Initial Comments:
This report is the result of a full Medicare recertification survey conducted on May 5, 2025 at AHN Monroeville Surgery Center. It was determined the facility was in substantial compliance with the requirements of 42 CFR, Title 42, Part 416 - Conditions for Coverage for Ambulatory Surgical Centers.
Plan of Correction:
416.41(a) STANDARD
CONTRACT SERVICES
Name - Component - 00
When services are provided through a contract with an outside resource, the ASC must assure that these services are provided in a safe and effective manner.
Observations:
Based on a review of facility documents and staff interviews (EMP), it was determined that the governing body failed to amend the Master Services Agreement with Allegheny Health Network to include the services of AHN Infection Control Director and the Infection Prevention Manager from Forbes Hospital.
Findings include:
On May 5, 2025, a review of Infection Control and Prevention Plan-Monroeville Ambulatory Surgery Center 2024 (Last Approved: 01/18/2024) was completed and revealed the following: "II. FUNDAMENTALS: A. Governing Body / IC&P Reporting Structure: The ASC Board of Managers delegates authority for oversight of the IC&P program to the AHN MASC Infection Prevention Committee (IPC). The ASC Board of Manager's delegates authority for the development, implementation, monitoring, and enforcement of the IC&P program to the AHN MASC Infection Preventionists (IPs). B. Infection Prevention - AHN Infection Control Director: Provides AHN guidance for the function of infection prevention; Oversees all network Infection Prevention personnel and budget activities; Participates in the review and approval of all infection prevention policies and plans to ensure standardization of best practices across the network and alignment with national standards for IP practices; Participates in the AHN Peri-Op CARE Committee in reviewing and approving products for use at AHN ... Infection Prevention Committee (IPC): Ultimate responsibility for overseeing and implementing the infection control and prevention plan is delegated by the governing body to the Infection Prevention Committee. Committee membership includes, but may not be limited to: Forbes Hospital Members: ...Infection Prevention Manager ...".
On May 5, 2025, a review of the Master Services Agreement- Ambulatory Surgery Centers (Effective January 1, 2025) was completed and revealed that Infection Control services from either the AHN Infection Control Director or the Forbes Hospital Infection Prevention Manager were not included and had not been evaluated by the Governing Body.
On May 5, 2025, at approximately 3:00PM, EMP1 confirmed that Infection Control Services were not included Master Services Agreement.
Plan of Correction:Plan of Correction:
1. Immediate Action:
o The Monroeville Ambulatory Surgery Center (MASC) Infection Control and Prevention Plan will be immediately revised to accurately reflect the current operational structure. Specifically, all references to an affiliation with the Forbes Hospital infection control department will be removed.
2. Review and Approval Process:
o The revised Infection Control and Prevention Plan will be presented to the following committees for review and approval:
Infection Control Quarterly Meeting
Quality Meeting
Medical Executive Committee Meeting
3. Governing Body Approval:
o Following approval from the above-mentioned committees, the final revised Infection Control and Prevention Plan will be presented to the Board of Managers for final approval at its annual meeting in September 2025.
4. Implementation Date:
o The revised Infection Control and Prevention plan will be implemented immediately following the Board of Manager's approval.
5. Monitoring:
o Compliance with the revised Infection Control and Prevention Plan will be a standing agenda item at the Quarterly Infection Control and Quality Meetings.
o The administrator will oversee the compliance
Responsible Party: Administrator and the Quality Department
Evidence of Completion:
- Approved minutes from the Infection Control Quarterly Meeting, Quality Meeting, and Medical Executive Committee Meeting, documenting review and approval of the revised Infection Control and Prevention Plan.
- Minutes from the Board of Managers meeting in September 2025, documenting final approval of the revised Infection Control and Prevention Plan.
- A copy of the revised Infection Control and Prevention Plan with the date of implementation.
-
416.44(a)(1) STANDARD
PHYSICAL ENVIRONMENT
Name - Component - 00
The ASC must provide a functional and sanitary environment for the provision of surgical services.
Each operating room must be designed and equipped so that the types of surgery conducted can be performed in a manner that protects the lives and assures the physical safety of all individuals in the area.
Observations:
Based on observations and staff interview (EMP), it was determined the facility failed to ensure a functional and sanitary environment by failing to maintain proper flooring in one operating room.
