The Value of Implementing an Ultrasound Quality Control Program

Abstract

Ultrasound quality control (QC) has received less guidance from regulatory bodies as compared to other imaging modalities. However, image quality is no less important in ultrasound. This article aims to identify optimal quality tests and testing cadences to ensure the highest diagnostic image quality.

Furthermore, it aims to demonstrate the implementation of such a program in a manner that brings sonographers the most benefit with the least burden. We describe its adoption by an ultrasound team to improve QC sensitivity and efficiency.

What began as a paper-based QC process with poor compliance evolved into a digital system using the assistance of software, resulting in 100% compliance. Sonographers were directly involved in the process improvement program. Equally important, imaging leadership and management were in support of the implementation.

While imaging departments have ongoing QC programs for their mammography (MG), computed tomography (CT), magnetic resonance (MR), positron emission tomography (PET), and single photon emission computed tomography (SPECT) units, ultrasound (US) QC is an outlier. Perhaps this is because ultrasound lacks the characteristics that drive many regulations for other modalities, like shielding requirements and ionizing radiation risk.^1,2

Ultrasound’s differences, though, are the same features that make it uniquely powerful in a clinical setting. The lower cost and lack of ionizing radiation make it well suited for use in a wider range of settings, so that unlike other imaging modalities, ultrasound is often located outside radiology departments.

This dispersion may help explain why major radiology regulatory bodies have provided comparatively few guidelines around US QC. With any modality, the higher the image quality, the more empowered the medical team is to give their best recommendation for the patient. It is critical to consider the aspects of image quality and patient safety that are common to all modalities as well as those unique to ultrasound. Even with few QC regulations for guidance, clinical experience can help determine the aspects of image quality most critical to accurate diagnosis. Further, understanding the physics and engineering underlying ultrasound image generation can identify the parts of the image generation chain most prone to failure.  

To that end, an ongoing QC process should be developed as a sustainable addition to the sonographers’ workflow and one which can be monitored and managed by the medical physicist. The process should be easy to implement, yield high-value outcomes, and help bolster sonographers’ confidence in identifying reportable actions while not being a time burden that could impede patient throughput.

While the fundamental image generation methods and clinical applications of ultrasound may have notable differences from other modalities, many key considerations for developing a valuable and sustainable QC program are similar. QC is a set of prescribed tests performed over the lifetime of the equipment conducted at specific time intervals and influenced by the clinical usage of the unit. Typically, the first check of quality for all imaging units, including ultrasound, is acceptance testing during commissioning of the unit before it is put into clinical service. Acceptance testing is important for confirming the unit meets specifications and establishing initial performance levels to which the unit can be compared over its lifetime. For some modalities, such as MR and CT, this initial performance level is used by the physicist to set the thresholds for ongoing technologist QC tests.

Ultrasound could benefit from adding structured QC guidelines comparable to other modalities. While many imaging departments have an established schedule of annual surveys of ultrasound equipment, in the authors’ experience, few have established regular checks for physical damage or imaging anomalies.

Many departments have not established a clear mechanism to document the equipment’s status or escalate quality issues. Annual testing alone is insufficient to ensure continued image quality.³ Should an issue arise shortly after an annual inspection, it could go undetected until the following inspection. By contrast, other imaging modalities such as CT and MR have daily or weekly checks to ensure image quality and patient safety are maintained.

In our experience, in-house service events are not proactive; they are triggered after issues arise. There is a misconception that in-house biomedical technical service or vendor-specific maintenance is sufficient in keeping ultrasound units in optimal condition in terms of image quality and patient safety.¹ However, service is only triggered when a sonographer identifies and escalates an issue. In many cases, the lack of QC structure leaves the sonographer uncertain about what degree of image degradation warrants calling service.

Figure 1 illustrates monitoring of imaging unit performance over its lifetime. Often, lacking direct guidance, imaging departments rely entirely on an annual medical physics inspection for formalized image quality monitoring.

