Bronxcare Hospital Center

“FACILITIES, SUPPLIES, EQUIPMENT MAINTENANCE CFR(s): 482.41(c)(2) Facilities, supplies, and equipment must be maintained to ensure an acceptable level of safety and quality. This Standard is not met as evidenced by: 21204 Based on observation, document review, and interview, the facility failed to ensure dialysis staff recognized and responded appropriately to equipment malfunction and ensured timely removal of malfunctioning equipment from service to maintain patient safety. Findings include: During a tour of the dialysis unit on 9/22/2025 at approximately 12:00 PM, the dialysis machine at Station #3 displayed a red visual alarm signal without an accompanying audible alarm. Staff did not respond to the visual alarm for approximately 10 minutes during observation by the surveyor. When questioned, Staff B (Registered Nurse) stated that the red alarm had been present since the initiation of the dialysis treatment and that staff were unaware of the cause of the alarm. On 9/22/2025 at approximately 12:10 PM, Staff A (Nurse Administrator) stated they were also unaware of the issue. A Biomedical Technician was then called to assess the machine. Upon evaluation, the technician was unable to immediately identify the cause of the alarm and removed the machine from service for further inspection. The patient was subsequently transferred to another machine to continue treatment. Review of the machine’s inspection report dated 9/24/25 revealed the dialysis machine’s “traffic light” alarm system was malfunctioning and inoperable. Failure of this system indicates that a critical safety monitoring mechanism was not functioning.”

“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: 16362 . Based on medical record review, document review, and staff interview, the facility failed to maintain an effective, ongoing, data-driven Quality Assessment and Performance Improvement (QAPI) program. Findings include: The facility, in its review of an identified incident, did not identify all related quality-of-care issues, implement appropriate corrective actions, or develop monitoring mechanisms to ensure the issues did not recur. See Tag A-0283 - Quality Improvement Activities: §482.21(b)(2)(ii), (c)(1), (c)(3). .”

“PATIENT RIGHTS: PERSONAL PRIVACY CFR(s): 482.13(c)(1) The patient has the right to personal privacy. This Standard is not met as evidenced by: 10723 . Based on observation, document review and interview, the facility did not ensure that the patient’s rights to confidentiality of patient information, respect and dignity was maintained while receiving care in the Emergency Department. Findings: The facility’s policy and procedure titled “Patient’s Bill of Rights,” last reviewed 06/2023 states the following: “The hospital shall ensure that all patients...are assured their rights to ...considerate and respectful care... and confidentiality of information.” The facility’s policy and procedure titled “Abuse, Neglect and Harassment Prevention,” last reviewed 07/2023 states the following: The hospital “is committed to the provision of...which upholds the right of any patient to be treated with dignity and respect and be free from all forms of abuse, neglect or harassment...Abuse can be...verbal.” On 11/4/2025 at 12:15 PM, in the Emergency Department at the nurses’ station in the presence of the surveyor, several staff members, patients and visitors, Staff OO (Emergency Medicine Attending) spoke to Patient #2 in a loud, abrasive and demeaning manner while revealing confidential patient information. During interview of Staff Q (ED Leadership) on 11/04/2025 at approximately 12:20 PM, Staff Q reported that upon notification of the incident by the surveyor, they immediately removed Staff OO from the unit. During interview of Staff QQ (Hospital Leadership) on 11/5/2025 approximately 2:00 PM, Staff QQ acknowledged this finding. .”

