Complaint Survey: October 18, 2019 Newark Beth Israel Medical Center 201 Lyons Avenue, Newark, NJ 07112 Provider Number: 319803 1 ID Prefix Tag DEFICIENCY CORRECTIVE ACTION X 000 A Federal Allegation survey was conducted on October 9-11 and October 15-18, 2019. The Centers for Medicare & Medicaid Services (“CMS”) and the New Jersey Department of Health (“NJDOH”) conducted a complaint survey of Newark Beth Israel Medical Center (“NBIMC” or “the facility”) from October 9-18, 2019. Seven weeks later, on December 12, 2019, CMS provided NBIMC with a Statement of Deficiencies (Form 2567) describing certain findings of that complaint survey. The Form 2567 described two conditions of immediate jeopardy (“IJ”) related to Quality Assessment and Performance Improvement (“QAPI”) for the facility’s Transplant Program (“Program”). CMS declared the IJ based on the survey it conducted in seven days in October 2019. On December 16, 2019, within four days of receiving notice of the IJs, NBIMC submitted a removal plan that described specific actions the facility had completed to address all alleged deficiencies identified by CMS that underlay the IJ status. NBIMC submits this Plan of Correction (“POC”) as required by federal and state law and regulations in response to the entire Form 2567. Neither NBIMC’s submission of the POC nor its contents constitute the facility’s agreement that the surveyors’ findings or conclusions are accurate, that they constitute deficiencies, or that that the Form 2567 correctly determines the scope or severity of any of those alleged deficiencies. Nor is the Plan of Correction or its submission an admission of the facility’s liability. Rather, the POC reflects NBIMC and the Program’s ongoing commitment to serving its patients and their families according to the highest levels of professional care. NBIMC has taken immediate, and continues to take, corrective actions in compliance with CMS’ Conditions of Participation (“CoPs”). Accordingly, the facility requests that CMS accept these corrective action plans as evidence of the facility’s compliance with the CoPs. X 001 AHO ALO SPECIAL REQUIREMENTS FOR TRANSPLANT CENTERS CFR(s): 482.68 The corrective actions are detailed at Tags X 099, X 101, X 103, and X 104. The corrective actions are detailed at Tags X 149 and X 152. DATE OF COMPLETION AND RESPONSIBLE PARTY (OR DESIGNEE) 2 X 073 AHO X 087 AHO ORGAN RECEIPT CFR(s): 482.92(b) PATIENT RECORDS CFR(s): 482.94(c) As required, the Transplant Program has a policy entitled “Multidisciplinary Team Roles in All Phases of Transplant” that requires staff to accurately complete the form for “Pre-Transplant Verification – Upon Organ Receipt.” Nevertheless, the facility’s medical records contain a clerical error that makes it appear as if an “organ was verified two (2) hours and 47 minutes prior to its arrival to the OR.” The Transplant Program will continue to reinforce with its Cardiothoracic Operating Room staff the importance of accuracy in EHR documentation. AVP, Perioperative Services 1/17/2020 The Assistant Vice President (“AVP”) will monitor accuracy by reviewing perioperative reports for all transplant patients until 100% compliance has been achieved for three consecutive months. AVP, Perioperative Services 2/3/2020 Compliance data will be reported to the Operating Room Committee, Heart Transplant QAPI, Lung Transplant QAPI, and the Transplant Steering Committee (“TSC”) quarterly for a year and then reporting frequency to be reassessed. Although the Program has a transplant evaluation process and a medical record policy, the Program is taking steps to enhance compliance at all stages: pre-transplantation, inpatient, and post transplantation. AVP, Perioperative Services 2/3/2020 The Interim Transplant Director is re-training the Transplant team on procedures for verifying the accuracy of all documentation. Interim Transplant Director 1/17/2020 The Interim Transplant Director will monitor accuracy by reviewing a random sample of pre and post-transplant documentation of 5 cases per month until 100% compliance has been achieved for three consecutive months. Interim Transplant Director 2/3/2020 For inpatient, QRM will monitor accuracy of the inpatient record through closed record review of all transplant admission discharges per month until 100% compliance has been achieved for three consecutive months. Quality Manager 2/3/2020 Compliance data will be reported to the Heart Transplant QAPI, Lung Transplant QAPI, and the TSC quarterly for a year with reporting frequency to be reassessed at the conclusion of that period. Interim