department of health and human services · sop”), which is further described below. for purposes...

FORM CMS-2567 (02-99) Previous Versions Obsolete Event ID: NVYT12 Facility ID: TNP53127 If continuation sheet of 330

DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES

PRINTED: 12/10/2018 FORM APPROVED

OMB NO. 0938-0391 STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION

(X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER:

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(X2) MULTIPLE CONSTRUCTION A. BUILDING _____________________ B. WING _____________________

(X3) DATE SURVEY COMPLETED

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NAME OF PROVIDER OR SUPPLIER VANDERBILT UNIVERSITY MEDICAL CENTER

STREET ADDRESS, CITY, STATE, ZIP CODE

1211 MEDICAL CENTER DRIVE NASHVILLE, TN 37232

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Correction and is conducting monitoring and auditing as described herein to ensure ongoing compliance. Immediately following the survey, the Hospital reviewed existing policies and procedures to determine whether revisions and/or new policies were required. Although numerous policies are in place to meet the requirements of 42 CFR §482.13 and address the cited deficiency, the Hospital made updates to select policies and procedures applicable to medication administration. The updates to policies and procedures are also discussed in detail in response to Tags A 144 and A 145, below. The Hospital has reviewed its policies and procedures related to monitoring of patients during and after medication administration and made the following changes:

• The Hospital has revised its policy previously titled Transport of the Critically Ill Patient, which revisions were approved on November 27, 2018, to broaden application of the policy beyond critically ill patients. As such, the newly amended policy is titled “Transport of Patients” (hereinafter, “Transport Policy”). This policy provides that every patient shall be transported with equipment, supplies, and staff appropriate to monitor and support the patient’s physiological needs. Physiological “needs” in the context of this statement refers to a patient’s medical requirements, based on the patient’s current

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clinical condition and clinical course of treatment as determined by the multidisciplinary healthcare team. An example would include a patient with provider-ordered cardiac telemetry monitoring would be transported with the monitor unless there is an order stating otherwise. The policy details that the level of care is maintained during transport and after arrival at the receiving department/unit, and describes specific monitoring and documentation requirements. The amended policy states that when a patient requires continuous monitoring, a clinical staff member is required to be available to receive handover of the patient pursuant to the Hospital’s CL SOP - Clinical Handover Communication procedure. Any such handover will be documented in the medical record. In the event a clinical staff member is not available to receive the patient, the transporting clinical staff member must remain with the patient. Further, the Transport Policy states that patients receiving medications that could lead to respiratory depression and/or respiratory distress are monitored during and after transport, with the duration and frequency of the monitoring to be based on the patient’s condition, type of medication, and route. Documentation will be in accordance with VUMC’s Medication Administration Policy.






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The Transport Policy further states that such monitoring may include, but is not limited to, direct observation, vital signs, and neuro checks. The revised Transport Policy further requires appropriate documentation to be completed in the patient’s medical record upon leaving and returning to the unit, including the times the patient leaves and returns to the unit. The clinical staff members who may transport patients include RNs, paramedics and other clinical staff as outlined in the Transport Policy and associated Standard Operating Procedure entitled “Transport of Patients Receiving Medications That May Cause Impaired Consciousness or Undesired Changes in Vital Signs” (“Transport SOP”), which is further described below. For purposes of transport of patients, staff appropriate to monitor and support the patient’s physiological needs is determined based on the patient’s current clinical condition. Further, a non-clinical staff member may transport a patient in the event a patient’s physiological needs do not require monitoring or support pursuant to the Transport Policy and Transport SOP, Medication Administration Policy, or High Alert Medication Policy. In December 2018, the Hospital adopted the Transport SOP, which sets forth specific parameters for transport of adult patients in Vanderbilt University

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Hospital that have received medication that may cause impaired consciousness or undesired changes in vital signs, other than critically ill patients who are addressed in the Transport Policy. The SOP was amended in January 2019 and provides as follows in regard to staff members who may transport patients:

• An RN/paramedic accompanies the

patient being transported when: IV medication has been

administered within the past 30 minutes for minimal sedation/anxiolysis in preparation for a procedure/test. Patient is monitored utilizing pulse oximeter during transport and until patient returns to baseline neurocognitive status, maintaining consistent level of care for patients while off the unit.

New IV analgesic or sedative medication (e.g., benzodiazepine, opioid) has been administered within the past 30 minutes.

Patient is on PCA/epidural/continuous controlled substance infusion with a change in medication, dose, concentration, or rate of administration within the last hour, maintaining consistency

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with MM SOP - Patient-Controlled Analgesia (PCA) and Continuous Controlled Substance Infusion: Administration and Management.

Patient is receiving cardiac/telemetry monitoring. A RN/paramedic trained in basic arrhythmia accompanies the patient during transport and throughout the procedure/test unless it is confirmed that monitoring can be maintained by a qualified telemetry technician.

Patient needs observation based on the criteria above or RN/Paramedic judgement and there is not a RN/Paramedic to receive and observe the patient during testing or procedure. RN/Paramedic will document their assessment supporting their decision.

• Transporter accompanies the

patient when: Patient has been on an

established regimen and has been observed by the RN/paramedic to be awake and easily arousable.

After receiving a new IV

analgesic or sedative medication (e.g.,






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benzodiazepine, opioid), patient has been observed by the RN/paramedic for 30 minutes and is awake and easily arousable.

Patient on

PCA/epidural/continuous controlled substance infusion with no change in medication, dose, concentration, or rate of administration within the last hour.

• A provider may accompany a

patient during transport and observe if needed. All clinical staff members assigned to monitor patients are qualified to monitor for medication reactions, including for respiratory distress. These qualifications are set forth in the staff member’s respective job descriptions, training, licensing prerequisites and ongoing competency requirements. In regard to transport of patients, the determination of staff appropriate to monitor and support the patient’s physiological needs is based on the patient’s clinical condition, as described in the Transport Policy and Transport SOP.

• Beginning on December 3, 2018, the Hospital staffed a nurse in the radiology department, whose role is

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to provide surveillance of patients who have not met the criteria to be accompanied by a licensed professional. The Radiology Resource Nurse (RRN) is responsible for patients who do not require the consistent presence of a nurse for monitoring or supporting the patient’s physiological needs, pursuant to the Transport Policy and Transport SOP and other policies related to patient monitoring. In this context, “surveillance” means that the RRN will be expected to have situational awareness of patients present in the Radiology area, be accessible to the members of the Radiology team and stay at the side of, and provide care and assistance to, any patient whose condition changes while in the Radiology area. The RRN will also call on additional support as needed for the care of a patient. Such surveillance is achieved by a combination of the RRN’s physical presence in the Radiology area, as well as real-time audio and video monitoring of patients in the Radiology area and real-time communication with other staff members conducting real-time audio and video monitoring of patients in the Radiology area. This nurse will also act as a resource to the radiology technologists and licensed professionals






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accompanying patients, and serve as liaison between the radiology department and the inpatient care areas to facilitate safe, patient transports to radiology. This nurse position is staffed Monday through Friday, from 7am to 4pm. When this nurse is not the revised Transport policy will apply to require the transporting clinical staff member to remain with the patient. VUMC is currently posting nursing positions to create around the clock staffing of the nurse in the radiology department. As of January 1, 2019, the Hospital extended radiology nurse coverage from 7 am to 7 pm. As of January 21, 2019, the Hospital extended radiology resource nurse coverage to 24 hours per day, 7 days a week. Each patient that requires monitoring based on the Transport Policy and its associated SOP, the Medication Administration Policy, or any patient specific provider orders is being accompanied to the radiology department and monitored by a nurse or paramedic consistent with the applicable policies. In the event the radiology nurse has reached capacity of patients to monitor or is not otherwise available to receive handover of patients, in accordance with the revised Transport Policy, the clinical staff member(s) transporting additional patients to

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the radiology areas will remain with the patient they are transporting.

• The Hospital has revised its High Alert Medication Policy, which revisions were approved on November 27, 2018, to detail required monitoring of patients receiving administration of high alert medications. Specifically, the amended High Alert Medication Policy states that the patient’s clinical status is monitored to evaluate patient response to medication and/or adverse reactions, and the duration and frequency of monitoring is based on the patient’s condition, the type of medication, and route of administration. Such monitoring may include, but is not limited to, direct observation, monitoring of vital signs and neurological status. In accordance with the revisions made to the Hospital’s High Alert Medication Policy and Chart, Paralyzing Agents and controlled substances have parameters for monitoring that vary based on the specific medication. For example, a patient receiving an intermittent dose of a controlled substance intravenously, who is not on continuous monitoring (cardiac or pulse oximetry) will be visually observed for at least five minutes by clinical staff and are subsequently

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reassessed within one hour. The Hospital has revised its High Alert Medication Policy and Chart to include specified monitoring parameters for high alert medications. Specifically, a Patient Monitoring column has been added to the High Alert Medication Chart which specifies the monitoring requirements for each type of High Alert Medication listed in the Chart, including the duration and frequency of monitoring, and issues and reactions for which to monitor. The specifications for monitoring and type of monitoring are outlined for ease of access and use by Hospital staff in the High Alert Chart. Paralyzing Agents continue to be included as a High Alert Medication. Pursuant to the High Alert Medication Chart, a patient receiving a Paralyzing Agent will have continuous cardiac and respiratory monitoring. In addition, after reassessing guidance from the Institute for Safe Medication Practices (ISMP) the Hospital has added controlled substances, including opioids and benzodiazepines, to the High Alert Medication Policy and Chart. A patient receiving an initial dose of a controlled substance by route as defined by the Hospital’s High Alert Medication Chart, will be continuously monitored by a

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qualified clinical staff member for at least five minutes and again within the hour if not subject to continuous monitoring based on the patient’s clinical condition.

Additionally, the Hospital has revised its Procedural Sedation Policy (attached) and developed a Minimal Sedation Standard Operating Procedure (“Minimal Sedation SOP”) to include monitoring guidelines for minimal sedation. These guidelines include classification of sedation (minimal, moderate, deep, nitrous), who is eligible to fulfill the monitor role, qualifications of a monitor, education required for monitors, equipment necessary for monitoring, what assessment requirements are (parameters that must be included), the frequency of monitoring and the required documentation.

• The Hospital’s Medication

Administration Policy has been revised, which revisions were approved on November 27, 2018, to detail required monitoring of patients receiving medications. Specifically, the amended Medication Administration Policy states that the patient’s clinical status is monitored to evaluate patient response to medication and/or adverse reactions, and the

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duration and frequency of monitoring is based on the patient’s condition, the type of medication, and route of administration. Such monitoring may include, but is not limited to, direct observation, monitoring of vital signs and neuro checks. The Medication Administration Policy has been further amended to require specific documentation in the medical record regarding medication administration and monitoring.

The staff member transporting the patient will know the needed duration and frequency of monitoring by referring to the Hospital’s existing Transport Policy, Transport SOP, the updated High Alert Medication Policy and Chart (attached) and any orders for monitoring as entered into the patient’s medical record, as further informed by the staff member’s knowledge of the specific patient’s condition, including information gained during the Hospital’s Clinical Handover Procedure. The Hospital has revised its High Alert Medication Policy and Chart to include specified monitoring parameters for high alert medications. Specifically, a Patient Monitoring column has been added to the High Alert Medication Chart

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which specifies the monitoring requirements for each type of High Alert Medication listed in the Chart, including the duration and frequency of monitoring, and issues and reactions for which to monitor. The specifications for monitoring and type of monitoring are outlined for ease of access and use by Hospital staff in the High Alert Chart. For example, Paralyzing Agents continue to be included as a High Alert Medication. Pursuant to the High Alert Medication Chart, a patient receiving a Paralyzing Agent will have continuous cardiac and respiratory monitoring. In addition, after reassessing guidance from the Institute for Safe Medication Practices (ISMP) the Hospital has added controlled substances, including opioids and benzodiazepines, to the High Alert Medication Policy and Chart. A patient receiving an initial dose of a controlled substance by route as defined by the Hospital’s High Alert Medication Chart, will be continuously monitored by a qualified clinical staff member for at least five minutes and again within the hour if not subject to continuous monitoring based on the patient’s clinical condition.






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The Hospital has further revised its Medication Administration Policy (attached). The revised Medication Administration Policy includes the following direction for monitoring the patient’s clinical status and response to medications and/or adverse reactions:

• The duration and frequency of monitoring is based on patient’s condition, type of medication, and route of administration.

• Monitoring may include, but is not limited to, visual observation, vital signs, and neuro checks.

• High alert medications are monitored as defined in the High Alert Medication policy.

• For additional guidance on appropriate monitoring, staff may refer to Lexi-comp Online™ which is readily available via electronic clinical systems, or contact the Pharmacy.

In addition, the Hospital’s CL SOP - Clinical Handover Communication procedure (attached) sets forth guidelines to ensure that the communication of information and the transfer of responsibility and authority for the care of a patient

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between individuals or teams is completed. Clinical handovers follow a Hospital-approved structure that includes the most current patient information (including medication administrations) and interactive communication, with a focus on current condition, plan of care and safety. In the case of an administration of a high alert medication, such as Versed in certain routes of administration, the clinical handover communication would focus on potential cardiopulmonary compromise and applicable monitoring in accordance with the Hospital’s Transport Policy (attached). When a patient is transported off the clinical unit for a test or procedure, the staff will follow the guidance of the Transport SOP.

• The Hospital reviewed its policies and procedures related to moderate sedation, specifically the Standard Operating Procedure for Moderate Sedation, to ensure sufficient safeguards are in place. The Hospital determined that it has in place comprehensive guidance regarding the administration of moderate sedation, specifically including procedures for ensuring patients receiving sedation are continuously observed and physiologically monitored






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throughout the sedation period by a nurse, advanced practice nurse, physician, or other qualified and trained staff as approved by the Hospital’s Sedation Committee. The SOP for Moderate Sedation details the post anesthesia recovery scoring system and score that is required to discontinue monitoring. The SOP for Moderate Sedation also includes conditions for transporting patients who have undergone moderate sedation, including required monitoring. The Hospital has determined that no updates to the SOP for Moderate Sedation are required.

• The Hospital has revised the High Alert Medication Policy and Chart, Transport Policy, Transport SOP, Clinical Handover Communication procedure, Procedural Sedation Policy, and Minimal Sedation Standard Operating Procedure (SOP) (each attached) to guide staff in situations requiring monitoring. In addition, staff will provide monitoring as ordered for a patient and documented in the patient’s medical record. To educate the staff on these updates, the Hospital has prepared an educational computer-based learning module which was assigned to all nurses, paramedics, provider staff and pharmacy staff

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working in inpatient and procedural areas, and approved credentialed providers for moderate or deep sedation, through the Hospital’s on-line Learning Module System on January 25, 2019 with the target completion date of February 4, 2019. Any staff who has not completed the learning module by February 4, 2019 will be required to do so prior to the start of their next shift. The specific policies and standard operating procedures addressed in the learning modules are as follows: High Alert Medication Policy and Chart, Medication Administration Policy, Procedural Sedation Policy and Minimal Sedation Standard Operating Procedure.

• Training: By December 3, 2018, the Hospital required all managers, clinical staff leaders (CSLs), nurses, licensed practical nurses (LPNs), respiratory therapists and paramedics working in inpatient and procedural areas of the Hospital to complete education through its on-line education system, which addresses the updates to the Transport Policy, High Alert Medication Policy, and Medication Administration Policy including the requirements for monitoring patients during transport and during and

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after medication administration, appropriate handover, and related medical record documentation. No clinical staff member listed above has been able to begin a shift after December 3rd without confirmation of training and subsequent competency testing. The Hospital’s Chief Nursing Officers monitor this education requirement and provide regular updates to directors of these departments to ensure compliance. The Hospital’s CNOs oversee this education requirement in collaboration with the Hospital’s education department and local nursing unit leaders. Compliance rates (meaning the clinical staff members required to complete the education who have not yet completed the training) are reviewed on a weekly basis by the Hospital’s CNOs. As of January 23, 2019, 1,492 individuals, which is 99% percent of the total number of 1,509 of Hospital’s staff members required to receive the education, had completed the training requirement for monitoring patients during transport and during and after medication administration, appropriate handover, and related medical record documentation. As to paramedics, the Hospital complies with Tenn. Comp. R. & Regs. 1200-12-4-.01. Paramedics

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at the Hospital only perform extended skills or procedures when such treatment is conducted under authorized medical control and nursing supervision and is within the scope of practice identified in state law. Paramedics employed in this capacity demonstrate continued training and competence in order to perform their professional duties, consistent with their scope of practice. Paramedics work in the Emergency Department, and do not work in inpatient and procedural areas of the Hospital. However, it is possible that a paramedic may transport a patient from the Emergency Department to inpatient or procedural areas, and as such, the Transport Policy would apply to such paramedic. Given the potential application to transports, the Hospital is requiring paramedics to complete this additional training and education regarding updated patient monitoring procedures. The Hospital’s job description for paramedics states that paramedics are responsible for triage care in the field and the Emergency Department, and are further responsible for effective communication to ensure safe and quality patient care in transport and handover. The paramedic job






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description requires paramedics to deliver patient care within the Tennessee paramedic scope of practice. Paramedics are utilized in, and are under the supervision of clinical care providers in, the Hospital’s emergency service/care areas pursuant to TN state law. All paramedics are trained on the Hospital’s CL SOP - Clinical Handover Communication procedure. The Clinical Handover Procedure sets forth guidelines to ensure the communication of information and the transfer of responsibility/authority for the care of the patient between individuals or teams. Clinical handovers follow a Hospital-approved structure that includes the most current patient information (including medication administrations) and interactive communication with a focus on current condition, plan of care and safety. In the case of an administration of a high alert medication, such as Versed in certain routes of administration, the clinical handover communication would focus on potential cardiopulmonary compromise and applicable monitoring in accordance with the Hospital’s Transport Policy (attached). Paramedics are also trained on the High Alert Medication






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Chart (attached) which includes specified monitoring parameters for all high alert medications. Paramedics in the Hospital will receive information pertaining to a patient being transported through the clinical handover process consistent with the Clinical Handover Communication procedure. Through this handover process, the paramedic will be notified of the specific monitoring requirements for the patient. The Paramedic duties are stated within the Paramedic Scope of Practice document (attached).

By December 3, 2018, the Hospital required all current managers, clinical staff leaders (CSLs), nurses, licensed practical nurses (LPNs), and respiratory therapists working in inpatient and procedural areas of the Hospital and paramedics working in the Emergency Department to complete computer-based training on the Transport Policy. New clinical staff (which includes nurses and paramedics) must complete this training as a mandatory portion of the Hospital’s clinical orientation. Completion rates for new staff are monitored on a weekly basis.

UPDATE: The Hospital is

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monitoring the completion of the required training programs, and as of December 18, 2018, 2,514 individuals, which is 99% percent of the Hospital’s staff members required to receive the education, had completed the training requirement for monitoring patients during transport and during and after medication administration, appropriate handover, and related medical record documentation. 1% of staff remain on FMLA, and will not be allowed to return to work until training has been completed. The 2,514 individuals constitutes 99% of the Hospital’s total number of staff members required to complete the training as of December 18, 2018, out of a total of 2,563 individuals (at the time) required to complete the training for monitoring patients during transport and during and after medication administration, appropriate handover, and related medical record documentation. Specifically, the Hospital has required all managers, clinical staff leaders (CSLs), nurses, licensed practical nurses (LPNs), respiratory therapists and paramedics working in inpatient and procedural areas of the Hospital to complete education through its on-line education






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system, which addresses the updates to the Transport Policy, High Alert Medication Policy, and Medication Administration Policy including the requirements for monitoring patients during transport and during and after medication administration, appropriate handover, and related medical record documentation. No clinical staff member listed above has been able to begin a shift after December 3, 2018 without confirmation of training and subsequent competency testing. As of January 25, 2019, 2,502 individuals have completed the training, who represent 98% of the current number of 2,546 managers, clinical staff leaders (CSLs), nurses, licensed practical nurses (LPNs), respiratory therapists and paramedics working in inpatient and procedural areas of the Hospital required to complete such training. As to the scoring system, the Hospital’s computer-based training module titled, “2019 FY Moderate Sedation at VUMC” in the Hospital’s online education system addresses the scoring system. Additionally, the Hospital developed a new computer-based training module titled “2019 FY High Alert






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Medication and Procedural Sedation,” which has been assigned to all nurses, paramedics, provider staff and pharmacy staff working in inpatient and procedural areas, and approved credentialed providers for moderate or deep sedation, to educate them on the revised Procedural Sedation policy. The new module will have a specific post-completion test question directly related to the scoring system. The module will be assigned to all applicable staff on January 25, 2019 with a completion date of February 4, 2019. Any staff member who has not completed the training as of February 4, 2019, will not be allowed to return to work until the module is complete. Any new staff will also be required to complete training as a part of the clinical orientation process. The Hospital will monitor staff’s compliance with the use of, and documentation of, the scoring system consistent with Hospital’s applicable policies and procedures.

• A computer-based training module titled “2019 FY Moderate Sedation at VUMC” in the Hospital’s Learning Module System is assigned to applicable staff members upon hire as a part of the mandatory clinical

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orientation. This training module includes details of the Moderate Sedation policy/guide and direct links to the source documents.

• In addition, the Hospital developed a new computer-based training module titled, “2019 FY High Alert Medication and Procedural Sedation,” which has been assigned via the Hospital’s Learning Module System to all nurses, paramedics, provider staff and pharmacy staff working in inpatient and procedural areas, and approved credentialed providers for moderate or deep sedation, to educate them on the revised Procedural Sedation policy. The module will be assigned to all applicable staff on January 25, 2019 with a completion date of February 4, 2019. Any staff member who has not completed the training as of February 4, 2019, will not be allowed to return to work until the module is complete.

All of the Hospital’s policies are stored on a central online document management interface (PolicyTech). This document management software allows for all staff

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members to easily access any of the Hospital’s policies and standard operating procedures. For additional guidance on appropriate monitoring, staff may refer to Lexi-comp Online™ which is readily available via electronic clinical systems or contact the Hospital’s Pharmacy.

• Monitoring: Beginning on December 3, 2018 and continuing for the following three months, the Hospital’s Chief Nursing Officers oversee weekly chart reviews of 5 patients from each unit, randomly selected, to assess for compliance with improvement in medication safety, transport and monitoring of patients. To date, the Hospital’s Chief Nursing Officers have directed the unit level nurse managers’ performance of weekly chart reviews of a minimum of five patients from each unit, or 100% of patients transported if the unit has transported less than five patients within the week, to assess for compliance with policies and procedures related to patient monitoring and safe patient transport. The unit level nurse management team has been instructed to select cases for review that facilitate immediate performance feedback to team members, and to evaluate practices

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on both day and night shift observations. Such patient records are reviewed for documentation of the appropriate monitoring, handover communication, and documentation consistent with the Transport Policy, Medication Administration Policy and High Alert Medication Policy. In the event such an audit reveals non-compliance, inconsistencies or questions, the Chief Nursing Officers will follow-up with the unit level nurse managers for additional steps required to achieve compliance, such as targeted education and training. Results of the chart audit are reported to the CNOs weekly, and the unit level leaders will also consult the CNOs as needed to determine additional steps required to achieve compliance. The unit level leaders review the patient movement compliance reports daily. The Chief Nursing Officers will review monthly updates of such chart review audits to the VUMC Nursing Quality Committee.

To further the Hospital’s commitment to safe patient transport, the Hospital has developed a dashboard that permits tracking of inter-facility patient movement, as well as






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administration of high alert medications. This tool allows for identification, monitoring and ongoing feedback concerning the Hospital’s safe patient transport practices.

UPDATE: As of December 18, 2018, the Hospital’s Chief Nursing Officers have overseen two weekly chart reviews, of 5 patients from each unit. Following the first audit during the week of December 3, 2018, the Hospital’s Chief Nursing Officers determined that the Hospital’s medical record layout required revisions in order to accommodate the additional documentation requirements. Following these updates to the medical record which were effective December 10, 2018, the following weekly audit resulted in a compliance rate of 93%. Chart audits are completed in real time, allowing unit managers to provide immediate training to staff who exhibit noncompliance with documentation requirements.

The Hospital’s Monitoring of Patient Transport audit tool (attached) includes the following quality indicators of safe patient transport practices:

• Appropriate qualifications of






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staff transporting the patient, based on clinical factors.

• Time Left Unit. • Patient destination. • Handover report (if appropriate). • Time returned to unit (unless

transferred to a different unit). • Condition upon return to unit

(unless transferred to a different unit).

The Hospital has reviewed its policies and procedures related to access and administration of Paralyzing Agents and made the following changes:

• A multi-disciplinary work group comprised of Hospital leaders including Physicians, Pharmacy, Risk, Nursing, Quality, and Health Informatics was convened beginning on January 19, 2018 to assess Paralyzing Agents included on the override medication list. This workgroup determined to remove vecuronium from the AcuDose (Hospital’s automated dispensing cabinet) override status list, which removal was approved by the VUMC Pharmacy, Therapeutics and Diagnostic Committee on February 23, 2018 and implemented on March 1, 2018. The work group determined to retain availability of the following Paralyzing Agents in the AcuDose cabinets in the Hospital: rocuronium, succinylcholine, vecuronium and cisatracurium. The work group






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determined that rocuronium and succinylcholine would remain on the override list, based on the work group’s determination that the clinical risks to patients of not having immediate access to rocuronium and succinylcholine outweighed the potential safety benefits from removing the Paralyzing Agent from override status. The four Paralyzing Agents are medications that must be accessed quickly during an emergency medical event. In particular, the work group considered the potential risks that may arise in the event rocuronium and/or succinylcholine is not available in certain inpatient and procedural areas of the Hospital when needed in an emergency for a rapid sequence intubation. The work group determined that vecuronium and cisatracurium would remain available in the AcuDose cabinet, but would be removed from override status list so that they could not be dispensed without a written physician order and pharmacy verification. Vecuronium and cisatracurium were retained in AcuDose based on the fact that manual delivery from the Hospital pharmacy can often take between thirty (30) minutes to one hour to be delivered. Alternatively, dispensing from the AcuDose






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cabinet can often occur within about ten (10) minutes. It is standard practice to make available in the AcuDose cabinet any medication that is dispensed in a certain volume, particularly given that vecuronium and cisatracurium require a physician order and pharmacist review. Some Paralyzing Agents are contraindicated with patient care requirements, and the selection of a prescribed Paralyzing Agent by a physician is based on the patient’s clinical indications. As such, the work group decided to retain multiple Paralyzing Agents in the AcuDose cabinet. Additionally, as noted elsewhere, the medication administration process has been enhanced with additional security measures for all Paralyzing Agents, including shrink wrap packaging and a required Independent Double Check process.

The Hospital’s Medication Safety Officer in partnership with the VUMC Pharmacy, Therapeutics and Diagnostic Committee will reassess the Paralyzing Agents, including rocuronium, on the override list annually. Specifically, in December of each calendar year, the Medication Safety Officer will review the Paralyzing Agents included on the override medication list to






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determine the appropriateness of the override list. This annual assessment of the Paralyzing Agents included on the override medication list will weigh the clinical risks of having access to certain Paralyzing Agents on the override list against the benefits of removing such Paralyzing Agents from the override list. The Medication Safety Officer will review every case in which rocuronium and/or succinylcholine was dispensed from AcuDose via override; how frequently Paralyzing Agents were dispensed from AcuDose cabinets; whether a delay in accessing the medication causes patient harm; implications related to why staff selects a specific Paralyzing Agent; utilization of all Paralyzing Agents available in the AcuDose cabinet; the time of the override compared to medication order; and the time of the override compared to the medication administration time. The determination as to whether or not a delay in accessing the medication causes harm, and whether or not such medication should be available on override status, is a multidisciplinary decision. The Medication Safety Officer considers harm or potential patient harm secondary to medication delay in






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conjunction with the Hospital’s Pharmacy Policy committee and the VUMC Pharmacy, Therapeutics and Diagnostic Committee.

While the Medication Safety Officer’s annual assessment will include a review of data from prior periods to assist in assessing the continued appropriateness of the Paralyzing Agents on override status, this assessment is a proactive approach to determine whether there should be a change to the Paralyzing Agents on override status and any clinical implications to patient care.

In addition to the safety measures related to Paralyzing Agents outlined herein of Independent Double Check, vial packaging, naming conventions, and system alerts that have been implemented as part of the Plan of Correction, the Hospital has implemented further proactive measures to ensure safe storage and dispensing of Paralyzing Agents. Barcode assisted medication administration (“BCMA”) systems involve the use of scanners and software to verify all medications electronically before they are administered to patients, and further to document the medication in the electronic






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medication administration record. BCMA systems are utilized where available throughout the Hospital, and the Hospital is implemented BCMA systems in radiology areas by December 11, 2018. The Medication Use Safety Improvement Committee continually monitors trends in data related to medication use and will continue to monitor professional organizations for updated Institute for Safe Medication Practices (ISMP) recommendations as to medication administration. Additionally, the Hospital has performed a gap analysis with the ISMP Targeted Medication Safety Best Practices for Hospitals and has participated in an ISMP high alert self-assessment and benchmarking review. Both the gap analysis and high alert self-assessment include a review of Paralyzing Agent practice. The Hospital performs an ongoing review of the ISMP quarterly action agenda recommendations through the Medication Management group, a subcommittee of the Medication Use Safety Improvement Committee.

Further, since 2016 the Hospital’s Pharmacy, Therapeutics and Diagnostics Committee has reviewed every medication

12/11/18






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introduced to the Hospital’s formulary using a developed Risk Mitigation Plan for Formulary Additions Checklist. This proactive strategy reviews potential failure modes in procurement, clinical decision support, high alert, look alike-sound alike (LASA), adverse drug event risk, hazardous medications, packaging and labeling, order review, preparation, administration, monitoring and transitions of care to prepare our hospital and system for a certain medication. The Medication Use Safety Improvement Committee will continue to oversee and take actions to prevent, monitor and evaluate adverse drug events, particularly through the Medication Use Safety Improvement Committee subcommittees on Adverse Drug Events.

• The Hospital has changed the naming convention from “Neuromuscular Blocking Agents”, as referenced in certain policies, including the High Alert Medication Policy, to “Paralyzing Agents” for consistency throughout the Hospital. The Hospital has also standardized the nomenclature utilized for Paralyzing Agents across the Hospital in eStar (Hospital’s electronic medical record) and AcuDose, such that both electronic systems present the

11/27/18






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name as “PARALYZING AGENT” followed by the medication name. Paralyzing Agents will no longer be able to be pulled up on the AcuDose override screen by typing in the drug name. Instead, “PARA” will be typed in - the first two letters of “Paralyzing Agent” - which will then pull up the list of Paralyzing Agents in the AcuDose cabinet. The four Paralyzing Agents are the only medications that result on both electronic systems in a search for “PARA”. Signs are attached to the AcuDose cabinets indicating that “PARA” must be used to access Paralyzing Agents. The new nomenclature of “Paralyzing Agent: [medication name]” was effective in both eStar and AcuDose as of November 27, 2018. Effective on November 27, 2018, this updated procedure is documented by an amendment to the Hospital’s High Alert Medications Charts for both Adult Patients and Pediatric Patients, which are incorporated into the High Alert Medications Policy. These charts have been amended to list the four (4) specific Paralyzing Agents available at the Hospital, and to reflect the updated nomenclature of “Paralyzing Agent [medication name]”.

• On November 27, 2018, the

11/27/18






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Hospital implemented a warning in AcuDose and eStar, stating: “WARNING: PARALYZING AGENT - Causes Respiratory Arrest – Patient Must Be Ventilated.” The Hospital amended the High Alert Medications Charts for both Adult Patients and Pediatric Patients, effective on November 27, 2018, to specify this pop-up warning as a Specific Safety Strategy for PARALYZING AGENTS.

