Brooklyn Hospital Center - Downtown Campus

“QAPI CFR(s): 482.21 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: 48940 Based on medical record (MR) review, document review, and staff interview, the facility failed to (1) ensure that the General Surgery Department maintain a quality assessment and performance improvement program and (2) collect, analyze, and track patient outcomes to identify areas for improvement. (Patient #1) These failures place surgical patients at risk for serious adverse outcomes. Findings: Review of facility’s quality assessment and performance improvement program data revealed there is no evidence of quality meetings in the General Surgery Department. Review of the medical record (MR) for patient #1 identified a patient who was admitted for a gastric bypass surgery on 05/23/2023 and was discharged on 05/25/2023. On 05/30/2024 Staff A, surgeon note documented a call from the Medical Examiner that the patient was brought in for autopsy Monday. The Medical Examiner stated, they discovered peritonitis from the GJ (gastrojejunostomy tube) which was disrupted and food in the patient’s stomach. There was no documented evidence this call was reported for quality review and investigation. See Tag A 0309”

“DISCHARGE PLANNING CFR(s): 482.43 The hospital must have in effect a discharge planning process that focuses on the patient goals and treatment preferences and includes the patient and his or her caregivers support person(s) in the discharge planning for post-discharge care. The discharge planning process and the discharge plan must be consistent with the patient’s goals for care and his or her treatment preferences, ensure an effective transition of the patient from hospital to post-discharge care, and reduce the factors leading to a preventable hospital readmissions This Condition is not met as evidenced by: 37527 Based on medical record review, document review and interview, the facility failed to provide accurate, detailed discharge instructions for dietary and activity restrictions for patients who received bariatric surgery. Findings: The facility failed to ensure bariatric patients received detailed dietary and activity instructions at discharge. This failure was identified in eight (8) of 13 medical records reviewed. (Patient #s 1, 4, 5, 6, 7, 8, 10, and 13). See TAG A0802”

“QAPI EXECUTIVE RESPONSIBILITIES CFR(s): 482.21(e)(1), (e)(2), (e)(5) 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: 48940 Based on medical record (MR) review, document review, and staff interview, the facility failed to (1) ensure that the General Surgery Department maintain a quality assessment and performance improvement program and (2) investigate and analyze patient outcomes related to bariatric surgical procedures to identify areas of improvement for patient care and safety. (Patient #1) Findings: Review of the facility’s document titled, “Bylaws, Rules, and Regulations of the Professional Staff of The Brooklyn Hospital Center” dated September 9, 2021, the surgical department must hold “regularly scheduled monthly meetings to total no less than ten (10) per calendar year.” Additionally, the document states, “All clinical departments are responsible for designing, implementing, measuring, assessing, and improving patient care processes (quality and patient safety) in their respective areas. Each shall be responsible for corrective action and its documentation.” Review of the medical record for Patient #1 identified a 31-year-old patient was admitted for a laparoscopic sleeve conversion to gastric bypass surgery on 05/23/2023. The patient was discharged on 05/25/2023. On 05/30/2024 at 12:47 PM, Staff A, surgeon note documented in the outpatient medical record: “Additional Comments: Call from ME (Medical Examiner)-patient brought in for autopsy Monday. Medical Examiner called to tell me, they discovered peritonitis from the GJ which was disrupted and food in the stomach. He wanted to know if it was normal for patients to eat so soon after surgery. I responded NO, patients are on liquid only on discharge with protein shakes starting Tuesday, given the holiday. Received call from patient on Sunday 05/28/23 at 9:36 AM, Patient requesting more pain meds for gas pain. I told her she needs to first come to the ED to be evaluated.” Review of Bariatric Surgery post-operative quality indicators for January 2023 to December 2023 revealed one (1) mortality in May 2023. Per interview with Staff K, Vice President (VP) and Chief of Experience and Quality