Initial Comments:
This report is the result of an Annual Registration survey conducted on September 14, 2021, 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 24, 2021, 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:
551.21 (e)(1-3) LICENSURE
Criteria for ambulatory surgery
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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 one of one medical records reviewed (MR2).
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 14, 2021, of MR2, admitted June 4, 2021, for a surgical abortion procedure under 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.
An interview conducted on September 14, 2021, at 11:29 AM with EMP2, confirmed MR2's signed consent forms did not contain 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.
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.
561.1 Drugs & Biologicals LICENSURE
CHAPTER 561 - PHARMACEUTICAL SERVICES
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561.1 Drugs and Biologicals
The ASF shall provide drugs and biologicals in a safe and effective
manner to meet the needs of patients, and to adequately support the organization's clinical capabilities commensurate with their licenses classification, in accordance with accepted ethical and professional practice and applicable State and Federal law, including the Pharmacy Act (63 P.S. 390-1 -390.13), 49 Pa. Code Chapter 27 (relating tot he State Board of Pharmacy), The Controlled Substance, Drug, Device and Cosmetic ACT (35 P.S. 780-101-780-144) and Chapter 25 (relating to controlled substances, drugs, devices and cosmetics).
Observations:
Based on facility policy, observation and interview with staff (EMP), it was determined the facility failed to discard medications according to the manufacturer's expiration date.
Findings include:
A review of facility policy "Injections," last revised August 26, 2019, revealed "This policy addresses injection types and safe injection practices. ...If a multi-dose vial has been opened or accessed (e.g., needle-punctured) the vial should be dated and discarded within 28 days unless the manufacturer specifies a different (shorter or longer) date for that opened vial. If a multi-dose vial has not been opened or accessed (e.g., needle-punctured), it should be discarded according to the manufacturer's expiration date."
An observation on September 14, 2021, at 1:35 PM revealed a box containing four multiple dose vials of lidocaine. Further observation revealed the vials had a manufacturer's expiration date of July 2021. Further observation revealed one of the vials had been opened on September 11, 2021, after the manufacturer's expiration date.
An interview on September 14, 2021, at 1:36 PM with EMP3 and EMP4 confirmed the four lidocaine multiple dose vials had a manufacturer's expiration date of July 2021, and that one of the vials had been opened on September 11, 2021, after the manufacturer's expiration date.
Plan of Correction:The Center Manager immediately discarded all expired vials of lidocaine and reviewed finding with clinical team.
At the next scheduled site meeting (11/10/21), all facility staff will
receive re-training on safe and effective management of medications used in the facility.
Staff training will include review of the facility's Injection Policy including proper storage and use of medications, locating and reading expiration dates on packaging, and medication stock rotation. In addition, staff will be instructed to only label vials with open and updated expiration date and to double-check vials for expiration date before use. A training sign-in log will be maintained as evidence of staff training.
The Center Manager will audit medication vials for expiration dates twice a month for 2 months and then return to once monthly monitoring to ensure sustained compliance. The Center Manager will report out on monitoring activities and results at upcoming quarterly Infection Control Committee meeting(s) and quarterly Compliance, Risk, Quality Management (CQRM) Committee meeting (expected 1/22). The Chief Operating Officer will include audit results in the CRQM (Compliance, Risk, Quality Management) report to the Governing Board (January Board Meeting).
The Director of Patient Services will ensure completion of corrective actions by January 31, 2022.
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