clinical laboratory accreditation standards only (pdf)

2nd Edition

JOINT COMMISSION INTERNATIONAL

ACCREDITATION STANDARDS FOR

CliniCAl lAborAtoriEs

Effective

1 April 2010

International Patient SafetyGoals (IPSG)

Goals

The following is a list of all goals. They are presented here for your convenience without their requirements,intent statements, or measurable elements. For more information about these goals, please see the next sectionin this chapter, “Goals, Standards, Intents, and Measurable Elements.”

IPSG.1 Identify Patients Correctly

IPSG.2 Improve Effective Communication

IPSG.3 Not applicable for laboratories

IPSG.4 Ensure Correct-Site, Correct-Procedure, Correct-Patient Surgery

IPSG.5 Reduce the Risk of Health Care–Associated Infections

IPSG.6 Not applicable for laboratories

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Management andLeadership (MGT)

Standards

The following is a list of all standards. They are presented here for your convenience without their require-ments, intent statements, or measurable elements. For more information about these standards, please see thenext section in this chapter, “Standards, Intents, and Measurable Elements.”

Planning MGT.1 The leaders are responsible for laboratory planning.

MGT.1.1 The leaders plan the type and scope of services to be provided after communicatingwith customers regarding their needs.

Contract and Reference Laboratory Services

MGT.1.2 The laboratory director and other leaders define the process for selecting and approving contractand reference laboratory services, including services that provide blood and blood products.

Contract Laboratory Services

MGT.1.2.1 The laboratory director is responsible for assuring the consistent per-formance of contract laboratory services.

Reference Laboratory Services

MGT.1.2.2 The laboratory director is responsible for assuring the consistent per-formance of reference laboratory services.

Resource Planning

MGT.1.3 The leaders are responsible for providing adequate resources for the provision ofplanned laboratory services.

Responsibility and AuthorityMGT.2 Responsibilities for administrative direction and clinical direction of the laboratory are defined in

writing. In addition, other leadership roles are also defined.

MGT.2.1 The directorship of the laboratory is effective.

MGT.2.2 The laboratory director is responsible for requiring practices that respect the needs ofpatients and other customers.

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Communication and Coordination MGT.3 Laboratory leaders provide for communication and coordination throughout the laboratory and

with outside customers.

MGT.3.1 Leaders communicate to laboratory staff the priority of meeting the needs of clinicians,patients, and other users of laboratory services.

MGT.3.2 Necessary policies are developed for communicating with clinicians who order tests.

Quality Management and Improvement Process

Planning and Coordination of the Quality Management and Improvement Program

MGT.4 Laboratory leaders are responsible for planning, documenting, implementing, and monitoring aquality management and improvement program.

MGT.4.1 The laboratory’s program for process design and quality measurement, analysis, andimprovement is systematic and addresses • the goals of the quality management and improvement system; • all of the quality management and improvement system’s components; • the methodology used to measure and improve processes and services; and • the systems used for quality control of laboratory testing and other services.

MGT.4.1.1 Laboratory leaders ensure that the program is coordinated and an appro-priate individual(s) is appointed to implement and manage the process.

MGT.4.1.2 The leaders assign adequate resources to quality management andimprovement activities.

MGT.4.1.3 Leaders communicate the key elements of the quality management andimprovement program to employees.

MGT.4.1.4 The leaders define performance and quality control activities used tomonitor the laboratory’s processes and the systems used to ensure properoperation and control of these processes.

Design of New Processes

MGT.4.1.5 The laboratory designs new and redesigns existing systems and processesaccording to quality improvement principles.

MGT.4.1.6 The leaders prioritize which processes are to be measured and whichimprovement activities will be implemented.

Data Collection for Quality Measurement

MGT.4.2 The laboratory’s leaders identify key measures (indicators) to measure clinical and man-agerial structures, processes, and outcomes.

MGT.4.2.1 Quality measurement includes those aspects of the following that areselected by leaders:a) The laboratory’s safety and infection control programsb) The laboratory’s quality control programsc) Preanalytic processes, including

• patient preparation;• specimen quality processes (collection, labeling, preservation,

transportation, and rejection); and• completeness of requisitions.

