Key words
ultrasound - education - training - quality assurance - imaging
1. Introduction
In 2006, the Education and Practical Standards Committee (EPSC) of the European Federation
of Societies in Medicine and Biology (EFSUMB) developed a set of minimum training
requirements [1] recommending structured theoretical and practical training for gynecological, obstetric,
gastroenterological, nephro-urological, breast, and vascular ultrasound (US). Three
levels of training and expertise were proposed, and a curriculum for each of the three
levels of training was developed for the many different fields of US application.
The paper also acknowledged that a systematic recording of findings of any US examination
in the patient records was mandatory.
Now, the EFSUMB has described a concept of professionalism, which aims to make medical
US a reliable professional service based on common and uniform quality standards with
respect to regular service structures and management when US examinations are performed.
This includes a relevant clinical indication, followed by a thorough and structured
US examination with reliable and comprehensible storage of images/cine-loops and a
clear systematic report.
The presented standards may appear demanding and not all US professionals currently
in practice may achieve them. Nevertheless, the EFSUMB is committed to the approach
of developing optimal rather than minimal professional standards with respect to exemplary
patient care.
Professional medical US practitioners in Europe, including physicians and non-physicians
who specialize in US, must all have completed comprehensive curricular training and
received formal approval by the different national regulatory authorities to comply
with legal regulations.
This EFSUMB position paper has been prepared following the EFSUMB regulations for
the preparation of policy documents [2] and has been approved by the EFSUMB Executive Bureau. Therefore, the paper presents
a common position across the different medical professions within the EFSUMB regarding
the optimal standards for the performing and reporting of US examinations reported
by any professional US operator regardless of where and “who performs your scan” [3] and other variable conditions in the respective national health care systems.
2. Legal Aspects and Indication for Medical Ultrasound
2. Legal Aspects and Indication for Medical Ultrasound
All medical facilities providing US services, i. e., hospitals, doctor’s offices,
outpatient clinics, and other health service institutions, under whose legal responsibility
medical ultrasonography is carried out, are legally and ethically responsible for
the proper training of personnel to safely use equipment of appropriate quality with
an understanding of the limitations of medical ultrasound [1].
US devices, including hand-held devices, are subject to a medical device regulation
– Regulation (EU) 2017/745 of the European parliament and of the council of April
5, 2017 on medical devices [4] – and national implementation is undertaken under the Medical Product laws of the
individual countries, e. g. [5]
[6]. A special institution (notified body) within Europe certifies if the device is
in compliance with these directives before the product is sold by the manufacturer
or importer. After a positive evaluation the CE-mark is given with a 4-digit number
to identify this notified body [7]. Additional information about the possible output values (thermal/ mechanical index)
of this device for the user is also integrated into this CE-mark evaluation.
In the USA medical devices are regulated by the Food and Drug Administration (FDA)
[8]. These regulations classify the application risk of a device and can define upper
output limits (e. g., spatial peak temporal averaged intensity 720 mWcm–2 for all US applications except ophthalmology with only 50 mWcm–2) or output values that have to be displayed by the manufacturer for users. Additionally,
information about compliance with international/national standards concerning general
requirements for basic safety and essential performance is required to be stated [9]
[10]
[11].
In practice, the user can see the active output with regard to two indices: the mechanical
(MI) and thermal index (TI) that have to be displayed on the monitor. Depending on
the individual settings, these indices are changed online and should not exceed the
maximum values specified as “Good Practice” for the specific medical application.
In general, for all applications the ALARA principle (as low as reasonably achievable)
is always the best choice according to a benefit/risk-analysis in unclear situations.
In any situation, US practitioners should follow the safety recommendations given
by national and international societies and their special committees [12]
[13].
Regular long-term certified maintenance of US equipment and transducers is mandatory
to ensure optimal function of the different US techniques. Maintenance should be performed
within the optimal standards described by equipment manufacturers.
Position Statement 1: Medical facilities are responsible for safety, legal aspects
of ultrasound services, and the regular maintenance of medical ultrasound equipment
(agree/disagree/abstain: 17/0/0).
