Medical Laboratories Quality Management and Challenges in Ethiopia: A Systematic Review

Introduction

Quality in medical diagnostics defined as the reliability, accuracy, and timeliness of laboratory test results.¹ In medical laboratory practice, quality needs to be viewed as “systems thinking”, which is used in other business practices. Systemic thinking is a comprehensive analytical approach to understand how different elements interact within a system or structure for monitoring of quality in medical laboratories. Therefore, to ensure efficiency, effectiveness and accuracy of services provided to the customer, a quality system that monitors these areas is required.²

Inadequate quality of medical laboratory services results in producing wrong information, unnecessary expenditures, suffering and misery in human lives.³ For example, over-treatment of antibiotics for inappropriate clinical conditions leads to the development of drug-resistant microorganisms.⁴

Quality laboratory testing greatly affect the affordability and quality of patient care. Any errors or defects within a medical laboratory influences patient care and can also incur added costs.⁵ As a result, nowadays, quality is given a priority in many health care system.⁶

Quality laboratory services need the practice of a quality management which focuses on applying twelve quality essentials; personnel, organization, purchasing and inventory, equipment, process control, documents and records, information management, occurrence management, assessment, facility and safety, process improvement, and customer services.¹ Laboratory quality management is a continuous improvement process that measures processes from a client satisfaction point-of-view.⁷ Implementing total quality management in a healthcare laboratory need to incorporate quality planning and quality improvement with laboratory quality assurance to provide full quality management system.⁸

In Ethiopia, quality management system in medical laboratories was implemented since 2009 for the aim of improving quality of services. National Laboratory Strategic Plan was set in 2010 to strengthen laboratory quality systems and laboratory accreditation. As a result, the so called Strengthening Laboratory Management Toward Accreditation (SLMTA) programme was launched in 45 medical laboratories.⁹ This review was designed to evaluate the status of quality management practice and challenges facing medical laboratories in Ethiopia.

Methods and Materials

Study Design and Setting

Systematic qualitative literature review was made in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guideline¹⁰ to evaluate the quality management practice status and challenges among medical laboratories in Ethiopia.

Search Strategy

Comprehensive updated published studies from 2010 to 2022 were identified by searching from the international electronic bibliographic database of PubMed (NML), web of science (TS), google scholar, African journals online (AJOL) and Cochrane Library using EndNote X7 application software. Both primary studies and review articles were manually searched with several keywords like “quality”, “medical laboratory”, “quality management system”, “implementation”, and ‘challenges ‘in different combinations. The database searches were performed in the English language without research design restriction in June 2022.

Selection Criteria

We included studies that addressed the practice of the quality management, service quality, and challenges facing medical laboratories in Ethiopia. Studies were considered eligible if they were published in the English language with the full-text format at peer-reviewed journals and conducted in Ethiopian settings. Based on these criteria, the selection of studies was performed independently by the two authors (BM and HB). Differences were resolved by discussion and consensus. Studies potentially eligible for inclusion in the review were initially screened by title abstract review and/or title and then critical reviewing of full-text studies was made. Finally, from the 650 identified studies, 36 published full-text articles were considered for the synthesis of this review (Figure 1).

Figure 1 Flow diagram of article selection process.

Data Extraction and Analysis

Data extraction form was prepared in Excel sheet by including first author’s name, publication year, objective of the study, study setting, study group, and results (Table 1). An analysis of full-text articles was conducted to identify substantial information relevant to the quality management practice status, service quality, and challenges among medical laboratories in Ethiopia.

Table 1 Data Summary for Medical Laboratories Quality Management and Challenges in Ethiopia

Results

This systematic review was conducted on published studies, which were conducted in different health facilities of Addis Ababa, South region, Amhara region, Oromia region, and Tigray region of Ethiopia. Thirty-six studies published between 2010 and 2022 were included in this review. The findings of this review were sorted into two main categories, namely service quality and challenges among medical laboratories.

