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.

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

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.

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.

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

https://doi.org/10.1371/journal.pone.0358136.g001

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).

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

https://doi.org/10.1371/journal.pone.0358136.t001

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)

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

https://doi.org/10.1371/journal.pone.0358136.t002

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

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.