Gov't pleads to unauthorised COVID testing labs to seek accreditation

Gov't pleads to unauthorised COVID testing labs to seek accreditation

Senior staff reporter

Friday, January 22, 2021

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THE island's accreditation agency has issued a plea to facilities involved in 'back-door' COVID-19 testing to come forward to seek authorisation to administer tests for the virus.

Despite the health ministry naming labs that are approved to offer tests for the novel coronavirus, the unauthorised market is thriving locally, state minister in the Ministry of Industry, Investment and Commerce (MIIC), Dr Norman Dunn told a press conference yesterday.It is not clear, however, whether the responsible ministries have taken action against the unauthorised labs, as based on responses to questions about sanctions against those operating outside the law, the authorities have so far relied on anecdotal and media reports.

With the US, Canada and other countries now requiring negative COVID tests to enter their borders, more Jamaicans are getting tested, and those seeking to avoid the cost of some $20,000 for a polymerase chain reaction (PCR) test have been searching for alternative options.Dermon Spence, permanent secretary in the MIIC, which has responsibility for accreditation, appealed for entities to start the accreditation process. “We are equipped and we are prepared to respond and we are extending the invitation to all these unauthorised facilities that are operating outside of the registered and approved space,” he said.

Amidst the furore surrounding reports of unauthorised testing, the Ministry of Health and Wellness announced the approval of eight labs for COVID-19 testing, but yesterday the Jamaica National Agency for Accreditation (JANAAC) pointed out that not all eight have full accreditation.

What they have achieved is “no objection” approval from the health ministry, based on the standard of the facilities and procedures, and World Health Organization (WHO)-approved training.Accreditation is a wide-ranging, and extensive technical process, which allows for pre-accreditation until all requirements have been fulfilled. This puts the labs which have achieved pre-accreditation in a stronger position for approval to do COVID-19 tests.

Chief executive officer of JANAAC, Sharonmae Shirley, explained that accreditation is a continuous process, and that for now, these “no objection” labs are the ones which people should use. She stressed that the facilities are at the same time continuing with their accreditation programmes.

Said Shirley: “They will continue to perform based on their initial approval. Going forward, all of these entities that are not yet accredited [are invited] to come into the loop so that you're recognised because what will happen is that those entities that have the pre-accreditation certificate will now be in a stronger position and will be able to access a greater portion of the market because of this recognition.”

Shirley assured that the national accreditation agency is equipped and prepared to respond to the need for more approved labs for testing, even if there is a flood of applications.

Meanwhile, permanent secretary in the health ministry Dunstan Bryan said doctors are not engaging in illegal activity simply by administering COVID-19 tests, as long as the testing environment meets the safety standards. “Doctors, if they utilise the antigen test, would not be doing anything illegal, however, if they do that point-of-care test outside of an environment that protects themselves and the client from infection it then falls under the rubric of the Public Health Act in terms of health and safety,” Bryan explained. He said the facilities for PCR testing are very specific, requiring a specific type of machine and protocols that ensure patient isolation. The concerns mainly surround antigen testing, which can be administered by any licensed clinician, but must follow the infection prevention and control measures. The permanent secretary stressed that the “no objection” approval means that the public health authorities have trained and done the necessary sensitisation programmes with these labs in accordance with the WHO. “For the labs that we have on our list, what we are attesting to is the fact that these have gone through training for the WHO-approved antigen tests that are now in the island,” he stressed. “So we are not giving accreditation, what we are saying is that we have no objection.”

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