In 2008, the St. Augustine Medical Laboratory became the Caribbean’s first medical laboratory to achieve accreditation to the International Organisation for Standardisation (ISO) medical laboratory standard, ISO 15189. The certificate of accreditation was granted by the Quality Management Program - Laboratory Services (now known as Accreditation Canada (AC) Diagnostics), a subsidiary of the Ontario Medical Association of Canada. Our accreditation demonstrates the laboratory’s commitment to quality and competence.


Accreditation Canada Diagnostics

An Internationally Recognized Standard

Accreditation to ISO 15189 is a tool to demonstrate the competence of medical laboratories and ensure the delivery of timely, accurate and reliable results. To demonstrate the quality and reliability of their services, medical laboratories can seek accreditation to ISO 15189: Medical laboratories – Requirements for quality and competence, an internationally recognized standard that contains the requirements necessary for diagnostic laboratories to demonstrate their competence to deliver reliable services.

ISO 15189 covers the essential elements for medical laboratories to demonstrate the quality and competence of their services, as well as to consistently deliver technically valid test or “examination” results as they are known in the standard. The standard, which has been developed with strong involvement from the medical, scientific and clinical community, is for the use of medical laboratories in developing their management systems and maintaining their own competence; and for accreditation bodies to confirm or recognize the competence of these laboratories through accreditation.



Ensuring Compliance

To ensure continued compliance, the St. Augustine Medical Laboratory is regularly assessed according to ISO stipulations to check that they are maintaining their standards of technical expertise. The Laboratory is also required to participate in regular proficiency testing programs (known as external quality assurance programs or EQAS) as an on-going demonstration of their competence.

The Road to ISO 15189

In 2009, Dr. Bal Ramsaran was the American Association for Clinical Chemistry (AACC) featured expert as part of an on-going series known as Expert Access. During the live online program, Dr. Ramsaran discussed the road to ISO 15189 accreditation.

Accreditation Canada Diagnostics

Accreditation to ISO 15189 by Accreditation Canada (AC) Diagnostics is a mark of excellence recognized around the world. They assess the ability of a facility to perform medical testing or the collection of specimens with formal recognition of this competence through accreditation to our ISO 15189 Plus™ requirements. They also provides facilities with the tools they need to standardize their processes, address diminishing resources and set a quality benchmark.

American Association of Bioanalysts Proficiency Testing

In addition to continued compliance to ISO 15189, the St. Augustine Medical Laboratory undergoes proficiency testing through the American Association of Bioanalysts (AAB). The AAB is a national professional association whose members are clinical laboratory directors, owners, supervisors, managers, medical technologists, medical laboratory technicians, physician office laboratory technicians and phlebotomists. The St. Augustine Medical Laboratory also participates in inter-laboratory comparisons with accredited labs in the United States.