Abstract
Introduction:
Patient safety has been an undervalued component of quality healthcare but is a challenging area of research.
Ultrasound is the most common imaging modality in the world. Research on patient safety in ultrasound is generally focused on bioeffects and safe operation of ultrasound equipment. However, other safety issues exist in practice that warrant consideration.
This paper forms the first part of a PhD study exploring patient safety in medical diagnostic ultrasound, beyond the notion of bioeffects.
The ultimate aim of the study is to inform the final phase of the research study which will consider the next steps in improving the quality and safety of healthcare experienced by patients.
Methods:
A qualitative study using semi-structured, one-on-one interviews. A thematic analysis categorised data into codes and generated final themes.
Results:
A heterogeneous mix of 31 sonographers, who reflected the profile of the profession in Australia, were interviewed between September 2019 and January 2020. Seven themes emerged from the analysis. These were bioeffects, physical safety, workload, reporting, professionalism, intimate examinations and infection control.
Conclusion:
This study presents a comprehensive analysis of sonographers’ perceptions of patient safety in ultrasound imaging, not previously available in the literature. Consistent with the literature, patient safety in ultrasound tends to be viewed in technical terms through the potential for bioeffects of tissue damage or physical harm to the patient. However, other patient safety issues have emerged, and while not as well recognised, have the potential to negatively impact on patient safety.
Introduction
Patient safety is a priority for healthcare professionals, 1 but has been an under-recognised component of quality healthcare. 2 Inconsistent language surrounding patient safety makes it a challenging area to study. 3
Sonography is the most common medical imaging modality worldwide. 4 Medicare-funded ultrasound examinations in Australia have increased by 100% in the last 10 years to more than 11 million ultrasound examinations yearly. 5 In this study, the term sonographer is attributed to those whose primary role is producing and interpreting medical ultrasound imaging, as in previous publications. 6
Sonographers’ perceptions of patient safety focus on bioeffects and safe operation of ultrasound equipment. 7 However, there are other patient safety risks associated with sonography practice. Intimate examinations such as testicular and transvaginal (TV) examinations pose physical and psychological risk to patients. 8 Ultrasound imaging poses infection risks for patients. 9 Furthermore, sonography practice is highly operator-dependent and the quality of the ultrasound examination is related to the operators’ skill, training and experience, and there is a risk of incorrect or missed diagnoses when ultrasound imaging is sub-optimal, putting patients’ safety at risk. 10
Aims
This study addresses a paucity of patient safety research in ultrasound 7 by exploring Australian sonographers’ perceptions of patient safety in ultrasound imaging. It is only the second to explore Australian sonographers’ perceptions of patient safety in ultrasound, beyond bioeffects.
In this study, data analysis has been broken into two parts. Part 1, reported here, identifies sonographers’ perceptions of risk to patient safety during ultrasound imaging. Part 2, reported subsequently, describes how sonographers respond to these risks in practice.
Methods
This qualitative study used semi-structured, one-on-one interviews, conducted by the primary researcher. None of the participants were known to the primary researcher. It is also worth noting that the primary researcher is not a sonographer. Initially, there was a question that this may mean the project lacked insight of a sonographer. However, this proved a major boon to the study. With no pre-conceptions about the culture and inherent challenges of the sonography work environment, the sonographers interviewed informed each aspect of the study and the data could be interpreted without fear of insider bias.
Ethical considerations
Ethical approval granted by Monash University Human Research Ethics Committee, project 19091.
Recruitment
An invitation was issued via eBlast, by sending a single email message to a large email list simultaneously, in August 2019 to sonographers on the Australian Sonographer Accreditation Registry (ASAR) email list who agreed to be invited to participate in ASAR-facilitated research (N = 7234). A reminder was sent in September 2019. ASAR membership presents a good representation of the sonography workforce in Australia as the overwhelming majority of sonographers in Australia are included on the ASAR. Participants were invited to face-to-face, phone, or Zoom interviews so that opportunities to participate would not be affected by geographical distribution. Virtual meetings have proven effective in capturing data from dispersed populations across Australia. 11
Recruitment continued until adequate data was gathered to illuminate the aims of the study, in line with the notion of information power. 12
Developing the interview questions
An interview guide ensured the line of questions remained consistent across interviews. The guide was developed with input from senior academic and clinical staff, including an ultrasound educator and a sonographer involved in point-of-care ultrasound training. The first part of the interview collected demographic details such as respondents’ specialisation, number of years practicing and their workplace setting. This was done to determine whether the interviewees represented a cross-section of the sonography workforce in Australia. The second part of the interview comprised open-ended questions. Open-ended questions allow participants to express themselves with minimal influence and not lead their responses in any particular direction. 13 In keeping with semi-structured interviews, responses were explored for more understanding when required. 13
Questions included the following:
When you hear the term ‘patient safety’ what does it mean to you?
