Berkshire Medical Center

“PATIENT RIGHTS CFR(s): 482.13 A hospital must protect and promote each patient’s rights. This Condition is not met as evidenced by: 37556 The Hospital was out of compliance for the Condition of Participation for Patient Rights. Based on a review of security footage, medical records, hospital policies, and staff interviews, the hospital failed to ensure staff compliance with established procedures. On 4/4/25 at approximately 4:30 A.M., a physical altercation took place between Security Officer (SO) #1, Certified Nurse Assistant (CNA) #1, and Patient #1. SO#1 and CNA #1 used excessive force and unapproved techniques to restrain Patient #1. Unauthorized staff (nursing and security) accessed the security camera video footage and witnessed this incident, and failed to promptly escalate safety concerns, waiting three days (4/7/25) to report the incident to Emergency Department (ED) leadership. Cross Reference: Patient Rights: Personal Privacy (Tag 143) & Care in a Safe Setting (Tag 0144).”

“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: 45980 The Hospital was out of compliance for the Condition of Participation for Nursing Services. Based on record review and interviews, the Hospital failed to ensure nursing staff reported abnormal findings to a provider (backflow of blood into the intravenous (IV) tubing of a central line) for one Patient (#2) out of a total sample of ten patients. Cross Reference: 482.23(b)(3) - A registered nurse must supervise and evaluate the nursing care for each patient. (395)”

“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: 37556 Based on a review of security footage, medical records, hospital policies, and staff interviews, the hospital failed to ensure staff compliance with established procedures. On 4/4/25 at approximately 4:30 A.M., SO#1 and CNA #1 used excessive force and unapproved techniques to restrain Patient #1 and several unauthorized staff (nursing and security) accessed security camera video footage to watch the event. Findings include: Review of the Hospital’s Policy, titled, Patient Bill of Rights and Patient Responsibilities, dated November 2023, indicated that Patient’s had the right to privacy (within the physical capacity of the Hospital) during medical treatment or other rendering of care. Review of the Department of Public Health’s (DPH) Health Care Facility Reporting System (HCFRS), dated 4/13/25, indicated that on 4/4/25 at approximately 4:30 A.M., SO#1 and CNA #1 used excessive force utilizing unapproved techniques to subdue Patient #1 during a restraint application. Several unauthorized staff members (nursing and security) reviewed the security camera footage of the event violating patient privacy. Further review of the Hospital’s investigation indicated the security camera footage access was further limited and staff directly involved viewing the video without authorization and without a clinical need had been counselled, however, there was no documentation to support system wide corrective actions were developed or implemented. During an interview on 7/15/24 at 2:15 P.M., and throughout the Survey, the Patient Safety Officer (PSO) provided documentation of the Hospital’s Internal Investigation and review of Patient #1’s restraint event on 4/4/25, however, she said there was no documentation at the time of Survey to support the Hospital implemented system wide corrective actions in response to the patient privacy concerns related to the event.”

