CC Lab Quality Assurance

• Quality Assurance is a set of activities for ensuring quality in processes
• The aim of Quality Assurance is to prevent defects with a focus on the process used to make the product
• Quality Assurance includes maneuvers encountered in the pre-analytic, analytic, and post-analytic phases to ensure quality and monitor different phases
• Components of a Quality Assurance Program:

  1. Patient Identification

  • Patient Identity Verification
  • 3 way ID
• Components of a Quality Assurance Program:

  2. Sample Collection

  • Quality Specimen
  • Factors that affect the handling of samples for the assay
  • Additive
  • Type of specimen
• Components of a Quality Assurance Program:

  3. Testing

  • Checking of the laboratory request form
  • Discrepancy must be clarified prior to testing
• Components of a Quality Assurance Program:

  4. Delta Check

  • Compare the recent patient result from the previous results
  • Detect interchanged specimen or other errors
  • Correlation
• Components of a Quality Assurance Program:

  5. Validation of the Laboratory result

  • All results should be checked at least twice
  • Basic information (Gender/Age)
  • Validator
  • Check the result (Unit)
  • Signature in the Lab result
• Components of a Quality Assurance Program:

  6. Panic/Critical Values

  • Result indicates a life-threatening condition
  • Must be relayed immediately to the Attending physician/Nurse
• Quality Control is the operational techniques and activities used to satisfy quality requirements
• Quality control in Clinical Chemistry involves statistical processes, monitoring and evaluating the analytical process, and estimating sources of errors
• Internal Quality Control:

  • Purpose: Detect analytical errors and prevent the reporting of incorrect patient test results
  • Analytical Methods Control Materials
• Test Performance Parameters:

  A. Accuracy

  B. Precision/Reproducibility

  C. Reliability

  D. Analytical sensitivity

  E. Analytical specificity

  F. Linearity
• Control Materials:

  A. Pooled Control Sera

  • Mixture of residual patient serum sent to the lab daily

  B. Commercially prepared

  • Purchased from manufacturers, prepared from human or bovine-based products
• Control Materials must be analyzed between 5 and 20 days for highly precise assays (5 days) and less precise assays (20 days)
• Levey-Jennings Chart:

  1. Obtain Control values

  2. Compute for the mean

  3. Compute for the SD

  4. Compute for the limits
• In single-celled organisms, substances can easily enter the cell due to a short distance
• In multicellular organisms, the distance for substances to enter the cell is larger due to a higher surface area to volume ratio
• Multicellular organisms require specialised exchange surfaces for efficient gas exchange of carbon dioxide and oxygen due to their higher surface area to volume ratio