Maimonides Medical Center

“MAINTENANCE OF PHYSICAL PLANT CFR(s): 482.41(a) The condition of the physical plant and the overall hospital environment must be developed and maintained in such a manner that the safety and well-being of patients are assured. This Standard is not met as evidenced by: 36207 . Based on observation, document review, and staff interview, the facility failed to maintain a safe and functional Emergency Department (ED) physical environment in accordance with the Guidelines for Design and Construction of Hospital and Health Care Facilities, 1992-1993 Edition, which establishes minimum construction and patient care space requirements. Specifically, the facility failed to maintain treatment cubicles with a minimum of eighty (80) square feet of clear floor space and failed to provide privacy curtains between patient treatment areas. Findings include: Review of the New York State Electronic Certificate of Need (NYSE-CON) on 05/28/2026 at 2:00 PM revealed that the last major renovation of the Emergency Department (Project No. 910689) was completed on 11/30/1997. During an interview on 05/29/2026 at 12:30 PM, Staff C (Facilities Leadership) and Staff D (ED Medical Leadership) confirmed the renovation date. The Guidelines for Design and Construction of Hospital and Health Care Facilities, 1992-1993 Edition, Section 7.9.0, Definitive Emergency Care, states: “When treatment cubicles are in open multibed areas, each cubicle shall have a minimum of 80 square feet (7.43 square meters) of clear floor space and shall be separated from adjoining cubicles by curtains.” During a tour of the Emergency Department conducted on 05/27/2026 between 1:15 PM and 2:45 PM, the following observations were made: a. On the North Side/Critical Care Unit, patient treatment bays were divided into two separate treatment spaces identified as Bay 58A and 58B, Bay 59A and 59B, and similar configurations. Each original treatment cubicle appeared to have been subdivided into two patient care spaces separated by curtains, resulting in approximately forty (40) square feet of space per patient treatment area rather than the required minimum of eighty (80) square feet. b. On the South Side/Sub-Acute Unit, nine (9) patients were observed on stretchers in the hallway between the nurses’ station and Bays 10 through 15, and six (6) additional patients were observed on stretchers in the hallway between the nurses’ station and Bays 5 through 9. Patients were positioned in close proximity to one another without privacy curtains or other physical barriers. These conditions failed to provide the minimum patient care space required by applicable design standards and failed to ensure visual and auditory privacy during the provision of care. The overcrowded conditions also limited staff access around patient stretchers, impeded the safe movement of equipment and personnel, and increased the potential for breaches of confidentiality. During the tour on 05/27/2026 at 1:15 PM, Staff D stated that the Emergency Department contained 88 patient bays/cubicles and served approximately 140 to 160 patients per day. Staff D further stated that the Emergency Department experienced frequent patient overflow. These observations and statements were made in the presence of Staff C (Facilities Leadership), Staff D (ED Medical Leadership), and Staff E (Nurse Manager), who acknowledged the observed conditions. .”

“EMERGENCY SERVICES POLICIES CFR(s): 482.55(a)(3) [If emergency services are provided at the hospital --] (3) The policies and procedures governing medical care provided in the emergency service or department are established by and are a continuing responsibility of the medical staff. This Standard is not met as evidenced by: 37527 . Based on medical record review, policy review, and staff interview, the facility failed to ensure nursing staff completed a discharge assessment and implemented a safe discharge plan for one (1) of five (5) Emergency Department patients reviewed (Patient #4). The facility’s policy titled “Discharge” (last reviewed 06/09/2025) required the primary nurse to complete the nursing portion of the medical record, ensure appropriate referrals were made, verify the patient had transportation, and assess the patient’s ability to care for themselves or confirm the availability of appropriate social or family support. Patient #4 presented to the Emergency Department on 07/25/2025 after a fall while walking on the street and was evaluated for injuries including jaw pain and left wrist pain. The patient underwent diagnostic testing, received pain medication, and was evaluated by Orofacial services. The patient was discharged on 07/26/2025 at 2:15 AM and left the Emergency Department ambulatory at 2:56 AM. There was no documented evidence that nursing staff completed a discharge assessment, evaluated the patient’s ability to safely return home, verified the availability of transportation or support services, or made referrals to Case Management, Social Work, or other support services as indicated. As a result, the facility could not demonstrate that the patient’s post-discharge needs and safety were assessed prior to discharge. During an interview on 06/02/2026 at 10:55 AM, Staff F, Administrator, reviewed the record and acknowledged the finding. .”

“IC PROFESSIONAL ADHERENCE TO POLICIES CFR(s): [The infection preventionist(s)/infection control professional(s) is responsible for:] (v) The prevention and control of HAIs, including auditing of adherence to infection prevention and control policies and procedures by hospital personnel. This Standard is not met as evidenced by: 37527 . Based on medical record (MR) review, observation, document review, and interview, in one of four (4) patients, nursing staff did not ensure intravenous (IV) tubing was properly dated and timed, as per facility policy. Findings: Review of Patient #3’s MR revealed that this patient was admitted to the Cardiac Intensive Care Unit (CCU) for invasive hemodynamic monitoring (use of sensors and catheters to monitor a patient’s heart function). A midline catheter (a long IV catheter inserted into a vein in the upper arm) was placed on 10/24/2025, and a central line catheter (a thin, flexible tube inserted into a large vein in the chest, neck, or groin and advanced into the large vein that carries blood to the heart) was placed on 10/27/2025. On 10/29/2025 at 1:23PM, a physician order was placed to change Patient #3’s IV tubing every four (4) days. On 10/30/2025 at 5:00AM, the patient’s IV tubing was changed. During a tour of the CCU on 10/30/2025 at 12:00PM, Patient #3’s IV tubings were found undated and untimed to help indicate when the tubing was to be changed. Tubing #1 had a pink label with the words “Change Sunday.” Tubing #s 2, 3, and 4 had brown labels with the words, “Change Friday.” All four (4) labels had lines designated for the date and time that were blank. Review of the facility’s policy and procedure (P&P) titled, “Standards of Nursing Practice for Care of The Adult Patient with Midline Catheter,” revised 08/2022, indicated: “Note the date and time labeled on the dressing, all hanging IV solutions, and administration sets.” This finding was shared with Staff I (Administrator) and Staff J (Administrator) on 10/30/2025 at 12:20 PM. During interview of Staff K (Nurse) on 10/30/2025 at 3:19 PM, Staff K stated that they do not always write the date on the tubing. During interview of Staff I (Administrator) on 10/30/2025 at 3:51 PM, Staff I confirmed these findings and stated that they were unaware of a policy guiding staff to date/time IV tubing.”

