Quality Assurance part of quality management focused on providing confidence that quality requirements will be fulfilled Quality Control

l part of the quality management focused on fulfilling quality requirement Accuracy true value of the sample o The best estimated true value can be measured in two ways Reference Method Peer group comparison Precision degree of replication and reproducibility o The best estimate replication uses: Standard Deviation Coefficient of Variation The smaller the SD or CV the more precise.

STATISTICS branch of mathematics that collects, analyzes, summarizes and present

information about observation. *OBSERVATION numerical results. MEAN ( ) calculated average of the set values. o Median value of the middle observation, when the set is arranged in rank order. Mode most frequently observed value Range measure of the spread of the dispersion of data points difference between the largest and the smallest observed value largest and the smallest data is considered Standard Deviation measures the spread or variation or dispersion of the set of data about the mean or expected values

n= # of observations *it is the square root of VARIANCE, is the average of the squared differences from the mean Low SD = data points tend to be very close to the MEAN, not spread out. High SD = data are widely spread out over a large range of values Coefficient of Variation defined as the ratio of the standard deviation to the mean value of the data used in the analysis(percentage)

Clinical Chemistry (Laboratory)

WHEN DO WE DETERMINE THAT A LABORATORY TEST RESULT IS NORMAL OR ABNORMAL? STATISTICAL ANALYSIS of laboratory test data determines the lines of normal/abnormal values. IN CHEMISTRY, when control limits are set at 2SD the sample results are reported at a 95% confidence level. ,when control limits are set at 3SD the sample results are reported at a 99% confidence level 4.87 0.54 = 4.3 4.87 + 0.54 = 5.41 4.3 5.41 ] = 3.25 4.87 - [ [ ] = 6.49 4.87 + 3.25 6.49 ] = 3.79 4.87 [ ] = 5.95 4.87 + [ 3.79 5.95

If the results are NORMAL were comfortable about them and do not worry. But if the result is ABNORMAL were uncomfortable and we fear that there is something wrong with the patient, or just as bad, something is wrong with the test procedure. TERMS: in & out control ranges control specimen and calibrators normal & abnormal ranges for patients WHAT DOES THE NORMA DISTRIBUTION LOOK LIKE? AND WHAT IS IT CALLED? Symmetrical curve represents the Normal Distribution. - It is a continuous function which approximates the exact binomial distribution of events SHIFT 6 consecutive data results on the same side of the mean o Causes: Modification of procedures, either intentional or unintentional Changes in concentration of standards or reagents Altering the temperature at which solutions are boiled or incubated Change of pipettes or volumetric flasks without prior calibration Change in line voltage TREND when there is a consistent increase/decrease in data points over a period of 6 o May result from: Deterioration or gradual evaporation of reagents Gradual change in pH Gradual but consistent contamination of reagents IMPRECISION large amount of scatter about the mean. Usually caused by errors in technique INACCURACY may see as a trend/shift, usually caused by change in the testing process

days

Clinical Chemistry (Laboratory)

ERRORS: RANDOM ERRORS errors affect the reproducibility or precision of a test system, o Usually 13s or R4s rules o Can be due to: Variations in line voltage Pipettes, dispensers contamination Volume dispensed Bubbles in lines of reagents, etc. SYSTEMATIC ERRORS (bias, shift, and trends) these errors affect the accuracy of the test system o Usually 22s, 41s or 10x rules o Can be due to: Calibration lot changes Temperature changes in incubator unit Light source deterioration Electronics Reagent lot changes

WESTGARD RULES The short hand notation is use to abbreviate the different decision criteria or control rules: 13s 22s R4s 41s 10x a single control value exceeds 3SD(red) from the target Result of 2 quality control samples are both SD from their mean in the same direction (both high or low) Result of 2 quality control samples are both 2SD from their mean but in opposite directions (one high and the other is low) Four consecutive results of 1 quality control are all >1SD from the mean and all in the same direction (all high or all low) 10 consecutive results of 1 quality control are all on the same side of the mean and all in the same direction

Clinical Chemistry (Laboratory)

Clinical Chemistry (Laboratory)