Introduction
Assisted reproductive technology (ART), particularly in vitro fertilization (IVF), depends on the precision of embryologists. Human errors, including gamete or embryo misidentification, can have serious emotional, legal, ethical, and reputational consequences [1-3]. Although stringent protocols and technological interventions, such as double witnessing, radio-frequency identification tagging, and electronic witnessing systems, have been implemented [4-6], near-miss incidents continue to occur because of factors such as stress and communication failures [7,8]. International standards, including International Organization for Standardization (ISO) 15189 and International Federation of Fertility Societies guidelines, emphasize robust patient identification and chain-of-custody protocols; however, embryologist training remains inconsistent worldwide [9].
A European Society of Human Reproduction and Embryology (ESHRE) survey reported that fewer than half of European countries offer formal licensing or structured training for embryologists, resulting in variable laboratory safety standards [9]. Although standardized education is important for error prevention and for fostering a strong safety culture, evidence regarding the effect of such training on embryologists’ safety awareness remains limited [10].
To address this gap, the CHA University Global IVF Group in the Republic of Korea developed the IVF Laboratory Patient and Sample Identity Verification Training Program, a structured curriculum based on the Simultaneous, Aloud, inFormation, Electronic witnessing, Monitoring, One by one, and DocumEnt (SAFE MODE)/7-CHA Guidelines framework. The program was designed to prevent mismatches involving oocytes, sperm, embryos, and patients by enhancing safety awareness, protocol adherence, and ethical responsibility.
This cross-sectional pre–post survey study evaluated the program’s effectiveness among embryologists with different levels of professional experience. The primary objectives were to assess the impact of SAFE MODE-based training on embryologists’ awareness of patient and sample identity verification, competence in safety protocols, and ethical responsibilities. The study also explored whether the program could support internationally harmonized safety frameworks in IVF laboratories.
Methods
1. Study design and participants
This study used a multicenter cross-sectional survey design with a pre–post educational intervention component to evaluate the effectiveness of a standardized training program for embryologists designed to prevent mismatches among patients, oocytes, sperm, and embryos. The intervention was based on the 7-CHA Guidelines for Patient and Sample Identity Verification, developed by the CHA University Global IVF Group, as summarized in Table 1 and illustrated in Figure 1.
The 7-CHA Guidelines comprise seven key verification principles: (1) simultaneous check, (2) call aloud together, (3) information double-check, (4) electronic witnessing double-check, (5) visual monitoring together, (6) one by one, and (7) document cross-check. The protocol was collectively designated SAFE MODE.
The study was conducted across six CHA University Fertility Center clinics in South Korea and included all embryologists employed between August 2021 and June 2025. Eligible embryologists were routine users of the patient and sample identity verification system and were engaged in IVF laboratory procedures. To ensure comprehensive representation of the eligible embryologist population, no exclusion criteria were applied.
This retrospective study used anonymized survey data and did not involve identifiable human participants; therefore, institutional review board approval was not required.
2. Intervention: patient and sample identity verification training program
The training program comprised 14 lectures, each lasting 40 minutes, delivered remotely via Zoom in two identical sessions to ensure full participation. The curriculum focused on (1) analysis of patient/specimen mix-up incidents and associated risk factors in IVF laboratories and (2) practical application of SAFE MODE across andrology and embryology workflows (Table 1, Figure 1).
Lectures 1–5 covered an overview of patient safety and patient safety procedures in andrology, including patient identification and sperm preparation. Lectures 6–13 addressed patient safety procedures in embryology, including oocyte retrieval, intracytoplasmic sperm injection, embryo culture, embryo transfer, biopsy, and cryopreservation (Table 2). Lecture 14 focused on documentation and record management. Recently hired embryologists underwent training after 8 weeks of employment.
3. Survey administration
Surveys were administered at multiple time points to assess the training effect. A mid-term survey, conducted after lectures 1–5, was administered in August and December 2021 to all embryologists (n=116), of whom 61 responded. A completion survey, conducted after lectures 1–14, was administered in December 2022 to the same cohort, with 60 respondents. Additional completion surveys were administered to recently hired embryologists from January 2023 through March 2024 (n=19; 100% response rate) and from April 2024 through June 2025 (n=20; 100% response rate); all recently hired respondents had less than 1 year of experience. A total of 155 embryologists were invited to participate, yielding 99 valid responses. Respondents in the 2021–2022 surveys were stratified by experience as follows: less than 1, 1–2, 3–5, 6–9, and 10 years or more. The 2023–2025 surveys included only embryologists with less than 1 year of experience (Table 3, Figure 2).
Although all eligible embryologists were invited to participate, response collection was influenced by routine IVF laboratory schedules and clinical workloads.
4. Survey instrument
A 17-item questionnaire was developed to evaluate the effectiveness of the SAFE MODE-based training program. The instrument included items assessing (1) participant characteristics, (2) satisfaction with training logistics, (3) changes in patient safety awareness and procedural performance, based on retrospective pre–post self-assessment, (4) perceived necessity and usefulness of the training, (5) training difficulty, and (6) willingness to provide feedback. All items except the experience question and open-ended feedback items were rated on a 5-point Likert scale, with 1 indicating ‘strongly disagree,’ ‘very low,’ or ‘very little,’ and 5 indicating ‘strongly agree,’ ‘very high,’ or ‘very much.’
The full list of questions was as follows:
- 1) What is the duration of your work experience as an embryologist, including experience at other hospitals? Response options: less than 1, 1–2, 3–5, 6–9, and 10 years or more.
- 2) How satisfied are you with your current job duties?
- 3) Before the training, how familiar were you with each SAFE MODE procedure included in the 7-CHA Guidelines? Separate items: simultaneous check, call aloud together, information double-check, electronic witnessing double-check, visual monitoring together, one by one, and document cross-check.
- 4) Before the training, how would you rate your level of awareness regarding patient safety verification?
- 5) Before the training, how would you rate your competence in performing patient safety verification?
- 6) Before the training, did you consider patient safety verification important and necessary?
- 7) To what extent did your awareness of patient safety verification improve after the training?
- 8) To what extent did your competence in performing patient safety verification improve after the training?
- 9) After the training, do you believe that patient safety verification training is necessary?
- 10) Since the implementation of the patient safety verification training, do you believe that the training has helped you perform your duties more safely?
- 11) Did the training help you perform patient identification tasks in andrology (e.g., semen verification)?
- 12) Did the training help you perform patient identification tasks in embryology (e.g., oocyte identification)?
- 13) Are you currently performing your duties in accordance with the content of the patient safety verification training?
- 14) Was the training schedule (date and time) appropriate?
- 15) How would you rate the difficulty of the training?
- 16) Are you willing to provide feedback or suggestions to improve the training?
- 17) Would you be willing to publicly offer recommendations for improving patient safety verification procedures?
The questionnaire was administered anonymously via Google Forms. Participants retrospectively rated both their pre-training and post-training status at the time of each survey.
5. Variables
The primary outcomes were patient safety awareness and procedural performance. Secondary variables included job satisfaction, perceived training difficulty, SAFE MODE knowledge, and willingness to propose improvement plans. Higher scores indicated higher levels of the measured constructs.
6. Statistical analysis
The sample size was calculated using the standard correlation formula in G*Power 3.1 (University of Düsseldorf) [11,12].
Assuming a medium effect size (r=0.30), α=0.05, and power (1−β)=0.95, a minimum of 111 embryologists was required. After accounting for a 30% non-response rate, the target sample size was set at 155 or more participating embryologists. Data were analyzed using SPSS ver. 25.0 (IBM Corp.). Descriptive statistics were used to summarize embryologist characteristics. The independent t-test was used to compare groups by experience level and survey round, and Pearson correlation analysis and multiple regression analysis were used to evaluate associations among variables and identify factors associated with the outcomes. Statistical significance was set at p<0.05. No data were missing, and all collected data were included in the analyses.
7. Bias consideration
Selection bias was minimized by inviting all embryologists from the six clinics to participate. Response bias was reduced through anonymous and voluntary survey administration. Information bias was mitigated by using a standardized questionnaire and uniform data collection procedures across all sites. However, residual bias related to retrospective self-assessment cannot be excluded.
Results
1. Characteristics of participating embryologists
Of the 155 eligible embryologists, 99 (63.9%) completed the survey. The mid-term survey was administered to 61 participants after completion of lectures 1–5. The completion survey was administered after lectures 1–14 to the same cohort, with 60 respondents. Two additional cohorts of recently hired embryologists with less than 1 year of experience were also evaluated (n=19 and n=20). Respondents were stratified by years of professional experience as follows: less than 1 year, 53 participants (53.5%); 1–2 years, eight participants (8.1%); 3–5 years, 16 participants (16.2%); 6–9 years, 11 participants (11.1%); and 10 years or more, 11 participants (11.1%) (Table 3).
2. Changes in safety awareness and performance
The paired t-test demonstrated significant post-training improvements in both safety awareness and self-reported performance, with the largest improvements observed among embryologists with less than 1 year of experience. In this subgroup, safety awareness increased from 2.88±0.64 to 4.00±0.53 at mid-term (t=4.97, p=0.002), and performance improved from 3.13±0.64 to 4.00±0.54 (t=2.97, p=0.021). Comparable improvements were observed in the 1–2- and 3–5-year experience groups (Tables 4 and 5). In contrast, senior embryologists with 6 or more years of experience showed no significant changes, most likely because their baseline scores were already high, suggesting a ceiling effect.
3. Impact of experience level on training gains
The independent-samples t-test confirmed that pre- to post-training improvements were significantly greater among embryologists with less than 1 year of experience than among those with 1 or more years of experience. Embryologists with less than 1 year of experience showed substantial gains in safety awareness (from 2.91±0.66 to 3.28±0.82, p<0.001) and performance (from 4.04±0.62 to 4.40±0.63, p<0.001). Embryologists with 1 or more years of experience demonstrated significant improvement only in performance (from 3.93±0.80 to 4.22±0.66, p=0.036), with no significant change in safety awareness (p=0.195) (Table 6).
4. Training phase and cohort comparison of outcomes
Participants who completed all 14 lectures (n=60) reported significantly higher post-training performance scores than those who completed only the first five lectures (n=61; 4.17±0.67 vs. 3.84±0.66, p=0.007). Participants who completed the full program also reported greater recognition of the necessity of such training (4.35±0.71 vs. 3.59±0.97, p<0.001) (Table 7).
5. Correlation analysis
Pearson correlation analysis indicated significant associations among the key variables. Job satisfaction was positively correlated with perceived training difficulty (r=0.236, p<0.05), post-training performance capability (r=0.228, p<0.05), willingness to propose improvement initiatives (r=0.309, p<0.01), and SAFE MODE knowledge (r=0.220, p<0.05) (Table 8).
Significant positive correlations were also observed between pre- and post-training measures. Pre-training safety awareness was significantly correlated with pre-training performance capability (r=0.363, p<0.001) and post-training safety awareness (r=0.440, p<0.001). Pre-training performance capability was strongly correlated with post-training performance capability (r=0.407, p<0.001). Post-training safety awareness was positively correlated with post-training performance capability (r=0.215, p<0.05). Perceived training difficulty was also positively correlated with post-training performance capability (r=0.389, p<0.001) and SAFE MODE knowledge (r=0.368, p<0.001).
Discussion
This multicenter study provides robust evidence that a structured training program based on the SAFE MODE framework was associated with significant improvements in embryologists’ safety awareness and self-reported performance related to the prevention of patient-level mismatches involving oocytes, sperm, and embryos in ART laboratories. The greatest improvements were observed among embryologists with less than 1 year of experience, who showed substantial gains in both safety awareness and performance (Tables 4 and 5). These findings build on and extend previous reports showing that formalized training can improve procedural accuracy and risk awareness in high-stakes clinical settings [13,14].
