Newark Beth Israel Medical Center 201 Lyons Ave, Newark, NJ 007112 Provider Number: 310002 Survey Date: October 18, 2019 Page 1 ID Tag Deficiency Corrective Action A 000 Initial Comments 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. 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”) to the facility and its Transplant Program, CMS declared the IJ based on the survey it conducted on seven days in October 2019. On December 16, 2019, within four days of receiving notification 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. The Program submitted a Removal Plan for the Immediate Jeopardy, and a follow up survey was completed on December 18, 2019. 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 a deficiency, or that that the Form 2567 correctly determines the scope or severity of any of the deficiencies. Nor is the Plan of Correction or its submission an admission of the facility’s liability. Date of Completion and Responsible Party (or Designee) Newark Beth Israel Medical Center 201 Lyons Ave, Newark, NJ 007112 Provider Number: 310002 ID Tag Deficiency A 000 Survey Date: October 18, 2019 Page 2 Corrective Action Rather, the Plan of Correction reflects NBIMC’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 furtherance of compliance with CMS’ Conditions of Participation (“CoPs”). Accordingly, the facility respectfully requests that CMS accept these corrective action plans as evidence of the facility’s compliance with the CoPs. A 115 PATIENT RIGHTS CFR(s): 482.13 As the finding notes, the facility has a patient rights policy that complies with the CMS Conditions of Participation. 1. The corrective actions that emphasize and reinforce the requirements of this policy are detailed at Tag 0130 2. The corrective actions that emphasize and reinforce the requirements of this policy are detailed at Tag 0131 3. The corrective actions that emphasize and reinforce the requirements of this policy are detailed at Tag 0132 4. The corrective actions that emphasize and reinforce the requirements of this policy are detailed at Tag 0133 5. The corrective actions that emphasize and reinforce the requirements of this policy are detailed at Tag 0147 A 130 PATIENT RIGHTS: PARTICIPATION IN Although the facility already has policies for patient rights and informed consent, the facility has implemented additional Date of Completion and Responsible Party (or Designee) Newark Beth Israel Medical Center 201 Lyons Ave, Newark, NJ 007112 Provider Number: 310002 Survey Date: October 18, 2019 Page 3 ID Tag Deficiency Corrective Action A 130 CARE PLANNING CFR(s):482.13(b)(1) procedures to reinforce the obligation to inform family members when a patient is admitted and to include the family in the patient’s plan of care. Date of Completion and Responsible Party (or Designee) In particular, we have developed a checklist for the Catheterization Lab (“Cath Lab”) when scheduling procedures for patients who are residents of other healthcare facilities, which will be part of the patients’ electronic health records (“EHR”). The checklist requires the scheduler to obtain the transferring facility’s face sheet and any advanced directives. Director of Cath Lab 12/18/2019 When a patient arrives for the procedure, the Cath Lab admitting nurse will determine if the patient has capacity to consent or clearly lacks capacity to consent. If the Cath Lab admitting nurse is not able to make such determination or has a question about capacity, the admitting nurse will engage the provider for his/her determination and further assessment. The provider may consult with a psychiatrist to determine capacity. If the provider determines that the patient does not have capacity, the admitting nurse and/or physician will take all reasonable efforts to contact the surrogate decision maker. Director of Cath Lab 1/10/2020 At the conclusion of the Cath Lab procedure, the charge nurse will make appropriate notifications to the authorized representative and/or the patient’s resident facility regarding the post-procedure plan of care. Director of Cath Lab 1/10/2020 The facility is drafting a fact sheet for appropriate staff education and follow-up. The facility will reeducate Cath Lab staff about the policy and related requirements and the need Director of Cath Lab 2/3/2020 Newark Beth Israel Medical Center 201 Lyons Ave, Newark, NJ 007112 Provider Number: 310002 ID Tag Deficiency A130 A 131 Survey Date: October 18, 2019 Page 4 Corrective Action Date of Completion and Responsible Party (or Designee) to contemporaneously document in the EHR the relevant interactions with the transferring facility and family members. PATIENTS RIGHTS: INFORMED CONSENT CFR(s): 482.13(b)(2) General Consent The Cath Lab will monitor compliance through a retrospective review of all charts until 100% compliance has been achieved for three consecutive months. Director of Cath Lab 2/3/2020 The monitoring results will be presented at the Cath Lab QAPI monthly meeting. The monitoring results will also be presented to the hospital Performance Improvement Committee (“PIC”) quarterly for a year with reporting frequency to be reassessed at the conclusion of that period. Although the facility has both patients’ rights and general consent policies, the facility has taken and will continue to take steps