Summary:
Summary Statement of Deficiencies D0000 The Novant Health Twin City Pediatrics - Winston Salem laboratory was found in compliance with 42 CFR Part 493 Requirements for Laboratories as a result of an off- site survey performed on January 22, 2021. D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). (a) 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 review of instrument printouts and review of reported SARS-CoV-2 results 3 /2/21-3/5/21, and email from the TC (technical consultant) 2/24/21, the laboratory failed to report SARS-CoV-2 test results as required on 3 of 3 random days (12/10/20, 1/6/21, 1/29/21) reviewed. Findings: 1. Review of instrument printouts from the Abbott ID NOW and reported results from the laboratory's data system 3/2/21-3/5/21 revealed: a. The laboratory tested 13 patients for SARS-CoV-2 on 12/10/20. 2 of 13 patient results were not reported as required on 12/10/20. b. The laboratory tested 9 patients for SARS-CoV-2 on 1/6/21. 1 of 9 patient results was not reported as required on 1/6/21. c. The laboratory tested 16 patients for SARS-CoV-2 on 1/29/21. 1 of 16 results was not reported as required on 1/29/21. 2. In an email on 2/24/21 at 5:44 p.m., the TC stated that some of the laboratory's SARS-CoV-2 results were not reported. She stated the results were not entered in the laboratory's electronic medical records 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 -- system, so they were not included in the data reported electronically each day to the state authorities. -- 2 of 2 --