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 Hematology quality control (QC) records, the patient log, and an interview with the Laboratory Director, the laboratory failed to ensure at least two levels of quality control were performed and acceptable, prior to analyzing patient specimens and reporting the results on one day in December 2018. The findings include: 1. A review of the QC records for Abbott Cell Dyn Emerald Hematology analyzer revealed the High and Normal QC were outside acceptable ranges on 12/11 /2018, with no evidence the QC was rerun or other