Annapolis Dermatology Center

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 review of the procedure manual, review of proficiency testing (PT) records, and interview with the laboratory director (LD), the laboratory failed to verify the accuracy of potassium hydroxide (KOH) preparations at least twice annually in one of two years reviewed. Findings: 1. The "Proficiency Testing - KOH" procedure stated that "Proficiency Testing for KOH slides by clinical dermatologists at Annapolis Dermatology Center will occur annually via the American Academy of Dermatology approved self-assessment examination." 2. Review of PT records from 2025-2026 showed that PT was performed once in January 2025 and once in January 2026 as of the time of the onsite survey on 08/19/2026. 3. During the exit interview on 08/19 /2026 at 12:30 PM, the LD confirmed that accuracy for KOH preparations was not verified at least twice annually in 2025. 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 results. (b)(4) Preparation of slides, solutions, calibrators, controls, reagents, stains, 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 -- 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 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 standard operating procedure manual and quality assurance (QA) review and interview with the laboratory staff, the laboratory did not ensure that proficiency testing (PT) was performed at least twice annually. Findings: 1. The procedure, "Quality Control Program" states that "The Laboratory Director will randomly select five (5) processed cases every six (6) months each calendar year to forward to a third party laboratory for comparative diagnosis." 2. A review of QA records showed that "Doctor #1" began reading slides at the laboratory in August, 2017. 5 cases from this doctor were sent out and reviewed 6/11/18; and 3. For "Doctor #2," 10 cases from 2017 and 5 cases from 2018 were sent out and reviewed 6/11/18; and 4. During an interview at 1:40 PM, when laboratory staff was asked about the delay in sending out PT, they stated that "We forgot." 3. During an interview on 6/12/18 at 2:15 PM, the LD confirmed that PT slides were not sent out at least twice annually. 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: 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 -- Note: This is a repeat deficiency. The laboratory was cited during the re-certification survey on 6/29/2016 for not recording the lot numbers and expiration dates of stains used for staining tissue samples prior to slide preparation. The