Standards and Legislation

In 2003, during the CAREC EU-funded project Strengthening of Medical Laboratory Services in the Caribbean, the Caribbean region agreed to adopt the international Standard, ISO 15189 as the Standard for medical laboratories within the region. In 2004, the Project developed Guidance Documents in English, Spanish, Dutch and French for implementation of ISO 15189.

In reviewing the Preparedness of Caribbean laboratories for Accreditation, CMLF determined that key issues included the critical need for support from health decision-makers for:

  1. Introduction of national systems for licensing, oversight and monitoring including systems for monitoring of laboratory safety
  2. Assignment of dedicated trained Quality Managers
  3. Provision of resources – human and financial – to ensure continuous quality assured services
  4. Continued training of staff in QMS

In 2010, CMLF, building on the stepwise approach outlined in the initial approach to licensing of medical laboratories within the Caribbean region, developed Stepwise Phases for Quality Management Systems Implementation and Preparation for Accreditation in Medical Laboratories.

In 2011, CMLF participated with the Pan American Health Organisation/World Health Organisation and US Centers for Disease Control and Prevention in the development of the Laboratory Quality Management Systems – Stepwise Implementation Process (LQMS-SIP).