Health laboratory services play a pivotal role in disease prevention, diagnosis, management and monitoring (1). Despite technological advancements in clinical laboratory services in many developed countries, laboratory services have not met the minimum standard in resource-limited nations. This is because there are a limited number of skilled medical laboratory professionals, poor infrastructures, and limited availability of advanced equipment (2). According to the World Health Organization (WHO), there is a global shortage of healthcare professionals, with an estimated 18 million healthcare workers needed to achieve universal health coverage (3). The American Bureau of Laboratory Statistics projects a nationwide need for a 13% average increase in medical laboratory technologists and technicians between 2016 and 2026, which is nearly double the current 7% underlying average increase in all occupations (4). Furthermore, the lack of national and local medical laboratory policies leads to common laboratory service interruptions in low-income countries like Ethiopia (5). Clinical laboratory risk analysis shows that multiple risks may occur due to chemicals in the laboratory environment, biological factors, differences in work equipment, and the inherent dangers of biomedical research (6). As a result, efforts to achieve equality in healthcare services remain important policy concerns, particularly in developing countries (7).

Quality in medical diagnostics is defined as the reliability, accuracy, and timeliness of laboratory test results. This needs quality management practices which focus on ensuring 12 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 (8). Poor quality laboratory services often lead to unnecessary expenditures, misery in human lives and suffering, and overuse of antibiotics for inappropriate clinical circumstances which result in the emergence of drug-resistant microorganisms (9). In addition, interruption of laboratory service may cost a human life, create a negative impact on an organization's reputation, and cause revenue loss (10). Furthermore, laboratory service interruptions are not compatible with ongoing hospital operations and would have an immediate negative impact on the high-acuity clinical services that are essential for acute care hospitals (11). In sub-Saharan Africa, the major challenge in delivering quality health services is lack of reliable medical laboratory services (12). The most common challenges are a lack of internal quality control materials and other reagents, inconsistent electric power supply, and a limited number of trained laboratory personnel. In addition, inflated equipment maintenance and calibration costs are obstacles in delivering a timely laboratory service (13).

Some studies revealed that laboratory service quality in Ethiopia remains insufficient due to several reasons, including lack of quality and adequate equipment, non-adherence to standard operating procedures, no continuing professional development, unavailability of adequate supplies and reagents, poor customer service management, lack of regular internal and external quality assessment activity, interrupted laboratory service, absence of result verification, and inadequate laboratory safety (14).

In Ethiopia, clients are often not satisfied with clinical laboratory services due to poor service delivery and interruption (15). However, the quality level of health laboratory services and frequency of service interruptions are not sufficiently evaluated in hospitals in Eastern Ethiopia. Therefore, this study aimed to assess the level of health laboratory service quality, frequency of service interruption, and its predictors in public hospitals in Harar town, eastern Ethiopia.

The study was conducted in two public hospitals situated in Harar town, eastern Ethiopia. Harar is the capital city of Harari regional state. The city is one of the oldest cities in Ethiopia, and is 526 km away from Addis Ababa, the capital city of Ethiopia. According to the Central Statistical Agency forecast of 2022, the population of Harari regional state was 276,431, of whom 139,576 were male and 136,855 female (16). Harari region has two public hospitals, one military hospital and one private hospital. The public hospitals, namely Hiwot Fana Specialized University Hospital (HFSUH) and Jugel General Hospital (JGH), were selected for this study as they provide multidimensional healthcare services.

A facility-based cross-sectional study was conducted from January to April 2024.

The study populations were the HFSUH and JGH laboratories in Harar town and laboratory professionals who were working in these public hospitals during the data collection period.

We estimated the sample size for analyzing predictors of service interruptions using a single population proportion formula by taking 28% laboratory service interruption in hospitals in Addis Ababa (17). Level of significance (α) = 0.05, marginal error (d) = 5%, Z (α/2) = Z-score at 95% confidence interval (CI) = 1.96. Based on the formula the sample size (n) would be 272. However, the total number of laboratory professionals working in the selected hospitals was 59. Therefore, we employed a sample size correction factor and the final sample size became 54 after considering a 10% non-response rate.

A convenient sampling technique to assess the level of health laboratory service quality was to collect primary data using the WHO Standardized Stepwise Laboratory Improvement Process Towards Accreditation (SLIPTA) checklist version 2:2015 (18). The WHO SLIPTA checklist, version 2:2015, evaluates laboratory quality system performance based on 12 essentials, and was established to strengthen clinical and public health laboratory systems in developing countries and to achieve the requirements of ISO 15189.

The study also utilized a checklist adopted from the Ethiopian Hospital Standard Transformation Guideline (EHSTG), which had originally been devised to determine the magnitude of laboratory service interruption and its predictors in the selected public hospitals (19). The second checklist adopted from EHSTG was used to assess the status of laboratory service interruption. The assessment was conducted in all laboratory units including clinical chemistry, parasitology, urinalysis and body fluid analysis, hematology, serology, mycology, and bacteriology services. The checklist was used to collect interrupted tests based on the number of tests expected to be done for three consecutive months in both hospitals. Moreover, a structured self-administered questionnaire was used to get data for the socio-demographic characteristics and professional experiences of the study participants.

