Summary:
Summary Statement of Deficiencies D0000 An onsite Complaint survey was completed on February 05, 2026, to investigate complaint intake number GA22023021. The allegation was substantiated. The following deficiencies were cited: 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 observation during the laboratory tour and staff interviews, the laboratory failed to consistently document quality control for all waived tests from February 2024 through February 2026. Findings: 1. On February 05, 2026 at 12:35 PM, a review of maintenance and laboratory records revealed that the laboratory failed to consistently document required daily Quality Control (QC) for all in-house waived testing from February 2024 to February 2026. 2. A review of documentation further revealed that the Standard Operating Procedures, temperature logs, maintenance logs, and Quality Control logs had not been reviewed and signed by the laboratory director. 3. During the laboratory tour, in the clinic laboratory, on February 05, 2026 at 1:15 PM, revealed expired Healgen COVID-19/Flu A&B Rapid Combo test kits, which expired on October 31, 2025, were observed, in use for patient testing, on the date of survey. 4. During the laboratory tour , in the clinic laboratory, on February 05, 2026 , at 1:15 PM, observation of instrument calibration and maintenance stickers revealed that the LabCorp Model 642E centrifuge was last calibrated on August 26, 2023, and that the Midmark Ritter Autoclave last received preventative maintenance in September 2022. 5. On February 05, 2026, at 3:00 PM, interviews conducted in the clinic laboratory, with the lead Medical Assistant and laboratory staff, confirmed the lack of required consistent daily Quality Control documentation. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --