Summary:
Summary Statement of Deficiencies D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratorys and, as applicable, the manufacturers 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 calibration records for the Beckman Coulter DxH 500 analyzer, the patient log, and an interview with Testing personnel (TP) #1, the laboratory failed to run controls to ensure correct values after performing calibration. This is was noted for one possible calibration performed in the first half of 2026. The findings include: 1. A review of calibration records for the DxH 500 analyzer showed a calibration was performed on 1/22/26 at 1:28 pm. There was no record of controls being performed until the following day, 1/23/26 at 10:09 am. The patient log revealed 7 patients Complete Blood Count (CBC) were performed. 2. TP #1 confirmed the above findings during an interview on 7/1/26 at 12:53 pm. 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 --