on 03/13/24 at 4:00 PM, they stated that this mortality was for the death of Patient #1. Review of the Morbidity and Mortality reports from May 2023 to August 2023, revealed no documented evidence that the death of Patient #1 was discussed, analyzed, or opportunities for improvement were identified and implemented. Review of Quality Council quarterly meeting minutes from May 2023 to December 2023, Quality and Patient Safety Committee quarterly meeting minutes from May to December 2023, Quality Council Meeting for Clinical Services biannual meeting minutes from May 2023 to December 2023, showed no documented evidence that the facility collected, reviewed, or investigated the death of Patient #1. During interview with Staff A, Chief of Surgery, on 03/07/24 at 11:38 AM, they indicated that they documented the phone call with the Medical Examiner in Patient #1’s medical record. Staff A stated that they requested the autopsy report from the Medical Examiner during the phone conversation but were told that only Patient #1’s family could view the report. Staff A indicated that quality improvement activities for the surgery department include Morbidity and Mortality (M&M) surgical case reviews that examine post-operative complications to identify if standard of care was met and room for improvement. Staff A stated that an M&M was not completed for Patient #1, because they personally reviewed the medical record, could not identify any issues, and did not receive the autopsy report. During interview with Staff K, VP of Quality and Chief Experience Officer on 03/07/24 at 3:10 PM, revealed that in the case of Patient #1’s death, the expectation would be for the surgeon to notify the Quality Department through incident reporting. The Quality Department would then collect and review the data to determine if standard of care was met. During interview with Staff M, Director of Quality Management, on 03/14/24 at 1:00 PM, they revealed that there is no evidence of quality meetings in the General Surgery Department prior to November 2023”

“SUPERVISION OF CONTRACT STAFF CFR(s): 482.23(b)(6) All licensed nurses who provide services in the hospital must adhere to the policies and procedures of the hospital. The director of nursing service must provide for the adequate supervision and evaluation of all nursing personnel which occur within the responsibility of the nursing service, regardless of the mechanism through which those personnel are providing services (that is, hospital employee, contract, lease, other agreement, or volunteer). This Standard is not met as evidenced by: 37527 Based on document review and interview, the hospital did not ensure nursing supervision of the Bariatric Coordinator who provides patient education to post-surgical Bariatric patients in the inpatient setting. Findings include: Review of Staff N, Bariatric Coordinator personnel file, they had a current license as a licensed professional nurse (LPN) by New York State. During interview with Staff A, Chief of Surgery, Head of Bariatric Surgery on 3/7/2024 at 11:38 AM, Staff A stated, though the position was categorized as non-clinical, Staff N coordinates the care for patients and provides education throughout their preoperative visits and in the hospital during the patient’s admission and prior to discharge. During interview with Staff N, Bariatric Coordinator, on 3/13/2024 at 11:39 AM, they explained that they go to the inpatient unit to see the patients as part of continuity of care. They provide education for the patient as well as provide contact information for the patients to have if needed after discharge. During interview with Staff A, Chief of Surgery, on 03/14/2024 at 10:38 AM, they stated: “The Bariatric Coordinator is a large touch point for the patients’ education wise, psychosocial wise ...reports directly to me.” During interview with Staff T, VP of Nursing Operations, on 3/14/2024 at 1:57 PM, they stated they did not provide oversight to Staff N, Bariatric Coordinator. Staff T indicated that the Chief Nursing Operator oversees all nurses in the inpatient setting. During interview on 03/14/2024 at 2:16 PM, Staff G, Nurse Manager on unit 8W post-surgical unit stated: “I don’t know if she is a nurse or a dietician ...No, no I do not supervise Staff N, just the nurses, the Patient Care Attendants (PCAs), and the secretary.” During interview with Staff V, Director of HR Operations, on 03/14/2024 at 3:44 PM, they confirmed Staff N’s lack of nursing supervision on inpatient units.”