to enhance compliance and to reinforce the need to obtain necessary information. The facility adopted an electronic format for general consent effective January 2019, which postdates some of the findings that CMS identified. Director of Cath Lab 2/3/2020 The facility is also instituting additional requirements for hospital staff to (a) complete the consent process with the patient by taking all reasonable steps to obtain required information, and (b) confirm that the general consent for treatment form is fully completed. Assistant Vice President (“AVP”), Patient Financial Services 1/13/2020 All facility registration staff responsible for registering patients (e.g., inpatient, outpatient in a bed, emergency services, observation, and same-day services) will receive additional training, including both written and in-service components, regarding the necessity of and procedures for full completion of the General Consent for Treatment form. AVP, Patient Financial Services 2/3/2020 Newark Beth Israel Medical Center 201 Lyons Ave, Newark, NJ 007112 Provider Number: 310002 ID Tag Deficiency A131 A 132 PATIENT RIGHTS: INFORMED DECISION CFR(s): 482.13(b)(3) Survey Date: October 18, 2019 Page 5 Corrective Action Date of Completion and Responsible Party (or Designee) Additionally, the Admitting Department will reconcile the list of admitted patients with the completed General Consent for Treatment forms for completeness by the following day. Discrepancies identified during reconciliation will be resolved by Admitting or referred to Social Work. AVP, Patient Financial Services 2/3/2020 The Admitting Department will monitor compliance through a retrospective review of thirty (30) charts per month for three consecutive months or until 100% compliance has been achieved for three consecutive months. The monitoring results will be presented at the hospital PIC quarterly for a year with reporting frequency to be reassessed at the conclusion of that period. Although the facility has policies for patient rights and informed consent, the facility has implemented additional procedures to reinforce the obligations to inform family members when a patient is admitted and to include the family in the patient’s plan of care. AVP, Patient Financial Services 2/3/2020 All facility staff responsible for scheduling and/or registering patients will receive additional training regarding the information they must obtain about a patient’s advance directives, healthcare proxies, and surrogate decision makers. This training will involve written and in-service components. AVP, Patient Financial Services 1/17/2020 When patients who are residents of other healthcare facilities arrive for a procedure and/or are admitted, the admitting nurse will confirm receipt of a Universal Transfer Form. If such a patient arrives without a Universal Transfer Form, the admitting nurse will (a) contact the patient’s resident facility, (b) request Chief Nursing Officer (“CNO”) 2/3/2020 Newark Beth Israel Medical Center 201 Lyons Ave, Newark, NJ 007112 Provider Number: 310002 ID Tag Deficiency A 132 A 133 Survey Date: October 18, 2019 Page 6 Corrective Action Date of Completion and Responsible Party (or Designee) a copy of the Universal Transfer Form, and (c) confirm whether the patient has any advance directives from the resident facility. PATIENT RIGHTS: ADMISSION STATUS NOTIFICATION CFR(s): 482.13(b)(4) Advance Directive: The Admitting Department will monitor compliance with advance directive documentation in the General Consent by a retrospective review of thirty (30) charts per month until 100% compliance has been achieved for three consecutive months. Compliance data will be reported to the hospital’s PIC quarterly for a year with reporting frequency to be reassessed at the conclusion of that period. AVP, Patient Financial Services 2/3/2020 Universal Transfer Form: The facility will monitor compliance with the timely receipt of Universal Transfer Forms via retrospective review as part of Health Information Management (“HIM”) closed record review. 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. Although the facility has policies for patient rights and informed consent, the facility has implemented additional procedures to reinforce the obligations to inform family members when a patient is admitted and to include the family in the patient’s plan of care. Director, HIM 2/3/2020 At the conclusion of Cath Lab procedures, the charge nurse will make appropriate notifications to the authorized representative and/or the patient’s resident facility regarding the plan of care post-procedure. The nurse is required to document this notification in the EHR. Director of Cath Lab 2/3/2020 Newark Beth Israel Medical Center 201 Lyons Ave, Newark, NJ 007112 Provider Number: 310002 ID Tag Deficiency Survey Date: October 18, 2019 Page 7 Corrective Action Date of Completion and Responsible Party (or Designee) The facility will monitor compliance with documentation of notification to a patient’s authorized representative and the patient’s resident facility through a retrospective review of all charts for Cath Lab patients who came from outside facilities for a procedure until 100% compliance has been achieved for three consecutive months. Director of Cath Lab 2/3/2020 The monitoring results will be presented at the Cath Lab QAPI monthly meeting. The monitoring results will also be presented to the hospital’s PIC quarterly for a year with reporting frequency to be reassessed at the conclusion of that period. On October 14, 2019, immediately after the incident, the facility took the following actions: Director of Cath Lab 2/3/2020 A 133 A 144 PATIENT RIGHTS: CARE IN SAFE SETTING CFR(s): 482.13(c)(2)      Vice President, Behavioral Health and Patient Experience The onsite psychiatrist interviewed the minor patient who 10/14/2019 was then discharged to the custody of a parent. The facility notified the patient’s parent. The facility notified the Newark Police Department. The facility filed an “Unusual Incident Report” with the New Jersey Division of Mental Health Addiction Services (“DMHAS”). The facility filed a report with NJDOH. In addition, the facility immediately adopted a new policy, The Minor Patient in Psychiatric Emergency Services policy, that creates enhanced practices to protect minors in the Psychiatric Emergency Screening Services (“PESS”) Unit:  The policy includes specific instructions to minimize contact between minors and adult patients. Director, PESS 10/24/2019 Newark Beth Israel Medical Center 201 Lyons Ave, Newark, NJ 007112 Provider Number: 310002 ID Tag A 144 Deficiency Survey Date: October 18, 2019 Page 8 Corrective Action All PESS Unit staff received training, including both written and in-service components, regarding this new policy. Any staff on leave will be educated upon their return before assuming duties. Date of Completion and Responsible Party (or Designee) Director, PESS 11/1/2019 The facility will monitor compliance with the minor patient Director, PESS protection through direct observation of staff interventions -1/20/2020 no comingling of minor patients with adults or presence of a hall way monitor when minor patients are comingled with adult patients. The Behavioral Health Management Team will do 30 observations per month for three consecutive months or until 100% compliance has been achieved for three consecutive months. The compliance data will be reported at the Behavioral Health Directors meeting on a monthly basis and then presented at the hospital PIC quarterly for a year and then reporting frequency to be reassessed. Vice President, Behavioral Health and Patient Experience 2/3/2020 The PESS staff is being trained on proper q 15 minute observations and documentation. Director, PESS 1/17/2020 The Behavioral Health Management Team will monitor compliance with 15 minute check documentation via retrospective review of 30 charts per month for three consecutive months or until 100% compliance has been achieved for three consecutive months. Director, PESS 1/20/2020 The compliance data will be reported at the Behavioral Health Directors meeting on a monthly basis and then presented at the hospital PIC quarterly for a year and then reporting Vice President, Behavioral Health and Patient Experience Newark Beth Israel Medical Center 201 Lyons Ave, Newark, NJ 007112 Provider Number: 310002 ID Tag A 147 Deficiency PATIENT RIGHTS: CONFIDENTIALITY OF RECORDS CFR(s): 482.13(d)(1) Survey Date: October 18, 2019 Page 9 Corrective Action frequency to be reassessed. The facility 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 facility also has clearly articulated procedures for staff members to complain or air grievances internally. Date of Completion and Responsible Party (or Designee) 2/3/2020 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 facility is aware of and adhering to its legal obligations to investigate the source of the disclosure. In addition, the facility will enhance its annual HIPAA training to emphasize the need to maintain the confidentiality of PHI disclosed in any group meetings where such information is discussed. The facility will also provide additional education regarding basic uses and disclosure of PHI. Compliance Officer; Privacy Officer; Chair, Ethics Committee 2/3/2020 The facility’s Human Resources department will monitor for 100% attendance and completion of training. Vice President and Chief Human Resources Officer 2/3/2020 The facility will also emphasize the availability of the Ethics Consultation Service (“ECS”) and the Compliance Helpline for employees who want or need to raise matters or complaints that would involve confidential patient information or patient’ VP, Behavioral Health and Patient Experience; Compliance Officer Newark Beth Israel Medical Center 201 Lyons Ave, Newark, NJ 007112 Provider Number: 310002 ID Tag A147 A 263 Deficiency QAPI CFR(s): 482.21 Survey Date: October 18, 2019 Page 10 Corrective Action care and management. 1. The corrective actions are detailed at Tag 286, Part A Date of Completion and Responsible Party (or Designee) 2/3/2020 2. The corrective actions are detailed at Tag 286, Part B A 286 A 286 PATIENT SAFETY CFR(s): 482.21(a), (c)(2), (e)(3) PATIENT SAFETY CFR(s): 482.21(a), (c)(2), (e)(3) 3. The corrective actions are detailed at Tag 309, Part A 4. The corrective actions are detailed at Tag 309, Part B A 286 Part A Although the facility has a QAPI plans for the heart and lung transplant programs related to adverse event review, the facility 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 from January 2018 to present to correct 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. A 286 Part B, 1 Quality Manager 12/20/2019 The facility has implemented a policy that provides for the availability and readiness of back up ECMO equipment for any Newark Beth Israel Medical Center 201 Lyons Ave, Newark, NJ 007112 Provider Number: 310002 ID Tag A286 Deficiency Survey Date: October 18, 2019 Page 11 Corrective Action Date of Completion and Responsible Party (or Designee) transplant procedure involving the use of ECMO. 