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. 2026 Sep 15;21(9):e0358136. doi: 10.1371/journal.pone.0358136

Assessment of vaccination competency among health workers in health facilities in East Wollega, Oromia, Western Ethiopia: An observational study

Adugna Olani 1, Gedefa Bayisa 2,*, Merga Chala 1, Lami Gurmessa 1, Jiregna Fayera 3
Editor: David J Diemert4
PMCID: PMC13577397  PMID: 42743175

Abstract

Background

Vaccination competency is a critical determinant of immunization quality and safety. However, limited evidence exists on the practical skills of frontline providers in Ethiopia.

Methods

A facility-based observational study assessing vaccination competency among health care providers involved in routine childhood immunization.

Results

A total of 34 providers were observed while administering 10 vaccine doses each, resulting in 340 observed vaccination encounters. Competency was assessed using a structured checklist covering patient/parent education, medical and office protocols, vaccine preparation, vaccine administration, and record-keeping. A composite competency score was calculated for each provider and expressed as a percentage. Domain-specific competency scores were summarized using descriptive statistics, and providers scoring ≥80% were classified as competent. We observed 340 vaccination procedures performed by healthcare providers in 34 health facilities. Most providers were aged 30–39 years (19/34), male (22/34), held a Bachelor of Science (23/34), and had 6–10 years of work experience (20/34). Competency varied across domains, with the highest performance in vaccine administration (71%) and the lowest in record-keeping (22%). The overall mean competency score was 50%, below the predefined 80% competence threshold.

Conclusion

Moderate technical skills but failure in infection control, patient communication, and documentation resulted in weak practical competency, were observed from this study. Data indicate a gap between knowledge-based practice and actual performance. To improve immunization service, it is essential to enhance supervision and mentorship, focus on vaccine information system usage, and provide regular competency-based training for EPI providers. Strengthening routine monitoring and supportive supervision is critical, along with further research to identify barriers and assess training effectiveness. Addressing these gaps is vital for enhancing the quality and coverage of immunization services.

Introduction

Immunization is widely acknowledged as one of the most cost – effective public health measures, and it is essential in lowering the morbidity and mortality rates of diseases that can be prevented by vaccination [1]. The World Health Organization (WHO) estimates that vaccinations avert 2–3 million deaths annually [2]. But the availability of vaccines is not the only factor that affects the quality of vaccination services; healthcare providers’ ability to follow safe and efficient procedures is also a factor. This implies using the right vaccination administration methods, following infection control guidelines, and keeping thorough records [3]

Ethiopia has achieved notable progress in increasing the coverage of childhood vaccinations. The Expanded Program on Immunization (EPI), which was put into place by the Ethiopian government, has improved vaccine accessibility nationwide [4]. According to the latest WHO/UNICEF Estimates of National Immunization Coverage (WUENIC), Ethiopia achieved 84% coverage for the first dose (DTP1) and 74% coverage for the third dose (DTP3) of the diphtheria–tetanus–pertussis vaccine in 2024, indicating that routine immunization coverage remains below national and global targets [5].. But even with these advancements, there are still issues with making sure vaccinations are given in a safe and efficient manner. There have been reports of problems like poor documentation practices, inconsistent adherence to infection prevention guidelines, and insufficient training of healthcare providers [6]

In order to reduce adverse events following immunization (AEFI) and preserve public confidence in vaccination programs, infection prevention is especially important in vaccination practices. Furthermore, accurate record-keeping is crucial for tracking immunization coverage at the community and national levels as well as for tracking each person’s vaccination status. Finding coverage gaps and putting effective interventions in place become difficult without accurate records [7].

In order to pinpoint areas that need focused capacity-building and quality improvement initiatives, it is essential to evaluate the vaccination competencies of EPI providers. Research indicates that increasing provider competencies may result in better vaccination procedures and greater rates of immunization coverage [8]. Furthermore, studies suggest that continuous training and assistance for medical professionals greatly improves health outcomes in vaccination programs [9].

In conclusion, even though Ethiopia has achieved impressive strides in childhood vaccination coverage through its EPI, it is still imperative to assess and improve the skills of those who administer vaccinations. In order to address particular issues with the vaccination process, stakeholders can create customized interventions by concentrating on competency assessment. This approach will not only improve the quality of immunization services but also ensure that all children receive safe and effective vaccinations.

One of the most inexpensive public health initiatives is immunization. However, the availability of vaccines and the ability of providers to adhere to safe and efficient procedures are both factors that affect the quality of vaccination services. Although childhood vaccination coverage has increased in Ethiopia, there are still issues with safe administration, infection prevention compliance, and accurate record-keeping. Evidence for focused capacity-building and quality improvement can be obtained by evaluating vaccination competencies.

Objectives

General objective

  • To assess the competency of health workers regarding safe vaccination practices in the immunization service areas of Western Ethiopia, October–November 2025

Specific objectives

  • To determine health workers’ practices related to patient or caregiver education and informed consent before vaccine administration.

  • To assess health workers’ adherence to recommended vaccine preparation and administration techniques.

  • To assess health workers’ compliance with infection prevention measures during vaccination.

  • To assess health workers’ preparedness to manage AEFI, including anaphylaxis.

  • To assess health workers’ practices related to vaccination documentation and use of immunization records.

Materials and methods

Study design and setting

This facility-based cross-sectional study was conducted in East Wollega Zone, Oromia Regional State, Ethiopia from October to November, 2025. The zone has 69 public health facilities, including hospitals and health centers, providing routine healthcare services including childhood immunization through the Ethiopian EPI. Thirty-four public health facilities providing routine vaccination services were included in the study. Facilities were selected from those providing childhood immunization services during the study period, as the study aimed to assess competencies of health workers involved in vaccine delivery.

Study population and sampling

The study included 34 EPI providers from 34 health facilities. One EPI provider responsible for routine vaccination services on the day of data collection was included from each facility. Each provider was observed while vaccinating 10 children.

Eligibility criteria

Inclusion criteria.

  • Licensed health care providers (e.g., nurses, midwives, health officers) involved in routine childhood immunization services

  • Were actively providing vaccinations under the EPI during the study period

  • Had at least 6 months of experience in immunization service delivery at the study facility

  • Were present and on duty during the data collection period

  • Provided informed consent to be observed while administering vaccines

Exclusion criteria.

  • Were students, interns, or trainees not independently responsible for vaccine administration

  • Were on leave, reassigned, or not providing immunization services during the data collection period

  • Performed fewer than 10 observed vaccination encounters during the observation period

Sample size

The study included 340 vaccinations observation from 34 EPI providers. Each provider was observed while vaccinating 10 children, resulting in 34 × 10 = 340 observed child vaccination encounters.

Vaccination services assessed

Observations were conducted during routine childhood immunization sessions. Vaccines administered included those in the Ethiopian Expanded Program on Immunization (EPI), such as Bacille Calmette–Guérin (BCG), oral polio vaccine (OPV), pentavalent, pneumococcal conjugate vaccine (PCV), rotavirus, and measles-containing vaccine (MCV), according to the national immunization schedule. Providers were observed while administering vaccines appropriate for the child’s age.

Data collection tools and procedures

Ethical approval was granted by the Wollega University Institutional Review Board. Written informed consent was obtained from EPI providers and caregivers before data collection, and confidentiality was maintained throughout the study. Data were collected during routine childhood immunization sessions using a structured competency assessment checklist adapted from the Ethiopian National EPI guidelines and the WHO immunization standards. Vaccines administered during the observations included those recommended under the national childhood immunization schedule, such as BCG, OPV, pentavalent vaccine, PCV, MCV), according to the child’s age. One trained data collector directly observed each EPI provider while vaccinating 10 children without interfering with routine service delivery. Observable competencies, including caregiver communication, vaccine preparation, infection prevention practices, vaccine administration, and documentation, were assessed through direct observation. Facility-level practices, such as cold chain monitoring, were verified through observation of equipment and available records, while provider characteristics were confirmed through interview and supporting documentation where available.

Data analysis

Competency was assessed using a structured observational checklist. Each item was scored as ‘1’ if performed correctly and ‘0’ if not performed. Each EPI provider was observed while vaccinating 10 children. Because observations were repeated for each provider, child-level observations were considered clustered within providers. Child-level competency indicators were summarized across the 340 observed vaccination encounters, while provider-level competency scores were calculated by aggregating observations from the 10 encounters for each provider and converting the total score into a percentage. Variability between providers was assessed by comparing the distribution and range of competency scores across the 34 providers. Analyses were conducted at both child-observation and provider levels, depending on the nature of the competency indicator. While no explicit national numeric cut-off exists, the ≥ 80% threshold is widely used in WHO-supported programs and comparable studies and was therefore adopted as the competency benchmark.

Variables and measurements

The outcome variable was vaccination competency, assessed through overall, domain-level, and item-level performance. Independent variables included selected health worker characteristics: age, sex, educational qualification, and work experience. Descriptive statistics were used to summarize competency scores across domains and individual items.

Ethics statement

Ethics approval was obtained from the Institute of Health Sciences Research, Technology Transfer and Postgraduate Study Directorate of Wollega University (Reference No. IHSRPTTAD111/2014). Participant recruitment and direct observation were conducted from 1 October 2025–30 November 2025. Verbal informed consent was obtained from all healthcare providers before observation. Verbal consent was documented by the data collectors on the observation checklist before commencement of each observation session. Confidentiality and anonymity of participants were maintained throughout the study.

Results

A total of 340 vaccination procedures were directly observed across 34 facilities. Providers’ competencies were evaluated in five domains: patient/parent education, medical and office protocols, vaccine preparation, vaccine administration, and record-keeping.