Findings include:
During tour of the facility on May 5, 2025, at approximately 12:15 PM, a section of the floor seam in OR#3 near the entrance of the door was noted to have indentations that did not provide a smooth surface. In addition, the floor seam in the corner of OR#3, also near the door was not intact, providing an small open space within the flooring, creating a risk for infection control.
On May 5, 2025, at approximately 12:40 PM, EMP3 confirmed the above observation for OR#3.
Plan of Correction:Plan of Correction:
1. Immediate Corrective Action:
o The indentations in the floor seam and the separated floor seam in OR#3 near the entrance will be repaired/replaced.
o The separated flooring seam in the pre-operative area near the administrative offices will be repaired/replaced.
2. Preventative Measures:
o Monthly safety rounding will be implemented to include a specific assessment of the condition of floors in all patient care areas, with a focus on seams, integrity, and potential trip/fall hazards.
o Findings from monthly rounding will be reported to the Infection Control Committee and presented at the Quarterly Meeting for review and action as needed.
3. Implementation Date:
o Immediate Corrective Action: Immediately.
o Monthly rounding Form Revision: Start in June 2025
4. Date of Completion: June 30, 2025
416.45(a) STANDARD
MEMBERSHIP AND CLINICAL PRIVILEGES
Name - Component - 00
Members of the medical staff must be legally and professionally qualified for the positions to which they are appointed and for the performance of privileges granted. The ASC grants privileges in accordance with recommendations from qualified medical personnel.
Observations:
Based on a review of facility documents, credential files (CF) and staff interview (EMP), it was determined that the facility failed to complete a query of the National Practitioner Data Bank (NPDB) prior to approval of the delineation of privileges by the Credentialing Committee for one of ten credential files reviewed (CF6).
Findings include:
On May 5, 2025, a review the Allegheny Health Network Surgery Center Medical Staff Bylaws (Last Revised: May 27, 2021) was completed and revealed: "4.A.4. Steps to Be Followed for Initial Applicants: (c) The Credentialing and Privileging Office will also query the National Practitioner Data Bank and obtain privileged peer review evaluations from professional health care providers, both individual peers and other hospitals, regarding the quality and efficiency of services provided by the applicant."
On May 5, 2025, a review of the initial appointment file of CF6 (Initial Appointment: 10/01/2024 through September 30, 2025) was completed and revealed that CF6 submitted and signed the completed application for initial appointment to the Medical Staff on April 2, 2024. The delineation of privileges were approved on August 12, 2024; prior to query of the NPDB on August 30, 2024 and prior to receipt of written references on August 26, 2024 and August 27, 2024.
On May 5, 2025 at approximately 12:30PM, EMP7 confirmed the above.
Plan of Correction:1. Specific Corrective Action for CF6:
o Immediately initiate and complete an NPDB query for CF6.
o Review the NPDB report for any reportable actions or information.
o If any adverse information is revealed, the Credentialing Specialists and Committee will immediately evaluate the information to determine if the privileges granted should be modified or rescinded.
2. Systemic Corrective Actions (Already Implemented & Ongoing):
o Counseling and Education: On May 11, 2025, the Credentialing Verification Services (CVS) team addressed clerical errors with the specialist responsible for the error. The specialist was coached on ASC-specific requirements and the importance of attention to detail.
o Team Education: On May 12, 2025, a comprehensive education session was held with all CVS specialists to reinforce their understanding of ASC-specific credentialing requirements and address deficient areas.
o Enhanced Auditing Process:
The CVS manager or delegate is currently auditing 46% of every specialist's completed files for errors.
Once a specialist achieves a 96% accuracy rate, the audit frequency will be reduced to 15% of their files.
A minimum of 15% of each specialist's files will be audited monthly to ensure ongoing compliance.
3. Preventative Measures:
o Policy Reinforcement: The Allegheny Health Network Surgery Center Medical Staff Bylaws, specifically section 4.A.4(c) regarding NPDB queries, will be reviewed with all relevant personnel (Credentialing Committee members, CVS staff, Medical Staff Leadership).
o Process Improvement:
Explore the feasibility of assigning permanent CVS staff to ASC files to ensure consistent application of ASC-specific requirements.
