Academic Alliance In Dermatology Inc

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Academic Alliance in Dermatology Inc on 05/01/2025. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiency: D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. The procedures for evaluation of the competency of the staff must include, but are not limited to-- This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory Technical Consultant failed to complete two annual competencies for one testing person (B) of two testing persons (A, B) for two of two years (2023, 2024). Findings included: The CMS-209, signed and dated by the Laboratory Director 5/1/2025, showed the Laboratory Director was also the Technical Consultant. Testing Person B's 2023 and 2024 competencies were not completed by the Technical Consultant. Interview with the Laboratory Consultant on 05/01/2025 at 11:10 a.m. confirmed the above. 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 An announced CLIA recertification survey was conducted at Academic Alliance in Dermatology Inc. on 09/29/20. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiencies: D5781

Summary Statement of Deficiencies D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on review of patient test reports and interview with the Laboratory Manager, the laboratory failed to have the complete address of the location where the test was performed for the histopathology testing for two of two years reviewed (2017-2018). Findings Included: 1. Review of 3 histopathology final reports pulled from 2017-2018 revealed that all reports did not have the complete address of the location where the testing was performed, and only the city was documented. 2. Interview on 11/08/2018 at 10:30 AM with the Laboratory Manager confirmed that the complete address on reports had been removed and replaced with the city and a code. However, a review of the reports with the Laboratory Manager confirmed the code was not included on the report. 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 --