IJCA - Volume 3 - Flipbook - Page 28
26 The International Journal of Conformity Assessment
laboratories reported a lack of support from regulatory
bodies for achieving accreditation. Regulatory
bodies did not differentiate between accredited and
non-accredited laboratories and did not encourage
accredited laboratories. Respondents con昀椀rmed that
there were no incentives from regulatory bodies for
accredited laboratory employees.
Effect of the COVID-19Pandemic on the
Utilization of Accreditation
This study was conducted during the COVID-19
pandemic, providing an opportunity to observe its
impact on the accreditation system in Ethiopia.
This section offers a a highlight and an overview for
readers rather than a detailed analysis.
COVID-19, an ongoing global public health crisis, has
affected many services, including the accreditation
process. The Ethiopian accreditation system was
not exempt from these challenges. One out of three
suspended accredited healthcare laboratories was
suspended due to the COVID-19 pandemic. The study
昀椀ndings indicate that the pandemic forced the CAB to
prioritize pandemic prevention. Laboratory personnel
who were signatories to ENAO were also assigned
to pandemic prevention efforts. The study shows
that the COVID-19 pandemic dramatically impacted
the accreditation utilization processes, potentially
necessitating changes or adjustments to the timeline
rules and requirements of the Ethiopian national
accreditation body due to the challenges faced by
CABs during this period.
Healthcare facility laboratory accreditation is
an essential measurement for any conformity
assessment body’s performance, as it is a signi昀椀cant
means of assuring quality service. Thus, accreditation
utilization is a cornerstone for healthcare facility
laboratories. Some CABs were assessed offsite by
sending all requirements to ENAO. Respondents
from this study noted that the sudden shift from
onsite assessments to offsite and desk review
assessments did not allow CABs su昀케cient time to
adjust their necessary requirements, nor did it give
ENAO assessors adequate time to review the needed
documents for accreditation. This situation created
a dilemma for all conformity assessment bodies
involved in the accreditation process.
Trend of Accreditation
The Ethiopian National Accreditation O昀케ce (ENAO)
was established in 2010 via the ministry of council
by proclamation number 195/2010 as the sole
accreditation body in Ethiopia. It began providing
accreditation services in 2013 for three CABs after
being recognized as an a昀케liated member by ILAC in
2012. In 2017, ENAO became a full member of ILAC
MRA, accrediting seven healthcare laboratories during
that 昀椀scal year, bringing the total number of accredited
CABs to 17 over four previous 昀椀scal years. By 2019,
the healthcare facility laboratory accreditation rate
had increased by 10. Currently, there are around 46
accredited CABs, irrespective of their utilization status.
Four accredited laboratories were not included in this
study, as illustrated in Table 3.
Table 3: Accreditation trends in Ethiopia from the beginning
(2013) to 2021
YEAR
FREQUENCY
PERCENT
2013
2014
2015
2016
2017
2018
2019
2020
2021
Total
2
4
3
1
7
2
12
13
6
50
4.0
8.0
6.0
2.0
14.0
4.0
24.0
26.0
12.0
100.0
Summary of Associated Factors for
Accreditation Utilization in Ethiopia
A binary logistic regression analysis was performed
to determine whether there is an association between
accreditation utilization and independent factors.
Not appointing a quality manager was 0.13 times
less likely to utilize accreditation than appointing
(0.13, CI [0.3-0.595]). Healthcare facility laboratories
without committed upper management were 0.2
times less likely to utilize accreditation compared to
those with committed management (0.22, CI [0.013.85]). Respondents from laboratories that a昀케rmed
accreditation budget allocation to a “large extent”
were 1.5 times more likely to utilize accreditation than
those a昀케rming a “moderate extent” or “small extent”
(1.52, CI [0.7-3.3]). Laboratories a昀케rming competency
declaration to a “very small extent” were 0.4 times
less likely to utilize accreditation than those a昀케rming
to a “small extent” or “moderate extent” (0.4, CI
[0.003-0.56]). Laboratories supported by regulatory
bodies to at least a “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]).