The QC program at the author’s outpatient imaging center started from American College of Radiology (ACR) accreditation recommendations. It evolved with physicist and sonographer input to capture the key metrics of ultrasound image quality and most likely system failures, while being sensitive to sonographer workload and time. This QC schedule includes routine observational inspections and phantom-based tests. Responsibilities are designated to sonographers and the physicist; together, they form the QC team.

For the ultrasound QC program to succeed, leadership and sonographers both need to see long-term benefits, especially if QC is not mandated by regulation. If the program is non-burdensome, the likelihood of acceptance is high. In our opinion and experience, these factors ensure adherence.

Figure 1: A comparison of QC programs over the lifetime of an imaging unit either to meet minimum regulations (top) or as informed by accreditation recommendations, peer-reviewed literature, and sonographer and physicist experience (bottom).

Current State of US QC Regulations and Recommendations

The common thread among all accreditation and professional organizations is that QC is important for patient safety and continued image quality. Yet there is no clear consensus on which tests to perform and at what frequency.

The ACR and the American Institute of Ultrasound in Medicine (AIUM) specify some tests that are required and other tests that are recommended or optional. The tests have suggested different frequencies targeted toward the physicist, service engineer, and sonographer (Table 1).^4,5,6,7 Joint Commission (JC) does not mention US specifically,⁸ while the Intersocietal Accreditation Commission (IAC) provides some guidance within the Quality Improvement section of the standards related to ultrasound imaging.⁹

The American Association of Medical Physicists (AAPM) issued a report on B-mode ultrasound in 1998, which is still relevant today.¹⁰ The European Federation of Societies for Ultrasound in Medicine and Biology (EFSUMB) also has recommendations that align with other societies, listing tasks and tests in terms of four levels. The highest level, four, are specialized tests that only a medical physicist can perform.¹¹

Without clear QC regulations, the monitoring of ultrasound equipment performance is driven by institutional process. While a sonographer may notice defects, they may not feel confident to issue a repair ticket or communicate with a superior, given the lack of formal QC process. A defective probe might be put aside with a note to not use it, or a port may be taped over to indicate it is defective. While these indicators may prevent inappropriate use of broken equipment, established QC checks and follow-up steps can more quickly initiate the repair of these clinical resources.

Tools to support QC checks, such as a simple uniformity phantom, can be useful for establishing the degree of image degradation and informing the next steps. With high turnover of sonographers and management, processes need to become well established and communicated with every change. It is important to have a more formal program to provide sonographers with clarity regarding expectations, communication, and workflow.

Elements for an Efficient and Effective QC Program

Medical imaging QC tests aim to monitor major aspects of clinical readiness, such as quality of the images produced, physical aspects of the equipment, and patient safety (including infection control). While these types of tests are similar to other imaging modalities, the underlying image production method for ultrasound differs, leading to some distinct considerations for structuring QC.

A significant aspect of an effective QC program is monitoring image quality and providing guidance when an image is sub-optimal. Attributes of inferior images include a lack of uniformity across the image, noticeable resolution degradation, unexplained artifacts, inadequate signal, and increased noise.

In ultrasound, the transducer contains the key elements for generating and receiving signals and is typically the source of any image degradation. A damaged transducer element may result in shadows or streaks, and delamination of the transducer membrane may lead to an image artifact. Troubleshooting falls to the physicist or service engineer to determine the severity, cause, and any remedial action to take. ACR and AIUM agree that ultrasound systems should have thorough testing at least annually, preferably physicist-conducted, to ensure the integrity of the complete imaging chain. However, their recommendations differ as to how to build a routine QC program.

Physical and mechanical integrity is another important aspect of maintaining the quality of imaging systems. An ultrasound imaging unit’s shape and size are noticeably different than its large tube- or doughnut-shaped counterparts. Being compact and truly mobile, it can be taken to a different room on the same or different floor, to a different specialty area of a hospital, or to different clinics within a large enterprise — all within a single day.