“DISCHARGE PLANNING - PT RE-EVALUATION CFR(s): The hospital’s discharge planning process must require regular re-evaluation of the patient’s condition to identify changes that require modification of the discharge plan. The discharge plan must be updated, as needed, to reflect these changes This Standard is not met as evidenced by: 37527 Based on medical record review, document review and interview, the facility failed to provide accurate, detailed discharge instructions for dietary and activity restrictions for patients who received bariatric surgery. (Patient #s 1, 4, 5, 6, 7, 8, 10, and 13). Findings include: During interview with Staff N, Bariatric Coordinator on 03/13/2024 at 11:30 AM, regarding dietary information for bariatric surgical patients, she stated: “Dietary information to patients’ pre-surgery includes Stage 1 liquid diet for two (2) weeks; Stage 2 is soft diet for four (4) weeks and stage three (3) is regular diet.” On 03/13/2024 Staff M, Director of Quality Management provided surveyors with a folder containing loose leaf education material including: “The Brooklyn Hospital Center Keeping Brooklyn Safe; Frequently Asked Questions about Bariatric (Weight Loss) Surgery. Page one (1), Paragraph six (6) states: How long is the surgery, hospital stay, and recovery? Bariatric surgery can take from 45 mins to 2 hours. You will stay in the hospital the night after surgery and probably go home the following day. You will be on a liquid diet for a few weeks, then a soft diet for a few weeks while you heal. Most patients are back to normal activities within 2-4 weeks after surgery.” Review of the Medical Record (MR) for Patient #1 identified: A 31-year-old patient was admitted for a laparoscopic sleeve conversion to gastric bypass surgery on 05/23/2023. The patient was discharged on 05/25/2023. The discharge instructions stated: “a. Diet and Modifiers at Discharge: No Restrictions. b. Activity at Discharge: No Restrictions. c. Drink 3 ounces per hour on Post-op Day 2, drink 4 ounces per hour on Post-Op Day 3. Narcotics that are prescribed for pain can cause or worsen constipation so increase your fluid intake, eat high fiber foods (prunes/bran)...” On 05/30/2024 at 12:47 PM, Staff A, surgeon note documented in the outpatient medical record: “Additional Comments: Call from ME (Medical Examiner)-patient brought in for autopsy Monday. ME called to tell me, they discovered peritonitis from the GJ (gastrojejunostomy tube) which was disrupted and food in the stomach. He wanted to know if it was normal for patients to eat so soon after surgery. I responded NO, patients are on liquid only on discharge with protein shakes starting Tuesday, given the holiday. Received call from patient on Sunday 05/28/23 at 9:36 AM, Patient requesting more pain meds for gas pain. I told her she needs to first come to the ED to be evaluated.” There was no documented evidence in the MR that this patient who underwent gastric surgery, received dietary or activity instructions that were specific to her procedure. Patient #4: 52-year-old admitted on 05/24/2023 for sleeve gastrectomy. The patient was discharged on 05/24/2024. Discharge instructions stated: “a. Diet and Modifiers at Discharge: Clear Liquids. b. Activity at Discharge: No tub baths, may shower daily, progressively increase over the next month, limit to light, non-stressful activities. c. Drink 3 ounces per hour on Post-op Day 2, drink 4 ounces per hour on Post-Op Day 3.” d. Narcotics that are prescribed for pain can cause or worsen constipation so increase your fluid intake, eat high fiber foods (prunes/bran) ...” Similar dietary instruction was noted for Patient #5, who was admitted on 05/24/2023 or laparoscopic sleeve gastrectomy. The patient was discharged on 05/25/202. Patient #6 was a 36-year-old admitted for sleeve gastrectomy on 03/05/2024 and discharged on 03/06/2024. Discharge diet instructions stated: “a. Diet and Modifiers at Discharge: Bariatric Stage I Clear Liquid Diet (CLD). b. Activity at Discharge: Progressively increase over the next month. c. Drink 3 ounces per hour on Post-op Day 2, drink 4 ounces per hour on Post-Op Day 3. d. Narcotics that are prescribed for pain can cause or worsen constipation so increase your fluid intake, eat high fiber foods (prunes/bran) ...” Patient #7 was a 56-year-old admitted for a sleeve gastrectomy on 03/05/2024. The patient was discharged on 03/05/2024. The discharge instructions stated: “a. Diet and Modifiers at Discharge: Bariatric Stage I Clear Liquid Diet (CLD). b. Activity at Discharge: No restrictions, progressively increase over the next month.” Patient #8 was admitted on 05/24/2023 for a laparoscopic sleeve gastrectomy on 03/06/2024. Discharged on 03/07/2024. Discharge instructions stated: “a. Diet and Modifiers at Discharge: Bariatric Stage I Clear Liquid Diet. b. Activity at Discharge: Progressively increase over the next month. c. Drink 3 ounces per hour on Post-op Day 2, drink 4 ounces per hour on Post-Op Day 3. d. Narcotics that are prescribed for pain can cause or worsen constipation so increase your fluid intake, eat high fiber foods (prunes/bran) ...” Patient #10 was admitted on 03/12/2024 for sleeve gastrectomy and discharged on 03/13/2024. Discharge instructions stated: “a. Activity at Discharge: No restrictions, progressively increase over the next month. b. Narcotics that are prescribed for pain can cause or worsen constipation so increase your fluid intake, eat high fiber foods (prunes/bran) ... c. Drink 4 ounces of water per day.” Patient #13 was admitted on 03/12/2024 for a sleeve gastrectomy and discharged on 03/13/2024. Discharge instructions stated: “Activity at Discharge: No restrictions, progressively increase over the next month. Narcotics that are prescribed for pain can cause or worsen constipation so increase your fluid intake, eat high fiber foods (prunes/bran) ...” There was no documented evidence these patients received detailed discharge instruction for dietary and activity modifications pertinent to their surgery. Review of facility policy titled “Admission and Discharge Policy, C-415” effective 05/2023, states on page four (4), #2 “The attending physician shall ensure that each patient has a comprehensive individualized discharge plan which meets the patient’s post hospital care needs.” During interview on 03/07/2024 at 11:37AM, Staff A, Chief of Surgery confirmed a call was received from the Medical Examiner’s (ME) office saying the patient was brought in. It was approximately Monday about 10:AM to 11:AM in the day. Another call was received from someone else in the ME’s office asking if we let our patients eat food. “I said no. We didn’t ...” During interview on 03/14/2024 at 9:41 AM, Staff F, Staff Nurse was shown a copy of discharge instructions. Staff F stated the discharge orders get written by the doctor, “I am only responsible to print and explain.” At follow up interview with Staff A on 03/14/2024 at 10:38 AM, Staff A stated there was no policy specific to the bariatric program. The program’s registered dietician/nutritionist left approximately one (1) year ago. The bariatric coordinator provides education on diet prior to surgery. During interview with Staff N, Bariatric Coordinator, on 03/13/2024 at 11:39 AM, Staff N confirmed she conducts bariatric education with patients prior to the surgery. Staff N could not confirm conducting education following the procedure. An Immediate Jeopardy (IJ) situation was identified on 03/15/2024 at 2:23 PM due to the facility’s failure to provide diet and activity specifications to patients in the bariatric surgery unit. The facility provided an IJ Removal Plan to survey staff on 03/15/2024 at 9:00 PM The plan included: 1) A new policy titled “Inpatient Discharge Instructions,” which includes requirements for medication reconciliation, assessment of diet advancement, highlighting warning signs and problems, explanation of test results, diagnosis information, activity and rehabilitation guidelines, special needs identification, and follow-up appointments. 2) Changes to the electronic medical record to modify dietary and activity guidelines for bariatric surgical patients. 3) All pertinent staff (RNs, physicians, dieticians, social workers, and case managers) scheduled to work will be educated on the new policy between 3/15/24 - 3/18/24 or before providing patient care. 4) The development of a weekly monitoring plan. The IJ Removal Plan was accepted on 03/15/2024 at 9:40 PM. The IJ was removed on 3/19/2024 based on onsite verification of the facility’s implementation of the IJ Removal Plan.”

“DISCHARGE PLANNING-QUALIFIED PERSONNEL CFR(s): Any discharge planning evaluation or discharge plan under this paragraph must be developed by or under the supervision of a registered nurse, social worker, or other appropriately qualified personnel. This Standard is not met as evidenced by: 48940 Based on document review and interview, the hospital did not ensure that the Bariatric Coordinator who provides discharge planning education and training prior to discharge to patients in the Bariatric Program is appropriately qualified. Findings include: Review of the facility’s Job Description of the Bariatric Coordinator, undated, indicated that the individual in this position is required to have a bachelor’s degree in nursing or a bachelor’s degree in nutrition and dietetics. Licensure requirements for an Registered Nurse (RN) are to be a New York State License Registered Professional Nurse or if a dietitian to be a New York State License Certified Dietitian-Nutritionist. Review of Staff N, Bariatric Coordinator personnel file, they had a current license as a licensed professional nurse (LPN) by New York State. They were hired on 1/7/2020. During interview with Staff A, Chief of Surgery, Head of Bariatric Surgery on 3/7/2024 at 11:38 AM, Staff A stated, though the position was categorized as non-clinical, Staff N not only coordinates the care for the patients, but also provides education throughout their preoperative visits in the outpatient setting and in the hospital during the patient’s admission and prior to discharge. During interview with Staff V, Director of HR Operations, on 03/14/2024 at 3:44 PM, they confirmed this finding.”