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 laboratory records and the Wisconsin Electronic Disease Surveillance System (WEDSS) records and interview with a medical assistant, the laboratory did not report test results for two of two random SARS CoV-2 tests performed by Speedy Labs in February 2022. Findings include: 1. Random review of testing records in the laboratory found two patients (Patient one and two) that had SARS CoV-2 testing performed in this laboratory in February 2022. 2. Review of results in the WEDSS database using the Public Health Analysis Visualization - Reporting (PHAVR) Application showed no results from this laboratory for either patient. 3. An attempt to pull a report showing all patient tests reported to WEDSS from this laboratory resulted in no records. The search was performed on May 10, 2022 and resulted in no qualifying records with either the CLIA laboratory identification number or the laboratory name. 4. During an interview with the medical assistant (staff A) on March 1, 2022 at approximately 10:45 AM, staff A stated the laboratory had obtained access for reporting results to the state health department "within the last week or two" and confirmed the laboratory had not reported SARS CoV-2 test results to the state or local health department prior to getting access. 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 --