capacity is not only required as an essential component of anesthe-sia services, but is also consistent with the requirements under the Patients’ Rights standard, guaranteeing patients care in a safe setting.

aS-4.3 Anesthesia services throughout the hospital (including all departments in all campuses and off-site locations where anesthesia services are provided) must be organized into one anesthesia service. Areas where anesthesia services are furnished may include (but are not limited to):

AS-4.3.1 Operating theatre both inpatient and outpatient; AS-4.3.2 Obstetrical suite(s); AS-4.3.3 Radiology department; AS-4.3.4 Clinics; AS-4.3.5 Emergency department;

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AS AS-4.3.6 Psychiatry department; AS-4.3.7 Outpatient surgery areas; AS-4.3.8 Special procedures areas (e.g., endoscopy suite, pain management clinic, etc.)

aS-5 The anesthesia services must be under the direction of one individual who is a qualified doctor of medicine (MD). Consistent with the standard for it to approve medical staff documentation, the hospital’s governing body approves, after considering the medical staff’s recommendations, medical staff documentation establishing criteria for the qualifications for the director of the anesthesia services. Such criteria must be consistent with applicable laws and regulations.

aS-6 Hospitals to address whether the sedation typically provided in the emer-gency department or procedure rooms involves anesthesia or analgesia. In establishing such policies, the hospital is expected to take into account the characteristics of the patients served, the skill set of the clinical staff in providing the services, as well as the characteristics of the sedation medica-tions used in the various clinical settings.

aS-6.1 However, hospital anesthesia services policies and procedures are expected to also address the minimum qualifications and supervision requirements for each category of practitioner who is permitted to provide analgesia services, particularly moderate sedation.

aS-6.2 These regulations require the hospital to assure that any staff administering drugs for analgesia must be appropriately qualified, and that the drugs are administered in accordance with accepted standards of practice. Specifically:

AS-6.2.1 The Medical Staff standard requires the medical staff documentation include criteria for determining the privileges to be granted to individual practitioners and a procedure for applying the criteria to individuals requesting privileges.

AS-6.2.2 The Nursing Services standard requires: AS-6.2.2.1 Nursing personnel be assigned to provide care based on the specialized

qualifications and competence of the nursing staff available. AS-6.2.2.2 Drugs and biologicals must be prepared and administered in accordance with

applicable laws and regulations, and accepted standards of practice. AS-6.2.2.3 If intravenous medications are administered by personnel other than doctors

of medicine, the personnel must have special training for this duty.

aS-7 It is expected that the anesthesia services policies and procedures will un-dergo periodic re-evaluation that includes analysis of adverse events, medi-cation errors and other quality or safety indicators related not only to anes-thesia, but also to the administration of medications in clinical applications that the hospital has determined involve analgesia rather than anesthesia.

Interpretive Guidelines: • Hospitalsarefreetodeveloptheirownspecificorganizationalarrangementsinordertodeliverallanesthesiaservicesinawell-organizedmanner.Althoughnotrequiredunderthestandardtodoso,awell-organizedanesthesiaservicewoulddevelopthehospital’sanesthesiapoliciesandproceduresincollaborationwithseveralotherhospitaldisciplines(e.g.,surgery,pharmacy,nursing,safetyexperts,materialman-agement,etc.)thatareinvolvedindeliveringtheseservicestopatientsinthevariousareasinthehospital.

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aS-8 A well-organized anesthesia service must be integrated into the hospital’s required Quality Management System in order to assure the provision of safe care to patients.

Surveyor Guidance: • Requestacopyoftheorganizationalchartforanesthesiaservices. • Determinethatadoctorofmedicineastheauthorityandresponsibilityfordirecting

allanesthesiaservicesthroughoutthehospital. • Lookforevidenceinthedirector’sfileofthedirector’sappointmentprivilegesand

qualifications,consistentwiththecriteriaadoptedbythehospital’sgoverningbody.Reviewthepositiondescription.Confirmthatthedirector’sresponsibilitiesincludeatleastthefollowing:

- Planning,directing,andsupervisingallactivitiesoftheservice; - Evaluatingthequalityandappropriatenessoftheanesthesiaservicesprovidedto

patientsaspartofthehospital’sQualityManagementSystem; • Requestacopyofandreviewthehospital’sanesthesiaservicespoliciesandprocedures. - Dotheyapplyinallhospitallocationswhereanesthesiaservicesareprovided? - Dotheyindicatethenecessaryqualificationsthateachclinicalpractitionermust

possessinordertoadministeranesthesiaaswellasmoderatesedationorotherformsofanalgesia?

- Dotheyaddresswhatclinicalapplicationsareconsideredtoinvolveanalgesia,inparticularmoderatesedation,ratherthananesthesia,basedonidentifiablenationalguidelines?Whatarethenationalguidelinesthattheyarefollowingandhowisthatdocumented?

• Doesthehospitalhaveasystembywhichadverseeventsrelatedtotheadministrationofanesthesiaandanalgesia,includingmoderatesedation,aretrackedandactedupon?

aS-9 Organization and Staffing: The organization of anesthesia services must be appropriate to the scope of the services offered. Anesthesia must be admin-istered only by:

aS-9.1 A qualified anesthesiologist;

aS-9.2 A doctor of medicine (other than an anesthesiologist);

aS-9.3 A dentist, oral surgeon, or podiatrist who is qualified to administer anesthe-sia under local law; or

aS-10 Delivery of Services: Anesthesia services must be consistent with needs and resources. Policies on anesthesia procedures must include the delineation of preanesthesia and postanesthesia responsibilities. The policies must ensure that the following are provided for each patient:

aS-10.1 Anesthesia services must be delivered in a manner that is consistent with the needs and the resources of the hospital. Anesthesia policies at a mini-mum must address:

AS-10.1.1 How the hospital’s anesthesia services needs will be met; AS-10.1.2 Delivery of anesthesia services consistent with recognized standards for

anesthesia care. A well-designed anesthesia services policy would address issues such as:

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AS-10.1.2.1 Patient consent; AS-10.1.2.2 Infection control measures; AS-10.1.2.3 Safety practices in all anesthetizing areas; AS-10.1.2.4 Protocol for supportive life functions, e.g., cardiac and respiratory emergencies; AS-10.1.2.5 Reporting requirements; AS-10.1.2.6 Documentation requirements; AS-10.1.2.7 Equipment requirements, as well as the monitoring, inspection, testing, and main-

tenance of anesthesia equipment in the hospital’s biomedical equipment program. AS-10.1.3 Delineation of pre- and post-anesthesia staff responsibilities

Surveyor Guidance: • Reviewthepoliciesdevelopedonanesthesiaprocedures.Determinewhethertheanesthesiaservicepoliciesfordeliveryofcareaddresstheissuesidentifiedininter-pretiveguidelines.

aS-11 The policies must ensure that the following are provided for each patient:

aS-11.1 A pre-anesthesia evaluation completed and documented by an individual qualified to administer anesthesia, performed within 48 hours prior to surgery or a procedure requiring anesthesia services.

Interpretive Guidelines: • Apre-anesthesiaevaluationmustbeperformedforeachpatientwhoreceivesgeneral,regionalormonitoredanesthesia.Whilecurrentpracticedictatesthatthepatientreceivingmoderatesedationbemonitoredandevaluatedbefore,during,andaftertheprocedurebytrainedpractitioners,apre-anesthesiaevaluationperformedbysomeonequalifiedtoadministeranesthesiaisnotrequiredbecausemoderatesedationisnotconsideredtobeanesthesia,andthusisnotsubjecttothatrequirementunderthisregulation.

• Theevaluationmustbeperformedbysomeonequalifiedtoadministeranesthesiaasspecifiedinstandard:

- Aqualifiedanesthesiologist; - Adoctorofmedicine(otherthanananesthesiologist); - Adentist,oralsurgeonwhoisqualifiedtoadministeranesthesiaunderapplicable

lawsandregulations; • Althoughthestandardgenerallyprovidesbroadauthoritytophysicianstodelegate

taskstootherqualifiedmedicalpersonnel,themorestringentstandardsdonotpermitdelegationofthepre-anesthesiaevaluationtopractitionerswhoarenotqualifiedtoadministeranesthesia.

• Thepre-anesthesiaevaluationmustbecompletedanddocumentedwithin48hoursimmediatelypriortoanyinpatientoroutpatientsurgeryorprocedurerequiringanesthesiaservices.Thedeliveryofthefirstdoseofmedication(s)forthepurposeofinducinganesthesia,asdefinedabove,markstheendofthe48-hourtimeframe.

- Inaccordancewithcurrentstandardsofanesthesiacare,someoftheindividualelementscontributingtothepre-anesthesiaevaluationmaybeperformedpriortothe48-hourtimeframe.However,undernocircumstancesmaytheseelementsbeperformedmorethan30dayspriortosurgeryoraprocedurerequiringanesthesiaservices.Reviewoftheseelementsmustbeconducted,andanyappropriateupdatesdocumented,withinthe48-hourtimeframe.Thepre-anesthesiaevaluationofthepatientincludes,ataminimum:

- Elementsthatmustbeperformedwithinthe48-hourtimeframe: ◦ Reviewofthemedicalhistory,includinganesthesia,drugandallergyhistory;and ◦ Interview,ifpossiblegiventhepatient’scondition,andexaminationofthepatient.

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- Elementsthatmustbereviewedandupdatedasnecessarywithin48hours,butwhichmayalsohavebeenperformedduringorwithin30dayspriortothe48-hourtimeperiod,inpreparationfortheprocedure:

◦ Notationofanesthesiariskaccordingtoestablishedstandardsofpractice; ◦ Identificationofpotentialanesthesiaproblems,particularlythosethatmay

suggestpotentialcomplicationsorcontraindicationstotheplannedprocedure(e.g.,difficultairway,ongoinginfection,limitedintravascularaccess);

◦ Additionalpre-anesthesiadataorinformation,ifapplicableandasrequiredinaccordancewithstandardpracticepriortoadministeringanesthesia(e.g.,stresstests,additionalspecialistconsultation);

◦ Developmentoftheplanforthepatient’sanesthesiacare,includingthetypeofmedicationsforinduction,maintenanceandpost-operativecareanddiscussionwiththepatient(orpatient’srepresentative)oftherisksandbenefitsofthedeliveryofanesthesia.

Surveyor Guidance: • Reviewasampleofinpatientandoutpatientmedicalrecordsforpatientswhohadsurgeryoraprocedurerequiringadministrationofanesthesia.

• Determinewhethereachpatienthadapre-anesthesiaevaluationbyapractitionerqualifiedtoadministeranesthesia.

• Determinewhethereachpatient’spre-anesthesiaevaluationincludedatleasttheelementsdescribedabove.

• Determinethatthepre-anesthesiaevaluationwasupdated,completedanddocumentedwithin48hourspriortothedeliveryofthefirstdoseofmedication(s)givenforthepurposeofinducinganesthesiaforthesurgeryoraprocedurerequiringanesthesiaservices.

ar-11.2 Intraoperative Anesthesia Record: There must be an intraoperative anesthe-sia record or report for each patient who receives general, regional or moni-tored anesthesia. Current standard of care stipulates that an intraoperative anesthesia record, at a minimum, includes:

Interpretive Guidelines: • Nameandhospitalidentificationnumberofthepatient; • Name(s)ofpractitioner(s)whoadministeredanesthesia,andasapplicable,thename

andprofessionofthesupervisinganesthesiologistoroperatingpractitioner; • Name,dosage,routeandtimeofadministrationofdrugsandanesthesiaagents; • Techniques(s)usedandpatientposition(s),includingtheinsertion/useofanyintravas-

cularorairwaydevices; • NameandamountsofIVfluids,includingbloodorbloodproductsifapplicable; • Timed-baseddocumentationofvitalsignsaswellasoxygenationandventilation

parameters;and • Anycomplications,adversereactions,orproblemsoccurringduringanesthesia,

includingtimeanddescriptionofsymptoms,vitalsigns,treatmentsrendered,andpatient’sresponsetotreatment.

Surveyor Guidance: • Reviewrecordstodeterminethateachpatienthasanintraoperativeanesthesiarecordthatincludestheelementsdescribedabove.

ar-11.3 Postanethesia Evaluation: A postanesthesia evaluation completed and docu-mented by an individual qualified to administer anesthesia no later than 48 hours after surgery or a procedure requiring anesthesia services. The postanes-

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thesia evaluation for anesthesia recovery must be completed in accordance with local law and with hospital policies and procedures that have been approved by the medical staff and that reflect current standards of anesthesia care.

Interpretive Guidelines: • Thepostanesthesiaevaluationmustbecompletedanddocumentedbyanypractitionerwhoisqualifiedtoadministeranesthesia;thisneednotbethesamepractitionerwhoadministeredtheanesthesiatothepatient.Anesthesiamustbeadministeredonlyby:

- Aqualifiedanesthesiologist; - Adoctorofmedicine(otherthanananesthesiologist); - Adentist,oralsurgeon,orpodiatristwhoisqualifiedtoadministeranesthesia

underapplicablelawsandregulations; • Thecalculationofthe48-hourtimeframebeginsatthepointthepatientismovedinto

thedesignatedrecoveryarea. - Theevaluationgenerallyshouldnotbeperformedimmediatelyatthepointofmovement

fromtheoperativeareatothedesignatedrecoveryarea.Rather,acceptedstandardsofanesthesiacareindicatethattheevaluationshouldnotbeginuntilthepatientissuffi-cientlyrecoveredfromtheacuteadministrationoftheanesthesiasoastoparticipateintheevaluation,e.g.,answerquestionsappropriately,performsimpletasks,etc.

- WhiletheevaluationshouldbegininthePACU/ICUorotherdesignatedrecoverylocation,itmaybecompletedafterthepatientismovedtoanotherinpatientlocationor,forsamedaysurgeries,ifapplicablelawsandregulationsandhospitalpolicypermits,afterthepatientisdischarged,solongasitiscompletedwithin48hours.

- The48-hourtimeframeforcompletionanddocumentationofthepostanesthesiaevaluationisanoutsideparameter.Individualpatientriskfactorsmaydictatethattheevaluationbecompletedanddocumentedsoonerthan48hours.Thisshouldbeaddressedbyhospitalpoliciesandprocedures.

- Forthosepatientswhoareunabletoparticipateinthepostanesthesiaevaluation(e.g.,post-operativesedation,mechanicalventilation,etc.),apostanesthesiaevaluationshouldbecompletedanddocumentedwithin48hourswithnotationthatthepatientwasunabletoparticipate.Thisdocumentationshouldincludethereasonforthepatient’sinabilitytoparticipateaswellasexpectationsforrecoverytime,ifapplicable.

- Forthosepatientswhorequirelong-actingregionalanesthesiatoensureoptimummedicalcareofthepatient,whoseacuteeffectswilllastbeyondthe48-hourtimeframe,apostanesthesiaevaluationmuststillbecompletedanddocumentedwithin48hours.However,thereshouldbeanotationthatthepatientisotherwiseabletoparticipateintheevaluation,butfullrecoveryfromregionalanesthesiahasnotoccurredandisnotexpectedwithinthestipulatedtimeframeforthecompletionoftheevaluation.

• Theelementsofanadequatepost-anesthesiaevaluationshouldbeclearlydocumentedandconformtocurrentstandardsofanesthesiacare,including:

- Respiratoryfunction,includingrespiratoryrate,airwaypatency,andoxygensaturation;

- Cardiovascularfunction,includingpulserateandbloodpressure; - Mentalstatus; - Temperature; - Pain; - Nauseaandvomiting;and - Postoperativehydration. - Dependingonthespecificsurgeryorprocedureperformed,additionaltypesof

monitoringandassessmentmaybenecessary.

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Surveyor Guidance: • Reviewasampleofmedicalrecordsforpatientswhohadsurgeryoraprocedurerequiringgeneral,regionalormonitoredanesthesiatodeterminewhetherapostanesthesiaevaluationwaswrittenforeachpatient.

• Determinewhetherapractitionerwhoisqualifiedtoadministeranesthesiaconductedtheevaluation.

• Determinewhethertheevaluationwascompletedanddocumentedwithin48hoursafterthesurgeryorprocedure.

• Determinewhethertheappropriateelementsofapostanesthesiaevaluationaredocumentedinthemedicalrecord.

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emergency services

The hospital must meet the emergency needs of patients in accordance with acceptable standards of practice.

eS-1 Organization and Direction

eS-1.1 If emergency services are provided at the hospital, the hospital must ensure that specific emergency services organization and direction requirements are met.

eS-1.2 If emergency services are provided at the hospital the services must be organized under the direction of a qualified member of the medical staff.

Interpretive Guidelines: • Thehospital’smedicalstaffestablishescriteriaforthequalificationsforthedirectorofthehospital’semergencyservicesinaccordancewithapplicablelawsandregula-tionsandacceptablestandardsofpractice.

• Asingleemergencyservicesdirectormustberesponsibleforthehospital’semergencyservices.

Surveyor Guidance: • Verifythatemergencyservicesareorganizedunderthedirectionofaqualifiedmemberofthemedicalstaff.

eS-2 If emergency services are provided at the hospital the services must be inte-grated with other departments of the hospital;

eS-2.1 The hospital’s emergency service/department must be integrated with the other departments of the hospital such as surgical services, lab, ICU, diag-nostic services, etc. The hospital must demonstrate that its emergency services are truly integrated into its other departments.

eS-2.2 The integration must be such that the hospital can immediately make available the full extent of its patient care resources to assess and render appropriate care for an emergency patient.

eS-2.3 Emergency Services integration would include at a minimum:

ES-2.3.1 Coordination and communication between the Emergency Department and other hospital services/departments;

ES-2.3.2 Physical access for emergency department patients to the services, equip-ment, personnel, and resources of other hospital departments/services;

ES-2.3.3 The immediate availability of services, equipment, personnel, and resources of other hospital departments/services to emergency patients; and

ES-2.3.4 That the provision of services, equipment, personnel and resources of other hospital departments/services to emergency department patients is within timeframes that protect the health and safety of patients and is within acceptable standards of practice, including:

ES-2.3.4.1 The length of time it takes to transport the emergency patient from the ED to another hospital department where needed interventions or diagnostic services will be rendered.

ES-2.3.4.2 The length of time it takes to deliver equipment or supplies, or for the staff from other departments to travel from their location to the emergency department in order to provide needed interventions, tests, care, or services.

eS-2.4 Time is critical in the provision of emergency care. The hospital must be able to demonstrate how the hospital’s other departments provide emergency patients

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the care and services needed within safe and appropriate times. In emergency care situations, the time needed to provide the patient with appropriate diag-nostic and care interventions can have a significant effect on the patient. Delays in diagnosis and the provision of needed interventions are likely to adversely affect the health and safety of patients who require emergency care. Therefore, a hospital that cannot demonstrate integration of its emergency services with its other departments (including radiological services, OR, intensive care, labora-tory, etc.) would not be in compliance with the Emergency Services standard.

eS-2.5 Many hospitals offer urgent care services on the hospital campus or in provider-based clinics in the communities they serve. Those clinics must be in compliance with the hospital. Hospitals may organize their urgent care clinics as part of their outpatient department or emergency services depart-ment. An urgent care clinic that:

Interpretive Guidelines: • Thehospitalholdsouttothepublicasprovidingonlyurgentcareservicesandpossiblyotherservices;

• Clearlyadvisesthepublicthattheurgentcareclinicisnotanemergencyservicesdepartment.

Surveyor Guidance: • Verifythatthereareestablishedprocedurestoassureintegrationwitheitherhospitalservicesincludinglaboratory,radiology,andoperatingservicestoprovidecontinu-ityofcare.

eS-2.6 The policies and procedures governing medical care provided in the emer-gency service or department are established by and are a continuing re-sponsibility of the medical staff.

Interpretive Guidelines: • Thehospital’smedicalstaffmustestablishpoliciesandproceduresgoverningthemedicalcareprovidedintheemergencyserviceoremergencydepartment.

• Themedicalstaffmusthavehadongoing/continuingassessmentofthemedicalcareprovidedintheemergencyserviceordepartment.

• EmergencyserviceoremergencydepartmentpoliciesmustbecurrentandrevisedasnecessarybasedontheongoingmonitoringconductedbythemedicalstaffandtheemergencyserviceordepartmentQualityManagementSystemactivities.

Surveyor Guidance: • Verifythatproceduresandpoliciesforemergencymedicalservices(includingtriageofpatients)areestablished,evaluated,andupdatedonanongoingbasis.

eS-2.7 Personnel: The hospital must ensure the emergency services personnel requirements are met.

ES-2.7.1 The emergency services must be supervised by a qualified member of the medical staff.

Interpretive Guidelines: • Aqualifiedmemberofthemedicalstaffmustsupervisetheprovisionofemergencyservices.“Supervision”impliesamoreimmediateformofoversightbyaqualifiedmemberofthemedicalstaffduringalltimesthehospitalmakesemergencyservicesavailable.

• Asupervisormaybebrieflyabsentfromtheemergencydepartment,butisexpectedtobeinthehospitalandimmediatelyavailabletoprovidedirectionand/ordirectcareduringtheoperatinghoursoftheemergencydepartment.

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ES-2.7.2 The medical staff must establish criteria, in accordance with local law, regula-tions, and guidelines, delineating the qualifications a medical staff member must possess in order to be granted privileges for the supervision of the provision of emergency care services. Qualifications include necessary educa-tion, experience and specialized training, consistent with applicable laws and regulations and acceptable standards of practice.

Surveyor Guidance: • Verifythataqualifiedmemberofthemedicalstaffisdesignatedtosuperviseemer-gencyservices.

ES-2.7.3 There must be adequate medical and nursing personnel qualified in emergency care to meet the written emergency procedures and needs anticipated by the facility.

Interpretive Guidelines: • Thehospitalmuststafftheemergencydepartmentwiththeappropriatenumbersandtypesofprofessionalsandotherstaffwhopossesstheskills,education,certifications,specializedtrainingandexperienceinemergencycaretomeetthewrittenemergencyproceduresandneedsanticipatedbythefacility.

• ThehospitalmustdeterminethecategoriesandnumbersofMDs,specialists,RNs,EMTs,andemergencydepartmentsupportstaffthehospitalneedstometitsantici-patedemergencyneeds.

• Themedicalstaffmustestablishcriteria,inaccordancewithapplicablelawsandregulationsandacceptablestandardsofpracticedelineatingthequalificationsrequiredforeachcategoryofemergencyservicesstaff(e.g.,emergencyphysicians,specialistMD,RNs,EMTs,mid-levelpractitioners,etc.).

• Asasuggestedprudentpracticethehospitalshouldconductperiodicassessmentsofitsemergencyneedsinordertoanticipatethepolicies,procedures,staffing,training,andotherresourcesthatmaybeneededtoaddresslikelydemands.

• Additionally,thehospitalshouldworkcooperativelywithdesignatedemergencypreparednessagenciesandofficialsinordertoidentifylikelyriskstothecommunity(e.g.,naturaldisasters,masscasualties,terroristacts,etc.),toanticipatedemandsandresourcesneededbythehospitalemergencyservices,andtodevelopplans,methodsandcoordinatingnetworkstoaddressthoseanticipatedneeds.

Surveyor Guidance: • Verifythattherearesufficientmedicalandnursingpersonnelqualifiedintheneedsanticipatedbythefacilityandthattherearespecificassigneddutiesforemergencycarepersonnelandaclearchainofcommand.

• Interviewstafftodeterminethattheyareknowledgeable,withintheirownlevelofparticipationinemergencycareincluding:

- Parenteraladministrationofelectrolytes,fluids,bloodandbloodcomponents; - Careandmanagementofinjuriestoextremitiesandcentralnervoussystem; - Preventionofcontaminationandcrossinfection.

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outpatient services

If the hospital provides outpatient services, the services must meet the needs of the patients in accordance with acceptable standards of practice.

oS-1 This is an optional hospital service, however, if a hospital provides any degree of outpatient care to its patients, the hospital must comply with the requirements of this standard.

oS-2 The standards apply to both inpatient and outpatient services of the hospi-tal. The hospital must be in compliance in all on-campus and off-campus outpatient service locations.

oS-3 All outpatient services provided by the hospital, both on campus and at any provider-based clinics, must meet the needs of the patients, in accordance with acceptable standards of practice. The hospital must ensure that services, equipment, staff, and facilities are adequate to provide the outpatient services offered at each location in accordance with acceptable standards of practice.

oS-4 If the hospital offers outpatient surgical services, the Surgical Services standard requires that the offered services must be consistent in quality with inpatient care in accordance with the services offered.

oS-5 The hospital’s outpatient services must be integrated into its hospital-wide Quality Management System.

oS-6 Acceptable standards of practice include standards that are set forth appli-cable laws and regulations, or guidelines, as well as standards and recom-mendations promoted by nationally recognized professional organizations.

Surveyor Guidance: • Verifythatequipment,staffandfacilitiesareadequatetoprovidetheoutpatientservicesofferedateachlocationareinaccordancewithacceptablestandardsofpractice.

• Verifythatoutpatientservicesatalllocationsareincompliancewiththehospitalstandard.

• Determinelocationsandtype(s)ofoutpatientservicesprovided. • Verifythatthehospital’soutpatientservicesareintegratedintoitshospital-wide

QualityManagementSystem.

oS-7 Organization: Outpatient services must be appropriately organized and integrated with inpatient services.

oS-7.1 The organization of the hospital’s outpatient services must be appropriate to the scope and complexity of services offered.

oS-7.2 The hospital’s outpatient services, at all locations, must be integrated with inpatient services (e.g., medical records, radiology, laboratory, surgical ser-vices, anesthesia (including pain management) services, other diagnostic services, etc.), as appropriate to the outpatient services offered. The hospital must have written policies in place to assure the integration of outpatient services, including an established method of communication between outpatient service departments to corresponding inpatient services.

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oS-7.3 The hospital must coordinate the care, treatment and services provided to a patient. In order to provide continuity of care, it should have an established method of communication between inpatient services and outpatient care in order to provide continuity of care to its patients.

Surveyor Guidance: • Verifythattheoutpatientservicesareorganizedinamannerappropriatetothescopeandcomplexityofservicesoffered.

• Verifythatthehospitalhasanestablishedmethodofcommunicationandestablishedprocedurestoassureintegrationwithinpatientservicestoprovidecontinuityofcare.

• Reviewmedicalrecordsofoutpatientswhowerelateradmittedtothehospitalinordertodeterminethatpertinentinformationfromtheoutpatientrecordhasbeenincludedintheinpatientrecord.

• Determinethateachoutpatientservicelocationisintegratedwiththeappropriatehospitalinpatientservicesinaccordancewiththeneedsofthepatientcareprovidedateachofthoselocations.

oS-8 Personnel: The hospital must assign an individual to be responsible for outpatient services and have appropriate professional and nonprofessional personnel available.

oS-8.1 The outpatient services department must be accountable to a single indi-vidual who directs the overall operation of the hospital’s entire outpatient services (all locations, all outpatient services). The hospital should define in writing the qualifications and competencies necessary to direct the outpa-tient services. Qualifications include necessary education, experience and specialized training consistent with applicable laws and regulations and acceptable standards of practice.

oS-8.2 Adequate types and numbers of qualified professional and nonprofessional personnel must be available to provide patients with the appropriate level of care and services offered by the hospital’s outpatient department. The types and num-bers of qualified personnel are based on the scope and complexity of outpatient services offered and the number and types of patients treated as outpatients.

Surveyor Guidance: • Verifythatonepersonisassignedtomanageandberesponsibleforoutpatientservices. • Reviewtheorganization’spoliciesandprocedurestodeterminetheperson’sresponsibility. • Reviewthepositiondescriptionandpersonnelfileoftheindividualresponsibleforthe

outpatientservicestoensurethathe/shemeetsthequalifications,inaccordancewithapplicablelawsandregulations,acceptablestandardsofpracticeandhospitalpolicy.

• Reviewpersonnelfilestoverifythatthestaffqualificationsincludingeducation,experience,certifications,andcurrentlicensurewhereappropriate,andcompetenciesareappropriateforassignedresponsibilities.

• ComparedutyrosterstopatientlogtoverifythatsufficientMDs,nursesandotherstaffareavailabletoprovidecaretoverifythatthetypesandnumberofqualifiedpersonnelareappropriateforthetypesandnumbersofpatientsreceivingcare,andthefrequency,duration,andcomplexityofservicesoffered.

• Reviewpoliciesandcontracts,ifservicesprovidedareunderanarrangement.

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medication use

MU-1 Preparation and Administration of Drugs: Drugs and biologicals must be prepared and administered in accordance with applicable laws and regula-tions, the orders of the practitioner or practitioners responsible for the patient’s care and accepted standards of practice.

MU-1.1 Drugs and biologicals must be prepared and administered in accordance with applicable laws and regulations.

MU-1.2 Drugs and biologicals must be prepared and administered in accordance with the orders of the practitioner or practitioners responsible for the patient’s care.

MU-1.3 Drugs and biologicals must be prepared and administered in accordance with accepted standards of practice.

MU-1.4 Accepted standards of practice include maintaining compliance with appli-cable laws and regulations, as well as, any standards and recommendations promoted by nationally recognized professional organizations.

Surveyor Guidance: • Selectpatientsfromthepatientsample.Reviewtheirmedicationorders,medicationadministrationrecords,andappropriatemedicationdocumentationinthemedicalrecord.Observethepreparationandadministrationofmedicationstothosepatients.

• Aremedicationspreparedandadministeredinaccordancewithapplicablelawsandregulations,acceptednationalstandardsofpractice,manufacturer’sdirections,andhospitalpolicy?

