Summary:
Summary Statement of Deficiencies D0000 An onsite survey was completed on April 05, 2022, to investigate complaint number GA00221943. The allegation was substantiated. The following deficiencies were cited: D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 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 interview, the laboratory failed to follow current manufacturer's instructions for all waived tests performed by the Clinic's laboratory as required. Findings include: 1. Observation during the laboratory tour on 04/05/2022 at approximately 10:40 a.m. revealed there were no manufacturer's instructions available at the time of survey for the following waived tests: Assure Platinum Glucometer Point of Care Glucose testing and Binax Now COVID-19 Antigen Card testing by Abbott Diagnostics. 2. Observations during the tour and laboratory documents maintenance review on 04/05/2022 at approximately 1: 30 p.m. revealed there were no required Quality Control (QC) documentations available at the time of survey for the aforementioned waived tests from 2020 to April 05, 2022. 3. Interviews with the Clinic administrator and Nursing supervisor in the conference room at approximately 1:30 p.m. on 04/05/2022 confirmed the lack of manufacturer's instructions and Quality Control (QC) documentations for the aforementioned waived tests from 2020 to April 05, 2022. 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 --