Integrating and Digitalizing External Quality Assessment

Integrating external quality assessment (EQA) programs into a single digital management system is the next step in the evolution of laboratory quality management. Modern platforms make it possible to automate result entry, run real-time benchmarking and build an audit trail for accreditation under GOST R ISO 15189-2024.

From Manual Control to a Digital Ecosystem

The traditional approach to EQA means working with many disconnected providers: separate portals for entering results, paper reports, manual analysis of deviations and scattered documentation. For a multidisciplinary laboratory taking part in 10–15 EQA programs from 5–7 providers, this creates a significant administrative burden.

Problems with manual EQA management:

Digitalization solves these problems by shifting EQA management from reactive to proactive.

• Risk of errors when results are entered manually into provider portals
• No unified picture of quality across all areas of the laboratory
• No way to quickly analyze trends and round-to-round dynamics
• Difficult audit preparation, with reports collected from different sources
• Time lost on routine tasks instead of root-cause analysis and corrective actions

Architecture of an Integrated EQA System

Level 1: Analytical Equipment

Modern analyzers generate quality control data automatically. Key interfaces:

• HL7 / ASTM: standard protocols for transmitting laboratory data
• Middleware: intermediate software that validates results before they are sent to the LIS
• Built-in QC: the analyzers' automatic quality control modules

Level 2: Laboratory Information System (LIS)

The LIS serves as the central hub for all quality data:

• Registration of EQA rounds and control materials
• Automatic linking of results to a specific instrument, operator and reagent lot
• Storage of Levey-Jennings charts and Westgard rules for internal QC
• Report generation for auditors

Level 3: EQA Provider Platforms

Leading providers offer digital platforms with advanced analytics:

Level 4: Quality Dashboard

A single dashboard that brings together data from all sources:

• Status of all EQA programs in one interface
• Visualization of z-scores and SDI across all areas
• Automatic alerts when deviations occur
• Tracking of corrective and preventive actions (CAPA)
• Ready-made reports for internal and external audits

Measurable Results of Digitalization

Implementing integrated quality management systems delivers concrete improvements:

Building an EQA Program Portfolio

Selection Principles

For a multidisciplinary laboratory, the optimal EQA portfolio follows a "core + specialization" principle:

Basic level (mandatory minimum):

Extended level:

High-tech laboratories:

• CAP: international accreditation, broad coverage
• Randox RIQAS: monthly monitoring, fast feedback
• INSTAND e.V.: the standard for the German-speaking market and the CIS region
• Bio-Rad EQAS: integration via Unity Real-Time
• Labquality: a European provider focused on ISO 15189
• UK NEQAS: specialized programs, in-depth expertise
• RfB / DGKL: clinical chemistry, hematology
• QCMD: molecular diagnostics (PCR, qPCR, NGS)
• EMQN: genetics, oncogenomics
• NordiQC: immunohistochemistry
• ESP: pathomorphology

Mapping Providers to Testing Areas

GOST R ISO 15189-2024 Requirements for EQA Management

The standard sets clear requirements for organizing external quality assessment:

1. Mandatory participation (clause 7.3.7.3): the laboratory must take part in EQA/PT programs for all tests it performs

2. Alternative interlaboratory comparisons: if no provider program is available, the laboratory must organize its own interlaboratory comparisons

3. Analysis of results: not just participation, but systematic analysis that identifies trends

4. Corrective actions: documented CAPA for unsatisfactory results

5. Risk-based approach: prioritization of control areas based on risk assessment

6. Inclusion of POCT: point-of-care testing is subject to the same requirements

7. Staff competence: operators must be able to interpret EQA reports

Practical Implementation Recommendations

Stage 1: Audit of the Current State

• Compile a register of all EQA programs the laboratory participates in
• Assess coverage: is every test covered by external assessment?
• Identify gaps: areas without EQA are priorities for enrollment

Stage 2: Portfolio Optimization

• Eliminate duplication: for some areas, one provider is enough
• Add missing programs, with particular attention to molecular diagnostics and POCT
• Ensure peer grouping: every analyzer should have a relevant peer group

Stage 3: Digital Integration

• Integrate provider platforms (Unity Real-Time, RIQAS 24/7) with the LIS
• Set up automatic collection of internal and external QC data into a single dashboard
• Implement a system of automatic alerts for deviations

Stage 4: Continuous Improvement

• Review EQA results across all areas every quarter
• Analyze trends: a growing bias matters more than a single outlier
• Use EQA data to plan equipment maintenance and staff training

KombiMED's Comprehensive Approach

KombiMED is a German full-cycle partner for medical laboratories. We provide complete laboratory setups, from selecting equipment from 68+ leading global brands to integrating with international external quality assessment programs. Our approach: equipment + reagents + EQA + training = a working quality system.

Our specialists can help you:

Request a consultation on the end-to-end implementation of an external quality assessment system.

• Audit your current EQA program portfolio and identify gaps
• Build the optimal set of EQA programs for your laboratory's profile
• Integrate provider platforms with your laboratory information system
• Prepare your laboratory for accreditation under GOST R ISO 15189-2024