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Chemistry Block 1
Quality Assurance
22
Chemistry
Graduate
05/06/2010

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Term
Quality Assurance (QA)
Definition
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.
Term
Quality Control (QC)
Definition
A component of the laboratory's quality assurance system designed to assist in identifying and minimizing analytical errors
Term
Aliquot
Definition
A sample of a whole taken to determine the quantitative composition of the whole
(i.e. part of a specimen that was collected)
Term
Turnaround Time
Definition
Total amount of time required to obtain or collect a specimen, prepare the specimen, perform testing, and report the results
Term
Pre-analytical Factors
Definition
Factors that occur prior to testing patient specimen. (i.e. fasting)
Term
Analytical Factors
Definition
Factors the MLT has a direct impact on while performing tests
Term
Reagents
Definition
Chemicals added to the sample to cause chemical reactions
Term
Standards
Definition
Used as the basis for comparison of other solutions typically contain analytically pure substance(99.95%)
Term
Transcription Errors
Definition
Greatest single cause of errors in the laboratory
Term
Standard Operating Procedure (SOP)
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
Term
Additional areas of monitoring for NCCLS standards
Definition
1. Water Quality
2. Calibration of balances
3. Calibration of glassware
4. Electrical Power Supply stability
5. Instrument Temperature (incubator and refrigerator)
Term
Statistical QC
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
Term
Control Materials
Definition
Specimens or materials with are analyzed solely for quality control purposes and not used for calibration purposes
Term
Random Error
Definition
Unintentional false value occurring anytime
Term
Systematic Error
Definition
Error occurring as result of a specific problem with test procedure
Term
Range
Definition
Difference between upper and lower limits of a variable or a series of values
Term
Analyte
Definition
Substance undergoing analysis
Term
Lyophilized
Definition
Stabilized biological substance prepared by rapid freezing and dehydration under high vaccum
Term
Reconstitute
Definition
The restoration to original form of a substance previously altered for preservation and storage
Term
Sensitivity
Definition
A measure of the ability to detect small quantities of the measured component
Term
Minimum Identification requirements for control materials
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
Term
Three Stages of QC program
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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