IJCA - Volume 3 - Flipbook - Page 27
2024 | Volume 3, Issue 1
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Figure 2: Accreditation utilization statuses in Ethiopia, 2021
similarly by regulatory bodies, leading them to believe
that accreditation had little to no impact on their
laboratory operations. This perception was cited
as the primary reason for improper accreditation
utilization, eventually leading to withdrawal.
Inconsistent regulatory follow-up (0.014, CI [0.000.47, p-value 0.017), lack of appointment of a
quality manager (0.13, CI [0.3-0.595], p-value 0.008),
and personnel incompetence (0.4, CI [0.0030.56], p-value 0.04) were found to have signi昀椀cant
associations with accreditation utilization (Table 4).
Other hindering factors for accreditation utilization
included inadequate training of personnel, lack of
upper management commitment, limited resource
allocation, lack of incentives for accreditation awards,
inadequate awareness of ISO 15189 and QMS among
personnel, improper mentoring, and insu昀케cient
follow-up by regulatory bodies.
Almost all accredited healthcare facility laboratories
reported that no incentives were provided to
employees for their efforts in achieving accreditation.
Among the 276 participants in this study, 26 (9%)
expressed a desire to leave their institutions due
to the lack of recognition for their accreditation
efforts. Around 109 (39.5%) participants noted that
management was not committed to the implementing
of a quality management system (QMS) or achieving
accreditation. More than half of the participants rated
resource allocation for accreditation as ranging from
“very small extent” to “moderate extent.” The budget
for accreditation was not intentionally allocated by
upper management but was instead sourced from
other budget lines.
Regarding equipment calibration, 166 (60.1%) of
respondents stated that some of their equipment was
not calibrated due to inaccessibility or unaffordability
of calibrators. Calibration institutions were also
not decentralized. However, for assay calibration,
companies calibrated the machines, and most
calibrators were traceable and affordable. Despite
these challenges, nearly all laboratories did not plan
to cease accreditation due to calibration issues.
Around 112 (40.5%) participants were not
knowledgeable about ISO 15189. Thirty (10.9%)
participants complained that the standard (ISO 15189)
was very complicated to understand. Seventy-seven
(27.9%) participants believed that accreditation was not
important and saw it as an additional burden. However,
199 (72.1% n=276) participants gave their answer
as “moderate extent,” indicating their belief that
accreditation has at least some modest advantage to
the customer.
Six (13% n=46) laboratories did not have mentors,
while the remaining 40 (87% n=46) healthcare
facility laboratories had mentors. Only 44 (15.9%
n=276) participants felt that mentors were used
to a “moderate extent,” whereas the other 232
(84.1% n=276) rated the extent as “very small” to
“small.” Respondents indicated that mentors did not
effectively demonstrate how to implement a quality
management system or acheive accreditation. Nearly
all laboratories believed they could sustain their
accreditation status without mentors and had no
plans to cease if mentoring stopped.
Almost half of the accredited laboratories were
evaluated by regulatory bodies, yet nearly all accredited