What is the first thing you think of when you hear the term ‘patient safety’ in ultrasound?
Can you provide an example(s) of where you have seen/heard of lapses in safety in ultrasound and how these were dealt with in practice?
Following this, probing questions explored areas that did not present initially, a strategy employed in qualitative interviews. 13 For example, if a participant did not raise the area of intimate examinations, this was explored using probing questions only as outlined below, never forcing the issue with participants. By conducting the interviews in this way, it was possible to differentiate between items that sonographers primarily consider when they think of patient safety from those that are not as prominent.
Examples of probing questions included the following:
Are there other patient safety issues which are present particularly in ultrasound practice?
We have not discussed intimate examinations in ultrasound. What are your perspectives surrounding patient safety in this area?
Impact of COVID
The authors acknowledge that the data collection occurred prior to the COVID-19 pandemic in Australia. COVID-19 affected work practices in ultrasound; the authors were mindful of this in interpreting the data.
Data analysis
Interviews were transcribed using a transcription service, then transferred to nVivo™. nVivo is a software package produced by QSR International which helps researchers to organise, analyse and find insights in qualitative data.. Data underwent a thematic analysis (TA) (Table 1), in keeping with Braun and Clarke’s method (Table 1). 14
Braun and Clarke’s phases for thematic analysis. 14
Results
The invitation attracted 31 respondents. All 31 were interviewed between September 2019 and January 2020. Interviews ranged from 47 to 95 minutes long. All of the interview data were included in the analysis.
Table 2 presents the demographic characteristics. Most sonographers worked in general sonography, defined as a range of ultrasound examinations including pelvic, abdominal, musculo-skeletal, vascular, obstetric, gynaecological and small-parts ultrasound. The percentage of obstetrics and gynaecological sonographers was low, but this was because it refers to sonographers who solely worked in that area. ‘Other’ included one sonographer working in high-risk perinatal cardiac ultrasound and one specialist vascular sonographer. Four sonographers were involved in sonographer education outside clinical environments. Two of these had ceased clinical practice entirely within the last 5 years, but were included as their perspectives were valuable in informing the study. Sonographers were employed in three geographical settings – metropolitan, rural and remote, with various levels of experience, from 4 years’ experience to 30.
Demographic characteristics (N = 31).
While this sample largely reflects the profile of the profession in Australia, there was larger representation from public institutions compared to a 2019 sonographer employment survey which found that 72% of sonographers were employed in private practice. 5
Seven themes emerged from the data, some featuring more prominently than others. Figure 1 shows the relative prominence of the themes, larger icons representing areas of greatest level of concern.

Major themes identified by sonographers.
When discussing risk in ultrasound imaging, sonographers interviewed often posited risks alongside what they felt were protective measures in mitigating the risk. This evolved organically in the interviews and not as a result of prompting. This inter-relationship between risk and protective measures is presented in Tables 3–9 with supporting quotations drawn from nVivo codes.
Biological risk.
ODS: Output Display Standards; ALARA: As Low As Reasonably Achievable.
Physical safety of the patient.
Workload.
Reporting.
Professionalism.
Intimate examination.
Infection control.
Theme 1: bioeffects
Bioeffects associated with ultrasound was the most common theme; 28 (90%) participants raised it as the first or second issue related to patient safety. Sonographers were concerned about mechanical and thermal effects of ultrasound especially when ‘machines keep getting more powerful’ (PS16). Twenty (64%) sonographers mentioned the Output Display Standards (ODS) (mechanical index (MI) and thermal index (TI)) and the As Low As Reasonably Achievable (ALARA) principle in managing biological risk.
Theme 2: physical safety
Physical safety during ultrasound examinations was the second most common theme, mentioned by 22 (71%) participants without probing, ‘physical safety of the patient of course is paramount’ (PS22). This included mechanical table-height adjustment, trip hazards and falls from narrow examination tables or the treadmill associated with cardiac examinations. Ten sonographers related this risk especially with the elderly, ‘scanning a 97 year-old frail lady . . . we don’t have any sides on our ultrasound beds’ (PS14).
Theme 3: workload
Nineteen (61%) sonographers reported significant changes in workload, ‘Ask any sonographer, scan times are being cut. So, an expectation is to still perform the study in less time’ (PS10) which left respondents feeling concerned about the implications for patient safety.
