PRINTED: 12/12/2019 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ (X3) DATE SURVEY COMPLETED C 310002 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE 201 LYONS AVE NEWARK BETH ISRAEL MEDICAL CENTER (X4) ID PREFIX TAG 10/18/2019 NEWARK, NJ 07112 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A 000 INITIAL COMMENTS PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE A 000 This is a Federal Allegation Survey conducted October 9-11, & October 15-18, 2019. The facility was found to not be in compliance with 42 CFR Part 482, Medicare Conditions of Participation (CoP) for Hospitals, for these Complaint Investigations: Complaint Numbers NJ 00129025, NJ 00129277, and NJ 00129301. Condition and Standard level deficiencies were evident. The following Conditions of Participation (CoPs) are out of compliance: 482.13 Patient Rights 482.21 Quality Assessment and Performance Improvement (QAPI) 482.51 Surgical Services An Immediate Jeopardy (IJ) was called related to Quality Assessment and Performance Improvement (QAPI). The facility identified adverse events, but failed to implement corrective measures to ensure that similar future adverse events did not reoccur. The facility was notified of the IJ on December 12, 2019 at 2:34 PM. A 115 PATIENT RIGHTS CFR(s): 482.13 A 115 A hospital must protect and promote each patient's rights. This CONDITION is not met as evidenced by: Based on interviews, review of medical records, LABORATORY DIRECTOR'S OR PROVIDER/SUPPLIER REPRESENTATIVE'S SIGNATURE (X6) DATE TITLE Any deficiency statement ending with an asterisk (*) denotes a deficiency which the institution may be excused from correcting providing it is determined that other safeguards provide sufficient protection to the patients . (See instructions.) Except for nursing homes, the findings stated above are disclosable 90 days following the date of survey whether or not a plan of correction is provided. For nursing homes, the above findings and plans of correction are disclosable 14 days following the date these documents are made available to the facility. If deficiencies are cited, an approved plan of correction is requisite to continued program participation. FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: CSPG11 Facility ID: NJ10709 If continuation sheet Page 1 of 73 PRINTED: 12/12/2019 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ (X3) DATE SURVEY COMPLETED C 310002 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE 201 LYONS AVE NEWARK BETH ISRAEL MEDICAL CENTER (X4) ID PREFIX TAG 10/18/2019 NEWARK, NJ 07112 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A 115 Continued From page 1 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE A 115 hospital policies and procedures, interviews, and related documentation, it was determined that the facility failed to protect and promote the rights of each patient by not implementing their plan of care, completing surgical and other consents, notifying a family member of the patient's admission to the facility, and maintaining confidentiality of clinical records and Protected Health Information (PHI). Findings include: 1. The facility failed to adhere to their patient rights policy when implementing the patient's plan of care. (Cross refer to Tag 0130) 2. The facility failed to ensure all informed surgical consents are completed per facility policy prior to surgery. (Cross refer to Tag 0131) 3. The facility failed to adhere to their policies and procedures for the rights of an incapacitated patient, and their advance directives for healthcare. (Cross refer to Tag 0132) 4. The facility failed to ensure a patient's right to have a family member notified of his/her admission to the hospital. (Cross refer to Tag 0133) 5. The facility failed to ensure all staff maintain patients' rights to confidentiality of their clinical record and Protected Health Information (PHI), as per facility policies. (Cross refer to Tag 0147) A 130 PATIENT RIGHTS:PARTICIPATION IN CARE PLANNING CFR(s): 482.13(b)(1) FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: CSPG11 A 130 Facility ID: NJ10709 If continuation sheet Page 2 of 73 PRINTED: 12/12/2019 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ (X3) DATE SURVEY COMPLETED C 310002 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE 201 LYONS AVE NEWARK BETH ISRAEL MEDICAL CENTER (X4) ID PREFIX TAG 10/18/2019 NEWARK, NJ 07112 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A 130 Continued From page 2 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE A 130 The patient has the right to participate in the development and implementation of his or her plan of care. This STANDARD is not met as evidenced by: Based on facility policy review, medical record review, and interviews with staff and a patient's family member, it was determined that the facility failed to inform a patient's family member when he/she was kept overnight at the facility, and include the family in the patient's plan of care and treatment. Findings include: Reference: Facility policy titled, Patient Rights, states, "... Medical Care - To make informed decisions regarding the course of care and treatment ... To participate in the development and implementation of your plan of care. ..." 1. Review of Medical Record #5 revealed that the Patient arrived for an outpatient cardiac catheterization on 5/31/18 at 9:15 AM. The "Consent For Diagnostic Catheterization And Interventional Procedures" was verbally obtained from the Patient's son on 5/31/18 at 10:20 AM. 2. Patient #5 was not discharged on 5/31/18, post catheterization, back to the transferring facility. a. The 5/31/18 "Other Procedures" note at 12:21 PM states, "discharged from the cath lab procedure room ... was very diaphoretic upon arrival ... would like to keep [him/her] overnight pending biopsy results and perhaps blood cultures ..." b. The 5/31/18 "Admission Note - Nursing," at FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: CSPG11 Facility ID: NJ10709 If continuation sheet Page 3 of 73 PRINTED: 12/12/2019 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ (X3) DATE SURVEY COMPLETED C 310002 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE 201 LYONS AVE NEWARK BETH ISRAEL MEDICAL CENTER (X4) ID PREFIX TAG 10/18/2019 NEWARK, NJ 07112 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A 130 Continued From page 3 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE A 130 2:00 PM states, " ... transferred from cath lab, lethargic, diaphoretic ..." c. The 6/1/18 "Progress Note - Physician" at 8:24 AM states, " ... came from [name of transferring facility] for endomyocardial biopsy and was found to be diaphoretic, hypertensive, tachycardic and febrile to 102 [degrees Fahrenheit]. Pulmonary was consulted for suspicion for HAP {hospital acquired pneumonia} ... Neurologic: Awake but does not follow any purposeful commands. ... Impression and Plan: ... Fever, hypoxemia ...Continue vancomycin and cefpime ... CT scan result noted ..." d. The 6/1/18 "Progress Notes" at 1:07 PM states, " ... Extensive discussion with daughter, Patient is DNR ..." 3. A telephone interview with the family member of Patient #5 was held on 10/17/19. The family member of Patient #5 called the transferring facility on 5/31/18 to follow up on patient status post catheterization, and was informed the patient "was still not back." The family member then stated he/she proceeded to go to a scheduled "family meeting/therapy session," at the transferring facility, on 6/1/18 at 8:00 AM. When he/she arrived to the facility he/she was informed by the charge nurse that the patient was "kept for observation and unsure why." The family member then proceeded to the [this] transfer facility on 6/1/18, "I had to track {him/her} down," and was informed upon arrival the patient was admitted for a "biopsy, sweating, 102 temperature, CT-Scan and IV antibiotics, without notifying us [the family]..." 4. Staff #2 and Staff #59 confirmed there was no FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: CSPG11 Facility ID: NJ10709 If continuation sheet Page 4 of 73 PRINTED: 12/12/2019 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ (X3) DATE SURVEY COMPLETED C 310002 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE 201 LYONS AVE NEWARK BETH ISRAEL MEDICAL CENTER (X4) ID PREFIX TAG 10/18/2019 NEWARK, NJ 07112 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A 130 Continued From page 4 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE A 130 evidence that the family of Patient #5 was informed that he/she remained at the facility post catheterization, or that they were included in the patient's plan of care and treatment that was implemented. A 131 PATIENT RIGHTS: INFORMED CONSENT CFR(s): 482.13(b)(2) A 131 The patient or his or her representative (as allowed under State law) has the right to make informed decisions regarding his or her care. The patient's rights include being informed of his or her health status, being involved in care planning and treatment, and being able to request or refuse treatment. This right must not be construed as a mechanism to demand the provision of treatment or services deemed medically unnecessary or inappropriate. This STANDARD is not met as evidenced by: Based on review of facility documents, and staff interviews, it was determined that the facility failed to adhere to their patient rights policy for general consent to treatment in eight (8) of twenty (20) medical records reviewed (Medical Records #1, #2, #3, #5, #8, #12, #13, and #17). Findings include: Reference #1: Facility policy titled, Patient Rights, states, " ... POLICY: ... 1. The management and staff support and affirm all of the fundamental rights which patients have based on law and regulation. ...Medical Care -To give informed and written consent prior to the start of specified, non-emergency medical procedures or treatments. ..." FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: CSPG11 Facility ID: NJ10709 If continuation sheet Page 5 of 73 PRINTED: 12/12/2019 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ (X3) DATE SURVEY COMPLETED C 310002 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE 201 LYONS AVE NEWARK BETH ISRAEL MEDICAL CENTER (X4) ID PREFIX TAG 10/18/2019 NEWARK, NJ 07112 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A 131 Continued From page 5 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE A 131 Reference #2: Facility policy titled, Consent, Informed, states, "... PURPOSE: ... To establish a mutual understanding between the patient and the physician or other licensed independent practitioner who provides care, treatment, or services about the care, treatment, and services that the patient receives. To recognize the right of each individual to fully participate in his/her health care decisions through the informed decision making process ..." 1. Upon review of Medical Record #2 on 10/10/19, the following was identified: a. A document in the medical record titled, "General Consent - Inpatient, Outpatient and Emergency Department - Teaching - English" lacked evidence of the patient's acknowledgement as follows: (i) Section 1, titled "Consent to Care," was noted to be missing the patient's initials. (ii) Section 5, titled "Release of Information," was noted to be missing the patient's signature. (iii) Section 15, titled "Advance Directive," was noted to be missing the patient's signature. 2. Upon review of Medical Record #8 on 10/10/19, the following was identified: a. A document in the medical record titled, "General Consent - Inpatient, Outpatient and Emergency Department - Teaching - English" was found to have the following missing elements: (i) Section 1, titled "Consent to Care," was noted FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: CSPG11 Facility ID: NJ10709 If continuation sheet Page 6 of 73 PRINTED: 12/12/2019 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ (X3) DATE SURVEY COMPLETED C 310002 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE 201 LYONS AVE NEWARK BETH ISRAEL MEDICAL CENTER (X4) ID PREFIX TAG 10/18/2019 NEWARK, NJ 07112 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A 131 Continued From page 6 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE A 131 to be missing the patient's initials. (ii) Section 5, titled "Release of Information," was noted to be missing the patient's signature. (iii) Section 15, titled "Advance Directive," the answer boxes following the statement "I have an Advance Directive/Living Will/Health Care Agent" did not identify a patient answer. (iv) Section 15, titled "Advance Directive", was noted to be missing the patient's signature. (v) An acknowledgement of the receipt of the Hospital's Privacy Notice was not acknowledged by the patient/patient representative. The area for patient/patient representative signature was blank. 3. Upon review of Medical Record #3 on 10/10/19, the following was identified: a. A document in the medical record titled, "General Consent - Inpatient, Outpatient and Emergency Department - Teaching - English" was found to have the following missing elements: (i) Section 1, titled "Consent to Care," was noted to be missing the patient's initials. (ii) Section 5, titled "Release of Information," was noted to be missing the patient's signature. (iii) Section 15, titled "Advance Directive," the answer boxes following the statement "I have an Advance Directive/Living Will/Health Care Agent" did not identify a patient answer. (iv) Section 15, titled "Advance Directive," was FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: CSPG11 Facility ID: NJ10709 If continuation sheet Page 7 of 73 PRINTED: 12/12/2019 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ (X3) DATE SURVEY COMPLETED C 310002 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE 201 LYONS AVE NEWARK BETH ISRAEL MEDICAL CENTER (X4) ID PREFIX TAG 10/18/2019 NEWARK, NJ 07112 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A 131 Continued From page 7 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE A 131 noted to be missing the patient's signature. (v) An acknowledgement of the receipt of the Hospital's Privacy Notice was not acknowledged by the patient/patient representative. The area for patient/patient representative signature was blank 4. Upon review of Medical Record #12 on 10/11/19, the following was identified: a. A document in the medical record titled, "General Consent - Inpatient, Outpatient and Emergency Department - Teaching - English" was found to have the following missing elements: (i) Section 1, titled "Consent to Care," was noted to be missing the patient's initials. (ii) Section 5, titled "Release of Information," was noted to be missing the patient's signature. (iii) Section 15, titled "Advance Directive," was noted to be missing the patient's signature. 5. Upon review of Medical Record #17, the following was identified: a. A document in the medical record titled, "General Consent - Inpatient, Outpatient and Emergency Department - Teaching - English" was found to have the following missing elements: (i) Section 15, titled "Advance Directive," was noted to be missing the patient's signature. 6. Upon review of Medical Record #1 on 10/10/19, the following was identified: a. A document in the medical record titled, FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: CSPG11 Facility ID: NJ10709 If continuation sheet Page 8 of 73 PRINTED: 12/12/2019 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ (X3) DATE SURVEY COMPLETED C 310002 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE 201 LYONS AVE NEWARK BETH ISRAEL MEDICAL CENTER (X4) ID PREFIX TAG 10/18/2019 NEWARK, NJ 07112 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A 131 Continued From page 8 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE A 131 "General Consent - Inpatient, Outpatient and Emergency Department - Teaching - English" was found to have the following missing elements: (i) Section 1, titled "Consent to Care," was noted to be missing the patient's initials. (ii) Section 5, titled "Release of Information," was noted to be missing the patient's signature. (iii) Section 8, titled "Financial Agreement," was noted to be missing an indication in either the "yes" or "no" checkbox. (iv) Section 14, titled "New Jersey Department of Health (IMM-32) Consent to Participate Form for the New Jersey Immunization Information System (NJIIS)", was noted to be missing an indication in either the "yes" or "no" checkbox. (iii) Section 15, titled "Advance Directive," was noted to be missing the patient's signature. b. A document in the medical record titled, "Appeals of Utilization Management Determinations" was found to be incomplete. The form states, "... by marking [the check mark] and signing below, agree to..." (i) The checkboxes on the form were empty. 