Summary:
Summary Statement of Deficiencies D0000 A Recertification Survey was initiated on 05/25/2023 and concluded on 05/25/2023. The facility was found not to be in compliance with the laboratory requirements of 42 CFR Part 493 with deficiencies cited. D5473 CONTROL PROCEDURES CFR(s): 493.1256(e)(2)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (2) Each day of use (unless otherwise specified in this subpart), test staining materials for intended reactivity to ensure predictable staining characteristics. Control materials for both positive and negative reactivity must be included, as appropriate. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on policy review and interview, the laboratory failed to document the intended reactivity of the Wright's Stain for manual differential each day of use for 3 of 3 years reviewed (2021, 2022, and 2023). Findings included: Review of the policy titled, "Wright's Stain," implemented 09/01/2022, revealed, "IV. Quality Control. The quality of the stain can be determined through examination of a well-prepared, peripheral blood smear, stained daily." A stain quality log was not available for review on the day of the survey, 05/25/2023. In an interview on 05/25/2023 at 12:45 PM, the Technical Consultant and Testing Personnel #1 stated stain quality had not been performed or documented on manual differentials performed in the laboratory. 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 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 -- 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 and interview, the laboratory failed to evaluate results of complete blood count (CBC) differentials performed by different methodologies twice a year for 2 of 2 years reviewed, 2021 and 2022. Findings included: During the laboratory tour on 05/25/2023 at 9:40 AM, a Beckman Coulter DxH520 CBC analyzer was observed in the laboratory. The analyzer performed an automated differential on all CBC specimens. Staining reagents for manual differentials were also observed in the laboratory. During an interview on 05/25/2023 at 9:40 AM, Testing Personnel (TP) #1 stated manual differentials were also performed in the laboratory. There was no documentation available for review to indicate the automated and manual differential methodologies were compared twice a year in 2021 or 2022. During an interview on 05/25/2023 at 12:45 PM, the Technical Consultant and TP #1 stated twice a year comparison between the automated differentials and manual differentials were not performed. -- 2 of 2 --