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Quality Assurance
| Question | Answer |
|---|---|
| quality assurance | comprehensive system monitoring the accuracy of test results where all steps before, during, and after the testing process are considered |
| JCAHO | joint commission on the accreditation of health care organization |
| CAP | college of american pathologists |
| AABB | american association of blood banks |
| commission on laboratory assessment | COLA |
| CLIA '88 | set standards for labs; waived testing, provider performed microscopy, moderate complexity and high complexity testing |
| pre-analytical factors | test requests, patient prep, specimen collection handling and storage |
| analytical factors | reagents, instrumentation and equipment, testing procedure, QC, preventative maintenance, access to procedure manuals, competency |
| post analytical factors | lost reports, delays in reporting |
| Quality control | monitors the analytical process; detects errors during the analysis and prevents reporting og erroneous test results |
| standard deviation | the dispersion of a group of data |
| the greater the SD, the _________________ | more spread out observations are |
| coefficient of variation (CV) | way of expressing SD in terms of average value of the observations used in the calculation |
| bias | the amount by which an analysis varies from the correct results |
| diagnostic sensitivity | the proportion of true positives of all the positives |
| diagnostic specificity | the proportion of true negatives of all the negatives |
| how many determinations are needed to establish an acceptable mean and practical SD? | at least 20 |
| most labs only use ___ SD or __% confidence rate | 2; 95 |
| "out of control" | too much dispersion in your results compared to other results |
| reference ranges | expected values for patients; usually 2SD from the mean |
| factors affecting reference ranges | age, sex, diet, medications, physical activity, pregnancy, smoking, geographic location (altitude), body weight, lab instrumentation, lab reagents |
| delta check | compares patient results with prior results |
| analytical measurement range (AMR) | range of analyte values that a method can directly measure without any dilution, concentration or other pre-treatment |
| clinical reportable range (CRR) | range of analyte values that a method can report as a quantitative result, allowing for specimen dilution, concentration or other pre-treatment used to expand the direct AMR |
| proficiency testing | determination of lab testing performance by intralab comparison |
| imprecision | large amount of scatter about the mean; usually caused by errors in technique |
| inaccuracy | may be seen as a trend or shift, usually caused by a change in the testing process |
| random error | no pattern, usually poor technique or malfunctioning equipment |
| 1 2S rule | warning rule; if one of the two control results falls outside of 2SD --> results can still be accepted and reported, evaluate 1 3S rule |
| 1 3S rule | if either of the two control results fall outside 3SD, run must be rejected |
| 2 2S rule | 2 consecutive control values for the same level fall outside 2 SD in the same direction, or both controls in the same run exceed 2 SD --> results cant be reported, corrective action needed |
| R 4S rule | one control exceeds the mean by -2 SD and the other exceeds by +2 SD (reject results) |
| 4 1S rule | requires control data from previous runs |
| 10x rule | 10 consecutive QC results for one level of control are on one side of the mean, or both levels of control gave 5 consecutive results that are on the same side of the mean |
| "out of control" | stop testing, identify and correct problem, repeat test, do not report results |
| accuracy | how close a measured value is to the accepted value |
| precision | reproducibility of results |
| reliability | the degree to which a test is consistent |
| trend | gradual movement of data points in a certain direction over time |
| shift | sudden jump in values |
| sentinel event | bad lab error; misidentification, failure to report critical results |
| standards | substances with exactly known compositions and concentrations |
| controls | biologic solutions resembling unknowns |
| calibrators | resemble a patient sample, have assigned values |
| central tendency | the distribution of data around a central value |
| "Gaussian" distribution | when the mean, median, and mode are the same number; graph shows a bell shaped curve with an equal amount of results above and below the highest points |
Created by:
kingsleya27