JOINT COMMISSION INTERNATIONAL ACCREDITATION STANDARDS FOR CLINICAL LABORATORIES, SECOND EDITION

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MANAGEMENT AND LEADERSHIP (MGT)

d) Postanalytic processes, including• efficient transfer of information;• timeliness of reporting test results;• adequacy of documentation; and• accuracy of reports.

MGT.4.2.2 Managerial measurement includes aspects of the following that are select-ed by leaders:a) The needs, expectations, and satisfaction of individuals and organi-

zations servedb) The appropriateness of tests offeredc) Key aspects of the procurement of routinely required supplies and

equipment essential to provide laboratory servicesd) Those aspects of laboratory employee expectations and satisfaction

selected by the leaderse) Those aspects of financial management selected by the leadersf ) Those aspects of the prevention and control of events that jeopard-

ize the safety of patients, families, and staff selected by the leaders,including the International Patient Safety Goals

Analysis of Measurement Data

MGT.4.3 Individuals with appropriate experience, knowledge, and skills systematically aggregateand analyze data in the laboratory.

MGT.4.4 The frequency of data analysis is appropriate to the process being studied and meetslaboratory requirements.

MGT.4.5 The analysis process includes comparisons internally, with other laboratories when avail-able, and with published scientific standards and desirable practices.

MGT.4.6 Data are analyzed when undesirable trends and variation are evident from the data.

Improvement

MGT.4.7 Improvement in quality and safety is achieved and sustained.

MGT.4.8 Improvement and safety activities are undertaken for the priority areas identified by thelaboratory’s leaders.

MGT.4.9 An ongoing program of identifying and reducing unanticipated adverse events and safe-ty risks to patients and staff is defined and implemented.

Quality Management and Improvement Program Review

MGT.4.10 Leaders manage the quality and improvement process and periodically review the effec-tiveness, adequacy, and relevance of the monitoring and improvement activities.

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Development andControl of Policies andProcedures (DCP)

Standards

The following is a list of all standards. They are presented here for your convenience, without their require-ments, intent statements, or measurable elements. For more information about these standards, please see thenext section in this chapter, “Standards, Intents, and Measurable Elements.”

DCP.1 The requirements for developing and maintaining the laboratory’s policies and procedures aredefined in a written protocol.

Preanalytic Policies and ProceduresDCP.2 Procedures for ordering tests are defined in writing.

DCP.2.1 Policies and procedures are developed to provide step-by-step specimen collection pro-tocols for each type of specimen submitted to the laboratory.

DCP.2.2 Policies and procedures are developed to guide how specimens are accessioned andprocessed in the laboratory.

Analytic Policies and ProceduresDCP.3 The laboratory has current written descriptions and instructions for performing test methods and

procedures.

Postanalytic Policies and ProceduresDCP.4 The laboratory develops policies, procedures, and controls for the postexamination processes.

DCP.4.1 The laboratory has defined a process for immediate notification of the responsible clini-cian when specific critical results indicate that the patient’s situation is life-threatening.

DCP.4.2 The laboratory has defined the process of measuring turnaround times.

DCP.4.3 The laboratory has a defined process for correcting reported results.

Record and Specimen Retention RequirementsDCP.5 A written protocol defines the storage and maintenance requirements for records, including

retained specimens, slides, tissues, and blocks.

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Resource Managementand LaboratoryEnvironment (RSM)

Standards


Provision of Resources RSM.1 The leaders provide sufficient resources to support the ongoing, uninterrupted operation of the

laboratory.

Human Resources

RSM.1.1 Personnel policies and procedures are described in writing and are followed.

Staff Qualifications

RSM.1.2 Pathology and clinical laboratory services are directed by one or more qualifiedprofessionals.

RSM.1.3 Supervisory staff and other leaders have the appropriate training and expertise to per-form all responsibilities.

RSM.1.4 The director of the laboratory provides an adequate number of qualified staff.

Staff Orientation and Education

RSM.1.5 All new staff members are oriented to the organization and the laboratory area(s) wherethey are assigned, as well as to their specific job responsibilities.

RSM.1.6 In-service or other education and training maintain and improve staff competence.

Competence Assessment and Performance Evaluation

RSM.1.7 Following orientation and/or training, and periodically thereafter, the competence ofeach staff member to perform assigned tasks is assessed.

Documented Personnel InformationRSM.2 Documented personnel information is maintained for each staff member.

