Harlem Hospital Center

“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: 39392 . Based on observation, medical record (MR) review, document review, and interview, the facility failed to track, and monitor, implemented corrective actions. Findings: Review of Patient #1’s MR identified the following: -Nursing Elopement Risk Assessment (9/24/2025 at 7:26 AM): Identified that Patient #1 was not at risk for elopement and was not cognitively impaired. -Social Work Note (9/25/2025 at 3:15 PM): Identified that the family of Patient #1 reported that Patient #1 had a history of wandering. -Nursing Note (9/29/2025 at 9:30 PM): Identified that Patient #1 was not found in his room at 3:20 PM, and that the patient had left the unit with an intravenous (IV) catheter in place. A Security Report, dated 9/30/2025 at 10:26 AM, revealed that Patient # 1 exited the unit with two female visitors on 9/29/25 at 3:48 PM. The facility’s policy and procedure (P&P), titled, “Left Before Discharge/Missing Person/Elopement,” last dated 08/2025, revealed that “inpatients are considered at risk for elopement if they meet any of the following listed criteria ...a prior history of elopement.” Review of the facility’s investigation of Patient #1’s elopement incident, dated 10/3/2025, revealed that the facility identified the implementation of a new elopement risk assessment tool as a corrective action. Upon request, the facility was unable to furnish documented evidence of the tracking and monitoring of the implementation of the new elopement risk assessment tool. During interview with Staff K (Administrator) on 1/27/2026 at 1:30 PM, Staff K confirmed that there was no audit monitoring performed for the new elopement risk assessment tool that was implemented on 12/3/2025.”

“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: 48939 . Based on document review, observation, medical record (MR) review, and interview, nursing staff did not complete neurovascular assessments as per physician’s order, in one (1) of three (3) vascular MRs reviewed. Findings: Review of the facility policy and procedure (P&P) titled, “Nursing Assessment and Plan for Care for Patients,” last revised 04/2025, directed registered nurses [RN] to “reassesses the patient at a minimal frequency of every shift, or more frequently, based on his/her care needs.” During a tour of the medical-surgical unit on 01/22/2026 at 11:00 AM, Patient #11 was identified to have a history of peripheral artery disease. Review of Patient #1’s MR revealed a physician order for neurovascular assessments every four (4) hours. The last neurovascular assessment completed was 01/21/2026 at 4:00 PM. Neurovascular assessments were due but not completed on 01/21/2026 at 8:00 PM, and 01/22/2026 at 12:00 AM, 4:00 AM, and 8:00 AM. During interview with Staff R (RN) and Staff E (Administrator) on 01/22/2026 at 11:05 AM, both Staff R and E acknowledged these findings.”

“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: 48940 Based on medical record review, document review, policy review, and interview, the facility failed to report incidents of alleged abuse through their occurrence and incident reporting system. This finding was observed in two (2) of ten (10) patients in the sample (Patients #9 and #11). Findings: Review of Patient #11’s MR on 10/2/24 identified on 9/18/24 at 10:07 AM, the social worker documented “Social worker met with patient at bedside this morning wherein the patient reported she was not well and that someone had locked her up and hit her during the night. -----“. On 9/18/24 at 4:09 PM, the nurse documented a noted that stated “Around 11 am I was called by the clerk that patient grandson wanted to talk to me. He was on the phone with patient’s daughter----. Patient’s daughter on the phone told me that the patient told them that someone slapped her last night”. Review of Patient #9’s MR on 10/2/24 identified that on 7/22/24 at 3:20 AM, the nurse documented that the patient alleged that the nurse who was covering a break for the staff member who was observing the patient was masturbating in their room. Review of the incidents/occurrences log on 10/2/24 identified that there were no incidents/occurrences reports filed for these incidents. Review on 10/3/24 of the policy “Patient Abuse Occurring on Hospital Premises,” last revised 06/2024, indicated the Director of Nursing/ADN/AOD or designee is responsible to “ensure any allegations of abuse, neglect, or harassment are reported through the facility’s occurrence/incident reporting system and to risk management staff.” On 10/4/24 at 12:15 PM, when Staff I (Chief Quality Officer) was asked to provide any incidents/occurrences reports for these two (2) allegations of abuse, the facility was unable to provide any reports. During interview with Staff Q (Associate Director of Nursing) on 10/7/24 at 2:30 PM, Staff Q stated the patient was confused and made comments earlier in the day that men in a boat had locked them up and hit them. Staff Q stated they did not make an incident report for Patient #11’s allegations due to the patient’s confusion and lack of evidence of injury on the patient’s face. During interview with Staff V (Director of Nursing) on 10/7/24 at 4:30 PM, Staff V was asked if any incident report was completed for Patient #9’s allegation, they stated there was not. When asked if they felt that a report should have been filed, they stated that one should have been filed.”