4. Monitoring and Evaluation:
o Credentialing Leadership will track all NPDB query dates to ensure compliance with the policy.
o The results of the enhanced auditing process will be reviewed monthly by Credentialing Leadership to identify any trends or areas needing further improvement.
o The Credentialing Committee will receive regular reports on credentialing activities, including NPDB query compliance.
5. Date of Completion:
o Corrective action for CF6: Immediately upon submission of this plan: 5/31/2025
o Systemic corrective actions and preventative measures: Ongoing.
Initial Comments:
This report is the result of a full State Licensure survey on May 5, 2025 at AHN Monroeville Surgery 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:
51.31 LICENSURE
Exceptions - Principle
Name - Component - 00
51.31. Principle
The Department may grant exceptions to this part when the policy and objectives contained therein are
otherwise met, or when compliance would create an unreasonable hardship and an exception would not impair or endanger the health, safety or welfare of a patient or resident. No exceptions or departures from this part will be granted if compliance with the requirement is provided for by statute.
Observations:
Based on review of facility documents and staff interview (EMP), it was determined the facility failed to comply with the required criteria as stated in the exception granted by the Department related to the integration of Allegheny Health Network Surgery Center Governing Body.
Findings include:
On May 5, 2025, a review of the approved exception request letter, dated July 31, 2023, sent to Allegheny Health Network Monroeville Surgery Center revealed that the facility requested and was granted an exception to: 28 Pa. Code 553.1. "Conditions: The request related to Governing Body... is granted based on the information provided in the narrative submitted. Allegheny Health Network Monroeville Surgery Center must be specifically addressed in the Allegheny Health Network bylaws of the governing body. All the bylaws of the Allegheny Health Network will apply to the ASF unless specifically stated otherwise. The governing body minutes must reflect the activities of the ASF ...".
On May 5, 2025, a review of the minutes of the August 26, 2024, Governing Body Meeting revealed that Quality and Safety indicators for the Allegheny Health Network Monroeville Surgery Center were merged into a statistical analysis with six other network facilities. Thus, the activities and results of the Allegheny Health Network Monroeville Surgery Center Quality and Safety initiatives did not stand alone and were not documented in the minutes.
On May 5, 2025, at 11:38 AM, EMP6 confirmed that the quality data/metrics for AHN Monroeville Surgery Center were not presented as facility specific data to the Governing Body.
Plan of Correction:This plan outlines the steps Monroeville Ambulatory Surgery Center will take to address the citation related to the inappropriate aggregation of quality data across all sites within the Ambulatory Surgery Division, rather than presenting site-specific data.
Presentation to Board of Directors
- The basis of this citation, along with this plan of correction, will be presented to the Board of Directors for the Ambulatory Surgery Division at the annual Board meeting at the end of the August / beginning of September 2025.
- Site-specific quality data for Monroeville ASC will be presented to the Board of Directors at the annual Board meeting. This data will include, but not be limited to, safety data such as wrong site surgeries, falls, transfers, 24-hour ED visits; ASCQR data that is required by CMS.
- Aggregated quality data across the Ambulatory Surgery Division will only be presented for benchmarking purposes. The presentation will clearly state that this data is not intended to evaluate the performance of Monroeville ASC in isolation.
- The scope and purpose of the data presented, including the clear distinction between site-specific data for Monroeville ASC and aggregated benchmarking data for the division, will be accurately documented in the meeting minutes.
Board Meeting Minutes will be reviewed to assure site specific information is discussed per the exception requirements.
This will be audited once as there is only one Board of Directors meeting where all information is discussed.
553.3 (13)(i-iv) LICENSURE
Govern Body Responsibilities
Name - Component - 00
Governing Body responsibilities include:
(13) Approving major contracts or arrangements affecting the medical care provided under its auspices, including, those concerning;
(i) The employment for contractual arrangements with practitioners and others providing direct patient care.
(ii) The provision of all treatment related services including, radiology, medical laboratory, pathology , anesthesia and pharmaceutical services.
(iii) The provision of care by other health care organizations.
(iv) The provision of education to students and post graduate trainees.
Observations:
Based on a review of facility documents and staff interviews (EMP), it was determined that the governing body failed to amend the Master Services Agreement with Allegheny Health Network to include the services of AHN Infection Control Director and the Infection Prevention Manager from Forbes Hospital.
