Initial Comments:
This report is the result of a full State Licensure survey initiated on April 17, 2026, and concluded on May 1, 2026, at Mid-Atlantic Gastrointestinal 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:
561.25 LICENSURE
Distressed drugs, devices and cosmetics
Name - Component - 00
561.25 Distressed drugs, devices and cosmetics
Drugs, devices and cosmetics which are outdated, visibly deteriorated, unlabeled or inadequately labeled, recalled, discontinued or obsolete shall be identified by the licensed pharmacist or responsible practitioner and shall be disposed of in compliance with applicable Commonwealth and Federal regulations.
Observations:
Based on review of facility documents, observation and employee interview (EMP), it was determined the facility failed to ensure glucometer control solutions were not expired and correct glucometer supply expiration dates were documented.
Findings include:
Review of facility policy "Blood Glucose Monitors Competency in Use-Quality Control-Cleaning (2) Policy: A blood glucose monitor is properly used to evaluate patien's blood glucose levels. All persons responsible for blood glucose monitors in the evaluation of patient blood glucose levels are proficient in the monitor's use. The blood glucose monitor is properly cleaned and maintained according to manufactuer guidelines. Purpose: To ensure accurate results of blood glucose monitoring, To ensure staff competency in use of blood glucose monitors, To ensure accurate blood glucose assessment by proper care of equipment ..."
Observation on April 17, 2026, Test Strip vial was not dated.
Observation on April 17, 2026, Control Solution bottles not dated.
On April 17, 2026, review of "AccuCheck Log" last revised January 2017, revealed "Expiration Date for Test Strips is 6 months from open date or bottle expiration date whichever comes first. ... Expiration Date for control solution is 3 months from open date or bottle expiration whichever comes first."
Further review of AccuCheck Logs revealed:
April 2026 Log: Dates for Test Strip Lot: Test Strip Open date: March 27, 2026, Test Strip Expiration date was documented as occuring on March 21, 2027, which is longer than six months.
March 2026 Log: Dates for Test Strip Lot: Test Strip Open date: January 7, 2026, Test Strip Expiration date was documented as occuring on March 21, 2027, which is longer than six months.
No dates for level 1 contol and Level 2 control soulutions open and expiration for April 2026 log.
No dates for level 1 contol and Level 2 control soulutions open and expiration for three March 2026 logs.
No dates for level 1 contol and Level 2 control soulutions open and expiration for February 2026 log.
January 2026 Log: Dates for Control solutions open date 12/24/2025 expiration date March 24, 2026.
Interview with EMP1 on April 17, 2026, EMP1 confirmed the information noted above is accurate.
Plan of Correction:S0000 INITIAL COMMENTS
Notification to Center
The Center Administrator (CA) notified the Medical Director and Governing Board (GB) .of the agency visit and preliminary findings on 04/17/2026 & 5/1/2026.
S6142 561.25 DISTRESSED DRUGS, DEVICES, AND COSMETICS EXPIRATION DATE GLUCOMETER CONTROL SOLUTION / GLUCOMETER TEST STRIP & LOG DOCUMENTATION CORRECTIVE ACTIONS / SYSTEMIC CHANGES:
The CA reviewed the Blood Glucose Monitors Competency in Use – Quality Control – Cleaning (2) policy and verified all current glucometer test strips and control solutions were labeled correctly on 05/05/2026. The CA will review this policy and will re-educate all applicable staff to ensure the manufacturer instruction for use (MIFU) is followed regarding expiration dates for glucometer control solutions, glucometer test strips, and to accurately document information on glucometer logs by 5/22/2026. Any staff not in attendance will review the information on their next scheduled day at the Center and will sign the acknowledgement of review once it has been completed. The CA will ensure all applicable staff have completed the 2026 annual Blood Glucose competency by 05/22/2026. Applicable staff who are not in attendance at the center during this time will complete the annual Glucose competency on their next scheduled day at the Center. Moving forward all glucometer control solutions and testing strips will be labeled with the correct expiration date and documented accurately in the glucose log. Corrective actions will be completed by 5/22/2026.
MONITORING AND SUSTAINING THE PLAN Beginning 05/25/2026 the CA or designee will review the glucose control solutions and glucose monitoring strips weekly for 4 weeks to ensure the open date and the expiration date is present, meets MIFU guidelines, and is documented appropriately for 100% compliance. Once the initial monitoring period is over and the goal is met the Glucose Control Solution and Glucose monitoring strips will be monitored during the monthly expiration out date review, and glucose logs will be monitored monthly to ensure they are accurately completed for 100% compliance. Any non-compliance will be addressed immediately, and re-education completed as needed. The CA or designee will ensure the Glucose competency is completed by applicable staff upon hire and annually thereafter for 100% compliance. Focused monitoring will be completed by 6/22/2026.
RESPONSIBLE PARTY AND REPORTING
The CA is responsible to implement the changes identified in this POC.
The CA will provide results of this survey, the corrective actions, and results from monitoring to the Quality Assurance Improvement Committee quarterly for review and recommendations.
Recommendations will be submitted to the Governing Board for review and approval.
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