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Module GLP-34 · Version 1.0

Laboratory Utilization, Vendors, and Instrument Selection

Build a defensible instrument or vendor decision using a needs assessment, a transparent weighted scorecard, a total-cost-of-ownership calculation, and a vendor claim audit, then design a utilization intervention that reduces low-value testing without blocking legitimate exceptions.

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Who this module is for

Laboratory scientists, technical supervisors, and section leads participating in instrument or test-menu procurement decisions

Learning objectives

  • Define clinical use cases, stakeholders, current gaps, demand, and success criteria before comparing vendors
  • Compare methods and vendors across analytical, operational, informatics, service, safety, and financial dimensions using a transparent weighted scorecard and a total-cost calculation
  • Use utilization data to design an intervention that reduces low-value or duplicate testing while preserving access, an exception path, and a balancing measure

How completion works

Mark every required section done and answer every knowledge check in those sections correctly. The final save completes the module automatically.

Sources

15 sources

  1. 1. 42 CFR 493.1253, Establishment and verification of performance specifications, Subpart K, Quality System for Nonwaived Testing (current eCFR text)

    Source note · federal regulation

  2. 2. 42 CFR 493.17, Test categorization, Subpart A (current eCFR text)

    Source note · federal regulation

  3. 3. 42 CFR 493.1451(b)(8), Standard: Technical supervisor responsibilities, Subpart M (current eCFR text); CMS Survey and Certification Letter 13-07, CLIA Brochure #10, Assessing Personnel Competency

    Source note · federal regulation

  4. 4. College of American Pathologists. All Common Checklist, COM.40300 Verification of Test Performance Specifications - FDA-cleared/approved (Phase II). CAP Accreditation Program, 12.09.2025 edition.

    Source note · accreditation standard

  5. 5. College of American Pathologists. Laboratory General Checklist, GEN.48500 Interface Result Integrity (Phase II). CAP Accreditation Program, 12.09.2025 edition.

    Source note · accreditation standard

  6. 6. College of American Pathologists. Laboratory General Checklist, GEN.43875 Autoverification Validation (Phase II). CAP Accreditation Program, 12.09.2025 edition.

    Source note · accreditation standard

  7. 7. CLSI EP19, A Framework for Using CLSI Documents to Evaluate Medical Laboratory Test Methods, 3rd ed., Clinical and Laboratory Standards Institute, 2022

    Source note · consensus standard

  8. 8. CLSI QMS21-Ed1, Purchasing and Inventory Management, Clinical and Laboratory Standards Institute, published November 30, 2016, reaffirmed June 2021

    Source note · consensus standard

  9. 9. FDA, Cybersecurity in Medical Devices: Quality Management System Considerations and Content of Premarket Submissions, Guidance for Industry and FDA Staff, final guidance, February 2026 (docket FDA-2021-D-1158; supersedes June 2025 and September 2023 versions)

    Source note · federal regulation

  10. 10. Hueth KD, Prinzi A, et al. (CDC Laboratory Medicine Best Practices), "Effectiveness of Practices to Support Appropriate Laboratory Test Utilization: A Laboratory Medicine Best Practices Systematic Review and Meta-Analysis," American Journal of Clinical Pathology, 2018

    Source note · peer-reviewed literature

  11. 11. "Interventions to reduce repetitive ordering of low-value inpatient laboratory tests: a systematic review," BMJ Open Quality, 2023

    Source note · peer-reviewed literature

  12. 12. Konger RL, Ndekwe P, et al., "Reduction in Unnecessary Clinical Laboratory Testing Through Utilization Management at a US Government Veterans Affairs Hospital," American Journal of Clinical Pathology, 2016;145:355-364

    Source note · peer-reviewed literature

  13. 13. Kulshrestha MR, Tiwari V, Singh S, Pathak AK, "An Approach to Include the Cost of Consumables in Biochemistry Analyzer Procurement on the Reagent Rental Model Alleviates Hidden Expenses," EJIFCC, 2024;35(3):182-188

    Source note · peer-reviewed literature

  14. 14. Siddiqui S, et al., "Long-term alliance for pathology equipment and technology acquisition: a paradigm shift for improved quality and efficiency," Laboratory Medicine, 2023;55(2):117-124

    Source note · peer-reviewed literature

  15. 15. HHS Office of Inspector General, "Physician Relationships With Fellow Providers: Physicians, Hospitals, Nursing Homes, Etc.," Compliance guidance; CMS, "What Is Open Payments?" program overview

    Source note · federal regulation