Lead Editor, Investigative Desk
Medical professionals and owners of private health institutions say the Caribbean Public Health Agency (CARPHA) has no authority to validate labs in Trinidad and Tobago.
The claim comes even as Minister of Health Terrence Deyalsingh announced on Tuesday that private labs were now being considered to assist CARPHA in bolstering the number of COVID-19 tests health authorities will be able to conduct across the country.
Deyalsingh said then, “We are asking all private labs, once you have a PCR machine, to approach CARPHA for validation.”
Deyalsingh’s drive came the day after Prime Minister Dr Keith Rowley, in extending the “Stay-at-Home” measures from April 15 to April 30 on Monday, hinted that cases of COVID-19 cases could intensify by the middle of this month.
“Clearly, we’re not going to be in a position on April 15 to be able to tell the public you can come out and return to some resemblance of normalcy. It’s the other way around ... it’s quite likely, certainly possible, we may be in a worse situation than we were on the first 15 days of staying home,” Rowley said then.
However, the owner of a private health institution, speaking on the condition of strict anonymity, has told Guardian Media that CARPHA has no jurisdiction to certify a Trinidad and Tobago lab to undertake such testing.
“It’s not CARPHA’s duty to validate labs, it is for the Ministry of Health to do so. These labs must be licensed to practice,” the private owner said.
The owner said the ministry’s attempt to shift the testings to the private sector was being perceived as a weak move by the Government.
“Why hasn’t the Ministry of Health procured Point of Care (POCT) PCR testing equipment, which is reasonably priced and can be deployed at all RHA hospital labs and possibly health centres? Medical laboratory technologists from the RHA system can be quickly trained and deployed so that islandwide testing can be available.”
He added, “There are creditable companies such as Randox in England and Molbio in India that manufacture credible and certified POCT PCR machines that are benchtop analysers and are reasonably priced (US$15,000-30,000 range). They do not require a lot of infrastructure such as Biosafety Cabinets etc and can easily be deployed. In this way, the ministry, with its abundance of human and physical resources, can have more control and oversight in managing COVID-19 testing for the country.”
Another private health care owner in East Trinidad said as far as they knew, CARPHA did not have any jurisdiction to validate labs in the country. In fact, the owner questioned whether the ministry had any regulations in place for private medical labs in the country and also asked if there was a registry of licensed labs.
“Can the minister tell us what regulations are in place to prevent non-qualified persons to open and run medical labs and more importantly, at this time, offer inaccurate COVID-19 testing?” the owner, who also did not want to be named, asked.
Contacted via telephone yesterday, Chief Medical Officer Dr Roshan Parasram told Guardian Media that CARPHA, from a legal perspective, indeed could not validate labs but would be acting more as technical oversight to do the validation.”
“We are trying to be as stringent as possible in the validation of the test results. We have to ensure the results are of a certain quality and follow standard processes and are accurate and that is why the tests done by the labs are then sent to CARPHA who repeat the tests before it is sent it to us,” Parasram said.
Parasram said the ministry and CARPHA will be sending out a joint press release today to clarify any issues in relation to the local labs and CARPHA.
Guardian Media spoke to CARPHA executive director Dr Joy St John on Tuesday and had asked if they could validate local labs. St John”reserved comment on the matter” then pending a press release she said planned to send out that night. Contacted again on the same issue yesterday, St John again offered no comment but gave the assurance that a media release will be issued in the near future to address the matter.
Guardian Media also sent questions via WhatsApp to Minister of Health Terrence Deyalsingh on Tuesday evening for clarity on the issue.
These were the questions:
“Minister, is it really CARPHA’s duty to validate labs? Isn’t this the direct responsibility of the Ministry of Health? My understanding is it is up to the regulators, in this case, the MoH, to have an agency register as a lab and practice. Can you explain?”
The minister never responded to the questions although he read the message, as was indicated by the two blue delivered ticks.
Fuad: Law should be
put on books
MP for Barataria/San Juan Dr Fuad Khan, himself a former health minister, has also confirmed that CARPHA did not have any jurisdiction to validate local labs for COVID-19 testing, also noting there was nothing on the law books which currently allowed for this process.
“When I was minister of health, I had brought to parliament the Accreditation Bill, which took into consideration labs, hospitals and other institutions. We started the debate in parliament and when Colm Imbert, the former minister of health, pointed out some flaws on the bill, we were to get together and fix those flaws and back to parliament for debate after it was withdrawn to be returned for further debate, but it never came back. The reason being the flaws were to be corrected by the Ministry of Health,” Khan said.
He added, “There is no body for the accreditation of labs in Trinidad. CARPHA cannot accredit a lab. CARPHA is just a big lab to check out other labs. They can only ensure checks and balances that the kits are bonafide and accredited. Labs in Trinidad and Tobago have to use international standard test kits which have been approved by a recognised body aboard. These bodies usually have accredited lab kits and they would have accredited results. However, an unaccredited lab can use an accredited lab programme or kit.”
He also explained that labs are not internationally accredited or accredited by the Accreditation Council in T&T.
“Rules and regulations first must be observed via the parliamentary bill (in this case the Accreditation Bill) before you can go to the Accreditation Council of Trinidad and Tobago (ACTT). However, if a lab wants to get international accreditation they can apply through an international body such as the Joint Council of International Accreditation (JCI).”
Khan said he was of the view the Accreditation Bill should be brought back on the parliamentary agenda to be debated. He said under his tenure as health minister, results obtained at local labs had to be taken to be retested in the United Stated at an accredited lab.
“What we had found was that the Trinidad and Tobago labs were not close to the results we got from the US lab. And that is why it is important that we get the accreditation of labs done as soon as possible. Let me also add that ISO-certified does not necessarily mean they are accredited,” Khan said.