Cm2 principles of qa

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Cm2 principles of qa

  1. 1. PRINCIPLES OF QUALITY ASSURANCE Crizelda D. Liwanag, MS, RMT
  2. 2. Outline 1. Variables that affect quality of result 2. Quality assurance 1. Quality control 3. Quality assessment
  3. 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. 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. 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. 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. 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.

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