“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: 37556 Based on a review of security footage, medical records, hospital policies, and staff interviews, it was determined that the Hospital failed to ensure staff compliance with established procedures. On 4/4/25 at approximately 4:30 A.M., a physical altercation took place between Security Officer (SO) #1, Certified Nurse Assistant (CNA) #1, and Patient #1. SO#1 and CNA #1 used excessive force and unapproved techniques to restrain Patient #1. Staff who witnessed this incident also failed to promptly escalate safety concerns, waiting three days until (4/7/25) to report the incident to Emergency Department (ED) leadership. Findings include: Review of the Hospital’s Policy, titled Patient Bill of Rights and Patient Responsibilities, dated November 2023, indicated that Patient’s had the right to receive care in a safe setting. Review of the Hospital’s Policy titled Adverse Event Reporting, dated January 2024, indicated the purpose of the policy was to protect patient in the event of an adverse event/patient safety concern. The Policy indicated the following: - It’s staff responsibility to ensure prompt medical treatment was provided, if needed, by the appropriate physician and will ensure the attempting physician would be notified of the event when there was potential injury, actual injury, or death. - Employee(s) would document in the patient’s record details of the event, examination, and treatment provided and family notification, as necessary. - Staff education was primarily aimed at supporting the philosophy of patient restraints/seclusion and appropriate care and at decreasing the use of restraints and seclusion thought comprehensive assessment/reassessment and the use of less restrictive alternatives. Because restraint and seclusion was considered high-risk treatment, all staff that has direct patient contact must have initial and ongoing education and annual competency verification, which included but not limited to less restrictive alternatives - including skills so those staff who have direct patient contact are well equipped to handle behaviors and symptoms as much as possible without restraint or seclusion. Review of the Hospital’s policy, Notification and Response to Sentinel Events, undated, outlined a process for identifying, communicating, and investigating significant events to improve system safety and prevent recurrence. A patient incident is defined as any unusual event with actual or potential adverse outcomes. When a sentinel event occurs, the person who identifies it must complete a Quality Tracking Form or call the Quality Hotline. If warranted, a Root Cause Analysis (RCA) Team is convened within seven days, with a final report due within 45 days. The Director of Patient Safety or designee oversees the corrective action schedule to ensure timely implementation of RCA recommendations. Review of the Department of Public Health’s (DPH) Health Care Facility Reporting System (HCFRS), dated 4/13/25, indicated that on 4/4/25 at approximately 4:30 A.M., SO#1 and CNA #1 used excessive force utilizing unapproved techniques to subdue Patient #1 during a restraint application. Several unauthorized staff members reviewed the security camera footage of the event violating patient privacy; additionally, staff failed to promptly escalate patient safety concerns by waiting to report concerns to ED leadership on 4/7/25, several days after the event occurred. Hospital Leadership contacted Patient #1, who reported being upset with the experience. SO#1 and CNA #1 were immediately suspended on 4/7/25 and no longer employed by the Hospital following the event. Further review of the Hospital’s investigation indicated had revised the de-escalation training and began security and ED nursing staff re-education; however, the Restraint and Seclusion Committee was still revising the policy and still developing a strategic plan for security at the time of Survey on 7/14/25. Review SO #1’s education Transcript Report, generated on 7/15/25, indicated he last completed the “Staff Safety: De-escalation training on 1/14/23. CNA #1’s education Transcript Report, generated on 7/15/25, indicated she last completed the “Staff Safety: De-escalation training on 9/5/22. Although the Hospital reported revising its de-escalation training, there was no documentation to support there was a review to ensure annual staff training was completed as required by the Adverse Event Reporting policy, dated January 2024. Review of SO#1’s Time-Card Report, indicated he worked the remainder of the shift on 4/4/25, approximately 3.5 hours at the Hospital after using excessive force and unapproved techniques to Patient #1 during a restraint application. Review of CNA #1’s Time-Card Report, indicated she worked the remainder of the shift on 4/4/25 and worked on 4/4/25 and 4/6/25, approximately 24.5 hours at the Hospital after using excessive force and unapproved techniques to Patient #1 during a restraint application. Review of Patient #1’s medical record indicated he/she presented to the ED escorted by law enforcement under a section 12 order (a legal mechanism that allows for the involuntary commitment of individuals experiencing severe mental health crisis. Review of the ED Physician’s Progress Note, dated 4/4/25, indicated Patient #1 reported diffuse abdominal pain after confrontation [restraint], will obtain labs and reassess abdomen when Patient #1 was calmer. During an interview on 7/15/25 at 9:15 A.M., ED Physician stated he responded to Patient #1’s room (a psychiatric safe room in the ED) during the restraint application on 4/4/25 and was concerned the situation was escalating over the removal of a phone. He reported that within 24 hours of the restraint, he overheard staff discussing the restraint as overly forceful. He expressed concern about the level of force used on a physically small patient but did not escalate the incident to leadership at the time, as he was unaware of the extent of the physical force until the Hospital began its internal investigation. He added that had he known the degree of excessive force in real time, along with Patient #1’s complaints of abdominal pain, he would have ordered a chest and abdominal computed tomography (CT) scan to further assess for potential injury. During an interview on 7/15/25 at 2:15 P.M., and throughout the Survey, the Patient Safety Officer (PSO) provided documentation of the Hospital’s Internal Investigation and review of Patient #1’s restraint event on 4/4/25, however, she said there was no documentation at the time of Survey to support the Hospital implemented system wide corrective actions in response to the event.”

