Summary:
Summary Statement of Deficiencies 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 observation of the laboratory, interview with testing personnel, record requests, and interview with the laboratory director/owner, the laboratory failed to report SARS-CoV-2 results to Public Health authorities in 2020 and 2021. The findings include: 1. Observation of the laboratory on April 12, 2021 revealed the Healgen COVID-19 IgG/IgM rapid antibody test in use for patient testing. 2. Interview with testing personnel on April 12, 2021 at 10:40 am confirmed the laboratory performs patient testing for COVID 19 antibody. 3. Request for records of reporting to public health authorities revealed no records were present. 4. Interview with the laboratory director/owner on April 12, 2021 at 2:30 pm confirmed the laboratory began performing testing for COVID 19 antibodies sometime in early June 2020 until present and did not report any of the COVID 19 patient results to public health authorities. No list, number of patients, or number of days of non-reporting could be provided to the surveyor. 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 --