Quality Management

Approach focusing on process improvement as a means to meet a set standard

QUALITY MANAGEMENT SYSTEM

Process by which lab ensures quality results by closely monitoring pre-analytical, analytical, & post-analytical stages of testing

This phase may include specimen handling issues that occur even prior to the time the specimen is received in the laboratory.

EXAMPLE OF PRE ANALYTICAL PHASE

This phase may include what is usually considered the actual laboratory testing or diagnostic procedures, processes and products that ultimately provides a result.

This phase culminates in the production of value, final result or in case of histology, a diagnostic pathology report.

EXAMPLE OF ANALYTICAL PHASE

A system for recognizIng and minimizing (analytic) errors.

A system of ensuring accuracy and precision in the laboratory & involves monitoring of analytical processes.

It involves proficiency testing programs that periodically provide samples of unknown concentration of analytes to participating laboratories.

It is important in maintaining long term accuracy of the analytical methods.

Method used tΓΆ validate a particular measurement process. The results are compared with other external laboratories to give an objective indication of test accuracy.

Specimens that have known concentrations of an analyte for the test of interest. The testing laboratory does not know the targeted concentration when tested

National Reference Laboratory for Dengue, Influenza, Tuberculosis and other Mycobacteria, Malaria and other parasites, Bacterial enteric diseases, measles and other viral exanthems, Mycology, Enteroviruses, Antimicrobial resistance and Emerging Diseases; NRL for confirmatory testing of blood donors and blood units.

National Reference Laboratory for HIV/AIDS, Hepatitis and Sexually Transmitted Diseases.

National Reference Laboratory or Environmental and Occupational Health; Toxicology and Micronutrient Assay.

National Reference Laboratory for Hematology including immunohematology

National Reference Lab for Anatomic Pathology and Biochemistry

It occurs when the data set can be accurately described by the SD and the mean.

It is used to compare results obtained on a high and low control serum from different laboratories.

It is the most widely used QC chart in the clinical laboratory.

Main cause of shift

Main cause of trend

Main cause of outlier

It recognizes that the use of simple upper and lower control limits is not enough to identify analytical problems

Dispersion of repeated measurements about the mean due to analytical error

Difference between a measured value and its true value; due to systematic error, which can be either constant or proportional

Error varies from sample to sample. Causes include instrument instability, temperature variations, reagent variation, handling techniques, and operator variables

Error always in one direction

It is a performance improvement program in which the goal is to improve the process by eliminating variations or errors.

It is a system for reducing waste ("nonvalued activities") especially in production or manufacturing processes.

The ability of analytical method to measure the smallest concentration of the analyte of interest.

The ability of an analytical method to measure only the analyte of interest

The nearless or closeness of the assayed value to the true or target value

The ability of an analytical method to give repeated results on the sample that agree with one another

best for comparison of precision and accuracy among laboratories.

Random error:

A warning rule that initiates testing of control data by other rules.

This plot will give the earliest indication of systematic errors (trend) and shift.