“QUALITY IMPROVEMENT ACTIVITIES CFR(s): 482.21(b)(2)(ii), (c)(1), (c)(3) (b) Program Data (2) [The hospital must use the data collected to - .....] (ii) Identify opportunities for improvement and changes that will lead to improvement. (c) Program Activities (1) The hospital must set priorities for its performance improvement activities that-- (i) Focus on high-risk, high-volume, or problem-prone areas; (ii) Consider the incidence, prevalence, and severity of problems in those areas; and (iii) Affect health outcomes, patient safety, and quality of care. (3) The hospital must take actions aimed at performance improvement and, after implementing those actions, the hospital must measure its success, and track performance to ensure that improvements are sustained. This Standard is not met as evidenced by: 10723 . Based on medical record review, document review, and staff interview, in one of four mortalities reviewed (Patient #1), the facility failed to identify all quality-of-care issues, implement corrective actions, and develop monitoring mechanisms to prevent recurrence. Findings include: The facility’s Organizational Performance Improvement Plan dated 2024-2025 stated the following: “...It has the responsibility for monitoring the provision of care/services from admission to discharge in order to identify and resolve any breakdowns that may result in sub-optimal patient care and safety...The status of identified problems is tracked to assure improvement or problem resolution...Assessment of the monitoring and evaluation processes to determine its effectiveness.” Review of the facility’s Incident Reports (07/2025-10/2025) identified the following: An Incident Report dated 10/15/2025 documented that Patient #1 presented to the Emergency Department (ED) on 09/29/2025 with abdominal pain and was discharged. Approximately twenty minutes after discharge, Patient #1 returned to the ED after suffering a syncopal episode in an outpatient department. During evaluation, the patient was found pulseless. Resuscitation efforts were unsuccessful, and the patient expired. A review of the hospital’s investigation showed the facility did not, in its review of the incident, identify all quality-of-care issues, implement corrective actions, or establish monitoring mechanisms to prevent recurrence. The facility did not identify staff non-compliance with policies and procedures and did not implement corrective actions. The facility policy titled “Sepsis-Early Goal Directed Therapy (EGDT)/Severe Sepsis Protocol for Adults,” last reviewed 2/2025, stated, in part: “Every 15-minute vital signs will be taken and documented. Initiate fluid bolus (0.9% Normal Saline or Lactated Ringers) 30 ml/kg over 20-30 minutes ...Administer appropriate empiric antibiotic within one hour of identification of severe sepsis or septic shock ...Sepsis protocol is initiated in electronic medical record.” The facility policy titled “Chest Pain Policy,” last reviewed 07/2025, stated, in part: “Patient 18 years or older with chest pain suspected to be cardiac in nature or anginal equivalent, order Troponin (primary cardiac enzyme that indicates heart damage) at presentation and three hours later.” Although the Emergency Medicine investigation (undated) identified that the ED Attending did not address elevated lactic acid (a serious medical condition that can result from underlying conditions) and troponin levels, failed to repeat laboratory studies, and did not initiate the Sepsis Protocol, there was no documented evidence of staff education or a monitoring mechanism to ensure compliance. The Family Medicine investigation (undated) did not identify any quality-of-care issues. The investigation did not identify that the family medicine physician failed to ensure timely antibiotic administration, order fluid boluses, or initiate the Sepsis Protocol in the electronic medical record as required by policy. As a result, there was no medical staff education or monitoring mechanism implemented. The hospital corrective action plan included the implementation of a new policy and procedure titled “ERG (Emergency Room General) Admissions in The Emergency Department.” However, the facility could not provide documented evidence of medical and nursing staff education, or a monitoring mechanism related to the new policy. During interview on 11/12/2025 at 2:15 PM, Staff Q (ED Leadership) and Staff P (ED Attending) confirmed these findings. Per interview on 11/13/2025 at 10:20 AM, Staff S (Physician Leadership) confirmed these findings. A review of the nursing investigation dated 10/29/2025 did not identify the following: - failure to monitor vital signs every fifteen minutes as required by the Sepsis Protocol; - elevated troponin and lactic acid levels not acknowledged or escalated; - failure to escalate delays in antibiotic and fluid administration due to inability to obtain IV access. There was no documented evidence of nursing education or monitoring mechanisms to ensure compliance. The nursing investigation identified issues with the care provided and documented that nursing staff were educated; however, no monitoring mechanism was implemented to ensure compliance. Per interview with Staff JJ (ED Nursing Leadership) on 11/13/2025 at 10:48 AM, Staff JJ and Staff MM (ED RN) confirmed these findings.”