Theme 4: reporting
Eighteen (58%) respondents identified reporting practices in sonography with regard to patient safety. It did not always appear in the first responses but maintained a strong presence before probing questions. Reporting in sonography is perceived as being different to other imaging modalities. Sonographers feel responsible for detecting and communicating pathology to reporting physicians, ‘They haven’t found it, the sonographer has found it, that’s the massive difference’ (PS5).
Theme 5: professionalism
Professionalism featured in 17 (54%) responses. Professionalism pivoted around competency and fitness to practice (FtP), ‘Biggest issue with patient safety would be the competence of the sonographer because the success of that examination is totally dependent on the sonographer’ (PS19). Sonographers showed trepidation around the measures in place to benchmark and measure sonographers’ professionalism.
Theme 6: intimate examinations
Patient safety during intimate examinations was mentioned by 13 (41%) participants, ‘we’re in close contact with patients more so than any other medical imaging profession’ (PS5). This generally occurred following probing questions and carried a low perception of risk to the patient.
Theme 7: infection control
Eleven (35%) participants expressed concerns for infection control during ultrasound examinations, four of these arising only after probing questions. The majority of these were primarily concerned with contamination of internal probes.
Discussion
It is worth noting that the invitation initially included participation in either a one-to-one interview or a focus group. However, low interest in focus groups led to only one-to-one interviews being conducted. Eight (26%) participants were asked why they were not interested in a focus group. For some, it was the convenience of organising a one-on-one interview. However, six (20%) did not feel comfortable discussing patient safety issues in a group, especially those with experiences of unsafe practice. Focus groups can pose ethical challenges when discussing sensitive information. 15 Patient safety in diagnostic medical ultrasound is a very real issue for sonographers, reinforcing the importance of this topic.
Bioeffects
The majority of sonographers raised concerns about bioeffects before probing questions. Sonographers were concerned that increasing intensities being used in ultrasound could potentially cause biological effects in patients. Average intensities for B-mode ultrasound examinations have increased 20 times from 1991 to 2010. 16 Newer techniques such as Doppler ultrasound operate at higher acoustic intensities. 17 In response to increasing beam intensities in medical ultrasound, manufacturers established ODSs which alert operators to the potential for bioeffects. 17 In our study, most sonographers felt that manufacturers’ defaults in monitoring ODSs provide adequate protection for patients by alerting sonographers to potential risks. Sonographers also referred to the ALARA principle in performing diagnostically acceptable imaging at the lowest possible exposure, to reduce the risk of biological damage to the patient.
Results of in vivo and in vitro studies have shown that ultrasound, at the levels associated with medical imaging, can cause an increase in temperature of insonated tissue up to 4.3°C.18,19 Despite these findings, the risk of injury to patients due to increased tissue temperature caused by ultrasound imaging remains unclear.7,16,17 Therefore, sonographers must remain vigilant in the face of increasing ultrasound intensities in order to balance the potential risk of exposure to ultrasound against improved diagnostic capability. 17
Physical safety
Falls in hospitals impact patient safety, resulting in longer hospital stays and higher costs. 20 Our study illustrates how sonographers believe the ultrasound imaging environment poses particular risks to patients’ physical safety. Sonographers felt that it was ‘not just patient safety, but family safety’ (PS7) that was at risk of physical harm. Trailing cables, narrow tables with removable parts and mechanical table height create opportunities for fall hazards and crush injuries. Due to their portability, ultrasound machines can be temporarily located outside the imaging department which may add to this risk. 4
Nine sonographers highlighted that multiple people present, especially children, in the room add to the physical safety risk, ‘Mothers having kids with them, they’re running around, and they get caught under the elevating table’ (PS19). Physical safety was also a concern during stress echocardiograms, whereby exercising on a treadmill could result in the patient falling, with two sonographers reporting incidents of this occurring.
Limited data are available but one study showed a slightly higher risk of serious events, whereby patients required treatment, following falls within radiology (5%) relative to other departments (4%). 21 No evidence regarding physical safety of the patient specifically during ultrasound was available.
Within medical imaging, interactions with patients are brief and there is limited information available regarding patients’ stability. 22 Radiology staff may not be skilled at recognising risks which contribute to falls in the imaging environment.21,22 Falls prevention in hospitals should focus on the prevention of all falls.20,22 Sonographers should be part of these programmes so that they can recognise patients at risk of falls.
Theme 3 – workload
Workload in medical imaging has been defined as ‘the product of the number and complexity of examinations performed per time unit’. 23 In our study, and in keeping with workload data, 5 sonographers reported that ‘Requests for ultrasound are increasing’ (PS23). Sonographers were concerned for patient safety as ‘We’re not given enough time to do scans safely’ (PS26), and felt rushed to complete more, and often more complicated, examinations in the same time.