“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: 48939 . Based on document review and interview, the facility failed to: - Measure, analyze, and track quality indicators for maternal morbidity related to obstetrical hemorrhage, as per their Quality Assurance Performance Improvement (QAPI) Plan. (See Tag A-0273) - (A) Identify delays with the administration of the Massive Transfusion Protocol (MTP) and notification to the Maternal Fetal Medicine (MFM) specialist; and (B) Analyze causes and implement preventive actions where a patient required an unplanned hysterectomy. (See Tag A-0286) .”

“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: 16362 . Based on medical record review, document review, and interview, in one (1) of six (6) medical records, the facility failed to ensure that the discharge planning evaluation identified the patient’s post-hospital care needs and ensured the availability of appropriate services prior to discharge (Patient #7). (See Tag A-0807) .”

“SURGICAL SERVICES CFR(s): 482.51 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: 48939 . Based on document review, medical record (MR) review, and interview, the facility failed to provide surgical services in accordance with acceptable standards of practice. Findings: - The facility failed to timely and appropriately implement the Massive Transfusion Protocol (MTP), in one (1) of three (3) MRs reviewed (Patient #1), and the Interdisciplinary Guideline for the Management of Obstetrical Hemorrhage, in two (2) of three (3) MRs reviewed (Patient #s 1 and 2). (See Tag A-0951) .”

“MEDICAL STAFF - ACCOUNTABILITY CFR(s): 482.12(a)(5) [The governing body must] ensure that the medical staff is accountable to the governing body for the quality of care provided to patients. This Standard is not met as evidenced by: 48939 . Based on document review, medical record (MR) review, and interview, it was determined the facility failed to report the findings of a peer review to the governing body. Findings: The policy and procedure (P&P) titled, “Peer and Performance Review,” last revised 03/01/2023, indicated, “At a minimum, peer review is required for all NYPORTS [New York Patient Occurrence Reporting and Tracking System] serious reportable events requiring root cause analysis and The Joint Commission Sentinel Events...The findings of the peer review process are communicated to the appropriate parties, are used to support recommendations for renewing or revising clinical privileges, and are integrated into performance improvement activities.” Per interview of Staff E (Administrator) on 12/11/2024 at 10:08AM, Staff E stated that peer reviews and corrective actions are reported to the governing body. Staff E further indicated they had sent an email about the peer review dated 11/22/2024 to the governing body on 12/5/2024. Review of the facility email dated 12/5/2024, between Staff E and the Governing Body, revealed there was no description of the findings of the peer review or corrective actions taken. Per interview of Staff E on 12/11/2024 at 10:08 AM, when asked about the notification to the governing body, Staff E stated that as a result of this survey, a quality and safety meeting was scheduled for Monday [12/16/2024] with the Board of Trustees. Upon request, the facility could not furnish documented evidence that peer review findings or corrective actions were reported to the Governing Body prior to the start of this survey. .”

“PATIENT RIGHTS: NOTICE OF RIGHTS CFR(s): 482.13(a)(1) A hospital must inform each patient, or when appropriate, the patient’s representative (as allowed under State law), of the patient’s rights, in advance of furnishing or discontinuing patient care whenever possible. This Standard is not met as evidenced by: 37560 . Based on medical record review, document review, and interview, in three (3) of the three (3) records reviewed, the hospital did not ensure that each Medicare beneficiary who is an inpatient (or his/her representative) is provided the standardized notice, “An Important Message from Medicare” (IM), within two (2) days of admission and a copy of the signed IM in advance of the patient’s discharge. Findings include: Review of facility policy titled “Implementation of Discharge Review Program,” last reissued on 6/27/2024, states, “It is the responsibility of the Case Management Department to issue the IM to all patients admitted via the Emergency Department when feasible ...to follow up and issue the IM to the patient or patient representative as soon as possible or at least 24-48 hours prior to discharge.” Review of Patient #6’s medical record (MR) revealed that the patient was brought to the facility on 6/27/2024 for left lower extremity redness and pain with fever. The patient had multiple comorbidities and was a Medicare recipient. The patient was transferred to a Skilled Nursing Facility (SNF) for continued rehabilitation. There was no documented evidence in the MR that the patient was furnished with “An Important Message from Medicare” (IM) notice within two (2) days of admission and a copy of the signed IM notice prior to discharge. Review of Patient #12’s MR revealed that the patient was admitted to the facility on 11/21/2024 for abdominal pain due to fecal impaction. The patient had multiple comorbidities and was a Medicare recipient. The patient was transferred to a SNF for rehabilitation on 12/2/2024. There was no documented evidence in the MR that the patient was furnished with an IM notice prior to discharge. Review of Patient #13’s MR revealed that the patient was admitted to the facility on 11/18/2024 for rectal bleeding. The patient had multiple comorbidities and was a Medicare recipient. The patient was transferred to a SNF for rehabilitation on 12/3/2024. There was no documented evidence in the MR that the patient was furnished with an IM notice prior to discharge. Staff W (Administrator) confirmed these findings during an interview and review of the MRs on 12/3/2024 at 2:00 PM. .”