As with any medical imaging procedure, a US examination should only be performed for
a reasonable medical indication. Although the risk is very low, the potentially harmful
physical effects of US energy on examined body tissues [14] must be taken into account when establishing the indication. The purpose, procedure,
limits, and complications of the US examination, particularly for invasive US-guided
procedures, for which informed written or verbal consent is required, should be explained
to the patient. “Preventive” whole-body US examinations of asymptomatic persons are
not recommended. They have no medical indication and are controversial as part of
a general health check, owing to incidental findings which may be of uncertain clinical
relevance and false-positive findings with potentially negative psychological, medical,
and economic effects [15]
[16].
Position Statement 2: Every ultrasound examination requires an appropriate medical
indication and justification (17/0/0).
3. Organization of Medical Ultrasound Service
3. Organization of Medical Ultrasound Service
Medical facilities dedicated to training doctors or other healthcare professionals
who perform ultrasound scans, such as university clinics, teaching hospitals, and
other medical training centers, departments, sections, or similar work units providing
medical US services, should have a responsibility hierarchy. They should be managed
and headed by a responsible US practitioner with the highest level of expertise. The
organization of the US service must allow for continuous training, supervision, and
quality assurance of novices and practitioners with less experience. The most suitable
and beneficial manner in which this teaching and expertise development can occur is
the “mentoring” system, where two practitioners, one senior and one junior, take turns
performing scanning in the same room in order to ensure supervision, teaching, continuous
learning, and professional development to keep the diagnostic professional standard
of the staff stable over a long period.
Previous patient examination findings and clinical information should be available
to the examiners before starting any new patient examination. This applies to images
and written reports for diagnostic imaging – not only previous US exams but also other
relevant imaging (CT, MRI, X-ray, endoscopy, laboratory findings, etc.) – and the
patients’ clinical records. In a digitalized workflow this requires access to a Picture
Archiving and Communication System (PACS) and hospital information system in the US room.
Activities that can be delegated to (non-scanning) US assistants include all organizational
work regarding patient appointment scheduling, patient transport organization, patient
reception, in-department management of patients, examination preparation, environmental
maintenance and material supply organization, patient support to the examination couch,
and routine documentation.
Position Statement 3: Medical ultrasound services with a training mandate should facilitate
continuous training and mentoring, ideally delivered in teams of two practitioners
(16/1/0).
4. Medical Ultrasound Scanning Room
4. Medical Ultrasound Scanning Room
The spatial design of US rooms and departments should take into account the spectrum
and workload with respect to performed examinations and interventions. An efficient
workflow, adequate lighting conditions, compliance with hygienic working conditions,
and patient safety must be ensured through appropriate room design. Each examination
room should provide sufficient space for US equipment, stretcher and/or patient bed,
examiner, documentation station, disinfectant facilities and must also allow for emergency
patient care. Intervention rooms require additional space for assistance, intervention
equipment, preparation and processing of biological material, resuscitation equipment,
and patient transfer. A working surface for sterile material, patient monitoring,
oxygen supply, and infusion, as well as dimmable room lighting and a movable spotlight
are preconditions for US-guided interventions.
The size of dedicated rooms needed to ensure an ideally efficient workflow in medical
ultrasound depends on several sub-functions and where to place them. The following
paragraph lists typical sub-functions and their space requirements [17]
[18].
Single US room:
A) Core space:
-
US workstation for ambulatory patients alone:
the examination couch plus 1 m in every direction, including the space for the US
unit (referred to in the figures as a light green rectangle) makes 12 m2
[18]. With the addition of a desk and a handwashing sink, 16 m2 of space are required ([Fig. 1])
-
US workstation for both ambulatory and bedridden patients:
e. g. 25 m2 for additionally placing a bed perpendicular to the examination couch. The examination
couch should not have to be moved away to make space for a patient bed. The US system
can be turned 90° towards either the couch or the patient’s bed ([Fig. 2]).
Fig. 1 Minimum requirement for a basic ultrasound room for outpatients only: for an examination
couch plus 1 meter in each direction and the ultrasound machine, 3 × 4 m are required
(12 m2, light green area, to reappear in the following bigger room figures). To additionally
include a desk area and hand washing area, the space requirement is approximately
17.5 m2 (e. g. 5.5 × 3 m).
Fig. 2 Minimum requirement for a basic clinical ultrasound room for ambulatory and bedridden
patients in a hospital: 20 m2 (4 × 5 m, light green area plus adjacent white area) must be provided for an examination
couch and patient bed, the ultrasound machine (to be turned 90° towards either the
couch or the patient’s bed) plus 1 m in each direction of the examination couch and
the patient bed. Together with a small desk space and hand washing area, the space
requirement amounts to approximately 25 m2 (e. g. 6.25 × 4 m).
B) Additional space requirements for:
-
Organizational assistant desk space: e. g., 3 m2
-
Reporting desk space: e. g., 3 m2
-
Staff hand washing sink space: e. g., 1.5 m2
-
Patient hand washing sink space: e. g., 1.5 m2
-
Teamwork space for junior US practitioner in training: e. g., 2 m2
-
Patient’s changing room(s): e. g., 2 m2 each
-
Simple interventions such as fine needle punctures including preparation and handling
of potentially infectious aspirated biological material: e. g., 2 m2 ([Fig. 3])
-
Complex interventions such as drainage procedures with sterile instrument table plus
1 m free space around for sterile dressed assistant person: e. g., 8 m2 ([Fig. 4])
Fig. 3 A Examples of clinical ultrasound room plans for ambulatory and bedridden patients,
suitable for performing simple US-guided interventions such as fine needle aspiration
and biopsy and for working in a team of two practitioners plus one assisting person
for reasons of workflow efficiency, education, and quality assurance. A Approximately 36 m2 (e. g. 6 × 6 m) are required for the examination couch, an additional patient bed,
the ultrasound machine, two desk spaces, two patient changing rooms, hand washing
space, and a combined bench and cupboard for intervention preparation and material
storage.
Fig. 3 B Examples of clinical ultrasound room plans for ambulatory and bedridden patients,
suitable for performing simple US-guided interventions such as fine needle aspiration
and biopsy and for working in a team of two practitioners plus one assisting person
for reasons of workflow efficiency, education, and quality assurance. B A more comfortable solution can be achieved by moving the desks away from the wall
and facing them into the room and placing an office shelf in front of the back desk
to prevent the person writing the report from being observed by the patient. To allow
clinical observation of the patient, the second desk for the assistant should not
be separated by an office shelf. Adding separate hand washing basins for patients
and staff requires a total area of at least 38.5 m2 (e. g. 7 × 5.5 m).
Fig. 4 Clinical ultrasound room for ambulatory and bedridden patients with two patient changing
rooms and two desks, suitable for complex interventions such as drainage procedures:
approximately 45 m2 (e. g. 7.5 × 6 m) are required for an examination couch, an additional patient bed,
the ultrasound machine, one desk space for the person to write the report divided
from the rest of the room at least by an office shelf, a second desk space for the
assistant person with an open view of the patient, two patient changing rooms, two
separate hand washing spaces for personnel and patients, a combined bench and cupboard
for intervention preparation and material storage and additional space for sterile
setup (including sterile instrument table).
The specified numbers are net space requirements. Additional space will be necessary
for walls to separate certain areas, for example
The space required for medical US can be calculated by combining the modular functional
parts that are needed, e. g., 16.5 m2 for a US room for ambulatory patients only ([Fig. 1]), while 25 m2 are needed for a US room with one desk for one US practitioner in a hospital ([Fig. 2]), with or without one changing room.
The optimal size of an efficient US room in a hospital, including space for a team
of two US practitioners, two changing rooms for a quick workflow, space for an organizational/documentation
assistant, space for performing simple interventions, is at least 36–42 m2 ([Fig. 3]) or 45 m2 ([Fig. 4]), when complex interventions with a sterile instrument table setup are to be performed
[17]. Providing privacy for focused work on the report and telephone communication separate
from the patient will need even more space either inside the room or in an extra room.
