18 Apr 2020

Gap in medical testing regulations could cost lives - medics

6:56 pm on 18 April 2020

There is a gap in regulations covering medical testing outside laboratories, and it could cost lives, the New Zealand Medical Association says.

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Photo: AFP

They are calling for greater regulation of the testing of samples outside of laboratories, including Covid-19 tests, and many more medical tests performed in a range of clinical settings.

The practice (known as point-of-care testing) has significantly increased, and the association said now, during a pandemic, is the right time to put in place national regulations.

The testing and analysis of samples with point-of-care testing kits is done in places such as emergency departments, GP surgeries, pharmacies, and could be done at the newly-established community based assessment centres.

  • If you have symptoms of the coronavirus, call the NZ Covid-19 Healthline on 0800 358 5453 (+64 9 358 5453 for international SIMs) or call your GP - don't show up at a medical centre

The chair of the association, Dr Kate Baddock, said they need to have greater regulations at the national level, so they can ensure the tests and therefore the results, can be trusted.

"We are in the middle of a pandemic, and point-of-care testing has dramatically increased, which means right now is the right time to put in place national regulation to safeguard all concerned."

The result of a lack of regulations means people get a false sense of security around results, she said.

"If you have an unregulated kit being used, and people are then relying upon the results that are being produced as being true and accurate, and they may not be, then this can obviously influence health outcomes.

A portrait of The Chairperson of the General Practice Council of the Medical Association, Kate Baddock

New Zealand Medical Association chair Dr Kate Baddock. Photo: RNZ/Karen Brown

"An example is a test for a clot in the leg. If you have a non-regulated kit being used, and they do the test on somebody and the test says they're okay, and that person actually did have a clot and dies, that is not a good outcome.

"Because we don't regulate, that is something that potentially could happen."

Dr Baddock said she supports the use of point-of-care tests, as long as they have been regulated by the government.

"Point-of-care testing can offer sigificant advantages over lab testing in that it's immediate, it's right at where the patient is, the turn-around time is so little. When you have to measure something frequently, you can do it. But you've got to be able to rely on the results!"

Regulations would have to come from central government, Dr Baddock said, as is the case in other countries.

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