Date Published: February 24, 2017
Author(s): George Alemnji, Lisa Edghill, Giselle Guevara, Sacha Wallace-Sankarsingh, Rachel Albalak, Sebastien Cognat, John Nkengasong, Jean-Marc Gabastou.
Implementing quality management systems and accrediting laboratories in the Caribbean has been a challenge.
We report the development of a stepwise process for quality systems improvement in the Caribbean Region.
The Caribbean Laboratory Stakeholders met under a joint Pan American Health Organization/US Centers for Disease Control and Prevention initiative and developed a user-friendly framework called ‘Laboratory Quality Management System – Stepwise Improvement Process (LQMS-SIP) Towards Accreditation’ to support countries in strengthening laboratory services through a stepwise approach toward fulfilling the ISO 15189: 2012 requirements.
This approach consists of a three-tiered framework. Tier 1 represents the minimum requirements corresponding to the mandatory criteria for obtaining a licence from the Ministry of Health of the participating country. The next two tiers are quality improvement milestones that are achieved through the implementation of specific quality management system requirements. Laboratories that meet the requirements of the three tiers will be encouraged to apply for accreditation. The Caribbean Regional Organisation for Standards and Quality hosts the LQMS-SIP Secretariat and will work with countries, including the Ministry of Health and stakeholders, including laboratory staff, to coordinate and implement LQMS-SIP activities. The Caribbean Public Health Agency will coordinate and advocate for the LQMS-SIP implementation.
This article presents the Caribbean LQMS-SIP framework and describes how it will be implemented among various countries in the region to achieve quality improvement.
Strengthening laboratory services and systems to meet the challenge of the growing burden of diseases of global public health importance has been the focus of discussions and recommendations by the international community.1,2,3 Implementing laboratory quality management systems (QMS) and attaining accreditation has been an important part of these discussions.4,5 Laboratory accreditation to international standards verifies laboratories’ competence and ensures that they can provide evidence that test results are reliable and accurate to support patient care and public health practices.6,7
Rich in culture and diverse ethnicities, the Caribbean has the world’s largest collection of small island states, many of them independent nations. Many of them depend almost solely on tourism as the main economic driver, resulting in a variety of different growth rates and per capita incomes. A disease outbreak can have catastrophic impacts on the social and economic development of these already fragile economies, which can lead to global isolation. Evidence has shown that a priority for government is to ensure that the health sector, specifically medical laboratories, maintain a high capacity to provide reliable and timely information to protect public health and guarantee long-term sustainability of economic growth factors.
The implementation of the LQMS-SIP is a joint effort by several stakeholders in the region, with each partner performing activities specific to its recognised role and providing expertise in the implementation process as required. Specifically, the Caribbean Community Regional Organisation for Standards and Quality, which is the Caribbean Community centre for promoting efficiency and competitive production in goods and services through standardising and verifying quality, has hosted the Secretariat of the LQMS-SIP since mid 2013. Stakeholders agreed, at a regional consultation in 2014, that the management of the LQMS-SIP will be a mutual cooperation and collaboration among the two recognised Caribbean National Accreditation Bodies and the National Accreditation Focal Points, based within the Bureau of Standards of each country, and the Caribbean Regional Organisation for Standards and Quality Secretariat. The Caribbean Public Health Agency, mandated to serve as a coordination unit for the Caribbean Public Health Laboratory Network, will continue this function to ensure coordination and collaboration of various stakeholders for a common interest. The Ministries of Health of various countries, recognised as the principal owners of the process, are expected to work closely with the above entities as they rollout and implement the LQMS-SIP in their various countries. Other stakeholders including the Pan American Health Organisation/WHO, the US Centers for Disease Control and Prevention, professional associations and non-government organisations will work to sustain functional Public Private Partnerships to advance the course and ensure the sustainability of the LQMS-SIP.10
Well-designed and effective QMS operating in laboratories according to the requirements of an international standard such as ISO 15189, which could eventually lead to accreditation, is necessary for the Caribbean Region. The benefits of accreditation include the release of quality assured results for patients, cost savings in laboratory management, improved turn-around times, client satisfaction and enhanced staff competency.6,4,7 Furthermore, the International Health Regulations are an incentive for countries to develop, strengthen, and maintain the capacities of their laboratories to detect, assess, notify, and report health events to the WHO.1 Since countries in the Caribbean are signatory to this requirement, strengthening countries’ existing capacities for public health surveillance and quality laboratory services are critical for International Health Regulations implementation and continuous improvement of the health sector.