Summary:
Summary Statement of Deficiencies D0000 An announced CLIA virtual recertification survey was conducted for Virginia Physicians, Inc- Reynolds Primary Care on January 20, 2021 by the Virginia Department of Health's Office of Licensure and Certification. The survey included an entrance telephone interview and virtual record review conducted on 1/15/2021. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. The laboratory was not in compliance with the following Condition under 42 CFR part 493 CLIA Regulations: D6063 - 42 CFR. 493.1421 Condition: Laboratory Testing Personnel. Specific deficiencies cited are as follows. D6063 LABORATORY TESTING PERSONNEL CFR(s): 493.1421 The laboratory must have a sufficient number of individuals who meet the qualification requirements of 493.1423, to perform the functions specified in 493. 1425 for the volume and complexity of tests performed. This CONDITION is not met as evidenced by: Based on a review of the Centers for Medicare and Medicaid Services Laboratory Personnel Report form, available testing personnel records, patient test logs, and interviews, the laboratory failed to retain documentation of personnel qualifications for one of two testing personnel from September 14, 2020 to the date of the survey on January 20, 2021. See D6065. D6065 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(1)(2)(3)(4)(i) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located or have earned a doctoral, master's, or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology 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 -- from an accredited institution; or (b)(2) Have earned an associate degree in a chemical, physical or biological science or medical laboratory technology from an accredited institution; or (b)(3) Be a high school graduate or equivalent and have successfully completed an official military medical laboratory procedures course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or (b)(4)(i) Have earned a high school diploma or equivalent; and 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), available testing personnel records, test logs, and interviews, the laboratory failed to retain documentation of personnel qualifications for one (1) of two (2) testing personnel responsible for reporting patient microscopy test results from 9/14/20 to 1/20/21. Findings include: 1. Review of the laboratory's CMS 209 form revealed 2 testing personnel (TP) identified as performing non-waived urine sediment and wet prep microscopy procedures. 2. Review of the laboratory personnel documents for TP A revealed a 1991 secondary education school record from Bangladesh. The inspector requested to review US equivalent education credentials for TP A. The technical consultant (TC) stated on 1/20/21 at approximately 10:30 AM: "Our tech is trying to get us a copy of completed US medial laboratory technician diploma. I have requested it but do not have it yet. We hope to have it by the end of February." See Personnel Code Sheet. 3. Review of the laboratory personnel training records revealed that TP A's initial training was verified /signed by the TC on 9/14/20. Review of patient test logs revealed TP A as performing patient microscopy procedures from September 2020 to the date of the survey, a four month timeframe. 4. In an exit interview with the TC at 11:00 AM, the above listed findings were confirmed. -- 2 of 2 --