ISO 15189:2022 · Section 7 · Process requirements
Clause 7.2: Pre-examination processes
Check the exact requirement in your licensed copy of the standard.
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What this clause is about
Pre-examination work connects the clinical question to a specimen suitable for the intended examination. Errors at this stage can remain invisible during technically satisfactory analysis. The laboratory needs clear information for users, reliable patient and specimen identification, appropriate collection instructions, controlled transportation, and consistent decisions at receipt. Responsibilities often cross organizational boundaries, so instructions must be practical for people outside the laboratory.
Explain which examinations are available, what clinical information is useful, and how patients should prepare where preparation affects interpretation. Collection instructions should cover identification, specimen type, container, volume, collection timing, and handling needs. Staff collecting specimens need access to current instructions and a route for resolving uncertainty before collection. Record details necessary to connect the specimen to the patient, request, collection event, and collector.
Transportation arrangements should preserve specimen integrity and protect people handling the package. Establish appropriate time, temperature, packaging, and tracking conditions for relevant specimen groups. At receipt, check identity, request completeness, specimen condition, and suitability against documented acceptance criteria. Prioritize urgent specimens without bypassing identity safeguards. When an irreplaceable or clinically important specimen falls outside normal criteria, use an authorized exception process with documented limitations and communication.
Preparation and storage before examination also require control, including aliquot identification and retention conditions. Review rejection patterns with collection teams to address causes rather than repeatedly rejecting the same problems. LabToolkit Pro can support controlled collection instructions, receipt checklists, and exception records while staff retain responsibility for each acceptance decision.
What assessors typically ask to see
- How can a collector obtain current patient preparation, identification, container, volume, and transport instructions at the collection location?
- What prevents a specimen from being accepted when its identification cannot be reliably connected to the patient request?
- How are transport conditions established, monitored where appropriate, and investigated when delays or unsuitable temperatures occur?
- Who can accept an irreplaceable specimen outside routine criteria, and how are limitations communicated to the user?
- How are aliquots, stored specimens, and urgent requests identified so that preparation does not break traceability?
- How do rejection trends and collection incidents lead to feedback, revised instructions, or targeted staff support?
Documents and records that usually provide evidence
- Controlled user and collection guidance covering preparation, specimen requirements, identification, transport, and contact routes for clinical queries.
- Request and collection records linking patient identifiers, requested examinations, relevant clinical details, collection timing, and collector identity.
- Transport instructions and monitoring records showing applicable packaging, journey conditions, receipt timing, and management of deviations.
- Specimen receipt logs recording suitability checks, acceptance decisions, urgency, identity queries, and any resolution before examination.
- Exception authorization records describing the clinical reason for testing unsuitable material, agreed limitations, and communication with users.
- Rejection reviews and improvement records connecting recurring collection problems to feedback, training, revised processes, and subsequent evaluation.
Ready-made forms mapped to clause 7.2: Meeting Schedule, Communication Log, Sample Referral Log, Specimen Acceptance Criteria (reference Card), Sample Rejection Log, Oral Request Form, Sample Acceptance Exceptions Log, Sample Requirements, Transport Systems and Method Review Form.
Common findings to avoid
- Collection instructions are technically correct but unavailable where patients are prepared or specimens are collected outside normal hours.
- Urgent specimens bypass identity checks because staff assume that rapid analysis is more important than reliable attribution.
- Exception decisions are recorded as accepted without the reason, authorizing person, or limitations needed for later interpretation.
- Aliquots carry only a handwritten test abbreviation and cannot be reliably traced to the original specimen and request.
How LabToolkit Pro maps documents to this clause
Each SOP, form and record in LabToolkit Pro can carry clause tags. When a document tagged 7.2 becomes effective, it counts as direct evidence on the readiness dashboard for ISO 15189:2022; links from other standards through the crosswalk are shown separately as indicative coverage. Gaps appear clause by clause, so you can see which parts of 7.2 still need a controlled document or a current record. Readiness is a planning aid — only an accreditation body confirms conformity.
Frequently asked questions
Must every unsuitable specimen be rejected?
Not always. Some specimens are difficult or impossible to recollect, and testing may still support patient care. An authorized person should evaluate the identification, clinical need, and limitations, discuss these with the user when appropriate, and document the decision. Unresolved identity problems need particularly careful handling and cannot simply be ignored.
Who controls transport provided by another organization?
The laboratory should establish relevant specimen requirements and agree responsibilities with the transport provider or collection organization. Monitor whether the arrangement preserves suitability and provides useful information when problems occur. External transport does not remove the need to assess delays, packaging failures, or temperature excursions at receipt.
How should rejection data be used?
Group problems in ways that support action, such as collection location, specimen type, or reason for rejection. Review patterns with the people responsible for collection and transport, while protecting patient information. Check whether changes actually improve suitability rather than treating the number of completed training sessions as the outcome.
Check the exact requirement in your licensed copy of the standard.
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