Transplant Director 2/3/2020 3 X 093 AHO ALO QUALIFIED SOCIAL WORKER CFR(s): 482.94(d) All of the Program’s social workers are New Jersey licensed, have completed a course of study with a specialization in clinical practice, and held a master’s degree at time of hire. Therefore, the Program social workers are not required to meet the second criteria in the CoP. X 099 AHO ALO QUALITY ASSESSMENT/PERFORMANCE IMPROVEMENT CFR(s): 482.96 X 99 (1) – (2) The QAPI plans for both the heart and lung transplant programs were revised to provide oversight by the TSC. The Quality Resource Management (QRM) Department – which is responsible for the hospital’s quality reporting, quality metric performance, the adverse/serious event reporting and review process, and performance improvement activities – is now also responsible for the same functions related to the transplant program. Chief Quality Officer (“CQO”) 12/14/2019 Specifically, NBIMC has taken the following steps:  The Transplant Quality Coordinators, who formerly were decentralized and reported to the heart or lung program administrators, now report to the hospital’s Quality Manager in QRM.  The Quality Manager will serve as preceptor for the Transplant Quality Coordinators while they complete an augmented training program, which will include a review of the requirements of CMS Conditions of Participation for Transplant QAPI; adverse event reporting, management and corrective action implementation; serious safety event classification; root cause and apparent cause analysis; validation and analysis of data and metrics; and proper creation of meeting minutes, adverse event logs, and performance improvement activities. QRM will be responsible for monitoring the implementation of the initiatives outlined in this plan. This will include post-procedure debriefings, validating successful completion of education and training, and post-procedure audits. All of these results will be reported to the CEO, CQO, and the Transplant Steering Committee. Although the Program has separate heart and lung transplant QAPI plans related to adverse event review, the Program has taken and will CQO 12/14/2019 Quality Manager 12/16/2019 Quality Manager 12/14/2019 4 X 099 AHO ALO X 099 AHO ALO continue to take steps to enhance the process. The Program has implemented a policy that provides for the availability and readiness of back up equipment for any transplant procedure involving the use of ECMO. Chief Nursing Officer (“CNO”) 12/13/19 All perfusion and anesthesia staff have been educated about the requirement prior to participating in any transplant procedure. CNO; Chair of Anesthesia 12/13/19 Situational Awareness education will be provided to CTOR staff. Situational awareness is an educational and safety strategy in which individuals are trained to understand and be aware of what is happening within their environment, to recognize when the ordinary and expected routine has been or is being compromised, and to react appropriately. AVP, Perioperative Services 12/13/19 Documentation of the availability and readiness of back up ECMO will be reflected on the Perfusion checklist and reported during the universal timeout prior to the start of the transplant surgery. CNO 12/13/19 The transplant surgeon or designee will conduct post-procedure debriefings at which opportunities for improvement may be identified. Events gathered from the transplant debriefings will be tracked, trended, and monitored by the QRM Department and reported to the TSC. All identified opportunities, deviations in care that did not cause harm, precursor events, and adverse events will be escalated to the QRM Department and entered into NBIMC’s incident reporting system. An assigned quality advisor will then conduct an independent review, including an apparent or root cause analysis as appropriate. Chair of Cardiothoracic Surgery; Quality Manager 12/16/19 In addition, QRM will audit the availability and readiness of back up ECMO equipment post procedure and report compliance to the TSC. Quality Manager 12/13/19 X 99 (3) The Adverse Event Team membership list will be updated to include representatives from all categories of staff involved in the care of transplant patients who are already members of the QAPI team. The Adverse Event Team is a subcommittee of the QAPI team and will have a Interim Transplant Administrator 2/3/2020 5 X 099 AHO ALO X 101 AHO ALO standing agenda item at each QAPI meeting. The Adverse Event Team will receive additional training about adverse events, determining if an adverse event is a safety event (a