Initial Comments:
This report is the result of a revisit conducted on February 2, 2022, as the result of a previous Annual Registration survey conducted on September 24, 2021, at PPSP Surgical Locust Street Health Center. (Correction to initial comments, onsite survey conducted September 14, 2021). 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 February 2, 2022, as a result of a previous State Re-Licensure survey conducted on September 24, 2021, at PPSP Surgical Locust Street Health Center. (Correction to initial comments, onsite survey conducted September 14, 2021). 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 review of the approved "Plan of Correction," facility documents, and interview with staff (EMP), it was determined the facility failed to complete all elements of the Plan of Correction (PoC) submitted and accepted by the "Department" for survey dated September 24, 2021. The corrective action date as approved by the Department was November 8, 2021.
Findings include:
A review on February 2, 2022, of the facility Plan of Correction statement 551.21(e)(1-3) Criteria for ambulatory surgery submitted and accepted by the Department revealed "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. ...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."
A review on February 2, 2022, of the facility document "Quarterly Update of Risk and Quality Management Activities" report to the PPSP Board of Directors dated December 13, 2021, revealed there was no medical record audit results regarding disclosure of the comparative risks, benefits and alternatives associated with performing the procedure in the ambulatory surgical facility instead of in a hospital reported to the Board as per the Plan of Correction.
A request was made on February 2, 2022, at 9:27 AM to EMP1 for the medical records consent form audit results from December 2021 and January 2022 regarding disclosure of the comparative risks, benefits and alternatives associated with performing the procedure in the ambulatory surgical facility instead of in a hospital. No audit results was provided.
An interview conducted on February 2, 2022, at 9:30 AM with EMP1 confirmed audits of the medical records had not been conducted and there was no audit results reported to the CRQM Report to the Governing Board. EMP1 stated "I have not audited any medical records. The consent form was not ready until December 21 (2021)."
An email communication received February 2, 2022, at 6:16 PM authored by EMP2, the Director of Patient Services confirmed the medical record audits had not been completed by the Risk and Quality Management Coordinator.
Plan of Correction:The facility has taken the following actions to implement the Plan of Correction approved 11/8/2021:
- The Informed Consent form (1004 ICF In-Clinic Abortion) for surgical abortion was updated 12/21/21 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. The updated consent was sent to the printer and was finalized for publication in January 2022. It was printed, copied and delivered to the facility with their January delivery. The new form was added to patient education and informed consent packets immediately and EMR updates were finalized 2/2/22.
- The Center Manager presented the updated consent form to facility staff for review on 2/2/22 (staff sign-off completed) and again at their monthly site meeting on 2/16/22 (training documented in meeting minutes).
- Monitoring activites (patient medical record audits) are in process with initial audits completed in February (compliance 57%). Additional changes were made to the EMR which led to 100% compliance in March. Audits will continue monthly in April and May and the return to annual monitoring in July as part of the annual abortion services audit. These audits will be conducted by the facility's RQM Coordinator.
- Survey findings and the updated consent form was reviewed by the facility's Patient Safety Committee (2/8/22). The Risk and Quality Management (RQM) Coordinator reported out on monitoring activities and initial audit results at the March CRQM Committee Meeting (3/22/22) and will do this again at the June meeting (date not set yet). The COO will include both report outs in quarterly CRQMs report to the Board.
- The RQM Coordinator will ensure monitoring activities are completed and the Director of Patient Servivces will ensure final completion of the plan of correction.
551.101 LICENSURE
Correction of Deficiency - Policy
Name - Component - 00
551.101 Policy
If an ASF notifies the Department that it has completed a plan of correction and corrected its
deficiencies, the Department will conduct a survey to ascertain completion of the plan of correction.
Upon finding full or substantial compliance, as defined in 551.82 (b)(relating to a regular license),
the Department will issue a regular license.
Observations:
Based on an unannounced on-site revisit, review of the approved "Plan of Correction," facility documents, and interview with staff (EMP), it was determined the facility failed to complete all elements of the Plan of Correction (PoC) submitted and accepted by the "Department" for survey dated September 24, 2021. The corrective action date as approved by the Department was November 8, 2021.
