CCML 250 METHOD EVALUATION QUESTIONS
What is the role of the lab in method evaluation? - Answer -Select and evaluate
methods that suit lab situation
What is the lab "situation" in method eval? - Answer -Patient Population
What do regulations of methods require? - Answer -Successful performance of
proficiency testing (PT or EQA)
What is method validation? - Answer -invloves investigatin and documenting a test
repeatedly giving expected results. Includes:4QC
personnel competency assessment
internal and external proficiency testinf
correlation with clinical findings
instrument calibration
ongoing eval to determine if significant changes have occured
Why do method eval? - Answer --improve accuracy/precision
- allow automation
- reduce reagent or labour cost
- measure a new analyte
- better align existing method with reference method
- account for new source of antibody
- change platforms
Method evaluation determines: - Answer -size of INHERENT analitical error and helps
determine if this error is acceptable, and if method will be successful in proficiency
testing
What does daily QC determine - Answer -increases in analytical error
Basic approach to method eval - Answer -apply clinical perspective
establish analytical goals
data collection
error analysis-statistical
objective conclusions - estimates of error
New method introduction approach - Answer -Establish need
Method selection
Define quality goal
Method eval - method development
Implementation
Routine analysis -QC practices
