Summary:
Summary Statement of Deficiencies D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Based on observation of the Beckman AcT5 hematology analyzer and the microscope in the laboratory, review of laboratory document and patients' test records, and interviews with the Testing Person and the Technical Consultant/Technical Supervisor, the laboratory failed to have a system that twice a year evaluates and defines the relationship between different methodologies for Differentials. Findings include: a. Laboratory documents revealed the laboratory reported hematology Differential results using the automated Beckman AcT5 test system, and the microscope, a manual method. b. The laboratory was unable to provide for review a written policy and laboratory documents for a system that compares different methods of testing for the same result. c. The Testing Person and the Technical Consultant /Technical Supervisor affirmed (4/25/18) not having a written policy or process and documents for comparing Differential results by the different methods. d. The correlation of results reported could not be assured. Based on the reported estimated annual test volume, the laboratory reported approximately 128 Differential results annually, of which 8 were using the manual microscopy method. One example is #P29768152 on 6/15/17. 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 --