Summary:
Summary Statement of Deficiencies D0000 An unannounced complaint survey, #2020019058 and #2021001346, was conducted on February 19, 2021. Urgent Care at Longwood clinical laboratory was found not in compliance with 42 CFR 493, requirements for clinical laboratories. D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Based on record review, observation, and interview, the laboratory failed to follow the manufactures' instructions for Covid-19 antibody testing form 04/07/2020 to 02/19 /2021. Findings: Review of the manufactures' instructions section titled "Conditions of Authorization for the Laboratory" noted "Authorized laboratories using the Ecotest COVID-19 IgG/IgM Rapid Test Device ("your product" in the conditions below), must adhere to the Conditions of Authorization indicated in the Letter of Authorization. 1. Authorized laboratories* using your product will include the test result reports, all authorized Fact Sheets. Under exigent circumstances, other appropriate methods for disseminating these Fact Sheet may be used, which may include mass media." Review of the "Covid-19 Testing" patient test report for 4 out of 4 (#1, #2, #3, #4) observed patients showed that there was no information was provided to the patients with how to access the "Facts Sheet for Recipients." Review of the "Covid-19 Testing" patient test report for 5 out of 5 (#1, #2, #3, #4, #5) previously tested patients showed there was no information was provided to the patients with how to access the "Facts Sheet for Recipients." During observation of four patients on 02/19/2021 between 12:15 AM and 3:10 PM, the testing personnel 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 -- did not give the patients the "Fact Sheet for Recipients." During an interview at 4:17 PM, the Administrator stated the laboratory has performed approximately 20,000 Covid-19 antibody tests. -- 2 of 2 --