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 and 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 will be reflected on the Perfusion checklist and reported during the universal timeout prior to the start of the transplant surgery. CNO 2/3/2020 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 Quality Resource Management (“QRM”) department and reported to the Transplant Steering Committee (“TSC”). All identified opportunities; deviations in care that did not cause harm, precursor events, and adverse events will be escalated to the Quality Resource Management department and entered into the facility’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 2/3/2020 Newark Beth Israel Medical Center 201 Lyons Ave, Newark, NJ 007112 Provider Number: 310002 ID Tag Deficiency Survey Date: October 18, 2019 Page 12 Corrective Action Date of Completion and Responsible Party (or Designee) In addition, QRM will audit the availability and readiness of back up ECMO equipment post procedure and report compliance to the TSC. A 286 Part B, 2 Quality Manager 2/3/2020 The facility has implemented a policy requiring the availability of a second surgeon for cases in which such staffing is warranted. Chair, Cardiothoracic Surgery 12/13/2019 The cardiothoracic surgeons, anesthesia staff, perfusionists, and transplant cardiologists and pulmonologists have been educated about the second surgeon policy prior to participating in any transplant procedure. Chairs, Cardiothoracic Surgery & 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 and to recognize when the ordinary and expected routine has been or is being compromised, and to react appropriately. In this context, the plan of correction contemplates educating the identified staff members about CMS’s findings and the facility’s plan so that the transplant staff recognize potential safety concerns and understands that they are encouraged and expected to escalate those concerns. 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 Chair, Cardiothoracic Surgery; Quality Manager A 286 A 286 PATIENT SAFETY CFR(s): 482.21(a), (c)(2), (e)(3) Newark Beth Israel Medical Center 201 Lyons Ave, Newark, NJ 007112 Provider Number: 310002 ID Tag Deficiency A 286 A 286 PATIENT SAFETY CFR(s): 482.21(a), (c)(2), (e)(3) Survey Date: October 18, 2019 Page 13 Corrective Action 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 the facility’s incident reporting system. An assigned quality advisor will then conduct an independent review, including an apparent or root cause analysis as appropriate. A 286 Part B, 3 Date of Completion and Responsible Party (or Designee) 12/16/2019 NBI has revised the intra-op 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. Closed loop communication is when the sender gives a message, the receiver repeats this back to the sender. The sender then confirms the message. It is the safety method to escalate a clinical concern among the perfusionist, surgeon and anesthesiologist to confirm all these parties are aware 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-op monitoring policy prior to the next transplant procedure in which they are directly involved. CNO; Chair of Anesthesia 12/13/2019 Situational awareness education will be provided to CTOR and AVP, Perioperative Newark Beth Israel Medical Center 201 Lyons Ave, Newark, NJ 007112 Provider Number: 310002 ID Tag Deficiency A 286 A 286 Survey Date: October 18, 2019 Page 14 Corrective Action 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 and to recognize when the ordinary and expected routine has been or is being compromised, and to react appropriately. PATIENT SAFETY CFR(s): 482.21(a), (c)(2), (e)(3) 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 Quality Resource Management 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 Quality Resource Management 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. In addition, QRM will audit MAP, O2 saturation and cerebral oximetry monitoring and report compliance to the TSC. A 286 Part B, 4 (a) and 4(b) Date of Completion and Responsible Party (or Designee) Services 12/13/2019 Chair of Cardiothoracic Surgery; Quality Manager 12/13/2019 Quality Manager 2/3/2020 Although the facility has a hospital performance improvement plan and an adverse event policy, the facility has taken and will continue to take steps to enhance compliance. The Adverse Event Team membership list will be updated to include representatives from all categories of staff involved in the care of transplant patients. The Adverse Event Team will receive education about adverse events, determining if an Interim Transplant Administrator 2/3/2020 Newark Beth Israel Medical Center 201 Lyons Ave, Newark, NJ 007112 Provider Number: 310002 ID Tag Deficiency A 286 A 286 Survey Date: October 18, 2019 Page 15 Corrective Action Date of Completion and Responsible Party (or Designee) 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. PATIENT SAFETY CFR(s): 482.21(a), (c)(2), (e)(3) The Adverse Event Team is accountable for the entire safety event review process including: reporting, analysis, implementation of 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. A 286 Part B, 5 Interim Transplant Administrator 2/3/2020 The facility 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, transplant cardiologists and pulmonologists have been educated about the uniform set of criteria for selection of hearts and lungs based on size before their next transplant surgery. 