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International Accreditation of Healthcare Facilities

Standards › Standard 41 › Standard operating procedures (SOPs)

Standard operating procedure (SOP) · TRM-SOP-001 · Version 1.0 · Approved by the ASF Expert Committee

Supports: 41.2

At a glance

  • Before treatment, each patient is told which parts of the practice are supported by evidence and which are not (TRM-FRM-001).
  • No claim is made that the service cures or prevents a condition without evidence.
  • The patient is given the statement in writing.
  • Consent is taken after the statement is explained.
  • Stop and get help straight away if: treatment starts with no evidence statement, or a claim is made with no evidence.

1. Purpose

To make sure patients make informed choices and are not misled about what treatment can do (41.2).

2. Scope

Applies to Clinical and support staff in the hospital
Locations All wards, clinics and departments of the facility
When Whenever the activity described is carried out
Does not apply to Activities covered by another document listed in section 15

3. Definitions

Term Meaning
Clinical lead The doctor or nurse in charge of the area at the time

4. Background

Patients have a right to know whether a traditional or complementary treatment has evidence behind it. Telling them honestly, before treatment, lets them decide with full information.

5. Responsibilities

Role Responsibility Competence
Service lead Owns the statement and the claims rules Clinical director
Practitioner Gives the statement and records it Service lead

6. Materials and equipment

Item Requirement Condition
Records and forms named in this document Current version Checked before use

7. Safety

8. Before you start

9. Procedure

Step 1. Explain.

  • Explain honestly which parts of the practice are supported by evidence and which are not.

Key point: Explained.

Step 2. Record.

  • Record the statement given and the patient’s understanding (TRM-FRM-001).

Key point: Recorded.

Step 3. Consent.

  • Take consent only after the statement is explained (CON-SOP-001).

Key point: Consented.

10. Decision points

11. Special situations

Situation Action
Out of hours Follow the same steps. Use the on-call contact on the wall of the area.

12. Escalation

13. Monitoring

Measure Target Frequency Owner If not met
Patients with an evidence statement before treatment 100% Quarterly Service lead Escalate to the clinical director

14. Records

Record Kept in Retention
Record named in this document Patient record or the area file the period set by the facility’s records policy years

15. Training

16. Related documents

ID Title Use
TRM-FRM-001 Evidence disclosure record Record
CON-SOP-001 Informed consent before significant care (existing) Procedure

17. Evidence

Reference Note
E-009 Based on the WHO Traditional Medicine Strategy 2014–2023, the WHO guidance on substandard and falsified medical products, and the ASF Hospital standard for informed consent and incident reporting.
E-006 ASF Policy Framework v1.2. Adapted.
E-009 ASF Expert Committee consensus.

18. Change history

Version Date What changed Approval
1.0 the date of approval First version set Expert Committee approval

E-learning for this document

References

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