preventable harm event), classification of safety events, and the tools for safety event review – root cause analysis, apparent cause analysis, and peer review. ACTIONS TO IMPROVE PERFORMANCE/TRACKING CFR(s): 482.96(a) The Adverse Event Team is accountable for the entire safety event review process including: reporting, analysis, implementation of the recommendations, and monitoring to ensure that the recommendations lead to the intended outcome. The resulting recommendations for each safety event review will include discipline specific education and training plans when education is part of the corrective action plan. The Adverse Event Team will also assign responsible parties for education and all other recommendations. X 101 1-2b Interim Transplant Administrator 2/3/2020 Although the Program has separate heart and lung transplant QAPI plans related to adverse event review, the Program has taken and will continue to take steps to enhance the process. The Program has implemented a policy that provides for the availability and readiness of back up equipment for any transplant procedure involving the use of ECMO. CNO 12/13/2019 All perfusion and anesthesia staff have been educated about the requirement prior to participating in any transplant procedure. CNO; Chair of Anesthesia 12/13/2019 Situational Awareness education will be provided to CTOR staff. Situational awareness is an educational and safety strategy in which individuals are trained to understand and be aware of what is happening within their environment, to recognize when the ordinary and expected routine has been or is being compromised, and to react appropriately. AVP of Perioperative Services 12/13/2019 Documentation of the availability and readiness of back up ECMO is now reflected on the Perfusion checklist and will be reported during the universal timeout prior to the start of the transplant surgery. CNO 12/13/2019 The transplant surgeon or designee will conduct post-procedure debriefings at which opportunities for improvement may be identified. Chair of Cardiothoracic 6 X 101 AHO ALO X 101 AHO ALO Events gathered from the transplant debriefings will be tracked, trended, and monitored by the Quality Resource Management (“QRM”) Department and reported to the Transplant Steering Committee. All identified opportunities, deviations in care that did not cause harm, precursor events, and adverse events will be escalated to the QRM Department and entered into NBIMC’s incident reporting system. An assigned quality advisor will then conduct an independent review, including an apparent or root cause analysis as appropriate. Surgery; Quality Manager 12/16/2019 In addition, QRM will audit the availability and readiness of back up ECMO equipment post procedure and report compliance to the TSC. Quality Manager 12/13/2019 X 101 2c The Adverse Event Team membership list will be updated to include representatives from all categories of staff involved in the care of transplant patients who are already members of the QAPI team. The Adverse Event Team is a subcommittee of the QAPI team and will have a standing agenda item at each QAPI meeting. The Adverse Event Team will receive education about adverse events, determining if an adverse event is a safety event (a preventable harm event), classification of safety events, and the tools for safety event review – root cause analysis, apparent cause analysis, and peer review. The Adverse Event Team is accountable for the entire safety event review process including: reporting, analysis, implementation of the recommendations, and monitoring to ensure that the recommendations lead to the intended outcome. The resulting recommendations for each safety event review will include discipline specific education and training plans when education is part of the corrective action plan. The Adverse Event Team will also assign responsible parties for education and all other recommendations. Interim Transplant Administrator 2/3/2020 Interim Transplant Administrator 2/3/2020 7 X 101 AHO ALO X 101 3 The Program has implemented a policy requiring the availability of second surgeon for cases in which such staffing is warranted. The cardiothoracic surgeons, anesthesia staff, perfusionists, and transplant cardiologists and pulmonologists have been educated about the second surgeon policy. X 101 AHO ALO Chair for Cardiothoracic Surgery 12/13/2019 Chair for Cardiothoracic Surgery; Chair of Anesthesia 12/13/2019 Situational awareness education will be provided to CTOR and Transplant OR circulators and techs along with transplant coordinators. Situational