Summary:
Summary Statement of Deficiencies D0000 An announced CLIA Recertification survey was conducted at the Pediatric and Adolescent Health Partners on 08/03/22 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: D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on the review of the manufacturer operator's guide, lack of documentation, and interview, the lab failed to perform and document the monthly maintenance for the hematology analyzer for three of 12 months in 2021 and the six month maintenance performed every six months in 2021. Findings include: 1. Review of the manufacturer operator's guide revealed instructions for performing monthly cleaning procedures utilizing the Boule Cleaning Kit listed under "Section 8: Cleaning, Maintenance & Transport", "8.2 Monthly Cleaning" and 8.3 Six Month Cleaning". 2. Review of the maintenance records for the Medonic M-series analyzer (serial number 47341) revealed lack of documentation of the performance of the monthly maintenance for June, October and November 2021. In addition, the review revealed lack of documentation of the six month maintenance performed every six months in 2021. The lab performed and documented the six month maintenance on 01/29/21. During an interview with the lab administrator on 08/03/22 at approximately noon, the inspector requested to review aforementioned documents. The documents were not available for review. The lab administrator stated, "I didn't always have the time to ensure the maintenance was performed and documented due to staffing." 3. An exit interview with the lab administrator on 08/03/22 at 1330 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 --