IJCA - Volume 3 - Flipbook - Page 31
2024 | Volume 3, Issue 1
respondents in most of the accredited laboratories
visited. These challenges contributed to the gaps
faced in different assessment experiences and
remain unresolved problems.
The majority of respondents agreed that good quality
equipment, due to proper calibration, is crucial for the
accreditation process. However, some equipment,
such as microscopes, were di昀케cult to calibrate due
to the absence of calibrators in the country, while
others, like hygrometers, were calibrated without
traceable evidence. More than half (166, 60.1%) of
the respondents claimed that it is di昀케cult to get
affordable calibration services, and 20 (7.2%) a昀케rmed
that the calibration institute is decentralized to a
“moderate extent.” This poses a signi昀椀cant challenge
for effective accreditation utilization. However, none
of the respondents indicated that their lab planned to
cease accreditation due to calibration unaffordability
and inaccessibility (17).
Almost all accredited healthcare facilities participated
in pro昀椀ciency testing (PT), a mandatory requirement
for accreditation. They accessed PT through EPHI
and One World Accuracy, with the budget centrally
allocated by the CDC through EPHI, alleviating
affordability concerns. Laboratories implementing
accreditation well did not plan to cease due to PT
inaccessibility or unaffordability issues, as successful
PT participation is a mandatory requirement by
Ethiopia’s accreditation body (ENAO).
Of the 46 laboratories visited, most were accredited
for GeneXpert. Most respondents (160, (60.1%)
stated they could not afford PT for all scopes,
leading to most of the accredited laboratories being
accredited with limited scope: GeneXpert. Some
respondents received PT samples from the Ethiopian
Public Health Institute without any expenditure,
which facilitated their accreditation. However, the
Ethiopian Public Health Institute sourced these PT
samples from the CDC. The study done by Green昀椀eld
D. and Braithwaite J. (“Health sector accreditation
research: a systematic review”) con昀椀rmed the
high costs of pro昀椀ciency testing (26). Due to these
challenges, it was noted that the government should
not necessarily force laboratories to establish a PT
provider in the country.
Around 77 respondents (27.9%) claimed accreditation
is not important, seeing it as merely extra work,
a昀케rming this to a “very small extent” and “small
extent.” In the current study, awareness of ISO 15189
and quality management systems, as well as the
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initiation of laboratory staff regarding accreditation
utilization, varied from institution to institution.
Greater than half of the respondents agreed they
are aware of ISO 15189 and quality management
systems. Around 20 respondents (7.2%) believed
that accreditation adds nothing to the user’s results,
considering it an extra burden for lab personnel. This
aligns with a study by Alkhenizan A. and Shaw C.
on the attitude of healthcare professionals towards
accreditation (27). This perception has created
disagreements and con昀氀icts between lab personnel
and management, which is a barrier to successful
accreditation utilization.
Routine workload was also a challenge, making staff
too busy to accomplish the extra tasks required
for accreditation, which demands a considerable
increase in the number of laboratory professionals.
Even though a little more than half of the respondents
had awareness and training related to either QMS or
accreditation process or both, 36 respondents (13%)
had di昀케culty understanding the standard (ISO15189)
to a “large extent” and “moderate extent.” Quality
management system training was believed to be
the key for a successful accreditation utilization
process, requiring all staff to be trained. However,
114 respondents (41.4%) believed that the trainings
were inadequate in terms of quality and quantity for
successful accreditation utilization. The trainings in
our country were unplanned and not based on the
actual gaps that the accreditation requires. Similarly,
research done in Ethiopia by Tilahun M. et al. in 2013
and Abay S. et al. 2015 reported that training inadequacy
and inconsistency were challenges for laboratories
participating in the accreditation process (28, 29).
The lack of adequate training regarding QMS
and accreditation remains a challenge, with 112
respondents (40.5%) unaware of the ISO 15189
standard. Around 246 respondents (89.1%) stated
their institution had a mentor (30) ([10.9%] noted
they did not have a mentor), but in most of the
study sites, the quality and adequacy of mentorship
were questioned. Some mentors had the same
training experience and knowledge as the mentee
lab personnel, providing little additional support.
All respondents did not believe they received the
expected support from external mentors. Some
mentors did not show mentees how to implement
ISO 15189, instead producing documents centrally
and distributing them to each CAB (mentee). This is a
signi昀椀cant problem that can affect those who sustain
accreditation status and didn’t plan to cease from