MU-2 Preparation and Administration of Drugs: Drugs and biologicals must be pre-pared and administered in accordance with applicable laws and regulations, the orders of the practitioner or practitioners responsible for the patient’s care and accepted standards of practice. All drugs and biologicals must be administered by, or under supervision of, nursing or other personnel in accordance with applicable laws and regulations, including applicable licensing requirements, and in accordance with the approved medical staff policies and procedures.

MU-3 Orders of the practitioner or practitioners responsible for the patient’s care: In accordance with standard practice, all practitioner orders for the adminis-tration of drugs and biological must include at least the following:

MU-3.1 Name of the patient;

MU-3.2 Age and weight of the patients, or other dose calculation requirements, where applicable;

MU-3.3 Date and time of the order;

MU-3.4 Drug name;

MU-3.5 Dose, frequency, and route;

MU-3.6 Exact strength or concentration, when applicable;

MU-3.7 Quantity and/or duration, when applicable;

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MU-3.8 Specific instructions for use, when applicable; and

MU-3.9 Name of the prescriber.

MU-4 Hospital and Medical Staff Approved Policies and Procedures

MU-4.1 Hospital’s policy must approve policies and procedures for medication administration, consistent with the requirements of applicable laws and regulations and accepted standards of practice. It is recommended that the medical staff consult with nurses, pharmacists, Quality Management System program staff, and others in developing these policies and procedures. The adopted policies and procedures must address key issues related to medica-tion administration, which include but are not limited to:

MU-5 Personnel Authorized to Administer Medication

MU-5.1 Policies and procedures must identify categories of licensed personnel and the types of medications they are permitted to prepare and administer, in accordance with applicable laws and regulations. The policies and proce-dures must also address education and training for all personnel preparing and administering drugs and biologicals.

MU-5.2 Medication preparation and administration education and training is typi-cally included in hospital orientation or other continuing education for nursing staff and other authorized healthcare personnel. Training or continu-ing education topics regarding medication preparation and administration may include but are not limited to the following:

MU-5.2.1 Safe handling and preparation of authorized medications; MU-5.2.2 Knowledge of the indications, side effects, drug interactions, compatibility,

and dose limits of administered medications; MU-5.2.3 Equipment, devices, special procedures, and/or techniques required for

medication administration;

MU-5.3 Policies and procedures must address the required components of the training and if the training provided during hospital orientation imparts sufficient education or whether ongoing in-services or continuing education will be required to demonstrate competence.

MU-6 Basic Safe Practices for Medication Administration: The hospital’s policies and procedures must reflect accepted standards of practice that require the following be confirmed prior to each administration of medication:

MU-6.1 The patient’s identity. Acceptable patient identifiers include but are not limited to: the patient’s full name; an identification number assigned by the hospital; or date of birth. Identifiers must be confirmed by patient wristband, patient identification card, patient statement (when possible) or other means outlined in the hospital’s policy. The patient’s identification must be confirmed to be in agreement with the medication administration record and medication labeling prior to medication administration to ensure that the medication is being given to the correct patient.

MU-6.2 The correct medication, to ensure that the medication being given to the patient matches that prescribed for the patient;

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MU-6.3 The correct dose, to ensure that the dosage of the medication matches the prescribed dose, and that the prescription itself does not reflect an unsafe dosage level (i.e., a dose that is too high or too low);

MU-6.4 The correct route, to ensure that the method of administration – orally, intramuscular, intravenous, etc., is the appropriate one for that particular medication and patient; and

MU-6.5 The appropriate time, to ensure adherence to the prescribed frequency and time of administration.

MU-7 Timing of Medication Administration

MU-7.1 Appropriate timing of medication administration must take into account the complex nature and variability among medications; the indications for which they are prescribed; the clinical situations in which they are administered; and the needs of the patients receiving them. The chemical properties, mecha-nism of action, or therapeutic goals of some medications require administra-tion at the exact time prescribed, or within a narrow window of its prescribed scheduled time, to avoid compromising patient safety or achievement of the intended therapeutic effect. However, the therapeutic effect of many other medications is uncompromised by a much broader window of time for administration. Consequently, the application of a uniform required window of time before or after the scheduled time for the administration of all medi-cations, without regard to their differences, could undermine the ability of nursing staff to prioritize nursing care activities appropriately. This could also result in staff work-arounds that jeopardize patient safety due to the imposi-tion of unrealistic or unnecessary time constraints for medication administra-tion. Instead, hospital policies and procedures must specifically address the timing of medication administration, based on the nature of the medication and its clinical application, to ensure safe and timely administration. The policies and procedures must address at least the following:

MU-7.1.1 Medications not eligible for scheduled dosing times; MU-7.1.2 Medications eligible for scheduled dosing times; MU-7.1.3 Administration of eligible medications outside of their scheduled dosing times

and windows; and MU-7.1.4 Evaluation of medication administration timing policies, including adherence

to them.

MU-8 Medications Not Eligible for Scheduled Dosing Times:

MU-8.1 The policies and procedures must identify medications, which are not eligi-ble for scheduled dosing times, either in general or in specific clinical applica-tions. These are medications that require exact or precise timing of adminis-tration, based on diagnosis type, treatment requirements, or therapeutic goals. The policies and procedures must reflect consideration of factors including, but not limited to, the pharmacokinetics of the prescribed medi-cation; specific clinical applications; and patient risk factors. Examples of medications that hospitals may choose to identify as not eligible for sched-uled dosing times may include, but are not limited to:

MU-8.1 Stat doses (immediate);

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MUMU-8.2 First time or loading doses (initial large dose of a drug given to bring blood, tissue or fluid levels to an effective concentration quickly);

MU-8.3 One-time doses; doses specifically timed for procedures;

MU-8.4 Time-sequenced doses; doses timed for serum drug levels;

MU-8.5 Investigational drugs; or

MU-8.6 Drugs prescribed on an as needed basis (prn doses).

MU-8.2 The policies and procedures must ensure timely administration of such medications. In addition they must specify if the policy for the administra-tion of these medications will be applied hospital-wide or only for specific diagnosis types, hospital units or clinical situations.

MU-9 Medications Eligible for Scheduled Dosing Times

MU-9.1 Medications eligible for scheduled dosing times are those prescribed on a repeated cycle of frequency, such as once a day, BID (twice a day), TID (three times a day), hourly intervals (every 1, 2, 3 or more hours), etc. The goal of this scheduling is to achieve and maintain therapeutic blood levels of the prescribed medication over a period of time.

MU-9.2 Medication administration policies and procedures typically establish stand-ardized dosing times for the administration of all “scheduled” medications. For example, medications prescribed for BID (twice a day) administration might, under a given hospital’s policies and procedures, be scheduled to be administered at 08:00 and 16:00 hours. Another hospital might choose to schedule BID medications at 07:30 and 14:30. Use of these standardized times facilitates the medication administration process, e.g., by providing to the hospital’s pharmacy that morning doses of all BID drugs must be dis-pensed and delivered to patient units in time for the scheduled administra-tion. For the nursing staff, the scheduled administration time might prompt prioritization of additional activities that may be required, in the case of particular drugs, such as vital sign assessment or the collection and review of blood work, to ensure safe and timely medication administration.

MU-9.3 Policies and procedures for medications eligible for scheduled dosing times must also address: first dose medications, including parameters within which nursing staff are allowed to use their own judgment regarding the timing of the first and subsequent doses, which may fall between scheduled dosing times; retiming of missed or omitted doses; medications that will not follow scheduled dosing times; and patient units that are not subject to following the scheduled dosing times.

MU-10 Time-Critical Scheduled Medications

MU-10.1 Time-critical scheduled medications are those for which an early or late admin-istration of greater than thirty minutes might cause harm or have significant, negative impact on the intended therapeutic or pharmacological effect. Ac-cordingly, scheduled medications identified under the hospital’s policies and procedures as time-critical must be administered within thirty minutes before or after their scheduled dosing time, for a total window of 1 hour.

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MUMU-10.2 It is possible for a given medication to be time critical for some patients, due to diagnosis, clinical situation, various risk factors, or therapeutic intent, but not time-critical for other patients. Therefore, hospital policies and proce-dures must address the process for determining whether specific scheduled medications are always time-critical, or only under certain circumstances, and how staff involved in medication administration will know when a scheduled medication is time critical. Examples of time-critical scheduled medications/medication types may include, but are not limited to:

MU-10.2.1 Antibiotics; MU-10.2.2 Anticoagulants; MU-10.2.3 Insulin; MU-10.2.4 Anticonvulsants; MU-10.2.5 Immunosuppressive agents; MU-10.2.6 Pain medication; MU-10.2.7 Medications prescribed for administration within a specified period of time of

the medication order; MU-10.2.8 Medications that must be administered apart from other medications for

optimal therapeutic effect; or MU-10.2.9 Medications prescribed more frequently than every 4 hours.

MU-11 Non-Time-Critical Scheduled Medications

MU-11.1 Non-time critical scheduled medications are those for which a longer or shorter interval of time since the prior dose does not significantly change the medica-tion’s therapeutic effect or otherwise cause harm. For such medications greater flexibility in the timing of their administration is permissible. Specifically:

MU-11.1 Medications prescribed for daily, weekly or monthly administration may be within 2 hours before or after the scheduled dosing time, for a total window that does not exceed 4 hours.

MU-11.2 Medications prescribed more frequently than daily but no more frequently than every 4 hours may be administered within 1 hour before or after the scheduled dosing time, for a total window that does not exceed 2 hours.

MU-12 Missed or Late Administration of Medications

MU-12.1 The hospital’s policies and procedures must address the actions to be taken when medications eligible for scheduled dosing times are not administered within their permitted window of time. This includes doses which may have been missed due to the patient being temporarily away from the nursing unit, for example, for tests or procedures; patient refusal; patient inability to take the medication; problems related to medication availability; or other reasons that result in missed or late dose administration. Likewise, policies and proce-dures must also outline guidelines for the administration and timing of new medications which are initiated between standardized dosing times.

MU-12.2 These policies and procedures must identify parameters within which nursing staff are allowed to use their own judgment regarding the rescheduling of missed or late doses and when notification of the physician or other practi-tioner responsible for the care of the patient is required prior doing so. In either case, the reporting of medication errors that are the result of missed or late dose administration must be reported to the attending physician.

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MUMU-13 Evaluation of Medication Administration Timing Policies

MU-13.1 Hospitals must periodically evaluate their medication administration timing policies, including staff adherence to the policies, to determine whether they assure safe and effective medication administration. Medication errors related to the timing of medication administration must be tracked and analyzed to determine their causes. Based on the results of the evaluations of the policies and the medication administration errors, the medical staff must consider whether there is a need to revise the policies and procedures governing medication administration timing.

MU-13.2 Hospitals may adopt policies and procedures that permit the use of standing orders to address well defined clinical scenarios involving medication admin-istration. The policies and procedures must address the process by which a standing order is developed; approved; monitored; initiated by authorized staff; and subsequently authenticated by physicians or practitioners respon-sible for the care of the patient. The specific criteria for a nurse or other authorized personnel to initiate the execution of a particular standing order must be clearly identified in the protocol for the order, i.e., the specific clinical situations, patient conditions or diagnoses in which initiating the order would be appropriate. Policies and procedures must address the education of the medical, nursing, and other applicable professional staff on the conditions and criteria for using standing orders and the individual staff responsibilities associated with their initiation and execution. An order that has been initiated for a specific patient must be added to the patient’s medical record at the time of initiation, or as soon as possible thereafter. Likewise, standing order policies and procedures must specify the process whereby the physician or other practitioner responsible for the care of the patient acknowledges and authenticates the initiation of all standing orders after the fact, with the exception of influenza and pneumococcal polysac-charide vaccines, which do not require such authentication.

MU-13.3 The policies and procedures must also establish a process for monitoring and evaluating the use of standing orders, including proper adherence to the order’s protocol. There must also be a process for the identification and timely completion of any requisite updates, corrections, modifications, or revisions.

Surveyor Guidance: • Verifythatthereisaneffectivemethodfortheadministrationofdrugs.Usethefollowingindicatorsforassessingdrugadministration:

• Verifythattherearepoliciesandproceduresapprovedbythemedicalstaffcoveringwhoisauthorizedtoadministermedications,andthatthepoliciesarefollowed.

- Verifynursingstaffauthorizedtoadministerdrugsandbiologicalarepracticingwithinapplicablelawsandregulationsofthescopeofpractice.

- Arepersonnelotherthannursingpersonneladministeringdrugsorbiologicals?Ifyes,determineifthosepersonnelareadministeringdrugsorbiologicalsinaccordancewithapplicablelawsandregulations.Usetheaboveprocedurestodeterminecompliance.

• Verifythattherearepoliciesandproceduresapprovedbymedicalstaffaddressingthetimingofmedicationadministration.

- Verifythatthehospitalhas,consistentwithitspolicies,identifiedmedications:whichare:

◦ Noteligibleforscheduleddosingtimes;

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MU ◦ Eligibleforscheduleddosingtimesandaretime-critical;andeligibleforsched-uleddosingtimesandarenottime-critical.

- Verifythehospitalhasestablishedtotalwindowsoftimethatdonotexceedthefollowing:

◦ 1hourfortime-criticalscheduledmedications ◦ 2hoursformedicationsprescribedmorefrequentlythandaily,butnomore

frequentlythanevery4hours;and ◦ 4hoursformedicationsprescribedfordailyorlongeradministrationintervals. • Verifythatthehospital'spolicydescribesrequirementsfortheadministrationof

identifiedtime-criticalmedications.Isitclearwhethertime-criticalmedicationsormedicationtypesareidentifiedassuchfortheentirehospitalorareunit,patientdiagnosis,orclinicalsituationspecific?

• Reviewasampleofmedicalrecordstodeterminewhethermedicationadministrationconformedwithapractitioner’sorder,i.e.,thatthecorrectmedicationwasadminis-teredtotherightpatientattherightdoseviathecorrectroute,andthattimingofadministrationcompliedwiththehospital'spoliciesandprocedures.Checkthatthepractitioner'sorderwasstillinforceatthetimethedrugwasadministered.

• Observethepreparationofdrugsandtheiradministrationtopatients[medicationpass]inordertoverifythatproceduresarebeingfollowed.

- Isthepatient’sidentityconfirmedpriortomedicationadministration? - Areprocedurestoassurethecorrectmedication,dose,androutefollowed? - Aredrugsadministeredinaccordancewiththehospital’sestablishedpoliciesand

proceduresfortimelymedicationadministration? - Doesthenurseremainwiththepatientuntilmedicationistaken? • Interviewpersonnelwhoadministermedicationtoverifytheirunderstandingofthe

policiesregardingtimelinessofmedicationadministration. - Aretheyabletoidentifytime-criticalandnon-time-criticalscheduledmedications?

Medicationsnoteligibleforscheduleddosingtimes? - Aretheyabletodescriberequirementsforthetimingofadministrationoftime

criticalandnon-timecriticalmedicationsinaccordancewiththehospital’spolicies? • Ifthehospitalusesstandingorders,verifythattherearepoliciesandproceduresthat

addresstheprocessbywhichastandingorderisdeveloped;approved;monitored;initiatedbyauthorizedstaff;andsubsequentlyauthenticatedbyphysiciansorpracti-tionersresponsibleforthecareofthepatient.

• Asktoseeanexampleofoneormorestandingordersinvolvingmedicationadminis-tration,includingthedocumentationonthedevelopmentoftheorder,evidenceoftrainingofpersonnelontheorder'sprotocol,andperiodicevaluationoftheuseofthestandingorder,includingadherencetopolicies.

• Interviewnursingstafftodeterminewhethertheyinitiatemedicationsinaccordancewithstandingorders.Aretheyfamiliarwiththehospital'spoliciesandproceduresforusingstandingorders?Aretheyfollowingthepoliciesandprocedures?

MU-14 Orders for drugs and biologicals must be documented and signed by a practitioner who is authorized to write orders by hospital policy and in accordance with applicable laws and regulations, and who is responsible for the care of the patient.

MU-14.1 All orders for drugs and biologicals, must be documented and signed by a practitioner who is authorized by hospital policy, and in accordance with

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MUapplicable laws and regulations, to write orders and who is responsible for the care of the patient:

MU-14.1.1 Physician; MU-14.1.2 A doctor of optometry who is legally authorized to practice optometry by the MU-14.1.3 A clinical psychologist, but only with respect to clinical psychologist services

and only to the extent permitted by law.

MU-14.2 In accordance with standard practice, elements that must be present in orders for all drugs and biologicals to ensure safe preparation and administration include:

MU-14.2.1 Name of patient (present on order sheet or prescription); MU-14.2.2 Age and weight of patient, when applicable; MU-14.2.3 Date and time of the order; MU-14.2.4 Drug name; MU-14.2.5 Exact strength or concentration, when applicable; MU-14.2.6 Dose, frequency, and route; MU-14.2.7 Quantity and/or duration, when applicable; MU-14.2.8 Specific instructions for use, when applicable; and MU-14.2.9 Name of prescriber.

MU-14.3 Hospitals are encouraged to promote a culture in which it is not only accept-able, but also strongly encouraged, for staff to bring to the attention of the prescribing practitioner questions or concerns they have regarding orders. Any questions about orders for drugs or biologicals are expected to be resolved prior to the preparation, or dispensing, or administration of the medication.

Surveyor Guidance: • Reviewthehospital’spolicyfordrugandbiologicalorders.Doesitrequirethatordersbeinwritingandsignedbyapractitionerwhoisauthorizedbyhospitalpolicyandinaccordancewithapplicablelawsandregulations,towriteordersandwhoisresponsi-bleforthecareofthepatient?

• Reviewasampleofopenandclosedpatientmedicalrecords.Althoughtheregulationappliestoinpatientandoutpatientmedicalrecords,thesampleshouldbeweightedtoincludemoreinpatientrecords.

• Determinewhetherallordersfordrugsandbiologicals,withtheexceptionofinflu-enzaandpneumococcalpolysaccharidevaccines,arewritteninthepatient’smedicalrecordandsignedbyapractitionerwhoisauthorizedtowriteordersbyhospitalpolicyandinaccordancewithapplicablelawsandregulations,andwhoisresponsi-bleforthecareofthepatient.

• Determinewhetherallordersfordrugsandbiologicalscontaintherequiredelements. • Verifythattheprescribingpractitionerhasreviewedandauthenticatedtheordersin

accordancewithhospitalpolicyand/orapplicablelawsandregulations.

MU-15 If Verbal Orders Are Used, They Are To Be Used Infrequently.

MU-15.1 Verbal orders, if used, must be used infrequently. This means that the use of verbal orders must not be a common practice. Verbal orders pose an increased risk of miscommunication that could contribute to a medication or other error, resulting in a patient adverse event. Verbal orders should be used only to meet the care needs of the patient when it is impossible or impractical for the order-ing practitioner to write the order or enter it into a computer (in the case of a hospital with an electronic prescribing system) without delaying treatment. Verbal orders are not to be used for the convenience of the ordering practitioner.

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MUMU-15.2 Hospitals are expected to develop appropriate policies and procedures that govern the use of verbal orders and minimize their use, such as:

MU-15.2.1 Describe limitations or prohibitions on the use of verbal orders; MU-15.2.2 Provide a mechanism to ensure validity/authenticity of the practitioner

issuing a verbal order; MU-15.2.3 List the elements required for inclusion in the verbal order process; MU-15.2.4 Describe situations in which verbal orders may be used; MU-15.2.5 Define the types of personnel who may issue and receive verbal orders; and MU-15.2.6 Establish protocols for clear and effective communication, verification, and

authentication of verbal orders.

Surveyor Guidance: • Aretherepoliciesandproceduresinplacetominimizetheuseofverbalorders? • Interviewdirectcarestafftodeterminewhetheractualpracticeisconsistentwith

verbalorderpoliciesandprocedures. • Reviewbothopenandclosedpatientmedicalrecordsfortheuseofverbalorders.

Werethepoliciesandproceduresfortheuseofverbalordersfollowed? • Doesthenumberofverbalordersfoundinthesampledrecordssuggestroutineuse,

whichtheregulationsdonotpermit?Thenumberofverbalordersisnotinitselfevidenceofnoncompliance,butshouldresultinmorefocusedanalysis.Forexample:

- Isthereapatterntotheuseofverbalorders?Somepatternsmightmakesense–e.g.,forordersenteredbetween00:00and07:00hours,itmightbeplausiblethatitwasimpossiblefortheprescribingpractitionertowrite/computer-entertheorder.Ontheotherhand,ifonepatientcareunithasahighproportionofverbalorders,whileanotherdoesnot,thismightbeaflagforinconsistentimplementationofthehospital’spoliciesandproceduresforverbalorders.

- Areverbalordersusedfrequentlyforcertaintypesofsituations,andifso,isitreasonabletoassumethatitisimpossibleorimpracticalfortheprescribingpracti-tionerstowrite/entertheordersinsuchsituations?

- Docertainpractitionersuseverbalordersfrequently?Fromthelimitednumberofrecordssampleditmaybedifficulttodetecttrendsrelatedtospecificpractitioners,butifasurveyorfindssuchevidence,furtherinvestigationiswarrantedtodeter-mineifitisevidenceofnoncompliance.

MU-15.3 When verbal orders are used, they must only be accepted by persons who are authorized to do so by hospital policy and procedures consistent with applicable laws and regulations.

Interpretive Guidelines: • Averbalorderfordrugsandbiologicalsmayonlybeacceptedbyapractitionerwhoispermittedbyapplicablelawsandregulationsandhospitalpolicytoacceptverbalorders.Thepractitionermustpromptlydocumenttheverbalorderinthemedicalrecord.

Surveyor Guidance: • Determinewhetherthehospitalhaspoliciesandproceduresgoverningwhoisauthor-izedtoacceptverbalorders.

• Determinewhetherthehospital’spoliciesandproceduresforacceptanceofverbalordersareconsistentwithapplicablelawsandregulations.

• Reviewopenandclosedpatientmedicalrecordscontainingverbalordersfordrugsandbiologicals.Determinewhethertheordersaredocumentedbyauthorizedhospitalpersonnel,consistentwithapplicablelawsandregulations.

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• Interviewseveraldirectcarestafftodetermineiftheyarepermittedtotakeverbalordersfordrugsandbiologicals,anddeterminewhethersuchstaffhavebeenauthor-izedtodosoinaccordancewithhospitalpolicy.

MU-16 Blood transfusions and intravenous medications must be administered in accordance with applicable laws and regulations and approved medical staff policies and procedures. If blood transfusions and intravenous medications are administered by personnel other physicians, the personnel must have special training for this duty.

MU-16.1 Generally intravenous (IV) medications and blood transfusions are adminis-tered to patients by nursing staff, consistent with applicable laws and regu-lations governing scope of practice, and approved medical staff policies and procedures. Education and training regarding these procedures are typically included in the nurse’s hospital orientation. Nursing staff that receive train-ing for intravenous medication administration and/or blood transfusion administration during hospital orientation or during other continuing educa-tion programs would meet the requirements of this regulation.

MU-16.2 The competencies must be documented in the nurse’s record. Content of the training must be based on applicable laws and regulations for intrave-nous medication administration and blood transfusion and must address at least the following: fluid and electrolyte balance; venipuncture techniques, including both demonstration, and supervised practice; and, for blood transfusion training: blood components; blood administration procedures based on hospital policy, and applicable laws and regulations; requirements for patient monitoring, including frequency and documentation of monitor-ing; the process for verification of the right blood product for the right patient; and identification and treatment of transfusion reactions.

MU-16.3 All applicable laws and regulations and scope of practice requirements must be met regarding the administration of intravenous medications and blood transfusions, as applicable.

Surveyor Guidance: • Reviewthebloodtransfusionandintravenousmedicationspractices: - Doesthehospitalincludetrainingforadministeringbloodtransfusionsandintravenous

medicationsduringnursingorientationorthroughothercontinuingeducationprograms? - Doesthetrainingincludethefollowingcontent: ◦ Fluidandelectrolytebalance, ◦ Venipuncturetechniques,demonstrations,andsupervisedpractice ◦ Withrespecttobloodtransfusions: ▫ Bloodcomponents, ▫ Bloodadministrationproceduresperhospitalpolicy,applicablelawsand

regulations,andnationallyrecognizedstandardsofpractice; ▫ Patientmonitoringrequirements,includingfrequencyanddocumentationof

monitoring; ▫ Processforverificationoftherightbloodproductfortherightpatient;and • Transfusionreactions:identification,treatment,andreportingrequirements. - ArebloodtransfusionsandIVmedicationsadministeredinaccordancewithapplicable

lawsandregulationsandapprovedhospitalandmedicalstaffpoliciesandprocedures?

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- ArebloodtransfusionsandIVmedicationsadministeredbypersonnelwhoaretrainedandworkingwithintheirscopeofpracticeinaccordancewithapplicablelawsandregulationsandhospitalandmedicalstaffpolicies?

• Reviewasampleofmedicalrecords.DeterminetheidentityofstaffthatadministeredbloodcomponentsandIVmedicationsandreviewtheiremployeerecords.

- DotheyhavedocumentationofcompletionofbloodtransfusionandIVadministrationtrainingduringhospitalorientationorthroughothercontinuingeducationprograms?

MU-17 There must be a hospital procedure for reporting transfusion reactions, adverse drug reactions, and errors in administration of drugs.

Surveyor Guidance: • Requestthehospitalprocedureforreportingadversedrugreactionsanderrorsandtransfusionreactions.Reviewtheincidentreportsorotherdocumentationthattheprocedureisbeingimplementedandregularlymonitoredthroughhospital’sQualityManagementSystem.

MU-18 Pharmaceutical Services: The hospital must have pharmaceutical services that meet the needs of the patients. The institutions must have a pharmacy directed by a registered pharmacist or a drug storage area under competent supervision. The medical staff is responsible for developing policies and procedures that minimize drug errors. This function may be delegated to the hospital’s organized pharmaceutical service.

MU-19 Provision of pharmaceutical services must meet the needs of the patients’ therapeutic goal by promoting a safe medication use process that ensures optimal selection of medications, dose, dosage form, frequency, route, duration of therapy and that substantially reduces or eliminates adverse drug events and duplication of treatment. A registered pharmacist must direct the hospital’s pharmacy. If a drug storage area is used instead of a pharmacy at any location providing pharmacy services, that storage area must be under competent supervision in accordance with applicable laws and regulations. Pharmaceutical Services would include:

MU-19.1 The procuring, manufacturing, compounding, packaging, dispensing, order-ing, distributing, disposition, use, and administering of all medications, biologicals, chemicals and the use of medication related devices.

MU-19.2 Provision of medication-related information to hospital healthcare profes-sionals and patients necessary to optimize therapeutic outcomes.

MU-19.3 Provision of pharmaceutical care. Pharmaceutical care is defined as the direct, responsible provision of medication-related care for the purpose of achieving definite outcomes that improve a patient’s quality of life while minimizing patient risk.

MU-20 Functions of Pharmaceutical Care are the:

MU-20.1 Collection and organization of patient-specific information;

MU-20.2 Determination of the presence of medication-therapy problems both poten-tial and actual;

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MU-20.3 Summary of the patient’s medication-related health care needs; Identifica-tion and specification of pharmacotherapeutic goals; Development of a pharmacotherapeutic regimen;

MU-20.4 Implementation of a monitoring plan in collaboration with the patient, if applicable, and other health care professionals;

MU-20.5 Monitoring the effects of the pharmacotherapeutic regimen; and redesign-ing the regimen and monitoring plan as indicated.

MU-21 The development of policies and procedures to minimize medication errors should be based on accepted professional principles; external alerts and proactive review of facility reported and reviewed adverse drug events. It is important to flag new types of mistakes and continually improve and refine things, based on what went wrong.

MU-21.1 The hospital’s medical staff must develop policies and procedures to minimize drug errors, but may delegate this function to the hospital’s organized pharma-ceutical service. Policies and procedures to minimize drug errors should include:

MU-21.1.1 High-alert medications - dosing limits, administration guidelines, packaging, labeling and storage;

MU-21.1.2 Limiting the variety of medication-related devices and equipment. For exam-ple limit the types of general-purpose infusion pumps to one or two;

MU-21.1.3 Availability of up-to-date medication information; MU-21.1.4 Availability of pharmacy expertise. Pharmacist available on-call when phar-

macy does not operate 24 hours a day; MU-21.1.5 Standardization of prescribing and communication practices to include: MU-21.1.5.1 Avoidance of dangerous abbreviations; MU-21.1.5.2 All elements of the order – dose, strength, units (metric), route, frequency,

and rate; MU-21.1.5.3 Alert systems for look-like and sound-alike drug names; MU-21.1.5.4 Use of facility approved pre-printed order sheets whenever possible. MU-21.1.6 That orders to resume previous orders are prohibited; MU-21.1.7 A voluntary, non-punitive, reporting system to monitor and report adverse

drug events (including medication errors and adverse drug reactions); MU-21.1.8 The preparation, distribution, administration and proper disposal of hazardous

medications; MU-21.1.9 Drug recalls; MU-21.1.10 That patient-specific information is readily accessible to all individuals in-

volved in provision of pharmaceutical care. The patient information must be sufficient to properly order, prepare, dispense, administer and monitor medi-cations as appropriate;

MU-21.1.11 Identification of when weight-based dosing for pediatric populations is required; and

MU-21.1.12 Requirements for review and revision based on facility-generated reports of adverse drug events and Quality Management System activities.

MU-21.2 The hospital should have a means to incorporate external alerts and/or recommendations from national associations and governmental agencies for review and facility policy and procedure revision consideration.

MU-21.3 The hospital’s pharmacy services must be integrated into its hospital-wide Quality Management System.

