ABSTRACT
Background and Aims
Clinical specimen rejection is a significant issue in laboratory medicine, particularly in resource‐limited settings such as Ethiopia. Understanding the underlying reasons for specimen rejection is crucial for implementing effective strategies to minimize errors, enhance laboratory performance, and improve patient care. The aim of this study was to assess the rate and reasons for clinical specimen rejection at Debre Tabor Comprehensive Specialized Hospital Laboratory from June 17 to July 16, 2025.
Methods
An institution based cross‐sectional study was conducted from June 17 to July 16, 2025. It included all specimens submitted for diagnostic testing during the study period. Data were analyzed using STATA version 17. Descriptive statistics were used to assess the rejection rate and identify possible reasons. Binary and Multivariable logistic regression was used to show the association between the rejection rate and independent variables and p‐value < 0.05 was considered as statistically significant.
Results
Out of 952 specimens analyzed, 58; 6.09% (95% CI: 4.6–7.6) were rejected. Mislabeled samples (17; 29.3%) and clotted samples (15; 25.86%) were the common causes of specimen rejection. Most rejections were associated with specimens collected by non‐laboratory health professionals 35 (60.3%), not trained refresher training 44 (75.9%), and those with over 6 years of experience 40 (69%). The highest rejection rates were observed from the inpatient service and during the day shift, 51 (87.94%) and 45 (77.58%), respectively. Samples not collected by laboratory personnel and health professionals not taken refresher training had higher odds of rejection.
Conclusion
The present study showed that the overall specimen rejection rate was relatively high from previous studies conducted. Mislabeled samples, clotted specimens, and low sample volume were the most common reasons of rejection. Samples taken by health professionals not taking refresher training and collected by health professionals other than laboratory personnel showed high risk to be rejected.
Keywords: clinical specimen, Ethiopia, laboratory performance, sample rejection rate, sample rejection reasons
1. Introduction
Clinical laboratories play a vital role in patient care and treatment, making them indispensable in healthcare systems. Timely and precise laboratory results are critical for disease management and prevention [1]. To ensure optimal service delivery, a high‐quality laboratory system is necessary, which involves establishing and maintaining an effective quality control system across all areas of laboratory operations. This encompasses proper management of requests, patient preparation and identification, specimen collection and transport, as well as processing, testing, interpreting, and reporting results throughout all phases of the testing process [2, 3].
Laboratory errors can occur at the pre‐analytical, analytical, and post‐analytical stages of the testing process, with about 70% happening during the pre‐analytical phase. Most errors stem from labor‐intensive tasks related to the collection, handling, transportation, preparation, and storage of diagnostic specimens [4]. Sample collection is a critical aspect of this phase, essential for ensuring quick, accurate, and reliable test results. Historically, efforts to enhance laboratory diagnosis have primarily focused on the analytical stage. However, modern approaches emphasize the importance of improving the pre‐analytical and post‐analytical stages alongside the analytical quality [5]. Errors at any stage can compromise the reliability of laboratory testing and affect patient care. Thus, maintaining high standards in specimen collection, handling, and transportation is vital for achieving quality laboratory results [6]. Despite advancements in quality control and laboratory technology, sample rejection remains a prevalent issue in medical facilities worldwide. Understanding the extent and causes of specimen rejection is vital for implementing targeted interventions to enhance laboratory service quality, improve diagnostic accuracy, and optimize patient outcomes [7]. In Ethiopia, studies have identified several common reasons for sample rejection in clinical laboratories. The major ones include hemolysis, clotted specimens, insufficient sample volume, labeling errors, poor transportation and storage [8].
The rejection of specimens can have serious clinical implications, as it requires recollection, which can slow down diagnosis and treatment particularly in emergency and intensive care settings where prompt test results are critical for life‐saving interventions [9]. For instance, recollecting venous blood can cause discomfort and carries risks such as hematoma. Similarly, obtaining additional urine and stool samples can be challenging, and patients requiring catheterization face a higher risk of infection. Generally, recollection of samples can lead to patient dissatisfaction, long waiting time, anxiety, discomfort, and diminished trust in healthcare services [10].
Beyond the clinical consequences, sample rejection also has a significant financial impact on healthcare systems. The need for repeat collections increases operational costs, adds to laboratory workloads, and extends hospital stays [11]. Large healthcare facilities could lose millions annually due to the costs associated with recollection and retesting. Additionally, rejected samples Moreover, they contribute to increased workloads and prolonged turnaround times in clinical laboratories [12]. This study aims to assess the sample rejection rates and identifying the causes at Debre Tabor Comprehensive Specialized Hospital Laboratory which provides insights on the rejection rate and to improve the underlying causes of the rejection.