“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: 47318 . Based on medical record (MR) review, document review, and interview, the hospital failed to maintain an effective, ongoing, hospital-wide, data driven quality assessment and performance improvement (QAPI) program. Findings: The facility failed to: - Investigate occurrences to identify opportunities for improvement. (See Tag A-0283) - Track, trend, and analyze elopements to implement corrective actions (See Tag A-0286)”

“QUALITY IMPROVEMENT ACTIVITIES CFR(s): 482.21(b)(2)(ii), (c)(1), (c)(3) (b) Program Data (2) [The hospital must use the data collected to - .....] (ii) Identify opportunities for improvement and changes that will lead to improvement. (c) Program Activities (1) The hospital must set priorities for its performance improvement activities that-- (i) Focus on high-risk, high-volume, or problem-prone areas; (ii) Consider the incidence, prevalence, and severity of problems in those areas; and (iii) Affect health outcomes, patient safety, and quality of care. (3) The hospital must take actions aimed at performance improvement and, after implementing those actions, the hospital must measure its success, and track performance to ensure that improvements are sustained. This Standard is not met as evidenced by: 47318 Based on document review and interview, in two (2) of 25 occurrences reviewed, the facility failed to investigate occurrences to identify opportunities for improvement (Patients #17 and #18). Findings: Review of the facility’s Incident/Occurrences Log and Reports, dated from 01/01/2025 to 06/16/2025, identified the following: Occurrence Report dated 5/24/2025 identified that at 10:15AM, Patient #17 was punched on the right side of their face by another patient while sitting in a chair. The patient complained of headache, ringing in their ears, and ear discharge. The patient was transferred to the Emergency Room at the Grand Concourse campus for a Cat Scan (CT) of the head. Occurrence Report dated 5/24/2025 identified that at 12:20PM, Patient # 18 was punched on the right side of their face by another patient while speaking with a nurse. Patient #2 was examined and had no bleeding, swelling, or injuries. Upon request, no investigations for these occurrences could be furnished. Electronic mail dated 6/23/2025 at 4:09 PM from Staff H (Administrator) confirmed that no investigative reports were on file. The facility policy and procedure (P&P) titled, “Incident Reporting,” last reviewed 03/2023, instructed staff to “...retain the yellow “Department Copy” for the completeness of their file and conduct follow up investigation and action as deemed appropriate.” During interview of Staff HH (Administrator) on 06/24/2025 at 1:58 PM, Staff HH stated that all investigations are to be completed by the nurse manager of the unit the incident/occurrence took place on. Staff HH explained that when no follow-up is received by Risk Management, an email is sent requesting a response to the original email for the investigation. These findings were shared with Staff F (Coordinator), Staff G (Coordinator), and Staff HH (Administrator) on 06/24/2025 at approximately 2:10 PM.”

“PATIENT RIGHTS CFR(s): 482.13 A hospital must protect and promote each patient’s rights. This Condition is not met as evidenced by: 17636 . Based on medical record review, document review, and interview, in two (2) of 19 medical records reviewed, it was determined the facility failed to (a) protect patients right to receive care in a safe setting and (b) follow its procedures for grievance resolution. These findings were evident in Medical Records #1 and #2. Findings include: The facility failed to follow its policy for the submission of grievances. See detailed findings at A-0121. The facility failed to provide a written response to a complainant. See detailed findings at A-0123. The facility failed to follow its Constant Observation policy, which requires the observer to be at arm’s length when a patient is on constant observation. See detailed findings at A-0144. .”

