Summary:
Summary Statement of Deficiencies D0000 An announced CLIA Recertification survey was conducted at the Pediatric Healthcare on 01/31/23 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. Specific deficiencies cited are as follows: The laboratory is performing COVID-19 testing and is in compliance with the applicable COVID-19 reporting requirements. D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on the review of proficiency testing (PT) records, lack of documentation, and interview, the lab director and testing personnel failed to review and sign three of three attestation statements reviewed for the calendar year 2022. Findings include: 1. Review of the College of American Pathologists (CAP) PT records for the calendar year 2022 revealed the lack of review and signature documentation by the lab director and testing personnel for all three attestation statements in 2022: CAP DI - A, B and C 2022. 2. An exit interview with the office manager and lab consultant on 01/31/23 at approximately 11:00 AM confirmed the findings. 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 --