awareness is an educational and safety strategy in which individuals are trained to understand and be aware of what is happening within their environment, to recognize when the ordinary and expected routine has been or is being compromised, and to react appropriately. AVP for Perioperative Services; Interim Transplant Administrator 12/13/2019 The transplant surgeon or designee will conduct post-procedure debriefings at which opportunities for improvement may be identified. Events gathered from the transplant debriefings will be tracked, trended, monitored by the QRM Department, and reported to the Transplant Steering Committee. All identified opportunities, deviations in care that did not cause harm, precursor events, and adverse events will be escalated to the QRM Department and entered into the Program’s incident reporting system. An assigned quality advisor will then conduct an independent review, including an apparent or root cause analysis as appropriate. Chair for Cardiothoracic Surgery; Quality Manager 12/16/2019 X 101 4 Although the Program has a standard process for transducer level placement, the Program has taken and will continue to take steps to enhance compliance. The QAPI team recommended reviewing and monitoring transducer level replacement and blood pressure correlation, which requires further review with the Adverse Event Team before implementation. In the interim, there is a standardized process to place the transducer at the Chair, Anesthesia 2/3/2020 8 X 101 AHO ALO X 101 AHO ALO appropriate level. The Department of Anesthesia will monitor that transducers are at the correct level by direct observation of 100% of transplant cases per month until 100% compliance has been achieved for three consecutive months. The percentage of compliance will be reported at the Adverse Event Team meetings and to the TSC. X 101 5 Chair, Anesthesia 2/3/220 NBIMC has revised the intra-operative monitoring policy to require the perfusionists to monitor and document MAP, O2 saturation, and cerebral oximetry every 15 minutes. CNO 12/13/2019 Closed loop communication will be used to escalate clinical concerns related to the MAP, O2 saturation and cerebral oximetry. In closed loop communication, the sender gives a message and the receiver repeats this back to the sender. The sender then confirms the message. It is the safety method to confirm all parties are aware of and confirm changes in MAP, O2 saturation and cerebral oximetry. Closed loop communication is a communication technique that reduces the risk of errors that result from misunderstandings. CNO 12/13/2019 Perfusionists and anesthesia staff have been educated about the changes to the intra-operative monitoring. CNO; Chair of Anesthesia 12/13/2019 Situational awareness education will be provided to CTOR and Transplant OR circulators and techs along with transplant coordinators. Situational awareness is an educational and safety strategy in which individuals are trained to understand and be aware what is happening within their environment, to recognize when the ordinary and expected routine has been or is being compromised, and to react appropriately. AVP, Perioperative Services 12/13/2019 The transplant surgeon or designee will conduct post-procedure debriefings at which opportunities for improvement may be identified. Events gathered from the transplant debriefings will be tracked, trended, and monitored by the QRM Department and reported to the Transplant Steering Committee. All identified opportunities, deviations in care that did not cause harm, precursor events, and adverse events will be escalated to the QRM Department and entered into NBIMC’s incident reporting system. An assigned quality advisor will then conduct an Chair of Cardiothoracic Surgery; Quality Manager 12/13/2019 9 X 101 AHO ALO X 101 AHO ALO X 101 AHO ALO independent review, including an apparent or root cause analysis as appropriate. In addition, QRM will audit MAP, O2 saturation and cerebral oximetry monitoring and report compliance to the TSC. X 101 6 Quality Manager 2/3/2020 The Program has implemented policies to outline a uniform set of criteria for selection of hearts and lungs based on size. VP for Medical Affairs 12/13/2019 The cardiothoracic surgeons and transplant cardiologists and pulmonologists have been educated about the uniform set of criteria for selection of hearts and lungs based on size. VP for Medical Affairs 12/13/2019 Situational awareness education will be provided to CTOR and Transplant OR circulators and technicians and transplant coordinators. Situational awareness