“NURSING SERVICES CFR(s): 482.23 The hospital must have an organized nursing service that provides 24-hour nursing services. The nursing services must be furnished or supervised by a registered nurse. This Condition is not met as evidenced by: 48001 Based on medical record review, document review and interview, in one (1) of five (5) medical records (MR) reviewed, the facility failed to maintain safety for patients at risk for falls. (Patient #1) Findings include: Review of the MR for Patient #1 identified the facility (a) failed to conduct an accurate patient fall risk assessment, (b) implement appropriate preventive measures to prevent falls, (c) document patient post fall assessment, (d) update the patient’s nursing care plan after a fall. See Tag 0395 See Tag 0396”

“QAPI PERFORMANCE IMPROVEMENT PROJECTS CFR(s): 482.21(d) As part of its quality assessment and performance improvement program, the hospital must conduct performance improvement projects. (1) The number and scope of distinct improvement projects conducted annually must be proportional to the scope and complexity of the hospital’s services and operations. (2) A hospital may, as one of its projects, develop and implement an information technology system explicitly designed to improve patient safety and quality of care. This project, in its initial stage of development, does not need to demonstrate measurable improvement in indicators related to health outcomes. (3) The hospital must document what quality improvement projects are being conducted, the reasons for conducting these projects, and the measurable progress achieved on these projects. (4) A hospital is not required to participate in a QIO cooperative project, but its own projects are required to be of comparable effort. This Standard is not met as evidenced by: 48001 Based on medial record review, document review, and interview, in one (1) of five (5) medical records (MR) reviewed the facility failed to ensure that staff documents a patient fall in the facility’s occurrence reporting system for aggregate and trending. (Patient #1) Findings: Review of the Medical Record for Patient #1 identified: An 80-year-old patient arrived in the Emergency Department on 02/02/2024 at 4:59 PM with complaint of right foot infection and foot pain. The patient was admitted to the medical surgical unit on 02/02/2024 at 8:58 PM with a diagnosis of right great toe pain due to peripheral artery disease. On 2/3/24 at 3:16 AM, Staff P, physician, documented, “I was notified by the nurse that the patient had a fall while he was going to the bathroom ...” There is no documented evidence that an occurrence report was completed after the patient fall. Review of the document, “Voice Occurrence Reporting System Guideline,” not dated, states: “RESPONSIBILITY: It is the responsibility of all individuals who are employed by or affiliated with NYC Health+ Hospitals to report all accidents, injuries, unsafe conditions, and other unusual occurrence. PURPOSE: The purpose of the guideline is to 1) provide guidance on reporting adverse events and good catches in VOICE, and 2) support the identification of those events where actions may need to be taken to improve systems or processes with goal of improving patient and staff safety and the work environment, without fixing blame on any individual. Events reported are aggregated and trended ... DEFINITIONS: Examples of an unexpected adverse occurrence, or adverse event include but are not limited to ... (a)Falls. OCCURRENCE REPORTING PROCEDURE: 1. The employee or staff member who is involved, observes, or first becomes aware of an occurrence should immediately complete an occurrence report in VOICE ...9 (the facility’s electronic occurrence reporting system).” During interviews on 6/13/24 at 11:30AM with Staff R, Director of Nursing Operations, Staff R confirmed the findings of no documentation on the fall. During interview on 6/17/24 at 11:00 AM with Staff A, Chief of Quality Management stated they also reviewed Patient #1 MR and could not locate any documentation from nursing re patient’s fall.”