Sociodemographic and professional characteristics of study participants

The sociodemographic data reveals a diverse sample of participants across various categories. In terms of age, the majority fall within the 30–39 age group, comprising 19 individuals, while 14 participants are aged between 20 and 29. There is a notable decrease in representation for those aged 40 and above, with only one participant in the 40 + category. Gender distribution shows a predominance of males, with 22 male participants compared to 12 females. Regarding education levels, most participants hold a Bachelor of Science degree, totaling 23 individuals, followed by 8 participants with a diploma and 3 with a Master’s degree or Master of Public Health (MSc/MPH). Lastly, work experience varies among the participants; 20 individuals have between 6–10 years of experience, while 10 have 1–5 years, and only 4 participants have over 11 years of experience

Competency assessment result

Domain-specific vaccination competency among healthcare workers varied across the assessed areas (Fig 1) The highest competency level was observed in administering immunizations, with 71% of healthcare workers meeting or exceeding competency criteria. Vaccine preparation was the second highest domain, with 59% meeting/exceeding competency, followed by patient/parent education (57%). Competency was lower in medical and office protocols, where 41% of healthcare workers met/exceeded the competency criteria. Record-keeping demonstrated the lowest competency level, with 22% of healthcare workers meeting/exceeding the required criteria.

Fig 1. Domain-specific vaccination competency among EPI providers based on observed vaccination practices (n = 34 providers and 340 child vaccination encounters).

Fig 1

Child-level vaccination practices were assessed through direct observation of immunization encounters. In the patient/parent education domain, 65% of observed encounters included welcoming the patient/family and establishing rapport. Providers explained vaccines and injection types in 68% of encounters, addressed questions and literacy or language barriers in 79%, screened for contraindications in 56%, and reviewed comfort measures and post-vaccination care in 68%.

During vaccine administration, patient identity was verified in 68% of observed encounters. Correct positioning or restraint and identification of the injection site were performed in 85% of encounters, while anatomical landmarks were correctly located in 94%. The correct vaccine route was demonstrated in 74% of encounters, needle insertion at the correct angle in 82%, and correct needle withdrawal after injection in 74%. Post-injection pressure application was performed in 94% of encounters. Strategies to reduce anxiety or pain were used in 56% of encounters, while proper sharps disposal and vial disposal were observed in 79% and 82% of encounters, respectively (Table 1).

Table 1. Child-level vaccination competency among observed vaccination encounters (n = 340).

Competency domain Competency item Meets/exceeds competency (%)
Patient/Parent Education Welcomes patient/family and establishes rapport 65%
Explains vaccines and type of injection 68%
Answers questions/addresses literacy or language barriers 79%
Screens for contraindications 56%
Reviews comfort measures and aftercare 68%
Administering Immunizations Verifies patient identity 68%
Positions/restraints correctly 85%
Identifies injection site 85%
Locates anatomic landmarks 94%
Demonstrates correct vaccine route 74%
Inserts needle at correct angle 82%
Injects and withdraws needle correctly 74%
Applies pressure post-injection 94%
Uses strategies to reduce anxiety/pain 56%
Proper sharps disposal 79%
Proper vial disposal 82%

Provider-level competency varied across the assessed vaccination practice areas. In the patient/parent education domain, only 6% of providers verified receipt of Vaccine Information Statements (VIS). For medical and office protocols, competency levels ranged from 21% for identifying the location and indication of epinephrine to 56% for demonstrating proper vaccine handling. Other competencies in this domain included identifying the location of medical protocols (44%), maintaining Cardiopulmonary Resuscitation (CPR) certification (50%), and reporting needlestick injuries and maintaining sharps logs (32%).

Within the vaccine preparation domain, competency ranged from 6% for performing hand hygiene before preparation and maintaining aseptic technique during septum cleaning to 85% for checking vial expiration dates/labels. Other observed competencies included checking refrigerator/freezer temperature (59%), preparing vaccines in a clean medication area (68%), selecting the correct needle size (79%), and preparing vaccines according to manufacturer instructions (76%). For safe injection practices, 74% of providers demonstrated adherence to recommended practices, and 74% appropriately labeled filled syringes.

Provider competency in record-keeping activities was comparatively lower. Only 18% of providers fully documented vaccination details, including lot number, injection site, VIS, and initials. Similarly, 26% used an immunization registry/computer system, and 21% updated patient vaccination record cards (Table 2)

Table 2. Provider level vaccination competency among EPI providers (n = 34).

