Dermatology Medical Group

Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on the surveyor's review of Proficiency Testing (PT) records, random selection of fourteen (14) patient reports, and interviews on July 31, 2026, it was determined that the laboratory did not verify the accuracy of high complexity Histopathology and moderate complexity Mycology tests at least twice annually for the years 2023, 2024, and 2025. The findings included: 1. The laboratory conducted Histopathology testing for Mohs Micrographic Surgery and Mycology using Potassium Hydroxide (KOH) testing, which are not listed in subpart I of the 42 CFR part 493. For test procedures not listed in subpart I, the laboratory must verify the accuracy of the test procedures at least twice annually. 2. On July 31, 2026, at approximately 11:00 a.m., the laboratory testing personnel confirmed that the laboratory did not maintain records for accuracy verification of tests at least twice annually during 2023, 2024, and 2025. 3. The laboratory's testing declaration form, signed by the laboratory director on July 22, 2026, stated that the laboratory performed approximately 1140 tests annually. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) (b) The procedure manual must include the following when applicable to the test procedure: (b)(1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (b)(2) Microscopic examination, including the detection of inadequately prepared slides. (b)(3) Step-by- step performance of the procedure, including test calculations and interpretation of 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. (b)(4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (b)(5) Calibration and calibration verification procedures. (b)(6) The reportable range for test results for the test system as established or verified in 493.1253. (b)(7) Control procedures. (b)(8)

Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on the surveyor's review of the laboratory's testing reagent expiration dates, and an interview with laboratory personnel (LP) on 11/4/2020 between 2:00 p.m. and 3:30 p..m, it was determined several reagents used for tissue staining were expired. Findings include: 1. On 11/4/2020, an inspection was conducted between 2:00 p.m and 3:30 p.m. 2. During a review of the reagent expiration dates , it was noted at approximately 2:30 p.m. that the expiration dates on several containers of the reagents used in the tissue staining process were expired. The LP recognized that these reagents were indeed expired. These reagents were currently in use. 3. The vendor, reagent and expiration dates are indicated below Vendor Reagent Expiration Date Advantik Eosin 8/1/2020 Advantik Eosin 6/22/2017 A/M Gill's Hem. 1/17/2020 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 --