Summary:
Summary Statement of Deficiencies D0000 An announced CLIA initial survey was conducted at Centra Urgent Care-Forest on June 3, 2021 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: 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 procedures, microscopy proficiency testing (PT) records, and an interview, the laboratory failed to verify the accuracy of Wet Prep Potassium Hydroxide (KOH) examinations twice annually in calendar year 2020. Findings include: 1. Review of the laboratory's procedures revealed a protocol to utilize PT to verify Wet Prep/KOH microscopy examination accuracy. 2. Review of the laboratory's Medical Laboratory Evaluation (MLE) PT reports (2020 Events 1-3) revealed the laboratory failed twice annual accuracy verification by receiving the following unsatisfactory scores in calendar year 2020: 2020 1st Event: unsatisfactory score; one of two unacceptable response (Wet Prep PPM-1 failed), 2020 2nd Event: unsatisfactory score; one of two unacceptable response (No score/Not graded for Wet Prep PPM-7 due to failure to participate). 3. In an interview with the practice manager, nurse manager, technical consultant, and lead testing personnel on 06/03/21, at approximately 3:30 PM, the above findings were confirmed. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. 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 -- This STANDARD is not met as evidenced by: Based on a review of the laboratory's Wet Prep/ Potassium Hydroxide (KOH) microscopy proficiency testing (PT) records, PT