“DATA COLLECTION & ANALYSIS CFR(s): 482.21(a), (b)(1),(b)(2)(i), (b)(3) (a) Program Scope (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 improve health outcomes ... (2) The hospital must measure, analyze, and track quality indicators ... and other aspects of performance that assess processes of care, hospital service and operations. (b)Program Data (1) The program must incorporate quality indicator data including patient care data, and other relevant data such as data submitted to or received from Medicare quality reporting and quality performance programs, including but not limited to data related to hospital readmissions and hospital-acquired conditions. (2) The hospital must use the data collected to-- (i) Monitor the effectiveness and safety of services and quality of care; and .... (3) The frequency and detail of data collection must be specified by the hospital’s governing body. This Standard is not met as evidenced by: 48939 . Based on document review and interview, the facility failed to measure, analyze, and track quality indicators for maternal morbidity related to obstetrical hemorrhage, as per their Quality Assurance Performance Improvement (QAPI) Plan. Findings: The policy and procedure (P&P) titled, “Patient Occurrence Reporting and Disclosure,” last revised 12/21/2023, indicated, “Examples of sentinel events include ... severe maternal morbidity (leading to permanent harm or severe harm).” The document titled, “Department of Obstetrics and Gynecology [OB/Gyn] Performance Improvement Plan 2024 - 2025” indicated, “The following are the PI [Performance Improvement] projects that the department has decided to work on for this PI cycle ...Anemia/Obstetrical Hemorrhage: Reduce maternal morbidity and comply with Joint Commission Standards.” The document titled, “Performance Improvement Summary 2024 Q1 Q2 [Quarter 1 and 2],” presented at the hospital-wide QAPI Meeting in 09/2024, identified the following: -Indicator: “Population with Hemorrhage:” o Q4 2023 = 3.19% o Q1 2024 = 3.24% o Q2 2024 = 3.77% -Indicator: “Patient Received Blood Transfusion:” o Q4 2023 = .34% o Q1 2024 = 1.73% o Q2 2024 = 1.58% Other indicators included the patient’s Hemoglobin on Admission, Compliance with Hemorrhage Risk Assessment on Admission, and Post-Partum and Entering a Code H [Code Hemorrhage] in the “RL Datix” (adverse event reporting) system. The document stated that entering a Code H in the RL Datix system was no longer required after 01/01/2024. A review of the facility’s Adverse Events from 08/2024 to 12/2024 revealed that of 11 hemorrhage events, two (2) had completed reviews. It was identified that the facility’s hemorrhage rate increased from Q4 2023 to Q2 2024, the blood transfusion rate decreased from Q1 2024 to Q2 2024, and that hemorrhages were no longer being entered into the facility’s occurrence event reporting system. Although indicators were identified to measure maternal hemorrhage, the indicators did not capture maternal morbidities, as outlined in the facility’s occurrence reporting policy or the OB/Gyn Department’s PI Plan. Per interview of Staff I (Administrator) on 12/09/2024 at 2:08 PM, Staff I stated that because the facility is not differentiating between the types of hemorrhage (Stages 1-4), they could not answer why the transfusion rate decreased while the hemorrhage rate increased. Staff I further stated that the facility does not track indicators for maternal morbidity due to hemorrhage (e.g., unplanned hysterectomy) and does not compare maternal hemorrhage metrics to national benchmarks, focusing instead on “preparedness and response.””