is an educational and safety strategy in which individuals are trained to understand and be aware what is happening within their environment, to recognize when the ordinary and expected routine has been or is being compromised, and to react appropriately. AVP for Perioperative Services; Interim Transplant Administrator 12/13/2019 The transplant surgeon or designee will conduct post-procedure debriefings at which opportunities for improvement may be identified. Events gathered from the transplant debriefings will be tracked, trended, and monitored by the QRM Department and reported to the Transplant Steering Committee. All identified opportunities, deviations in care that did not cause harm, precursor events, and adverse events will be escalated to the QRM Department and entered into Program’s incident reporting system. An assigned quality advisor will then conduct an independent review, including an apparent or root cause analysis as appropriate. Chair of Cardiothoracic Surgery; Quality Manager 12/16/2019 In addition, QRM will audit compliance with organ sizing criteria and report compliance to the TSC. X 101 7 Quality Manager 2/3/2020 The hospital has recently created the new position of Chief Quality Officer (CQO) who reports to the hospital Chief Executive Officer (“CEO”). The CQO’s responsibilities now include oversight for the Transplant Program QAPI and adverse event review. CEO 12/13/2019 10 X 101 AHO ALO X 101 AHO ALO X 103 X 104 AHO ALO ANALYSIS/DOCUMENTATION OF ADVERSE EVENT CFR(s): 482.96(b)(2) EFFECT CHANGES TO PREVENT REPEAT INCIDENTS CFR(s): 482.96(b)(2) The transplant surgeon or designee will conduct post-procedure debriefings at which opportunities for improvement may be identified. Events gathered from the transplant debriefings will be tracked, trended, and monitored by the QRM Department and reported to the Transplant Steering Committee. All identified opportunities, deviations in care that did not cause harm, precursor events, and adverse events will be escalated to the QRM Department and entered into Program’s incident reporting system. An assigned quality advisor will then conduct an independent review, including an apparent or root cause analysis as appropriate. Chair of Cardiothoracic Surgery; Quality Manager 12/16/2019 In addition, QRM will audit compliance with reoccurrence of identified adverse events. X 101 8 The Program submitted a Removal Plan for the Immediate Jeopardy, and a follow-up survey by NJDOH was completed on December 18, 2019. X 103 1, 2 Quality Manager 12/13/2019 Although the Program has QAPI plans for the heart and lung transplant programs related to adverse event review, the Program has taken and will continue to take steps to enhance the process. The transplant quality coordinators are reviewing the Adverse Event log for the heart and lung transplant Program since January 2018 to address any inaccuracies and to identify any outstanding recommendations that have not been implemented and monitored. Quality Manager 2/4/2020 The Interim Transplant Administrator and Quality Manager will review, analyze and present the data to the Heart and Lung Transplant QAPI committees, as applicable, and the TSC. Interim Transplant Administrator 2/4/2020 Additionally, on an ongoing basis, the Quality Manager will directly oversee the transplant quality coordinators, with a focus on the accuracy of their data entry and documentation. Quality Manager 12/16/2019 and ongoing X 104 1a (i), (ii) The Program has implemented a policy that provides for the availability and readiness of backup equipment for any transplant procedure involving the use of ECMO. CNO 12/13/2019 11 X 104 AHO ALO X 104 AHO ALO All perfusion and anesthesia staff will be educated about the requirement prior to participating in any transplant procedure. CNO; Chair of Anesthesia 12/13/2019 Situational Awareness education will be provided to CTOR staff. Situational awareness is an educational and safety strategy in which individuals are trained to understand and be aware of what is happening within their environment, to recognize when the ordinary and expected routine has been or is being compromised, and to react appropriately. AVP, Perioperative Services 12/13/2019 Documentation of the availability and readiness of back up ECMO is reflected on the Perfusion checklist and will be reported during the universal timeout prior to the start of the transplant surgery. CNO 12/13/2019 The transplant surgeon or designee will conduct post procedure debriefings, at which opportunities for improvement may be identified. Events gathered