• On November 27, 2018, the Hospital implemented new procedures for shrink wrap packaging to be added to all vials of Paralyzing Agents dispensed in AcuDose throughout the Hospital, and effective November 27, 2018 amendments to the Hospital’s High Alert Medications Charts for both Adult Patients and Pediatric Patients were approved to specify a Specific Safety Strategy that all Paralyzing Agents dispensed in AcuDose cabinets throughout the Hospital will have shrink wrap packaging. The Hospital Executive Pharmacy Leadership will monitor compliance with the required shrink wrap packaging of Paralytic Agents by conducting random audits of all AcuDose cabinets throughout the Hospital and validating packaging compliance for a minimum of three

11/27/18






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months of consecutive 100% compliance. Specifically, beginning with the week of November 26, 2018, each week the directors of the Hospital pharmacies oversee their staff in auditing 25% of the AcuDose cabinets in the Hospital, to inspect all Paralyzing Agents stored in the AcuDose cabinet being audited to determine whether each Paralyzing Agent includes the appropriate shrink wrap packaging. Each week during the month, a different 25% of the AcuDose cabinets is audited, such that 100% of AcuDose cabinets will have been audited within the course of one month. The directors of the Hospital pharmacies will continue to audit 25% of the AcuDose cabinets each week until such audits result in three consecutive months of 100% compliance with required shrink wrap packaging procedures. As such, each AcuDose cabinet in the Hospital will be audited at least three times during the audit period. UPDATE: As of December 18, 2018, four weeks of audits have been performed of AcuDose cabinets in the Hospital, and as such, every AcuDose cabinet in the Hospital has been audited. Of the 143 vials of Paralyzing Agents contained in the AcuDose cabinets audited the week of November 25,






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2018, three vials were identified without the proper shrink wrap packaging--these vials were discarded. During the weeks of December 2, December 9, and December 16, every vial of a Paralyzing Agent contained in the AcuDose cabinets audited included the required shrink wrap packaging, establishing 100% compliance. UPDATE: As of January 24, 2019, nine weeks of audits have been performed of AcuDose cabinets in the Hospital, and as such, every AcuDose cabinet in the Hospital has been audited at least twice. During the weeks of December 23, December 30, January 6, January 13 and January 20, every vial of a Paralyzing Agent contained in the AcuDose cabinets audited included the required shrink wrap packaging, continuing 100% compliance. The weekly Paralyzing Agent compliance audits will continue for three months from November 25, 2018. For ongoing sustainment, monitoring and oversight thereafter, the Hospital has incorporated these weekly audits into the Hospital’s current monthly medication safety checks that are conducted in every unit/area that has medications. This oversight process has become a part of the Hospital’s standard

2/24/19






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assessment for medication safety.

• As of November 27, 2018, the

Hospital finalized and implemented new procedures to require the additional Specific Safety Strategy for all Paralyzing Agents to include an Independent Double Check conducted by two licensed registered nurses prior to the administration of a Paralyzing Agent, where electronic clinical systems prompt dual sign off for bolus doses and upon the following for infusions:

o Initiation of infusion o Change of container o Handover

The Hospital has amended the High Alert Medications Charts for both Adult Patients and Pediatric Patients, which revisions were approved on November 27, 2018, to specify the Specific Safety Strategy that all Paralyzing Agents require such Independent Double Check. The Double Check process related to patient level detail is documented within the Patient’s Medication Administration Record (MAR), which is located in the Electronic Medical Record (EMR).

The Hospital’s CNOs, Pharmacy and Quality departments are collectively responsible for monitoring compliance with all

11/27/18

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medication administrations requiring a two-person sign off, which is a component of an independent double check. Prior to a qualified staff member administering the medication, it is scanned through the Barcode Medication Administration (BCMA) tool which forces a dual sign-off. This sign-off prompt requires an additional qualified clinical staff member to confirm the correct medication, correct dose and correct route of administration. Both staff members are then required to acknowledge the double check within the Medication Administration Record (MAR) portion of the Hospital’s Electronic Medical Record (EMR) prior to administration.

The two-person sign-off information is tracked and trended by the Hospital’s Quality Department and reviewed on a weekly basis by the Hospital’s CNOs and Pharmacy leadership. The Hospital’s Medication Usage Safety Improvement Committee and the Nursing Quality Committee reviews this data on a monthly basis to determine additional improvement opportunities.

Training: By November 26, 2018, every nurse and paramedic who

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work in an area of the Hospital where Paralyzing Agents are available in AcuDose dispensing cabinets, were required to complete an online training module outlining the process changes, Independent Double Check, vial packaging and naming convention changes. Any nurse or paramedic staff member required to complete such training, and who has not completed the computer-based training prior to November 27, 2018 for any reason, including being on vacation or not scheduled to work at the Hospital during the time period, has not been permitted to begin their next shift at the Hospital without first completing the required training.

• UPDATE: The Hospital is monitoring the completion of the required training programs, and as of December 18, 2018, 1,487 individuals, which is 99% percent of the Hospital’s staff members required to receive the education, had completed the training requirement. 1% of staff remain on FMLA, and will not be allowed to return to work until training has been completed.

Specifically, by November 26, 2018, every nurse and paramedic who works in an area of the Hospital where Paralyzing Agents are

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available in AcuDose dispensing cabinets, was required to complete an online training module outlining the process changes, dual sign-off, vial packaging and naming convention changes. Any nurse or paramedic staff member required to complete such training, and who had not completed the computer-based training prior to November 27, 2018 for any reason, including being on vacation or not scheduled to work at the Hospital during the time period, has not been permitted to begin their next shift at the Hospital without first completing the required training.

As of January 25, 2019, 1,492 individuals have completed the training, who represent 99% of the Hospital’s total number of 1,509 nurses and paramedic staff members required to complete such training.

• Monitoring: The Hospital has implemented several measures to monitor compliance with the updated medication administration requirements. Beginning on November 27, 2018, the Hospital’s Enterprise Medication Safety Officer, in collaboration with the Chief Nursing Officers, Executive Pharmacy Leadership, and Chief of Staff, began to compile monthly

1/25/19

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reports of overrides from AcuDose cabinets for paralyzing agents, which will be reviewed at the medication safety committee, as well as on the unit level, and assessed for appropriateness. Such monthly reporting will be ongoing, and continue for three months following November 27, 2018. Thereafter, and continuing indefinitely the Enterprise Medication Safety Officer will continue to review all unreconciled dispense reports that identify medication overrides without an order linked, and provide monthly override performance reports to the medication safety committee as part of ongoing medication safety committee work. In the event such monthly reports reveal non-compliance, inconsistencies or questions, the medication safety committee will elevate these issues to Chief Nursing Officers, Executive Pharmacy Leadership, and Chief of Staff to determine whether additional steps are required for compliance, such as targeted education and/or training.

When a provider electronically enters an order for a medication, the order is verified by the Hospital Pharmacy, and then the medication is available in the AcuDose cabinet under the patient’s specific profile.






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In the event of an emergency (i.e., acute patient decompensation where delay of necessary medication would cause harm) certain medications may need to be obtained from the AcuDose cabinet as an override prior to pharmacy verification. There will always be an order (entered electronically or given verbally in an emergency) for any medication prior to administration, consistent with the Hospital’s Provider Order Policy.

As noted by the Institute for Safe Medication Practices (ISMP) (attached), there are important, legitimate reasons for the medication override process in emergent situations (i.e., antidotes, rescue and reversal agents, and life-sustaining medications).

In addition, beginning on November 27, 2018 and continuing on a monthly basis until 100% compliance is achieved, Hospital’s Chief Nursing Officers began to review monthly reports of Independent Double Check, in order to verify compliance with the Independent Double Check procedure for Paralyzing Agents. Such monthly reporting will be provided to medication safety committees and the Hospital’s

11/27/18






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Nursing Quality Committee.

In the event a double check is not performed by two nurses for a high alert medication, the high alert medication will still be accessible to only one nurse in an emergency situation, but it may not be administered without a second nurse. Pursuant to the Hospital’s policies, procedures and protocols all high alert medications are only administered when two nurses are present, even during an emergency situation. A high alert medication remains accessible by a single nurse, but administration requires dual sign-off.

• UPDATE: In order to evaluate initial compliance of staff overrides related to paralyzing agents, audit frequency has been increased to weekly for the first month, after which the audits will be conducted on a monthly frequency. As of December 18, 2018, the Hospital’s Enterprise Medication Safety Officer, in collaboration with the Chief Nursing Officers, Executive Pharmacy Leadership, and Chief of Staff have completed three weekly reviews of overrides from AcuDose cabinets for Paralyzing Agents, which weekly report has been reviewed at the medication safety committee, as well as on the unit






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level, and assessed for appropriateness. This weekly review showed a 95% compliance rate with the Hospital’s policies and procedures regarding overrides of Paralyzing Agents. As of December 18, 2018, the Hospital’s Chief Nursing Officers have completed three weekly reviews in order to verify compliance with the Independent Double Check procedure for Paralyzing Agents. These three weekly reviews each showed a 100% compliance rate.

The Hospital is developing a unit-specific override compliance dashboard to provide ongoing monitoring and ensure compliance of overrides of high alert medications. This expands the Hospital’s review of overrides of Paralyzing Agents to include all high alert medications. System-level compliance throughout the Hospital will continue to be monitored by the Hospital’s Medication Usage Safety Improvement Committee.

The Hospital also imposes the following general requirements for nurse training and education regarding its policies and procedures:

• In regard to nurse training on






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medication administration, medical record documentation, and monitoring of patients receiving medication, all newly hired nurses are required to complete computer-based training related to the preparation of drugs and safe medication practices. All nurse residents, who are new graduate registered nurses hired with less than six months of nursing experience, are required to complete such education regarding safe medication practices, as well as attend a workshop on medication safety. These trainings have been updated to include education as to the revisions to the Medication Policy, the new nomenclature for Paralyzing Agents, the updated requirements for monitoring patients receiving High Alert Medications.

• Further, all nurses and nurse residents receive ongoing education on an annual basis regarding a variety of topics determined by Hospital nurse leaders, educators and staff. Nursing staff must validate competency in the identified topics between January and June of each calendar year through a variety of methods, including an online learning module, skill validation on a mannequin, observation of daily practice, etc. The Hospital will include medication






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administration, patient monitoring, documentation and other issues discussed in this Plan of Correction in such annual competencies, as appropriate and based on the issues revealed in results of the audits described herein.

The Hospital has reviewed its policies and procedures related the role of the “Help All Nurse”, which is a type of resource nurse, and made the following changes:

• The Hospital has updated Scope of Care documents in each department that relies on a “Help All Nurse” (or similar position), in order to define the applicable role and duties. At the Hospital, “Resource Nurse” is generally used to describe a nursing role that usually does not take patient assignment during the shift but takes direction from the Clinical Staff Leader or Resource Staff Leader to assist other nurses as workloads demand, including rapid response teams, STAT calls, and transports. Resource Nurse roles in various departments include Float Nurse; Procedural Nurse; Admit Discharge, Transfer Nurse; and Patient Flow Nurse. The Scopes of Care were revised in intensive care units and non-intensive care units to define the

11/20/18






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applicable Resource Nurse role (including the “Help All Nurse” as applicable) by November 20, 2018. Nursing leadership of each Hospital department that utilizes such a Resource Nurse role will review the departments Scope of Care document on an annual basis to ensure duties of the position remain complete and accurate.

The role of the Resource Nurse, or “Help All” nurse, within the unit is a staffing assignment, rather than a position in which a nurse is employed with a job title, therefore no job description exists. The following are details surrounding this unit assignment. A Resource Nurse (e.g., Float Nurse, Procedural Nurse, Help-All Nurse, ADT (admit, discharge, transfer) Nurse, and Patient Flow Nurse), is a nursing role that may be available if the unit has adequate baseline staffing to utilize such a Resource Nurse, who usually does not take patient assignment. The role of the Resource Nurse will be assigned by the Clinical Staff Leader (more commonly known as Charge Nurse) to assist unit RNs with patient assignments as work demands. Tasks assigned may include but are not limited to providing procedural assistance, and participating






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in Rapid Response Team response, STAT response, admission/ discharge or transfer processes, relief coverage (breaks and lunch) and patient transport. Staff serving in a Resource Nurse capacity must, at a minimum, be an RN II, which is attained after one year of relevant clinical experience. The nurse is required to be oriented to the role with a nurse experienced in the Resource Nurse role prior to taking on the role of this assignment. All staff within the units are aware of the Resource Nurse duties and are encouraged to utilize this resource opportunity to enhance patient safety and care. The role of Resource Nurses is not different from the role of the bedside nurse and thus, the Resource Nurse possesses the same knowledge and competencies as all nurses on the unit. The nurses in question simply do not take a patient assignment and are available to assist the nurses on the unit with the types of tasks described above.

The Hospital has reviewed its policies and procedures related to state reporting, and has made the following changes:

• The Hospital reviewed its Occurrence Reporting: Patient and Visitor policy, which outlines

11/27/18






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requirements of every Hospital employee, attending physician and house staff member to report certain occurrences to the Hospital’s Office of Risk and Insurance Management, either through the online occurrence reporting system or through a phone call to Risk Management. The Hospital has revised the Occurrence Reporting: Patient and Visitor policy to require Risk Management to report any a) incidents of abuse, neglect, or misappropriation reported to the Hospital department as complaints for certification processes; b) strike by staff; c) external disaster impacting a Hospital facility; d) disruption of any service vital to the continued safe operation of the Hospital facility, or to the health and safety of its patients and personnel; and e) fires at a Hospital facility that disrupt the provision of patient care services or cause harm to the patients or staff, or that are reported by the facility to any entity, including but not limited to a fire department charged with preventing fires. These policy revisions were approved by Executive Policy Committee of the Medical Center Medical Board effective November 27, 2018. The Occurrence Reporting: Patient and Visitor policy places the responsibility for






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reporting to the Tennessee Department of Health pursuant to the Health Data Reporting Act of 2002 with the Office of Risk and Insurance Management.

The most recent updates to the Hospital’s Occurrence Reporting: Patient and Visitor policy were approved January 3, 2019 and supersede the Hospital’s November 2018 policy. The November 2018 version of the policy superseded in turn the October 2017 policy. A redline of the current policy to the October 2017 policy is attached to this Plan of Correction, showing changes including, but not limited to, removal of the reference to the Health Data Reporting Act of 2002, the addition of definitions of abuse, neglect and misappropriation, and identification of event reporting objectives, including “[i]dentification of those Events which are required to be reported to third-parties as required under applicable law, rule, or regulation.” The policy also states that the Hospital’s Office of Risk and Insurance Management reports to the Tennessee Department of Health in compliance with the Department’s reporting requirements, including events identified as abuse, neglect, and misappropriation, as those terms are defined in the policy.

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Effective on November 27, 2018, the Hospital implemented a revised procedure during the established weekly meeting of the Event Review Committee to include regular evaluations of whether occurrences reported to the Office of Risk and Insurance Management require a report to the Tennessee Department of Health, pursuant to state law requirements. The Event Review Committee reviews patient events with harm or potential harm on a weekly basis, to identify those events which may require an Event Analysis pursuant to the Hospital policies, further investigation by Risk and Insurance Management, external reporting, or other potential safety or risk issues. The Event Review Committee is a Quality Improvement Committee (QIC) as defined pursuant to TCA §§ 63-1-150 and 68-11-272 and is comprised of representatives from Risk and Insurance Management; Quality, Safety, and Risk Prevention; and Patient Safety Officers. The Event Review Committee reports to the Self Insurance Trust, which reports to the Hospital Medical Center Medical Board. The participants of the Event Review Committee have been informed of the changes to the Occurrence Reporting policy and these additional procedures. The

11/27/18






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Senior Vice President of Quality, Safety and Risk Prevention and the Vice President of Risk and Insurance Management will continue participate in such weekly committee meetings and will monitor state reporting processes to ensure the Hospital reports as required by state and federal law. Further, the Hospital is currently communicating with the Tennessee Department of Health regarding additional guidance on reportable events under state law.

UPDATE: As of December 18, 2018, the Event Review Committee has convened 2 times in accordance with the process described above.

• The Hospital has reviewed its policy outlining reporting requirements to the Davidson County Medical Examiner, including its Deaths Requiring Reporting to the Medical Examiner policy (hereinafter, “Medical Examiner Policy”). The Hospital has amended the Medical Examiner Policy, which amendments were approved on November 27, 2018, to clarify that all details supporting a decision of: a) a suspicious, unusual or unnatural death, including

11/27/18






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unexplained surgical and anesthetic deaths, and b) death during or as a result of a diagnostic or therapeutic procedure, medication error, or adverse, allergic, or toxic reaction to a therapeutic agent, shall be reported to the Medical Examiner. The revised Medical Examiner Policy also requires all conversations with the Medical Examiner’s Office to be documented in the patient’s medical record, including the rationale for reporting pursuant to the criteria outlined in the Policy.

The Hospital has attached to this Plan of Correction the QI audit tool for Medical Examiner Reporting. Of note, the components of the QI audit tool for reporting to the Medical Examiner are based on the Hospital’s Deaths Requiring Reporting to the Medical Examiner Policy. The QI indicators within this review includes the following elements: Patient Summary, Death Report, TDS notification, and ME notification. The Hospital’s Office of Decedent Affairs reviews 100% of all Hospital deaths for disposition documentation prior to the body being released to the morgue. All decedent charts receive a second review for death reporting details. This review is focused on documentation and timely notification to the Medical Examiner






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Office. If a case previously declined by the Medical Examiner Office is identified as meeting reporting criteria or new information is provided, a referral to the Medical Examiner Office is made by the Hospital’s Office of Decedent Affairs. Total review numbers and cases requiring follow-up will be reviewed monthly at the Hospital’s Transfer Review Committee.

• Training: By December 3, 2018, the Hospital required every Attending Physician and House Staff to complete education regarding the revised Medical Examiner Policy requirements, reporting requirements under state law, and documentation in the medical record under the Policy, as well as documenting communications and disclosure with family and/or patient representative.

UPDATE: As of December 18, 2018, 3,850 individuals have completed the required education regarding the revised Medical Examiner Policy requirements, reporting requirements under state law, and documentation in the medical record, representing 99.9% of the Hospital’s total Attending Physicians and House Staff members. There are 4 individuals

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that remain on FMLA. Further, the Hospital has been in communication with the Tennessee Deputy State Chief Medical Examiner, who has provided written materials outlining deaths reportable to the medical examiner for distribution to appropriate staff members at the Hospital. The Hospital is working with the Tennessee Deputy State Chief Medical Examiner to schedule on-site education at the Hospital.

• Monitoring: The Office of Decedent Affairs is reviewing Medical Examiner reporting to ensure the Hospital reports as required by state law. Any deaths not previously reported which are identified as unusual or suspicious will be immediately reported to the medical examiner. Additionally, beginning on December 3, 2018, this group began to audit 100% of patient deaths occurring in the Hospital, in order to assess compliance with state reporting requirements. Any death identified as unusual or suspicious and that has not already been reported by the time of the Office of Decedent Affairs’ review will be immediately reported to the Medical Examiner. In the event such an audit reveals non-compliance, inconsistencies or questions, the Office of Decedent

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Affairs will elevate these issues immediately to the VUMC Quality Steering Committee to determine whether additional steps are required for compliance, such as reporting to the Medical Examiner, targeted education and/or training. Monthly reports of audits will be provided to Chief of Staff and Quality Safety Risk Prevention for oversight of reporting to the Medical Examiner.

UPDATE: In accordance with the process outlined above, the Office of Decedent Affairs has been reviewing 100% of deaths occurring in the Hospital on or after December 3, 2018 and ensuring they are reported to the Medical Examiner’s Office in accordance with state reporting requirements.

The Hospital has implemented the corrective actions described in this Plan of Correction and is conducting monitoring and auditing as described herein to ensure ongoing compliance. The Hospital has reviewed its policies and procedures related to monitoring of patients during and after medication administration and made the following changes:

• The Hospital has revised its policy previously titled Transport of the

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Critically Ill Patient, which revisions were approved on November 27, 2018, to broaden application of the policy beyond critically ill patients. As such, the newly amended policy is titled “Transport of Patients” (hereinafter, “Transport Policy”). This policy provides that every patient shall be transported with equipment, supplies, and staff appropriate to monitor and support the patient’s physiological needs. Physiological “needs” in the context of this statement refers to a patient’s medical requirements, based on the patient’s current clinical condition and clinical course of treatment as determined by the multidisciplinary healthcare team. An example would include a patient with provider-ordered cardiac telemetry monitoring would be transported with the monitor unless there is an order stating otherwise. The policy details that the level of care is maintained during transport and after arrival at the receiving department/unit, and describes specific monitoring and documentation requirements. The amended policy states that when a patient requires continuous monitoring, a clinical staff member is required to be available to receive handover of the patient pursuant to the Hospital’s CL SOP - Clinical Handover Communication procedure. Any such handover will be documented in the medical record. In the event a clinical staff






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member is not available to receive the patient, the transporting clinical staff member must remain with the patient. Further, the Transport Policy states that patients receiving medications that could lead to respiratory depression and/or respiratory distress are monitored during and after transport, with the duration and frequency of the monitoring to be based on the patient’s condition, type of medication, and route. Documentation will be in accordance with VUMC’s Medication Administration Policy. The Transport Policy further states that such monitoring may include, but is not limited to, direct observation, vital signs, and neuro checks. The revised Transport Policy further requires appropriate documentation to be completed in the patient’s medical record upon leaving and returning to the unit, including the times the patient leaves and returns to the unit. The clinical staff members who may transport patients include RNs, paramedics and other clinical staff as outlined in the Transport Policy and associated Standard Operating Procedure entitled “Transport of Patients Receiving Medications That May Cause Impaired Consciousness or Undesired Changes in Vital Signs” (“Transport SOP”), which is further described below. For purposes of transport of patients, staff appropriate to monitor






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and support the patient’s physiological needs is determined based on the patient’s current clinical condition. Further, a non-clinical staff member may transport a patient in the event a patient’s physiological needs do not require monitoring or support pursuant to the Transport Policy and Transport SOP, Medication Administration Policy, or High Alert Medication Policy. In December 2018, the Hospital adopted the Transport SOP, which sets forth specific parameters for transport of adult patients in Vanderbilt University Hospital that have received medication that may cause impaired consciousness or undesired changes in vital signs, other than critically ill patients who are addressed in the Transport Policy. The SOP was amended in January 2019 and provides as follows in regard to staff members who may transport patients:



administered within the past 30 minutes for minimal sedation/anxiolysis in preparation for a procedure/test. Patient is monitored utilizing pulse oximeter during transport and until patient returns to baseline neurocognitive status, maintaining consistent level of

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care for patients while off the unit.


Patient is on PCA/epidural/continuous controlled substance infusion with a change in medication, dose, concentration, or rate of administration within the last hour, maintaining consistency with MM SOP - Patient-Controlled Analgesia (PCA) and Continuous Controlled Substance Infusion: Administration and Management.


Patient needs observation based on the criteria above or RN/Paramedic judgement and there is not a RN/Paramedic to receive and observe the patient during testing or procedure.






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RN/Paramedic will document their assessment supporting their decision.




After receiving a new IV analgesic or sedative medication (e.g., benzodiazepine, opioid), patient has been observed by the RN/paramedic for 30 minutes and is awake and easily arousable.

Patient on PCA/epidural/continuous controlled substance infusion with no change in medication, dose, concentration, or rate of administration within the last hour.


patient during transport and observe if needed. All clinical staff members assigned to monitor patients are qualified to monitor for medication reactions, including for respiratory distress. These qualifications are set forth in






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the staff member’s respective job descriptions, training, licensing prerequisites and ongoing competency requirements. In regard to transport of patients, the determination of staff appropriate to monitor and support the patient’s physiological needs is based on the patient’s clinical condition, as described in the Transport Policy and Transport SOP.

• Beginning on December 3, 2018, the Hospital staffed a nurse in the radiology department, whose role is to provide surveillance of patients who have not met the criteria to be accompanied by a licensed professional. The Radiology Resource Nurse (RRN) is responsible for patients who do not require the consistent presence of a nurse for monitoring or supporting the patient’s physiological needs, pursuant to the Transport Policy and Transport SOP and other policies related to patient monitoring. In this context, “surveillance” means that the RRN will be expected to have situational awareness of patients present in the Radiology area, be accessible to the members of the Radiology team and stay at the side of, and provide care and assistance to, any patient whose condition changes

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while in the Radiology area. The RRN will also call on additional support as needed for the care of a patient. Such surveillance is achieved by a combination of the RRN’s physical presence in the Radiology area, as well as real-time audio and video monitoring of patients in the Radiology area and real-time communication with other staff members conducting real-time audio and video monitoring of patients in the Radiology area. This nurse will also act as a resource to the radiology technologists and licensed professionals accompanying patients, and serve as liaison between the radiology department and the inpatient care areas to facilitate safe, patient transports to radiology. This nurse position is staffed Monday through Friday, from 7am to 4pm. When this nurse is not the revised Transport policy will apply to require the transporting clinical staff member to remain with the patient. VUMC is currently posting nursing positions to create around the clock staffing of the nurse in the radiology department. As of January 1, 2019, the Hospital extended radiology nurse coverage from 7 am to 7 pm. As of January 21, 2019, the Hospital extended radiology resource nurse coverage to 24 hours per day, 7 days a week. Each

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patient that requires monitoring based on the Transport Policy and its associated SOP, the Medication Administration Policy, or any patient specific provider orders is being accompanied to the radiology department and monitored by a nurse or paramedic consistent with the applicable policies. In the event the radiology nurse has reached capacity of patients to monitor or is not otherwise available to receive handover of patients, in accordance with the revised Transport Policy, the clinical staff member(s) transporting additional patients to the radiology areas will remain with the patient they are transporting.

• The Hospital has revised its High Alert Medication Policy, which revisions were approved on November 27, 2018, to detail required monitoring of patients receiving administration of high alert medications. Specifically, the amended High Alert Medication Policy states that the patient’s clinical status is monitored to evaluate patient response to medication and/or adverse reactions, and the duration and frequency of monitoring is based on the patient’s condition, the type of medication, and route of administration. Such monitoring may include, but is not limited to,

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direct observation, monitoring of vital signs and neurological status. In accordance with the revisions made to the Hospital’s High Alert Medication Policy and Chart, Paralyzing Agents and controlled substances have parameters for monitoring that vary based on the specific medication. For example, a patient receiving an intermittent dose of a controlled substance intravenously, who is not on continuous monitoring (cardiac or pulse oximetry) will be visually observed for at least five minutes by clinical staff and are subsequently reassessed within one hour. The Hospital has revised its High Alert Medication Policy and Chart to include specified monitoring parameters for high alert medications. Specifically, a Patient Monitoring column has been added to the High Alert Medication Chart which specifies the monitoring requirements for each type of High Alert Medication listed in the Chart, including the duration and frequency of monitoring, and issues and reactions for which to monitor. The specifications for monitoring and type of monitoring are outlined for ease of access and use by Hospital staff in the High Alert Chart. Paralyzing Agents continue to be included as a High Alert Medication. Pursuant to the High

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Alert Medication Chart, a patient receiving a Paralyzing Agent will have continuous cardiac and respiratory monitoring. In addition, after reassessing guidance from the Institute for Safe Medication Practices (ISMP) the Hospital has added controlled substances, including opioids and benzodiazepines, to the High Alert Medication Policy and Chart. A patient receiving an initial dose of a controlled substance by route as defined by the Hospital’s High Alert Medication Chart, will be continuously monitored by a qualified clinical staff member for at least five minutes and again within the hour if not subject to continuous monitoring based on the patient’s clinical condition.

Additionally, the Hospital has revised its Procedural Sedation Policy (attached) and developed a Minimal Sedation Standard Operating Procedure (“Minimal Sedation SOP”) to include monitoring guidelines for minimal sedation. These guidelines include classification of sedation (minimal, moderate, deep, nitrous), who is eligible to fulfill the monitor role, qualifications of a monitor, education required for monitors, equipment necessary for monitoring, what assessment requirements are (parameters that






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must be included), the frequency of monitoring and the required documentation.

• The Hospital’s Medication Administration Policy has been revised, which revisions were approved on November 27, 2018, to detail required monitoring of patients receiving medications. Specifically, the amended Medication Administration Policy states that the patient’s clinical status is monitored to evaluate patient response to medication and/or adverse reactions, and the duration and frequency of monitoring is based on the patient’s condition, the type of medication, and route of administration. Such monitoring may include, but is not limited to, direct observation, monitoring of vital signs and neuro checks. The Medication Administration Policy has been further amended to require specific documentation in the medical record regarding medication administration and monitoring.

The staff member transporting the patient will know the needed duration and frequency of monitoring by referring to the Hospital’s existing Transport Policy, Transport SOP, the updated High Alert Medication Policy and Chart

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(attached) and any orders for monitoring as entered into the patient’s medical record, as further informed by the staff member’s knowledge of the specific patient’s condition, including information gained during the Hospital’s Clinical Handover Procedure. The Hospital has revised its High Alert Medication Policy and Chart to include specified monitoring parameters for high alert medications. Specifically, a Patient Monitoring column has been added to the High Alert Medication Chart which specifies the monitoring requirements for each type of High Alert Medication listed in the Chart, including the duration and frequency of monitoring, and issues and reactions for which to monitor. The specifications for monitoring and type of monitoring are outlined for ease of access and use by Hospital staff in the High Alert Chart. For example, Paralyzing Agents continue to be included as a High Alert Medication. Pursuant to the High Alert Medication Chart, a patient receiving a Paralyzing Agent will have continuous cardiac and respiratory monitoring. In addition, after reassessing guidance from the Institute for Safe Medication Practices (ISMP) the Hospital has






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added controlled substances, including opioids and benzodiazepines, to the High Alert Medication Policy and Chart. A patient receiving an initial dose of a controlled substance by route as defined by the Hospital’s High Alert Medication Chart, will be continuously monitored by a qualified clinical staff member for at least five minutes and again within the hour if not subject to continuous monitoring based on the patient’s clinical condition.





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In addition, the Hospital’s CL SOP - Clinical Handover Communication procedure (attached) sets forth guidelines to ensure that the communication of information and the transfer of responsibility and authority for the care of a patient between individuals or teams is completed. Clinical handovers follow a Hospital-approved structure that includes the most current patient information (including medication administrations) and interactive communication, with a focus on current condition, plan of care and safety. In the case of an administration of a high alert medication, such as Versed in certain routes of administration, the clinical handover communication would focus on potential cardiopulmonary compromise and applicable monitoring in accordance with the Hospital’s Transport Policy (attached). When a patient is transported off the clinical unit for a test or procedure, the staff will follow the guidance of the Transport

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SOP.

• The Hospital reviewed its policies and procedures related to moderate sedation, specifically the Standard Operating Procedure for Moderate Sedation, to ensure sufficient safeguards are in place. The Hospital determined that it has in place comprehensive guidance regarding the administration of moderate sedation, specifically including procedures for ensuring patients receiving sedation are continuously observed and physiologically monitored throughout the sedation period by a nurse, advanced practice nurse, physician, or other qualified and trained staff as approved by the Hospital’s Sedation Committee. The SOP for Moderate Sedation details the post anesthesia recovery scoring system and score that is required to discontinue monitoring. The SOP for Moderate Sedation also includes conditions for transporting patients who have undergone moderate sedation, including required monitoring. The Hospital has determined that no updates to the SOP for Moderate Sedation are required.

