Summary:
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)