Service Quality of Medical Laboratories

Even though all laboratory professionals (n=184) were informed about quality management, only about 138 (79%) were engaged in practicing it. These laboratories also had poor or very poor performance in a quality management system with five quality indicators; control of documents, control of records, setting policies and preparation of manuals, setting of processes, procedures, and communication.¹¹ Similarly, medical laboratories statuses towards the AFRO-WHO accreditation showed that only a laboratory from 30 laboratories achieved 156 (62%) scores, which is the minimum score required for WHO accreditation.¹² In addition, from laboratories of health center enrolled (n=89), 71 (79.8%) achieved zero stars, only 6 (6.7%) achieved star one, 9 (10.1%) achieved star two, and only 3 (3.4%) achieved star three.¹³ However, from those laboratories which were implementing the system (n=45), 42 (93%) laboratories showed overall service improvements.¹⁴ For example, a laboratory improved from the baseline score (78 points) in 2012 by achieving 198 scores (3 stars) in 2013 and 249 scores (5 stars) in 2014.¹⁵ In addition, as one tool of quality management, SLMTA implementation increased the status of 20 laboratories from 29 laboratories from star zero to star one and above.¹⁶ Most quality officers and managers of laboratories viewed the SLMTA program as being the most important step in the improvement process of service quality. Nevertheless, from the analysis of 17 CEOs of the hospital, only 10 (59%) understood the requirements, the importance and the outcomes of the SLMTA program, while the others seven CEOs (41%) were uncertain.¹⁷

In this review, the service quality of medical laboratories was assessed with five quality indicators; namely frequency of laboratory errors, proficiency test performance, specimen rejection rate, turnaround time, and customer satisfaction.

Frequency of Laboratory Errors

In frequency of laboratory errors, six papers^18–23 were looked at specific major technical laboratory errors. Shiferaw et al,¹⁸ showed that 47 of 201 (23.4%) laboratories in the study had major false positive and false negative errors in diagnosing tuberculosis. Similarly, Mekonen et al¹⁹ showed that 20 of 55 (36.4%) health center laboratories had false positive and false negative results in diagnosing tuberculosis. In addition, Desalegn et al²⁰ demonstrated that only 96 of 135 (68.9%) peripheral laboratories read positive and negative AFB slides correctly. Measuring with some indicators like smear size, specimen quality, smear thickness, smear evenness and smear cleanliness, Weldemhret et al²¹ showed that the performance of sputum smear quality were 68%, 61, 64%, 62 and 66% respectively. On the other hand, Tadesse et al study²² showed that 742 of 2606 (28.5%) hematology laboratory specimens in the study had different technical errors. One study conducted, Teka and Kibatu²³ showed that 65% of the 213-control measurement values were outside of the allowable errors limits in clinical chemistry laboratory.

Proficiency Test Performance

In proficiency test performance, one paper was looked at for evaluating the performance of laboratory professionals in tuberculosis microscopy. Mengistu et al²⁴ showed that only 11 of 81 (13.6%) laboratory professionals reported all positive and negative tuberculosis smear panel slides correctly. The others 70 of 81 (86.4%) laboratory professionals reported at least one false positive or false negative result in tuberculosis microscopy.

Specimen Rejection Rate

In specimen rejection, two articles were looked at for evaluating service quality of medical laboratories. Habtamu Molla et al²⁵ showed that 116 of 8063 (1.4%) laboratory specimens were rejected due to different technical errors. Similarly, Shiferaw et al²⁶ noted that 221 of 42,923 (0.5%) laboratory samples were rejected.

Turnaround Time (TAT)

In turnaround time, two articles were looked at to evaluate service quality of medical laboratories. Gebreyes et al²⁷ showed that only 41 of 253 (16.2%) clinical chemistry test results were released within the target TAT. Shiferaw and Yismaw²⁸ also showed that 68.1% of the EID for HIV, 53.8% of the TB genexpert tests and 76.5% of the viral load had delayed turnaround time compared with the standard.

Customer Satisfaction

In customer satisfaction, five articles were looked at to evaluate service quality of medical laboratories. Studies showed that different customers of laboratories had different level of satisfaction. For example, Desalegn et al²⁹ noted that 240 of 422 (56.9%) pregnant mothers were satisfied with Focused Antenatal Care (FANC) laboratory service. A study conducted on satisfaction level of patients (n=502), 73.5% of patients were found to be satisfied.³⁰ In another national survey analysis, the satisfaction level of physicians (medical doctors) in medical laboratory services was 55%.³¹ In one study, the clinician’s (medical doctors, nurses and health officers) satisfaction level with clinical laboratory services was 72.8%.³² However, the pooled client satisfaction level with medical laboratory services was 66%.³³

Quality Challenges

In this review, the quality challenges were demonstrated in three categories, which includes problems associated with laboratory professionals, inadequate support from management bodies and others.

