Pennsylvania Department of Health
20 20 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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20 20 SURGERY CENTER, LLC - Inspection Results	Scope of Citation Number of Residents Affected By Deficient Practice

Initial comments:
This report is the result of a State licensure survey conducted on August 26, 2024, at 20/20 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:

555.3 (d)(1) LICENSURE Requirements:

555.3 Requirements for membership and privileges.

(d) 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.

Observations:

Based on a review of facility credential files (CF) and staff interview (EMP), it was determined that the facility failed to address the administration of anesthesia in the delineation of privileges for four of four medical staff reappointments (CF1, CF2, CF3, and CF4).

Findings include:

On August 26, 2024, a review of CF1 (Reappointment Term: September 1, 2024 through September 30, 2026) was completed. The delineation of privileges (signed August 15, 2024) failed to address the administration of anesthesia.

On August 26, 2024, a review of CF2 (Reappointment Term: September 1, 2024 through September 30, 2026) was completed. The delineation of privileges (signed August 15, 2024) failed to address the administration of anesthesia.

On August 26, 2024, a review of CF3 (Reappointment Term: September 1, 2024 through September 30, 2026) was completed. The delineation of privileges (signed August 15, 2024) failed to address the administration of anesthesia.

On August 26, 2024, a review of CF4 (Reappointment Term: September 1, 2024 through September 30, 2026) was completed. The delineation of privileges (signed August 15, 2024) failed to address the administration of anesthesia.

On August 26, 2024, at 12:50 PM, EMP1 confirmed the above findings.

Plan of Correction - To be completed: 09/09/2024

The Medical Staff shall include "The use of local anesthetics and parenteral sedation for ophthalmologic conditions." to the list of Medical Staff delineations of privileges.

The Medical Staff shall edit the delineation of privileges to add a section for administration of anesthesia.

A letter will be sent out to all Medical Staff members regarding the change in delineation of privileges and it will require signature for acknowledgement.

Plan of Correction will be initiated immediately. But not expected to be in complete compliance until October 14th, 2024. The Medical Staff shall expect 100% compliance at that time.

555.22 (a)(1-2) LICENSURE Surgical Services - Preoperative Care:

555.22 Pre-operative Care

(a) Pertinent medical histories and physical examinations, and supplemental information regarding drug sensitivities documented day of surgery or one of the following:
(1) If medical evaluation, examination and referral are made from a private practitioner's office, hospital or clinic, pertinent records thereof shall be available and made part of the clinical record at the time the patient is registered and admitted tot he ASF. This information is considered valid no more than 30 days prior to the date of surgery.
(2) A practitioner shall examine the patient immediately before surgery to evaluate the risk of anesthesia and of the procedure to be performed. The information shall be clearly documented in the medical record.

Observations:

Based on review of facility documents, medical records (MR), and interview with facility staff (EMP), it was determined that the facility failed to ensure that medical histories and physical examinations were performed no more than 30 days prior to date of surgery for three of ten medical records reviewed (MR5, MR6 and MR8).

Findings include:

On August 26, 2024, a review of facility policy, "History and Physical" (Last Approved: 04/25/2024) was completed and revealed the following: " ... 1. An appropriate current history is required regardless of the type of anesthesia planned and/or given, as well as when no anesthesia is given ...".

On August 26, 2024, MR5 (Date of Surgery: August 19, 2024) was reviewed and revealed the history and physical was completed in office on June 25, 2024.

On August 26, 2024, MR6 (Date of Surgery: August 19, 2024) was reviewed and revealed the history and physical was completed in office on July 11, 2024.

On August 26, 2024, MR8 (Date of Surgery: August 20, 2024) was reviewed and revealed the history and physical was completed in office on June 18, 2024.

On August 26, 204, at 11:03 AM, EMP1 verified the above findings.

Plan of Correction - To be completed: 09/09/2024

The Administrator shall have all staff members sign off the Medical Clearance Policy 8.35.

The Director of Nursing will review all patients charts to ensure that all patients scheduled for surgery have a medical exam from their PCP dated within 30 days or less to the scheduled surgery. This shall be evaluated at the time of the pre-op phone call.

Should the medical exam be over 30 days, each practitioner shall review and update the initial exam.

The Administrator will develop an audit for the Director of Nursing to complete 10 charts per month for 3 months to ensure 100% compliance. If there is not 100% compliance the audit will continue until we have 3 consecutive months of 100% compliance.

Plan of correction will be initiated immediately but not expected to be in complete compliance until October 14, 2024. The Director of Nursing and the Administrator will expect 100% compliance at that time.

The results of the audit will be reported to the Quality Assurance and Improvement Committee

563.12 (6) LICENSURE Form and Content of Record:

563.12 Form and content of record

The ASF shall maintain a separate medical
record for each patient. Each record shall be accurate, legible and
promptly completed. Patient medicals shall be constructed to stand alone and be easily identified as ASF records. Medical records must include at least the following:
(6) Entries related to anesthesia administration

Plan of Correction - To be completed: 09/09/2024

The Administrator shall review with Certified Registered Nurse Anesthetist the regulation (563.12) that "Each record shall be accurate, legible and promptly complete" when documenting

The Administrator along with anesthesia personnel will also review anesthesia Pre-anesthesia check charting and determine what will be beneficial to promote proper documentation on these are charts

An audit will be developed for the Director of Nursing to review 5 medical records per month for 6 months to ensure that the pre-anesthesia equipment check is charted accurately

Plan of correction will be initiated immediately but not expected to be in complete compliance until October 14, 2024.

