Laboratory Quality Indicators: 8 Essential ISO 15189 Measures

Laboratory quality indicators are the measures a medical laboratory uses to show that its processes are performing — sample rejection rates, turnaround times, critical result notification times, EQA performance, corrected reports — and ISO 15189:2022 keeps them where the 2012 edition put them: as a required evaluation tool, now at clause 8.8.2 within 8.8 Evaluations, with a link to the objectives in clause 5.5. The requirement is short and the failure mode is consistent. Laboratories collect indicators because the standard asks for them, report them at management review because the standard asks for that too, and never set the target, the review interval or the action that turns a number into a decision. This guide sets out what clause 8.8.2 asks for, the eight indicators that cover the examination pathway from request to report, how to define each so it can be acted on, where the indicator set connects to the rest of the 2022 edition, and the four ways an indicator programme fails assessment.

What clause 8.8.2 requires

Clause 8.8 of ISO 15189:2022 covers evaluations — 8.8.1 general, 8.8.2 quality indicators, 8.8.3 internal audits — and UKAS’s transition gap analysis maps the 2012 requirement at 4.14.7 to both 8.8.2 and to 5.5, objectives and policies, grading the change as minor. The substance carried over: the laboratory establishes quality indicators to monitor and evaluate performance throughout the critical aspects of the pre-examination, examination and post-examination processes; plans the process for each — purpose, methodology, interpretation, limits, action plan and duration of measurement; and reviews the indicators periodically so that they remain appropriate. The link to 5.5 is the part most programmes miss: an indicator with no objective behind it is data, and an objective with no indicator is a wish. Our guide to ISO 15189 covers the clause structure the indicators sit in.

Eight laboratory quality indicators that cover the pathway

Eight laboratory quality indicators are a working set, not a ceiling; clause 8.8.2 asks for coverage of the critical aspects of all three phases, and a laboratory with a large point-of-care estate adds a POCT indicator — operator competence currency, device QC compliance — because POCT is inside scope since ISO 22870 was absorbed. Our guides to pre-analytical errors and critical value reporting cover the two indicators that most often expose a real patient-safety gap.

Defining laboratory quality indicators so they can be acted on

Clause 8.8.2 asks the laboratory to plan each indicator’s purpose, methodology, interpretation, limits, action plan and duration of measurement. A definition that satisfies that list has six parts.

1. Purpose: the process risk or objective the indicator monitors — “detect locations generating pre-examination errors”, tied to a 5.5 objective.
2. Numerator and denominator: stated precisely, with the data source. “Rejected samples” needs a definition of rejected; “samples received” needs a system field.
3. Stratification: the breakdown that makes the number actionable — by location, analyte, priority or route. A laboratory-wide rejection rate is a statistic; the same rate by ward is a conversation.
4. Limit: the target or threshold, and the rule for breaching it — three consecutive months above, or any single month above a higher bound.
5. Action plan: who reviews it, how often, and what a breach triggers — usually a nonconformity under 7.5 or a corrective action under 8.7.
6. Duration: how long the indicator is measured before it is reviewed for continued relevance; indicators that never change are retired and replaced.

Where laboratory quality indicators connect to the rest of the standard

Four ways an indicator programme fails assessment

1. Numbers without limits. Laboratory quality indicators with no target are monitoring without evaluation; the assessor asks what the laboratory would do at 8% and gets no answer.
2. Limits without action. A turnaround indicator red for six months with no nonconformity raised contradicts the action plan clause 8.8.2 requires.
3. No stratification. An identification error rate that cannot be broken down by location cannot drive the feedback clause 7.2 expects the laboratory to give to collectors.
4. Indicators that never change. The same eight measures with the same targets since 2014, never reviewed for relevance, fail the periodic review the clause asks for.

Building the programme

• Start from the objectives in 5.5 and the risks in 5.6; pick indicators that monitor them, not indicators that are easy to extract.
• Automate extraction from the LIMS for the volume indicators; hand-counted indicators die within a year.
• Review at two levels: operational review monthly by the section lead with authority to raise nonconformities; strategic review at management review with the director.
• Feed results back outside the laboratory. Rejection and identification rates by ward, sent to the ward, is the single most effective use of a laboratory quality indicator in the published literature and in practice.
• Record the review of the indicator set itself, annually, with the retirements and additions.

Frequently asked questions

What are laboratory quality indicators under ISO 15189?
Measures the laboratory establishes under clause 8.8.2 of ISO 15189:2022 to monitor and evaluate performance across the critical aspects of the pre-examination, examination and post-examination processes, each planned with a purpose, methodology, interpretation, limits, action plan and measurement duration, and reviewed periodically.

How many indicators are needed?
The standard sets no number; it requires coverage of the critical aspects of all three phases. Eight across the pathway — rejection, identification, transport, IQC, EQA, turnaround, critical result notification and corrected reports — is a workable core, extended for POCT and specialist disciplines.

Which clause is it in the 2022 edition?
8.8.2, within 8.8 Evaluations, alongside 8.8.3 internal audits. UKAS’s transition gap analysis maps the 2012 requirement at 4.14.7 to 8.8.2 and to 5.5 objectives and policies.

Do indicators need targets?
Yes. The clause requires limits and an action plan; an indicator without a limit cannot be evaluated, and a breached limit with no action is a finding.

How often should they be reviewed?
Operationally at a cadence matched to the process — weekly for urgent turnaround and IQC, monthly for most — and at management review under 8.9; the indicator set itself is reviewed periodically for continued appropriateness.

Where this leaves you

Build laboratory quality indicators from the objectives and risks, define each with a numerator, denominator, stratification, limit, action route and review interval, extract them automatically, act on breaches through 7.5 and 8.7, and review the set annually. Clause 8.8.2 is short; the assessor’s question — “what did you do when it went red?” — is the whole of it.

References

• ISO 15189:2022 — Medical laboratories — Requirements for quality and competence — Clause 8.8 Evaluations; clause 5.5 objectives and policies; clause structure via the ISO Online Browsing Platform.
• UKAS: ISO 15189:2022 transition update — The F598 gap analysis template mapping 2012 clause 4.14.7 to 2022 clauses 8.8.2 and 5.5.

More on ISO 15189

• Laboratory quality indicators — you are here
• ISO 15189: patients, pre-examination and findings
• ISO 15189:2022: the major changes
• Pre-analytical errors
• Critical value reporting
• ISO 15189 vs ISO 17025

The Quality Objectives and Policy Statement, the Risk and Opportunity Register, the Internal Quality Control Procedure, the Results Review and Authorisation Procedure and the ISO 15189 Internal Audit Checklist are in the ISO 15189 Toolkit, or start with the free templates.