Mark Bas­sant

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.