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 a phone interview with the laboratory's Director of Operations on 06/22 /2022 and subsequent email correspondence on 07/05/2022 the laboratory has no written procedure for and are not following a product insert procedure for reporting SARS-CoV-2 testing results. 1. An interview with the Director of Operations on 06/22 /2022 confirmed that the laboratory has no written procedure for reporting SARS- CoV-2 test results to the loceal Public Health District or the State of Idaho. 2. An interview with the Director of Operations on 06/22/2022 confirmed that the laboratory had no record of reporting SARS-CoV-2 results for their Independent Living Center patients, since testing began on 11/06/2020 . 3. An email from the Director of Operations on 07/05/2022 confirmed that the laboratory had no written procedure for reporting and that results for SARS-CoV-2 testing were not being reported for their Independent Living Center patients since testing began on 11/06/2020. 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 timing and frequency, as the Secretary may prescribe. 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 -- This CONDITION is not met as evidenced by: Based on a phone interview with the laboratory's Director of Operations on 06/22 /2022 and subsequent email correspondance on 07/05/2022 the laboratory is not reporting SARS-CoV-2 test results for their Independent Living Center patients since testing began on 11/06/2020. The findings include: 1. An interview with the Director of Operations on 06/22/2022 confirmed that the laboratory had no record of reporting SARS-CoV-2 results for their Independent Living Center patients since testing began on 11/06/2020. 2. An email from the Director of Operations on 07/05/2022 confirmed that results for SARS-CoV-2 testing were not being reported for their Independent Living Center patients since testing began on 11/06/2020. -- 2 of 2 --