CAP Pro Course - Chemistry - QC, Calibration, and Reportable Range

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Author: Kevin F. Foley, PhD, DABCC, MT, SC
Reviewers: DeRhonda Crawford, MT(ASCP); Alec Saitman, PhD, DABCC (CC, TC)

Continuing Education Credits

Objectives

  • Explain the role of quality control testing in ensuring accurate patient results.
  • Discuss calibration and calibration verification, identifying when each procedure is required.
  • Define analytical measurement range and describe which actions need to be undertaken when a result exceeds this range.
  • Identify the requirements for comparing results if the laboratory uses more than one instrument/method to test for an analyte.

Course Outline

  • Explain the role of quality control testing in ensuring accurate patient results.
      • Quality Control
      • Quality Control for Qualitative Chemistry Tests
      • Evaluating Quality Control (QC) Results
      • Quality Control (QC) Failures
      • Delta Check
      • Proficiency Testing (PT)
      • Proficiency Testing (PT) Requirements
      • A Medical Laboratory Scientist has installed a new urine drug screen on her immunoassay analyzer. What should be her starting assumption about the fre...
      • A Medical Laboratory Scientist working in a toxicology laboratory is looking for controls for a urine oxycodone assay. The cutoff for the assay is set...
      • A Medical Laboratory Scientist (MLS) receives a package of proficiency testing (PT) samples for her laboratory's serum protein electrophoresis test. W...
  • Discuss calibration and calibration verification, identifying when each procedure is required.
      • Calibration and Calibration Verification
      • Calibration Versus Linearity
      • Calibration and Calibration Verification Frequency
      • A hospital had a plumbing issue that resulted in water flooding the floor of the laboratory. As a result, a large chemistry analyzer was unplugged and...
      • A Medical Laboratory Scientist is asked to perform a linearity check on an AST assay that is being validated in the laboratory. Which of the following...
      • Which of the following is the testing of materials that have known concentrations in order to substantiate an instrument's calibration?
      • When a Medical Laboratory Scientist calibrates or recalibrates an assay, what is actually being performed or being assessed?
  • Define analytical measurement range and describe which actions need to be undertaken when a result exceeds this range.
      • Analytical Measurement Range (AMR)
      • Analytical Measurement Range (AMR), continued
      • Decision Tree: Analytical Measurement Range (AMR) Verification
      • Extending the Measurement Range
      • Dilution Protocols
      • Which of the terms below is closest in meaning and practical use for the term AMR?
      • A TPO antibody test has an AMR of 0-150 IU/mL. The laboratory has validated a dilution protocol. The reportable range for the assay is 0-300 IU/mL. If...
      • At the request of physicians, a laboratorian validates a dilution protocol for her laboratory's ACTH assay. Which of the following would be true?
      • A body fluid assay for CEA has a validated range of 0-100 ng/mL. When the instrument reads ">100 ng/mL," a technologist performs a 1:10 dilution an...
      • Which of the following is true concerning the extension of the analytical measurement range (AMR)?
  • Identify the requirements for comparing results, if the laboratory uses more than one instrument/method to test for an analyte.
      • Instrument/Method Comparisons
      • Instrument/Method Comparisons, continued
      • A hospital laboratory has two instruments that perform troponin testing. One is a high-sensitivity troponin assay that has an analytical measurement r...
      • A laboratory supervisor receives a call from an irate physician who is complaining that when her patient had his creatinine measured at the hospital t...
      • A regional health system uses portable point-of-care (POC) chemistry analyzers at multiple locations throughout the city. They also have a regional la...
      • A large volume laboratory has a backup immunoassay instrument that is sometimes used when hepatitis B testing orders increase. What should be the prac...
  • References
      • References

Additional Information

Level of Instruction: Intermediate
Intended Audience: This program is designed as an educational and training tool for MLS, MT, and MLT personnel, medical laboratory science students and interns, pathology residents, and practicing pathologists.
Author: Kevin F. Foley, PhD, DABCC, MT, SC is the Northwest chemistry, toxicology, immunology, and POC director for Kaiser Permanente. He also teaches pharmacology, clinical chemistry, immunology, and medicinal chemistry at Oregon Health Sciences University. Dr. Foley earned his PhD in clinical pharmacology and toxicology at the East Carolina School of Medicine in North Carolina. His research areas include cardiovascular risk and inflammation markers, as well as the neuropharmacology of amphetamine-like compounds. He is a frequent contributor to several clinical laboratory publications and is active in the American Association of Clinical Chemistry.
Reviewer Information: DeRhonda Crawford, MT(ASCP) is the chemistry supervisor at Gwinnett Medical Center in Lawrenceville, Georgia and the technical supervisor for the Gwinnett Medical Center in Duluth, Georgia. She holds a BS in Medical Technology from the Medical College of Georgia. 
Reviewer Information: Dr. Alec Saitman, PhD, DABCC (CC, TC) received his Ph.D. in Organic Chemistry at the University of California, San Diego, where he focused his research on the total synthesis of marine natural products. He completed his fellowship training in clinical chemistry and toxicology in the Department of Pathology at the University of California, San Diego under the guidance of Dr. Robert Fitzgerald. Alec’s current focus is on clinical mass spectrometry method development for the quantitative analysis of small molecules in patient specimens. 

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