2. Materials and Methods
2.1. Study Design, Period, Area, and Setting
The study was conducted at Debre Tabor Comprehensive Specialized Hospital, Debre Tabor town located in the South Gondar Zone of the Amhara Region in Northwest Ethiopia. It is approximately 104 and 664 kilometer from Bahir Dar and the capital Addis Ababa, respectively. The hospital was established in 1953 and serves more than 2.5 million people in its catchment area. The hospital has medical, surgical, pediatric, gynecology, pharmacy, outpatient, inpatient, emergency, and laboratory departments. The laboratory department has parasitology, microbiology, hematology, clinical chemistry, and molecular laboratory departments. An institutional based cross‐sectional study was conducted to assess the sample rejection rate and its underlying causes at Debre Tabor Comprehensive Specialized Hospital from June 17 to July 16, 2025.
2.2. Source and Study Population
All human clinical specimens that were sent to the Debre Tabor Comprehensive Specialized Hospital laboratory for different laboratory testing were the source population. All received clinical samples which were requested at Debre Tabor Comprehensive Specialized Hospital and arrived at laboratory sample reception for Hematology, Clinical Chemistry, Microbiology, Serology, and Parasitology tests from June 17 to July 16, 2025, and which fulfilled the eligibility criteria were the study populations.
2.3. Eligibility Criteria
All requested samples in the study period which were fully documented on the sample receiving registration book were included and samples with an unknown rejection status and not fully registered were excluded.
2.4. Sample Size Determination and Sampling Technique
All samples that were requested for diagnostic testing from June 17 to July 16, 2025 were included in the study.
2.5. Study Variables
The main outcome variable of the study was sample rejection rate. Sample type, sample collector characteristics, requested test type, and reason of rejection were considered explanatory variables used to classify and describe the pattern of rejection.
2.6. Data Collection Methods
Data were collected using structured checklists which is filled in the collection site and from the laboratories sample receiving registration book when the samples were received. The first checklist included the information regarding the data collector and the second included the information regarding the sample. The data collectors were recorded all samples requested to the laboratory during the study period. The data that had been taken were those whose information were fully recorded.
2.7. Data Quality Control and Management
Data collectors were trained, and regular supervision was carried out to ensure the quality of the data. The data were checked for completeness, clarity, and consistency. Double data entry was also applied to minimize any errors. Lastly, data cleansing and missing data were checked at the end phase of data quality control. The findings were carefully documented, transcribed, and evaluated.
2.8. Data Process and Analysis
After the raw data was collected, the variables were inserted in the checklist into the Epidata version 3.1 and then was exported and analyzed by using STATA software version 17. The rejection criteria of laboratory samples were based on ISO 15189:2022 [13]. Descriptive statistics were employed to summarize the rejection rate separately by type of sample, characteristics of sample collector, requested laboratory test, and reasons for rejection and present the results using tables and figures. Sample rejection rate and predictor variables were taken in to bivariable analysis with considering p‐value < 0.25 as significant and then taken to multivariable regression with considering p‐value < 0.05 as statistically significant.
2.9. Ethical Approval and Consent
The study was conducted after obtaining ethical clearance from the Debre Tabor University, the College of Health Science the ethical review committee (Reference Number: 0325/2025). A permission letter was also obtained from Debre Tabor Comprehensive Specialized Hospital to collect the data. All the collected data were kept confidential by using codes instead of any personal identifiers. Moreover, all methods were performed in accordance with the relevant guidelines and regulations.
3. Results
Out of 952 clinical specimens analyzed in the laboratory majority of the samples were blood samples 638 (67.02%) and the least analyzed samples were body fluids 11 (1.16%). After the assessment of all samples 58 (6.09%) (95% CI: 4.6–7.6) were rejected. None of body fluids sample were rejected and the majority of the rejected specimen were blood sample that constituted 47 (81.03%) of all rejected specimen (Table 1).
Table 1.
