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European Journal of Radiology 80 (2011) 519–525

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European Journal of Radiology


journal homepage: www.elsevier.com/locate/ejrad

Quality assurance in diagnostic ultrasound


Outi Sipilä a,∗ , Vilma Mannila a,b,1 , Eija Vartiainen c,2
a
HUS Helsinki Medical Imaging Center, Helsinki University Central Hospital, P.O. Box 340, 00029 HUS, Finland
b
Department of Physics, University of Helsinki, P.O. Box 64, 00014 Helsinki University, Finland
c
HUS Helsinki Medical Imaging Center, Helsinki University Central Hospital, P.O. Box 750, 00029 HUS, Finland

a r t i c l e i n f o a b s t r a c t

Article history: Objective: To setup a practical ultrasound quality assurance protocol in a large radiological center, results
Received 1 July 2010 from transducer tests, phantom measurements and visual checks for physical faults were compared.
Received in revised form 30 October 2010 Materials and methods: Altogether 151 transducers from 54 ultrasound scanners, from seven different
Accepted 9 November 2010
manufacturers, were tested with a Sonora FirstCall aPerioTM system (Sonora Medical Systems, Inc., Long-
mont, CO, USA) to detect non-functional elements. Phantom measurements using a CIRS General Purpose
Keywords:
Phantom Model 040 (CIRS Tissue Simulation and Phantom Technology, VA, USA) were available for 135
Ultrasound
transducers. The transducers and scanners were also checked visually for physical faults. The percentages
QA/QC
Technical aspects
of defective findings in these tests were computed.
Results: Defective results in the FirstCall tests were found in 17% of the 151 transducers, and in 16% of the
135 transducers. Defective image quality resulted with 15% of the transducers, and 25% of the transducers
had a physical flaw. In 16% of the scanners, a physical fault elsewhere than in the transducer was found.
Seven percent of the transducers had a concurrent defective result both in the FirstCall test and in the
phantom measurements, 8% in the FirstCall test and in the visual check, 4% in the phantom measurements
and in the visual check, and 2% in all three tests.
Conclusion: The tested methods produced partly complementary results and seemed all to be necessary.
Thus a quality assurance protocol is forced to be rather labored, and therefore the benefits and costs must
be closely followed.
© 2010 Elsevier Ireland Ltd. All rights reserved.

1. Introduction example, in the recent American College of Radiology (ACR) stan-


dard on monitoring the performance of real time US equipment [11]
The benefits from continuous ultrasound (US) image quality the choice for the methodology in performing QA and analyzing the
assurance (QA) are widely recognized [1–11]. However, in practice, results was partly left to the user. At the same time, the technical
systematic QA is often neglected. One obvious reason for that is the development of US equipment is fast and modern scanners have
lack of formal requirements for QA, as opposed to modalities using new imaging modes, e.g. harmonic and compound imaging, with
ionizing radiation. Ultrasound equipment is also relatively cheap, ever increasing choice of user parameters. Additionally, the base-
meaning that the man power needed for systematic maintenance line image quality parameters seem to be seldom available to the
including QA can quickly be relatively costly. Also, there are addi- customer when purchasing the equipment.
tional facts, which further increase the threshold to implement QA: Continuing performance assessment can include inspection
prudent use of diagnostic ultrasound has generally been considered of the physical condition and electrical safety of the US equip-
to be safe, e.g. [12], and there are many different professional groups ment, evaluating image quality and Doppler measurements with
utilizing it. Although the parameters for good image quality, e.g. a phantom and testing the functionality of the elements of the
contrast-to-noise ratio and resolution, are not different than in the transducers [1–11,13–16]. Also, the quality and proper adjustments
other modalities, there is no consensus of the methods to be utilized of the monitor should be verified [17]. International organizations
in measuring the parameters and the relative benefits of them. For have recommendations or standards for phantom measurements
to show adequate image or Doppler quality [1,2,13]. Often, the
analysis of the images has been performed visually with man-
ual measurements [1–5], but automatic image analysis has also
∗ Corresponding author. Tel.: +358 50 427 0807; fax: +358 9 471 75893.
been utilized [6–10]. The usefulness of phantom based measure-
E-mail addresses: outi.sipila@hus.fi (O. Sipilä), vilma.mannila@hus.fi
ments with modern US equipment has also been questioned [5,14].
(V. Mannila), eija.vartiainen@hus.fi (E. Vartiainen).
1
Tel.: +358 50 427 2561; fax. +358 9 471 71345. Recently, a transducer test checking the functional condition of
2
Tel.: +358 50 427 9600; fax. +358 9 471 71354. each element of the transducer has become available [14–16]. It

