Alliance Dermatology Physicians Pc

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