Advisory Statement A18/03 - Clarification of consent requirements for transvaginal and transrectal ultrasound procedures

Page last updated: 23 April 2018

Advisory Statement A18/03 - Clarification of consent requirements for transvaginal and transrectal ultrasound procedures (PDF 83 KB)

Purpose

To provide advice about the consent requirements for transvaginal and transrectal ultrasound procedures, through Standard 2.2, Consumer Consent and Information Standard of the Diagnostic Imaging Accreditation Scheme (DIAS).

Issue

The DIAS Advisory Committee recently reviewed the requirements of Standard 2.2 with regard to the consent requirements for transvaginal and transrectal ultrasound procedures.

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. 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.

For high risk and invasive procedures it is expected that written consent is obtained prior to the procedure being performed. However the DIAS Advisory Committee has considered whether transvaginal and transrectal ultrasound procedures should be considered invasive under Standard 2.2, thus requiring written consent regardless of the level of risk which applies for the procedure and the individual patient.

Requirements

Through Standard 2.2, prior to any diagnostic imaging procedure being performed (including transvaginal and transrectal ultrasound), patients must have access to information about the procedure and informed consent must be obtained from the patient, or substitute decision maker, with evidence of this consent recorded. For transvaginal and transrectal procedures, the DIAS Advisory Committee has further confirmed that

  • Verbal informed consent is sufficient for low risk transvaginal and transrectal ultrasound procedures. However, practices which already obtain written consent for transvaginal and transrectal ultrasound procedures can continue to do so.
  • Written consent must be obtained for all high risk procedures, such as those which use transvaginal or transrectal scanning as imaging guidance (e.g. for biopsies) or are otherwise determined by the practice to be high risk for the individual patient.

As evidence of compliance for the purposes of accreditation, practices must include in their Consumer Consent and Information Policy information about how individual patient risk is assessed and how informed consent is obtained and documented (for both verbal and written consent).

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 A18/03


Title
Clarification of consent requirements for transvaginal and transrectal ultrasound procedures
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 ultrasound 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
D18-375826
Links to other statements or advisory documents
User Guide for Practices Applying for Accreditation
Notes (if applicable)
N/A