“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: 45980 Based on record review and interviews, the Hospital failed to ensure nursing staff reported abnormal findings to a provider (backflow of blood into the intravenous (IV) tubing of a central line) for one Patient (#2) out of a total sample of ten patients. Findings include: Review of Patient #2 ’ s medical records indicated that he/she was admitted to the Hospital due to sepsis (a life-threatening complication of an infection) and pneumoperitoneum (presence of air or gas in the peritoneal cavity). Patient #2 underwent an exploratory laparotomy (surgical procedure when the abdomen is opened to examine the organs inside) which revealed a perforated gastric ulcer (complication where the ulcer erodes through the stomach wall, creating a hole or perforation) requiring surgical intervention. In the Operating Room (OR) an internal jugular central venous catheter (CVC) was placed under ultrasound guidance which was confirmed by chest x-ray to be appropriately placed. After the procedure Patient #2 required vasopressor (medication that increases blood pressure) support and was transferred to the Surgical Intensive Care Unit (SICU) for further management. Review of the progress note documented by the Attending Physician, dated 6/11/25 at 5:14 P.M., indicated Patient #2 was post-operative day (POD) # 2, continued to not open his/her eyes or follow commands despite being weaned off vasopressors and sedation. A head computed tomography (CT) scan was ordered which showed a large middle cerebral artery (MCA) territory infarct (obstruction of blood flow to an organ). A code stroke was activated, and a CT angiogram (imaging to visualize the blood vessels) of the head and neck was ordered. Review of the CT Angiogram of Carotid Arteries dated 6/11/25 at 2:09 P.M., concluded that the left sided central venous catheter is mispositioned and enters the left common carotid artery and extends into the ascending thoracic aorta. There is a six by three-millimeter (mm) nonocclusive thrombus (blood clot) within the left common carotid artery extending just superior to the catheter insertion site and is a potential source of thromboembolism (when a blood clot breaks off and travels through the bloodstream, obstructing a blood vessel and reducing blood flow) to the brain. During an interview on 7/14/25 at 5:05 P.M., and throughout the survey, the Patient Safety Officer said the mispositioned CVC event was identified for review on 6/11/25 and an investigation was initiated on 6/12/25. The Patient Safety Officer said Registered Nurse (RN) #3 had noticed backflow in the IV tubing of the CVC and didn ’ t notify the team until after the event when questioned if there was anything unusual with the line. She said any amount of backflow observed in the IV tubing of the central line is abnormal and the expectation is for the nurse to notify the provider. She said the Hospital identified an opportunity for education on Identifying Arterial Malposition of Central Venous Catheters but said the education has not yet been implemented. During an interview on 7/15/25 at 7:59 A.M., the General Surgery Program Director said he was involved in the investigation for Patient #2 mispositioned CVC event. He said it was discussed that a nurse observed backflow in the IV tubing of the central line after the event. The General Surgery Program Director said the presence of backflow in the IV tubing of the central line should have prompted further evaluation and the expectation was for the nurse to notify the provider. During an interview on 7/15/25 at 8:33 A.M., the Senior Director of Nursing Specialty Care said the investigation determined there may have been confirmation bias due to the results of the chest x-ray confirming placement. She said RN #3 mentioned after the event observing backflow into the IV tubing of the CVC. The Senior Director of Nursing Specialty Care said the expectation when backflow is observed is for the nurse to notify the provider. She said the Hospital is exploring the development of a checklist with descriptors and actions to take if malposition of a CVC is suspected. Additionally, she said the Hospital identified an opportunity for education on Identifying Arterial Malposition of Central Venous Catheters; however, the education has not yet been implemented. During an interview on 7/15/25 at 1:49 P.M., RN # 3 said she was caring for Patient #2 during the day shift on 6/11/25. She said she observed a small amount of backflow into the IV tubing of Patient #2 ’ s central line. She said she attributed the backflow to the patient ’ s position, and once she changed the tubing the backflow was no longer present. RN # 3 said that an x-ray had confirmed the central line was in the correct position. She further said that she did not feel a small amount of backflow was abnormal, as there was no pulsatile (rhythmic or pulsing) flow, and that the backflow had resolved once the tubing was changed. RN # 3 said she did not notify the provider of the observed backflow in the IV tubing but did ask the charge nurse to look and both concluded there was no concern.”