Quality Control in a BioMedical Laboratory

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Definitions

Quality Control - QC refers to the measures that must be included during each assay to verify that the test is working properly.

Quality Assurance - QA is defined as the overall program that ensures that the final results reported by the laboratory are correct

Quality Assessment - quality assessment (also known as proficiency testing) is a means to determine the quality of the results generated by the laboratory. It is usually an external evaluation of the laboratory's performance. Internal quality assessment programs can also be instituted. Quality assessment is a challenge to the effectiveness of the QA and QC programs.

"The aim of quality control is simply to ensure that the results generated by the test are correct. However, quality assurance is concerned with much more: that 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"

Many variables can affect the quality of results

  1. The educational background and training of the laboratory personnel
  2. The condition of the specimens
  3. The controls used in the test runs
  4. The interpretation of the results
  5. The transcription of results
  6. The reporting of results
 
Overview
Definitions
Quality Assurance
- Record Keeping
- Reviewing Transcriptional measures
Quality Control
- Warning Rules
Quality Assessment
Quality Control in Clinical Virology
Written Procedures
Pathology Department Accreditation
Audit in the Clinical Laboratory
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