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Infrastructure—Basic Facilities RSM.3 Laboratory leaders have planned for basic facilities, including adequate space, utilities, and

equipment.

Laboratory Space

RSM.3.1 There is sufficient space for all areas under control of the laboratory. The laboratoryleaders have planned and provided for appropriate space for all laboratory areas.

RSM.3.1.1 Spaces for specific laboratory areas are adequate.

Utilities Management

RSM.3.2 A plan for providing and maintaining necessary utilities is defined and implemented.

RSM.3.2.1 There is a system to inspect, test, and maintain critical operating compo-nents for utility systems and to investigate and correct utility systemproblems.

Laboratory Equipment and Other Materials RMS.4 Laboratory leaders ensure that analytic and other equipment, as well as other material resources

required for the provision of services, are adequate, appropriate, and available.

RSM.4.1 Laboratory equipment is maintained, tested, and inspected.

RSM.4.1.1 A historical record is maintained for each analytical instrument and pieceof equipment used by the laboratory.

RSM.4.2 Maintenance and inspection ensure that equipment is safe.

RSM.4.3 There are defined processes in place for validating and maintaining computer softwareand information, when they are used by the laboratory.

Reagents and Other Supplies

RSM.4.4 The laboratory follows written guidelines for the periodic evaluation of all reagents,including water, to provide for accuracy and precision of results.

RSM.4.5 Laboratory records include documentation of required information for reagents, andreagents are completely and accurately labeled.

Safety and SecurityRSM.5 There is a plan to ensure that laboratory services and facilities are secure.

Hazardous Materials and WasteRSM.6 The laboratory has a plan for inventory, handling, storage, and use of hazardous materials and the

control and disposal of hazardous waste.

RSM.6.1 The laboratory uses a coordinated process to reduce the risks of infection as a result ofexposure to biohazardous materials and waste.

RSM.6.2 The laboratory follows defined guidelines for handling and disposing of hazardouschemicals and waste (including chemotherapeutic materials and waste).

RSM.6.3 If radioactive materials are used in the laboratory, there are processes for safe handlingand monitoring of them.


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RESOURCE MANAGEMENT AND LABORATORY ENVIRONMENT (RSM)

Work Environment—Laboratory Safety

RSM.7 The laboratory designs a safe, accessible, effective, and efficient environment consistent with itsmission, services, and law and regulation.

RSM.7.1 Laboratory leaders address fire safety.

RSM.7.1.1 The laboratory conducts fire drills regularly.

RSM.7.2 Adequate safety devices and equipment are provided.

RSM.7.3 When a laboratory performs electron microscopy, the laboratory has processes to ensuresafety and quality.


Quality ControlProcesses (QCP)

Standards


Quality Control Common to All Areas of TestingQCP.1 Quality control processes are established for each test method, and data from these processes are

available and used to monitor and ensure the stability of test systems.

QCP.1.1 The laboratory has a program of external graded interlaboratory comparison testing orproficiency testing for analytes for each specialty and subspecialty for which such testingis available.

QCP.1.1.1 Proficiency sample testing is performed in the same manner as patientsample testing.

QCP.1.1.2 The laboratory uses a system for verifying the accuracy and reliability oftest results obtained for those tests not included in the formal proficiencytesting program.

QCP.1.2 The laboratory uses a system to evaluate and correlate the relationship between results forthe same test performed with different methodologies or instruments or at different sites.

QCP.1.3 The laboratory performs initial validation for new instruments and analytical systems toverify that the method(s) will produce accurate and reliable results.

QCP.1.4 The laboratory validates electronic or internal monitoring systems prior to using themfor routine quality control.

QCP.1.5 Calibration, linearity checks, and other function checks are performed on instrumentsand analytic systems used for patient testing.

QCP.1.6 The quality control processes of the laboratory include a coordinated review of patientresults, quality control results, and instrument function checks.

QCP.1.7 The laboratory takes remedial action for deficiencies identified through quality controlmeasures or authorized inspections and documents such actions.

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Specialty Quality Control

Histopathology

QCP.2 There are quality control processes in place for surgical pathology and autopsy services.

QCP.2.1 The laboratory has implemented processes for ensuring the proper identification,preservation, and documentation of receipt of surgical specimens sent for analysis.

QCP.2.1.1 When immunohistochemistry is performed, the laboratory has appropri-ate quality control processes.

