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 two Siemens Rapid Point 500 analyzers (serial numbers 40662 and 40557) for performing Blood gas tests, review of patient test report, the lack of laboratory records, and interview with Testing Person-17, it was determined that the laboratory failed to twice annually compare results between the two analyzers. Findings included: a. The laboratory used the two Siemens Rapid Point 500 analyzers interchangeably to test for pH, pCO2, pO2, HCO3-act, BE(B) [O2Hb], and FIO2. b. Laboratory records documented comparisons of results in September 2018 and August 2019. c. The laboratory failed to provide records documenting comparisons performed a second time in 2018 and 2019. d. Testing Person-17 affirmed (1/15/20 @ 3pm) the aforementioned findings, that comparisons were performed only once each year. e. The use of the analyzers interchangeably to provide reliable, comparable results could not be assured in the absence of documented correlations performed twice annually f. The laboratory stated (CLIA Application, 12/18/19) reporting approximately 25,000 Blood gas results annually. 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 --