Summary:
Summary Statement of Deficiencies 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, the laboratory failed to report SARS-CoV-2 test results as required for 14 of 16 days from August 6, 2021 to September 24, 2021. The findings include: 1. Review of SARS-CoV-2 patient test records revealed testing for SARS-CoV-2 antibody and antigen. Available patient test records for SARS-CoV- 2 antibody indicated antibody testing performed beginning August 6, 2021, and antigen testing beginning September 11, 2021. 2. Review of documentation for SARS- CoV-2 public health reporting revealed no reporting was done for antibody tests, and negative antigen tests were not reported. Nine of nine days for antibody testing was not reported for a total of fourteen patients, five of seven days for antigen testing was not reported for a total of seven patients. A total of 21 patient SARS-CoV-2 test results were not reported to public health authorities. 3. Phone interview with the laboratory director on September 28, 2021 at 1:30 pm confirmed the laboratory did not report either negative or positive antibody test results and did not report negative antigen test results to public health authorities in August and September 2021 for 14 of 16 days of testing. 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 --