• The Hospital has revised the High Alert Medication Policy and Chart, Transport Policy, Transport SOP,

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Clinical Handover Communication procedure, Procedural Sedation Policy, and Minimal Sedation Standard Operating Procedure (SOP) (each attached) to guide staff in situations requiring monitoring. In addition, staff will provide monitoring as ordered for a patient and documented in the patient’s medical record. To educate the staff on these updates, the Hospital has prepared an educational computer-based learning module which was assigned to all nurses, paramedics, provider staff and pharmacy staff working in inpatient and procedural areas, and approved credentialed providers for moderate or deep sedation, through the Hospital’s on-line Learning Module System on January 25, 2019 with the target completion date of February 4, 2019. Any staff who has not completed the learning module by February 4, 2019 will be required to do so prior to the start of their next shift. The specific policies and standard operating procedures addressed in the learning modules are as follows: High Alert Medication Policy and Chart, Medication Administration Policy, Procedural Sedation Policy and Minimal Sedation Standard






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Operating Procedure.

• Training: By December 3, 2018, the Hospital required all managers, clinical staff leaders (CSLs), nurses, licensed practical nurses (LPNs), respiratory therapists and paramedics working in inpatient and procedural areas of the Hospital to complete education through its on-line education system, which addresses the updates to the Transport Policy, High Alert Medication Policy, and Medication Administration Policy including the requirements for monitoring patients during transport and during and after medication administration, appropriate handover, and related medical record documentation. No clinical staff member listed above has been able to begin a shift after December 3rd without confirmation of training and subsequent competency testing. The Hospital’s Chief Nursing Officers monitor this education requirement and provide regular updates to directors of these departments to ensure compliance. The Hospital’s CNOs oversee this education requirement in collaboration with the Hospital’s education department and local nursing unit leaders. Compliance rates (meaning the clinical staff members required to complete the education who have not yet completed the training) are

12/3/18






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reviewed on a weekly basis by the Hospital’s CNOs. As of January 23, 2019, 1,492 individuals, which is 99% percent of the total number of 1,509 of Hospital’s staff members required to receive the education, had completed the training requirement for monitoring patients during transport and during and after medication administration, appropriate handover, and related medical record documentation. As to paramedics, the Hospital complies with Tenn. Comp. R. & Regs. 1200-12-4-.01. Paramedics at the Hospital only perform extended skills or procedures when such treatment is conducted under authorized medical control and nursing supervision and is within the scope of practice identified in state law. Paramedics employed in this capacity demonstrate continued training and competence in order to perform their professional duties, consistent with their scope of practice. Paramedics work in the Emergency Department, and do not work in inpatient and procedural areas of the Hospital. However, it is possible that a paramedic may transport a patient from the Emergency Department to inpatient or procedural areas, and as such, the Transport Policy would apply to

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such paramedic. Given the potential application to transports, the Hospital is requiring paramedics to complete this additional training and education regarding updated patient monitoring procedures. The Hospital’s job description for paramedics states that paramedics are responsible for triage care in the field and the Emergency Department, and are further responsible for effective communication to ensure safe and quality patient care in transport and handover. The paramedic job description requires paramedics to deliver patient care within the Tennessee paramedic scope of practice. Paramedics are utilized in, and are under the supervision of clinical care providers in, the Hospital’s emergency service/care areas pursuant to TN state law. All paramedics are trained on the Hospital’s CL SOP - Clinical Handover Communication procedure. The Clinical Handover Procedure sets forth guidelines to ensure the communication of information and the transfer of responsibility/authority for the care of the patient between individuals or teams. Clinical handovers follow a Hospital-approved structure that includes the most current patient






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information (including medication administrations) and interactive communication with a focus on current condition, plan of care and safety. In the case of an administration of a high alert medication, such as Versed in certain routes of administration, the clinical handover communication would focus on potential cardiopulmonary compromise and applicable monitoring in accordance with the Hospital’s Transport Policy (attached). Paramedics are also trained on the High Alert Medication Chart (attached) which includes specified monitoring parameters for all high alert medications. Paramedics in the Hospital will receive information pertaining to a patient being transported through the clinical handover process consistent with the Clinical Handover Communication procedure. Through this handover process, the paramedic will be notified of the specific monitoring requirements for the patient. The Paramedic duties are stated within the Paramedic Scope of Practice document (attached).

By December 3, 2018, the Hospital required all current managers, clinical staff leaders (CSLs), nurses,

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licensed practical nurses (LPNs), and respiratory therapists working in inpatient and procedural areas of the Hospital and paramedics working in the Emergency Department to complete computer-based training on the Transport Policy. New clinical staff (which includes nurses and paramedics) must complete this training as a mandatory portion of the Hospital’s clinical orientation. Completion rates for new staff are monitored on a weekly basis.

UPDATE: The Hospital is monitoring the completion of the required training programs, and as of December 18, 2018, 2,514 individuals, which is 99% percent of the Hospital’s staff members required to receive the education, had completed the training requirement for monitoring patients during transport and during and after medication administration, appropriate handover, and related medical record documentation. 1% of staff remain on FMLA, and will not be allowed to return to work until training has been completed. The 2,514 individuals constitutes 99% of the Hospital’s total number of staff members required to complete the training as of December 18, 2018, out of a total






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of 2,563 individuals (at the time) required to complete the training for monitoring patients during transport and during and after medication administration, appropriate handover, and related medical record documentation. Specifically, the Hospital has required all managers, clinical staff leaders (CSLs), nurses, licensed practical nurses (LPNs), respiratory therapists and paramedics working in inpatient and procedural areas of the Hospital to complete education through its on-line education system, which addresses the updates to the Transport Policy, High Alert Medication Policy, and Medication Administration Policy including the requirements for monitoring patients during transport and during and after medication administration, appropriate handover, and related medical record documentation. No clinical staff member listed above has been able to begin a shift after December 3, 2018 without confirmation of training and subsequent competency testing. As of January 25, 2019, 2,502 individuals have completed the training, who represent 98% of the current number of 2,546 managers, clinical staff leaders (CSLs), nurses,






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licensed practical nurses (LPNs), respiratory therapists and paramedics working in inpatient and procedural areas of the Hospital required to complete such training. As to the scoring system, the Hospital’s computer-based training module titled, “2019 FY Moderate Sedation at VUMC” in the Hospital’s online education system addresses the scoring system. Additionally, the Hospital developed a new computer-based training module titled “2019 FY High Alert Medication and Procedural Sedation,” which has been assigned to all nurses, paramedics, provider staff and pharmacy staff working in inpatient and procedural areas, and approved credentialed providers for moderate or deep sedation, to educate them on the revised Procedural Sedation policy. The new module will have a specific post-completion test question directly related to the scoring system. The module will be assigned to all applicable staff on January 25, 2019 with a completion date of February 4, 2019. Any staff member who has not completed the training as of February 4, 2019, will not be allowed to return to work until the module is complete. Any new staff will also be required to

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complete training as a part of the clinical orientation process. The Hospital will monitor staff’s compliance with the use of, and documentation of, the scoring system consistent with Hospital’s applicable policies and procedures.

• A computer-based training module titled “2019 FY Moderate Sedation at VUMC” in the Hospital’s Learning Module System is assigned to applicable staff members upon hire as a part of the mandatory clinical orientation. This training module includes details of the Moderate Sedation policy/guide and direct links to the source documents.

• In addition, the Hospital developed a new computer-based training module titled, “2019 FY High Alert Medication and Procedural Sedation,” which has been assigned via the Hospital’s Learning Module System to all nurses, paramedics, provider staff and pharmacy staff working in inpatient and procedural areas, and approved credentialed providers for moderate or deep sedation, to educate them on the revised Procedural Sedation policy. The module will be assigned to all applicable staff on January 25, 2019

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with a completion date of February 4, 2019. Any staff member who has not completed the training as of February 4, 2019, will not be allowed to return to work until the module is complete.

All of the Hospital’s policies are stored on a central online document management interface (PolicyTech). This document management software allows for all staff members to easily access any of the Hospital’s policies and standard operating procedures. For additional guidance on appropriate monitoring, staff may refer to Lexi-comp Online™ which is readily available via electronic clinical systems or contact the Hospital’s Pharmacy.

• Monitoring: Beginning on December

3, 2018 and continuing for the following three months, the Hospital’s Chief Nursing Officers oversee weekly chart reviews of 5 patients from each unit, randomly selected, to assess for compliance with improvement in medication safety, transport and monitoring of patients. To date, the Hospital’s Chief Nursing Officers have directed the unit level nurse managers’ performance of weekly

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chart reviews of a minimum of five patients from each unit, or 100% of patients transported if the unit has transported less than five patients within the week, to assess for compliance with policies and procedures related to patient monitoring and safe patient transport. The unit level nurse management team has been instructed to select cases for review that facilitate immediate performance feedback to team members, and to evaluate practices on both day and night shift observations. Such patient records are reviewed for documentation of the appropriate monitoring, handover communication, and documentation consistent with the Transport Policy, Medication Administration Policy and High Alert Medication Policy. In the event such an audit reveals non-compliance, inconsistencies or questions, the Chief Nursing Officers will follow-up with the unit level nurse managers for additional steps required to achieve compliance, such as targeted education and training. Results of the chart audit are reported to the CNOs weekly, and the unit level leaders will also consult the CNOs as needed to determine additional steps required






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to achieve compliance. The unit level leaders review the patient movement compliance reports daily. The Chief Nursing Officers will review monthly updates of such chart review audits to the VUMC Nursing Quality Committee.

To further the Hospital’s commitment to safe patient transport, the Hospital has developed a dashboard that permits tracking of inter-facility patient movement, as well as administration of high alert medications. This tool allows for identification, monitoring and ongoing feedback concerning the Hospital’s safe patient transport practices.

UPDATE: As of December 18, 2018, the Hospital’s Chief Nursing Officers have overseen two weekly chart reviews, of 5 patients from each unit. Following the first audit during the week of December 3, 2018, the Hospital’s Chief Nursing Officers determined that the Hospital’s medical record layout required revisions in order to accommodate the additional documentation requirements. Following these updates to the medical record which were effective






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December 10, 2018, the following weekly audit resulted in a compliance rate of 93%. Chart audits are completed in real time, allowing unit managers to provide immediate training to staff who exhibit noncompliance with documentation requirements.


• Appropriate qualifications of staff transporting the patient, based on clinical factors.





• A multi-disciplinary work group comprised of Hospital leaders including Physicians, Pharmacy, Risk, Nursing, Quality, and Health Informatics was convened beginning on January 19, 2018 to assess Paralyzing Agents included






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on the override medication list. This workgroup determined to remove vecuronium from the AcuDose (Hospital’s automated dispensing cabinet) override status list, which removal was approved by the VUMC Pharmacy, Therapeutics and Diagnostic Committee on February 23, 2018 and implemented on March 1, 2018. The work group determined to retain availability of the following Paralyzing Agents in the AcuDose cabinets in the Hospital: rocuronium, succinylcholine, vecuronium and cisatracurium. The work group determined that rocuronium and succinylcholine would remain on the override list, based on the work group’s determination that the clinical risks to patients of not having immediate access to rocuronium and succinylcholine outweighed the potential safety benefits from removing the Paralyzing Agent from override status. The four Paralyzing Agents are medications that must be accessed quickly during an emergency medical event. In particular, the work group considered the potential risks that may arise in the event rocuronium and/or succinylcholine is not available in certain inpatient and procedural areas of the Hospital when needed in an emergency for a






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rapid sequence intubation. The work group determined that vecuronium and cisatracurium would remain available in the AcuDose cabinet, but would be removed from override status list so that they could not be dispensed without a written physician order and pharmacy verification. Vecuronium and cisatracurium were retained in AcuDose based on the fact that manual delivery from the Hospital pharmacy can often take between thirty (30) minutes to one hour to be delivered. Alternatively, dispensing from the AcuDose cabinet can often occur within about ten (10) minutes. It is standard practice to make available in the AcuDose cabinet any medication that is dispensed in a certain volume, particularly given that vecuronium and cisatracurium require a physician order and pharmacist review. Some Paralyzing Agents are contraindicated with patient care requirements, and the selection of a prescribed Paralyzing Agent by a physician is based on the patient’s clinical indications. As such, the work group decided to retain multiple Paralyzing Agents in the AcuDose cabinet. Additionally, as noted elsewhere, the medication administration process has been enhanced with additional security






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measures for all Paralyzing Agents, including shrink wrap packaging and a required Independent Double Check process.

The Hospital’s Medication Safety Officer in partnership with the VUMC Pharmacy, Therapeutics and Diagnostic Committee will reassess the Paralyzing Agents, including rocuronium, on the override list annually. Specifically, in December of each calendar year, the Medication Safety Officer will review the Paralyzing Agents included on the override medication list to determine the appropriateness of the override list. This annual assessment of the Paralyzing Agents included on the override medication list will weigh the clinical risks of having access to certain Paralyzing Agents on the override list against the benefits of removing such Paralyzing Agents from the override list. The Medication Safety Officer will review every case in which rocuronium and/or succinylcholine was dispensed from AcuDose via override; how frequently Paralyzing Agents were dispensed from AcuDose cabinets; whether a delay in accessing the medication causes patient harm; implications related to why staff






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selects a specific Paralyzing Agent; utilization of all Paralyzing Agents available in the AcuDose cabinet; the time of the override compared to medication order; and the time of the override compared to the medication administration time. The determination as to whether or not a delay in accessing the medication causes harm, and whether or not such medication should be available on override status, is a multidisciplinary decision. The Medication Safety Officer considers harm or potential patient harm secondary to medication delay in conjunction with the Hospital’s Pharmacy Policy committee and the VUMC Pharmacy, Therapeutics and Diagnostic Committee.


In addition to the safety measures related to Paralyzing Agents






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outlined herein of Independent Double Check, vial packaging, naming conventions, and system alerts that have been implemented as part of the Plan of Correction, the Hospital has implemented further proactive measures to ensure safe storage and dispensing of Paralyzing Agents. Barcode assisted medication administration (“BCMA”) systems involve the use of scanners and software to verify all medications electronically before they are administered to patients, and further to document the medication in the electronic medication administration record. BCMA systems are utilized where available throughout the Hospital, and the Hospital is implemented BCMA systems in radiology areas by December 11, 2018. The Medication Use Safety Improvement Committee continually monitors trends in data related to medication use and will continue to monitor professional organizations for updated Institute for Safe Medication Practices (ISMP) recommendations as to medication administration. Additionally, the Hospital has performed a gap analysis with the ISMP Targeted Medication Safety Best Practices for Hospitals and has participated in an






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ISMP high alert self-assessment and benchmarking review. Both the gap analysis and high alert self-assessment include a review of Paralyzing Agent practice. The Hospital performs an ongoing review of the ISMP quarterly action agenda recommendations through the Medication Management group, a subcommittee of the Medication Use Safety Improvement Committee.

Further, since 2016 the Hospital’s Pharmacy, Therapeutics and Diagnostics Committee has reviewed every medication introduced to the Hospital’s formulary using a developed Risk Mitigation Plan for Formulary Additions Checklist. This proactive strategy reviews potential failure modes in procurement, clinical decision support, high alert, look alike-sound alike (LASA), adverse drug event risk, hazardous medications, packaging and labeling, order review, preparation, administration, monitoring and transitions of care to prepare our hospital and system for a certain medication. The Medication Use Safety Improvement Committee will continue to oversee and take actions to prevent, monitor and evaluate adverse drug events, particularly through the Medication






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Use Safety Improvement Committee subcommittees on Adverse Drug Events.

• The Hospital has changed the naming convention from “Neuromuscular Blocking Agents”, as referenced in certain policies, including the High Alert Medication Policy, to “Paralyzing Agents” for consistency throughout the Hospital. The Hospital has also standardized the nomenclature utilized for Paralyzing Agents across the Hospital in eStar (Hospital’s electronic medical record) and AcuDose, such that both electronic systems present the name as “PARALYZING AGENT” followed by the medication name. Paralyzing Agents will no longer be able to be pulled up on the AcuDose override screen by typing in the drug name. Instead, “PARA” will be typed in - the first two letters of “Paralyzing Agent” - which will then pull up the list of Paralyzing Agents in the AcuDose cabinet. The four Paralyzing Agents are the only medications that result on both electronic systems in a search for “PARA”. Signs are attached to the AcuDose cabinets indicating that “PARA” must be used to access Paralyzing Agents. The new nomenclature of “Paralyzing Agent: [medication name]” was effective in both eStar and AcuDose as of






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November 27, 2018. Effective on November 27, 2018, this updated procedure is documented by an amendment to the Hospital’s High Alert Medications Charts for both Adult Patients and Pediatric Patients, which are incorporated into the High Alert Medications Policy. These charts have been amended to list the four (4) specific Paralyzing Agents available at the Hospital, and to reflect the updated nomenclature of “Paralyzing Agent [medication name]”.

• On November 27, 2018, the Hospital implemented a warning in AcuDose and eStar, stating: “WARNING: PARALYZING AGENT - Causes Respiratory Arrest – Patient Must Be Ventilated.” The Hospital amended the High Alert Medications Charts for both Adult Patients and Pediatric Patients, effective on November 27, 2018, to specify this pop-up warning as a Specific Safety Strategy for PARALYZING AGENTS.

• On November 27, 2018, the Hospital implemented new procedures for shrink wrap packaging to be added to all vials of Paralyzing Agents dispensed in AcuDose throughout the Hospital, and effective November 27, 2018

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amendments to the Hospital’s High Alert Medications Charts for both Adult Patients and Pediatric Patients were approved to specify a Specific Safety Strategy that all Paralyzing Agents dispensed in AcuDose cabinets throughout the Hospital will have shrink wrap packaging. The Hospital Executive Pharmacy Leadership will monitor compliance with the required shrink wrap packaging of Paralytic Agents by conducting random audits of all AcuDose cabinets throughout the Hospital and validating packaging compliance for a minimum of three months of consecutive 100% compliance. Specifically, beginning with the week of November 26, 2018, each week the directors of the Hospital pharmacies oversee their staff in auditing 25% of the AcuDose cabinets in the Hospital, to inspect all Paralyzing Agents stored in the AcuDose cabinet being audited to determine whether each Paralyzing Agent includes the appropriate shrink wrap packaging. Each week during the month, a different 25% of the AcuDose cabinets is audited, such that 100% of AcuDose cabinets will have been audited within the course of one month. The directors of the Hospital pharmacies will continue to audit 25% of the AcuDose cabinets each week until such audits result in






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three consecutive months of 100% compliance with required shrink wrap packaging procedures. As such, each AcuDose cabinet in the Hospital will be audited at least three times during the audit period. UPDATE: As of December 18, 2018, four weeks of audits have been performed of AcuDose cabinets in the Hospital, and as such, every AcuDose cabinet in the Hospital has been audited. Of the 143 vials of Paralyzing Agents contained in the AcuDose cabinets audited the week of November 25, 2018, three vials were identified without the proper shrink wrap packaging--these vials were discarded. During the weeks of December 2, December 9, and December 16, every vial of a Paralyzing Agent contained in the AcuDose cabinets audited included the required shrink wrap packaging, establishing 100% compliance. UPDATE: As of January 24, 2019, nine weeks of audits have been performed of AcuDose cabinets in the Hospital, and as such, every AcuDose cabinet in the Hospital has been audited at least twice. During the weeks of December 23, December 30, January 6, January 13 and January 20, every vial of a Paralyzing Agent contained in the






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AcuDose cabinets audited included the required shrink wrap packaging, continuing 100% compliance. The weekly Paralyzing Agent compliance audits will continue for three months from November 25, 2018. For ongoing sustainment, monitoring and oversight thereafter, the Hospital has incorporated these weekly audits into the Hospital’s current monthly medication safety checks that are conducted in every unit/area that has medications. This oversight process has become a part of the Hospital’s standard assessment for medication safety.

• As of November 27, 2018, the Hospital finalized and implemented new procedures to require the additional Specific Safety Strategy for all Paralyzing Agents to include an Independent Double Check conducted by two licensed registered nurses prior to the administration of a Paralyzing Agent, where electronic clinical systems prompt dual sign off for bolus doses and upon the following for infusions:


The Hospital has amended the High Alert Medications Charts for both Adult Patients and Pediatric Patients, which revisions were

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approved on November 27, 2018, to specify the Specific Safety Strategy that all Paralyzing Agents require such Independent Double Check. The Double Check process related to patient level detail is documented within the Patient’s Medication Administration Record (MAR), which is located in the Electronic Medical Record (EMR).

The Hospital’s CNOs, Pharmacy and Quality departments are collectively responsible for monitoring compliance with all medication administrations requiring a two-person sign off, which is a component of an independent double check. Prior to a qualified staff member administering the medication, it is scanned through the Barcode Medication Administration (BCMA) tool which forces a dual sign-off. This sign-off prompt requires an additional qualified clinical staff member to confirm the correct medication, correct dose and correct route of administration. Both staff members are then required to acknowledge the double check within the Medication Administration Record (MAR) portion of the Hospital’s Electronic Medical Record (EMR) prior to administration.






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• Training: By November 26, 2018, every nurse and paramedic who work in an area of the Hospital where Paralyzing Agents are available in AcuDose dispensing cabinets, were required to complete an online training module outlining the process changes, Independent Double Check, vial packaging and naming convention changes. Any nurse or paramedic staff member required to complete such training, and who has not completed the computer-based training prior to November 27, 2018 for any reason, including being on vacation or not scheduled to work at the Hospital during the time period, has not been permitted to begin their next shift at the Hospital without first completing the required training.

UPDATE: The Hospital is monitoring the completion of the

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required training programs, and as of December 18, 2018, 1,487 individuals, which is 99% percent of the Hospital’s staff members required to receive the education, had completed the training requirement. 1% of staff remain on FMLA, and will not be allowed to return to work until training has been completed.

Specifically, by November 26, 2018, every nurse and paramedic who works in an area of the Hospital where Paralyzing Agents are available in AcuDose dispensing cabinets, was required to complete an online training module outlining the process changes, dual sign-off, vial packaging and naming convention changes. Any nurse or paramedic staff member required to complete such training, and who had not completed the computer-based training prior to November 27, 2018 for any reason, including being on vacation or not scheduled to work at the Hospital during the time period, has not been permitted to begin their next shift at the Hospital without first completing the required training.

As of January 25, 2019, 1,492 individuals have completed the training, who represent 99% of the Hospital’s total number of 1,509 nurses and paramedic staff

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members required to complete such training.

• Monitoring: The Hospital has implemented several measures to monitor compliance with the updated medication administration requirements. Beginning on November 27, 2018, the Hospital’s Enterprise Medication Safety Officer, in collaboration with the Chief Nursing Officers, Executive Pharmacy Leadership, and Chief of Staff, began to compile monthly reports of overrides from AcuDose cabinets for Paralyzing Agents, which will be reviewed at the medication safety committee, as well as on the unit level, and assessed for appropriateness. Such monthly reporting will be ongoing, and continue for three months following November 27, 2018. Thereafter, and continuing indefinitely the Enterprise Medication Safety Officer will continue to review all unreconciled dispense reports that identify medication overrides without an order linked, and provide monthly override performance reports to the medication safety committee as part of ongoing medication safety committee work. In the event such monthly reports reveal non-compliance, inconsistencies or questions, the medication safety

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committee will elevate these issues to Chief Nursing Officers, Executive Pharmacy Leadership, and Chief of Staff to determine whether additional steps are required for compliance, such as targeted education and/or training.

When a provider electronically enters an order for a medication, the order is verified by the Hospital Pharmacy, and then the medication is available in the AcuDose cabinet under the patient’s specific profile. In the event of an emergency (i.e., acute patient decompensation where delay of necessary medication would cause harm) certain medications may need to be obtained from the AcuDose cabinet as an override prior to pharmacy verification. There will always be an order (entered electronically or given verbally in an emergency) for any medication prior to administration, consistent with the Hospital’s Provider Order Policy.

As noted by the Institute for Safe Medication Practices (ISMP) (attached), there are important, legitimate reasons for the medication override process in emergent situations (i.e., antidotes, rescue and reversal agents, and






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life-sustaining medications).

In addition, beginning on November 27, 2018 and continuing on a monthly basis until 100% compliance is achieved, Hospital’s Chief Nursing Officers began to review monthly reports of Independent Double Check, in order to verify compliance with the Independent Double Check procedure for Paralyzing Agents. Such monthly reporting will be provided to medication safety committees and the Hospital’s Nursing Quality Committee.


UPDATE: In order to evaluate initial compliance of staff overrides related to paralyzing agents, audit

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frequency has been increased to weekly for the first month, after which the audits will be conducted on a monthly frequency. As of December 18, 2018, the Hospital’s Enterprise Medication Safety Officer, in collaboration with the Chief Nursing Officers, Executive Pharmacy Leadership, and Chief of Staff have completed three weekly reviews of overrides from AcuDose cabinets for Paralyzing Agents, which weekly report has been reviewed at the medication safety committee, as well as on the unit level, and assessed for appropriateness. This weekly review showed a 95% compliance rate with the Hospital’s policies and procedures regarding overrides of Paralyzing Agents. As of December 18 2018, the Hospital’s Chief Nursing Officers have completed three weekly reviews in order to verify compliance with the Independent Double Check procedure for Paralyzing Agents. These three weekly reviews each showed a 100% compliance rate.

The Hospital is developing a unit-specific override compliance dashboard to provide ongoing monitoring and ensure compliance of overrides of high alert medications. This expands the Hospital’s review of overrides of Paralyzing Agents to include all






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high alert medications. System-level compliance throughout the Hospital will continue to be monitored by the Hospital’s Medication Usage Safety Improvement Committee.


• In regard to nurse training on medication administration, medical record documentation, and monitoring of patients receiving medication, all newly hired nurses are required to complete computer-based training related to the preparation of drugs and safe medication practices. All nurse residents, who are new graduate registered nurses hired with less than six months of nursing experience, are required to complete such education regarding safe medication practices, as well as attend a workshop on medication safety. These trainings have been updated to include education as to the revisions to the Medication Policy, the new nomenclature for Paralyzing Agents, the updated requirements for monitoring patients receiving High Alert Medications.

• Further, all nurses and nurse






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residents receive ongoing education on an annual basis regarding a variety of topics determined by Hospital nurse leaders, educators and staff. Nursing staff must validate competency in the identified topics between January and June of each calendar year through a variety of methods, including an online learning module, skill validation on a mannequin, observation of daily practice, etc. The Hospital will include medication administration, patient monitoring, documentation and other issues discussed in this Plan of Correction in such annual competencies, as appropriate and based on the issues revealed in results of the audits described herein.


• The Hospital has updated Scope of Care documents in each department that relies on a “Help All Nurse” (or similar position), in order to define the applicable role and duties. At the Hospital, “Resource Nurse” is generally used to describe a nursing role that usually does not take patient assignment during the shift but takes direction from the

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Clinical Staff Leader or Resource Staff Leader to assist other nurses as workloads demand, including rapid response teams, STAT calls, and transports. Resource Nurse roles in various departments include Float Nurse; Procedural Nurse; Admit Discharge, Transfer Nurse; and Patient Flow Nurse. The Scopes of Care were revised in intensive care units and non-intensive care units to define the applicable Resource Nurse role (including the “Help All Nurse” as applicable) by November 20, 2018. Nursing leadership of each Hospital department that utilizes such a Resource Nurse role will review the departments Scope of Care document on an annual basis to ensure duties of the position remain complete and accurate.

The role of the Resource Nurse, or “Help All” nurse, within the unit is a staffing assignment, rather than a position in which a nurse is employed with a job title, therefore no job description exists. The following are details surrounding this unit assignment. A Resource Nurse (e.g., Float Nurse, Procedural Nurse, Help-All Nurse, ADT (admit, discharge, transfer) Nurse, and Patient Flow Nurse), is a nursing role that may be available if the unit has adequate baseline staffing to utilize such a






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Resource Nurse, who usually does not take patient assignment. The role of the Resource Nurse will be assigned by the Clinical Staff Leader (more commonly known as Charge Nurse) to assist unit RNs with patient assignments as work demands. Tasks assigned may include but are not limited to providing procedural assistance, and participating in Rapid Response Team response, STAT response, admission/ discharge or transfer processes, relief coverage (breaks and lunch) and patient transport. Staff serving in a Resource Nurse capacity must, at a minimum, be an RN II, which is attained after one year of relevant clinical experience. The nurse is required to be oriented to the role with a nurse experienced in the Resource Nurse role prior to taking on the role of this assignment. All staff within the units are aware of the Resource Nurse duties and are encouraged to utilize this resource opportunity to enhance patient safety and care. The role of Resource Nurses is not different from the role of the bedside nurse and thus, the Resource Nurse possesses the same knowledge and competencies as all nurses on the unit. The nurses in question simply do not take a patient






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assignment and are available to assist the nurses on the unit with the types of tasks described above.


The Hospital has revised its policy previously titled Transport of the Critically Ill Patient, which revisions were approved on November 27, 2018, to broaden application of the policy beyond critically ill patients. As such, the newly amended policy is titled “Transport of Patients” (hereinafter, “Transport Policy”). This policy provides that every patient shall be transported with equipment, supplies, and staff appropriate to monitor and support the patient’s physiological needs. Physiological “needs” in the context of this statement refers to a patient’s medical requirements, based on the patient’s current clinical condition and clinical course of treatment as determined by the multidisciplinary healthcare team. An example would include a patient with provider-ordered cardiac

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telemetry monitoring would be transported with the monitor unless there is an order stating otherwise. The policy details that the level of care is maintained during transport and after arrival at the receiving department/unit, and describes specific monitoring and documentation requirements. The amended policy states that when a patient requires continuous monitoring, a clinical staff member is required to be available to receive handover of the patient pursuant to the Hospital’s CL SOP - Clinical Handover Communication procedure. Any such handover will be documented in the medical record. In the event a clinical staff member is not available to receive the patient, the transporting clinical staff member must remain with the patient. Further, the Transport Policy states that patients receiving medications that could lead to respiratory depression and/or respiratory distress are monitored during and after transport, with the duration and frequency of the monitoring to be based on the patient’s condition, type of medication, and route. Documentation will be in accordance with VUMC’s Medication Administration Policy. The Transport Policy further states that such monitoring may include, but is not limited to, direct observation, vital signs, and neuro checks. The revised Transport






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Policy further requires appropriate documentation to be completed in the patient’s medical record upon leaving and returning to the unit, including the times the patient leaves and returns to the unit. The clinical staff members who may transport patients include RNs, paramedics and other clinical staff as outlined in the Transport Policy and associated Standard Operating Procedure entitled “Transport of Patients Receiving Medications That May Cause Impaired Consciousness or Undesired Changes in Vital Signs” (“Transport SOP”), which is further described below. For purposes of transport of patients, staff appropriate to monitor and support the patient’s physiological needs is determined based on the patient’s current clinical condition. Further, a non-clinical staff member may transport a patient in the event a patient’s physiological needs do not require monitoring or support pursuant to the Transport Policy and Transport SOP, Medication Administration Policy, or High Alert Medication Policy. In December 2018, the Hospital adopted the Transport SOP, which sets forth specific parameters for transport of adult patients in Vanderbilt University Hospital that have received medication that may cause impaired consciousness or undesired changes in vital signs, other than critically ill patients who are






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addressed in the Transport Policy. The SOP was amended in January 2019 and provides as follows in regard to staff members who may transport patients:





Patient is on PCA/epidural/continuous controlled substance infusion with a change in medication, dose, concentration, or rate of administration within the last hour, maintaining consistency with MM SOP - Patient-Controlled Analgesia (PCA) and Continuous Controlled Substance Infusion: Administration and






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Management.