Findings include:
On May 5, 2025, a review of Infection Control and Prevention Plan-Monroeville Ambulatory Surgery Center 2024 (Last Approved: 01/18/2024) was completed and revealed the following: "II. FUNDAMENTALS: A. Governing Body / IC&P Reporting Structure: The ASC Board of Managers delegates authority for oversight of the IC&P program to the AHN MASC Infection Prevention Committee (IPC). The ASC Board of Manager's delegates authority for the development, implementation, monitoring, and enforcement of the IC&P program to the AHN MASC Infection Preventionists (IPs). B. Infection Prevention - AHN Infection Control Director: Provides AHN guidance for the function of infection prevention; Oversees all network Infection Prevention personnel and budget activities; Participates in the review and approval of all infection prevention policies and plans to ensure standardization of best practices across the network and alignment with national standards for IP practices; Participates in the AHN Peri-Op CARE Committee in reviewing and approving products for use at AHN ... Infection Prevention Committee (IPC): Ultimate responsibility for overseeing and implementing the infection control and prevention plan is delegated by the governing body to the Infection Prevention Committee. Committee membership includes, but may not be limited to: Forbes Hospital Members: ...Infection Prevention Manager ..."
On May 5, 2025, a review of the Master Services Agreement- Ambulatory Surgery Centers (Effective January 1, 2025) was completed and revealed that Infection Control services from either the AHN Infection Control Director or the Forbes Hospital Infection Prevention Manager were not included.
On May 5, 2025, at approximately 3:00PM, EMP1 confirmed that Infection Control Services were not included Master Services Agreement.
Plan of Correction:Plan of Correction:
1. Immediate Action:
o The Monroeville Ambulatory Surgery Center (MASC) Infection Control and Prevention Plan will be immediately revised to accurately reflect the current operational structure. Specifically, all references to an affiliation with the Forbes Hospital infection control department will be removed.
2. Review and Approval Process:
o The revised Infection Control and Prevention Plan will be presented to the following committees for review and approval:
Infection Control Quarterly Meeting
Quality Meeting
Medical Executive Committee Meeting
3. Governing Body Approval:
o Following approval from the above-mentioned committees, the final revised Infection Control and Prevention Plan will be presented to the Board of Managers for final approval at its annual meeting in September 2025.
4. Implementation Date:
o The revised Infection Control and Prevention plan will be implemented immediately following the Board of Manager's approval.
5. Monitoring:
o Compliance with the revised Infection Control and Prevention Plan will be a standing agenda item at the Quarterly Infection Control and Quality Meetings.
o The administrator will oversee the compliance
Responsible Party: Administrator and the Quality Department
Evidence of Completion:
- Approved minutes from the Infection Control Quarterly Meeting, Quality Meeting, and Medical Executive Committee Meeting, documenting review and approval of the revised Infection Control and Prevention Plan.
- Minutes from the Board of Managers meeting in September 2025, documenting final approval of the revised Infection Control and Prevention Plan.
- A copy of the revised Infection Control and Prevention Plan with the date of implementation.
555.3 (d)(1-2) LICENSURE
Requirements
Name - Component - 00
Granting of clinical privileges shall follow established policies and procedures in the bylaws or similar rules and regulations the procedures shall provide the following.
(1) Written record of the application, which includes the scope of privileges sought and granted. The delineation "clinical privileges"shall address the administration of anesthesia.
(2) A review, summarized on record with appropriate documentation of the qualifications of the applicant.
Observations:
Based on a review of facility documents, credential files (CF) and staff interview (EMP), it was determined that the facility failed to complete a query of the National Practitioner Data Bank (NPDB) prior to approval of the delineation of privileges by the Credentialing Committee for one of ten credential files (CF6).
Findings include:
On May 5, 2025, a review the Allegheny Health Network Surgery Center Medical Staff Bylaws (Last Revised: May 27, 2021) was completed and revealed: "4.A.4. Steps to Be Followed for Initial Applicants: (c) The Credentialing and Privileging Office will also query the National Practitioner Data Bank and obtain privileged peer review evaluations from professional health care providers, both individual peers and other hospitals, regarding the quality and efficiency of services provided by the applicant."
