Module GLP-01 · Version 1.1
Following a Result through the Total Testing Process
A result can fail before an analyzer ever sees the specimen, and it can fail after the analyzer prints a number. Trace a basic metabolic panel from order to clinical use, name the owner and record at each handoff, and work one guided case where a hemolyzed, high-potassium specimen is the earliest failed control rather than the analyzer.
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Who this module is for
New and cross-training laboratory staff building a working model of the total testing process before assigned bench training
Learning objectives
- Map ordering, identification, collection, transport, preparation, analysis, verification, reporting, acknowledgment, and use as one connected path
- Distinguish process ownership from physical location so a failure is traced to its handoff, not just to a room or a device
- Identify the controls, handoffs, records, and recovery actions available at each point on the path
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
13 sources
1. 42 CFR § 493.1241, Standard: Test request. Electronic Code of Federal Regulations, current text. https://www.law.cornell.edu/cfr/text/42/493.1241.
Source note · federal regulation
2. 42 CFR § 493.1242, Standard: Specimen submission, handling, and referral. Electronic Code of Federal Regulations, current text. https://www.law.cornell.edu/cfr/text/42/493.1242.
Source note · federal regulation
3. 42 CFR § 493.1253, Standard: Establishment and verification of performance specifications. Electronic Code of Federal Regulations, current text. https://www.law.cornell.edu/cfr/text/42/493.1253.
Source note · federal regulation
4. 42 CFR § 493.1256, Standard: Control procedures. Electronic Code of Federal Regulations, current text. https://www.law.cornell.edu/cfr/text/42/493.1256.
Source note · federal regulation
5. 42 CFR § 493.1291, Standard: Test report. Electronic Code of Federal Regulations, current text. https://www.law.cornell.edu/cfr/text/42/493.1291.
Source note · federal regulation
6. Clinical and Laboratory Standards Institute. QMS01: A Quality Management System Model for Laboratory Services, 5th ed., QMS01Ed5E, 2019. https://clsi.org/shop/standards/qms01/.
Source note · consensus standard
7. Clinical and Laboratory Standards Institute. PRE01: Patient and Laboratory Specimen Identification Processes, 1st ed., PRE01Ed1E, 2024. https://clsi.org/shop/standards/pre01/.
Source note · consensus standard
8. Clinical and Laboratory Standards Institute. EP28-A3c: Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline, 3rd ed., reaffirmed 2020. https://clsi.org/shop/standards/ep28/.
Source note · consensus standard
9. College of American Pathologists. Laboratory General Checklist, GEN.41345 Turnaround Time (Phase II). CAP Accreditation Program, 12.09.2025 edition.
Source note · accreditation standard
10. College of American Pathologists. Laboratory General Checklist, GEN.43875 Autoverification Validation (Phase II). CAP Accreditation Program, 12.09.2025 edition.
Source note · accreditation standard
11. Plebani M. The detection and prevention of errors in laboratory medicine. Annals of Clinical Biochemistry. 2010;47(2):101-110. doi:10.1258/acb.2009.009222.
Source note · peer-reviewed literature
12. Lippi G, von Meyer A, Cadamuro J, Simundic AM. Managing hemolyzed samples in clinical laboratories. Critical Reviews in Clinical Laboratory Sciences. 2019;56(7):552-567. doi:10.1080/10408363.2019.1664391.
Source note · peer-reviewed literature
13. DiToro DF, Conrad MJ, Jarolim P. Hemolysis Index and Potassium Reporting: Contextual Evidence-Based Reporting Criteria. American Journal of Clinical Pathology. 2022;157(6):809-813. doi:10.1093/ajcp/aqab217.
Source note · peer-reviewed literature