Pennsylvania Department of Health
DELMONT SURGERY CENTER, LLC
Patient Care Inspection Results

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Severity Designations


Minimal Citation - No Harm	Minimal Harm	Actual Harm	Serious Harm

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DELMONT SURGERY CENTER, LLC - Inspection Results	Scope of Citation Number of Residents Affected By Deficient Practice

Initial comments:

This report is the result of a full Medicare recertification survey conducted on January 25, 2024, at Delmont Surgery Center, LLC. 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:

Initial comments:

This report is the result of a State licensure survey conducted on January 25, 2024 at Delmont Surgery Center, LLC. 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:

416.41(a) STANDARD CONTRACT SERVICES:

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 interview (EMP), it was determined that the governing body failed to evaluate the safety and efficacy of contract services as a part of the Quality Assurance Program.

Findings include

On January 25, 2024, a review of the facility governing body bylaws was complete and revealed the following: Policy 203- "Governing Body Responsibilities/Requirements" (Last Approved: August 5, 2020): "The Governing Body of Delmont Surgery Center is responsible for: 1.Conforming to applicable federal, state and local laws" Further reveal revealed no specific language in the governing body bylaws that addressed the governing body's responsibility in assuring the safety and efficacy of contract services.

On January 25, 2024, a review of the facility governing body minutes was completed which included the minutes from March 21, 2023; June 26, 2023; August 9, 2023; September 21, 2023; and November 8, 2023. There was no evaluation of the safety and efficacy of the facility's contract services noted in the minutes.

On January 25, 2024, a review of the facility quality assessment and performance improvement plan was completed. On January 25, 2024, a review of the quality assessment performance and improvement meeting minutes was completed and included the minutes from March 7, 2023; May 30, 2023; August 15, 2023; and November 21, 2023. There was no quality assurance of the facility's contract services noted in the minutes.

On January 25, 2024, at 1:50 PM, EMP1 asked if the contract services have to be evaluated by the governing body, and then confirmed that the facility's contract services were not evaluated by the governing body for safety and efficacy.

Plan of Correction - To be completed: 03/04/2024

After a Special Meeting with the GB on 2/5/24, Administrative Policy and Procedure #203 will be revised to reflect that it is the Governing Body's responsibility to annually assess all contracts between Delmont Surgery Center and each respective Vendor to ensure that each service provided is done so in a safe and efficient manner.

Starting with the 1st Quarter Governing Body meeting of 2024, scheduled for 3/4/2024, any contracted services at Delmont Surgery Center will be discussed and reviewed to monitor the efficacy and safety.

416.43(e) STANDARD GOVERNING BODY RESPONSIBILITIES:

The governing body must ensure that the QAPI program-
(1) Is defined, implemented, and maintained by the ASC.
(2) Addresses the ASC's priorities and that all improvements are evaluated for effectiveness.
(3) Specifies data collection methods, frequency, and details.
(4) Clearly establishes its expectations for safety.
(5) Adequately allocates sufficient staff, time, information systems and training to implement the QAPI program.

Observations:
Based on a review of facility documents and staff interview (EMP), it was determined that the governing body failed to evaluate the quality assurance plan for 2022 and approve and/or modify the quality assurance plan for 2023.

Findings include:

On January 25, 2024, a review of the facility governing body bylaws was complete and revealed the following: Policy 203- "Governing Body Responsibilities/Requirements" (Last Approved: August 5, 2020): "7. Directly overseeing the Center's quality assessment and performance improvement program (QAPI), ...reviewing (at least annually) the effectiveness of the QAPI, receiving reports of QAPI activities and, when relevant, acting on the aforementioned reports ..." Policy 205-"Governing Body Activities" (Last Approved: August 5, 2020): 1. The Governing Body's activities include: "1. Meeting at least annually and keeping minutes or other records necessary for the orderly conduct of the Center. Meetings should include, but not be limited to a review of: "...c. Quality Management and Improvement Program ...i. Revisions are made as needed to maintain compliance."

