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 review of laboratory's procedures, review of 2019, 2020, and 2021 analyzer service, maintenance, and calibration records, and interview with the lab supervisor 6 /18/21, the laboratory failed to retain all calibration documentation for the Beckman Coulter AcT Diff 2 hematology analyzer. Findings: Review of the Act Diff Calibration procedure states, "Important after you have finished calibration, be sure that you have the following printouts for your records: - Reproducibility Summary results - Carryover summary results - Current CAL factors(prior to calibration) - Calibration Summary results - New CAL factors(after calibration)" Review of the 2019, 2020, and 2020 analyzer service, maintenance, and calibration records revealed: 1. Clinical engineering performed service on 2/4/19. The service record stated, "... Repro and carry-over passed. Completed S-cal; all parameters passed with no adjustments needed. Gave reports to......" The Act Diff 2 maintenance log was initialed as calibration performed on 2/4/19. The calibration records revealed no documentation for the 2/4/19 calibration. 2. Clinical engineering performed service on 4/29/19. The service record stated, "Pre-calibration procedure and S-cal completed..." The Act Diff 2 maintenance log was initialed as calibration performed on 4/29/19. The calibration records revealed only the carryover and reproducibility summaries. There was no other documentation available for the 4/29/19 calibration. During interview at approximately 12:45pm, the laboratory supervisor confirmed the calibration records were not available. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --