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 record review of instrument comparison documentation and interview with Technical Supervisor (TS) #1 , the laboratory failed to perform instrument comparison for two BD Affirm MicroProbe processors for analytes bacterial vaginosis, vulvovaginal candidiasis and trichomoniasis two times a year from January 1, 2020 to March 16, of 2022. Findings: 1. Review of laboratory instrument comparison documentation showed the laboratory failed to perform comparison studies in unison using testing materials with known values (proficiency testing samples, split samples or "blind" samples) and define the relationship between results for two BD Affirm MicroProbe processors for analytes bacterial vaginosis, vulvovaginal candidiasis and trichomoniasis two times a year. 2. Interview with TS #1 on March 16, 2022 at 8:15 AM, confirmed the laboratory failed to perform in unison twice a year instrument comparison for two BD Affirm MicroProbe processors for analytes bacterial vaginosis, vulvovaginal candidiasis and trichomoniasis two times a year from January 1, 2020 to March 16, of 2022. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- identified in the analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on record review, procedures and interview with the technical supervisor (TS) #1, the laboratory failed to identify and correct problems to prevent recurrence and failed to document and monitor