Initial Comments:
This report is the result of an unannounced revisit survey conducted on March 26, 2025, following a State Licensure survey completed on December 18, 2025, at Ophthalmology Surgical Center. It was determined that 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:
553.3 (6) LICENSURE
Governing Body Responsibilities
Name - Component - 00
Governing Body responsibilities include:
(6) Adopting policies or procedures necessary for the orderly conduct of the ASF.
Observations:
Based on review of facility documents, observation, and staff interview (EMP), it was determined the facility failed to follow their established policy and manufacture guidelines for glucometer supplies.
Findings include:
On March 26, 2026, review of manufacture guidelines "True Metrix Self-Monitoring Blood Glucose Test Strips Instructions for Use" revealed "... Caring for Test Strips ... Write date opened on test strip vial label when removing the first test strip. Discard all unused test strips in vial after either date printed next to EXP on the test strip vial label or four months after date opened, whichever comes first. Using test strips past these dates may cause inaccurate results. ..."
On March 26, 2026, review of facility policy "Glucometer Pre-Test Protocol" last revision date of January 2026, revealed "Purpose: To provide guidelines for the performance of pre-testing of the glucometer. Policy: The glucometer will be checked prior to the patient being tested to ensure the appropriate functioning of the meter. These checks will be documented on the Glucometer Quality Control Log Sheet. Procedure: 2. Run a test on the meter with the test strips and a level 1 or level 2 control solutions. Document the control test results on the Control Test Log Sheet. Check expiration dates on all. Use only the control solutions that are compatible with the glucometer. Control Solutions are good for three months after opening and should have the open date and the 3-month expiration date noted on the bottles. Document the information on the Control test log sheet each time a new bottle of test strips/control is opened. When a bottle of test strips is opened document the open date on the vial of test strips."
On March 26, 2026, review of "Quality Control Record for Glucometer" last revised December 24, 2024, revealed "Level 1 Control open date April 4, 2026, discard date July 4, 2026; Level 2 Control open date April 4, 2026, discard date July 4, 2026."
Observation on March 26, 2026, facility Level 1 and Level 2 control solution bottles did not have open, or expiration dates noted.
Observation on March 26, 2026, facility test strip bottle did not have open date noted.
Interview with EMP1 on March 26, 2026, EMP1 confirmed information noted above is complete and accurate.
Plan of Correction:Plan of Correction:
When opening a new container of test strips the open date and the 4 month expiration date will be written on the container of test strips. The open date and expiration date will be listed on the controls (1 and 2) as well.
The glucometer logs will be checked every surgery day by DON or practice Director should the DON not be present on a surgery day.
Policy SS-1014.1 will be updated.
All pertinent surgical staff will be made aware by DON through our surgery morning huddles of the updated policy. The updated policy will be printed out for staff to read and sign off.
After DON checks the glucometer log on surgery days the check will be recorded and the log will be kept in the DONs office. The log will now include an additional sign off from DON specific to each control (1 and 2) in addition to the test strips vial.
If it should be found that the process is not being followed the DON will re-educate pertinent staff and document re-education. Re-education also took place on the date of 3-26-26 with all pertinent staff verbalizing understanding of what the process will be.
Education of the rest of the nursing staff will be completed on 4-23-26 to ensure all PRN staff have cycled through the schedule and have been present for education.
The audits performed by the DON or the practice Director if the DON is not present on a surgery day will take place each surgery day at the end of the day to ensure all is up to date and current policy and procedure is being followed.
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