On May 5, 2025, a review of the initial appointment file of CF6 (Initial Appointment: 10/01/2024 through September 30, 2025) was completed and revealed that CF6 submitted and signed the completed application for initial appointment to the Medical Staff on April 2, 2024. The delineation of privileges were approved on August 12, 2024; prior to query of the NPDB on August 30, 2024 and prior to receipt of written references on August 26, 2024 and August 27, 2024.
On May 5, 2025 at approximately 12:30PM, EMP7 confirmed the above.
Plan of Correction:1. Specific Corrective Action for CF6:
o Immediately initiate and complete an NPDB query for CF6.
o Review the NPDB report for any reportable actions or information.
o If any adverse information is revealed, the Credentialing Specialists and Committee will immediately evaluate the information to determine if the privileges granted should be modified or rescinded.
2. Systemic Corrective Actions (Already Implemented & Ongoing):
o Counseling and Education: On May 11, 2025, the Credentialing Verification Services (CVS) team addressed clerical errors with the specialist responsible for the error. The specialist was coached on ASC-specific requirements and the importance of attention to detail.
o Team Education: On May 12, 2025, a comprehensive education session was held with all CVS specialists to reinforce their understanding of ASC-specific credentialing requirements and address deficient areas.
o Enhanced Auditing Process:
The CVS manager or delegate is currently auditing 46% of every specialist's completed files for errors.
Once a specialist achieves a 96% accuracy rate, the audit frequency will be reduced to 15% of their files.
A minimum of 15% of each specialist's files will be audited monthly to ensure ongoing compliance.
3. Preventative Measures:
o Policy Reinforcement: The Allegheny Health Network Surgery Center Medical Staff Bylaws, specifically section 4.A.4(c) regarding NPDB queries, will be reviewed with all relevant personnel (Credentialing Committee members, CVS staff, Medical Staff Leadership).
o Process Improvement:
Explore the feasibility of assigning permanent CVS staff to ASC files to ensure consistent application of ASC-specific requirements.
4. Monitoring and Evaluation:
o Credentialing Leadership will track all NPDB query dates to ensure compliance with the policy.
o The results of the enhanced auditing process will be reviewed monthly by Credentialing Leadership to identify any trends or areas needing further improvement.
o The Credentialing Committee will receive regular reports on credentialing activities, including NPDB query compliance.
5. Date of Completion:
o Corrective action for CF6: Immediately upon submission of this plan: 5/31/2025
o Systemic corrective actions and preventative measures: Ongoing.
567.1 LICENSURE
Principle
Name - Component - 00
567.1 Principle
The ASF shall have a sanitary environment, properly constructed,
equipped and maintained to protect surgical patients and ASF personnel from
cross-infection and to protect the health and safety of patients.
Observations:
Based on observations and staff interview (EMP), it was determined the facility failed to maintain proper flooring in order to protect the health and safety of patients in one operating room and the preoperative area.
Findings include:
During tour of the facility on May 5, 2025, at approximately 12:15 PM, a section of the floor seam in OR#3 near the entrance of the door was noted to have indentations that did not provide a smooth surface. In addition, the floor seam in the corner of OR#3, also near the door was not intact, providing an small open space within the flooring, creating a risk for infection control.
During additional tour of the facility, a flooring seam in the pre-operative area near the administrative offices was noted to be separated creating a risk for trips and falls and infection control.
On May 5, 2025, at approximately 12:40 PM, EMP3 confirmed the above observation for OR#3.
On May 5, 2025, at approximately 10:40 AM, EMP1 confirmed the above observation for the pre-operative area.
Plan of Correction:Plan of Correction:
1. Immediate Corrective Action:
o The indentations in the floor seam and the separated floor seam in OR#3 near the entrance will be repaired/replaced.
o The separated flooring seam in the pre-operative area near the administrative offices will be repaired/replaced.
2. Preventative Measures:
o Monthly safety rounding will be implemented to include a specific assessment of the condition of floors in all patient care areas, with a focus on seams, integrity, and potential trip/fall hazards.
o Findings from monthly rounding will be reported to the Infection Control Committee and presented at the Quarterly Meeting for review and action as needed.
3. Implementation Date:
o Immediate Corrective Action: Immediately.
o Monthly rounding Form Revision: Start in June 2025
4. Date of Completion: June 30, 2025
|