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 policy and procedure review, record review and staff interview, the laboratory failed to report 160 SARS-CoV-2 negative patient tests results, as required, for 16 weeks of testing reviewed (4/19/21 to 8/11/21). The findings were: 1. Review of the laboratory's documentation showed 203 patient SARS-CoV-2 tests were performed using the Cepheid Xpert Xpress test system since 4/19/21. There was no evidence the 160 SARS-CoV-2 negative patient results had been reported to the State Public Health Laboratory. 2. Review of the laboratory's procedures showed no evidence the laboratory had developed a policy and procedure for reporting SARS- CoV-2 positive and negative test results to the appropriate agencies. 3. Interview with medical assistant #1 on 8/11/21 at 2 PM revealed she was unaware the laboratory was required to report negative SARS-CoV-2 patient results and confirmed only the positive SARS-CoV-2 patient test results were reported to the State Public Health Laboratory. 4. Interview with the office manager on 8/11/21 at 2:35 PM revealed she was unable to locate the policy. 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 --