Summary:
Summary Statement of Deficiencies D0000 A CLIA recertification survey was conducted for the Pediatric Health Care Associates, PC laboratory on 04/07/2026 pursuant to the Clinical Laboratory Improvement Amendments (CLIA) of 1988 and CLIA regulations at 42 CFR 493 D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b)(8) 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. The procedures for evaluation of the competency of the staff must include, but are not limited to-- This STANDARD is not met as evidenced by: . Based on record review and staff interview the Technical Consultant (TC) failed to ensure all testing personnel (TP) received competency assessment at the laboratory. Findings include: 1. Record review on 4/7/2026 of the laboratory personnel records revealed: a. 6 TPs listed on the Laboratory Personnel Report. b. 3 of 6 TP did not have competency assessments documented for the years 2024, 2025, and 2026 to date. Specifically TP3, TP4, and TP5. 3. During interview with staff on 4/7/2026 at 9:30 AM, TC2 stated, "competency was not done at this lab location for those TP. Competencies were conducted at another CLIA lab." 4. The laboratory performs 15,938 tests in the specialties of Hematology and Urinalysis annually. 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 --