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Based on a review of facility documents, a review of medical records (MR) and interview with staff (EMP), it was determined that Philhaven Hospital failed to conform to all applicable State laws.

Findings include:

Philhaven Hospital was not in compliance with the following State law related to Act 13 of 2002, Medical Care Availability and Reduction of Error (MCARE) Act 40 PS. ?1303.310.

Section 302. Definitions. "Incident." An event, occurrence or situation involving the clinical care of a patient in a medical facility which could have injured the patient but did not either cause an unanticipated injury or require the delivery of additional health care services to the patient. The term does not include a serious event. "Infrastructure failure." An undesirable or unintended event, occurrence or situation involving the infrastructure of a medical facility or the discontinuation or significant disruption of a service which could seriously compromise patient safety. "Serious event." An event, occurrence or situation involving the clinical care of a patient in a medical facility that results in death or compromises patient safety and results in an unanticipated injury requiring the delivery of additional health care services to the patient. The term does not include an incident.

Section 307. Patient safety plans. (a) Development and compliance.--A medical facility shall develop, implement and comply with an internal patient safety plan that shall be established for the purpose of improving the health and safety of patients. The plan shall be developed in consultation with the licensees providing health care services in the medical facility. (b) Requirements.--A patient safety plan shall: (1) Designate a patient safety officer as set forth in section 309. (2) Establish a patient safety committee as set forth in section 310. (3) Establish a system for the health care workers of a medical facility to report serious events and incidents which shall be accessible 24 hours a day, seven days a week. (4) Prohibit any retaliatory action against a health care worker for reporting a serious event or incident in accordance with the act of December 12, 1986 (P.L.1559, No.169), known as the Whistleblower Law. (5) Provide for written notification to patients in accordance with section 308(b).

Section 310. Patient safety committee. (a) Composition.-- (1) A hospital's patient safety committee shall be composed of the medical facility's patient safety officer and at least three health care workers of the medical facility and two residents of the community served by the medical facility who are not agents, employees or contractors of the medical facility. No more than one member of the patient safety committee shall be a member of the medical facility's board of trustees. The committee shall include members of the medical facility's medical and nursing staff. The committee shall meet at least monthly.

Section 313. Medical facility reports and notifications. (a) Serious event reports. A medical facility shall report the occurrence of a serious event to the department and the authority within 24 hours of the medical facility's confirmation of the occurrence of the serious event. ... (c) Infrastructure failure reports. A medical facility shall report the occurrence of an infrastructure failure to the department within 24 hours of the medical facility's confirmation of the occurrence or discovery of the infrastructure failure. ... (e) Notification to licensure boards. --If a medical facility discovers that a licensee providing health care services in the medical facility during a serious event failed to report the event in accordance with section 308 (a), the medical facility shall notify the licensee's licensing board of the failure to do report. (f) Failure to report or notify. --Failure to report a serious event or an infrastructure failure as required by this section or to develop and comply with the patient safety plan in accordance with section 307 or to notify the patient in accordance with section 308 (b) shall be a violation of the Health Care Facilities Act ... "

This is not met as evidenced by:

Based on review of facility documents, a review of medical records (MR), and interview with staff (EMP), it was determined the facility failed to review their Patient Safety Plan on an annual basis, failed to ensure that their Patient Safety Committee met monthly, and failed to report events to the Patient Safety Authority and to the Department.

Findings include:

A review of Philhaven Hospital Patient Safety Plan was conducted on February 24, 2012. It was determined that the facility had not reviewed their Plan since January 2007.

An interview with the EMP2 revealed the Patient Safety Officer was unaware of the specific requirements of the Law regarding the reporting of disturbances on the unit that resulted in police action, and the transfer of patients to a higher level of medical care.


A review of Philhaven Hospital Patient Safety Committee meetings minutes revealed there were no minutes to document meetings held in April, July, August, September 2011. None of the documented meetings reflected the actual date of the meeting and failed to contain a list of committee members in attendance, including whether or not the two community members were present.