Alliance Dermatology Physicians Pc

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 review of the laboratory's peer review records, and interview with the Practice Manager (PM), the laboratory failed to ensure that the verification of accuracy for MOHS microscopic slide examinations was performed at least twice annually, as required for tests not included in subpart I for 2 of 2 years (2024 and 2025). Findings Include: 1. On the day of the survey, 03/30/2026 at 09:47 am, the laboratory failed to provide documentation for the verification of accuracy of MOHS microscopic slide examinations stained using hematoxylin and eosin (H&E) performed at least twice annually for 2 of 2 years in 2024 and 2025. 2. The laboratory performed 406 microscopic slide examinations (histopathology) in 2025 (CMS-116, estimated annual volume, dated 3/23/2026). 3. The PM confirmed the findings above on 03/30/2026 at 10:15 am. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. 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 -- This STANDARD is not met as evidenced by: Based on lack of documentation and interview with the Practice Manager (PM), the laboratory failed to monitor and document room humidity to ensure operating conditions were met for 1 of 1 Lecia DM1000 microscope and 1 of 1 Avantix QS12 cryostat used to perform histopathology microscopic slide examinations from 06/04 /2024 to 03/30/2026. Findings include: 1. The manufacturer's operating environment specifications stated: "Lecia DM1000 microscope: 15-35 degrees Celsius (ambient temperature); maximum 80 % relative humidity." The Avantix Cryostat operating environment specifications stated:" 5-35 degrees Celsius (ambient temperature); maximum 60 % relative humidity." 2. On the day of the survey, 03/30/2026 at 09:45 am, the laboratory failed to provide documentation for the monitoring of room humidity to ensure operating conditions were met for the following instruments used to perform histopathology microscopic examinations from 06/04/24 to 03/30/2026: - 1 of 1 Lecia DM1000 microscope - 1 of 1 Avantix Cryostat 3. The laboratory performed 406 histopathology microscopic slide examinations in 2025 (CMS 116, estimated annual volume, dated 03/23/2026). 4. The PM confirmed the above findings on 03/30 /2026 at 10:15 am. 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 review of laboratory procedure, lack of documentation and interview with the Practice Manager (PM), the Laboratory Director (LD) failed to follow and maintain the laboratory's established Quality Assessment (QA) program for 2 of 2 years from 06/04/2024 to 03/30/2026. Findings included: 1. The laboratory's Formal Policy Statement stated, " This procedure manual is reviewed by the Laboratory Director annually and at other times as required by major changes in procedure or other circumstances affecting laboratory performance of test." 2. On day of the survey, 03/30/2026 at 10:00 am, the laboratory failed to provide documentation of the annual review of the laboratory's procedure manual performed for 2 of 2 years from 06 /04/2024 to 03/30/2026. 3. The PM confirmed the finding above on 03/30/2026 at 10: 15 am. -- 2 of 2 --

Summary Statement of Deficiencies D6127 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on lack of competency assessment record and interview with the Practice Manager (PM), the Technical Supervisor failed to evaluate and document the performance of 1 of 2 Testing personnel (TP) responsible for the Moh's microscopic examination at least semi-annually during the first year of employment. Findings include: 1. On the day of survey 09/13/2022 at 10:47 AM, the laboratory failed to provide competency assessment records for testing personnel #1(CMS 209 TP # 1) performing Moh's microscopic examination for the semiannual performance of the 1st year of employment. 2. TP #1 joined the facility on 6/16/2021. 3. PM confirmed the above findings on 09/13/2022 at 11:40 AM. 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 review of the laboratory's procedure manuals and interview with practice manager and mohs technologist, the laboratory failed to follow their competency assessment policy to evaluate 1 of 1 testing personnel (TP) for their mohs micrographic examination competency assessment and 1 of 2 regulatory personnel for their yearly competency assessment in 2018, 2019 and 2020. Findings include: 1. The Competency and CLIA competency policy states, "Evaluation and documenting competency of personnel responsible for testing is requires at least semi annual during the 1st year the individual sees patient specimen. After the first year, competency must be performed at least annually". " Documented competency is required for individuals clinical consultants (CC), technical consultant, technical supervisors (TS), and general supervisors (GS)..." 2. On the day of survey, 07/10/2020, the laboratory could not provide the following documents for 1 of 1 TP who performed mohs micrographic examinations from August of 2018 to July of 2020: - Their semi annual competency performed on February of 2019 and August of 2019. - Their first annual competency performed in 2020. - Their regulatory competency assessment for postions held on the CMS -209, Laboratory Personnel Form (CC, TS and GS) in 2018, 2019 and 2020. 3. The practice manager and mohs technologist confirmed the findings above on 07/10/2020 around 10:25 am. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) 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 -- The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on review of cryostat temperature logs and interview with the practice manager and mohs technologist, the laboratory failed to document temperatures and