Challenges of Clinical Chemistry Analyzers Utilization in Public Hospital Laboratories of Selected Zones of Oromia Region, Ethiopia: A Mixed Methods Study

Clinical laboratory services have a great influence on clinical decisions and 60-70% of the most important decisions on admission, discharge, and medication are based on laboratory results [1]. Due to this overwhelming dependence of clinical decisions on laboratory reporting, clinical laboratories have to improve their services. The key to improvement of laboratory services is the implementation of correct automation technologies [1,2]. The utilization of automation technology in clinical laboratories of developing countries is greatly affected by many factors such as their malfunction and absence of their maintenance, shortage of laboratory consumables, inadequate logistical support, absence of governmental standards, poor laboratory infrastructure and shortage of well-trained laboratory staff [3,4].

are factors that contribute to equipment breakdowns [6]. The modern practice of clinical chemistry relies ever more heavily on automation [7,8]. Thus, identifying the different challenges relating to clinical chemistry automation utilization faced by laboratories is important to work on and resolve those obstacles. Therefore, this study was aimed to identify challenges of clinical chemistry analyzers utilization in public hospital laboratories of selected zones of Oromia region, Ethiopia.

Ethics Statement
Ethical clearance was obtained from the Institutional Review risks, autonomy to participate and the right to withdraw or refuse to participate in the study at any time. Throughout the study period, confidentiality of the data was strictly followed. Informed written and signed consent was obtained from all participants.

Data Collection
Checklist (S1 Checklist) was used to collect detailed information concerning the facilities and clinical chemistry analyzers.
Questionnaire (S1 Questionnaire) was used to collect data such as sociodemography, educational level, working experience, training and skills status from all laboratory professionals (n=93) who were working in clinical chemistry section and volunteer to participate.
First, the respondents were communicated to get their consent.
Once their consent was known, the prepared questionnaires were distributed to each participant. Then, filled questionnaires were collected by checking the completeness of the data.
In-depth interviews were conducted with 68 purposively selected professionals coming from various origins using interview guide (S2 Guide). Three clinical directors, 2 finance heads and 2 laboratory heads refused to participate in the study. Before engaging in the interview, a suitable time and an outlying office in hospitals were arranged for interviews. Then, face-to-face interviews were conducted in Afaan Oromoo by the first author. Responses were audio-recorded, lasting between 22-30 minutes, and field notes were also taken.

Data Analysis
The quantitative data were cleaned by EPI-Data 3.1, then exported to SPSS version 25 (IBM, USA) and analyzed using descriptive statistics. Qualitative data was analyzed using a thematic analysis. Qualitative analysis software NViVOv.10.0 (QRS International Pty Ltd, Melbourne, Australia) was used to aid this process. The first author transcribed the interviews and then translated into English. The second and third authors reviewed the transcripts and coded units into categories. Each category was then reviewed by the last author and grouped into major themes and finally written by narrating texts and quotation of verbatim.

Data Quality Assurance
All data collection tools, which were developed for this study, reviewed by experts and validated before data collection by pilot study. During data collection, filled questionnaires and checklists were checked for completeness and validity. The transcribed and translated data obtained from in-depth interviews were read and checked multiple times against the recorded audio for accuracy of verbatim and transcripts.

Description of Hospitals
Out of 15 hospitals included in the study, 8 (53.3%) were primary hospitals, 5 (33.3%) were general hospitals and 2 (13.3%) were specialized hospitals. Regarding duration of service, 8 (53.3%) hospitals had less than 5 years of service whereas 7 (46.7%) had greater than or equal to 5 years of service.

Background Characteristics of Study Participants
Among 93 survey participants, 76 (81.7%) of them were males.

Challenges of Clinical Chemistry Analyzers Utilization
Wide Variety of Analyzers: As shown in Table 3, there were 14different makes and models of clinical chemistry analyzers in the assessed hospital laboratories. The most widely used analyzer was Dirui CS-T240 (22.6%) followed by Biosystem A25 (12.9%). Concerning the problems encountered the laboratory due to analyzers. The reasons why curative maintenances were not done for non-functional analyzers were due to delayed responses to repair requests (n=7) and unavailability of spare parts (n=6) whereas the curative maintenance of one analyzer was on progress during the study period. One of laboratory heads indicated the problem of analyzer maintenance by saying: There were 3 open system analyzers which did not adapt to other manufacturers' reagents. As clearly indicated by respondents, this was done intentionally by manufacturers' and/or their vendors for the benefit they get from the sale of reagents.  Laboratory quality officers also explained the severity of the problem by saying: There was also no formal pre-purchase consultation system in all laboratories.

Lack of End-Users
Laboratory heads indicated the challenges as follows: platforms of clinical chemistry [13].
Non-functionality of clinical chemistry analyzers was also another major challenge for their utilization. During the study period, 21 (68%) of clinical chemistry analyzers were out of service due to an installation problem, hardware malfunction, calibration and quality control failure, reagent shortage and lack of user training. A study conducted in Jimma zone revealed 33.3% of clinical chemistry analyzers were out of service [14] and other study showed that about 39% of medical equipment found in Ethiopian public hospitals and other facilities was out of service at any one time [5]. Another study reported that over 50% of the medical equipment in developing countries is not functioning, not used correctly or not maintained, with some being entirely unnecessary or inappropriate to fulfil its intended purpose [15]. World Health Organization estimated 70% of laboratory and medical equipment in resource poor settings is out of service due to mismanagement of the technology acquisition process, lack of user-training and lack of effective technical support [16].
This study showed that the majority of the laboratories were unable to give clinical chemistry testing service due to reagents shortage. Stock-outs of quality control (normal), quality control (pathological), calibrator and assay reagents were occurred in 7 (46.7%), 8 (53.3%), 9 (60.0%) and 5 (33.3%) hospitals respectively.
Challenges related to laboratory supplies were also reported in Jimma zone [14], Addis Ababa [17] and Sub-saharan Africa [3].  [14] and Addis Ababa [19]. The selection criteria used were only automation grade (semi-automated/fully automated) and the cost of the analyzer. According to World Health Organization procurement guideline, selection criteria should include detail review of equipment quality specifications and product specifications [18].

Limitations
The use of non-probability sampling was probably the main impediment to the generalizability of results. In addition, we didn't conduct in-depth interviews with biomedical engineers from respective hospitals, zonal health departments, Oromia regional health bureau and Ethiopian Public Health Institute which might reveal the root cause of these challenges.

Conclusion
In summary, we identified major challenges that affected the