Medical testing chaotic

-national lab director
Standardisation project aims at redressing this By Samantha Alleyne
Stabroek News
August 25, 2003

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“There have been many cases, where people commit suicide because of a wrong HIV result. It is as scary as that.”

Testing for diseases by Guyana’s numerous medical laboratories is chaotic and can often produce erroneous results with serious implications for patients, says a leading health official.

National Lab Director, Yvette Irving, who is attached to the Ministry of Health recalled that about six years ago the Caribbean Epidemiology Centre (CAREC) officials took one sample and sent it to five different local labs and all five labs gave different results. “So that is why I know this is not a problem we are having now. This problem has always been here and the licensing or certification is not helping...”

“Licensing of labs is a voluntary process, and you would not believe it but we have labs that are operating where people are not technologists. It is as chaotic as that. Somebody needs to say something, but I don’t know who.”

According to her most of the HIV testing is done by private labs and there have been many cases, “where people commit suicide because of a wrong HIV result, it is as scary as that.”

Now CAREC, located in Trinidad, is in the process of initiating a European Union-funded project aimed at improving the management of public and private laboratories in the Caribbean.

‘Strengthening of the Medical Laboratory’ is a four-year project which was approved in May of 2000 and some $9.7M euros has been allocated.

The intended results, from which some fifteen countries are expected to benefit, are legislation and accreditation, human resource development, laboratory management, regional co-ordination, and operational research.

Irving told Stabroek News that local labs might be testing the same individual for the same disease and end up with different results: “If you are testing the same person you are generally not supposed to have a result that is that extreme but should be in the same range, if not alike. Remember if you are doing testing and you are from two separate laboratories you have a different technologist doing the testing, you are in a different environment, you might be using a different test kit and equipment, but generally if somebody has high glucose it should be high no matter what method you use or in which environment it was done.”

Getting tests to correspond is vital since it is these results the doctors rely on in making a diagnosis and then prescribing treatment.

According to her this problem has been recognised over the seven to eight years by CAREC throughout the Caribbean and as a result it has been doing surveys to check the quality of lab results.

“...They have tried to get a project on stream to address the quality of the laboratories on the whole. Not just the testing in the laboratories but the pre-testing process, the testing process and the post- testing process...”

She noted that all of these categories had to come together to give the final results. Irving said labs had to ensure that there was quality in pre-testing: “when the sample was taken from the patient there must be quality assurance, the samples have to be timed properly. Patients have to be prepared “and your result is only as good as the sample you collect.

“If you collect a sample from a patient who is supposed to give you a sample for fasting- blood sugar and the patient did not fast and you collect that sample [and] you are processing it as a fasting- blood sugar even though the patient ate; you can give a glucose that is higher than what is expected for a fasting patient because the patient did not fast and the doctor will be misled. He will think that the person is diabetic when the person is not...”

Improving the human factor

Irving said that as part of the project a National Advisory Committee has been formed chaired by Minister of Health, Dr Leslie Ramsammy. The committee comprises stakeholders the University of Guyana, the Guyana National Bureau of Standards, the Ministry of Finance, the Guyana Medical Association, the health ministry and the Pan American Health Organisation (PAHO) among others.

The committee is tasked with coming up with a strategic plan for laboratory testing in Guyana and to keep in touch with the project’s management in Trinidad to help them improve the country’s quality.

“We hope in the next five years that we would have all laboratories in Guyana being accredited towards one standard and the standard that we are trying to implement in laboratories in the Caribbean is ISO (the International Organisation for Standardisation) 15189.” Irving said this new standard was specifically for the medical laboratories, and had particular requirements for quality and competence. Competence has to do with your testing-personnel...”

Irving said when someone graduated with an associate degree in medical lab science they were supposed to have some skills in certain areas of laboratory work. “Meaning they should be able to move from the classroom into the laboratory and be able to do the basic tests.”

However, this was not the case today, said Irving.

She said the university did not have adequate facilities and there were often too many students who might not get exposure to practical aspects.

“What this project is trying to do, is start from the universities and add certain competencies into the curriculum so that graduates will know some basic things when they leave the university and go into the work place... What they are doing [the project officials] is to speak to the people who head the labs where these students go to work and asking them, `What do you expect of an entry - level technologist?’...”

A workshop is planned at the end of October in Trinidad and a representative of the University of Guyana will accompany Irving so that a general curriculum for all the teaching facilities in the Caribbean for medical- lab science can be devised.

The project is also training two persons in Guyana, one is Irving herself as a Laboratory Manager, who will interact with the labs; and a Quality Manager, Lynette Hardy, who is the Chief Technologist at the National Blood Transfusion Centre. Irving and Hardy will be trained over the next three years and then will implement what they have learnt in three pilot laboratories: the Georgetown hospital lab, the West Demerara Regional Hospital lab and the Eureka lab. She said that at the end of three years they hope to expand training to all laboratories, “so we will train technologists, we will implement quality systems in laboratories, whatever we were taught we have to come back to Guyana and implement.”

Irving decided to use the three labs listed above for the pilot project because one is public lab, one a private lab and the other a regional lab.

External accreditation and evaluation needed

In Guyana, every lab receives a licence from the GNBS but it is not accredited, which is what Irving, through the project, will be hoping to implement.

When a lab is accredited, it basically means that it is competent in what it is doing, “and accreditation is done by an external body, the same person who licenses you cannot accredit you.”

Presently the labs are being licensed to a standard ISO 17025 but within the five years it is the hoped that labs will be accredited by ISO 15189. She said since Guyana did not have any accrediting agency the labs would have to be accredited by a body outside of Guyana.

Guyana has some twenty-five labs in addition to a few small- physician office laboratories, (POLs).

Not all labs in Guyana are `certified’ by the GNBS and the bureau usually publishes the names of the labs to which they have issued licences. The problem lies in ensuring that the labs follow guidelines to which they are committed.

According to her, one of the certifying - requirements of a lab is for it to be enrolled in a proficiency-testing or external-quality assessment, which should be located out of Guyana.

However, she said labs here had not had any proficiency -testing schemes.

Because standardisation is voluntary, “that is why we are having a problem with labs complying, so what we hope to do is that it can be legislated and be made mandatory because all medical laboratories should get accredited to ISO 15189.”

The countries expected to benefit from the CAREC project are; Antigua & Barbuda; The Bahamas; Barbados; Belize; Dominica; the Dominican Republic; Grenada; Guyana; Haiti; Jamaica; Saint Kitts & Nevis; Saint Lucia; Saint Vincent & the Grenadines; Suriname; and Trinidad & Tobago.