EDITIONEN·FR·ქართ

Accréditation Sans Frontières

International Accreditation of Healthcare Facilities

Standards › ASF Health Standards v10 › Standard 41

Standard 41

Complementary and Traditional Medicine

Complementary and traditional medicine: practitioner registration, honest disclosure of evidence, referral of warning signs, product safety and labelling, and adverse event review..

5
criteria
9
documents
5
e-learning courses
1
references

Criteria on this page

41.141.241.341.441.5

How to read the colours
Red: Must. Required in every setting. Criteria that protect life are always red.
Green: Medium. Required, adapted to what a transition setting can realistically do.
Yellow: Minimum. The lowest acceptable level in a humanitarian setting, where resources are very limited.

Each criterion is shown in three settings: Humanitarian settings, Transition and fragile, and Standard. In standard settings, every criterion is Must.

Reference, not a requirement. Every policy, SOP, form and course on this page is a draft to help you. Adapt it to your hospital, write your own, or upload your own documents. What the assessor checks is that the standard is met and that you can show how.
Training colours: red means essential, green recommended, yellow optional. Each course shows its level for each setting: humanitarian, transition and fragile, and standard.
41.1Practitioners Are Qualified and RegisteredHumanitarian settings: MinimumTransition and fragile: MustStandard: Must

Every practitioner is qualified and registered as the regulator of the profession requires for the practice they offer. Registration is checked and kept current.

Humanitarian settings
Minimum
Transition and fragile
Must
Standard
Must

Why it matters. A practitioner who is not qualified or registered may harm patients. Verifying the qualification and registration of every practitioner protects the public.

How the surveyor verifies this criterion

Sample. Review registration and qualification records for all practitioners who delivered treatment in the last 12 months.

1. Each practitioner holds the registration or qualification the regulator requires.

Method. Check each practitioner against the regulator’s register.

Evidence to show. Practitioner registration register (TRM-REG-001).

Pass when. Every practitioner is on the regulator’s register for the practice offered.

2. Practice is limited to the scope the registration allows.

Method. Check each treatment type against the scope recorded for the practitioner.

Evidence to show. Practitioner qualification and registration (TRM-POL-001).

Pass when. No treatment falls outside the registered scope.

Immediate fail (any one means the criterion is not met). A practitioner offering treatments with no registration and no check on file.

Staff responsible

Role Responsibility Level
Secretary (ISCO 3344) Keeps the Practitioner registration register Must
Manager (ISCO 1342) Maintains the Practitioner qualification and registration Must

Documents: who does each step

Document Writes Approves Fills in Checks and signs Files and uploads
TRM-REG-001 · Practitioner registration register Secretary (ISCO 3344) Chief executive (ISCO 1120) Secretary (ISCO 3344) Manager (ISCO 1342) Secretary (ISCO 3344)
TRM-POL-001 · Practitioner qualification and registration Chief executive (ISCO 1120) Governing body members N/A Chief executive (ISCO 1120) Secretary (ISCO 3344)

E-learning: who must take each course

Course Who must take it
Credentialing, Competence and the Training Matrix (T-14) Manager; Nurse

References

41.2Patients Are Told What Is and Is Not Supported by EvidenceHumanitarian settings: MinimumTransition and fragile: MustStandard: Must

Before treatment, patients are told honestly which elements of the practice are supported by evidence and which are not. No claim is made that the service cannot support.

Humanitarian settings
Minimum
Transition and fragile
Must
Standard
Must

Why it matters. 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.

How the surveyor verifies this criterion

Sample. Review consent and information records for 20 patients starting treatment.

1. Each patient is told which elements are supported by evidence and which are not.

Method. Check each record for the evidence statement given before treatment.

Evidence to show. Evidence disclosure record (TRM-FRM-001).

Pass when. Every sampled patient has an evidence statement recorded.

2. No claim is made that the service cures or prevents a condition without evidence.

Method. Check each sampled claim in the patient information and the service advertising.

Evidence to show. Disclosure of evidence to patients (TRM-SOP-001).

Pass when. No sampled claim is unsupported.

Immediate fail (any one means the criterion is not met). A patient told a herbal remedy cures cancer, with no evidence statement.

Staff responsible

Role Responsibility Level
Nurse (ISCO 2221) Completes the Evidence disclosure record Must
Manager (ISCO 1342) Maintains the Disclosure of evidence to patients Must

Documents: who does each step

Document Writes Approves Fills in Checks and signs Files and uploads
TRM-SOP-001 · Disclosure of evidence to patients Manager (ISCO 1342) Chief executive (ISCO 1120) Manager (ISCO 1342) Chief executive (ISCO 1120) Secretary (ISCO 3344)
TRM-FRM-001 · Evidence disclosure record Manager (ISCO 1342) Chief executive (ISCO 1120) Secretary (ISCO 3344) Manager (ISCO 1342) Secretary (ISCO 3344)

E-learning: who must take each course

Course Who must take it
Patient Identification, Informed Consent and Patient Rights (T-07) Manager; Nurse

References

In process of development. Will be available soon.