C) Important technical equipment for a professional workflow in an US room:
-
Ventilation technology with heating and cooling to ensure a comfortable room temperature
for an undressed patient including a sufficient cleaning rate of aerosols (downward
airflow better than upward airflow)
-
Dimmable ceiling light with remote control
-
Movable ceiling mounted spotlight source for interventions
-
One computer workstation per person working in the room, typically two, one for the
organization and documentation assistant and one for the US practitioner for reporting
and documentation, double-screen workstations superior to single screens.
-
PACS workstation(s)
-
In rooms for complex interventions (e. g., biopsies, drainage, etc.), movable, ceiling-mounted
secondary PACS screen to provide other imaging of the patient (e. g. CT) during intervention
near the US system monitor
-
Stainless steel mobile instrument table
-
Ceiling-mounted connection sockets for cables and supply hoses for the US system and
the patient as precondition to avoid cables and hoses getting under the wheels of
US system, bed, stools, etc.:
The following figures show examples of efficient US room designs for different purposes:
Even more space will be required than the numbers provided in these examples
-
when reporting is to be performed in a separate room, divided from the scanning room
by a wall with a door,
-
when endocavitary examinations or any other additional aspects need to be included
-
when national regulations on hygiene require certain space or even a separate room
for cleaning and disinfection of transducers and materials used,
-
when structural architecture conditions in an existing building like load-bearing
walls or pillars do not allow placement of all modular functions with optimal density.
Further facilities may possibly be placed in additional room(s), especially if there
is more than one US scanning room in an institution:
-
Material supply storage
-
Staff toilet (e. g., 1.5 × 3 m)
-
Patient toilet (e. g., 1.5 × 3 m, handicapped accessible: e. g., 4 × 3 m)
-
Facilities for disposal and cleaning (excrement from bedridden patients and infectious
materials and instruments)
-
Staff changing rooms
-
Reception desk
-
Office for secretariat/administration.
Position Statement 4: Specifically designed medical ultrasound rooms of appropriate
size are recommended for an optimally safe and efficient workflow (17/0/0).
5. Medical Ultrasound Hygiene
5. Medical Ultrasound Hygiene
Adequate preparation and cleaning of the transducer, US unit and the examination couch
are required to avoid potential infection transmission [19]
[20]
[21]
[22]
[23]
[24]. Adherence to published protocols for the cleaning and reprocessing of medical US
equipment varies considerably among US practitioners worldwide and is disadvantageous
to good practice [25].
Guidelines for transducer and scan hygiene predominantly refer to the use of non-sterile
gel as a coupling agent [19]
[20]
[21]
[22]
[23]
[24]. The standard use of spray or liquid disinfectants, which are used to disinfect
the transducers before and after use, as coupling agents instead of gel can simplify
the workflow and shorten the examination duration per patient. Care should be taken
to ensure that only disinfectants compatible with the transducer materials, as documented
in the manufacturersʼ guidelines, are used. Disinfectant sprays and liquids specifically
designed for disinfecting mucous membranes (e. g., octenidine) may be superior to
alcohol-based disinfectant coupling agents because they form a lubricating layer on
the skin for the transducer instead of evaporating rapidly.
Position Statement 5: Hygiene plans and standards for cleaning and disinfecting ultrasound
equipment should be implemented for every ultrasound service with monitoring of compliance
(17/0/0).
6. Structured Medical Ultrasound Examination
6. Structured Medical Ultrasound Examination
US examinations should follow a predefined standardized scheme in which all relevant
organs and/or structures are imaged completely and systematically on two planes and
in different patient positions, if appropriate. In addition to normal organs and structures
relevant to the indication, all pathological findings should be examined with US when
encountered. Complementary US techniques such as Doppler US, elastography, and contrast-enhanced
ultrasound (CEUS) should be applied selectively, when necessary, to answer the clinical
question or to characterize pathological findings according to accepted practice guidelines
[26]
[27]
[28]
[29].
