Accreditation: Delivering Confidence to COVID-19 Testing

In recent weeks, there have been several articles/discussions in the media regarding the accreditation of private laboratories for COVID-19 testing. It is critical that we understand what accreditation is and how it impacts our medical testing laboratories and safeguard our health. As the national accreditation body of Jamaica, operating under the Ministry of Industry, Investment and Commerce (MIIC), the Jamaica National Agency for Accreditation (JANAAC) has a mandate to facilitate trade and safeguard health and wellbeing through accredited conformity assessment services.

Accreditation underpins the confidence that individuals, organisations and governments seek in the reliability of conformity assessment results, such as COVID-19 laboratory testing. In this unprecedented crisis, the results of medical laboratories conducting COVID-19 testing, are fundamental to the management of this global pandemic. The independent evaluation and accreditation of laboratories by the national accreditation body of Jamaica (JANAAC), which is the only internationally recognised accreditation body in the English-speaking Caribbean, give the assurance that the test results can be trusted. Accreditation confirms that the personnel, facilities, equipment and procedures meet international standards. These results influence the diagnosis and care of patients as well as the government’s decisions (restrictions, surveillance, etc.) to contain the spread of the virus within the population.

JANAAC has accredited to the ISO 15189:2012 Standard, fourteen (14) medical laboratories, seven (7) in Jamaica, including the two public sector laboratories, the National Public Health Laboratory (NPHL) and the University of the West Indies Microbiology Laboratory and the MircoLab, a private lab that is approved to conduct COVID-19 polymerase chain reaction (PCR) testing in Jamaica. JANAAC has also accredited seven (7) medical-testing labs which operate in other Caribbean territories, including the Caribbean Public Health Agency (CARPHA) and The Eric Williams Medical Sciences Complex Medical Laboratory in Trinidad, and The Eureka Medical Laboratories in Guyana that are also assisting the region in battling the COVID-19 pandemic.

The ISO 15189 International Standard specifies the quality management system requirements for medical laboratories and provides the benchmark against which they assess their competence. Though the accredited medical testing laboratories have not yet applied for COVID-19 testing scope extensions, their quality management processes confirm their competence to generate reliable testing results that lead to quality outcomes. The Agency supports COVID-19 testing by all accredited medical and testing labs that have the requisite competent personnel and suitable facilities and equipment. JANAAC is a signatory to the International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Agreement (MRA) for the ISO 15189 (Medical/Clinical Testing), ISO/IEC 17025 (Testing Laboratories), and ISO/IEC 17020 (Inspection Bodies) Standards. As an ILAC-MRA signatory, the test or inspection reports from CABs that are accredited by JANAAC are accepted worldwide.

The Jamaica National Agency for Accreditation (JANAAC) notes with interest, the measures taken by the Ministry of Health and Wellness (MoHW) to expand the nation’s capacity to conduct COVID-19 testing. The MoHW’s impending approval of some eight other labs (The Gleaner Article, Monday, November 2, 2020) that will be trained by the PAHO to use the new antigen tests to extend the testing capabilities is a commendable initiative to increase the nation’s COVID-19 testing capacity. According to the World Health Organization (WHO), the antigen test is easy-to-use, cost-effective, has a rapid turnaround time (15 minutes to >2 days), therefore providing the opportunity for early diagnosis and reduction in the transmission of the virus. Similar to the PCR test, the antigen test has a high specificity (>97%) in detecting the virus. Care should be taken in the use of the data as the antigen test kits have moderate sensitivity resulting in false negative and false positive results that makes it best suited to be used on symptomatic patients. A confirmatory PCR test may be necessary; the results should be discussed with the attendant physician who can assess symptoms with the results provided.

Nations across the globe struggle to emerge from the destabilising social and economic disruptions attributable to the impact of COVID-19. The numbers of infections and fatalities that rise at an alarming rate signal the need for effective measures to prevent, detect and treat the virus. In response, JANAAC, with immediate effect is making its internationally recognised accreditation services for scope extensions to include COVID-19 testing for both medical and testing laboratories available at 50% of the standard costs. The remaining 50% contribution will not become due until the 2021/2022 fiscal year. We believe this is vital to the normalisation of commerce and free movement of people within and across international borders.

JANAAC remains steadfast in its mission to deliver internationally recognised accreditation and technical training services to private and public sector conformity assessment bodies (CABs), that is, medical laboratories, inspection bodies and certification bodies.