41.3Conventional Care Is Not Replaced When It Is NeededHumanitarian settings: MustTransition and fragile: MustStandard: Must

Where a patient needs conventional diagnosis or treatment, the service refers them and does not delay or replace it. Warning signs are identified and acted on.

Humanitarian settings
Must
Transition and fragile
Must
Standard
Must

Why it matters. A patient with a serious illness who uses only traditional treatment may be harmed by delay. A service must refer the patient to conventional care when it is needed.

How the surveyor verifies this criterion

Sample. Review records for 20 patients with symptoms that need conventional diagnosis, including warning signs recorded.

1. Warning signs are identified and recorded at each visit.

Method. Check each record for the warning signs screen.

Evidence to show. Referral to conventional care and warning signs (TRM-SOP-002).

Pass when. Every visit has a warning sign screen recorded.

2. A patient with a warning sign is referred without delay.

Method. Check each warning sign for the referral time and the destination.

Evidence to show. Referral and warning sign record (TRM-FRM-002).

Pass when. Every warning sign has a referral within the set time.

3. Conventional treatment is not replaced where it is needed.

Method. Check each referred patient for a continuing conventional plan.

Evidence to show. Referral and warning sign record (TRM-FRM-002).

Pass when. No referred patient was kept on complementary treatment alone.

Immediate fail (any one means the criterion is not met). A patient with chest pain treated with herbs for a week instead of being referred.

Staff responsible

Role Responsibility Level
Manager (ISCO 1342) Maintains the Referral to conventional care and warning signs Must
Nurse (ISCO 2221) Completes the Referral and warning sign record Must

Documents: who does each step

Document Writes Approves Fills in Checks and signs Files and uploads
TRM-SOP-002 · Referral to conventional care and warning signs Manager (ISCO 1342) Chief executive (ISCO 1120) Manager (ISCO 1342) Chief executive (ISCO 1120) Secretary (ISCO 3344)
TRM-FRM-002 · Referral and warning sign record Manager (ISCO 1342) Chief executive (ISCO 1120) Secretary (ISCO 3344) Manager (ISCO 1342) Secretary (ISCO 3344)

E-learning: who must take each course

Course Who must take it
Complaints Handling and Patient Feedback (T-12) Manager; Nurse

References

In process of development. Will be available soon.

41.4Products Are Safe, Sourced, Labelled and Not MisleadingHumanitarian settings: MustTransition and fragile: MustStandard: Must

Products supplied by the service have a known source, are labelled with ingredients and warnings, and are not presented with unlicensed claims. Adverse reactions to products are recorded.

Humanitarian settings
Must
Transition and fragile
Must
Standard
Must

Why it matters. Products used or sold in traditional and complementary practice can contain undeclared drugs, heavy metals or allergens. Knowing the source and reading the label protects patients.

How the surveyor verifies this criterion

Sample. Review product records for 15 products supplied in the last 12 months, including their labels.

1. Each product is labelled with its ingredients and warnings.

Method. Check each label against the required content.

Evidence to show. Product sourcing and labelling register (TRM-REG-002).

Pass when. Every label shows the ingredients and warnings.

2. No product is presented with an unlicensed claim.

Method. Check each product and its advertising for claims.

Evidence to show. Product safety, sourcing and labelling (TRM-POL-002).

Pass when. No sampled product carries an unlicensed claim.

Immediate fail (any one means the criterion is not met). A product with no known source, no ingredient label and a claim that it cures diabetes.

Staff responsible

Role Responsibility Level
Secretary (ISCO 3344) Keeps the Product sourcing and labelling register Must
Manager (ISCO 1342) Maintains the Product safety, sourcing and labelling Must

Documents: who does each step

Document Writes Approves Fills in Checks and signs Files and uploads
TRM-REG-002 · Product sourcing and labelling register Secretary (ISCO 3344) Chief executive (ISCO 1120) Secretary (ISCO 3344) Manager (ISCO 1342) Secretary (ISCO 3344)
TRM-POL-002 · Product safety, sourcing and labelling Chief executive (ISCO 1120) Governing body members N/A Chief executive (ISCO 1120) Secretary (ISCO 3344)

E-learning: who must take each course

Course Who must take it
Supplier Evaluation and Purchasing (T-13) Manager; Nurse

References

In process of development. Will be available soon.

41.5Adverse Events Are Recorded and ReviewedHumanitarian settings: MinimumTransition and fragile: MediumStandard: Must

Adverse events from any treatment or product are recorded and reviewed. The review leads to a change in practice where a pattern is found.

Humanitarian settings
Minimum
Transition and fragile
Medium
Standard
Must

Why it matters. Adverse events from traditional treatments are rarely reported, so harm stays hidden. Recording and reviewing them is how the service learns what is unsafe.

How the surveyor verifies this criterion

Sample. Review the adverse event register for the last 12 months and the review records for each pattern found.

1. Each adverse event is recorded.

Method. Compare the incident log with the adverse event register.

Evidence to show. Adverse event register (TRM-REG-003).

Pass when. Every adverse event is in the register.

Immediate fail (any one means the criterion is not met). Three patients report the same reaction to a product, with no review and no change.

