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with staff (EMP), it was determined that the facility failed to conform to all applicable State laws.

Based on a review of facility documents, a review of medical records (MR) and interview Findings include:

Kirkbride Center 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 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 have a patient safety plan, failed to have a patient safety committee and failed to report events to the Department.

Findings include:

A review of facility's "CoreCare Behavioral Health Management, Inc. d/b/a Kirkbride Center ...Corporate and Medical Bylaws," no date revealed "...Directors...3.1 Management by Board. The business, property, and affairs of the Corporation shall be managed under the direction of the Board. The Board may exercise all such powers of the Corporation and do all such lawful acts and things as are not by applicable law, by the Articles of Incorporation or by these Bylaws directed or required to be exercised or done by the shareholders..."

1) A request was made to EMP1 on February 17, 2011, at approximately 9:30 a.m. for the facility's patient safety plan. EMP1 confirmed that the facility did not have a patient safety plan.

2) A request was made to EMP1 on February 17, 2011, at approximately 9:30 a.m. for the facility's patient safety committee meeting minutes. EMP1 confirmed the facility did not have a patient safety committee.

3) A review of MR1 nursing progress notes revealed an incident that had occurred on June 30, 2010, where the patient became verbally and physically aggressive towards staff related to staff explaining the unit rules to the patient. The patient attempted to bite staff, the patient was given intramuscular medication (IM) to help control behavior and the patient continued to threaten staff with a telephone and also the patient removed a wooden piece of bed and threatened staff. The patient was placed in four point restraints. The patient sustained an injury to the back of the patient's head, where there was bleeding.

An interview with EMP1 on February 18, 2011, at approximately 2:00 p.m. confirmed that the facility had made no reports to the department and the authority or had sent written notification to the patient for serious events.

4) A review of MR2 nursing progress notes revealed that the patient was involved in a physical altercation with another patient on June 28, 2011, where the patient listed in MR2 sustained increased swelling to the patient's finger and the physician had ordered an x-ray.

An interview with EMP1 on February 18, 2011, at approximately 2:00 p.m. confirmed that the facility had made no reports to the department and the authority or had sent written notification to the patient for serious events.
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5) A review of MR3 nursing progress notes revealed that the patient was found in her room on January 13, 2011, by staff bleeding with a laceration on the back of her head from an apparent fall. The patient was transferred to an acute care hospital for additional care and was treated with three staples for the laceration.

An interview with EMP1 on February 18, 2011, at approximately 2:00 p.m. confirmed that the facility had made no reports to the department and the authority or had sent written notification to the patient for serious events.

6) A review of MR4 nursing progress notes revealed that the patient was involved in a physical altercation with another patient on June 14, 2010, where the patient was thrown to the floor and the patient was also struck by a walker. Further review of MR4 revealed that the patient was transferred to an acute care hospital's emergency department for additional care.

An interview with EMP1 on February 18, 2011, at approximately 2:00 p.m. confirmed that the facility had made no reports to the department and the authority or had sent written notification to the patient for serious events.
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7) A review of facility internal event report dated October 31, 2010, revealed that a patient was found on the floor in lounge area and was non responsive. A further review of the internal incident report revealed the patient was sent to an acute care hospital for care and additional services.

An interview with EMP1 on February 18, 2011, at approximately 2:00 p.m. confirmed that the facility had made no reports to the department and the authority or had sent written notification to the patient for serious events.
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Based on an observation tour of the patient care units and interview with staff (EMP), it was determined that the facility failed to conform to all applicable State requirements.

State law requires all Health Care Facilities to be in compliance with the guidelines contained in the Facilities Guidelines Institute (FGI) manual.

Kirkbride Center was not in compliance with section "2.5 Specific Requirements for Psychiatric Hospitals...2.5-7.2.2.4 Bathroom hardware and accessories...(1) Grab bars...(c) Where grab bars are provided, the space between the bar and the wall shall be filled to prevent a cord being tied around it for hanging..."

This is not met as evidenced by:

1) An Observation tour of the third floor nursing unit conducted on February 18, 2011, at approximately 11:45 a.m. revealed that the patient bathrooms located in the patient room numbers 307, 309, 310, and 317, were observed to have grab bars, where there was a space between the bar and the wall, where a cord can be tied around it for hanging

An interview with EMP2 on February 18, 2011, at approximately 11:45 a.m. confirmed that the patient bathrooms located in the patient rooms had a space between the bar and the wall where a cord can be tied around it for hanging.

2) An Observation tour of the fourth floor nursing unit conducted on February 18, 2011, at approximately 12:15 p.m. revealed that the patient bathrooms located in the patient room numbers 410 and 416 were observed to have grab bars, where there was a space between the bar and the wall, where a cord can be tied around it for hanging.

An interview with EMP2 on February 18, 2011, at approximately 12:15 p.m. confirmed the patient bathrooms located in the patient rooms had a space between the bar and the wall where a cord can be tied around it for hanging.

Based on review of facility documents, a review of medical records (MR) and interviews with staff (EMP), it was determined that the facility failed to follow its policy to ensure that each adult restraint and seclusion order was written for a maximum of four hours for four of seven medical records reviewed (MR1, MR2, MR4, and MR7).

