Carilion Family Medicine Parkway

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Carilion Family Medicine - Parkway on July 21, 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: D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) (b)(1)(i) Establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (b)(1)(ii) Perform and document the maintenance activities specified in paragraph b(1)(i) of this section. This STANDARD is not met as evidenced by: Based on a review of policies and procedures, equipment maintenance records, and interviews, the laboratory failed to document that the urinalysis centrifuge's revolutions per minute (RPM) calibration protocols ensured reliable urine microscopy results per procedure for 24 of 24 months reviewed (July 17, 2024 through the date of the recertification inspection, July 21, 2026). Findings include: 1. Review of the laboratory's policy and procedure manual revealed a urine microscopy procedure (titled: Urinalysis with Microscopic Exam) which stated, "Fill a urine centrifuge tube with 12 mls well mixed urine. Centrifuge for 5 minutes at 1800-2000 rpms or 3 minutes at 3000 rpm." The inspector noted that the procedure also referenced Clinical Laboratory Diagnosis by Samuel A. Levinson and Robert P. MacFate and Gradwohl's Clinical Laboratory Methods and Diagnosis by Frankel, Sam, and Reitman. The reference methods outlined instructions as, "The sediment is prepared as follows, centrifuge 10-15 mL of urine at 1,500-2,000 rpm for 5 minutes decant supernatant, resuspend the sediment of the remaining 1 ml of urine by tapping the tube gently against countertop and place one drop on a microscope slide for examination." 2. Review of the laboratory's biomedical equipment maintenance records for the review 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 -- timeframe, 7/17/24 to 7/21/26, revealed the following RPM calibration verification recorded for the urinalysis centrifuge (Unico SN 504464) dated: 2/17/25 with speed verified as "expected 3400 RPM, input 3390; 1/23/26 with speed verified as "expected 3400 RPM, input 3395; The inspector requested to review a calibration verification at 1,800-2,000 rpm (per the procedure) or 1,500-2,000 rpm (per procedure's reference). No additional records were available. The inspector inquired regarding the RPM checks outlined above as they were outside the procedure guidelines. The technical consultant (TC) stated on 7/21/26 at 3 PM, "Those RPM checks are outside of the higher RPM option on our procedure and also exceed 10 % variation. We will look at options to use a different centrifuge going forward." 3. An exit interview with the primary testing personnel and TC on 7/21/26 at 3:30 PM confirmed the above findings. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced CLIA Recertification survey was conducted at the Carilion Family Medicine Parkway on 10/26/22 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: The laboratory is performing COVID-19 testing and is in compliance with the applicable COVID-19 reporting requirements. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on the review of policy and procedures (P&P), quality control (QC) records, lack of documentation, and interviews, the lab failed to retain documentation of the performance of the daily QC procedures for the 20 analytes assayed on the Beckman Coulter DxC 700 chemistry analyzer from 01/11/21 up to 08/27/21. Findings include: 1. Review of the P&P revealed a general procedure to perform and review chemistry QC materials each day of patient testing for the following analytes: alanine aminotransferase (ALT), albumin, alkaline phosphatase (ALP), asparate aminotransferase (AST), direct bilirubin, total bilirubin, BUN (Urea), total calcium, carbon dioxide (CO2), cholesterol, chloride, creatinine, glucose, HDL cholesterol, LDLD, potassium, total protein, sodium, triglyceride and total hemoglobin A1C. 2. Review of available printed daily QC documents from the Beckman Coulter DxC 700 chemistry analyzer located in a cardboard box revealed a date of 09/24/21. The inspector requested to review documentation prior to 09/24/21. In an interview with the testing personnel on 10/26/22 at approximately 11:15 AM, they stated, "I'm not sure where those records would be, the other testing personnel was in charge of that." Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- In an additional interview with the technical consultant on 10/26/22 at approximately 11:30 AM, they stated that the instrument should be able to retrieve the records from the hard drive. The inspector and the testing personnel attempted to retrieve the requested data from the chemistry analyzer. The last date available for review via the chemistry analyzer hard drive was 08/30/21. The instrument was unable to retrieve the requested data from 01/11/21 up to 08/27/21. The technical consultant and the inspector searched the room in which previous chemistry QC records were stored, to include calendar year 2019 and 2020. The requested records from 01/01/21 up to 08/27 /21 were not available for review. 3. An exit interview with the technical consultant on 10/26/22 at approximately 1500 confirmed the findings. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)