Summary:
Summary Statement of Deficiencies D0000 An announced CLIA Validation survey was conducted at the Sheltering Arms Institute on 05/09/23 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: D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on the review of the Laboratory Personnel Report Form (CLIA) (CMS-209 Form), proficiency testing (PT) records, and interviews, the lab failed to rotate four of four blood gas with chemistry (AQ) PT events among all 13 testing personnel (TP) in 2022 and for the first event in 2023. Findings include: 1. Review of the CMS-209 personnel form revealed 13 TP performing chemistry blood gas procedures in the calendar year 2022 and up to date of survey on 05/09/23. An interview with the lab manager and general supervisor on 05/09/23 at approximately 11:30 AM revealed that the site has approximately nine respiratory therapists that perform the blood gas testing as needed for patients during lab operating hours and after the lab staff have departed for the day. The respiratory therapists are trained and have competency assessments for the blood gas analyzers. 2. Review of the College of American Pathologists (CAP) PT records revealed that the same TP personnel (TP-A)performed all three events in 2022 and the first event in 2023 for the AQ testing module: CAP AQ A-C 2022 - TP A, CAP AQ A 2023 - TP A. 3. An exit interview with the lab director, lab manager, and general supervisor on 05/09/23 at approximately 1500 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 --