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Blood Bank

Individualized Quality Control Plan

The Individualized Quality Control Plan (IQCP) represents a significant shift in how clinical laboratories approach quality control under the Clinical Laboratory Improvement Amendments (CLIA). Traditionally, QC frequency was rigid (e.g., “Run two levels of controls every day”). However, modern technology often has built-in electronic checks that make daily liquid QC redundant or excessive. IQCP is a voluntary, risk-based approach that allows laboratories to customize their QC frequency based on their specific technology, environment, and patient population, provided they can prove the system is robust enough to detect errors

In Blood Bank, IQCP is primarily applied to non-waived testing where the default CLIA requirement (run external QC every day of patient testing) is burdensome or duplicative of internal instrument checks

The Three Components of IQCP

An IQCP is not just a decision to run less QC; it is a formal document that must contain three distinct elements: Risk Assessment (RA), Quality Control Plan (QCP), and Quality Assessment (QA)

Risk Assessment (The “Why”)

This is the investigative phase. The laboratory must examine the entire testing process (Pre-analytic, Analytic, Post-analytic) to identify potential sources of error. The assessment must cover five mandatory areas:

  1. Specimen: What could go wrong with the sample? (Clots, Hemolysis, Labeling errors, Transport temperature)
  2. Test System: What are the failure points of the instrument/reagent? (Optics drift, Pipetting errors, Reagent stability, Software glitches)
  3. Reagent: Can the reagent degrade? Is it sensitive to light or temperature?
  4. Environment: Does the room temperature fluctuate? Is there vibration? Are utilities (water/power) stable?
  5. Testing Personnel: Is there high turnover? Is training adequate? Is fatigue a factor?
  • Scoring Risk: For each hazard identified, the lab scores the Likelihood of it happening and the Severity of harm if it does
  • Mitigation: The lab then lists the controls already in place to stop these errors (e.g., “Instrument has internal temperature sensors,” “LIS has logic checks,” “Staff have annual competency”)

Quality Control Plan (The “What”)

Based on the Risk Assessment, the laboratory writes the actual QC policy

  • The Decision: If the Risk Assessment shows that the instrument’s internal electronic checks are extremely robust and stable, the lab might decide to reduce the frequency of external liquid QC from Daily to Weekly or Monthly
  • The Content: The QCP defines:
    • Number and type of QC materials
    • Frequency of testing
    • Criteria for acceptability
  • Constraint: The QCP cannot be less stringent than the manufacturer’s instructions. If the package insert says “Run QC Daily,” you cannot use IQCP to run it weekly. You can only use IQCP to reduce regulatory requirements (CLIA) that exceed manufacturer requirements

Quality Assessment (The “Watch”)

This is the ongoing monitoring phase to ensure the new plan is working

  • Monitoring: The lab must track specific monitors (e.g., proficiency testing scores, patient result trends, instrument error logs, corrective actions)
  • Trigger for Re-evaluation: If the lab switches to Weekly QC and suddenly starts failing Proficiency Testing, the QA component triggers a return to the Risk Assessment phase. The IQCP failed; daily QC must be reinstated

IQCP in Blood Bank: Applications

While routine ABO/Rh/Antibody Screen reagents generally require daily QC by regulation (and manufacturer IFU), IQCP is frequently applied to ancillary devices

Sterile Connecting Devices (Tubing Welders)

  • Default Requirement: Verify the weld integrity daily
  • IQCP Approach
    • Risk Assessment: The device has internal sensors and alarms if the wafer is cold or the clamp is misaligned. The risk of a bad weld going undetected is low
    • QCP: Perform a physical “tug test” and visual inspection on every weld made. Perform a comprehensive QC check (checking alignment/temperature) Weekly instead of Daily

Automated Cell Washers

  • Default Requirement: Check saline fill volume and decant speed daily
  • IQCP Approach
    • Risk Assessment: Daily Check Cells (Coombs Control) are the ultimate functional check. If the washer fails, the Check Cells fail
    • QCP: Rely on the Daily Check Cell result as the primary QC. Perform physical RPM/Timer verification Quarterly

Fetal Screen (Rosette Test) Kits

  • Default Requirement: Run Positive and Negative controls every day of use
  • IQCP Approach
    • Risk Assessment: This is a manual test with stable reagents, but the result is highly operator-dependent (microscopic reading)
    • Outcome: Risk Assessment often concludes that IQCP is NOT: appropriate here. The risk of operator error is high, and internal controls don’t exist. Therefore, Daily External QC remains the standard

Implementation Steps

  1. Gather Information: Collect manufacturer manuals, Package Inserts, and historical QC data (proving the instrument is stable)
  2. Conduct Risk Assessment: Use a Fishbone diagram or spreadsheet to map out errors in the 5 mandatory categories
  3. Define Mitigation: List the internal controls (e.g., “System alarms for low reagent”)
  4. Determine QC Frequency: Balance the residual risk against the cost/effort of QC
  5. Write the Plan: Document the QCP in the procedure manual
  6. Sign-Off: The Laboratory Director must sign and approve the IQCP before implementation
  7. Monitor: Review the plan annually as part of the Quality Assessment review

Limitations

  • Manufacturer Trump Card: If the manufacturer’s package insert explicitly states “Quality Control must be performed daily,” an IQCP cannot override this
  • Waived Testing: IQCP applies to Non-Waived testing
  • New Instruments: A lab typically runs standard CLIA QC for a period (e.g., 6 months) to gather baseline stability data before moving an instrument to an IQCP. You cannot write an IQCP for a machine you have no history with