“PATIENT RIGHTS: GRIEVANCE PROCEDURES CFR(s): 482.13(a)(2)(i) [At a minimum:] The hospital must establish a clearly explained procedure for the submission of a patient’s written or verbal grievance to the hospital. This Standard is not met as evidenced by: 17636 . Based on document review and interview, the facility failed to implement its procedure for submitting a verbal grievance. These findings were evident in one (1) of nine (9) grievances reviewed. Findings include: A review of the policy titled “Patient Complaints and Grievances,” which was last revised on 07/2023, revealed that “Hospital staff members who receive a complaint will have the ability to document and report the complaint via the hospital intranet-’ REPORT A COMPLAINT GRIEVANCE’-and complete the form template. Once the form is completed by the hospital staff person, a notification will be sent to Patient Relations, who will then follow up accordingly with the complainant and the involved department.” A review of an email dated 1/24/25 at 5:35 PM revealed that Staff C, Director of Risk Management, documented, “I had a lengthy conversation with the Corporate Compliance Officer at Patient #1’s residence who inquired about the following: 1. Why the patient was placed on a 2:1 instead of a 1:1, and why the patient was assaulted? 2. Immediate steps taken to ensure the safety of Patient #1. 3. Where we stand with a write-up of the investigation, and they requested a copy of the write-up.” A review of all grievances for 2025 revealed that this grievance was not documented in the grievance log. During an interview conducted on 2/27/25 at 3:40 PM with Staff C, Director of Risk Management, Staff C stated they spoke on 1/24/25 with the Corporate Compliance Officer where Patient #1 resided regarding Patient #1’s assault at the hospital on 1/24/25. Staff C stated they referred the Officer to the Patient Relations Department to submit a complaint. Staff C also acknowledged not submitting a complaint to the Patient Relations Department. During an interview conducted on 3/03/25 at 10:15 AM with Staff H, Patient Relations Manager, Staff H stated the department had not received a complaint regarding Patient #1’s injuries. These findings were shared with Staff B, Regulatory Assessment Coordinator, on 3/6/25 at 3:45 PM, who acknowledged the findings. .”

“PATIENT RIGHTS: NOTICE OF GRIEVANCE DECISION CFR(s): 482.13(a)(2)(iii) At a minimum: In its resolution of the grievance, the hospital must provide the patient with written notice of its decision that contains the name of the hospital contact person, the steps taken on behalf of the patient to investigate the grievance, the results of the grievance process, and the date of completion. This Standard is not met as evidenced by: 17636 . Based on document review and interview, the facility failed to provide the complainant with a written notice of the results of a grievance process. These findings were evident in one (1) of nine (9) grievances. Findings include: A review of the policy titled “Patient Complaints and Grievances,” which was last revised on 07/2023, revealed, “It is the goal to provide a written response to the complainant within seven business days from receipt of a grievance. A written response will include the name of the contact person, steps taken to investigate, outcome/results of the grievance process, and the date of completion.” A review of an email dated 1/24/25 at 5:35 PM revealed Staff C, Director of Risk Management, documented, “I had a lengthy conversation with the Corporate Compliance Officer at the patient’s residence, where the patient currently resides, who inquired about the following: 1. Why the patient was placed on a 2:1 instead of a 1:1, and why the patient was assaulted? 2. Immediate steps taken to ensure the safety of Patient #1. 3. Where we stand with a write-up of the investigation, and they requested a copy of the write-up.” There was no documented evidence that the facility provided a written response to these questions to the Corporate Compliance Officer. These findings were shared with Staff B, Regulatory Assessment Coordinator, on 3/6/25 at 3:45 PM, who acknowledged the findings. .”

