Industry ministry, JANAAC regulating COVID-19 testing facilitiesMonday, March 01, 2021
THE Ministry of Industry, Investment and Commerce and the Jamaica National Agency for Accreditation (JANAAC) are seeking to regulate COVID-19 testing facilities through the Pre-Accreditation Approval Programme (PAAP).
State minister Dr Norman Dunn said that the programme will enable facilities to adequately meet public demand for fast, accurate and cost-effective COVID-19 testing in order to ensure “the best possible health outcomes for the entire population. The provision of accurate test results is integral to the decisions made by Government leaders and health care professionals in treating this global health crisis. It is equally important in building global trust, which is necessary to reduce the uncertainties associated with overseas travel,” Dr Dunn said.
He was addressing a JIS Think Thank last Friday at the agency's office in Kingston.
PAAP will expand the nation's network of laboratories and medical facilities that have the required capabilities to conduct tests. This will also reduce conditions that may give rise to unauthorised facilities conducting COVID-19 testing on the black market.
Dr Dunn pointed out that JANAAC's international recognition for the accreditation of medical and testing labs assures that the results generated by these entities can be trusted.
“This not only facilitates trade but also protects consumers' well-being. Accreditation underscores data quality, data handling and client care, which are pivotal factors, as medical decisions are based on the results generated by our medical testing labs,” he noted further.
Chief executive officer of JANAAC, Sharonmae Shirley, who also addressed the JIS think tank, explained that PAAP will provide a pathway to accreditation for those conformity assessment bodies that do not currently satisfy all the requirements of the relevant international standard.
She outlined that JANAAC will assess COVID-19 testing providers against 12 minimum requirements, summarised from clauses 126.96.36.199-4, 4.8 and technical requirements 5.1 to 5.9 of the International Standardisation Organisation (ISO) 15189:2012 standard (clinical samples); or clauses 4 to 7 and 8.6.2 of the ISO/International Electrotechnical Commission (IEC) 17025:2017 standard (non-clinical samples).
She said that entities interested in applying to the JANAAC PAAP must ensure conformity with the previously mentioned clauses of the relevant standards.
Labs and Point-Of-Care Diagnostic Testing (POCT) facilities will need to conform to the international standards in implementing a medium-term plan to seek accreditation. The standard that is used for accreditation under PAAP will depend on several factors, such as the type of laboratory provider and any local or national requirements. Applicants are required to purchase a copy of the standard(s) applicable to their scope of work.
Shirley told JIS News that the Ministry of Health and Wellness, through the National Public Health Laboratory (NPHL), will organise an external quality assessment programme for PAAP applicants.
“As a mandatory requirement, PAAP applicants must demonstrate their technical competence through participation in appropriate quality assurance mechanisms, such as external quality assessment,” she noted.
Shirley, in highlighting the importance of the undertaking, said it is “crucial that testing facilities are regulated and accredited, as standards must be maintained to not only ensure quality but to safeguard the health of the nation”.
“If you receive a false-negative COVID-19 test result because the facility was negligent in conducting the test, you, the patient, run the risk of compromising the health of others while inadvertently neglecting yours,” she pointed out.
She advised citizens to be vigilant and to only utilise the services of accredited laboratories, which are listed on the health ministry and JANAAC websites.
JANAAC is the only internationally recognised accreditation body in the English-speaking Caribbean that is a signatory to the International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Arrangement and the Inter-American Accreditation Cooperation Multilateral Recognition Arrangement (MLA) for ISO/IEC 17025 (testing laboratories) and ISO 15189 (medical testing).
The agency is also a signatory to the ILAC Mutual Recognition Arrangement for accreditation of inspection bodies to the ISO/IEC 17020 standard.
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