from the transplant debriefings will be tracked, trended, and monitored by the QRM Department and reported to the TSC. All identified opportunities, deviations in care that did not cause harm, precursor events, and adverse events will be escalated to the QRM Department and entered into the Program’s incident reporting system. An assigned quality advisor will then conduct an independent review, including an apparent or root cause analysis as appropriate. Chair of Cardiothoracic Surgery and Quality Manager 12/16/2019 In addition, QRM will audit the availability and readiness of back up ECMO equipment post procedure and report compliance to the TSC. X 104 1 (iii) Quality Manager 2/3/2020 The Adverse Event Team membership list will be updated to include representatives from all categories of staff involved in the care of transplant patients who are already members of the QAPI team. Interim Transplant Administrator 2/3/2020 The Adverse Event Team is a subcommittee of the QAPI team and will have a standing agenda item at each QAPI meeting. The Adverse Event Team will receive education about adverse events, determining if an adverse event is a safety event (a preventable harm event), classification of safety events, and the tools for safety event review – root cause analysis, apparent cause analysis, and peer review. The Adverse Event Team is accountable for the entire safety event review process including: reporting, analysis, implementation of the recommendations, and monitoring to ensure that the recommendations lead to the intended outcome. The resulting recommendations for each safety Interim Transplant Administrator 2/3/2020 12 X 104 AHO ALO X 104 AHO ALO event review will include discipline specific education and training plans when education is part of the corrective action plan. The Adverse Event Team will also assign responsible parties for education and all other recommendations. X 104 2 The Program has implemented a policy requiring the availability of second surgeon for cases in which such staffing is warranted. Chair of Cardiothoracic Surgery 12/13/2019 The cardiothoracic surgeons, anesthesia staff, perfusionists, and transplant cardiologists and pulmonologists have been educated about the second surgeon policy. Chairs of Cardiothoracic Surgery and Anesthesia Situational awareness education will be provided to CTOR and Transplant OR circulators and techs along with transplant coordinators. Situational awareness is an educational and safety strategy in which individuals are trained to understand and be aware of what is happening within their environment, to recognize when the ordinary and expected routine has been or is being compromised, and to react appropriately. AVP for Perioperative Services; Interim Transplant Administrator 12/13/2019 The transplant surgeon or designee will conduct post-procedure debriefings at which opportunities for improvement may be identified. Events gathered from the transplant debriefings will be tracked, trended, monitored by the QRM Department, and reported to the Transplant Steering Committee. All identified opportunities, deviations in care that did not cause harm, precursor events, and adverse events will be escalated to the QRM Department and entered into the Program’s incident reporting system. An assigned quality advisor will then conduct an independent review, including an apparent or root cause analysis as appropriate. X 104 3 Chair of Cardiothoracic Surgery; Quality Manager 12/16/2019 12/13/2019 Although the Program has a standard process for transducer level placement, the Program has taken and will continue to take steps to enhance compliance. The QAPI team has recommended reviewing and monitoring transducer level replacement and blood pressure correlation, which requires further review with the Adverse Event Team before implementation. In the Chair, Anesthesia 2/3/2020 13 X 104 AHO ALO interim, there is a standardized process to place the transducer at the appropriate level. The Department of Anesthesia will monitor that transducers are at the correct level by direct observation of 100% of transplant cases per month until 100% compliance has been achieved for three consecutive months. The percentage of compliance will be reported at the Adverse Event Team meetings and to the TSC. X 104 AHO ALO Chair, Anesthesia 2/3/220 X 104 4 NBI has revised the intra-operative monitoring policy to require the perfusionists to monitor and document MAP, O2 saturation, and cerebral oximetry every 15 minutes. CNO 12/13/2019 Closed loop communication will be used to escalate clinical concerns