Competency domain Competency item Meets/exceeds competency (%)
Patient/Parent Education Verifies receipt of VIS 6%
Medical and Office Protocols Identifies location of medical protocols 44%
Identifies epinephrine location/indication 21%
Maintains CPR certification 50%
Reports needlestick injuries and maintains sharps log 32%
Demonstrates proper vaccine handling 56%
Vaccine Preparation Performs hand hygiene before preparation 6%
Checks refrigerator/freezer temperature 59%
Checks vial expiration/label 85%
Prepares in clean medication area 68%
Selects correct needle size 79%
Maintains aseptic technique (septum cleaning) 6%
Prepares vaccine per manufacturer instructions 76%
Adherence to safe injection practices 74%
Labels filled syringes 74%
Record-Keeping Fully documents vaccination (lot, site, VIS, initials, etc.) 18%
Uses immunization registry/computer system 26%
Updates patient vaccination record card 21%

Discussion

The present study identified substantial variation in vaccination competencies across different domains. Although providers demonstrated good performance in several technical aspects of vaccine administration, particularly injection site identification and anatomic landmark recognition, important deficiencies were observed in infection prevention, documentation, and adherence to immunization protocols. These findings suggest that targeted in-service training, supportive supervision, and regular competency assessments are needed to strengthen routine immunization practices and improve the quality and safety of vaccination services.

This study revealed significant gaps in vaccination practices. While providers showed adequate technical injection skills, infection prevention practices were alarmingly poor, echoing findings from Addis Ababa infection control studies where hand hygiene compliance was < 10%. Documentation also remained weak, consistent with national assessments of immunization data quality in Ethiopia. The extremely low use of VIS/informed consent (2%) highlights a gap in patient education, which is critical for informed consent and vaccine confidence. The strong link between education, experience, and competency suggests that continuous professional development is essential.

In this study, adherence to hand hygiene remained critically low at 5%, and aseptic technique for vial septum cleaning was only 3%. Glove use during administration was also observed at just 3%. These findings are consistent with an infection control study in Addis Ababa, Ethiopia, which reported poor compliance with hand hygiene before patient contact (~7%). While other studies often report higher compliance in self-reports, our observational findings demonstrate much lower real-world adherence, underscoring the gap between knowledge and practice [10,11].

Our study found only moderate performance in cold chain management and handling practices. For example, 60% checked refrigerator/freezer temperatures, 71% checked vial expiration/label, and 57% demonstrated correct vaccine handling. This contrasts with earlier cold chain studies in Oromia, which found ~50–60% good practice. Although some aspects (e.g., vial checking) were stronger in our study, overall cold chain adherence is still insufficient, suggesting continued challenges in consistent implementation [12]

Documentation remains the weakest domain. In our updated results, only 10% fully documented vaccinations, 25% updated patient cards, and 45% used digital registries. These results are consistent with national-level assessments of Ethiopia’s immunization program, which have highlighted poor data quality, discrepancies in reporting, and limited use of registries. Our observational data reinforces that documentation is a persistent systemic gap [6].

The updated results show that 65% of providers established rapport and 69% explained vaccines, while 80% answered questions and addressed literacy/language barriers. However, only 2% verified VIS use, and only 55% screened for contraindications. These findings mirror other reports from LMICs, where verbal communication is more common than providing standardized written materials. Our 2% VIS provision rate is particularly low compared with international standards [9]

Awareness of emergency protocols remains inadequate in the updated results. Only 30% identified epinephrine storage and use, and 50% identified medical protocols. Similar findings are echoed in infection control and safety studies in Ethiopia, which have reported low awareness and preparedness for emergency response. This underlines the need for routine drills and protocol reinforcement [13].

Overall, the updated results confirm patterns reported in previous Ethiopian and regional studies. While some technical skills such as rapport building and injection technique were moderate to strong, infection prevention, documentation, VIS provision, and emergency preparedness remain critically weak. The reliance on direct observation in this study revealed even lower actual practice levels compared to self-reported rates in other studies, highlighting the urgent need for training, supervision, and behavioral interventions to improve immunization service quality.

Limitations and methodological transparency

Several methodological limitations should be considered when interpreting the findings. First, although the study included 34 facilities across the region, facility selection was not randomized, limiting the representativeness and generalizability of results to all health facilities in western Ethiopia.

Second, only one EPI provider was observed per facility. This may not capture intra-facility variation in performance, and provider selection was based on who was actively vaccinating on the day of the visit, introducing potential selection bias.

Third, although measures were taken to minimize the Hawthorne effect—such as reassuring providers that observations were confidential and would not be used for performance evaluation—some degree of behavior change due to being observed may still have occurred

Fourth, the clustered nature of the data reduces the effective sample size. Although 340 observations were collected, the true analytical power reflects the number of clusters (34 providers). Failure to account for clustering could underestimate standard errors and overstate statistical significance.

Fifth, although data collectors were trained, the study did not include formal assessment of inter-rater reliability (e.g., kappa statistics), which may introduce observer variability

Finally, confidentiality requirements prevented linking provider performance to specific facility characteristics. This limits exploration of contextual factors (workload, supervision, supply availability) that may influence performance outcomes.

Despite these limitations, the study provides important insights into EPI provider competencies across multiple health facilities and identifies practical areas for quality improvement in routine immunization service delivery.