Distribution of sample acceptance and rejection rate by the type of sample collected in Debre Tabor Comprehensive Specialized Hospital.
| Variables | Category | Accepted | Rejected | ||
|---|---|---|---|---|---|
| Frequency | Percentage | Frequency | Percentage | ||
| Type of sample collected | Blood | 591 | 66.1 | 47 | 81.03 |
| Urine and stool | 200 | 22.4 | 8 | 13.8 | |
| Sputum | 92 | 10.3 | 3 | 5.17 | |
| Body fluids | 11 | 1.2 | 0 | 0 | |
| Total | 894 | 100 | 58 | 100 | |
Several reasons were raised for sample rejection in the laboratory. Mislabeling of sample took the majority 17 (29.3%) followed by clotted sample 15 (25.86%) and insufficient sample volume 12 (20.68%). Contaminated sample and hemolyzed sample 3 (5.2%) were accounted for the minority rejection reason (Figure 1).
Figure 1.
Reasons for sample rejection in Debre Tabor Comprehensive Specialized Hospital Laboratory.
Most of the samples were collected by the laboratory personnel 744 (78.15%) and large number of samples were collected during the day shift than the night shift. Majority of samples were collected by health professionals who had a degree and a diploma 583 (61.24%) and 296 (31.09%) respectively. Most of the health professional lack trainings for sample collection and worked in the area for more than 6 years. (Table 2).
Table 2.
Characteristics of sample collectors in Debre Tabor Comprehensive Specialized Hospital.
| Variables | Categories | Frequency | Percentage |
|---|---|---|---|
| Sample collected by | Laboratory personnel | 744 | 78.15 |
| Other health professionals | 208 | 21.85 | |
| Educational level of sample collector | Diploma | 296 | 31.09 |
| Degree | 583 | 61.24 | |
| Masters | 62 | 6.51 | |
| General practitioner | 9 | 0.95 | |
| Specialist | 2 | 0.21 | |
| Refresher training taken for sample collection | Yes | 164 | 17.2 |
| No | 788 | 82.8 | |
| Work shift | Day | 726 | 76.26 |
| Night | 226 | 23.74 | |
| Working experience of health professional in years | < 1 | 1 | 0.1 |
| 1–3 | 1 | 0.1 | |
| 4–6 | 242 | 25.4 | |
| > 6 | 708 | 74.4 |
Majority of the rejected samples were collected by non‐laboratory health professionals 35 (60.3%) and the degree and the diploma holders 34 (58.7%) and 22 (37.9%) respectively. They were collected the largest number of samples as well as large number of samples were rejected from it. (Table 3).
Table 3.
Distribution of sample rejection by characteristics of sample collectors in Debre Tabor Comprehensive Specialized Hospital.
| Variables | Categories | Rejection rate | |
|---|---|---|---|
| Frequency | Percentage | ||
| Sample collected by | Laboratory personnel | 23 | 39.7 |
| Other health professionals | 35 | 60.3 | |
| Educational level of sample collector | Diploma | 22 | 37.9 |
| Degree | 34 | 58.7 | |
| Masters | 2 | 3.4 | |
| Refresher training taken for sample collection | Yes | 14 | 24.1 |
| No | 44 | 75.9 | |
| Work shift | Day | 45 | 77.58 |
| Night | 13 | 22.42 | |
| Working experience of health professional in years | < 6 | 18 | 31 |
| > 6 | 40 | 69 | |
Samples included in this study were collected from all the inpatient and the outpatient departments. The inpatient services showed 51 (87.94%) of rejection rate. The highest number of samples collected from the medical ward 399 (41.96%) then the out‐patient department 169 (17.75%), pediatrics ward 153 (16.07%), surgical ward 124 (13.03%), and the list were from gynecology and obstetrics ward 103 (11.24%). The medical and pediatric wards accounted for the largest 18 (31.03%) sample rejection rate while the gynecology and obstetrics ward and the outpatient department accounted for the least 7 (12.07%) rejected samples. (Figure 2).
Figure 2.
Distribution of sample rejection in different departments of Debre Tabor Comprehensive Specialized Hospital.
Samples from different departments were collected for different laboratory analysis. It includes hematology, parasitology, clinical chemistry, serology and microbiology. Some of the tests that are included were the hematological analysis which included test for cell count, hemoglobin, hematocrit, red cell indices and morphological tests. The clinical chemistry analysis which included organ function tests and hormonal assessments. The parasitological tests included blood film, stool and urine analysis and others that can detect systemic parasites. Microbiological tests include body fluid analysis, culture, PCR, and different staining techniques. The majority of samples were rejected from the hematology tests 23 (39.65%), the second were clinical chemistry tests 13 (22.43%), the third were microbiological tests 11 (18.96%), the forth were serological tests 7 (12.07%), and the last were parasitological tests 4 (6.89%).