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Surveyor Guidance: • Interviewthechiefpharmacistortheindividualdelegatedtofulfillthechiefpharma-cist’sfunctions.Determinethateitherthemedicalstaffhasdevelopedpoliciesandproceduresregardingthemanagementofpharmaceuticalsorthatthisfunctionisfulfilledbythepharmacyservice.

• Verifythatthepurposeofpharmaceuticalpoliciesandproceduresistominimizedrugerrors.Reviewthepharmaceuticalpoliciesandprocedures,thehospital’sformularyand,ifthereisapharmacyandtherapeuticcommittee,theminutesofthecommitteemeetings.

• Doesamultidisciplinarycommitteecomposedofrepresentativesfromnursing,pharmacy,administrationandmedicinedeveloppoliciesandprocedures?

• Aretherepoliciesandprocedurestominimizedrugerrors? • Arepoliciesandproceduresreviewedandamendedbasedon: - Facility-generatedreportsofadversedrugevents; - FacilityQualityManagementSystemactivitiespertainingtopharmaceuticalcare; - Evaluationofexternalalertsand/orrecommendationsfromnationalassociations; - Evaluationofliteraturefornewtechnologiesorsuccessfulpracticesthathave

demonstratedenhancedmedicationsafetyinotherorganizations. • Isthestafffamiliarwiththemedication-relatedpoliciesandprocedures? • Isthereamethodtoperiodicallyreviewandevaluatetheactualimplementationof

pharmaceuticalpoliciesandproceduresbystaff? • Uponreviewofpatientclinicalrecordsareissueswithregardtoprovisionofpharma-

ceuticalservicesidentified?Isthefacilityawareoftheissues?Wasthereafailuretoimplementapolicyandprocedure?

• Arepharmacistsanintegralcomponentofpharmaceuticalcare? • Verifythatthehospital’spharmacyservicesareintegratedintoitshospital-wide

QualityManagementSystem.

MU-22 Pharmacy Management and Administration: The pharmacy or drug storage area must be administered in accordance with accepted professional principles.

MU-22.1 The hospital may utilize a unit dose system, individual prescription, floor stock system or a combination of these systems, properly stored.

MU-22.2 Pharmaceutical services must be administered in accordance with accepted professional principles. Accepted professional principles include compliance with applicable laws, regulations and guidelines governing pharmaceutical services.

MU-22.3 A fundamental purpose of pharmaceutical services is to ensure the safe and appropriate use of medications and medication-related devices. The phar-macy director, with input from appropriate hospital staff and committees, develops, implements and periodically reviews and revises policies and procedures governing provision of pharmaceutical services.

MU-22.4 Methods a hospital may use to maintain professional principles include:

MU-22.4.1 Policies and procedures have been developed and are being followed; MU-22.4.2 Drugs and biologicals are stored in accordance with manufacturer’s directions

and applicable laws and regulations; MU-22.4.3 Employees provide pharmaceutical services within their scope of license and

education; MU-22.4.4 Pharmacy records have sufficient detail to follow the flow of pharmaceuticals

from their entry into the hospital through dispensation/administration;

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MU-22.4.5 Maintaining controls over drugs and medications including the floor stock and those of the pharmacy or drug room;

MU-22.4.6 Maintaining pharmacy and accounting records pertaining to the requisitioning and dispensing of drugs and pharmaceutical supplies;

MU-22.4.7 Ensuring that only a licensed pharmacist is dispensing drugs; MU-22.4.8 Only pharmacists or pharmacy-supervised personnel compound, label and

dispense drugs or biologicals.

Surveyor Guidance: • Arethepoliciesandproceduresconsistentwithacceptedprofessionalprinciples? • Determinethatprofessionalprinciplesaremaintainedbyverifyingthat: - Policiesandprocedureshavebeendevelopedandarebeingfollowed; - Drugsandbiologicalsarestoredinaccordancewithmanufacturers’directionsand

applicablelawsandregulationrequirements; - Recordshavesufficientdetailtofollowtheflowofcontrolfromentrythrough

dispensation;and - Employeesprovidepharmaceuticalserviceswithintheirscopeoflicenseandeducation. • Doesthehospitalhaveameanstoincorporateexternalalertsand/orrecommenda-

tionsfromnationalassociationsandgovernmentalagenciesforreviewandfacilitypolicyandprocedurerevisionconsideration?

• Arepoliciesdevelopedtopromoteconsistentapplicationofpharmaceuticalservicesandcarethroughoutthehospital?

• Isthepharmacydirectorperiodicallymonitoringimplementationofpoliciesandprocedures?

• Arepoliciesandproceduresreviewedandrevisedaswarranted? • Areservicesprovidedinamannerconsistentwithacceptedprofessionalprinciples? • Isthepharmacyresponsiblefortheprocurement,distributionandcontrolofall

medicationproductsusedinthehospital(includingmedication-relateddevices)forinpatientandoutpatientcare?

MU-22.5 A full-time, part-time, or consulting pharmacist must be responsible for devel-oping, supervising, and coordinating all the activities of the pharmacy services.

MU-22.5.1 Direction of pharmaceutical services may not require continuous on-premise supervision at the hospital’s single pharmacy or at any pharmacy location but may be accomplished through regularly scheduled visits, in accordance with applicable laws and regulations and accepted professional principles.

MU-22.5.2 A single pharmacist must be responsible for the overall administration of the pharmacy service and must be responsible for developing, supervising, and coordinating all the activities of the hospital wide pharmacy service.

MU-22.5.3 The job description or the written agreement for the responsibilities of the pharmacist should be clearly defined and include development, supervision and coordination of all the activities of pharmacy services.

MU-22.5.4 A professional, competent, legally qualified pharmacist must manage the pharmacy. The director of pharmacy service must be thoroughly knowledge-able about hospital pharmacy practice and management.

MU-22.5.5 Pharmacists and pharmacy technicians must perform their duties within scope of their license and education.

MU-22.5.6 The pharmacy director should be actively involved in those committees responsible for establishing medication-related policies and procedures.

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MUSurveyor Guidance: • Determinewhetherthepharmacistisafull-time,orpart-timeemployeeoremployed

onaconsultativebasis. • Reviewtheimplementationofthechiefpharmacist’sresponsibilitiesby: - Reviewingwrittenstatusreports; - Reviewingminutesofmeetings(ifany)withfacilitystaffregardingpharmaceutical

services; - Reviewingschedules,timelogs,etc.; - Reviewingthejobdescriptionorthewrittenagreementtoseethattheresponsibili-

tiesofthepharmacistareclearlydefinedandincludedevelopmentsupervisionandcoordinationofalltheactivitiesofpharmacyservices;

- Determiningwhetherthepharmacydirectorroutinelyevaluatestheperformanceandcompetencyofpharmacypersonnel.Doperformanceevaluationsincludehigh-riskactivitiessuchasthecompoundingofhazardousmedications,pharmacy-basedprescriptiveactivities(e.g.aminoglycosideprotocols)andpharmaceuticalcareforhigh-riskpatients(pediatric,ICU,geriatricetc.)?

• Determinewhetherthepharmacydirectorisactivelyinvolvedinthosecommitteesresponsibleforestablishingmedication-relatedpoliciesandprocedures.

MU-22.6 The pharmaceutical service must have an adequate number of personnel to ensure quality pharmaceutical services, including emergency services.

Interpretive Guidelines: • Theremustbesufficientpersonneltorespondtothepharmaceuticalneedsofthepatientpopulationbeingserved.

• Thepharmaceuticalservicesstaffmustbesufficientintypes,numbers,andtrainingtoprovidequalityservices,including24hour,7-dayemergencycoverage,orthereisanarrangementforemergencyservices,asdeterminedbytheneedsofthepatientsandasspecifiedbythemedicalstaff.

• Thenumberofpharmacistsand/orthenumberofhoursofservicesprovidedbypharmacistsatthehospital,orateachlocationofthehospitalthatprovidespharma-ceuticalservices,mustmeetandbeinaccordancewiththeneedsofitspatientsandacceptedprofessionalprinciples(aspreviouslydefined),andreflectthescopeandcomplexityofthehospital’spharmaceuticalservices.

• Theremustbesufficientnumbersandtypesofpersonneltoprovideaccurateandtimelymedicationdelivery,ensureaccurateandsafemedicationadministrationandtoprovideappropriateclinicalservicesaswellastheparticipationincontinuousqualityimprovementprogramsthatmeettheneedsofthepatientpopulationbeingserved.

Surveyor Guidance: • Determinethatthepharmaceuticalservicesstaffissufficientinnumberandtrainingtoprovidequalityservices,including24hour,7-dayemergencycoverage,orthereisanarrangementforemergencyservices,asdeterminedbytheneedsofthepatientsandasspecifiedbythemedicalstaff.

• Determineiftherearesufficientpersonneltoprovideaccurateandtimelymedicationdelivery,ensureaccurateandsafemedicationadministrationandtoprovideappro-priateclinicalservicesaswellastheparticipationincontinuousqualityimprovementprogramsthatmeettheneedsofthepatientpopulationbeingserved.

MU-22.7 Current and accurate records must be kept of the receipt and disposition of all scheduled drugs.

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Interpretive Guidelines: • Componentsofarecordsystemtomaintaincurrentandaccuraterecordsofthereceiptanddispositionofscheduleddrugswouldinclude:

• Accountabilityprocedurestoensurecontrolofthedistribution,use,anddispositionofallscheduleddrugs.

• Recordsofthereceiptanddispositionofallscheduleddrugsmustbecurrentandmustbeaccurate.

• Recordstracethemovementofscheduleddrugsthroughouttheservice. • Thepharmacistisresponsiblefordeterminingthatalldrugrecordsareinorderand

thatanaccountofallscheduleddrugsismaintainedandreconciled. • Therecordsystem,delineatedinpoliciesandprocedures,tracksmovementofall

scheduleddrugsfromthepointofentryintothehospitaltothepointofdepartureeitherthroughadministrationtothepatient,destructionorreturntothemanufacturer.Thissystemprovidesdocumentationonscheduleddrugsinareadilyretrievablemannertofacilitatereconciliationofthereceiptanddispositionofallscheduleddrugs.

• Alldrugrecordsareinorderandanaccountofallscheduleddrugsismaintainedandanydiscrepanciesincountarereconciledpromptly.

• Thehospitalsystemiscapableofreadilyidentifyinglossordiversionofallcontrolledsubstancesinsuchamannerastominimizethetimeframebetweentheactuallossordiversiontothetimeofdetectionanddeterminationoftheextentoflossordiversion.

• Facilitypoliciesandproceduresshouldminimizescheduleddrugdiversion.

Surveyor Guidance: • Determineifthereisarecordsysteminplacethatprovidesinformationoncontrolledsubstancesinareadilyretrievablemanner.

• Reviewtherecordstodeterminethattheytracethemovementofscheduleddrugsthroughouttheservice.

• Determineifthereisasystem,delineatedinpoliciesandprocedures,thattracksmovementofallscheduleddrugsfromthepointofentryintothehospitaltothepointofdepartureeitherthroughadministrationtothepatient,destructionorreturntothemanufacturer.Determineifthissystemprovidesdocumentationonscheduleddrugsinareadilyretrievablemannertofacilitatereconciliationofthereceiptanddispositionofallscheduleddrugs.

• Determineifthepharmacistisresponsiblefordeterminingthatalldrugrecordsareinorderandthatanaccountofallscheduleddrugsismaintainedandperiodicallyreconciled.

• Isthehospitalsystemcapableofreadilyidentifyinglossordiversionofallcontrolledsubstancesinsuchamannerastominimizethetimeframebetweentheactuallossesordiversiontothetimeofdetectionanddeterminationoftheextentoflossordiversion?

• Determineiffacilitypolicyandproceduresminimizescheduleddrugdiversion.

MU-22.8 Delivery of Services: In order to provide patient safety, drugs and biologicals must be controlled and distributed in accordance with applicable standards of practice, consistent with applicable laws and regulations.

Interpretive Guidelines: • Drugsandbiologicalsmustbecontrolledanddistributedinaccordancewithapplica-blelawsandregulations,andinaccordancewithapplicablestandardsofpractice.Applicablestandardsofpracticeincludecompliancewithallapplicablelaws,regula-tions,andguidelines,aswellas,standardsandrecommendationspromotedbynation-allyrecognizedprofessionalorganizationsthatapplytopharmaceuticalcareandthecontrolanddistributionofdrugsandbiologicals.

• Theproceduresestablishedtopreventunauthorizedusageanddistributionmustprovideforanaccountingofthereceiptanddispositionofdrugs.

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MU • Thepharmacist,inconsultationwithappropriatehospitalstaffandcommittees,istodevelopandimplementguidelines,protocols,policiesandproceduresfortheprovi-sionofpharmaceuticalservicesthatensurepatientsafetythroughtheappropriatecontrolanddistributionofmedications,medication-relateddevicesandbiologicals.

• Forhighriskmedicationsandhigh-riskpatients(pediatric,geriatricorpatientswithrenalorhepaticimpairment)thereshouldbesystemsinplacetominimizeadversedrugevents.Suchsystemscouldincludebutnotlimitedto;checklists,doselimits,pre-printedorders,specialpackaging,speciallabeling,double-checksandwrittenguidelines.“High-riskmedications”arethosemedicationsinvolvedinahighpercent-ageofmedicationerrorsand/orsentineleventsandmedicationsthatcarryahigherriskforabuse,errors,orotheradverseoutcomes.Examplesofhigh-riskdrugsmayincludeinvestigationaldrugs,controlledmedications,medicationswithanarrowtherapeuticrange,psychotherapeuticmedicationsandlook-alike/sound-alikemedica-tionsandthosenewtothemarketornewtothehospital.

• Allmedicationorders(exceptinemergencysituations)shouldbereviewedforappro-priatenessbyapharmacistbeforethefirstdoseisdispensed.

• Reviewofmedicationordersshouldincludethefollowing: - Therapeuticappropriatenessofapatient’smedicationregimen; - Therapeuticduplicationinthepatient’smedicationregimen; - Appropriatenessofthedrug,dose,frequency,routeandmethodofadministration; - Realorpotentialmedication-medication,medication-food,medication-laboratory

testandmedication-diseaseinteractions; - Realorpotentialallergiesorsensitivities; - Othercontraindications. • Theeffectsofmedication(s)onpatientsaremonitoredtoassuremedicationtherapyis

appropriateandminimizestheoccurrenceofadverseevents.Thatmonitoringprocessincludes:

- Clinicalandlaboratorydatatoevaluatetheefficacyofmedicationtherapytoanticipateorevaluatetoxicityandadverseeffects;

- Physicalsignsandclinicalsymptomsrelevanttothepatient’smedicationtherapy; - Assessingthepatient’sownperceptionsaboutsideeffects,and,whenappropriate,

perceivedefficacy. • Sterileproductsshouldbepreparedandlabeledinasuitableenvironmentbyappro-

priatelytrainedandqualifiedpersonnel. • Thepharmacyshouldparticipateinhospitaldecisionsaboutemergencymedication

kits.Thesupplyandprovisionofemergencymedicationsstoredinthekitsmustbeconsistentwithstandardsofpracticeandappropriateforaspecifiedagegroupordiseasetreatmentaswellasconsistentwithapplicablelawsandregulations.

• Thepharmacyshouldbeinvolvedintheevaluation,useandmonitoringofdrugdeliverysystems,administrationdevicesandautomateddrug-dispensingmachines.Theevaluationandmonitoringshouldincludethepotentialformedicationerrors.

• Thereisapolicythataddressestheuseofmedicationsbroughtintothehospitalbypatientsortheirfamilies.

• Thereisaprocessandpolicytoensurethatinvestigationalmedicationsaresafetycontrolledandadministered.Proceduresfortheuseofinvestigationalmedicationsincludethefollowing:Awrittenprocessforreviewing,approving,supervisingandmonitoringinvestigationalmedicationsspecifyingthatwhenpharmacyservicesareprovided,thepharmacycontrolsthestorage,dispensing,labeling,anddistributionoftheinvestigationalmedication.

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• Medicationsdispensedbythehospitalareretrievedwhenrecalledordiscontinuedbythemanufacturerorforsafetyreasons.

• Thehospitalpharmacymustensurethatmedicationordersareaccurateandthatmedicationsareadministeredasordered.Thepharmacyshouldhaveasystemtoreconcilemedicationsthatarenotadministered,thatremaininthepatient’smedicationdrawer,slot,etc.,whenthepharmacyinventoriespatientmedicationsorrestockspatientmedications.Thepharmacyshoulddeterminethereasonthemedicationswerenotused.

- Forexample,didthepatientrefusethemedication,wasthereaclinicalortreatmentreasonthemedicationwasnotused,orwasthemedicationnotusedduetoanerror?

Surveyor Guidance: • Aretherelimitsonthenumberofpossibleconcentrationsforamedication,particu-larlyhigh-alertdrugslikemorphineandheparin?

• Isaccesstoconcentratedsolutions(e.g.potassiumchloride,sodiumchloridesolutionsgreaterthan0.9%)restricted?

• Arequestionsregardingtheorderresolvedwiththeprescriberandawrittennotationofthesediscussionsdocumentedinthepatient’smedicalrecordorpharmacycopyoftheprescriber’sorder?

• Identifyandassessthequalityassuranceproceduresforthepreparationofsterileproducts. • Isappropriatemonitoringofmedicationtherapybeingconducted? • Isthepharmacyinvolvedintheevaluation,useandmonitoringofdrugdelivery

systems,administrationdevicesandautomateddrugdispensingmachines?Theevaluationandmonitoringshouldincludethepotentialformedicationerrors.

• Reviewtheproceduresestablishedtopreventunauthorizedusageanddistribution.Theseproceduresmustprovideforanaccountingofthereceiptanddispositionofdrugs.

• Aremedicationstorageareasperiodicallyinspectedtomakesuremedicationsareproperlystored?

• Doesthehospitalretrieveandremovemedicationsavailableorpatientusewhenthehospitalhasbeeninformedofadrugrecall?Doestherecallincludenotificationofpatientsthathavebeenimpactedandthosethatwouldorder,dispenseoradministerthemedication?

MU-23 All compounding, packaging, and dispensing of drugs and biologicals must be under the supervision of a pharmacist and performed consistent with applicable laws and regulations.

MU-23.1 All compounding, packaging, and dispensing of drugs and biologicals must be conducted by a registered pharmacist or under the supervision of a registered pharmacist and performed consistent with applicable laws and regulations.

MU-23.2 Medications must be prepared safely. Safe preparation procedures could include:

Interpretive Guidelines: • Onlythepharmacycompoundsoradmixesallsterilemedications,intravenousadmixtures,orotherdrugsexceptinemergenciesorwhennotfeasible(forexample,whentheproduct’sstabilityisshort).

• Whenevermedicationsareprepared,staffusessafetymaterialsandequipmentwhilepreparinghazardousmedications.

• Wherevermedicationsareprepared,staffusestechniquestoassureaccuracyinmedicationpreparation.

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• Whenevermedicationsareprepared,staffusesappropriatetechniquestoavoidcontami-nationduringmedicationpreparation,whichincludebutarenotlimitedtothefollowing:

- Usingcleanorsteriletechniqueasappropriate; - Maintainingclean,uncluttered,andfunctionallyseparateareasforproductprepa-

rationtominimizethepossibilityofcontamination; - Usingalaminarairflowhoodorotherappropriateenvironmentwhilepreparingany

intravenous(IV)admixtureinthepharmacy,anysterileproductmadefromnon-sterileingredients,oranysterileproductthatwillnotbeusedwithin24hours;and

- Visuallyinspectingtheintegrityofthemedications.

MU-23.3 Medications should be dispensed in a manner that is safe and meets the needs of the patient:

MU-23.3.1 Quantities of medications are dispensed which minimize diversion and poten-tial adverse events while meeting the needs of the patient;

MU-23.3.2 Medications are dispensed in a timely manner. The hospital must have a system that ensures that medication orders get to the pharmacy and medica-tions get back to patients promptly.

MU-23.3.3 Whenever possible, medications are dispensed in the most ready to adminis-ter form available from the manufacturer or, if feasible, in unit doses that have been repackaged by the pharmacy;

MU.23.3.4 The hospital consistently uses the same dose packaging system, or, if a different system is used, provides education about the use of the dose packaging system; and

MU-23.3.5 All concerns, issues or questions are clarified with the individual prescriber before dispensing.

Surveyor Guidance: • Determinethatonlypharmacistsorpharmacysupervisedpersonnelcompound,labelanddispensedrugsorbiologicalsinaccordancewithapplicablelawsandregulationsandasacceptednationalprinciplesby:

- Reviewingpoliciesandprocedures; - Interviewingpharmacyandhospitalstafftodeterminehowdrugsandbiologicals

arepreparedanddispensed; - Observingonsitedispensingandcompoundingoperations(ifapplicable); - Reviewingrecordsofdrugsandbiologicalsremovedfromthepharmacybynon-

pharmacypersonnel;and - Inspectingdrugstorageareas. • Verifythroughinterviewsofpharmacyandhospitalstaff,observationofon-sitedispensing

operations,inspectionandreviewofhospitalrecordsthatcompounding,dispensingandpackagingofdrugsandbiologicalsareperformedunderthesupervisionofapharmacist,inaccordancewithapplicablelawsandinamannertopromotepatientsafety.

MU-24 All drugs and biologicals must be kept in a secure area, and locked when appropriate.

MU-24.1 A secure area means that drugs and biologicals are stored in a manner to prevent unmonitored access by unauthorized individuals. Drugs and biologi-cals must not be stored in areas that are readily accessible to unauthorized persons. For example, if medications are kept in a private office, or other area where patients and visitors are not allowed without the supervision or pres-ence of a health care professional (for example, ambulatory infusion), they are

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considered secure. Areas restricted to authorized personnel only would generally be considered secure areas. If there is evidence of tampering or diversion, or if medication security otherwise becomes a problem, the hospi-tal is expected to evaluate its current medication control policies and proce-dures, and implement the necessary systems and processes to ensure that the problem is corrected, and that patient health and safety are maintained.

MU-24.2 All controlled substances must be locked. Hospitals are permitted flexibility in the storage of non-controlled drugs and biologicals when delivering care to patients, and in the safeguarding of drugs and biologicals to prevent tampering or diversion. An area in which staff are actively providing care to patients or preparing to receive patients, i.e., setting up for procedures before the arrival of a patient, would generally be considered a secure area. When a patient care area is not staffed, both controlled and non-controlled substances are expected to be locked. Generally labor and delivery suites and critical care units are staffed and actively providing patient care around the clock, and, therefore, considered secure. However, hospital policies and procedures are expected to ensure that these areas are secure, with entry and exit limited to appropriate staff, patients and visitors.

MU-24.3 The operating theatre is considered secure when the theatre is staffed and staff is actively providing patient care. When the theatre is not in use (e.g., weekends, holidays and after hours), it would not be considered secure. A hospital may choose to lock the entire theatre, lock non-mobile carts con-taining drugs and biologicals, place mobile carts in a locked room, or other-wise lock drugs and biologicals in a secure area. If an individual operating theatre is not in use, the hospital is expected to lock non-mobile carts, and ensure mobile carts are in a locked room.

MU-24.4 This regulation gives hospitals the flexibility to integrate patient self-admin-istration of non-controlled drugs and biologicals into their practices as appropriate. When a hospital allows a patient to self-administer selected drugs and biologicals, the hospital authorizes the patient to have access to these medications. This regulation is consistent with the current practice of giving patients access at the bedside to urgently needed medications, such as nitroglycerine tablets and inhalers. It supports the current practice of placing selected nonprescription medications at the bedside for the patient’s use, such as lotions and creams, and rewetting eye drops.

Interpretive Guidelines: • Hospitalsareexpectedtoaddresspatientself-administrationofnon-controlleddrugsandbiologicalsintheirpoliciesandprocedures.

• Thisregulationsupportshospitaldevelopment,incollaborationwiththemedicalstaffandthenursingandpharmacydepartments,offormalpatientmedicationself-admin-istrationprogramsforselectpopulationsofpatients.

• Hospitalpoliciesandproceduresnecessarytoensurepatientsafetyandsecurityofmedications.

• Thepoliciesandproceduresareexpectedtoincludemeasurestoensurethesecurityofbedsidedrugsandbiologicals.

• Policiesandproceduresareexpectedtoaddressboththecompetenceofthepatienttoself-administerdrugsandbiologicalsaswellaspatienteducationregardingself-administrationofdrugsandbiologicals.

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MU-24.5 Due to their mobility, mobile nursing medication carts, anesthesia carts, epi-dural carts and other medication carts containing drugs or biologicals (hereaf-ter, all referred to as “carts”) must be locked in a secure area when not in use. Hospital policies and procedures are expected to address the security and monitoring of carts, locked or unlocked, containing drugs and biologicals in all patient care areas to ensure their safe storage and to ensure patient safety.

MU-24.6 Medication automated distribution units with security features, such as logon and password or biometric identification, are considered to be locked, since they can only be accessed by authorized personnel who are permitted access to the medications. Such units must be stored in a secure area.

Surveyor Guidance: • Reviewhospitalpoliciesandproceduresgoverningthesecurityofdrugsandbiologi-calstodeterminewhethertheyprovideforsecuringandlockingasappropriate.

• Reviewhospitalpoliciesandproceduresgoverningpatientself-administrationofdrugsandbiologicals.

• Observewhethermedicationsinvariousareasofthehospitalarestoredinasecurearea,andlockedwhenappropriate.

• Determinethatsecurityfeaturesinautomatedmedicationdistributionunitsareimplementedandactivelymaintained,e.g.,thataccessauthorizationsareregularlyupdatedtoreflectchangesinpersonnel,assignments,etc.

• Interviewstafftodeterminewhetherpoliciesandprocedurestorestrictaccesstoauthorizedpersonnelisimplementedandeffective.

• Interviewpatientsandstafftodeterminewhetherpoliciesandproceduresregardingpatientself-administrationofdrugsandbiologicalsareimplementedandeffective.

MU-24.7 Narcotics

MU-24.7.1 Narcotics drugs must be kept locked within a secure area. A secure area means the drugs and biologicals are stored in a manner to prevent unmoni-tored access by unauthorized individuals.

MU-24.7.2 Medication automated distribution units with logon and password/biometric identification are considered to be locked, since they can only be accessed by authorized personnel who are permitted access to narcotics.

MU-24.7.3 Mobile nursing medication carts, anesthesia carts, epidural carts and other medication carts containing narcotics must be locked within a secure area.

Surveyor Guidance: • Determinewhetherthereisahospitalpolicyandprocedurethatrequiresnarcoticdrugstobekeptinalockedstoragearea.

• Observeinvariouspartsofthehospitalwhethernarcoticdrugsarelockedandstoredinasecurearea.

• Determinewhethersecurityfeaturesinautomatedmedicationdistributionunitsareimplementedandactivelymaintained,e.g.,thataccessauthorizationsareregularlyupdatedtoreflectchangesinpersonnel,assignments,etc.

• Interviewstafftodeterminewhetherpoliciesandprocedurestorestrictaccesstoauthorizedpersonnelisimplementedandeffective.

MU-24.8 Only authorized personnel may have access to locked areas. The hospital must assure that only authorized personnel may have access to locked areas where drugs and biologicals are stored.

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MU MU-24.8.1 A hospital has the flexibility to define which personnel have access to locked areas, based on the hospital’s needs as well as applicable laws and regulations. For example, a hospital could include within its definition of “authorized per-sonnel” ancillary support personnel, such as engineering, housekeeping staff, orderlies and security personnel as necessary to perform their assigned duties.

MU-24.8.2 The hospital’s policies and procedures must specifically address how “author-ized personnel” are defined for purposes of this section. It is not necessary for the policy to name specific authorized individuals, but the policy should be clear in describing the categories of personnel who have authorized access, as well as whether there are as below:

MU-24.8.2.1 Different levels of access authorized in different areas of the hospital, or at different times of day;

MU-23.8.2.2 Or for different classes of drugs and biologicals, etc. MU-24.8.3 The hospital’s policies and procedures must also address how it prevents unau-

thorized personnel from gaining access to locked areas where drugs and biologicals are stored. Whenever unauthorized personnel have access, or could gain access, to those locked areas, the hospital is not in compliance with this requirement and is expected to reevaluate and tighten its security measures.

Surveyor Guidance: • Determinewhetherthereisahospitalpolicyandproceduredefiningauthorizedperson-nelthatarepermittedaccesstolockedareaswheredrugsandbiologicalsarestored.

• Determinewhetherthereisahospitalpolicyandprocedureforlimitingaccesstolockedstorageareastoauthorizedpersonnelonly.

• Observewhetherornotaccesstolockedstorageareasislimitedtopersonnelauthor-izedbythehospital’spolicy.

MU-24.9 Abuses and losses of controlled substances must be reported, in accordance with applicable laws and regulations, to the individual responsible for the pharmaceutical service, and to the chief executive officer, as appropriate.

Surveyor Guidance: • Interviewthepharmacists,orpharmacyemployeestodeterminetheirunderstandingofthecontrolleddrugpolicies.

• Conductaspotcheckofdruguseandotherinventoryrecordstoensurethatdrugsareproperlyaccountedfor.

• Reviewreportsofpharmaceuticalservicestodetermineiftherearereportedproblemswithcontrolleddrugsandwhatactionshavebeentakentocorrectthesituation.

• Interviewthepharmacydirector,pharmacistandpharmacyemployeestodeterminetheirunderstandingofthecontrolleddrugpolicies.Isthereapolicyandprocedureforhandlingcontrolleddrugdiscrepancies?