Algorithms with predefined transducer positions have been published for almost all
US applications, in particular for abdominal US [30]
[31]
[32]
[33]
[34], thoracic US [35]
[36], joint US [37], thyroid US [38]
[39], echocardiography [40], vascular US [41]
[42]
[43]
[44], and US-guided interventions [45]
[46]. If standard examination algorithms have not been published for a particular US
application, the US practitioner should follow an institutional or at least an individual
standardized examination scheme to ensure that it is retrospectively clear what was
examined and how.
Position Statement 6: A structured medical ultrasound examination based on standard
algorithms is recommended (17/0/0).
7. Acquisition of Medical Ultrasound Images and Cine-Loops
7. Acquisition of Medical Ultrasound Images and Cine-Loops
In institutions with a digitized workflow, the complete image bundle of any US examination
should be stored digitally, primarily as a DICOM dataset in the system, that ideally
covers the patient’s entire US examination. The raw data should be available for dedicated
software analysis if further processing of the dataset is required (e. g., CEUS or
volumetric post-processing). All single images, representative cine-loops, and/or
3 D volume datasets selected by the examiner to demonstrate his diagnostic conclusions
should be sent to the PACS unit.
The still images dataset must include:
-
all organs to be assessed on at least two, ideally perpendicular, planes, both showing
the maximal extension of the organ including measurements in 3 dimensions for volume
calculation, if applicable,
-
all pathologic findings on at least two, ideally perpendicular, planes, both showing
the maximal extension of the lesion/pathologic change including measurements in at
least 3 dimensions. In case of multiplicity of pathologic lesions, image storage may
be limited to a selection, showing the range of variety, including one or more typical
“reference lesions” with size/volume measured for follow-up purposes.
-
the target lesion/target organ should be:
-
in the center of the image
-
in optimal size
-
with optimal achievable contrast (adjust transducer frequency, frame rate, dynamic
range, gain and time gain compensation (TGC) setting)
-
with optimal achievable image definition (adjust transducer frequency and use compounding
techniques)
-
measured on each plane with two maximal diameters
-
Organs/lesions too wide to fit into a single transducer aperture width should be recorded
with an image widening/panoramic technique or additional cine-loops
-
Topographic pictograms are better and more rapidly understood than written transducer
position labels, with the advantage of being independent of any language differences.
Video sequences should be used
-
for complete volume acquisition: ideally two steady sweeps should be taken in the
same perpendicular planes as used for the still image documentation of, e. g., a whole
organ, organ section, a tumor, or other defined pathologic entity.
-
for documentation of certain physiologic or pathologic dynamic phenomena (e. g., heart
action, fetal movements, bowel wall movements, blood flow, contrast enhancement, lung
sliding): the respective organ/structure should be taken with the transducer held
still in an adapted plane.
-
for anatomical representation of an organ/anatomical structure/pathology: The organ/lesion
view should be taken in only one steady sweep from the outside of one margin to the
outside of the other margin, in a recognizable direction.
-
for representation of a dynamic phenomenon (e. g., inner movements, blood flow, contrast
enhancement) the cine-loop should contain a representative time period [44].
3 D volume datasets
may replace cine-loops of steady sweeps through organs or pathologic findings obtained
for complete volume acquisition.
Labeling
Still images and cine-loops should be labeled with appropriate pictograms/terminology/abbreviations
(standardized at least on the local US service level). Topographic pictograms are
better and more rapidly understood than written transducer position labels, with the
advantage of being independent of language differences.
Non-image information which must be provided with any still image or cine-loops include:
Patient identification data, institution/examiner identification data, date and time
of the examination image or cine-loop
Additional data to specify technical details of the exam:
US system/model, US transducer, frequency, mechanical and thermal index, and other
technical pre- and post-processing settings used, focus position(s), if applicable.
Position statement 7: Ultrasound images and cine-loops from all standard ultrasound
views and any abnormal finding should be stored and reported (16/0/1).
