Advanced Dermatology Assoc Ltd

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(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: (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 observation of the laboratory, lack of documentation, and interview with Testing Personnel (TP) #13, the laboratory failed to monitor and document room temperature and humidity to ensure operating conditions were met in the histopathology laboratory from 06/22/2022 to the day of survey. Findings Include: 1. On the day of survey, 01/29/2024 at 10:58 am, during the laboratory tour, the surveyor discovered room temperature and humidity was not monitored in the laboratory where the cryostat was located from 06/22/2022 to the day of survey. 2. According to manufacturer's instructions, operating conditions for the Avantik cryostat are from +5C up to +35C and at a maximum relative humidity of 60%. 3. The laboratory was not able to provide room temperature or humidity records for the laboratory from 06/22/2022 to 01/29/2024. 4. The laboratory's annual volume for Histopathology is 205. (CMS-116) 5. Interview with TP #13 on 01/29/2024 at 11:30 am confirmed the findings 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 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 Laboratory competency policy and interview with testing personnel (TP) #11, the laboratory failed to follow their competency assessment policies to assess 4 of 5 clinical consultants (CC) and 1 of 2 general supervisors (GS) for competency in 2020. Findings include: 1. The competency policy states "staff who hold CLIA supervisors positions: (general supervisor, Technical consultant, technical supervisor, or clinical consultant), will be assessed annual for their supervisor competence in addition to laboratory. 1. On the day of survey, 06/09/2020, the laboratory could not provide competency assessment performed on 4 of 5 CC and 1 of 2 GS. 3. TP #11 confirmed the findings above on 06/09/2020 around 09:30 am. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- 493.1253. (7) Control procedures. (8)