Initial Comments:
This report is the result of an unannounced revisit conducted on May 21, 2021, following a State licensure survey conducted on March 16, 2021, at Berkshire Eye 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 Department of Health (Department) documents, facility documents, and staff interview (EMP), it was determined the facility failed to complete quarterly Propofol Emergency Safety Drills.
Findings include:
Review of the Department's database revealed the facility, a Class B ambulatory surgery center, was granted an exception to 28 Pa. Code 551.31(a) to administer Propofol as sedation in 2007.
Review of the facility's policy "Propofol Emergency Safety Drills," revealed "Policy It is the policy of Berkshire Eye Surgery Center to ensure the safety of patients when Propofol is administered as a sedation agent at the facility. To comply with guidelines for the use of Propofol in an ambulatory surgery facility, Berkshire Eye Surgery Center will conduct unannounced quarterly safety drills. The drills will be used to assess anesthesia provider(s) and staff responses to Propofol emergencies as well as to identify any gaps/deficits in processes established to address complications associated with the administration of Propofol. ... "
Interview on May 21, 2021, at approximately 1:00 PM with EMP1 confirmed quarterly propofol drills were not completed. EMP1 confirmed the propofol drill was not conducted on April 16, 2021 as outlined in facility's Plan of Correction (POC).
Cross Reference
551.64 Content Of Plan of Correction
Plan of Correction:A Propofol drill was completed on 5/14/2021. The drill was lead by Dr. Geyer, the Chief Anesthesiologist for the Center. Dr. Geyer has been made aware that these drills must be completed quarterly. The next drill is scheduled for July 15,2021.
The Clinical Director will stay in touch with Dr. Geyer to make sure that these drills are completed quarterly.
551.64 LICENSURE
Content of plan of correction
Name - Component - 00
551.64 Content of Plan of Correction
A plan of correction shall address deficiencies cited in the compliance directive of the Department. the plan shall state specifically what corrective action is to be taken, by whom and when.
Observations:
Based on an unannounced follow-up on-site survey completed on May 21, 2021, review of the facility's Plan of Correction (PoC), documents provided by the facility, and staff interview (EMP), it was determined the Berkshire Eye Surgery Center failed to correct deficient practice and follow the PoC submitted to and accepted by the Department.
Findings include:
1. Review of 551.31(a) Exception - Principle revealed the facility continued to be non-compliant with this regulation.
The PoC stated "The Clinical Director has spoken with the Chief Anesthesiologist at the surgery center to insure that quarterly drills will be completed. To date drills have been done biannually. The next drill is now scheduled for Friday, April 16th and will now be done quarterly. The drills will be documented and the outcomes and recommendations coming from the drill will be reported at the quarterly meetings. This will insure that the drills are performed quarterly."
Cross reference with 51.31 Exceptions - Principle
2. Review of 553.3(8)(iii) Governing Body Responsibilities revealed the facility continued to be non-compliant with this regulation.
The PoC stated "In accordance with corporate policy annual employee evaluations are due by the end of the first quarter annually. All evaluations have been completed for all employees as of 3/31/2021. If evaluations are not completed by this date the corporation e-mails the Administrator/Clinical Director."
Cross reference with 553.3(8)(iii) Governing Body Responsibilities
3. Review of 555.3(e) Requirements revealed the facility continued to be non-compliant with this regulation.
The PoC stated "The surgery center uses a third party vendor to complete credentialing. A monthly chart is provided to the Administrator/Clinical Director which provides the dates of when credentialing was last completed and when it is due again. All credentialing is due again in 2022 except for one surgeon who is due in the summer of 2021. The details of credentialing will be presented at the next Governing Board Meeting on May 18th. Then all files will be brought up to date."
Cross reference with 555.3(e) Requirements
Plan of Correction:As just reported, Propofol drills are now being scheduled quarterly. The last drill was held on May 14th 2021 and the next drill is scheduled for July 15th.
