Standard 41: Complementary and Traditional Medicine

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.

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. Registration is checked and kept current.

Method. Check each practitioner for the check date and the expiry date.

Evidence to show. Staff verification register (STF-FRM-001, existing, reused).

Pass when. Every registration is current at the time of treatment.

3. 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.

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.

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.

3. Consent is recorded after the evidence is explained.

Method. Check each consent for a date on or after the evidence statement.

Evidence to show. Consent record (CON-FRM-001, existing, reused).

Pass when. Every consent is recorded after the evidence statement.

Immediate fail (any one means the criterion is not met)

• A patient told a herbal remedy cures cancer, with no evidence statement.

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.

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.

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.

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

1. Each product has a known and licensed source.

Method. Check each product against the supplier register.

Evidence to show. Licensed supplier and batch source register (PHA-REG-003, existing, reused).

Pass when. Every product has a known and licensed source.

2. 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.

3. 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.

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.

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.

2. Each adverse event is reviewed.

Method. Check each entry for the review date and the reviewer.

Evidence to show. Adverse reaction record (PRO-FRM-006, existing, reused).

Pass when. Every entry has a review recorded.

3. A pattern of events leads to a change in practice.

Method. Check each pattern for the change made and its date.

Evidence to show. Incident reporting and management (INC-POL-001, existing, reused).

Pass when. Every pattern has a recorded change in practice.

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.