• Reviewreportsofpharmaceuticalservicestodetermineiftherearereportedproblemswithcontrolleddrugsandwhatactionshavebeentakentocorrectthesituation.

• Determineifcontrolleddruglosseswerereportedtoappropriateauthoritiesinaccordancewithapplicablelawsandregulations.

MU-25 Outdated, mislabeled, or otherwise unusable drugs and biologicals must not be available for patient use.

MU-25.1 The hospital must have a pharmacy labeling, inspection, and inventory management system that ensures that outdated, mislabeled, or otherwise unusable drugs and biologicals are not available for patient use.

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MUSurveyor Guidance: • Spot-checkthelabelsofindividualdrugcontainerstoverifythattheyconformto

applicablelawsandregulations,and/orcontainthefollowingminimalinformation: - Eachpatient’sindividualdrugcontainerbearshis/herfullname,theprescriber’s

name,andstrengthandquantityofthedrugdispensed.Appropriateaccessoryandcautionarystatementsareincludedaswellastheexpirationdate.

- Eachfloorstockcontainerbearsthenameandstrengthofthedrug,lotandcontrolnumberofequivalent,andexpirationdate.

• Iftheunitdosesystemisutilized,verifythateachsingleunitdosepackagebearsnameandstrengthofthedrug,lotandcontrolnumberequivalent,andexpirationdate.

• Inspectpatient-specificandfloorstockmedicationstoidentifyexpired,mislabeledorunusablemedications.

MU-26 When a pharmacist is not available, drugs and biologicals must be removed from the pharmacy or storage area only by personnel designated in the policies of the medical staff and pharmaceutical service, in accordance with applicable laws and regulations.

Interpretive Guidelines: • Routineafter-hoursaccesstothepharmacybynon-pharmacistsforaccesstomedica-tionshouldbeminimizedandeliminatedasmuchaspossible.Theuseofwell-de-signednightcabinets,after-hoursmedicationcarts,andothermethodsmayprecludetheneedfornon-pharmacisttoenterthepharmacy.Policiesandproceduresshouldbeconsistentwithapplicablelawsandregulations.

• Ifanurgentoremergentpatientneedoccurs,thehospitalmustbeabletoprovidemedicationstothepatientsinitsfacility.

• Thehospitalmusthaveaprocessforprovidingmedicationstomeetpatientneedswhenthepharmacyisclosed.

• Whennon-pharmacisthealthcareprofessionalsareallowedbylawandregulationtoobtainmedicationsafterthepharmacyisclosed,thefollowingsafeguardsareapplied:

- Accessislimitedtoasetofmedicationsthathasbeenapprovedbythehospital.Thesemedicationscanbestoredinanightcabinet,automatedstorageanddistribu-tiondevice,oralimitedsectionofthepharmacy.

- Onlytrained,designatedprescribersandnursesarepermittedaccesstomedications. - Qualitycontrolprocedures(suchasanindependentsecondcheckbyanother

individualorasecondaryverificationbuiltintothesystem,suchasbarcoding)areinplacetopreventmedicationretrievalerrors.

- Thehospitalarrangesforaqualifiedpharmacisttobeavailableeitheron-calloratanotherlocation(forexample,atanotherorganizationthathas24-hourpharmacyservice)toanswerquestionsorprovidemedicationsbeyondthoseaccessibletonon-pharmacystaff.

- Thisprocessisevaluatedonanon-goingbasistodeterminethemedicationsaccessedroutinelyandthecausesofaccessingthepharmacyafterhours.

- Changesareimplementedasappropriatetoreducetheamountoftimesnon-pharma-cisthealthcareprofessionalsareobtainingmedicationsafterthepharmacyisclosed.

Surveyor Guidance: • Determinethroughpharmacyrecordsthatwhenthepharmacistisnotavailable,drugsareremovedfromthepharmacy(drugstoragearea)onlybyadesignatedindividual(inaccordancewithapplicablelawsandregulations)andonlyinamountssufficientforimmediatetherapeuticneeds.

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• Reviewpoliciesandprocedurestodeterminewhoisdesignatedtoremovedrugsandbiologicalsfromthepharmacyorstorageareaandtheamountanon-pharmacistmayremoveintheabsenceofapharmacist.Theindividual(s)designatedshouldbeidentifiedbynameandqualifications.

• Determinethatasystemisinplacethataccuratelydocumentstheremovalofmedica-tions(typeandquantity)fromeitherthepharmacyortheafterhourssupply.

• Determinethatthepharmacistreviewsallmedicationremovalactivityandcorrelatestheremovalwithcurrentmedicationordersinthepatientmedicationprofile.

• Determineifthepharmacistroutinelyreviewsthecontentsoftheafter-hourssupplytodetermineifitisadequatetomeettheafter-hoursneedsofthehospital.

MU-27 Drugs and biologicals not specifically prescribed as to time or number of doses must automatically be stopped after a reasonable time that is prede-termined by the medical staff.

Interpretive Guidelines: • Inaccordancewithacceptedstandardsofpractice,themedicalstaff,incoordinationandconsultationwiththepharmacyservice,determinesandestablishesthereason-abletimetoautomaticallystopordersfordrugsandbiologicalsnotspecificallyprescribedastotimeornumberofdoses.Thehospitalmustimplement,monitor,andenforcethisautomaticstopsystem.

Surveyor Guidance: • Reviewpoliciesandprocedurestodeterminethatthereisaprotocolestablishedbythemedicalstafftodiscontinueandreviewpatients’medicalrecordstodeterminecompliancewithstop-orderpolicy.

MU-28 Drug administration errors, adverse drug reactions, and incompatibilities must be immediately reported to the attending physician and, if appropri-ate, to the hospital-wide Quality Management System.

MU-28.1 Hospitals are required to ensure that the attending physician is made imme-diately aware of drug administration errors, adverse drug reactions, and incompatibilities. When the attending physician is unavailable, the covering physician must be notified.

MU-28.2 When the covering physician must be notified, the patient’s attending physician must be notified as soon as he/she is available.

MU-28.3 In addition, when appropriate, such events must also be reported to the hospital-wide Quality data program.

MU-28.4 The hospital must adopt policies and procedures that identify the types of events that must be reported immediately to the attending physician, as well as those to be reported to the Quality Management System.

Interpretive Guidelines: • Drugadministrationerror: - Thedefinitionofamedicationerroris―Anypreventableeventthatmaycauseor

leadtoinappropriatemedicationuseorpatientharmwhilethemedicationisinthecontrolofthehealthcareprofessional,patient,orconsumer.Sucheventsmayberelatedtoprofessionalpractice,healthcareproducts,procedures,andsystems,includingprescribing;ordercommunication;productlabeling,packaging,and

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nomenclature;compounding;dispensing;distribution;administration;education;monitoring;anduse.

• Adversedrugreaction: - Anadversedrugreactionisdefinedasanadversedrugreaction(ADR)asAny

unexpected,unintended,undesired,orexcessiveresponsetoadrugthat: ◦ Requiresdiscontinuingthedrug(therapeuticordiagnostic) ◦ Requireschangingthedrugtherapy ◦ Requiresmodifyingthedose(exceptforminordosageadjustments) ◦ Necessitatesadmissiontoahospital ◦ Prolongsstayinahealthcarefacility ◦ Necessitatessupportivetreatment ◦ Significantlycomplicatesdiagnosis ◦ Negativelyaffectsprognosis,or ◦ Resultsintemporaryorpermanentharm,disability,ordeath. - Consistentwiththedefinition,anallergicreaction(animmunologichypersensitivity

occurringastheresultofunusualsensitivitytoadrug)andanidiosyncraticreaction(anabnormalsusceptibilitytoadrugthatispeculiartotheindividual)arealsoconsideredADRs.

• Drugincompatibilities: - Adrugincompatibilityoccurswhendrugsinterferewithoneanotherchemicallyor

physiologically.Drugsknowntobeincompatiblemustnotbemixed,administeredtogether,oradministeredwithinatimeframewheretheywillinterferewitheachother.

- WhenIVmedicationsareadministeredwithknownincompatibilities,anerrorhasoccurredanditneedstobereportedtotheattendingphysicianimmediately.AnyunexpectedreactionthatoccursbetweenIVmedicationsnotpreviouslyidentifiedasincompatiblealsoneedstobereported.

- Hospitalscanminimizetheriskofadministeringincompatiblemedicationsbymakingavailablepertinentresources,suchasdrugincompatibilitychartsandonlineincompatibilityreferences.Theincompatibilityinformationneedstobereadilyavailabletostaffadministeringmedications.Theinformationneedstobekeptup-to-dateastheinformationisfrequentlyupdatedbydrugmanufacturers.

MU-28.5 The immediate reporting requirement applies to drug administration errors, adverse drug reactions or incompatibilities that have harmed or have the potential to harm the patient. If the outcome of the drug administration error is unknown, the physician must also be notified without delay.

Interpretive Guidelines: • Drugadministrationerrorsthatresultinnoorinsignificantharmtothepatientmustalsobedocumentedinthemedicalrecordbutdonotrequireimmediatereportingtotheattendingphysician.Forexample,ifananalgesicdoseismissedduringthenightshift,itcanbereportedfirstthinginthemorning.Hospitalstaffisexpectedtousetheirclinicaljudgment,basedonpatientpresentationandassessmentinaccordancewithhospitalpolicyandprocedures,todeterminewhetherimmediatereportingisrequired.

• Ontheotherhand,forpurposesofreportingtothehospital’sQualityManagementSystem,hospitalsmust,trackandreportnotonlytheerrorsthatcauseorriskharmtothepatient,butalsothosewhichdonot.Such“nearmisses"andsuspectedADRsmayrevealimportantinformationaboutsystemsvulnerabilitiesthatthehospitalshouldaddressinordertoavoideventsthatresultinharm.

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MU • Hospitalsmustestablishpoliciesandproceduresforreportingofmedicationerrors,thoseeventsthatrequireimmediatereporting,thehospital’spoliciesmustestablishtimeframesforreportingthatarebasedontheclinicaleffectoftheerroronthepatient.

• Toimprovestaffwillingnesstoreportmedicationerrorincidents,hospitalsareencour-agedtoadoptanon-punitiveapproachthatfocusesonsystemissuesratherthanindividualhealthcareprofessionals.Anon-punitiveapproachislikelytoencouragereportingbythosewhootherwisemayfearretributionorhospitaldisciplinaryaction.

• InadditiontoemployingbroaddefinitionsofmedicationerrorsandADRsfortheQualityManagementSystemtrackingpurposesandencouragingreportingofmedica-tionerrors,ADRsanddrugincompatibilities,thehospitalmusttakeadditionalstepstoidentifytheseeventsaspartofitsQualityManagementSystem.Reliancesolelyonincidentreportingfailstoidentifythemajorityoferrorsandadversereactions.Proactiveidentificationincludesobservationofmedicationpasses,concurrentandretrospectivereviewofapatient’sclinicalrecords,ADRsurveillanceteam,implemen-tationofmedicationusageevaluationsforhigh-alertdrugs,andidentificationofindicatordrugsthat,whenordered,automaticallygenerateadrugregimenreviewforapotentialadversedrugevent.

• ThehospitalmusthaveamethodbywhichtomeasuretheeffectivenessofitssystemsforidentifyingandreportingtotheQualityManagementSystemmedicationerrorsandADRs.Suchmethodscouldincludeuseofestablishedbenchmarksforthesizeandscopeofservicesprovidedbythehospital,orstudiesonreportingratespublishedinpeer-reviewedjournals.Hospitalsareencouraged,andmayberequiredbyapplicablelawsandregulationstoparticipateinreportingofdrugadministrationerrors,adversedrugreactions,andincompatibilities.

Surveyor Guidance: • Doesthehospitalhavepoliciesandproceduresthatdefinemedicationserrors,ADRs,anddrugincompatibilities?Dotheyaddressthecircumstancesunderwhichtheymustbereportedimmediatelytotheattendingphysician,aswellastothehospital’sQualityManagementSystem?Dotheyaddresshowreportingistooccur?

• AreallmedicationerrorsandsuspectedADRspromptlyrecordedinthepatient’smedicalrecord,includingthosenotsubjecttoimmediatereporting?

• Ifuponreviewofasampleofrecords,asuspectedADRormedicationerrorisidenti-fied,determineifitwasreportedimmediatelytotheattendingorcoveringphysician,inaccordancewiththehospital’swrittenpoliciesandprocedures.Ifitisreportedtoacoveringphysician,determineifitwasalsoreportedtotheattendingphysicianwhenhe/shebecameavailable.

• Askhospitalstaffwhattheydowhentheybecomeawareofamedicationerror,ADRordrugincompatibility.Isstaffawareofanddotheyfollowthehospital’spolicyandprocedures?

• Askhospitalstaffhowtheymanagedrugincompatibilities.Whattoolsdotheyuseintheclinicalsettingtominimizetheriskofincompatibilities?HowistheinformationrelatedtodrugincompatibilitiesmadeavailabletotheclinicalstaffadministeringIVmedications(posters,onlinetools,etc.)?Howoftenistheinformationupdatedtoensureaccuracy?

• Interviewhospitalstafftoascertainawarenessofthehospital’spolicyonreportinganddocumentationofmedicationerrorsandadversedrugreactions.

• Howdoesinformationregardingmedicationerrors,adversedrugreactions,andincompatibilitiesgetreportedtothehospitalQualityManagementSystem?Askstafftospeaktotheprocess.

• ForQualitydata-reportingpurposes,isthehospital’sdefinitionofanADRandmedicationerrorbasedonlocalregulations?

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MU-29 Information relating to drug interactions and information of drug therapy, side effects, toxicology, dosage, indications for use, and routes of adminis-tration must be available to the professional staff.

Interpretive Guidelines: • Thefacilityhasimmediatelyavailablesufficienttextsandotherresourcesondrugtherapy.Thepharmacistalsoshouldbereadilyavailablebytelephoneorothermeanstodiscussdrugtherapy,interactions,sideeffects,dosageetc.,withpractitionerstoassistindrugselectionandwithnursingpersonneltoassistintheidentificationofdrug-inducedproblems.

Surveyor Guidance: • Examinethesourcesofdruginformationavailableatthenursingstationand/ordrugstorageareaanddetermineiftheyarecurrent.

• Determinewhetherstaffdevelopmentprogramsondrugtherapyareavailabletofacilitystafftocoversuchtopicsasnewdrugsaddedtotheformulary,howtoresolvedrugtherapyproblems,andothergeneralinformationastheneedarises.

MU-30 A formulary system must be established by the medical staff to assure quality pharmaceuticals at reasonable costs.

Interpretive Guidelines: • Themedicalstaffmustestablishaformularysystem.Theformularylistsmedicationsfordispensingoradministrationthatthehospitalmaintainsorthatarereadilyavailable.

• Inaccordancewithacceptedstandardsofpractice,themedicalstaff,inconsultationwiththepharmacyservice,shoulddevelopwrittencriteriafordeterminingwhatmedicationsareavailablefordispensingoradministration.Ataminimum,thecriteriaincludetheindicationforuse,effectiveness,risks(includingpropensityformedicationerrors,abusepotential,andsentinelevents),andcosts.

• Processesandmechanismsshouldbeestablishedtomonitorpatientresponsestoanewlyaddedmedicationbeforethemedicationismadeavailablefordispensingoradministrationwithinthehospital.

• Medicationsdesignatedasavailablefordispensingoradministrationarereviewedperiodicallybasedonemergingsafetyandefficacyinformation.

• Thehospitalshouldhaveprocessestoapproveandprocuremedicationsthatarenotonthehospital’smedicationlist.

• Thehospitalshouldhaveprocessestoaddressmedicationshortagesandoutages,includingthefollowing:

- Communicatingwithappropriateprescribersandstaff; - Developingapprovedsubstitutionprotocols; - Educatingappropriatehealthcareprofessionals,andstaffabouttheseprotocols;and - Obtainingmedicationsintheeventofadisaster.

Surveyor Guidance: • Interviewthepharmacisttodeterminethatthemedicalstaffhasestablishedaformu-larythatlistsdrugsthatactuallyareavailableinthehospital.

• InterviewthePharmacyDirectortodeterminethatthereisaprocessforcreationandperiodicreviewofaformularysystem.

• Determinethattheformularylistsdrugsthatareavailable.

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laboratory services

lS-1 The hospital must maintain, or have available, adequate laboratory services to meet the needs of its patients. The hospital must ensure that all labora-tory services provided to its patients are performed in a facility certified in accordance with applicable laws and regulations.

lS-2 The hospital must maintain or have available laboratory services whenever its patients need those services. The hospital may make laboratory services available directly, through contractual agreements, or through a combina-tion of direct and contractual services. The scope and complexity of the hospital laboratory service must be adequate to meet the needs of its patients. The hospital must maintain, or have available, adequate laboratory services to meet the needs of its patients at each campus or off-campus location of the hospital. All laboratory services, whether direct or contrac-tual, whether conducted in a lab or in another location, must be provided in accordance with requirements. Every hospital laboratory service must be operating under a current license appropriate to the level of services per-formed. The hospital’s laboratory services, including any contracted services, must be integrated into its hospital-wide Quality Management System.

lS-3 Patient laboratory results and all other laboratory clinical patient records are considered patient medical records and the hospital must comply with the requirements of the Medical Records.

Surveyor Guidance: • Determinethetotalnumberoflaboratories,thelocationofeachlaboratory,andeverylocationwherelaboratoryproceduresareperformed.

• Verifythatthelaboratoryserviceandalllaboratorylocationsareintegratedintothehospital-wideQualityManagementSystem.

• Iflaboratoryservicesarecontracted,verifythatthereviewofthequalityofthoseservicesisintegratedintothehospital-wideQualityManagementSystem.

lS-4 Adequacy of Laboratory Services: The hospital must have laboratory ser-vices available, either directly or through a contractual agreement with a certified laboratory.

Interpretive Guidelines: • Thelicensuremaybeaccomplishedbyhavingonecertificatefortheentirehospital’slaboratoryservices,byhavingonecertificateforeachlaboratory,orbythehospitalhavingamixture.

• Whateverthearrangement,alllaboratoryservicesmustbeprovidedinaccordancewithapplicablelawsandregulationsandunderacurrentapplicablelawsandregula-tionscertificate,evenwhenthoselaboratoryservicestakeplaceoutsideofalab.

Surveyor Guidance: • Determinewhichservicesareprovideddirectlybythefacilityandwhichareprovidedthroughcontractualagreements.

• Determineifthereisanationallaboratoryorganizationthatcertifiestheappropriatetestspecialties.

• Ifthehospitalprovideslaboratoryservicesinmultiplelocations,verifythatalllaboratoryservicesareoperatingunderacurrentnationallaboratorycertificate.

• Examinerecordsanddetermineiftheservices,includingemergencyservices,areprovidedinaccordancewiththehospital’spolicies.

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lS-5 Emergency laboratory services must be available 24 hours a day.

Interpretive Guidelines: • Thehospitalmustprovideemergencylaboratoryservices24hoursaday,7daysaweek. - Theseonsiteemergencyservicesmaybeprovideddirectlybythehospitalor

throughonsitecontractedlaboratoryservices. - Emergencylabservicesincludecollection,processing,andprovisionofresultsto

meetapatient’semergencylaboratoryneeds.

lS-5.1 In a hospital with multiple hospital campuses, these emergency laboratory services must be available onsite 24/7 at each campus.

Interpretive Guidelines: • Themedicalstaffmustdeterminewhichlaboratoryservicesaretobeimmediatelyavailabletomeettheemergencylaboratoryneedsofpatientswhomaybecurrentlyatthehospitalorthosepatientswhomayarriveatthehospitalinanemergencycondition.

• Theemergencylaboratoryservices(procedures,tests,personnel)availableshouldreflectthescopeandcomplexityofthehospital’soperationandbeprovidedinaccordancewithapplicablelawsandregulations,andguidelinesandacceptablestandardsofpractice.

lS-5.2 At a hospital with off-campus locations the medical staff must determine which, if any, laboratory services must be immediately available to meet the emergency laboratory needs of the patients who are likely to seek care at each off-campus location.

Interpretive Guidelines: • Theemergencylaboratoryservicesavailablemustreflectthescopeandcomplexityofthehospital'soperationsatthelocationandbeprovidedinaccordancewithapplica-blelawsandregulations,andguidelinesandacceptablestandardsofpractice.

• Theservicesmustbeavailableduringthehoursofoperationofthatlocation.

Surveyor Guidance: • Reviewthewrittendescriptionoftheemergencylaboratoryservices.Reviewrecords(includingaccessionrecords,worksheets,andtestreports)toverifythe24-houravailabilityofemergencyservicesandthatthoseservicesareprovidedwhenrequired.

lS-6 A written description of services provided must be available to the medical staff.

Surveyor Guidance: • Verifytheexistenceofawrittendescriptionofthelaboratoryservicesprovided,includingthosefurnishedonroutineandstatbasis(eitherdirectlyorunderanarrangementwithanoutsidefacility).

• Verifythatthedescriptionofservicesisaccurateandcurrent.

lS-7 The laboratory must make provision for proper receipt and reporting of tissue specimens.

Interpretive Guidelines: • Thelaboratorymusthavewritteninstructionsforthecollection,preservation,trans-portation,receipt,andreportingoftissuespecimenresults.

Surveyor Guidance: • Reviewtissuerecords(accessionrecords,worksheets,andtestreports)todeterminewhetherthelaboratoryfollowsthewrittenprotocol.

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lS-8 The medical staff and a pathologist must determine which tissue specimens require a macroscopic (gross) examination and which require both macro-scopic and microscopic examinations.

Interpretive Guidelines: • Laboratorywrittenpolicies,approvedbythemedicalstaffandapathologist,muststatewhichtissuespecimensrequireamacroscopicexaminationandwhichtissuespecimensrequirebothmacroscopicandmicroscopicexamination.

Surveyor Guidance: • Verifythatthehospitalhasawrittenpolicyforexaminationrequirements. • Reviewthewrittenpoliciesandtissuereportstoassurethattissuespecimensare

examinedinaccordancewiththewrittenpolicies. • Verifythatthepoliciesareinaccordancewiththeserequirementsandotherapplica-

blelaws,regulations,andguidelines.

lS-9 Blood Supply & Management

lS-9.1 The hospital shall have a blood use policy based on current scientific knowl-edge and that reduces unnecessary transfusions and minimizes the risks associated with transfusion. The policy shall describe the appropriate use of alternatives to transfusion where possible.

Interpretive Guidelines: • Thepreparationofbloodandbloodproductsusedforpatientcareshallbeprepared: - Inunitsthathaveeffectivequalitysystems,includingqualitymanagementinplace. - Usingqualitystandards - Inunitsthathaveeffectivedocumentationsystemsinplace - Usingappropriatelytrainedstaff - Subjecttoregularqualityassessment

lS-9.2 Blood and blood products used for patient care shall be subject to quality-assured screening for transfusion transmissible infections, including HIV, hepatitis B, hepatitis C, treponema pallidum (Syphilis) and, where relevant, other infections that pose a risk to the safety of the blood supply, such as trypanosomacruzi (Chagas disease) and Plasmodium species (malaria); as well as testing for blood groups and compatibility.

lS-9.3 If an organization uses the services of an external blood blank, it shall have an agreement with the blood bank that governs the procurement, transfer, and availability of blood and blood products and to ensure blood and blood products comply with the requirements.

lS-9.4 The hospital must maintain adequate records, which identify the source and disposition of all units of blood and blood components for no less than ten (10) years from the date of disposition, and they shall be stored in such a manner they are available for prompt retrieval.

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radiologic services

rS-1 The hospital must maintain, or have available, diagnostic radiologic services. If therapeutic services are also provided, they, as well as the diagnostic services, must meet professionally approved standards for safety and personnel qualifications.

Interpretive Guidelines: • Thehospitalmustmaintain,orhaveavailable,diagnosticradiologicalservicesaccordingtotheneedsoftheirpatients.

• Theseservicesmustbemaintainedoravailableatalltimes. • Allradiologicalservicesprovidedbythehospital,includingdiagnosticand,ifoffered,

therapeutic,mustbeprovidedinaccordancewithacceptablestandardsofpracticeandmustmeetprofessionallyapprovedstandardsforsafetyandpersonnelqualifications.

• Thescopeandcomplexityofradiologicalservicesofferedshouldbespecifiedinwritingandapprovedbythemedicalstaffandgoverningbody.

rS-2 Acceptable standards of practice include maintaining compliance with applicable laws and regulations, and guidelines governing radiological services, including facility licensure and/or certification requirements, as well as any standards and recommendations promoted by nationally recognized professional organizations.

rS-3 Radiological services may be provided by the hospital directly or through a contractual arrangement. The same standards apply whether the service is provided by the hospital directly or under contract. Diagnostic radiology services provided under contract may be provided either on the hospital premises or in an adjacent or other nearby, readily accessible facility.

rS-4 The hospital’s radiological services, including any contracted services, must be integrated into its hospital-wide Quality Management System.

rS-5 Safety for Patients and Personnel: The radiologic services, particularly ionizing radiology procedures, must be free from hazards for patients and personnel.

Interpretive Guidelines: • Thehospitalmustadoptandimplementpoliciesandproceduresthatprovidesafetyforpatientsandpersonnel.

Surveyor Guidance: • Observelocationswhereradiologicalservicesareprovided.Aretheysafeforpatientsandpersonnel?Areanyhazardstopatientsorpersonnelobserved?

rS-6 Proper safety precautions must be maintained against radiation hazards. This includes adequate shielding for patients, personnel, and facilities, as well as appropriate storage, use and disposal of radioactive materials.

Interpretive Guidelines: • Thehospitalpoliciesmustcontainsafetystandardsforatleast: - Adequateshieldingforpatients,personnelandfacilities; - Labelingofradioactivematerials,waste,andhazardousareas; - Transportationofradioactivematerialsbetweenlocationswithinthehospital; - Securityofradioactivematerials,includingdeterminingwhomayhaveaccessto

radioactivematerialsandcontrollingaccesstoradioactivematerials;

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RS - Testingofequipmentforradiationhazards; - Maintenanceofpersonalradiationmonitoringdevices; - Properstorageofradiationmonitoringbadgeswhennotinuse; - Storageofradionuclidesandradiopharmaceuticalsaswellasradioactivewaste;and - Disposalofradionuclides,unusedradiopharmaceuticals,andradioactivewaste.

Methodsofidentifyingpregnantpatients. • Thehospitalmustimplementandensurecompliancewithitsestablishedsafetystandards.

Surveyor Guidance: • Verifythatpatientshielding(aprons,etc.)isproperlymaintainedandroutinelyinspectedbythehospital.

• Verifythathazardousmaterialsarestoredproperlyinasafemanner. • Observeareaswheretestingisdoneforviolationsinsafetyprecautions.

rS-7 Periodic inspection of equipment must be made and hazards identified must be properly corrected.

Interpretive Guidelines: • Thehospitalmusthavepoliciesandproceduresinplacetoensurethatperiodicinspectionsofradiologyequipmentareconducted,currentandthatproblemsidenti-fiedarecorrectedinatimelymanner.

• Thehospitalmustensurethatequipmentisinspectedinaccordancewithmanufactur-er’sinstructions,applicablelawsandregulations,andguidelines,andhospitalpolicy.

• Thehospitalmusthaveasysteminplace,qualifiedemployeesorcontracts,tocorrecthazards.

• Thehospitalmustbeabletodemonstratecurrentinspectionandpropercorrectionofallhazards.

Surveyor Guidance: • Reviewtheinspectionrecords(logs)toverifythatperiodicinspectionsareconductedinaccordancewithmanufacturer’sinstructions,applicablelaws,regulations,andguidelinesandhospitalpolicy.

• Determinethatanyproblemsidentifiedareproperlycorrectedinatimelymanner.

rS-8 Radiation workers must be checked periodically, by the use of exposure meters or badge tests, for amount of radiation exposure.

Interpretive Guidelines: • Therequirementthat“radiationworkersmustbecheckedperiodically,byuseofexposuremetersorbadgetests,foramountofradiationexposure‖wouldincluderadiologicalservicespersonnel,aswellas,otherhospitalemployeeswhomayberegularlyexposedtoradiationduetoworkingnearradiationsources.Thiscouldincludepersonnelsuchascertainnursingandmaintenancestaff.

Surveyor Guidance: • Verifythatthehospitalrequiresperiodicchecksonallradiologypersonnelandanyotherhospitalstaffexposedtoradiationandthatthepersonnelareknowledgeableaboutradiationexposureformonth,year,andcumulative/entireworkinglife.

• Observethatappropriatestaffmembershavearadiation-detectingdeviceandthattheyappropriatelyweartheirradiation-detectingdevice.

• Reviewrecordstoverifythatperiodictestsofradiologypersonnelbyexposuremetersortestbadgesareperformed.

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RSrS-9 Radiologic services must be provided only on the order of practitioners with clinical privileges or, consistent with applicable laws and regulations, of other practitioners authorized by the medical staff and the governing body to order the services.

Surveyor Guidance: • Reviewmedicalrecordstodeterminethatradiologicalservicesareprovidedonlyontheordersofpractitionerswithclinicalprivilegesandtopractitionersoutsidethehospitalwhohavebeenauthorizedbythemedicalstaffandthegoverningbodytoorderradiologicalservices,consistentwithapplicablelawsandregulations.

rS-10 Personnel: The hospital must ensure that specific radiology personnel requirements are met.

rS-11 A qualified full-time, part-time or consulting radiologist must supervise the ionizing radiology services and must interpret only those radiologic tests that are determined by the medical staff to require a radiologist’s special-ized knowledge. For purposes of this section, a radiologist is a doctor of medicine who is qualified by education and experience in radiology.

