Novant Health Twin City Pediatrics

Summary Statement of Deficiencies D6072 TESTING PERSONNEL RESPONSIBILITIES CFR(s): 493.1425(b)(3) (b)(3) Adhere to the laboratory's quality control policies, document all quality control activities, instrument and procedural calibrations and maintenance performed; This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and procedures, review of 2024, 2025, and 2026 Medonic hematology maintenance records, and interview with the TC (technical consultant) 5/29/26, and email correspondence 6/2/26, testing personnel failed to perform and document Medonic monthly cleaning as required for 5 of 29 months from January 2024 to May 2026. Review of the laboratory's "Medonic M- Series Hematology Analyzer" procedure on 5/29/26 revealed "... G. Maintenance ... 3. Monthly cleaning a. Clean the aspiration probes using an alcohol wipe. b. Fill a cup with 10 ml 2% hypochlorite (Bottle #2 from Boule Cleaning Kit) and one cup with 18 ml diluent (Recommend use of the dispense function for obtaining diluent see Section 5.5 of Medonic User's Manual; Dispense Function) c. Aspirate hypochlorite as a pre- dilute sample. Repeat aspiration for a total of 2 times. d. Run 2 blank samples by aspirating diluent as a pre-diluted sample. e. Perform a background check, in pre- dilute mode, to verify all values are within range. f. Test all three levels of control. When all control results are within acceptable limits, patient testing may commence. g. Document on the Medonic M-Series Maintenance Log. ..." Review of 2024, 2025, and 2026 Medonic maintenance logs and instrument printouts on 5/29/26 revealed there was no documentation of monthly maintenance for the following months: 1. 2024 - March, August; 2. 2025 - January December; 3. 2026 - February. During interview 5/29/26 at approximately 2:00 p.m., the TC confirmed the maintenance records were not available for review. In email correspondence on 6/2/26, the TC verified that the laboratory was unable to provide documentation of monthly cleaning for the missing months. 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 --

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 --

Summary Statement of Deficiencies D5783