7. An interview with Staff #62 on 10/11/19 at 10:20 AM, confirmed that the above sections should have contained either the patient's initials and/or signature, that all yes/no boxes should be checked, and boxes are not to be left blank on the general consent. All sections on the general consent are to be completed. FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: CSPG11 Facility ID: NJ10709 If continuation sheet Page 9 of 73 PRINTED: 12/12/2019 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ (X3) DATE SURVEY COMPLETED C 310002 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE 201 LYONS AVE NEWARK BETH ISRAEL MEDICAL CENTER (X4) ID PREFIX TAG 10/18/2019 NEWARK, NJ 07112 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A 131 Continued From page 9 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE A 131 8. Patient #5 arrived to the facility on 5/31/18 at 9:15 AM for an outpatient cardiac catheterization. The following medical record review revealed: a. The "General Consent: Inpatient, Outpatient & Emergency Department- English" was obtained on 5/31/18. (i) The "Patient Signature/Authorized Representative," was not completed. (ii) "The Patient is unable to sign because:," was not completed. b. The "Appeals of Utilization Management Determinations" consent was not signed, dated or witnessed. 9. The above findings were confirmed with Staff #2 and Staff #59. 10. Upon review of Medical Record #13, the following was revealed: a. A document in the medical record titled, "General Consent - Inpatient, Outpatient and Emergency Department - Teaching - English" was found to have the following missing elements: (i) Section 1, titled "Consent to Care," was noted to be missing the patient's initials. (ii) Section 5, titled "Release of Information," was noted to be missing the patient's signature. (iii) Section 8, titled "Financial Agreement," was noted to be missing an indication in either the "yes" or "no" checkbox. FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: CSPG11 Facility ID: NJ10709 If continuation sheet Page 10 of 73 PRINTED: 12/12/2019 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ (X3) DATE SURVEY COMPLETED C 310002 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE 201 LYONS AVE NEWARK BETH ISRAEL MEDICAL CENTER (X4) ID PREFIX TAG 10/18/2019 NEWARK, NJ 07112 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A 131 Continued From page 10 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE A 131 (iv) Section 15, titled "Advance Directive," was noted to be missing the patient's signature. 11. The above findings were confirmed with Staff #2. A 132 PATIENT RIGHTS: INFORMED DECISION CFR(s): 482.13(b)(3) A 132 The patient has the right to formulate advance directives and to have hospital staff and practitioners who provide care in the hospital comply with these directives, in accordance with §489.100 of this part (Definition), §489.102 of this part (Requirements for providers), and §489.104 of this part (Effective dates). This STANDARD is not met as evidenced by: Based on review of facility documents and staff interviews, it was determined that the facility failed to adhere to their policies and procedures for the rights of an incapacitated patient, and their advance directives for healthcare. Findings include: Reference #1: Facility policy titled, Patient Rights, states, " ... Medical Care ... To make informed decisions regarding the course of care and treatment, including ... formulating advance directives ..." Reference #2: Facility policy titled, Advance Directive For Healthcare, states, " ... PROCEDURE: A. 1. An inquiry will be made of each adult patient, at the time of admission ... concerning the existence and location of an Advance Directive for Health Care. If the patient is incapable of responding to this inquiry, the FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: CSPG11 Facility ID: NJ10709 If continuation sheet Page 11 of 73 PRINTED: 12/12/2019 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ (X3) DATE SURVEY COMPLETED C 310002 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE 201 LYONS AVE NEWARK BETH ISRAEL MEDICAL CENTER (X4) ID PREFIX TAG 10/18/2019 NEWARK, NJ 07112 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A 132 Continued From page 11 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE A 132 medical center will ask the family or person with knowledge of the patient, if available. 2. Pre-Admission clerk shall inquire of each adult patient concerning the existence of an Advance Directive. The patient will be asked to bring a copy of the Advance Directive at the time of admission. ...7. If an adult patient is incapacitated at the time of admission, ... and is unable to receive information due to the incapacitated condition or mental disorder, or articulate whether or not her or she has executed an Advance Directive, then medical center personnel may give Advance Directive information to the individual's family or surrogate in the same manner as other material about policies and procedures are given to the families of incapacitated individuals. ..." 1. Upon review of Medical Record #5, the following was revealed: a. The Patient arrived for an outpatient cardiac catheterization on 5/31/18 at 9:15 AM. b. The Patient's neurological and mental status was addressed as follows: (i) The "Cardiac Catheterization Procedure Log Report" on 5/31/18 at 9:20 AM states, " ...Chronological Log ...Neurological: State=Unresponsive, Comment= Pt {patient} came from [name of outside brain trauma unit]. Opens eyes to painful stimuli only ..." (ii) The "Cardiac Catheterization Lab" report on 5/31/18 states, " ...Pre Mental Status ...Responsive to painful stimuli ...Advance Directive: ...No ..." FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: CSPG11 Facility ID: NJ10709 If continuation sheet Page 12 of 73 PRINTED: 12/12/2019 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ (X3) DATE SURVEY COMPLETED C 310002 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE 201 LYONS AVE NEWARK BETH ISRAEL MEDICAL CENTER (X4) ID PREFIX TAG 10/18/2019 NEWARK, NJ 07112 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A 132 Continued From page 12 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE A 132 c. The "General Consent: Inpatient, Outpatient & Emergency Department- English" was obtained on 5/31/18. (i) The consent did not have any signatures. (ii) The Advance Directive/POLST information on the consent was marked as "NO." 2. The "Other Procedures" note on 5/31/18 at 12:21 PM, for Patient #5 states, "discharged from the cath lab procedure room" and "would like to keep [him/her] overnight pending biopsy ..." a. The 6/1/18 "Orders" at 12:55 PM, states, " ... Do Not Resuscitate." (i) There was no evidence of a copy of a DNR in the medical record. b. The 6/2/18 "Patient History Forms" at 6:48 AM states, " ... Advance Directive: No ... Practitioner Order for Life Sustaining Treatment (POLST): No ... Patient Wishes to Receive Further Information of Advance Directives: No ..." c. A "New Jersey Practitioner Orders For Life-Sustaining Treatment (POLST)" was signed and dated on 6/4/18. 3. A telephone interview with a family member of Patient #5 was held on 10/17/19. The family member of Patient #5 stated when he/she arrived to the facility on 6/1/18, he/she asked facility staff "what is the code status" of his/her family member, "because the first week in [the name of the receiving facility] he/she had a strict DNR status ..." FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: CSPG11 Facility ID: NJ10709 If continuation sheet Page 13 of 73 PRINTED: 12/12/2019 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ (X3) DATE SURVEY COMPLETED C 310002 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE 201 LYONS AVE NEWARK BETH ISRAEL MEDICAL CENTER (X4) ID PREFIX TAG 10/18/2019 NEWARK, NJ 07112 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A 132 Continued From page 13 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE A 132 4. Upon interview on 10/18/19, Staff #2 and Staff #59 confirmed that Patient #5 was transferred to the facility on 5/31/18, and there was no evidence that a Universal Transfer Form was received from the transfer facility or requested, to determine the patient's DNR status upon admission. A 133 PATIENT RIGHTS: ADMISSION STATUS NOTIFICATION CFR(s): 482.13(b)(4) A 133 The patient has the right to have a family member or representative of his or her choice and his or her own physician notified promptly of his or her admission to the hospital. This STANDARD is not met as evidenced by: Based on medical record review, and staff interviews, and an interview with a patient's family member, it was determined that the facility failed to ensure a patient's right to have a family member notified of his/her admission to the hospital. Findings include: 1. Review of Medical Record #5 revealed that the Patient arrived for an outpatient cardiac catheterization on 5/31/18 at 9:15 AM. The "Consent For Diagnostic Catheterization And Interventional Procedures" was verbally obtained from the Patient's son on 5/31/18 at 10:20 AM. 2. Patient #5 was not discharged back to the transferring facility, post catheterization, on 5/31/18. a. The "Other Procedures" note on 5/31/18 at 12:21 PM states, "discharged from the cath lab FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: CSPG11 Facility ID: NJ10709 If continuation sheet Page 14 of 73 PRINTED: 12/12/2019 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ (X3) DATE SURVEY COMPLETED C 310002 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE 201 LYONS AVE NEWARK BETH ISRAEL MEDICAL CENTER (X4) ID PREFIX TAG 10/18/2019 NEWARK, NJ 07112 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A 133 Continued From page 14 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE A 133 procedure room ... was very diaphoretic upon arrival ... would like to keep [him/her] overnight pending biopsy results and perhaps blood cultures ..." b. The 5/31/18 "Admission Note - Nursing" at 2:00 PM states, " ... transferred from cath lab, lethargic, diaphoretic ..." c. The 6/1/18 "Progress Note - Physician" at 8:24 AM states, " ... came from [name of transferring facility] for endomyocardial biopsy and was found to be diaphoretic, hypertensive, tachycardic and febrile to 102. Pulmonary was consulted for suspicion for HAP {hospital acquired pneumonia} ... Neurologic: Awake but does not follow any purposeful commands. ... Impression and Plan: ... Fever, hypoxemia ...Continue vancomycin and cefpime ... CT scan result noted ..." 3. A telephone interview with the family member of Patient #5 was held on 10/17/19. The family member of Patient #5 stated he/she called the transferring [sending] facility on 5/31/18 to follow up on the patient's status, post catheterization, and was informed the Patient "was still not back." The family member then stated he/she proceeded to go to a scheduled "family meeting/therapy session" at the transferring facility, on 6/1/18 at 8:00 AM. When he/she arrived to the facility he/she was informed by the charge nurse that the Patient was "kept for observation and unsure why." The family member then proceeded to go to the transfer facility on 6/1/18, "I had to track {him/her}down," and was informed upon arrival the patient was admitted for a "biopsy, sweating, 102 temperature, CT-Scan and IV antibiotics, without notifying us [the family]..." FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: CSPG11 Facility ID: NJ10709 If continuation sheet Page 15 of 73 PRINTED: 12/12/2019 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ (X3) DATE SURVEY COMPLETED C 310002 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE 201 LYONS AVE NEWARK BETH ISRAEL MEDICAL CENTER (X4) ID PREFIX TAG 10/18/2019 NEWARK, NJ 07112 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A 133 Continued From page 15 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE A 133 4. Staff #2 and Staff #59 confirmed there was no evidence, that the family of Patient #5 was informed that he/she remained at the facility post catheterization. A 144 PATIENT RIGHTS: CARE IN SAFE SETTING CFR(s): 482.13(c)(2) A 144 The patient has the right to receive care in a safe setting. This STANDARD is not met as evidenced by: Based on medical record review, staff interviews, review of video surveillance, and review of facility documents, it was determined that the facility failed to ensure a minor patient was supervised in the presence of an adult patient with a history of aggressive, violent, and erratic behavior. Findings include: Reference: Facility document titled, Safety and Security Precautions in Behavioral Health, states, "Every 15-Minute (q 15) Check: Patients are observed at least every 15 minutes and remain on this precaution throughout hospitalization. All patients shall be placed on every 15-minute checks on admission (unless a more restrictive precaution is ordered by the physician)." 1. During a tour of the Psychiatric Emergency Screening Services (PESS) Unit, on 10/17/19 at 10:40 AM, seven (7) patient rooms were observed. The PESS Unit is divided into two (2) areas. Hall A, consisting of Rooms #5, #6 & #7, with a bathroom containing a shower. Hall B consisting of Rooms #1, #2, #3 & #4, with a bathroom containing a shower. Hall A and Hall B are divided by a wall with a locked door. FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: CSPG11 Facility ID: NJ10709 If continuation sheet Page 16 of 73 PRINTED: 12/12/2019 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ (X3) DATE SURVEY COMPLETED C 310002 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE 201 LYONS AVE NEWARK BETH ISRAEL MEDICAL CENTER (X4) ID PREFIX TAG 10/18/2019 NEWARK, NJ 07112 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A 144 Continued From page 16 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE A 144 a. Upon interview, on 10/17/19 at 10:45 AM, Staff #79, stated Patient #29 is a minor, was in Room #4 in Hall B, was discharged, and waiting for her/his mother on 10/11/19. At approximately 09:30 AM on 10/11/19, Patient #29 had to use the rest room, however, the bathroom in Hall B was not functioning. Patient #30 was showering in the bathroom in Hall A and was asked by Staff #73 to hurry up because someone needed to use the bathroom. Staff #73 walked Patient #29 from Hall B to Hall A to use the bathroom. After Patient #29 was finished, she/he told Staff #73 that a patient walked into the bathroom and kissed her/him. b. On 10/17/19 at 10: 47 AM, Staff #79 stated at the time of the incident, staff were in the nursing station room gathered around the round table having an interdisciplinary meeting. No one was aware of what happened in the bathroom. c. Upon interview on 10/17/19 at 11:52 AM, Staff #77 stated Patient #30 was finishing up showering at the time she/he was walking Patient #29 to the Hall A bathroom and when she returned to escort her/him [Patient #29] back [to Hall B], Patient #29 asked "What's wrong with that guy?" She proceeded to tell her that Patient #30, entered the bathroom while she/he was on the toilet, kissed her/him all over the face, then threw a toilet paper roll at her/him. 2. On 10/17/19 at 12:00 PM, a review of video surveillance views, recorded of the PESS Unit Hall A on 10/11/19, was conducted, indicating the following: (times referenced are those of the time stamp on the videos). a. At 09:36:14 (AM), Patient #30, an adult FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: CSPG11 Facility ID: NJ10709 If continuation sheet Page 17 of 73 PRINTED: 12/12/2019 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ (X3) DATE SURVEY COMPLETED C 310002 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE 201 LYONS AVE NEWARK BETH ISRAEL MEDICAL CENTER (X4) ID PREFIX TAG 10/18/2019 NEWARK, NJ 07112 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A 144 Continued From page 17 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE A 144 patient, is observed exiting the bathroom, clad in pajama bottoms, holding a towel and other articles of clothing, heading to his/her room (Room #6) which is in view of the enclosed nurse's station area. A round table with staff is visible on the video surveillance view. b. At 09:36:28 (AM), Patient #29, a minor, escorted by Staff #77, are observed entering Hall A. (i) Patient #30 is observed watching Patient #29 as she/he is walking past him/her. c. At 09:36:30 (AM), Patient #30 is observed, in the presence of Staff #77, reaching over and tapping Patient #29 on the right upper arm. (i) Patient #29 is observed looking back at Patient #30 and pulling her/his upper body back, away from Patient #30. d. At 09:36:40 (AM), Patient #29 enters the bathroom and closes the door. (i) Staff #77 is observed entering the nursing station room. (ii) Staff #76 is observed sitting at a round table. (iii) Patient #30 is in full view from the window in the nursing station room in Hall A, in the corridor outside of his/her room (Room #6). (iv) Patient #30 is exhibiting erratic behavior: pacing, dropping and picking up items repeatedly. e. At 09:36:50 (AM), Patient #30, is in the corridor and continues the erratic behavior of FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: CSPG11 Facility ID: NJ10709 