Advanced Dermatology& Skin Cancer Institute

Summary Statement of Deficiencies D0000 An offsite revisit survey was completed on September 25, 2025 for deficiencies cited on September 10, 2025. All deficiencies have been corrected. The facility is in compliance with 42 CFR Part 493, Requirements for Laboratories. 45469 The laboratory was found to be in compliance with 42 CFR Part 493, Requirements for Laboratories as a result of a recertification survey completed on September 10, 2025. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) (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 upon observations, patient test records and interview of facility personnel, the laboratory failed to ensure expired EosinY stain was not used to stain 6 patient samples between September 6 and September 9, 2025. The findings included: 1. Observations made on September 10, 2025 at 09:32 found one partial container of Mercedes Scientific EosinY stain lot 2323725 expiration 2025-09-05 in the flammable cabinet. 2. Review of patient test records found the laboratory tested 6 patient specimens between September 6 and September 9, 2025 as follows: M25-249 M25- 250 M25-251 M25-252 M25-253 M25-254 3. During interview of the histotechnician conducted September 10, 2025 at 9:40 AM, she confirmed the expired stain was used to stain the 6 specimens. 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 D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on a review of personnel records, policies and procedures and interview of facility personnel it was revealed that the laboratory failed to have a procedure to assess the competency of consultants, supervisors and testing personnel performing Microbiology and Histopathology procedures. Findings included: 1. A review of personnel records found no documentation of competency assessment for testing person three on the CMS Report 209 Laboratory Personnel Report. 2. Review of policies and procedures found no written procedure available to review for assessing the competency of consultants, supervisors or testing personnel. 3. During interview of the Laboratory Director conducted July 24, 2023 at 1:41 PM, he confirmed he did not have a written policy to assess the competency of all consultants, supervisors and testing personnel. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on review of the CMS Report 209 Laboratory Personnel Report, the 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 -- laboratory's personnel files and staff interview it was revealed the technical consultant failed to assess the competency at least semi-annually in the first year of testing for one of two testing personnel performing Microbiology procedures. The findings included: 1. Review of the CMS Report 209 Laboratory Personnel Report found the laboratory identified two testing personnel performing moderate complexity testing. 2. Review of the laboratory's personnel files found no semi-annual competency assessments for testing person three(hire date 04/2021). 3. During interview of the laboratory director conducted July 24, 2023 at 1:41 PM, he confirmed there were no semi-annual competency assessment available for review for testing person three. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: Based on review of the CMS Report 209 Laboratory Personnel Report, the laboratory's personnel files and staff interview it was revealed the technical consultant failed to assess the competency of one of two testing personnel performing Microbiology testing. The findings included: 1. Review of the CMS Report 209 Laboratory Personnel Report found the laboratory identified two testing personnel performing moderate complexity testing. 2. Review of the laboratory's personnel files found no annual competency assessment for testing person three(hire date 04/2021). 3. During interview of the laboratory director conducted July 24, 2023 at 1:41 PM, he confirmed there was no annual competency assessment available for review for testing person three. -- 2 of 2 --