Summary:
Summary Statement of Deficiencies 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 Quality Control (QC) & calibration records for the Beckman Coulter Act Diff hematology analyzer and interview with the laboratory testing person, the laboratory failed to be consistent in retaining the QC & calibration records for the calendar years 2020 and 2021. FINDINGS: 1. The laboratory performs 3 levels of 4-C controls on the Beckman Coulter Act Diff hemtology analyzer each day of testing however, the testing personnel were not consistent with retaining printed copies for the controls during the calendar years 2020 and 2021 . 2. The laboratory performed the required calibration every six months, however during the survey the records were not available for the calendar years 2020 and 2021. 3. The laboratory testing person confirmed on November 30, 2022 at approximately 2:30 PM, that when preparing for the survey he was unable to locate the records for the calendar years 2020 and 2021. D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (2)(i) Using calibration materials appropriate for the test system and, if possible, 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 -- traceable to a reference method or reference material of known value; and (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Based on review of Beckman Coulter AcT Diff hematology analyzer records and an interview with the laboratory testing person,the laboratory failed to perform the required six-month calibration for the Beckman Coulter AcT Diff analyzer due on April 23, 2020. FINDINGS: 1. The laboratory's calibration policy and the manufacturer policy for the Beckman Coulter AcT Diff hematology analyzer requires the analyzer to be calibrated every six months and/or as needed after preventative maintenance. a. The last calibration record available for review was dated October 23, 2019, therefore the next calibration was due April 23, 2020. b. Approximately 196 patient specimens were tested and reported for automated complete blood count (CBC) during the time period when analyzer was out of calibration from April 23, 2020 through January 2, 2022. -- 2 of 2 --