If continuation sheet Page 18 of 73 PRINTED: 12/12/2019 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ (X3) DATE SURVEY COMPLETED C 310002 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE 201 LYONS AVE NEWARK BETH ISRAEL MEDICAL CENTER (X4) ID PREFIX TAG 10/18/2019 NEWARK, NJ 07112 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A 144 Continued From page 18 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE A 144 dropping a towel and articles of clothing on the floor, then picking up the towel, pacing, picking at himself/herself, drying himself/herself off, and attempting to dress. No effort was made by staff in the nursing room area to redirect Patient #30. f. At 09:38:18 (AM), Patient #30, is no longer in view from the nursing station area window, and is observed on the video surveillance, opening the bathroom door, while Patient #29 was occupying it and stepping inside. g. At 09:38:37 (AM), Patient #30 exits the bathroom, walks in the corridor in view of the nursing station area and continues picking up articles of clothing from the corridor floor. h. At 09:38:54 (AM), Patient #30 is observed heading back to the bathroom, and opens the door. (i) Patient #30 does not enter the bathroom. i. At 09:38:55 (AM), Patient #30 steps away from the bathroom, exhibiting erratic behavior. j. At 09:39:04 (AM), Patient #30 is observed entering his room (Room #6). k. At 09:39:45 (AM), Patient #30 is observed exiting Room #6. (i) Patient #30 is standing in the corridor in view of the nursing station area, exhibiting erratic behavior. l. At 09:39:50 (AM), Patient #30 is observed returning to the bathroom. FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: CSPG11 Facility ID: NJ10709 If continuation sheet Page 19 of 73 PRINTED: 12/12/2019 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ (X3) DATE SURVEY COMPLETED C 310002 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE 201 LYONS AVE NEWARK BETH ISRAEL MEDICAL CENTER (X4) ID PREFIX TAG 10/18/2019 NEWARK, NJ 07112 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A 144 Continued From page 19 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE A 144 (i) The bathroom is still occupied by Patient #29. (ii) Patient #30 proceeds to open the door to the bathroom. (iii) Patient #30 walks away without entering the bathroom. m. At 09:40:07 (AM), Patient #30 is talking to staff through the nursing station room window and gestures towards his/her room (Room #6). n. At 09:40:27 (AM), Patient #30 is observed entering Room #6 and closing the door. o. At 09:40:40 (AM), Staff #77 is observed in the corridor of Hall A, opening the door to Room #6 and stepping inside. p. At 09:41:44 (AM), Patient #29, exits the bathroom. (i) Staff #77 exits Room #6. (ii) Staff #77 walks toward Patient #29. (iii) Patient #29 is observed talking to Staff #77. (iv) Staff #77 unlocks the door separating Hall A and Hall B and leads Patient #29 to Hall B. q. On 10/17/19 at 12:58 PM Staff #77 and Staff #79 confirmed the above findings. 3. Review of Medical Record #29, on 10/17/19 at 11:40 AM, indicated the following: a. The Behavioral Health Form, Psychiatric Screening states, Patient #29, a 14 year old was FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: CSPG11 Facility ID: NJ10709 If continuation sheet Page 20 of 73 PRINTED: 12/12/2019 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ (X3) DATE SURVEY COMPLETED C 310002 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE 201 LYONS AVE NEWARK BETH ISRAEL MEDICAL CENTER (X4) ID PREFIX TAG 10/18/2019 NEWARK, NJ 07112 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A 144 Continued From page 20 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE A 144 brought into the Emergency Department by police for a psychiatric evaluation on 10/10/19 at 23:34 (PM). b. Past Medical History: Bipolar Disorder c. Screening Progress Note dated 10/11/19 at 07:00 AM, states, "... patient is discharged ... Mother will be here at 830 or 900am [sic]." d. Upon review of the Q15 Minute Flowsheet, it lacked evidence of a 15 minute check between 09:16 AM and 09:44 AM on 10/11/19 . 4. Review of Medical Record #30, on 10/17/19 at 11:30 AM indicated the following: a. The BH Behavioral Health Form, Psychiatric Screening form dated 10/9/19, at 03:17 (AM) states, Patient #30 was brought to Crisis by EMS (Emergency Medical Services) escorted by Newark Police, for exhibiting "erratic behavior" in the community. (i) The medical record did not further explain what the patient's erratic behavior was. b. The Presenting Problem Screening note: "The Patient is a 25 Year-old [sic] ... with a history significant for Polysubstance Abuse, Induced Psychotic Disorder,violent,and erratic behavior ... he became agitated,violent,urinating on the Floor,and banging at the windows ... He presents somewhat stranged [sic] ..." c. The Screening Progress Note dated 10/10/19 at 10:16 AM, states, "Patient has been aggressive in the Unit, requiring to be medicated twice [sic]." FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: CSPG11 Facility ID: NJ10709 If continuation sheet Page 21 of 73 PRINTED: 12/12/2019 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ (X3) DATE SURVEY COMPLETED C 310002 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE 201 LYONS AVE NEWARK BETH ISRAEL MEDICAL CENTER (X4) ID PREFIX TAG 10/18/2019 NEWARK, NJ 07112 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A 144 Continued From page 21 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE A 144 d. The Screening Progress Note dated 10/11/19 at 09:40 AM, states, 'it was reported patient went into the bathroom knowingly when a minor female patient was in the bathroom told her to be quiet and kissed her on the face." e. Review of the Q15 Minute Flowsheet for 10/11/19 lacked evidence of a 15 minute check between 09:16 AM and 09:44 AM. 5. On 10/17/19 at 1:08 PM, Staff #78 stated during an interview, that all Behavioral Health patients are on q15 minute checks by default. 6. Upon interview on 10/17/19 at 1:09 PM, Staff #78 stated the facility does not have a policy for the protection of minor patients from adult patients in the PESS unit. 7. Patient #29, a minor, was left unsupervised and unattended in a locked unit with an adult patient with known aggressive, violent, and erratic behavior, and a history of Psychotic Disorder. 8. On 10/17/19 at 2:01 PM, Staff #78 confirmed the above findings. A 147 PATIENT RIGHTS: CONFIDENTIALITY OF RECORDS CFR(s): 482.13(d)(1) A 147 The patient has the right to the confidentiality of his or her clinical records. This STANDARD is not met as evidenced by: Based on review of a published newspaper article, interviews, and review of facility policies FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: CSPG11 Facility ID: NJ10709 If continuation sheet Page 22 of 73 PRINTED: 12/12/2019 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ (X3) DATE SURVEY COMPLETED C 310002 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE 201 LYONS AVE NEWARK BETH ISRAEL MEDICAL CENTER (X4) ID PREFIX TAG 10/18/2019 NEWARK, NJ 07112 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A 147 Continued From page 22 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE A 147 and procedures, it was determined that the facility failed to ensure all staff maintain patients' rights to confidentiality of their clinical record and Protected Health Information (PHI). Reference #1: Facility Policy #: P-10, titled, PATIENT RIGHTS, states, "... POLICY: ... 2. Patient's rights are set forth by Federal and State regulatory agencies. All hospital staff adopts and promotes patient rights. Patient's Rights are as follows: ... Medical Records [bullet] To the confidentiality of your clinical record and protected health information. ..." Reference #2: Facility Policy #: H-11, titled, BASIC USES AND DISCLOSURES OF PATIENT INFORMATION, states, '... DEFINITIONS: "Protected Health Information" or "PHI" as used in all the Facility's I-IIPAA (sic) policies, is information, in any form or medium (including oral, written and electronic communications), that is created by the Facility, another healthcare provider or a health plan, and relates to an individual's physical or mental health (provision of payment for) and identifies, or could be reasonably expected to be used to identify, an individual. ... Examples of PHI include a patient's name, address, telephone number, diagnosis, date of birth, age over 90, and/or date of service as well as any and all other identifying information found in the patient's clinical and billing records. POLICY: Employees, volunteers and members of the Medical Staff of the Facility must maintain the confidentiality and privacy of patient information in accordance with the Health Information Portability and Accountability Act of 1996 ("HIPAA") ... In sum, HIPAA requires the Facility to adhere to certain rules, as set forth below. PROCEDURES: I. GENERAL RULES ... B. Other uses and FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: CSPG11 Facility ID: NJ10709 If continuation sheet Page 23 of 73 PRINTED: 12/12/2019 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ (X3) DATE SURVEY COMPLETED C 310002 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE 201 LYONS AVE NEWARK BETH ISRAEL MEDICAL CENTER (X4) ID PREFIX TAG 10/18/2019 NEWARK, NJ 07112 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A 147 Continued From page 23 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE A 147 disclosures of PHI. The Facility will not use or disclose PHI for purposes other than treatment, payment and health care operations, ..." Reference #3: Facility Policy #: M-14, titled, MEDICAL RECORDS CONFIDENTIALITY, SECURITY, AVAILABILITY AND RETENTION, states, "... PURPOSE: To ensure the confidentiality, security, availability and retention of medical records. ... The information contained in the medical record belongs to the patient, which entitles the patient to the protected right of information. All patient care information shall be regarded as confidential and available only to authorized users. ..." 1. A newspaper article published 10/3/19 by nj.com, found at https://www.nj.com/news/2019/10/nj-hospital-kept -patient-on-life-support-for-months-to-boost-its-su rvival-rates-investigation-reveals.html, identifies patients' Protected Health Information (PHI) within the content of the article, and references a recording of a meeting among surgeons, cardiologists, transplant coordinators, nurses, and social workers, in which patients at the facility were discussed. Per documentation in the article, "... This story is based on medical records, emails and text messages, and interviews with family members as well as eight current and former staff at Newark Beth Israel, who spoke on the condition of anonymity for fear of jeopardizing their jobs or future employment in the field. The recordings were corroborated by staff members present during those discussions and verified the identities of the speakers." a. Eight (8) facility staff members, as referenced in the above newspaper article, violated the FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: CSPG11 Facility ID: NJ10709 If continuation sheet Page 24 of 73 PRINTED: 12/12/2019 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ (X3) DATE SURVEY COMPLETED C 310002 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE 201 LYONS AVE NEWARK BETH ISRAEL MEDICAL CENTER (X4) ID PREFIX TAG 10/18/2019 NEWARK, NJ 07112 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A 147 Continued From page 24 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE A 147 patients' rights by not maintaining the confidentiality and privacy of patient information, and sharing the patients' PHI with the news reporter(s) for purposes other than treatment, payment and health care operations. b. On 10/17/19 at 1:07 P.M., during a telephone interview with Patient #5's family member, he/she stated he/she and his/her family have a transcript of the audio recording of the transplant team meeting, referred to in the above article, that was provided to them by the newspaper reporter. Reference #4: Facility Policy # Comp 12, titled, COMPLIANCE HELPLINE, states, "PURPOSE: To maintain a Compliance HelpLine (sic) Program which allows employees to report compliance and business ethics issues, questions, or concerns, to the Compliance Department and provides for investigation and resolution of such issues, questions or concerns. ... POLICY: --[facility's corporate system name]-- and its affiliates shall maintain 24-hour toll-free telephone line (Compliance HelpLine (sic) Program) enable individuals to make disclosures to the Compliance Department. Such disclosures may include any issues, questions or concerns identified by or associated with the Systems Code of conduct, policies and procedures, practices, ... The Compliance HelpLine (sic) Program shall emphasize a non-retribution, non-retaliation policy and shall include a reporting mechanism for anonymous communications for which appropriate confidentiality shall be maintained. ..." Reference #5: Facility Policy #: E-2, titled, Ethics Consultation Service, states, "... POLICY: 1. The Bioethics Consultation service may be utilized 24 hours per day, 7 days per week, and 365 days FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: CSPG11 Facility ID: NJ10709 If continuation sheet Page 25 of 73 PRINTED: 12/12/2019 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ (X3) DATE SURVEY COMPLETED C 310002 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE 201 LYONS AVE NEWARK BETH ISRAEL MEDICAL CENTER (X4) ID PREFIX TAG 10/18/2019 NEWARK, NJ 07112 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A 147 Continued From page 25 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE A 147 per year. Consults may be requested by any member of the staff, the patient, or a family member or friend. Consults may be made anonymously. Common reasons for consultation include the following but this is by no means an exhaustive list: a. conflicts regarding end of life care... c. Professional just conduct ... PROCEDURE: 1. When an existing or potential ethical dilemma regarding patient care is identified by a health care team member, patient, family members, or caregiver, resolution should be first attempted by the interested parties. ... 2. If there is unsuccessful resolution of the dilemma among the interested parties, the initiator contacts the hospital operator for the on-call ethics consultant of the Ethics Consultation Service Team. Permission for an ethics consultation from any member of the health care team is not required. ..." Reference #6: Facility Policy #: C-26, titled, Code of Ethics, states, ... Procedure: ... VI. Resolution of Conflict or Ethical Issues: Hospital Staff should seek guidance from appropriate sources, within the organization when any type of ethical question or conflict arises. ... XI. Confidentiality: The Hospital recognizes the importance of maintaining patient and other business related information in a confidential manner. ..." 1. The Employee Complaint and Grievance process and meeting minutes were reviewed. The facility provided documentation of employee complaints from January 2018 to present, along with their resolutions. The facility followed their process for employee complaints. There was no evidence of reported concerns regarding the care of transplant patients within the Employee Complaint and Grievance meeting minutes. FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: CSPG11 Facility ID: NJ10709 If continuation sheet Page 26 of 73 PRINTED: 12/12/2019 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ (X3) DATE SURVEY COMPLETED C 310002 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE 201 LYONS AVE NEWARK BETH ISRAEL MEDICAL CENTER (X4) ID PREFIX TAG 10/18/2019 NEWARK, NJ 07112 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A 147 Continued From page 26 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE A 147 2. The Ethics Committee Meeting minutes were reviewed. There was no evidence of reported concerns regarding transplant patients within the ethics committee meeting minutes. 