Summary:
Summary Statement of Deficiencies D0000 The laboratory was sent a manually created CMS-2567 with survey ID # Temp0285. 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 the nurse practitioner (NP) practice provider, the laboratory failed to report positive and negative SARS-CoV-2 test results for specimens tested from October 1, 2021 through January 19, 2022. Findings: 1. The NP stated that the laboratory started performing the "Celltrion DiaTrust Covid-19 Ag [antigen] Rapid Test" on October 1, 2021. The laboratory calendar showed the lot number COVGCCM1005 and expiration date of 2022.07.13 recorded on October 4, 2021. 2. The NP provided a folder with rapid SARS-CoV-2 Ag test results. There were multiple headings on the worksheets identifying the data as rapid COVID-19 Ag test results. The worksheets contained patient names, date of testing and the test result. The dates of testing were recorded as 12/10/21 - 12/17/21, 12/28/21, 12/29/21, 12/30/21, 12/31/21, 1/3/22, 1/4/22, 1/6/22, 1/14/22, and 1/17/22. When asked about the worksheets from October 1, 2021, through December 9, 2021, the NP stated that the missing worksheets had been shredded after the final patient results had been uploaded into the electronic medical record (EMR). 3. During the onsite visit on 01/19/2022 at 1:45 pm, the NP was not able to provide the total number of rapid SARS-CoV-2 Ag test results tested between October 1, 2021 through January 19, 2022. 4. On 01/27/2022 at 9:22 am, the NP confirmed that the laboratory had 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 -- performed 523 rapid SARS-CoV-2 Ag test results between October 1, 2021 through January 19, 2022. The NP confirmed that none of the rapid SARS-CoV-2 Ag test results had been reported to the Maryland Department of Health (MDH). -- 2 of 2 --