The Administrator will expect 100% compliance at that time. When audit is reviewed, we must have at least 3 consecutive months of 100% compliance.

The results of the audit will be reported to the Quality Assurance and Improvement Committee

563.12 (8) LICENSURE Form and Content of Record:

Observations:

Based on a review of facility documents, medical records (MR) and staff interview (EMP), it was determined that the facility failed to document the circumstances surrounding the decision to terminate the scheduled left cataract procedure in one of three medical records reviewed (MR2).

Findings include:

On August 26, 2024, a review of facility policy, Clinical Records Documentation " (Last Approved; 04/25/2024) was completed and revealed the following, "Policy Statement: Surgery Center personnel shall adhere to charting standards in patient medical records in accordance with the following procedures ...IV. Each patient record will reflect compliance with physician ' s orders, reflect knowledge of and adherence to Continuous Quality Improvement standards, and communicate status of status of the patient ' s condition ... VI. Patient records will be confidential, current, and accurate...".

On August 26, 2024, a review of facility incidents revealed that a scheduled left cataract procedure for MR2 (Date of Surgery- October 31, 2023) was cancelled due to the inability to adequately sedate the patient.

On August 26, 2024, a review of MR2 revealed the following note by the CRNA at 7:58 AM, "Patient tolerated anesthesia and surgical procedure well." Further review revealed no documentation in the medical record regarding the inability for the patient to achieve proper sedation.

On August 26, 2024, at 11:03 AM, EMP1 confirmed the above.

Plan of Correction - To be completed: 09/09/2024

The Administrator will review with all nursing staff members Regulation 563.12 that all medical records shall be "accurate and legible and promptly complete". She will also review Policy 6.10 Clinical Record Documentation (XV). When an incident occurs resulting in the change of standard procedure all nurse's notes shall be pertinent, accurate and concise so that they contribute to the continuity of care.

The Administrator shall review patient charts that have reportable incident since last inspection to have late entry nursing notes added if necessary to complete chart accurately

An audit shall be developed by the Administrator and the Safety Officer (Director of Nursing). The audit shall be on every patient chart that there is a reportable incident. It will include review to ensure that there is an anesthesia nursing note and/or an OR nursing note.

Plan of Correction will be initiated immediately but not expected to be in complete compliance until October 1, 2024. The Administrator and Safety Officer shall be initiated immediately and then ongoing until we have 3 months of consecutive compliance of 100%.

The results of the audit will be reported to the Quality Assurance & Improvement Committee.

567.43 LICENSURE Ventilation System:

The ventilation system shall be inspected and maintained in accordance with the written maintenance schedule to ensure that a properly conditioned air supply meeting minimum filtration, humidity and temperature requirements is provided in critical areas such as the surgical and recovery suites under
Chapter 571 (relating to construction standards).

Observations:

Based on review of facility documents and staff interviews (EMP), it was determined the facility failed to maintain adequate air changes per hour in the procedure rooms.

Findings include:

Review of facility policy, "Infection Control Guidelines", last approved April 25, 2024, revealed: " ... Environmental requirements: ... Monitoring of Air exchange will be completed annually ... ".

During interview with EMP1 on August 26, 2024, at approximately 11:50 AM, EMP1 explained that the facility opened in 2004, and the HVAC system was not replaced since the facility was opened.

Review of "The American Institute of Architects (AIA) ... Guidelines for Design and Construction of Hospital and Health Care Facilities ... 2001 Edition", revealed: " ... Table 7.22 ... Ventilation Requirements for Areas Affecting Patient Care in Hospitals and Outpatient Facilities ... Minimum total air changes per hour ... Procedure room ... 15 ... .

Review of facility document " ... Air Outlet Devices Air Exchange ... Facility 20/20 Surgery Center ... Date Completed: 8/7/2024" revealed: " ... Procedure Room #2 Laser ... Air Exchange per Hour 12.8... Lensx Room ... Air Exchange per Hour ... 3.3 ...".

During a tour of the facility with EMP1 on August 26, 2024, at approximately 12:00 PM, EMP1 confirmed that the above two rooms are classified as procedure rooms. EMP1 further explained that laser procedures are performed in the the Lensx Room.

EMP1 confirmed the above findings on August 26, 2024, at approximately 12:15 PM.

Plan of Correction - To be completed: 09/09/2024

The Administrator shall have a certified company in environmental services in health care facilities come in and do a survey

No cases will be performed in the procedure/ laser room until surveys complete to be in 100% compliance with regulations and then inspected by surveyor. This is to be expected to be in complete compliance on September 30th, 2024.

The Administrator has Northstar Environmental Ltd. coming to the facility to conduct a complete air balance survey on October 11, 2024

The HVAC system will be altered as required by the environmental company to ensure 100% compliance

The Administrator shall have the company reinspect the facility in two months, then in four months, then annually to ensure air quality is in compliance as per policy and regulations.

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