Conclusion and recommendations

Conclusion

The vaccination providers demonstrate moderate technical skills but major weaknesses in infection prevention, patient communication, and documentation. In this study, no statistically significant correlation was found between the dependent and independent variables. However, direct observation during data collection revealed that the competency of EPI focal persons in practice was generally low. This finding highlights an important gap between theoretical knowledge and actual performance in immunization service delivery. While the absence of correlation may indicate that the selected variables are not strong predictors of competency, the observed low performance suggests that other unmeasured factors—such as training, supervision, workload, or motivation—may play a critical role.

Recommendations

  1. Ensure supervision and mentorship with emphasis on VIS use and patient education.

  2. Integrate competency-based refresher courses for EPI providers.

  3. Provide regular in-service training and refresher courses for EPI focal persons to strengthen practical skills.

  4. Strengthen routine monitoring, mentorship, and supportive supervision at health facility level.

  5. Further Research:•

    • Conduct studies with larger samples or alternative study designs to explore other factors influencing competency.

    • Employ qualitative methods (e.g., interviews, focus groups) to gain deeper insights into barriers affecting practice

    • Consider intervention-based studies to assess the effectiveness of training and supervision programs.

  6. Policy Implication: The observed competency gap should be addressed at program and policy level to improve immunization service quality and coverage.

Key messages

What is already known on this topic

Vaccination programs in low- and middle-income countries rely on competent health workers to ensure safe and effective immunization services. However, health workers’ knowledge and practices can be inconsistent, leading to vaccine wastage and reduced immunization coverage. In Ethiopia, there is limited evidence on vaccinators’ competencies and operational challenges.

What this study adds

This study provides primary data on the knowledge, attitudes, and practices of Ethiopian vaccinators regarding cold chain management. It identifies specific gaps that may compromise vaccine effectiveness and program quality. These findings offer concrete targets for workforce training and improved operational protocols.

How this study might affect research, practice or policy

Results can guide targeted interventions to strengthen vaccine storage and handling in public health facilities. Policymakers can use these insights to enhance training, supervision, and monitoring systems for vaccinators. Future research can evaluate interventions aimed at improving immunization quality and coverage in Ethiopia and similar Low- and Middle-Income Countries (LMICs)

Acknowledgments

We would like to express our heartfelt appreciation to Wollega University for providing academic guidance and institutional support throughout this study. Our sincere gratitude extends to the data collectors and supervisors, whose dedication and commitment ensured the accuracy and quality of the data. We also acknowledge the invaluable contributions of the research team; whose hard work and collaboration made this research possible. Finally, we extend our deep appreciation to all participating health facilities for their cooperation and support during data collection.

Abbreviations

AEFI

Risk of Adverse events following immunization

BCG

Bacille Calmette–Guérin

CPR

Cardiopulmonary Resuscitation

DTP

diphtheria–tetanus–pertussis

EPI

Expanded Program on Immunization

LMIC

Low- and Middle-Income Countries

MCV

measles-containing vaccine

OPV

oral polio vaccine

PCV

pneumococcal conjugate vaccine

UNICEF

United Nations Children’s Fund

VIS

Vaccine Information Statements

WHO

World Health Organization

WUENIC

WHO/UNICEF Estimates of National Immunization Coverage

Data Availability

De-identified data that support the findings of this study are available upon reasonable request, subject to institutional and ethical approvals. Requests for data access should be directed to the Research Ethics Review Committee, Wollega University, Nekemte, Ethiopia (email: WU@ethionet.et).

Funding Statement

The author(s) received no specific funding for this work.

References

Decision Letter 0

David J Diemert

7 Aug 2026

Dear Dr. Bayisa,

Thank you for submitting your manuscript to PLOS ONE. After careful consideration, we feel that it has merit but does not fully meet PLOS ONE’s publication criteria as it currently stands. Therefore, we invite you to submit a revised version of the manuscript that addresses the points raised during the review process.

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Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

1. Is the manuscript technically sound, and do the data support the conclusions?

Reviewer #1: Partly

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2. Has the statistical analysis been performed appropriately and rigorously? -->?>

Reviewer #1: No

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The PLOS Data policy

Reviewer #1: No

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Reviewer #1: Yes

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Reviewer #1: General comments

Health care/Vaccine providers are critical to the delivery of immunization programmes. This is a valuable study because it investigates competencies of providers within a Low- and Middle-Income setting. The study lacks detail particularly within the methodology and results section. These additional details would enhance the quality of the article and the utility of the study for the readers.

Specific Comments

Line 61 -65

What is already known on this topic

Vaccination programs in low- and middle-income countries often face challenges in maintaining. vaccine potency due to gaps in cold chain management.

I would consider excluding this statement from the abstract as this does not describe the study, which extends beyond cold-chain management. Specifically, this study did not evaluate the cold chain through objective examination of temperature monitoring and recording. Information regarding the cold chain was according to self-reported or observed competency (checking refrigerator temperatures), rather than documenting what these temperatures were including any breaches.

