Legislation

There is New Zealand legislation which covers the blood spot cards, in particular, the Health and Disability Commissioner Act 1994, the Code of Health and Disability Services Consumers' Rights 1996, the Privacy Act 1993 and the Health Information Privacy Code (HIPC) 1994.

The Health and Disability Commissioner Act 1994, outlines the role of the Commissioner and the process for submitting and resolving complaints about health and disability services.

The Code of Health and Disability Consumers' Rights 1996 confers a number of rights on all consumers of health and disability services in New Zealand and places corresponding obligations on providers of those services. Newborn metabolic screening is a health service that is covered by the Code. Consumers (or in this case their parents) must be fully informed (right 6) and give informed consent (right 7) before they receive this service. Right 7 also outlines the use of residual material as follows:

Right 7 (9) Every consumer has the right to make a decision about the return or disposal of any body parts or bodily substances removed or obtained in the course of a health care procedure.

7 (10) No body part or bodily substance removed or obtained in the course of a health care procedure may be stored, preserved, or used otherwise than —

with the informed consent of the consumer; or
for the purposes of research that has received the approval of an ethics committee; or
for the purpose of one or more of the following activities, being activities that are each undertaken to assure or improve the quality of services:—
1. a professionally-recognised quality-assurance programme
2. an external audit of services
3. an external evaluation of services.

Further information on these acts can be viewed on:

http://www.privacy.org.nz

http://www.hdc.org.nz

http://www.legislation.govt.nz

Please note: The Code of Health and Disability Consumers' Rights confers rights on consumers who receive health services. In the case of newborn metabolic screening, the consumer is the newborn 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.

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 on line at http://www.privacy.org.nz/filestore/docfiles/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 appropriate 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 NZ processes are of a similar standard to those elsewhere in the world. A part of checking the quality of testing involves ensuring that the laboratory has satisfactory performance on external (the laboratory participates in programmes from the Centre 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 are

Only authorised staff from the screening programme can access stored blood spot cards. The data stored is also secured by restricted access. The stored data consists of demographic data (for example the baby's name, sex, birth date, time, weight, the mothers details and LMC details) and results of the screening test.

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. Absolutely no other DNA testing is done on samples unless authorised by the parents/guardians/individual or through legal avenues eg court order.