Summary:
Summary Statement of Deficiencies D0000 This Statement of Deficiencies was created as a result of an on-site CLIA complaint investigation survey conducted at your facility on April 21, 2025. The investigation was in response to an allegation of the laboratory failing to follow manufacturer's instructions when using glucometers to perform fingerstick glucose testing. The allegations were found to be substantiated. The findings and conclusions of any investigation by the Division of Public and Behavioral Health shall not be construed as prohibiting any criminal or civil investigations, actions or other claims for relief that may be available to any party under applicable federal, state, or local laws. D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Based on a review of laboratory documentation, observation, and an interview with the laboratory testing personnel, the laboratory failed to ensure that testing was performed according to the manufacturer's instructions. Findings include: 1. A review of the laboratory records found that there was no documentation that seven of seven testing personnel had been trained according to the manufacturer's instructions for performing fingerstick blood glucose with the ReliOn Prime and Verio One Touch glucometers. 2. A review of laboratory records found that there was no documentation of controls being performed for either the ReliOn Prime or the Verio One Touch glucometers that were in use at the facility. The manufacturer's instructions for both glucometers indicate that controls must be performed to ensure the meter is functioning correctly. The manufacturer's instructions for the ReliOn Prime glucometer states to, "Use Control Solution to check that the meter and test strips are working correctly. It is important that you carry out this simple check regularly." It Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- then recommends that controls should be performed when each new bottle of test strips is opened, if test strips have been exposed to temperatures outside of 39-86 degrees Fahrenheit, when the battery is changed, if malfunction is suspected, or if results do not correlate with physical symptoms. The manufacturer's instructions for the Verio One Touch glucometer states to perform control solution testing whenever a new vial of test strips is opened, if the meter is dropped or damaged, if malfunction is suspected, or if results do not correlate with physical symptoms. 3. A review of laboratory records found that the testing personnel were not monitoring the temperature and humidity where the testing supplies were stored to ensure that the storage conditions were appropriate. The manufacturer's instructions for the Verio One Touch test strips and controls indicated that they are to be stored between 41 and 86 degrees Fahrenheit and below 90% humidity. The manufacturer's instructions for the ReliOn Prime controls and test strips indicated that they are to be stored between 39 and 86 degrees Fahrenheit. There were no thermometers available in the storage areas to determine the room temperature. 4. An interview with the testing personnel on April 21, 2025 at approximately 3:00 PM, found that they were unaware of the need to modify the expiration dates of the testing strips and control solutions after opening the vials. The manufacturer's instructions for the ReliOn Prime indicated that test strips were to be discarded three months after opening. The manufacturer's instructions for the Verio One Touch indicated that the test strips and controls were to be discarded six months after opening. The testing personnel indicated that there were no other strips available at the time of survey. 5. A review of the patient records found that three of four patients at the facility had orders to check their blood glucose levels prior to administration of insulin. 6. An interview with the Executive Director and the Wellness Director on April 21, 2025 at approximately 3:30 PM confirmed that the testing personnel had not completed training for performing fingerstick blood glucose testing. The Executive Director and Wellness Director also indicated that no controls had been performed, and the temperatures and humidity were not being monitored at the time of survey. The laboratory performs approximately 5,475 glucose tests annually. -- 2 of 2 --