Summary:
Summary Statement of Deficiencies D0000 A special focused survey was performed at St. Gabriel Health Clinic, INC, CLIA ID 19D0899156 on March 2, 2021 through March 10, 2021. St. Gabriel Health Clinic, INC was found not in compliance with the following CONDITION LEVEL DEFICIENCIES: 42 CFR 493.41 CONDITION: Reporting of SARS-CoV-2 Test Results 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. This CONDITION is not met as evidenced by: Based on record review and interview with personnel, the laboratory failed to report SARS-Co-V-2 patient test results from the Abbott Binax Now COVID-19 Ag Cards as required for five (5) of six (6) days reviewed from January 18, 2021 through January 23, 2021. Findings: 1. Review of patient logs from the week of January 18, 2021 through January 23, 2021 revealed seventy one (71) patients had COVID testing performed on the following dates: January 19, 2021: sixteen (16) patients January 20, 2021: thirteen (13) patients January 21, 2021: twelve (12) patients January 22, 2021: fourteen (14) patients January 23, 2021: sixteen (16 ) patients 2. In phone interview on March 8, 2021 at 3:02 pm the Quality Assurance Manager stated the laboratory had not reported COVID test results to the state agency. The Quality Assurance Manager stated she received the link for enrolling into Louisiana's electronic reporting system on March 8, 2021. The Quality Assurance Manager confirmed the identified seventy one (71) patients' COVID results were not reported to the state agency as required. 3. Via email correspondence on March 10, 2021 at 2:22 pm, the Quality Assurance Manager stated the laboratory began COVID antigen testing around July 2020. 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 --