“PATIENT SAFETY CFR(s): 482.21(a), (c)(2), (e)(3) (a) Standard: Program Scope (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: 48939 . Based on document review, medical record (MR) review, and interview, the facility failed to: (A) Identify delays with the administration of the Massive Transfusion Protocol (MTP) and notification to the Maternal Fetal Medicine (MFM) specialist, in two (2) of 11 hemorrhage events (Patient #1 & Patient #2); and (B) Analyze causes, in ten (10) of 11 adverse hemorrhage events, and implement preventive actions, in one (1) of 11 adverse hemorrhage events where a patient required an unplanned hysterectomy (Patient #3). Findings for (A): Review of the facility policy and procedure (P&P) titled, “Initiation of Massive Transfusion Protocol (MTP),” revised 06/08/2015 indicated, “Round #1: Emergency issue of four (4) units of uncrossmatched O Rh negative RBCs [red blood cells], followed by four (4) FFP [fresh frozen plasma] and one (1) single donor platelet...if a second (crossmatched) specimen is required, continue using type O blood until a second specimen is received.” The facility P&P titled, “Interdisciplinary Guideline for the Management of Obstetrical Hemorrhage,” revised 07/13/2022, indicated that the MFM (Maternal Fetal Medicine) specialist should be notified for Stage II hemorrhage or higher. The document titled, “Organizational Quality Improvement Plan 2024 - 2025,” effective 01/25/2024, indicated, “For all sentinel events and/or serious events, a Root Cause Analysis is completed and coordinated by Risk Management with input from Patient Safety and Quality Management. Risk reduction strategies are implemented and follow-up monitoring to assess effectiveness is completed by the involved department(s) and reported to the Department of Risk Management and Quality Management.” Review of Patient #1’s MR identified that on 11/17/2024, Patient #1 underwent a cesarean section. The physician’s Delivery Report, dated 11/17/2024, revealed that Patient #1 had complications including extensive bleeding that required blood transfusions. At 4:00AM, the Massive Transfusion Protocol (MTP) was activated, however, there was a 32-minute delay in the patient receiving the transfusion due to awaiting crossmatch results (a blood test to verify donor and recipient blood compatibility). In addition, there was an approximate 5-hour delay in notification to the MFM. Per interview of Staff F (Administrator) on 12/3/2024 at 1:00PM, Staff F confirmed that Patient #1 received less blood than was prescribed by the MTP policy, and that the infusion of blood products was delayed. Review of Patient #2’s MR identified that on 09/02/2024 at 12:29AM, Patient #2 underwent a vacuum vaginal delivery (a procedure that uses a vacuum to help deliver a baby) that was complicated by a vaginal laceration and dehiscence (wound rupture along an incision line) of an old cesarean section incision. Patient #2 had subsequent bleeding, kidney failure, seizure, and stroke. On 09/02/2024 at 5:49 PM, the MFM Provider documented that they were notified of Patient #2’s condition on at 2:00 PM (approx. 12 hours after Patient #2’s laceration and dehiscence). Per interview Staff A (Provider) on 12/05/2024 at 10:55 AM, Staff A confirmed the facility did not review Patient #1’s MTP administration and did not identify the 32-minute delay in transfusion of blood products. Staff A acknowledged that there was an approximate five (5) hour delay in notifying the MFM about Patient #1, and an approximate 12-hour delay in notifying the MFM about Patient #2. There was no documented evidence that during the investigation the facility recognized the delay in implementing the MTP or delayed notification of the MFM. Findings for (B): The policy and procedure (P&P) titled, “Patient Occurrence Reporting and Disclosure,” last revised 12/21/2023, indicated, “Examples of sentinel events include ... severe maternal morbidity (leading to permanent harm or severe harm).” Review of the facility’s Occurrence/Adverse Events from 08/2024 to 12/2024 revealed eleven (11) maternal hemorrhage events. Of the eleven (11) hemorrhage events, nine (9) were not reviewed. Review of Patient #3’s MR identified that this patient was admitted for labor management on 11/05/2025 at 39 weeks and 6 days gestation (the period of time between conception and birth during which a baby develops inside a mother’s womb/full term = 39 to 40 weeks and 6 days). Patient #3 suffered a maternal hemorrhage immediately following spontaneous vaginal delivery, received MTP, and underwent an emergency hysterectomy that was reported to the state occurrence reporting and tracking system. The facility’s review of Patient #3’ unplanned hysterectomy did not include a corrective action plan nor recommendations for improvement. Per interview of Staff EE (Administrator) on 12/11/2024 at 10:17 AM, Staff EE confirmed that no formal review of Patient #3’s case was performed nor corrective actions implemented. When asked why the review for Patient #3 was blank, they stated, “If a case is more serious, such as the maternal death, we have to prioritize those, and the less serious cases get bumped.” Staff EE further added, “There are two types of review: the full committee review and a smaller core committee review.” Staff EE explained that the small core committee reviews cases to determine priority. Upon request, the facility was unable to provide documented evidence of core committee reviews for the nine (9) other maternal hemorrhage cases that did not undergo review.”

“RN SUPERVISION OF NURSING CARE CFR(s): 482.23(b)(3) A registered nurse must supervise and evaluate the nursing care for each patient. This Standard is not met as evidenced by: 16362 . Based on medical record review, document review, and interview, in one (1) of five (5) medical records reviewed, nursing staff failed to conduct a timely assessment and document the patient’s skin condition to ensure adequate management of a patient at risk for pressure injuries (Patient #7). Findings Include: The facility policy and procedure (P&P) titled “Pressure Injuries: Screening, Assessment, Treatment, and Documentation Policy,” dated 3/29/2024, states, “On admission, all patients are screened and assessed for risk for developing pressure Injuries including pressure injury history and current ..Complete skin assessment and document any pressure injuries / non-pressure wounds ... Procedure: The nurse will assess and document pressure injury on admission and when the dressings are changed per the order. The documentation required in the worklist manager /EER is site, stage, and wound size (length, width, and depth in centimeters) on admission and weekly.” A review of the medical record for Patient #7 identified that the patient presented to the Emergency Department (ED) on 3/25/2024 at 10:24 AM for management of respiratory symptoms secondary to viral infection. The patient was from a Group Home, and their medical history was significant for cerebral palsy with VP shunt and was nonverbal. There was no documented evidence that nursing staff conducted a skin assessment during the patient’s 13-hour stay in the ED; the patient’s risk for developing pressure injuries and their existing pressure injuries were not assessed, and pressure injury preventive measures were not documented. On 3/26/2024 at midnight, the patient was admitted to a medical/surgical unit. On 3/26/2024, at midnight, the Nursing staff documented a “Blister at the back of both knees and left heel.” There was no documentation of the wound size as prescribed by the policy “Pressure Injuries: Screening, Assessment, Treatment, and Documentation Policy.” On 3/26/2024 at 8:00 PM, nursing staff documented “Skin Integrity: Redness and dryness behind bilateral knee; scaly. Braden Score of 13 (High risk for skin breakdown).” The Wound Care Consult on 3/27/2024 identified the following wounds: Wound #1: Left heel (ruptured blister), skin intact. Wound #2: Left Toe 2nd (Bruise with scab forming), measuring 0.66 centimeters (cm) x 0.34 cm x 0 cm; the skin was intact, and no treatment was required. Wound #3: The right heel (Healing ruptured blister) measures 1.00 cm x 1.5 cm x 0 cm. Cleanse with a wound cleanser, then apply a silicone foam dressing every 3 days or PRN as needed. Treatment is required. Wound #4: Right knee (ruptured blister), measuring 18 cm x 4 cm x 0.1 cm, moderate serous sanguineous (Thin blood-tinged) drainage. Wound #5: Left knee (ruptured blister), measuring 11 cm x 6 cm x 0.1 cm, moderate serous sanguineous drainage. During an interview with Staff LL (Wound Care Staff) on 12/10/2024 at 10:43 AM, Staff LL confirmed that the patient’s skin was not assessed in the ED and that there should have been documentation of skin assessment during their first 12 hours in the ED and every shift. .”

