Academic Alliance In Dermatology Inc

Summary Statement of Deficiencies D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on record review, observation, and interview, the laboratory failed to have a Laboratory Director who provided overall management and direction in accordance from 09/2023 through 09/2025. (See D6079, D6080, and D6093) D6079 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(a)(b) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, record and report test results promptly, accurately and proficiently, and for assuring compliance with the applicable regulations. (a) The laboratory director, if qualified, may perform the duties of the technical supervisor, clinical consultant, general supervisor, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications under 493.1447, 493.1453, 493.1459, and 493.1487 respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: Based on record review, observation, and interview, the Laboratory Director failed to provide effective oversight and administration of the laboratory from 09/2023 through 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 -- 09/2025. An unannounced CLIA revisit was conducted 11/24/2025 for the survey ending on 07/22/2025 for Academic Alliance in Dermatology Inc. Previously cited deficiencies were found to be uncorrected and new deficiency practice cited. Findings included: 1. The Laboratory Director failed to ensure protection from chemical hazards from 10/23/2023 to 7/17/2025. (See D3011) This is an uncorrected citation. 2. Based on record review and interview the Laboratory Director failed to develop a policy or provide evidence of the required onsite visits for one of one six month period reviewed (01/2025 - 07/2025). (See D 6080) These is an uncorrected citation. 3. Based on record review and interview, the Laboratory Director failed to ensure that the quality assessment program was maintained to assure the quality of laboratory services provided for 2024-2025. (See D 6093) This is an uncorrected citation. 4. The Regional Director of Operations stated on 11/24/2025 at 12:10 p.m. via phone call he was aware the

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Academic Alliance in Dermatology on 7/17/25-7/22/25. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiencies: D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: Based on observation and interview, the laboratory failed to ensure protection from chemical hazards from 10/23/2023 to 7/17/2025. Findings included; 1. During a tour of the laboratory on 7/17/25 at 10:12 a.m., Clear-Rite 3, 100% Dehyrdrant, and Eosin- Y with Phloxine were observed stored in the safety cabinet. The primary container for the Clear-Rite 3, 100% Dehyrdrant, and Eosin-Y with Phloxine labels included the hazard sign for respiratory and stated Do not Breath dust/fume/gas/mist/vapors/spray and to use explosion proof ventilating. 2. The Histology technician confirmed on 7/17 /25 at 10:12 a.m., the laboratory did not have a fume hood to mitigate exposure to harmful chemical fumes from the Clear-Rite 3, 100% Dehyrdrant, and Eosin-Y with Phloxine. D6080 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(c) (c) The laboratory director must: (c)(1) Be onsite at least once every 6 months, with at least 4 months between the minimum two on-site visits. Laboratory directors may elect to be on-site more frequently and must continue to be accessible to 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 to provide telephone or electronic consultation as needed; and (c)(2) Provide documentation of these visits, including evidence of performing activities that are part of the laboratory director responsibilities. This STANDARD is not met as evidenced by: Based on record review and interview the Laboratory Director failed to develop a policy or provide evidence of the required onsite visits for one of one six month period reviewed (01/2025 - 07/2025). Findings included: 1. Review of records revealed no policy regarding the Laboratory Director being onsite every 6 months and no evidence of onsite visit for 01/2025 to 07/2025. 2. Interview with the Histology Tech on 7/17/25 at 11:10 a.m. confirmed the above. 3. The Laboratory Director confirmed via email on 7/21/25 at 10:37 a.m., the last time he was onsite in the laboratory was 4/27/2023. D6093 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) (e)(5) Ensure that the quality control and quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur; This STANDARD is not met as evidenced by: Based on record review and interview, the Laboratory Director failed to ensure that the quality assessment program was maintained to assure the quality of laboratory services provided for 2024-2025. Findings included: 1. The laboratory CLIA Compliance Manual approved by the Laboratory Director on 6/4/2025, included the job description for Laboratory Director which stated the Director was responsible for compliance. 2. The Quality Assurance Quality Control procedure provided failed to indicate how the Laboratory Director was to document how the Quality Assessment Program was maintained. 3. Monthly Quality Assurance Checklists were provided for review including four pre-signed blank checklist forms with the Laboratory Director's signature. The Monthly Quality Assurance Checklists for 1/15/24, 9/16/24, and 3/3/25 all had identical signatures of the Laboratory Director. The Histology Technician stated on 7/17/25 at 10:50 a.m., the Histology Technicians completed the Monthly Quality Assurance Checklist and signed and dated the blank checklist forms which had the Laboratory Director's pre-signed signature. 4. The Laboratory Director stated via email on 7/21/25 at 10:37 a.m., the Mohs techs do the reviewing which is documented on the Quality Assurance checklist. -- 2 of 2 --