KINGSTON, Jamaica — Accurate testing is paramount in diagnosing and treating any disease, so Chief Executive Officer (CEO) of the Jamaica National Agency for Accreditation (JANAAC), Sharon-Mae Shirley, is imploring facilities to certify their coronavirus (COVID-19) testing service.

“The JANAAC Pre-Accreditation Approval Programme (PAAP) is designed to increase confidence in the quality, safety and reliability of COVID-19 testing services in Jamaica. Successful applicants under the JANAAC PAAP will be awarded a Pre-Accreditation Certificate confirming their competence and conformance to the technical requirements to conduct COVID-19 testing,” she told JIS News.

Shirley said that JANAAC’s impartial and internationally recognised accreditation services open the gateway for accredited clients to receive international recognition and acceptance of their test results.

JANAAC is the only internationally recognised accreditation body in the English-speaking Caribbean that is a signatory to the ILAC MRA and the IAAC MLA for ISO/IEC 17025 (testing laboratories) and ISO 15189 (medical testing).

“JANAAC’s stamp of approval attests to the entities’ conformance to the management and technical requirements of relevant international standards. Each successful entity under the programme is expected to become accredited within two years of completing the PAAP,” Shirley shared.

She noted that under the programme, JANAAC will conduct on-site assessments at labs and Point-Of-Care Diagnostic Testing (POCT) facilities to witness the suitability of the facilities, equipment, sampling practices, test methods, traceability and accuracy of test results.  Test reports, patient handling, among other technical activities, will also be monitored.

“Strict adherence to the relevant health and safety protocols will be observed to safeguard the clients and the JANAAC technical team. Remote assessments may also be performed for follow-up visits,” Shirley added.

 She explained that during the PAAP assessment, the National Laboratory Services will provide testing panels for inter-laboratory comparison (ILC), as required.

For interested entities, Shirley said that the completion of the programme can take less than two weeks.

“Once JANAAC receives a completed application form and associated documentation, it is reviewed within a day of submission and an assessment team is selected. When 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,” she explained.

Shirley told JIS News that in the event breaches are found, the facility will be given time to implement corrective action(s) for deficiencies identified. A re-visit by the JANAAC Assessment Team may be necessary in this event.

“Depending on the testing provider’s ability to address breaches, the process could range from seven days to six weeks. After resolving the issues identified, JANAAC will award a pre-accreditation certificate to the facility. JANAAC will only approve POCTs that utilise the test kits or antigen test kits for the detection of COVID-19 that are sanctioned by the World Health Organization (WHO) and Pan American Health Organization (PAHO). POCTs may contact the Ministry of Health and Wellness for further information on this matter,” she informed.

On pricing, Shirley shares that the technical services provided by JANAAC for its Pre-accreditation Approval Programme is heavily subsidised by the Government and excludes all internal JANAAC costs.

“Applicants will only be required to pay for travel-related costs (as applicable) and external fees. This provides an advantage to a wider cross-section of labs and POCTs to seek endorsement as official COVID-19 testing providers. The costs for the service can be found on the JANAAC website www.janaac.gov.jm,” she said.

Applicants are required to purchase a copy of the standard(s) that apply to their scope of work. JANAAC will assess COVID-19 testing providers against 12 minimum requirements, summarised from clauses 4.1.1.2-4, 4.8 and technical requirements 5.1-5.9 of the ISO 15189:2012 standard (clinical samples) or clauses 4-7 and 8.6.2 of the ISO/IEC 17025:2017 standard (non-clinical samples).

“Entities interested in applying to the JANAAC PAAP must ensure conformance with the mentioned clauses of the relevant standards and can familiarise themselves with the minimum requirements of the programme,” Shirley said.

JANAAC will publish on its website (www.janaac.gov.jm), a list of all the entities awarded pre-accreditation certificates to offer COVID-19 testing services. JANAAC will also share the list with the media and Consumer Affairs Commission for dissemination. The list will also be shared with the Ministry of Health and Wellness.

The application form and minimum requirements can be downloaded from: www.janaac.gov.jm/paap.html. Completed application forms can be emailed to servicerequest@janaac.gov.jm. Persons may also call (876) 968-7790/968-7799 to make enquiries via telephone.