Quality Assurance

Quality Assurance (QA) in Serologic and Molecular testing isn’t just about one thing – it’s a comprehensive system ensuring accuracy and safety from start to finish. Think of it as a three-legged stool: if any leg is weak, the whole thing wobbles! Those legs are Blood Samples, Reagents, and Test Procedures

Here’s an overview of how QA applies to each:

Blood Samples: The Starting Material

• Goal: Ensure the sample unequivocally belongs to the correct patient and is suitable for testing. Errors here are often the most critical!
• Key QA Checks
  • Positive Patient Identification: Absolute cornerstone! Using at least two unique identifiers (Name, DOB/MRN) verified directly against the patient’s ID band/information before collection
  • Impeccable Labeling: MUST be done at the bedside/chairside immediately after collection. Requires full patient name, second identifier, date/time of collection, phlebotomist ID. Must be legible and secure. No pre-labeling!
  • Correct Tube & Collection: Using the right tube (usually EDTA), proper fill volume, appropriate collection technique to avoid hemolysis or clots, and proper mixing
  • Transport & Receipt: Prompt transport, avoiding temperature extremes. Lab verification of label info vs. order, checking for hemolysis/clots/QNS, and documenting receipt time. Sample age limits must be respected
  • Clear Acceptance/Rejection Criteria: Defined rules for rejecting improperly identified, labeled, or compromised samples

Reagents: The Testing Tools

• Goal: Guarantee that all reagents (antisera, reagent cells, AHG, etc.) are potent, specific, and perform exactly as expected
• Key QA Checks
  • Receipt & Validation: Checking shipment conditions, verifying order, inspecting vials, logging lot numbers/expiration dates. Crucially, validating new lots/shipments against current lots before use
  • Proper Storage: Maintaining required temperatures (usually 1-6°C) with continuous monitoring and alarms. Organized storage to prevent mix-ups
  • Daily Quality Control (QC): Testing each day of use with known positive and negative controls to confirm expected reactivity and specificity. Documenting all QC results meticulously
  • Inventory Management: Rotating stock (FIFO - First-In, First-Out), tracking usage, and promptly discarding expired reagents
  • Troubleshooting: Having clear procedures for investigating and documenting QC failures before using the reagent for patient testing

Test Procedures: The Method

• Goal: Ensure every test is performed consistently, accurately, and precisely according to validated instructions, regardless of who performs it
• Key QA Checks
  • Standard Operating Procedures (SOPs): Detailed, up-to-date written procedures for every test, readily available and followed exactly
  • Personnel Training & Competency: Ensuring staff are initially trained and regularly assessed (annually) for their ability to perform each test correctly
  • Equipment Maintenance & Calibration: Regular checks, calibration, and maintenance of centrifuges, incubators, pipettes, automated systems, etc
  • Adherence to Critical Steps: Precisely following instructions for incubation times/temps, washing, centrifugation speeds/times, reagent/sample volumes
  • Objective Interpretation & Reporting: Using standardized criteria for reading/grading results and reporting them accurately. Utilizing procedural controls (Rh control, Check Cells, etc.)
  • Proficiency Testing (PT): Participating in external programs to assess overall laboratory performance against peers
  • Troubleshooting & Corrective Action: Documenting investigation and resolution of any errors or discrepancies