Additional risk considerations must be given for physical damage to any part of the ultrasound system when in transit. Because systems may be brought to various locations within the enterprise, ambient room lighting, for example, could have some impact on the sonographer’s ability to resolve contrast and thus image quality¹². Ultrasound also requires a sonographer to actively hold the transducer in contact with the patient, introducing a risk of physical damage unique to this modality. If the patient has skin obstructions such as keratosis or excessive body hair, for example, this could force the sonographer to increase pressure, risking additional wear to the transducer membrane. Further, the material properties inherent to the matching layer, which interfaces between the transducer element and the tissue, make it susceptible to damage, such as delamination, cracking, and pitting. Consequently, failure rates at annual surveys are high, and more frequent visual checks are beneficial.¹³

Due to inherent direct patient contact, infection control and patient safety can be intertwined with quality control in US. The main cleanliness and safety considerations are maintaining disinfection and sterilization of the complete ultrasound system and ensuring probe integrity and electrical cable soundness. Safety is ensured through a process of disinfection and visual inspection as performed by the sonographer. Even though these are performed continuously, adding a formalized process gives a clear mechanism by which to report any issues.

Ultrasound units can also be used in surgical environments, intensive care units, and isolation areas requiring consideration for the varying sterilization standards of different clinical settings. Where we have no control is when there are external factors such as ultrasound gel manufacturers recalling lots due to contamination where patients suffered some harm.^14,15

As informed by experience and literature, Table 2 summarizes the minimum recommendations for an efficient QC program performed by the QC sonographer. Previous literature based on failure rates from a four-year, large institution study suggests at least having a quarterly mechanical integrity and uniformity assessment as part of an US QC program, which was the cycle implemented at our facility.¹⁶

A subsequent multisite trial showed that annual physics surveys and preventive maintenance of ultrasound probes are inadequate, and more frequent tests should be performed by the users of the equipment.¹³ Choosing to document the mechanical integrity of the probes, cables, control panel, and knobs was made primarily from experience rather than literature-based evidence. The sonographers were already in the habit of consistent, ongoing observational tracking of damage to the imaging equipment. Documenting this daily gave the sonographers credit for effort already going toward ensuring quality and safety, as well as a regular opportunity and clear method to report any observed issues. On the other hand, the QC team did not feel that documenting per-patient cleaning activities would give a comparable advantage relative to the time invested.

Managing Workflow of an Ultrasound QC Program

The components of a workflow improvement project begin with three basic assumptions:

1. Data is available.
2. Processes can be changed.
3. Improvements are achievable.

The resulting QC program is most effective and best accepted if the sonographers have clear directions, the data can be tracked over time, failures are efficiently communicated, and reports are available to the physicist as well as for inspection, audits, or accreditation (Figure 2).

Figure 2: Paper QC workflow vs. digital QC workflow; characteristics of a digital QC system with centralized data management.

Training is crucial to the success of the US QC program. Initially, sonographers may need to invest time in becoming familiar with the QC process. However, since the process is defined with their input, sonographers tend to feel a greater sense of ownership over image quality and patient safety. Additionally, a well-defined, well-trained, and collaborative process is an efficient one.

Below we describe a QC improvement project and the ongoing experience over the past several years at a breast ultrasound imaging facility. The QC program was developed as described earlier from recommendations, literature, and experience. QC tracking software was used to instantiate that plan as a consistent, efficient process.

As the clinic had a QC program in place for mammography and dedicated breast MR equipment, this team fully supported the introduction of an US QC program. They were already using and familiar with an electronic QC tracking system for mammography and breast MR, and there was a keen interest in having the same for the US breast imaging systems.

The author’s breast ultrasound fleet consisted of six high-end ultrasound systems used for diagnostic imaging and biopsy procedures, each with either two or three high frequency linear probes. A QC plan was developed, and a centralized electronic QC system was implemented to ensure all information was reported within a single database. All probes and all ultrasound base units were individually tracked, including ongoing testing, QC failures, and equipment replacements. The QC system supported the information needs of the QC team. A dashboard presented the tests due per device for the sonographer, based on the established schedule (Figure 3). In the case of failures, the system sent email notifications to the management team. Information was stored in a database, and the data could be filtered for QC management, audits, failure pattern detection, and physicist reports. Data-driven decisions such as future purchases and service requirements could be informed by filtering the data appropriately.