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Patient on

PCA/epidural/continuous controlled substance infusion with no change in medication, dose, concentration, or rate of administration within the last hour.


patient during transport and observe if needed. All clinical staff members assigned to monitor patients are qualified to monitor for medication reactions, including for respiratory distress. These qualifications are set forth in the staff member’s respective job descriptions, training, licensing prerequisites and ongoing competency requirements. In regard to transport of patients, the determination of staff appropriate to monitor and support the patient’s physiological needs is based on the patient’s clinical condition, as described in the Transport Policy and Transport SOP.

• Beginning on December 3, 2018, the Hospital staffed a nurse in the radiology department, whose role is to provide surveillance of patients who have not met the criteria to be accompanied by a licensed professional. The Radiology

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Resource Nurse (RRN) is responsible for patients who do not require the consistent presence of a nurse for monitoring or supporting the patient’s physiological needs, pursuant to the Transport Policy and Transport SOP and other policies related to patient monitoring. In this context, “surveillance” means that the RRN will be expected to have situational awareness of patients present in the Radiology area, be accessible to the members of the Radiology team and stay at the side of, and provide care and assistance to, any patient whose condition changes while in the Radiology area. The RRN will also call on additional support as needed for the care of a patient. Such surveillance is achieved by a combination of the RRN’s physical presence in the Radiology area, as well as real-time audio and video monitoring of patients in the Radiology area and real-time communication with other staff members conducting real-time audio and video monitoring of patients in the Radiology area. This nurse will also act as a resource to the radiology technologists and licensed professionals accompanying patients, and serve as liaison between the radiology department and the inpatient care areas to facilitate safe, patient






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transports to radiology. This nurse position is staffed Monday through Friday, from 7am to 4pm. When this nurse is not the revised Transport policy will apply to require the transporting clinical staff member to remain with the patient. VUMC is currently posting nursing positions to create around the clock staffing of the nurse in the radiology department. As of January 1, 2019, the Hospital extended radiology nurse coverage from 7 am to 7 pm. As of January 21, 2019, the Hospital extended radiology resource nurse coverage to 24 hours per day, 7 days a week. Each patient that requires monitoring based on the Transport Policy and its associated SOP, the Medication Administration Policy, or any patient specific provider orders is being accompanied to the radiology department and monitored by a nurse or paramedic consistent with the applicable policies. In the event the radiology nurse has reached capacity of patients to monitor or is not otherwise available to receive handover of patients, in accordance with the revised Transport Policy, the clinical staff member(s) transporting additional patients to the radiology areas will remain with the patient they are transporting.

• The Hospital has revised its High






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Alert Medication Policy, which revisions were approved on November 27, 2018, to detail required monitoring of patients receiving administration of high alert medications. Specifically, the amended High Alert Medication Policy states that the patient’s clinical status is monitored to evaluate patient response to medication and/or adverse reactions, and the duration and frequency of monitoring is based on the patient’s condition, the type of medication, and route of administration. Such monitoring may include, but is not limited to, direct observation, monitoring of vital signs and neurological status. In accordance with the revisions made to the Hospital’s High Alert Medication Policy and Chart, Paralyzing Agents and controlled substances have parameters for monitoring that vary based on the specific medication. For example, a patient receiving an intermittent dose of a controlled substance intravenously, who is not on continuous monitoring (cardiac or pulse oximetry) will be visually observed for at least five minutes by clinical staff and are subsequently reassessed within one hour. The Hospital has revised its High Alert Medication Policy and Chart to include specified monitoring

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parameters for high alert medications. Specifically, a Patient Monitoring column has been added to the High Alert Medication Chart which specifies the monitoring requirements for each type of High Alert Medication listed in the Chart, including the duration and frequency of monitoring, and issues and reactions for which to monitor. The specifications for monitoring and type of monitoring are outlined for ease of access and use by Hospital staff in the High Alert Chart. Paralyzing Agents continue to be included as a High Alert Medication. Pursuant to the High Alert Medication Chart, a patient receiving a Paralyzing Agent will have continuous cardiac and respiratory monitoring. In addition, after reassessing guidance from the Institute for Safe Medication Practices (ISMP) the Hospital has added controlled substances, including opioids and benzodiazepines, to the High Alert Medication Policy and Chart. A patient receiving an initial dose of a controlled substance by route as defined by the Hospital’s High Alert Medication Chart, will be continuously monitored by a qualified clinical staff member for at least five minutes and again within the hour if not subject to continuous monitoring based on the patient’s






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clinical condition.


• The Hospital’s Medication Administration Policy has been revised, which revisions were approved on November 27, 2018, to detail required monitoring of patients receiving medications. Specifically, the amended Medication Administration Policy states that the patient’s clinical status is monitored to evaluate patient response to medication and/or adverse reactions, and the duration and frequency of monitoring is based on the patient’s condition, the type of medication, and route of administration. Such

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monitoring may include, but is not limited to, direct observation, monitoring of vital signs and neuro checks. The Medication Administration Policy has been further amended to require specific documentation in the medical record regarding medication administration and monitoring.

The staff member transporting the patient will know the needed duration and frequency of monitoring by referring to the Hospital’s existing Transport Policy, Transport SOP, the updated High Alert Medication Policy and Chart (attached) and any orders for monitoring as entered into the patient’s medical record, as further informed by the staff member’s knowledge of the specific patient’s condition, including information gained during the Hospital’s Clinical Handover Procedure. The Hospital has revised its High Alert Medication Policy and Chart to include specified monitoring parameters for high alert medications. Specifically, a Patient Monitoring column has been added to the High Alert Medication Chart which specifies the monitoring requirements for each type of High Alert Medication listed in the Chart, including the duration and






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frequency of monitoring, and issues and reactions for which to monitor. The specifications for monitoring and type of monitoring are outlined for ease of access and use by Hospital staff in the High Alert Chart. For example, Paralyzing Agents continue to be included as a High Alert Medication. Pursuant to the High Alert Medication Chart, a patient receiving a Paralyzing Agent will have continuous cardiac and respiratory monitoring. In addition, after reassessing guidance from the Institute for Safe Medication Practices (ISMP) the Hospital has added controlled substances, including opioids and benzodiazepines, to the High Alert Medication Policy and Chart. A patient receiving an initial dose of a controlled substance by route as defined by the Hospital’s High Alert Medication Chart, will be continuously monitored by a qualified clinical staff member for at least five minutes and again within the hour if not subject to continuous monitoring based on the patient’s clinical condition.

The Hospital has further revised its Medication Administration Policy (attached). The revised Medication






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Administration Policy includes the following direction for monitoring the patient’s clinical status and response to medications and/or adverse reactions:





In addition, the Hospital’s CL SOP - Clinical Handover Communication procedure (attached) sets forth guidelines to ensure that the communication of information and the transfer of responsibility and authority for the care of a patient between individuals or teams is completed. Clinical handovers follow a Hospital-approved structure that includes the most current patient information (including medication administrations) and






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interactive communication, with a focus on current condition, plan of care and safety. In the case of an administration of a high alert medication, such as Versed in certain routes of administration, the clinical handover communication would focus on potential cardiopulmonary compromise and applicable monitoring in accordance with the Hospital’s Transport Policy (attached). When a patient is transported off the clinical unit for a test or procedure, the staff will follow the guidance of the Transport SOP.

• The Hospital reviewed its policies and procedures related to moderate sedation, specifically the Standard Operating Procedure for Moderate Sedation, to ensure sufficient safeguards are in place. The Hospital determined that its has in place comprehensive guidance regarding the administration of moderate sedation, specifically including procedures for ensuring patients receiving sedation are continuously observed and physiologically monitored throughout the sedation period by a nurse, advanced practice nurse, physician, or other qualified and trained staff as approved by the Hospital’s Sedation Committee. The SOP for Moderate Sedation details






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the post anesthesia recovery scoring system and score that is required to discontinue monitoring. The SOP for Moderate Sedation also includes conditions for transporting patients who have undergone moderate sedation, including required monitoring. The Hospital has determined that no updates to the SOP for Moderate Sedation are required.

• The Hospital has revised the High Alert Medication Policy and Chart, Transport Policy, Transport SOP, Clinical Handover Communication procedure, Procedural Sedation Policy, and Minimal Sedation Standard Operating Procedure (SOP) (each attached) to guide staff in situations requiring monitoring. In addition, staff will provide monitoring as ordered for a patient and documented in the patient’s medical record. To educate the staff on these updates, the Hospital has prepared an educational computer-based learning module which was assigned to all nurses, paramedics, provider staff and pharmacy staff working in inpatient and procedural areas, and approved credentialed providers for moderate or deep sedation, through the Hospital’s on-line Learning Module System on January 25, 2019 with the target






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completion date of February 4, 2019. Any staff who has not completed the learning module by February 4, 2019 will be required to do so prior to the start of their next shift. The specific policies and standard operating procedures addressed in the learning modules are as follows: High Alert Medication Policy and Chart, Medication Administration Policy, Procedural Sedation Policy and Minimal Sedation Standard Operating Procedure.

• Training: By December 3, 2018, the Hospital is requiring all managers, clinical staff leaders (CSLs), nurses, licensed practical nurses (LPNs), respiratory therapists and paramedics working in inpatient and procedural areas of the Hospital to complete education through its on-line education system, which addresses the updates to the Transport Policy, High Alert Medication Policy, and Medication Administration Policy including the requirements for monitoring patients during transport and during and after medication administration, appropriate handover, and related medical record documentation. No clinical staff member listed above has been able to begin their shift after December 3rd without confirmation of training and

12/3/18






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subsequent competency testing. The Hospital’s Chief Nursing Officers monitor this education requirement and provide regular updates to directors of these departments to ensure compliance. The Hospital’s CNOs oversee this education requirement in collaboration with the Hospital’s education department and local nursing unit leaders. Compliance rates (meaning the clinical staff members required to complete the education who have not yet completed the training) are reviewed on a weekly basis by the Hospital’s CNOs. As of January 23, 2019, 1,492 individuals, which is 99% percent of the total number of 1,509 of Hospital’s staff members required to receive the education, had completed the training requirement for monitoring patients during transport and during and after medication administration, appropriate handover, and related medical record documentation.

As to paramedics, the Hospital complies with Tenn. Comp. R. & Regs. 1200-12-4-.01. Paramedics at the Hospital only perform extended skills or procedures when such treatment is conducted under authorized medical control and nursing supervision and is within the scope of practice identified in state






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law. Paramedics employed in this capacity demonstrate continued training and competence in order to perform their professional duties, consistent with their scope of practice. Paramedics work in the Emergency Department, and do not work in inpatient and procedural areas of the Hospital. However, it is possible that a paramedic may transport a patient from the Emergency Department to inpatient or procedural areas, and as such, the Transport Policy would apply to such paramedic. Given the potential application to transports, the Hospital is requiring paramedics to complete this additional training and education regarding updated patient monitoring procedures. The Hospital’s job description for paramedics states that paramedics are responsible for triage care in the field and the Emergency Department, and are further responsible for effective communication to ensure safe and quality patient care in transport and handover. The paramedic job description requires paramedics to deliver patient care within the Tennessee paramedic scope of practice. Paramedics are utilized in, and are under the supervision of clinical care providers in, the






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Hospital’s emergency service/care areas pursuant to TN state law. All paramedics are trained on the Hospital’s CL SOP - Clinical Handover Communication procedure. The Clinical Handover Procedure sets forth guidelines to ensure the communication of information and the transfer of responsibility/authority for the care of the patient between individuals or teams. Clinical handovers follow a Hospital-approved structure that includes the most current patient information (including medication administrations) and interactive communication with a focus on current condition, plan of care and safety. In the case of an administration of a high alert medication, such as Versed in certain routes of administration, the clinical handover communication would focus on potential cardiopulmonary compromise and applicable monitoring in accordance with the Hospital’s Transport Policy (attached). Paramedics are also trained on the High Alert Medication Chart (attached) which includes specified monitoring parameters for all high alert medications. Paramedics in the Hospital will receive information pertaining to a patient being transported through






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the clinical handover process consistent with the Clinical Handover Communication procedure. Through this handover process, the paramedic will be notified of the specific monitoring requirements for the patient. The Paramedic duties are stated within the Paramedic Scope of Practice document (attached).


UPDATE: The Hospital is monitoring the completion of the required training programs, and as of December 18, 2018, 2,514 individuals, which is 99% percent of the Hospital’s staff members required to receive the education,

12/3/18






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had completed the training requirement for monitoring patients during transport and during and after medication administration, appropriate handover, and related medical record documentation. 1% of staff remain on FMLA, and will not be allowed to return to work until training has been completed. The 2,514 individuals constitutes 99% of the Hospital’s total number of staff members required to complete the training as of December 18, 2018, out of a total of 2,563 individuals (at the time) required to complete the training for monitoring patients during transport and during and after medication administration, appropriate handover, and related medical record documentation. Specifically, the Hospital has required all managers, clinical staff leaders (CSLs), nurses, licensed practical nurses (LPNs), respiratory therapists and paramedics working in inpatient and procedural areas of the Hospital to complete education through its on-line education system, which addresses the updates to the Transport Policy, High Alert Medication Policy, and Medication Administration Policy including the requirements for monitoring patients during






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transport and during and after medication administration, appropriate handover, and related medical record documentation. No clinical staff member listed above has been able to begin a shift after December 3, 2018 without confirmation of training and subsequent competency testing. As of January 25, 2019, 2,502 individuals have completed the training, who represent 98% of the current number of 2,546 managers, clinical staff leaders (CSLs), nurses, licensed practical nurses (LPNs), respiratory therapists and paramedics working in inpatient and procedural areas of the Hospital required to complete such training.

As to the scoring system, the Hospital’s computer-based training module titled, “2019 FY Moderate Sedation at VUMC” in the Hospital’s online education system addresses the scoring system. Additionally, the Hospital developed a new computer-based training module titled “2019 FY High Alert Medication and Procedural Sedation,” which has been assigned to all nurses, paramedics, provider staff and pharmacy staff working in inpatient and procedural areas, and approved credentialed providers for moderate






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or deep sedation, working in inpatient and procedural areas, and approved credentialed providers for moderate or deep sedation, to educate them on the revised Procedural Sedation policy. The new module will have a specific post-completion test question directly related to the scoring system. The module will be assigned to all applicable staff on January 25, 2019 with a completion date of February 4, 2019. Any staff member who has not completed the training as of February 4, 2019, will not be allowed to return to work until the module is complete. Any new staff will also be required to complete training as a part of the clinical orientation process. The Hospital will monitor staff’s compliance with the use of, and documentation of, the scoring system consistent with Hospital’s applicable policies and procedures.







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All of the Hospital’s policies are stored on a central online document management interface (PolicyTech). This document management software allows for all staff members to easily access any of the Hospital’s policies and standard operating procedures. For additional guidance on appropriate monitoring, staff may refer to Lexi-comp Online™ which is readily available

2/4/19






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via electronic clinical systems or contact the Hospital’s Pharmacy.

• Monitoring: Beginning on December 3, 2018 and continuing for the following three months, the Hospital’s Chief Nursing Officers oversee weekly chart reviews of 5 patients from each unit, randomly selected, to assess for compliance with improvement in medication safety, transport and monitoring of patients. To date, the Hospital’s Chief Nursing Officers have directed the unit level nurse managers’ performance of weekly chart reviews of a minimum of five patients from each unit, or 100% of patients transported if the unit has transported less than five patients within the week, to assess for compliance with policies and procedures related to patient monitoring and safe patient transport. The unit level nurse management team has been instructed to select cases for review that facilitate immediate performance feedback to team members, and to evaluate practices on both day and night shift observations. Such patient records are reviewed for documentation of the appropriate monitoring, handover communication, and

12/3/18






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documentation consistent with the Transport Policy, Medication Administration Policy and High Alert Medication Policy. In the event such an audit reveals non-compliance, inconsistencies or questions, the Chief Nursing Officers will follow-up with the unit level nurse managers for additional steps required to achieve compliance, such as targeted education and training. Results of the chart audit are reported to the CNOs weekly, and the unit level leaders will also consult the CNOs as needed to determine additional steps required to achieve compliance. The unit level leaders review the patient movement compliance reports daily. The Chief Nursing Officers will review monthly updates of such chart review audits to the VUMC Nursing Quality Committee.

To further the Hospital’s commitment to safe patient transport, the Hospital has developed a dashboard that permits tracking of inter-facility patient movement, as well as administration of high alert medications. This tool allows for identification, monitoring and ongoing feedback concerning the Hospital’s safe patient transport






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practices.




• Time Left Unit. • Patient destination.






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• Handover report (if appropriate). • Time returned to unit (unless




• A multi-disciplinary work group comprised of Hospital leaders including Physicians, Pharmacy, Risk, Nursing, Quality, and Health Informatics was convened beginning on January 19, 2018 to assess Paralyzing Agents included on the override medication list. This workgroup determined to remove vecuronium from the AcuDose (Hospital’s automated dispensing cabinet) override status list, which removal was approved by the VUMC Pharmacy, Therapeutics and Diagnostic Committee on February 23, 2018 and implemented on March 1, 2018. The work group determined to retain availability of the following Paralyzing Agents in the AcuDose cabinets in the Hospital: rocuronium, succinylcholine, vecuronium and cisatracurium. The work group determined that rocuronium and succinylcholine would remain on the override list, based on the work group’s determination that the






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clinical risks to patients of not having immediate access to rocuronium and succinylcholine outweighed the potential safety benefits from removing the Paralyzing Agent from override status. The four Paralyzing Agents are medications that must be accessed quickly during an emergency medical event. In particular, the work group considered the potential risks that may arise in the event rocuronium and/or succinylcholine is not available in certain inpatient and procedural areas of the Hospital when needed in an emergency for a rapid sequence intubation. The work group determined that vecuronium and cisatracurium would remain available in the AcuDose cabinet, but would be removed from override status list so that they could not be dispensed without a written physician order and pharmacy verification. Vecuronium and cisatracurium were retained in AcuDose based on the fact that manual delivery from the Hospital pharmacy can often take between thirty (30) minutes to one hour to be delivered. Alternatively, dispensing from the AcuDose cabinet can often occur within about ten (10) minutes. It is standard practice to make available in the AcuDose cabinet any medication






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that is dispensed in a certain volume, particularly given that vecuronium and cisatracurium require a physician order and pharmacist review. Some Paralyzing Agents are contraindicated with patient care requirements, and the selection of a prescribed Paralyzing Agent by a physician is based on the patient’s clinical indications. As such, the work group decided to retain multiple Paralyzing Agents in the AcuDose cabinet. Additionally, as noted elsewhere, the medication administration process has been enhanced with additional security measures for all Paralyzing Agents, including shrink wrap packaging and a required Independent Double Check process.

The Hospital’s Medication Safety Officer in partnership with the VUMC Pharmacy, Therapeutics and Diagnostic Committee will reassess the Paralyzing Agents, including rocuronium, on the override list annually. Specifically, in December of each calendar year, the Medication Safety Officer will review the Paralyzing Agents included on the override medication list to determine the appropriateness of the override list. This annual assessment of the Paralyzing Agents included on the override






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medication list will weigh the clinical risks of having access to certain Paralyzing Agents on the override list against the benefits of removing such Paralyzing Agents from the override list. The Medication Safety Officer will review every case in which rocuronium and/or succinylcholine was dispensed from AcuDose via override; how frequently Paralyzing Agents were dispensed from AcuDose cabinets; whether a delay in accessing the medication causes patient harm; implications related to why staff selects a specific Paralyzing Agent; utilization of all Paralyzing Agents available in the AcuDose cabinet; the time of the override compared to medication order; and the time of the override compared to the medication administration time. The determination as to whether or not a delay in accessing the medication causes harm, and whether or not such medication should be available on override status, is a multidisciplinary decision. The Medication Safety Officer considers harm or potential patient harm secondary to medication delay in conjunction with the Hospital’s Pharmacy Policy committee and the VUMC Pharmacy, Therapeutics and






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Diagnostic Committee.


In addition to the safety measures related to Paralyzing Agents outlined herein of Independent Double Check, vial packaging, naming conventions, and system alerts that have been implemented as part of the Plan of Correction, the Hospital has implemented further proactive measures to ensure safe storage and dispensing of Paralyzing Agents. Barcode assisted medication administration (“BCMA”) systems involve the use of scanners and software to verify all medications electronically before they are administered to patients, and further to document the medication in the electronic medication administration record. BCMA systems are utilized where available throughout the Hospital,






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and the Hospital is implemented BCMA systems in radiology areas by December 11, 2018. The Medication Use Safety Improvement Committee continually monitors trends in data related to medication use and will continue to monitor professional organizations for updated Institute for Safe Medication Practices (ISMP) recommendations as to medication administration. Additionally, the Hospital has performed a gap analysis with the ISMP Targeted Medication Safety Best Practices for Hospitals and has participated in an ISMP high alert self-assessment and benchmarking review. Both the gap analysis and high alert self-assessment include a review of Paralyzing Agent practice. The Hospital performs an ongoing review of the ISMP quarterly action agenda recommendations through the Medication Management group, a subcommittee of the Medication Use Safety Improvement Committee.

Further, since 2016 the Hospital’s Pharmacy, Therapeutics and Diagnostics Committee has reviewed every medication introduced to the Hospital’s formulary using a developed Risk Mitigation Plan for Formulary

12/11/18






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Additions Checklist. This proactive strategy reviews potential failure modes in procurement, clinical decision support, high alert, look alike-sound alike (LASA), adverse drug event risk, hazardous medications, packaging and labeling, order review, preparation, administration, monitoring and transitions of care to prepare our hospital and system for a certain medication. The Medication Use Safety Improvement Committee will continue to oversee and take actions to prevent, monitor and evaluate adverse drug events, particularly through the Medication Use Safety Improvement Committee subcommittees on Adverse Drug Events.

• The Hospital has changed the naming convention from “Neuromuscular Blocking Agents”, as referenced in certain policies, including the High Alert Medication Policy, to “Paralyzing Agents” for consistency throughout the Hospital. The Hospital has also standardized the nomenclature utilized for Paralyzing Agents across the Hospital in eStar (Hospital’s electronic medical record) and AcuDose, such that both electronic systems present the name as “PARALYZING AGENT” followed by the medication name. Paralyzing Agents will no longer be

11/27/18






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able to be pulled up on the AcuDose override screen by typing in the drug name. Instead, “PARA” will be typed in - the first two letters of “Paralyzing Agent” - which will then pull up the list of Paralyzing Agents in the AcuDose cabinet. The four Paralyzing Agents are the only medications that result on both electronic systems in a search for “PARA”. Signs are attached to the AcuDose cabinets indicating that “PARA” must be used to access Paralyzing Agents. The new nomenclature of “Paralyzing Agent: [medication name]” was effective in both eStar and AcuDose as of November 27, 2018. Effective on November 27, 2018, this updated procedure is documented by an amendment to the Hospital’s High Alert Medications Charts for both Adult Patients and Pediatric Patients, which are incorporated into the High Alert Medications Policy. These charts have been amended to list the four (4) specific Paralyzing Agents available at the Hospital, and to reflect the updated nomenclature of “Paralyzing Agent [medication name]”.

• On November 27, 2018, the Hospital implemented a warning in AcuDose and eStar, stating: “WARNING: PARALYZING AGENT - Causes Respiratory Arrest – Patient Must Be Ventilated.” The

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Hospital amended the High Alert Medications Charts for both Adult Patients and Pediatric Patients, effective on November 27, 2018, to specify this pop-up warning as a Specific Safety Strategy for PARALYZING AGENTS.

• On November 27, 2018, the Hospital implemented new procedures for shrink wrap packaging to be added to all vials of Paralyzing Agents dispensed in AcuDose throughout the Hospital, and effective November 27, 2018 amendments to the Hospital’s High Alert Medications Charts for both Adult Patients and Pediatric Patients were approved to specify a Specific Safety Strategy that all Paralyzing Agents dispensed in AcuDose cabinets throughout the Hospital will have shrink wrap packaging. The Hospital Executive Pharmacy Leadership will monitor compliance with the required shrink wrap packaging of Paralytic Agents by conducting random audits of all AcuDose cabinets throughout the Hospital and validating packaging compliance for a minimum of three months of consecutive 100% compliance. Specifically, beginning with the week of November 26, 2018, each week the directors of the Hospital pharmacies oversee their staff in auditing 25% of the AcuDose cabinets in the Hospital,

11/27/18






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to inspect all Paralyzing Agents stored in the AcuDose cabinet being audited to determine whether each Paralyzing Agent includes the appropriate shrink wrap packaging. Each week during the month, a different 25% of the AcuDose cabinets is audited, such that 100% of AcuDose cabinets will have been audited within the course of one month. The directors of the Hospital pharmacies will continue to audit 25% of the AcuDose cabinets each week until such audits result in three consecutive months of 100% compliance with required shrink wrap packaging procedures. As such, each AcuDose cabinet in the Hospital will be audited at least three times during the audit period. UPDATE: As of December 18, 2018, four weeks of audits have been performed of AcuDose cabinets in the Hospital, and as such, every AcuDose cabinet in the Hospital has been audited. Of the 143 vials of Paralyzing Agents contained in the AcuDose cabinets audited the week of November 25, 2018, three vials were identified without the proper shrink wrap packaging--these vials were discarded. During the weeks of December 2, December 9, and December 16, every vial of a Paralyzing Agent contained in the






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AcuDose cabinets audited included the required shrink wrap packaging, establishing 100% compliance. UPDATE: As of January 24, 2019, nine weeks of audits have been performed of AcuDose cabinets in the Hospital, and as such, every AcuDose cabinet in the Hospital has been audited at least twice. During the weeks of December 23, December 30, January 6, January 13 and January 20, every vial of a Paralyzing Agent contained in the AcuDose cabinets audited included the required shrink wrap packaging, continuing 100% compliance. The weekly Paralyzing Agent compliance audits will continue for three months from November 25, 2018. For ongoing sustainment, monitoring and oversight thereafter, the Hospital has incorporated these weekly audits into the Hospital’s current monthly medication safety checks that are conducted in every unit/area that has medications. This oversight process has become a part of the Hospital’s standard assessment for medication safety.

• As of November 27, 2018, the Hospital finalized and implemented new procedures to require the additional Specific Safety Strategy for all Paralyzing Agents to include an Independent Double Check

11/27/18






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conducted by two licensed registered nurses prior to the administration of a Paralyzing Agent, where electronic clinical systems prompt dual sign off for bolus doses and upon the following for infusions:



The Hospital’s CNOs, Pharmacy and Quality departments are collectively responsible for monitoring compliance with all medication administrations requiring a two-person sign off, which is a component of an independent double check. Prior to a qualified staff member administering the medication, it is scanned through the Barcode Medication Administration (BCMA) tool which

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forces a dual sign-off. This sign-off prompt requires an additional qualified clinical staff member to confirm the correct medication, correct dose and correct route of administration. Both staff members are then required to acknowledge the double check within the Medication Administration Record (MAR) portion of the Hospital’s Electronic Medical Record (EMR) prior to administration.


• Training: By November 26, 2018, every nurse and paramedic who work in an area of the Hospital where Paralyzing Agents are available in AcuDose dispensing cabinets, were required to complete an online training module outlining the process changes, Independent Double Check, vial packaging and naming convention changes. Any

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nurse or paramedic staff member required to complete such training, and who has not completed the computer-based training prior to November 27, 2018 for any reason, including being on vacation or not scheduled to work at the Hospital during the time period, has not been permitted to begin their next shift at the Hospital without first completing the required training.

UPDATE: The Hospital is monitoring the completion of the required training programs, and as of December 18, 2018, 1,487 individuals, which is 99% percent of the Hospital’s staff members required to receive the education, had completed the training requirement. 1% of staff remain on FMLA, and will not be allowed to return to work until training has been completed.

Specifically, by November 26, 2018, every nurse and paramedic who works in an area of the Hospital where Paralyzing Agents are available in AcuDose dispensing cabinets, was required to complete an online training module outlining the process changes, dual sign-off, vial packaging and naming convention changes. Any nurse or paramedic staff member required to complete such training, and who had not completed the computer-

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based training prior to November 27, 2018 for any reason, including being on vacation or not scheduled to work at the Hospital during the time period, has not been permitted to begin their next shift at the Hospital without first completing the required training.


• Monitoring: The Hospital has implemented several measures to monitor compliance with the updated medication administration requirements. Beginning on November 27, 2018, the Hospital’s Enterprise Medication Safety Officer, in collaboration with the Chief Nursing Officers, Executive Pharmacy Leadership, and Chief of Staff, began to compile monthly reports of overrides from AcuDose cabinets for paralyzing agents, which will be reviewed at the medication safety committee, as well as on the unit level, and assessed for appropriateness. Such monthly reporting will be ongoing, and continue for three months following November 27, 2018.

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Thereafter, and continuing indefinitely the Enterprise Medication Safety Officer will continue to review all unreconciled dispense reports that identify medication overrides without an order linked, and provide monthly override performance reports to the medication safety committee as part of ongoing medication safety committee work. In the event such monthly reports reveal non-compliance, inconsistencies or questions, the medication safety committee will elevate these issues to Chief Nursing Officers, Executive Pharmacy Leadership, and Chief of Staff to determine whether additional steps are required for compliance, such as targeted education and/or training.

When a provider electronically enters an order for a medication, the order is verified by the Hospital Pharmacy, and then the medication is available in the AcuDose cabinet under the patient’s specific profile. In the event of an emergency (i.e., acute patient decompensation where delay of necessary medication would cause harm) certain medications may need to be obtained from the AcuDose cabinet as an override prior to pharmacy verification. There will always be an order (entered electronically or






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given verbally in an emergency) for any medication prior to administration, consistent with the Hospital’s Provider Order Policy.



In the event a double check is not performed by two nurses for a high alert medication, the high alert medication will still be accessible to only one nurse in an emergency situation, but it may not be administered without a second nurse. Pursuant to the Hospital’s

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policies, procedures and protocols all high alert medications are only administered when two nurses are present, even during an emergency situation. A high alert medication remains accessible by a single nurse, but administration requires dual sign-off.

UPDATE: In order to evaluate initial compliance of staff overrides related to paralyzing agents, audit frequency has been increased to weekly for the first month, after which the audits will be conducted on a monthly frequency. As of December 18, 2018, the Hospital’s Enterprise Medication Safety Officer, in collaboration with the Chief Nursing Officers, Executive Pharmacy Leadership, and Chief of Staff have completed three weekly reviews of overrides from AcuDose cabinets for Paralyzing Agents, which weekly report has been reviewed at the medication safety committee, as well as on the unit level, and assessed for appropriateness. This weekly review showed a 95% compliance rate with the Hospital’s policies and procedures regarding overrides of Paralyzing Agents. As of December 18 2018, the Hospital’s Chief Nursing Officers have completed three weekly reviews in order to verify compliance with the






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Independent Double Check procedure for Paralyzing Agents. These three weekly reviews each showed a 100% compliance rate.



In regard to nurse training on medication administration, medical record documentation, and monitoring of patients receiving medication, all newly hired nurses are required to complete computer-based training related to the preparation of drugs and safe medication practices. All nurse residents, who are new graduate registered nurses hired with less than six months of nursing experience, are required to






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complete such education regarding safe medication practices, as well as attend a workshop on medication safety. These trainings have been updated to include education as to the revisions to the Medication Policy, the new nomenclature for Paralyzing Agents, the updated requirements for monitoring patients receiving High Alert Medications.

• Further, all nurses and nurse residents receive ongoing education on an annual basis regarding a variety of topics determined by Hospital nurse leaders, educators and staff. Nursing staff must validate competency in the identified topics between January and June of each calendar year through a variety of methods, including an online learning module, skill validation on a mannequin, observation of daily practice, etc. The Hospital will include medication administration, patient monitoring, documentation and other issues discussed in this Plan of Correction in such annual competencies, as appropriate and based on the issues revealed in results of the audits described herein.