0720-048X/$ – see front matter © 2010 Elsevier Ireland Ltd. All rights reserved.
doi:10.1016/j.ejrad.2010.11.015
520 O. Sipilä et al. / European Journal of Radiology 80 (2011) 519–525

has been shown that when performing Doppler two consecutive 135 transducers (89%) were also measured with the phantom. The
dead elements in the active aperture can have an impact on the tissue mimicking material of the phantom simulated the acous-
velocity results [15]. In a recent study utilizing transducer tests, tical properties of the human tissue, and the speed of the sound
nearly 40% of 676 transducers used daily in clinical departments in the phantom was 1540 ± 6 m/s. The attenuation coefficient was
was found to be defective [16]. 0.5 dB/(cm MHz) in this study.
Our imaging center has been expanded rapidly during the last Before the phantom measurements, the quality of the monitor
years, now including 19 imaging units performing about 110 000 was checked utilizing the test image in the scanner, if available, and
radiological US exams every year in a totally digital environ- a Pehamed CD/Lux light intensity measuring device (PEHA med.
ment. Some of the imaging units are concentrating on the basic Geräte GmbH, Germany).
healthcare, some are a part of a central or a university hospital. The phantom measurement protocol included measurements of
The working methods and culture differ. Maintenance of the US the homogeneity, penetration depth, beam profile, near field, axial
equipment has often been minimal. A common protocol for QA is and lateral resolution, vertical and horizontal calliper accuracy, and
necessary for ensuring optimal image quality for different types of size of anechoic and high scatter masses [19]. Also, the symmetry
exams and to gain synergy benefits in managing the vast amount of the reverberations and the noise pattern of a clean transducer
of equipment cost-effectively. The purpose of this work, as a part imaging the air was checked (the air image). This did not require a
of a larger project in setting up US QA, was to compare the results phantom, but was performed during the phantom measurements.
of visual checks for physical faults, phantom measurements and Due to the variety of the equipment, exactly the same imaging
transducer tests in order to form a practical QA protocol in a large parameter settings in the measurements were not always possible.
radiological imaging center. The main principle in selecting the parameters was to include min-
imum processing of the signal. The following choices were made
for the parameters: Output power was set to the maximum level,
2. Materials and methods
time-gain-compensation (TGC) to achieve uniform signal across the
field of view, and dynamic range to 60 dB. A linear gray map was
2.1. Transducer tests
selected. Individual gain settings were allowed to obtain the best
possible visibility for each measurement. Rejection, edge enhance-
Altogether 151 transducers from 54 US scanners (28 models),
ment, filtering and frame averaging were set to the lowest level
from 7 different manufacturers, were measured with a Sonora First-
possible. Line density was selected as the highest possible. A sin-
Call aPerioTM system (Sonora Medical Systems, Inc., Longmont, CO,
gle focus at the same depth as the structure studied was utilized,
USA) [18]. The scanners were purchased in 1998–2009, with the
and the image depth was selected to allow the best field of view
median purchase year of 2004 (Table 1). At the time of purchase,
for the structure. Whenever possible, abdomen was selected as the
most of them were high-end scanners for radiological studies.
body part to be imaged. The more sophisticated features, e.g. sec-
The 151 transducers were 85% of the total amount of transducers
ond harmonic imaging and spatial/frequency compounding, were
in these scanners. The FirstCall system needed a specific adapter,
switched off. The two frequencies utilized in the measurements of
to which the transducer was connected during the test. Also, each
each transducer type are listed in Table 1, mainly being the mini-
transducer type had a specific definition file for the FirstCall system.
mum and the maximum frequency of the transducer. Besides the
The adapter for one scanner model was not available, except for
results, the TI, MI and frame rate values for every transducer and
one transducer attachable in an older type of transducer port. Also,
measurement were noted down, in order to verify the same user
the definition file was lacking for a few transducer types. For some
parameter settings in the future measurements. Also, an image
transducers, the definition file was not optimal, and the results
from each measurement was saved to PACS.
were unambiguous. The FirstCall system was rented from BBSMed-
Due to the lack of baseline parameters for the phantom mea-
ical AB (Sweden) for three days, including a person to operate the
surements, the defects in image quality were detected utilizing only
equipment.
the homogeneity measurement and the air image. In the homo-
The test system analyzed the sensitivity, pulse width, center
geneity measurements, the defects could usually be seen as clear
frequency and fractional bandwidth for each element of the trans-
vertical streaks or larger areas lacking signal near the transducer
ducer. Also, the accumulated capacitance of every element and its
surface when imaging homogeneous region of the phantom (Fig. 2).
wiring was displayed for almost every measurable transducer type.
The areas of signal drop were most clearly seen in a real-time image
The functionality of the elements of a transducer was catego-
when moving the transducer. In the air image, clear vertical streaks
rized as in Mårtensson et al. [16]: The sensitivity of a functionally
or asymmetry in the reverberation pattern were interpreted as
acceptable element was at least 75% of the mean sensitivity of the
defects (Fig. 3). The percentage of the transducers with defective
elements in the transducer. For a weak element, the correspond-
image quality was computed.
ing value was 10–75%. The sensitivity of a dead element was less
than 10% of the highest sensitivity value in the transducer. The
2.3. Visual checks for physical faults
transducer was considered defective, if there were more than four
consecutive weak elements, or at least two consecutive dead ele-
During the phantom measurements, the 51 scanners were also
ments, or at least three dead elements altogether. In Fig. 1, an
checked for possible flaws in casing, power cord, keyboard, knobs
example of the sensitivity and capacitance values for a defective
and connectors. The 135 transducers with both the FirstCall test and
transducer are shown. The percentage of defective transducers was
the phantom measurements were inspected to find changes in the
computed, as well as the percentage of transducers with unambigu-
lens, cable, cable jacket, casing and connector of the transducer. The
ous results.
percentages of defective scanners and transducers were computed.