On January 25, 2024, a review of the facility Quality Assurance Improvement Plan (Last Approved: February 22, 2022) was completed.

On January 25, 2024, a review of the facility governing body minutes was completed which included the minutes from March 21, 2023; June 26, 2023; August 9, 2023; September 21, 2023; and November 8, 2023. There was no evaluation of the effectiveness of the quality improvement plan noted in the minutes as defined by facility policy 205.

On January 25, 2024, at 1:45 PM, EMP1 confirmed that the Quality Assurance Plan for the facility had not been evaluated for effectiveness and was not approved by the facility Governing Body for 2023.

Plan of Correction - To be completed: 02/05/2024

The GB will review, discuss and make any needed changes to the Quality Assessment and Performance Improvement Plan annually.
This will be done at their upcoming scheduled 1st quarter meeting to be held on March 4, 2024 and an ongoing annual assessment will continue to be conducted and noted in the respected GB meeting minutes.

416.46(a) STANDARD ORGANIZATION AND STAFFING:

Patient care responsibilities must be delineated for all nursing service personnel. Nursing services must be provided in accordance with recognized standards of practice. There must be a registered nurse available for emergency treatment whenever there is a patient in the ASC.

Observations:
Based on a review of personnel files (PF) and employee interview (EMP), it was determined that the facility failed to maintain job descriptions with clearly delineated position requirements for registered nurses in eight of eight personnel files (PF1, PF2, PF3, PF4, PF5, PF6, PF7 and PF8) and failed to maintain a job description for one of 10 personnel files (PF4).

Findings include:

On January 25, 2024, a review of facility personnel files was completed and revealed the following: Job Description (Approved: April 2010): Pre-Op/ PACU Nurse "Other Qualifications and Considerations: 4. BLS (basic Life Support) and/or ACLS (Advanced Cardiac Life Support and/or PALS (Pediatric Advanced Life Support) certification as require by Nurse Administrator."

On January 25, 2024, a review of facility personnel files was completed and revealed the following: Job Description (Approved: November 21, 2013; Updated May 2021): OR Nurse "Other Qualifications and Considerations: 9. BLS, ACLS certification as may be required by Nurse Administrator."

On January 25, 2024, a review of PF1, PF2, PF3, PF4, PF5, and PF6 revealed that these registered nurses were certified in BLS, ACLS and PALS. A review of PF7 and PF8 revealed these registered nurses were certified only in BLS. Thus, the standard was not consistent, and the job descriptions did not accurately reflect the requirements of the position.

On January 25, 2024, at 1:00 PM, EMP1 confirmed that the registered nurse job description required updating. EMP1 stated that all registered nurses did not require ACLS and PALS as anesthesia personnel and physicians were certified in both ACLS and BLS. EMP1 acknowledged that the job descriptions required clarification. Additionally, EMP1 confirmed there was no job discription for PF4.

Plan of Correction - To be completed: 02/05/2024

Job Descriptions for the Preoperative /Postoperative RN & OR Nurse have been reviewed and revised to reflect appropriate required certification(s). Each employee file was reviewed and properly corrected to contain an updated job description for each staff member pertaining to their role at the Center. Each employee is to review and initial the updated job description and the new job description will be placed on their respective file. Each employee has been made aware of the required education /certifications to be held for their position and if needed, take the appropriate measures to ensure certification.

553.3 (5)(i)(ii) LICENSURE Governing Body Responsibilities :

Governing Body responsibilities include:
(5) Adopting bylaws or similar rules and regulations for the orderly development and management of the ASF, which:
(i) Describe the authority delegated to the person in charge and to the medical staff.
(ii) Require the governing body to review and approve the bylaws, or similar rules and regulations, of the medical staff.

Observations:

Based on a review of facility documents, personnel files (PF), and employee interview (EMP), it was determined that the governing body failed to formally appoint the nurse administrator and failed to describe the authority delegated to the nurse administrator.

Findings include:

On January 25, 2024, a review of Policy 203,"Governing Body Responsibilities/Requirements" (Last Approved: August 5, 2020) was completed and revealed: 6(a) "Describe the authority delegated to the person in charge and to the Medical Staff of the Center."

