Templates and records · ISO 15189 · Clause 7.2

Pre-examination incident and sample rejection log

The phase where most laboratory errors happen: haemolysed, mislabelled, poorly stored samples or samples in the wrong tube, and what is decided about each one.

In one sentence

The pre-examination incident and sample rejection log records each sample that fails the acceptance criteria — identification, container, volume, time, temperature, integrity — the decision to reject it or accept it with reservations, the notice to the requester and the warning accompanying the result, because clause 7.2 of ISO 15189:2022 requires documented acceptance and rejection criteria and, if a compromised sample is accepted, the report to state the problem.

Content reviewed on 17 October 2026

Where the standard requires it: ISO 15189 · Clause 7.2 Clauses are cited using the numbering of ISO 15189:2022, the edition in force since the transition ended in December 2025 and the same one the Academy uses.
Type of information: Mandatory record Documented criteria and record of compromised samples (7.2)
Who fills it in: Sample reception staff Accepting an irreplaceable sample with reservations is decided by a consultant
When: On receipt of each sample Also when the problem is detected during the examination, such as haemolysis
How long it is kept: Set by the laboratory ISO 15189 asks for the retention time of each record to be defined, taking into account legal and user requirements (8.4). Those forming part of the medical record also follow the applicable health regulations.

What the standard requires

What ISO 15189 demands and what it leaves to your judgement

The standard requires the laboratory to define in writing its sample acceptance and rejection criteria, and samples to be traceable from request to report, with unambiguous patient identification.

If a compromised sample is clinically critical or irreplaceable and the laboratory decides to process it, the final report must state the nature of the problem and, where appropriate, warn of the caution needed when interpreting the result.

The standard does not require a log in any particular format, but pre-examination incidents are the basis of the quality indicators for that phase required by 8.8.2. Without a log there is no indicator.

Read it in context: Process requirements, in the ISO 15189 Academy

Structure

Fields the template should include

Date, time and request number
Source: centre, department or collection point
Type of incident: identification, container, volume, time, temperature, haemolysis
Tests affected
Decision: rejection, acceptance with reservations, recollection
Consultant who decides if accepted with reservations
Notice to the requester: who, when and how
Comment included in the report

Example

Example: haemolysed sample from a health centre

Company, people and figures are fictitious: the example only shows what a properly completed record looks like.

Field	Content
Request	26-041733 · 8 April 2026, 10:42
Source	Network health centre (fictitious)
Incident	Moderate haemolysis (index 150) in serum
Tests affected	Potassium and LDH
Decision	Potassium and LDH rejected · rest reported
Notice	Message to the centre requesting recollection · 11:05
Report	"Potassium and LDH not reported due to haemolysed sample; recollection requested"
Trend	This centre accounts for 31% of April's haemolysis · phlebotomy training proposed

At the audit

Mistakes auditors commonly flag

Samples rejected with no documented notice to the requester.
Compromised samples processed with no warning on the report.
Rejection criteria that staff do not know or apply differently on each shift.
Incidents not aggregated by source and not leading to improvement actions.
Labels corrected by hand in the laboratory with no traceability.

In Kimobox

How this record is kept in Kimobox

1Sample traceability is recorded from collection to final report.
2Each incident is recorded on a form and feeds the dashboard indicators by originating centre.
3Recurring incidents can be opened as a nonconformity, with a mandatory root cause and verification of effectiveness.

Frequently asked questions

What people ask us before getting started

Can a sample that fails the criteria be processed?

Yes, if it is clinically critical or irreplaceable and the laboratory decides so. But the report must state the problem and, where appropriate, the caution with which the result should be interpreted.

Is the laboratory responsible for pre-examination incidents if collection happens elsewhere?

Collection may not be under the laboratory's control, but ISO 15189 makes it responsible for defining and communicating instructions, applying the acceptance criteria and monitoring the quality of that phase.

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