Module CC-02 · Version 1.0
Calibration and Analytical Measurement Systems
How a laboratory establishes and verifies the relationship between instrument signal and assigned analyte value, why calibration, calibration verification, and quality control are three distinct activities, and what a technologist does when a calibration signal drifts.
Your next section
Start section 1Read without an account. Sign in to save.
Who this module is for
Clinical laboratory scientists and trainees working toward independent bench authority on automated chemistry or immunoassay analyzers.
Learning objectives
- Differentiate calibration, calibration verification, and quality control as distinct required activities
- Interpret a simple calibration curve and its residual pattern to judge whether a fit is trustworthy
- Recognize the events that may require calibration action under the method instructions and laboratory policy
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
10 sources
1. 42 CFR § 493.1255, "Standard: Calibration and calibration verification procedures," Electronic Code of Federal Regulations, current text mirrored at Legal Information Institute (Cornell Law School), law.cornell.edu/cfr/text/42/493.1255, cross-checked against govinfo.gov CFR Title 42 text.
Source note · federal regulation
2. Centers for Medicare & Medicaid Services, "Revisions to State Operations Manual (SOM), Appendix C, Survey Procedures and Interpretive Guidelines for Laboratories and Laboratory Services (CLIA)," QSO-25-10, released 2024-12-06.
Source note · federal guidance
3. Centers for Medicare & Medicaid Services, "Medicare, Medicaid, and CLIA Programs; Laboratory Requirements Relating to Quality Systems and Certain Personnel Qualifications" (CLIA quality systems final rule background document), cms.gov.
Source note · federal guidance
4. Clinical and Laboratory Standards Institute, "EP06, Evaluation of Linearity of Quantitative Measurement Procedures," 2nd edition, published 2020-11-24.
Source note · consensus standard
5. Clinical and Laboratory Standards Institute, "EP09, Measurement Procedure Comparison and Bias Estimation Using Patient Samples," 3rd edition (EP09c), published 2018-06-20.
Source note · consensus standard
6. Clinical and Laboratory Standards Institute, "EP15, User Verification of Precision and Estimation of Bias," EP15-A3, published 2014-09-11, reaffirmed 2019-09.
Source note · consensus standard
7. Clinical and Laboratory Standards Institute, "EP17, Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures," EP17-A2, published 2012-06-18, reaffirmed 2017-06, and EP17-Ed2-IG, published 2021-08-26.
Source note · consensus standard
8. Joint Committee for Traceability in Laboratory Medicine (JCTLM), "About Us" and ISO-documents summary pages, jctlm.org/about-us and jctlm.org/publications/iso-documents.
Source note · consensus standard
9. International Federation of Clinical Chemistry and Laboratory Medicine (IFCC), "Commutability in Metrological Traceability (WG-CMT)," ifcc.org/ifcc-scientific-division/sd-working-groups/wg-cmt.
Source note · professional society guidance
10. Westgard QC, "Calibration Verification Criteria for Acceptable Performance," westgard.com/lessons/basic-method-validation/cal-verification-criteria.html.
Source note · professional society guidance