New lab working towards international accreditation

After years of practising lab science the former country lab director Yvette Irving has opened her own laboratory as she sees the needs for lab results in Guyana to be on par with those in other countries. While her quest is to have her new lab accredited internationally she is willing to work with other labs to ensure they too can accomplish that.

Irving, who up to a few years ago was working with the Ministry of Health and helped to develop the Health Facilities Act,

Yvette Irving
Yvette Irving

is heading an all-female line-up at the QualiTEST Laboratory which was recently opened at its First Street, Alberttown location.

“QualiTEST ‒ the name says quality in your tests. So we want to ensure that the results that patients are given here mean that we address a quality management system from the beginning to the end in the processing of the samples,” Irving told the Sunday Stabroek in a recent interview.

She noted the existence of the Health Facility Act which requires that a laboratory be licensed by the Ministry of Health as well as being certified by the Guyana National Bureau of Standards (GNBS) before it can become operational.

As a result, while her lab has been officially open Irving said it is still not operational as she is awaiting her licence from the ministry before she starts testing.

This, she said is very important, but it is a requirement that many local laboratories are not meeting even though it is stipulated in the law. In some cases this may be because a lab pre-dates the act, and previously would not have needed a licence.

For Irving the Ministry of Health needs to place some more emphasis on quality and strengthen its quality assurance department in all its institutions. She has offered her assistance in this area if needed.

 

There are instances where labs have opened at various sites around the country, but according to Irving even if the main lab has a licence this will not cover the smaller sites which have to be licensed individually.

“One license for the main lab cannot work for those little labs around the place…” she said, explaining that there is another standard the bureau uses and the smaller sites could be licensed with a point of care standard.

Irving went on to say that claiming that only the samples are taken at the smaller sites while the actual test is done at the main lab makes no difference, since the satellite labs still need to be checked to ensure that the collection of samples is being done according to the standard.

She noted that it is easy to meet the standards but people have just become comfortable with the way things are, and for years they might not have been checked. A licence has to be renewed annually.

‘Trying’

That being said Irving said that ministry and the country is “trying to move to ensure that quality testing is what the population gets.” She said the standards and technical service unit at the Ministry of Health is supposed to go to the various laboratories every year to ensure that they are certified by the GNBS and that the labs are being careful about the safety of patients, among other things.

“But I am not sure if it [the unit] actually functions but that is what is supposed to happen… so I think with all those things then there should be quality testing coming out of the laboratories, but I can’t say. I can say what would be happening at QualiTEST,” Irving said.

She recalled that as lab director at the Ministry of Health she had tried her best but the department did not have a lot of staff and as such they were unable to monitor testing all around the country. However, she had attempted to develop quality management systems for each region but unfortunately was unable to implement them.

“A quality management system in the various health facilities, not only for labs is very important… for instance like the infant mortality that has been happening recently at the Georgetown Public Hospital Corporation and I can’t say if they have or they don’t have… but it shows that there is something wrong with their quality management system if they have one, or [otherwise] it is just non-existent,” Irving said.

She said the country is not where it is supposed to be in terms of quality lab testing and that she would like to see at least one or two labs accredited to the international standard (the ISO). There are just eight or nine labs certified by the GNBS while there are other labs working towards this certification even though they are operational.

“International accreditation says your lab tests match with any produced in any country in the world; that the quality of your test is on par with any other country,” Irving said, noting that a test from such a lab would be accepted in countries like the US.

An insured person can be reimbursed in the US if they have a test done at an internationally accredited lab.

“Certification says that your lab has quality to operate in Guyana… but other countries might not accept your results, but if you are accredited with the ISO they will accept it,” she said.

There are such accredited labs in Jamaica and Trinidad and these labs can work along with labs in Guyana in assisting them to become internationally accredited.

However, notwithstanding this Irving said Guyana is better off than some other countries in the Caribbean as the country has accepted the accreditation standard and there is the Health Facility and Health Professionals Act.

“Some countries have nothing, so anybody can open a lab under any mango tree, any guava tree, in any little bottom house…” she said adding that the issue in Guyana is compliance and enforcement.

She called on the health ministry to take the lead in enforcing the laws. While to become internationally accredited calls for a lot of work, Irving said it could be done within two years

Qualified

Another concern for Irving is that there are times when the persons who are doing the tests in labs are not qualified or certified, as “people just think anybody could do testing, and that should not happen as people need to be trained.”

The lab specialist pointed out that in other societies if the phlebotomist damages a person’s nerve during a procedure they can be taken to court.

“It happens here in Guyana, your whole hand can be damaged… I have seen no damage of nerves but the entire hand got black because of a bad phlebotomy and nobody does anything. You just say well, I went to that lab and this is what happened but nothing happens…” she said.

Meantime, Irving said she does not see herself as a competitor to other labs noting

that the work that she is involved in means that she can offer the right service and at the same time support the other labs to bring their service up to the standard of international accreditation.

The motto of QualiTEST is ‘Precision and Professiona-lism’ and initially tests would be done in the areas of chemistry haematology & serology, electrolytes, kidney and liver function tests and urine analysis, among others.

Within a year Irving and her team hope to move towards receiving international accreditation for the various tests and eventually the entire lab would be accredited with an ISO accreditation.

When she was 15, Irving lost her mother to cervical cancer and it was from that age she felt that had she known more about signs and symptoms she would have urged her mother to take a test.

“So this whole thing about testing was always in my head…” she said, adding that when she went to the University of Guyana she read for a certificate in med-lab science and later she read for diplomas in micro-biology and chemical phytology.

In 1991 she secured a Government of Guyana scholarship to study in Canada for her bachelors in med-lab science and upon her return she worked at the Georgetown Public Hospital Corporation (GPHC) as the lab superintendent. Six years later she got a PAHO scholarship to read for her masters in medical science phytology, and for her research she looked at the prevalence of cervical cancer among Amerindian women which back then was very high, largely because there was little access to pap smear testing.

“I started thinking how I could help people, so that a little girl at the age if fifteen – her mother would not be taken away from her…that is what triggered my research on cervical cancer,” she said.

After leaving the Ministry of Health Irving went to Africa where she worked as a technical manager in an International Organization for Standardization (ISO) accredited laboratory where she worked for 14 months. She is back in Guyana but travels to other Caribbean countries frequently as she now works for a Center for Disease Control and Prevention (CDC) /PEPFAR funded project which is preparing 12 countries in the Caribbean for international accreditation. Guyana is not covered under that project since it has its own CDC project with an office here, while the office for the 12 other Caribbean countries is based in Barbados.

She works as a consultant with the various laboratories which are preparing for accreditation and it was precisely because of the work that she does with those labs that she saw the need to open a lab with similar standards in Guyana and head it herself.

Presently she also teaches the laboratory quality management course at the University of Guyana.

Irving is the single parent of one daughter who just graduated with high honours in Management Information Systems and who was recently accepted by New York University to read for her masters in Internet Security.

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