On January 25, 2024, a review of the minutes of the November 8, 2023, Governing Body Meeting was completed and revealed the following statement, "Medical Advisory Board recommended approval of Governing Body to appoint EMP1as the nurse administrator effective December 4, 2023." There is no formal approval noted in the minutes by the governing body. There is no description of delegated authority to the nurse administrator by the governing body in the minutes.

On January 25, 2024, a review of PF5 revealed that the job description in the file was for PF5s former role as the Director of Nursing.

On January 25, 2024, at 1:30 PM, EMP1 confirmed the above findings.

Plan of Correction - To be completed: 02/05/2024

At the next scheduled GB meeting to be held on 3/4/24, a formal approval will be discussed under the first agenda point under "Old Business." This formal approval will be recorded on the meeting minutes to include Lauren Stewart, RN as the Nurse Administrator. Lauren is the delegated person of authority to run the day to day operations of the facility. The job description for the Nursing Administrator, which outlines the responsibilities/authority for this position, had been corrected and placed on Lauren Stewarts personnel file, in place of the old position as DON.

553.3(8)(v) LICENSURE Governing Body Responsibilities:

553.3 Governing Body responsibilities include:
(8) Establishing personnel policies and practices which adequately support
sound patient care to include, the following:
(v) Written job descriptions shall exist for each type of job in the ASF.

Observations:

Based on a review of personnel files (PF) and employee interview (EMP), it was determined that the facility failed to maintain job descriptions with clearly delineated position requirements for registered nurses in eight of eight personnel files (PF1, PF2, PF3, PF4, PF5, PF6, PF7 and PF8) and failed to maintain a job description for one of 10 personnel files (PF4).

Findings include:

On January 25, 2024, a review of facility personnel files was completed and revealed the following: Job Description (Approved: April 2010): Pre-Op/ PACU Nurse "Other Qualifications and Considerations: 4. BLS (basic Life Support) and/or ACLS (Advanced Cardiac Life Support and/or PALS (Pediatric Advanced Life Support) certification as require by Nurse Administrator."

On January 25, 2024, a review of facility personnel files was completed and revealed the following: Job Description (Approved: November 21, 2013; Updated May 2021): OR Nurse "Other Qualifications and Considerations: 9. BLS, ACLS certification as may be required by Nurse Administrator."

On January 25, 2024, a review of PF1, PF2, PF3, PF4, PF5, and PF6 revealed that these registered nurses were certified in BLS, ACLS and PALS. A review of PF7 and PF8 revealed these registered nurses were certified only in BLS. Thus, the standard was not consistent, and the job descriptions did not accurately reflect the requirements of the position.

On January 25, 2024, at 1:00 PM, EMP1 confirmed that the registered nurse job description required updating. EMP1 stated that all registered nurses did not require ACLS and PALS as anesthesia personnel and physicians were certified in both ACLS and BLS. EMP1 acknowledged that the job descriptions required clarification. Additionally, EMP1 confirmed there was no job discription for PF4.

Plan of Correction - To be completed: 02/05/2024

All registered nurse job descriptions have been reviewed and amended to reflect specific, required certifications. All personnel at the Center are required to have Basic Life Support (BLS)training. Those taking care of patients in the PACU are required to have BLS as well as ACLS training. Those in the OR circulator positions are required to have BLS. Each staff member must maintain the required certifications and are responsible for obtaining and renewing certifications to safely care for patient's at the the Center.

Each staff member's file has been reviewed and new job descriptions to reflect these changes have been reviewed by each employee. After having an understanding of each job description and the certifications required, each employee is to initial the new job description and is placed on the respective employees chart. Those staff members not holding appropriate certification for their job descriptions are in the process of obtaining proper certification as well as maintaining such training thereafter.

All future new hires will be given the newly amended job description in which pertains to their role at the Center. After having an understanding of their job description and the required certifications, they will initial and this will be placed on their files to indicate their understanding.