“CONTENT OF RECORD CFR(s): 482.24(c) The medical record must contain information to justify admission and continued hospitalization, support the diagnosis, and describe the patient’s progress and response to medications and services. This Standard is not met as evidenced by: 10723 . Based on medical record review, document review, and interview, in one (1) of four (4) records reviewed, the facility did not ensure nursing staff documented the blood products administered to Patient #1 in PACU (Post Anesthesia Care Unit). Findings: Review of Patient #1’s medical record revealed on 11/17/2024, the patient underwent a cesarean section with an estimated 2.5 Liters of blood loss. Review of Patient #1’s Blood Transfusion Record Tags revealed the following blood products were administered on 11/17/2024 in PACU: One unit of Packed Red Blood Cells (PRBCs) from 7:33 AM - 7:51 AM; one unit of PRBCs from 7:54 AM - 8:20 AM; one unit of Fresh Frozen Plasma (FFP) from 8:00 AM - 8:25 AM, and one-unit PRBCs from 8:31 AM - 8:40 AM. No documentation was found in the medical record that the blood products were administered to the patient. Per interview with Staff MM (Registered Nurse/RN) on 12/4/2024 at 11:01 AM, Staff MM stated, “On 11/17/2024, I came to work at 7:00 AM. Patient #1 was in PACU. We did a two-person verification of the blood products ... I know the blood products were given.” Staff MM could not provide documented evidence in the medical record of the blood products administered to Patient #1 on 11/17/2024 between 7:33 AM and 8:40 AM. The facility policy and procedure (P&P) titled “Documentation by Nursing Personnel,” last revised 4/20/2023, stated the following: “The registered nurse is responsible for completing and accurately documenting the patient’s prioritized needs in the Focus Charting Format.” .”

“INFECTION CONTROL PROGRAM CFR(s): 482.42(a)(1) The hospital infection prevention and control program, as documented in its policies and procedures, employs methods for preventing and controlling the transmission of infections within the hospital and between the hospital and other institutions and settings; This Standard is not met as evidenced by: 10723 . Based on observation, document review, and interview, the facility did not ensure A) in ten (10) of 13 (thirteen) Operating Room (OR) observations, all generally accepted infection control measures were followed and B) in two (2) of two (2) observations, staff performed hand hygiene in accordance with acceptable standards of infection control. These failures potentially placed patients at increased risk for infection. Findings for (A): The facility’s policy and procedure (P&P) titled, “Surgical Attire Requirements to the Operating Rooms and Procedural Areas,” dated 1/25/2024, stated, “Semi-restricted area: scalp, hair, ... must be covered. Restricted area: In addition to the requirements for semi-restricted areas, beards are covered with a barrier containing all hair ...Head/Hair cover (worn in semi-restricted area and restricted area): Disposable head and beard covers, and hoods are required and provided at entrances to semi-restricted areas. If reusable head covering is used, they must be covered with a disposable head covering. Health care providers entering the semi-restricted areas should completely cover their scalp and hair.” Observations in the facility’s Operating Room (OR) Suite during a tour between 11:20 AM and 12:05 PM on 11/27/2024 identified the following: (1) In OR #1, within the sterile field, the surgeon had uncovered sideburns. (2) In OR #2, a vendor had approximately one (1) inch of uncovered hair above their nape and uncovered sideburns. A nurse with approximately four (4) inches of a reusable head covering exposed. (3) In OR #4, within the sterile field, a surgical provider had the sides of their beard uncovered and approximately two (2) inches of uncovered hair above their nape. (4) In OR #6, a nurse was opening sterile equipment and had approximately two (2) inches of uncovered hair above their nape and three (3) inches of uncovered hair above their forehead. (5) In OR #7, a provider had approximately four (4) inches of uncovered hair above their nape. (6) In OR #9, two (2) providers had the sides of their beards uncovered within the sterile field. An provider had approximately four (4) inches of uncovered hair above their nape. A nurse had the sides of their beard uncovered. (7) In OR #11, within the sterile field, a surgical assistant had uncovered hair on each side of the temple area. A technician had uncovered hair above each ear. Two providers had the sides of their beard uncovered. (8) In OR #12, a provider had uncovered hair at the side of the temples within the sterile field. A technician had hair exposed on the right side of their face. A nurse had approximately two (2) inches of uncovered hair above their nape and approximately two (2) inches of a reusable head covering exposed. A nurse had approximately two (2) inches of a reusable head covering exposed. (9) In OR #13, within the sterile field, a technician had approximately three (3) inches of uncovered hair above their nape. Observations in the facility’s Ambulatory Operating Room (OR) Suite during a tour between 12:10 PM and 12:30 PM on 11/27/2024 identified the following: (10) In OR #1, within the sterile field, a provider had approximately two (2) inches of uncovered hair above their nape. At 11:40 AM, Staff Y (Coordinator) was in the restricted area with their mustache, sideburns, and hair above the forehead uncovered. Per the interview with Staff Y at the time of the observation, they stated that all hair should be covered in the restricted areas. At 11:42 AM, Staff DD (Director) was in the restricted area with uncovered sideburns. Per the interview with Staff DD during the observation, they reported that staff should cover all hair in the restricted areas. At 11:45 AM, Staff CC (Technician) was in the restricted area with their mustache uncovered. Per the interview with Staff CC, at the time of the observation, they acknowledged that all hair should be covered in the restricted area. Staff AA (Surgeon) was entering the restricted area with an uncovered beard. Per the interview with Staff AA, at the time of the observation, they stated, “I’ll cover my beards in surgery.” In the restricted area, Staff BB (Surgeon) had uncovered hair above each ear. Staff Z (Environmentalist) had uncovered hair on the sides of their beard and on the right side of their face. Per the interview at the time of the observation, Staff Z stated, “All hair should have been covered.” During the tours, Staff T (Director) confirmed during an interview on 11/27/2024 that self-launder reusable head coverings must be completely covered with a bouffant. Findings for (B): Observations in the facility’s K7 (Medical/Telemetry) Unit and PMCU (Progressive Medical Care) Unit on 11/27/24 during a tour between 12:10 PM and 1:30 PM on 11/27/24 identified the following: (1) Patient #8 had a Stage 3 Pressure Injury on the sacrum. Staff GG (Nursing Staff) was observed performing dressing changes to the patient’s pressure injury. Staff GG removed the old dressing from the Patient’s sacrum without changing gloves and performing hand hygiene; they used the contaminated gloves to open the “Vashe” solution [Wound cleanser]. After completing wound care, Staff GG put the bottle of Vashe solution in the patient’s drawer for reuse without labeling the bottle with the date they opened the solution and the staff initials. (2) Patient #9 had a Stage 4 Pressure Injury to the sacrum and a Stage 3 on their thigh. Staff FF (Nursing Staff) was observed performing dressing changes to the patient’s sacrum. Staff FF removed the old dressing from the Patient’s sacrum and left it at the bedside on the chuck. The nurse proceeded with wound care and application of a new dressing without changing their gloves and performing hand hygiene. Staff FF and the PCA (Personal Care Aide) turned the patient to provide wound care for the 2nd pressure injury on the thigh. At the time of observation, Staff FF had not removed their gloves and performed hand hygiene until a nurse manager reminded them to do so. These observations were made in the presence of Staff HH (Director) and Staff MM (Manager), who confirmed these findings. .”