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 and 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 Newark Beth Israel Medical Center 201 Lyons Ave, Newark, NJ 007112 Provider Number: 310002 ID Tag Deficiency Survey Date: October 18, 2019 Page 16 Corrective Action Date of Completion and Responsible Party (or Designee) 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 facility’s incident reporting system. An assigned quality advisor will then conduct an independent review, including an apparent or root cause analysis as appropriate. Chair, Cardiothoracic Surgery; Quality Manager 12/16/2019 In addition, QRM will audit compliance with organ sizing criteria and report compliance to the TSC. A 286 Part B, 6 Quality Manager 2/3/2020 A 286 A 286 PATIENT SAFETY CFR(s): 482.21(a), (c)(2), (e)(3) Although the facility has a hospital performance improvement plan and an adverse event policy, the facility has taken and will continue to take steps to enhance compliance. 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. Interim Transplant Administrator 2/3/2020 The Adverse Event Team is accountable for the entire safety event review process including: reporting, analysis, implementation of recommendations, and monitoring to ensure that the recommendations lead to the intended Interim Transplant Administrator 2/3/2020 Newark Beth Israel Medical Center 201 Lyons Ave, Newark, NJ 007112 Provider Number: 310002 ID Tag Deficiency A 286 A 309 QAPI EXECUTIVE RESPONSIBILITIES CFR(s): 482.21(e)(1), (e)(2), (e)(5) Survey Date: October 18, 2019 Page 17 Corrective Action Date of Completion and Responsible Party (or Designee) 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. A309 A1-2: Although the facility has a hospital performance improvement plan and an adverse event policy, the facility has taken and will continue to take steps to enhance compliance. 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 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. Interim Transplant Administrator 2/3/2020 The Adverse Event Team is accountable for the entire safety event review process including: reporting, analysis, implementation of 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 Newark Beth Israel Medical Center 201 Lyons Ave, Newark, NJ 007112 Provider Number: 310002 Survey Date: October 18, 2019 Page 18 ID Tag Deficiency Corrective Action A 309 QAPI EXECUTIVE RESPONSIBILITIES CFR(s): 482.21(e)(1), (e)(2), (e)(5) A 309 A3 Although the facility has standard process for transducer level placement, the facility 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 appropriate level. A 309 QAPI EXECUTIVE RESPONSIBILITIES CFR(s): 482.21(e)(1), (e)(2), (e)(5) 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 up to the Transplant Steering Committee. A309 A4 Date of Completion and Responsible Party (or Designee) Chair, Anesthesia 2/3/2020 Chair, Anesthesia 2/3/2020 Although the facility has a QAPI plans for the heart and lung transplant programs related to adverse event review, the facility 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 2/3/2020 The Interim Transplant Administrator and Quality Manager will Interim Transplant Newark Beth Israel Medical Center 201 Lyons Ave, Newark, NJ 007112 Provider Number: 310002 ID Tag Deficiency A 309 A309 A309 Survey Date: October 18, 2019 Page 19 Corrective Action review, analyze and present the data to the Heart and Lung Transplant QAPI committees, as applicable, and the Transplant Steering Committee. QAPI EXECUTIVE RESPONSIBILITIES CFR(s): 482.21(e)(1), (e)(2), (e)(5) QAPI EXECUTIVE RESPONSIBILITIES CFR(s): 482.21(e)(1), (e)(2), (e)(5) 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. A309 A5 Date of Completion and Responsible Party (or Designee) Administrator; Quality Manager 2/4/2020 Quality Manager 12/16/2019 Although the facility has an adverse event policy, which includes reporting, the facility has taken and will continue to take steps to enhance compliance. The facility will educate the Adverse Event Team regarding adverse events and reporting, determining if the adverse event is a safety event (a preventable harm event), classification of the safety events, and the tools for safety event review – root cause analysis, apparent cause analysis, and peer review. Interim Transplant Administrator 2/3/2020 The Interim Transplant Administrator will confirm that all events entered into OTTR are reported to the Adverse Event Team. The Interim Transplant Administrator will report compliance as a standing agenda item at the monthly Adverse Event Team meetings and the Transplant Steering Committee meetings. A309 A6 Interim Transplant Administrator 2/3/2020 The facility has implemented a policy that provides for the availability and readiness of back up ECMO equipment for any transplant procedure involving the use of ECMO. CNO 12/13/2019 Newark Beth Israel Medical Center 201 Lyons Ave, Newark, NJ 007112 Provider Number: 310002 ID Tag A 309 Deficiency Survey Date: October 18, 2019 Page 20 Corrective Action All perfusion and anesthesia staff have been educated about the requirement prior to participating in any transplant procedure. 