Advisory Statement A18/02 - Nuclear medicine imaging procedures: consent requirements for the administration of radiopharmaceuticals

Page last updated: 23 April 2018

Advisory Statement A18/02 - Nuclear medicine imaging procedures: consent requirements for the administration of radiopharmaceuticals (PDF 86 KB)

Purpose

To provide advice about the consent requirements under the Diagnostic Imaging Accreditation Scheme (DIAS) for the administration of radiopharmaceuticals for nuclear medicine imaging procedures, through Standard 2.2, Consumer Consent and Information Standard.

Issue

The DIAS Advisory Committee recently reviewed the requirements of Standard 2.2 with regard to the consent requirements for nuclear medicine imaging procedures, in particular whether the insertion of an IV cannula would be considered an invasive procedure, and if the administration of radiopharmaceuticals is high risk.

In part, Standard 2.2 requires practices to obtain informed consent (verbal or written) from a patient, or substitute decision maker, prior to each diagnostic imaging procedure being performed. For high risk and invasive procedures written consent must be obtained prior to the procedure being performed.

It is the responsibility of the practice to determine the level of risk associated with each diagnostic imaging procedure for the individual patient, and to take this into account when deciding the appropriate form of consent for that patient. Regardless of the type of consent required, the practice must document that the patient’s consent has been documented.

Requirements

The DIAS Advisory Committee has confirmed the following in relation to nuclear medicine imaging procedures
  • as detailed in the DIAS User Guide, the insertion of an IV cannula is not an invasive procedure and does not require written consent
  • for the majority of population groups, the administration of a radiopharmaceutical for the purposes of a nuclear medicine imaging procedure is not high risk when performed in accordance with appropriate professional standards, and
  • informed patient consent must be obtained and recorded for all nuclear medicine imaging procedures. Written consent is required for any nuclear medicine imaging procedure which would be considered high risk based on the patient’s individual circumstances.

For more information

Practices should refer to the DIAS information resources for clarifying information about the evidentiary requirements for Standard 2.2, and contact their accreditor for further information and advice. 

Diagnostic Imaging Accreditation Scheme Advisory Statement A18/02

Title
Nuclear medicine diagnostic imaging: consent requirements for the administration of radiopharmaceuticals
Version
Version 1
Date of publication

April 2018
Replaces

Not applicable
Status

Active
Compliance

Mandatory
Approved by

Diagnostic Imaging Accreditation Scheme Advisory Committee
Review date

April 2020
Information in this statement applies to
DIAS Accreditors
Providers of Medicare-funded diagnostic imaging services

Relevant standard

Standard 2.2, Consumer Information and Consent
Prepared by
Secretariat, Diagnostic Imaging Accreditation Scheme Advisory Committee
Contact details
Phone: 02 6289 8859
Email: dias@health.gov.au
Trim reference
D18-375817
Links to other statements or advisory documents
User Guide for Practices Applying for Accreditation
Notes (if applicable)
N/A