related to the MAP, O2 saturation and cerebral oximetry. In closed loop communication, the sender gives a message and the receiver repeats this back to the sender. The sender then confirms the message. It is the safety method to confirm all parties are aware of and confirm changes in MAP, O2 saturation and cerebral oximetry. Closed loop communication is a communication technique that reduces the risk of errors that result from misunderstandings. CNO 12/13/2019 Perfusionists and anesthesia staff have been educated about the changes to the intra-operative monitoring policy. CNO; Chair of Anesthesia 12/13/2019 Situational awareness education will be provided to CTOR and Transplant OR circulators and techs along with transplant coordinators. Situational awareness is an educational and safety strategy in which individuals are trained to understand and be aware what is happening within their environment, to recognize when the ordinary and expected routine has been or is being compromised, and to react appropriately. AVP, Perioperative Services 12/13/2019 The transplant surgeon or designee will conduct post-procedure debriefings at which opportunities for improvement may be identified. Events gathered from the transplant debriefings will be tracked, trended, and monitored by the QRM Department and reported to the Transplant Steering Committee. All identified opportunities, deviations in care that did not cause harm, precursor events, and adverse events will be escalated to the QRM Department and entered into NBIMC’s incident Chair of Cardiothoracic Surgery; Quality Manager 12/16/2019 14 X 104 AHO ALO X 104 AHO ALO X 104 AHO ALO reporting system. An assigned quality advisor will then conduct an independent review, including an apparent or root cause analysis as appropriate. In addition, QRM will audit MAP, O2 saturation and cerebral oximetry monitoring and report compliance to the TSC. X 104 5 Quality Manager 2/3/2020 The Program has implemented policies to outline a uniform set of criteria for selection of hearts and lungs based on size. VP for Medical Affairs 12/13/2019 The cardiothoracic surgeons and transplant cardiologists and pulmonologists have been educated about the uniform set of criteria for selection of hearts and lungs based on size. VP for Medical Affairs 12/13/2019 Situational awareness education will be provided to CTOR and Transplant OR circulators and technicians and transplant coordinators. Situational awareness is an educational and safety strategy in which individuals are trained to understand and be aware what is happening within their environment, to recognize when the ordinary and expected routine has been or is being compromised, and to react appropriately. AVP for Perioperative Services; Interim Transplant Administrator 12/13/2019 The transplant surgeon or designee will conduct post-procedure debriefings at which opportunities for improvement may be identified. Events gathered from the transplant debriefings will be tracked, trended, and monitored by the QRM Department and reported to the Transplant Steering Committee. All identified opportunities, deviations in care that did not cause harm, precursor events, and adverse events will be escalated to the QRM Department and entered into Program’s incident reporting system. An assigned quality advisor will then conduct an independent review, including an apparent or root cause analysis as appropriate. Chair of Cardiothoracic Surgery; Quality Manager 12/16/2019 In addition, QRM will audit compliance with organ sizing criteria and report compliance to the TSC. X 104 6 Quality Manager 2/3/2020 The Adverse Event Team membership list will be updated to include representatives from all categories of staff involved in the care of transplant patients who are already members of the QAPI team. Interim Transplant Administrator 2/3/2020 15 X 104 AHO ALO X 149 AHO ALO PATIENT AND LIVING DONOR RIGHTS CFR(s): 482.102 The Adverse Event Team is a subcommittee of the QAPI team and will have a standing agenda item at each QAPI meeting. The Adverse Event Team will receive education about adverse events, determining if an adverse event is a safety event (a preventable harm event), classification of safety events, and the tools for safety event review – root cause analysis, apparent cause analysis, and peer review. The Adverse Event Team is accountable for the entire safety event review process including: reporting, analysis, implementation of the recommendations, and monitoring to ensure that the recommendations lead to the intended outcome. The resulting recommendations