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 record review and interview with the Laboratory Director (LD), the laboratory failed to report SARS-Co-V-2 test results as required for 53 of 53 patient tests performed with 1 positive test result since the laboratory opened on 10/19/2020. Findings include: 1. The surveyor requested the facility's SARS-CoV-2 patient test results and documentation of reporting via email correspondence on 3/7/21 at 2:47 pm. 2. An interview with the LD on 3/10/21 at 3;00 pm via a phone call revealed the laboratory had performed a total of 53 patient tests with the Cue Covid-19 Test system for SARS-CoV-2. The laboratory did not report any test results (negative and/or positive) to the Washtenaw County Health Department. 3. The laboratory received an email from the Washtenaw County Health Department which instructed them to only report "positive Covid-19 test results." "We do not need negative results to be reported to us." 4. A email from the LD on 3/7/2021 at 4:49 pm, the LD stated "I realize I made an error in asking the patient to report her positive results to her own health department since she was not in Washtenaw County but I followed up with her husband to make sure everything was taken care of and it was." 5. The LD confirmed the above findings on 3/10/21 at 13:00 pm via a phone call. 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 --