ISO 15189:2022 · Section 4 · General requirements
Clause 4.3: Requirements regarding patients
Check the exact requirement in your licensed copy of the standard.
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What this clause is about
Patient needs should shape how laboratory services are designed and delivered, even when the laboratory rarely meets patients directly. A dependable technical result is essential, but patients also need accessible information, respectful treatment, appropriate consent arrangements and clear routes for questions or concerns. Service decisions should consider the clinical consequences for the person behind each sample.
Review the patient journey from preparation and collection through reporting and any subsequent use of samples or information. Identify where confusing instructions, language barriers, physical access restrictions or avoidable delays may compromise care. Work with referring services and collection teams to resolve these problems rather than treating them as outside the laboratory's responsibility.
Set out how patients receive understandable preparation advice and how staff address requests for explanation within their professional competence. Consent arrangements depend on the procedure, local law and clinical setting; routine collection and invasive procedures may need different approaches. Explain how privacy, dignity and respectful communication are maintained, particularly for vulnerable people or sensitive examinations.
Create reliable routes for feedback and complaints, including concerns received indirectly through clinicians. Review patterns and tell relevant teams what changed. Where a significant laboratory incident affects patient care, coordinate appropriate communication and clinical follow up with authorised professionals. Decisions about retained samples, secondary use and release of information should follow documented permissions and applicable requirements. Useful evidence links patient concerns to practical service changes, rather than merely showing that a patient information leaflet exists. Improvement should be assessed from the patient's perspective as well as the laboratory's workflow.
What assessors typically ask to see
- How are preparation and collection instructions checked for clarity, accessibility and current clinical relevance?
- How do staff identify consent requirements for different procedures and respect a patient declining an examination?
- How are concerns from patients received, investigated and communicated without creating barriers to future care?
- How are patients or their clinical teams informed when a laboratory error has significant implications?
- What changes have been made after reviewing patient feedback, access difficulties or recurring collection problems?
Documents and records that usually provide evidence
- Patient information and preparation instruction SOP
- Patient information leaflets and accessibility review records
- Consent forms and procedure specific consent records
- Patient feedback and complaints register
- Patient related incident communication records
- Sample retention and secondary use authorisation records
Ready-made forms mapped to clause 4.3: Event / Training Attendance Register, Meeting Schedule, Meeting Agenda, Meeting Minutes, Memorandum, Communication Log.
Common findings to avoid
- Instructions assume all patients can read the same language or access information through a smartphone.
- Consent arrangements are copied between procedures without considering their different risks or legal requirements.
- Complaints are closed after a response letter without examining whether the underlying service problem remains.
- Incident records describe technical correction but omit assessment of patient impact and necessary communication.
How LabToolkit Pro maps documents to this clause
Each SOP, form and record in LabToolkit Pro can carry clause tags. When a document tagged 4.3 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 4.3 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 routine examination have written consent?
Not automatically. The appropriate consent process depends on the examination, collection procedure, clinical setting and applicable law. Define how consent is established and when explicit documentation is necessary. Staff should recognise when a patient needs further explanation or when proceeding would exceed the permission already given.
How can a laboratory without patient contact assess patient needs?
Use referring clinicians, collection centres, complaints, rejected sample reviews and patient representatives where appropriate. Look for consequences such as repeated collection, inaccessible instructions or delayed urgent care. Indirect contact does not remove the need to evaluate how laboratory decisions affect patients.
Can patient feedback change technical procedures?
Yes, provided changes remain clinically and technically justified. Feedback about difficult collection appointments might prompt revised preparation instructions, appointment options or transport arrangements. Review the proposed change for safety, document authorisation and check whether it reduces the problem without introducing a new risk elsewhere in the service.
Check the exact requirement in your licensed copy of the standard.
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