IJCA - Volume 3 - Flipbook - Page 26
24 The International Journal of Conformity Assessment
The distribution of the respondents by position
included 40 laboratory heads, 44 quality o昀케cers,
36 store managers, 22 MD/CEO/DGs, and 134
operational workers. These individuals were
interviewed to provide their opinions on the utilization
of accreditation and the challenges faced by medical
laboratories in utilizing ISO 15189 accreditation.
Among the respondents, 214 (77.5%) were male. The
majority, 147 (53.3%), were in the age group of 26 to
35, followed by 70 (25.4%) in the age group of 36 to
45. In terms of educational attainment, the majority of
the respondents, 120 (43.5%), held a master’s degree,
followed by 108 (39.1%) with a bachelor’s degree.
The working experience of the study participants in
their respective organizations ranged from 昀椀ve to 10
years for the majority of participants, 152 (55.1%). The
detailed demographic characteristics are illustrated
in Table 2.
Table 2: Demographic characteristics of respondents from
public and private health facilities who participated in this
study (n= 276), Ethiopia, 2021
VARIABLES
DEMOGRAPHIC
ITEM
FREQUENCY PERCENT
Sex
Female
Male
Total
62
214
276
22.5
77.5
100
Age Group
20-25
26-35
36-45
46-55
Total
28
147
70
31
276
10.1
53.3
25.4
11.2
100
Educational
Level
College diploma
Bachelor’s degree
Master’s degree
PhD
Total
28
108
120
20
276
10.1
39.1
43.5
7.3
100
6-10
11-15
>15
Total
152
76
48
276
55.1
27.5
17.4
100
40
44
36
134
22
276
14.5
15.9
13.0
46.8
5.8
100
Work
Experience
Management Laboratory head
Level
Quality manager
Store manager
Operational
MD/CEO/DG
Total
ACCREDITATION UTILIZATION RATE
The results indicated that in Ethiopia, 38 (83%
n=46) accredited health facilities were effectively
utilizing accreditation practices in accordance
with the ISO 15189 standard. These facilities had
competent laboratory personnel and committed
management, which facilitated proper utilization
of the accreditation. Conversely, eight (17% n=46)
accredited health facility laboratories were not
utilizing the accreditation due to various challenges.
Among the accredited facilities, three (6% n=46) had
their accreditation suspended for speci昀椀c periods. The
reasons for suspension included calibration failures
of major equipment within the accreditation scope.
These laboratories received suspension letters from
ENAO and were required to refrain from using any
ENAO/ILAC symbols during the suspension period.
Another signi昀椀cant reason for suspension of
accreditation was the cost involved. Respondents
indicated that accreditation fees and related costs
such as pro昀椀ciency testing (PT) and calibration, were
additional 昀椀nancial burdens. Some respondents
believed that accreditation added no value to their
business. These cost-related reasons for suspension
and withdrawal were predominantly observed in
private healthcare facility laboratories.
One facility (1%) had its accreditation terminated due
to the incompetence of its staff and uncommitted
management, which hindered the continuation of
the accreditation process. The termination occurred
during the document review processs by ENAO. After
the laboratory submitted its available documents
and necessary requirements, ENAO requested all
documents required by ISO 15189. When these
documents were not submitted within the speci昀椀ed
timeframe, the laboratory’s accreditation was
terminated for non-compliance with competence
requirements.
Additionally, four healthcare facility laboratories in the
Tigray region were not included in this study due to
unsuitable situations during the data collection time.
The accreditation utilization status is illustrated in
Figure 2. A detailed categorization of the hindering
factors is provided in the section below.
Challenges of Accreditation Utilization
The study found that eight out of 46 (17%) accredited
healthcare facility laboratories were not utilizing their
accreditation. Speci昀椀cally, four facilities (9% n=46)
withdrew from accreditation due to high staff
turnover, management negligence, lack of appropriate
training, and incompetent staff. During focus group
discussion, respondents explained that accredited
and non-accredited laboratories are often treated
