IJCA - Volume 3 - Flipbook - Page 30
28 The International Journal of Conformity Assessment
top management resistance, lack of awareness on
QMS, inadequate training, and insu昀케cient support
for the quality improvement process (18, 19).
Laboratory professionals believe that awareness
and commitment from top management are crucial
for successful accreditation. Despite some support
from upper management in certain laboratories, full
participation and commitment were still lacking.
Healthcare facility staff lack adequate knowledge
about the importance of accredited laboratories
beyond support for clinical management,
discouraging laboratory professionals from striving
for better quality and accreditation utilization. This
is similar to a report from Addis Ababa Public Health
Laboratories in 2019 by Misganaw A. et al. (20).
The low incentive levels for lab personnel signi昀椀cantly
contributed to the high turnover of laboratory
professionals. According to the respondents, there
is a high turnover, especially among experienced
professionals who frequently plan to join higher-paying
organizations for a better lifestyle and experience.
This 昀椀nding is supported by research conducted in the
Caribbean Region, which highlighted that maintaining a
su昀케cient number of well-quali昀椀ed laboratory workers is
an ongoing challenge, exacerbated by attrition rates as
staff leave the public sector for more lucrative jobs in
the private sector (21).
Inadequate upper management commitment,
laboratory personnel incompetence, and viewing
accreditation as a one-time achievement rather than
an ongoing process were identi昀椀ed as challenges.
Accreditation requires daily effort, not just a single
assessment cycle. Similar research conducted
in China supported these 昀椀ndings, showing that
laboratory professionals still do not recognize the
importance of accreditation and consider it as
unnecessary extra work mandated by the Ethiopian
national accreditation body (22).
Findings showed that management is concerned
not only with the allocation of resources but also
with how these resources translate into an improved
quality management system for the laboratory. In this
study, 50 respondents (18.1%) indicated that upper
management allocated budget for accreditation to a
“very small extent,” and 53 (19.2%) to a “small extent,”
showing that management often did not prioritize
budget for accreditation purposes, instead using other
budget lines. The results showed that laboratories
with better budget allocation for accreditation were
1.5 times more likely to utilize accreditation than those
where respondents answered “moderate extent” and
“small extent” (1.52, CI [0.7-3.3]). Inadequate budget
allocation for pro昀椀ciency testing (PT) and calibration
was also a signi昀椀cant challenge, as 110 respondents
(39.9%) complained about insu昀케cient funds for
these purposes. Despite this, the budget for PT and
calibration was often covered by the CDC trough EPHI.
Studies by Koplan JP, published in the Bulletin of
WHO, and by Gurmessa A. and A. Misganaw at Addis
Ababa governmental hospital laboratories, support the
昀椀nding that 昀椀nancial resource limitations for PT and
calibration are signi昀椀cant challenges for accreditation
in sub-Saharan countries (11, 23).
Facility and infrastructure signi昀椀cantly contribute
to low accreditation utilization and slow progress.
Some laboratories lacked adequate space for testing,
with various machines located in a single room. The
result showed that 98 respondents (35.5%) reported
inadequate infrastructure to a “small and very small
extent.” Previous research by Abay S. indicated
that laboratory design and 昀氀oor quality contributed
to a low success in accreditation implementation
(24). Many respondents noted that their laboratory
facilities or infrastructure of their laboratories were
far below standard, leading to failure before the
assessment process. This situation often resulted
in termination and withdrawal from accreditation.
This is also supported by the report in Addis Ababa
by Sisay A., which indicates that achieving and
maintaining accreditation status requires a signi昀椀cant
investment of resources. Additionally, the report
“Factors Affecting Implementation of Laboratory
Quality Management System in Addis Ababa Public
Health Laboratories” highlights similar challenges (25).
Some respondents noted that without calibrated
equipment traceable to higher reference materials,
participation in the accreditation process is
challenging. In 2017, ENAO reported the advantages
and disadvantages of decentralizing the calibration
institute, which improved calibration e昀케ciency
but raised issues in the provision of quality of
calibration services and the stimulation of local
private participation in their own calibration. Among
the disadvantages were issues of traceability
for meeting national policies and international
requirements (15). In the current study, respondents
criticized the centralized system, arguing that it
hindered the provision of calibration services and
their overall journey toward accreditation. Reagent
and quality control material stock-outs, followed by
test interruptions, were other challenges reported by