3. There was no evidence that any staff member sought guidance from sources within the organization with their concerns regarding the care and management of transplant patients post operatively, as per facility policies and procedures. a. Staff #2 confirmed the above during survey and during a telephone conversation on 11/14/19 at 3:00 P.M.. A 263 QAPI CFR(s): 482.21 A 263 The hospital must develop, implement and maintain an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement program. The hospital's governing body must ensure that the program reflects the complexity of the hospital's organization and services; involves all hospital departments and services (including those services furnished under contract or arrangement); and focuses on indicators related to improved health outcomes and the prevention and reduction of medical errors. The hospital must maintain and demonstrate evidence of its QAPI program for review by CMS. This CONDITION is not met as evidenced by: FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: CSPG11 Facility ID: NJ10709 If continuation sheet Page 27 of 73 PRINTED: 12/12/2019 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ (X3) DATE SURVEY COMPLETED C 310002 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE 201 LYONS AVE NEWARK BETH ISRAEL MEDICAL CENTER (X4) ID PREFIX TAG 10/18/2019 NEWARK, NJ 07112 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A 263 Continued From page 27 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE A 263 Based on observation, staff interviews, and review of facility documentation, it was determined that the facility failed to maintain a quality assessment and performance improvement program that accurately tracks adverse events to analyze their causes, implements preventative actions, and implements polices and procedures for the maintenance of medical equipment. Findings include: 1. The facility failed to ensure it accurately documents its adverse patient events, to ensure tracking and analysis for its Quality Assessment and Performance Improvement activities. (Cross refer to Tag 286, Part A.) 2. The facility failed to ensure that its adverse event analysis is used to effect changes and prevent repeat incidents. (Cross refer to Tag 286, Part B.) 3. The facility's governing body failed to ensure that the recommendations and monitoring for adverse events in the heart and lung transplant programs were implemented and maintained. (Cross refer to Tag 309, Part A.) 4. The facility's governing body failed to ensure the implementation of policies and procedures that address the oversight required for the maintenance of medical equipment. (Cross refer to Tag 309, Part B.) A 286 PATIENT SAFETY CFR(s): 482.21(a), (c)(2), (e)(3) A 286 (a) Standard: Program Scope FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: CSPG11 Facility ID: NJ10709 If continuation sheet Page 28 of 73 PRINTED: 12/12/2019 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ (X3) DATE SURVEY COMPLETED C 310002 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE 201 LYONS AVE NEWARK BETH ISRAEL MEDICAL CENTER (X4) ID PREFIX TAG 10/18/2019 NEWARK, NJ 07112 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A 286 Continued From page 28 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE A 286 (1) The program must include, but not be limited to, an ongoing program that shows measurable improvement in indicators for which there is evidence that it will ... identify and reduce medical errors. (2) The hospital must measure, analyze, and track ...adverse patient events ... (c) Program Activities ..... (2) Performance improvement activities must track medical errors and adverse patient events, analyze their causes, and implement preventive actions and mechanisms that include feedback and learning throughout the hospital. (e) Executive Responsibilities, The hospital's governing body (or organized group or individual who assumes full legal authority and responsibility for operations of the hospital), medical staff, and administrative officials are responsible and accountable for ensuring the following: ... (3) That clear expectations for safety are established. This STANDARD is not met as evidenced by: A. Based on staff interview and document review, it was determined that the facility failed to ensure it accurately documents its adverse patient events to ensure tracking and analysis for its Quality Assessment and Performance Improvement activities. Findings include: Reference: Facility document titled, Performance Improvement Plan, states, "...V. Program Goals ...2. Transform data into useable information that identifies process stability or predictability in relationship to performance expectations...". FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: CSPG11 Facility ID: NJ10709 If continuation sheet Page 29 of 73 PRINTED: 12/12/2019 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ (X3) DATE SURVEY COMPLETED C 310002 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE 201 LYONS AVE NEWARK BETH ISRAEL MEDICAL CENTER (X4) ID PREFIX TAG 10/18/2019 NEWARK, NJ 07112 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A 286 Continued From page 29 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE A 286 1. A review of the "Adverse Event Log - Lung Transplant Program 2018" revealed the following documentation inaccuracies: a. Adverse event #12 indicated the outcome of the event was renal failure due to hypotension during surgery. Adverse event #12 had a medical record number that did not identify a transplant patient. (i) Staff #2 confirmed that the medical record number was incorrect. b. Staff #2 could not identify which patient correlated to adverse event #12, but thought it may be for Patient #11. This surveyor was unable to confirm which patient was reflected in adverse event #12. 2. A review of the "Adverse Event Log - Lung Transplant Program 2019" revealed the following documentation inaccuracies: a. Adverse event #1 indicated a transplant date of 12/15/19. (i) Staff #2 confirmed that the transplant date was incorrect and should have been written as 12/15/18. b. Adverse event #2 indicated a transplant date of 7/3/1905 (i) Staff #2 confirmed that the transplant date was incorrect. c. Adverse event #8 indicated that the outcome of the event was mortality. FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: CSPG11 Facility ID: NJ10709 If continuation sheet Page 30 of 73 PRINTED: 12/12/2019 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ (X3) DATE SURVEY COMPLETED C 310002 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE 201 LYONS AVE NEWARK BETH ISRAEL MEDICAL CENTER (X4) ID PREFIX TAG 10/18/2019 NEWARK, NJ 07112 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A 286 Continued From page 30 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE A 286 (i) The medical record number that was documented as adverse event #8, was for a patient that was currently in the hospital. (ii) Staff #2 confirmed that the medical record number was incorrect for adverse event #8. (iii) Staff #2 could not identify the patient that correlated to adverse event #8. B. Based on staff interview and document review, it was determined that the facility failed to ensure that its adverse event analysis of the Heart and Lung Transplant adverse event log is used to effect changes and prevent repeat incidents. This lack of action resulted in an Immediate Jeopardy for patients. Findings include: Reference: Facility document titled, Performance Improvement Plan, states, "... II. Organization-wide Methodology... PLAN the improvement ... Do the improvement ... CHECK the results ... Helpful Tools/Techniques: examine process, Monitoring processes, communication flow, policies and procedures, competency and educational needs ... ACT to hold the gain (initiate action permanently). Prevent the problem and its root causes from recurring. Implement policies, practice changes, education ..." 1. A review of the "Adverse Event Log - Lung Transplant Program 2019" revealed that Patient #12 was identified as having an adverse event regarding equipment malfunction during a transplant that took place on 12/15/2019. a. The documented outcome of the review FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: CSPG11 Facility ID: NJ10709 If continuation sheet Page 31 of 73 PRINTED: 12/12/2019 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ (X3) DATE SURVEY COMPLETED C 310002 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE 201 LYONS AVE NEWARK BETH ISRAEL MEDICAL CENTER (X4) ID PREFIX TAG 10/18/2019 NEWARK, NJ 07112 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A 286 Continued From page 31 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE A 286 indicated "Recommendation to use primed CBP (cardiopulmonary bypass) machine in the event of ECMO (extracorporeal membrane oxygenation) issues going forward. Perfusionists will be informed." (i) The facility was unable to provide evidence of education that took place with the perfussionists, regarding the proposed recommendation for the adverse event of Patient #12. (ii) There were two other identified issues with ECMO equipment, contributing to patient adverse events. Adverse event #4 and adverse event #7, occurred after Patient #12's occurrence. (iii) An interview on 10/11/19 with Staff #20, a perfusionist, revealed that adverse event identifiers and recommendations may or may not be relayed to the perfusionists. Staff #20 indicated that there were not regularly scheduled meetings to discuss cases, and not everyone attends when there are meetings. 2. The "Adverse Event Log - Heart Transplant Program 2018" indicated, for adverse event #1, a transplant procedure that took place on 1/17/18. The outcome was "...Recommendation from the team: Have a 2nd (second) surgeon available for difficult and prolonged cases....."; This adverse event resulted in mortality for the patient. The "Adverse Event Log - Heart Transplant Program 2018" indicated for the adverse event #8, a transplant procedure that took place on 5/2/18, the outcome was "...Plan to encourage transplant physicians to ask and offer assistance for difficult and lengthy cases....." a. The facility was unable to provide evidence of FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: CSPG11 Facility ID: NJ10709 If continuation sheet Page 32 of 73 PRINTED: 12/12/2019 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ (X3) DATE SURVEY COMPLETED C 310002 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE 201 LYONS AVE NEWARK BETH ISRAEL MEDICAL CENTER (X4) ID PREFIX TAG 10/18/2019 NEWARK, NJ 07112 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A 286 Continued From page 32 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE A 286 physician education or monitoring for the above adverse events. 3. The "Adverse Event Log - Heart Transplant Program 2018" was reviewed, and the following was identified: a. Adverse event #4, a transplant procedure that took place on 3/12/18, that resulted in a neurological deficit, the outcome recommendation was "...Plan to review transducer level placement with correlation to cuff blood pressure for accuracy....." (i) The facility was unable to provide evidence of the review and monitoring of the transducer level placement and blood pressure cuff correlation. b. Adverse event #3, a transplant procedure that took place on 4/5/18, that resulted in a severe neurological deficit, the outcome recommendation was "...Plan to review transducer level placement with correlation to cuff blood pressure for accuracy....." (i) Adverse event #3 took place twenty-four (24) days after adverse event #4, and had the same outcome recommendations. (ii) The facility was unable to provide evidence of the review and monitoring of the transducer level placement and blood pressure cuff correlation. c. The above findings were confirmed with Staff #21 and Staff #22. 4. The "Adverse Event Log - Heart Transplant Program 2018" and the "Adverse Event Log Lung Transplant Program 2018" were reviewed FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: CSPG11 Facility ID: NJ10709 If continuation sheet Page 33 of 73 PRINTED: 12/12/2019 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ (X3) DATE SURVEY COMPLETED C 310002 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE 201 LYONS AVE NEWARK BETH ISRAEL MEDICAL CENTER (X4) ID PREFIX TAG 10/18/2019 NEWARK, NJ 07112 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A 286 Continued From page 33 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE A 286 and the following was identified: a. Adverse event #20, on the heart transplant log, was a transplant procedure that took place on 8/19/18 that resulted in renal failure requiring hemodialysis. The outcome and recommendation was "...Opportunity for improvement regarding the frequency of blood pressure documentation the OR (operating room). It is unknown whether the patient had periods of hypotension... Continuous monitoring equipment acquisition... perfusion to document BPs (blood pressures) every 15 min (minutes) vs (versus) every 30 min - Surgeon to pause when patient placed on bypass to assess adequate BP." (i) The facility was unable to provide evidence of education to physicians and perfusionists, as well as monitoring for the above recommendations. b. Adverse event #22, on the heart transplant log, was a transplant procedure that took place on 9/21/18, thirty-three (33) days after the heart transplant adverse event #20, that resulted in altered mental status and a return to the OR. The outcome and recommendation was "...Opportunities for improvement were suggested regarding the intraop [sic] management, specifically of blood pressure..." Recommendations that were documented on the "Cardiothoracic Surgery Adverse Event Multidisciplinary Meeting" minutes from 10/19/18 indicated "...Increase the frequency of blood pressure monitoring and documentation in the OR....." (i) The facility was unable to provide evidence of education or monitoring of the above recommendations. FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: CSPG11 Facility ID: NJ10709 If continuation sheet Page 34 of 73 PRINTED: 12/12/2019 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ (X3) DATE SURVEY COMPLETED C 310002 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE 201 LYONS AVE NEWARK BETH ISRAEL MEDICAL CENTER (X4) ID PREFIX TAG 10/18/2019 NEWARK, NJ 07112 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A 286 Continued From page 34 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE A 286 c. Adverse event #12, on the lung transplant log, was a transplant procedure that took place on 10/10/18 that resulted in renal failure requiring hemodialysis "...likely due to hypotension in OR....." The recommendation and monitoring as per the "Lung Transplant Program Adverse Event Multidisciplinary Meeting" minute from 11/27/18 was to "monitor for future occurrences." (i) The facility was unable to provide evidence of education or monitoring of the above recommendations. 5. Upon review of the Medical Record #11, the "Operative Report" written by Physician #25 noted, "...It was seen that that the donor lung was oversized. For this reason an atypical wedge resection was carried out... the middel [sic] lobe was partially resected as well as the upper lobe. The procedure was continued with a left sided lung transplant. This was carreid [sic]out by [Physician #73] in the same technique....." a. A review of the Lung Transplant Program "Adverse Event Multidisciplinary Meeting" that took place on 11/27/18, identified adverse events that took place during the transplant process for Patient #11. The "Recommendations/Action" noted that the "Multidisciplinary team discussed the case at length," and the "Monitor/Follow-Up" was to "Monitor for future occurrences." (i) The Lung Transplant Program "Adverse Event Multidisciplinary Meeting" minutes lacked evidence of the mismatched donor lung size and resulting intra-operative resections. 6. An interview with Staff #21 and Staff #22 FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: CSPG11 Facility ID: NJ10709 If continuation sheet Page 35 of 73 PRINTED: 12/12/2019 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ (X3) DATE SURVEY COMPLETED C 310002 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE 201 LYONS AVE NEWARK BETH ISRAEL MEDICAL CENTER (X4) ID PREFIX TAG 10/18/2019 NEWARK, NJ 07112 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A 286 Continued From page 35 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE A 286 revealed that there was no documented evidence to support the tracking and monitoring of the above adverse events to prevent reoccurrences. 7. The facility was notified of the IJ on December 12, 2019 at 2:34 PM. A 309 QAPI EXECUTIVE RESPONSIBILITIES CFR(s): 482.21(e)(1), (e)(2), (e)(5) A 309 The hospital's governing body (or organized group or individual who assumes full legal authority and responsibility for operations of the hospital), medical staff, and administrative officials are responsible and accountable for ensuring the following: 1) That an ongoing program for quality improvement and patient safety, including the reduction of medical errors, is defined, implemented, and maintained . (2) That the hospital-wide quality assessment and performance improvement efforts address priorities for improved quality of care and patient safety and that all improvement actions are evaluated. (5) That the determination of the number of distinct improvement projects is conducted annually. This STANDARD is not met as evidenced by: A. Based on document review and staff interview, it was determined that the facility's governing body failed to ensure that the recommendations and monitoring for adverse events in the heart and lung transplant programs were implemented and maintained. FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: CSPG11 Facility ID: NJ10709 If continuation sheet Page 36 of 73 PRINTED: 12/12/2019 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ (X3) DATE SURVEY COMPLETED C 310002 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE 201 LYONS AVE NEWARK BETH ISRAEL MEDICAL CENTER (X4) ID PREFIX TAG 10/18/2019 NEWARK, NJ 07112 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A 309 Continued From page 36 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE A 309 Findings include: Reference: Facility document titled, Performance Improvement Plan, states, "... II. Organization-wide Methodology... PLAN the improvement ... Do the improvement ... CHECK the results ... Helpful Tools/Techniques: examine process, Monitoring processes, communication flow, policies and procedures, competency and educational needs ... ACT to hold the gain (initiate action permanently). Prevent the problem and its root causes from recurring. Implement policies, practice changes, education ..." 