Summary:
Summary Statement of Deficiencies D0000 The laboratory was found to be in substantial compliance with CLIA regulations (42 CFR Part 493). No deficiencies were cited. D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). (a) 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. This CONDITION is not met as evidenced by: Based on record review and staff interview, the laboratory failed to report 1,662 negative SARS-CoV-2 test results out of 1,704 total tests performed between June 28, 2021 and December 17, 2021. Findings include: 1) Review on 12/20/2021 of SARS- CoV-2 test records revealed the laboratory began SARS-CoV-2 testing using the GeneXpert Cepheid on 6/28/2021. The laboratory performed a total of 1,704 tests from 6/28/21 to 12/17/2021 of which 1,662 test results were negative (not detected) for SARS-CoV-2 from June to December 17, 2021. 2) Interview with Staff A (General Supervisor) on 12/20/2021 at 10:30 a.m. revealed the positive test results are reported to the state public health agency by the ordering providers and staff health unit. Staff A further revealed the laboratory does not have a policy for reporting SARS-CoV-2 test results. 3) Interview on 12/20/2021 at 11:55 a.m. with Staff B and Staff C (Nurses) from the organization's staff health unit confirmed only positive results are reported to the State's Division of Public Health. 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 --