NPAAC QC/EQA Flashcards
What are the QC/EQA process goals?
- minimise risk erroneous result
- improve overall performance of pathology service
- performance goals
- assays/procedures fit for purpose
- document who has responsibility for improving poorly performing assay/procedure
- set target performances
- determine significance of QC/EQA failure
EQA
- external agency objectively check lab results
- comparison with peers
- establishment of trueness
- identify possible deficiencies and guide corrective action for improvement
- id reliability of particular method, materials and equipment
- impact of training
What are the documentations needed for performance goals for lab assays/procedures
- selection of assays fit for purpose
- selection of target/range for QC samples
- acceptance criteria for QC results
- collect info on lab measurements/issues with harmonization
- collect info for accreditation of labs
Define the QC process
- QC material conc clinically relevant and within measurement range
- QC failure escalation document evaluate specimens measured between last successful QC and first failed QC
EQA program
- must participate relevant QAP for each test, document enrolment, participation and evaluation
- processing/reporting must be performed in similar manner to routine specimens
- EQA must be reviewed and non concordant results/failures must be investigated and actions taken documented
Selection of EQA programs
- accreditation to ISO 17043
- aims, range of services, criteria
- reporting procedures, suitability of data analysis, interpretatin of results
What are the steps needed for introduction of a new assay?
- documented procedure
- approved/authorised by designated person
- validation/verification must incl stat correlation against excisting
- studies of concordance if qualitative
- ID MOU
What are the options for quality assurance of rarely encountered antibodies?
- sample exchange between labs
- compare with reference laboratory
- international EQAP if available
- liaise with commerical manufacturers
What is the difference between accreditation and certification?
Accreditation - process of inspection of laboratories and licensing by third party to ensure conformity to pre defined criteria
ISO 15189
evidence of compliance
certification- framework, procedures
What is proficiency testing?
Interlab comparisons that are organised regularly to assess performance of analytical labs and competence of analytical personnel
NATA/NPAAC requirement - medical pathology services must be enrolled, participate and perform to an acceptable standard in EQA programs that cover all testing methods performed where such programs are available
What are the limitations of QAP in detecting quality problems in the lab?
- specimens may not reflect patients /matrix/spiked/not serum but PLEX samples etc
- specimen handling also; lyophilised, frozen, stabilised w preservative
- insensitive to ass day to day performance/small number of samples infreq
- low power to detect outliers
- may not test all assays
- target setting is not ideal/bias/majority
- artificial
What the advantages of joining EQAP for labs?
- NATA requirement/MBS rebate
- peer review
- platform performance
- detect whole of lab issue/vertical audit
- improvement
- KPI
For QAP reports how does RCPA QAP determine target results?
For biochemistry gold standard/biological variation preferred as available
Immunopathology working party- expert panel or consensus method (absolute, percentage or a combination of the two)
In Immunopathology qualitative 80% consensus and quant historic medical 80% of what labs achieved
Pitfalls of consensus
- bias method/skewed result
- may not be true answer
- best method may not be the most common method
When you dont have an available EQAP - what should you do?
Reason
- assay rare
- expensive to send away
- no recognised program
- same exchange is difficult (transport, not feasible)
NPAAC standard for participation in EQAP
- lab must demonstrate
- appropriate validation procedures to determine suitability of results
- documented QC procedure developed for ongoing assessment of results
Often labs just re-test their internal known samples