Table 4 showed the statistical analysis of factors for sample rejection using binary logistic regression. Samples collected by non‐laboratory health professionals had 1.85 times higher odds of rejecting compared to samples collected by laboratory professionals and samples taken by health professionals not trained refresher training had increased odds of rejection.
Table 4.
Binary and Multivariable logistic regression analysis of sample rejection rate among clinical specimens. (n = 952).
| Variables | COR (95% CI) | AOR (95% CI) | p value | |
|---|---|---|---|---|
| Sample collected by | Laboratory personnel | I | I | |
| Other health professionals | 1.84 (1.29–2.398) | 1.85 (1.3–2.4) | < 0.001* | |
| Refresher training taken for sample collection | Yes | I | I | |
| No | 0.94 (0.701–1.08) | 1.18 (0.46–2.12) | 0.0145* | |
| Work shift | Day | I | I | |
| Night | −0.079 (−0.715–0.55) | −0.23 (−0.89–0.42) | > 0.99 |
Statistically significant p < 0.05; I: reference group.
4. Discussion
Laboratory tests provide essential information that influences diagnostic and therapeutic decisions, with an estimated 60%–70% of these decisions relying on test results. As a result, laboratory tests are an indispensable part of modern clinical diagnosis. Sample rejection rate is an important quality indicator in laboratory medicine. Reported rates typically range from less than 1% in well performing laboratories to around 1%–2% in routine practice, while > 2% indicate quality concerns [14]. Our study aimed to assess the sample rejection rate and reasons of rejection among clinical specimen requested for diagnostic testing at Debre Tabor Comprehensive Specialized Hospital. The overall rejection rate was found 58 (6.09%) and this result was in line with studies conducted in tertiary medical center in developing world [15] and Zimbabwe [16]. This may be attributed to comparable health care system challenges, disease burdens, high testing demands, and systemic constraints common in developing countries. Mislabeling of sample, clotted sample, and insufficient volume of sample were found the leading rejection reasons in this study. The result is higher than the study conducted in Debre Markos, Ethiopia [17] and Pakistan [18]. This discrepancy may be due to the inclusion of different sample types in our study for several diagnostic approaches rather the other study mainly focus on blood sample. Study conducted in Malaysia [19] showed clotting of samples as the leading cause of rejection and another study conducted in Zimbabwe [20] showed insufficient volume of sample as the major reason and a study conducted in India [21] also showed mislabeling of samples was the commonest sample rejection reason. Specimen rejection may have significant consequences for patients and their clinical management. Defects in laboratory specimens that result in specimen rejection are a cause of inconvenience and discomfort to patients, lead to a delay in the availability of often critical laboratory results, and, if the methods used to detect specimen defects are not effective, may also represent a major compromise of patient safety.
The majority of samples were collected by laboratory professionals during the day shift with degree and diploma qualifications from different departments of the hospital. The day shift has more patient flow and the number of health professionals with diploma and degree qualifications were higher in number. The inpatient services cover the majority of rejection rate with the medical ward as the first and then followed by pediatrics and surgical wards. The results were consistent with study conducted at S.t Paul Hospital Millennium Medical College, Addis Ababa, Ethiopia [22] and tertiary healthcare facility, USA [14]. The majority of samples were collected from the inpatient service of the hospital and the majority of rejections found there. The heavy work load, complexity of patient conditions, urgency of collection, and frequent drawing of sample may be the possible reasons. Blood samples were the largest and hematological tests were the leading diagnostic tests in our study. The findings were supported by studies conducted in Ethiopia at Debre Markos [17] and University of Gondar Hospital [23]. The reason for this may be hematological tests more prone to rejection compared to others. Rejection reasons such as clotted sample, insufficient volume, and hemolysis of sample mainly affect the hematological parameters.
Majority of health professionals were not taken refresher training for sample collection and the rejection rate was increased in the health professionals with greater than 6 years of experience. This result was similar with study conducted in Turkey [24]. Although most of the rejected samples were collected by health professionals with more than 6 years of experience the majority were not received refresher training in sample collection. Not taking refresher training and samples taken by health professionals other than laboratory personnel showed higher odds of rejection. This finding is inline with studies conducted in Turkey [25] Qatar [26]. The consistency may be due to the necessity of updated training for sample collection related with the ongoing update in test principles and collecting containers. A lack of continuous training may lead to reliance on outdated practices and routine‐based errors. The familiarity of the laboratory staff with pre‐analytical procedures and updated test procedures also reduce the risk of sample rejection comparing with other health professionals.