“DISCHARGE PLANNING-EVALUATION CFR(s): §482.43(a)(2) Standard: Discharge Planning Evaluation (2)A discharge planning evaluation must include an evaluation of a patient’s likely need for appropriate post-hospital services, including, but not limited to hospice care services, post-hospital extended care services, home health services, and non-health care services and community based care providers, and must also include a determination of the availability of the appropriate services as well as of the patient’s access to those services. This Standard is not met as evidenced by: 16362 . Based on medical record (MR) review, document review, and interview, in one (1) of six (6) medical records, the facility failed to ensure that the discharge planning evaluation identified the patient’s post-hospital care needs and ensured the availability of appropriate services prior to discharge (Patient #7). Findings: Review of Patient #7’s MR identified that Patient #7 was admitted from a group home on 3/25/2024 for continued respiratory observation secondary to flu symptoms and fever spikes. The patient’s medical history included developmental/physical delay and cerebral palsy. On 3/26/2024 at 9:52 AM, the initial discharge evaluation documented that the patient lived in a Group Home with home care services. The discharge plan screening process identified that the patient requires assistance with activities of daily living (ADL) and ambulation. The initial discharge plan was for the patient to return to the group home or Short-Term Rehabilitation Facility pending their skilled needs at the time of discharge. The social worker assistant noted that the patient screened in for services and that the patient’s discharge plan was pending medical course. On 3/28/2024 at 11:20 AM, the patient’s “Discharge Summary” stated a plan to discharge the patient to the Group Home with home health services. On 4/3/2024 at 3:02 PM, a physician documented that the patient was hemodynamically stable, afebrile, and medically optimized for discharge back to the group home. The patient was discharged to the Group Home on 4/03/2024 at 5:00 PM. Review of the facility’s policy titled, “Organization, Role, and Function of the Case Management Team”, last revised 10/2023, stated, “... appropriate and safe discharge planning. Collaborates with other departments to facilitate coordination of services throughout the continuum of care ... Collaborates with vendors and post-acute care providers in home care agencies... Coordinates with appropriate community resources to ensure continuity of care, including referral to the health home ... The nurse case manager ensures the appropriateness of the final discharge plan and confirms the final disposition.” During interview on 12/9/2024 at 11:05 AM with Staff JJ (Social Work/SW staff), they stated that group homes do not have skilled nursing services and that the patient should have been referred to home care services or a sub-acute nursing home. Staff JJ added that they did not make a referral for a face-to-face assessment by the physician, which is required to initiate a home care referral. During an interview on 12/9/2024 at 12:35 PM with Staff KK (Manager), they stated that it is the responsibility of the social work assistant to request a face-to-face assessment from the medical doctor and set up home care services. A review of the facility’s policy titled, “Organization, Role, and Function of the Case Management Team,” effective 10/2023, states, “The interdisciplinary team continues to reassess the goals of the discharge plan during the interdisciplinary review process to ensure it meets the patients’ needs.” There was no reassessment of the patient’s wound care status. There was no documented discussion with the Group Home to determine their ability to care for the patient with multiple pressure injuries on bilateral knees and heels. During interview on 12/9/2024 at 12:35 PM, Staff KK (Manager) stated that they remembered sending information to the group home on 4/1/24 regarding updated diagnoses clarification that the facility was requesting. The physician updated the information and sent it to the facility. During interview on 12/10/2024 at 1:09 PM, Staff JJ (SW staff) and Staff KK (Manager) agreed and confirmed that the patient required advanced wound care at the time of discharge, and they should have initiated a referral for a higher level of care. The patient returned to the Emergency Department on 4/4/2024 at 5:30 PM within twenty-four hours of discharge from the facility with worsening bilateral leg wounds and altered mental status. On 4/4/2024 at 9:02 PM, ED Provider Note documented that they spoke with an on-call nurse from the group home who reported that the patient had multiple new wounds, which they were unable to care for. .”

