Summary:
Summary Statement of Deficiencies D0000 The Main Street Family Care laboratory was found to be in compliance with the requirements at 42 CFR, Part 493, 'Requirements for Laboratories' as a result of an onsite survey on November 2, 2022. 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, review of patient SARS-COV-2 test records and interview with the laboratory director, the laboratory failed to report positive SARS-CoV-2 test results as required for one of four days selected for review in 2022. The findings include: 1. Observation of the laboratory on November 10, 2022 at 8 am revealed the GenBody waived SARS-CoV-2 antigen test in use for patient testing . 2. SARS-CoV-2 patient logs and test reporting documentation was reviewed for the dates of 06/13/22, 07/11/22, 07/13/22 and 08/22/22. 3. Documentation revealed that positive SARS-CoV-2 results were not reported as required on 07/11/22 for three patients. 4. Interview with the laboratory director on 11/02/2022 at 11 am confirmed the laboratory did not report positive SARS-CoV-2 results as required for one of four dates in 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 --