1. A review of the "Adverse Event Log - Lung Transplant Program 2019" revealed that Patient #12 was identified as having an adverse event of equipment failure during the transplant procedure that took place on "12/15/2019" [sic]. a. Outcome review of the incident on the adverse event log indicated "...no harm to the patient, near miss event...". The recommendation following the review was to "... use primed CBP (cardiopulmonary bypass) machine in the event of ECMO (extracorporeal membrane oxygenation) issues going forward. Perfusionists will be informed." (i) The facility was unable to provide evidence of education that took place with the perfusionists, regarding the proposed recommendation for the adverse event of Patient #12. (ii) There were two other identified issues with ECMO equipment, contributing to patient adverse events, that occurred after Patient #12's incident. Adverse event #4 resulted in patient neurological FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: CSPG11 Facility ID: NJ10709 If continuation sheet Page 37 of 73 PRINTED: 12/12/2019 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ (X3) DATE SURVEY COMPLETED C 310002 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE 201 LYONS AVE NEWARK BETH ISRAEL MEDICAL CENTER (X4) ID PREFIX TAG 10/18/2019 NEWARK, NJ 07112 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A 309 Continued From page 37 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE A 309 compromise, and adverse event #7 in which the patient was identified as high risk due to comorbidities, and expired in the operating room. (iii) An interview on 10/11/19 with Staff #20, a perfusionist, revealed that adverse event identifiers and recommendations may or may not be relayed to the perfusionists. Staff #20 indicated that there were not regularly scheduled meetings to discuss cases, and not everyone attends when there are meetings. 2. The "Adverse Event Log - Heart Transplant Program 2018" indicated, for adverse event #1, a transplant procedure that took place on 1/17/18. The outcome was "...Recommendation from the team: Have a 2nd (second) surgeon available for difficult and prolonged cases....."; This adverse event resulted in mortality for the patient. The "Adverse Event Log - Heart Transplant Program 2018" indicated for the adverse event #8, a transplant procedure that took place on 5/2/18, the outcome was "...Plan to encourage transplant physicians to ask and offer assistance for difficult and lengthy cases....." a. The facility was unable to provide evidence of physician education or monitoring for the above adverse events. 3. The "Adverse Event Log - Heart Transplant Program 2018" was reviewed, and the following was identified: a. Adverse event #4, a transplant procedure that took place on 3/12/18, that resulted in a neurological deficit, the outcome recommendation was "...Plan to review transducer level placement with correlation to cuff FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: CSPG11 Facility ID: NJ10709 If continuation sheet Page 38 of 73 PRINTED: 12/12/2019 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ (X3) DATE SURVEY COMPLETED C 310002 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE 201 LYONS AVE NEWARK BETH ISRAEL MEDICAL CENTER (X4) ID PREFIX TAG 10/18/2019 NEWARK, NJ 07112 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A 309 Continued From page 38 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE A 309 blood pressure for accuracy....." (i) The facility was unable to provide evidence of the review and monitoring of the transducer level placement and blood pressure cuff correlation. b. Adverse event #3, a transplant procedure that took place on 4/5/18, that resulted in a severe neurological deficit, the outcome recommendation was "...Plan to review transducer level placement with correlation to cuff blood pressure for accuracy....." (i) Adverse event #3 took place twenty-four (24) days after adverse event #4, and had the same outcome recommendations. (ii) The facility was unable to provide evidence of the review and monitoring of the transducer level placement and blood pressure cuff correlation. c. The above findings were confirmed with Staff #21 and Staff #22. 4. The "Adverse Event Log - Heart Transplant Program 2018" and the "Adverse Event Log Lung Transplant Program 2018" were reviewed and the following was identified: a. Adverse event #20, on the heart transplant log, was a transplant procedure that took place on 8/19/18 that resulted in renal failure requiring hemodialysis. The outcome and recommendation was "...Opportunity for improvement regarding the frequency of blood pressure documentation the OR (operating room). It is unknown whether the patient had periods of hypotension... Continuous monitoring equipment acquisition... perfusion to document BPs (blood pressures) every 15 min FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: CSPG11 Facility ID: NJ10709 If continuation sheet Page 39 of 73 PRINTED: 12/12/2019 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ (X3) DATE SURVEY COMPLETED C 310002 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE 201 LYONS AVE NEWARK BETH ISRAEL MEDICAL CENTER (X4) ID PREFIX TAG 10/18/2019 NEWARK, NJ 07112 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A 309 Continued From page 39 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE A 309 (minutes) vs (versus) every 30 min - Surgeon to pause when patient placed on bypass to assess adequate BP." (i) The facility was unable to provide evidence of education to physicians and perfusionists, as well as monitoring for the above recommendations. b. Adverse event #22, on the heart transplant log, was a transplant procedure that took place on 9/21/18, thirty-three (33) days after the heart transplant adverse event #20, that resulted in altered mental status and a return to the OR. The outcome and recommendation was "...Opportunities for improvement were suggested regarding the intraop [sic] management, specifically of blood pressure..." Recommendations that were documented on the "Cardiothoracic Surgery Adverse Event Multidisciplinary Meeting" minutes from 10/19/18 indicated "...Increase the frequency of blood pressure monitoring and documentation in the OR....." (i) The facility was unable to provide evidence of education or monitoring of the above recommendations. c. Adverse event #12, on the lung transplant log, was a transplant procedure that took place on 10/10/18 that resulted in renal failure requiring hemodialysis "...likely due to hypotension in OR....." The recommendation and monitoring as per the "Lung Transplant Program Adverse Event Multidisciplinary Meeting" minute from 11/27/18 was to "monitor for future occurrences." (i) The facility was unable to provide evidence of education or monitoring of the above FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: CSPG11 Facility ID: NJ10709 If continuation sheet Page 40 of 73 PRINTED: 12/12/2019 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ (X3) DATE SURVEY COMPLETED C 310002 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE 201 LYONS AVE NEWARK BETH ISRAEL MEDICAL CENTER (X4) ID PREFIX TAG 10/18/2019 NEWARK, NJ 07112 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A 309 Continued From page 40 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE A 309 recommendations. 5. Upon review of the Medical Record #11, the "Operative Report" written by Physician #25 noted, "...It was seen that that the donor lung was oversized. For this reason an atypical wedge resection was carried out... the middel [sic] lobe was partially resected as well as the upper lobe. The procedure was continued with a left sided lung transplant. This was carreid [sic]out by [Physician #73] in the same technique....." a. A review of the Lung Transplant Program "Adverse Event Multidisciplinary Meeting" that took place on 11/27/18, identified adverse events that took place during the transplant process for Patient #11. The "Recommendations/Action" noted that the "Multidisciplinary team discussed the case at length," and the "Monitor/Follow-Up" was to "Monitor for future occurrences." (i) The Lung Transplant Program "Adverse Event Multidisciplinary Meeting" minutes lacked evidence of the mismatched donor lung size and resulting intra-operative resections. 6. An interview with Staff #21 and Staff #22 revealed that there was no documented evidence to support the tracking and monitoring of the above adverse events to prevent reoccurrences. B. Based on document review and staff interview, it was determined that the facility's governing body failed to ensure the implementation of policies and procedures that address the oversight required for the maintenance of medical equipment. Findings include: FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: CSPG11 Facility ID: NJ10709 If continuation sheet Page 41 of 73 PRINTED: 12/12/2019 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ (X3) DATE SURVEY COMPLETED C 310002 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE 201 LYONS AVE NEWARK BETH ISRAEL MEDICAL CENTER (X4) ID PREFIX TAG 10/18/2019 NEWARK, NJ 07112 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A 309 Continued From page 41 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE A 309 Reference #1: Facility policy titled, Medical Equipment Management Plan 2019, states, "... The Board of Directors receives regular reports of the activities of the Medical Equipment Program from the Safety Committee...[The facility] maintains an inventory of all equipment. This inventory is kept in a Computerized Maintenance Management System (CMMS). The Hospital evaluates new types of equipment... to determine if they should be included in the inventory... The assignment of an Equipment Management Number (EM#) include assessment of the medical device's Function, Physical Risks associated with equipment during usage, Maintenance Requirements, and Incident History. The EM# is the sum of the individual point scores assigned below... Equipment Function:... 9-Surgical/ICU, 10-Life Support/ Life Saving, Maintenance: ... 3- Average (<=once year), 5-Extensive (> once year), Failure: ... 1-None or Minimal. 2- Significant, Risk: ... 5-Patient Death/Major Injury... A value of EM# 19 and higher are considered High Risk, all others are considered Non-High Risk and a possible candidate for the AEM (Alternative Equipment Maintenance Program) ... Certain pieces of equipment from some departments are part of the Medical Equipment Management Program but are not maintained by Clinical Engineering Support Services. To assure that proper inspections and maintenance is performed, Clinical Engineering Support Services periodically audits departments serviced by outside vendors ... The hospital identifies High-Risk medical equipment on the inventory for which there is a risk of serious injury or death to a patient or staff member should the equipment fail." FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: CSPG11 Facility ID: NJ10709 If continuation sheet Page 42 of 73 PRINTED: 12/12/2019 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ (X3) DATE SURVEY COMPLETED C 310002 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE 201 LYONS AVE NEWARK BETH ISRAEL MEDICAL CENTER (X4) ID PREFIX TAG 10/18/2019 NEWARK, NJ 07112 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A 309 Continued From page 42 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE A 309 1. On 10/17/19, review of the outside vendor's Safety Inspection Reports, indicated that one (1) out of six (6) LivaNova S5 Heart-Lung bypass machines was not maintained in accordance with the manufacturer's instructions for the time period between 4/22/19 and 9/10/19. 2. Upon interview on 10/17/19 at 4:30 PM, Staff #38 stated the following: a. The LivaNova S5 Heart-Lung bypass machines were not included in the hospital's Medical Equipment Monitoring Program because they were maintained by an outside vendor and are a part of the Alternative Equipment Maintenance Program (AEM). (i) As per facility policy (Reference #1), "Non-High Risk" medical equipment is a possible candidate for the AEM. (ii) Staff #38 confirmed that failure of the heart-lung bypass machine could result in serious injury or death to a patient. This does not meet the definition of "Non-High Risk" medical equipment in facility policy (Reference #1). b. Staff #38 confirmed that he/she received the inspection reports and stated he/she did not report the results of the inspection reports to the Safety Committee. c. There was no evidence the results of the inspection reports were included in the hospital's audits of medical equipment serviced by outside vendors, as per facility policy in reference #1. A 353 MEDICAL STAFF BYLAWS CFR(s): 482.22(c) FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: CSPG11 A 353 Facility ID: NJ10709 If continuation sheet Page 43 of 73 PRINTED: 12/12/2019 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ (X3) DATE SURVEY COMPLETED C 310002 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE 201 LYONS AVE NEWARK BETH ISRAEL MEDICAL CENTER (X4) ID PREFIX TAG 10/18/2019 NEWARK, NJ 07112 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A 353 Continued From page 43 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE A 353 The medical staff must adopt and enforce bylaws to carry out its responsibilities. The bylaws must: This STANDARD is not met as evidenced by: Based on medical record review, review of the facility's Medical Staff Bylaws Rules and Regulations, and staff interviews, it was determined that the facility failed to ensure that the medical staff carried out its responsibilities of accurate documentation, communicating with the patient's family regarding the condition of the patient, and completion of the informed surgical consent by the attending surgeon, as outlined in their bylaws. Findings include: Reference #1: Facility document titled, Medical Staff Bylaws [November 2017-2018], states, " ... ARTICLE III: MEDICAL STAFF MEMBERSHIP ... SECTION 3: RESPONSIBILITIES OF MEMBERSHIP ...I. To know, understand, and abide by these Bylaws and Rules and Regulations and the Bylaws of the Hospital, and rules and regulations and policies adopted by the Board of Trustees, their respective departments, divisions or specialty groups or any other authority within the Medical Center; ..." Reference #2: Facility document titled, Medical Staff Rules and Regulations [November 2017-2018], states, "GENERAL CONDUCT OF CARE A. Each patient's medical condition is the responsibility of a member of the Medical Staff defined as a doctor of medicine or a doctor of osteopathy ... K. ... 4. the attending surgeon or physician who performs the surgery has the obligation to provide the patient or legal guardian FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: CSPG11 Facility ID: NJ10709 If continuation sheet Page 44 of 73 PRINTED: 12/12/2019 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ (X3) DATE SURVEY COMPLETED C 310002 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE 201 LYONS AVE NEWARK BETH ISRAEL MEDICAL CENTER (X4) ID PREFIX TAG 10/18/2019 NEWARK, NJ 07112 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A 353 Continued From page 44 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE A 353 with risks, benefits, and alternatives or legal guardian's permission and signature on the consent form "Authorization for Blood and /or Blood Product Transfusion". ... ADMISSION AND DISCHARGE OF PATIENTS ... 3. A member of the Medical Staff shall be responsible for the medical care and treatment of each patient in the Medical Center, for prompt completeness and accuracy of the medical records, ... for communication and coordination among all practitioners involved and for transmitting reports of the condition of the patient to the referring practitioner and to the relatives of the patient. ... MEDICAL RECORDS The medical record contains sufficient information to identify the patient, support the diagnosis, justify the treatment, and document the course and results accurately. ... 