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Quality Assurance and

Quality Control
CLINICAL CHEMISTRY 1

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As per ISO 8402:1994..…. standard quality is defined as “the totality of characteristics of an entity that bear on its ability to satisfy STATED and IMPLIED needs. .

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OBJECTIVES Importance of Quality Management Concepts of Quality Control CLSI Guidelines Basic QC STATISTICS Quality Control Rules Interpretations of Control Results .

QUALITY ASSURANCE QUALITY CONTROL METHOD EVALUATION .

defined by WHO as the total process whereby the quality of laboratory reports can be guaranteed. .…..

and at the .correct reference data.right time.right price .right result. at the .right specimen. from the . with result interpretation based on . on the .right patient.

Purpose of Quality Assurance: provide test results that are relevant. timely. . reliable. interpreted correctly.

4 Different Aspects of Quality Assurance  QUALITY CONTROL  EXTERNAL QUALITY ASSESSMENT  PROFICIENCY SURVEILLANCE  STANDARDIZATION .

STANDARD – a solution that contains a known amount of analyte and used to calibrate an assay method.g. 100 mg/dL of glucose .. e.

.CONTROL – used to monitor the performance of the assay method once it has been calibrated. Controls are used to make sure that the measurement process is stable and if the results produced are ACCEPTABLE.

Px sample .Control Px sample Controls are run alongside with patient samples.

. plasma or urine Ideally.Control Material attributes: Matrix – refers to all characteristics of the sample. control material should have the same matrix as the specimen being tested so that they will behave the same as the real specimen. e. (CLSI .g. serum.

Must be analyzed at least once during each analytical run. Lab should have guidelines for out of control situations …. Repeating controls/reanalyzing control may be non productive . OUT of CONTROL SITUATION ….When to run a CONTROL? ….

Quality Assurance .refers to all those planned and systematic activities to provide confidence that the results given out by the laboratory are correct .

.Quality Control .refers to operational techniques that must be included during each assay run to verify that the requirements for Quality are met with.

QUALITY ASSURANCE PROCESS Preanaly tical process Analytic al process Postanalytic al process .

Patient instructi on Preanalytical Process Test ordering Specime Labellin n g Collectio n Specime n transpor t .

equipments. supplies Validation of test methods Equipment checks QC monitoring procedures Procedure manual . reagents.Analytical Process Test methods.

Post-Analytical QA Process Validation of test results Reporting of test results Interfacing to Laboratory Information Systems (LIS’s) Corrective action plan Records maintenance .