Figure 3: The dashboard shows currently due QC tests associated with base units and probes respectively.

Results

One outcome of implementing a QC program was an improved understanding of imaging unit performance, including the types and frequencies of failures. Because the QC tracking software product used a structured database, quantitative metrics could be used to demonstrate the effectiveness of the process in terms of failure rate tracking, imaging unit readiness, and QC program compliance.

Another result was better process clarity and issue escalation through the use of a QC software product with a full-cycle failure workflow. Furthering these gains in fleet tracking and QC team communication, all recorded worksheets provided a comments field to gather sonographer observations, so the database could track issues that would not yet warrant a service call or removing a transducer from clinical use. This flexible aspect of tracking allowed for a more complex understanding of imaging unit performance, rather than a simple pass or fail model.

Over two years, 2,654 QC tests were completed by the sonographers for ultrasound imaging units and individual transducers. There were no missed tests, showing that sonographer compliance with the QC program is 100%.

Tests could be indicated as skipped in the instance that a daily QC test was not needed, such as when the center was closed or equipment was out for repair. Across the fleet, 121 tests were recorded as skipped. In all cases, the sonographer indicated an appropriate reason that QC was not needed.

Over the two-year period, eight tests recorded unit QC failures. This 0.30% failure rate showed that imaging units were consistently patient-ready; the QC program was effective in identifying instances where attention was needed to address changes in imaging quality or physical damage or deterioration. This is a low failure rate compared to those shown in other publications but expected because the equipment was new when tracking was initiated.

Of the eight failures, three were issues with the imaging unit monitors, three were issues with the transducer wells or ports, one was an improperly secured piece of peripheral equipment, and one was an issue of dead elements causing significant visible deterioration in the image. Interestingly, one ultrasound machine was the source of six out of the eight failures.

The database-based QC system could also track patterns across individual probes over time, represented in Figure 4. For example, Probe 1 required immediate repair/replacement, whereas Probe 2 presented an artifact, resolved by cleaning the transducer port of dust. Probe 3 showed a pattern of repeated issues that required replacement.

While the majority of probes were without issue, the patterns shown, particularly in 2 and 3, support the importance of frequent QC testing. These examples demonstrate the value of a structured QC program and the advantage of using a uniformity phantom to assess image quality. 

Figure 4: Transducer QC lifecycle. Timeline representation of transducer failure cases. Transducer 1: Failure and immediate removal from service. Transducer 2: Artifact remedied by cleaning. Transducer 3: Repeated artifacts preceding failure and removal from service. Twelve remaining transducers were without issues.

Sonographers also gained clarity on the QC process and handling failures. Before implementation of an ultrasound quality control program, performing QC and tracking results on paper was a burdensome task. Sonographers spent too long locating a poorly understood ultrasound phantom, finding the paper log, and deciding which aspect of the phantom to measure, as there was little guidance or communication. This resulted in QC being performed poorly or haphazardly (Figure 2). Staff turnover, whether sonographer or manager, exacerbated this lack of clarity. New staff coming from facilities without a structured QC program would be unfamiliar with QC principles and processes.

After implementation of a structured, software-based QC program, routine visual checks on the system were more efficient. Checklists were presented to the sonographer at the specified frequency. Any failures or concerns were automatically routed to a centralized database, notifying the appropriate parties by email and ensuring all information was included in reports. Both QC principles and processes were inherent in the structure as configured within the centralized management software (Figure 5).

Better communication also came about as a result of the QC program. This started with greater clarity for the sonographers as to what tests to perform or aspects of cleanliness and safety to review.