QCP.2.2 The laboratory implements quality control and assurance processes for evaluating theongoing qualifications of individuals who perform gross analysis of tissue and micro-scopic analysis of tissue.

QCP.2.3 There are defined processes to document the ongoing proficiency of individuals whoperform microscopic analysis of tissue.

QCP.2.4 The laboratory has implemented processes to ensure access to required patient informa-tion and to cross-reference such information to assist in providing a complete and prop-er diagnosis.

Cytopathology

QCP.3 A pathologist or physician qualified in cytology maintains the quality of the cytopathology servicethrough direct supervision.

QCP.3.1 The cytology laboratory has a process to measure, assess, and improve quality.

Clinical Laboratory Testing

Clinical Chemistry, Hematology, and Coagulation

QCP.4 The laboratory leaders have defined quality control processes for all clinical chemistry, hematology,and coagulation tests.

QCP.4.1 For tests that produce quantitative results (such as many clinical chemistry, hematology,and coagulation analyses), laboratory quality meets certain requirements. The laborato-ry defines and follows certain quality control guidelines.

QCP.4.2 The laboratory has quality control processes in place for blood film evaluation and dif-ferential counts.

Microbiology

QCP.5 The laboratory has quality control processes when performing bacteriology, mycobacteriology, and mycology.

QCP.5.1 Antimicrobial, antimycobacterial, and antifungal susceptibility testing systems are veri-fied with approved reference organisms.

QCP.5.2 All stains are tested with appropriate controls.

Molecular Microbiology Testing

QCP.5.3 There are adequate quality control procedures when molecular microbiology testing isperformed.


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QUALITY CONTROL PROCESSES (QCP)

Parasitology

QCP.6 If the laboratory is performing parasitology, appropriate reference materials, equipment, and meth-ods are used.

Virology

QCP.7 If the laboratory performs tests for identifying viruses, records detailing the systems used and thereactions observed are maintained.

QCP.7.1 The laboratory uses controls that will identify erroneous results in tests for identifyingviruses.

Urinalysis and Clinical Microscopy

QCP.8 The laboratory ensures the quality of tests performed in urinalysis and clinical microscopy.

Diagnostic Immunology and Serology

QCP.9 The laboratory runs serologic tests on unknown specimens, including those for syphilis, concur-rently with a positive control serum of known titer and a negative control, or controls of gradedreactivity, to ensure specificity of antigen reactivity.

QCP.9.1 Equipment, glassware, reagents, controls, and techniques for syphilis tests conform tomanufacturers’ specifications.

Radiobioassay and Other Tests Using Radioisotopes

QCP.10 The laboratory uses written quality control procedures that provide diagnostic reliability andpatient and staff safety when it uses in vitro radioisotopes.

QCP.10.1 Any laboratory performing in vivo testing uses an appropriate quality control system forsuch testing and equipment performance checks.

Blood Bank and Transfusion Services

Director Responsibility

QCP.11 The director of the blood bank or transfusion services is responsible for developing policies andprocedures and implementing practices that ensure the safety of patients being transfused.

Donor Selection and Testing

QCP.11.1 There are defined procedures and practices for blood donor selection and blood collec-tion. Staff are trained and assessed as competent to perform these procedures.

QCP.11.1.1 A detailed history of a donor is performed prior to selection for blooddonation.

QCP.11.1.2 An adequate physical examination is performed prior to approving theindividual as a blood donor.

QCP.11.1.3 Donor blood is collected safely and aseptically according to a definedprotocol.

QCP.11.1.4 Written guidelines are implemented when autologous blood is collected.

QCP.11.2 Blood and related donor records are properly identified, and the identification is main-tained from collection through the time the unit is transfused.


QCP.11.3 Donor blood undergoes routine testing before being used for transfusion. In addition,process controls are used to ensure appropriate tracking and prevent blood from beingreleased prematurely.

Blood Component Preparation or Modification

QCP.11.4 When components are prepared or modified by the organization, there are defined procedures for their processing and storage, and appropriate quality control measuresare taken.

Whole Blood

QCP.11.4.1 Tests and processes are used to maintain the quality of whole blood. Thisincludes whole blood from which components and products are to beprocessed.

Red Blood Cells

QCP.11.4.2 Defined processes are implemented to maintain the quality of red bloodcells.

