IJCA - Volume 3 - Flipbook - Page 24
22
The International Journal of Conformity Assessment
SAMPLE SIZE DETERMINATION
All key personnel in 46 accredited laboratories across
the country were included in this study. A total of 276
personnel participated, providing both quantitative and
qualitative data. The key personnel included the medical
director/CEO, laboratory head, quality o昀케cer, equipment
o昀케cer, and two additional laboratory personnel.
Sampling method: A purposive sampling technique
was applied to select key healthcare accreditation
personnel: medical director/CEO, laboratory
head, quality manager, purchase personnel, and
equipment focal personnel. These individuals
were chosen for their substantial engagement with
accreditation requirements, which was essential for
generating objective evidence for the assessment of
accreditation utilization and the associated factors.
A questionnaire incorporating a Likert scale was
administered to each accredited laboratory to ensure
credible research 昀椀ndings. The questionnaire was
prepared in English, as all selected key personnel
were pro昀椀cient in the English language, eliminating
the need for translation to local languages.
personnel’s educational background, characteristics
of laboratory QMS implementation, work experience
of personnel, laboratory stakeholders, pro昀椀ciency
testing (PT) issues, calibration issues, and knowledge
and attitudes towards laboratory accreditation.
Two senior laboratory technologists were trained to
use the questionnaire for data collection. The principal
investigators were involved in overseeing the entire
data collection process, assisting the data collectors
throughout. They also regularly collected the 昀椀lled
questionnaires and checked them for consistency.
DATA QUALITY ASSURANCE
To ensure data quality, two data collectors were
trained via email on the data collection procedures.
The questionnaire was pre-tested at the Ethiopian
Public Health Institute (EPHI) bacteriology reference
laboratory in Addis Ababa before the actual data
collection (pre-analytical phase).
During the analytical phase, the principal investigator
checked the completeness, accuracy, and
consistency of the collected data on a daily basis. In
the post-analytical phase, the principal investigator
reviewed the overall data consistency. Any
questionnaires found to be incomplete, inaccurate, or
inconsistent were returned to the data collectors for
correction. Additionally, the data was cleaned, edited,
and coded after data entry.
DATA ANALYSIS AND INTERPRETATION
Figure 1: Map of Ethiopia with cities where accredited
healthcare facilities are located, 2021. The names of each
accredited lab are listed in Appendix III. Note: Tigray
Region accredited labs are not indicated on this map.
DATA COLLECTION PROCEDURE
The data collection instrument consisted of an
anonymously administered Likert scale questionnaire,
prepared by reviewing different standards, guidelines,
and documents. The questionnaire aimed to
determine the utilization rate of accreditation and
identify the hindering factors affecting accreditation
utilization. It included questions on several topics:
laboratory pro昀椀le, current laboratory status, key
Quantitative data was entered, cleaned, and
analyzed using SPSS version 20.0 software. For
qualitative data from in-depth interviews and openended questions, the information was organized,
categorized, summarized, and discussed by narrating
the 昀椀ndings thematically. Descriptive statistics were
computed for most of the study variables. Frequency
distribution, tables, and graphs were used to
present the 昀椀ndings. A p-value of less than 0.05 was
considered statistically signi昀椀cant when examining
associations between accreditation utilization and its
hindering factors.
For this study, accredited medical laboratories were
classi昀椀ed into the following categories: laboratories
that were accredited and later withdrew; laboratories
that sustained their performance and reapplied for
the second round of accreditation according to the
accreditation cycle; laboratories that applied for
accreditation but were terminated or did not reapply;
and laboratories that were accredited but suspended
for a de昀椀ned period.