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 and to recognize when the ordinary and expected routine has been or is being compromised, and to react appropriately. Date of Completion and Responsible Party (or Designee) CNO; Chair of Anesthesia 12/13/2019 AVP of Perioperative Services 12/13/2019CNO 12/13/2019 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. 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 Quality Resource Management (“QRM”) department and reported to the Transplant Steering Committee (“TSC”). All identified opportunities; deviations in care that did not cause harm, precursor events, and adverse events will be escalated to the Quality Resource Management department and entered into the facility’s incident reporting system. An assigned quality advisor will then conduct an independent review, including an apparent or root cause analysis as Chair of Cardiothoracic Surgery; Quality Manager 12/16/2019 Newark Beth Israel Medical Center 201 Lyons Ave, Newark, NJ 007112 Provider Number: 310002 ID Tag Deficiency A309 Survey Date: October 18, 2019 Page 21 Corrective Action appropriate. In addition, QRM will audit the availability and readiness of back up ECMO equipment post procedure and report compliance to the TSC. A309 Date of Completion and Responsible Party (or Designee) QAPI EXECUTIVE RESPONSIBILITIES CFR(s): 482.21(e)(1), (e)(2), (e)(5) Quality Manager 2/3/20 A 309 B Although the facility has a medical equipment management plan, the facility has taken and will continue to take steps to enhance compliance. The facility has revised the medical equipment management plan to give the biomedical engineering department oversight of the preventive maintenance for cardiopulmonary bypass machines. CNO 12/20/2019 All staff members who use cardiopulmonary bypass equipment will receive additional training on the changes to the preventive maintenance plan in accordance with the manufacturer’s instructions. Any staff on leave will be educated upon their return before resuming duties. CNO 12/18/19 The facility will monitor compliance with the preventive CNO maintenance plan monthly for six months or until 100% 12/18/19 compliance has been achieved for three consecutive months. Compliance data will be reported to the hospital’s Safety Committee and the hospital’s PIC quarterly for a year and then reporting frequency to be reassessed at the conclusion of that period. Newark Beth Israel Medical Center 201 Lyons Ave, Newark, NJ 007112 Provider Number: 310002 Survey Date: October 18, 2019 Page 22 ID Tag Deficiency Corrective Action A 353 MEDICAL STAFF BYLAWS CFR(s): 482.22(c) A353 1-3 Date of Completion and Responsible Party (or Designee) The facility will review the Medical Staff Bylaws (“Bylaws”) to confirm alignment with the CoPs and the New Jersey Hospital Licensing Standards for Medical Staff. Vice President, Medical Affairs (“VPMA”) 2/3/2020 The Medical Staff leadership will reinforce the Bylaws’ mechanism to address the following provider performance issues:  Inaccuracies, inconsistencies, and incomplete documentation regarding plan of care, medical records, and informed consent; and  Communications with patient’s family regarding condition of patient. VPMA 2/3/2020 Medical Staff leadership will be responsible for monitoring the above and addressing performance issues with individual practitioners. A subcommittee of the Medical Records Committee will monitor provider performance through retrospective clinical pertinence reviews (closed medical record review). The Chairs of the Medical Staff will review the data and address poor performers as part of the existing OPPE process. VPMA Director, HIM 2/3/2020 Compliance data will be reported to the hospital’s Medical Records Committee bimonthly and the hospital’s Medical Executive Committee quarterly for a year and then reporting frequency to be reassessed at the conclusion of that period. VPMA Director, HIM 2/3/2020 Newark Beth Israel Medical Center 201 Lyons Ave, Newark, NJ 007112 Provider Number: 310002 Survey Date: October 18, 2019 Page 23 ID Tag Deficiency Corrective Action A 353 MEDICAL STAFF BYLAWS CFR(s): 482.22(c) A353 4-5 Date of Completion and Responsible Party (or Designee) Although the facility has an informed consent policy, the facility has implemented additional procedures to make certain all informed consents are properly executed, documented, and administered prior to procedure. The facility, through a group of physician leaders and senior administrators will review the informed consent process and revise the policy and forms as necessary to address (1) who has the authority and responsibility to obtain informed consent, and (2) the requirement that informed consent be accurately and completely