Term
| What do inspections ensure in the laboratory? |
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Definition
| laboratories are efficient and working at the highest standards |
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Term
| How can labs pass inspection? |
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Definition
| following proper procedure at all times, and maintains proper documentation |
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Term
| if a laboratory has a deficiency what has to be done? |
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Definition
| deficiency has to be corrected on site or by documentation to CAP before accreditation |
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Term
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Definition
| Read, Observe, Ask and Discover |
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Term
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Definition
| Pathologist, physician, doctoral in science with expertise in medial pathology |
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Term
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Definition
| person who qualifies as a director, 4 years experience |
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Term
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Definition
| person experiences in the field under direct supervision of a qualified director to perform high complexity testing |
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Term
| what are the three areas in a lab? |
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Definition
specimen prep area (clean)
specimen processing area with specialized fume hood (dirty)
specimen testing area (clean) |
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Term
| What are wipe tests and why are they done? |
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Definition
| swab instruments monthly to confirm absence of contamination, performed when contamination is suspected |
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Term
| Why do documents regarding set-up and normal operations need to be available? |
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Definition
| routine maintenance, and instrument troubleshooting |
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Term
| What proficiency testing procedures? |
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Definition
| labs send multiple specimens to groups of labs for comparison analysis, PTs are integrated into the daily workload |
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Term
| If PT is not required what is done instead? |
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Definition
| participation in external PT or by utilizing an alternative method for determining the reliability of the results |
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Term
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Definition
| every action in the lab must be documented in the procedure manual to assure quality across the lab |
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Term
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Definition
| techniques for monitoring performance |
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Term
| What are the components of the procedure manual? |
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Definition
| written QM/QC program in place, shows how to run the lab start to finish, and shows how to handle problems that are encountered |
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Term
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Definition
| documented to verify performance of the molecular test |
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Term
| Diagnostic and analytical sensitivity |
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Definition
diagnostic = ability to detect a disease or condition
analytical = ability of an assay to detect a given analyte |
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Term
| diagnostic and analytical specificity |
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Definition
diagnostic= degree to which an assay is negative when disease is absent
analytical = degree to which interfering substances are not detected in an assay |
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Term
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Definition
| reproducibility of a result |
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Term
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Definition
| required to ensure the continued accuracy of a test method |
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Term
| when is calibration performed? |
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Definition
| when reagent lots are changed, after machine maintenance or service and at least every 6 months |
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Term
| When 2 systems are used to test same analyte, how often are they checked against each other? |
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Definition
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Term
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Definition
| positive and negative control |
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Term
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Definition
| controls, at more than one concentration level, in every run |
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Term
| How long are final reports kept for? |
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Definition
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Term
| Who requires ASRs for use in the clinical laboratories |
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Definition
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Term
| Cap checklist for molecular laboratories require a genetic counselor on staff? |
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Definition
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