Summary:
Summary Statement of Deficiencies D0000 A remote complaint special focused COVID-19 reporting survey for complaint number 2021011749 was conducted on 08/26/21 to 09/16/21 at Consulate Health Care of Winter Haven, a clinical laboratory in Winter Haven, Florida. Consulate Health Care of Winter Haven was not in compliance with Code of Federal Regulations (CFR), Part 493, requirements of clinical laboratories. The following Condition was not met: D1002 Reporting of Sars-Cov-2 Test Results 493.41 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 the laboratory failed to report negative COVID- 19 test results to the Department of Health (DOH) since testing began 12/30/20. Findings Included: Review of the testing revealed that the laboratory was using the Abbott BinaxNOW COVID-19 Antigen card rapid test. Interview on 09/07/21 at 2:47 PM with the Director of Nursing confirmed that COVID-19 testing began on 12/20 /20. Review of a random sample of Patient results revealed #1 tested 08/27/21 (Positive), #2 tested 01/26/21 (Negative), #3 tested 12/29/20 (Negative), and #4 tested 08/23/21 (Positive). Review of reporting documentation revealed that only the Positives (#1 and #4) were reported to the DOH. Interview on 08/31/21 at 11:54 AM with the Director of Nursing confirmed that only the Positive results were reported to the DOH. 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 --