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• The Hospital has updated Scope of Care documents in each department that relies on a “Help All Nurse” (or similar position), in order to define the applicable role and duties. At the Hospital, “Resource Nurse” is generally used to describe a nursing role that usually does not take patient assignment during the shift but takes direction from the Clinical Staff Leader or Resource Staff Leader to assist other nurses as workloads demand, including rapid response teams, STAT calls, and transports. Resource Nurse roles in various departments include Float Nurse; Procedural Nurse; Admit Discharge, Transfer Nurse; and Patient Flow Nurse. The Scopes of Care were revised in intensive care units and non-intensive care units to define the applicable Resource Nurse role (including the “Help All Nurse” as applicable) by November 20, 2018. Nursing leadership of each Hospital department that utilizes such a Resource Nurse role will review the departments Scope of Care document on an annual basis to ensure duties of the position remain complete and accurate.

The role of the Resource Nurse, or “Help All” nurse, within the unit is a staffing assignment, rather than a position in which a nurse is

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employed with a job title, therefore no job description exists. The following are details surrounding this unit assignment. A Resource Nurse (e.g., Float Nurse, Procedural Nurse, Help-All Nurse, ADT (admit, discharge, transfer) Nurse, and Patient Flow Nurse), is a nursing role that may be available if the unit has adequate baseline staffing to utilize such a Resource Nurse, who usually does not take patient assignment. The role of the Resource Nurse will be assigned by the Clinical Staff Leader (more commonly known as Charge Nurse) to assist unit RNs with patient assignments as work demands. Tasks assigned may include but are not limited to providing procedural assistance, and participating in Rapid Response Team response, STAT response, admission/ discharge or transfer processes, relief coverage (breaks and lunch) and patient transport. Staff serving in a Resource Nurse capacity must, at a minimum, be an RN II, which is attained after one year of relevant clinical experience. The nurse is required to be oriented to the role with a nurse experienced in the Resource Nurse role prior to taking on the role of this assignment. All staff within the units are aware of






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the Resource Nurse duties and are encouraged to utilize this resource opportunity to enhance patient safety and care. The role of Resource Nurses is not different from the role of the bedside nurse and thus, the Resource Nurse possesses the same knowledge and competencies as all nurses on the unit. The nurses in question simply do not take a patient assignment and are available to assist the nurses on the unit with the types of tasks described above.


• The Hospital reviewed its Occurrence Reporting: Patient and Visitor policy, which outlines requirements of every Hospital employee, attending physician and house staff member to report certain occurrences to the Hospital’s Office of Risk and Insurance Management, either through the online occurrence reporting system or through a phone call to Risk Management. The Hospital has revised the Occurrence Reporting: Patient and Visitor policy to require Risk Management to report any a) incidents of abuse, neglect, or misappropriation reported to the

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Hospital department as complaints for certification processes; b) strike by staff; c) external disaster impacting a Hospital facility; d) disruption of any service vital to the continued safe operation of the Hospital facility, or to the health and safety of its patients and personnel; and e) fires at a Hospital facility that disrupt the provision of patient care services or cause harm to the patients or staff, or that are reported by the facility to any entity, including but not limited to a fire department charged with preventing fires. These policy revisions were approved by Executive Policy Committee of the Medical Center Medical Board effective November 27, 2018. The Occurrence Reporting: Patient and Visitor policy places the responsibility for reporting to the Tennessee Department of Health pursuant to the Health Data Reporting Act of 2002 with the Office of Risk and Insurance Management.

The most recent updates to the Hospital’s Occurrence Reporting: Patient and Visitor policy were approved January 3, 2019 and supersede the Hospital’s November 2018 policy. The November 2018 version of the policy superseded in turn the October 2017 policy. A redline of the current policy to the October 2017 policy is attached to

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this Plan of Correction, showing changes including, but not limited to, removal of the reference to the Health Data Reporting Act of 2002, the addition of definitions of abuse, neglect and misappropriation, and identification of event reporting objectives, including “[i]dentification of those Events which are required to be reported to third-parties as required under applicable law, rule, or regulation.” The policy also states that the Hospital’s Office of Risk and Insurance Management reports to the Tennessee Department of Health in compliance with the Department’s reporting requirements, including events identified as abuse, neglect, and misappropriation, as those terms are defined in the policy.

Effective on November 27, 2018, the Hospital implemented a revised procedure during the established weekly meeting of the Event Review Committee to include regular evaluations of whether occurrences reported to the Office of Risk and Insurance Management require a report to the Tennessee Department of Health, pursuant to state law requirements. The Event Review Committee reviews patient events with harm or potential harm on a weekly basis, to identify those events which may require an Event Analysis pursuant to the Hospital

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policies, further investigation by Risk and Insurance Management, external reporting, or other potential safety or risk issues. The Event Review Committee is a Quality Improvement Committee (QIC) as defined pursuant to TCA §§ 63-1-150 and 68-11-272 and is comprised of representatives from Risk and Insurance Management; Quality, Safety, and Risk Prevention; and Patient Safety Officers. The Event Review Committee reports to the Self Insurance Trust, which reports to the Hospital Medical Center Medical Board. The participants of the Event Review Committee have been informed of the changes to the Occurrence Reporting policy and these additional procedures. The Senior Vice President of Quality, Safety and Risk Prevention and the Vice President of Risk and Insurance Management will continue participate in such weekly committee meetings and will monitor state reporting processes to ensure the Hospital reports as required by state and federal law. Further, the Hospital is currently communicating with the Tennessee Department of Health regarding additional guidance on reportable events under state law.

UPDATE: As of December 18, 2018, the Event Review Committee






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has convened 2 times in accordance with the process described above.

• The Hospital has reviewed its policy outlining reporting requirements to the Davidson County Medical Examiner, including its Deaths Requiring Reporting to the Medical Examiner policy (hereinafter, “Medical Examiner Policy”). The Hospital has amended the Medical Examiner Policy, which amendments were approved on November 27, 2018, to clarify that all details supporting a decision of: a) a suspicious, unusual or unnatural death, including unexplained surgical and anesthetic deaths, and b) death during or as a result of a diagnostic or therapeutic procedure, medication error, or adverse, allergic, or toxic reaction to a therapeutic agent, shall be reported to the Medical Examiner. The revised Medical Examiner Policy also requires all conversations with the Medical Examiner’s Office to be documented in the patient’s medical record, including the rationale for reporting pursuant to the criteria outlined in the Policy.

The Hospital has attached to this Plan of Correction the QI audit tool for Medical Examiner Reporting. Of

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note, the components of the QI audit tool for reporting to the Medical Examiner are based on the Hospital’s Deaths Requiring Reporting to the Medical Examiner Policy. The QI indicators within this review includes the following elements: Patient Summary, Death Report, TDS notification, and ME notification. The Hospital’s Office of Decedent Affairs reviews 100% of all Hospital deaths for disposition documentation prior to the body being released to the morgue. All decedent charts receive a second review for death reporting details. This review is focused on documentation and timely notification to the Medical Examiner Office. If a case previously declined by the Medical Examiner Office is identified as meeting reporting criteria or new information is provided, a referral to the Medical Examiner Office is made by the Hospital’s Office of Decedent Affairs. Total review numbers and cases requiring follow-up will be reviewed monthly at the Hospital’s Transfer Review Committee.

• Training: By December 3, 2018, the Hospital required every Attending Physician and House Staff to complete education regarding the revised Medical Examiner Policy requirements, reporting

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requirements under state law, and documentation in the medical record under the Policy, as well as documenting communications and disclosure with family and/or patient representative.

UPDATE: As of December 18, 2018, 3,850 individuals have completed the required education regarding the revised Medical Examiner Policy requirements, reporting requirements under state law, and documentation in the medical record, representing 99.9% of the Hospital’s total Attending Physicians and House Staff members. There are 4 individuals that remain on FMLA. Further, the Hospital has been in communication with the Tennessee Deputy State Chief Medical Examiner, who has provided written materials outlining deaths reportable to the medical examiner for distribution to appropriate staff members at the Hospital. The Hospital is working with the Tennessee Deputy State Chief Medical Examiner to schedule on-site education at the Hospital.

• Monitoring: The Office of Decedent Affairs is reviewing Medical Examiner reporting to ensure the Hospital reports as required by state law. Any deaths not

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previously reported which are identified as unusual or suspicious will be immediately reported to the medical examiner. Additionally, beginning on December 3, 2018, this group began to audit 100% of patient deaths occurring in the Hospital, in order to assess compliance with state reporting requirements. In the event such an audit reveals non-compliance, inconsistencies or questions, the Office of Decedent Affairs will elevate these issues immediately to the VUMC Quality Steering Committee to determine whether additional steps are required for compliance, such as reporting to the Medical Examiner, targeted education and/or training. Monthly reports of audits will be provided to Chief of Staff and Quality Safety Risk Prevention for oversight of reporting to the Medical Examiner.


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The Hospital has implemented the corrective actions described in this Plan of Correction and is conducting monitoring and auditing as described herein to ensure ongoing compliance.

The Hospital has reviewed its policies and procedures related to its Quality Assurance and Performance Improvement (QAPI) process, and has committed to ensure comprehensive and robust investigation and implementation of safety measures:

• The Hospital has reviewed its current procedures in place to ensure a thorough and prompt analysis of a critical adverse event, near misses and all the causes, and implementation of preventive actions that include implementing additional safety parameters as needed. The Hospital’s existing QAPI program is typically initiated at the department or unit level, or through a report from staff through the online occurrence reporting system. Reported events are assessed by the Office of Risk and Insurance Management, Quality Safety and Risk Prevention, and operational leadership, and may be analyzed by the Event Review Committee. Each event report is reviewed locally by the designated manager and Clinical Risk Manager, before being referred to the applicable Hospital safety team






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in which the event occurred. The Safety Teams use standardized tools to assess each case for the potential of being a Serious Safety Event (“SSE”). A clinical review is performed to assess if there were potential deviations in generally accepted practices that resulted in patient harm. If it is deemed so, then the SSE Leadership team for the entity is called together. The applicable SSE Leadership team is comprised of the Hospital’s executive leaders (Chief Executive Officer, Chief Nursing Officer, Chief Operating Officer, Chief of Staff, Risk Management and other designees). The SSE Leadership team reviews the case and then votes on the SSE. This procedure creates situational awareness and accountability for organizational leaders. Once the SSE is confirmed, a Serious Safety Event Notification goes out to Hospital leadership across the health system. An SSE analysis is conducted and includes frontline clinicians, those directly involved with the case, unit leadership, support teams and other departments. Each case is unique and participants are invited relative to their role in the event. The analysis is facilitated by members of the Hospital Safety team, with Risk Management and physician leaders






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in Quality and Patient Safety roles who participate as well. An action plan is developed and distributed to the participants for implementation. Where the plan includes requirements for training of appropriate personnel, such training is initiated promptly. On a monthly basis, SSEs and the associated action plans are presented to the Hospital’s executive team members in their respective Quality Committees and summary reports at the Hospital Quality Steering Committee. The SSE analysis process has also been reviewed in detail with the VUMC Board Quality and Safety Committee, which receives reports at each meeting regarding Hospital quality and safety initiatives and concerns from the Deputy CEO of VUMC. The Senior Vice President of Quality, Safety and Risk Prevention will monitor the QAPI program to ensure comprehensive and robust investigation and implementation of safety measures. In the situation reviewed during the survey, the death of Patient #1, including the circumstances involved in the medication error, patient monitoring, and medication administration safeguards, was promptly reviewed by the Hospital’s QAPI program, pursuant to the process outlined above. The results






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of the robust QAPI investigation were not shared with the Medical Examiner. Going forward, if the QAPI process or other processes as defined in this document determine the death was unusual or suspicious VUMC will promptly notify the Medical Examiner.

The Hospital has reviewed its policies and procedures related to monitoring of patients during and after medication administration and made the following changes:

The Hospital has revised its policy previously titled Transport of the Critically Ill Patient, which revisions were approved on November 27, 2018, to broaden application of the policy beyond critically ill patients. As such, the newly amended policy is titled “Transport of Patients” (hereinafter, “Transport Policy”). This policy provides that every patient shall be transported with equipment, supplies, and staff appropriate to monitor and support the patient’s physiological needs. Physiological “needs” in the context of this statement refers to a patient’s medical requirements, based on the patient’s current clinical condition and clinical course of treatment as determined by the multidisciplinary healthcare team. An example would include a patient with provider-ordered cardiac telemetry monitoring would be transported with the monitor unless

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there is an order stating otherwise. The policy details that the level of care is maintained during transport and after arrival at the receiving department/unit, and describes specific monitoring and documentation requirements. The amended policy states that when a patient requires continuous monitoring, a clinical staff member is required to be available to receive handover of the patient pursuant to the Hospital’s CL SOP - Clinical Handover Communication procedure. Any such handover will be documented in the medical record. In the event a clinical staff member is not available to receive the patient, the transporting clinical staff member must remain with the patient. Further, the Transport Policy states that patients receiving medications that could lead to respiratory depression and/or respiratory distress are monitored during and after transport, with the duration and frequency of the monitoring to be based on the patient’s condition, type of medication, and route. Documentation will be in accordance with VUMC’s Medication Administration Policy. The Transport Policy further states that such monitoring may include, but is not limited to, direct observation, vital signs, and neuro checks. The revised Transport Policy further requires appropriate documentation to be completed in






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the patient’s medical record upon leaving and returning to the unit, including the times the patient leaves and returns to the unit. The clinical staff members who may transport patients include RNs, paramedics and other clinical staff as outlined in the Transport Policy and associated Standard Operating Procedure entitled “Transport of Patients Receiving Medications That May Cause Impaired Consciousness or Undesired Changes in Vital Signs” (“Transport SOP”), which is further described below. For purposes of transport of patients, staff appropriate to monitor and support the patient’s physiological needs is determined based on the patient’s current clinical condition. Further, a non-clinical staff member may transport a patient in the event a patient’s physiological needs do not require monitoring or support pursuant to the Transport Policy and Transport SOP, Medication Administration Policy, or High Alert Medication Policy. In December 2018, the Hospital adopted the Transport SOP, which sets forth specific parameters for transport of adult patients in Vanderbilt University Hospital that have received medication that may cause impaired consciousness or undesired changes in vital signs, other than critically ill patients who are addressed in the Transport Policy. The SOP was amended in January

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2019 and provides as follows in regard to staff members who may transport patients:











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Patient is receiving

cardiac/telemetry monitoring. A RN/paramedic trained in basic arrhythmia accompanies the patient during transport and throughout the procedure/test unless it is confirmed that monitoring can be maintained by a qualified telemetry technician.











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patient during transport and observe if needed. All clinical staff members assigned to monitor patients are qualified to monitor for medication reactions. These qualifications are set forth in the staff member’s respective job descriptions, training, licensing prerequisites and ongoing competency requirements. In regard to transport of patients, the determination of staff appropriate to monitor and support the patient’s physiological needs is based on the patient’s clinical condition, as described in the Transport Policy and Transport SOP.

• Beginning on December 3, 2018, the Hospital staffed a nurse in the radiology department, whose role is to provide surveillance of patients who have not met the criteria to be accompanied by a licensed professional. The Radiology Resource Nurse (RRN) is responsible for patients who do not

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require the consistent presence of a nurse for monitoring or supporting the patient’s physiological needs, pursuant to the Transport Policy and Transport SOP and other policies related to patient monitoring. In this context, “surveillance” means that the RRN will be expected to have situational awareness of patients present in the Radiology area, be accessible to the members of the Radiology team and stay at the side of, and provide care and assistance to, any patient whose condition changes while in the Radiology area. The RRN will also call on additional support as needed for the care of a patient. Such surveillance is achieved by a combination of the RRN’s physical presence in the Radiology area, as well as real-time audio and video monitoring of patients in the Radiology area and real-time communication with other staff members conducting real-time audio and video monitoring of patients in the Radiology area. This nurse will also act as a resource to the radiology technologists and licensed professionals accompanying patients, and serve as liaison between the radiology department and the inpatient care areas to facilitate safe, patient transports to radiology. This nurse position is staffed Monday through






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Friday, from 7am to 4pm. When this nurse is not the revised Transport policy will apply to require the transporting clinical staff member to remain with the patient. VUMC is currently posting nursing positions to create around the clock staffing of the nurse in the radiology department. As of January 1, 2019, the Hospital extended radiology nurse coverage from 7 am to 7 pm. As of January 21, 2019, the Hospital extended radiology resource nurse coverage to 24 hours per day, 7 days a week. Each patient that requires monitoring based on the Transport Policy and its associated SOP, the Medication Administration Policy, or any patient specific provider orders is being accompanied to the radiology department and monitored by a nurse or paramedic consistent with the applicable policies. In the event the radiology nurse has reached capacity of patients to monitor or is not otherwise available to receive handover of patients, in accordance with the revised Transport Policy, the clinical staff member(s) transporting additional patients to the radiology areas will remain with the patient they are transporting.

• The Hospital has revised its High Alert Medication Policy, which revisions were approved on

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November 27, 2018, to detail required monitoring of patients receiving administration of high alert medications. Specifically, the amended High Alert Medication Policy states that the patient’s clinical status is monitored to evaluate patient response to medication and/or adverse reactions, and the duration and frequency of monitoring is based on the patient’s condition, the type of medication, and route of administration. Such monitoring may include, but is not limited to, direct observation, monitoring of vital signs and neurological status. In accordance with the revisions made to the Hospital’s High Alert Medication Policy and Chart, Paralyzing Agents and controlled substances have parameters for monitoring that vary based on the specific medication. For example, a patient receiving an intermittent dose of a controlled substance intravenously, who is not on continuous monitoring (cardiac or pulse oximetry) will be visually observed for at least five minutes by clinical staff and are subsequently reassessed within one hour. The Hospital has revised its High Alert Medication Policy and Chart to include specified monitoring parameters for high alert medications. Specifically, a Patient






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Monitoring column has been added to the High Alert Medication Chart which specifies the monitoring requirements for each type of High Alert Medication listed in the Chart, including the duration and frequency of monitoring, and issues and reactions for which to monitor. The specifications for monitoring and type of monitoring are outlined for ease of access and use by Hospital staff in the High Alert Chart. Paralyzing Agents continue to be included as a High Alert Medication. Pursuant to the High Alert Medication Chart, a patient receiving a Paralyzing Agent will have continuous cardiac and respiratory monitoring. In addition, after reassessing guidance from the Institute for Safe Medication Practices (ISMP) the Hospital has added controlled substances, including opioids and benzodiazepines, to the High Alert Medication Policy and Chart. A patient receiving an initial dose of a controlled substance by route as defined by the Hospital’s High Alert Medication Chart, will be continuously monitored by a qualified clinical staff member for at least five minutes and again within the hour if not subject to continuous monitoring based on the patient’s clinical condition.






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• The Hospital’s Medication Administration Policy has been revised, which revisions were approved on November 27, 2018, to detail required monitoring of patients receiving medications. Specifically, the amended Medication Administration Policy states that the patient’s clinical status is monitored to evaluate patient response to medication and/or adverse reactions, and the duration and frequency of monitoring is based on the patient’s condition, the type of medication, and route of administration. Such monitoring may include, but is not limited to, direct observation, monitoring of vital signs and neuro

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checks. The Medication Administration Policy has been further amended to require specific documentation in the medical record regarding medication administration and monitoring.

The staff member transporting the patient will know the needed duration and frequency of monitoring by referring to the Hospital’s existing Transport Policy, Transport SOP, the updated High Alert Medication Policy and Chart (attached) and any orders for monitoring as entered into the patient’s medical record, as further informed by the staff member’s knowledge of the specific patient’s condition, including information gained during the Hospital’s Clinical Handover Procedure. The Hospital has revised its High Alert Medication Policy and Chart to include specified monitoring parameters for high alert medications. Specifically, a Patient Monitoring column has been added to the High Alert Medication Chart which specifies the monitoring requirements for each type of High Alert Medication listed in the Chart, including the duration and frequency of monitoring, and issues and reactions for which to monitor. The specifications for monitoring






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and type of monitoring are outlined for ease of access and use by Hospital staff in the High Alert Chart. For example, Paralyzing Agents continue to be included as a High Alert Medication. Pursuant to the High Alert Medication Chart, a patient receiving a Paralyzing Agent will have continuous cardiac and respiratory monitoring. In addition, after reassessing guidance from the Institute for Safe Medication Practices (ISMP) the Hospital has added controlled substances, including opioids and benzodiazepines, to the High Alert Medication Policy and Chart. A patient receiving an initial dose of a controlled substance by route as defined by the Hospital’s High Alert Medication Chart, will be continuously monitored by a qualified clinical staff member for at least five minutes and again within the hour if not subject to continuous monitoring based on the patient’s clinical condition.

The Hospital has further revised its Medication Administration Policy (attached). The revised Medication Administration Policy includes the following direction for monitoring the patient’s clinical status and response to medications and/or






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adverse reactions:





In addition, the Hospital’s CL SOP - Clinical Handover Communication procedure (attached) sets forth guidelines to ensure that the communication of information and the transfer of responsibility and authority for the care of a patient between individuals or teams is completed. Clinical handovers follow a Hospital-approved structure that includes the most current patient information (including medication administrations) and interactive communication, with a focus on current condition, plan of care and safety. In the case of an administration of a high alert medication, such as Versed in






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certain routes of administration, the clinical handover communication would focus on potential cardiopulmonary compromise and applicable monitoring in accordance with the Hospital’s Transport Policy (attached). When a patient is transported off the clinical unit for a test or procedure, the staff will follow the guidance of the Transport SOP.

• The Hospital reviewed its policies and procedures related to moderate sedation, specifically the Standard Operating Procedure for Moderate Sedation, to ensure sufficient safeguards are in place. The Hospital determined that it has in place comprehensive guidance regarding the administration of moderate sedation, specifically including procedures for ensuring patients receiving sedation are continuously observed and physiologically monitored throughout the sedation period by a nurse, advanced practice nurse, physician, or other qualified and trained staff as approved by the Hospital’s Sedation Committee. The SOP for Moderate Sedation details the post anesthesia recovery scoring system and score that is required to discontinue monitoring. The SOP for Moderate Sedation also includes conditions for






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transporting patients who have undergone moderate sedation, including required monitoring. The Hospital has determined that no updates to the SOP for Moderate Sedation are required.

• The Hospital has revised the High Alert Medication Policy and Chart, Transport Policy, Transport SOP, Clinical Handover Communication procedure, Procedural Sedation Policy, and Minimal Sedation Standard Operating Procedure (SOP) (each attached) to guide staff in situations requiring monitoring. In addition, staff will provide monitoring as ordered for a patient and documented in the patient’s medical record. To educate the staff on these updates, the Hospital has prepared an educational computer-based learning module which was assigned to all nurses, paramedics, provider staff and pharmacy staff working in inpatient and procedural areas, and approved credentialed providers for moderate or deep sedation, through the Hospital’s on-line Learning Module System on January 25, 2019 with the target completion date of February 4, 2019. Any staff who has not completed the learning module by February 4, 2019 will be required to do so prior to the start of their next

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shift. The specific policies and standard operating procedures addressed in the learning modules are as follows: High Alert Medication Policy and Chart, Medication Administration Policy, Procedural Sedation Policy and Minimal Sedation Standard Operating Procedure.

• Training: By December 3, 2018, the Hospital required all managers, clinical staff leaders (CSLs), nurses, licensed practical nurses (LPNs), respiratory therapists and paramedics working in inpatient and procedural areas of the Hospital to complete education through its on-line education system, which addresses the updates to the Transport Policy, High Alert Medication Policy, and Medication Administration Policy including the requirements for monitoring patients during transport and during and after medication administration, appropriate handover, and related medical record documentation. No clinical staff member listed above has been able to begin a shift after December 3rd without confirmation of training and subsequent competency testing. The Hospital’s Chief Nursing Officers monitor this education requirement and provide regular updates to directors of these departments to ensure compliance.

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The Hospital’s CNOs oversee this education requirement in collaboration with the Hospital’s education department and local nursing unit leaders. Compliance rates (meaning the clinical staff members required to complete the education who have not yet completed the training) are reviewed on a weekly basis by the Hospital’s CNOs. As of January 23, 2019, 1,492 individuals, which is 99% percent of the total number of 1,509 of Hospital’s staff members required to receive the education, had completed the training requirement for monitoring patients during transport and during and after medication administration, appropriate handover, and related medical record documentation. As to paramedics, the Hospital complies with Tenn. Comp. R. & Regs. 1200-12-4-.01. Paramedics at the Hospital only perform extended skills or procedures when such treatment is conducted under authorized medical control and nursing supervision and is within the scope of practice identified in state law. Paramedics employed in this capacity demonstrate continued training and competence in order to perform their professional duties, consistent with their scope of

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practice. Paramedics work in the Emergency Department, and do not work in inpatient and procedural areas of the Hospital. However, it is possible that a paramedic may transport a patient from the Emergency Department to inpatient or procedural areas, and as such, the Transport Policy would apply to such paramedic. Given the potential application to transports, the Hospital is requiring paramedics to complete this additional training and education regarding updated patient monitoring procedures. The Hospital’s job description for paramedics states that paramedics are responsible for triage care in the field and the Emergency Department, and are further responsible for effective communication to ensure safe and quality patient care in transport and handover. The paramedic job description requires paramedics to deliver patient care within the Tennessee paramedic scope of practice. Paramedics are utilized in, and are under the supervision of clinical care providers in, the Hospital’s emergency service/care areas pursuant to TN state law. All paramedics are trained on the Hospital’s CL SOP - Clinical Handover Communication






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procedure. The Clinical Handover Procedure sets forth guidelines to ensure the communication of information and the transfer of responsibility/authority for the care of the patient between individuals or teams. Clinical handovers follow a Hospital-approved structure that includes the most current patient information (including medication administrations) and interactive communication with a focus on current condition, plan of care and safety. In the case of an administration of a high alert medication, such as Versed in certain routes of administration, the clinical handover communication would focus on potential cardiopulmonary compromise and applicable monitoring in accordance with the Hospital’s Transport Policy (attached). Paramedics are also trained on the High Alert Medication Chart (attached) which includes specified monitoring parameters for all high alert medications. Paramedics in the Hospital will receive information pertaining to a patient being transported through the clinical handover process consistent with the Clinical Handover Communication procedure. Through this handover process, the paramedic will be






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notified of the specific monitoring requirements for the patient. The Paramedic duties are stated within the Paramedic Scope of Practice document (attached).


UPDATE: The Hospital is monitoring the completion of the required training programs, and as of December 18, 2018, 2,514 individuals, which is 99% percent of the Hospital’s staff members required to receive the education, had completed the training requirement for monitoring patients during transport and during and after medication administration, appropriate handover, and related






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medical record documentation. 1% of staff remain on FMLA, and will not be allowed to return to work until training has been completed. The 2,514 individuals constitutes 99% of the Hospital’s total number of staff members required to complete the training as of December 18, 2018, out of a total of 2,563 individuals (at the time) required to complete the training for monitoring patients during transport and during and after medication administration, appropriate handover, and related medical record documentation. Specifically, the Hospital has required all managers, clinical staff leaders (CSLs), nurses, licensed practical nurses (LPNs), respiratory therapists and paramedics working in inpatient and procedural areas of the Hospital to complete education through its on-line education system, which addresses the updates to the Transport Policy, High Alert Medication Policy, and Medication Administration Policy including the requirements for monitoring patients during transport and during and after medication administration, appropriate handover, and related medical record documentation. No clinical staff member listed above






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has been able to begin a shift after December 3, 2018 without confirmation of training and subsequent competency testing. As of January 25, 2019, 2,502 individuals have completed the training, who represent 98% of the current number of 2,546 managers, clinical staff leaders (CSLs), nurses, licensed practical nurses (LPNs), respiratory therapists and paramedics working in inpatient and procedural areas of the Hospital required to complete such training. As to the scoring system, the Hospital’s computer-based training module titled, “2019 FY Moderate Sedation at VUMC” in the Hospital’s online education system addresses the scoring system. Additionally, the Hospital developed a new computer-based training module titled “2019 FY High Alert Medication and Procedural Sedation,” which has been assigned to all nurses, paramedics, provider staff and pharmacy staff working in inpatient and procedural areas, and approved credentialed providers for moderate or deep sedation, to educate them on the revised Procedural Sedation policy. The new module will have a specific post-completion test question






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directly related to the scoring system. The module will be assigned to all applicable staff on January 25, 2019 with a completion date of February 4, 2019. Any staff member who has not completed the training as of February 4, 2019, will not be allowed to return to work until the module is complete. Any new staff will also be required to complete training as a part of the clinical orientation process. The Hospital will monitor staff’s compliance with the use of, and documentation of, the scoring system consistent with Hospital’s applicable policies and procedures.


• In addition, the Hospital developed a new computer-based training module titled, “2019 FY High Alert Medication and Procedural Sedation,” which has been assigned via the Hospital’s Learning Module System to all nurses, paramedics,

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provider staff and pharmacy staff working in inpatient and procedural areas, and approved credentialed providers for moderate or deep sedation, to educate them on the revised Procedural Sedation policy. The module will be assigned to all applicable staff on January 25, 2019 with a completion date of February 4, 2019. Any staff member who has not completed the training as of February 4, 2019, will not be allowed to return to work until the module is complete.


• Monitoring: Beginning on December

3, 2018 and continuing for the following three months, the Hospital’s Chief Nursing Officers oversee weekly chart reviews of 5 patients from each unit, randomly selected, to assess for compliance

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with improvement in medication safety, transport and monitoring of patients. To date, the Hospital’s Chief Nursing Officers have directed the unit level nurse managers’ performance of weekly chart reviews of a minimum of five patients from each unit, or 100% of patients transported if the unit has transported less than five patients within the week, to assess for compliance with policies and procedures related to patient monitoring and safe patient transport. The unit level nurse management team has been instructed to select cases for review that facilitate immediate performance feedback to team members, and to evaluate practices on both day and night shift observations. Such patient records are reviewed for documentation of the appropriate monitoring, handover communication, and documentation consistent with the Transport Policy, Medication Administration Policy and High Alert Medication Policy. In the event such an audit reveals non-compliance, inconsistencies or questions, the Chief Nursing Officers will follow-up with the unit level nurse managers for additional steps required to achieve compliance, such as






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targeted education and training. Results of the chart audit are reported to the CNOs weekly, and the unit level leaders will also consult the CNOs as needed to determine additional steps required to achieve compliance. The unit level leaders review the patient movement compliance reports daily. The Chief Nursing Officers will review monthly updates of such chart review audits to the VUMC Nursing Quality Committee.


UPDATE: As of December 18, 2018, the Hospital’s Chief Nursing Officers have overseen two weekly chart reviews, of 5 patients from each unit. Following the first audit during the week of December 3, 2018, the Hospital’s Chief Nursing Officers determined that the






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Hospital’s medical record layout required revisions in order to accommodate the additional documentation requirements. Following these updates to the medical record which were effective December 10, 2018, the following weekly audit resulted in a compliance rate of 93%. Chart audits are completed in real time, allowing unit managers to provide immediate training to staff who exhibit noncompliance with documentation requirements.












