1. PRINCIPLES OF QUALITY
ASSURANCE
Crizelda D. Liwanag, MS, RMT

2. Outline
1. Variables that affect quality of result
2. Quality assurance
1. Quality control
3. Quality assessment

3. 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

4. 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

5. 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

6. 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

7. 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.