documented. The provider responsible for the procedure or an designee who will be participating in the procedure and is appropriately qualified and trained will obtain informed consent and make sure it is appropriately documented. The facility has identified and directed “gatekeepers” (i.e. nurses, APNs, or supervisory staff) to review the informed consent documentation and delay related procedures until the informed consent forms are properly completed. A properly completed informed consent form identifies the individual who obtained informed consent, and is dated and signed. The exception to this rule, in accordance with the facility’s policy, is for procedures relating to life or limb threatening conditions. VPMA 2/3/20 In particular, the “Consent to Surgical Procedures” form has already been modified to require that the name(s) of the person(s) performing the procedure be included. Director, HIM 12/30/19 Newark Beth Israel Medical Center 201 Lyons Ave, Newark, NJ 007112 Provider Number: 310002 ID Tag Deficiency A 353 Survey Date: October 18, 2019 Page 24 Corrective Action The Vice President of Medical Affairs (“VPMA”) has met with the facility’s department heads; the Medical Executive Committee; and Committee for Division Chairs to review (1) the “gatekeeper” role, (2) authority to delay procedures until informed consent complete, and (3) what constitutes a properly executed informed consent. All practitioners who obtain informed consent will receive enhanced training on what constitutes a properly executed informed consent and who can obtain informed consent. The facility will monitor compliance via retrospective review as part of HIM closed record review. HIM will review thirty (30) charts per month for three consecutive months or 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 and then reporting frequency to be reassessed at the conclusion of that period. A 820 IMPLEMENTATION OF A DISCHARGE PLAN CFR(s): 482.43(c)(3), (5) Date of Completion and Responsible Party (or Designee) VPMA 2/3/2020 VPMA 2/3/2020 VPMA; Director, HIM 2/3/2020 Although the facility has a discharge policy, the facility has taken and will continue to take steps to enhance compliance. The facility revised the discharge instruction policy to require nursing staff to provide to all patients who have had an invasive procedure discharge instructions pertaining to that procedure at the time of discharge Director, Cath Lab 12/20/2019 All staff involved in patient discharge from the Cath Lab will receive additional training regarding the discharge process. Director, Cath Lab 2/3/2020 A 820 Newark Beth Israel Medical Center 201 Lyons Ave, Newark, NJ 007112 Provider Number: 310002 ID Tag Deficiency Survey Date: October 18, 2019 Page 25 Corrective Action Date of Completion and Responsible Party (or Designee) Any staff on leave will be educated upon their return before resuming duties. A 940 SURGICAL SERVICES CFR(s): 482.51 The facility will monitor compliance by retrospective review of 30 cardiac biopsy charts per month or 100% if fewer than 30 until compliance has been achieved for three consecutive months. Director, Cath Lab 2/3/2020 The data will be presented at the Cardiac Cath Lab QAPI meeting monthly and the hospital PIC quarterly for a year and then reporting frequency to be reassessed. A 940 1 Director, Cath Lab 2/3/2020 Although the facility has a medical equipment management plan, the facility has taken and will continue to take steps to enhance compliance. A 940 The facility has revised the medical equipment management plan to give the biomedical engineering department oversight of the preventative maintenance for cardiopulmonary bypass machines. CNO 12/20/2019 All staff who uses cardiopulmonary bypass equipment will receive additional training on the changes to the preventative maintenance plan in accordance with the manufacturer’s instructions. Any staff on leave will be educated upon their return before resuming duties. CNO 12/18/19 The facility will monitor compliance with the preventative maintenance plan monthly for six months or until 100% compliance has been achieved for three consecutive months. CNO 12/18/19 Newark Beth Israel Medical Center 201 Lyons Ave, Newark, NJ 007112 Provider Number: 310002 ID Tag Deficiency Survey Date: October 18, 2019 Page 26 Corrective Action Date of Completion and Responsible Party (or Designee) Compliance data will be reported to the hospital’s Safety Committee and the hospital’s PIC quarterly for a year with reporting frequency to be reassessed at the conclusion of that period. A 940 A 940 2 See Tag 951 A A 940 A 940 3 See Tag 951 B A 940 940A 4 See Tag 951 C A 940 940A 5 See Tag 955 A 951 A 951 OPERATING ROOM POLICIES CFR(s): 482.51(b) A 951 A – B Although the facility has an intraoperative patient data collection and documentation policy, the facility has taken and will continue to take steps to enhance compliance. The facility has revised this policy to require documentation of anesthetic gases and medications administered while the patient is on cardiopulmonary bypass. The facility also amended the perfusion documentation forms to include a section for anesthetic gases and medications. All perfusion documentation forms are now part of the EHR. CNO 12/20/2020 Newark Beth Israel Medical Center 201 