MDL set for full accreditation as it moves to permanent role
The coronavirus testing facility Molecular Diagnostic Laboratory will “imminently” move onto a pathway to provisional registration, with a view to getting full accreditation by the end of this fiscal year.
Ricky Brathwaite, the chief executive of the Bermuda Health Council (BHeC), said the move was necessary because MDL, initially assumed to be a short-term lab, would have to take on a permanent role with the ongoing pandemic.
Dr Brathwaite said: “It’s our responsibility to ensure all laboratories are accredited or on a pathway towards accreditation.
“Since last April we have been trying to figure out the timing, of how long the laboratory would have to exist. It’s no longer considered temporary, so then our legal responsibility kicks in for regulation.”
He said it had been apparent for “the last few months” that the lab’s role would need to be expanded.
Dr Brathwaite explained the move had not been prompted by complaints about the lab’s performance or the availability of tests.
MDL is one of four approved local clinical laboratories tasked with work related to Covid-19, along with C & S West, Helix and the Bermuda Hospitals Board’s laboratories.
According to the BHeC, MDL was set up as a temporary facility through a collaboration with the Caribbean Public Health Agency, the Pan American Health Organisation and local lab professionals.
The regulatory move reflects its long-term role with expanded laboratory and research capacities.
Dr Brathwaite said full accreditation would require on-island inspections.
Status can be granted by the College of American Pathologists, the Caribbean Laboratory Accreditation Scheme, the Commission on Office Laboratory Accreditation, or Joint Commission International – with other accreditation bodies possible after a review by the health minister.
According to the BHeC, MDL is already monitored regularly with local and international checks on its results.
Dr Brathwaite said provisional legislation would cover the lab’s compliance with local legislation.
He added: “We recognise the need for robust technical approval to ensure the public’s sustained confidence in our laboratories, their scientific methodologies, and their testing results.”