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 surveyor review of test records and a report from the Wisconsin Electronic Disease Surveillance System (WEDSS), observation at the test site, and email communication with the Crusaders of Justicia Executive Director (staff A), the laboratory did not report eight of eight positive SARS CoV-2 Antigen test results from January 31 to February 23, 2022 to the Wisconsin state or local public health departments. Findings include: 1. Review of test records at the Crusaders of Justicia building at 1521 Washington Street in Manitowoc Wisconsin showed 58 rapid SARS CoV-2 Antigen tests were performed on 14 days between January 31 to February 23, 2022. The results included eight positive tests results. 2. Observation at the Crusaders of Justicia building on February 23, 2022 at 2:11 PM revealed a CLIA Certificate of Waiver posted on the building window. The CLIA certificate number and laboratory information shown was 14D2247436, United Covid Control, Ummah Relief, 339 W River Road, Elgin, IL 60123. 3. Email communication with staff A on May 9, 2022 confirmed United Covid Control staff performed rapid SARS CoV-2 Antigen testing at Crusaders of Justicia under the 14D2247436 CLIA certificate. 4. Review of a report from the WEDSS database created on May 5, 2022 showed United Covid Control reported zero of the eight positive test results from January 31 to February 23, 2022 at the Crusaders of Justicia location to the Wisconsin health department. 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 --