Summary:
Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on review of 2018 and 2019 Beckman Coulter Act Diff 2 hematology calibration records, review of the manufacturer's assay sheet, and interview with Technical Consultant(TC) 11/14/2019, the laboratory failed to discard expired calibration material that was used for calibration of the hematology analyzer. Findings: Review of the calibration records revealed the analyzer's 6-month calibration was performed on 5/14/2019. The manufacturer's assay sheet for the S-Cal Calibrator-lot # 4766, used for the calibration revealed the calibrator expired on 5/4 /2019. Review of records also revealed changes were made to the calibration factors for hemoglobin(hgb) and mean corpuscular volume(MCV) based on the results of the calibration. During interview at approximately 2:15pm, the TC confirmed the calibrator was expired when used for the calibration. 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 --