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• A multi-disciplinary work group comprised of Hospital leaders including Physicians, Pharmacy, Risk, Nursing, Quality, and Health Informatics was convened beginning on January 19, 2018 to assess Paralyzing Agents included on the override medication list. This workgroup determined to remove vecuronium from the AcuDose (Hospital’s automated dispensing cabinet) override status list, which removal was approved by the VUMC Pharmacy, Therapeutics and Diagnostic Committee on February 23, 2018 and implemented on March 1, 2018. The work group determined to retain availability of the following Paralyzing Agents in the AcuDose cabinets in the Hospital: rocuronium, succinylcholine, vecuronium and cisatracurium. The work group determined that rocuronium and succinylcholine would remain on the override list, based on the work group’s determination that the clinical risks to patients of not having immediate access to rocuronium and succinylcholine outweighed the potential safety benefits from removing the Paralyzing Agent from override status. The four Paralyzing Agents are medications that must be accessed quickly during an emergency medical event. In






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particular, the work group considered the potential risks that may arise in the event rocuronium and/or succinylcholine is not available in certain inpatient and procedural areas of the Hospital when needed in an emergency for a rapid sequence intubation. The work group determined that vecuronium and cisatracurium would remain available in the AcuDose cabinet, but would be removed from override status list so that they could not be dispensed without a written physician order and pharmacy verification. Vecuronium and cisatracurium were retained in AcuDose based on the fact that manual delivery from the Hospital pharmacy can often take between thirty (30) minutes to one hour to be delivered. Alternatively, dispensing from the AcuDose cabinet can often occur within about ten (10) minutes. It is standard practice to make available in the AcuDose cabinet any medication that is dispensed in a certain volume, particularly given that vecuronium and cisatracurium require a physician order and pharmacist review. Some Paralyzing Agents are contraindicated with patient care requirements, and the selection of a prescribed Paralyzing Agent by a physician is based on the patient’s






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clinical indications. As such, the work group decided to retain multiple Paralyzing Agents in the AcuDose cabinet. Additionally, as noted elsewhere, the medication administration process has been enhanced with additional security measures for all Paralyzing Agents, including shrink wrap packaging and a required Independent Double Check process.

The Hospital’s Medication Safety Officer in partnership with the VUMC Pharmacy, Therapeutics and Diagnostic Committee will reassess the Paralyzing Agents, including rocuronium, on the override list annually. Specifically, in December of each calendar year, the Medication Safety Officer will review the Paralyzing Agents included on the override medication list to determine the appropriateness of the override list. This annual assessment of the Paralyzing Agents included on the override medication list will weigh the clinical risks of having access to certain Paralyzing Agents on the override list against the benefits of removing such Paralyzing Agents from the override list. The Medication Safety Officer will review every case in which rocuronium and/or succinylcholine was dispensed from






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AcuDose via override; how frequently Paralyzing Agents were dispensed from AcuDose cabinets; whether a delay in accessing the medication causes patient harm; implications related to why staff selects a specific Paralyzing Agent; utilization of all Paralyzing Agents available in the AcuDose cabinet; the time of the override compared to medication order; and the time of the override compared to the medication administration time. The determination as to whether or not a delay in accessing the medication causes harm, and whether or not such medication should be available on override status, is a multidisciplinary decision. The Medication Safety Officer considers harm or potential patient harm secondary to medication delay in conjunction with the Hospital’s Pharmacy Policy committee and the VUMC Pharmacy, Therapeutics and Diagnostic Committee.

While the Medication Safety Officer’s annual assessment will include a review of data from prior periods to assist in assessing the continued appropriateness of the Paralyzing Agents on override status, this assessment is a proactive approach to determine






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whether there should be a change to the Paralyzing Agents on override status and any clinical implications to patient care.

In addition to the safety measures related to Paralyzing Agents outlined herein of Independent Double Check, vial packaging, naming conventions, and system alerts that have been implemented as part of the Plan of Correction, the Hospital has implemented further proactive measures to ensure safe storage and dispensing of Paralyzing Agents. Barcode assisted medication administration (“BCMA”) systems involve the use of scanners and software to verify all medications electronically before they are administered to patients, and further to document the medication in the electronic medication administration record. BCMA systems are utilized where available throughout the Hospital, and the Hospital is implemented BCMA systems in radiology areas by December 11, 2018. The Medication Use Safety Improvement Committee continually monitors trends in data related to medication use and will continue to monitor professional organizations for updated Institute for Safe






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Medication Practices (ISMP) recommendations as to medication administration. Additionally, the Hospital has performed a gap analysis with the ISMP Targeted Medication Safety Best Practices for Hospitals and has participated in an ISMP high alert self-assessment and benchmarking review. Both the gap analysis and high alert self-assessment include a review of Paralyzing Agent practice. The Hospital performs an ongoing review of the ISMP quarterly action agenda recommendations through the Medication Management group, a subcommittee of the Medication Use Safety Improvement Committee.

Further, since 2016 the Hospital’s Pharmacy, Therapeutics and Diagnostics Committee has reviewed every medication introduced to the Hospital’s formulary using a developed Risk Mitigation Plan for Formulary Additions Checklist. This proactive strategy reviews potential failure modes in procurement, clinical decision support, high alert, look alike-sound alike (LASA), adverse drug event risk, hazardous medications, packaging and labeling, order review, preparation, administration, monitoring and






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transitions of care to prepare our hospital and system for a certain medication. The Medication Use Safety Improvement Committee will continue to oversee and take actions to prevent, monitor and evaluate adverse drug events, particularly through the Medication Use Safety Improvement Committee subcommittees on Adverse Drug Events.

• The Hospital has changed the naming convention from “Neuromuscular Blocking Agents”, as referenced in certain policies, including the High Alert Medication Policy, to “Paralyzing Agents” for consistency throughout the Hospital. The Hospital has also standardized the nomenclature utilized for Paralyzing Agents across the Hospital in eStar (Hospital’s electronic medical record) and AcuDose, such that both electronic systems present the name as “PARALYZING AGENT” followed by the medication name. Paralyzing Agents will no longer be able to be pulled up on the AcuDose override screen by typing in the drug name. Instead, “PARA” will be typed in - the first two letters of “Paralyzing Agent” - which will then pull up the list of Paralyzing Agents in the AcuDose cabinet. The four Paralyzing Agents are the only medications that result on both

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electronic systems in a search for “PARA”. Signs are attached to the AcuDose cabinets indicating that “PARA” must be used to access Paralyzing Agents. The new nomenclature of “Paralyzing Agent: [medication name]” was effective in both eStar and AcuDose as of November 27, 2018. Effective on November 27, 2018, this updated procedure is documented by an amendment to the Hospital’s High Alert Medications Charts for both Adult Patients and Pediatric Patients, which are incorporated into the High Alert Medications Policy. These charts have been amended to list the four (4) specific Paralyzing Agents available at the Hospital, and to reflect the updated nomenclature of “Paralyzing Agent [medication name]”.


• On November 27, 2018, the

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Hospital implemented new procedures for shrink wrap packaging to be added to all vials of Paralyzing Agents dispensed in AcuDose throughout the Hospital, and effective November 27, 2018 amendments to the Hospital’s High Alert Medications Charts for both Adult Patients and Pediatric Patients were approved to specify a Specific Safety Strategy that all Paralyzing Agents dispensed in AcuDose cabinets throughout the Hospital will have shrink wrap packaging. The Hospital Executive Pharmacy Leadership will monitor compliance with the required shrink wrap packaging of Paralytic Agents by conducting random audits of all AcuDose cabinets throughout the Hospital and validating packaging compliance for a minimum of three months of consecutive 100% compliance. Specifically, beginning with the week of November 26, 2018, each week the directors of the Hospital pharmacies oversee their staff in auditing 25% of the AcuDose cabinets in the Hospital, to inspect all Paralyzing Agents stored in the AcuDose cabinet being audited to determine whether each Paralyzing Agent includes the appropriate shrink wrap packaging. Each week during the month, a different 25% of the AcuDose cabinets is audited, such that 100%

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of AcuDose cabinets will have been audited within the course of one month. The directors of the Hospital pharmacies will continue to audit 25% of the AcuDose cabinets each week until such audits result in three consecutive months of 100% compliance with required shrink wrap packaging procedures. As such, each AcuDose cabinet in the Hospital will be audited at least three times during the audit period. UPDATE: As of December 18, 2018, four weeks of audits have been performed of AcuDose cabinets in the Hospital, and as such, every AcuDose cabinet in the Hospital has been audited. Of the 143 vials of Paralyzing Agents contained in the AcuDose cabinets audited the week of November 25, 2018, three vials were identified without the proper shrink wrap packaging--these vials were discarded. During the weeks of December 2, December 9, and December 16, every vial of a Paralyzing Agent contained in the AcuDose cabinets audited included the required shrink wrap packaging, establishing 100% compliance. UPDATE: As of January 24, 2019, nine weeks of audits have been performed of AcuDose cabinets in the Hospital, and as such, every

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AcuDose cabinet in the Hospital has been audited at least twice. During the weeks of December 23, December 30, January 6, January 13 and January 20, every vial of a Paralyzing Agent contained in the AcuDose cabinets audited included the required shrink wrap packaging, continuing 100% compliance. The weekly Paralyzing Agent compliance audits will continue for three months from November 25, 2018. For ongoing sustainment, monitoring and oversight thereafter, the Hospital has incorporated these weekly audits into the Hospital’s current monthly medication safety checks that are conducted in every unit/area that has medications. This oversight process has become a part of the Hospital’s standard assessment for medication safety.


o Initiation of infusion

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o Change of container o Handover


The Hospital’s CNOs, Pharmacy and Quality departments are collectively responsible for monitoring compliance with all medication administrations requiring a two-person sign off, which is a component of an independent double check. Prior to a qualified staff member administering the medication, it is scanned through the Barcode Medication Administration (BCMA) tool which forces a dual sign-off. This sign-off prompt requires an additional qualified clinical staff member to confirm the correct medication, correct dose and correct route of administration. Both staff members are then required to acknowledge the double check within the

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Medication Administration Record (MAR) portion of the Hospital’s Electronic Medical Record (EMR) prior to administration.


• Training: By November 26, 2018, every nurse and paramedic who work in an area of the Hospital where Paralyzing Agents are available in AcuDose dispensing cabinets, were required to complete an online training module outlining the process changes, Independent Double Check, vial packaging and naming convention changes. Any nurse or paramedic staff member required to complete such training, and who has not completed the computer-based training prior to November 27, 2018 for any reason, including being on vacation or not scheduled to work at the Hospital during the time period, has not been

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permitted to begin their next shift at the Hospital without first completing the required training.


Specifically, by November 26, 2018, every nurse and paramedic who works in an area of the Hospital where Paralyzing Agents are available in AcuDose dispensing cabinets, was required to complete an online training module outlining the process changes, dual sign-off, vial packaging and naming convention changes. Any nurse or paramedic staff member required to complete such training, and who had not completed the computer-based training prior to November 27, 2018 for any reason, including being on vacation or not scheduled to work at the Hospital during the time period, has not been permitted to begin their next shift at the Hospital without first completing the

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required training.


• Monitoring: The Hospital has implemented several measures to monitor compliance with the updated medication administration requirements. Beginning on November 27, 2018, the Hospital’s Enterprise Medication Safety Officer, in collaboration with the Chief Nursing Officers, Executive Pharmacy Leadership, and Chief of Staff, began to compile monthly reports of overrides from AcuDose cabinets for paralyzing agents, which will be reviewed at the medication safety committee, as well as on the unit level, and assessed for appropriateness. Such monthly reporting will be ongoing, and continue for three months following November 27, 2018. Thereafter, and continuing indefinitely the Enterprise Medication Safety Officer will continue to review all unreconciled dispense reports that identify medication overrides without an order linked, and provide monthly

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override performance reports to the medication safety committee as part of ongoing medication safety committee work. In the event such monthly reports reveal non-compliance, inconsistencies or questions, the medication safety committee will elevate these issues to Chief Nursing Officers, Executive Pharmacy Leadership, and Chief of Staff to determine whether additional steps are required for compliance, such as targeted education and/or training.


As noted by the Institute for Safe






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Medication Practices (ISMP) (attached), there are important, legitimate reasons for the medication override process in emergent situations (i.e., antidotes, rescue and reversal agents, and life-sustaining medications).


In the event a double check is not performed by two nurses for a high alert medication, the high alert medication will still be accessible to only one nurse in an emergency situation, but it may not be administered without a second nurse. Pursuant to the Hospital’s policies, procedures and protocols all high alert medications are only administered when two nurses are present, even during an emergency situation. A high alert medication

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remains accessible by a single nurse, but administration requires dual sign-off.

UPDATE: In order to evaluate initial compliance of staff overrides related to paralyzing agents, audit frequency has been increased to weekly for the first month, after which the audits will be conducted on a monthly frequency. As of December 18, 2018, the Hospital’s Enterprise Medication Safety Officer, in collaboration with the Chief Nursing Officers, Executive Pharmacy Leadership, and Chief of Staff have completed three weekly reviews of overrides from AcuDose cabinets for Paralyzing Agents, which weekly report has been reviewed at the medication safety committee, as well as on the unit level, and assessed for appropriateness. This weekly review showed a 95% compliance rate with the Hospital’s policies and procedures regarding overrides of Paralyzing Agents. As of December 18 2018, the Hospital’s Chief Nursing Officers have completed three weekly reviews in order to verify compliance with the Independent Double Check procedure for Paralyzing Agents. These three weekly reviews each showed a 100% compliance rate.

The Hospital is developing a unit-






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specific override compliance dashboard to provide ongoing monitoring and ensure compliance of overrides of high alert medications. This expands the Hospital’s review of overrides of Paralyzing Agents to include all high alert medications. System-level compliance throughout the Hospital will continue to be monitored by the Hospital’s Medication Usage Safety Improvement Committee.


In regard to nurse training on medication administration, medical record documentation, and monitoring of patients receiving medication, all newly hired nurses are required to complete computer-based training related to the preparation of drugs and safe medication practices. All nurse residents, who are new graduate registered nurses hired with less than six months of nursing experience, are required to complete such education regarding safe medication practices, as well as attend a workshop on medication safety. These trainings have been updated to include education as to the revisions to the Medication






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Policy, the new nomenclature for Paralyzing Agents, the updated requirements for monitoring patients receiving High Alert Medications.



• The Hospital has updated Scope of Care documents in each department that relies on a “Help All Nurse” (or similar position), in order to define the applicable role and

11/20/18






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duties. At the Hospital, “Resource Nurse” is generally used to describe a nursing role that usually does not take patient assignment during the shift but takes direction from the Clinical Staff Leader or Resource Staff Leader to assist other nurses as workloads demand, including rapid response teams, STAT calls, and transports. Resource Nurse roles in various departments include Float Nurse; Procedural Nurse; Admit Discharge, Transfer Nurse; and Patient Flow Nurse. The Scopes of Care were revised in intensive care units and non-intensive care units to define the applicable Resource Nurse role (including the “Help All Nurse” as applicable) by November 20, 2018. Nursing leadership of each Hospital department that utilizes such a Resource Nurse role will review the departments Scope of Care document on an annual basis to ensure duties of the position remain complete and accurate.

The role of the Resource Nurse, or “Help All” nurse, within the unit is a staffing assignment, rather than a position in which a nurse is employed with a job title, therefore no job description exists. The following are details surrounding this unit assignment. A Resource Nurse (e.g., Float Nurse, Procedural Nurse, Help-All Nurse,






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ADT (admit, discharge, transfer) Nurse, and Patient Flow Nurse), is a nursing role that may be available if the unit has adequate baseline staffing to utilize such a Resource Nurse, who usually does not take patient assignment. The role of the Resource Nurse will be assigned by the Clinical Staff Leader (more commonly known as Charge Nurse) to assist unit RNs with patient assignments as work demands. Tasks assigned may include but are not limited to providing procedural assistance, and participating in Rapid Response Team response, STAT response, admission/ discharge or transfer processes, relief coverage (breaks and lunch) and patient transport. Staff serving in a Resource Nurse capacity must, at a minimum, be an RN II, which is attained after one year of relevant clinical experience. The nurse is required to be oriented to the role with a nurse experienced in the Resource Nurse role prior to taking on the role of this assignment. All staff within the units are aware of the Resource Nurse duties and are encouraged to utilize this resource opportunity to enhance patient safety and care. The role of Resource Nurses is not different from the role of the bedside nurse






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and thus, the Resource Nurse possesses the same knowledge and competencies as all nurses on the unit. The nurses in question simply do not take a patient assignment and are available to assist the nurses on the unit with the types of tasks described above.

The Hospital has implemented the corrective actions described in this Plan of Correction and is conducting monitoring and auditing as described herein to ensure ongoing compliance.


• The Hospital reviewed its Occurrence Reporting: Patient and Visitor policy, which outlines requirements of every Hospital employee, attending physician and house staff member to report certain occurrences to the Hospital’s Office of Risk and Insurance Management, either through the online occurrence reporting system or through a phone call to Risk Management. The Hospital has revised the Occurrence Reporting: Patient and Visitor policy to require Risk Management to report any a) incidents of abuse, neglect, or misappropriation reported to the

11/27/18






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Hospital department as complaints for certification processes; b) strike by staff; c) external disaster impacting a Hospital facility; d) disruption of any service vital to the continued safe operation of the Hospital facility, or to the health and safety of its patients and personnel; and e) fires at a Hospital facility that disrupt the provision of patient care services or cause harm to the patients or staff, or that are reported by the facility to any entity, including but not limited to a fire department charged with preventing fires. These policy revisions were approved by Executive Policy Committee of the Medical Center Medical Board effective November 27, 2018. The Occurrence Reporting: Patient and Visitor policy places the responsibility for reporting to the Tennessee Department of Health pursuant to the Health Data Reporting Act of 2002 with the Office of Risk and Insurance Management.

The most recent updates to the Hospital’s Occurrence Reporting: Patient and Visitor policy were approved January 3, 2019 and supersede the Hospital’s November 2018 policy. The November 2018 version of the policy superseded in turn the October 2017 policy. A redline of the current policy to the October 2017 policy is attached to

1/3/19






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this Plan of Correction, showing changes including, but not limited to, removal of the reference to the Health Data Reporting Act of 2002, the addition of definitions of abuse, neglect and misappropriation, and identification of event reporting objectives, including “[i]dentification of those Events which are required to be reported to third-parties as required under applicable law, rule, or regulation.” The policy also states that the Hospital’s Office of Risk and Insurance Management reports to the Tennessee Department of Health in compliance with the Department’s reporting requirements, including events identified as abuse, neglect, and misappropriation, as those terms are defined in the policy.

Effective on November 27, 2018, the Hospital implemented a revised procedure during the established weekly meeting of the Event Review Committee to include regular evaluations of whether occurrences reported to the Office of Risk and Insurance Management require a report to the Tennessee Department of Health, pursuant to state law requirements. The Event Review Committee reviews patient events with harm or potential harm on a weekly basis, to identify those events which may require an Event Analysis pursuant to the Hospital

11/27/18






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policies, further investigation by Risk and Insurance Management, external reporting, or other potential safety or risk issues. The Event Review Committee is a Quality Improvement Committee (QIC) as defined pursuant to TCA §§ 63-1-150 and 68-11-272 and is comprised of representatives from Risk and Insurance Management; Quality, Safety, and Risk Prevention; and Patient Safety Officers. The Event Review Committee reports to the Self Insurance Trust, which reports to the Hospital Medical Center Medical Board. The participants of the Event Review Committee have been informed of the changes to the Occurrence Reporting policy and these additional procedures. The Senior Vice President of Quality, Safety and Risk Prevention and the Vice President of Risk and Insurance Management will continue participate in such weekly committee meetings and will monitor state reporting processes to ensure the Hospital reports as required by state and federal law. Further, the Hospital is currently communicating with the Tennessee Department of Health regarding additional guidance on reportable events under state law.

UPDATE: As of December 18, 2018, the Event Review Committee






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has convened 2 times in accordance with the process described above.

• The Hospital has reviewed its policy outlining reporting requirements to the Davidson County Medical Examiner, including its Deaths Requiring Reporting to the Medical Examiner policy (hereinafter, “Medical Examiner Policy”). The Hospital has amended the Medical Examiner Policy, which amendments were approved on November 27, 2018, to clarify that all details supporting a decision of: a) a suspicious, unusual or unnatural death, including unexplained surgical and anesthetic deaths, and b) death during or as a result of a diagnostic or therapeutic procedure, medication error, or adverse, allergic, or toxic reaction to a therapeutic agent, shall be reported to the Medical Examiner. The revised Medical Examiner Policy also requires all conversations with the Medical Examiner’s Office to be documented in the patient’s medical record, including the rationale for reporting pursuant to the criteria outlined in the Policy.

The Hospital has attached to this Plan of Correction the QI audit tool for Medical Examiner Reporting. Of

11/27/18






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note, the components of the QI audit tool for reporting to the Medical Examiner are based on the Hospital’s Deaths Requiring Reporting to the Medical Examiner Policy. The QI indicators within this review includes the following elements: Patient Summary, Death Report, TDS notification, and ME notification. The Hospital’s Office of Decedent Affairs reviews 100% of all Hospital deaths for disposition documentation prior to the body being released to the morgue. All decedent charts receive a second review for death reporting details. This review is focused on documentation and timely notification to the Medical Examiner Office. If a case previously declined by the Medical Examiner Office is identified as meeting reporting criteria or new information is provided, a referral to the Medical Examiner Office is made by the Hospital’s Office of Decedent Affairs. Total review numbers and cases requiring follow-up will be reviewed monthly at the Hospital’s Transfer Review Committee.

• Training: By December 3, 2018, the Hospital is requiring every Attending Physician and House Staff to complete education regarding the revised Medical Examiner Policy requirements, reporting

12/3/18






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requirements under state law, and documentation in the medical record under the Policy, as well as documenting communications and disclosure with family and/or patient representative.

UPDATE: As of December 18, 2018, 3,850 individuals have completed the required education regarding the revised Medical Examiner Policy requirements, reporting requirements under state law, and documentation in the medical record, representing 99.9% of the Hospital’s total Attending Physicians and House Staff members. There are 4 individuals that remain on FMLA. Further, the Hospital has been in communication with the Tennessee Deputy State Chief Medical Examiner, who has provided written materials outlining deaths reportable to the medical examiner for distribution to appropriate staff members at the Hospital. The Hospital is working with the Tennessee Deputy State Chief Medical Examiner to schedule on-site education at the Hospital.

• Monitoring: The Office of Decedent Affairs is reviewing Medical Examiner reporting to ensure the Hospital reports as required by state law. Any deaths not

12/3/18






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previously reported which are identified as unusual or suspicious will be immediately reported to the medical examiner. Additionally, beginning on December 3, 2018, this group began to audit 100% of patient deaths occurring in the Hospital, in order to assess compliance with state reporting requirements. In the event such an audit reveals non-compliance, inconsistencies or questions, the Office of Decedent Affairs will elevate these issues immediately to the VUMC Quality Steering Committee to determine whether additional steps are required for compliance, such as reporting to the Medical Examiner, targeted education and/or training. Monthly reports of audits will be provided to Chief of Staff and Quality Safety Risk Prevention for oversight of reporting to the Medical Examiner.







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The Hospital has revised its policy previously titled Transport of the Critically Ill Patient, which revisions were approved on November 27, 2018, to broaden application of the policy beyond critically ill patients. As such, the newly amended policy is titled “Transport of Patients” (hereinafter, “Transport Policy”). This policy provides that every patient shall be transported with equipment, supplies, and staff appropriate to monitor and support the patient’s physiological needs. Physiological “needs” in the context of this statement refers to a patient’s medical requirements, based on the patient’s current clinical condition and clinical course of treatment as determined by the multidisciplinary healthcare team. An example would include a patient with provider-ordered cardiac telemetry monitoring would be transported with the monitor unless there is an order stating otherwise. The policy details that the level of care is maintained during transport and after arrival at the receiving department/unit, and describes

11/27/18






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specific monitoring and documentation requirements. The amended policy states that when a patient requires continuous monitoring, a clinical staff member is required to be available to receive handover of the patient pursuant to the Hospital’s CL SOP - Clinical Handover Communication procedure. Any such handover will be documented in the medical record. In the event a clinical staff member is not available to receive the patient, the transporting clinical staff member must remain with the patient. Further, the Transport Policy states that patients receiving medications that could lead to respiratory depression and/or respiratory distress are monitored during and after transport, with the duration and frequency of the monitoring to be based on the patient’s condition, type of medication, and route. Documentation will be in accordance with VUMC’s Medication Administration Policy. The Transport Policy further states that such monitoring may include, but is not limited to, direct observation, vital signs, and neuro checks. The revised Transport Policy further requires appropriate documentation to be completed in the patient’s medical record upon leaving and returning to the unit, including the times the patient leaves and returns to the unit. The clinical staff members who may






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transport patients include RNs, paramedics and other clinical staff as outlined in the Transport Policy and associated Standard Operating Procedure entitled “Transport of Patients Receiving Medications That May Cause Impaired Consciousness or Undesired Changes in Vital Signs” (“Transport SOP”), which is further described below. For purposes of transport of patients, staff appropriate to monitor and support the patient’s physiological needs is determined based on the patient’s current clinical condition. Further, a non-clinical staff member may transport a patient in the event a patient’s physiological needs do not require monitoring or support pursuant to the Transport Policy and Transport SOP, Medication Administration Policy, or High Alert Medication Policy. In December 2018, the Hospital adopted the Transport SOP, which sets forth specific parameters for transport of adult patients in Vanderbilt University Hospital that have received medication that may cause impaired consciousness or undesired changes in vital signs, other than critically ill patients who are addressed in the Transport Policy. The SOP was amended in January 2019 and provides as follows in regard to staff members who may transport patients:







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Patient is receiving cardiac/telemetry monitoring. A RN/paramedic trained in basic arrhythmia accompanies






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the patient during transport and throughout the procedure/test unless it is confirmed that monitoring can be maintained by a qualified telemetry technician.






Patient on PCA/epidural/continuous controlled substance infusion with no change in medication, dose, concentration, or rate of






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administration within the last hour.



• Beginning on December 3, 2018, the Hospital staffed a nurse in the radiology department, whose role is to provide surveillance of patients who have not met the criteria to be accompanied by a licensed professional. The Radiology Resource Nurse (RRN) is responsible for patients who do not require the consistent presence of a nurse for monitoring or supporting the patient’s physiological needs, pursuant to the Transport Policy and Transport SOP and other

12/3/18






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policies related to patient monitoring. In this context, “surveillance” means that the RRN will be expected to have situational awareness of patients present in the Radiology area, be accessible to the members of the Radiology team and stay at the side of, and provide care and assistance to, any patient whose condition changes while in the Radiology area. The RRN will also call on additional support as needed for the care of a patient. Such surveillance is achieved by a combination of the RRN’s physical presence in the Radiology area, as well as real-time audio and video monitoring of patients in the Radiology area and real-time communication with other staff members conducting real-time audio and video monitoring of patients in the Radiology area. This nurse will also act as a resource to the radiology technologists and licensed professionals accompanying patients, and serve as liaison between the radiology department and the inpatient care areas to facilitate safe, patient transports to radiology. This nurse position is staffed Monday through Friday, from 7am to 4pm. When this nurse is not the revised Transport policy will apply to require the transporting clinical staff member to remain with the patient.






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VUMC is currently posting nursing positions to create around the clock staffing of the nurse in the radiology department. As of January 1, 2019, the Hospital extended radiology nurse coverage from 7 am to 7 pm. As of January 21, 2019, the Hospital extended radiology resource nurse coverage to 24 hours per day, 7 days a week. Each patient that requires monitoring based on the Transport Policy and its associated SOP, the Medication Administration Policy, or any patient specific provider orders is being accompanied to the radiology department and monitored by a nurse or paramedic consistent with the applicable policies. In the event the radiology nurse has reached capacity of patients to monitor or is not otherwise available to receive handover of patients, in accordance with the revised Transport Policy, the clinical staff member(s) transporting additional patients to the radiology areas will remain with the patient they are transporting.

• The Hospital has revised its High Alert Medication Policy, which revisions were approved on November 27, 2018, to detail required monitoring of patients receiving administration of high alert medications. Specifically, the amended High Alert Medication

1/21/19

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Policy states that the patient’s clinical status is monitored to evaluate patient response to medication and/or adverse reactions, and the duration and frequency of monitoring is based on the patient’s condition, the type of medication, and route of administration. Such monitoring may include, but is not limited to, direct observation, monitoring of vital signs and neurological status. In accordance with the revisions made to the Hospital’s High Alert Medication Policy and Chart, Paralyzing Agents and controlled substances have parameters for monitoring that vary based on the specific medication. For example, a patient receiving an intermittent dose of a controlled substance intravenously, who is not on continuous monitoring (cardiac or pulse oximetry) will be visually observed for at least five minutes by clinical staff and are subsequently reassessed within one hour. The Hospital has revised its High Alert Medication Policy and Chart to include specified monitoring parameters for high alert medications. Specifically, a Patient Monitoring column has been added to the High Alert Medication Chart which specifies the monitoring requirements for each type of High Alert Medication listed in the Chart,

2/7/19






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including the duration and frequency of monitoring, and issues and reactions for which to monitor. The specifications for monitoring and type of monitoring are outlined for ease of access and use by Hospital staff in the High Alert Chart. Paralyzing Agents continue to be included as a High Alert Medication. Pursuant to the High Alert Medication Chart, a patient receiving a Paralyzing Agent will have continuous cardiac and respiratory monitoring. In addition, after reassessing guidance from the Institute for Safe Medication Practices (ISMP) the Hospital has added controlled substances, including opioids and benzodiazepines, to the High Alert Medication Policy and Chart. A patient receiving an initial dose of a controlled substance by route as defined by the Hospital’s High Alert Medication Chart, will be continuously monitored by a qualified clinical staff member for at least five minutes and again within the hour if not subject to continuous monitoring based on the patient’s clinical condition.

Additionally, the Hospital has revised its Procedural Sedation Policy (attached) and developed a Minimal Sedation Standard Operating Procedure (“Minimal

2/7/19






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Sedation SOP”) to include monitoring guidelines for minimal sedation. These guidelines include classification of sedation (minimal, moderate, deep, nitrous), who is eligible to fulfill the monitor role, qualifications of a monitor, education required for monitors, equipment necessary for monitoring, what assessment requirements are (parameters that must be included), the frequency of monitoring and the required documentation.

• The Hospital’s Medication Administration Policy has been revised, which revisions were approved on November 27, 2018, to detail required monitoring of patients receiving medications. Specifically, the amended Medication Administration Policy states that the patient’s clinical status is monitored to evaluate patient response to medication and/or adverse reactions, and the duration and frequency of monitoring is based on the patient’s condition, the type of medication, and route of administration. Such monitoring may include, but is not limited to, direct observation, monitoring of vital signs and neuro checks. The Medication Administration Policy has been further amended to require specific documentation in the medical record regarding medication

11/27/18






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administration and monitoring.

The staff member transporting the patient will know the needed duration and frequency of monitoring by referring to the Hospital’s existing Transport Policy, Transport SOP, the updated High Alert Medication Policy and Chart (attached) and any orders for monitoring as entered into the patient’s medical record, as further informed by the staff member’s knowledge of the specific patient’s condition, including information gained during the Hospital’s Clinical Handover Procedure. The Hospital has revised its High Alert Medication Policy and Chart to include specified monitoring parameters for high alert medications. Specifically, a Patient Monitoring column has been added to the High Alert Medication Chart which specifies the monitoring requirements for each type of High Alert Medication listed in the Chart, including the duration and frequency of monitoring, and issues and reactions for which to monitor. The specifications for monitoring and type of monitoring are outlined for ease of access and use by Hospital staff in the High Alert Chart. For example, Paralyzing






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Agents continue to be included as a High Alert Medication. Pursuant to the High Alert Medication Chart, a patient receiving a Paralyzing Agent will have continuous cardiac and respiratory monitoring. In addition, after reassessing guidance from the Institute for Safe Medication Practices (ISMP) the Hospital has added controlled substances, including opioids and benzodiazepines, to the High Alert Medication Policy and Chart. A patient receiving an initial dose of a controlled substance by route as defined by the Hospital’s High Alert Medication Chart, will be continuously monitored by a qualified clinical staff member for at least five minutes and again within the hour if not subject to continuous monitoring based on the patient’s clinical condition.