5. Conclusions and Recommendations
The rejection rate of sample at Debre Tabor Comprehensive Specialized Hospital was high. Mislabeling of sample, clotted sample, and insufficient volume of sample were the leading rejection reasons in this study. Most of the rejected samples were collected from the inpatient service, by non‐laboratory health professionals with greater than 6 years of experience and lacked formal or refreshment training, for hematological tests, and during the day shift. It is recommended refreshment training should be given to health professionals and reducing the work load to focus and rely on standard in data collection. Enhanced supervision, targeted feedback and monitoring system, continuous quality improvement initiatives and improved communication between laboratory and clinical teams are crucial to reduce specimen rejection and enhance overall laboratory performance.
6. Strength and Limitations of the Study
This study assess the sample rejection rate and reasons of rejection which is essential to improve laboratory quality and patient safety as increasing of rejected samples delay diagnosis and treatment. However, the study has limitations that it was conducted over a 1 month period, which may be too short to accurately reflect the true specimen rejection rate.
Author Contributions
Mahider Shimelis Feyisa: conceptualization, investigation, funding acquisition, writing – original draft, validation, visualization, writing – review and editing, methodology, formal analysis, software, supervision, data curation, resources, project administration. Ayenew Berhan: conceptualization, investigation, methodology, validation, formal analysis, supervision, data curation, software, writing – review and editing, writing – original draft. Mekides Andargie Ferede: conceptualization, investigation, writing – original draft, writing – review and editing, visualization, methodology, formal analysis, resources. Alemie Fentie: writing – review and editing, funding acquisition, validation, software, supervision, resources. Andargachew Almaw: writing – original draft, conceptualization, methodology, visualization, project administration, data curation, software. Ayenew Assefa: writing – original draft, funding acquisition, investigation, conceptualization, validation, formal analysis. Dessie Tegegne: writing – review and editing, visualization, validation, methodology, conceptualization, formal analysis, supervision. Birhanemaskal Malkamu: visualization, writing – original draft, methodology, software, supervision, data curation. Birhanu Getie: visualization, writing – review and editing, validation, investigation, conceptualization, supervision. Shewaneh Damtie: writing – review and editing, visualization, writing – original draft, funding acquisition, conceptualization, methodology, software. Getu Abeje: writing – review and editing, visualization, funding acquisition, conceptualization, formal analysis, software. Teklehaimanot Kiros: writing – original draft, funding acquisition, investigation, validation, formal analysis, data curation. Rahel Birhanu Arage: conceptualization, writing – original draft, writing – review and editing, methodology, formal analysis, supervision. Besfat Berihun Erega: writing – original draft, funding acquisition, methodology, validation, conceptualization, software, formal analysis, data curation, supervision. Habtam Desse Alemayehu: conceptualization, methodology, writing – review and editing, writing – original draft, project administration, supervision. Ermias Bekele Enyew: conceptualization, investigation, funding acquisition, validation, methodology, writing – review and editing, formal analysis, supervision. Bruktawit Eshetu: writing – review and editing, visualization, investigation, conceptualization, formal analysis, supervision. Mulat Erkihun: writing – review and editing, visualization, funding acquisition, writing – original draft, conceptualization, methodology, software, formal analysis, data curation, supervision.
Funding
The authors have nothing to report.
Consent
The requirement for informed consent was waived by Debre Tabor University, College of Health Science Ethical review committee because no direct patient involvement occurred, and all data were confidentially handled during analysis.
Conflicts of Interest
The authors declare no conflicts of interest.
Transparency Statement
The correspondent author Mahider Shimelis Feyisa affirms that this manuscript is an honest, accurate, and transparent account of study being reported: that no important aspects of the study have been omitted; and that any discrepancies from the study as planned (and, if relevant, registered) have been explained.
Data Availability Statement
The data that support the findings of this study are available on request from the corresponding author. The data are not publicly available due to privacy or ethical restrictions.
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Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Data Availability Statement
The data that support the findings of this study are available on request from the corresponding author. The data are not publicly available due to privacy or ethical restrictions.