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 and email communication with the laboratory director (LD) and the technical consultant (TC) the laboratory failed to report SARS-CoV-2 test results as required for 8 of 8 days reviewed from November 2021 through January 2022. Findings: 1. SARS-CoV-2 testing documentation from patients ' charts was reviewed from November 1, 2021 through January 31, 2022. Data was provided in an email from the LD on 03/22/2022. 2. During a presurvey phone interview on 03/08 /2022 at 11:45 AM and during an interview on 03/17/2022 at 11:30 AM on the day of the survey, the LD stated that the laboratory had not reported any SARS-CoV-2 test results since they began testing in November 2021. 3. Documentation revealed that SARS-CoV-2 test results were not reported as required for 2 days in November 2021, 4 days in December 2021 and for 2 days in January 2022. 4. Sixteen test results were not reported as required during the period of review. 5. The laboratory performed 16 SARS-CoV-2 tests during the period of review. 6. The LD confirmed the findings in an email on 03/22/2022. 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 --