“PATIENT RIGHTS: CARE IN SAFE SETTING CFR(s): 482.13(c)(2) The patient has the right to receive care in a safe setting. This Standard is not met as evidenced by: 17636 . Based on medical record review, document review, and interview, in two (2) of 19 medical records reviewed, the facility failed to protect patients’ right to receive care in a safe setting. These findings were evident in medical records #1 and #2. Findings include: The policy titled “Observation Status Concourse Acute Care Division,” last revised on 7/24, revealed, “Constant Observation 1:1 [one staff member assigned to monitor one patient] is a level of observation required for patients at risk to harm themselves. The assigned staff member must be positioned at arms’ length and within constant eyesight of the patient at all times.” Patient #1 was admitted to the Intensive Care Unit on 1/20/25 with diagnoses of Sepsis (a life-threatening reaction to an infection) secondary to Pneumonia, Hypernatremia (high blood sodium) secondary to Dehydration, Acute Kidney Injury, a previous history of Down’s Syndrome and the patient was primarily non-verbal. On 1/21/25, the physician downgraded Patient #1’s condition, and the patient was transferred to room 1505B. On 1/24/25 at 12:44 AM, a nurse documented that Patient #1 was “on a 2:1 Close Observation” [one staff assigned to monitor two patients] for safety. On 1/23/25 at 5:11 AM, Patient #2 presented to the Emergency Department with worsening hallucinations and paranoia for the past year and was admitted to room 1505A for Acute Delirium and Auditory Hallucinations. Upon admission, the physician placed Patient # 2 on 1:1 Constant Observation for elopement precautions. On 1/24/25 at 3:00 AM, the physician documented, “Patient Care Technician (PCT) report patient in 1505A [Patient #2] attacked patient in 1505B [Patient #1] by punching him in the face with both hands. The PCT called for assistance and tried to intervene immediately. RN called Medical Emergency Treatment (MET) code as patient noted to be bleeding from the face ...” During an interview on 2/28/25 at 10:35 AM, Staff A, Patient Care Technician (PCT), stated that on 1/24/25 at approximately 2:41 AM, they were seated at the door of room 1505 and were monitoring both patients [Patient #1 and Patient #2] simultaneously. Patient #2 got off their bed and “punched Patient #1 very hard in the face two to three times with both hands. Patient #2 reported that Patient #1 was making noises, and they were snitching on him.” Staff F, RN, stated during an interview conducted on 2/28/25 at 11:40 AM that upon their arrival in the patient’s room on 1/24/25, they observed the patient’s [Patient #1] face, gown, and sheet was bloody, and their right eye was shut. Patient # 1 sustained two (2) 0.5 centimeters (cm) superficial lacerations below the right eye, a one (1) cm laceration of the upper right lip that extended intraorally, and a one (1) cm laceration in the center of the lip which required sutures as well as a small amount of acute subdural hematoma measuring 2 millimeters. Patient #1 was also exposed to an infectious viral disease, which required prophylactic treatment. Patient #2’s assessment revealed they sustained bruises on their right hand. There was no documented evidence that Patient #2, who was on 1:1 constant observation, was monitored at arm’s length in accordance with the policy, and the safety of Patient #1, who was on 2:1, was not maintained. These findings were shared with Staff B, Regulatory Assessment Coordinator, on 3/03/25 at 12:45 PM. An Immediate Jeopardy (IJ) situation was identified on 03/03/25 at 12:45 PM due to the facility’s failure to protect patients’ right to receive care in a safe setting. The facility provided an IJ Removal Plan to survey staff, which was accepted on 03/03/2025 at 7:10 PM. The IJ Removal Plan included: (a) Revision of the policy titled “Observation Status Concourse Acute Care Division,” dated 03/03/25, which states “any patient who is vulnerable, such as a patient with an intellectual disability, cannot be in a room with a patient who is on constant observation.” (b) Beginning on 3/03/25, the facility will educate all nursing staff on the revised policy on “Observation Status Acute Care Division.” Staff education will continue at the start of each shift until 100% of staff are educated on the policy. (c) When ancillary staff (Patient Care Technicians /Certified Nurse Assistants) are assigned to perform constant observation of patients, they cannot be assigned additional duties. (d) The facility will educate Medical Doctors, Residents in Family Medicine, Internal Medicine, and the Emergency Department on the “Observation Status Concourse Acute Care Division” policy and the updated criteria for placing vulnerable patients. The IJ was removed on 03/04/25 at 4:16 PM based on the on-site verification of the implementation of the IJ Removal Plan through observations, interviews, and document reviews. .”