As shown in Figure 5, in our clinic tests were scheduled at daily, weekly, and quarterly frequencies. The physicist did the initial training on the expectations associated with each check and then the worksheets could instantiate those checks as a repeatable process. The specificity of the lists makes it easy for the sonographer to quickly indicate the area of concern, and the “All Passing” button saves unnecessary clicking by marking all fields with a single click. Tests only appear on the dashboard when due; they disappear once complete until required again per the set frequency.

The daily test captured cleanliness of the visible surfaces of the system, while the weekly tests captured more internal aspects of cleanliness, like filters and ports, as well as checking for system damage. Quarterly tests were structured to check for electrical and mechanical issues and to ensure image quality through the full image generation chain from the transducer elements, through each port on the base unit, to the pixels displayed on the imaging unit monitor. Uniformity phantom testing assessed key aspects of ultrasound image quality. Protected time was appreciated by the QC sonographer for performing these tasks.

Communication for managers and physicists was also enhanced. Anyone who needed to view the information had secure, online access. The medical physicist could sign off on tasks electronically as they were completed. Emails were automatically sent in the case of overdue or failure tests, as shown in Figure 6, so that managers could trust QC was being performed and passing unless emailed otherwise.

Resolution emails were also sent as the issue was addressed and confirmed as resolved. A built-in full-cycle failure workflow added reminders of open issues to the dashboard and required comments to explain how the issue was resolved or a subsequent passing test to prove that the resolution was effective.  

Figure 5: The set of worksheets used to instantiate the QC plan by clarifying aspects of testing, collecting data, and initiating failure workflows when appropriate. 

Figure 6: Failure workflow with failing field and message indicating that emails will automatically be sent.

Comments stored in the database could be used to capture more detail about the imaging unit performance (Figure 7). All comments around a failure and resolution were automatically included on appropriate reports, giving the imaging team credit for catching and resolving any changes in performance or observed areas of damage.

Some issues did not warrant a failure designation because they could be immediately resolved by the sonographer. The comments were still valuable for capturing performance changes, however. (For example: “Few small dropouts from crystals seen. Air can used. Not changed from previous QC. US images for patient care not affected.”)

Other issues initiated closer inspection by the physicist or engineering — for example, “Ultrasound Probe QT011875 … has bubbling on the rubber at the edges causing drop out on the ultrasound images. A work order has been placed and the probe has been decommissioned and sent to …Biomed for disposal.”

The comments associated with skipped tests also gave useful information, capturing the types of down time. Some comments helped characterize the down time, such as “Service engineer replacement, part did not work. Adding work order ticket.” Closure of the imaging center accounted for most skipped tests.

Figure 7: Example of how tracking in a QC database can tell the story around a failure.

Key Benefits

1. With a centralized, network-based intranet database solution, information can be accessed by QC sonographers, physicists, and management from any location.
2. The high visibility of QC data and clarity of process means QC is done consistently and aligned with recommended checks at appropriate frequencies.
3. QC sonographers are empowered to bring forward concerns so that repairs can be done in a timely manner.
4. Automated email generation in the case of failure or missed tests helped make QC team communication efficient.
5. Database structure allows tracking of performance levels for individual machines and probes over time.
6. Reports can show equipment clinical readiness, isolate issues, and inform future purchases.
7. QC software that supports all modalities helps with adoption of the process and consistency across the department.

Discussion

In many ways, the outpatient imaging center was well positioned to institute a successful US QC program in terms of fleet size and physicist involvement. Being part of a breast imaging center, the team was familiar with the value and rigor of QC in mammography, well established and broadly enforced thanks to the Mammography Quality Standards Act (MQSA).

Both authors can also speak to the success of implementing a structured software-based US QC process at other institutions and offer some considerations. Smaller departments without a QC phantom may wish to consider in-air measurements of uniformity. Larger institutions may consider a rotating program where the phantom moves among sites through the quarter, so sonographers could do quarterly phantom-based testing. Larger institutions will particularly benefit from QC tracking software with a centralized database to ensure all sites are performing consistent QC with less travel and management burden for the supervisors and physicists.

