MEDICAL testing facilities have virtually mushroomed in Jamaica in the past two decades, but they remain unregulated and unmonitored despite the reliance of doctors on them to produce accurate results on which treatment decisions rest.

There are more than 51 medical laboratories and 77 other testing and collection facilities, a recent survey has found.

The labs also handle sensitive and confidential medical information, but they operate to no set standards, except for the self-regulation practised by some.

To set up a lab now really requires only one thing – the capital to finance it.

The rising competition in the field has prompted the more competitive labs to seek a marketing edge through service quality.

But now the Ministry of Health is moving to remove the decision about standards and compliance from the individual operators, and has promulgated a new law to establish a Medical Laboratories Council that will standardise, accredit and police the facilities.

The Health Facilities Act (Medical Laboratories 2005) bill is before the Lower House of Parliament and will go before the Senate when the House resumes its sittings after the summer break, health minister John Junor.

Sittings began Tuesday.

“We feel that the time is right, because of the profusion of the number of labs opening,” said Junor in a Sunday Observer interview.

“Everything else is governed and so there must be some regulations in areas where lack of proficiency has serious consequences for people.”

What Junor was alluding to in that comment is, if a lab produces incorrect results that lead to adverse medical consequences for the patient, that patient has little legal recourse against the facility.

That situation changes, however, once the medical labs council begins its work as the authority to license the facilities and their practitioners.

The Sunday Observer has been doing exposés on the loose regulation of sub-sectors in health – mostly generated around HIV/AIDS and the stigma associated with the disease – last reporting on the fallacy of medical privacy in some areas, and the lack of legislation to protect confidentiality of sensitive medical information at pharmacies and labs.

The medical labs bill will address the privacy issue for the latter sub-sector.

The law, when passed, will impose prison terms ranging up to two years, and/or fines of up to $3 million, for unapproved facilities and confidentiality breaches.

But Trevor Campbell, managing director and owner of one of the oldest testing facilities, MicroLabs Limited in Kingston, contends that the ministry has waited too long to bring the act into fruition, leaving exposed the lives of Jamaicans who depend on these labs to provide an error-proof service.

The Sunday Observer for weeks, sought information from the health ministry on the oversight of private labs, but its technical officers, instead of referring to the bill to close the regulatory gap, chose to evade the queries.

It was Campbell who informed the Sunday Observer that his and other facilities had no reporting relationship with the ministry, nor, he said, had the health officials ever made an attempt to ensure that the private labs were safe.

“The public has nothing protecting them and they have no way of knowing if the lab that they go to complies with international standards to do tests,” said the MicroLabs manager.

“Theoretically, anybody can open a lab if they have the money to buy the equipment and reagents. However, the persons working in the lab have to be a registered medical technologist and they have to re-register every year.”

There is already a law that regulates lab technicians, many of whom are employed in state-run hospitals and medical centres.

Campbell said that his lab, and most other privately run labs in the island, do comply with international standards.

MicroLabs, he noted, is a member of the American Proficiency Institutes (API), which reviews his lab regularly to ensure the correct procedures are being followed when specimen are tested.

This is done, he said, not through visits, but using the following procedure:

. API sends specimen to MicroLabs for testing;

. MicroLabs tests and returns the samples;

. API then evaluates the results.

“The Ministry of Health nor the Medical Association of Jamaica has never contacted us in respect to our confidentiality policies and procedures,” Campbell said.

But all members of his staff have signed a mandatory ‘Patient Privacy and Confidentiality Agreement’.

“It is a carefully constructed legal and ethical document and it specifically addresses the legal consequences of any infraction of this code of conduct,” he said.

“We also have several fully certified HIV counsellors in our laboratory, who help us to police our policies and assure patients of the integrity of our system.”

Other labs, like Biomedical and Caledonia Medical Laboratory Limited, say they have no similar affiliation with an oversight body, but they also stand by the efficacy of their results and the professionalism of their operations, pointing to strict quality control procedures their labs follow to ensure that the results are medically irrefutable.

“We are also in the process of getting accreditation and will be assessed by the Bureau of Standards,” said Heather Wint, acting technical manager for Biomedical.

Wint also noted that while there is no specific policy on the confidentially of lab results and tests, Biomedical’s employees are aware of the importance of keeping medical information private.

“The employees know that the information is confidential and should not be discussed with anyone outside of the lab,” she said. “If they do, the matter will be dealt with seriously.”

The new medical labs act, however, will take the onus away from the lab manager, and give clients recourse in the courts.

The bill stipulates a fine of $1 million or imprisonment or a term not exceeding 12 months on any laboratory practitioner or employee who discloses any information to any person other than to whom he or she is authorised to report such information.

And, any person who practises as a laboratory practitioner without certification can be penalised up to $500,000 and/or six months in prison.

The new law will also establish a complaints board to conduct investigations on its own recognisance or pursuant to a complaint made by a client of the lab or an employee.

The board will be required to submit a written report to the Medical Labarotories Council of any investigation it conducts.

A Medical Laboratories Appeal Tribunal will also be created under the law to hear appeals on matters decided by the council, such as the granting or revocation of licensing certificates, and renewal or refusal of recertification.

However, persons who operate laboratories without a valid licence can be fined up to $3 million or serve a prison term not exceeding two years or both.

If a person operates the laboratory or collection centre during the period when the licence was revoked or suspended, they too can be fined $3 million and/or imprisoned for two years, the new law proposes.

davidsont@jamaicaobserver.com