“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: 17636 . Based on document review, interview, and review of facility incidents, the facility, in its review of incidents, failed to (a) identify the lack of adequate monitoring of patients and (b) implement measures to prevent a recurrence of similar incidents. These findings were evident in one (1) of eight (8) incidents reviewed. Findings include: The policy titled “Sentinel Event,” last revised 03/2023, revealed that “the event is assigned to a root cause analysis team for intensive analysis and corrective action.” Surveyor review on 2/28/25 of the form titled “Occurrence Reporting Form” revealed an incident that occurred on 1/24/25 at 2:48 AM where a patient [Patient #2] assaulted their roommate [Patient #1], which resulted in physical injuries to the patient. Medical record review revealed the patient’s nurse documented on 1/24/25 at 12:44 AM that Patient #1 in room 1505B was on close observation (2:1 observation requiring one staff monitoring two patients). The Charge Nurse documented on the form titled “Daily Staff Assignment” for 1/23/25 from 11:00 PM to 1/24/25 at 7:30 PM that the patient in 1505A was on Constant Observation (1:1 observation requiring one staff monitoring one patient). The Charge Nurse assigned one (1) Patient Care Technician to simultaneously monitor Patient #1 and Patient #2. Review of the form titled “Risk Management Investigative Response Tool “ revealed that item #6 requires documentation for “what action was/what action will be taken to prevent the recurrence of this event,” and item #7 requires “identification of the committee that will review this event.” There was no documentation of any response to items #6 and #7 on the form. There was no identification and analysis in the quality assessment and performance improvement minutes or the Medical Advisory Meeting that one (1) Patient Care Technician was assigned to monitor two (2) patients simultaneously, one of whom was a 1:1 constant observation at arm’s length and the other on a 2:1 observation. These findings were shared with Staff B, Regulatory Assessment Coordinator, on 3/03/25 at 12:45 PM, who acknowledged the findings.”

“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: 33919 . Based on medical record (MR) review, document review, and interview, the facility failed to fully investigate, identify, and evaluate an infection control issue. This failure placed patients at increased risk of infection. Findings: The facility failed to: - Identify that inspection and replacement of the internal transducer protectors was not performed on a hemodialysis machine used to treat a Hepatitis B virus positive patient, prior to the machine’s use on non-Hepatitis B virus patients. (See Tag A-0286)”

“PHYSICAL ENVIRONMENT CFR(s): 482.41 The hospital must be constructed, arranged, and maintained to ensure the safety of the patient, and to provide facilities for diagnosis and treatment and for special hospital services appropriate to the needs of the community. This Condition is not met as evidenced by: 19043 . Based on document review and interview, the facility failed to maintain hemodialysis equipment to ensure patient safety. Findings: The facility failed to: - Ensure electrical safety tests were performed and documented during preventative maintenance (PM), in accordance with manufacturers and the National Fire Protection Association’s (NFPA) 99 (health care facilities code) recommendations. (See Tag A-0724)”

“INFECTION PREVENTION CONTROL ABX STEWARDSHIP CFR(s): 482.42 The hospital must have active hospital-wide programs for the surveillance, prevention, and control of HAIs and other infectious diseases, and for the optimization of antibiotic use through stewardship. The programs must demonstrate adherence to nationally recognized infection prevention and control guidelines, as well as to best practices for improving antibiotic use where applicable, and for reducing the development and transmission of HAIs and antibiotic resistant organisms. Infection prevention and control problems and antibiotic use issues identified in the programs must be addressed in collaboration with the hospital-wide quality assessment and performance improvement (QAPI) program. This Condition is not met as evidenced by: 19043 . Based on document review and interview, the facility failed to ensure staff complied with standards of infection control practices to avoid potential sources of cross contamination. This failure placed patients at risk for exposure to infectious diseases. Findings: The facility failed to: - Ensure preventive measures were implemented after a non-isolation designated hemodialysis machine (a machine used to treat non-isolation dialysis patients) was used to treat a Hepatitis B Virus positive patient. (See Tag A-0750)”