The data was collected by four trained laboratory professionals and supervised by senior experienced medical laboratory professionals who are certified in Laboratory Quality Management and Strengthening Laboratory Management Toward Accreditation.

The level of laboratory service interruption was measured across three consecutive months using a standard checklist adopted from the EHSTG. A “tick” was recorded if the test was done or not interrupted and “x” if the test was not done or interrupted. The test counted as interrupted if the test was not done for 1 or more than 1 day. Then calculation is done as follows:  •

Percentage of interrupted tests in each hospital = (sum of interrupted tests from all services/number of tests expected to be done in the hospital) × 100.

Laboratory service interruption: if the test was performed 3 months prior to initiation of the study in the hospital and it is not done for the one or more days during the study period, it counted as interrupted (19).

Laboratory service quality: the degree to which a set of inherent characteristics fulfills requirements (8).

Management review: top management reviews the organization’s quality management system at planned intervals to ensure its continuing suitability, adequacy, effectiveness, and alignment with the strategic direction of the organization (20).

Resources: means availability of budget, reagent and supply, quality equipment, calibration and control, and equipment maintenance with spare parts (8).

The checklists and questionnaire were pre-tested in Haramaya General Hospital with 5% of the total calculated sample size of laboratory professionals to identify ambiguity and potential challenges. In the actual study the raw data was checked every day for completeness and consistency. Training was given to data collectors on the purpose of the study and its method of data collection.

After checking the completeness and consistency of the collected data, the data were entered and analyzed using SPSS software version 26. Descriptive statistics were performed to calculate, the means, percentage of interruption of tests in each laboratory unit, and the frequency of event occurrences. The SLIPTA Checklist contains 12 main sections that have a total of 275 points. Each item has been awarded a point value of 2, 3, or 5 points based on relative importance and/or complexity. Service levels were evaluated based on the final scores of 12 quality system essential elements. Those laboratories that scored <55%, 55%–64%, 65%–74%, 75%–84%, 85%–94%, and ≥95% were awarded 0, 1, 2, 3, 4, and 5 stars, respectively (18). Bivariate and multivariable logistic regressions were used to identify the association between outcome and independent variables. Independent variables with p-value <0.25 were carried on into a multivariable logistic regression model. Independent variables that had p-values <0.05 with 95% CI were considered to be a significant association. The major findings were summarized and presented in tables and figures.

The principle of health research ethics was maintained, and ethical clearance was obtained from Haramaya University's College of Health and Medical Science and the Institutional Health Research Ethical Review Committee. The permission letter and informed, voluntary, and signed consent were taken from the HFSUH and JGH directors. Similarly, informed written signed consent was obtained from each study participant after explaining the research purpose, procedure, period, possible risk, and benefit. Every study participant had the right to make a decision about participation in the study and participants who were not willing to participate in the study were not forced to participate. All responses were coded to maintain confidentiality of the respondents for the information given.

The result of this study was submitted to Haramaya University, College of Health and Medical Sciences, and the School of Medical Laboratory Sciences as well as Harari Regional State Health Office, HFSUH, and JGH to inform the policies and programs.

According to EHSTG, 76 types of tests are expected to be performed in a specialized hospital whereas 68 types of tests are anticipated in a general hospital (19). In our study, 72 (94.7%) and 64 (94%) types of tests are available in HFSUH and JGH, respectively. Both hospital laboratories have clinical chemistry, parasitology, urinalysis and body fluid analysis, hematology, serology, mycology, and bacteriology service units. According to the SLIPTA Checklist, which contains 12 main sections, our assessment findings indicate that from the two laboratories, none of them met the required standard. The mean score of the two hospitals was 168.5 (61%). The mean laboratory service quality scores of HFSUH and JGH laboratories were 212 (77%) and 127 (46.1%), respectively.

The least mean service quality scores were observed in information management (47.60%), equipment (51.4%), purchasing and inventory (56.25%), management review (57.12%), and occurrence management (58.30%) in the two hospitals. Mean scores above average were recorded for process improvement (69%), evaluation, and audits (70%). Considerably greater scores for the 12 essential quality elements were observed in the HFSUH laboratory than the JGH laboratory, but none of them met the SLIPTA recommended maximum mean score (Figure 1).

The total numbers of interrupted tests in public hospitals were assessed based on existing laboratory services. The existing laboratory service performance was followed on a daily basis for 90 days to detect potential laboratory test interruptions. The data collectors recorded the type of test interrupted, the time of interruptions and the reason for the interruptions. Of all 72 tests in the two hospitals, on average 31 (43.05%) tests were interrupted at least for 1 day. Clinical chemistry test interruption accounted for 16 (51.6%) followed by 7 in serology (22.6%) and 4 in hematology (12.9%). Parasitological and urine analysis tests were the least interrupted, with parasitology test interruption occurring only for 1 day and no interruption of urinalysis.