Line 95

The 2016 Ethiopian Demographic and Health Survey (EDHS) found that about 83% of the country's

Can the authors provide a more up to date assessment of vaccine coverage?

Line 100

In order to reduce the risk of adverse events after immunization (AEFI)

This should be Adverse events following immunisation

Line 160-206

The methodology section requires further detail, specifically please address these points;

Study design and setting – to provide a broader context.

How many health facilities are there in Western Ethiopia as this will provide an indication of what percentage were sampled.

Were these sites selected only on the basis of providing immunisations?

Study Population and Sampling

34 EPI providers were selected – what proportion of all EPI providers at these sites does this represent?

Sample Size

340 vaccination sessions observed – is this 10 sessions per provider and if so this would be observation of 100 children per provider (10X10) Please clarify?

Data Analysis

The provider was scored on each child using the same competency check list – however, some of these competencies are “session specific” and some “child specific”. Could this be analysed separately ?

Could the data be analysed in greater depth? That is for each provider was the competencies consistent across individual children (intra-observer variability) and for each competency what was the variability between providers (inter-observer variability) ?

Eligibility Criteria

This is provider specific and should be listed under study population and sampling

Other

Could the authors provide a description of the vaccines administered and to which age groups.

Could the authors outline if these competencies link to national recommendations and guidelines. That is, what are providers educated and taught to do against which their competencies can be matched?

Could the authors clarify which competencies are assessed using self-report and which through observation/documentation?

Line 247……

Inclusion of discussion points in the results section

Could the authors ensure that interpretation of results is included in the discussion section, rather in the results section (which should a documentation of the results). An example is provided below.

These findings suggest that while certain technical competencies are being performed well, 259 significant gaps exist in crucial areas such as record-keeping and adherence to medical protocols, 260 highlighting the need for targeted training and reinforcement of best practices to enhance patient 261 care and safety. By addressing these gaps and promoting a culture of excellence in immunization 262 administration, healthcare providers can optimize outcomes, reduce errors, and ultimately enhance 263 the overall quality of care delivered to patients (Table 2).

Line 278

In this study, adherence to hand hygiene remained critically low at 5%, and aseptic technique for vial septum cleaning was only 3%..............

The issue of injection technique is critical given the risk of immunisation errors with injection site infection. Could the authors elaborate on the competency “Uses sterile syringe/needle for each injection”. Under this paragraph as it would seem alarming that approximately 25% of providers are NOT using sterile syringes and needles. Does this imply that the mandated use of auto-disable syringes are not used in the Ethiopian context. Although not part of this study do the authors then have any comments about the prevalence of injection site infection in the Ethiopian context?

Line 325

Failure to account for clustering could underestimate standard errors and overstate statistical significance

No statistical analyses were performed as this was purely a descriptive study. From the data collected any statistical associations would be difficult to evaluate. However, did the authors look at any correlation between provider work experience, age, gender and competency scores?

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Reviewer #1: No

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PLoS One. 2026 Sep 15;21(9):e0358136. doi: 10.1371/journal.pone.0358136.r002

Author response to Decision Letter 1


9 Aug 2026

General comments

Health care/Vaccine providers are critical to the delivery of immunization programmes. This is a valuable study because it investigates competencies of providers within a Low- and Middle-Income setting. The study lacks detail particularly within the methodology and results section. These additional details would enhance the quality of the article and the utility of the study for the readers.

Response: We sincerely thank the reviewer for the positive assessment of the importance of this study and for the constructive suggestions to improve the manuscript. We agree that additional methodological and results-related details were needed to improve transparency, interpretation, and the usefulness of the findings for readers. In response to these comments, we have revised the manuscript accordingly.

For clarity, our point-by-point responses are provided immediately following each reviewer comment, and all changes made in the revised manuscript are indicated using Track Changes/highlighted revisions. We have expanded the Methods section to provide additional details on the study population, sampling, vaccination services assessed, competency assessment tools, alignment with national and WHO immunization guidelines, assessment procedures, and data analysis. We have also revised the Results and Discussion sections to improve clarity and ensure appropriate separation of findings from interpretation.

Specific Comments

1. Line 61 -65

What is already known on this topic

Vaccination programs in low- and middle-income countries often face challenges in maintaining. vaccine potency due to gaps in cold chain management.

I would consider excluding this statement from the abstract as this does not describe the study, which extends beyond cold-chain management. Specifically, this study did not evaluate the cold chain through objective examination of temperature monitoring and recording. Information regarding the cold chain was according to self-reported or observed competency (checking refrigerator temperatures), rather than documenting what these temperatures were including any breaches.

