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Also called: Quality control, Calibration, EQA

Haematology Analyser Quality Control and Calibration

The routine that keeps every FBC result trustworthy — from the morning control run to external quality assessment and accreditation.

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Internal quality control

  • Run control blood at the levels the manufacturer recommends (usually low, normal and high) every day before patients.
  • Plot each result on a Levey-Jennings chart against the control’s target and limits.
  • Apply simple Westgard rules — for example, reject the run if one control is outside 3 SD, or two consecutive controls are outside 2 SD on the same side.
  • Never report patient results from a run whose controls failed.

Calibration

Calibration aligns the analyser to a reference. It is done at installation, after major repairs or part replacements, when controls show a persistent shift, and at the manufacturer’s interval.

External quality assessment (EQA)

An EQA provider sends unknown samples; you run them like patients and receive a report comparing you with other labs. It catches bias that internal QC cannot.

Accreditation

Medical laboratories in Malaysia can be accredited to MS ISO 15189 under the Department of Standards Malaysia’s laboratory accreditation scheme. Documented IQC, EQA, calibration and maintenance are core requirements.

Frequently asked questions

How often should haematology controls be run?
At least once a day before patient testing, and after maintenance, reagent lot changes or calibration.
What do I do if controls fail?
Stop reporting, check reagents, controls and maintenance, rerun, and recalibrate if a shift persists. Record what you did.
Does a GP clinic need EQA?
It is good practice for any site reporting results and is required for accreditation.

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