Interpretive Guidelines: • Themedicalstaffmustestablish,inaccordancewiththisregulationandapplicablelawsandregulationsandguidelines,thequalificationsnecessaryforradiologistappointmenttothemedicalstaff.

• Theremustbewrittenpoliciesdevelopedandapprovedbythemedicalstafftodesig-natewhichradiologicaltestsrequireinterpretationbyaradiologist.

• Whentelemedicineisused,andtheradiologistwhointerpretsradiologicaltestsandthepatientarelocatedindifferentlocalities,theradiologistinterpretingtheradiologi-caltestmustbelicensedand/ormeettheotherapplicablestandardsthatarerequiredbyapplicablelawsandregulationsinboththelocalityofwherethepractitionerislocatedandthelocalitywherethepatientislocated.

• Supervisionoftheradiologyservicesmayonlybeperformedbyaradiologistwhoisamemberofthemedicalstaff.Supervisionshouldincludeatleastthefollowing:

- Ensuringthatradiologyreportsaresignedbythepractitionerwhointerpretedthem; - Assigningdutiestoradiologypersonnelappropriatetotheirleveloftraining,

experience,andlicensureifapplicable; - Enforcinginfectioncontrolstandards; - Ensuringthatemergencycareisprovidedtopatientswhoexperienceanadverse

reactiontodiagnosticagentsintheradiologyservice; - Ensuringthatfiles,scans,andotherimagerecordsarekeptinasecureareaand

arereadilyretrievable;and - Trainingradiologystaffonhowtooperatetheequipmentsafely,performtestsoffered

bythefacilityandonthemanagementofemergencyradiationhazardsandaccidents.

Surveyor Guidance: • Reviewtheradiologist’scredentialingfiletoverifythathe/shemeetsthequalificationsestablishedbythemedicalstaffforappointment.

• Reviewrecordstodeterminethataradiologistinterpretsthoseteststhathavebeendesignatedbythemedicalstafftorequireinterpretationbyaqualifiedradiologist.

• Verifythatsupervisionoftheradiologyservicesisrestrictedtoaradiologistwhoisamemberofthemedicalstaff.

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RSrS-12 Only personnel designated as qualified by the medical staff may use the radiologic equipment and administer procedures.

Interpretive Guidelines: • Thereshouldbewrittenpolicies,developedandapprovedbythemedicalstaff,consistentwithapplicablelawsandregulations,todesignatewhichpersonnelarequalifiedtousetheradiologicalequipmentandadministerprocedures.

Surveyor Guidance: • Determinewhichstaffmembersareusingdifferingpiecesofradiologicalequipmentand/oradministeringpatientprocedures.Reviewtheirpersonnelfolderstodeterminetheymeetthequalificationsestablishedbythemedicalstaffforthetaskstheyperform.

rS-13 Records: Records of radiologic services must be maintained.

Interpretive Guidelines: • Thehospitalmustmaintainrecordsforallradiologyproceduresperformed.Ataminimum,therecordsshouldincludecopiesofreportsandprintouts,andanyfilms,scansorotherimagerecords,asappropriate.

• Thehospitalshouldhavewrittenpoliciesandproceduresthatensuretheintegrityofauthenticationandprotecttheprivacyofradiologyrecords.

• Patientradiologyrecordsareconsideredpatientmedicalrecordsandthehospitalmustcomplywiththemedicalrecords.Themedicalrecordsrequiresthatmedicalrecords,whichwouldincluderadiologyfilms,imagerecords,scans,reports,andprintoutsmustbesecure,properlystored,beaccessibleandpromptlyretrievableforanycare,procedure,treatment,ortestprovidedorconductedwithinthepast5years.

Surveyor Guidance: • Determinethehospital’sproceduresformaintainingradiologyrecords.

rS-14 The radiologist or other practitioner who performs radiology services must sign reports of his or her interpretations.

Surveyor Guidance: • Reviewradiologicalrecordstodeterminethatreportsaresignedbythepractitionerwhoreadsandevaluatestheroentgenogram.

rS-15 The hospital must maintain the following for at least 5 years:

rS-15.1 Copies of reports and printouts

rS-15.2 Films, scans, and other image records, as appropriate.

Surveyor Guidance: • Verifythatthehospitalmaintainsrecordsforatleast5years. • VerifythatradiologyrecordsaremaintainedinthemannerrequiredbytheMedical

Records.

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nuclear medicine services

nM-1 If the hospital provides nuclear medicine services, those services must meet the needs of the patients in accordance with acceptable standards of practice. This is an optional hospital service. However, if a hospital provides any degree of nuclear medicine services to its patients, the hospital must comply with the requirements of this standard.

nM-1.1 The hospital’s nuclear medicine services must be integrated into its hospital-wide Quality Management Services program.

nM-1.2 If nuclear medicine services are provided under arrangement, the governing body must ensure that the services are provided in a safe and effective manner.

nM-1.3 Nuclear medicine services must be provided in accordance with acceptable standards of practice. Acceptable standards of practice include maintaining compliance with applicable laws, regulations and guidelines governing the use of nuclear medicine, including facility licensure and/or certification requirements, as well as any standards and recommendations promoted by nationally recognized professional organizations.

Surveyor Guidance: • Determineifthehospitalprovidesnuclearmedicineservices.Ifnuclearmedicineservicesareoffered,determinethetype(s)ofservicesprovidedandthelocationwhereeachserviceisprovided.

• Determineifthehospital’snuclearmedicineservicesareintegratedintoitshospital-wideQualityManagementSystem.

nM-2 Organization and Staffing: The organization of the nuclear medicine service must be appropriate to the scope and complexity of the services offered.

Interpretive Guidelines: • Thehospitalmustprovidetheappropriateequipmentandtypesandnumbersofqualifiedpersonnelnecessarytofurnishtheservicesofferedbythehospitalinaccord-ancewithacceptablestandardsofpractice.

• Thescopeofnuclearmedicineservicesofferedbythehospitalshouldbedefinedinwriting,andapprovedbytheMedicalstaff.

Surveyor Guidance: • Reviewthehospitalpolicies&procedurestoverifythatthescopeofthenuclearmedicineservicesofferedisdefinedinwriting.

nM-2.1 There must be a director who is a doctor of medicine qualified in nuclear medicine.

Interpretative Guidelines: • Thenuclearmedicineservicedirectormustbeadoctorofmedicineandmustdemon-stratethrougheducation,experienceandspecializedtrainingthathe/sheisqualifiedinnuclearmedicine,appropriatetothescopeandcomplexityofservicesoffered.

Surveyor Guidance: • Reviewtheservicedirector’scredentialingfiletoverifythathe/sheisaM.D.andhasthenecessaryeducation,experienceandspecializedtraininginnuclearmedicine,appropriatetothescopeandcomplexityofservicesoffered.

nM-2.2 The qualifications, training, functions and responsibilities of the nuclear medicine personnel must be specified by the service director and approved by the medical staff.

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Interpretive Guidelines: • Thehospitalmusthavewrittenpolicies,developedandapprovedbythenuclearmedicineservicedirectorandmedicalstaffthatspecifythequalifications,training,functionsandexperienceofpersonnelresponsibleforperformingeachtypeofnuclearmedicineprocedure.

• Qualificationsincludeataminimum,jobtitle,education,experience,specializedtraining,andlicensure/certification,consistentwithapplicablelawsandregulations.

Surveyor Guidance: • Reviewpersonnelfilesfornuclearmedicinestafftoverifythattheymeetthenecessaryqualifications,specifiedbythemedicalstaff,toperformtheirspecifieddutiesandresponsibilities.

• Verifythatthequalifications,training,functionsandresponsibilitiesofnuclearmedicinestaffarespecifiedbythedirectorandapprovedbythemedicalstaff.

nM-3 Delivery of Service: Radioactive materials must be prepared, labeled, used, transported, stored, and disposed of in accordance with acceptable stand-ards of practice.

nM-3.1 The hospital must establish, in writing, safety standards for radioactive materials that address, at a minimum:

NM-3.1.1 Handling of equipment and radioactive materials; NM-3.1.2 Protection of patients and personnel from radiation hazards; NM-3.1.3 Labeling of radioactive materials, waste, and hazardous areas; NM-3.1.4 Transportation of radioactive materials between locations within the hospital; NM-3.1.5 Security of radioactive materials, including determining who may have access

to radioactive materials and controlling access to radioactive materials; NM-3.1.6 Testing of equipment for radiation hazards; Maintenance of personal radiation

monitoring devices; NM-3.1.7 Storage of radionuclides and radio pharmaceuticals as well as radioactive waste;

and NM-3.1.8 Disposal of radionuclides, unused radio pharmaceuticals, and radioactive

waste. NM-3.1.9 The hospital must implement and ensure compliance with its established

safety standard.

Surveyor Guidance: • Verifythatsafetyprecautionsarefollowedinthefunctioningofthenuclearmedicineserviceandthatpersonnelandpatientswearappropriatebodyshielding(e.g.,leadapronsorleadgloves)whenappropriate.

• Verifythatradioactivematerialsareprepared,labeled,used,transported,storedanddisposedofinaccordancewithapplicablelawsandregulationsandacceptablestandardsofpractice.

nM-3.2 In-house preparation of radiopharmaceuticals is by, or under, the direct supervision of an appropriately trained registered pharmacist or doctor of medicine.

Interpretive Guidelines: • In-housepreparationofradiopharmaceuticalsmustbeperformedby,ordirectlysupervisedby,aregisteredpharmacistorMDwhoisqualifiedthrougheducation,experienceandtraining,inthepreparationofradiopharmaceuticals,consistentwithapplicablelawsandregulations.

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NMSurveyor Guidance: • Ifradiopharmaceuticalsarepreparedin-house,determinethatthepreparationis

performedby,ordirectlysupervisedby,aregisteredpharmacistorMDwhoisqualifiedthrougheducation,experienceandtraining,consistentwithapplicablelawsandregulations.

nM-3.3 There is proper storage and disposal of radioactive material.

Surveyor Guidance: • Verifythroughobservationanddocumentreviewthatradioactivematerials,includingradioactivewaste,haveappropriatestorageanddisposal.

• Determinehowthehospitaldisposesofunneededradionuclidesandradiopharmaceuticals. - Arethesemethodsinaccordancewithapplicablelawsandregulations,andguidelines? - Arethemethodsdescribedinhospitalpolicy?

nM-3.4 If laboratory tests are performed in the nuclear medicine service, the service must meet the applicable requirement for laboratory services.

Interpretive Guidelines: • Refertothestandardsforindependentlaboratoryiflaboratorytestsareperformedinthenuclearmedicineservice.

• Allinvitrotestsandallinvivoproceduresclassifiedunderradiobioassaymustbeperformedinaccordancewiththerequirementsofstandardsincludingqualitycontrolcalibrationandrecordretention,etc.

nM-4 Facilities: Equipment and supplies must be appropriate for the types of nuclear medicine services offered and must be maintained for safe and efficient performance. The equipment must be:

nM-4.1 The nuclear medicine service must function in accordance with applicable regulations and guidelines governing radiation safety.

nM-4.2 Reagents must be labeled to ensure proper identification, use, storage and safe handling and date of preparation and assay.

nM-4.3 The hospital must develop and implement a preventive maintenance sched-ule to ensure that nuclear medicine equipment is maintained in safe operat-ing condition to ensure accurate results and patient, staff, and public safety.

Surveyor Guidance: • Verifythatthenuclearmedicineservicefollowsitspreventivemaintenancescheduleandthatanyproblemsidentifiedarecorrectedinatimelymanner.

• Reviewpreventivemaintenancerecordstoverifythatequipmentisinspected,testedandcalibratedatleastannuallybyqualifiedpersonnel.

nM-5 Records: The hospital must maintain signed and dated reports of nuclear medicine interpretations, consultations, and procedures.

nM-5.1 The hospital must maintain records for all nuclear medicine procedures performed. At a minimum, the records must include signed and dated reports of nuclear medicine interpretations, consultations, and procedures.

nM-5.2 Nuclear medicine patient records, including interpretations, consultations, and procedures are patient medical records and the hospital must comply with the Medical Records standard.

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nM-5.3 The hospital must maintain copies of nuclear medicine reports for at least 5 years. Nuclear medicine patient records, like all patient medical records, must be maintained in accordance with the Medical Records standard.

Surveyor Guidance: • Verifythatcopiesofnuclearmedicinereportsaremaintainedforatleast5years.

nM-6 The practitioner approved by the medical staff to interpret diagnostic procedures must sign and date the interpretation of these tests.

Surveyor Guidance: • Verifythatreportsofnuclearmedicineinterpretationsaresignedanddatedonlybypractitionersauthorizedbythemedicalstafftoperformtheseinterpretations.

nM-7 The hospital must maintain records of the receipt and distribution of radi-opharmaceuticals.

Surveyor Guidance: • Verifythatthehospitalmaintainsaccuraterecordsofthereceiptanddistributionofradiopharmaceuticals.Requesttoseethemostrecentdocumentationforthedeliveryofradiopharmaceuticals.

nM-8 Nuclear medicine services must be ordered only by practitioners whose scope of licensure and whose defined staff privileges allow such referrals.

Surveyor Guidance: • Verifythatnuclearmedicineservicesareorderedonlybypractitionersauthorizedtodosobythemedicalstaff,consistentwithapplicablelawsandregulations.

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rehabilitation services

If the hospital provides rehabilitation, physical therapy, occupational therapy, audiology, or speech pathology services, the services must be organized and staffed to ensure the health and safety of patients.

re-1 If rehabilitative services are provided, they must be organized and staffed in such a manner to ensure the health and safety of patients. This includes providing rehabilitative services in accordance with practitioner orders and acceptable standards of practice.

re-2 Acceptable standards of practice include compliance with any applicable laws, regulations or guidelines, as well as standards and recommendations promoted by nationally recognized professional organizations.

re-3 The hospital’s rehabilitation services must be integrated into its hospital-wide Quality Management System program.

Surveyor Guidance: • Determineifthehospitalprovidesanydegreeofrehabilitationservices. • Determineifthehospital’srehabilitationservicesareintegratedintoitshospital-wide

QualityManagementServices.

re-4 Organization and Staffing: The organization of the service must be appro-priate to the scope of the services offered.

re-4.1 The hospital must provide the appropriate equipment and types and num-bers of qualified personnel necessary to furnish the rehabilitation services offered by the hospital in accordance with acceptable standards of practice.

re-4.2 The scope of rehabilitation services offered by the hospital should be de-fined in written policies and procedures, and approved by the Medical staff.

re-4.3 Each service, whether provided through a single discipline department or within a multidiscipline department, must function with established lines of authority and responsibility to ensure the health and safety of patients. There must be an adequate number of qualified staff available when needed to evaluate each patient, initiate the plan of treatment, and supervise sup-portive personnel when they furnish rehabilitation services. The number of qualified staff is based on the type of patients treated and the frequency, duration, and complexity of the treatment required.

Surveyor Guidance: • Reviewthehospital’spoliciesandprocedurestoverifythatthescopeofrehabilitationservicesofferedisdefinedinwriting.

• Ifservicesareprovidedunderanarrangement,reviewpoliciesandcontracts. • Foreachservice,determinethatadequatetypesandnumbersofqualifiedstaffare

availabletoensuresafeandefficientprovisionoftreatment. • Reviewmedicalrecordstoverifythataqualifiedprofessionalevaluatesthepatient

andinitiateseachtreatmentepisode. • Reviewasampleofpersonnelfilestoverifycurrentlicensure,certificationsand

ongoingtraining,consistentwithapplicablelawsandregulations.

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re-5 The director of the services must have the necessary knowledge, experience, and capabilities to properly supervise and administer the services.

re-5.1 Each service must be accountable to an individual that directs the overall hospital-wide operation of that service. An individual may serve as the direc-tor of a multi-service department or as director of single service departments.

re-5.2 The service director must demonstrate through education, experience, and/or specialized training that he/she has the necessary knowledge, experience and capabilities to properly supervise and administer the service(s).

re-5.3 The director may be part-time or full time. In all situations, the time spent direct-ing the service should be appropriate to the scope of the services provided.

re-5.4 Physical therapy, occupational therapy, or speech-language pathology or audiology services, if provided, must be provided by qualified physical therapists, physical therapist assistants, occupational therapists, occupa-tional therapy assistants, speech-language pathologists, or audiologists.

Surveyor Guidance: • Verifythateachserviceisaccountabletoanindividualwhodirectstheoveralloperationofthatservice.

• Reviewtheservicedirector’spositiondescriptiontoverifythathe/shehasbeengrantedtheauthorityandresponsibilityforoperationoftheservice,consistentwithhospitalpolicies,applicablelawsandregulationsofacceptedstandardsofpractice.

• Ifthedirectordoesnotworkfull-time,determinethatthenumberofhours(reviewtimesheets)spentworkingisappropriatetothescopeofservicesprovided.

• Reviewthedirector’spersonnelfiletodeterminethathe/shehasthenecessaryeduca-tion,experienceandspecializedtrainingtoproperlysuperviseandadministertheservice.Thisincludesmaintainingcurrentlicensureandcertificationsasrequiredbyapplicablelawsandregulations.

• Interviewthedirectortodetermineifhe/shehasthenecessaryknowledge,experienceandcapabilitiestoproperlysuperviseandadministertheservice.

re-6 Delivery of Services

re-6.1 Services must only be provided under the orders of a qualified and licensed practitioner who is responsible for the care of the patient, acting within his or her scope of practice under applicable laws and regulations, and who is authorized by the hospital’s medical staff to order the services in accordance with hospital policies and procedures and applicable laws and regulations.

Interpretive Guidelines: • Thepractitionermusthavemedicalstaffprivilegestowriteordersfortheseservices.Privilegesmustbegrantedinamannerconsistentwiththescopeofpracticelaw,aswellaswithhospitalpoliciesandproceduresgoverningrehabilitationservicesdevelopedbythemedicalstaffandapprovedbythegoverningbody.

• Practitionerswhomaybegrantedprivilegestoorderrehabilitationservicesincludephysicians,andmayalso,inaccordancewithhospitalpolicy,beextendedtootherpractitionersaslongastheymeettheparametersofthisrequirement.Theygenerallywouldnotbeconsideredresponsibleforthecareofthepatientorqualifiedtoorderrehabilitationservices.

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Surveyor Guidance: • Reviewthemedicalstaffpoliciesandproceduresforrehabilitationservicesprivileg-ing.Dotheyidentifythetypesofeligiblepractitionersandtheirqualificationcriteria?

• Reviewmedicalrecordsofpatientsreceivingrehabilitationservices.Determinewhowrotetheordersfortherehabilitationservices.Determineifthepractitionerisresponsibleforthecareofthepatientandprivilegedtowriteordersforrehabili-tationservices.Verifythepractitionermeetshospitalmedicalstaffpoliciesandproceduresaswellasapplicablelawsandregulationsfororderingrehabilitationservices.

re-7 All rehabilitation services orders must be documented in the patient’s medical record.

Interpretive Guidelines: • Thepatient’smedicalrecordmustcontaindocumentationofallrehabilitationservicesordered.Themedicalrecordentriesmustcomplywiththestandard.

Surveyor Guidance: • Reviewasampleofpatientmedicalrecordsthatreceivedrehabilitationservices.Determinewhethertherehabilitationserviceordersarelegible,complete,dated,timed,authenticated,andmeetallothermedicalrecordrequirements.

re-8 The provision of care and the personnel qualifications must be in accord-ance with national acceptable standards of practice and must also meet the requirements of this standard.

re-8.1 The provision of rehabilitation services care and development of the plan of care for rehabilitation services can be initiated only after a qualified licensed practitioner responsible for the care of the patient writes the order for services. Physical therapy, occupational therapy, or speech-language pathol-ogy must be furnished under a plan of care. The standard specifies the following rehabilitation services plan of care requirements:

RE-8.1.1 Establishment of the plan: The plan must be established before treatment begins by one of the following: (1) A physician. (2) The physical therapist furnishing the physical therapy services. (3) A speech-language pathologist furnishing the speech-language pathology services. (4) An occupational therapist furnishing the occupational therapy services.

RE-8.1.2 Content of the plan: The plan: (1) Prescribes the type, amount, frequency, and duration of the physical therapy, occupational therapy, or speech-lan-guage pathology services to be furnished to the individual; and (2) Indicates the diagnosis and anticipated goals.

RE-8.1.3 Changes in the plan: Any changes in the plan are implemented in accord-ance with hospital policies and procedures.

re-8.2 Rehabilitation services must be provided by qualified physical therapists, physical therapy assistants, occupational therapists, occupational therapy assistants, and/or speech-language pathologists who meet the personnel qualifications. Hospitals must have policies and procedures consistent with applicable laws and regulations.

re-8.3 Rehabilitation services must be provided according to national standards of practice as established by professional organizations.

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RESurveyor Guidance: • Reviewmedicalrecordsofpatientswhoreceivedrehabilitationservices.Determine

whethertherequiredcareplanwasdevelopedandimplemented. • Reviewemployeepersonnelfilestoverifytherehabilitationserviceproviders(i.e.,

physicaltherapists,physicaltherapyassistants,occupationaltherapists,occupationaltherapyassistants,and/orspeech-languagepathologists)havethenecessaryeducation,experience,training,anddocumentedcompetenciestoproviderehabilitationservices.

• Askthehospitalwhatnationalstandardsofrehabilitationpracticeprovidethebasisforitsrehabilitationservices.Istheresupportingdocumentation?

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respiratory care

The hospital must meet the needs of the patients in accordance with accept-able standards of practice. The following requirements apply if the hospital provides respiratory care services.

rC-1 If a hospital provides care to patients who require respiratory care services, the hospital must meet the needs of those patients, in accordance with acceptable standards of practice. This is an optional hospital service. How-ever, if a hospital provides any degree of respiratory care to its patients, the hospital must comply with the requirements of this standard.

rC-2 Acceptable standards of practice include compliance with applicable stand-ards that are set forth in applicable laws, regulations or guidelines, as well as standards and recommendations promoted by nationally recognized pro-fessional organizations.

rC-3 The hospital’s respiratory services must be integrated into its hospital-wide Quality Management System program.

Surveyor Guidance: • Determineifthehospitalprovidesanydegreeofrespiratorycareservices. • Determinethatthetypeandamountofrespiratorycareprovidedmeetstheneedsof

thepatientsandisdeliveredinaccordancewithacceptablestandardsofpractice. • Determineifthehospital’srespiratoryservicesareintegratedintoitshospital-wide

QualityManagementSystem.

rC-4 Organization and Staffing: The organization of the respiratory care services must be appropriate to the scope and complexity of the services offered.

rC-4.1 The hospital must provide the appropriate equipment and types and num-bers of qualified personnel necessary to furnish the services offered by the hospital in accordance with acceptable standards of practice.

rC-4.2 The scope of diagnostic and/or therapeutic respiratory services offered by the hospital should be defined in writing, and approved by the Medical staff.

Surveyor Guidance: • Reviewthehospital’sorganizationalcharttodeterminetherelationshipofrespiratorycareservicestootherservicesprovidedbythehospital.

• Reviewthehospitalpoliciesandprocedurestoverifythatthescopeofthediagnosticand/ortherapeuticrespiratorycareservicesprovidedisdefinedinwriting.

rC-5 There must be a director of respiratory care services who is a doctor of medicine with the knowledge, experience and capabilities to supervise and administer the service properly. The director may serve on either a full-time or part-time basis.

Surveyor Guidance: • Verifythatadirectorhasbeenappointedandthathe/shehasfixedlinesofauthorityanddelegatedresponsibilityforoperationoftheservice.

• Interviewstaffregardingtheroleandoversightactivitiesconductedbythedirector. • Reviewtheservicedirector’scredentialingfiletodeterminethathe/sheisaMDand

hasthenecessaryeducation,experienceandspecializedtrainingtosuperviseandadministertheserviceproperly.

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rC-6 There must be adequate numbers of respiratory therapists, respiratory therapy technicians, and other personnel who meet the qualifications specified by the medical staff, consistent with applicable laws and regula-tions. There must be sufficient personnel available to respond to the res-piratory care needs of the patient population being served.

Surveyor Guidance: • Interviewrespiratorycarestaffregarding:servicesprovided,schedules,andavail-abilityofrespiratorycarestaffthroughoutthedayandweektodeterminethatthenumberandtypeofstaffavailableisappropriatetothevolumeandtypesoftreat-mentsfurnished.Ifneeded,reviewstaffingandon-callschedules.

• Reviewasampleofpersonnelfilesforrespiratorycarestafftodeterminethatthepersonnelmeetthequalificationsspecifiedbythemedicalstaff,consistentwithapplicablelawsandregulations.

rC-7 Delivery of Services: Services must be delivered in accordance with medical staff directives.

rC-7.1 There should be written policies for the delivery of respiratory care services that are developed and approved by the medical staff. Appropriate to the scope of services provided, the written policies should address at least the following:

Interpretive Guidelines: • Equipmentassembly,operation,andpreventivemaintenance; • Safetypractices,includinginfectioncontrolmeasuresforequipment,sterilesupplies,

biohazardouswaste,postingofsigns,andgaslineidentification; • Handling,storage,anddispensingoftherapeuticgasestobothinpatientsandoutpatients; • Cardiopulmonaryresuscitation; • Procedurestofollowintheadventofadversereactionstotreatmentsorinterventions; • Pulmonaryfunctiontesting; • Therapeuticpercussionandvibration; • Bronchopulmonarydrainage; • Mechanicalventilatoryandoxygenationsupport; • Aerosol,humidification,andtherapeuticgasadministration; • Storage,access,control,administrationofmedicationsandmedicationerrors;and • Proceduresforobtainingandanalyzingbloodsamples(e.g.,arterialbloodgases).

rC-8 Personnel qualified to perform specific procedures and the amount of supervi-sion required for personnel to carry out specific procedures must be designated in writing. The hospital must have written policies to address, at a minimum:

Interpretive Guidelines: • Eachtypeofrespiratorycareserviceprovidedbythehospital; • Thequalifications,includingjobtitle,licensureconsistentwithapplicablelawsand

regulations,education,trainingandexperienceofpersonnelauthorizedtoperformeachtypeofrespiratorycareserviceandwhethertheymayperformitwithoutsupervision;and

• Thetypeofpersonnelqualifiedtoprovidethedirectsupervision.

Surveyor Guidance: • Reviewtreatmentlogs,jobdescriptionsofrespiratorycarestaff,andpoliciesandprocedurestodeterminethefollowing:

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RC - Dutiesandresponsibilitiesofstaff; - Qualificationsandeducationrequired,includinglicensure,consistentwithapplica-

blelawsandregulations; - Specializedtrainingorexperienceneededtoperformspecificduties.

rC-9 If blood gases or other clinical laboratory tests are performed in the respiratory care unit, the unit must meet the applicable requirements for laboratory services.

rC-10 Services must only be provided under the orders of a qualified and licensed practitioner who is responsible for the care of the patient, acting within his or her scope of practice under applicable laws and regulations, and who is authorized by the hospital’s medical staff to order the services in accordance with hospital policies and procedures and applicable laws and regulations.

Interpretive Guidelines: • Respiratorycareservicesmustbeorderedbyaqualifiedandlicensedpractitionerwhoisresponsibleforthecareofthepatient.Thepractitionermusthavemedicalstaffprivilegestowriteordersfortheseservices.Privilegesmustbegrantedinamannerconsistentwithdesignatedscopeofpracticelaw,aswellaswithhospitalpoliciesandproceduresgoverningrespiratorycareservicesdevelopedbythemedicalstaffandapprovedbythegoverningbody.Practitionerswhomaybegrantedprivilegestoorderrespiratorycareservicesincludephysicians,andmayalso,inaccordancewithhospitalpolicy,beextend-edtootherpractitionersaslongastheymeettheparametersofthisrequirement.

Surveyor Guidance: • Reviewthemedicalstaffpoliciesandproceduresforrespiratorycareservicesprivileg-ing.Dotheyidentifythetypesofeligiblepractitionersandtheirqualificationcriteria?

• Reviewthemedicalrecordsofpatientsreceivingrespiratorycareservices.Determinewhowrotetheordersfortherespiratorycareservices.Doesthisindividualholdprivilegestoorderrespiratorycareservicesandishe/sheresponsibleforthecareofthepatient?

• Verifythepractitionerwritingrespiratorycareserviceordersmeetshospitalmedicalstaffpoliciesandproceduresandapplicablelawsandregulationsfororderingrespiratoryservices.

rC-11 All respiratory care services orders must be documented in the patient’s medical record. The patient’s medical record must contain documentation of all respiratory care services ordered. The medical record entries must comply with the standard.

Surveyor Guidance: • Reviewasampleofpatientmedicalrecordsthatreceivedrespiratorycareservices. • Determinewhethertherespiratorycareservicesordersarelegible,complete,dated,

timed,authenticated,andmeetallothermedicalrecordrequirements.

