Some labs reselling kits to unapproved private facilitiesSunday, March 07, 2021
BY KIMBERLEY HIBBERT
A Jamaica Observer probe has revealed that some of the labs approved for COVID-19 testing by the Ministry of Health and Wellness (MOHW) are subletting the tests to private doctors without any training or adherence to testing standards.
A well-placed Sunday Observer source shared that the approved labs are operating like a cartel and marking up the tests by 150 to 200 per cent, then charging a separate fee to doctors to use their name as an affiliate.
“Only three people, apart from the labs, have been approved by JANAAC [Jamaica National Agency for Accreditation], yet some labs have at least 20 people doing testing for them. Whose standards are being maintained with all these people doing the subletting of the testing? Nothing has changed. Anybody, once they have money, can pay the labs some money and set up a tent anywhere. Nothing has changed except a select group of people control the testing and there are no standards being maintained,” the source said.
“People testing under labs have failed the JANAAC approval. Basically, private labs are outsourcing at a tremendous profit to private doctors who are then testing without any of the regulations the MOH insisted had to be in place. The tests come into the island and are sold for less than $2,000 and re-sold at upwards of $4,500. Then you're charged anywhere from $1,000 to $2,500 to use their name to do the testing or use their logo,” the source added.
“It's just straight double standard. If it is so rigorous and so dangerous that it's only eight people you trust to do it, why is it that you allow these eight people to go out, institute it in lax environment where you have no control over the training, and you have no control over where the tests are being done? Why is there a change?” the source asked.
When the Sunday Observer contacted JANAAC, CEO Sharonmae Shirley, in a written response to the newspaper's queries, said the agency is not aware of approved COVID-19 testing labs that sell the tests to private doctors.
Shirley reinforced that permits are granted through the Standards and Regulations Division of the MOHW for the acquisition of COVID-19 test kits, adding that from a quality and safety perspective subletting or selling the COVID-19 test kits should not be allowed.
“Each entity should be assessed in its own right, based on the competence of the personnel and the suitability of the location for sample collection and testing,” Shirley said.
She added that, if the sample is not being collected by private doctors in the manner required by the MOHW and the facility does not have the requisite biohazard management systems in place, then the collection and testing would be in breach of the Public Health Act.
On January 21, 2021, JANAAC and the Ministry of Industry, Investment and Commerce launched a Pre-Accreditation Approval Programme (PAAP) for unaccredited medical and testing laboratories and point-of-care testing, (POCT) providers — doctors offices, medical centres and pharmacies — to participate in a process wherein JANAAC will verify and validate their technical competence to conduct COVID-19 testing.
Successful applicants under the JANAAC PAAP are then awarded a Pre-Accreditation Certificate confirming their competence and conformance to the technical requirements to conduct COVID-19 testing. JANAAC then advises the MOHW of the labs and POCTs that have been awarded an accreditation or pre-accreditation certificate for COVID-19 testing to facilitate addition to the health and wellness ministry database of approved COVID-19 testing facilities and for subsequent publication on the MOHW website. This information is also shared with the media and the Consumer Affairs Commission for dissemination.
While Shirley was unable to speak to sanctions that would apply to entities approved by the health ministry for COVID-19 testing, she said if the practice is occurring with PAAP customers their approval will be rescinded by JANAAC.
Further, the CEO said 26 medical facilities submitted applications for pre-accreditation approval since the launch of the JANAAC PAAP up to the end of February 2021.
Shirley said, so far, 14 assessments were conducted by the JANAAC team of accreditation experts for clients that satisfied its application requirements. The remaining clients, according to Shirley, are implementing measures to prepare for assessments, and some are being assisted in that process by the National Accreditation Focal Point Jamaica.
However, provisional pre-accreditation approval for COVID-19 testing was granted to only three medical facilities.
Shirley said these facilities include Oneness Health Centre Limited in Montego Bay, Windsor Wellness Centre and Dunrobin Medical and Wellness Centre, both in the Corporate Area, which are the first POCTs to be endorsed by the agency.
Shirley added that after two years of obtaining pre-accreditation approval, all applicants under JANAAC PAAP are expected to transition to the respective general accreditation programmes.
When the Sunday Observer contacted Dr Alfred Dawes, principal of Windsor Wellness Centre, he said he was working with one of the accredited labs, explaining that it was the only opportunity for him to offer COVID-19 testing under the current regulation.
“I have JANAAC approval and I am working towards a formal public-private partnership with the Ministry of Health. I had to go through a stringent process that includes the protocols in place, the environment, training, in order to qualify for the JANAAC approval,” he said.
Asked if he was aware that some of his colleagues without JANAAC approval were being sold tests by the accredited labs and conducting COVID-19 testing in areas not approved, he said, “I can't speak to anybody else who is doing any testing right now.”
But, Dr Lincoln Wright, a community-based physician in Port Maria, St Mary, is in disagreement with labs being the main facilities approved for testing.
“Approving nine labs is madness. All that did was create a bottleneck situation. People who were travelling, had surgeries, and they had to be put off. The date they got for the test was after the surgery should have been done. Persons travelling had to cancel flights as the testing dates were long after they should have departed the island. We don't have enough hospitals and health centres doing the testing.
“When you go to health centres, most health centres hours are scaled down — and in remote areas they are not opened every day of the week. We are not sure they are doing the antigen testing either, which has a quicker turnaround time,” Dr Wright said.
Asked if he was aware that some of the approved labs were subletting COVID-19 tests to private doctors, he said he did not know exactly what was happening but charged that it was insulting to doctors to ask them to go through hoops to do a COVID-19 test.
“If the doctors have a medical centre or facility, they should test. Doctors do not only use a stethoscope or blood pressure machine in their office any more. They do urine tests, ECGs, ultrasounds and offer procedures. This COVID test is basic. All you have to do is practise good, sterile techniques. In this pandemic we need all hands on deck with open arms to do the testing. There are far too many barriers,” Dr Wright said.
Meanwhile, Dr Michelle Hamilton, head of the National Public Health Laboratory Services, thanked the Sunday Observer for bringing the development to her attention and asked that questions be sent to her and a response would be provided. Up to press time, no response was provided.
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