Summary:
Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Holston Medical Group- Abingdon Primary Care on July 9, 2026 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. Specific deficiency cited is as follows: D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(a) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess and, when indicated, correct problems identified in the postanalytic systems specified in 493.1291. This STANDARD is not met as evidenced by: Based on a tour, review of the laboratory's procedures, quality assessment (QA) logs, lack of documentation, patient logs, and interviews, the laboratory failed to maintain a mechanism to ensure the accuracy of manually transcribed microscopy results per policy for 21 of 24 months reviewed while reporting 2,249 patients' results (survey timeframe June 6, 2024 to July 9, 2026). Findings include: 1. During a tour of the laboratory on 7/9/26 at 10:30 AM, the inspector noted one Olympus CH2 microscope in use for patient microscopy testing (Serial Number 5D0675) and inquired how microscopy results are entered into the patient chart. The primary testing personnel (TP) stated on 7/9/26 at 10:30 AM, "We have a log sheet that we write the microscopy results onto and they are then manually entered". The inspector followed up with an inquiry as to how the laboratory monitors the quality/accuracy of the manually entered microscopy results. The TP stated on 7/9/26 at 10:40 AM, "Once a month I take one random wet prep and four urine patient IDs that had microscopy to double check that the patient chart matches what is written on the log sheet." 2. Review of the laboratory's procedures revealed a QA protocol (titled: "Verification of Manual - Wet Prep and Urine Microscopic Results") that stated, "Manual entries of wet prep and 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 -- urine microscopic results must be routinely verified to maintain result accuracy, meet quality assurance standards, and comply with CLIA requirements. Manual entries are to be reviewed monthly, occurring no later that the 20th of the following month." 3. Review of all available QA logs revealed the following dates of "Manual Entry Verification Audit Log" documentation: 04/20/26 (Patient IDs from testing in April 2026 were reviewed- ID xxx0056, xxx0863, xxx0058, xxx0171); 05/20/26 (Patient IDs from testing in May 2026 were reviewed- ID xxx1139, xxx0272, xxx0069, xxx1095); 06/19/26 (Patient IDs from testing in June 2026 were reviewed- ID xxx0585, xxx0873, xxx0715, xxx0153, xxx1011); The inspector requested to review additional manual entry verification records specifically for the timeframe of June 2024- March 2026. No additional periodic quality audits were available for review upon request. 4. Review of the laboratory's microscopy patient test logs during timeframe of 6/6/24 through March 2026 (period in lapse of QA records) revealed the laboratory reported 2,249 manually transcribed microscopy results without documentation of QA of the Postanalytic System for accuracy of test results. 5. An interview with the Supervisor and Operations Manager/Laboratory Manager on 7/9/26 at 2 PM confirmed the above findings. -- 2 of 2 --