Sonographers felt that funding models for ultrasound imaging rely on scanning greater volumes of patients and believed that ‘when volume goes up that much, corners are being cut’ (PS24), ‘And I can’t see how anyone’s taking notice of how patient care suffers in those circumstances’ (PS26). Sonographers felt that Medicare rebates were ‘not enough to cover how much it’s going to cost to perform’ (PS26), especially for complex examinations that take longer. The fee-per-service payment model provided by Medicare appears to favour high-volume, low-value care, with concerns over reduced safety standards of this model.24,25 Medicare rebates for ultrasound were unchanged in Australia from 1998 until 2020 when small increases in some rebates were seen, a preliminary step towards parity between the Medicare benefits and the real cost of providing services to patients. 26 In practices which do not bulk bill, a similar phenomenon exists, sonographers felt that providers ‘have to charge from two to three hundred dollars’ (PS26) for the same examinations to be profitable. Sonographers felt this led employers to increase the number of examinations being performed daily by reducing appointment times and incentivised remuneration schemes whereby sonographers get paid ‘a premium to get a certain number of patients done’ (PS26).
Theme 4 – reporting
Sonographers do not generate final reports in Australia but contribute significantly by providing evidence, such as sonographer worksheets and still images, which form the report.27,28 Some sonographers view this mechanism as an opportunity ‘to have a second set of eyes look at things’ (PS17). For others, this only increases the points at which errors in reporting could occur due to breakdown or misinterpretation in communication in translating findings from a dynamic scan via static modes of communication. Further to this was the fear of omissions as final reports condense ‘our complex report [worksheet] into a few sentences’ (PS13). One sonographer speculated ‘is ultrasound better off reported by the people who are actually doing the scans?’ (PS4). Studies show close correlation between sonographer findings and reports.29,28 However, evidence has shown that sonographers tend to use disclaimers regarding image quality, which presents uncertainty in sonographers’ findings from their worksheets. 29 Errors in radiological diagnosis can arise at different phases, including acquisition of images, interpretation of findings as well as missed diagnoses. 30 Sonographers must possess excellent skills in imaging and clinical reasoning, but also in communicating findings from a dynamic examination to a third party to formalise reports. 30
Theme 5 – professionalism
The theme of professionalism revolved around the notion of competency and FtP. Interviewees felt that once a sonographer graduates or finishes training, FtP is not benchmarked against a clearly established framework. Sonographers in Australia are subject to the National Code of Conduct for Health Care Workers but unlike practitioners registered with the Australian Health Practitioner Regulation Agency (AHPRA), no overarching governance specifically for sonographers exists. 8
ASAR approves courses of study in sonography, maintaining a register of accredited sonographers in Australia. To be eligible for Medicare, ultrasound examinations must be carried out by accredited sonographers. ASAR, however, cannot remove sonographers from the register due to professional misconduct, nor prevent a sonographer from practising. 31 Fourteen (45%) sonographers cited continuous professional development (CPD) as the most common mechanism of maintaining and measuring competency and FtP. CPD as a competency or FtP mechanism in healthcare is controversial, with little evidence that CPD itself enhances patient safety.32,33 While FtP and competency hold every person in a profession to a minimum standard,32,33 CPD focuses on individual learning interests.32,33Just three sonographers commented on the shortcoming of CPD, citing how sonographers attending a conference ‘turn up on day one and register, then go off and party’ (PS24), while achieving a ‘hell of a lot of points’ (PS19). A study in 2010 described similar findings, where users of CPD, while aware that their accreditation body accepted reflective notes as a valid CPD activity, redefined it as a non-valid activity because of their reluctance to spend time writing reflective notes, instead engaging in tick-box exercises by turning up. 32
Correlating with our study, Lalzad et al. found that sonographers performing neonatal cranial ultrasound, that is, after their initial training in sonography, were supervised ‘until competency was reached’, with no benchmark for how this competency was measured. 16 In our study, nine respondents reported that competency was often measured via sonographers’ ‘personal relationship with the radiologist’ (PS5), relying on the reporting physician ‘getting a sense of how good they think you are’ (PS16) rather than any clear measure of competency.
