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 review of patient SARS-COV-2 test records and public health SARS-COV- 2 data transmission records and interview with the technical consultant, the laboratory failed to report 29 of 501 patient test results for SARS-COV-2 for a total of 21 out of 84 testing days. The findings include: 1. Review of patient SARS-COV-2 test records and public health electronic data transmission records revealed that 29 of 501 results for SARS-COV-2 were not reported to public health authorities. Provided patient records indicate testing for SARS-COV-2 began on February 19, 2021. 2. Review of patient test records revealed there was a total of 84 test days. SARS-COV-2 test results were not reported for 21 of 84 testing days. 3. Phone interview with the technical consultant on September 29, 2021 at 12:15 pm confirmed that 29 of 501 SARS COV-2 patient test results were not reported to public health for a total of 21 out of 84 days in 2021. 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 --