“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: 48001 Based on medial record review, document review, and interview, in 1 (one) of 5 (five) medical records reviewed the facility staff failed to conduct an accurate patient fall risk assessment and implement appropriate preventive measures to prevent falls. Findings The facility’s policy and procedure (P&P) titled, “Fall and Injury Prevention Policy-System Wide,” effective 3/2023, states: “PURPOSE: To maintain safety by identifying patients at risk for falls and implementing appropriate interventions to reduce the risk of patient falls and prevent injury resulting from a fall ... Responsibilities: -All staff members are responsible for creating a safe environment of care. -The RN/Clinical Nurse assesses the patient for risk of fall and risk of fall with injury and completes the following: Completes the appropriate fall risk screening tools in the medical record. Review the patient’s history for physiological condition or changes in the status that may affect fall/fall injury risk. Initiates or modifies the plan of care based on assessment/reassessment. Communicates high-risk status where applicable to team members and at handoff. -Provide patient/family education on falls risk, specific risk factors and prevention steps. POLICY/PROCEDURE: Adult Inpatient Procedure: As part of the adult admission assessment, the Morse Fall Risk Scale will be completed as part of the admission process, determining the patient’s fall risk. Based upon the fall risk quantified by the assessment tool, patients will be considered: no risk, low risk, moderate risk, high risk ... Inpatient Interventions: Based on the patient’s risk factors, an individualized care plan prevent falls will be documented in the EMR ...” Review of the Medical Record for Patient #1 identified: An 80-year-old patient arrived in the Emergency Department on 02/02/2024 at 4:59 PM with complaint of right foot infection and foot pain and was triaged at 5:13 PM. The triage RN assessment documents a Morse Fall Risk Scale (assessment tool for predicting a patient’s potential for fall in a health care setting) risk score - zero (0). Review of the documented Morse Fall Scale (MFS) revealed items to be considered are History of Falling, Secondary Diagnosis, Ambulatory Aid, IV Therapy, Gait, Mental Status. The patient’s ambulatory aid was not considered when calculating the morse fall scale risk score. As result the patient was not scored at a higher-level. The patient was admitted to the medical surgical unit on 02/02/2024 at 8:58 PM with a diagnosis of right great toe pain due to peripheral artery disease. On 02/3/2024 at 3:00 AM, the RN initial assessment documented a morse fall scale risk score - 45 Moderate Fall Risk. Patient use of ambulatory aid was not considered when calculating the morse fall scale risk score. As a result, the patient was not scored at a higher-level score. On 2/3/24 at 3:16 AM, Staff P, physician, documented, “I was notified by the nurse that the patient had a fall while he was going to the bathroom. I went to bedside and spoke with the patient and stated his cane slipped while walking but denies head trauma or LOC (loss of consciousness), physical examination are within normal limits and no further imaging are indicated. I placed one to one (1:1) for safety and fall precautions.” On 2/5/24 Consulting MD Physical Therapist documented, the patient complained of pain s/p fall; pain score 2-4; limited ADLs and ambulation and on 2/6/24 Physical Therapist documented pain score 6, Rt. Knee. Pain was also documented by the physicians on 2/7/24 and 2/9/24. On 2/9/24 Internal Medicine documentation,” Pt complains of right hip + leg pain after fall - ordered X-ray RT hip and femur. X-ray showed deformity of the right inferior pubic ramus which could represent fracture. Orthopedic surgery consulted and did not recommended intervention.” Patient was treated with medication and physical therapy per documentation. On 02/14/24 11:21AM Orthopedic PA note revealed “patient complaint of right posterior and suprapatellar knee pain after fall on 2/2 while walking to hospital bathroom. On exam, patient is greatly contracted when RLE is passively extended past ~90 degrees. Additionally, patient has significant muscle atrophy at Quadriceps and hamstrings likely related to immobility. Patient educated on importance of early ROM/quad strengthening exercises guided by PT 2-3 x week to avoid further contractures.” Review of the nursing documentation of the morse fall scale risk score post fall identified the ambulatory aid assist and gait functioning ability, were reflected inconsistently and history of falling was not reflected in the morse score. As a result, the patient was not scored at a higher-level score. For example: On 2/5/24, 2/6/24, 2/7/24 the morse fall scale risk score -35. There was no documented evidence the RN implemented post fall interventions per facility policy. The facility’s policy and procedure (P&P) titled, “Fall and Injury Prevention Policy-System Wide,” effective 3/2023, includes: “Adult Interventions: Fall Precautions for patients at risk for falls and at risk for injury to a fall. Yellow fall risk sign, yellow wrist band. Purposeful rounding, pain, personal needs (toileting). Call bell within reach. Educate the patient to use the call bell for assistance. Post-Fall interventions: includes, -The RN needs to document in the EMR the patient’s signs or symptoms that result from a fall. -The RN needs to complete the following assessment and documentation: RN must complete vital signs. RN must complete a pain assessment related to the patient’s fall. RN must repeat MFS post-fall. -RN will update the nursing care plan of care post fall (e.g., rounding frequency and toileting needs if needed).” During interviews on 6/13/24 at 11:30 AM with Staff R, Director of Nursing Operations, Staff R confirmed the findings of no documentation on the fall. During interview on 6/17/24 at 11:00 AM with Staff A, Chief of Quality Management stated they also reviewed Patient #1 MR and could not locate any documentation from nursing re patient’s fall.”

