Dermatology Associates

Summary Statement of Deficiencies D0000 At the time of the announced, onsite recertification survey, Dermatology Associates was found to NOT be in compliance with the CLIA laboratory requirements of 42 CFR 493. 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 record review and staff interview, the laboratory failed to send histopathology patient slides for peer review more than once annually in 2022. Findings include: The record review of documented peer review for 2022 showed that patient slides were sent on 6/9/2022 to a Dermatopathologist to verify accuracy of results. There was no other documented peer review for 2022. The interview with Testing Person E on 6/19/24 at 10:00am confirmed that slides were only sent out once for peer review in 2022. 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 D0000 At the time of the announced, onsite recertification survey, Dermatology Associates was found to NOT be in compliance with the CLIA laboratory requirements of 42 CFR 493. . 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 observation and interview with laboratory personnel, the laboratory used a reagent that had exceeded its expiration date. The findings include: During a tour of the laboratory on 5/18/20, one opened container of Toluidine Blue, lot #K17AL1 expiration date 10/31/19, was observed next to the microscope. There were no other containers of Toluidine Blue in the laboratory. During an interview with the laboratory testing person at 1:20pm on 5/18/20, she confirmed that the Toluidine Blue had expired. 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 D5609 HISTOPATHOLOGY CFR(s): 493.1273(e)(f) (e) The laboratory must use acceptable terminology of a recognized system of disease nomenclature in reporting results. (f) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on record review and staff interview it was determined that the laboratory failed to document the interpretation of the Hematoxylin and Eosin stain (H&E stain) quality control slide for 2017 and 2018. The findings include: During a review of the laboratory's quality control records, it was determined that the laboratory had no records available to show that the interpretation of the Hematoxylin and Eosin stain quality control slides had been documented for 2017 and 2018. During an interview with the laboratory staff on June 25 at approximately 11:00 AM she confirmed that the Pathologist had read, but not documented her interpretation of the Hematoxylin and Eosin stain quality control slides. 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 --