Summary:
Summary Statement of Deficiencies D0000 A validation survey was performed on November 24, 2025 by the State of Michigan Licensing and Regulatory Affairs Department. The laboratory was found to be out of compliance with CLIA regulations (42 CFR Part 493, Laboratory Requirements) for the following condition-level deficiency: 493.1250 Condition: Analytic systems. 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 record review and interview with technical consultant #1, the laboratory failed to establish policies to assess technical consultant and clinical consultant competency for two (November 2023 to November 2025) of two years reviewed. Findings include: 1. A review of competency assessments for the clinical consultant and technical consultants revealed a lack of competency assessments used to assess their performance of consultant duties. 2. The surveyor requested the laboratory's staff competency assessment policy on 11/24/25 at 8:53 am and was provided with the "Point of Care Testing (POCT) Procedure for Updating Roster of Testing Personnel". This policy did not address assessing clinical or technical consultants. 3. An interview on 11/24/25 at 9:33 am with technical consultant #1 confirmed the laboratory had not established a policy to assess consultant competency. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on record review and interview with technical consultant #1, the laboratory failed to follow quality assessment policies and procedures to assess general laboratory system requirements for one (2024) of two years reviewed. Findings include: 1. A review of the laboratory's "Lab- POCT: Quality Assurance/Process Improvement" policy revealed a section stating, "Quality Assurance is the comprehensive, ongoing process for monitoring and evaluating every step of the laboratory's testing process from patient identification and specimen collection through test analysis and test result reporting. Proces Improvement emphasizes the need to redesign policies and procedure to improve the laboratory process. The following procedure ensures quality results are generated ny competent personnel." This policy included a section titled "Evaluation of Quality Assurance" stating, "the following mechanisms are used a part of Process Improvement [sic]: Monthly: Quality control records Patient result logs