Staff responsible

Role Responsibility Level
Secretary (ISCO 3344) Keeps the Adverse event register Medium
Manager (ISCO 1342) Checks the criterion at each review Medium

Documents: who does each step

Document Writes Approves Fills in Checks and signs Files and uploads
TRM-REG-003 · Adverse event register Secretary (ISCO 3344) Chief executive (ISCO 1120) Secretary (ISCO 3344) Manager (ISCO 1342) Secretary (ISCO 3344)

E-learning: who must take each course

Course Who must take it
Incident Reporting, Just Culture and Open Disclosure (T-09) Manager; Nurse

References

  1. WHO (2021). Global Patient Safety Action Plan 2021–2030: Towards Eliminating Avoidable Harm in Health Care. Used for: Global patient safety action plan: adverse event reporting, review and learning. General patient safety. https://news.gmj.ge/guideline/global-patient-safety-action-plan-2021-2030-towards-eliminating-avoidable-harm-in-health-care/

Who is responsible for Standard 41

Each criterion names the positions responsible for it. Every position links to its own terms of reference.

Criterion Responsible Supports
41.1 Practitioners Are Qualified and Registered Compliance officer
General practitioner (GP)
Legal counsel
41.2 Patients Are Told What Is and Is Not Supported by Evidence General practitioner (GP)
Consultant physician (internal medicine)
Complaints and patient experience officer
41.3 Conventional Care Is Not Replaced When It Is Needed General practitioner (GP)
Consultant physician (internal medicine)
Family physician (GP) lead
41.4 Products Are Safe, Sourced, Labelled and Not Misleading Chief pharmacist
Clinical pharmacist
Pharmacist (dispensing)
41.5 Adverse Events Are Recorded and Reviewed Risk manager
Clinical audit officer
General practitioner (GP)

Role details: reporting, supervision and training

Training shown is the general recommendation. Role-specific training is set in the next improvement round.

Role Reports to Supervises Recommended training
Legal counsel Chief executive officer (CEO) None Facility induction; safeguarding adults (general recommendation)
Compliance officer Chief executive officer (CEO) None Facility induction; safeguarding adults (general recommendation)
Risk manager Chief quality and safety officer None Facility induction; safeguarding adults (general recommendation)
Clinical audit officer Quality manager Medical records quality auditor Facility induction; safeguarding adults (general recommendation)
Complaints and patient experience officer Quality manager None Facility induction; safeguarding adults (general recommendation)
Consultant physician (internal medicine) Head of department (per specialty) Resident physician / house officer Facility induction; safeguarding adults (general recommendation)
General practitioner (GP) Medical director None Facility induction; safeguarding adults (general recommendation)
Chief pharmacist Medical director Clinical pharmacist, Pharmacist (dispensing), Pharmacy technician, Clinical trials coordinator Facility induction; safeguarding adults (general recommendation)
Clinical pharmacist Chief pharmacist None Facility induction; safeguarding adults (general recommendation)
Pharmacist (dispensing) Chief pharmacist None Facility induction; safeguarding adults (general recommendation)
Family physician (GP) lead Medical director Practice nurse (immunisation, chronic care), Walk-in clinic physician, Same-day procedure nurse Facility induction; safeguarding adults (general recommendation)

Questions and answers

The criterion text is the authority. These answers summarise it.

Who does Standard 34 apply to?

Services that offer complementary and traditional medicine, including practitioners and any products they supply to patients.

What do the colours mean for this standard?

Red (Must) is required. Green (Medium) is recommended. Yellow (Minimum) is the lowest acceptable level in humanitarian settings. Standard setting is Must on every criterion.

Must practitioners be registered?

Yes. Under 41.1 every practitioner is qualified and registered as the regulator requires, and registration is checked and kept current.

Are patients told what the evidence shows?

Yes. Under 41.2 patients are told honestly, before treatment, which parts of the practice are supported by evidence and which are not.

Can a practice replace conventional care?

No. Under 41.3 where a patient needs conventional diagnosis or treatment, the service refers them and does not delay or replace it.

What must be true of products sold or supplied?

Under 41.4 products have a known source, are labelled with ingredients and warnings, make no unlicensed claims, and adverse reactions to them are recorded.

How are adverse events handled?

Under 41.5 adverse events from any treatment or product are recorded and reviewed, and the review leads to a change in practice where a pattern is found.

Guidelines for this standard

5 guideline(s) are held in the GMJ Guidelines Library and listed here. Each link opens the full guideline on news.gmj.ge. The complete library, grouped by standard, is at Guidelines.

  1. WHO Benchmarks for the Training of Ayurveda (WHO)
  2. WHO guidelines for assessing quality of herbal medicines with reference to contaminants and residues (WHO)
  3. WHO Guidelines on Developing Consumer Information on Proper Use of Traditional, Complementary and Alternative Medicine (WHO)
  4. WHO Traditional Medicine Strategy 2014-2023 (WHO)
  5. WHO Global Traditional Medicine Strategy 2025-2034 (WHO)

Also relevant to this standard: