QA Investigation Results

Pennsylvania Department of Health
PPSP FAR NORTHEAST HEALTH CENTER
Health Inspection Results
PPSP FAR NORTHEAST HEALTH CENTER
Health Inspection Results For:


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Initial Comments:

This report is the result of an Annual Registration survey conducted on September 17, 2021, at PPSP Far Northeast 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 17, 2021, at PPSP Far Northeast 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:




551.21 (e)(1-3) LICENSURE
Criteria for ambulatory surgery

Name - Component - 00
551.21 Criteria for ambulatory surgery

(e) In obtaining informed consent, the practitioner performing the surgery shall be responsible for disclosure of:
(1) The risks, benefits and alternatives associated with the anesthesia which will be administered.
(2) The risks, benefits and alternatives associated with the procedure which will be performed.
(3) The comparative risks, benefits and alternatives associated with performing the procedure in the ambulatory surgical facility instead of in a hospital.

Observations:

Based on a review of facility documents, medical record review (MR) and interview with staff (EMP), it was determined the facility failed to ensure disclosure of the comparative risks, benefits, and alternatives associated with performing a surgical procedure in the ambulatory surgical facility (ASF) instead of in a hospital for three of three medical records reviewed (MR2, MR3 and MR6).

Findings include:

A review of facility document "Administrative Chapter 4" dated June 2020 revealed "4.2.1. General Information. ...I. The informed consent process must take place. Consent procedures for minors and others must be consistent with state law. It is the professional and legal duty of every affiliate to provide each patient with adequate information regarding the nature of the proposed services including the following: A. Anticipated benefits B. Medically recognized risks and possible complications C. Alternatives."

A review on September 17, 2021, of MR2, admitted on January 6, 2021, for a surgical abortion with monitored anesthesia care, revealed signed "Pennsylvania Abortion Control Act - Informed Consent" and "Information for Informed Consent In-Clinic Abortion" consent forms. Further review revealed neither form contained evidence of documentation that the patient was provided with the comparative risks, benefits and alternatives associated with performing a surgical abortion procedure in the ASF instead of in a hospital.

A review on September 17, 2021, of MR3, admitted on August 27, 2021, for a surgical abortion with monitored anesthesia care, revealed signed "Pennsylvania Abortion Control Act - Informed Consent" and "Information for Informed Consent In-Clinic Abortion" consent forms. Further review revealed neither form contained evidence of documentation that the patient was provided with the comparative risks, benefits and alternatives associated with performing a surgical abortion procedure in the ASF instead of in a hospital.

A review on September 17, 2021, of MR6, admitted on July 30, 2021, for a surgical abortion with local anesthesia, revealed signed "Pennsylvania Abortion Control Act - Informed Consent" and "Information for Informed Consent In-Clinic Abortion" consent forms. Further review revealed neither form contained evidence of documentation that the patient was provided with the comparative risks, benefits and alternatives associated with performing a surgical abortion procedure in the ASF instead of in a hospital.

An interview conducted on September 17, 2021, at 2:16 PM with EMP1 confirmed the signed consent forms for MR2, MR3 and MR6 did not contain evidence of documentation that the patients was provided with the comparative risks, benefits and alternatives associated with performing a surgical abortion procedure in the ASF instead of in a hospital.





Plan of Correction:

Updates will be made to the Informed Consent form (1004 ICF In-Clinic Abortion) for surgical abortion to include disclosure of the comparative risks, benefits and alternatives associated with performing the procedure in the ambulatory surgical facility instead of in a hospital.

At the November facility site meeting and via email, all facility staff will receive training on the requirement to include the comparative risks, benefits, and alternatives associated with performing surgical abortion procedure in the ASF instead of in a hospital. The training will include review of the updated consent form and how to talk about the comparative risks. Training records and/or read receipts will be maintained as evidence of staff training.

To monitor compliance, 10 medical records will be audited for required documentation weekly for one month (December 2021) and monthly for three months (January - March 2022). Finally, this requirement will be added to annual abortion services audits. Audit results will be reported to the Center Manager (who will address any issues) and the Center Manager will report monitoring activities and audit findings at the quarterly Patient Safety Committee.

The Risk and Quality Management Coordinator will conduct auditing and ensure reporting, and will provide support to the Center Manager as needed. In addition, the Chief Operating Officer will include audit results in the quarterly CRQM (Compliance, Risk, Quality Management) report to the Governing Board.

The Director of Patient Services will ensure timely completion of corrective action plan by January 31, 2022.