Summary:
Summary Statement of Deficiencies 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 review of laboratory logs, testing instruction for use (IFU) and an interview with the site manager on 2/1/2022, the laboratory failed to follow the manufacturer's instructions for performing COVID-19 and Influenza testing. The findings include: 1. A review of the manufacturer's IFU identified the following test storage requirements: Indicaid COVID-19 antigen rapid test 2-30 C (36-86 F) do not freeze FaStep COVID- 19 IgG/IgM rapid test 2-30 C (36-86 F) do not freeze Consult Diagnostic Influenza A&B test 2-30 C (35-86 F) Accula SARS-CoV-2 test 15-30 C (59-86 F) do not refrigerate or freeze 2. A review of the laboratories January 2022 temperature log identified that the laboratory failed to store the test kits above 32 F for 14 of 24 days. 3. An interview with the laboratory manager on 2/1/2022 at 9:25 am confirmed that the am temperatures were below the storage requirements. 4. The CLIA certificate number 13D2232224 for the Covid Clinic Post Falls was hanging on the wall of the 140 N Milwaukee, Boise, Idaho location. It was later confirmed by email with a Covid Clinic project manager that the Boise location is testing under the Post Falls CLIA certificate. D1002 REPORTING OF SARS-CoV-2 TEST RESULTS During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such 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 -- timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: Based on direct obervation, a record review and an interview with the laboratory manager on 2/1/2022, the laboratory failed to report SARS-CoV-2 test results as required since testing began on September 2, 2021. The findings include: 1. It was observed that the laboratory was testing for SARS-CoV-2 using the Accula SARS- CoV-2 test, Indicaid COVID-19 rapid antigen test,and the FaStep COVID-19 IgG /IgM rapid test. 2. The laboratory failed to have documentation of reporting SARS- CoV-2 test results to the state of Idaho from September 2, 2021 to February 1, 2022. 3. An interview with the laboratory manager on 2/1/2022 at 9:16 am confirmed that the laboratory has not reported SARS-CoV-2 test results to the state of Idaho. 4. The CLIA certificate number 13D2232224 for the Covid Clinic Post Falls was hanging on the wall of the 140 N Milwaukee, Boise, Idaho location. It was later confirmed by email with a Covid Clinic project manager that the Boise location is testing under the Post Falls CLIA certificate. -- 2 of 2 --