Laboratory Performance Criteria

In line with other external quality assurance schemes, EMQN uses performance criteria in its EQA schemes. These criteria are aimed at identifying laboratories that perform below the set standards in one or more aspects of the annual quality assurance scheme. Our published criteria do NOT apply to pilot EQA schemes.

The central purpose of external quality assessment is to ensure that laboratories are delivering a service of the highest possible quality. EMQN maintains the principle of assessment by professional consensus and attempts to improve standards by education and peer group review rather than by censure or penalty. Performance criteria are necessary to allow an individual laboratory’s performance to be measured against national/international standards and to identify any laboratory which is failing to meet these criteria. Participants who fall below the standards detailed in the following documents are deemed to be performing poorly.

The performance criteria for poor performance and persistent poor performance are ratified by the EMQN Board and endorsed (where required) by the relevant national performance monitoring organisation (for example, the UK National Quality Assessment Advisory Panel (NQAAP) for Genetics for UK labs). Performance scores and relevant raw data may be shared with the relevant Advisory Panel (UK), FOPH (Switzerland), RCPAQAP (Australia) or relevant organisation (all countries) under defined circumstances.

Poor performance

Poor performance is incurred for the following reasons and applies to all laboratories (see performance criteria above).

  • Non-submission of results with no acceptable prior notification to the Scheme;
  • Critical genotyping error (incorrect result for the patient);
  • Critical interpretation error which adversely affects patient management;
  • Incorrect/inappropriate advice.

All poor performance is ratified by the EMQN Board without disclosing the identity of the laboratory. Laboratories that have received a poor performance will be asked to perform a root cause analysis and provide a summary of corrective and preventative actions to the Scheme.

Persistent poor performance

Laboratories who perform poorly in two out of any three consecutive EQA rounds or incur a poor performance within one year following a previous persistent poor performance designation will be classed as “red” whilst the persistent poor performance status stands.

Laboratories performing poorly on genotyping in one round of EQA and interpretation in the next round will have the same consequences as performing poorly on genotyping for two rounds of EQA. A participant who has performed poorly for more than one disease/EQA in more than one EQA round may, at the discretion of the EMQN Director, be referred to the EMQN Board for Persistent Poor Performance even if they have not met the criteria for Persistent Poor Performance in any individual EQA.

Once a Swiss, Australian or UK laboratory meets the criteria for a persistent poor performance, the Scheme is obliged to notify FOPH (Swiss) or RCPAQAP (Australia), or NQAAP for Genetics (UK) respectively.