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Module GLP-06 · Version 1.0

Accept, Reject, or Investigate?

A practical walk through the risk-based decision a laboratory professional makes when a specimen arrives imperfect: reject it, request recollection, correct a processing defect, or accept it under a documented, approved exception. Builds a repeatable risk screen, a defect-to-disposition matrix, and a guided case using a hemolysis index, then asks the learner to disposition five case cards and identify which one also needs nonconforming-event review.

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Who this module is for

Medical laboratory scientists, medical laboratory technicians, and laboratory students who receive, evaluate, or process specimens before testing.

Learning objectives

  • Differentiate mandatory rejection from conditionally acceptable specimens
  • Weigh test urgency, irreplaceability, likely bias, alternate specimen, and recollection risk
  • Communicate and document exceptions without hiding the limitation

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

14 sources

  1. 1. Electronic Code of Federal Regulations. 42 CFR §493.1232, Standard: Specimen identification and integrity. https://www.ecfr.gov/current/title-42/chapter-IV/subchapter-G/part-493/subpart-K/section-493.1232.

    Source note · federal regulation

  2. 2. Electronic Code of Federal Regulations. 42 CFR §493.1242, Standard: Specimen submission, handling, and referral. https://www.ecfr.gov/current/title-42/chapter-IV/subchapter-G/part-493/subpart-J/section-493.1242.

    Source note · federal regulation

  3. 3. Electronic Code of Federal Regulations. 42 CFR §493.1249, Standard: Preanalytic systems quality assessment. https://www.ecfr.gov/current/title-42/chapter-IV/subchapter-G/part-493/subpart-J/section-493.1249.

    Source note · federal regulation

  4. 4. Electronic Code of Federal Regulations. 42 CFR §493.1251, Standard: Procedure manual. https://www.ecfr.gov/current/title-42/chapter-IV/subchapter-G/part-493/subpart-K/section-493.1251.

    Source note · federal regulation

  5. 5. Electronic Code of Federal Regulations. 42 CFR §493.1283, Standard: Records system. https://www.ecfr.gov/current/title-42/chapter-IV/subchapter-G/part-493/subpart-K/section-493.1283.

    Source note · federal regulation

  6. 6. Clinical and Laboratory Standards Institute. Handling, Transport, Processing, and Storage of Blood Specimens for Routine Laboratory Examinations, 1st ed., CLSI guideline PRE04. August 2023. https://clsi.org/shop/standards/pre04/.

    Source note · consensus standard

  7. 7. Clinical and Laboratory Standards Institute. Nonconforming Event Management, 2nd ed., CLSI guideline QMS11. August 25, 2015, reaffirmed September 2019. https://clsi.org/shop/standards/qms11/.

    Source note · consensus standard

  8. 8. College of American Pathologists. All Common Checklist, COM.06300 Specimen Rejection Criteria. 2020 public checklist copy; verify the laboratory's current licensed checklist before production. https://documents-cloud.cap.org/appsuite/learning/LAP/TLTM/resources/checklists/2020/cl-com.pdf.

    Source note · accreditation standard

  9. 9. Centers for Disease Control and Prevention and National Institutes of Health. Guidelines for Safe Work Practices in Human and Animal Medical Diagnostic Laboratories. MMWR Supplements. 2012;61(Suppl):1-102. https://www.cdc.gov/mmwr/preview/mmwrhtml/su6101a1.htm.

    Source note · federal guidance

  10. 10. Centers for Disease Control and Prevention. Specimen Packing and Shipping Guidance for Infectious Diseases Laboratories. https://www.cdc.gov/laboratory/specimen-submission/pdf/Specimen-Packing-and-Shipping-Guidance-Infectious-Diseases-Laboratories.pdf.

    Source note · federal guidance

  11. 11. Lippi G, von Meyer A, Cadamuro J, Simundic AM. Managing hemolyzed samples in clinical laboratories. Clinical Chemistry and Laboratory Medicine. 2019;57(7):974-988. https://pubmed.ncbi.nlm.nih.gov/31603708/.

    Source note · peer-reviewed literature

  12. 12. Lippi G, Cadamuro J, von Meyer A, Simundic AM. Methods for hemolysis interference study in laboratory medicine: a critical review. Biochemia Medica. 2020;30(2):020503. https://pmc.ncbi.nlm.nih.gov/articles/PMC7109502/.

    Source note · peer-reviewed literature

  13. 13. Dimeski G, Jones BW, Tilley V, Greenslade MN, Russell AW. Current methods of haemolysis detection and reporting as a source of risk to patient safety: a narrative review. Annals of Clinical Biochemistry. 2017;54(1):1-12. https://pmc.ncbi.nlm.nih.gov/articles/PMC5242478/.

    Source note · peer-reviewed literature

  14. 14. Lippi G, Cadamuro J, von Meyer A, Simundic AM. Practical recommendations for managing hemolyzed samples in clinical chemistry testing. Clinical Chemistry and Laboratory Medicine. 2018;56(5):718-727. https://pubmed.ncbi.nlm.nih.gov/29373316/.

    Source note · peer-reviewed literature