Findings include:
A review on February 2, 2022, of the facility Plan of Correction statement 551.21(e)(1-3) Criteria for ambulatory surgery and Plan of Correction statement 561.1 Drugs and Biologicals submitted and accepted by the Department revealed the facility had not performed the audits of medical records and medications that was stipulated in the Plan of Correction. The final anticipated completion date of the Plan of Correction was January 31, 2022.
Cross Reference:
551.21(e)(1-3) Criteria for ambulatory surgery
561.1 Drugs and Biologicals
Plan of Correction:TThe Plan of Correction approved 11/8/21 has been implemented and final activities will be completed by 5/31/22.
The facility team received training on and review of medication management requirements 9/15/21 and again in 2/2/22. The training was provided by the Center Manager and documented in meeting minutes.
For monitoring compliance, the Center Manger developed an audit tool (approved by the Director of Patient Services) that includes monitoring for outdated medications (none present), proper stock rotation, and clear labeling of expiration dates. Two audits were completed in February (2/2 and 2/23) and March (3/9 and 3/30) finding 100% compliance. Two audits will be conducted in Aril and monthly monitoring will resume in May to ensure sustained compliance. Monitoring activities are being conducted by the Center Manager and the facility's lead RN.
Monitoring activities and audit results will be reported at next scheduled quarterly Infection Control Committee meeting (5/10/22) and quarterly Compliance, Risk, Quality Management (CQRM) Committee meeting (not yet scheduled). The Chief Operating Officer will include audit results in the quarterly CRQM (Compliance, Risk, Quality Management) report to the Governing Board (5/26/22).
To prevent delays in future, the facilities Risk and Quality Management Coordinator will take lead in monitor completion of all actions and activities supporting the center manager and the Director of Patient Services. The Director of Patient Servivces will ensure final completion of the plan of correction.
561.1 Drugs & Biologicals LICENSURE
CHAPTER 561 - PHARMACEUTICAL SERVICES
Name - Component - 00
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 review of the approved "Plan of Correction," facility documents, and interview with staff (EMP), it was determined the facility failed to complete all elements of the Plan of Correction (PoC) submitted and accepted by the "Department" for survey dated September 24, 2021. The corrective action date as approved by the Department was November 8, 2021.
Findings include:
A review on February 2, 2022, of the facility Plan of Correction statement 561.1 Drugs and Biologicals submitted and accepted by the Department revealed "...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."
A request was made on February 2, 2022, at 10:10 AM to EMP1 for the audits that was done in December 2021 and January 2022 of medication vials to ensure all medications was discarded according to the manufacturer's expiration dates. No audit results was provided.
An interview conducted on February 2, 2022, at 9:54 AM with EMP1 confirmed the medication audits that was to have been conducted in December 2021 and January 2022 to ensure all medications was discarded according to the manufacturer's expiration dates had not been conducted.
Plan of Correction:The Plan of Correction approved 11/8/21 has been implemented and final activities will be completed by 5/31/22.
The facility team received training on and review of medication management requirements 9/15/21 and again in 2/2/22. The training was provided by the Center Manager and documented in meeting minutes.
For monitoring compliance, the Center Manger developed an audit tool (approved by the Director of Patient Services) that includes monitoring for outdated medications (none present), proper stock rotation, and clear labeling of expiration dates. Two audits were completed in February (2/2 and 2/23) and March (3/9 and 3/30) finding 100% compliance. Two audits will be conducted in Aril and monthly monitoring will resume in May to ensure sustained compliance. Monitoring activities are being conducted by the Center Manager and the facility's lead RN.
Monitoring activities and audit results will be reported at next scheduled quarterly Infection Control Committee meeting (5/10/22) and quarterly Compliance, Risk, Quality Management (CQRM) Committee meeting (not yet scheduled). The Chief Operating Officer will include audit results in the quarterly CRQM (Compliance, Risk, Quality Management) report to the Governing Board (5/26/22).
The Director of Patient Servivces will ensure final completion of the plan of correction.
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