Summary:
Summary Statement of Deficiencies D5545 HEMATOLOGY CFR(s): 493.1269(b)(d) (b) For all nonmanual coagulation test systems, the laboratory must include two levels of control material each 8 hours of operation and each time a reagent is changed. (d) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Through a review of quality control (QC) documentation for D-Dimer assays performed in November 2023, a review of patient test records in November 2023, and interviews with laboratory staff, it was determined the laboratory failed to perform two levels of quality control for D-Dimer assays each 8 hours of testing in 1 of 20 days reviewed. Survey findings include: A) A review of D-Dimer assay QC Reports for November 2023 revealed that quality control was documented once each day of testing in November 2023 and QC was performed at 08:22 a.m. on November 6, 2023.. B) A review of patient test records revealed that a D-Dimer assay was performed and reported on patient 100904 at 06:30 p.m. on November 6, 2023 which was greater than 8 hours since the QC was performed. C) During an interview at 03: 00 p.m. on 2/7/24, the employee #3 (as listed on the form CMS-209) stated that QC for D-Dimer determinations are only performed one time daily and confirmed that the laboratory failed to perform D-Dimer quality control each eight hours of patient testing. D5779