Response: Thank you for this important comment. We agree that the original statement regarding cold chain management was too broad and could imply that the study evaluated vaccine potency, temperature monitoring records, or cold chain breaches, which were not assessed in this study. We have removed this statement from the abstract and revised the "What is already known on this topic" section to better reflect the focus of our study, which was the assessment of health worker vaccination competency across multiple domains, including vaccine preparation, administration, communication, and record-keeping.

2. Line 95

The 2016 Ethiopian Demographic and Health Survey (EDHS) found that about 83% of the country's

Can the authors provide a more up to date assessment of vaccine coverage?

Response: Thank you for this helpful suggestion. We agree that the 2016 EDHS estimate is outdated. We have revised the manuscript to cite the most recent WHO/UNICEF Estimates of National Immunization Coverage (WUENIC), which provide updated national immunization coverage estimates for Ethiopia.

3. Line 100

In order to reduce the risk of adverse events after immunization (AEFI)

This should be Adverse events following immunisation.

Response: Thank you for this correction. We have revised the terminology throughout the manuscript and replaced "adverse events after immunization (AEFI)" with the correct term "adverse events following immunization (AEFI)" in accordance with WHO terminology.

4. Line 160-206

The methodology section requires further detail, specifically please address these points;

a. Study design and setting – to provide a broader context.

i. How many health facilities are there in Western Ethiopia as this will provide an indication of what percentage were sampled.

Response: Thank you for this suggestion. We have clarified the study setting by specifying that the study was conducted in East Wollega Zone, Oromia Region, Western Ethiopia, rather than broadly referring to Western Ethiopia. East Wollega Zone has 68 public health facilities providing healthcare services, including routine immunization. The 34 health facilities included in this study represented 50% of the public health facilities in the zone.

ii. Were these sites selected only on the basis of providing immunisations?

Response: Thank you for this important clarification. The health facilities were not selected solely because they provided immunization services. Facilities were selected from public health facilities that provided routine childhood vaccination services through the Ethiopian Expanded Programme on Immunization (EPI), as the study aimed to assess the competency of health workers directly involved in vaccine delivery. Therefore, availability of routine immunization services was an eligibility criterion for facility inclusion.

b. Study Population and Sampling

i. 34 EPI providers were selected – what proportion of all EPI providers at these sites does this represent?

Response: We have clarified the selection of EPI providers in the Methods section. One EPI provider responsible for routine vaccination services on the day of data collection was selected from each participating health facility. Therefore, the 34 selected EPI providers represented the providers delivering vaccination services at the 34 included facilities during the data collection period. We have added this clarification to the revised manuscript.

c. Sample Size

i. 340 vaccination sessions observed – is this 10 sessions per provider and if so this would be observation of 100 children per provider (10X10) Please clarify?

Response: Thank you for this comment. We have clarified the sample size description. The 340 vaccination observations represent 10 vaccination /child observations per EPI provider (34 providers × 10 children = 340 observations). Each provider was observed while vaccinating 10 individual children; therefore, the study included 340 child–provider vaccination observations in total. The manuscript has been revised to avoid ambiguity

d. Data Analysis

i. The provider was scored on each child using the same competency check list – however, some of these competencies are “session specific” and some “child specific”. Could this be analysed separately?

Response: Thank you for this important observation. We agree that the competency checklist included both child-specific and session/provider-level indicators. In the revised manuscript, we have clarified that child-specific competencies were assessed across the 340 observed vaccination encounters, whereas session/provider-level competencies were summarized based on the 34 EPI providers. We have revised the Data Analysis and Results sections accordingly to avoid inappropriate repetition of session-level indicators across multiple child observations.

ii. Could the data be analysed in greater depth? That is for each provider was the competencies consistent across individual children (intra-observer variability) and for each competency what was the variability between providers (inter-observer variability) ?

Response: Thank you for this valuable suggestion. We agree that repeated observations of each provider provide an opportunity to assess both within-provider consistency and between-provider variability. In the revised analysis, we have added provider-level assessment by calculating competency scores for each provider across the 10 observed vaccination encounters. We have also summarized the range of competency performance across providers for each domain to demonstrate variability in vaccination practices. Additionally, we clarified that observations were clustered within providers (34 providers, 10 observations per provider).

e. Eligibility Criteria

i. This is provider specific and should be listed under study population and sampling.

Response: Thank you for this comment. We agree that the eligibility criteria were specific to EPI providers rather than a separate study component. We have moved the eligibility criteria to the "Study Population and Sampling" section and clarified the selection of participating providers.

f. Other

i. Could the authors provide a description of the vaccines administered and to which age groups.

Response: Thank you for this helpful suggestion. We have added a new subsection, "Vaccination Services Assessed," to the Methods section. This subsection describes the routine childhood vaccines included in the observations and their corresponding target age groups according to the Ethiopian National Expanded Programme on Immunization (EPI) schedule.

ii. Could the authors outline if these competencies link to national recommendations and guidelines. That is, what are providers educated and taught to do against which their competencies can be matched?

