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 a remote survey and email communication with a certified medical assistant (CMA) and facility personnel, the laboratory failed to report SARS-Co-V-2 test results as required for 27 of 27 employees tested, using the CareStart COVID-19 antigen Rapid diagnostic kit from December 11, 2020 to January 13, 2021. Findings Include: 1. The laboratory CMA was contacted by email on January 21, 2021 11:25 AM in regards to the laboratory performing testing for COVID-19 without state approval. 2. The surveyor received an email from the laboratory CMA on January 22, 2021 at 12:53 PM, stating, "We purchased test kits for employees only but understand that we must not administer any additional tests to employees until this form has been completed, submitted and approved. 3. The surveyor later received an email from a facility personnel on January 27, 2021 at 9:58 AM, stating, "CareStart COVID-19 antigen Rapid diagnostic tests were used to perform 27 tests" and 27 of 27 test results were not reported as required. 4. The surveyor received an email from a facility personnel on January 27, 2021 at 2:33 PM, stating, they started testing on December 11, 2020 and the last day of testing was on January 18, 2021. 5. The laboratory performed the following number of CareStart COVID-19 antigen Rapid diagnostic tests: - December 11, 2020: 24 tests were analyzed. - January 13, 2021: 2 tests were analyzed. - January 18, 2021: 1 test was analyzed. 6. The facility personnel confirmed on January 27, 2021 at 2:33 PM. the CareStart COVID-19 antigen Rapid diagnostic tests were performed and the results were not reported as required. 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 --