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| A broad spectrum of plans, policies and procedures that provide an administrative system to manage a laboratory's efforts to achieve quality goals. It includes actions necessary to provide confidence that laboratory services will be adequate to satisfy medical needs for patient care. |
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| A component of the laboratory's quality assurance system designed to assist in identifying and minimizing analytical errors |
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A sample of a whole taken to determine the quantitative composition of the whole
(i.e. part of a specimen that was collected) |
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| Total amount of time required to obtain or collect a specimen, prepare the specimen, perform testing, and report the results |
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| Factors that occur prior to testing patient specimen. (i.e. fasting) |
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| Factors the MLT has a direct impact on while performing tests |
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| Chemicals added to the sample to cause chemical reactions |
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Definition
| Used as the basis for comparison of other solutions typically contain analytically pure substance(99.95%) |
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| Greatest single cause of errors in the laboratory |
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| Standard Operating Procedure (SOP) |
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Definition
a manual that establishes step by step procedures typically contains
Test name, test principle, patient preparation, specimen requirements, reagent preparation and materials, test procedures, among others |
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| Additional areas of monitoring for NCCLS standards |
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Definition
1. Water Quality
2. Calibration of balances
3. Calibration of glassware
4. Electrical Power Supply stability
5. Instrument Temperature (incubator and refrigerator) |
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Definition
| Subsystem of QC, its purpose is to monitor test methodology by testing control material in same manner as patient specimens and then evaluating results |
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| Specimens or materials with are analyzed solely for quality control purposes and not used for calibration purposes |
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Definition
| Unintentional false value occurring anytime |
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| Error occurring as result of a specific problem with test procedure |
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Definition
| Difference between upper and lower limits of a variable or a series of values |
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| Substance undergoing analysis |
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| Stabilized biological substance prepared by rapid freezing and dehydration under high vaccum |
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| The restoration to original form of a substance previously altered for preservation and storage |
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| A measure of the ability to detect small quantities of the measured component |
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| Minimum Identification requirements for control materials |
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Definition
| Name of reagent or material, Lot number, Concentration of the analyte, Date received/prepared/opened and expiration date annotated on container with initials, new expiration date, storage conditions |
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| Three Stages of QC program |
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Definition
| Establish Statistical limit of variations for each test and control level, Using data to evaluate subsequent data generated by each test, Take remedial action when indicated for rules (i.e. find reason for error, fix problem) Reanalyze control and patient data |
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