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 observation of testing, interview and email communication with laboratory staff and providers, and review of test records and records in the Wisconsin Electronic Disease Surveillance System (WEDSS), the laboratory did not report eight of eight rapid antigen test results performed on February 21, 23, or 24, 2022 to the local or state public health department. Findings include: 1. Observation of testing personnel (staff A) on February 25, 2022 at approximately 11:00 AM showed testing personnel performed rapid antigen testing and entered results into the Polaris Digital Partners (PDP) online system and on a paper card that included the patient's name, date of birth, test result and PDP number. 2. Interview with staff A on February 25, 2022 at approximately 11:30 AM revealed the laboratory started patient testing on February 21, 2022 and stated staff at the laboratory were not responsible for reporting results to public health. 3. Email communication with a representative from the PDP Support Team on March 5, 2022, revealed PDP engaged LifePoint Informatics to report all Wisconsin patient results from this laboratory to the State of Wisconsin. On March 8, 2022, the PDP Support Team supplied an encrypted list of tests performed at this location prior to February 25, 2022. The list showed one test on February 21, three tests on February 23, and four tests (including two positive results) on February 24, 2022. 4. Review of records in the WEDSS database (the state system which documents reported COVID 19 results) showed no test results (positive or negative) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- from this laboratory for the eight tests performed on February 21, 23 or 24, 2022. A report created on March 7, 2022 from the WEDSS database showed the laboratory had not reported any results from this laboratory's CLIA number as of March 7, 2022. -- 2 of 2 --