Code of Health and Disability Services Consumers’ Rights

New Zealand has a legal framework that sets out the rights of consumers of heath and disability services.  The framework flows from the Health and Disability Commissioner Act 1994 (the Act), and the Code of Health and Disability Services Consumers' Rights 1996 (the Code).

The Code includes three rights that together form the elements of informed consent.  The three rights are: the right to effective communication (Right 5); the right to be fully informed (Right 6); and the right to consent freely given by a competent person (Right 7).  Consumers (and in this case, their parents/guardians) must be fully informed (Right 6) and give informed consent (Right 7) before they receive this service.

The Act outlines the process for submitting and resolving complaints about health and disability services.

See the Health and Disability Commissioner website at http://www.hdc.org.nz/ for more information. 

Please note: The Code confers rights on consumers who receive health services. In the case of newborn metabolic screening, the consumer is the baby. However, as a baby is not competent to consent, consent to blood tests and storage must be given by the parents or other persons entitled to consent on behalf of the baby. Later, when the consumer (baby) becomes competent to consent, he or she will be entitled to exercise his or her rights directly.

The Health and Disability Commissioner released a Report on Opinion in response to a claim relating to newborn metabolic screening in 1999: http://www.hdc.org.nz/files/hdc/opinions/99hdc09011.pdf

The Privacy Act and the Health Information Privacy Code

The Privacy Act 1993 and the Health Information Privacy Code (HIPC) 1994 cover the blood spot cards.

Further information on these Acts can be viewed at:
http://www.privacy.org.nz/
http://www.legislation.govt.nz

In 2003, the former Privacy Commissioner Bruce Slane issued a report following his inquiry into the collection, retention, use and release of newborn metabolic screening test samples. The report identified areas of concern and recommendations for the programme and can be viewed online at http://www.privacy.org.nz/assets/Files/70989185.pdf

What other safeguards are in place for the programme?

The laboratory which performs the screening for the programme must be IANZ accredited against the international standard ISO 15189. This is the highest accreditation programme available. IANZ stands for International Accreditation New Zealand. Accreditation by IANZ ensures that the laboratory that carries out these tests is technically competent, has appropriate processes and is using up-to-date technology. It is an internationally recognised process for assessing and recognising the technical competence and the effective quality processes of a professional service (in this case a medical testing laboratory) and its staff. Accreditation involves checking that the laboratory has processes to ensure staff are both adequately trained and competent in the tasks they perform; that equipment is regularly maintained and has functional checks before each use and that there are robust processes for tracking specimens, testing and reporting. Overseas experts are regularly brought in to ensure New Zealand processes are of a similar standard to elsewhere in the world.  Part of checking the quality of testing involves ensuring that the laboratory has satisfactory performance on external (the laboratory participates in programmes from the Centres for Disease Control - CDC in America and other external programmes) and internal quality assurance programmes.  For further information on IANZ see their website: www.ianz.govt.nz

Samples are stored securely in a locked area

Blood spot cards are stored securely and confidentially by the laboratory. 

DNA and stored data

As part of metabolic screening, about 1 percent of samples have a test for a change in DNA (mutation) associated with cystic fibrosis. No other DNA testing is done on samples unless authorised by the parents/guardians/individual or through legal avenues (eg a court order).