8. Medical Ultrasound Reporting
8. Medical Ultrasound Reporting
The main purpose of the written US report is to communicate findings, conclusions,
and the relevance to the clinical enquiry to the referring clinician. In medical facilities,
where patient records are kept electronically, US findings should be recorded, reported,
and archived electronically, too.
Beside patient identification data, each report should contain relevant information
about when, where, and by whom the examination was performed, for what indication,
and which equipment was used. Subsequently normal and pathological findings must be
documented in a systematic approach. Limitations of the examination quality and confidence
level should be indicated.
What to communicate to the patient during, or shortly after the examination, depends
on the circumstances of the examination.
A structured report using standardized reporting templates that is either self-designed or from commercially
available software solutions, designed specifically for US, using globally accepted
lexicons is recommended for a medical US examination. Conventional reports are basically
written as long sentences, with certain fixed expressions describing normal and pathological
findings. Structured reporting using digital “report templates” standardizes and simplifies
reports by sometimes exchanging the sentences with short phrases and giving the examiner
a chance to select different options quickly [47]
[48]
[49]
[50]
[51]
[52]. Structured documentation has proven to be a promising approach to standardizing
findings, improving the overall reporting quality of various diagnostic modalities,
and facilitating interdisciplinary communication [53]
[54]
[55]
[56]
[57]
[58]. In addition, referring physicians and US practitioners generally prefer structured
reports over free-text findings [59]
[60]
[61]. Since US plays a key role in patient follow-up and treatment planning, comprehensive
and understandable reports are essential. Complete and unequivocally interpretable
initial findings are the basis for follow-up examinations and are essential for the
subsequent examiner to evaluate the presence of any changes.
Inexperienced examiners, in particular, can benefit from the use of structured documentation,
as relevant content and the naming of anatomical structures are indicated and the
recommended terminology is offered during the preparation of the report, thus serving
as a checklist for the examiner [52]
[60]
[61]. It is the responsibility of senior physicians to supervise the preparation and
quality of findings during specialty training. The report templates must correspond
to a systematic standardized US examination of the respective examination type (e. g.,
abdominal, echocardiography, joint, obstetric, endoscopic, etc.). Some manufacturers
have initiated the incorporation of report templates in the US equipment. US report
templates are also provided by several Radiology Information Systems (RIS).
For particular examination types, “Imaging Reporting and Data Systems”, with the goal
of standardizing malignancy risk stratification criteria for reliable US assessment
and reducing interpretation variability, e. g. Breast Imaging Reporting and Data System,
BI-RADS [53], Thyroid Imaging Reporting and Data System, TI-RADS [55], or Liver Imaging Reporting and Data System, LI-RADS [56]
[57]
[58] may be used as key elements of structured US reporting [53].
Future perspectives are in a line with Artificial Intelligence (AI) developments,
where trained software would help to increase scanning time in lieu of time spent
reporting. Successful AI implementation in standardized reporting requires a globally
uniform lexicon, although diversity of languages may contribute to delay of the implementation
of an AI solution in a US reporting routine. The methodology of developing weighted
criteria, e. g., “I-RAD” systems is the same as for deep machine learning computer
systems, which are trained for medical imaging artificial intelligence [62].
The US imaging spectrum is so large that recommendation of a single common “report
form” that covers all fields, is not possible. However, there are a number of mandatory
rules to follow ([Table 1]):
Table 1
Mandatory content of ultrasound examination reports.
|
1.
|
Institutional identification (name of hospital/practice/referring physician and investigator
identification)
|
|
2.
|
Patient identification (family name, first name, sex, birth date. Patientʼs address
may, in hospitals, be replaced by internal file number to relate patient data to medical
history and address data stored in central system: e. g. HIS)
|
|
3.
|
Date and time of US examination
|
|
4.
|
Relevant anamnestic and clinical information stating the indication for the examination
|
|
5.
|
Diagnostic question(s) to be solved by the US examination
|
|
6.
|
Scanning conditions and, if so, limitations of the examination, e. g., regions/organs
not seen
|
|
7.
