Ariel Precision Medicine

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 lack of documentation and interviews with the Laboratory Director (LD), Chief Science Officer (CSO) and the Chief Executive Officer (CEO), the laboratory failed to establish and follow procedures to assess the competency of 1 of 1 clinical consultant (CC) for their responsibilities as CC in 2023 and 2024. Findings Include: 1. On the day of survey, 06/2//2025 at 01:30 pm, the laboratory could not provide a procedure for assessing the competency for the responsibilities of the clinical consultant position. 2. The laboratory could not provide competency assessment documentation for 1 of 1 CC (CMS 209 personnel #2) from 07/11/2023 to 06/25 /2025. 3. The CEO confirmed the finding above on 06/25/2025 at 01:30 pm. D6128 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) (b)(9) Thereafter, evaluations must be performed at least annually unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individuals performance must be reevaluated to include the use of the new test methodology or instrumentation. This STANDARD is not met as evidenced by: Based on lack of documentation, record, review and interviews with the Laboratory Director (LD), Chief Science Officer (CSO) and the Chief Executive Officer (CEO), 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 failed to follow established procedures to assess the competency of 1 of 2 testing personnel (TP) for their testing responsibilities in 2023 and 2024. Findings Include: 1. The laboratory's Personnel Competency Assessment Standing Operation Procedure states: " The Laboratory Directory, or the Director's designee, will perform annual competency assessments for all laboratory testing personnel. The competency assessment will be documented on the Annual Competency Assessment form." 2. On the day of survey, 06/25/2025 at 01:30 pm, the laboratory could not provide the annual competency assessment for 1 of 2 TP (CMS 209 personnel #2) for their testing responsibilities in 2023 and 2024. 3. The CEO confirmed the finding above on 06/25 /2025 at 01:30 pm. -- 2 of 2 --

Summary Statement of Deficiencies D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on observation of the laboratory and interview with the Chief Executive Officer (CEO), Technical Supervisor (TS), and Laboratory Director LD), the laboratory failed to perform and document maintenance as defined and with the frequency specified by the manufacturer on 1 of 1 thermometer used to monitor Room Temperature (RT) from 07/15/2021 to the day of the survey. Findings Include: 1. On the day of the survey, 07/11/2023 at 03:53 PM, an observation of the laboratory revealed that the following thermometer used to record RT for the Genotyping samples processing expired on 06 March 2022. -Traceable- S/N- 200190858. 2. CEO, TS, and LD confirmed the above findings on 07/11/2023 at 04:00 PM. D5783

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 procedure manuals and interview with the Laboratory Director (LD) and Vice President of Operations (VPO), the laboratory failed to follow and establish a complete competency assessment procedure to assess 1 of 2 clinical consultant (CC) for their regulatory responsibilities in 2019 to the day of survey. Findings include: 1. The Lab Personnel Competency Assessment procedure states: "a) Quality control i) During on boarding for all new laboratory hires. ii) 6 month post- start and at 1 year post-start date of new laboratory hires. iii) Annually for laboratory personnel with >1 year at Ariel." 2. On the day of survey, 07/15/2021, the laboratory could not provide the following 2019 competency assessment records: - The 6 month competency assessment for TP #3. - The annual competency assessment for TP #2. 3. The laboratory could not provide a complete policy to assess the competency of 1 of 2 CC (#2) for their regulatory responsibilities in 2019, 2020 and 2021. 4. The CC#2 was not assessed for competency in 2019, 2020 and 2021. 5. The LD and VPO confirmed the findings above on 07/15/2021 around 10:45 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 --