“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: 33919 . Based on medical record (MR) review, document review, and interview, the facility failed to identify that inspection and replacement of the internal transducer protectors was not performed on a hemodialysis machine used to treat a Hepatitis B virus positive patient, prior to the machine’s use on non-Hepatitis B virus patients. This failure placed all non-Hepatitis B virus hemodialysis patients at risk for exposure to the Hepatitis B virus. Findings: Review of Patient #1’s medical record identified that Hemodialysis Machine #14 (a non-isolation designated machine) was used to treat Patient #1, a Hepatitis B Virus positive patient, on 3/8/2024. The facility’s Hemodialysis Treatment Sheets, dated from 3/8/2024 to 3/11/2024, verified that Patient #s 2 and 3 were subsequently dialyzed on Machine #14 since it’s use on the Hepatitis B positive patient (Patient #1) on 3/8/2024. Machine #14’s Repair Log, dated 3/11/2024, identified that Machine #14 was terminally disinfected on 3/11/2024. There was no documented evidence that the internal transducer protectors were inspected and changed prior to Machine #14’s return to general use on non-Hepatitis B virus patients. During interview of Staff L (Biomedical Technician) on 4/4/2024 at 10:15 AM, Staff L confirmed they were not informed of the use of Machine #14 on a Hepatitis B Virus positive patient. Staff L also stated that if they had been notified of the exposure, they would have opened the machine and inspected/replaced the internal transducer protectors and disinfected the metal ports connecting the tubing. Although Staff L verbalized the steps they would follow had they been notified of an exposure, Staff L confirmed they did not inspect or replace the internal transducer protectors prior to returning hemodialysis Machine #14 to general use. Confirmation and review of the facility’s investigation revealed that the investigation did not identify the need to notify the Biomedical technician of the use of Machine #14 on a Hepatitis B positive patient, and the potential contamination of the machine’s internal transducer protectors. Thus, Machine #14 was not inspected to verify there was no contamination to the internal transducer protectors, mitigating Hepatitis B exposure to non-immune patients. During interview of Staff E (Chief of Nephrology) on 4/5/2024 at 9:30AM, Staff E confirmed the facility’s investigation did not identify the need for Biomedical’s physical inspection of the internal transducer protectors on Machine #14 to rule out cross-contamination, prior to returning the machine to use on the general hemodialysis population. Staff E acknowledged that the Biomedical technician should have been notified of the machine’s use on a Hepatitis B virus positive patient.”