Findings include:

A review facility policy "Seclusion or restraint," dated July 25, 2008, revealed "...g. The physician writes/gives an order for the seclusion or restraints which must include the following:...iii. Maxium [Maximum] duration of the intervention (note: initial maximum duration and subsequent renewals are not to exceed 4 hours..."

1) A review of MR1 revealed that the patient was placed in restraints on June 30, 2010. A further review of MR1 revealed no documentation in the physician order that the physician wrote the maximum duration of the intervention not to exceed four hours.

2) A review of MR2 revealed the patient was placed in seclusion on June 28, 2010. A further review of MR2 revealed no documentation in the physician order that the physician wrote the maximum duration of the intervention not to exceed four hours.

3) A review of MR4 revealed the patient was placed in seclusion on June 15, 2010. A further review of MR4 revealed no documentation in the physician order that the physician wrote the maximum duration of the intervention not to exceed four hours.

4) A review of MR7 revealed the patient was placed in restraints on April 6, 2010. A further review of MR7 revealed no documentation in the physician order that the physician wrote the maximum duration of the intervention not to exceed four hours.

8) An interview with EMP1 on February 18, 2011, confirmed that MR1, MR2, MR4, and MR7, revealed no documentation that the physician wrote the maximum duration of the intervention not to exceed four hours.

Based on a review of facility documents, and interviews with staff (EMP), it was determined that the facility failed to train staff in the application of restraints that was consistent with hospital policy, related to the contradiction of the facility's definition for restraint and seclusion.

Findings include:

1) A review of facility's policy "Subject: seclusion or restraint," dated July 25, 2008, revealed "...Therapeutic/Physical Hold: The application of physical force without the use of any device, for the purpose of restraining the free movement of a patient's body. Holding a patient in a manner that restricts his/her movement constitutes restraint for this patient (may be indicated when administering IM medications involuntarily, transporting, and/or the prevention of harm to self and others by a patient)..."

An interview with EMP1 and EMP2 on February 18, 2011, at approximately 1:45 p.m. confirmed that the above policy states holding a patient in a manner that restricts his/her movement constitutes restraint.

2) A review of facility's nursing policy and procedural manual revealed a facility policy "Safety Techniques Training...Assist Techniques," no date which revealed "...Introduction to Assist Techniques...Description: Assist Techniques are used to temporarily bring an individual under control and/or to "assist" the individual to some other area. These techniques are not escorts but rather are used in crisis or emergency situations. They are also not restraints...Training the Technique:...Explanation of the Safety Assist...2. Cup hands; place the palms of each hand above the individuals elbows and push them forward and across the front of the individuals body...3. from this modified "bear hug" position, transfer your hands to the individuals opposite wrists. Maintain grasp above the bony protrusions...5. Make sure the individuals arms are "tucked"...prevent the individual from slipping out of the assist...7. Use a Shuffle to the rear (backwards) to assist the individual to the predetermined location...Cautions and Limitations:...This technique is not a restraint but rather an intervention of temporary control (e.g. less than 30 seconds)..."

An interview with EMP1 and EMP2 on February 18, 2011, at approximately 1:45 p.m. confirmed that the above policy is available for facility staff for their review and education. Further, EMP1 and EMP2 confirmed the above training policy contradicts the facility policy for restraint and seclusion related to holding a patient in a manner that restricts his/her movement constitutes restraint, where the above policy does not constitute the holding a patient in a manner that restricts his/her movement constituting a restraint.

Based on a review of facility documents, a review of medical records (MR), and interviews with staff (EMP), it was determined the facility failed to develop an ongoing data-driven quality assurance and performance improvement program that incorporates areas that affects patient safety related to restraints and seclusion.

Findings include:

A review of facility's "CoreCare Behavioral Health Management, Inc. d/b/a Kirkbride Center ...Corporate and Medical Bylaws," no date revealed "...Article XI...Kirkbride: Purpose and Responsibilities...11.2...The Responsibilities of the Medical Staff are:...11.2.1 To maintain and account for the quality and appropriateness of patient care rendered by all clinicians and consultants authorized to practice at Kirkbride Center through the following measures:...(b) A continuing education program, based in part, on needs demonstrated through the Quality Assurance and Improvement Program and other activities of individual Medical Staff member;...11.2.6 To assist the Medical Director and Hospital Administrator in the identification of Kirkbride patient and program needs, based on Quality Assurance and Improvement data and available resources, in order to make annual recommendations to the Governing Body regarding the development of appropriate facility goals and objectives as part of an ongoing evaluation process..."

1) A review of the following medical regards involved events, where the patient's were placed in restraints or seclusion:

A review of MR1 revealed an incident that had occurred on June 30, 2010, where the patient became verbally and physically aggressive towards staff and was placed placed in four point restraints and the patient sustained an injury to the back of the patient's head, where there was bleeding.

A review of MR4 revealed on June 15, 2010, the patient became loud, disruptive, was throwing tables and chairs and attempted to be aggressive towards staff and the patient was placed in seclusion.

A review of MR6 revealed on February 18, 2010, the patient became severely agitated and physically aggressive towards staff and the patient was held on the floor for four to five minutes.

2) A request was made to EMP1 on February 18, 2011, at approximately 1:30 p.m. for documented evidence for the year 2010 and 2011, that restraints and seclusion were incorporated into the facility's quality assurance and performance improvement program. EMP1 provided no quality assurance and performance improvement documentation for the year 2010 and 2011, related to restraints and seclusion