Summary:
Summary Statement of Deficiencies D5219 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(2) (c)(2) Any test or procedure listed in subpart I of this part for which compatible proficiency testing samples are not offered by a CMS-approved proficiency testing program. This STANDARD is not met as evidenced by: Based on review of the Laboratory Test List & Annual Volume form, lack of verification of accuracy records and confirmed by the laboratory director (LD) at 11: 19 am on 6/12/2025, the laboratory failed to verify the accuracy at least twice annually for slides stained using hematoxylin and eosin (H&E) stain, immunohistochemical stain, special stain and direct immunofluorescent stain for one out of one time period from 11/1/2024 - 6/16/2025. The findings include: 1. The Laboratory Test List & Annual Volume form confirmed the laboratory read H&E, immunohistochemical, special stain and direct immunofluorescent stained slides. 2. The LD confirmed the laboratory started reading the slides processed with the listed stains on 11/1/2024. 3. At the time of the survey, the LD confirmed the laboratory had not verified the accuracy for patient slides stained with H&E, immunohistochemical, special stains and direct immunofluorescent stains. 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. 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 review of the Laboratory Test List and Annual volume report and confirmed by interview with the laboratory director (LD) at 10:56 am on 6/12/2025, the laboratory failed to perform comparison testing twice annually for one of one time period for glass stained slides and slides read by digital image from 11/1/2024 - 6/12 /2025. The findings include: 1. The Laboratory Test List & Annual Volume form confirmed the laboratory read H&E, immunohistochemical, special stain and direct immunofluorescent stained slides. 2. The LD confirmed the laboratory started reading the slides processed with the listed stains digitally on 11/1/2024. 3. At the time of the survey, the LD confirmed the laboratory did not perform comparison testing between the glass stained slides and the slides read by digital image from 11/1/2024 - 6/12/25. -- 2 of 2 --