Problems Associated with Laboratory Professionals

The main problems were improper provision of information,^30,33,34 lack of commitment,^{11,12,17,22,35,36} poor professional skill,^{15,18,19,21,23,24,32,37,38} poor communication,^31–33,35 poor internal quality control practice^{19,23,29,35,36,39,40} and inadequate utilization of laboratory documents.^{13,14,31,32,35,40,41}

Inadequate Support from Management Bodies

In this category, quality challenges were limited budget allocation for laboratory,^{15–17,35,37,38,41} poor laboratory infrastructure,^{11,13,16,30,42} limited supply of reagents and equipment’s,^{16,18,20,23,28,29,36,41–44} poor recognition and rewards for laboratory professionals.⁴⁵

Others

The other quality challenges were limited on job training access^{9,14,17,26,35,36,41,43} and high workload.^{27,28,38,41,42}

Discussion

Practicing quality management is possible in medical laboratories of resource-limited countries.⁴⁶ However, it was found to be weak implementation status.⁴⁷ Our systematic review of 36 studies on implementation of quality management system showed that even though there was good beginning in most medical laboratories, still QMS was not achieved as expected in each laboratory.^11–17

Practicing the system of quality management facilitated the attainment of target quality indicators, and led to high client satisfaction.⁴⁸ An interrupted practice of quality systems may cause a services quality decline and hence poor accreditation achievement.⁴⁹ According to this review, service quality among Ethiopian medical laboratories was limited. This fact was shown with different quality indicators like frequency of laboratory errors, proficiency test performance, specimen rejection rate, turnaround time and customer satisfaction level. The error rate in medical laboratory diagnostics is about 0.3% according to accurate and recent information retrieved from scientific literature.⁵⁰ However, the error rate in most medical laboratories of Ethiopia was higher than 0.3%.^18–23 Even though the variety of proficiency testing was limited, AFB proficiency test performance in most Ethiopian medical laboratories was good when we compared to the standard passing score.⁵¹ As a standard, specimen rejection rate in medical laboratories should be below 0.3%.⁵² When we evaluated the service quality of medical laboratories with the standard specimen rejection rate, most Ethiopian medical laboratories had poor quality services.^25,26 In addition, this review noted that most laboratory tests had delayed TAT.²⁷ As good performance laboratory indicator, at least 90% of the tests need to be released within the target turnaround time.²⁸ Customer satisfaction also considered as laboratory service quality indicator and serves as an important improvement process tool using benchmark satisfaction level of 80% and above.⁵³ The overall customer satisfaction level in most Ethiopian medical laboratories was below this benchmark satisfaction level.^29–33

Accessing quality laboratory services is a challenge in low-resource countries.⁵⁴ According to this review, the main challenges of laboratory service were problems associated with laboratory professionals,^11,13,15,19 inadequate support from management bodies,^11,15,16,45 high workload²⁷ and limited on job training access.⁹ A similar study in Nigerian medical laboratories showed that poor infrastructure, financial limitations, insufficient capacity building, lack of consumables and equipment’s, and motivated and dedicated laboratory personnel have been the main service quality challenges.⁵⁵ Another study at hospitals and institutions of Sri Lanka showed that the main challenges of quality services were lack of knowledge on ISO standards and limited training access for laboratory professionals.⁵⁶

Conclusion

The status of quality management practice among medical laboratories in Ethiopia is limited. The main quality compromising factors were problems associated with laboratory professionals, inadequate support from management bodies, high workload, and limited on-job training access. Therefore, all responsible stakeholders should focus on ensuring Quality Management Systems and the system should be applied in all Medical laboratories. Only this will ensure the improvement of quality within medical laboratories across Ethiopia.

Recommendation

This review strongly recommends that regional health bureaus, Ethiopian public health institute, Ethiopian Ministry of Health, and other stakeholders should focus on strengthening and implementation of quality management among medical laboratories to ensure the overall quality of healthcare system.