Iowa Dermatology Clinic, Plc

Summary Statement of Deficiencies D6128 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) (b)(9) Thereafter, evaluations must be performed at least annually unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individuals performance must be reevaluated to include the use of the new test methodology or instrumentation. This STANDARD is not met as evidenced by: Based on review of laboratory personnel records, the Laboratory Personnel Report, and confirmed by interview with the Laboratory Director identifier #1 (LD #1) at 9:03 am on 9/23/26, the technical supervisor failed to document annual competency assessments for three out of three testing personnel who performed high complexity gross specimen examinations in 2025. The findings include: 1. LD #1 confirmed that testing personnel identifiers #2, #3, and #4 all performed gross specimen examinations. 2. LD #1 confirmed at the time of the survey, the laboratory did not document the 2025 annual competency assessments for testing personnel identifiers #2, #3 and #4. 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 --

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 --