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 surveyor review of the CareStart Covid-19 Antigen Test and interview with the Vice President of Operations (AVPO) via Telephone on 7/28/22 the laboratory failed to follow the Information For Use (IFU) when performing Covid tests from September 2021 to the date of the survey. The findings include: 1. The IFU stated " Authorized laboratories using your product must have a process in place for reporting test results to healthcare providers and relevant public health authorities, as appropriate. " but the laboratory did not report test results to relevant public health authorities. 2. The laboratory performs approximately 5 COVID tests per month. 3. The AVOP confirmed on 7/28/22 at 11:14 that the laboratory did not follow the IFU. 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 the Carestart COVID-19 Antigen Test system and interview with the Office Manager (OM), and Associate Vice President of Operations 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 -- (AVPO) via telephone on 7/28/22, the laboratory failed to report all SARS-CoV-2 test results from September 2021 to the date of survey. The findings include: 1. The AVOP stated they were "unaware they had to report COVID-19 test results" to the State of New Jersey. 2. Approximately 5 patients are run monthly. 3. The AVOP confirmed on 7/28/22 at 11:14 am the laboratory failed to report all SARS-CoV-2 test results. -- 2 of 2 --