553.4 (f) LICENSURE Other Functions:

553.4 OTHER FUNCTIONS

(f) The governing body shall ensure that personnel are provided with
continuing education which is relevant to their responsibilities within the
organization.

Observations:

Based upon a review of personnel files (PF) and employee interview (EMP), it was determined that the facility failed to assure annual competency for facility staff in 2023 for ten of ten personnel files reviewed (PF1, PF2, PF3, PF4, PF5, PF6, PF7, PF8, PF9, and PF10).

Findings include:

On January 25, 2023, a review of Administrative Policies and Procedures, Policy 206-"Administrative Services " (Last Reviewed: March 4, 2019) was completed and revealed: "3.The Nurse Administrator ensures adequate nurse staffing and provides for the on-going education of the nursing staff."

On January 25, 2023, during a review of personnel files, a request was made for annual staff competencies and/or staff education for 2023. None were provided.

On January 25, 2024, at 1:26 PM, EMP1 stated that EMP1 could demonstrate staff competency for 2022; but was unable to obtain and files from "Health Stream" (continuing education vendor) for 2023. EMP1 confirmed that there are no records of continuing education for facility staff in 2023 and stated, "I am non compliant for education in 2023."

Plan of Correction - To be completed: 02/05/2024

For the year of 2023, it was an unfortunate oversight that there were no records to indicate that education was completed on our outsourced education platform (Healthstream).

Effective immediately, all staff have been given information for annual, mandatory education to completed for the 2024 year. The deadline for this education to be completed is July 27, 2024. These can be completed at any time. After courses are completed, staff is to print a copy of each module certification and provide a copy to be placed in the Staff Education/Competency Binder. Education will be monitored and the Nurse Administrator will ensure that staff adequately completes this annual education.

In addition, annual competencies will be conducted in the 2nd quarter of each respective year and a log/record will be kept on file to denote that staff has been trained in certain areas of care that are appropriate to the Center.
Examples of training would include proper use of glucometer, EKG machine, fire safety drills, safe administration of medication, mock code blue drills, etc.

557.2 (b) LICENSURE The Plan:

557.2 The Plan

(b) The written plan shall be endorsed by the governing body and the medical director who are responsible for the establishment and direction of the program and which indicates the staff person responsible for the implementation of the program.

Observations:

Based on a review of facility documents and staff interview (EMP) it was determined that the governing body failed to evaluate the quality assurance plan for 2022 and approve and/or modify the quality assurance plan for 2023.

Findings include:

On January 25, 2024, a review of the facility governing body bylaws was complete and revealed the following: Policy 203- "Governing Body Responsibilities/Requirements" (Last Approved: August 5, 2020): "7. Directly overseeing the Center ' s quality assessment and performance improvement program (QAPI), ...reviewing (at least annually) the effectiveness of the QAPI, receiving reports of QAPI activities and, when relevant, acting on the aforementioned reports ..." Policy 205-"Governing Body Activities" (Last Approved: August 5, 2020): 1. The Governing Body's activities include: "1. Meeting at least annually and keeping minutes or other records necessary for the orderly conduct of the Center. Meetings should include, but not be limited to a review of: "...c. Quality Management and Improvement Program ...i. Revisions are made as needed to maintain compliance."

On January 25, 2024, a review of the facility Quality Assurance Improvement Plan (Last Approved: February 22, 2022) was completed.

On January 25, 2024, a review of the facility governing body minutes was completed which included the minutes from March 21, 2023; June 26, 2023; August 9, 2023; September 21, 2023; and November 8, 2023. There was no evaluation of the effectiveness of the quality improvement plan noted in the minutes as defined by facility policy 205.

On January 25, 204, at 1:45 PM, EMP1 confirmed that the Quality Assurance Plan for the facility had not been evaluated for effectiveness and was not approved by the facility Governing Body for 2023.

Plan of Correction - To be completed: 02/05/2024

Each year, starting with the next scheduled meeting to be held on 3/4/2024, the GB will annually review and revise if necessary the Quality Assurance Performance Improvement Plan. This annual review and its action of taking place will be documented in the meeting minutes to ensure compliance as well as dated on the Plan itself as to when the Plan was reviewed, amended and/or approved.

