Summary:
Summary Statement of Deficiencies D0000 An announced CLIA Recertification on-site survey was conducted at CMG Piedmont Primecare East on February 10, 2021 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. The initial contact and entrance interview with laboratory conducted on January 21, 2021 with off-site record review of documentation and a follow-up email on February 5 & 8, 2021. 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 the review of proficiency testing (PT) records, lack of documentation and interview with the technical consultant, the lab failed to verify the accuracy of the urine sedimentation examinations twice a year in 2019 and 2020. Findings include: 1. The laboratory utilizes Medical Laboratory Evaluation (MLE) PT for verification of accuracy of urine sediment examinations, categorized as non-regulated analytes. 2. MLE provides two samples per survey event for urine sedimentation evaluation. Review of the MLE PT results revealed the laboratory received the following: 2018 M3- 1 of 2 unacceptable responses, 2019 M1- 1 of 2 unacceptable responses, 2019 M3- 1 of 2 unacceptable responses, 2020 M1- 1 of 2 unacceptable responses, 2020 M3- 1 of 2 unacceptable responses. On February 10, 2021 at approximately 12:15 PM, the surveyor requested documentation of