“NURSING CARE PLAN CFR(s): 482.23(b)(4) The hospital must ensure that the nursing staff develops, and keeps current, a nursing care plan for each patient that reflects the patient’s goals and the nursing care to be provided to meet the patient’s needs. The nursing care plan may be part of an interdisciplinary care plan. This Standard is not met as evidenced by: 48001 Based on medial record review, document review, and interview, in one (1) of five (5) medical records (MR) reviewed, the facility staff failed to document patient post fall assessment and update the patient’s nursing care plan after a fall. (Patient #1) Findings: Review of the Medical Record for Patient #1 identified: An 80-year-old patient arrived in the Emergency Department on 02/02/2024 at 4:59 PM with complaint of right foot infection and foot pain. The patient was admitted to the medical surgical unit on 02/02/2024 at 8:58 PM with a diagnosis of right great toe pain due to peripheral artery disease. On 02/3/2024 at 3:00 AM, the RN initial assessment documented a Morse Fall Scale (MFS) risk score - 45 Moderate Fall Risk. On 2/3/24 at 3:16 AM, Staff P, physician, documented, “I was notified by the nurse that the patient had a fall while he was going to the bathroom. I went to bedside and spoke with the patient and stated his cane slipped while walking but denies head trauma or LOC (loss of consciousness), physical examination are within normal limits and no further imaging are indicated. I placed one to one (1:1) for safety and fall precautions.” On 2/5/24 Consulting MD PT documented, “ c/o pain s/p fall; pain score 2-4; limited ADLs and ambulation” and on 2/6/24 Physical Therapist documented pain score 6, Rt. Knee. Pain was also documented by the physicians on 2/7/24 and 2/9/24. Review of the nursing care plan dated 2/3/24, 2/6/24 and 2/12/24, there was no documented evidence that the RN completed a patient assessment and updated the patient’s nursing care plan post fall. The facility’s policy and procedure (P&P) titled, “Fall and Injury Prevention Policy-System Wide,” effective 3/2023, includes: “Post-Fall interventions: includes, -The RN needs to document in the EMR the patient’s signs or symptoms that result from a fall. -The RN needs to complete the following assessment and documentation: RN must complete vital signs. RN must complete a pain assessment related to the patient’s fall. RN must repeat MFS post-fall. -RN will update the nursing care plan of care post fall (e.g., rounding frequency and toileting needs if needed).” During interviews on 6/13/24 at 11:30 AM with Staff R, Director of Nursing Operations, Staff R confirmed the findings of no documentation on the fall. During interview on 6/17/24 at 11:00 AM with Staff A, Chief of Quality Management stated they also reviewed Patient #1 MR and could not locate any documentation from nursing re patient’s fall.”

“STANDARD TAG FOR OUTPATIENT SERVICES CFR(s): 482.54 Standard-level Tag for §482.54 Condition of Participation: Outpatient Services If the hospital provides outpatient services, the services must meet the needs of the patients in accordance with acceptable standards of practice. This Standard is not met as evidenced by: 48001 Based on document review, medical record (MR) review, and interview, in one (1) of 13 Medical Records reviewed, the providers did not inform the patient of the risk and benefits when the patient refused treatment. (Patient #1). Findings: Review of the medical record for Patient #1 identified: patient presented to vascular clinic on 4/19/24 for follow up secondary to Peripheral Artery Disease (PAD). Physician documented 80-year-old male with past medical history of hypertension (HTN), peripheral vascular disease (PAD), and alcohol abuse admitted earlier in the year on 2/2/24 through 2/22/24 for complaints of right great toe pain/infection and difficulty walking. At vascular surgery clinic visit on 04/19/2024 approximately 10:33AM it was noted angiogram scheduled for 4/4/24 was not done. Right foot with slight toe tenderness, warm with blackening, dry gangrene to dorsum of the right great toe. Sent to Emergency Room (ER) for right foot/ big toe possibly infection and need for vascular intervention, angiogram and IV antibiotic treatment. Review of the Outpatient vascular clinic Medical Record (MR) identified follow up: General Surgery on 2/27/24 findings, “right foot with toe tenderness, warm, able to wiggle toes, healed ulcer to dorsum of right great toe, with plan for possible angioplasty on 3/11/24, adamantly refuses amputation.” General Surgery NP 3/05/24, “pre-op for procedure on 3/11/2024, declined recommendation for amputation”. Internal medicine on 03/05/24 states, “fracture of right inferior pubic ramus for which orthopedic did not recommend any surgical intervention and for management with pain medication.” General Surgery on 03/26/24, “re consultation for evaluation of the possibility for amputation which, patient adamantly refuses, rescheduled for right lower extremity (RLE) angiogram with chief of surgical services.” Review of patient’s #1 medical record, there were no refusal of treatment form found in the MR. Per hospital policy, “Informed Consent for Treatment/Procedure for Adults and Minors, effective 12/20/22,” states, “Refusal of Treatment; (b) when a patient refuses to consent to a recommended treatment, the physician will document in the medical record, in detail ...risk, benefits, alternatives ....the consequences of such refusal ...patient’s capacity to understand and refuse treatment.” During interview on 6/11/24 at 12:33 PM with Staff E, Chief of Surgical Services for Inpatient and Ambulatory Surgical Services, reported he did not recall why there was no detailed documentation in the medical record along with a refusal of treatment form during first admission on 2/2/24 and his multiple clinic visits.”