565.1 LICENSURE Laboratory - Principle:

565.1 Principle

The ASF shall have procedures for obtaining routine and emergency
laboratory services to meet the needs of patients.

Observations:

Based on review of medical records (MR), facility documents and interview with staff (EMP), it was determined that the facility failed to follow the facility policy for performing and documenting a urine pregnancy test for six of twenty medical records reviewed (MR2, MR3, MR4, MR5, MR6 and MR7).

Findings Include:

Review of the facility's "Urine Pregnancy Testing Policy", last revised "April 9, 2019", revealed: "... All menstruating females, regardless of age, are required to have a urine pregnancy test. ...If a pregnancy test is required, it will be completed by the nurse, utilizing the Accutest pregnancy tests. ... Record the pregnancy test results on the Patient Assessment form. ...The patient and physician will be notified of all positive results."

A review of MR2 on January 25, 2024, revealed that there was no documentation that a pregnancy test was performed pre-operatively.

A review of MR3 on January 25, 2024, revealed that there was no documentation that a pregnancy test was performed pre-operatively.

A review of MR4 on January 25, 2024, revealed that there was no documentation that a pregnancy test was performed pre-operatively.

A review of MR5 on January 25, 2024, revealed that there was no documentation that a pregnancy test was performed pre-operatively.

A review of MR6 on January 25, 2024, revealed that there was no documentation that a pregnancy test was performed pre-operatively.

A review of MR7 on January 25, 2024, revealed that there was no documentation that a pregnancy test was performed pre-operatively.

On January 25, 2024, at approximately 12:50 PM, EMP1 confirmed that there was no documentation that pregnancy tests were completed pre-operatively for MR2, MR 3, MR4, MR5, MR6 and MR7 as per facility policy.

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Based on observation and interview with staff (EMP), it was determined that the facility failed to follow manufacturer's instructions for a single patient use glucose meter.

Findings Include:

On January 25, 2024, at 2:30 PM, review of the facility's "Blood Glucose Monitoring" policy, last approved on May 21, 2023, revealed: " ... Purpose: To provide guidelines for the use and maintenance of the Accu-Chek and to assure patient safety. ...".

During the facility tour on January 25, 2024, at approximately 9:30 AM, when asked to see the glucometer used by the facility to test patient blood sugar levels, EMP1 presented the Accu-chek Aviva device. EMP1 confirmed that this device has been used on more than one patient.

On January 25, 2024, at approximately 10:00 AM, after contacting the manufacturer, EMP1 confirmed that the Accu-chek Aviva is a single patient use glucose meter.

Plan of Correction - To be completed: 02/05/2024

Nursing Policy #108 Urine Pregnancy Testing has been reviewed and revised to reflect that all menstruating females that are to receive general or sedation anesthesia are required to have a urine pregnancy test.
If a woman has not had a menstrual cycle for over 1 year, has a history of having a hysterectomy or are receiving local anesthesia a urine pregnancy test does not need to be completed. This will be documented as "N/A" on their chart under Same Day Testing / Urine Pregnancy as well as denote why (examples ; local procedure, post menopausal, history of hysterectomy)

Staff was made aware of the incomplete charting that was audited by the DOH and have been instructed to complete charting to indicate why a "n/a" is documented.

A new HemoCue GL201 glucometer for multi-patient use is in the process of being purchased. I am working with our medical supply vendor to obtain the glucometer and schedule an in-service for staff from HemoCue to ensure all staff can be educated as well as passed off on the proper use of the new glucometer. Manufacture guidelines for the new glucometer will be readily available in the PACU are for staff to reference as needed.

2/12/2024 : All charts at the Center are audited and will be monitored to ensure that pregnancy tests are 1.) being completed on appropriate patients meeting the criteria to be tested 2.) documented not applicable and the reason why (ie, pmp, hysterectomy, local procedure).

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