Summary:
Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Central Virginia Family Physicians on March 7-8, 2024 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. Specific deficiencies cited are as follows: D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on a tour, review of analyzer manufacturer's maintenance logs, lack of documentation, and interviews, the laboratory failed to document performance of required monthly Cepheid GeneXpert instrument maintenance for four (4) of twelve (12) months reviewed for calendar year 2023. Findings include: 1. During a tour of the laboratory on 3/7/24 at 10 AM, the inspector noted one Cepheid GeneXpert System analyzer (Serial Number 843962) in use for patient Chlamydia trachomatis (CT) / Neisseria gonorrhea (NG) polymerase chain reaction (PCR) testing. 2. Review of the laboratory's 2023 monthly Cepheid GeneXpert System maintenance logs revealed manufacturer's instructions which stated "For each maintenance activity listed, check the box(es) under the day of the month that the activities were performed and enter initials in the bottom row. Save the maintenance file after entering data. Refer to Chapter 5 (Operating Instructions) and Chapter 9 (Service and Maintenance)." The Cepheid maintenance logs outlined under heading "Monthly" the following three required tasks: Archive tests, Purge tests, replace fan filters. 3. The inspector noted there was no documentation of the monthly maintenance tasks outlined above recorded in August, September, November, and December of calendar Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- year 2023. The inspector requested to review documentation for the monthly tasks during the 4 months. No records were available. 4. An exit interview with the Director of Ancillary Services and Laboratory Supervisor on 3/8/24 at 12:30 PM confirmed the above findings. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on a tour, review of procedures, manufacturer's user guide, calibration verification records, lack of documentation, and interview, the laboratory failed to perform calibration verification studies every six (6) months per their policy for twenty-nine (29) of 29 chemistry analytes reviewed from the test menu of Beckman and BioRad Variant instruments from May 10, 2023 to January 30, 2024. Findings include: 1. During a tour of the laboratory on 3/7/24 at approximately 10:00 AM, the inspector noted the following chemistry analyzers in use for routine chemistry and endocrinology patient testing: Beckman DXC 700 AU (serial number SN 2019020767) and BioRad Variant (SN 16190). 2. Review of the laboratory's procedures revealed a policy (titled: Six Month Linearity on DXC 700 AU) that stated, "Calibration verification is the measurement in which a curve approximates a straight line (linear range). The linear range is the numerical range of at least 5 different concentrations spaced across the tests' ranges. Every 6 months the linearity calibration verification procedures must be performed." The inspector noted the following twenty-eight (28) routine chemistry analytes were listed on the 6 Month Linearity procedure: Sodium, Potassium, Chloride, Albumin, Alkaline Phosphatase, Alanine Transaminase ALT, Aspartate Aminotransferase AST, Direct Bilirubin, Urea Nitrogen, Calcium, Carbon Dioxide, Creatine Kinase, Cholesterol, Glucose, Uric Acid, Creatinine, Iron, Lipase, High Density Lipoprotein, Low Density Lipoprotein, Total Protein, Triglycerides, Phosphorus, Total Bilirubin, Amylase, Gamma Glutamyl Transferase GGT, Lactate Dehydrogenase LDH, and Magnesium. 3. Review of the BioRad Variant manufacturer users guide revealed a two-point calibration for the Hemoglobin A1c assay. The inspector inquired regarding the laboratory's protocol for -- 2 of 3 -- calibration verification for the assay. The laboratory supervisor stated on 3/7/24 at 1 PM, "Our policy is to use BioRad's Lyphocheck Hemoglobin A1c linearity kit every six months." 4. Review of laboratory's records revealed the following lapse from 6 month calibration verification schedule for the 29 analytes outlined above: DXC 700 calibration verification documentation dated 5/10/23 and 1/30/24; BioRad calibration verification documentation dated 5/15/23 and 1/23/24. The inspector requested to review calibration verification for the 29 analytes performed in November 2023. No documentation was available for review. 5. An exit interview with the Director of Ancillary Services and Laboratory Supervisor on 3/8/24 at 12:30 PM confirmed the above findings. -- 3 of 3 --