Response: Thank you for this important comment. We have clarified in the "Data Collection Tools and Procedures" section that the competency assessment checklist was adapted from the Ethiopian National Expanded Programme on Immunization (EPI) guidelines and the World Health Organization (WHO) immunization standards. The assessed competencies reflect the expected practices and performance standards for routine childhood immunization services in Ethiopia.

iii. Could the authors clarify which competencies are assessed using self-report and which through observation/documentation?

Response: Thank you for this valuable suggestion. We have revised the "Data Collection Tools and Procedures" section to specify the assessment methods used for each competency domain. Practical vaccination competencies were assessed through direct observation of routine immunization sessions, facility-related practices were verified through observation and review of available records, and provider characteristics, where applicable, were obtained through provider interview and verified using supporting documentation when available.

5. Line 247……

Inclusion of discussion points in the results section

Could the authors ensure that interpretation of results is included in the discussion section, rather in the results section (which should a documentation of the results). An example is provided below.

These findings suggest that while certain technical competencies are being performed well, 259 significant gaps exist in crucial areas such as record-keeping and adherence to medical protocols, 260 highlighting the need for targeted training and reinforcement of best practices to enhance patient 261 care and safety. By addressing these gaps and promoting a culture of excellence in immunization 262 administration, healthcare providers can optimize outcomes, reduce errors, and ultimately enhance 263 the overall quality of care delivered to patients (Table 2).

Response: Thank you for this helpful comment. We agree that the highlighted text contains interpretation rather than objective presentation of the findings. We have revised the manuscript by removing these interpretive statements from the Results section and incorporating them into the Discussion section. The Results section now presents only the observed competency findings, while their implications and potential explanations are discussed in the Discussion.

6. Line 278

In this study, adherence to hand hygiene remained critically low at 5%, and aseptic technique for vial septum cleaning was only 3%..............

The issue of injection technique is critical given the risk of immunisation errors with injection site infection. Could the authors elaborate on the competency “Uses sterile syringe/needle for each injection”. Under this paragraph as it would seem alarming that approximately 25% of providers are NOT using sterile syringes and needles. Does this imply that the mandated use of auto-disable syringes are not used in the Ethiopian context. Although not part of this study do the authors then have any comments about the prevalence of injection site infection in the Ethiopian context?

Response: Thank you for this important observation. We agree that the original wording of the competency item could be misinterpreted as indicating syringe or needle reuse. The item was intended to assess adherence to safe injection practices, including compliance with recommended injection procedures and the use of a new sterile auto-disable syringe and needle for each vaccination, rather than reuse of injection equipment alone. We have revised the wording in the manuscript to improve clarity. Routine childhood immunization services in Ethiopia use single-use auto-disable syringes in accordance with national EPI and WHO recommendations; therefore, our findings should not be interpreted as evidence of syringe or needle reuse. We also acknowledge that our study did not assess the prevalence of injection-site infections or adverse events following immunization.

7. Line 325

Failure to account for clustering could underestimate standard errors and overstate statistical significance

No statistical analyses were performed as this was purely a descriptive study. From the data collected any statistical associations would be difficult to evaluate. However, did the authors look at any correlation between provider work experience, age, gender and competency scores?

Response: Thank you for this important comment. We agree that observations were clustered because each provider was observed while vaccinating 10 children. However, this study was designed as a descriptive competency assessment, and no inferential statistical analyses, hypothesis testing, or estimation of associations were performed. Therefore, no statistical significance testing was conducted that could be affected by underestimated standard errors due to clustering. We have clarified in the Data Analysis section that observations were summarized at both child-observation and provider levels.

Regarding the potential association between provider characteristics (age, gender, and work experience) and competency scores, these analyses were not performed because the study was primarily designed to describe competency levels rather than identify predictors of competency. Additionally, the sample included only 34 providers, limiting the statistical power for multivariable analysis. We have acknowledged this as a limitation in the revised manuscript.

Attachment

Submitted filename: Response to Reviewers...docx

pone.0358136.s002.docx (24.8KB, docx)

Decision Letter 1

David Diemert

27 Aug 2026

Assessment of vaccination competency among health workers in health facilities in East Wallaga, Oromia, Western Ethiopia: an observational study

PONE-D-26-23930R1

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Acceptance letter

David Diemert

PONE-D-26-23930R1

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Associated Data

    This section collects any data citations, data availability statements, or supplementary materials included in this article.

    Supplementary Materials

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    Submitted filename: PONE-D-26-23930.docx

    pone.0358136.s001.docx (17.1KB, docx)
    Attachment

    Submitted filename: Response to Reviewers...docx

    pone.0358136.s002.docx (24.8KB, docx)

    Data Availability Statement

    De-identified data that support the findings of this study are available upon reasonable request, subject to institutional and ethical approvals. Requests for data access should be directed to the Research Ethics Review Committee, Wollega University, Nekemte, Ethiopia (email: WU@ethionet.et).


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