The laboratories at both hospitals did not provide continuous diagnostic services for all available tests according to EHSTG. In the HFSUH laboratory 19/76 (25%) laboratory tests were interrupted at least for 1 day; accounting for the highest interruptions were of serology tests (6/9, 31.6%), hematology tests (5/19, 26.3%) and clinical chemistry (5/19, 26.3%). Of the 68 tests, 43 (63.2%) at JGH laboratory services were interrupted for at least 1 day, in which clinical chemistry tests (28/43, 65.1%), serology (7/43, 16.3%), and hematology (3/43, 7%) accounted to the highest proportions of interruptions.

We also assessed the common reasons for laboratory service interruptions. Cardiac function tests, thyroid stimulating hormone (TSH) and hematological tests were interrupted due to a shortage of reagents. Serological tests, occult blood, and potassium hydroxide (KOH) tests were discontinued mainly due to a shortage of test kits in the HFSUH laboratory. In the JGH laboratory all clinical chemistry tests and some hematological tests were interrupted due to a shortage of reagents. Besides occult blood, KOH tests, and serological tests were interrupted due to a lack of test kits. In this hospital cerebrospinal fluid (CSF) analysis, India ink, culture, and sensitivity were not started in the hospital. Chemistry tests for blood glucose, lipid profiles, liver function tests, renal function tests, and cardiac function tests had a longer interruption, starting after 63 days of interruption, but albumin was interrupted again, due to a failure to pass calibration.

Out of 31 laboratory service interruptions in these public hospitals, 27 (87%) were due to shortages of reagents and test kits. KOH tests, India ink, and hematology tests (bleeding time, reticulocyte count, and prothrombin time) were interrupted for 90 days in both hospitals. HFSUH laboratory experienced interruptions in cardiac function tests (lactate dehydrogenase, creatinine kinase subunit M and B, and creatinine phosphokinase) for 90 days and from hormonal tests TSH was interrupted for 90 days. Jugel General Hospital laboratory experienced interruptions in electrolyte tests, cardiac function tests, and hormonal tests for 90 days each. HFSUH laboratory experienced no interruptions in CSF analysis and electrolyte tests. JGH laboratory experienced a 90-day interruption in CSF analysis and electrolyte tests, and also 63-day interruptions in liver function tests and renal function tests (Table 1).

In total, 52 laboratory professionals participated, with a response rate of 96.3% in which 28 (53.8%) were male and 24 (46.2%) female. The highest number (22, 42.3%) of participants fell between the 30 and 35 years age group with a mean age of 36.19 years (SD = 6.38, a range of 24–54 years). The participants’ educational backgrounds are diverse; 40 (76.9%) of them have BSc degrees, 8 (15.4%) have a diploma or certificate, and 4 (7.7%) have a master's degree. In addition, 23 (44.2%) had 6–10 years’ work experience as laboratory professionals and the majority of the respondents 37 (71.1%) were working in a current hospital for more than 6 years. The majority of participants (47, 90.4%) identified as ordinary laboratory staff and a few participants (5, 9.6%) were occupying specialized positions such as safety officers, quality officers, and laboratory heads (Table 2).

According to this study, 37 (71.1%) of the participants responded that their laboratory services were continuously available while the rest (12, 23.1%) of them indicated that their laboratory services were interrupted frequently. Nearly 81% (42) of them were dissatisfied with their salary and 37 (71.2%) of them blamed failings on a high workload (Table 3). In addition, 39 (75%) of them responded that there was lack of adequate training in their hospital laboratory while 37 (71.2%) stated that their laboratory had inadequate working spaces. Concerning continuous power supply, 36 (69.2%) participants reported that their laboratory obtained continuous power supply and 35 (67.3%) water supply, whereas 36 (69.2%) laboratory professionals responded that backup power was unavailable when the electric power went off.

Three-fourth (38%) of the study participants believed that their clinical laboratory department had the insufficient budget. In addition, 38 (73%) of them indicated a shortage of human resources. Forty-one (78.8%) laboratory professionals understood that laboratory equipment was inadequate and 30 (57.7%) of them described malfunctioning equipment while 25 (48%) participants thought that equipment did not receive maintenance on time. According to this study concerning top management support, 36 (69.2%) laboratory professionals indicated that there were delayed responses from upper management for questions related to laboratory service, and 32 (61.5%) suggested there were no smooth communication systems.

In the bivariate analysis variables like insufficient human resources, unavailability of sufficient reagents and timely delivery of supplies, inadequate laboratory equipment, unavailability of equipment maintenance on time, unavailability of additional laboratory equipment to be used as a backup, occurrence of natural disaster or emergency, and delayed response of upper management response for questions related to laboratory service were all found to be significant. Variables with a p-value <0.25 were selected as candidates for multivariable logistic regression analysis. In multivariable logistic regression analysis variables like unavailability of sufficient reagents (p = 0.04) and supplies on time and lack of upper management response to laboratory service reports (p = 0.015) were statistically associated with laboratory service interruption (Table 4).

For the financial reason, the study was conducted only in two public hospitals, and the laboratory service interruptions for less than 1 day were not also considered.