IJCA - Volume 3 - Flipbook - Page 22
20 The International Journal of Conformity Assessment
The International Laboratory Accreditation
Cooperation-Mutual Recognition Arrangement
(ILAC MRA) is an agreement signed by signatory
accreditation bodies to recognize the equivalence of
the accreditation schemes operated within the scope
of their signatory status. The ILAC MRA ensures that
CABs in different economies operate to the same
international standards (6).
ISO 15189 is a standard established by Technical
Committee-TC212, first published in 2003 and
updated in 2007 (second edition), for the quality and
competence of medical laboratories (7). It is derived
from ISO 17025, the general requirement for testing
and calibration. Currently, ISO 15189 is used as the
standard for medical laboratory quality management
systems, declaring quality and competence (8).
The accreditation of healthcare programs began in
the 1980s globally (9) and around the 1990s in Europe
during the period of quality healthcare improvement.
The pioneer accreditation programs were the North
American models for the joint commission on
hospital accreditation and then expanded to include
healthcare organizations and the Canadian council on
hospital accreditation (10).
Several key meetings have taken place to strengthen
and standardize medical laboratories in Africa,
including gatherings in January 2008 (Maputo,
Mozambique), April 2008 (Lyon, France), September
2008 (Yaoundé, Cameroon), September 2008
(Dakar, Senegal), July 2009 (Kigali, Rwanda), and
September 2009 (Kigali, Rwanda). In each meeting,
WHO and CDC were involved, leading to the creation
of the WHO-AFRO checklist. Laboratories that
demonstrated outstanding performance in the WHOAFRO process were encouraged to apply for ISO
15189 accreditation (10).
Few laboratories in developing countries have
established the international ISO 15189 standard
easily and affordably, often by designing customized
implementations. In response, the World Health
Organization Regional Office for Africa created a
stepwise approach called Stepwise Laboratory
(Quality) Improvement Process Towards
Accreditation (SLIPTA), implemented through the
Strengthening Laboratory Management Toward
Accreditation (SLMTA) program, due to financial
limitations for accreditation. SLIPTA uses a star
rating system from 0 to 5 to grade laboratories,
acknowledging their current status rather than
bringing radical changes in competence. It aims to
provide consecutive technical support and recognize
their progress using a scaled method (11).
ISO 15189 is a comprehensive standard for medical
laboratories that covers all stages of laboratory
activities, from pre-analytical to post-analytical,
including personnel competence, equipment,
methods, environment, and proper utilization of
reagents and supplies. Medical laboratories are
regularly reassessed by qualified assessors to ensure
sustained quality and are required to participate
in proficiency testing programs (EQAs). ISO 15189
accreditation necessitates competent technical
staff, committed management, efficient resources,
adequate time, and well-equipped laboratory
infrastructure (10, 11).
Quality laboratory services depend on trained
and competent laboratory professionals who gain
knowledge and skills through continuous professional
education. However, in sub-Saharan countries, most
healthcare organizations neglect this. The quality
provided by individual laboratories is questioned, and
not all facilities are enrolled in proficiency testing
programs (11).
As of December 2019, five regional cooperation
bodies were recognized under the ILAC MRA:
African Accreditation Cooperation (AFRAC), Asia
Pacific Accreditation Cooperation Incorporated
(APAC), Arab Accreditation Cooperation (ARAC),
European Cooperation for Accreditation (EA), and
Inter-American Accreditation Cooperation (IAAC).
Additionally, there were 101 accreditation body
signatories via the MRA from these recognized
regional cooperation bodies from 103 economies,
and one unaffiliated accreditation body, KCA from the
Kyrgyz Republic (5).
Out of 104 economies, some are full ILAC MRA
signatories, some are ILAC-associated members, and
some are affiliate members under 102 signatories.
The Ethiopian National Accreditation Office (ENAO),
South African National Accreditation Service
(SANAS), and Kenyan National Accreditation Services
(KENAS) are examples of full MRA signatories.
Accreditation bodies that are associate members of
ILAC and signatories to a recognized regional MRA
are automatically accepted as signatories to the
ILAC MRA (12). In addition to evaluations carried
out directly by ILAC, recognized regional cooperation
bodies conduct peer evaluation visits, such as
ENAO’s evaluation by Africa’s regional accreditation
body, African Accreditation Cooperation (AFRAC) (5).