• The duration and frequency of monitoring is based on patient’s condition, type of medication, and






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route of administration. • Monitoring may include, but is not

limited to, visual observation, vital signs, and neuro checks.



In addition, the Hospital’s CL SOP - Clinical Handover Communication procedure (attached) sets forth guidelines to ensure that the communication of information and the transfer of responsibility and authority for the care of a patient between individuals or teams is completed. Clinical handovers follow a Hospital-approved structure that includes the most current patient information (including medication administrations) and interactive communication, with a focus on current condition, plan of care and safety. In the case of an administration of a high alert medication, such as Versed in certain routes of administration, the clinical handover communication would focus on potential cardiopulmonary compromise and applicable monitoring in accordance






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with the Hospital’s Transport Policy (attached). When a patient is transported off the clinical unit for a test or procedure, the staff will follow the guidance of the Transport SOP.

• The Hospital reviewed its policies and procedures related to moderate sedation, specifically the Standard Operating Procedure for Moderate Sedation, to ensure sufficient safeguards are in place. The Hospital determined that its has in place comprehensive guidance regarding the administration of moderate sedation, specifically including procedures for ensuring patients receiving sedation are continuously observed and physiologically monitored throughout the sedation period by a nurse, advanced practice nurse, physician, or other qualified and trained staff as approved by the Hospital’s Sedation Committee. The SOP for Moderate Sedation details the post anesthesia recovery scoring system and score that is required to discontinue monitoring. The SOP for Moderate Sedation also includes conditions for transporting patients who have undergone moderate sedation, including required monitoring. The Hospital has determined that no updates to the SOP for Moderate






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Sedation are required.

• The Hospital has revised the High Alert Medication Policy and Chart, Transport Policy, Transport SOP, Clinical Handover Communication procedure, Procedural Sedation Policy, and Minimal Sedation Standard Operating Procedure (SOP) (each attached) to guide staff in situations requiring monitoring. In addition, staff will provide monitoring as ordered for a patient and documented in the patient’s medical record. To educate the staff on these updates, the Hospital has prepared an educational computer-based learning module which was assigned to all nurses, paramedics, provider staff and pharmacy staff working in inpatient and procedural areas, and approved credentialed providers for moderate or deep sedation, through the Hospital’s on-line Learning Module System on January 25, 2019 with the target completion date of February 4, 2019. Any staff who has not completed the learning module by February 4, 2019 will be required to do so prior to the start of their next shift. The specific policies and standard operating procedures addressed in the learning modules are as follows: High Alert

2/7/19






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Medication Policy and Chart, Medication Administration Policy, Procedural Sedation Policy and Minimal Sedation Standard Operating Procedure.

• Training: By December 3, 2018, the Hospital required all managers, clinical staff leaders (CSLs), nurses, licensed practical nurses (LPNs), respiratory therapists and paramedics working in inpatient and procedural areas of the Hospital to complete education through its on-line education system, which addresses the updates to the Transport Policy, High Alert Medication Policy, and Medication Administration Policy including the requirements for monitoring patients during transport and during and after medication administration, appropriate handover, and related medical record documentation. No clinical staff member listed above has been able to begin a shift after December 3rd without confirmation of training and subsequent competency testing. The Hospital’s Chief Nursing Officers monitor this education requirement and provide regular updates to directors of these departments to ensure compliance. The Hospital’s CNOs oversee this education requirement in collaboration with the Hospital’s education department and local

12/3/18






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nursing unit leaders. Compliance rates (meaning the clinical staff members required to complete the education who have not yet completed the training) are reviewed on a weekly basis by the Hospital’s CNOs. As of January 23, 2019, 1,492 individuals, which is 99% percent of the total number of 1,509 of Hospital’s staff members required to receive the education, had completed the training requirement for monitoring patients during transport and during and after medication administration, appropriate handover, and related medical record documentation.

As to paramedics, the Hospital complies with Tenn. Comp. R. & Regs. 1200-12-4-.01. Paramedics at the Hospital only perform extended skills or procedures when such treatment is conducted under authorized medical control and nursing supervision and is within the scope of practice identified in state law. Paramedics employed in this capacity demonstrate continued training and competence in order to perform their professional duties, consistent with their scope of practice. Paramedics work in the Emergency Department, and do not work in inpatient and procedural areas of the Hospital. However, it is






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possible that a paramedic may transport a patient from the Emergency Department to inpatient or procedural areas, and as such, the Transport Policy would apply to such paramedic. Given the potential application to transports, the Hospital is requiring paramedics to complete this additional training and education regarding updated patient monitoring procedures. The Hospital’s job description for paramedics states that paramedics are responsible for triage care in the field and the Emergency Department, and are further responsible for effective communication to ensure safe and quality patient care in transport and handover. The paramedic job description requires paramedics to deliver patient care within the Tennessee paramedic scope of practice. Paramedics are utilized in, and are under the supervision of clinical care providers in, the Hospital’s emergency service/care areas pursuant to TN state law. All paramedics are trained on the Hospital’s CL SOP - Clinical Handover Communication procedure. The Clinical Handover Procedure sets forth guidelines to ensure the communication of information and the transfer of






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responsibility/authority for the care of the patient between individuals or teams. Clinical handovers follow a Hospital-approved structure that includes the most current patient information (including medication administrations) and interactive communication with a focus on current condition, plan of care and safety. In the case of an administration of a high alert medication, such as Versed in certain routes of administration, the clinical handover communication would focus on potential cardiopulmonary compromise and applicable monitoring in accordance with the Hospital’s Transport Policy (attached). Paramedics are also trained on the High Alert Medication Chart (attached) which includes specified monitoring parameters for all high alert medications. Paramedics in the Hospital will receive information pertaining to a patient being transported through the clinical handover process consistent with the Clinical Handover Communication procedure. Through this handover process, the paramedic will be notified of the specific monitoring requirements for the patient. The Paramedic duties are stated within the Paramedic Scope of Practice






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document (attached).


UPDATE: The Hospital is monitoring the completion of the required training programs, and as of December 18, 2018, 2,514 individuals, which is 99% percent of the Hospital’s staff members required to receive the education, had completed the training requirement for monitoring patients during transport and during and after medication administration, appropriate handover, and related medical record documentation. 1% of staff remain on FMLA and will not be allowed to return to work until training has been completed.






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The 2,514 individuals constitutes 99% of the Hospital’s total number of staff members required to complete the training as of December 18, 2018, out of a total of 2,563 individuals (at the time) required to complete the training for monitoring patients during transport and during and after medication administration, appropriate handover, and related medical record documentation. Specifically, the Hospital has required all managers, clinical staff leaders (CSLs), nurses, licensed practical nurses (LPNs), respiratory therapists and paramedics working in inpatient and procedural areas of the Hospital to complete education through its on-line education system, which addresses the updates to the Transport Policy, High Alert Medication Policy, and Medication Administration Policy including the requirements for monitoring patients during transport and during and after medication administration, appropriate handover, and related medical record documentation. No clinical staff member listed above has been able to begin a shift after December 3, 2018 without confirmation of training and subsequent competency testing.






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As of January 25, 2019, 2,502 individuals have completed the training, who represent 98% of the current number of 2,546 managers, clinical staff leaders (CSLs), nurses, licensed practical nurses (LPNs), respiratory therapists and paramedics working in inpatient and procedural areas of the Hospital required to complete such training. As to the scoring system, the Hospital’s computer-based training module titled, “2019 FY Moderate Sedation at VUMC” in the Hospital’s online education system addresses the scoring system. Additionally, the Hospital developed a new computer-based training module titled “2019 FY High Alert Medication and Procedural Sedation,” which has been assigned to all all nurses, paramedics, provider staff and pharmacy staff working in inpatient and procedural areas, and approved credentialed providers for moderate or deep sedation, to educate them on the revised Procedural Sedation policy. The new module will have a specific post-completion test question directly related to the scoring system. The module will be assigned to all applicable staff on






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January 25, 2019 with a completion date of February 4, 2019. Any staff member who has not completed the training as of February 4, 2019, will not be allowed to return to work until the module is complete. Any new staff will also be required to complete training as a part of the clinical orientation process. The Hospital will monitor staff’s compliance with the use of, and documentation of, the scoring system consistent with Hospital’s applicable policies and procedures.


• In addition, the Hospital developed a new computer-based training module titled, “2019 FY High Alert Medication and Procedural Sedation,” which has been assigned via the Hospital’s Learning Module System to all nurses, paramedics, provider staff and pharmacy staff working in inpatient and procedural areas, and approved credentialed

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providers for moderate or deep sedation, to educate them on the revised Procedural Sedation policy. The module will be assigned to all applicable staff on January 25, 2019 with a completion date of February 4, 2019. Any staff member who has not completed the training as of February 4, 2019, will not be allowed to return to work until the module is complete.


• Monitoring: Beginning on December 3, 2018 and continuing for the following three months, the Hospital’s Chief Nursing Officers oversee weekly chart reviews of 5 patients from each unit, randomly selected, to assess for compliance with improvement in medication safety, transport and monitoring of patients. To date, the Hospital’s

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Chief Nursing Officers have directed the unit level nurse managers’ performance of weekly chart reviews of a minimum of five patients from each unit, or 100% of patients transported if the unit has transported less than five patients within the week, to assess for compliance with policies and procedures related to patient monitoring and safe patient transport. The unit level nurse management team has been instructed to select cases for review that facilitate immediate performance feedback to team members, and to evaluate practices on both day and night shift observations. Such patient records are reviewed for documentation of the appropriate monitoring, handover communication, and documentation consistent with the Transport Policy, Medication Administration Policy and High Alert Medication Policy. In the event such an audit reveals non-compliance, inconsistencies or questions, the Chief Nursing Officers will follow-up with the unit level nurse managers for additional steps required to achieve compliance, such as targeted education and training. Results of the chart audit are reported to the CNOs weekly, and






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the unit level leaders will also consult the CNOs as needed to determine additional steps required to achieve compliance. The unit level leaders review the patient movement compliance reports daily. The Chief Nursing Officers will review monthly updates of such chart review audits to the VUMC Nursing Quality Committee.


UPDATE: As of December 18, 2018, the Hospital’s Chief Nursing Officers have overseen two weekly chart reviews, of 5 patients from each unit. Following the first audit during the week of December 3, 2018, the Hospital’s Chief Nursing Officers determined that the Hospital’s medical record layout required revisions in order to accommodate the additional documentation requirements.






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Following these updates to the medical record which were effective December 10, 2018, the following weekly audit resulted in a compliance rate of 93%. Chart audits are completed in real time, allowing unit managers to provide immediate training to staff who exhibit noncompliance with documentation requirements.







• A multi-disciplinary work group comprised of Hospital leaders including Physicians, Pharmacy,






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Risk, Nursing, Quality, and Health Informatics was convened beginning on January 19, 2018 to assess Paralyzing Agents included on the override medication list. This workgroup determined to remove vecuronium from the AcuDose (Hospital’s automated dispensing cabinet) override status list, which removal was approved by the VUMC Pharmacy, Therapeutics and Diagnostic Committee on February 23, 2018 and implemented on March 1, 2018. The work group determined to retain availability of the following Paralyzing Agents in the AcuDose cabinets in the Hospital: rocuronium, succinylcholine, vecuronium and cisatracurium. The work group determined that rocuronium and succinylcholine would remain on the override list, based on the work group’s determination that the clinical risks to patients of not having immediate access to rocuronium and succinylcholine outweighed the potential safety benefits from removing the Paralyzing Agent from override status. The four Paralyzing Agents are medications that must be accessed quickly during an emergency medical event. In particular, the work group considered the potential risks that may arise in the event rocuronium






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and/or succinylcholine is not available in certain inpatient and procedural areas of the Hospital when needed in an emergency for a rapid sequence intubation. The work group determined that vecuronium and cisatracurium would remain available in the AcuDose cabinet, but would be removed from override status list so that they could not be dispensed without a written physician order and pharmacy verification. Vecuronium and cisatracurium were retained in AcuDose based on the fact that manual delivery from the Hospital pharmacy can often take between thirty (30) minutes to one hour to be delivered. Alternatively, dispensing from the AcuDose cabinet can often occur within about ten (10) minutes. It is standard practice to make available in the AcuDose cabinet any medication that is dispensed in a certain volume, particularly given that vecuronium and cisatracurium require a physician order and pharmacist review. Some Paralyzing Agents are contraindicated with patient care requirements, and the selection of a prescribed Paralyzing Agent by a physician is based on the patient’s clinical indications. As such, the work group decided to retain multiple Paralyzing Agents in the






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AcuDose cabinet. Additionally, as noted elsewhere, the medication administration process has been enhanced with additional security measures for all Paralyzing Agents, including shrink wrap packaging and a required Independent Double Check process.

The Hospital’s Medication Safety Officer in partnership with the VUMC Pharmacy, Therapeutics and Diagnostic Committee will reassess the Paralyzing Agents, including rocuronium, on the override list annually. Specifically, in December of each calendar year, the Medication Safety Officer will review the Paralyzing Agents included on the override medication list to determine the appropriateness of the override list. This annual assessment of the Paralyzing Agents included on the override medication list will weigh the clinical risks of having access to certain Paralyzing Agents on the override list against the benefits of removing such Paralyzing Agents from the override list. The Medication Safety Officer will review every case in which rocuronium and/or succinylcholine was dispensed from AcuDose via override; how frequently Paralyzing Agents were dispensed from AcuDose cabinets;






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whether a delay in accessing the medication causes patient harm; implications related to why staff selects a specific Paralyzing Agent; utilization of all Paralyzing Agents available in the AcuDose cabinet; the time of the override compared to medication order; and the time of the override compared to the medication administration time. The determination as to whether or not a delay in accessing the medication causes harm, and whether or not such medication should be available on override status, is a multidisciplinary decision. The Medication Safety Officer considers harm or potential patient harm secondary to medication delay in conjunction with the Hospital’s Pharmacy Policy committee and the VUMC Pharmacy, Therapeutics and Diagnostic Committee.

While the Medication Safety Officer’s annual assessment will include a review of data from prior periods to assist in assessing the continued appropriateness of the Paralyzing Agents on override status, this assessment is a proactive approach to determine whether there should be a change to the Paralyzing Agents on override status and any clinical






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implications to patient care.

In addition to the safety measures related to Paralyzing Agents outlined herein of Independent Double Check, vial packaging, naming conventions, and system alerts that have been implemented as part of the Plan of Correction, the Hospital has implemented further proactive measures to ensure safe storage and dispensing of Paralyzing Agents. Barcode assisted medication administration (“BCMA”) systems involve the use of scanners and software to verify all medications electronically before they are administered to patients, and further to document the medication in the electronic medication administration record. BCMA systems are utilized where available throughout the Hospital, and the Hospital is implemented BCMA systems in radiology areas by December 11, 2018. The Medication Use Safety Improvement Committee continually monitors trends in data related to medication use and will continue to monitor professional organizations for updated Institute for Safe Medication Practices (ISMP) recommendations as to medication administration. Additionally, the






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Hospital has performed a gap analysis with the ISMP Targeted Medication Safety Best Practices for Hospitals and has participated in an ISMP high alert self-assessment and benchmarking review. Both the gap analysis and high alert self-assessment include a review of Paralyzing Agent practice. The Hospital performs an ongoing review of the ISMP quarterly action agenda recommendations through the Medication Management group, a subcommittee of the Medication Use Safety Improvement Committee.

Further, since 2016 the Hospital’s Pharmacy, Therapeutics and Diagnostics Committee has reviewed every medication introduced to the Hospital’s formulary using a developed Risk Mitigation Plan for Formulary Additions Checklist. This proactive strategy reviews potential failure modes in procurement, clinical decision support, high alert, look alike-sound alike (LASA), adverse drug event risk, hazardous medications, packaging and labeling, order review, preparation, administration, monitoring and transitions of care to prepare our hospital and system for a certain medication. The Medication Use Safety Improvement Committee will






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continue to oversee and take actions to prevent, monitor and evaluate adverse drug events, particularly through the Medication Use Safety Improvement Committee subcommittees on Adverse Drug Events.

• The Hospital has changed the naming convention from “Neuromuscular Blocking Agents”, as referenced in certain policies, including the High Alert Medication Policy, to “Paralyzing Agents” for consistency throughout the Hospital. The Hospital has also standardized the nomenclature utilized for Paralyzing Agents across the Hospital in eStar (Hospital’s electronic medical record) and AcuDose, such that both electronic systems present the name as “PARALYZING AGENT” followed by the medication name. Paralyzing Agents will no longer be able to be pulled up on the AcuDose override screen by typing in the drug name. Instead, “PARA” will be typed in - the first two letters of “Paralyzing Agent” - which will then pull up the list of Paralyzing Agents in the AcuDose cabinet. The four Paralyzing Agents are the only medications that result on both electronic systems in a search for “PARA”. Signs are attached to the AcuDose cabinets indicating that “PARA” must be used to access

11/27/18






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Paralyzing Agents. The new nomenclature of “Paralyzing Agent: [medication name]” was effective in both eStar and AcuDose as of November 27, 2018. Effective on November 27, 2018, this updated procedure is documented by an amendment to the Hospital’s High Alert Medications Charts for both Adult Patients and Pediatric Patients, which are incorporated into the High Alert Medications Policy. These charts have been amended to list the four (4) specific Paralyzing Agents available at the Hospital, and to reflect the updated nomenclature of “Paralyzing Agent [medication name]”.


• On November 27, 2018, the Hospital implemented new procedures for shrink wrap packaging to be added to all vials of Paralyzing Agents dispensed in

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AcuDose throughout the Hospital, and effective November 27, 2018 amendments to the Hospital’s High Alert Medications Charts for both Adult Patients and Pediatric Patients were approved to specify a Specific Safety Strategy that all Paralyzing Agents dispensed in AcuDose cabinets throughout the Hospital will have shrink wrap packaging. The Hospital Executive Pharmacy Leadership will monitor compliance with the required shrink wrap packaging of Paralytic Agents by conducting random audits of all AcuDose cabinets throughout the Hospital and validating packaging compliance for a minimum of three months of consecutive 100% compliance. Specifically, beginning with the week of November 26, 2018, each week the directors of the Hospital pharmacies oversee their staff in auditing 25% of the AcuDose cabinets in the Hospital, to inspect all Paralyzing Agents stored in the AcuDose cabinet being audited to determine whether each Paralyzing Agent includes the appropriate shrink wrap packaging. Each week during the month, a different 25% of the AcuDose cabinets is audited, such that 100% of AcuDose cabinets will have been audited within the course of one month. The directors of the Hospital pharmacies will continue to audit






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25% of the AcuDose cabinets each week until such audits result in three consecutive months of 100% compliance with required shrink wrap packaging procedures. As such, each AcuDose cabinet in the Hospital will be audited at least three times during the audit period. UPDATE: As of December 18, 2018, four weeks of audits have been performed of AcuDose cabinets in the Hospital, and as such, every AcuDose cabinet in the Hospital has been audited. Of the 143 vials of Paralyzing Agents contained in the AcuDose cabinets audited the week of November 25, 2018, three vials were identified without the proper shrink wrap packaging--these vials were discarded. During the weeks of December 2, December 9, and December 16, every vial of a Paralyzing Agent contained in the AcuDose cabinets audited included the required shrink wrap packaging, establishing 100% compliance. UPDATE: As of January 24, 2019, nine weeks of audits have been performed of AcuDose cabinets in the Hospital, and as such, every AcuDose cabinet in the Hospital has been audited at least twice. During the weeks of December 23, December 30, January 6, January

1/24/19






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13 and January 20, every vial of a Paralyzing Agent contained in the AcuDose cabinets audited included the required shrink wrap packaging, continuing 100% compliance. The weekly Paralyzing Agent compliance audits will continue for three months from November 25, 2018. For ongoing sustainment, monitoring and oversight thereafter, the Hospital has incorporated these weekly audits into the Hospital’s current monthly medication safety checks that are conducted in every unit/area that has medications. This oversight process has become a part of the Hospital’s standard assessment for medication safety.



The Hospital has amended the High Alert Medications Charts for both

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Adult Patients and Pediatric Patients, which revisions were approved on November 27, 2018, to specify the Specific Safety Strategy that all Paralyzing Agents require such Independent Double Check. The Double Check process related to patient level detail is documented within the Patient’s Medication Administration Record (MAR), which is located in the Electronic Medical Record (EMR). The Hospital’s CNOs, Pharmacy and Quality departments are collectively responsible for monitoring compliance with all medication administrations requiring a two-person sign off, which is a component of an independent double check. Prior to a qualified staff member administering the medication, it is scanned through the Barcode Medication Administration (BCMA) tool which forces a dual sign-off. This sign-off prompt requires an additional qualified clinical staff member to confirm the correct medication, correct dose and correct route of administration. Both staff members are then required to acknowledge the double check within the Medication Administration Record (MAR) portion of the Hospital’s Electronic Medical Record (EMR)






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prior to administration.


• Training: By November 26, 2018, every nurse and paramedic who work in an area of the Hospital where Paralyzing Agents are available in AcuDose dispensing cabinets, were required to complete an online training module outlining the process changes, Independent Double Check, vial packaging and naming convention changes. Any nurse or paramedic staff member required to complete such training, and who has not completed the computer-based training prior to November 27, 2018 for any reason, including being on vacation or not scheduled to work at the Hospital during the time period, has not been permitted to begin their next shift at the Hospital without first completing the required training.

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UPDATE: The Hospital is monitoring the completion of the required training programs, and as of December 18, 2018, 1,487 individuals, which is 99% percent of the Hospital’s staff members required to receive the education, had completed the training requirement. 1% of staff remain on FMLA and will not be allowed to return to work until training has been completed.

Specifically, by November 26, 2018, every nurse and paramedic who works in an area of the Hospital where Paralyzing Agents are available in AcuDose dispensing cabinets, was required to complete an online training module outlining the process changes, dual sign-off, vial packaging and naming convention changes. Any nurse or paramedic staff member required to complete such training, and who had not completed the computer-based training prior to November 27, 2018 for any reason, including being on vacation or not scheduled to work at the Hospital during the time period, has not been permitted to begin their next shift at the Hospital without first completing the required training.

As of January 25, 2019, 1,492 individuals have completed the training, who represent 99% of the

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Hospital’s total number of 1,509 nurses and paramedic staff members required to complete such training.

• Monitoring: The Hospital has implemented several measures to monitor compliance with the updated medication administration requirements. Beginning on November 27, 2018, the Hospital’s Enterprise Medication Safety Officer, in collaboration with the Chief Nursing Officers, Executive Pharmacy Leadership, and Chief of Staff, began to compile monthly reports of overrides from AcuDose cabinets for paralyzing agents, which will be reviewed at the medication safety committee, as well as on the unit level, and assessed for appropriateness. Such monthly reporting will be ongoing, and continue for three months following November 27, 2018. Thereafter, and continuing indefinitely the Enterprise Medication Safety Officer will continue to review all unreconciled dispense reports that identify medication overrides without an order linked, and provide monthly override performance reports to the medication safety committee as part of ongoing medication safety committee work. In the event such monthly reports reveal non-

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compliance, inconsistencies or questions, the medication safety committee will elevate these issues to Chief Nursing Officers, Executive Pharmacy Leadership, and Chief of Staff to determine whether additional steps are required for compliance, such as targeted education and/or training.


As noted by the Institute for Safe Medication Practices (ISMP) (attached), there are important, legitimate reasons for the medication override process in emergent situations (i.e., antidotes,






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rescue and reversal agents, and life-sustaining medications).



UPDATE: In order to evaluate initial compliance of staff overrides

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related to paralyzing agents, audit frequency has been increased to weekly for the first month, after which the audits will be conducted on a monthly frequency. As of December 18, 2018, the Hospital’s Enterprise Medication Safety Officer, in collaboration with the Chief Nursing Officers, Executive Pharmacy Leadership, and Chief of Staff have completed three weekly reviews of overrides from AcuDose cabinets for Paralyzing Agents, which weekly report has been reviewed at the medication safety committee, as well as on the unit level, and assessed for appropriateness. This weekly review showed a 95% compliance rate with the Hospital’s policies and procedures regarding overrides of Paralyzing Agents. As of December 18 2018, the Hospital’s Chief Nursing Officers have completed three weekly reviews in order to verify compliance with the Independent Double Check procedure for Paralyzing Agents. These three weekly reviews each showed a 100% compliance rate.

The Hospital is developing a unit-specific override compliance dashboard to provide ongoing monitoring and ensure compliance of overrides of high alert medications. This expands the Hospital’s review of overrides of






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Paralyzing Agents to include all high alert medications. System-level compliance throughout the Hospital will continue to be monitored by the Hospital’s Medication Usage Safety Improvement Committee.


• In regard to nurse training on medication administration, medical record documentation, and monitoring of patients receiving medication, all newly hired nurses are required to complete computer-based training related to the preparation of drugs and safe medication practices. All nurse residents, who are new graduate registered nurses hired with less than six months of nursing experience, are required to complete such education regarding safe medication practices, as well as attend a workshop on medication safety. These trainings have been updated to include education as to the revisions to the Medication Policy, the new nomenclature for Paralyzing Agents, the updated requirements for monitoring patients receiving High Alert Medications.






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• The Hospital has updated Scope of Care documents in each department that relies on a “Help All Nurse” (or similar position), in order to define the applicable role and duties. At the Hospital, “Resource Nurse” is generally used to describe a nursing role that usually does not take patient assignment during the

11/20/18






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shift but takes direction from the Clinical Staff Leader or Resource Staff Leader to assist other nurses as workloads demand, including rapid response teams, STAT calls, and transports. Resource Nurse roles in various departments include Float Nurse; Procedural Nurse; Admit Discharge, Transfer Nurse; and Patient Flow Nurse. The Scopes of Care were revised in intensive care units and non-intensive care units to define the applicable Resource Nurse role (including the “Help All Nurse” as applicable) by November 20, 2018. Nursing leadership of each Hospital department that utilizes such a Resource Nurse role will review the departments Scope of Care document on an annual basis to ensure duties of the position remain complete and accurate.

The role of the Resource Nurse, or “Help All” nurse, within the unit is a staffing assignment, rather than a position in which a nurse is employed with a job title, therefore no job description exists. The following are details surrounding this unit assignment. A Resource Nurse (e.g., Float Nurse, Procedural Nurse, Help-All Nurse, ADT (admit, discharge, transfer) Nurse, and Patient Flow Nurse), is a nursing role that may be available if the unit has adequate






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baseline staffing to utilize such a Resource Nurse, who usually does not take patient assignment. The role of the Resource Nurse will be assigned by the Clinical Staff Leader (more commonly known as Charge Nurse) to assist unit RNs with patient assignments as work demands. Tasks assigned may include but are not limited to providing procedural assistance, and participating in Rapid Response Team response, STAT response, admission/ discharge or transfer processes, relief coverage (breaks and lunch) and patient transport. Staff serving in a Resource Nurse capacity must, at a minimum, be an RN II, which is attained after one year of relevant clinical experience. The nurse is required to be oriented to the role with a nurse experienced in the Resource Nurse role prior to taking on the role of this assignment. All staff within the units are aware of the Resource Nurse duties and are encouraged to utilize this resource opportunity to enhance patient safety and care. The role of Resource Nurses is not different from the role of the bedside nurse and thus, the Resource Nurse possesses the same knowledge and competencies as all nurses on the unit. The nurses in question






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simply do not take a patient assignment and are available to assist the nurses on the unit with the types of tasks described above.


The Hospital has revised its policy previously titled Transport of the Critically Ill Patient, which revisions were approved on November 27, 2018, to broaden application of the policy beyond critically ill patients. As such, the newly amended policy is titled “Transport of Patients” (hereinafter, “Transport Policy”). This policy provides that every patient shall be transported with equipment, supplies, and staff appropriate to monitor and support the patient’s physiological needs. Physiological “needs” in the context of this statement refers to a patient’s medical requirements, based on the patient’s current clinical condition and clinical course of treatment as determined by the multidisciplinary healthcare team. An example would include a patient

11/27/18






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with provider-ordered cardiac telemetry monitoring would be transported with the monitor unless there is an order stating otherwise. The policy details that the level of care is maintained during transport and after arrival at the receiving department/unit, and describes specific monitoring and documentation requirements. The amended policy states that when a patient requires continuous monitoring, a clinical staff member is required to be available to receive handover of the patient pursuant to the Hospital’s CL SOP - Clinical Handover Communication procedure. Any such handover will be documented in the medical record. In the event a clinical staff member is not available to receive the patient, the transporting clinical staff member must remain with the patient. Further, the Transport Policy states that patients receiving medications that could lead to respiratory depression and/or respiratory distress are monitored during and after transport, with the duration and frequency of the monitoring to be based on the patient’s condition, type of medication, and route. Documentation will be in accordance with VUMC’s Medication Administration Policy. The Transport Policy further states that such monitoring may include, but is not limited to, direct observation, vital signs, and neuro






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checks. The revised Transport Policy further requires appropriate documentation to be completed in the patient’s medical record upon leaving and returning to the unit, including the times the patient leaves and returns to the unit. The clinical staff members who may transport patients include RNs, paramedics and other clinical staff as outlined in the Transport Policy and associated Standard Operating Procedure entitled “Transport of Patients Receiving Medications That May Cause Impaired Consciousness or Undesired Changes in Vital Signs” (“Transport SOP”), which is further described below. For purposes of transport of patients, staff appropriate to monitor and support the patient’s physiological needs is determined based on the patient’s current clinical condition. Further, a non-clinical staff member may transport a patient in the event a patient’s physiological needs do not require monitoring or support pursuant to the Transport Policy and Transport SOP, Medication Administration Policy, or High Alert Medication Policy. In December 2018, the Hospital adopted the Transport SOP, which sets forth specific parameters for transport of adult patients in Vanderbilt University Hospital that have received medication that may cause impaired consciousness or undesired changes in vital signs, other than






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critically ill patients who are addressed in the Transport Policy. The SOP was amended in January 2019 and provides as follows in regard to staff members who may transport patients:





Patient is on PCA/epidural/continuous controlled substance infusion with a change in medication, dose, concentration, or rate of administration within the last hour, maintaining consistency with MM SOP - Patient-Controlled Analgesia (PCA) and Continuous Controlled






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Substance Infusion: Administration and Management.






After receiving a new IV analgesic or sedative medication (e.g., benzodiazepine, opioid), patient has been observed by the RN/paramedic for 30






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minutes and is awake and easily arousable.




• Beginning on December 3, 2018, the Hospital staffed a nurse in the radiology department, whose role is to provide surveillance of patients who have not met the criteria to be accompanied by a licensed professional. The Radiology

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Resource Nurse (RRN) is responsible for patients who do not require the consistent presence of a nurse for monitoring or supporting the patient’s physiological needs, pursuant to the Transport Policy and Transport SOP and other policies related to patient monitoring. In this context, “surveillance” means that the RRN will be expected to have situational awareness of patients present in the Radiology area, be accessible to the members of the Radiology team and stay at the side of, and provide care and assistance to, any patient whose condition changes while in the Radiology area. The RRN will also call on additional support as needed for the care of a patient. Such surveillance is achieved by a combination of the RRN’s physical presence in the Radiology area, as well as real-time audio and video monitoring of patients in the Radiology area and real-time communication with other staff members conducting real-time audio and video monitoring of patients in the Radiology area. This nurse will also act as a resource to the radiology technologists and licensed professionals accompanying patients, and serve as liaison between the radiology department and the inpatient care areas to facilitate safe, patient






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transports to radiology. This nurse position is staffed Monday through Friday, from 7am to 4pm. When this nurse is not the revised Transport policy will apply to require the transporting clinical staff member to remain with the patient. VUMC is currently posting nursing positions to create around the clock staffing of the nurse in the radiology department. As of January 1, 2019, the Hospital extended radiology nurse coverage from 7 am to 7 pm. As of January 21, 2019, the Hospital extended radiology resource nurse coverage to 24 hours per day, 7 days a week. Each patient that requires monitoring based on the Transport Policy and its associated SOP, the Medication Administration Policy, or any patient specific provider orders is being accompanied to the radiology department and monitored by a nurse or paramedic consistent with the applicable policies. In the event the radiology nurse has reached capacity of patients to monitor or is not otherwise available to receive handover of patients, in accordance with the revised Transport Policy, the clinical staff member(s) transporting additional patients to the radiology areas will remain with the patient they are transporting.

