Salimetrics Llc

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, record review and interview with the General Supervisor (GS), the laboratory failed to follow established procedures to assess the competency of 2 of 2 General Supervisor (GS) for their supervisory responsibilities in 2023 and 2024. Findings Include: 1. The laboratory's Clinical Laboratory Quality System Regulations Manual states: " The Laboratory Director will annually evaluate the competency of the General Supervisor on form CL-001-F02." 2. On the day of survey, 06/04/2025 at 09:45 am, the laboratory could not provide the annual competency assessment for 2 of 2 GS (CMS 209 personnel #2 and #3) for their supervisory responsibilities in 2023 and 2024. 3. The GS confirmed the finding above on 06/04/2025 at 10:00 am. *** Repeat deficiency *** 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: 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 -- Based on review of the Laboratory Personnel Report (CMS-209), competency assessment (CA) records and interview with the General Supervisor (GS), the Technical Supervisor (TS) failed to evaluate the annual competency of 1 of 5 testing personnel (TP) that performed Enzyme-linked immunoabsorbant assay (ELISA) testing in 2024. Findings include: 1. On the day of survey, 06/04/2025 at 9:45 am, review of the laboratory's CA records revealed the TS failed to perform the annual competency assessment for 1 of 5 TP (CMS 209 TP# 1) that performed ELISA testing in 2024. 2. The laboratory reported an annual volume of 2600 ELISA tests (CMS 116 estimated annual volumen for 2024). 3. The GS confirmed the findings above on 06/04 /2025 at 9:45 am. -- 2 of 2 --

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 interview with the General Supervisor (GS), the laboratory failed to perform the annual competency assessment of 1 of 1 General Supervisor (GS) for their supervisory responsibilities in 2021 and 2022. Findings Include: 1. On the day of survey 04/17/2023 at 11:55 am, the laboratory could not provide the annual competency assessment for 1 of 1 GS (CMS 209 personnel #2) for their supervisory responsibilities in 2021 and 2022. 2. The TS confirmed the finding above on 04/17/2023 at 01:30 pm. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on review of proficiency testing (PT) records and interview with General Supervisor (GS), the laboratory failed to document the evaluation and verification activities for 8 of 8 PT testing performed in chemistry in 2022 and 2023 . Findings Include: 1. On the day of the survey, 04/17/2023 at 12:25 pm, a review of PT records revealed that the laboratory did not document the Laboratory Director (LD) review for the following PT testing: - 4 of 4 PT results for Melatonin in 2022 - 2 of 2 PT results 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 -- for Cortisol in 2022 (Q3, Q4) - 1 of 1 PT results for Melatonin in 2023 -1 of 1 PT results for Cortisol in 2023. 2. The laboratory did not document

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 procedure manuals and interview with the regulatory compliance specialist, the general supervisor (GS), testing personnel (TP) #1 and #2, the laboratory failed to establish a complete competency assessment procedure to assess the competency for 2 of 2 TP performing salivary amylase and cortisol tests on the Biotech ELX-808 plate reader in 2020. Findings include: 1. On the day of survey, 04/08/2021, the laboratory failed to provide a complete written competency assessment procedure, to evaluate the competency for 2 of 2 TP performing salivary amylase and cortisol tests on the Biotech ELX-808 at least semiannually during the first year the individual tests patient specimens and the assessment of CLIA 6 points of competency in 2020. 2. The laboratory could not provide 6 month competency assessment records for TP #1 and #2. 3. Competency assessment evaluations performed in 2020 did not include the following: - Evaluation of direct observations of routine test performance, specimen handling, processing and testing. - Evaluation of direct observations of performance of instrument maintenance and function checks. 4. The regulatory compliance specialist and GS confirmed the findings above on 04/08/2021 around 09:00 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 --