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food and dietetic services

fd-1 The hospital must have organized dietary services that are directed and staffed by adequate qualified personnel. A hospital that has a contract with an outside food management company and has a dietician who serves the hospital on a full-time, part-time, or consultant basis, must maintain at least the minimum standards specified in this section and provides for constant liaison with the hospital medical staff for recommendations on dietetic policies affecting patient treatment.

fd-2 The hospital’s food and dietetic services must be organized, directed and staffed in such a manner to ensure that the nutritional needs of the patients are met in accordance with practitioners’ orders and acceptable standards of practice.

fd-3 The hospital should have written policies and procedures that address at least the following:

fd-3.1 Availability of a diet manual and therapeutic diet menus to meet patients’ nutritional needs;

fd-3.2 Frequency of meals served;

fd-3.3 System for diet ordering and patient trays delivery;

fd-3.4 Accommodation of non-routine occurrences (e.g., parenteral nutrition (tube feeding), total parenteral nutrition, peripheral parenteral nutrition, change in diet orders, early/late trays, nutritional supplements, etc.);

fd-3.5 Integration of the food and dietetic service into the hospital-wide Quality Management System and Infection Control programs;

fd-3.6 Guidelines for acceptable hygiene practices of food service personnel; and Guidelines for kitchen sanitation.

fd-4 The same standards apply whether the food and dietetic services are pro-vided by the hospital directly, through a contractual agreement, or by off-site vendor.

fd-5 The hospital must be in compliance with applicable laws and regulations requirements for food and dietary personnel as well as food service stand-ards, laws and regulations.

fd-6 Organization: The hospital must ensure that the specific food and dietetic services organization requirements are met.

Interpretive Guidelines: • TheDietary/Nutritionservicedirectormustbeafull-timeemployeewhohasbeengrantedtheauthorityanddelegatedresponsibilitybythehospital’sgoverningbodyandmedicalstafffortheoperationofthedietaryservices.Thisauthorityanddelegat-edresponsibilityincludes,thedailymanagementoftheservice,implementingtrainingprogramsfordietarystaff,andassuringthatestablishedpoliciesandproceduresaremaintainedthataddressatleastthefollowing:

- Safetypracticesforfoodhandling; - Emergencyfoodsupplies;

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FD - Orientation,workassignments,supervisionofworkandpersonnelperformance; - Menuplanning,purchasingoffoodsandsupplies,andretentionofessentialrecords(e.g.,

cost,menus,personnel,trainingrecords,QualityManagementSystemreports,etc.); - ParticipationintheQualityManagementSystem • TheDietary/Nutritionservicedirectormustdemonstrate,througheducation,experi-

enceand/orspecializedtraining,thequalificationsnecessarytomanagetheservice,appropriatetothescopeandcomplexityofthefoodserviceoperations.

Surveyor Guidance: • Verifythatthedirectorofthefoodanddieteticservicesisafull-timeemployee. • ReviewtheDietary/Nutritiondirector’sjobdescriptiontoverifythatitisposition-

specificandthatresponsibilityandauthorityforthedirectionofthefoodanddietaryservicehasbeenclearlydelineated.

• ReviewtheDietary/Nutritiondirector’spersonnelfiletoverifythathe/shehasthenecessaryeducation,experience,andtrainingtomanagetheservice,appropriatetothescopeandcomplexityoffoodserviceoperations.

fd-7 There must be a qualified dietitian, full-time, part-time or on a consultant basis.

Interpretive Guidelines: • Aqualifieddietitianmustsupervisethenutritionalaspectsofpatientcare.Responsi-bilitiesofahospitaldietitianmayinclude,butarenotlimitedto:

- Approvingpatientmenusandnutritionalsupplements;patient,family,andcare-takerdietarycounseling;

- Performinganddocumentingnutritionalassessmentsandevaluatingpatienttolerancetotherapeuticdietswhenappropriate;

- Collaboratingwithotherhospitalservices(e.g.,medicalstaff,nursingservices,pharmacyservice,socialworkservice,etc.)toplanandimplementpatientcareasnecessaryinmeetingthenutritionalneedsofthepatients;

- Maintainingpertinentpatientdatanecessarytorecommend,prescribe,ormodifytherapeuticdietsasneededtomeetthenutritionalneedsofthepatients.

• Qualificationisdeterminedonthebasisofeducation,experience,specializedtrain-ing,applicablelawsandregulationswhenapplicable,andmaintainingprofessionalstandardsofpractice.

• Ifthequalifieddietitiandoesnotworkfull-time,andwhenthedietitianisnotavail-able,thehospitalmustmakeadequateprovisionsfordietaryconsultationthatmeetstheneedsofthepatients.Thefrequencyofconsultationdependsonthetotalnumberofpatients,theirnutritionalneedsandthenumberofpatientsrequiringtherapeuticdietsorothernutritionalsupplementation.

Surveyor Guidance: • Reviewthedietitian’spersonnelfiletodeterminethathe/sheisqualifiedbasedoneducation,experience,specializedtraining,and,ifrequiredbyapplicablelawsandregulations,islicensed,certified,orregisteredbythelocality.

• Ifthedietitianisnotfull-time,determinethatthenumberofhoursspentworkingisappropriatetoservethenutritionalneedsofthepatients,andthatthehospitalmakesadequateprovisionsforqualifiedconsultantcoveragewhenthedietitianisnotavailable.

fd-8 There must be administrative and technical personnel competent in their respective duties.

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Interpretive Guidelines: • Administrativeandtechnicalpersonnelmustbecompetentintheirassignedduties.Thiscompetencyisdemonstratedthrougheducation,experienceandspecializedtrainingappropriatetothetask(s)assigned.

• Personnelfilesshouldincludedocumentationthatthestaffmember(s)iscompetentintheirrespectiveduties.

Surveyor Guidance: • Reviewpersonnelfilesforadministrativeandtechnicalstafftodeterminetheyhaveappropriatecredentialsasrequiredandhavereceivedadequatetrainingandarecompetentintheirrespectiveduties.

fd-9 Diets: Menus must meet the needs of the patients.

Interpretive Guidelines: • Menusprovidedbythehospitalmustbenutritionallybalancedandmeetthespecialneedsofthepatients.

• Currentmenusshouldbepostedinthehospitalkitchen. • Inordertoensurethatthehospitalismeetingthenutritionalneedsofitspatients,

screeningcriteriashouldbedevelopedtoidentifypatientsatnutritionalrisk. • Onceapatientisidentified,asatalterednutritionalstatus,anutritionalassessment

shouldbeperformedonthepatient. • Inadditiontotheinitialnutritionalassessment,thepatientshouldbere-evaluatedas

necessarytoensuretheirongoingnutritionalneedsaremet. • Examplesofpatientswhomayrequireanutritionalassessmentinclude: - Allpatientsrequiringartificialnutritionbyanymeans(i.e.,enteralnutrition(tube

feeding),totalparenteralnutrition,orperipheralparenteralnutrition); - Patientswhosemedicalcondition,surgicalintervention,orphysicalstatusinter-

fereswiththeirabilitytoingest,digestorabsorbnutrients; - Patientswhosediagnosisorpresentingsigns/symptomsindicatesacompromised

nutritionalstatus(e.g.,anorexianervosa,bulimia,electrolyteimbalances,dyspha-gia,malabsorption,endstageorgandiseases,etc.);

- Patientswhosemedicalconditioncanbeadverselyaffectedbytheirnutritionalintake(e.g.,diabetes,congestiveheartfailure,patientstakingcertainmedications,renaldiseases,etc.).

fd-10 Patients who refuse the food served should be offered substitutes that are of equal nutritional value in order to meet their basic nutritional needs.

fd-11 Therapeutic diets must be prescribed by the practitioner or practitioners responsible for the care of the patients.

Interpretive Guidelines: • Therapeuticdietsmustbe: - Prescribedinwritingbythepractitionerresponsibleforthepatient’scare; - Documentedinthepatient’smedicalrecord(includingdocumentationaboutthe

patient’stolerancetothetherapeuticdietasordered);and - Evaluatedfornutritionaladequacy.

fd-11.1 In accordance with applicable laws and regulations and hospital policy, a dietitian may assess a patient’s nutritional needs and provide recommenda-

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FDtions or consultations for patients, but the patient’s diet must be prescribed by the practitioner responsible for the patient’s care.

Surveyor Guidance: • Verifythattherapeuticdietordersareprescribedandauthenticatedbythepractitioner(s)responsibleforthecareofthepatient.

fd-12 Nutritional needs must be met in accordance with recognized dietary practices and in accordance with orders of the practitioner or practitioners responsible for the care of the patients.

Interpretive Guidelines: • Recognizeddietarypracticesincludefollowingcurrentapplicablelawsandregula-tionsforrecommendeddietaryallowances.

Surveyor Guidance: • Askthehospitaltoshowyouwhatnationalstandardtheyarefollowingintheirmenustomeetthenutritionalneedsoftheirpatients.

• Reviewpatientrecordstoverifythatdietordersareprovidedasprescribedbythepractitioner(s)responsibleforthecareofthepatient.

• Fromthesamplepatientrecords,identifypatientswithspecialnutritionalneedstodetermine:

- Iftheirnutritionalneedshavebeenmet; - Ifappropriatetherapeuticdietshavebeenordered;and - Asappropriate,iftheirdietaryintakeandnutritionalstatusisbeingmonitored.

fd-13 A current therapeutic diet manual approved by the dietitian and medical staff must be readily available to all medical, nursing, and food service personnel.

Interpretive Guidelines: • Thetherapeuticdietmanualmustbeapprovedbythedietitianandthemedicalstaff. • Thepublicationorrevisiondateoftheapprovedtherapeuticdietmanualmustnotbe

morethan5yearsold. • Thetherapeuticdietmanual(orcopiesofit)mustbeavailabletoallmedical,nursing

andfoodservicepersonnel.

Surveyor Guidance: • Determinethatthetherapeuticdietmanualiscurrent,and: - Hasbeenapprovedbyboththemedicalstaffandaqualifieddietitian; - IsreadilyavailabletoMD,nursingandfoodservicepersonnel; - Isinaccordancewiththecurrentnationalstandards,suchasRDAorDRI; - Includesthedifferenttypesoftherapeuticdietsroutinelyorderedatthehospital;and - Isconsistentlyusedasguidancefororderingandpreparingpatientdiets.

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UR

utilization review

Ur-1 The hospital must have in effect a utilization review (UR) plan that provides for review of services furnished by the institution and by members of the medical staff to patients. .

Ur-2 The hospital UR plan should include a delineation of the responsibilities and authority for those involved in the performance of UR activities.

Ur-3 Establish procedures for the review of the medical necessity of admissions, the appropriateness of the setting, the medical necessity of extended stays, and the medical necessity of professional services.

Surveyor Guidance: • Verifythroughreviewofrecordsandreports,andinterviewswiththeURchairmanand/ormembersthatURactivitiesarebeingperformedasdescribedinthehospitalURplan.

• ReviewtheminutesoftheURcommitteetoverifythattheyincludedates,membersinattendance,extendedstayreviewswithapprovalordisapprovalnotedinastatusreportofanyactionstaken.

Ur-4 A UR committee consisting of two or more practitioners must carry out the UR. The other members may be any of the other types of practitioners.

Interpretive Guidelines: • Exceptasspecified,theURcommitteemustbeoneofthefollowing: - Astaffcommitteeoftheinstitution; - Agroupoutsidetheinstitution: ◦ Establishedbythelocalmedicalsocietyandsomeorallofthehospitalsinthe

locality;or • Thecommitteeorgroup’sreviewsmaynotbeconductedbyanyindividualwho: - Hasadirectfinancialinterest(forexample,anownershipinterest)inthathospital;or - Wasprofessionallyinvolvedinthecareofthepatientwhosecaseisbeingreviewed.

Surveyor Guidance: • DeterminethecompositionoftheURcommittee; • DeterminethatthegoverningbodyhasdelegatedtotheURcommitteetheauthority

andresponsibilitytocarryouttheURfunction; • VerifythatsmallhospitalsdelegatetheURfunctiontoanoutsidegroupifitisimprac-

ticaltohaveastaffcommittee; • Ascertainthatcommitteemembersarenotfinanciallyinvolvedinthehospital • (Ownershipof5percentorgreater)norparticipantsinthedevelopmentorexecution

ofthepatient’streatmentplan.

Ur-5 Scope and Frequency of Review

Interpretive Guidelines: • TheURplanmustprovideforreview: - Admissionstotheinstitution; - Thedurationofstays;and - Professionalservicesfurnishedincludingdrugsandbiologicals. • Reviewofadmissionsmaybeperformedbefore,at,orafterhospitaladmission. • Reviewsmaybeconductedonasamplebasis.

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UR • Admissionsmaybereviewedbefore,during,orafterhospitaladmissionasstatedinthehospital’sURplan.

• Reviewsmaybeconductedonasamplebasis,exceptforreviewsofextendedstaycases.

Surveyor Guidance: • ExaminetheURplanandotherdocumentationtodeterminethatthemedicalnecessityforpatientsisreviewedwithrespecttoadmission,durationofthestay,andtheprofessionalservicesfurnished.

• Verifythatthehospitalisreviewingthefollowing: - Durationofstayincasesreasonablyassumedtobeoutliercases;and - Professionalservicesincasesreasonablyassumedtobeoutliercases.

Ur-5.1 Determination Regarding Admissions or Continued Stays

UR-5.1.1 The determination that an admission or continued stay is not medically necessary.

Interpretive Guidelines: • MaybemadebyonememberoftheURcommitteeifthepractitioneror practitionersresponsibleforthecareofthepatient,concurwiththedeterminationorfailtopresenttheirviewswhenaffordedtheopportunity;and

• MustbemadebyatleasttwomembersoftheURcommitteeinallothercases.

UR-5.1.2 Before making a determination that an admission or continued stay is not medically necessary, the UR committee must consult the practitioner or practitioners responsible for the care of the patient, and afford the practition-er or practitioners the opportunity to present their views.

UR-5.1.3 If the committee decides that admission to or continued stay in the hospital is not medically necessary, written notification must be given, no later than 2 days after the determination, to the hospital, the patient, and the practitioner or practitioners responsible for the care of the patient.

UR-5.1.4 When other than a doctor of medicine makes an initial finding that the writ-ten criteria for extended stay are not met, the case must be referred to the committee, or subgroup thereof which contains at least one physician. If the committee or subgroup agrees after reviewing the case that the admission, or extended stay is not medically necessary or appropriate, the attending physi-cian is notified and allowed an opportunity to present his views and any additional information relating to the patient’s needs for admissions or ex-tended stay. When a physician member of the committee performs the initial review instead of a non-physician reviewer, and he finds that admissions or extended stay is not necessary no referral to the committee or subgroup is necessary and he may notify the attending practitioner directly.

UR-5.1.5 If the attending practitioner does not respond or does not contest the find-ings of the committee or subgroup or those of the physician who performed the initial review, then the findings are final.

UR-5.1.6 If the attending physician contests the committee or subgroup findings, or if he presents additional information relating to the patient’s need for extended stay, at least one additional physician member of the committee must review the case. If the two physician members determine that the patient’s stay is not medically necessary or appropriate after considering all the evidence, their determination becomes final. Written notification of this decision must be sent to the attending physician, patient (or next of kin), facility administrator, and the single locality agency no later than 2 days after such final decision and in no event later than 3 working days after the end of the assigned extended stay period.

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UR-5.1.7 There are only 5 working days in a given week. Normally these days are Monday through Friday, however, the institution has the option to establish 5 other days as working days. When a holiday falls on a working day, that day is not counted as a working day.

UR-5.1.8 In no case may a non-physician make a final determination that a patient’s stay is not medically necessary or appropriate.

UR-5.1.9 If, after referral of a questioned case to the committee or subgroup thereof, the physician reviewer determines that an admission or extended stay is justified, the attending physician shall be so notified and an appropriate date for subsequent extended stay review will be selected and noted on the patient’s record.

UR-5.1.10 Written notification of this final determination must be sent to the attending physician, the patient (or next of kin), the facility administrator and the single locality agency no later than 2 days after such final determination and in no event later than 3 working days after the end of the assigned extended stay period. Where possible, the written notification should be received by all involved parties within the stated time period. Where appropriate and desired, verbal notification may precede written notification.

Surveyor Guidance: • Reviewasampleof“medicallyunnecessary"decisionsinvolvingadmissionsorcontinuedstaythatarenotmedicallynecessaryanddeterminethatthesedecisionsaremadebyphysicians.

• Reviewasampleof“medicallyunnecessary"decisionsandverifythatthephysicianorpractitionerswereinformedofthecommitteesexpecteddecisionandweregivenanopportunitytocomment.

• Reviewasampleof“medicallyunnecessary"casesandverifythatallinvolvedpartiesarenotifiedofthedecisionthatcareismedicallynotnecessarynolaterthantwodaysfollowingthedecision.

UR-5.1.11 Extended Stay Review: The scheduling of the periodic reviews may:

Interpretive Guidelines: • Bethesameforallcases;or • Differfordifferentclassesofcases. • TheURcommitteemustmaketheperiodicreviewnolaterthan7daysaftertheday

requiredintheURplan.

Surveyor Guidance: • Reviewthefacility’sdefinitionofextendedstayintheURplan. • Verifythatthehospital’sURplanrequiresaperiodicreviewofeachcurrentinpatient

receivinghospitalservicesofextendeddurationandthatthereviewiscarriedoutatthespecifiedtimestatedinthefacility’sURplan.Thereviewmaybethesameforallcasesorbedifferentfordifferentclassesofcare.

• Ifthecommitteeusesadifferentnumberofdaysfordifferentdiagnosisorfunctionalcategoriesfortheperiodofextendedstay,thesurveyormustverifythatthereisawrittenlistwithlengthsofstaydesignatedforeachdiagnosisoffunctionalcategory.

• ReviewminutesoftheURcommittee.Determinethattheperiodicreviewsofextendedstayarecarriedoutonorbeforetheexpirationofthestatedperiodornolaterthan7daysafterthedayrequiredinthehospital’splan.

UR-5.1.12 Review of Professional Services: The committee must review professional services provided, to determine medical necessity and to promote the most efficient use of available health facilities and services.

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URInterpretive Guidelines: • “Professional”servicesincludetheaspectsofcarerenderedbylaboratorypersonnel,

physicaltherapists,nurses,andothers,aswellasservicesprovidedbyMDs. • Thereviewincludesmedicalnecessityandefficientuseofavailablehealthfacilities

andservices.Examplesoftopicsacommitteemayrevieware: - Availabilityanduseofnecessaryservices-underused,overuse,appropriateuse - Timelinessofschedulingofservices-operatingtheater,diagnostic - Therapeuticprocedures

Surveyor Guidance: • Determinethatthecommitteeperformsareviewofprofessionalservices.

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discharge planning

dP-1 The hospital must have in effect a discharge planning process that applies to all patients. The hospital’s policies and procedures must be specified in writing.

dP-1.1 This applies to all types of hospitals and requires all hospitals to conduct appropriate discharge planning activities for all inpatients. It applies to patients who are admitted to the hospital as inpatients. This does not apply to patients who appear in a hospital emergency department but are not admitted as hospital inpatients.

dP-1.2 The written discharge planning process must reveal a thorough, clear, com-prehensive process that is understood by the hospital staff.

dP-1.3 Adequate discharge planning is essential to the health and safety of all patients. Patients may suffer adverse health consequences upon discharge without benefit of appropriate planning. Such planning is vital to mapping a course of treatment aimed at minimizing the likelihood of having any patient rehospitalized for reasons that could have been prevented.

Surveyor Guidance: • Reviewhospitalwrittenpoliciesandprocedurestodeterminetheexistenceofadischargeplanningprocess.

• Reviewpatientcareplansfordischargeplanninginterventions. • Interviewasampleofhospitalstaffthatisinvolvedindirectpatientcare.Askthe

followingquestions: - Howisdischargeplanningconductedatthishospital? - Howareyoukeptapprisedofthehospital’spoliciesandproceduresfordischarge

planning? - Howisthiscommunicatedandintegratedintoaplanofcare?

dP-2 Identification of Patients in Need of Discharge Planning: The hospital must identify at an early stage of hospitalization all patients who are likely to suffer adverse health consequences upon discharge if there is no adequate discharge planning.

dP-2.1 The following factors have been identified as important: functional status, cognitive ability of the patient, and family support.

dP-2.2 Patients at high-risk of requiring post-hospital services must be identified through a screening process.

dP-2.3 The hospital should reevaluate the needs of the patients on an ongoing basis, and prior to discharge, as they may change based on the individual’s status.

dP-2.4 There is no set time frame for identification of patients requiring a discharge planning evaluation other than it must be done as early as possible. The timing is left up to the hospital, its staff, and attending MD.

Surveyor Guidance: • Interviewstaff.Howarethepatientswhoareinneeddischargeplanningidentified? • Reviewthehospital’shigh-riskscreeningprocedure. - Doesitidentifypatientswhoneeddischargeplanningevaluations? - Howdoesthehospital’shigh-riskscreeningprocedurework?

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DP - Whatstaffisinvolved?Whoisultimatelyaccountable? - Whoevaluatestheproceduretomakesurepatientsareappropriatelyevaluatedand

thatpatientsdonotsufferadverseconsequencesduetolackoforinsufficientdischargeplanning?

dP-3 Discharge Planning Evaluation: The hospital must provide a discharge planning evaluation to the patients upon the patient’s request, the request of a person acting on the patient’s behalf, or the request of the physician.

dP-3.1 The needs assessment can be formal or informal.

dP-3.2 A needs assessment generally includes an assessment of factors that impact on a patient’s needs for care after discharge from the acute care setting.

dP-3.3 These may include assessment of biopsychosocial needs, the patient’s and caregiver’s understanding of discharge needs, and identification of post-hospital care resources.

dP-3.4 The purpose of a discharge planning evaluation is to determine continuing care needs after the patient leaves the hospital setting. It is not intended to be a care-planning document. The hospital may develop an evaluation tool or protocol.

Surveyor Guidance: • Interviewasampleofhospitalstaffandask:Howarepatientsandcaregiversmadeawareoftheirrightstorequestadischargeplan?

• Talktoasampleofpatientsandfamilymemberswhoareexpectingadischargesoonandask:

- Didthehospitalstaffassisttheminplanningforpost-hospitalcare?Doesthepatient/familyexpressthattheyfeelpreparedfordischarge?

- Areyouawarethatyoumayrequestassistancewithdischargeplanning?

dP-4 A registered nurse, social worker, or other appropriately qualified personnel must develop, or supervise the development of, the evaluation.

dP-4.1 The responsibility for discharge planning is often multidisciplinary. It is not restricted to a particular discipline. The hospital has flexibility in designating the responsibilities of the registered nurse, social worker, or other appropri-ate qualified personnel for discharge planning.

dP-4.2 The responsible personnel should have experience in discharge planning, knowledge of social and physical factors that affect functional status at discharge, and knowledge of community resources to meet post-discharge clinical and social needs.

dP-4.3 Ideally, discharge planning will be an interdisciplinary process, involving disciplines with specific expertise, as dictated by the needs of the patient. For example, for a patient with emphysema, the discharge planner could coordi-nate respiratory therapy and nursing care, and financial coverage for home care services and oxygen equipment, and patient/caregiver education utiliz-ing cost effective, available community services in an expedient manner.

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Surveyor Guidance: • Reviewthewrittenpolicyandprocedurethatdesignatesdischarge-planningresponsi-bilities.

• Determinewhoisresponsiblefordischargeplanning.Askthedesignatedpersonneltodescribetheirqualificationsforandexperiencewithdischargeplanningandevaluatewhethertheyarefamiliarwiththecommunitystandardofpractice.Ifneeded,reviewthejobdescriptionsofthedesignatedpersonnelfordischargeplanningexpectations.Iflicensingisrequired,currentcredentialsmustbeonfile.

dP-5 The discharge planning evaluation must include an evaluation of the likelihood of a patient needing post-hospital services and of the availability of the services.

dP-5.1 The hospital is responsible for developing the discharge plan for patients who need a plan and for arranging its initial implementation. The hospital’s ability to meet discharge planning requirements is based on the following:

DP-5.1.1 Implementation of a needs assessment process with identified high-risk criteria; Evidence of a complete, timely, and accurate assessment;

DP-5.1.2 Maintenance of a complete and accurate file on community-based services and facilities including long term care, sub acute care, home care or other appropriate levels of care to which patients can be referred; and

DP-5.1.3 Coordination of the discharge planning evaluation among various disciplines responsible for patient care.

Surveyor Guidance: • Whatistheprocessthehospitalusestoidentifypatientswhoneedadischargeplan? • DoesthehospitaluseitsQualityManagementSystemtodeterminewhetherthe

dischargeplanningprocesseffectivelyidentifiespatientsinneedofplans,andwhethertheplansareadequateandappropriatelyexecuted?

• Ascertainwhethervariousdisciplinesareinvolvedwithdischargeplanning,includingphysical,speech,occupationalandrespiratorytherapistsanddietitians,inadditiontoMD,nurses,andsocialworkers.

dP-5.2 The discharge planning evaluation must include an evaluation of the likelihood of a patient’s capacity for self-care or of the possibility of the patient being cared for in the environment from which he or she entered the hospital.

Interpretive Guidelines: • Thecapacityforself-careincludestheabilityandwillingnessforsuchcare.Thechoiceofacontinuingcareproviderdependsontheself-carecomponents,aswellas,availabil-ity,willingness,andabilityoffamily/caregiversandtheavailabilityofresources.

• Thehospitalmustinformthepatientorfamilyastotheirfreedomtochooseamongprovidersofpost-hospitalcare.Patientpreferencesshouldalsobeconsidered;however,preferencesarenotnecessarilycongruentwiththecapacityforself-care.

• Patientsshouldbeevaluatedforreturntothepre-hospitalenvironment,butalsoshouldbeofferedarangeofrealisticoptionstoconsiderforpost-hospitalcare.ThisincludespatientsadmittedtoahospitalfromaSNF,whoshouldbeevaluatedtodetermineanappropriatedischargesite.

• Hospitalstaffshouldincorporateinformationprovidedbythepatientand/orcaregiv-erstoimplementtheprocess.

Surveyor Guidance: • Reviewasampleofdischargeplanningevaluations. - Gatherinformationaboutthepatient’sself-carecapacityfromtheclinicalrecord,

directclinicalobservation,andinformationobtainedfromthepatient,caregiver,

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DPandstaffinvolvedinthecareofthepatient;judgeappropriatenessofdischargedisposition.

- Noteifappropriateinterdisciplinaryinputisdocumented. - Didthepatientand/orcaregiverparticipateintheneedsassessmentanddecision

forpost-hospitalcareresources? • Isapatientwhowasadmittedfromahomeoranothersettinggivenafull-rangeof

realisticoptionsforpost-hospitalcontinuationofcare?

dP-6 The hospital personnel must complete the evaluation on a timely basis so that appropriate arrangements for post-hospital care are made before discharge, and to avoid unnecessary delays in discharge.

dP-6.1 Patient hospital length of stay varies widely. The timing of the discharge evaluation should be relative to the patient’s clinical condition and antici-pated length of stay.

dP-6.2 Assessment should start as soon after admission as possible and be updated periodically during the episode of care.

dP-6.3 Information about the patient’s age and sex could be collected on admission while functional ability data is best collected closer to discharge, indicating more accurately a patient’s continuing care requirements.

Surveyor Guidance: • Reviewseveralpatients’dischargeplansfortheappropriatecoordinationofhealthandsocialcareresourcesbasedontheindividualpatientandcaregiver’sexpectedpost-hospitalneeds.

• Isthereapatternofprolongedlengthofstayforcertainpatientpopulationsbecausetheevaluationforpost-hospitalcarewasdelayed?Ifso,isthedelayduetocircum-stancesbeyondthehospital’scontrol(e.g.,inabilitytoreachthebeneficiary’srespon-sibleperson(s),continuingchangeinthepatient’scondition,and/oristhedelayduetopoorhospitalplanningfortimelypost-hospitalarrangements)?

dP-7 The hospital must include the discharge planning evaluation in the patient’s medical record for use in establishing an appropriate discharge plan and must discuss the results of the evaluation with the patient or individual acting on his or her behalf.

dP-7.1 The hospital must demonstrate its development of discharge plan evalua-tion for patients in need and then must discuss the results of the evaluation with the patient or individual acting on his/her behalf. Documentation of these activities is expected.

dP-7.2 The discharge plan evaluation is generally found in the clinical notes if there is no dedicated form. The hospital will be expected to document its decision about the need for a plan, document the existence of plans when needed, and indicate what steps were taken to implement the plans initially. Evidence of an ongoing evaluation of the discharge planning needs of the patient is the important factor.

Surveyor Guidance: • Reviewseveralclinicalrecordsforevidenceofadischargeplanningevaluation. • Throughreviewoftheclinicalrecordnotesandquestioningofthepatientand/or

caregiverandstaff,verifydiscussionoftheevaluationwiththeinvolvedpersons.

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DPdP-8 Discharge Plan: The hospital must ensure that the discharge plan require-ments are met.

dP-8.1 A registered nurse, social worker, or other appropriately qualified personnel must develop, or supervise the development of, a discharge plan if the discharge planning evaluation indicates a need for a discharge plan.

Surveyor Guidance: • Examinepatients’clinicalrecordsforreferencestoaregisterednurse,socialworker,orotherdesignatedqualifiedpersonnelortheirsignatureonawrittendischargeplannotation.

• Askstafftodescribewhooverseesthedevelopmentofadischargeplan.

dP-8.2 In the absence of a finding by the hospital that a patient needs a discharge plan, the patient’s physician may request a discharge plan. In such a case, the hospital must develop a discharge plan for the patient.

Interpretive Guidelines: • Thephysiciancanmakethefinaldecisionastowhetheradischargeplanisnecessary.Thehospitalwilldevelopaplanifaphysicianrequestsoneeveniftheinterdiscipli-naryteamhaddeterminedonetobeunnecessary.

Surveyor Guidance: • Reviewthehospitalpolicyandproceduretodeterminewhomayrequestadischargeplan. • Istherereferencetoorexistenceofadischargeplanintheclinicalrecordwhen

requestedbyaphysician? • Askaphysicianinvolvedwithdischargeplanningaboutexperienceswithrequesting

developmentofdischargeplanswhentheinterdisciplinaryteamdoesnotrecom-mendaplan.

dP-8.3 The hospital must arrange for the initial implementation of the patient’s discharge plan.