“FACILITIES, SUPPLIES, EQUIPMENT MAINTENANCE CFR(s): 482.41(c)(2) Facilities, supplies, and equipment must be maintained to ensure an acceptable level of safety and quality. This Standard is not met as evidenced by: 19043 . Based on document review and interview, in eleven (11) of eleven (11) hemodialysis machines, the facility failed to ensure electrical safety tests were performed and documented during preventative maintenance (PM), in accordance with manufacturers and the National Fire Protection Association’s (NFPA) 99 (health care facilities code) recommendations. Findings: The 2012 edition of the National Fire Protection Association (NFPA) 99 code 10.5.2.1.2 stated that “All patient care-related electrical equipment used in patient care rooms shall be tested ... before being put into service for the first time and after any repair or modification that might have compromised electrical safety.” In addition, Section 6.3.3.1 stated, “ ...the effectiveness of the grounding system shall be determined by voltage measurements and impedance measurements.” The Fresenius 2008 T Hemodialysis Machine Manufacturer’s Instructions for Use (IFU) (reviewed on 4/4/2024), directed staff to “ ...measure the resistance...[and] verify the resistance is less than 0.2 ohm...[and that the] electrical chassis leakage [does] not exceed 100 microamperes.” The Instructions for Use also directed staff to “ ...record the measured values on either the 6-month ...or Annual Preventative Maintenance Checklist ...depending upon which is being performed...” Review of the facility’s 2023-2024 Preventive Maintenance (PM) Records for the 2008 T Hemodialysis Machines identified that no electrical safety test results were documented during the annual or semi-annual preventive maintenance. In addition, the work performed by the Biomedical staff during preventive maintenance was documented as “Pass.” There was no documented evidence that impedance and voltage measurements were obtained and documented. The instructions on the facility’s Preventive Maintenance Work Orders for 2024 directed biomedical technicians to, “ ...perform electrical safety ONLY if potential unsafe condition exists, is suspected, or repair(s) have been made, in accordance with NFPA 99 and ...policies ...” The instructions lacked guidance directing staff to perform and document the required electrical leakage and impedance measurements during the machines’ annual or semi-annual preventive maintenance. During interview of Staff L (Biomedical Technician) on 4/4/2024 at 10:15 AM, Staff L confirmed that the line voltage, ground resistance, and leakage measurements/results were not documented in the preventive maintenance records. In addition, Staff L was not able to confirm that these measurements had been obtained during the machines’ annual preventive maintenance.”

“INFECTION CONTROL SURVEILLANCE, PREVENTION CFR(s): The infection prevention and control program includes surveillance, prevention, and control of HAIs, including maintaining a clean and sanitary environment to avoid sources and transmission of infection, and addresses any infection control issues identified by public health authorities; and This Standard is not met as evidenced by: 19043 . Based on document review and interview, the facility failed to ensure preventive measures were implemented after a non-isolation designated hemodialysis machine (a machine used to treat non-isolation dialysis patients) was used to treat a Hepatitis B Virus positive patient. This failure placed all hemodialysis patients at risk for infection due to cross-contamination. Findings: Review of Patient #1’s medical record identified that Hemodialysis Machine #14 (a non-isolation designated machine) was used to treat Patient #1, a Hepatitis B Virus positive patient, on 3/8/2024. Review of Machine #14’s Repair Log, dated 3/11/2024, identified no documented evidence that the internal transducer protectors were inspected or replaced after the machine’s repair, and before the return of Machine #14 to treat the general non-isolation hemodialysis population (non-Hepatitis B Virus positive patients). During interview of Staff L (Biomedical Technician) on 4/4/2024 at 10:15 AM, Staff L confirmed they were not informed of the use of Machine #14 on a Hepatitis B Virus positive patient. Staff L also stated that if they had been notified of the exposure, they would have opened the machine and inspected/replaced the internal transducer protectors and disinfected the metal ports connecting the tubing. Although Staff L verbalized the steps they would follow had they been notified of an exposure, Staff L confirmed they did not inspect or replace the internal transducer protectors prior to returning dialysis Machine #14 to general use. Upon request, the facility could not provide a written policy, procedure, instructions, or guidance directing staff of the actions to take when non-isolation machines were used to treat Hepatitis B Virus positive patients. In addition, the facility could not furnish written guidance directing staff of the steps to follow when blood or saline passes through the external tubing and transducer protectors. Upon request, the facility could not provide documented evidence of staff education and/or guidance directing nursing staff to notify Biomedical staff of Hepatitis B cross-contamination to hemodialysis machines after use on Hepatitis B positive patients, and the need to inspect/replace internal transducer protectors, prior to returning non-isolation designated machines to general use. During interview of Staff E (Chief of Nephrology) on 4/5/2024 at 9:30AM, Staff E confirmed no physical inspection of the internal transducer protectors was performed on hemodialysis Machine #14. Staff E also confirmed there was no written guidance directing nursing staff to notify Biomedical staff of Hepatitis B Virus-contaminated machines/equipment, or the steps staff should follow if cross-contamination occurred.”