Summary:
Summary Statement of Deficiencies D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratory's and, as applicable, the manufacturer's test system criteria for acceptability before reporting patient test results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of the Beckman Coulter AcT diff Hematology analyzer quality control (QC) records, patient logs, and an interview with the current and the retiring Technical Consultants, the laboratory failed to ensure at least two levels of Hematology QC were run and were within acceptable limits before patient testing began. This was noted on one day of patient CBC (Complete Blood Count) testing in 2017. The findings include: 1. A review of the 2017 Hematology cumulative QC reports revealed only the Low level QC was within acceptable ranges on 3/1/2017. The Normal and High level QC were run, but outside acceptable ranges on this date. 2. A review of the patient log revealed 22 patient CBCs were performed on 3/1/2017. 3. During an interview on 6/8/2018 at 3:00 PM, the above noted findings were reviewed and confirmed with the current and the retiring Technical Consultants. SURVEYOR: Laura T. Williams, BS, MT (ASCP) Licensure and Certification Surveyor 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 --