QUALITY MANAGEMENT
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is important to customers. It can be assessed and monitored. It can be improved
Quality
It is widely accepted nowadays that medical decisions are reliant on laboratory results and to have these values for clinical decision making, an individual’s lab test result must have total error small enough to reflect the biological condition being evaluated.
QUALITY MANAGEMENT
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Quality
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Quantity
Give me the THREE PHASES OF TESTING PROCESS
● Pre-analytic phase ● Analytic phase ● Post-analytic phase
Pre-analytic phase
● role of PHYSICIAN ● Patient/Client Preparation ● Sample collection ● Personnel Competency ● Test Evaluations ● Sample receipt and Accessioning ● Sample Transport
Analytic phase
● role of MEDICAL TECHNOLOGIST ● Most crucial (where procedures are performed) → stage where quality control is employed → QUALITY CONTROL → activities ensuring quality of products (ie. lab results) ● Testing of sample
Post-analytic phase
role of PHYSICIAN ● Record Keeping ● Reporting
Measurement of the broader dimension of quality from the perspective of the end-use
-Bishop
Benefits of Laboratory Quality Assurance
● QA provides evidence of good performance → measured by statistical approach ● Laboratory mistakes are prevented → identify errors ● Significant improvements in testing performance can be achieved → Research findings from the College of American Pathologists, the University of Wisconsin, and the Centers for Disease Control and Prevention
→ “Planned and systematic activities to provide adequate confidence so that requirements for quality will be met”
● ISO 8042, 3.4; CLSI
_____________are services which are easily observed by the patient
pre-analytical and post-analytical
Quality control focuses on the ___________
analytic part
Why Is Quality Assurance of Testing Important ?
*Public expects high quality *Defines parameters & quality goals *Evaluation & improvement system *Assures reliability & comparability of results *Cost effective *Even the simplest of testing is not foolproof
A. QUALITY ASSURANCE MODEL (PILLARS)
● Staffing / personnel ● Quality control (QC) ● Proficiency testing (PT) also known as External quality assurance (EQA)
Able to execute responsibilities of director, supervisor, testing personnel
Staffing Components
Refers to the substance or base from which the control material is prepared. All of the characteristics of a sample
MATRIX
Measurement of Quality Control
→ Central Tendency → Range → Standard Deviation → Coefficient of Variation CRSC
involves the systematic monitoring of analytic processes to detect analytic errors that occur during analysis and to ultimately prevent the reporting of incorrect patient test results
Quality control
A testing designed to assess the “__________” of an analytical method
HEALTH