4. INFORMED CONSENT Informed consent ensures that a patient received adequate information about the proposed treatment modality and alternatives. ... d. Appropriate consent form(s) should be signed by the patient before the therapeutic modality is carried out. It is the responsibility of the physician performing the procedure to obtain the necessary written consent before the modality is carried out. Only a physician, including House Staff, can obtain consent. ... 5. CLINICAL OBSERVATIONS ...Pertinent progress notes shall be recorded at the time of the observation sufficient to permit continuity of care and transferability. Wherever possible, each of the patient's clinical problems should be clearly identified in the progress notes and correlated with specific orders as well as results of tests and treatment. ... 7. REPORTS OF PROCEDURES, TESTS AND THEIR RESULTS. All diagnostic and therapeutic procedures are recorded and authenticated in the medical record. ... a. Operative Procedures ... 2. FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: CSPG11 Facility ID: NJ10709 If continuation sheet Page 45 of 73 PRINTED: 12/12/2019 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ (X3) DATE SURVEY COMPLETED C 310002 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE 201 LYONS AVE NEWARK BETH ISRAEL MEDICAL CENTER (X4) ID PREFIX TAG 10/18/2019 NEWARK, NJ 07112 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A 353 Continued From page 45 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE A 353 operative reports shall include a detailed account of the operation describing all gross findings or organs examined by visual or palpatory means and techniques of the operative procedure. ... a comprehensive operative progress note is entered in the medical record immediately after surgery to provide pertinent information for use by any individual who is required to attend to the patient; ..." 1. Patient #5, a sixty year old male, was admitted on 4/5/18 with heart failure, LVAD (left ventricular assist device) and presented to the facility for open heart transplant (OHT), after a donor was identified. a. Upon review of the medical record, the following inaccurate documentation was revealed: (i) The 4/5/18 "ADVANCED HEART FAILURE INITIAL EVALUATION" states, " ...58 year old male ...". The Patient was 60 years old. (ii) The 4/6/18 "Progress Note - Physician," at 2:11 AM, states, " ...58 year old male ...". The Patient was 60 years old. (iii) The 4/27/18 "Progress Note - Physician Endocrine f/u" states, " ...Patient is a 58 year old status post heart transplant on 4/6/18." The Patient was 60 years old and the heart transplant date was 4/5/18. (iv) The 5/5/18 "Progress Note - Physician Endocrine covg [coverage]" states, " ...Age 60 years ...Patient is a 58 year old status post heart transplant on 4/6/18. ..." The Patient was 60 years old and the heart transplant date was 4/5/18. FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: CSPG11 Facility ID: NJ10709 If continuation sheet Page 46 of 73 PRINTED: 12/12/2019 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ (X3) DATE SURVEY COMPLETED C 310002 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE 201 LYONS AVE NEWARK BETH ISRAEL MEDICAL CENTER (X4) ID PREFIX TAG 10/18/2019 NEWARK, NJ 07112 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A 353 Continued From page 46 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE A 353 b. Upon review of the medical record, the following conflicting documentation was revealed: (i) The 4/6/18 "Progress Note - Physician" at 5:16 AM, states, " ...Intubated, has not woken up yet ... Neurological: Alert, oriented to time, place, and person. No focal neurological deficit." c. Upon review of Medical Record #5, the following incomplete documentation was revealed: (i) The 4/6/18 "Operative Report" states, " ... DESCRIPTION OF OPERATION: ... the pulmonary pressure was /mm Hg, the arterial blood pressure was /mm Hg, the cardiac output was liters/minute and the cardiac index was liters/minute. d. Upon review of the postoperative medical record as noted below, there was a period of time with no evidence of communication with the Patient's family regarding his/her status, treatment and plan of care. (i) The 4/7/18 "Progress Note-Physician" states, " ... not neurologically appropriate at this time ... Gaze to the left and up (looking at the lesion?) Alternatively, [he/she] is just still sedated by all of the anesthesia and the shaking is waking [him/her] up. ... Not sure whether there is reason to be concerned or not yet ..." (ii) 4/8/18 "Consultation Note Neurology" states, " ... abnormal head CT ... EEG - non conclusive status epilepticus ... discussed results with multiple family members ..." FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: CSPG11 Facility ID: NJ10709 If continuation sheet Page 47 of 73 PRINTED: 12/12/2019 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ (X3) DATE SURVEY COMPLETED C 310002 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE 201 LYONS AVE NEWARK BETH ISRAEL MEDICAL CENTER (X4) ID PREFIX TAG 10/18/2019 NEWARK, NJ 07112 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A 353 Continued From page 47 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE A 353 (iii) 4/21/18 "Progress Note -Physician ...Neurology Follow -up" states, " ... had MRI of the brain. ... Opens eyes but not following command, not verbal ... not withdrawing to pain ... Course: MRI of the brain showed punctate strokes, likely septic emboli ... discussed with family. ..." (iv) Between the dates of 4/9/18 and 4/20/18, there was no documented evidence that the physicians communicated the patient status, treatment plans, and/or alternatives with the family. 2. Patient #10, a fifty three (53) year old female, was admitted on 12/17/17 with worsening heart failure, and status post heart transplant on 1/17/18. a. Upon review of the medical record, the following conflicting documentation was revealed: (i) The "Perioperative Hand Off Form" dated 1/16/18, (patient went in to the Operating Room (OR) on 1/16/18 and was out of OR on 1/17/18), under "UNUSUAL EVENTS: INTRA-OP/PRIOR TO PACU TRANSFER:," was not completed, and the "COMMENTS:," was not completed. There was no date and time of the transfer on the form. (ii) The "Postoperative Note"-"CARDIOTHORACIC SURGERY BRIEF POST-OPERATIVE NOTE" dated 1/17/18 at 2:20 PM" states, " ...Disposition: Transfer to CTICU intubated and in stable, but critical condition." (iii) The "POSTOPERATIVE ANESTHESIA NOTE" ON 1/17/18 at 2:32 PM states, " ...Comments: Pt [patient] unlikely to survive the FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: CSPG11 Facility ID: NJ10709 If continuation sheet Page 48 of 73 PRINTED: 12/12/2019 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ (X3) DATE SURVEY COMPLETED C 310002 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE 201 LYONS AVE NEWARK BETH ISRAEL MEDICAL CENTER (X4) ID PREFIX TAG 10/18/2019 NEWARK, NJ 07112 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A 353 Continued From page 48 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE A 353 night - profound bleeding unable to maintain flow even with massive transfusion." (iv) The Operative Report" dated 1/17/18 at 4:51 PM states, " ...The patient was returned to the Cardiothoracic Intensive Care Unit in stable condition. There were no complications ..." 3. The above findings were confirmed by phone on 11/6/19 with Staff #2 and Staff #59. 4. Upon review of Medical Record #6, the following was identified: a. A "Consent for Lung Transplant Procedures" was obtained by Physician #74 on 2/6/19 at 2:30 PM. b. A transplant report located in the medical record, dated for 2/6/19, identified Physician #25 as the surgeon, not Physician #74. (i) The transplant report lacked evidence that Physician #74 was involved in the procedure. 5. Upon review of Medical Record #17, the following was identified: a. A "Consent for Heart Transplant Procedures" was obtained by Physician #75 on 10/14/18 at 6:35 PM. b. A transplant report located in the medical record, dated for 10/14/18, identified Physician #27 as the surgeon, not Physician #75. (i) The transplant report lacked evidence that Physician #75 was involved in the procedure. FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: CSPG11 Facility ID: NJ10709 If continuation sheet Page 49 of 73 PRINTED: 12/12/2019 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ (X3) DATE SURVEY COMPLETED C 310002 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE 201 LYONS AVE NEWARK BETH ISRAEL MEDICAL CENTER (X4) ID PREFIX TAG 10/18/2019 NEWARK, NJ 07112 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A 820 Continued From page 49 A 820 IMPLEMENTATION OF A DISCHARGE PLAN CFR(s): 482.43(c)(3), (5) PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE A 820 A 820 (3) The hospital must arrange for the initial implementation of the patient's discharge plan. (5) As needed, the patient and family members or interested persons must be counseled to prepare them for post-hospital care. This STANDARD is not met as evidenced by: Based on medical record review, review of facility policy, and staff interview, it was determined that the facility failed to ensure discharge instructions are provided to all patients receiving a cardiac catheterization procedure. Findings include: Reference: Facility Policy #: P-5, titled Patient Discharge, approved 12-2015, revised 10/18 and 6/19 states, "Purpose: ... To ensure that patients receive an explanation of their medial condition (s) upon discharge. ... Procedure: ... Review discharge instructions with patient and/or designated caregiver and answer questions. Have patient and/or designated caregiver sign the discharge instructions. Obtain patient and/or designated caregiver's signature. Place copy on patient record. ..." 1. Review of Patient #4's outpatient visits, for a cardiac catheterization on 1/30/2017 and 12/26/2017, lacked evidence that discharge instructions were provided to him/her regarding the care needed, or adverse signs and symptoms to report post procedure. a. Staff #59 confirmed, via e-mail on 11/5/19 and via telephone on 11/6/19, that the facility was FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: CSPG11 Facility ID: NJ10709 If continuation sheet Page 50 of 73 PRINTED: 12/12/2019 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ (X3) DATE SURVEY COMPLETED C 310002 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE 201 LYONS AVE NEWARK BETH ISRAEL MEDICAL CENTER (X4) ID PREFIX TAG 10/18/2019 NEWARK, NJ 07112 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A 820 Continued From page 50 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE A 820 unable to locate any discharge instructions for Patient #4's 1/30/2017 outpatient visit. b. Staff #59 confirmed, via e-mail on 11/6/19, that he/she was unable to find evidence of discharge instructions post catheterization for the outpatient visit on 12/26/2017. 2. Review of Patient #4's outpatient visits, for a cardiac catheterization on 12/20/18 and 1/24/19, lacked evidence that discharge instructions were provided to the facility the patient was discharged to, regarding the care needed, or adverse signs and symptoms to report post procedure. A 940 SURGICAL SERVICES CFR(s): 482.51 A 940 If the hospital provides surgical services, the services must be well organized and provided in accordance with acceptable standards of practice. If outpatient surgical services are offered the services must be consistent in quality with inpatient care in accordance with the complexity of services offered. This CONDITION is not met as evidenced by: A. Based on observation, staff interview, and review of facility documents, it was determined that the facility failed to ensure perfusion equipment is maintained accordance with manufacturer's instructions, to review, develop, and implement policies and procedures for perfusion services and patient monitoring during surgery, and failed to adhere to their informed consent policy. Findings include: FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: CSPG11 Facility ID: NJ10709 If continuation sheet Page 51 of 73 PRINTED: 12/12/2019 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ (X3) DATE SURVEY COMPLETED C 310002 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE 201 LYONS AVE NEWARK BETH ISRAEL MEDICAL CENTER (X4) ID PREFIX TAG 10/18/2019 NEWARK, NJ 07112 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A 940 Continued From page 51 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE A 940 1. The facility failed to ensure perfusion equipment is maintained according to the manufacturer's instructions. (Cross refer to Tag 0940, part B.) 2. The facility failed to ensure the development and implementation of policies and procedures that address the documentation required on the perfusion record in accordance with acceptable standards of practice. (Cross refer to Tag 0951, part A.) 3. The facility failed to ensure that policies and procedures addressing Perfusion Services are reviewed in accordance with State laws. (Cross refer to Tag 0951, part B.). 4. The facility failed to ensure the development and implementation of policies and procedures that address the documentation of patient monitoring during surgical procedures in accordance with New Jersey state law. (Cross refer to Tag 0951, part C.) 5. The facility failed to adhere to their informed consent policy in sixteen (16) of twenty (20) Medical Records reviewed for consents. (Cross refer to Tag 0955) B. Based on document review and staff interview, it was determined that the facility failed to ensure perfusion equipment is maintained according to the manufacturer's instructions. Findings include: Reference #1: The manufacturer's instructions for the LivaNova S5 Heart-Lung Machine states, "...The maintenance check must be carried out FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: CSPG11 Facility ID: NJ10709 If continuation sheet Page 52 of 73 PRINTED: 12/12/2019 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ (X3) DATE SURVEY COMPLETED C 310002 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE 201 LYONS AVE NEWARK BETH ISRAEL MEDICAL CENTER (X4) ID PREFIX TAG 10/18/2019 NEWARK, NJ 07112 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A 940 Continued From page 52 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE A 940 on the S5 System every 1000 (one thousand) hours or every 12 (twelve) months (whichever comes first). The operating hours of the system are displayed in the System menu..." 1. On 10/11/19 at 10:55 AM, Staff #38 stated the facility scheduled preventative maintenance for the LivaNova S5 Heart-Lung Machine every 6 (six) months. a. Staff #38 did not indicate that the heart-lung bypass machines required preventative maintenance based on the number of hours the machine was in operation. 2. Review of the previous two (2) years of heart-lung bypass machine Technical Safety Inspection reports on 10/17/19, indicated the following: a. One (1) out of six (6) heart-lung bypass machines was not maintained in accordance with the manufacturer's instructions for the time period between 4/22/19 and 9/10/19. (i) A comparison of the Technical Safety Inspection Reports dated 4/22/19 and 9/10/19 indicated that the machine (serial number 48E00818) had 1,057 (one thousand fifty-seven) "system hours" of operation between Safety Inspections. (ii) Staff #38 confirmed that the "system hours" documented on each Inspection Report indicated the cumulative hours of operation for each machine. (iii) Staff #38 and Staff #2 confirmed this finding at the time of discovery. FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: CSPG11 Facility ID: NJ10709 If continuation sheet Page 53 of 73 PRINTED: 12/12/2019 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ (X3) DATE SURVEY COMPLETED C 310002 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE 201 LYONS AVE NEWARK BETH ISRAEL MEDICAL CENTER (X4) ID PREFIX TAG 10/18/2019 NEWARK, NJ 07112 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A 940 Continued From page 53 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE A 940 b. On 10/17/19, a comparison of consecutive LivaNova S5 Heart-Lung Machine Inspection Reports dated September 2018 and April 2019, indicated that 3 (three) out of 6 (six) machines (Serial numbers: 48E00829, 48E00818, and 48E00816) had zero (0) "system hours" of use during the 7 (seven) month time period. (i) Review of the "system hours" of usage for the remaining 3 (three) machines did not indicate an increase in the hours they were used in the same time period, September 2018 to April 2019. (ii) Upon interview on 10/17/19 at 4:30 PM, Staff #38 failed to provide a reason the Safety Inspection Reports for 3 (three) out of 6 (six) LivaNova S5 Heart-Lung Machines indicated zero (0) "system hours" of operation. Staff #38 indicated the machines were in use. (iii) Staff #38 stated that he/she did not look closely at the Technical Safety Reports and had not noticed that the "system hours" documented on the reports did not change over the 7 (seven) month time period. (iv) Staff #38 stated that he/she usually received a verbal report from the technician that inspected the LivaNova S5 Heart-Lung Machines. 