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Contents

  1. Purpose
  2. Scope
  3. Policy Statement
  4. Patient Rights and Responsibilities
    1. Respect and Dignity
    2. Non-Discrimination
    3. Patient Safety
    4. Informed Consent
    5. Confidentiality and Privacy
    6. Communication with Patients
    7. Feedback and Complaints
  5. Patient Identification
  6. Ethical Considerations
  7. Accessibility of Services
  8. Closure, Acquisition and Merger of the Laboratory
  9. Availability of Information
  10. Handling Vulnerable Patients
  11. Patient Preparation and Instructions
  12. 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.
Satisfied Patients
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