IJCA - Volume 3 - Flipbook - Page 23
2024 | Volume 3, Issue 1
21
Despite the implementation of accreditation services
in Ethiopia, many accredited laboratories struggle to
maintain their quality services. Various challenges,
such as regulatory failure, lack of PT providers, lack
of calibration materials and calibrators, and lack of
awareness, have emerged since ENAO’s intervention
in 2017. (15).
Although efforts are being made to meet
accreditation requirements, no study has yet
examined the sustainability and utilization of
accreditation throughout the country. Addtionally,
there is a lack of data on the hindering factors
affecting accreditation utilization in Ethiopia. Thus,
this research project aims to identify the challenges
in the accreditation process that pose potential
threats to the sustainability of accreditation services
among Ethiopian medical laboratories.
Materials and Methods
STUDY DESIGN, STUDY AREA, AND STUDY PERIOD
Accreditation in Ethiopia began in 2010 following the
establishment of the Ethiopian National Accreditation
Office by the Council of Ministers under regulation
number 195/2010. It was re-established under
regulation number 279/2012 as the sole national
accreditation body to provide accreditation services
in medical laboratory (ISO 15189), testing laboratory
and calibration (ISO 17025), system certification (ISO
17021), inspection (ISO 17020), personnel certification
(ISO 17024), and product certification (ISO17065)
schemes, in accordance with ILAC rules (13, 14).
So far, more than 60 medical laboratories across
different scopes under healthcare institutions
are accredited in Ethiopia against ISO 15189
requirements. However, there are various
challenges, as accreditation is voluntary. Creating
an accreditation market has been very challenging,
and regulatory support is still needed due to many
documented and undocumented hindering factors.
Proficiency testing (PT) providers in the country
are lacking, forcing CABs to participate in EQAs
outside the country, which incurs high costs. Major
equipment calibrators and materials are also very
costly and not readily accessible in the country
(15). While documented information is limited,
these challenges might hinder proper accreditation
utilization. Therefore, this study aims to assess the
current accreditation utilization rate and identify the
major challenges faced by accredited laboratories
in Ethiopia.
A cross-sectional study design, incorporating both
quantitative and qualitative data, was employed
among accredited laboratories providing laboratory
services in Ethiopia. The study was conducted in
Ethiopia, located in the Horn of Africa. According to
the 2019 revision of the World Population Prospects,
Ethiopia’s total population was 109,224,414. The
capital city, Addis Ababa, is one of the world’s major
diplomatic hubs and hosts the African Union. As of
the 2019 report, the health coverage index in Ethiopia
was 39%, and the quality of care was inadequate, with
only 31% of quality processes and outputs meeting
standards (16). The country comprises 10 regional
states under a federal democratic arrangement and
68 administrative zones (17).
In Ethiopia, there are 353 functional hospitals and
107 under-construction hospitals, as well as 3,735
functional health centers and 96 under-construction
health centers, all of which are equipped with
recommended levels of diagnostic laboratories
(16). This indicates signi昀椀cant investment by the
government. However, not more than 46 medical
laboratories have been accredited by ENAO, of
which 36 are government healthcare facilities and
10 are private hospitals and standalone advanced
medical laboratories. Out of these, 22 are located in
Addis Ababa, and the remaining 24 are distributed
across different regions of the country. The study
was conducted between January 2021 and June
2021. Figure 2 illustrates the location of accredited
healthcare facilities in Ethiopia in 2021.