“OPERATING ROOM POLICIES 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: 48939 . Based on document review, medical record (MR) review, and interview, the facility failed to timely and appropriately implement the Massive Transfusion Protocol (MTP), in one (1) of three (3) MRs reviewed (Patient #1), and the Interdisciplinary Guideline for the Management of Obstetrical Hemorrhage, in two (2) of three (3) MRs reviewed (Patient #s 1 and 2). Findings: The facility policy and procedure (P&P) titled, “Initiation of Massive Transfusion Protocol (MTP),” revised 06/08/2015, indicated, “Timely replacement of volume and oxygen carrying capacity in these situations is critical ...For adult patients ...the following blood components will be issued: Round #1: Emergency issue of four (4) units of uncrossmatched O Rh negative RBCs [red blood cells], followed by four (4) units FFP [Fresh Frozen Plasma], and one (1) single donor platelet...if a second (crossmatched) specimen is required, continue using type O blood until a second specimen is received.” The P&P titled, “Interdisciplinary Guideline for the Management of Obstetrical Hemorrhage,” revised 07/13/2022, was indicated for “ ...continued blood loss, EBL [Estimated Blood Loss] greater than or equal to 1500 mL or greater than or equal to two (2) units RBCs given, at risk for occult bleeding/coagulopathy [a condition that impairs the blood’s ability to clot], or any patient with abnormal vital signs/labs/oliguria [low urine output].” Initial steps to respond to a Stage III hemorrhage included: “Mobilize additional help by provider communicating with the nurse, move to OR [operating room], notify OR team, [and] set up cell saver in the operative field. If consultation is required, delegate a resident to notify the needed specialist...MFM [Maternal Fetal Medicine] on service for Stage II or higher...senior surgical support, i.e. Gyn-Onc [gynecologist-oncologist] for planning surgical exploration or hysterectomy... Interventional Radiology if uterine preservation is considered when the patient is not responding to medical therapy.” Review of Patient #1’s MR identified this patient was admitted on 11/15/2024 for induction of labor at 39 weeks, 6 days gestation (the period between conception and birth during which a baby develops inside a mother’s womb/full term = 39 to 40 weeks and 6 days). On 11/17/2024 at 3:05AM, Patient #1 underwent a cesarean section (c-section) due to arrest of descent (the fetus did not descend far enough into the birth canal for vaginal birth). The Intraoperative Anesthesia Record, dated 11/17/2024, indicated “Code H called at 3:57AM, MTP activated at 4:00 AM, second large bore IV [intravenous] established 4:05 AM, blood work taken at the same time. Case converted to general anesthesia at 4:28AM due to hemodynamic instability.” Blood product administration was documented as follows: - 4:32 - 4:38 AM: 1-unit Packed Red Blood Cells (PRBCs) - 4:38 - 4:54 AM: 1-unit PRBCs - 4:47 - 4:54 AM: 1-unit Fresh Frozen Plasma (FFP) - 4:50 - 4:59 AM 1-unit Platelets There was no documented evidence that Patient #1 received four (4) units of uncrossmatched O Rh negative RBCs, followed by four (4) units of FFP, and one (1) single donor platelet, as per the MTP protocol. The Delivery Report, dated 11/17/2024 at 5:29AM, indicated that a Code H (obstetrical hemorrhage code) was activated due to extensive bleeding during the procedure. The note indicated that Patient #1 received medications to control bleeding while the provider “awaited cross-matched blood.” The Provider Note, dated 11/17/2024 at 7:00AM, indicated that while Patient #1 was in the recovery room, the patient had a high heart rate ~130s (normal: 60-100) and low blood pressure ~70s/50s (normal: 120/80). The note further indicated that a bedside ultrasound revealed free fluid in the space surrounding the abdominal organs, and that Patient #1’s blood cell count was below the normal range. A decision was made to administer an additional round of MTP and consider possible re-operation. A Nursing Note, dated 11/17/2024 at 7:45 AM, indicated Patient #1’s vital signs were: Heart Rate: 119; Respiratory Rate: 39 (normal: 16-20); Oxygen saturation: 100% on 3L oxygen (normal: 95%-100% on room air); and Blood Pressure: 83/59. The RRT (Rapid Response Team - group of healthcare professionals who respond quickly to patients showing signs of clinical deterioration) was called. Review of Patient #1’s MR identified that Patient #1 continued to bleed and subsequently expired on 11/17/2024, approximately twelve (12) hours after bleeding began. Per interview of Staff B (Provider) on 12/02/2024 at 11:09 AM, Staff B stated that after delivery, heavier than expected bleeding was noted. Staff B explained that residents were unable to obtain adequate retraction to visualize the full extension of the incision, which extended almost down to the cervix. Once the extension was sutured, bleeding stopped, and the patient’s incision was closed. In the Recovery Room, Patient #1 became hypotensive (had low blood pressure) and tachycardic (with a high heart rate). Staff B stated that Anesthesiology was consulted, and it was decided that Patient #1 needed more blood than the two (2) units given in the OR. Patient #1 was placed on vasopressors (medication to increase blood pressure) and a Rapid Response was activated. Staff B further stated that multiple ultrasounds to assess for bleeding were performed and suggested a possible five (5) cm hematoma (a collection of blood). Patient #1 was transported for a CT (a type of x-ray scan) and transferred to the Surgical Intensive Care Unit (SICU). Per interview of Staff N (Radiologist) on 12/02/2024 at 1:55 PM, Staff N confirmed that the CT revealed a large hematoma measuring 9.6 cm × 11 cm × 20.4 cm, extending into the abdomen and displacing the uterus. Staff N confirmed that a bedside ultrasound should have detected the hematoma, particularly along the right anterior (front) side. Per interview of Staff L (Provider) on 12/03/2024 at 10:29 AM, Staff L stated the following: - Role: Senior surgical support per the obstetrical hemorrhage P&P. - ~ 4:00AM: First notified near the end of Patient #1’s cesarean that bleeding was difficult to control; Staff L was informed that they would be kept updated on Patient #1’s condition. - ~ 7:00AM: Staff L informed that Patient #1 was hypotensive and might need to return to the OR. - ~ 7:10AM: A follow-up call reported to Staff L that Patient #1 was getting blood and was stabilizing. - ~ 9:00AM: Staff L was advised that CT imaging indicated an ongoing bleed. - ~ 9:45AM: Staff L arrived; the team had already performed the bedside hysterectomy. Per interview of Staff F (Provider) on 12/3/2024 at 1:00PM, Staff F confirmed that Patient #1 received two (2) units of RBCs and one (1) unit of FFP, initiated 32 minutes after the MTP activation. Staff F stated that under the MTP, the patient should have received four (4) units of RBCs and four (4) units of FFP. Staff F stated that the transfusion should have started sooner because a dedicated cooler containing RBCs and FFP is kept in the labor-and-delivery OR, eliminating the need to wait for products from the main blood bank. Per interview of Staff A (Provider) on 12/05/2024 at 10:55 AM, Staff A stated that the anesthesiologist is expected to the lead the MTP when a patient is hemorrhaging in the OR. Staff A further stated that the O-negative blood in the OR refrigerator should be infused without waiting for crossmatch. Staff A confirmed that the MTP was not followed for Patient #1 and that all available blood in the cooler should have been administered. Staff A confirmed that the MFM was notified at 8:30AM, but that it would have been useful to consult them when the MTP was activated at 4:00AM. Per interview of Staff F (Provider) on 12/10/2024 at 12:05 PM, Staff F confirmed that another provider scanned Patient #1’s belly several time and identified a collection of fluid. Staff F stated the finding was appropriately reported to the attending, but indicated that the team should have returned to the OR to explore what was going on. In the case of Patient #1, it was determined that all available blood products for emergency transfusion were not transfused, and the wait for cross-matched blood resulted in a 32-minute delay of blood administration, as per the facility’s MTP P&P. In addition, there was an approximate five (5) hour delay in escalating Patient #1’s condition to the MFM specialist for consultation and management of the maternal hemorrhage, as per the facility’s obstetrical hemorrhage management P&P. . Review of Patient #2’s MR identified that this patient was admitted on 08/31/2024 at 38 weeks, 6 days gestation. On 09/02/2024 at 12:29 AM, the patient underwent a vacuum vaginal delivery (a procedure that uses a vacuum to help deliver a baby through the birth canal) complicated by a vaginal laceration and dehiscence (a wound rupture along an incision line) of an old cesarean section incision. The Delivery Report, dated 09/02/2024 at 03:49AM, indicated that a Code H was activated due to brisk uterine bleeding. Patient #2 was taken to the OR on 09/02/2024 at approximately 2:35 AM. They received medications to decrease bleeding and two (2) units of RBCs. The patient underwent an exploratory laparotomy to identify the source of bleeding. A Provider Note, dated 09/02/2024 at 5:49 PM, indicated that the MFM was informed about Patient #2 at 2:00 PM (approximately 12-hours after Patient #2’s incision dehiscence), and that procedures were complicated by hemorrhagic shock that required vasopressors to increase Patient #2’s blood pressure. The note also indicated that Patient #2’s postoperative course was further complicated by low urine output and acute kidney injury, likely as a result of blood loss. Review of Patient #2’s MR further identified that Patient #2 developed severe complications including kidney failure, seizure, and stroke due to the bleeding. In the case of Patient #2, it was determined there was an approximate 12-hour delay in escalating Patient #2’s condition to the MFM specialist for consultation and management of the maternal hemorrhage, as per the facility’s obstetrical hemorrhage management P&P. An Immediate Jeopardy (IJ) situation was identified on 12/05/2024 at 4:18 PM due to the facility’s failure to timely and appropriately implement the facility’s MTP during a cesarean section (Patient #1), and the “Interdisciplinary Guideline for the Management of Obstetrical Hemorrhage” (Patient #1 and Patient #2). The facility provided an IJ Removal Plan to survey staff on 12/05/2024 at 6:03PM. The IJ Removal Plan included educating providers and nurses on the MTP and Interdisciplinary Care of Obstetrical Hemorrhage policy before the start of their shift. Providers to be educated included Attending and Resident Physicians, Nurse Practitioners, Physician Assistants, and Midwives in the following departments: Emergency Medicine, General and Trauma Surgery, Obstetrics, Critical Care, Anesthesiology, Interventional Radiology, and Blood Bank. Nursing staff from the following departments were also educated: Emergency Department, Operating Room, Post Anesthesia Care Unit, Labor and Delivery, Maternity, Critical Care Units, Rapid Response Team, and Interventional Radiology. The IJ Removal Plan was accepted on 12/05/2024 at 7:23 PM. The IJ was removed on 12/06/2024 at 4:31 PM, based on onsite verification, including interviews and document review, that the facility had implemented their Plan.”