Summary:
Summary Statement of Deficiencies D0000 An announced CLIA validation survey was conducted at Minor Emergency Family Care Center, INC on December 18, 2019 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. The specific deficiency cited is as follows: D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on a review of proficiency testing (PT) records, lack of documentation, and interviews, the laboratory failed to evaluate non-graded PT results for two (2) analyte challenges on one (1) of six (6) events in the twenty-four (24) months reviewed. Findings include: 1. Review of the laboratory's 2018 and 2019 American Proficiency Institute (API) PT documentation, a total of 6 events, revealed no evaluation or verification of accuracy for the following 2 non-graded responses on 2019 Event 1: API Hematology: Platelet Count Challenge Hem-02 API Urine Chemistry: Microscopic Sediment Challenge US-02 The inspector requested to review evaluation documentation for the two (2) analyte challenges listed above. No records were available for review. The technical consultant (TC) stated at approximately 2:45 PM "We did not document the times that API failed to grade, but we will complete necessary documentation in the future". 2. In an exit interview with the TC at approximately 3:45 PM, the above findings were confirmed. 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 --