PRINCIPLES OF QUALITY

ASSURANCE

Crizelda D. Liwanag, MS, RMT

Outline

1. Variables that affect quality of result

2. Quality assurance

1. Quality control

3. Quality assessment

Variables that affect the quality of

results

• The educational background and training of the laboratory personnel

• The condition of the specimens (from collection/receiving – processing –assaying)

• The controls used in the test runs

• The interpretation of the results

• The transcription of results

• The reporting of results

Quality Assurance

• QA - defined as the overall program that

ensures that the final results reported by

the laboratory are correct

• the right test is carried out on the right

specimen, and that the right result and right

interpretation is delivered to the right person at

the right time

Quality Assurance

• Components:

1. Pre-analytical

- test utilization, turnaround time

2. Analytical

- equipment, reagents, processing manuals

3. Monitoring

- QC materials, external QA/quality assessment

4. Post-analytical

- Critical values, documentation

Quality Control

• QC - refers to the measures that must be

included during each assay to verify that

the test is working properly.

– to ensure that the results generated by the test

are correct (w/ minimum turn around time).

– Accuracy (trend and shift)

– Precision

– Reliability

Quality Assessment

• a.k.a proficiency testing/proficiency

surveys or external QA

• is a means to determine the quality of the

results generated by the laboratory.

• usually an external evaluation of the

laboratory's performance. Internal quality

assessment programs can also be instituted.

• a challenge to the effectiveness of the QA and

QC programs.