All evaluations were completed by the end March 2021.
The re-credentialing application has been completed by the surgeon due to be re-credentialed in 2022. The results of the re-credentialing will be reported to the Governing Board at the next Quarterly Meeting in August.
The Clinical Director will be monitoring the drills, completing the evaluations, and monitoring re-credentialing. She will also be reporting these events to the Governing Board at the Quarterly Meetings.
553.3 (8)(iii) LICENSURE
Governing Body Responsibilities
Name - Component - 00
553.3 Governing Body responsibilities include:
(8) Establishing personnel policies and practices which adequately support
sound patient care to include, the following:
(iii) Personnel records shall include current information relative to periodic work performance evaluations.
Observations:
Based on review of facility documents, personnel files (PF), and staff interviews (EMP), it was determined the facility failed to review employee performance annually for two of ten personnel files (PF) reviewed (PF8 and PF10).
Findings include:
Review on March 16, 2021, of the facility's policy "Performance Evaluation and Wage and Salary Guidelines," revealed "Policy Annually, the Administrative and Clinical Director will jointly assess the employee's quality and quantity of work performance, attendance, and attitude on the Employee Performance Evaluation Form. The Director(s) will meet with the employee and, through discussion review, the past year's performance. At the conclusion, goals with target dates will be mutually agreed upon and documented. ..."
The following PFs were reviewed on May 21, 2021:
PF8 revealed the last performance evaluation was completed in 2019.
PF10 revealed no current employee performance evaluation.
Interview on May 21, 2021 at approximately 1:10 PM with EMP1 confirmed the performance evaluations were not completed annually for PF8 and PF10.
Plan of Correction:The last two evaluations were accidentally overlooked and were completed after this survey took place. Evaluations are completed annually by the end of the first quarter.
The Clinical Director completes the evaluations and they then get submitted to the corporate office. Once accepted by the corporate office the Clinical Director is notified so that the documents can be printed and placed in the employee file. The reminders from Corporate continue until the Clinical Director responds.
555.3 (e) LICENSURE
Requirements
Name - Component - 00
555.3 Requirements for membership and privileges
(e) Reappraisal and reappointment shall be required of every member of the medical staff at regular intervals no longer than every 2 years.
Observations:
Based on review of facility documents, credential files (CF), and staff interview (EMP), it was determined the facility failed to ensure each physician was reappraised and reappointed every two years for 2 of 10 credential files reviewed (CF1 and CF2).
Findings include:
Review on March 16, 2021, of the facility's policy "Credentialing and Privileging," last reviewed January 2021, revealed "Policy It is the policy of Berkshire Eye Surgery Center to credential and privilege all members of the medical staff according to established standards. ... 5) The re-credentialing process is as follows: a) The re-credentialing process will be triggered based on the date of the governing body's granting of privileges initially and every two years thereafter. ... c) The applicant will complete a delineation of privilege form, requesting privileges for procedures for which the applicant wishes to perform at the center. The delineation of privileges must be submitted prior to any file review by the medical director/designee and action taken governing body on the re-credentialing file. ... b) The Board will review and consider the requests for privileging of each member of the medical staff every two years as defined. ..."
Review of board meeting minutes revealed recredentialing was not addressed/listed.
Review on May 21, 2021 at approximately 1:30 PM revealed CF1 and CF2 were not reappraised and reappointed every two years.
Interview May 21, 2021 at approximately 1:45 PM with EMP1 confirmed CF1 and CF2 were not reappraised and reappointed every two years. EMP1 indicated they thought all reappraisal and reappointments were completed.
Plan of Correction:This Center uses a third party credentialing organization. The Clinical Director brought the re-credentialing needed to the attention of this party. The re-credentialing has been completed and the results will be presented to the Governing Board at the next Quarterly Meeting in August.
This third party informs the Clinical Director which providers are in need of re-credentialing.
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