Summary:
Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Planned Parenthood South Atlantic-Charlottesville on May 6, 2021 by the Virginia Department of Health's Office of Licensure and Certification. The survey included an initial virtual record review conducted on 05/06/21 prior to the onsite visit. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. Specific deficiency cited is as follows: D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on a review of the Centers for Medicare and Medicaid Services Laboratory Personnel Report Form (CMS 209), microscopy proficiency testing (PT) records, and an interview, the laboratory failed to verify the accuracy of Potassium Hydroxide (KOH) Wet Prep testing twice annually in calendar years 2019 and 2020. Findings include: 1. Review of the laboratory's CMS 209 personnel form revealed that one (1) testing personnel (TP A) performed patient KOH Wet Prep microscopy examinations during the review timeframe (January 2019 to May 6, 2021). See Testing Personnel Code Sheet. 2. Review of the laboratory's KOH Wet Prep PT documentation, a total of three (3) reports, revealed the laboratory director utilized PT to verify TP A's microscopy accuracy (PT events were dated as completed on 7/3/19, 7/25/20, 1/14 /21). The inspector requested to review additional verification of accuracy for calendar years 2019 and 2020. No documentation was available for review. The Senior Health Center Manager stated on 5/6/21 at approximately 11:00 AM: "Our policy is to document our provider's accuracy twice annually with Planned Parenthood Federation of America (PPFA) Center for Affiliate Learning and going forward we Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- have set a plan to do the Wet Prep proficiency in January and July of each year." 3. In an exit interview with the Senior Health Center Manager on 5/7/21, at approximately 12:30 PM, the above findings were confirmed. -- 2 of 2 --