Dermatology Consultants, Pa

Summary Statement of Deficiencies D0000 The Dermatology Consultants, PA laboratory was found to be out of compliance with the regulations of the Clinical Laboratory Improvement Amendments of 1988 (42 C.F. R. part 493) upon completion of the recertification survey performed on April 16, 2026. The following standard-level deficiencies were cited: 493.1254 Maintenance and function checks . D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) (b)(1)(i) Establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (b)(1)(ii) Perform and document the maintenance activities specified in paragraph b(1)(i) of this section. This STANDARD is not met as evidenced by: . Based on observation, document review, and interview with laboratory personnel, the laboratory failed to perform and document routine Microscopy equipment maintenance according to established procedures in 2024. Findings are as follows: 1. The laboratory performed Mohs Micrographic surgery under the Histopathology specialty and Mycology and Parasitology testing under the Microbiology specialty as confirmed by the Clinic Manager during a tour of the laboratory at 10:08 a.m. on 4/16 /26. 2. The following items were observed as present and available for use during the tour: A Leica DM 1000 microscope used for Mohs Micrographic Surgery slide review A Nikon Alphaphot-2 microscope used for Potassium Hydroxide (KOH) fungal and Scabies testing 3. The laboratory was required to perform monthly microscope maintenance as defined in the Microscope Use policy found in the Procedure Log binder provided by the laboratory and reviewed on the date of survey. 4. Performance of microscope maintenance was not documented on the Monthly Microscope Maintenance Log for seven of twelve months in 2024. See below. Months missing maintenance for Leica and Nikon microscopes in 2024: April June July September 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 -- October November December 5. In an interview at 12:10 p.m., the Clinic Manager confirmed the above findings. . -- 2 of 2 --

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 document review and interview with laboratory personnel, the laboratory failed to perform and document activities used to verify the accuracy of 1 of 2 Microbiology microscopic examinations at least twice annually in 2018 and 2019. Findings are as follows: 1. The laboratory performed parasitic (Scabies) microscopic examinations under the specialty of Microbiology as confirmed by the Clinic Manager (CM) during a tour of the laboratory at 1:15 p.m. on 09/01/20. 2. Documentation of the Scabies twice annual verification of accuracy was not found for 2018 and 2019 during review of laboratory records. The laboratory was unable to provide the verification documentation upon request. 3. Laboratory records indicated seven patients received Scabies testing in 2018 and four patients received Scabies testing in 2019. 4. In an interview at 2:20 p.m. on 09/01/20, the CM confirmed the above finding. . 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 document review and interview with laboratory personnel, the laboratory 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 -- failed to ensure a solution used for Microbiology microscopic examinations was not used after the expiration date had been exceeded in 2018 and 2019. Findings are as follows: 1. The laboratory performed fungal microscopic examinations under the Microbiology specialty as confirmed by the Clinic Manager (CM) during a tour of the laboratory at 1:15 p.m. on 09/01/20. 2. Expired Chlorazol Black solution was used for testing patient specimens in 2018 and 2019 as indicated on the KOH/Stain Reagent Log provided by the laboratory. See below for detailed information. Solution Exp. Dates used Chlorazol Black 9/15/18 09/16/18 - 12/31/19 3. The laboratory performed approximately 90 fungal microscopic examinations annually as indicated on the Form CMS-116 CLIA Application for Certification. 4. In an interview at 2:35 p.m. on 09/01 /20, the CM confirmed the above finding. -- 2 of 2 --