Medical tests are generally reliable
-says Standards Bureau head
September 1, 2003
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Director of the Guyana National Bureau of Standards (GNBS), Dr Chatterpaul Ramcharran does not feel that the certified medical laboratories in Guyana produce erroneous results as was recently claimed by National Lab Director, Yvette Irving.
Ramcharran told Stabroek News that while about five years ago the laboratories were at “gutter level” they had vastly improved through the work of the GNBS which had been certifying laboratories. He said he would recommend anyone to go to the GNBS certified laboratories for good testing results.
On Monday Stabroek News published an article in which it was stated that testing for diseases by the laboratories was chaotic and could often produce erroneous results with serious implications for patients.
Irving had said 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.
She had also stated that there were cases of people committing suicide after receiving wrong results for HIV. Ramcharran said he was aware of one such case and the testing had not been done at one of the certified labs.
He could not vouch for the labs that were not certified but only for the certified labs, adding that the bureau would like to be informed of any certified labs that had discrepancies.
The seven certified labs are: the Georgetown Public Hospital lab, the Eureka laboratory, the Guyana Responsible Parenthood Association laboratory, Bio- Med Lab, Sigma Lab, St Joseph Mercy Hospital lab and the Guyana Medical Laboratory.
“The others [labs] are working in terms of developing their manuals... and also their procedural manuals.”
“Where you can have weaknesses is when they don’t maintain this management system, for example if you have a rapid turnover of staff, your system must be strong enough to buffer the effects of this.”
According to Ramcharran, the labs were not using the ISO 17025 standard, since the GNBS along with other partners were still working towards that standard. He said that ISO 15189 just applied to medical laboratories and the GNBS did not only deal with medical labs but all labs.
He explained that when they started the certification project in Guyana about four years ago they started with the international standard ISO 17025 but the laboratories, particularly clinical laboratories, were operating at a level that they could not think of using the standard as it was far beyond what was being used.
“They were below, at the gutter level, so we had to derive a national standard, which is a standard which has been revised recently and it is very close to this [ISO 17025] now.”
He feels that the word “chaotic” might have applied four years ago but since then the labs have been brought up to the level where they could now use the international standard.
The GNBS is working with industrial and all other labs to implement the international standard.
Ramcharran said that there had been significant improvements, “in terms of complaints coming across to us.”
Explaining the aspect of proficiency testing, he said the labs did not have to be a member of the proficiency testing scheme but rather they only had to participate in one.
Ramcharran said that they could take part in the testing scheme locally if such a body existed in Guyana but because there was no such scheme in this country the body had to be external.
“What we are doing right now, is the bureau is co-ordinating a proficiency testing scheme by getting the reference material and sending the reference samples to laboratories and they are testing the samples and sending them back.”
He admitted that all the laboratories were not being involved in the proficiency- testing scheme as only some of them had been doing it on their own.
However, he contended that participation in a proficiency-testing scheme was once again voluntary. He said that the labs could apply their own quality control to double check on their results. “There are four or five different alternatives that they can use in terms of checking on their results. But proficiency-testing is one of their options, but in accreditation it will not be an option it will be mandatory...”
Ramcharran told Stabroek News that he “would be bold enough to make this statement that the standards department of the Ministry of Health has the responsibility and should be active in actual fact... in spearheading the proficiency-testing scheme in Guyana” but that had not yet been done.
Speaking of the upcoming European Union project, Dr Ramcharran said that it would not be successful if the agency in Guyana was not active and not involved in trying to maintain the system of the laboratories to be accredited. “Because a laboratory could be accredited, yes, and they have the staff, the equipment and everything and the accreditation. But if these people [agency] don’t maintain the system we will return back to square one.”
He disclosed that the GNBS would be working with the clinical labs up to the point where the project would kick in and it would concentrate on all the other labs.
Ramcharran is of the opinion that the standard department of the Health ministry should be more pro-active in making certification of laboratories mandatory.
“That is the national body where clinical laboratories are concerned and they should have the control, not only in the public sector laboratories, but all laboratories, and I feel they should not wait for legislation to do this. A lot can be done without legislation...”