Summary:
Summary Statement of Deficiencies D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on review of the laboratory's procedure manual, lack of eyewash station maintenance log and interview with the laboratory supervisor, determined the laboratory failed to follow written procedure for weekly eyewash station maintenance in 2016 and 2017. The findings include: 1. A review of the laboratory's procedure manual policy revealed the eyewash station requires a weekly flushing. The weekly eyewash station maintenance was not performed in 2016 and 2017. 2. Lack of documentation of the weekly eyewash station maintenance determined that the laboratory failed to perform the weekly eyewash station maintenance in 2016 and 2017. 3. Interview with the laboratory supervisor on May 21 2018 at 12:30 pm confirmed that the laboratory failed to perform weekly eyewash station maintenance in 2016 and 2017. 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. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- This STANDARD is not met as evidenced by: Based on lack of records available to review for comparison of test results using two of the same Complete Blood Count (CBC) analyzers and interview with the Laboratory Supervisor the laboratory failed to perform comparison of test results using two of the same CBC analyzers in 2016 and 2017. The Findings Include: 1. Lack of records available to review for comparison of test results using two of the same CBC analyzers the laboratory failed to perform comparison of test results for two of the same CBC analyzers in 2016 and 2017. 2. Interview with the Laboratory Supervisor on May 23, 2018 at 13:20 PM confirmed the laboratory failed to perform comparison of test results for two of the same CBC analyzers in 2016 and 2017. -- 2 of 2 --