• The Hospital has revised its High

1/21/19






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Alert Medication Policy, which revisions were approved on November 27, 2018, to detail required monitoring of patients receiving administration of high alert medications. Specifically, the amended High Alert Medication Policy states that the patient’s clinical status is monitored to evaluate patient response to medication and/or adverse reactions, and the duration and frequency of monitoring is based on the patient’s condition, the type of medication, and route of administration. Such monitoring may include, but is not limited to, direct observation, monitoring of vital signs and neurological status. In accordance with the revisions made to the Hospital’s High Alert Medication Policy and Chart, Paralyzing Agents and controlled substances have parameters for monitoring that vary based on the specific medication. For example, a patient receiving an intermittent dose of a controlled substance intravenously, who is not on continuous monitoring (cardiac or pulse oximetry) will be visually observed for at least five minutes by clinical staff and are subsequently reassessed within one hour. The Hospital has revised its High Alert Medication Policy and Chart to include specified monitoring






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parameters for high alert medications. Specifically, a Patient Monitoring column has been added to the High Alert Medication Chart which specifies the monitoring requirements for each type of High Alert Medication listed in the Chart, including the duration and frequency of monitoring, and issues and reactions for which to monitor. The specifications for monitoring and type of monitoring are outlined for ease of access and use by Hospital staff in the High Alert Chart. Paralyzing Agents continue to be included as a High Alert Medication. Pursuant to the High Alert Medication Chart, a patient receiving a Paralyzing Agent will have continuous cardiac and respiratory monitoring. In addition, after reassessing guidance from the Institute for Safe Medication Practices (ISMP) the Hospital has added controlled substances, including opioids and benzodiazepines, to the High Alert Medication Policy and Chart. A patient receiving an initial dose of a controlled substance by route as defined by the Hospital’s High Alert Medication Chart, will be continuously monitored by a qualified clinical staff member for at least five minutes and again within the hour if not subject to continuous monitoring based on the patient’s






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clinical condition.


• The Hospital’s Medication Administration Policy has been revised, which revisions were approved on November 27, 2018, to detail required monitoring of patients receiving medications. Specifically, the amended Medication Administration Policy states that the patient’s clinical status is monitored to evaluate patient response to medication and/or adverse reactions, and the duration and frequency of monitoring is based on the patient’s condition, the type of medication, and route of administration. Such

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monitoring may include, but is not limited to, direct observation, monitoring of vital signs and neuro checks. The Medication Administration Policy has been further amended to require specific documentation in the medical record regarding medication administration and monitoring.

The staff member transporting the patient will know the needed duration and frequency of monitoring by referring to the Hospital’s existing Transport Policy, Transport SOP, the updated High Alert Medication Policy and Chart (attached) and any orders for monitoring as entered into the patient’s medical record, as further informed by the staff member’s knowledge of the specific patient’s condition, including information gained during the Hospital’s Clinical Handover Procedure. The Hospital has revised its High Alert Medication Policy and Chart to include specified monitoring parameters for high alert medications. Specifically, a Patient Monitoring column has been added to the High Alert Medication Chart which specifies the monitoring requirements for each type of High Alert Medication listed in the Chart, including the duration and






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frequency of monitoring, and issues and reactions for which to monitor. The specifications for monitoring and type of monitoring are outlined for ease of access and use by Hospital staff in the High Alert Chart. For example, Paralyzing Agents continue to be included as a High Alert Medication. Pursuant to the High Alert Medication Chart, a patient receiving a Paralyzing Agent will have continuous cardiac and respiratory monitoring. In addition, after reassessing guidance from the Institute for Safe Medication Practices (ISMP) the Hospital has added controlled substances, including opioids and benzodiazepines, to the High Alert Medication Policy and Chart. A patient receiving an initial dose of a controlled substance by route as defined by the Hospital’s High Alert Medication Chart, will be continuously monitored by a qualified clinical staff member for at least five minutes and again within the hour if not subject to continuous monitoring based on the patient’s clinical condition.

The Hospital has further revised its Medication Administration Policy (attached). The revised Medication






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Administration Policy includes the following direction for monitoring the patient’s clinical status and response to medications and/or adverse reactions:





In addition, the Hospital’s CL SOP - Clinical Handover Communication procedure (attached) sets forth guidelines to ensure that the communication of information and the transfer of responsibility and authority for the care of a patient between individuals or teams is completed. Clinical handovers follow a Hospital-approved structure






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that includes the most current patient information (including medication administrations) and interactive communication, with a focus on current condition, plan of care and safety. In the case of an administration of a high alert medication, such as Versed in certain routes of administration, the clinical handover communication would focus on potential cardiopulmonary compromise and applicable monitoring in accordance with the Hospital’s Transport Policy (attached). When a patient is transported off the clinical unit for a test or procedure, the staff will follow the guidance of the Transport SOP.

• The Hospital reviewed its policies and procedures related to moderate sedation, specifically the Standard Operating Procedure for Moderate Sedation, to ensure sufficient safeguards are in place. The Hospital determined that its has in place comprehensive guidance regarding the administration of moderate sedation, specifically including procedures for ensuring patients receiving sedation are continuously observed and physiologically monitored throughout the sedation period by a nurse, advanced practice nurse, physician, or other qualified and






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trained staff as approved by the Hospital’s Sedation Committee. The SOP for Moderate Sedation details the post anesthesia recovery scoring system and score that is required to discontinue monitoring. The SOP for Moderate Sedation also includes conditions for transporting patients who have undergone moderate sedation, including required monitoring. The Hospital has determined that no updates to the SOP for Moderate Sedation are required.

• The Hospital has revised the High Alert Medication Policy and Chart, Transport Policy, Transport SOP, Clinical Handover Communication procedure, Procedural Sedation Policy, and Minimal Sedation Standard Operating Procedure (SOP) (each attached) to guide staff in situations requiring monitoring. In addition, staff will provide monitoring as ordered for a patient and documented in the patient’s medical record. To educate the staff on these updates, the Hospital has prepared an educational computer-based learning module which was assigned to all nurses, paramedics, provider staff and pharmacy staff working in inpatient and procedural areas, and approved credentialed providers for moderate or deep






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sedation, through the Hospital’s on-line Learning Module System on January 25, 2019 with the target completion date of February 4, 2019. Any staff who has not completed the learning module by February 4, 2019 will be required to do so prior to the start of their next shift. The specific policies and standard operating procedures addressed in the learning modules are as follows: High Alert Medication Policy and Chart, Medication Administration Policy, Procedural Sedation Policy and Minimal Sedation Standard Operating Procedure.

• Training: By December 3, 2018, the Hospital required all managers, clinical staff leaders (CSLs), nurses, licensed practical nurses (LPNs), respiratory therapists and paramedics working in inpatient and procedural areas of the Hospital to complete education through its on-line education system, which addresses the updates to the Transport Policy, High Alert Medication Policy, and Medication Administration Policy including the requirements for monitoring patients during transport and during and after medication administration, appropriate handover, and related medical record documentation. No clinical staff member listed above

2/4/19

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has been able to begin a shift after December 3rd without confirmation of training and subsequent competency testing. The Hospital’s Chief Nursing Officers monitor this education requirement and provide regular updates to directors of these departments to ensure compliance. The Hospital’s CNOs oversee this education requirement in collaboration with the Hospital’s education department and local nursing unit leaders. Compliance rates (meaning the clinical staff members required to complete the education who have not yet completed the training) are reviewed on a weekly basis by the Hospital’s CNOs. As of January 23, 2019, 1,492 individuals, which is 99% percent of the total number of 1,509 of Hospital’s staff members required to receive the education, had completed the training requirement for monitoring patients during transport and during and after medication administration, appropriate handover, and related medical record documentation.

As to paramedics, the Hospital complies with Tenn. Comp. R. & Regs. 1200-12-4-.01. Paramedics at the Hospital only perform extended skills or procedures when such treatment is conducted under authorized medical control and






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nursing supervision and is within the scope of practice identified in state law. Paramedics employed in this capacity demonstrate continued training and competence in order to perform their professional duties, consistent with their scope of practice. Paramedics work in the Emergency Department, and do not work in inpatient and procedural areas of the Hospital. However, it is possible that a paramedic may transport a patient from the Emergency Department to inpatient or procedural areas, and as such, the Transport Policy would apply to such paramedic. Given the potential application to transports, the Hospital is requiring paramedics to complete this additional training and education regarding updated patient monitoring procedures. The Hospital’s job description for paramedics states that paramedics are responsible for triage care in the field and the Emergency Department, and are further responsible for effective communication to ensure safe and quality patient care in transport and handover. The paramedic job description requires paramedics to deliver patient care within the Tennessee paramedic scope of practice. Paramedics are utilized in,






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and are under the supervision of clinical care providers in, the Hospital’s emergency service/care areas pursuant to TN state law. All paramedics are trained on the Hospital’s CL SOP - Clinical Handover Communication procedure. The Clinical Handover Procedure sets forth guidelines to ensure the communication of information and the transfer of responsibility/authority for the care of the patient between individuals or teams. Clinical handovers follow a Hospital-approved structure that includes the most current patient information (including medication administrations) and interactive communication with a focus on current condition, plan of care and safety. In the case of an administration of a high alert medication, such as Versed in certain routes of administration, the clinical handover communication would focus on potential cardiopulmonary compromise and applicable monitoring in accordance with the Hospital’s Transport Policy (attached). Paramedics are also trained on the High Alert Medication Chart (attached) which includes specified monitoring parameters for all high alert medications. Paramedics in the Hospital will






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receive information pertaining to a patient being transported through the clinical handover process consistent with the Clinical Handover Communication procedure. Through this handover process, the paramedic will be notified of the specific monitoring requirements for the patient. The Paramedic duties are stated within the Paramedic Scope of Practice document (attached).


UPDATE: The Hospital is monitoring the completion of the required training programs, and as of December 18, 2018, 2,514 individuals, which is 99% percent of






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the Hospital’s staff members required to receive the education, had completed the training requirement for monitoring patients during transport and during and after medication administration, appropriate handover, and related medical record documentation. 1% of staff remain on FMLA, and will not be allowed to return to work until training has been completed. The 2,514 individuals constitutes 99% of the Hospital’s total number of staff members required to complete the training as of December 18, 2018, out of a total of 2,563 individuals (at the time) required to complete the training for monitoring patients during transport and during and after medication administration, appropriate handover, and related medical record documentation. Specifically, the Hospital has required all managers, clinical staff leaders (CSLs), nurses, licensed practical nurses (LPNs), respiratory therapists and paramedics working in inpatient and procedural areas of the Hospital to complete education through its on-line education system, which addresses the updates to the Transport Policy, High Alert Medication Policy, and Medication Administration Policy






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including the requirements for monitoring patients during transport and during and after medication administration, appropriate handover, and related medical record documentation. No clinical staff member listed above has been able to begin a shift after December 3, 2018 without confirmation of training and subsequent competency testing. As of January 25, 2019, 2,502 individuals have completed the training, who represent 98% of the current number of 2,546 managers, clinical staff leaders (CSLs), nurses, licensed practical nurses (LPNs), respiratory therapists and paramedics working in inpatient and procedural areas of the Hospital required to complete such training. As to the scoring system, the Hospital’s computer-based training module titled, “2019 FY Moderate Sedation at VUMC” in the Hospital’s online education system addresses the scoring system. Additionally, the Hospital developed a new computer-based training module titled “2019 FY High Alert Medication and Procedural Sedation,” which has been assigned to all nurses, paramedics, provider staff and pharmacy staff working in inpatient and procedural areas, and






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approved credentialed providers for moderate or deep sedation, to educate them on the revised Procedural Sedation policy. The new module will have a specific post-completion test question directly related to the scoring system. The module will be assigned to all applicable staff on January 25, 2019 with a completion date of February 4, 2019. Any staff member who has not completed the training as of February 4, 2019, will not be allowed to return to work until the module is complete. Any new staff will also be required to complete training as a part of the clinical orientation process. The Hospital will monitor staff’s compliance with the use of, and documentation of, the scoring system consistent with Hospital’s applicable policies and procedures.


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All of the Hospital’s policies are stored on a central online document management interface (PolicyTech). This document management software allows for all staff members to easily access any of the Hospital’s policies and standard operating procedures. For additional guidance on appropriate monitoring, staff may refer to Lexi-comp Online™ which is readily available via electronic clinical systems or

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contact the Hospital’s Pharmacy.

• Monitoring: Beginning on December 3, 2018 and continuing for the following three months, the Hospital’s Chief Nursing Officers oversee weekly chart reviews of 5 patients from each unit, randomly selected, to assess for compliance with improvement in medication safety, transport and monitoring of patients. To date, the Hospital’s Chief Nursing Officers have directed the unit level nurse managers’ performance of weekly chart reviews of a minimum of five patients from each unit, or 100% of patients transported if the unit has transported less than five patients within the week, to assess for compliance with policies and procedures related to patient monitoring and safe patient transport. The unit level nurse management team has been instructed to select cases for review that facilitate immediate performance feedback to team members, and to evaluate practices on both day and night shift observations. Such patient records are reviewed for documentation of the appropriate monitoring, handover communication, and documentation consistent with the

12/3/18






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Transport Policy, Medication Administration Policy and High Alert Medication Policy. In the event such an audit reveals non-compliance, inconsistencies or questions, the Chief Nursing Officers will follow-up with the unit level nurse managers for additional steps required to achieve compliance, such as targeted education and training. Results of the chart audit are reported to the CNOs weekly, and the unit level leaders will also consult the CNOs as needed to determine additional steps required to achieve compliance. The unit level leaders review the patient movement compliance reports daily. The Chief Nursing Officers will review monthly updates of such chart review audits to the VUMC Nursing Quality Committee.







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• A multi-disciplinary work group comprised of Hospital leaders including Physicians, Pharmacy, Risk, Nursing, Quality, and Health Informatics was convened beginning on January 19, 2018 to assess Paralyzing Agents included on the override medication list. This workgroup determined to remove vecuronium from the AcuDose (Hospital’s automated dispensing cabinet) override status list, which removal was approved by the VUMC Pharmacy, Therapeutics and Diagnostic Committee on February 23, 2018 and implemented on March 1, 2018. The work group determined to retain availability of the following Paralyzing Agents in the AcuDose cabinets in the Hospital: rocuronium, succinylcholine, vecuronium and cisatracurium. The work group determined that rocuronium and succinylcholine would remain on the override list, based on the work group’s determination that the






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clinical risks to patients of not having immediate access to rocuronium and succinylcholine outweighed the potential safety benefits from removing the Paralyzing Agent from override status. The four Paralyzing Agents are medications that must be accessed quickly during an emergency medical event. In particular, the work group considered the potential risks that may arise in the event rocuronium and/or succinylcholine is not available in certain inpatient and procedural areas of the Hospital when needed in an emergency for a rapid sequence intubation. The work group determined that vecuronium and cisatracurium would remain available in the AcuDose cabinet, but would be removed from override status list so that they could not be dispensed without a written physician order and pharmacy verification. Vecuronium and cisatracurium were retained in AcuDose based on the fact that manual delivery from the Hospital pharmacy can often take between thirty (30) minutes to one hour to be delivered. Alternatively, dispensing from the AcuDose cabinet can often occur within about ten (10) minutes. It is standard practice to make available in the AcuDose cabinet any medication






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that is dispensed in a certain volume, particularly given that vecuronium and cisatracurium require a physician order and pharmacist review. Some Paralyzing Agents are contraindicated with patient care requirements, and the selection of a prescribed Paralyzing Agent by a physician is based on the patient’s clinical indications. As such, the work group decided to retain multiple Paralyzing Agents in the AcuDose cabinet. Additionally, as noted elsewhere, the medication administration process has been enhanced with additional security measures for all Paralyzing Agents, including shrink wrap packaging and a required Independent Double Check process.

The Hospital’s Medication Safety Officer in partnership with the VUMC Pharmacy, Therapeutics and Diagnostic Committee will reassess the Paralyzing Agents, including rocuronium, on the override list annually. Specifically, in December of each calendar year, the Medication Safety Officer will review the Paralyzing Agents included on the override medication list to determine the appropriateness of the override list. This annual assessment of the Paralyzing Agents included on the override






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medication list will weigh the clinical risks of having access to certain Paralyzing Agents on the override list against the benefits of removing such Paralyzing Agents from the override list. The Medication Safety Officer will review every case in which rocuronium and/or succinylcholine was dispensed from AcuDose via override; how frequently Paralyzing Agents were dispensed from AcuDose cabinets; whether a delay in accessing the medication causes patient harm; implications related to why staff selects a specific Paralyzing Agent; utilization of all Paralyzing Agents available in the AcuDose cabinet; the time of the override compared to medication order; and the time of the override compared to the medication administration time. The determination as to whether or not a delay in accessing the medication causes harm, and whether or not such medication should be available on override status, is a multidisciplinary decision. The Medication Safety Officer considers harm or potential patient harm secondary to medication delay in conjunction with the Hospital’s Pharmacy Policy committee and the VUMC Pharmacy, Therapeutics and






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Diagnostic Committee.


In addition to the safety measures related to Paralyzing Agents outlined herein of Independent Double Check, vial packaging, naming conventions, and system alerts that have been implemented as part of the Plan of Correction, the Hospital has implemented further proactive measures to ensure safe storage and dispensing of Paralyzing Agents. Barcode assisted medication administration (“BCMA”) systems involve the use of scanners and software to verify all medications electronically before they are administered to patients, and further to document the medication in the electronic medication administration record. BCMA systems are utilized where available throughout the Hospital,






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and the Hospital is implemented BCMA systems in radiology areas by December 11, 2018. The Medication Use Safety Improvement Committee continually monitors trends in data related to medication use and will continue to monitor professional organizations for updated Institute for Safe Medication Practices (ISMP) recommendations as to medication administration. Additionally, the Hospital has performed a gap analysis with the ISMP Targeted Medication Safety Best Practices for Hospitals and has participated in an ISMP high alert self-assessment and benchmarking review. Both the gap analysis and high alert self-assessment include a review of Paralyzing Agent practice. The Hospital performs an ongoing review of the ISMP quarterly action agenda recommendations through the Medication Management group, a subcommittee of the Medication Use Safety Improvement Committee.

Further, since 2016 the Hospital’s Pharmacy, Therapeutics and Diagnostics Committee has reviewed every medication introduced to the Hospital’s formulary using a developed Risk Mitigation Plan for Formulary






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Additions Checklist. This proactive strategy reviews potential failure modes in procurement, clinical decision support, high alert, look alike-sound alike (LASA), adverse drug event risk, hazardous medications, packaging and labeling, order review, preparation, administration, monitoring and transitions of care to prepare our hospital and system for a certain medication. The Medication Use Safety Improvement Committee will continue to oversee and take actions to prevent, monitor and evaluate adverse drug events, particularly through the Medication Use Safety Improvement Committee subcommittees on Adverse Drug Events.

• The Hospital has changed the naming convention from “Neuromuscular Blocking Agents”, as referenced in certain policies, including the High Alert Medication Policy, to “Paralyzing Agents” for consistency throughout the Hospital. The Hospital has also standardized the nomenclature utilized for Paralyzing Agents across the Hospital in eStar (Hospital’s electronic medical record) and AcuDose, such that both electronic systems present the name as “PARALYZING AGENT” followed by the medication name. Paralyzing Agents will no longer be

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able to be pulled up on the AcuDose override screen by typing in the drug name. Instead, “PARA” will be typed in - the first two letters of “Paralyzing Agent” - which will then pull up the list of Paralyzing Agents in the AcuDose cabinet. The four Paralyzing Agents are the only medications that result on both electronic systems in a search for “PARA”. Signs are attached to the AcuDose cabinets indicating that “PARA” must be used to access Paralyzing Agents. The new nomenclature of “Paralyzing Agent: [medication name]” was effective in both eStar and AcuDose as of November 27, 2018. Effective on November 27, 2018, this updated procedure is documented by an amendment to the Hospital’s High Alert Medications Charts for both Adult Patients and Pediatric Patients, which are incorporated into the High Alert Medications Policy. These charts have been amended to list the four (4) specific Paralyzing Agents available at the Hospital, and to reflect the updated nomenclature of “Paralyzing Agent [medication name]”.

• On November 27, 2018, the Hospital implemented a warning in AcuDose and eStar, stating: “WARNING: PARALYZING AGENT - Causes Respiratory Arrest – Patient Must Be Ventilated.” The

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Hospital amended the High Alert Medications Charts for both Adult Patients and Pediatric Patients, effective on November 27, 2018, to specify this pop-up warning as a Specific Safety Strategy for PARALYZING AGENTS.

• On November 27, 2018, the Hospital implemented new procedures for shrink wrap packaging to be added to all vials of Paralyzing Agents dispensed in AcuDose throughout the Hospital, and effective November 27, 2018 amendments to the Hospital’s High Alert Medications Charts for both Adult Patients and Pediatric Patients were approved to specify a Specific Safety Strategy that all Paralyzing Agents dispensed in AcuDose cabinets throughout the Hospital will have shrink wrap packaging. The Hospital Executive Pharmacy Leadership will monitor compliance with the required shrink wrap packaging of Paralytic Agents by conducting random audits of all AcuDose cabinets throughout the Hospital and validating packaging compliance for a minimum of three months of consecutive 100% compliance. Specifically, beginning with the week of November 26, 2018, each week the directors of the Hospital pharmacies oversee their staff in auditing 25% of the AcuDose cabinets in the Hospital,

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to inspect all Paralyzing Agents stored in the AcuDose cabinet being audited to determine whether each Paralyzing Agent includes the appropriate shrink wrap packaging. Each week during the month, a different 25% of the AcuDose cabinets is audited, such that 100% of AcuDose cabinets will have been audited within the course of one month. The directors of the Hospital pharmacies will continue to audit 25% of the AcuDose cabinets each week until such audits result in three consecutive months of 100% compliance with required shrink wrap packaging procedures. As such, each AcuDose cabinet in the Hospital will be audited at least three times during the audit period. UPDATE: As of December 18, 2018, four weeks of audits have been performed of AcuDose cabinets in the Hospital, and as such, every AcuDose cabinet in the Hospital has been audited. Of the 143 vials of Paralyzing Agents contained in the AcuDose cabinets audited the week of November 25, 2018, three vials were identified without the proper shrink wrap packaging--these vials were discarded. During the weeks of December 2, December 9, and December 16, every vial of a Paralyzing Agent contained in the






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AcuDose cabinets audited included the required shrink wrap packaging, establishing 100% compliance. UPDATE: As of January 24, 2019, nine weeks of audits have been performed of AcuDose cabinets in the Hospital, and as such, every AcuDose cabinet in the Hospital has been audited at least twice. During the weeks of December 23, December 30, January 6, January 13 and January 20, every vial of a Paralyzing Agent contained in the AcuDose cabinets audited included the required shrink wrap packaging, continuing 100% compliance. The weekly Paralyzing Agent compliance audits will continue for three months from November 25, 2018. For ongoing sustainment, monitoring and oversight thereafter, the Hospital has incorporated these weekly audits into the Hospital’s current monthly medication safety checks that are conducted in every unit/area that has medications. This oversight process has become a part of the Hospital’s standard assessment for medication safety.

• As of November 27, 2018, the Hospital finalized and implemented new procedures to require the additional Specific Safety Strategy for all Paralyzing Agents to include an Independent Double Check

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conducted by two licensed registered nurses prior to the administration of a Paralyzing Agent, where electronic clinical systems prompt dual sign off for bolus doses and upon the following for infusions:


The Hospital has amended the High Alert Medications Charts for both Adult Patients and Pediatric Patients, which revisions were approved on November 27, 2018, to specify the Specific Safety Strategy that all Paralyzing Agents require such Independent Double Check. The Double Check process related to patient level detail is documented within the Patient’s Medication Administration Record (MAR), which is located in the Electronic Medical Record (EMR). The Hospital’s CNOs, Pharmacy and Quality departments are collectively responsible for monitoring compliance with all medication administrations requiring a two-person sign off, which is a component of an independent double check. Prior to a qualified staff member administering the medication, it is scanned through the Barcode Medication Administration (BCMA) tool which

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forces a dual sign-off. This sign-off prompt requires an additional qualified clinical staff member to confirm the correct medication, correct dose and correct route of administration. Both staff members are then required to acknowledge the double check within the Medication Administration Record (MAR) portion of the Hospital’s Electronic Medical Record (EMR) prior to administration.


• Training: By November 26, 2018, every nurse and paramedic who work in an area of the Hospital where Paralyzing Agents are available in AcuDose dispensing cabinets, were required to complete an online training module outlining the process changes, Independent Double Check, vial packaging and naming convention changes. Any

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nurse or paramedic staff member required to complete such training, and who has not completed the computer-based training prior to November 27, 2018 for any reason, including being on vacation or not scheduled to work at the Hospital during the time period, has not been permitted to begin their next shift at the Hospital without first completing the required training.


Specifically, by November 26, 2018, every nurse and paramedic who works in an area of the Hospital where Paralyzing Agents are available in AcuDose dispensing cabinets, was required to complete an online training module outlining the process changes, dual sign-off, vial packaging and naming convention changes. Any nurse or paramedic staff member required to complete such training, and who had not completed the computer-

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based training prior to November 27, 2018 for any reason, including being on vacation or not scheduled to work at the Hospital during the time period, has not been permitted to begin their next shift at the Hospital without first completing the required training.


• Monitoring: The Hospital has implemented several measures to monitor compliance with the updated medication administration requirements. Beginning on November 27, 2018, the Hospital’s Enterprise Medication Safety Officer, in collaboration with the Chief Nursing Officers, Executive Pharmacy Leadership, and Chief of Staff, began to compile monthly reports of overrides from AcuDose cabinets for paralyzing agents, which will be reviewed at the medication safety committee, as well as on the unit level, and assessed for appropriateness. Such monthly reporting will be ongoing, and continue for three months following November 27, 2018.

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Thereafter, and continuing indefinitely the Enterprise Medication Safety Officer will continue to review all unreconciled dispense reports that identify medication overrides without an order linked, and provide monthly override performance reports to the medication safety committee as part of ongoing medication safety committee work. In the event such monthly reports reveal non-compliance, inconsistencies or questions, the medication safety committee will elevate these issues to Chief Nursing Officers, Executive Pharmacy Leadership, and Chief of Staff to determine whether additional steps are required for compliance, such as targeted education and/or training.

When a provider electronically enters an order for a medication, the order is verified by the Hospital Pharmacy, and then the medication is available in the AcuDose cabinet under the patient’s specific profile. In the event of an emergency (i.e., acute patient decompensation where delay of necessary medication would cause harm) certain medications may need to be obtained from the AcuDose cabinet as an override prior to pharmacy verification. There will always be an order (entered electronically or






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given verbally in an emergency) for any medication prior to administration, consistent with the Hospital’s Provider Order Policy.



In the event a double check is not performed by two nurses for a high alert medication, the high alert medication will still be accessible to only one nurse in an emergency situation, but it may not be administered without a second nurse. Pursuant to the Hospital’s

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policies, procedures and protocols all high alert medications are only administered when two nurses are present, even during an emergency situation. A high alert medication remains accessible by a single nurse, but administration requires dual sign-off.

UPDATE: In order to evaluate initial compliance of staff overrides related to paralyzing agents, audit frequency has been increased to weekly for the first month, after which the audits will be conducted on a monthly frequency. As of December 18, 2018, the Hospital’s Enterprise Medication Safety Officer, in collaboration with the Chief Nursing Officers, Executive Pharmacy Leadership, and Chief of Staff have completed three weekly reviews of overrides from AcuDose cabinets for Paralyzing Agents, which weekly report has been reviewed at the medication safety committee, as well as on the unit level, and assessed for appropriateness. This weekly review showed a 95% compliance rate with the Hospital’s policies and procedures regarding overrides of Paralyzing Agents. As of December 18 2018, the Hospital’s Chief Nursing Officers have completed three weekly reviews in order to verify compliance with the






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Independent Double Check procedure for Paralyzing Agents. These three weekly reviews each showed a 100% compliance rate.



• In regard to nurse training on medication administration, medical record documentation, and monitoring of patients receiving medication, all newly hired nurses are required to complete computer-based training related to the preparation of drugs and safe medication practices. All nurse residents, who are new graduate registered nurses hired with less than six months of nursing experience, are required to






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complete such education regarding safe medication practices, as well as attend a workshop on medication safety. These trainings have been updated to include education as to the revisions to the Medication Policy, the new nomenclature for Paralyzing Agents, the updated requirements for monitoring patients receiving High Alert Medications.


The Hospital has reviewed its policies and procedures related the role of the “Help All Nurse”, which is a type of resource nurse,






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and made the following changes:

• The Hospital has updated Scope of Care documents in each department that relies on a “Help All Nurse” (or similar position), in order to define the applicable role and duties. At the Hospital, “Resource Nurse” is generally used to describe a nursing role that usually does not take patient assignment during the shift but takes direction from the Clinical Staff Leader or Resource Staff Leader to assist other nurses as workloads demand, including rapid response teams, STAT calls, and transports. Resource Nurse roles in various departments include Float Nurse; Procedural Nurse; Admit Discharge, Transfer Nurse; and Patient Flow Nurse. The Scopes of Care were revised in intensive care units and non-intensive care units to define the applicable Resource Nurse role (including the “Help All Nurse” as applicable) by November 20, 2018. Nursing leadership of each Hospital department that utilizes such a Resource Nurse role will review the departments Scope of Care document on an annual basis to ensure duties of the position remain complete and accurate. The role of the Resource Nurse, or “Help All” nurse, within the unit is a






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staffing assignment, rather than a position in which a nurse is employed with a job title, therefore no job description exists. The following are details surrounding this unit assignment. A Resource Nurse (e.g., Float Nurse, Procedural Nurse, Help-All Nurse, ADT (admit, discharge, transfer) Nurse, and Patient Flow Nurse), is a nursing role that may be available if the unit has adequate baseline staffing to utilize such a Resource Nurse, who usually does not take patient assignment. The role of the Resource Nurse will be assigned by the Clinical Staff Leader (more commonly known as Charge Nurse) to assist unit RNs with patient assignments as work demands. Tasks assigned may include but are not limited to providing procedural assistance, and participating in Rapid Response Team response, STAT response, admission/ discharge or transfer processes, relief coverage (breaks and lunch) and patient transport. Staff serving in a Resource Nurse capacity must, at a minimum, be an RN II, which is attained after one year of relevant clinical experience. The nurse is required to be oriented to the role with a nurse experienced in the Resource Nurse role prior to taking






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on the role of this assignment. All staff within the units are aware of the Resource Nurse duties and are encouraged to utilize this resource opportunity to enhance patient safety and care. The role of Resource Nurses is not different from the role of the bedside nurse and thus, the Resource Nurse possesses the same knowledge and competencies as all nurses on the unit. The nurses in question simply do not take a patient assignment and are available to assist the nurses on the unit with the types of tasks described above.

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department of health and human services · sop”), which is further described below. for purposes...

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