for each safety event review will include discipline specific education and training plans when education is part of the corrective action plan. The Adverse Event Team will also assign responsible parties for education and all other recommendations. X 149 1 Interim Transplant Administrator 2/3/2020 The Program maintains a robust system of policies and procedures to maintain the confidentiality of protected health information (“PHI”). As the Form 2567 notes, those policies include Patient Rights and Basic Uses and Disclosures of Patient Information. The Program also has clearly articulated procedures for staff members to complain or air grievances internally. Nevertheless, those procedures and policies apparently did not prevent at least one person from recording and disclosing confidential PHI that was discussed at certain heart transplant multidisciplinary team meetings. The Program is aware of and adhering to its legal obligations to investigate the source of the disclosure. In addition, the Program will enhance its annual HIPAA training to emphasize the need to maintain the confidentiality and use of PHI Protected Health Information disclosed in any group meetings where such information needs to be discussed. The Program will also provide additional education regarding basic uses and disclosure of PHI. Compliance Officer; Privacy Officer; Chair, Ethics Committee 2/3/2020 Human Resources will monitor for 100% attendance and completion of training. Vice President and Chief Human Resources Officer 2/3/2020 The Program will also emphasize the availability of the Ethics Consultation Service and the Compliance Helpline for employees who want or need VP, Behavioral Health and Patient Experience; 16 X 149 AHO ALO X 149 AHO ALO to raise matters or complaints that would involve confidential patient information or patient care and management. X 149 2, 3 Although the Program has a policy for patient rights, the Program has implemented additional procedures for physicians to inform patients or their authorized representative about the patient’s medical condition and any change in status to include them in the plan of care. The Program will review the requirements for patient and family notification and documentation. The Program is developing and will implement a standard for communication with patients and their authorized representation. The Program will audit for adherence to the policy via chart review. The quality coordinators will review five (5) transplant patient charts weekly to monitor for compliance. The compliance will be reported to the respective heart and lung QAPI meetings and to the TSC. X 149 4 X 149 AHO ALO X 152 AHO ALO Compliance Officer 2/3/2020 Interim Transplant Director 2/3/2020 Quality Coordinators 2/3/2020 See Corrective Action for X 152 PATIENT INFORMED OF SURGICAL PROCEDURE CFR(s): 482.102(a)(2) X 152 Although the facility has an informed consent policy, the facility has implemented additional procedures to make certain that all informed consents are properly executed prior to procedure. During the survey when the surveyors were still on-site, the facility took immediate action to address partially completed informed consents. The facility identified and directed “gatekeepers” (i.e. nurses, APNs, or supervisory staff) to review informed consents and procedures until the informed consents are properly completed, dated, and signed. The exception to this rule, in accordance with the facility’s policy, is for life or limb threatening procedures. Interim Transplant Director 10/17/2019 The Vice President of Medical Affairs (“VPMA”) met with the following groups to review (1) the “gatekeeper” role, (2) their authority to delay procedures until informed consent complete, and (3) what constitutes a properly executed informed consent: Vice President, Medical Affairs (“VPMA”) 10/17/2019 17 X 152 AHO ALO    The facility’s department heads Medical Executive Committee Committee for Division Chairs All practitioners who obtain informed consent will receive training on what constitutes a properly executed informed consent and who can obtain informed consent. VPMA 12/20/2019 The facility will monitor compliance through retrospective review as part of HIM closed record review. HIM will review thirty (30) charts per month until 100% compliance has been achieved for three consecutive months. Compliance data will be reported to the hospital’s Medical Records Committee bimonthly and the hospital’s PIC quarterly for a year with reporting frequency to be reassessed at the conclusion of that period. Director, HIM 1/17/2020