Platelets

QCP.11.4.3 Defined processes are used to ensure the quality of platelets.

Plasma

QCP.11.4.4 Defined processes are used to ensure the quality of plasma.

Cryoprecipitated AHF

QCP.11.4.5 Defined processes are used to ensure the quality of cryoprecipitated AHF.

Blood and Component Storage Requirements (for Donor Facility and BloodTransfusion Services)

QCP.11.5 The blood bank director ensures that blood and components are stored in a secure andappropriate fashion in order to prevent damage or deterioration.

QCP.11.5.1 Storage areas used for blood and components are appropriate for the vol-ume and variety of components stored.

QCP.11.5.2 Storage areas for blood and components are monitored to ensure thatappropriate temperatures are maintained.

QCP.11.6 The laboratory maintains identification and traceability of specimens; reagents; testresults; and blood, blood components, and products.

Blood Transfusion Services

Testing of Blood Prior to Transfusion

QCP.11.7 The laboratory tests donor blood and recipient blood with potent typing sera and ade-quately reactive cells of a known type to determine the correct ABO blood group andRh type.

QCP.11.7.1 The potency and reliability of reagents used for ABO grouping, Rh typ-ing, antibody detection, and compatibility determinations are tested forreactivity.


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QUALITY CONTROL PROCESSES (QCP)

QCP.11.8 Before blood is administered, appropriate compatibility testing and antibody testing(except in an emergency) are performed. In addition, other procedural controls areimplemented.

Selecting Blood and Components for Transfusion

QCP.11.9 Specific procedures are followed when selecting blood and components for transfusion.

Blood Issuance and Transfusion

QCP.11.10The director of the blood transfusion services provides policies and procedures to guideacceptable practices for blood and component transfusion.

QCP.11.10.1 There are defined processes for checking blood out of the blood bankbefore transfusion.

QCP.11.10.2 Specific policies and practices are required before and during bloodadministration.

Recognizing Suspected Transfusion Reactions

QCP.11.10.3 The director has defined criteria for recognition of transfusion reactions,as well as steps to take when symptoms occur.

Blood Donor and Transfusion Services Record Requirements

QCP.11.11When the laboratory draws donor blood, prepares blood components, stores bloodand/or components, and/or issues blood for transfusion, there are specific records thatmust be maintained.

Histocompatibility Testing

QCP.12 When performing histocompatibility testing, the laboratory uses appropriate screening techniquesfor donors and recipients.

QCP.12.1 The laboratory performs mixed lymphocyte cultures or other recognized methods todetect cellular-defined antigens according to defined methods.

QCP.12.2 The laboratory performs HLA serologic typing of both donor and recipient, as appro-priate to the study or individual procedure performed.

QCP.12.3 Before transplantation is performed, the laboratory crossmatches potential recipientsand donors using the most reactive and recent sera, as appropriate to the study or indi-vidual procedure performed.

QCP.12.4 The laboratory uses reagents and antisera that are specific and verified with appropriatecontrols, when available.

QCP.12.5 The laboratory participates in at least one national or regional cell-exchange program, ifavailable, or develops an exchange system with another laboratory to validate interlabo-ratory reproducibility.

QCP.12.6 Storage of records and specimens is addressed.

Cytogenetics Testing

QCP.13 Laboratory procedures and practices in cytogenetics provide for accurate results.


QCP.13.1 Laboratory records identify the media used, the reactions observed, and the details ofeach step of the identification procedure.

QCP.13.2 The laboratory obtains and includes in the interpretative report all required clinicalinformation.

QCP.13.3 The laboratory maintains individual sample identification during all phases of testingand reporting.

Molecular Testing

QCP.14 The laboratory follows written policies and procedures for molecular testing.

QCP.14.1 Validation studies include representatives from each specimen type expected to be testedin the assay and specimens representing the scope of reportable results.

QCP.14.2 The laboratory establishes quality control limits, reference ranges, and reportable ranges.

QCP.14.3 The laboratory verifies each test run of patient samples in molecular pathology, usingquality controls.

QCP.14.4 Molecular testing reports include specific testing information.

Molecular Genetics

QCP.14.5 The laboratory follows written policies and procedures for molecular genetic testing.

QCP.14.6 Molecular genetic testing reports include specific testing information.


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