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# Lab quality

DefinitionTerm
Statistically determined range of values within which a test result must fall to be considered acceptable; it is a means of QC or QA Acceptable Control Range
Correctness of a result, freedom from error, or how close the answer is to the ‘true’ value Accuracy
Process whereby analytical analyses are carried out; includes generating work lists, doing the analyses, entering the results, QC measures, and result verification. Analytic Functions
Solutions made with dry chemicals that do not contain any water molecules. Anhydrous Solutions
The inverse logarithm of a number Antilog
Means by which a laboratory apparatus is checked to determine the exact units it will measure or deliver by relating them to a known concentration of an analyte Calibration
Used to compare the standard deviations of a group of samples; in percent, this is equal to the standard deviation divided by the mean; A measure of precision Formula = SD/Mean x 100 Coefficient of Variation – CV
A value used to express or estimate statistical parameter; an example is when the reference range is set using values 2 SD’s on either side of the mean, with 95% of the values falling above or below the mean. A 95% confidence interval. Confidence limits (confidence interval)
Material or solution with a known concentration of the analytes being measured; used for QC when the test result for the control specimen must be within certain limits for the unknown values (patients) to be considered reportable Control Specimen
The liquid that a sample is placed into in order to make a dilution. Diluent
Reciprocal of the dilution made; multiply the result by the reciprocal (denominator) of the dilution to correct for the dilution used. Dilution Factor
The scattering of the values of a frequency distribution from an average (mean) Dispersion
Those subjects who have a negative test yet DO have the disease False Negatives
Those subjects who have a positive test but do NOT have the disease False Positives
Particular symmetric statistical distribution, also known as a ‘normal’ distribution; statistically a toll used to set references ranges Gaussian curve or Distribution
The inverse of the exponential function y=a^. Consist of 2 parts: the Characteristic, which is the whole number; and the Mantissa, which is the decimal part. Logarithm
Statistically calculated mathematical average value for a valid series of numbers, as for a series of test results. The series of values is totaled and divided by the number in the series. Mean
The middle value of a body of data; the point that falls halfway between the highest and lowest in position. Median
The value that occurs most commonly in a mass of data Mode
The number of moles of solute per kilogram of solvent. Based off weight, not volume. Molality
Gram-molecular mass or weight of a compound per liter of solution. A 1 molar solution contains 1 mol of solute in 1L of solution Molarity
Number of equivalent weights per liter of solution. A 1 normality solution contains 1 equivalent weight in 1L solution. Normality
Includes functions that occur after the analyses itself, such as generating chart reports, printing result reports as needed, archiving results and billing. Post-Analytical Function
Functions in testing protocol that occur before the actual analyses – test ordering, specimen collection, and so forth. Pre-Analytical Function
Measure of the closeness of the results obtained when analysis on the same sample is repeated, agreement between replicate measurements. Precision, Reproducibility
Program under which samples are sent to a group of laboratories for analysis; results are compared with those of other laboratories participating in the program. Included as a component of QA programs. Proficiency Testing or Survey
Comprehensive set of policies, procedures, and practices necessary to make sure that a laboratories results are reliable. QA includes record keeping, calibration and maintenance of equipment, QC, proficiency testing, and training. Quality Assurance QA
Indicators that monitor the performance of a laboratory and are evaluated as part of continuous quality improvement Quality Assurance Indicators
Plan to carry out policies and practices necessary to comply with QA standards set by accreditation agencies to make certain that a laboratory’s results are reliable and that these results are used in the best interest of the patient. Quality assurance program
Set of laboratory procedures designed to ensure that a test method is working properly and that the results meet the diagnostic needs of the physician. QC includes testing control samples, charting the results, and analyzing them statistically. Quality Control QC
Visual documentation of information derived from using control specimens; values for control specimen assays used for a particular substance are plotted on the chart on a regular basis and are statistically analyzed for trends of change. Quality Control Chart
Plan to carry out procedures established to make certain that laboratory assay methods are working properly and that assay results meet the diagnostic needs of the physician; makes use of control specimens and standard solutions. Quality Control Program
Amount of something in proportion to an amount of something else; always describes a relative amount. Ratio
Any substance employed to produce a chemical reaction. Reagent
Range of values that includes 95% of the test results of a healthy reference population. Reference Range/Normal Range/Reference values
Ability of a laboratory assay to produce consistent results when testing is repeated successively. Reliability
The proportion of cases of having a specific disease or condition that give a positive test result. Only patients with the disease have the disease. Sensitivity
Progressive dilutions of a substance in a series of tubes in predetermined ratio to give concentrations of a specific amount Serial Dilutions
A term that describes when QC results are all distributed on one side of the mean or the other for 5-7 consecutive days. Shift
Statistical measurement of the degree of variation from the mean of a series of measurements; measure of precision or reproducibility. The square root of the variance. Standard deviation
A term that describes when quality control results either increase or decrease consistently over a period of time of 5-7 days. Trend
Those subjects who have a negative test and who do not have the disease. True Negatives
Those subjects who have a positive test and who have the disease. True Positives
An indication of the precision of a set of numbers. Variance
A set of QC rules that help the laboratory personnel decide when a QC value is ‘in control’ or ‘out of control’. Westgard Multirules
A warning rule where one of the 2 QC values fall outside of the plus 2 or minus 2 SD value. It is indicative of a random error. 1-2s
A rule that results in rejection of the QC results if one or more of the 2 QC values fall outside of the plus or minus 3SD. It is indicative of random error. 1-3s
Violated in 2 ways. The first is if 2 different QC levels analyzed in the same run and are outside the 2SD in the same direction. The second is if there are two 1-2s rule violations in a row for one level of control. Indicative of systematic error. 2-2s
A rule that is broken when the difference or range between 2 control values within a run is greater that 4SD. It is indicative of random error. R-4s
Violated in two ways. The first is when 4 values in a row of the same level of control all fall on the same side of the mean. The other way is when 2 levels of control are used in a run and each has had 2 values in a row fall on the same side of the mean. 4-1s
Violated in 2 ways. The first is when 10 consecutive values run for one level of control all fall on the same side of the mean. The other way is when the results are all on the same side of the mean for both QC levels for 5 days. 10x
These two rules are indicative of systematic error 2-2s and 10x
These 3 rules are indicative of random error R-4s, 1-3s,1-2s
Created by: Oahsis
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