A working QC and EQA system is built in a few months and then maintained for years. This page sets out the five phases we use in every investment memorandum, the digital set-up that keeps the work manageable, and who does what.
In five phases, starting with the test menu and ending in a routine that improves itself. For a new laboratory the first EQA samples should arrive before routine work starts; the timeline below assumes that.
Months 1–2. Map the test menu to EQA disciplines, mark mandatory and voluntary programmes, list the analysers and their peer groups, and set the accreditation target. Define the internal QC plan per test at the same time.
Months 2–3. Compare providers for coverage, peer groups, frequency, logistics, reporting and cost, then build a portfolio from core and specialist programmes.
Months 3–4. Register for the selected programmes, assign method and instrument codes, and write the work instruction for receiving, storing, analysing and reporting EQA samples.
Months 4–6. Process the first samples like patient samples, submit results on time, review every report and open CAPA for unacceptable results.
Ongoing. Review trends across all disciplines every quarter, remove duplicate programmes, add schemes as the test menu grows, and use EQA data to plan maintenance and training.
Five phases on a timeline
Same phases as the EQC roadmap in the investment memorandum
With the first patient result, which means planning it together with the equipment. The test menu follows from the analysers, and the EQA plan follows from the test menu. A laboratory aiming for CAP accreditation also needs six months of CAP proficiency testing before it can apply, so enrolling early shortens the whole project. Details are on ISO 15189 and accreditation.
Why EQA starts on day one
Milestones for a new laboratory aiming at CAP accreditation (laboratories outside the US and Canada)
It removes the manual steps where most errors and delays happen. An integrated set-up has four levels, and each one takes work off the quality team:
Four levels of a digital QC and EQA set-up
The practical gains are faster review of EQA reports, fewer transcription errors and audit documentation that exists already instead of being assembled before each visit. More in Integrating and digitalising external quality assessment and Quality control software.
Clear roles keep EQA from becoming one person’s side job. A typical split in a multidisciplinary laboratory:
| Laboratory director | Approves the QC and EQA plan, reviews quarterly summaries, decides on patient impact |
|---|---|
| Quality manager / EQA coordinator | Keeps the register and schedule, enrols, tracks reports and CAPA; plan roughly 40–80 hours for a CAP set-up and 10–40 hours for other providers |
| Section heads | Review results of their discipline, lead investigations, maintain internal QC rules and limits |
| Technical staff | Analyse EQA samples in routine, record handling and results |
| POCT coordinator | Device register, operator training, EQA and comparisons for point-of-care devices |
| IT / LIS | Interfaces to analysers, middleware and provider platforms |
A short list that prevents most early findings in an assessment:
From the first plan to the running system. The investment memorandum maps the test menu to EQA disciplines and providers, estimates the annual cost and lays out this roadmap; we supply the analysers, control materials and EQA programmes and, as the official CAP distributor for Central Asia and the Caucasus, handle CAP enrolment.
