National Hepatitis C Testing Policy May 2007

Appendix 3 Guiding Principles

Page last updated: July 2007

The following points expand on the guiding principles:

Test discussion and post-test discussion. Appropriate test discussion and post-test discussion should be an integral part of all voluntary, mandatory and compulsory testing. People with antibody-positive results will need continuing support and information, which may involve referral to community agencies such as hepatitis C councils and drug user organisations. Home-based testing does not provide for appropriate test discussion and is not supported.

Informed consent. While informed consent should be obtained for all people seeking testing, particular care should be taken to obtain specific informed consent from marginalised groups. The process of obtaining that consent may need to take account of cultural and language barriers and matters associated with discrimination.

Confidentiality. If people who have been tested or are contemplating testing are to have confidence in the health system it is essential that adequate mechanisms exist to ensure the confidentiality of test results at all levels—clinical, data management, and the notification process. People who are considering testing are entitled to be told about how notification to health authorities of confirmed positive tests results occurs and the confidentiality safeguards that apply.

Access. People who have been at risk of exposure to hepatitis C infection should have ready access to testing. Where barriers to testing exist, especially for marginalised groups, special provisions may need to be made to facilitate access. Funding arrangements should be such that the cost of testing does not discourage people at risk of infection from being tested.

Anonymous testing. To facilitate access for people who might be reluctant to seek hepatitis C testing, free de-identified testing should be available from a number of health care settings in each jurisdiction.

Health promotion. The benefits of testing should be maximised by using the opportunity to deliver health promotion messages aimed at minimising transmission and encouraging lifestyle modifications that may limit the adverse consequences of infection.

The primary health care context. The benefits of hepatitis C testing will be maximised when a patient’s other primary health care needs are taken into account. This applies particularly to people who inject illicit drugs, who may have complex health care needs and often experience discrimination by health care providers.

Monitoring and treatment. Continuous monitoring of their health status should be available to all people infected with hepatitis C, with assessment for treatment occurring in accordance with eligibility guidelines.

Regulation and quality assurance. Requirements for the registration and supply of hepatitis C test kits by the Therapeutic Goods Administration and for their use (this is discussed in Chapters 8 and 9) should be adhered to. Only TGA registered assays are to be used.

Cost-effectiveness. Testing should be carried out in a cost-effective manner.

Human rights. Testing practices must comply with federal and State or Territory anti-discrimination legislation and other relevant laws. This could mean that it is unlawful to require a person, on the basis of actual or imputed hepatitis C infection, to undergo a hepatitis C test as a pre-condition of any medical treatment or that it is unlawful to refuse, delay or defer treatment if the patient refuses the test.

Harm Reduction. Whilst this policy does not condone drug use it refers to policies and programs aimed at reducing drug related harm. Harm reduction interventions aim to improve health, social and economic outcomes for the community and the individual, and encompass a wide range of approaches, including Needle and Syringe Programs and assisting people with drug dependencies to seek treatment.

Remedies. Effective, practical and accessible redress (apart from recourse to the law) should be available for unauthorised hepatitis C testing - for example, a health care complaints mechanism.

Mandatory and compulsory testing. Mandatory or compulsory testing is appropriate only in specific circumstances:

  • Compulsory testing is appropriate in some rare situations (as provided for in public health legislation) where the welfare of others in the community depends on the testing of an individual - for example, if a person suspected on reasonable grounds of being hepatitis C positive persistently behaves in a way that places others at risk of infection. Adequate safeguards should exist to ensure that compulsory testing is used only when there are no alternatives. The right of appeal against a decision or order to be tested should always exist.
  • Mandatory testing, where a person may be prohibited from participation in certain activities unless they undergo testing and are found to be hepatitis C negative, is appropriate in some circumstances - for example, homologous blood donation. Any mandatory testing must be firmly based on scientific knowledge of how the virus is transmitted and on ethical considerations. To protect against potential abuse, any requirements for mandatory testing should be fully documented in guidelines that describe the justification, the procedure to be followed, and safeguards to ensure protection against abuse and compliance with ethical standards.
Mandatory and compulsory testing should always be accompanied by pre-test and post-test discussion.11

Surveillance. Information from hepatitis C testing contributes to an improved understanding of epidemiology and allows for targeting of health promotion interventions and planning of care and treatment services.

Anonymous de-identified testing. For surveillance purposes anonymous de-identified testing may be considered in special circumstances. It must, however, comply with the National Health and Medical Research Council’s National Statement on Ethical Conduct in Research Involving Humans12, include full scientific justification (as for all research), and be consistent with the Australian Hepatitis C Surveillance Strategy.

Infection control. Testing does not diminish the need for standard precautions in handling blood and body fluids in any health care setting.

11Test discussion, as outlined in this policy, is not required for blood donors. Post-test counselling is not required for blood donors who test negative for hepatitis C. Blood services should either provide post-test counselling for donors who test positive or refer these people to appropriate services.
12National Health and Medical Research Council 1999, National Statement on Ethical Conduct in Research Involving Humans, NHMRC, Canberra