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 a revisit conducted on February 2, 2022, as the result of a previous 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 revisit conducted on February 2, 2022, as the result of a previous Annual Registration 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 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 17, 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 11:30 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 11:35 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 started audits. The consent form was revised on December 21, 2022, and (paper forms) arrived (at the facility) in early January. (The new consent form) is not in the EMR (electronic medical record) yet. The audits are going to be done by Risk Quality Management. They are not done by the Center Manager. We give the patients a copy of the new consent form but that form is not scanned into the EMR and therefore there is no way to audit whether it is being done."

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 via team huddles and emails in September 2021 and again in February 2022 with required read receipts.

- Monitoring activites (patient medical record audits) are in process with initial audits completed in February and March (compliance 100%). 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 Risk and Quality Management (RQM) Coordinator.

- Survey findings and the updated consent form was reviewed by the facility's Patient Safety Committee (2/8/22). The 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 audit results in quarterly CRQM report to the Board (5/26/22).

- The RQM Coordinator will ensure monitoring activities are completed and the Director of Patient Servivces will ensure final completion of the plan of correction.

The consent form has been implemented, s


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 17, 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 the facility had not performed the audits of medical records 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






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 via team huddles and emails in September 2021 and again in February 2022 with required read receipts.

- Monitoring activites (patient medical record audits) are in process with initial audits completed in February and March (compliance 100%). 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 Risk and Quality Management (RQM) Coordinator.

- Survey findings and the updated consent form was reviewed by the facility's Patient Safety Committee (2/8/22). The 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 audit results in quarterly CRQM report to the Board (5/26/22).

To prevent delays in future, the RQM Coordinator will take lead role in developing and monitoring timely completion of all actions and activities related to the Plan of Correction in support of the center manager and the Director of Patient Services.

The Director of Patient Servivces will ensure final completion of the plan of correction.