Summary:
Summary Statement of Deficiencies D0000 A Complaint (LA 00056607) survey was performed at Acadia Total Health-CLIA ID 19D2149680 on January 28, 2021. Acadia Total Health was found not in compliance with the following CONDITION LEVEL DEFICIENCIES: 42 CFR 493.1100 CONDITION: Facility administration 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 review of the laboratory's test menu, patient test records, and interview with the Laboratory Director, the laboratory failed to report SARS-Co-V-2 test results for eighteen (18) of eighteen (18) patients reviewed from January 4, 2021 through January 26, 2021. Findings: 1. Review of patient SARS-Co-V-2 test records from January 4, 2021 through January 26, 2021 revealed the laboratory did not report eighteen (18) of eighteen (18) SARS-Co-V-2 antibody test results to the state agency. 2. In interview on January 28, 2021 at 10:41 am, the Laboratory Director stated the laboratory began using the Healgen test kits on April 28, 2020. The Laboratory Director further stated patient test results for COVID testing had not been reported to 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 -- the state agency. The Laboratory Director stated she was unaware that COVID antibody test results needed to be reported. 3. Review of the laboratory's test menu revealed the laboratory performed 900 COVID antibody tests since April 28, 2020. -- 2 of 2 --