DP-8.3.1 The hospital is required to arrange for the initial implementation of the dis-charge plan. This includes arranging for necessary post-hospital services and care, and educating patient/family/caregivers/community providers about post-hospital care plans.

Surveyor Guidance: • Reviewasampleofpatientrecords.Determineifthereisdocumentedevidenceofimplementationofthedischargeplan,includingcontactandtransmissionofinfor-mationtothepatient(whenpossible)andthenextcaregiver.Askstaffresponsibleforthepatient’scaretodescribethestepstakentoimplementtheplaninitiallyforthepatients.

• Interviewthepatientorcaregiverregardingimplementationoftheplanbyfacilitystaff.

dP-8.4 The hospital must reassess the patient’s discharge plan if there are factors that may affect continuing care needs or the appropriateness of the dis-charge plan.

DP-8.4.1 The discharge plan should be initiated as soon as possible after admission. As changes in the patient’s condition and needs occur, the discharge plan must be reassessed and updated to address those changes.

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DPSurveyor Guidance: • Reviewthehospital’spolicyonreassessmentofdischargeplans. • Reviewseveralclinicalrecordsforevidenceofreassessmentofthepatientandrelated

changeswithregardtothecareplan/criticalpathway(s)inthedischargeplanwhenwarranted.

• Askstaffinvolvedwithdischargeplanningtodiscussthereassessmentprocessand/orpresentaclinicalrecordthatdocumentsreassessment.

dP-8.5 As needed, the patient and family members or interested persons must be counseled to prepare them for post-hospital care.

DP-8.5.1 Evidence should exist that the patient and/or family and/or caregiver is/are provided information and instructions in preparation for post-hospital care and kept informed of the progress. It is important that the patient and caregivers who are expected to provide the care know, and as appropriate, can demonstrate or verbalize the care needed by the patient.

DP-8.5.2 Use of family caregivers in providing post-hospital care should occur when the family is both willing and able to do so. It is appropriate to use commu-nity resources with or without family support whenever necessary.

Surveyor Guidance: • Wherepossible,interviewpatientsandtheirfamilymemberstodeterminewhethertheyhavebeeninstructedinpost-hospitalcare.Potentialtrainingcouldincludethetiminganddosageofmedications,thewideeffectsofmedications,treatments,andtherapyregimens.Ifthepatientisbeingtransferredtoanalternatecaredeliverysetting,hasthisinformationbeensharedwiththepatient?

dP-8.6 Transfer or Referral: The hospital must transfer or refer patients, along with necessary medical information, to appropriate facilities, agencies, or outpa-tient services, as needed, for follow-up or ancillary care.

Interpretive Guidelines: • Thehospitalmustensurethatpatientsreceiveproperpost-hospitalcarewithintheconstraintsofahospital’sauthorityunderapplicablelawsandregulationsandwithinthelimitsofapatient’srighttorefusedischarge-planningservices.Ifapatientexer-cisestherighttorefusedischargeplanningortocomplywithadischargeplan,documentationoftherefusalisrecommended.

• “Medicalinformation"maybereleasedonlytoauthorizedindividuals.Examplesofnecessaryinformationincludefunctionalcapacityofthepatient,requirementsforhealthcareservicesprocedures,dischargesummary,andreferralforms.

• “Appropriatefacilities"referstofacilitiesthatcanmeetthepatient’sassessedneedsonapost-dischargebasisandthatcomplywithdesignatedhealthandsafetystandards.

Surveyor Guidance: • Askstaffinvolvedwithdischargeplanningtodescribetheprocessoftransferofpatientinformationfromthehospitaltoapost-dischargefacility.

• Doestheprocessassurecontinuityofcare? • Arethepatient’srights,suchasforconfidentiality,refusal,andpreferenceconsidered? • Ifrequired,isthereevidenceofwrittenauthorizationbythepatientbeforereleaseof

information? • Istheredocumentationthatcareinstructionhasbeencommunicatedtothepost

hospitalcaresetting?

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DPdP-8.7 Reassessment: The hospital must reassess its discharge planning process on an on-going basis. The reassessment must include a review of discharge plans to ensure that they are responsive to discharge needs.

Interpretive Guidelines: • Thehospital’sdischargeplanningprocessmustbeintegratedintoitsQualityManage-mentSystem.Thehospitalmusthaveamechanisminplaceforongoingreassessmentofitsdischargeplanningprocess.Althoughspecificparametersormeasuresthatwouldbeincludedinareassessmentarenotrequired,thehospitalshouldassurethefollowingfactorsinthereassessmentprocess:

- Timeeffectivenessofthecriteriatoidentifypatientsneedingdischargeplans; - Thequalityandtimelinessfordischargeplanningevaluationsanddischargeplans; - Thehospitaldischargepersonnelmaintaincompleteandaccurateinformationto

advisepatientsandtheirrepresentativesofappropriateoptions;and - Thehospitalhasacoordinateddischargeplanningprocessthatintegratesdis-

chargeplanningwithotherfunctionaldepartments,includingthequalityassuranceandutilizationreviewactivitiesoftheinstitutionandinvolvesvariousdisciplines.

Surveyor Guidance: • Reviewhospitalpoliciesandprocedurestodeterminehowoftenthedischargeplan-ningprocessisreassessed.

• Doesthehospital’sQualityManagementServicesdeterminewhetheritsdischargeplanningprocesseffectivelyidentifiespatientswhoneeddischargeplanning,whethertheplansareadequateandwhethertheplansareeffectivelyexecuted?

• Askhospitalstaffhowoftenthedischargeplanningprocessisreassessed.Whatdataisexaminedtodeterminehowwelltheprocessisworkinginprovidingforcontinuedcareofthepatient?

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organ, tissue and eye procurement

ot-1 The hospital must have written policies and procedures to address its organ procurement responsibilities.

ot-2 The hospital must have a written agreement with an Organ Procurement Organization (OPO) (i.e. Eurotransplant). At a minimum, the written agree-ment must address the following:

ot-2.1 The criteria for referral, including the referral of all individuals whose death is imminent or who have died in the hospital;

ot-2.2 Includes a definition of “imminent death”; includes a definition of “timely notification”;

ot-2.3 Addresses the OPO’s responsibility to determine medical suitability for organ donation;

ot-2.4 Specifies how the tissue and/or eye bank will be notified about potential donors using notification protocols developed by the OPO in consultation with the hospital-designated tissue and eye bank(s);

ot-2.5 Provides for notification of each individual death in a timely manner to the OPO (or designated third party) in accordance with the terms of the agreement;

ot-2.6 Ensures that the designated requestor training program offered by the OPO has been developed in cooperation with the tissue bank and eye bank designated by the hospital;

ot-2.7 Permits the OPO, tissue bank, and eye bank access to the hospital’s death record information according to a designated schedule, e.g., monthly or quarterly;

ot-2.8 Includes that the hospital is not required to perform credentialing reviews for, or grant privileges to, members of organ recovery teams as long as the OPO sends only “qualified, trained individuals” to perform organ recovery; and

ot-2.9 The interventions the hospital will utilize to maintain potential organ donor patients so that the patient organs remain viable.

ot-3 Hospitals must notify the OPO of every death or imminent death in the hospi-tal. When death is imminent, the hospital must notify the OPO both before a potential donor is removed from a ventilator and while the potential donor’s organs are still viable. The hospital should have a written policy, developed in coordination with the OPO and approved by the hospital’s medical staff and governing body, to define imminent death. The definition for “imminent death” should strike a balance between the needs of the OPO and the needs of the hospital’s care givers to continue treatment of a patient until brain death is declared or the patient’s family has made the decision to withdraw supportive measures. Collaboration between OPOs and hospitals will create a partnership that furthers donation, while respecting the perspective of hospital staff.

ot-4 The definition for “imminent death” might include a patient with severe, acute brain injury who:

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ot-4.1 Requires mechanical ventilation;

ot-4.2 Is in an intensive care unit (ICU) or emergency department;

ot-4.3 Exhibits clinical findings consistent with a Glasgow Coma Score that is less than or equal to a mutually-agreed-upon threshold; or

ot-4.4 MDs are evaluating a diagnosis of brain death; or

ot-4.5 An MD has ordered that life sustaining therapies be withdrawn, pursuant to the family’s decision.

ot-4.6 Hospitals and their OPO should develop a definition of “imminent death” that includes specific triggers for notifying the OPO about an imminent death.

ot-4.7 The definition agreed to by the hospital and the OPO may include all of the elements listed above or just some of the elements. The definition should be tailored to fit the particular circumstances in each hospital.

ot-4.8 “Timely notification” means a hospital must contact the OPO by telephone as soon as possible after an individual has died, has been placed on a venti-lator due to a severe brain injury, or who has been declared brain dead (ideally within 1 hour). That is, a hospital must notify the OPO while a brain dead or severely brain-injured, ventilator-dependent individual is still at-tached to the ventilator and as soon as possible after the death of any other individual, including a potential non-heart-beating donor. Even if the hospital does not consider an individual who is not on a ventilator to be a potential donor, the hospital must call the OPO as soon as possible after the death of that individual has occurred.

ot-4.9 Referral by a hospital to an OPO is timely if it is made:

OT-4.9.1 As soon as it is anticipated that a patient will meet the criteria for imminent death agreed to by the OPO and hospital or as soon as possible after a patient meets the criteria for imminent death agreed to by the OPO and the hospital (ideally, within one hour); and

OT-4.9.2 Prior to the withdrawal of any life sustaining therapies (i.e., medical or phar-macological support).

OT-4.9.3 Whenever possible, referral should be made early enough to allow the OPO to assess the patient’s suitability for organ donation before brain death is de-clared and before the option of organ donation is presented to the family of the potential donor. Timely assessment of the patient’s suitability for organ donation increases the likelihood that the patient’s organs will be viable for transplantation (assuming there is no disease process identified by the OPO that would cause the organs to be unsuitable), assures that the family is approached only if the patient is medically suitable for organ donation, and assures that an OPO representative is available to collaborate with the hospi-tal staff in discussing donation with the family.

OT-4.9.4 It is the OPO’s responsibility to determine medical suitability for organ donation, and, in the absence of alternative arrangements by the hospital, the OPO deter-mines medical suitability for tissue and eye donation, using the definition of potential tissue and eye donor and the notification protocol developed in con-sultation with the tissue and eye banks identified by the hospital for this purpose.

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OPSurveyor Guidance: • Reviewthehospital’swrittenagreementwiththeOPOtoverifythatitaddressesall

requiredinformation. • Verifythatthehospital’sgoverningbodyhasapprovedthehospital’sorganprocure-

mentpolicies. • Reviewasampleofdeathrecordstoverifythatthehospitalhasimplementeditsorgan

procurementpolicies. • Interviewthestafftoverifythattheyareawareofthehospital’spoliciesandproce-

duresfororgan,tissueandeyeprocurement. • Verifythattheorgan,tissueandeyedonationprogramisintegratedintothehospital’s

QualityManagementServices.

ot-4.10 Incorporate an agreement with at least one tissue bank and at least one eye bank to cooperate in the retrieval, processing, preservation, storage and distribution of tissues and eyes, as may be appropriate to assure that all usable tissues and eyes are obtained from potential donors, insofar as such an agreement does not interfere with organ procurement;

Interpretive Guidelines • Thehospitalmusthaveanagreementwithatleastonetissuebankandatleastoneeyebank.TheOPOmayserveasa"gatekeeper"receivingnotificationabouteveryhospitaldeathandshouldnotifythetissuebankoreyebankchosenbythehospitalaboutpotentialtissueandeyedonors.

• ItisnotnecessaryforahospitaltohaveaseparateagreementwithatissuebankifithasanagreementwithitsOPOtoprovidetissueprocurementservices;norisitnecessaryforahospitaltohaveaseparateagreementwithaneyebankifitsOPOprovideseyeprocurementservices.ThehospitalisnotrequiredtousetheOPOfortissueoreyeprocurementbutisfreetohaveanagreementwiththetissuebankoreyebankofitschoice.Thetissuebanksandeyebanksdefine"usabletissues"and"usableeyes."

• TherequirementsofthisregulationmaybesatisfiedthroughasingleagreementwithanOPOthatprovidesservicesfororgan,tissueandeye,orbyaseparateagreementwithanothertissueand/oreyebankoutsidetheOPO,chosenbythehospital.Thehospitalmaycontinuecurrentsuccessfuldirectarrangementswithtissueandeyebanksaslongasthedirectarrangementdoesnotinterferewithorganprocurement.

Surveyor Guidance: • Verifythatthehospitalhasanagreementwithatleastonetissuebankandoneeyebankthatspecifiescriteriaforreferralofallpotentialtissueandeyedonors,oranagreementwithanOPOthatspecifiesthetissuebankandeyebanktowhichreferralswillbemade.TheagreementshouldalsoacknowledgethatitistheOPO’sresponsibil-itytodeterminemedicalsuitabilityfortissueandeyedonation,unlessthehospitalhasanalternativeagreementwithadifferenttissueand/oreyebank.

ot-4.11 Ensure, in collaboration with the designated OPO, that the family of each potential donor is informed of its options to donate organs, tissues, or eyes, or to decline to donate.

Interpretative Guidelines: • ItistheresponsibilityoftheOPOtoscreenformedicalsuitabilityinordertoselectpotentialdonors.OncetheOPOhasselectedapotentialdonor,thatperson’sfamilymustbeinformedofthefamily’sdonationoptions.

• Ideally,theOPOandthehospitalwilldecidetogetherhowandbywhomthefamilywillbeapproached.

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OPSurveyor Guidance: • Verifythatthehospitalensuresthatthefamilyofeachpotentialdonorisinformedof

itsoptionstodonateorgans,tissues,oreyes,includingtheoptiontodeclinetodonate. • DoesthehospitalhaveQualityManagementSystemmechanismsinplacetoensure

thatthefamiliesofallpotentialdonorsareinformedoftheiroptionstodonateorgans,tissues,oreyes,ortodeclinetodonate?

ot-4.12 The individual designated by the hospital to initiate the request to the family must be an organ procurement representative or a designated requestor. A designated requestor is an individual who has completed a course offered or approved by the OPO and designed in conjunction with the tissue and eye bank community in the methodology for approaching potential donor families and requesting organ or tissue donation.

Interpretive Guidelines: • Theindividualdesignatedbythehospitaltoinitiatetherequesttoafamilymustbeanorganprocurementrepresentative,anorganizationalrepresentativeofatissueoreyebank,oradesignatedrequestor.Anyindividualsinvolvedinarequestfororgan,tissue,andeyedonationmustbeformallytrainedinthedonationrequestprocess.

• TheindividualdesignatedbythehospitaltoinitiatetherequesttothefamilymustbeanOPO,tissuebank,oreyebankrepresentativeoradesignatedrequestor.Adesig-natedrequestor"isdefinedasahospital-designatedindividualwhohascompletedacourseofferedorapprovedbytheOPOanddesignedinconjunctionwiththetissueandeyebankcommunity.

• Ideally,theOPOandthehospitalwilldecidetogetherhowandbywhomthefamilywillbeapproached.Ifpossible,theOPOrepresentativeandadesignatedrequestorshouldapproachthefamilytogether.

• Thehospitalmustensurethatanydesignated“requestor"fororgans,tissuesoreyeshascompletedatrainingcourseeitherofferedorapprovedbytheOPO,whichaddressesmethodologyforapproachingpotentialdonorfamilies.

Surveyor Guidance: • Reviewtrainingschedulesandpersonnelfilestoverifythatalldesignatedrequestorshavecompletedtherequiredtraining.

• HowdoesthehospitalensurethatonlyOPO,tissuebank,oreyebankstaffordesig-natedrequestorsareapproachingfamiliestoaskthemtodonate?

ot-4.13 Encourage discretion and sensitivity with respect to the circumstances, views, and beliefs of the families of potential donors.

Interpretive Guidelines: • Usingdiscretiondoesnotmeanajudgmentcanbemadebythehospitalthatcertainfamiliesshouldnotbeapproachedaboutdonation.Hospitalsshouldapproachthefamilywiththebeliefthatadonationispossibleandshouldtakestepstoensurethefamilyistreatedwithrespectandcare.Thehospitalstaff’sperceptionthatafamily’sgrief,race,ethnicity,religionorsocioeconomicbackgroundwouldpreventdonationshouldneverbeusedasareasonnottoapproachafamily.

• Allpotentialdonorfamiliesmustbeapproachedandinformedoftheirdonationrights.

Surveyor Guidance: • Interviewahospital-designatedrequestorregardingapproachestodonationrequests. • Reviewthedesignatedrequestortrainingprogramtoverifythatitaddressestheuseof

discretion. • Reviewthehospital’scomplaintfileforanyrelevantcomplaints.

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OPot-4.14 Ensure that the hospital works cooperatively with the designated OPO, tissue bank and eye bank in educating staff on donation issues.

Interpretive Guidelines: • Appropriatehospitalstaff,includingallpatientcarestaff,mustbetrainedondonationissues.ThetrainingprogrammustbedevelopedincooperationwiththeOPO,tissuebankandeyebank,andshouldinclude,ataminimum:

- Consentprocess; - Importanceofusingdiscretionandsensitivitywhenapproachingfamilies;Roleof

thedesignatedrequestor; - Transplantationanddonation,includingpediatrics,ifappropriate; - Qualityimprovementactivities;and - Roleoftheorganprocurementorganization. • Trainingshouldbeconductedwithnewemployeesannually,wheneverthereare

policy/procedurechanges,orwhenproblemsaredeterminedthroughthehospital’sQualityManagementSystem.

• ThosehospitalstaffwhomayhavetocontactorworkwiththeOPO,tissuebankandeyebankstaffmusthaveappropriatetrainingondonationissuesincludingtheirdutiesandroles.

Surveyor Guidance: • Reviewin-servicetrainingschedulesandattendancesheets. • Howdoesthehospitalensurethatallappropriatestaffhasattendedaneducational

programregardingdonationissuesandhowtoworkwiththeOPO,tissuebank,andeyebank?

ot-4.15 Ensure that the hospital works cooperatively with the designated OPO, tissue bank and eye bank in educating staff on reviewing death records to improve identification of potential donors.

Interpretive Guidelines: • HospitalsmustcooperatewiththeOPOs,tissuebanksandeyebanksinregularlyorperiodicallyreviewingdeathrecords.ThismeansthatthehospitalmustdeveloppoliciesandprocedureswhichpermittheOPO,tissuebank,andeyebankaccesstodeathrecordinformationthatwillallowtheOPO,tissuebankandeyebanktoassessthehospital’sdonorpotential,assurethatalldeathsorimminentdeathsarebeingreferredtotheOPOinatimelymanner,andidentifyareaswherethehospital,OPO,tissuebankandeyebankstaffperformancemightbeimproved.Thepoliciesmustaddresshowpatientconfidentialitywillbemaintainedduringthereviewprocess.

Surveyor Guidance: • VerifybyreviewofpoliciesandrecordsthatthehospitalworkswiththeOPO,tissuebank,andeyebankinreviewingdeathrecords.

• Verifythattheeffectivenessofanyprotocolsandpoliciesismonitoredaspartofthehospital’squalityimprovementprogram.

• Validatehowoftenthereviewsaretooccur.Reviewtheprotocolsthatareinplacetoguiderecordreviewsandanalysis.

• Determinehowconfidentialityisensured.

ot-4.16 Ensure that the hospital works cooperatively with the designated OPO, tissue bank and eye bank in educating staff on maintaining potential donors while necessary testing and placement of potential donated organs, tissues, and eyes take place.

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OP OT-4.16.1 The hospital must have policies and procedures, developed in cooperation with the OPO, that ensure that potential donors are maintained in a manner that maintains the viability of their organs. The hospital must have policies in place to ensure that potential donors are identified and declared dead within an acceptable time frame by an appropriate practitioner.

Surveyor Guidance: • Determinebyreview,whatpoliciesandproceduresareinplacetoensurethatpoten-tialdonorsareidentifiedanddeclareddeadbyanappropriatepractitionerwithinanacceptabletimeframe.

• VerifythattherearepoliciesandproceduresinplacetoensurethecoordinationbetweenfacilitystaffandOPOstaffinmaintainingthepotentialdonor.

ot-4.17 Organ Transplantation Responsibilities: For purposes of these standards, the term “organ” means a human kidney, liver, heart, lung, or pancreas. If a hospital performs any type of transplants, it must provide organ transplant related data.

Surveyor Guidance: • Verifybyreview,oneyearofreportssubmittedbythefacilitytotheOPTN,theScientificRegistry,theOPOs,andanydatasubmittedtotheMinistryofHealth.

• Verifythatpharmaceuticalsarestoredattemperaturesrecommendedbytheproductmanufacturer.

• Verifythateachoperatingtheatrehastemperatureandhumiditycontrolmechanisms. • Reviewtemperatureandhumiditytrackinglog(s)toensurethatappropriatetempera-

tureandhumiditylevelsaremaintained.

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physical environment

Pe-1 facilities

Pe-1.1 The hospital shall be constructed, arranged, and maintained to ensure the safety of the patient, and to provide facilities for diagnosis and treatment and for special hospital services appropriate to the needs of the community. Pertinent physical environment data/information shall be distributed regu-larly to Quality Management oversight.

Interpretive Guidelines: • Thisstandardappliestoalllocationsofthehospital,allcampuses,allsatellites,allprovider-basedactivities,andallinpatientandoutpatientlocations.

• Thehospital’sFacilityMaintenanceandhospitaldepartmentsorservicesresponsibleforthehospital’sbuildingsandequipment(bothfacilityequipmentandpatientcareequipment)mustbeincorporatedintothehospital’sQualityManagementSystemandbeincompliancewiththeQualityManagementSystemrequirements.

Surveyor Guidance: • SurveyofthePhysicalEnvironmentStandardshouldbeconductedbyonesurveyor.However,eachsurveyorashe/sheconductshis/hersurveyassignmentsshouldassessthehospital’scompliancewiththePhysicalEnvironmentStandard.

Pe-1.2 The condition of the physical plant and the overall hospital environment must be developed and maintained in such a manner that the safety and well being of patients are assured.

Interpretive Guidelines: • Thehospitalmustensurethattheconditionofthephysicalplantandoverallhospitalenvironmentisdevelopedandmaintainedinamannertoensurethesafetyandwellbeingofpatients.Thisincludesensuringthatroutineandpreventivemaintenanceandtestingactivitiesareperformedasnecessary,inaccordancewithallapplicablelawsregulations,guidelinesandmanufacturer’srecommendations,byestablishingmainte-nanceschedulesandconductingongoingmaintenanceinspectionstoidentifyareasorequipmentinneedofrepair.

• Theroutineandpreventivemaintenanceandtestingactivitiesshouldbeincorporatedintothehospital’sQualityManagementSystem.

Pe-1.3 The hospital shall have written plans that document and identify the follow-ing seven areas: Safety, Security, Emergency Management, Hazardous Materials (HAZMAT), Life Safety (includes Fire Safety), Medical Equipment, and Utility Systems.

Pe-1.4 The hospital shall maintain adequate facilities for its services.

Interpretive Guidelines: • Adequatefacilitiesmeansthehospitalhasfacilitiesthatare: • Designedandmaintainedinaccordancewithallapplicablelawsandregulations;and • Designedandmaintainedtoreflectthescopeandcomplexityoftheservicesitoffers

inaccordancewithacceptedstandardsofpractice.

Surveyor Guidance: • Observethefacilitylayoutanddetermineifthepatient’sneedsaremet.Toilets,sinks,specializedequipment,etc.shouldbeaccessible.

• Reviewthefacility’swatersupplyanddistributionsystemtoensurethatthewaterqualityisacceptableforitsintendeduse(drinkingwater,irrigationwater,labwater,etc.).

• Reviewthefacilitywaterqualitymonitoringlogsand,asappropriate,treatmentsystem.

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PEPe-1.5 Facilities, supplies, and equipment shall be maintained to ensure an accept-able level of safety and quality.

Interpretive Guidelines: • Facilitiesmustbemaintainedtoensureanacceptablelevelofsafetyandquality. • Suppliesandequipmentmustbemaintainedtoensureanacceptablelevelofsafety

andquality.Thiswouldincludethatsuppliesandequipmentarestoredinsuchamannertoensurethesafetyofthestoredsupplies,equipment(protectionagainsttheftordamage,contamination,ordeterioration),aswellas,thatthestoragepracticesdonotviolatefirecodesorotherwiseendangerpatients(storageofflammables,blockingpassageways,storageofcontaminatedordangerousmaterials,safestoragepracticesforpoisons,etc.).

• Thehospitalshouldidentifythesuppliesandequipmentitneedstomeetitspa-tients’needsforbothday-to-dayoperationsandthosesuppliesthatarelikelytobeneededinlikelyemergencysituationssuchasmasscasualtyeventsresultingfromnaturaldisasters,masstrauma,diseaseoutbreaks,etc.;thehospitalshouldmakeadequateprovisionstoensuretheavailabilityofthosesuppliesandequipment whenneeded.

Pe-1.6 The extent and complexity of facilities shall be determined by the services offered.

Interpretive Guidelines: • Physicalfacilitiesmustbelargeenough,numerousenough,appropriatelydesignedandequipped,andofappropriatecomplexitytoprovidetheservicesofferedinaccordancewithapplicablelawsandregulationsandguidelinesandacceptedstandardsofpracticeforthatlocationorservice.

Surveyor Guidance: • Verifythroughobservationthatthephysicalfacilitiesarelargeenoughandproperlyequippedforthescopeofservicesprovidedandthenumberofpatientsserved.

Pe-2 Safety Management Program

Pe-2.1 The hospital shall develop and maintain a Safety Management Program that provides a safe and hazard-free physical environment, which includes identi-fying and monitoring areas that pose safety risks.

Pe-2.2 The hospital shall address safety recalls and alerts.

Pe-2.3 The hospital shall conduct routine inspections of the facility in order to identify safety concerns.

Pe-2.4 The hospital shall require proper ventilation, light and temperature controls in pharmaceutical, food preparation, and other appropriate areas.

Interpretive Guidelines: • Thehospital’sSafetyManagementProgramshouldensuretheregularpatrollingofhospitalpropertyandbuildingstoassesstheactualandpotentialareasthatposesafetyissues.Thisprogramshouldcontainprovisionsforreporting,investigation,andsolutionsforsafetyrelatedissues.

Surveyor Guidance: • Identifythatthehospitalhasrelevantdocumentationoftheinspectionsofthefacility,includingtheeffectivenesspreventiveandcorrectiveactionsthatwereinvolved.

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PEPe-2.5 Diagnostic and therapeutic facilities must be constructed, and maintained to ensure patient safety. Diagnostic facilities are those that conduct tests for patients. Therapeutic facilities are those that provide health care services that help to restore or maintain a patient’s health.

Interpretive Guidelines: • Diagnosticfacilitiesprimarilyincludelaboratorytestingareasandimagingservices,suchasx-rays.Therapeuticfacilitiesincludeservicessuchasphysicaltherapy,occupationaltherapy,aquatictherapy,andcardiopulmonaryrehabilitation.

• Diagnosticandtherapeuticfacilitiesmustbeinroomsorareasspecificallydesignedforthepurposeintended.

Surveyor Guidance: • Determinethatx-ray,physicaltherapy,andotherspecializedservicesareprovidedinareasappropriatefortheserviceprovided.

• Verifythattheconditionofthehospitalismaintainedinamannertoassurethesafetyandwellbeingofpatients(e.g.,conditionofceilings,walls,andfloors,presenceofpatienthazards,etc.).

• Reviewthehospital’sroutineandpreventivemaintenanceschedulestodeterminethatongoingmaintenanceinspectionsareperformedandthatnecessaryrepairsarecompleted.

Pe-3 Security Management Program

Pe-3.1 The hospital shall develop and maintain a Security Management Program that provides a secure physical environment, which includes the identifica-tion and monitoring of security issues within the organization.

Pe-3.2 The hospital shall implement a written policy that prohibits harassment/mobbing in the workplace. The policy shall provide measures for employee awareness, on-going training, and investigation of harassment issues, as well as ensure confidential grievance procedures for all employees.

Interpretive Guidelines: • Theharassment/mobbingpolicyshouldbecommunicatedtoallemployeesuponorientation,andalsothroughperiodicmeansofeducation.Employeesshouldbemadeawareoftheprocessesinvolvedinpossibleinvestigations,particularlythatindividualprivacyisassuredfortheseissuesbytheorganization.

Pe-3.3 The hospital shall establish and maintain a violence prevention program as part of the facility’s security program.

Interpretive Guidelines: • Theviolencepreventionprogramshouldbemadeavailabletoallemployees,includ-ingmanagersandsupervisors.Allemployeesshouldreceivespecifictrainingcon-cerningitscontentandimplementation.Theviolencepreventionprogramshouldtrackprogressinthereductionofwork-relatedassaults,providemeasurestoreducetheseverityofinjuriessustainedbyemployeesanddecreasethethreattoworkersafety,andreflectthelevelandnatureofthreatsfacedbyemployees.Thehospitalshouldincludethefollowingmaincomponentsinthefacility’sViolencePreventionProgram:

- ManagementCommitmentandEmployeeInvolvement - WorksiteAnalysis:Astep-by-stepanalysisofthefacilitytofindexistingorpotential

hazardsforworkplaceviolence. - HazardPreventionandControl:Implementationofengineeringandworkpractices

topreventandcontrolidentifiedhazards.

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PE - SafetyandHealthTraining:Ensurestaffawarenessofsecurityhazardsandhowtoprotectthemselvesthroughestablishedpolicies,proceduresandtraining.

