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Medical labs not accredited

Only two of 60 labs being processed for accreditation

BY NADINE WILSON Observer staff reporter wilsonn@jamaicaobserver.com

Monday, October 22, 2012    

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DESPITE increasing pressure from Caricom for mandatory accreditation, none of Jamaica's 65 medical laboratories has been accredited, and the Medical Laboratories 2005 Act, which would help to streamline this process, is yet to be passed into law.

The latest call from Caricom came during a recent meeting in St Lucia, where startling information was shared about the quality of medical laboratories in the region. The issue, they said, was important, given the fact that an estimated 70 to 80 per cent of critical decisions made by doctors were based on laboratory results.

In the September issue of the Caribbean Partnership against HIV/AIDS (PANCAP) newsletter, it was disclosed that among Caricom countries, only The Bahamas, Barbados, Belize, and Guyana have established regulations which make it mandatory for the monitoring and licensing of medical laboratories. Bermuda was the only country that was shown to have implemented mandatory legislation requiring laboratories to become accredited.

Laboratories in Jamaica are currently self-regulated, for the most part, but the Health Facilities Act (Medical Laboratories 2005) is expected to make accreditation mandatory once passed.

A source at the Ministry of Health, who spoke on condition of anonymity, said the passing of the Act is one of the priorities for the ministry and it is currently with the ministry's legal department.

"We are working on the regulations, but it's on the legislative agenda, because we have recognised that we need it," the source told the Jamaica Observer.

Medical laboratories are still able to go ahead and apply for accreditation. But, according to the chief executive officer for the Jamaica National Agency for Accreditation (JANAAC), Marguerite Domville, only two of the over 60 private and public labs in the island are currently being processed for accreditation. Another 46 laboratory owners have taken application forms , but are yet to submit them.

"Accreditation is not an instant thing, it's a process, so it takes a little time," she said. "The statistic worldwide is between six months and two years to become accredited, because they have to meet an international standard."

Domville said she is aware of increasing international pressure for Jamaican labs to become accredited, based on standards established in the ISO 15189 medical laboratory standards by the International Organisation for Standardisation's Technical Committee.

Some of the requirements for accreditation, according to this standard, include having a proper quality management system in place and having qualified and trained staff.

Domville said many of the labs are currently working towards ensuring that they meet all the requirements before they turn in their applications.

"They will do so as soon as they are comfortable that they have all the different quality management systems in place," she said, adding that while the laboratories in Jamaica have seen drastic improvements over the years, self-declaration is no longer accepted throughout the world, hence the urgent need for accreditation.

"There are dishonest people, and the results have to be correct in the case of medical labs. If not, you will have serious errors," she said.

Meanwhile, managing director of Central Medical Laboratories Limited, Audrey Clarke, believes the Medical Laboratories Act is long overdue.

"I think we are moving slowly," she said in regard to the passing of the Act.

She said that although her laboratory conforms to international standards and has never come into question, accreditation would create a certification that has worldwide acceptability.

Managing director of Mid Lab, Eunice Griffiths, said she, too, did not have a problem with the call for mandatory accreditation. She too believes that talk of the impending law has caused some labs to tighten up where necessary.

"What it has done is that it has raised the bar in the labs, because I would say not all, but most labs, are already on their way to applying for accreditation," she said.

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