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 record review, interview with laboratory personnel, and email communication, the laboratory failed to report SARS-CoV-2 positive and negative test results for 28 of 28 days of testing in September 2021 through November 2021. Findings are as follows: 1. The laboratory performed SARS-CoV-2 testing using the CareStart COVID-19 Antigen Test as confirmed by Testing Personnel 1 (TP1) during a tour of the laboratory at 10:05 a.m. on 11/23/21. TP1 indicated only employees were tested. 2. In an interview at 11:30 a.m. on 11/23/21, TP1 indicated SARS-CoV-2 results had not been reported to the appropriate health authorities from test implementation in September 2021 through October 2021. 3. Patient testing logs were not completed for the testing. A spreadsheet with November test results was reviewed on date of survey. TP1 indicated these results had been reported to the Minnesota Department of Health (MDH). The laboratory was given 5 days to provide additional testing information from September 2021 through October 2021. 4. A test record table, provided by TP1 via email on 11/29/21, was reviewed. The document included testing dates and the number of positive and/or negative results obtained each day of testing and was dated 09/16/21 - 11/21/21. The email indicated results obtained after 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 -- 11/21/21 had been reported to MDH. Days of non-reporting are indicated below. 2021 Days not reported September 5 October 14 November 9 5. A total of 60 SARS-CoV-2 test results were not reported as required from 09/22/21 through 11/19/21 as indicated on the test record table. 4 positive results and 56 negative results were not reported. 6. The laboratory performed 60 SARS-CoV-2 tests between 09/22/21 and 11/19/21 as indicated on the test record table. 7. In an interview at 11:50 a.m. on 11/23/21, TP1 confirmed the above findings. -- 2 of 2 --