Contents
- Purpose
- Scope
- Policy Statement
- Patient Rights and Responsibilities
- Respect and Dignity
- Non-Discrimination
- Patient Safety
- Informed Consent
- Confidentiality and Privacy
- Communication with Patients
- Feedback and Complaints
- Patient Identification
- Ethical Considerations
- Accessibility of Services
- Closure, Acquisition and Merger of the Laboratory
- Availability of Information
- Handling Vulnerable Patients
- Patient Preparation and Instructions
- Staff Responsibilities
1. Purpose
To ensure that all patients are treated with dignity, respect, and fairness, and that
laboratory services are delivered in a manner that safeguards patient rights, safety,
and well-being in accordance with ISO 15189:2022.
2. Scope
This policy applies to all laboratory personnel involved in pre-examination,
examination, and post-examination processes that directly or indirectly impact patient care.
3. Policy Statement
The laboratory is committed to:
- Delivering patient-centered services.
- Ensuring ethical conduct in all interactions.
- Protecting patient rights, privacy, and safety.
- Providing equitable and non-discriminatory access to services.
4. Patient Rights and Responsibilities
4.1 Respect and Dignity
- All patients shall be treated with courtesy, respect, and dignity irrespective of age, gender, ethnicity, religion, or socio-economic status.
- Cultural, religious, and personal values of patients shall be respected.
4.2 Non-Discrimination
- Laboratory services shall be provided without discrimination.
- No patient shall be denied services based on personal characteristics or medical condition.
4.3 Patient Safety
The laboratory shall ensure patient safety at all stages, including:
- Patient identification.
- Sample collection.
- Handling and transportation of specimens.
- Risks to patients shall be identified and minimized.
4.4 Informed Consent
Informed consent shall be obtained where required prior to:
- Sample collection.
- Special or invasive procedures.
Patients shall be provided with clear information regarding:
- Nature and purpose of tests.
- Risks (if any).
- Alternatives, where applicable.
4.5 Confidentiality and Privacy
- Patient information shall be treated as strictly confidential.
- Access to patient data shall be restricted to authorized personnel only.
- Privacy shall be ensured during sample collection and consultation.
4.6 Communication with Patients
Opportunities will be provided to patients/laboratory users to:
- Provide helpful information to aid the laboratory in the selection of examination methods.
- Support interpretation of examination results.
The laboratory shall provide:
- Publicly available information about the examination process.
- Information on costs where applicable.
- Expected turnaround times.
Information provided to patients shall be:
- Clear.
- Accurate.
- Easily understandable.
- Examinations offered by the laboratory are periodically reviewed to ensure they are clinically appropriate and necessary.
Where appropriate, the laboratory shall include:
- Disclosure to patients, users and relevant persons of incidents that resulted or could have resulted in patient harm.
- Records of actions taken to mitigate those harms.
Patients shall be informed about:
- Sample requirements.
- Turnaround times.
- Test limitations, where applicable.
4.7 Feedback and Complaints
Patients have the right to:
- Provide feedback.
- Lodge complaints.
- Complaints shall be handled in accordance with the laboratory's complaint handling process.
- Patients shall be informed about the complaint resolution mechanism.
5. Patient Identification
- The laboratory shall ensure correct identification of patients using at least two unique identifiers (e.g., name, date of birth, ID number).
- Misidentification risks shall be minimized through standardized procedures.
6. Ethical Considerations
- All activities shall comply with ethical and professional standards.
- The laboratory shall avoid any conflict of interest affecting patient care.
- Testing shall be performed only when clinically justified.
7. Accessibility of Services
Laboratory services shall be accessible to all patients, including those with:
- Disabilities.
- Special needs.
- Reasonable accommodations shall be made where necessary.
8. Closure, Acquisition and Merger of the Laboratory
- Steps are taken to ensure the ongoing availability and integrity of retained patient samples and records in the event of closure, acquisition or merger of the laboratory.
- Consent and communication are adapted appropriately.
9. Availability of Information
Relevant information shall be available to:
- The patient.
- Any other health service provider upon the request of the patient or a healthcare provider acting on the patient's behalf.
10. Handling Vulnerable Patients
Special care shall be taken when dealing with:
- Children.
- Elderly patients.
- Physically or mentally challenged individuals.
- Consent and communication shall be adapted appropriately.
11. Patient Preparation and Instructions
Clear instructions shall be provided regarding:
- Fasting requirements.
- Medication restrictions.
- Sample collection procedures.
- Instructions shall be available in understandable formats and languages where possible.
12. Staff Responsibilities
All laboratory personnel shall:
- Adhere to this policy.
- Maintain professional conduct.
- Ensure patient comfort and safety.
- Report any incidents affecting patient care.