3. Upon interview on 10/17/19 at 4:50 PM, Staff #38 confirmed that the "system hours" of each heart-lung machine, displayed on the System menu, are not reviewed on a regular basis to ensure preventative maintenance is completed in accordance with the manufacturer's instructions. A 951 OPERATING ROOM POLICIES FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: CSPG11 A 951 Facility ID: NJ10709 If continuation sheet Page 54 of 73 PRINTED: 12/12/2019 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ (X3) DATE SURVEY COMPLETED C 310002 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE 201 LYONS AVE NEWARK BETH ISRAEL MEDICAL CENTER (X4) ID PREFIX TAG 10/18/2019 NEWARK, NJ 07112 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A 951 Continued From page 54 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE A 951 CFR(s): 482.51(b) Surgical services must be consistent with needs and resources. Policies governing surgical care must be designed to assure the achievement and maintenance of high standards of medical practice and patient care. This STANDARD is not met as evidenced by: A. Based on medical record review, document review, and staff interviews, it was determined that the facility failed to ensure the development and implementation of policies and procedures that address the documentation required on the perfusion record, in accordance with the acceptable standards of practice by the American Society of Extracorporeal Technology (AmSECT) Standards and Guidelines for Perfusion Practice. Findings include: Reference #1: Facility Perfusion Services policy titled "Intraoperative Patient Evaluation and Data Collection" states, ".. The following information must be noted on the perfusion record... Accurate documentation of... medications added..." Reference #2: The facility "Medical Staff Rules and Regulations" states, "...I. The following policies and procedures are governing the safe administration of drugs... Drugs to be administered... b. each dose of medication administered is recorded properly in the patient's medical record..." 1. Medical record review on 10/17/19 revealed seven (7) out of seven (7) medical records (#4, #5, #7, #9, #10, #16 and #17), lacked documentation of the anesthetic gas FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: CSPG11 Facility ID: NJ10709 If continuation sheet Page 55 of 73 PRINTED: 12/12/2019 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ (X3) DATE SURVEY COMPLETED C 310002 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE 201 LYONS AVE NEWARK BETH ISRAEL MEDICAL CENTER (X4) ID PREFIX TAG 10/18/2019 NEWARK, NJ 07112 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A 951 Continued From page 55 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE A 951 administered during cardiopulmonary bypass. a. The perfusion records lacked documentation of the type, dosage, and time of administration of anesthetic gas during cardiopulmonary bypass. b. The anesthesia records, for the corresponding dates of service and time periods, lacked documentation of the type, dosage, and time of administration of anesthetic gas during cardiopulmonary bypass. 2. Staff #38 confirmed that the anesthetic gas is administered through the heart-lung bypass machine. 3. The above was confirmed by Staff #38 via e-mail, on 11/5/19. Reference #3: The "American Society of Extracorporeal Technology (AmSECT) Standards and Guidelines for Perfusion Practice" states, "... The perfusion record (written and/or electronic) for each cardiopulmonary bypass (CBP) procedure shall be included as part of the patient's permanent medical record... The record shall include:... Information sufficient to accurately describe the procedure, personnel, and equipment (Appendix B)... Appendix B... Equipment a) Heart Lung Machine b) Cell Salvage (autotransfusion) Device, c) Heater/Cooler [Note: Items a-c must be uniquely identified (e.g. Pump 1,2,3 etc.). The related serial numbers for each component (e.g. roller pumps, vaporizer, blender etc.) are documented and stored locally.]" 4. Staff #38 confirmed, via e-mail on 11/5/19, that the facility follows AmSECT Guidelines. FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: CSPG11 Facility ID: NJ10709 If continuation sheet Page 56 of 73 PRINTED: 12/12/2019 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ (X3) DATE SURVEY COMPLETED C 310002 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE 201 LYONS AVE NEWARK BETH ISRAEL MEDICAL CENTER (X4) ID PREFIX TAG 10/18/2019 NEWARK, NJ 07112 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A 951 Continued From page 56 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE A 951 5. The facility's Perfusion Services policy titled "Intraoperative Patient Evaluation and Data Collection," failed to include the need to document the equipment used for CBP, in accordance with acceptable standards of practice. 6. Review of the Perfusion Records Form, on 10/17/19, revealed that the form fails to include space for the documentation of equipment used for cardiopulmonary bypass. a. Staff #38 stated that the equipment used during a procedure was documented on the Perfusion Checklist form, which was not included in the permanent medical record. b. Upon review on 10/17/19, Staff #38 failed to provide documentation of the equipment used in two (2) out of nine (9) medical records (#6 and #16) reviewed. c. This finding was confirmed by Staff #38 on 10/17/19 at 4:45 PM. Reference #4: The "American Society of Extracorporeal Technology (AmSECT) Standards and Guidelines for Perfusion Practice" states, "... The Perfusionist shall use a checklist for each cardiopulmonary bypass (CBP) procedure... Checklists shall be included as part of the patient's permanent medical record..." 7. On 10/17/19, complete documentation of the perfusion activities in seven (7) out of seven (7) closed medical records (#4, #5, #7, #9, #10, #16 and #17), failed to include the Perfusion Checklist. FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: CSPG11 Facility ID: NJ10709 If continuation sheet Page 57 of 73 PRINTED: 12/12/2019 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ (X3) DATE SURVEY COMPLETED C 310002 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE 201 LYONS AVE NEWARK BETH ISRAEL MEDICAL CENTER (X4) ID PREFIX TAG 10/18/2019 NEWARK, NJ 07112 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A 951 Continued From page 57 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE A 951 a. On 10/17/19 at 4:30 PM, Staff #38 confirmed that the facility does not retain the Perfusionist Checklist as part of the patient's permanent medical record. B. Based on document review and staff interview, it was determined that the facility failed to ensure that policies and procedures addressing Perfusion Services are reviewed in accordance with State laws. Findings include: Reference: The New Jersey Administrative Code Title 8, Chapter 43G, Subchapter 34.3 (a) states, "...Surgery service shall have written policies and procedures that are reviewed at least every three years..." 1. On 10/15/19, review of facility policies and procedures addressing Perfusion Services, revealed the following: a. The "Approved by" date written on each policy was 2/1/2002. b. The facility name documented on the heading of each policy, was "Heart Hospital of New Jersey Department of Cardiothoracic Surgery Perfusion Services" for the policies with the following titles: i. "Hypothermic Cardiopulmonary Bypass." ii. "Intraoperative Patient Evaluation and Data Collection." iii. "Deep Hypothermic Circulatory Arrest (DHCA) and Retrograde Cerebral Perfusion (RCP)." FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: CSPG11 Facility ID: NJ10709 If continuation sheet Page 58 of 73 PRINTED: 12/12/2019 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ (X3) DATE SURVEY COMPLETED C 310002 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE 201 LYONS AVE NEWARK BETH ISRAEL MEDICAL CENTER (X4) ID PREFIX TAG 10/18/2019 NEWARK, NJ 07112 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A 951 Continued From page 58 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE A 951 2. On 10/15/19, Staff #2 provided a signature page that documented the most recent date of policy review, for the above policies, was October 21, 2005. a. The above policies have not been reviewed every three (3) years in accordance with NJ State regulation, as per the above reference. 3. On 10/15/19 at 2:36 PM, this finding was confirmed by Staff #2. C. Based on medical record review, document review, and staff interviews, it was determined that the facility failed to ensure the development and implementation of policies and procedures that address the documentation of patient monitoring for body temperature during surgical procedures, in accordance with New Jersey state law. Findings include: Reference #1: The New Jersey Administrative Code Title 8 Chapter 43 G Subchapter 6.8(c) states, "The body temperature of each patient under general or major regional anesthesia lasting 45 [forty-five] minutes or more shall be continuously monitored and recorded every 15 [fifteen] minutes." Reference #2: Facility policy titled, Anesthesia Safety Regulations, states, "...The body temperature of each patient under anesthesia shall be continuously monitored..." 1. The facility's policy titled, Anesthesia Safety Regulations, (Reference #2), failed to include the FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: CSPG11 Facility ID: NJ10709 If continuation sheet Page 59 of 73 PRINTED: 12/12/2019 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ (X3) DATE SURVEY COMPLETED C 310002 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE 201 LYONS AVE NEWARK BETH ISRAEL MEDICAL CENTER (X4) ID PREFIX TAG 10/18/2019 NEWARK, NJ 07112 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A 951 Continued From page 59 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE A 951 requirement to document the patient's body temperature every fifteen (15) minutes. 2. Review of Anesthesia Records on 10/15/19 revealed the following: a. Five (5) out of eight (8) Anesthesia Records (in Medical Records #4, #5, #6, #11, and #17), contained incomplete documentation of the patients' body temperature during general anesthesia lasting more than forty-five (45) minutes. i. The body temperature in Anesthesia Record #4, dated 9/21/18, is recorded once every thirty (30) to forty-five (45) minutes throughout the approximately ten (10) hour procedure. ii. The body temperature in Anesthesia Record #5, dated 4/5/18, is recorded once every fifteen minutes for one (1) and one-half (1/2) hours, then once every one (1) hour for two (2) hours throughout the approximately ten (10) hour procedure. The body temperature was not documented on the Anesthesia Record for the remaining duration of the procedure, approximately six (6) and one-half (1/2) hours. iii. The body temperature was not recorded on Anesthesia Record #6, dated 2/6/19, for approximately two (2) hours out of the seven (7) hour procedure. iv. The body temperature was recorded on Anesthesia Record #11, dated 10/10/18, once every forty-five (45) minutes to one (1) hour throughout the approximately ten (10) hour procedure. FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: CSPG11 Facility ID: NJ10709 If continuation sheet Page 60 of 73 PRINTED: 12/12/2019 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ (X3) DATE SURVEY COMPLETED C 310002 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE 201 LYONS AVE NEWARK BETH ISRAEL MEDICAL CENTER (X4) ID PREFIX TAG 10/18/2019 NEWARK, NJ 07112 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A 951 Continued From page 60 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE A 951 v. The body temperature was recorded on Anesthesia Record #17, dated 10/17/18, once every thirty (30) minutes throughout the approximately three (3) and one-half (1/2) hour procedure. b. These findings were confirmed by Staff #48 on 10/15/19 at 12:52 PM. c. On 10/15/19 at 12:45 PM, Staff #48 stated the patient's body temperature is continuously monitored and should be recorded on the Anesthesia Record every fifteen (15) minutes. 3. On 10/15/19, at 12:40 PM, Staff #48 stated that the perfusionist also records body temperature on the Perfusion Record. a. The corresponding Perfusion Records for Anesthesia Records #4, #5, #6, #11, and #17, failed to include documentation of the patients' body temperature every fifteen (15) minutes. The documented temperatures were recorded at irregular intervals greater than fifteen (15) minutes. b. This finding was confirmed by Staff #38 at the time of discovery. A 955 INFORMED CONSENT CFR(s): 482.51(b)(2) A 955 A properly executed informed consent form for the operation must be in the patient's chart before surgery, except in emergencies. This STANDARD is not met as evidenced by: Based on review of facility documents, and staff interviews, it was determined that the facility FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: CSPG11 Facility ID: NJ10709 If continuation sheet Page 61 of 73 PRINTED: 12/12/2019 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ (X3) DATE SURVEY COMPLETED C 310002 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE 201 LYONS AVE NEWARK BETH ISRAEL MEDICAL CENTER (X4) ID PREFIX TAG 10/18/2019 NEWARK, NJ 07112 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A 955 Continued From page 61 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE A 955 failed to adhere to their informed consent policy in sixteen (16) of twenty (20) medical records reviewed for consents (Medical Records #1, #2, #4, #5, #6, #7, #8, #9, #10, #11, #12, #13, #15, #17, #19, #20). Findings include: Reference #1: Facility Policy #:I-1, titled, Consent, Informed, states, " ... POLICY: ... 1. Prior to any Procedure, the Physician must obtain informed consent from the patient or Surrogate Decision Maker. For a consent to be valid, it must be the result of an informed decision making process. In addition, the Physician must provide the patient or Surrogate Decision Maker necessary information to enable him/her to evaluate a proposed Procedure before agreeing to it. ... 2. ...The discussion between the Physician and the patient or Surrogate Decision Maker as part of the informed consent process must include: a) A description of the patient's condition and proposed Procedure, including anesthesia to be used, and the nature and purpose of such to patient. b) Potential benefits of the proposed Procedure to the patient. c) Potential short and longer term risks, or side effects, including potential problems that might occur during recuperation. d) A description of the risks and benefits based on available clinical evidence ... e) Reasonable alternative methods of treatment, including relevant risks, benefits and side effects of the alternatives. f) The possible results of declining the recommended Procedure. g) Who will conduct the intervention and administer the anesthesia. ... II. INFORMED CONSENT: ... 4. A properly executed informed consent must contain at least the following: c) Name of the Procedure for which informed consent is being given; e) FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: CSPG11 Facility ID: NJ10709 If continuation sheet Page 62 of 73 PRINTED: 12/12/2019 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ (X3) DATE SURVEY COMPLETED C 310002 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE 201 LYONS AVE NEWARK BETH ISRAEL MEDICAL CENTER (X4) ID PREFIX TAG 10/18/2019 NEWARK, NJ 07112 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A 955 Continued From page 62 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE A 955 Statement that the Procedure, including the anticipated benefit, material risks, and alternative therapies, were explained to the patient or the patient's Surrogate Decision Maker prior to the Procedure; f) A description of the Procedure; g) Signature of patient or Surrogate Decision Maker (with relationship); h) Date and time the consent is obtained from patient or Surrogate Decision Maker; and i) Date, time and signature of the professional person witnessing the consent ... [bullet] The patient shall be notified if Physicians other than the operating practitioner, including but not limited to residents, may perform important tasks related to surgery in accordance with hospital policy. ...VIII. TELEPHONE OR FAX CONSENT OF SURROGATE DECISION MAKER: ... 2. The Physician should have a licensed clinical professionals (sic) (RN, NP, PA), to witness the informed consent discussion when given by telephone. The licensed staff members must listen to the phone conversation at the same time. ... 4. The informed consent of the Surrogate Decision Maker shall be recorded on the consent form and witnessed by both persons hearing the consent given. ... 