Accreditation agency urges end to subletting of COVID-19 test kitsMonday, March 08, 2021
BY KIMBERLEY HIBBERT
CHIEF executive officer (CEO) of the Jamaica National Agency for Accreditation (JANAAC) Sharonmae Shirley is encouraging medical facilities to apply to the JANAAC Pre-Accreditation Approval Programme (PAAP) and get their organisations formalised for COVID-19 testing to ensure consistency in the quality of test results used to determine patient care.
Shirley made the appeal in a written response to queries by the Jamaica Observer regarding the subletting of COVID-19 test kits to private doctors by some of the labs approved for testing.
“We encourage persons to use a JANAAC PAAP approved facility. The JANAAC PAAP is designed with sufficient rigour to prevent this type of act from occurring. We urge entities previously approved by the Ministry of Health and Wellness to apply to the JANAAC PAAP and get their organisations integrated into our system.
“This will allow for JANAAC to conduct a robust assessment and monitoring system for the approved labs and point of care testing providers to verify the consistent quality of test results used to determine patient care,” said Shirley.
She told the Observer that for the pre-accreditation, JANAAC assesses applications against 12 minimum requirements, summarised from the technical requirements of the ISO 15189:2012 standard (clinical sample) or the ISO/IEC 17025:2017 standard (non-clinical samples).
With regards to what applicants, including private doctors, can expect, the process, Shirley said, application forms and associated documentation are reviewed within a day of submission and an assessment team is selected.
Shirley said once a date is confirmed with the applicant, an assessment of the testing facility is conducted against the minimum requirements and a report is submitted to the applicant within five working days.
The JANAAC CEO said the facility will be given time to implement corrective actions for deficiencies identified and a revisit by the JANAAC assessment team may be necessary.
She further pointed out that depending on the testing providers ability to close out findings, the process could range from seven days to six weeks.
Shirley added that after resolving the issues identified, JANAAC then awards a pre-accreditation certificate to the facility.
In the meantime, Shirley said JANAAC provides internationally recognised accreditation services that facilitate market access, assures confidence in the quality and integrity of goods and services, and safeguards consumer well-being.
“Accreditation is given to medical laboratories to the ISO 15189 standard; testing and calibration laboratories to the ISO/IEC 17025:2017 standard and inspection bodies to the ISO/IEC 17020 standard. JANAAC will soon offer accreditation services to certification bodies to the ISO/IEC 17021 Standard and Point-of-care Testing to the ISO 22870 Standard,” said Shirley.
Yesterday the Sunday Observer revealed the findings of a probe that revealed that some of the labs approved for COVID-19 testing by the health ministry are subletting the tests to private doctors without any training or adherence to testing standards.
A well-placed source shared that the approved labs were 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.
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