Novant Health Rowan Family Physicians

Summary Statement of Deficiencies D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) (b)(9) Thereafter, evaluations must be performed at least annually This STANDARD is not met as evidenced by: Based on review of technical consultant (TC) delegation of responsibilities, review of 2022, 2023, 2024 and 2025 testing personnel (TP) competency assessment records and interview with TC 08/14/25, the TC failed to perform annual competencies for 1 of 3 TP for the Urine Microalbumin/Creatinine ratio (ACR), Creatine Kinase-MB (CKMB), Troponin (TROP), Myoglobin (Mb) and D-Dimer testing from December of 2022 until May of 2025, a period of approximately 29 months. Findings: Review of TC delegation of responsibilities revealed under Section 4 "...Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently.". Review of 2022, 2023, 2024 and 2025 TP #2 competency assessment records revealed the TC evaluated competency of TP #2 in December of 2022 for the ACR, CKMB, TROP, Mb, and D-Dimer testing. The next evaluation of competency was performed in May of 2025, a period of approximately 29 months later. Interview with TC at approximately 12:00 p.m. confirmed the competency assessments for TP #2 were not performed annually as required. They stated TP #2 was not available during the times the TC was on-site to perform competency assessments. 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 D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on observation and interview with TC (technical consultant) on 12/17/2019, the laboratory failed to discard vacutainer blood tubes that had exceeded their expiration dates. Findings: During tour of the laboratory at approximately 3 pm, the surveyor observed expired light blue Sodium (NA) Citrate vacutainer blood tubes (lot #9004633, expiration date: 10/31/19) located in drawing area #2 and clinical area "Hall A", that were available for use. During interview at approximately 3:05 pm, the TC confirmed the vacutainer tubes were expired. She stated the laboratory does not send out light blue NA Citrate tubes for testing very often. 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 --