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Hematology

Quality Management

Quality Management in the clinical laboratory is a comprehensive system designed to ensure the accuracy of test results, the safety of patients, and the legal integrity of the institution. It moves beyond the simple daily task of running controls (Quality Control) to encompass a broader philosophy of system improvement (CQI), customized risk assessment (IQCP), and liability prevention (Risk Management)

Continuous Quality Improvement (CQI)

CQI is a proactive managerial philosophy that seeks to improve processes systematically rather than just correcting individual errors. It operates within the Quality Management System (QMS) framework, addressing the entire path of workflow (Pre-analytical, Analytical, and Post-analytical)

  • Methodologies
    • PDCA Cycle: A four-step iterative process (Plan, Do, Check, Act) used to test and implement solutions
    • Lean: Focuses on eliminating “Waste” (e.g., waiting, excessive motion, defects) to improve efficiency and turnaround time
    • Six Sigma: Focuses on reducing variation and defects to a near-zero level (DMAIC process: Define, Measure, Analyze, Improve, Control)
  • Key Performance Indicators (KPIs): Measurable metrics used to track quality, such as Turnaround Time (TAT), Specimen Rejection Rates, and Blood Culture Contamination rates
  • Root Cause Analysis (RCA): A retrospective investigation performed after a Sentinel Event to identify the systemic cause of the error (using tools like the “5 Whys” or Fishbone Diagram) rather than blaming individuals

Individualized Quality Control Plan (IQCP)

IQCP is a voluntary CLIA option that allows laboratories to customize their Quality Control frequency based on the specific risks of their environment, rather than adhering to the rigid default (daily liquid QC). This is particularly useful for Point-of-Care Testing (POCT) and unit-use devices

  • The 3 Components
    1. Risk Assessment (RA): The lab evaluates potential errors in the Specimen, Test System, Reagent, Environment, and Personnel. Risks are scored based on frequency and severity
    2. Quality Control Plan (QCP): A documented plan defining the control procedures (e.g., Electronic QC, Internal Checks) used to mitigate the identified risks. The plan cannot be less stringent than the manufacturer’s instructions
    3. Quality Assessment (QA): Ongoing monitoring (e.g., Proficiency Testing review, error log review) to ensure the plan remains effective
  • Application: IQCP allows labs to justify running external liquid controls less frequently (e.g., weekly or per shipment) for robust systems like POCT Coagulation or cartridge-based tests, relying instead on internal electronic monitoring