The QC tracking software used in this case has customizable worksheets to accommodate various clinical situations. For example, a maternal and fetal medicine department concerned with geometric measurement accuracy can acquire a phantom with additional structures so sonographers can access that aspect of performance quarterly.

One limitation is that any quality improvement effort, QC or otherwise, works best if the imaging team sees the value. In other modalities, the adoption of image quality standards have demonstrated improvements in image quality and patient outcomes.¹⁷ Sonographers need to see the value of QC for patients. Managers must appreciate the structure and communication efficiencies to be gained. Organizational leadership should also be willing to support QC process improvement. The physicist needs to be available to address image quality questions. Further, IT will need to be involved in supporting data centralization. With the team in agreement, the adoption of better QC methods supported by the implementation of the right QC tools will be successful.

Conclusions                                        

Based on our experience, there are several key steps to process improvement for ultrasound QC. First, identify regulations as well as recommendations to build an effective test set and testing schedule. Next, communicate the value of structured QC to leadership in terms of image quality, patient safety, and process clarity for sonographers. Then, select a QC team to own the QC process and champion the QC principles.

Choose tools to make the QC procedures clear for sonographers, including how to proceed when image quality issues arise. Finally, ensure effective communication within the QC team, whether it is knowing the testing schedule, being alerted to failures, or the ability to access reports for review.

References

1. Russell S, Ultrasound quality assurance and equipment governance. Ultrasound. 2014; 22(1); 66-69. doi:10.1177/1742271X13517694
2. Gallet JM, Embracing Ultrasound Quality Control, Medical Physics International Journal, 2021; 9(2); 199-204.
3. Martensson M et al., Ultrasound transducer function: annual testing is not sufficient, European Journal of Echocardiography, Volume 11, Issue 9, October 2010, 801-805.
4. Bierig SM and Jones A, Accuracy and Cost Comparison of Ultrasound Versus Alternative Imaging Modalities, Including CT, MR, PET, and Angiography. JDMS 25;138-144. May/June 2009.
5. Quality Control: Ultrasound and Breast Ultrasound (Revised 4-9-2025): Accreditation Support; last accessed 7/16/2025.
6. Madsen EL et al., AIUM Quality Assurance Manual for Gray Scale Ultrasound Scanners. ISBN 1-932962-31-X, 2014.
7. AIUM Routine Quality Assurance of Clinical Ultrasound Equipment (v2.0) 2020 available from http://aium.s3.amazonaws.com/resourceLibrary/rqa2.pdf; last accessed 7/16/2025.
8. 2025 Comprehensive Accreditation Manual available from store.jcrinc.com/2025-comprehensive-accreditation-manuals; last accessed 7/16/2025.
9. Standards can be found at https://intersocietal.org/programs/vascular-testing/standards/; last accessed 7/16/2025.
10. Goodsitt MM et al., Real-time B-mode ultrasound quality control test procedures. Report of AAPM Ultrasound Task Group No. 1, Volume 25, Issue 8, August 1998, pp1385-1406. https://doi.org/10.1118/1.598404.
11. 2012 EFSUMB Technical Quality Assurance Group US TQA/B. https://dx.doi.org/10.1055/s-0032-1325347.
12. Bevins NB et al., Display Quality Assurance. Report of AAPM Task Group 270, January 2019.
13. Dudley NJ and Wolley DJ, A multicentre survey of the condition of ultrasound probes. Ultrasound, Vol 24(4) pp190-197, 2016.
14. 2021 FDA Class 1 recall EcoGel 200 Clear Ultrasound Gel: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?id=189403; last accessed 7/24/2025.
15. 2025 CDC Alert: https://www.cdc.gov/healthcare-associated-infections/bulletins/outbreak-ultrasound-gel.html; last accessed 7/24/2025.
16. 2011 Hangiandreou H et al., Four-Year Experience with a Clinical Ultrasound Quality Control Program. Ultrasound in Med & Biol, Vol 37, No 8, pp1350-1357.
17. Suleiman et al., Mammography in the 1990s: The United States and Canada. Radiology, Vol 210, No 2, 1999.