Summary:
Summary Statement of Deficiencies 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 review of laboratory records and interview with the Corporate Compliance Nursing Manager, Nursing Director and Vice President of Compliance and Quality, the laboratory failed to establish and follow COVID-19 reporting polices from 01/26 /2021 to 03/11/2021. Findings Include: 1. On the day of survey, 03/11/2021, the laboratory could not provide the following procedures for: - Reporting employee negative COVID - 19 antigen test results to the appropriate agencies. - Reporting pateint negative COVID - 19 antigen test results to the appropriate agencies. - Reporting visitor positive and negative COVID-19 antigen test results to the appropriate agencies. 2. The Corporate Compliance Nursing Manager and Nursing Director confirmed the findings above on 03/11/2021 around 9:15 am. 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 lack of documentation and interview with the Corporate Compliance 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 -- Nursing Manager, Nursing Director (ND) and Vice President of Compliance and Quality, the laboratory failed to provide documentation of SARS-CO-V-2 antigen test results reported to the appropriate agencies as required for 1,313 of 1,313 employees and 2,022 of 2,022 patients tested from 1/26/2021 to 03/11/2021. Findings Include: 1. On the day of survey, 03/11/2021, the laboratory was unable to provide documentation of reporting SARS-CoV-2 antigen test results to local/state agencies performed on the Carestart COVID-19 Antigen test kits for 1,313 of 1,313 employees and 2,022 of 2,022 patients tested from 1/26/2021 to 03/11/2021. 2. The laboratory provided documentation for 2 of 2 positive SARS-CO-V-2 antigen test result to the chester county department of health. 3. When asked to provide documentation of SARS-CO-V-2 negative test results reported to the appropriate agencies the ND stated, "that's not my job, that's corporate's job". 4. The Corporate Compliance Nursing Manager and Nursing Director confirmed the findings above on 03/11/2021 at 9:20 am. -- 2 of 2 --