Initial Comments:
This report is the result of an Annual Registration survey conducted on September 11, 2018, at Ppsp Surgical Locust Street Health Center. It was determined the facility was in compliance with the requirements of the Pennsylvania Department of Health Regulations 28 Pa Code, Chapter 29, Subchapter D, Ambulatory Gynecological Surgery in Hospitals and Clinics.
Plan of Correction:
Initial Comments:
This report is the result of a State licensure survey conducted on September 11, 2018, at Ppsp Surgical Locust Street Health Center. It was determined the facility was not in compliance with the requirements of the Pennsylvania Department of Health's Rules and Regulations for Ambulatory Care Facilities, Annex A, Title 28, Part IV, Subparts A and F, Chapters 551-573, November 1999.
Plan of Correction:
553.3 (1) LICENSURE
Governing Body Responsibilities
Name - Component - 00
553.3
Governing Body responsibilities include:
(1) Conforming to all applicable Federal, State, and local laws.
Observations:
Based on review of the facility documents, medical records and interview with staff (EMP), it was determined the facility failed to conform to the following state laws:
The facility was not in compliance with the following State regulations:
"The Medical Care Availability and Reduction of Error Act, 40 P.S. 1303.101 et. Seq. 1303.308 Reporting and Notification. (b) Duty to notify patient. A medical facility through an appropriate designee shall provide written notification to a patient affected by a serious event or, with the consent of the patient, to an available family member or designee, within seven (7) days of the occurrence or discovery of a serious event ...".
This is not met as evidenced by:
Based on review of medical records (MR), facility documents, and interview with staff (EMP), it was determined the facility failed to provide written notification to the patient affected by a serious event within seven days of the occurrence of the event for one of one serious event medical records reviewed (MR15).
Findings include:
Review on September 11, 2018, of facility document, "Patient Safety Plan" dated March 2018, revealed "... Responsibilities of PSO: ... 2. Monitors the investigation and completion of reports to Patient Safety Authority following notification of an incident or serious event ... Written Notification: The Patient Safety Officer or designee will provide written notification to any patient affected by a serious event or, with the consent of the patient, to an available family member within seven days of occurrence or discovery of a serious event ...".
Review on September 11, 2018, of MR15 revealed a serious event occurred on June 4, 2018. Further review of MR15 revealed a serious
Plan of Correction:By 10/31/18, the Patient Safety Officer will update PPSP's PA Patient Safety and Abortion Services Policy to clarify facility staff requirements for reporting, to clarify the timeline, and to ensure compliance. In addition, the Patient Safety Officer and Director of Patient Services will provide training to the Surgical Locust Center staff on the Patient Safety Reporting requirements. This training will include a review of the updated policy and procedures to ensure timely notification, within 7 days, of the patient affected by a serious event. Staff will also be trained on what constitutes a serious event and when to recognize when one occurs. The training is currently scheduled for October 11, 2018.
On September 26th, the Patient Safety Officer, RQM Coordinator, and Center Manager reviewed the patient record (MR15) and identified opportunities for improved processes of communication and documentation. Serious events will be reported to PSRS based on patient report (if event occurred outside the facility) instead of waiting on medical records to confirm the event. In the case of a serious event occurring in the facility, the patient (or family member/designee with the patient's consent) will be notified of the serious event immediately while she is still in the center. The Center Manager and/or Recovery Room Nurse will provide the serious event notification letter to the patient (or family member/designee) upon recognizing that the serious event has occurred, and before the patient is discharged from facility.
To monitor compliance, the RQM Coordinator will audit all Patient Safety reports quarterly and the Patient Safety Officer will oversee the auditing process.
553.4 (c) LICENSURE
Other Functions
Name - Component - 00
553.4 OTHER FUNCTIONS
(c) If, the governing body is comprised of two or more members, and if majority of those practitioners, the governing body, either directly or by delegation, shall make - based on evidence of the education, training, and current competence - initial appointment, reappointments, and assignments or curtailment of clinical privileges of the practitioners.
Observations:
Based on review of facility policy and procedures, credential files (CF) and interview with staff (EMP), it was determined the facility ' s governing body failed to ensure the Medical Director's delineation of privileges were approved and granted by someone other than the Medical Director.
Findings include:
Review on September 11, 2018, of facility policy, "Abortion Policy Manual ... Policy Name: Governing Body Responsibilities" dated April 27, 2017, revealed "... Board Appointment ... The board may grant clinical privileges to qualified, licensed practitioners in accordance with their training, experience and demonstrated competence and judgment based on the peer review policy approved by the board. A written record of the application for clinical privileges, and the scope of privileges granted, shall be maintained ... The board must adopt and approve operative procedures performed at the facility ... The board must adopt and approve policies necessary for the orderly conduct of the ASF ...".
Review on September 11, 2018, of facility document "... Bylaws" date [unknown], revealed "... Article VI Board of Directors ... The number and composition of the Board shall first be determined under ... Agreement and Plan of Merger ... between ... and ... Except as otherwise provided by the Merger Agreement, the Board shall consist of no more than 30 individuals as directors with vote ...".
Review on September 11, 2018, of facility document, "Job Description ... Position: Medical Director" dated November 2017, revealed "...8. Provides medical supervision to staff physicians and on-call clinicians, including clinical privileging and periodic reviews ...".
Review on September 11, 2018, of facility document "Administrative C
Plan of Correction:By 10/31/18, the Medical Director's delineation of privileges will be reviewed and approved by a physician designee and presented to the Board of Directors (governing body). The updated privileging documents will be maintained in the Medical Director's personnel (credential) file and available for DOH review. To support ongoing compliance, the Governing Body Responsibilities Policy (Abortion Policy Manual) will be updated to include physician designation for the purposes of review, evaluation and approval of Medical Director privileging. The updated policy will be presented to the Board of Directors (governing body) at the next scheduled meeting on 10/25/18. Meeting minutes will be available for DOH review and will reflect Board review and approval. The Chief Operation Officer is responsible for the completion of and compliance to this Plan of Correction.
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