Eleven (35%) people specifically commented that a lack of regulatory oversight in medical sonography means that sonographers self-regulate their competency, ‘it’s more self-regulation than I’ve seen’ (PS6). Since the mid-1990s, reports of medical errors and professional misconduct in healthcare raised public concern about how healthcare professionals are regulated and there has been a clear shift away from models of self-regulation deemed inadequate in protecting patients. 34 Sonography practice in Australia, however, is still managed by professional bodies rather than regulatory authorities, who cannot prevent a sonographer from practising. 8
Theme 6 – intimate examinations
Ultrasound examinations often involve scans of sensitive regions such as the vagina, testes and breast, at close proximity and with prolonged contact with patients. 8 Thirteen (41%) respondents appreciated that intimate examinations place patients in a vulnerable position, ‘there’s a feeling of vulnerability for them because they have to remove the clothing off the top half of the body’ (PS13). However, even these sonographers mostly had a low perception of the risk to the patient, with sonographers placing a lot of trust in the mechanisms of informed consent and the use of chaperones in ensuring patient safety. Once consent and the use of chaperones were explored, further, it became clear that issues exist with how intimate examinations are managed in practice. These issues will be reported in the second part of this study.
Theme 7 – infection control
Ultrasound imaging creates a source for cross-infection on many levels, from the ultrasound coupling gel to the transfer of infection from sources such as the probe cord and even the machine keyboard.9,35 A striking observation from the data was the clear focus on the ultrasound probe used during internal examinations, such as TV ultrasounds, with only four sonographers mentioning the probe used in general scanning. Studies have highlighted that the probes used in routine scanning are neglected but carry significant risk of infection for patients. 9
There was also less emphasis on basic cross-contamination principles such as hand hygiene, wiping worksurfaces and ‘changing the linen even’ (PS24). This was initially surprising but other studies have had similar findings; 36 Westerway et al. found that while 84% of sonographers perform high-level disinfectant of the transducer after endocavity scanning, less than half performed hand hygiene between scanning patients. 37 Good basic hygiene is critical in ultrasound practice to keep patients safe from harm. 35 Sonographers are sometimes unaware of how important basic hygiene is in preventing the transfer of infections to patients. 36 Education and clearer protocols are effective interventions in raising awareness of basic infection control practices and should be implemented in ultrasound practice. 36
Limitations
Data collection occurred prior to COVID-19 in Australia. It is likely that the pandemic would affect some dimensions of the study. Sonographers’ awareness of infection control would likely now be heightened. Workflow patterns were affected, some imaging centres set limits on exam times and patient contact time. Additional people not being allowed to attend ultrasound examinations likely impacted some of the areas highlighted in the theme of physical safety. These areas would be worth re-exploring in future, but the findings from this project remain valid as we adjust to life post-pandemic.
Thirty-one interviews represent a small portion (<1%) of sonographers on ASAR; however, this was representative of the profile of the sonography workforce in Australia. The adherence to the notion of information power gave us confidence in the data to tell a compelling story and provide an opportunity for reflection on the patient safety issues that exist in sonography practice.
While not a limitation of the study, there was only one mention of equipment quality assurance (QA) during interviews. The aim of QA is to detect equipment faults before they affect diagnostic quality or safety and it has been noted that 37% of ultrasound probes may be faulty with 13% recommended for immediate replacement. 38 As such it was surprising that it did not feature.
Conclusion
Patient safety in ultrasound is viewed in technical terms. Consistent with the literature, bioeffects remain the most common patient safety concern, according to sonographers, in our study, followed by the risk of physical harm to the patient.
However, with probing questions, our study showed that sonographers identified other areas of concern in relation to patient safety in medical diagnostic ultrasound. Workload issues, reporting of ultrasound examinations, professionalism, management of intimate examinations and hygiene standards were also identified as potential risks to patient safety by sonographers.
Patient safety in ultrasound is a complex area. While sonographers perform many scans per day, sometimes interacting with patients for a short period of time, every patient should be viewed as individual in their biological, physical, psychological and emotional safety needs. Employers also need to recognise their role in patient safety by ensuring adequate time for staff professional development, providing sufficient resources for ultrasound examinations and acknowledging how workloads can impact on the quality of scans and patient safety. Part 2 of the study explores how sonographers respond to the patient safety concerns identified in part 1 of this study.
Footnotes
Acknowledgements
The authors would like to thank Professor Michal Schneider for her invaluable contribution to this work at its early stages.
Contributors
Declaration of Conflicting Interests
The author(s) declared no potential conflicts of interest with respect to the research, authorship and/or publication of this article.
Funding
The author(s) disclosed receipt of the following financial support for the research, authorship and/or publication of this article: This study was funded in part by the Victorian Medical Radiation Practitioners Education Trust.
Ethics Approval
Monash University Human Research Ethics Committee
Address: Monash University, Wellington Rd, Clayton VIC 3800, Australia
Reference: Project 19091, July 2019
Guarantor
John McInerney