|
Descriptions of US appearance of organs and pathologies
The report should describe image characteristics in grayscale or Doppler US using
standardized terminology, but not clinical diagnoses. It is advised to use text modules
for normal findings and frequent pathologies. The description should use these categories
for organs or structures: Position – Size – Shape – Contours – Echogenicity – Echo
Texture – Tubular Structures (vessels, ducts) – phase-specific enhancement pattern
with US contrast agent, relative stiffness with US elastography.
|
|
8.
|
Summary or interpretation including (suspected) diagnoses
Three parts are advised:
-
Answering the clinical question(s) raised
-
Listing other pathologic findings possibly in the order of their clinical relevance
(e. g., potential malignancies prior to simple cysts)
-
Closing remark about the remainder of the examined areas, excluding other abnormalities
in relation to possible limitations, e. g., due to unfavorable examination conditions
A cautious interpretation of images is advised to avoid potentially false conclusions.
Diagnostic statements should not predetermine the absolute diagnosis, e. g., “patient
has metastases”, but instead keep the relation to the method used: e. g., “typical
sonographic appearance of metastases”.
|
|
9.
|
Diagnostic and/or therapeutic consequences, possibly including suggestions for further
diagnostic workup or follow-up
Imperative instructions for further patient management within the examination report
derived from US findings may cause medicolegal problems if a recommended action is
not implemented by the clinically responsible physician. Therefore, considerations
regarding further medical management should be formulated as suggestions rather than
recommendations (e. g., not “surgery is necessary” but instead “surgery is worth considering”).
|
The text volume of a US report may range from summary notes in the patient’s file,
e. g., focused thoracic US: “No pleural effusion found on right side”, to very extensive
versions with recording of all cine-loops to be archived together with a detailed
report, with all nine categories, e. g., in second-trimester obstetric US screening,
the summary may be three to five pages long.
Position Statement 8: Structured ultrasound reporting and the use of templates and
text modules is recommended (17/0/0).
Communication of Medical US Findings
Selected relevant image material should be demonstrated, explained, and discussed
with the responsible clinician(s) as is the practice with all other imaging modalities.
This may happen via an individual personal exchange between the examiner and referring
clinician or in multi-disciplinary clinico-radiological meetings. To influence immediate
clinical management, in cases of high clinical urgency, a verbal report highlighting
the salient findings should be given directly to the responsible clinician prior to
issuing a formal report or even better by the presence and involvement of the responsible
clinician during the examination of the patient.
The complete digitally stored medical US image material and the report should be available
for all clinicians involved in patient care. Depending on national regulations, the
patient and other medical personnel may also have access to the images and the associated
report of the US examination.
Position Statement 9: The digitally stored and reported medical ultrasound data should
be available for all involved parties in the patient’s care and should be communicated
in a timely manner (17/0/0).
9. Medical Ultrasound Data Management and Archiving
9. Medical Ultrasound Data Management and Archiving
DICOM (Digital Imaging and Communication in Medicine) has been established as a non-proprietary
standard for the storage, communication and management of medical imaging information
and related data [63]
[64]. It is implemented in all modern medical US systems and, therefore, should be used
for digital documentation and archiving of medical US imaging. PACS (Picture Archiving
and Communication System) is the software solution that enable storages and reproduction
of any kind of medical DICOM imaging material and digital reports, which should be
used to archive and manage medical imaging data. Thus, US images and cine-loops are
available on an equal par with image files from other imaging modalities, allowing
demonstration in multidisciplinary meetings, direct comparison with findings from
cross-sectional imaging, follow-up imaging, the application of image-fusion techniques,
and the partial replacement of imaging involving radiation exposure. However, PACS
use and implementation may be variable among countries for a number of different reasons
[65].
Reluctance to archive US images digitally in an attempt to avoid the significant computer
server-based expenses is not acceptable, as the cost of memory modules has reduced
substantially. US practitioners from specialties other than radiology should seek
advice from their local information technology units and specialists, in order to
implement DICOM storage and PACS archiving in the hospital and outpatient setting
as well as in private clinic settings. All US scanners should be connected to PACS,
and patients preferably can be selected from a “worklist” to avoid basic data errors
[66].