Lyons Ave, Newark, NJ 007112 Provider Number: 310002 ID Tag Deficiency Survey Date: October 18, 2019 Page 27 Corrective Action The facility will reinforce the need for anesthesia staff to document on a paper perfusionist checklist the anesthetic gases and medications given during cardiopulmonary bypass. Date of Completion and Responsible Party (or Designee) Chair, Anesthesia 1/17/2020 All perfusion and anesthesia staff will receive additional training Chair, Anesthesia on the revised documentation requirements and the policy. CNO 1/24/2020 A 951 A 951 The facility will monitor compliance via monthly retrospective review of 30 cardiopulmonary bypass charts or 100% of cardiopulmonary bypass charts if fewer than 30, until 100% compliance has been achieved for three consecutive months. Compliance data will be reported to the Cardiothoracic QAPI meeting and the hospital’s PIC quarterly for a year with reporting frequency to be reassessed at the conclusion of that period. CNO 2/3/2020 All policies now have the facility’s header. The 2019 perfusion policies have been reviewed and approved by the Chair of the Cardiothoracic service. Going forward it is the responsibility of the Director of Cardiothoracic Surgery to ensure policies are reviewed every three years and revised sooner as needed. This will be monitored through the Hospital’s Policy and Procedure Committee. CNO 2/3/2020 The facility has updated the perfusion policies. The policies have been approved and reviewed by the Chair of Cardiothoracic Surgery. The perfusion policies will be reviewed at least every three years unless otherwise required by applicable law. A 951 C Chair, Cardiothoracic Services 1/6/2020 Newark Beth Israel Medical Center 201 Lyons Ave, Newark, NJ 007112 Provider Number: 310002 ID Tag Deficiency Survey Date: October 18, 2019 Page 28 Corrective Action Date of Completion and Responsible Party (or Designee) Although the facility has an anesthesia safety regulations policy, the facility has taken and will continue to take steps to enhance compliance. A 955 A 955 INFORMED CONSENT CFR(s): 482.51(b)(2) The anesthesia safety regulations policy will be revised to require documentation of the patient’s body temperature at least every fifteen minutes during procedures with general or major regional anesthesia that are 45 minutes or longer. Chair, Anesthesia 1/17/2020 The facility has reinforced to all anesthesia staff the need for continuous monitoring and documenting of patient body temperatures. Chair, Anesthesia 1/17/2020 All anesthesia staff will also receive additional training on the need for continuous monitoring and documenting of patient body temperatures. Chair, Anesthesia 1/17/2020 The facility will monitor compliance via retrospective record review of a sample of 30 charts each month. Compliance data will be reported to the Operating Room Committee monthly for three months or until 100% compliance has been achieved for three consecutive months. Compliance data will also be reported to the hospital’s Medical Executive Committee quarterly until 100% compliance has been achieved. Although the facility has an informed consent policy, the facility has implemented additional procedures to make certain all informed consents are properly executed, documented, and administered prior to procedure. Chair, Anesthesia 2/3/2020 VPMA 10/17/2019 Newark Beth Israel Medical Center 201 Lyons Ave, Newark, NJ 007112 Provider Number: 310002 ID Tag Deficiency Survey Date: October 18, 2019 Page 29 Corrective Action During the survey when the surveyors were still on-site, the facility took immediate action to address partially completed informed consents. The facility has identified and directed “gatekeepers” (i.e. nurses, APNs, or supervisory staff) to review the informed consent documentation and delay related procedures until the informed consent forms are properly completed. A properly completed informed consent form identifies the individual who obtained informed consent, and is dated and signed. The exception to this rule, in accordance with the facility’s policy, is for procedures relating to life or limb threatening conditions. The Vice President of Medical Affairs (“VPMA”) has met with the facility’s department heads; the Medical Executive Committee; and Committee for Division Chairs to review (1) the “gatekeeper” role, (2) authority to delay procedures until informed consent complete, and (3) what constitutes a properly executed informed consent. Date of Completion and Responsible Party (or Designee) VPMA 10/17/2019 VPMA 12/20/2020 All practitioners who obtain informed consent will receive enhanced training on what constitutes a properly executed informed consent and who can obtain informed consent. The facility will monitor compliance via retrospective review as part of HIM closed record review. HIM will review thirty (30) charts per month for three consecutive months or 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 VPMA 2/3/2020 Director, HIM 2/3/2020 Newark Beth Israel Medical Center 201 Lyons Ave, Newark, NJ 007112 Provider Number: 310002 ID Tag Deficiency Survey Date: October 18, 2019 Page 30 Corrective Action for a year and then reporting frequency to be reassessed at the conclusion of that period. Date of Completion and Responsible Party (or Designee)