IJCA - Volume 3 - Flipbook - Page 32
30 The International Journal of Conformity Assessment
accreditation whether the mentor stops mentoring or
not. This 昀椀nding is consistent with research reported
conducted in the Caribbean Region and Kenya, which
supports the current by indicating that low adequacy
and quality of mentorship contribute to slow
accreditation utilization (30, 31).
Most respondents (221, 80.1%) felt their laboratory
was wrongly evaluated by regulatory bodies for their
own interests, not providing supportive and helpful
feedback for accreditation. According to this study,
the healthcare facility laboratories supported by
regulatory bodies to at least at “moderate extent”
were 0.014 times less likely to utilize accreditation
than those supported to a “large extent” or “very large
extent” (0.014, CI [0.0-0.47]).
There is no clear difference between accredited and
non-accredited laboratories, which was mentioned
as a major challenge for the accreditation process.
All 276 respondents (100%) in this particular study
con昀椀rmed that regulatory bodies did not support
healthcare facilities through 昀椀nancial support or
acknowledgment incentives for accreditation.
Respondents suggested that regulatory bodies need
to consider the actual situation and capacity of the
country’s accreditation body (ENAO) and rethink their
approach. The lack of distinction between accredited
and non-accredited laboratories leads to improper
accreditation utilization, suspension, and withdrawal
from accreditation. Regulatory bodies should address
this issue for better quality laboratory services and
improved accreditation status.
Conclusion and Recommendation
Despites effort to implement accreditation utilization
effectively, maintaining accreditation remains a
challenge for many facilities visited in this study. The
昀椀ndings highlight the need for stronger engagement,
commitment, and advocacy among all stakeholders
to harmonize and lead the accreditation program
effectively. Of the 276 respondents, about 187 (67.8%)
had training experience related to QMS, while all were
aware of ISO 15189. However, gaps in the adequacy
and quality of training and mentorship remain.
Given that the accreditation status of most
medical laboratories is unstable, can be concluded
that there is a gap and limited effort to support
medical laboratory accreditation utilization.
Tthe regulatory body is not yet fully prepared to
support or facilitate the accreditation effectively.
The high turnover of trained and experienced
laboratory professionals, largely due to inadequate
incentives, has signi昀椀cantly impacted accreditation
utilization. Staff competence, management
commitment, and budget allocation were identi昀椀ed
as key factors for successful accreditation.
Although there have been slight improvements
in management commitment and lab personnel
competence, some management members and
laboratory staff still view accreditation as an extra
burden or as a one-time achievement that ends after
the assessment cycle. Workload challenges also
prevent staff from dedicating the necessary time
to accreditation tasks. In most of the healthcare
facility laboratories, the awareness and support
by upper management for accreditation utilization
was not as the laboratory personnel expected.
Calibration and traceability of laboratory equipment
were among the challenges for accreditation
utilization, and these issues were found to be
unavoidable for some healthcare facility laboratories.
Additionally, problems with laboratory infrastructure,
the lack of clear separation between accredited and
non-accredited laboratories by the regulatory body,
and reagent stockouts were not aligned with ISO
15189 standards, making them di昀케cult to resolve
quickly. Based on the 昀椀ndings of this study, the
following recommendations should be considered,
and any concerned body should give due attention to
improving accreditation utilization in Ethiopia
Healthcare facility management should better
understand the importance of having accredited
laboratories within their facilities and support these
efforts to strengthen accreditation utilization and
improve healthcare delivery. Top management and
staff should take pride in their profession and strive
to increase the reputation of their 昀椀eld through
effective accreditation utilization.
The Ministry of Health and relevant stakeholders
should differentiate between accredited and nonaccredited laboratories, recognizing the importance
of accredited laboratories in the country’s healthcare
plan, and should closely monitor and support
accreditation utilization.
Universities should consider revising their curricula
to incorporate concepts of medical laboratory quality
management systems and accreditation, ensuring
that laboratory professionals are more informed and
competent regarding QMS and accreditation at the
undergraduate level.