Position Statement 10: Digital image archiving of ultrasound examinations is mandatory.
In institutions use of the standard PACS is recommended (17/0/0).
10. Quality Considerations
10. Quality Considerations
Patients and referring physicians should expect to receive the best achievable quality
of medical US. As providers of medical US, the objective is to achieve a diagnostic
reliability level comparable to the level published in guidelines and other high-quality
review publications. Quality assurance reviews and maintenance of US equipment should
meet the accepted original manufacturer standards.
In comparison to other imaging modalities, US is more operator-dependent. This is
often perceived as a failure to examine the relevant area with the transducer or as
being the result of the region being obscured, e. g., by gas or bone. US examinations
can be as informative as other imaging modalities or even better and may even have
the advantage of superior spatial resolution, real-time live presentation, and the
ability to readily repeat the examination. It is vital that the target organ/region
is stored as an image or video file, because without this, there can be no re-evaluation
by a second expert. Every US practitioner must strive to achieve a level of imaging
reliability similar to other imaging modalities. An attempt should be made with US
to obtain images of all aspects of the target region/organ, to ensure that the examination
is reliable with respect to identifying or dismissing abnormalities. Where a full
examination is not possible, a thorough description of the regions/organs/aspects
that were not clearly imaged or where there was limited diagnostic quality should
be stated and the report should be written in a way that makes the limitations of
the examination clear. This applies not only to items 6. Scanning conditions and 7.
Descriptions of US appearance of organs and pathologies ([Table 1]), but also in particular to item 8. Conclusion part c). The value of a summarizing
statement regarding the other examined organs and regions without pathologies and
therefore not mentioned in parts a) and b) of the conclusion (e. g., “The remainder
of the ultrasound examination demonstrated no findings of clinical significance”)
must be put into perspective by an indication of any patient-specific or methodological
limitations of the examination of these organs and regions.
US diagnoses in parts a) and b) of the reportʼs conclusion should be formulated as
precisely and definitively as possible, but in a patient-specific manner, with relevant
differential diagnoses taken into account. To minimize loss of examiner reputation,
even the most typical sonographic appearance should only be referred to as such: e. g.,
“typical sonographic aspect like liver metastases”, not just “liver metastases”.
In order to be able to obtain pooled statistical data for quality assurance of a medical
institution and its qualified US practitioners (sensitivity, specificity, positive/negative
predictive value, and overall accuracy of US diagnoses), it is necessary to classify
the final diagnosis correctly according to the International Classification of Diseases
(ICD). Currently, there are a number of medical diagnostic procedures with mandatory
national quality databases, e. g., endoscopic US, and US departments can benchmark
against these national standards. It is recommended to perform quality assurance as
a regular activity in order to confirm the practice quality and be compared to other
institutions.
Position Statement 11: Regular critical review of medical ultrasound reports is recommended
(16/0/1).
11. Conclusion and Future Perspectives
11. Conclusion and Future Perspectives
The practice of medical US still varies considerably in the areas of procedure, image
storing, and reporting. Most practices will have some areas where they could improve.
In this manuscript we have described the areas that the EFSUMB considers to be an
optimum standard for all US practitioners to attain. Practitioners should also be
aware of existing guidelines and position papers, to continually assess and improve
their US practice.
The ability to store and share US images and videos in a standardized digital database,
co-joined with a report from the operator, is crucial to improve the applicability
and clinical yield of this modality, in terms of economic value, quality, and educational
value. Adhering to these standards makes the US examination a more reliable, reproducible,
and standardized imaging modality in line with other cross-sectional imaging methods.
With large datasets becoming available, US may benefit in the near future from deep
learning artificial intelligence solutions that could help to improve implementation
of unified standards and quality, thereby helping US practitioners to scan and report
readily, precisely, and accurately [62].
With a standardized approach, there are also better opportunities for appropriate
reimbursement and the timing of equipment update or renewal.