Experience-stratified analyses highlighted differential training benefits across career stages. Embryologists with less than 1 year of experience showed marked improvements in both safety awareness and performance, most likely because they had limited prior exposure to standardized protocols (Table 6). This finding directly addresses the well-documented global variability and inconsistency in embryologist training and competency assessment, which contribute to heterogeneous safety practices across laboratories [9]. By translating abstract safety principles into practical, workflow-integrated procedures for andrology and embryology, the SAFE MODE program may help early-career embryologists mitigate the risk of catastrophic errors, such as gamete or embryo mix-ups [3]. In contrast, senior embryologists with 6 or more years of experience showed only modest gains in performance (from 3.93±0.80 to 4.22±0.66, p=0.036) and no significant change in awareness, consistent with a ceiling effect among experienced practitioners (Table 6). This finding aligns with previous IVF laboratory research suggesting that, for experienced embryologists, educational programs emphasizing sustained vigilance and adherence to standardized safety protocols may be more effective than approaches centered on foundational knowledge acquisition [15]. Accordingly, experience-stratified training programs may be warranted. To prevent complacency and overfamiliarity, embryologists with less than 5 years of experience may benefit from continuous refresher training, whereas those with 6 or more years of experience—who showed limited improvement in safety awareness—may require targeted education using real clinical mix-up cases and reinforcement of professional responsibility to promote meaningful changes in risk perception and vigilance.
Completion of the full 14-module curriculum was associated with significantly higher scores reflecting safety culture and recognition of training necessity (4.35±0.71 vs. 3.59±0.97, p<0.001) (Table 7), underscoring the program’s potential to cultivate collective accountability and stronger safety attitudes. This interpretation is further supported by the finding that perceived training difficulty was positively correlated with post-training performance capability (r=0.389, p<0.001) and SAFE MODE knowledge (r=0.368, p<0.001), suggesting that more challenging content may have been associated with greater knowledge acquisition and improved self-reported performance (Table 8). Given the profound ethical, legal, psychological, and trust-related consequences of identification errors in IVF [16], these improvements are clinically and socially important. By integrating ethical responsibilities—such as safeguarding patient trust, preventing errors, and upholding procedural integrity—into technical training, the SAFE MODE approach is consistent with ISO 15189 accreditation standards, Good Laboratory Practice principles, and evolving frameworks that position patient safety as a fundamental ethical priority in laboratory medicine [17,18].
The positive correlation between post-training safety awareness and performance capability (r=0.215, p<0.05) further suggests that changes in attitudes and perceptions may drive performance improvements, supporting a durable culture of vigilance and shared responsibility (Table 8). In addition, improved leadership skills and emotional intelligence, as emphasized in the contemporary literature [19,20], may reinforce team collaboration, reduce performance gaps across experience levels, and promote a more cohesive laboratory culture.
The multicenter design and experience-stratified analysis strengthen the applicability of these findings across diverse ART settings. Nevertheless, several limitations should be acknowledged. First, although all embryologists across the six centers were invited to participate through standardized survey procedures to minimize selection bias, the survey was voluntary and was conducted during routine IVF laboratory operations. Therefore, the response rate was limited, and response bias cannot be completely excluded. Second, the absence of direct error-rate measurement limited the ability to objectively quantify improvements in safety performance. To address these limitations, future studies should incorporate objective metrics, such as simulation-based competency assessments or longitudinal monitoring of nonconformance rates, to provide more robust evidence of error reduction [21]. Evaluating the effects of individual SAFE MODE components, such as patient identification and cryopreservation protocols, would also provide valuable insights for targeted refinement and optimization.
Future studies should evaluate the long-term effects of the SAFE MODE program on error reduction and patient outcomes through randomized controlled trials or prospective real-world surveillance systems. In addition, scalable, open-access training modules based on the SAFE MODE framework could promote wider international adoption and help reduce the global disparities in embryologist training identified by ESHRE [9]. Artificial intelligence–assisted tools could also complement human training by automating routine verification processes while maintaining essential human supervision [22].
In conclusion, SAFE MODE-based training was associated with marked improvements in safety awareness and self-reported performance in the identification of oocytes, sperm, embryos, and patients, with particularly pronounced benefits among embryologists with less than 1 year of experience. Standardized, experience-tailored training appears to be an important strategy for fostering resilient safety cultures within ART laboratories and promoting patient-centered care in reproductive medicine.
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