Summary:
Summary Statement of Deficiencies D0000 A Validation Survey was conducted February 17, 2025 at Pineville Children's Clinic - CLIA ID # 19D0461054. Pineville Children's Clinic was found not in compliance with the following CONDITION LEVEL DEFICIENCIES: 42 CFR 493.1250 CONDITION: Analytic systems 42 CFR 493.1403 CONDITION: Laboratories performing moderate complexity testing; Laboratory Director D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on observation by surveyor, record review, and interview with personnel, the laboratory failed to ensure quality of testing within the analytic systems. Findings: 1. The laboratory failed to label in-use Complete Blood Count (CBC) quality controls with an open and expiration date as required by the manufacturer. Refer to D5415. 2. The laboratory failed to ensure supplies did not exceed their expiration dates for two (2) of three (3) rooms reviewed. Refer to D5417. 3. The laboratory failed to take