- RecordkeepingandEvaluationofProgram.

Pe-3.4 The hospital shall ensure that all patients, staff, visitors, and others are identified.

Interpretive Guidelines: • Thehospitalshoulddevelopandmaintainasystemthatprovidedidentificationbadgestoallemployees,aswellasvolunteers.Considerationshouldbegiventovendors,contractors,andoutsidehiredpersonnel,forproperreportingorsign-intothefacilityandmeansofidentification,suchashospital-issuedidentificationbadges.

Pe-4 emergency Management Program

Pe-4.1 The hospital shall develop and utilize an Emergency Management Program to address the safety and well being of patients in emergency situations.

Pe-4.2 The hospital shall require that the organization conduct a (HVA) hazard vulnerability analysis to identify potential emergencies in the organization and the community.

Interpretive Guidelines: • Assuringthesafetyandwellbeingofpatientswouldincludedevelopingandimple-mentingappropriateemergencypreparednessplansandcapabilities.

• Thehospitalmustdevelopandimplementacomprehensiveplantoensurethatthesafetyandwellbeingofpatientsareassuredduringemergencysituations.

• Thehospitalmustcoordinatewithallapplicableemergencypreparednessandhealthauthoritiestoidentifylikelyrisksfortheirarea(e.g.,naturaldisasters,bioterrorismthreats,disruptionofutilitiessuchaswater,sewer,electricalcommunications,fuel,nuclearaccidents,industrialaccidents,andotherlikelymasscasualties,etc.)andtodevelopappropriateresponsesthatwillassurethesafetyandwellbeingofpatients.

• Inordertoprepareforsuchanemergency,thehospitalmustconductahazardvulnerabilityanalysistoidentifypotentialemergenciesorothercircumstancesthatmayimpactthehospitalandthecommunity.Thehospitalmustmaintaindocumenta-tionthatthisanalysishasbeenconductedandthatthehospitalhasprioritizedactivi-tiestoaddressandprepareforthesevulnerabilities.

• Thefollowingissuesshouldbeconsideredwhendevelopingthecomprehensiveemergencyplan(s).

- Thedifferingneedsofeachlocationwherethehospitaloperates; - Thespecialneedsofpatientpopulationstreatedatthehospital(e.g.,patientswith

psychiatricdiagnosis,patientsonspecialdiets,newborns,etc.) - Securityofpatientsandwalk-inpatients; - Securityofsuppliesfrommisappropriation; - Pharmaceuticals,food,othersuppliesandequipmentthatmaybeneededduring

emergency/disastersituations; - Communicationtoexternalentitiesiftelephonesandcomputersarenotoperating

orbecomeoverloaded(e.g.,hamradiooperators,communityofficials,otherhealthcarefacilitiesiftransferofpatientsisnecessary,etc.);

- Communicationamongstaffwithinthehospitalitself; - Qualificationsandtrainingneededbypersonnel,includinghealthcarestaff,secu-

ritystaff,andmaintenancestaff,toimplementandcarryoutemergencyprocedures;

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PE - Identification,availabilityandnotificationofpersonnelthatareneededtoimple-mentandcarryoutthehospital’semergencyplans;

- Identificationofcommunityresources,includinglinesofcommunicationandnamesandcontactinformationforcommunityemergencypreparednesscoordinatorsandresponders;

- Provisionsifgas,water,electricitysupplyisshutofftothecommunity; - Transferordischargeofpatientstohome,otherhealthcaresettings,orotherhospitals; - Transferofpatientswithhospitalequipmenttoanotherhospitalorhealthcare

setting;and - Methodstoevaluaterepairsneededandtosecurevariousmaterialsandsuppliesto

effectuaterepairs.

Surveyor Guidance: • Verifythatthehospitalhasdevelopedandimplementedacomprehensiveplantoensurethatthesafetyandwellbeingofpatientsareassuredduringemergencysituations.

Pe-5 Hazardous Materials (HaZMat) Program

Pe-5.1 The hospital shall develop and maintain a Hazardous Materials Program that addresses the management of utilization, selection, storing, handling, trans-portation, and disposition of hazardous materials and waste. The program must also address:

PE-5.1.1 The hospital shall maintain a hazardous materials and waste inventory. PE-5.1.2 The hospital shall ensure investigation and reporting of spills, exposures, and

other incidents. PE-5.1.3 The hospital shall ensure use of personal protective equipment when exposed

to hazardous materials and waste. PE-5.1.4 The hospital shall require appropriate labeling of hazardous materials and waste. PE-5.1.5 The hospital shall require exposure levels to be monitored for hospital staff in

hazardous material areas. PE-5.1.6 The hospital shall maintain all required documentation (regulations, permits,

licenses, etc.)

Pe-5.2 The hospital must have procedures for the proper routine storage and prompt disposal of trash and rubbish.

Interpretive Guidelines: • Thetermtrashorrubbishreferstocommongarbageaswellasbiohazardouswaste.Thestorageanddisposaloftrashandrubbishmustbeinaccordancewithallinterna-tionallawsandregulations.ThehandlingandstorageofradioactivematerialsshouldfollowguidelinesinaccordancewiththeInternationalAtomicEnergyAgency(IAEA)SafetyStandards.

Surveyor Guidance: • Verifythatthehospitalhasdevelopedandimplementedpoliciesfortheproperstorageanddisposaloftrash.Verifythroughobservationthatstaffadheretothesepoliciesandthatthehospitalhassignage,asappropriate.

Pe-5.3 The hospital shall meet the following requirements for the installation and use of alcohol-based hand rub dispensers.

PE-5.3.1 Use of alcohol-based hand rub dispensers does not conflict with any laws and regulations that prohibit or otherwise restrict the placement of alcohol-based hand rub dispensers in health care facilities;

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PE PE-5.3.2 The dispensers are installed in a manner that minimizes leaks and spills that could lead to falls;

PE-5.3.3 The dispensers are installed in a manner that adequately protects against inappropriate access; and

PE-5.3.4 For dispensers that are stored in corridors, the corridor must be a minimum of 1830 mm.

PE-5.3.5 The maximum individual dispenser fluid capacity shall be: PE-5.3.5.1 1.2 liters for dispensers in rooms, corridors, and areas open to corridors. PE-5.3.5.2 2.0 liters for dispensers in suites of rooms. PE-5.3.6 The dispensers shall have a minimum horizontal spacing of 1.2 m from each other. PE-5.3.7 Not more than an aggregate 37.8 liters of alcohol-based hand rub solution

shall be in use in a single smoke compartment outside of a storage cabinet. PE-5.3.8 Storage of quantities greater than 18.9 liters in a single smoke compartment

shall be metal containers, metal intermediate bulk containers, and metal portable tanks.

PE-5.3.9 The dispensers shall not be installed over or directly adjacent to an ignition source. PE-5.3.10 In locations with carpeted floor coverings, dispensers installed directly over

carpeted surfaces shall be permitted only in sprinklered smoke compartments. PE-5.3.11 Where minimum corridor width is 1830 mm, projections of a maximum 152

mm from the corridor wall, above the handrail, shall be permitted for the installation of dispensing units.

PE-5.3.12 The dispensers are maintained in accordance with dispenser manufacturer guidelines.

Pe-6 life Safety Program (fire Safety)

Pe-6.1 The hospital shall develop and follow a Life Safety Program to ensure that the life safety from fire requirements is met by implementing requirements of all applicable laws and regulations.

Interpretive Guidelines: • Applicablelawsandregulationsarerequirementsupheldbyfirecontrolagencyorauthoritythathasjurisdictionforthehospital.Ifthehospitaldoesnotrelyonaspecificfireauthority,ataminimumthefollowingLifeSafetyProgramrequirementsshallbeaddressedbythehospital.

• Locationandconstructionofallsmokecompartmentsandbarriers • Regularinspectionofdoorsanddooropeningsinsmokebarriers • Smokebarrierpenetrationsaresealedandprotected • Hazardousareashavefireratedconstruction • Measuresforexit,exitaccess,andegressareunobstructed • Emergencylightingisprovided • Exitsignsareclearlymarkedandvisible • Onefiredrillpershiftforeachquarteroftheyearisconducted • Fireextinguishersarecheckedmonthly • Thehospital,regardlessofsizeornumberofbeds,mustcomplywithrelevantrequire-

mentsofallapplicablelawsandregulationsforallinpatientcarelocations.Hospitaldepartmentsandlocationssuchasemergencydepartments,outpatientcarelocations,etc.mustcomplywithapplicablelawsandregulations.

• Relevantauthoritiesmaywaivecertainprovisionsthatwouldresultinunreasonablehardshiponthefacility,onlyifpatienthealthandsafetyarenotnegativelyaffected.

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PEPe-6.2 The hospital shall have written fire control plans that contain provisions for prompt reporting of fires; extinguishing fires; protection of patients, person-nel and guests; evacuation; and cooperation with fire fighting authorities. The written fire control plan must also address:

PE-6.2.1 Reduction of fire risks. PE-6.2.2 Detection of fire and smoke by use of alarms including their transmission to

fire department, as well as response to alarms. PE-6.2.3 Isolation, abatement of fire and smoke containment. PE-6.2.4 Evacuation procedures for proximate area and smoke compartment. PE-6.2.5 Safe and unobstructed exit from the hospital when fire emergencies occur.

Interpretive Guidelines: • Thewrittenfirecontrolplansshouldaddressandidentifyelementssuchasautomaticsprinklersystems,firealarmsystems,smokeandfirebarrierlocations,fireextin-guisheruseandinspection,smokedetectors,firepumps,firedrills,examinationofdecorationsandfurnishingsfornon-flammability.

• Thehospitalmaynotkeepinservicerollerlatchesevenwhentheserollerlatchesaredemonstratingtheabilitytokeepthedoorclosed.Ahospitalwithdoorsinservicethathaverollerlatches,wherepositivelatchingisrequired,willnotbeincomplianceandwillbecited.

Surveyor Guidance: • Reviewthehospital’swrittenfirecontrolplanstoverifyitcoversrequiredareas. • Verifythathospitalstaffreportedallfiresasrequiredtoallrequiredofficials. • Interviewstaffthroughoutthefacilitytoverifytheirknowledgeoftheirresponsibilities

duringafire. • Determineifthehospitalisutilizingrollerlatchesondoorsthatrequirepositivelatches.

Pe-6.3 The hospital must maintain written evidence of regular inspections and approval by all applicable fire control agencies.

Surveyor Guidance: • Examplesofthesereportsmayincludealternativelifesafetymeasuresduringcon-struction,locationsofsmokeandfirebarriers,firesuppressionsystems,flammablematerialsstorage,andevidenceoffiredrills.Ifthehospitaldoesnotrelyonaspecificfireauthority,thehospitalshallkeepdocumentationandreportsofself-testsandinspections.Additionalinspectionreportexamplesinclude:Inspection,maintenanceandrepairofdoors;emergencylightingfunctionaltests;firealarmtests;firedrills;portablefireextinguisherchecks;medicalgasstorage;smokealarminspectionandtesting;inspectionofsprinklersystems;generatortesting;firebrigadetrainingandevaluation;evacuationdrillreports.

• Alternativelifesafetymeasuresarehealthandsafetymeasuresthatareusedwhenahospitalisundergoingconstruction,renovations,orrepairsthatcouldaffectpatients,staff,visitors,andpersonnelinthehospital.Thesemeasuresprovideforaplantoeliminatehazardscreatedbytheconstructionactivities.Examplesofareascommonlyaffectedinclude:

- Themeansofegressthatarecheckeddaily; - Themeansofegressthatarecontinuouslymaintainedfreefromobstructionsor

impediments; - Anassessmentisperformedofworkrelatingtotheimpactontheoccupiedarea(s)

andshallbeconductedandincludeprovisionsforinfectioncontrol,utilityrequire-ments,noise,vibration,andalternatelifesafetymeasures,thattheauthorityhavinglocaljurisdictionapprovedthealternatelifesafetymeasures;

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PE - Meansofexits,emergencyevacuationplans,fireprotectionsystemsandalarms;thehospitalmustrequireandimplementalternativelifesafetymeasureswheneverthereisariskfromconstruction.

Pe-7 Medical equipment Program

Pe-7.1 The hospital shall develop and maintain a Medical Equipment Program that provides for selection, safe use, inspection, testing, and maintenance of equipment to ensure an acceptable level of safety and quality.

Pe-7.2 This program shall also address medical equipment inventory and identifica-tion, as well as an equipment alert/recall system in use. Plans must provide for initial service inspections, proper training, and demonstration of use for rental and physician owned equipment, as well as the criteria for the selec-tion of medical equipment.

Pe-7.3 There must be a regular periodical maintenance and testing program for medical devices and equipment. A qualified individual such as a clinical or biomedical engineer, or other qualified maintenance person must monitor, test, calibrate, and maintain the equipment periodically in accordance with the manufacturer’s recommendations, risk based, industry practices and/or hospital experience, and applicable laws and regulations. Equipment mainte-nance may be conducted using hospital staff, contracts, or through a combi-nation of hospital staff and contracted services.

Pe-7.4 When the organization utilizes the method of conducting a risk assessment, industry practices and/or hospital experience, regarding the testing, calibra-tion and maintenance of equipment, this process should be formalized and consistent in order to reduce malfunctions, damage or otherwise inoperable equipment. As a part of this risk assessment process to determine mainte-nance intervals that consider safety, equipment availability and service life the following should be considered:

PE-7.4.1 Consulting manufacturer recommendations. PE-7.4.2 Applicable codes and standards or accreditation requirements. PE-7.4.3 Local or reported field experience. PE-7.4.4 Health and safety information relevant to potential hazards. PE-7.4.5 Appropriate training and education of staff regarding the use of equipment. PE-7.4.6 Likelihood of an injury or illness occurring and the likely severity of any injury. PE-7.4.7 Illness resulting from the use of equipment. PE-7.4.8 Maintenance strategies described in interpretive guidelines for PE.1.

Interpretive Guidelines: • Thehospitalidentifiestheequipmentitneedstomeetitspatients’needsforbothday-to-dayoperationsandequipmentthatislikelytobeneededinlikelyemergency/disastersituationssuchasmasscasualtyeventsresultingfromnaturaldisasters,masstrauma,diseaseoutbreaks,internaldisasters,etc.;andthatthehospitalmakesadequateprovisionstoensuretheavailabilityofthatequipmentwhenneeded.

SurveyorGuidance: • Interviewthepersoninchargeofmedicalequipmentanddetermineifthereisawrittenadequaterepair/periodicalmaintenanceprogram.

• Verifythataclinicalorbiomedicalengineerroutinelychecksallmedicaldevicesandequipment.

• Reviewmaintenancelogsforsignificantmedicalequipment(e.g.,cardiacmonitors,IVinfusionpumps,ventilators,etc.).

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PE • Verifythatequipmentandsuppliesaremaintainedinamannertoensuresafety. • Verifythatequipmentandsuppliesarestoredasrecommendedbythemanufacturer. • Verifythatequipmentandsuppliesarestoredinsuchamannerasnottoendanger

patientsafety. • Verifythatthehospitalhasidentifiedequipmentandsuppliesthatarelikelytobe

neededinanemergencysituation. • Verifythatthehospitalhasmadeadequateprovisionstoensuretheavailabilityof

equipmentandsupplieswhenneeded.

Pe-8 Utility Systems Program

Pe-8.1 The hospital shall develop and maintain a Utility Systems Program that en-sures a safe and effective facility that decreases the risk for hospital acquired illness. In addition the hospital must identify critical operating components and have methods for regular maintenance, inspections, and testing for these utility systems. The hospital must have a dependable emergency power source with relevant required maintenance procedures with inspection logs.

Pe-8.2 The hospital shall have provisions for emergency gas and water supply.

Interpretive Guidelines: • Thehospitalmusthaveasystemtoprovideemergencygasandwaterasneededtoprovidecaretoinpatientsandotherpersonswhomaycometothehospitalinneedofcare.Thisincludesmakingarrangementswithlocalutilitycompaniesandothersfortheprovisionofemergencysourcesofwaterandgas.Thehospitalshouldconsidernationallyacceptedreferencesorcalculationsmadebyqualifiedstaffwhendetermin-ingtheneedforatleastwaterandgas.

• Emergencygasincludesfuelssuchaspropane,naturalgas,fueloil,liquefiednaturalgas,aswellasanygasesthehospitalusesinthecareofpatientssuchasoxygen,nitrogen,nitrousoxide,etc.

• Thehospitalshouldhaveaplantoprotecttheselimitedemergencysupplies,andhaveaplanforprioritizingtheiruseuntiladequatesuppliesareavailable.Theplanshouldalsoaddresstheeventofadisruptioninsupply(e.g.,disruptiontothesurroundingcommunity).

• Validatethehospital’sUtilitySystemtoensurethatthereisaprocessinplacetoprovideforasafeandefficientfacilitythatreducestheopportunityforhospital-ac-quiredillnesses.

Surveyor Guidance: • Reviewthesystemusedbyhospitalstafftodeterminethehospital’semergencyneedsforgasandwater.

• Verifythatthesystemaccountsfornotonlyinpatients,butalsostaffandotherpersonswhocometothehospitalinneedofcareduringemergencies.

• Determinethesourceofemergencygasandwater,boththequantityofthesesuppliesreadilyavailableatthehospital,andwhatareneededwithinashorttimethroughadditionaldeliveries.

• Verifythatarrangementshavebeenmadewithutilitycompaniesandothersfortheprovisionofemergencysourcesofcriticalutilities,suchaswaterandgas.

Pe-8.3 There shall be emergency power and lighting in at least the operating, recovery, intensive care, and emergency rooms, and stairwells. In all other areas not serviced by the emergency supply source, battery lamps and flashlights must be available.

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PEInterpretative Guidelines: • Thehospitalmustperiodicallytestandinspectemergencypowerandlightinginthe

operating,recovery,intensivecare,emergencyrooms,andstairwells,aswellasothercriticalareas.

• Batterylampsandflashlightsmustbeprovidedforareaswithoutemergencypowersources. • Thehospitalmustreplace1-hourbatterieswith1½-hourbatteriesinemergencylight-

ingsystemsthatusebatteriesaspowersources.

Pe-8.4 There shall be proper ventilation, light, and temperature controls in pharma-ceutical, food preparation, laboratory, and other appropriate areas.

Interpretative Guidelines: • Theremustbeproperventilationinatleastthefollowingareas: - Areasusingethyleneoxide,nitrousoxide,guteraldehydes,xylene,pentamidine,or

otherpotentiallyhazardoussubstances; - Locationswhereoxygenistransferredfromonecontainertoanother; - Isolationroomsandreverseisolationrooms(bothmustbeincompliancewith

applicableregulations,andguidelines); - Pharmaceuticalpreparationareas(hoods,cabinets,etc.);andlaboratorylocations. - Theremustbeadequatelightinginallthepatientcareareas,andfoodandmedica-

tionpreparationareas. - Temperature,humidityandairflowintheoperatingtheatremustbemaintained

withinacceptablestandardstoinhibitbacterialgrowthandpreventinfection,andpromotepatientcomfort.

◦ Excessivehumidityintheoperatingtheatreisconducivetobacterialgrowthandcompromisestheintegrityofwrappedsterileinstrumentsandsupplies.

◦ Eachoperatingtheatreshouldhaveseparatetemperaturecontrol. • Thehospitalmustensurethatanappropriatenumberofrefrigeratorsand/orheating

devicesareprovidedandensurethatfoodandpharmaceuticalsarestoredproperlyandinaccordancewithnationallyacceptedguidelines(food)andmanufacturer’srecommendations(pharmaceuticals).

Surveyor Guidance: • Verifythatallfoodandmedicationpreparationareaarewelllighted. • Verifythatthehospitalisincompliancewithventilationrequirementsforpatientswithcon-

tagiousairbornediseases,suchastuberculosis,patientsreceivingtreatmentswithhazard-ouschemical,surgicalareas,andotherareaswherehazardousmaterialsarestored.

• Verifythatfoodproductsarestoredunderappropriateconditions(e.g.,time,tempera-ture,packaging,location)basedonapplicablelawsandregulations.

• Verifythatpharmaceuticalsarestoredattemperaturesrecommendedbytheproductmanufacturer.

• Verifythateachoperatingtheatrehastemperatureandhumiditycontrolmechanisms. • Reviewtemperatureandhumiditytrackinglog(s)toensurethatappropriatetempera-

tureandhumiditylevelsaremaintained.

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human resources/ staff administration

Hr-1 ProfeSSIonal PraCtICe SCoPe All staff, including contract staff, students, contractors and volunteers shall function within the limits of their scope of service as defined by their professional practice act, regulatory body, Ministry of Health, Medical Chamber or Nursing Chamber and/or organization policy at all times. This policy shall be strictly enforced and variations reported to Quality Management Oversight group.

Surveyor Guidance: • Reviewthepolicyandverifythatthehealthcareorganizationhasameansofensuringthatallstaff,includingcontractstaff,students,contractorsandvolunteersarefunc-tioningwithinthelimitsoftheirscopeofserviceasithasbeendefinedbythehealth-careorganization,MinistryofHealth,MedicalChamber,NursingChamberandrespectiveprofessionalpracticeactsandregulatorylaw.

• VerifytheprocessforcommunicatinganyvariationstotheQualityManagementOversightgroup.

Hr-2 dePartMental SCoPe of SerVICe All departments, clinical and non-clinical, including each patient unit and ward shall have a written scope of service that includes at least:

• Thehoursofoperation; • TypeofPatienttreated; • TypeofProfessionalsutilizedwithindepartment; • Methodsfordeterminingandmodifyingstaffingtomeetpatientorprocess

needs; • Descriptionofassessmentandreassessmentpracticeswithinthedepart-

ment, including timeframes. • TheOrganizationalpolicieswillidentifyhowoftenandunderwhatcircum-

stances each department’s scope of service must be reviewed and/or updated. (i.e. if a new service is added or discontinued, change of type of patient served, etc.)

Interpretive Guidelines: • Thehealthcareorganizationwillhaveadescriptionofthedepartmentscopeofservicesprovided,whetherclinical,non-clinicaland/orsupportive,andeachpatientwardorpatientunit.Thisdepartmentalscopeofservicewilladdressthefollowing:

- Thehoursofoperation; - Typeofpatienttreated; - Typeofprofessionalsutilizedwithindepartment; - Methodsfordeterminingandmodifyingstaffingtomeetpatientorprocessneeds;

and, - Descriptionofassessmentandreassessmentpracticeswithinthedepartment,

includingtimeframes.

Surveyor Guidance: • Verifythatthehealthcareorganizationhasadescriptionofthescopeofservicesprovidedforallservicesincludingclinical,non-clinicaland/orsupportive,includingeachpatientwardandpatientunit.Verifythatthedepartmentalscopesofserviceincludetheitemslistedabove.Reviewthedocumentsand/orflowchartsthatdescribethesequenceandinteractionoftheseprocessesorservices.

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Hr-3 JoB deSCrIPtIon All staff, whether clinical, non-clinical and/or supportive, including contract staff, students and volunteers shall have a current job description/responsibilities available that contains the experience, educational and physical requirements, supervision and performance expectations for that position.

Surveyor Guidance: • Reviewandverifyasamplingofjobdescriptionstoverifythatthehealthcarefacilityhasidentifiedtherequiredexperience,educationalandphysicalrequirementsandperformanceexpectationsforthepositionsreviewed.Thisincludesanycontractedstafffornursingand/orotherareasoftheorganization.

Hr-4 orIentatIon All staff, whether clinical, non-clinical or supportive, including contract staff, students, contractors and volunteers shall receive an orientation to specific job duties and responsibilities, and their work environment, as required by Ministry of Health, local and national regulations and the healthcare facility. The orientation shall take place prior to the individual functioning independently in their job.

Hr-4.1 Members of the medical staff will receive an orientation developed and approved by the healthcare facility that includes general safety practices, emergency procedures, infection control, confidentiality and other issues as required by the Ministry of Health or the healthcare facility.

Interpretive Guidelines: • Thehealthcarefacilitywillrequirethatallstaff,includingcontractstaff,students,contractorsandvolunteersreceiveanorientationpriortoworkingindependentlyintheirrespectiverolesforthehealthcarefacility.

• Theorientationwilladdress,ataminimum,thefollowingtopics: - Organizationalstructure; - Patientconfidentialityandethics; - Documentcontrol,retrievalandverification(specifictopolicies,procedures,and

workinstructions/protocols); - Internalreportingrequirementsforadversepatientevents; - Patientsafety; - Generalsafety(workenvironment); - Emergencyprocedures; - Infectioncontrolanduniversalprecautions;and, - Otherissuesasrequiredbythehealthcarefacility,MinistryofHealthandlocallaw

andregulations.Orientationtospecificjobdutiesmaybeaddressedwithinthedepartmentorservicewheretheemployeeisassigned,butcompletedpriortotheemployeeworkingindependently.VerifytheprocessinplaceformembersofthemedicalstaffcompletingageneralorientationasnotedwithinHR-4.

Hr-5 Staff eValUatIonS The performance/competency evaluation for staff shall contain indicators that will objectively measure the ability of staff to perform all job duties as outlined in the job description.

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Hr-5.1 The staff shall be evaluated initially and on an on-going basis against indica-tors that measure issues and opportunities for improvement. The measures selected may be considered from the following:

• Variationsand/orproblemprocessesidentifiedthroughtheanalysisofmeasured outcomes as required by the Quality Management System;

• High-risk,lowvolumeprocedures; • Newtechnology/equipment/processes; • Customersatisfactionfeedback; • Scheduledtrainingsessionoutcomes; • Staffassessmentsthatincludevariationsidentifiedthroughpriorstaff

performance measurement; • Stafffeedback; • Medicalstafffeedback;and, • RequirementsofMinistryofHealthandorotherapplicablelocallawsor

requirements; • Otherindicatorsasdeterminedbytheorganization

Hr-5.2 Measurements for contract staff may be modified based on organization out-comes and frequency of service of individuals. Modification of thismeasurement(s) will be made when needed and shall be justified by data analysis.

Hr-5.3 The organization shall collect objective performance data from sources that may include; individual evaluations, incident reports, risk management, staff and patient feedback, and/or data analysis to identify variations for further training, coaching, and mentoring.

Hr-5.4 Reassessment of objective data shall follow any intervention.

Hr-5.5 The outcomes of this aggregated data will be reported to Quality Manage-mentOversight as needed to monitor staff performance improvement.

Hr-5.6 The organization shall have a policy and procedure for sharing results of individual performance evaluations/competence assessment with staff members that allows for staff feedback within a timeframe defined by the organization, not to exceed one calendar year.

Hr-5.7 The organization shall require each staff member, including contract staff, to participate in continuing education as required by individual licensure/certifica-tion, professional association, law or regulation, or organization policy. Compli-ance with this standard shall be reported to the Quality Management group.

Interpretive Guidelines: • Thehealthcareorganizationmustcontinuallyevaluatetheperformance/competencyofstaff.Thisprocessofevaluationmustincludetheuseofindicatorsthatwillobjectivelymeasuretheabilityofstafftoperformalljobdutiesasoutlinedinthejobdescription.Theseindicatorsmayaddressoneormoreofthefollowing:

- Variationsand/orproblemprocessesidentifiedthroughtheanalysisofoutcomesmeasurementasrequiredbytheQualityManagementSystem;

- High-risk,lowvolumeprocedures; - Newtechnology/equipment/processes; - Customersatisfactionfeedback; - Scheduledtrainingsessionoutcomes;

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- Staffassessmentsthatincludevariationsidentifiedthroughpriorstaffperformancemeasurement;

- Stafffeedback; - Medicalstafffeedback;and, - RequirementsoftheMinistryofHealth,localapplicablelawsandregulationsand

otherorganizationsrecognizedbythehealthcarefacility.Theorganizationwillhaveapolicyandprocedureforsharingresultsofindividualperformanceevalua-tions/competenceassessmentwithstaffmembersthatallowsforstafffeedbackwithinatimeframedefinedbytheorganization,nottoexceedonecalendaryear.Thehealthcareorganizationmaymodifymeasurementsforcontractstaffbasedonorganizationoutcomesandfrequencyofserviceoftheindividuals.Thismeasurementmodificationwillbemadewhenneededandshallbejustifiedbydataanalysis.Theorganizationshallcollectandanalyzetheobjectiveperformancedatafromsourcesthatmayinclude;individualevaluations,incidentreports,riskmanagement,staffandpatientfeedback,and/ordataanalysistoidentifyvariationsforfurthertraining,coaching,andmentoring.Inordertocontinuallyimprovethefulfillmentoftheirjobresponsibilities,theorganizationshallrequireeachstaffmember,includingcontractstaff,toparticipateincontinuingeducationasrequiredbyindividuallicensure/certification,professionalassociation,laworregulation,orthehealthcareorganizationpolicy.

Surveyor Guidance: • Inasamplingofpersonnelrecords,verifythatthehealthcarefacilityhasaperfor-mance/competencyevaluationprocessthatincludesappropriatemeasuresasstatedwithintheStandard’sInterpretiveGuidelines.

• Verifythepolicyandpracticethehealthcarefacilityusestovalidatethecompetencyofstaffoccurswithinaspecifiedtimeframenolessthanoncepercalendaryear.

• Verifythepolicyandpracticethattheorganizationusestomeasurecontractstaffperformanceisbaseduponoutcomesandfrequencyofservice.

• Verifythatthehealthcarefacilityrequiresandmakesprovisionsforeachstaffmem-ber,includingcontractstaff,toparticipateincontinuingeducationasrequiredbyindividuallicensure/certification,professionalassociation,laworregulation,orthehealthcareorganizationpolicy.