5. It is not always possible that the physician discussion of informed consent with a Surrogate Decision maker is done in the presence of a nurse. In circumstances when the registered nurse does not hear the actual disclosure, two (2) licensed professional need to confirm with the physician that the discussion of informed consent took place. Both licensed professionals (one who must be an RN) need to sign the informed consent form indicating that they received such confirmation. ..." Reference #2: Facility Document titled, Medical Staff Rules and Regulations, states, "... MEDICAL RECORDS ... 4. INFORMED CONSENT ...d. ... It FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: CSPG11 Facility ID: NJ10709 If continuation sheet Page 63 of 73 PRINTED: 12/12/2019 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ (X3) DATE SURVEY COMPLETED C 310002 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE 201 LYONS AVE NEWARK BETH ISRAEL MEDICAL CENTER (X4) ID PREFIX TAG 10/18/2019 NEWARK, NJ 07112 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A 955 Continued From page 63 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE A 955 is the responsibility of the physician performing the procedure to obtain the necessary written consent before the modality is carried out. Only a physician, including House Staff, can obtain consent. ..." 1. Upon review of Medical Record #5, for date of admission 4/5/18, the following was revealed: a. The "Consent To Surgical Procedures" was obtained on 4/5/18. (i) The "Condition requiring treatment:" states, "explained to me that the following conditions appear to exist in my case:" was not completed. (ii) The "Proposed Procedures:" states, "I understand that the procedure(s) proposed for treating my condition is (are):" was not completed. (iii) The "Alternative Procedures:" states, "I understand that the alternative procedure(s) to the one(s) proposed including the following" was not completed. b. The "Anesthesia Consent" was obtained on 4/5/18. (i) The "Disclosure of Exceptions to Anesthesia (by patient or physician), if any, are" was not completed. 2. Upon review of Medical Record #10, the following was revealed: a. The "Consent To Surgical Procedures" was obtained for a lung transplant on 1/16/18. FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: CSPG11 Facility ID: NJ10709 If continuation sheet Page 64 of 73 PRINTED: 12/12/2019 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ (X3) DATE SURVEY COMPLETED C 310002 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE 201 LYONS AVE NEWARK BETH ISRAEL MEDICAL CENTER (X4) ID PREFIX TAG 10/18/2019 NEWARK, NJ 07112 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A 955 Continued From page 64 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE A 955 (i) The "Condition requiring treatment:" states, "explained to me that the following conditions appear to exist in my case:" was not completed. 3. Upon review of Medical Record #13, the following was revealed: a. The "Consent To Surgical Procedures" was obtained for a lung transplant and aortic valve replacement on 4/19/19. (i) The "Condition requiring treatment:" states, "explained to me that the following conditions appear to exist in my case:" was not completed. b. The "Consent For Administration Of Blood And Blood Products" was obtained on 4/19/19. (i) There was no physician signature on the consent. 4. Upon review of Medical Record #15, the following was revealed: a. The "Consent To Surgical Procedures" was obtained for a mediastinal exploration on 10/8/19. (i) There was no evidence of a anesthesia consent for the surgery as noted above. (ii) The above finding was confirmed with Staff #69. b. The "Consent To Surgical Procedures" was obtained for removal of the Heartmate 3 drive on 10/10/19. (i) The "Condition requiring treatment:" states, " Dr. [name of surgeon] explained to me that the FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: CSPG11 Facility ID: NJ10709 If continuation sheet Page 65 of 73 PRINTED: 12/12/2019 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ (X3) DATE SURVEY COMPLETED C 310002 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE 201 LYONS AVE NEWARK BETH ISRAEL MEDICAL CENTER (X4) ID PREFIX TAG 10/18/2019 NEWARK, NJ 07112 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A 955 Continued From page 65 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE A 955 following conditions appear to exist in my case." The "Statement of Physician:" was signed by an Advanced Practice Nurse (APN). c. The "Consent To Surgical Procedures" was obtained for a mediastinal exploration on 10/15/19. (i) The "Alternative Procedures:" states, "I understand that the alternative procedure(s) to the one(s) proposed including the following" was not completed. 5. Upon review of Medical Record #19, the following was revealed: a. The "Consent To Surgical Procedures" was obtained for a heart transplant on 10/15/19. (i) The "Condition requiring treatment:" states, "explained to me that the following conditions appear to exist in my case:" was not completed. 6. Upon review of Medical Record #20, the following was revealed: a. The "Consent To Surgical Procedures" was obtained for a lung transplant on 8/20/19. (i) The "Condition requiring treatment:" states, "explained to me that the following conditions appear to exist in my case:" was not completed. b. The "Consent To Surgical Procedures" was obtained for a tracheostomy on 8/29/19. (i) The "Condition requiring treatment:" states, "explained to me that the following conditions appear to exist in my case:" was not completed. FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: CSPG11 Facility ID: NJ10709 If continuation sheet Page 66 of 73 PRINTED: 12/12/2019 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ (X3) DATE SURVEY COMPLETED C 310002 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE 201 LYONS AVE NEWARK BETH ISRAEL MEDICAL CENTER (X4) ID PREFIX TAG 10/18/2019 NEWARK, NJ 07112 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A 955 Continued From page 66 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE A 955 c. The "Consent To Surgical Procedures" was obtained for a bronchoscopy on 9/5/19. (i) There was no evidence of the date and time the patient signed the consent. 7. The above findings were confirmed with Staff #59. 8. Upon review of Medical Record #2 on 10/10/19, the following was revealed: a. The "Consent To Surgical Procedures Flexible Bronchoscopy" was obtained on 9/22/19. (i) The "Condition requiring treatment:" states, "...explained to me that the following conditions appear to exist in my case:", was not completed. b. The "Consent To Surgical Procedures" was obtained for a percutaneous tracheostomy on 9/23/19. (i) The "Condition requiring treatment:" states, "...explained to me that the following conditions appear to exist in my case:", was not completed. c. The "Consent For Lung Transplant Surgical Procedures" was obtained on 10/1/19. (i) The "Condition requiring treatment:" states, "...explained to me that the following conditions appear to exist in my case:", was not completed. 9. Upon review of Medical Record #8 on 10/10/19, the following was revealed: a. The "Consent To Surgical Procedures" was FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: CSPG11 Facility ID: NJ10709 If continuation sheet Page 67 of 73 PRINTED: 12/12/2019 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ (X3) DATE SURVEY COMPLETED C 310002 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE 201 LYONS AVE NEWARK BETH ISRAEL MEDICAL CENTER (X4) ID PREFIX TAG 10/18/2019 NEWARK, NJ 07112 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A 955 Continued From page 67 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE A 955 obtained for a trialysis catheter on 10/3/19. (i) The "Condition requiring treatment:" states, "...explained to me that the following conditions appear to exist in my case:", was not completed. 10. Upon review of Medical Record #12 on 10/11/19, the following was revealed: a. The "Consent for Administration of Blood and Blood Products" was obtained on 9/30/19. (i) Section "1. ...recommended the following blood or blood product(s):", was not completed. b. The "Consent To Surgical Procedures" was obtained for a sternal wound washout on 10/11/19. (i) The "Condition requiring treatment:" states, "explained to me that the following conditions appear to exist in my case:" was not completed. c. An "Anesthesia Consent" was obtained on 10/19/19. (i) The "Alternative types of anesthesia are" was not completed. (ii) The "Disclosure of Exceptions to Anesthesia (by patient or physician), if any, are:" was not completed. 11. Upon review of Medical Record #11, the following was revealed: a. The "Consent to Surgical Procedures" was obtained by Physician #73 for a " B/L (bilateral) thoracotomy, double lung transplantation, and a FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: CSPG11 Facility ID: NJ10709 If continuation sheet Page 68 of 73 PRINTED: 12/12/2019 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ (X3) DATE SURVEY COMPLETED C 310002 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE 201 LYONS AVE NEWARK BETH ISRAEL MEDICAL CENTER (X4) ID PREFIX TAG 10/18/2019 NEWARK, NJ 07112 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A 955 Continued From page 68 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE A 955 re-exploration if bleeding" on 10/10/18 at 5:20 PM. (i) The "Condition requiring treatment:" states, "...explained to me that the following conditions appear to exist in my case:", was not completed. b. The "Consent For Lung Transplant Surgical Procedures" was obtained by Physician #25 on 10/10/18 at 7:20 PM for "Lung Transplant (take out diseased lungs and replace with donor lungs), possible extracorporeal membrane oxygenation (ECMO), possible tracheostomy." (i) The "Condition requiring treatment:" states, "...explained to me that the following conditions appear to exist in my case:", was not completed. c. An "Anesthesia Consent" was obtained on 10/10/18 at 5:20 PM. (i) The "benefits of proposed anesthesia are:" was not completed. (ii) The "alternative types of anesthesia are:" was not completed. (iii) "Disclosure of Exceptions to Anesthesia (by patient or physician), if any, are" was not completed. d. The "Consent for Surgical Procedures" was obtained on 10/13/18. (i) The "Condition requiring treatment:" states, "...explained to me that the following conditions appear to exist in my case:", was not completed. 12. Upon review of Medical Record #7 on FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: CSPG11 Facility ID: NJ10709 If continuation sheet Page 69 of 73 PRINTED: 12/12/2019 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ (X3) DATE SURVEY COMPLETED C 310002 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE 201 LYONS AVE NEWARK BETH ISRAEL MEDICAL CENTER (X4) ID PREFIX TAG 10/18/2019 NEWARK, NJ 07112 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A 955 Continued From page 69 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE A 955 10/11/19, the following was revealed: a. The "Consent for Surgical Procedures - EGD," was obtained on 5/17/19. (i) The "Condition requiring treatment:" states, "...explained to me that the following conditions appear to exist in my case:", was not completed. (ii) The "Alternative Procedures:" was not completed. 13. Upon review of Medical Record #9, the following was revealed: a. The "Consent to Surgical Procedures" was obtained by Physician #27 for a Heart Transplant. (i) The "Condition requiring treatment:" states, "...explained to me that the following conditions appear to exist in my case:", was not completed. (ii) The "Alternative Procedures" states, "...the alternative procedure(s) to the one(s) proposed including the following:" was not completed. (iii) The "Consent" was signed by Patient #9 and witnessed on 3/12/18 at 6:24 PM. The "Statement of the Physician" which states, "I explained all the above, answered all questions to that patient's satisfaction and that person expressed full understanding of the treatment and the risks and effects associated therewith and consented thereto....." was signed, but not dated or timed. 14. Upon review of Medical Record #6, the following was revealed: a. The "Consent For Lung Transplant Surgical FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: CSPG11 Facility ID: NJ10709 If continuation sheet Page 70 of 73 PRINTED: 12/12/2019 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ (X3) DATE SURVEY COMPLETED C 310002 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE 201 LYONS AVE NEWARK BETH ISRAEL MEDICAL CENTER (X4) ID PREFIX TAG 10/18/2019 NEWARK, NJ 07112 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A 955 Continued From page 70 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE A 955 Procedures" was obtained on 2/6/19. (i) The "Condition requiring treatment:" states, "...explained to me that the following conditions appear to exist in my case:", was not completed. b. The "Consent To Surgical Procedures Flexible Bronchoscopy" was obtained on 2/6/19. (i) The "Condition requiring treatment:" states, "...explained to me that the following conditions appear to exist in my case:", was not completed. (ii) The "Alternative Procedures" states, "...the alternative procedure(s) to the one(s) proposed including the following:" was not completed. (iii) The "Consent" states "Having read this form and talked with my physician, my signature below acknowledges that I voluntarily give my authorization and consent to the performance of the procedure described by my physician and the following designated associates:" was not completed. (iv) The physicians involved in the procedure, as noted on the transplant surgical notes, were not indicated on the "Consent for Lung Transplant Surgical Procedures" form. 15. Upon review of Medical Record #17, the following was identified: a. A "Consent for Heart Transplant Surgical Procedures" was obtained on 10/14/18 at 6:35 PM by Physician #75 for Heart Transplant. (i) The "Consent" states "Having read this form and talked with my physician, my signature below FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: CSPG11 Facility ID: NJ10709 If continuation sheet Page 71 of 73 PRINTED: 12/12/2019 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ (X3) DATE SURVEY COMPLETED C 310002 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE 201 LYONS AVE NEWARK BETH ISRAEL MEDICAL CENTER (X4) ID PREFIX TAG 10/18/2019 NEWARK, NJ 07112 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A 955 Continued From page 71 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE A 955 acknowledges that I voluntarily give my authorization and consent to the performance of the procedure described by my physician and the following designated associates:" was not completed. (ii) The physicians involved in the procedure, as noted on the transplant surgical notes, were not indicated on the "Consent for Heart Transplant Surgical Procedures" form. b. A review of the transplant surgical notes lacked evidence that Physician #75 was part of the procedure for which he/she obtained consent. 16. Upon review of Medical Record #1 on 10/10/19, the following was revealed: a. Section #10 on the "Consent for Diagnostic Catheterization and Interventional Procedures," dated 9/27/19, was blank. An alternative to the procedure was not indicated. 17. Multiple medical records for Patient #4 were reviewed for inpatient admissions and outpatient visits. The following was evident: a. The patient had a right Heart Catheterization outpatient procedure on 1/30/17. Page 2 of the consent, that contains the area of patient signature for informed consent, was not evident in the medical record; therefore, it could not be determined if the patient gave his/her informed consent. Staff #59 confirmed via e-mail on 11/5/19 and via telephone on 11/6/19, that the facility was unable to locate page 2 of the informed consent. b. A telephone consent from the patient's FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: CSPG11 Facility ID: NJ10709 If continuation sheet Page 72 of 73 PRINTED: 12/12/2019 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ (X3) DATE SURVEY COMPLETED C 310002 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE 201 LYONS AVE NEWARK BETH ISRAEL MEDICAL CENTER (X4) ID PREFIX TAG 10/18/2019 NEWARK, NJ 07112 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A 955 Continued From page 72 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE A 955 Surrogate Decision Maker (SDM), dated 9/27/18, for a tracheotomy, lacked evidence of a second signature witnessing the telephone consent, as per facility policy. (i) Staff #59 confirmed during interview on 10/16/19 that there should be a second nurse signature for this consent. FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: CSPG11 Facility ID: NJ10709 If continuation sheet Page 73 of 73