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 review of activated clotting time (ACT) quality control (QC) records, manufacturer QC assay documentation, patient records and interview with the laboratory manager, the laboratory failed to ensure results of QC materials met manufacturer's test system criteria for acceptability before reporting patient test results. Two of two QC materials for lot number G0DLA005 performed in October 2020 failed to meet the manufacturer's stated "acceptable performance range." Findings: 1. Review of ACT QC records showed the laboratory obtained an unacceptable QC result of 193 on October 14, 2020 and an unacceptable QC result of 188 on October 28, 2020 for QC lot number G0DLA005. 2. Review of manufacturer's assay documentation showed an acceptable performance range of 215 to 344 for QC lot number G0DLA005. 3. Patient records retrieved by the laboratory manager showed the laboratory reported two patient test results in October 2020. 4. Interview with the laboratory manager on November 10, 2020 at 1:30 PM confirmed the laboratory failed to ensure QC results met the manufacturer's acceptable performance range before reporting patient results. D5783