2.2. Phantom measurements 2.4. Concurrent defects

Phantom measurements were carried out on 51 scanners during For the 135 transducers with results from the FirstCall test,
three months by the same physicist using a CIRS General Purpose phantom measurements and visual checks, it was analyzed how
Phantom Model 040 (CIRS Tissue Simulation and Phantom Technol- many of them had (1) a defective result in both the transducer
ogy, VA, USA) [19]. Of the 151 transducers with the FirstCall result, test and the phantom measurement, (2) a defective result in the
Table 1
Scanners and transducers measured with the Sonora FirstCall aPerioTM system and using a CIRS General Purpose Phantom Model 040. The numbers of specific models and transducers included in the study are listed as well as
the frequencies utilized in the phantom measurements. Also, the earliest and latest as well as the median purchase year of every scanner model are included.

Manufacturer Model Number of Purchase Median Transducer Number of Number of Frequencies in phantom measurements
models years purchase year model transducers transducers
with FirstCall with phantom

Aloka SSD-ALPHA 10 1 2007 2007 UST-5411 1 1 5.0 13.0


Premier
UST-5548 1 1 3.8 7.5
UST-9130 1 1 3.0 6.0
SSD-ALPHA 5 1 2004 2004 UST-5410 1 1 5.0 13.0
UST-5712 1 1 5.0 10.0
UST-9126 1 1 3.0 6.0
SSD-5500/SSD- 10 1998–2004 2001 UST-5545 7 7 5.0 10.0/13.0
5500SV/SSD5000
UST-5543 2 2 7.5 13.0
UST-5548 2 2 3.8 7.5
UST-5524 1 1 3.8 7.5
UST-5712 3 3 5.0 10.0
UST-5710 1 1 5.0 10.0
UST-9128 1 1 3.0 6.0
UST-9126 4 4 3.0 6.0
UST-9119 4 4 2.5 5.0
UST-9114 2 2 3.0 6.0
SSD-3500 1 2003 2003 UST-5546 1 1 5.0 10.0
UST-5710 1 1 5.0 10.0
SSD-500 1 2003 2003 UST-5512U 1 1 7.5
UST-934N 1 1 3.5

Esaote MyLab70 XVG 1 2009 2009 LA523 1 1 4.0 13.0


LA522 1 1 3.0 9.0
CA631 1 1 1.0 8.0
CA123 1 1 3.0 9.0

GE Logiq E9 1 2008 2008 S1-5 1 1 2.0 4.0


LOGIQ 9 14 2001–2007 2005 M12L 13 12 9.0 12.0
10L 4 4 7.0 8.0
i12L 3 2 9.0 10.0
4C 12 11 2.0 4.0
3.5C 4 4 2.5 4.0
8C 4 4 5.0 8.0
O. Sipilä et al. / European Journal of Radiology 80 (2011) 519–525

10S 1 0 – –
4S 2 1 2.0 4.0
LOGIQ 7 1 2004 2004 M12L 1 1 7.0 12.0
10L 1 1 7.0 8.0
3.5 C 1 1 2.0 4.0
LOGIQ S6 3 2006 2006 M12L 3 3 7.0 12.0
10L 3 3 6.0 8.0
4C 3 3 2.0 4.0
LOGIQ 5 Pro 1 2004 2004 10L 1 1 6.0 8.0
3.5C 1 1 2.0 4.0
Logiq 2 1999 1999 10L 1 1 7.0 9.0
500/LOGIQ 500
PRO
LA39 1 1 4.6 6.6
C364 1 1 3.0 4.0
C358 1 1 2.0 5.0
VOLUSONi 1 2006 2006 12L-RS 1 1 pena resa
(4–13 MHz) (4–13 MHz)
4C-RS 1 1 pena resa
(2–5 MHz) (2–5 MHz)
521
522
Table 1
(Continued)

Manufacturer Model Number of Purchase Median Transducer Number of Number of Frequencies in


models years purchase year model transducers transducers phantom
with FirstCall with phantom measurements

LOGIQBOOK 1 2002 2002 10Lb-RS 1 0 – –


3C-RS 1 0 – –

Philips/ATL iU22 2 2007 2007 L15-7io 1 1 gena resa


(7–15 MHz) (7–15 MHz)
C8-5 2 2 pena resa
(5–8 MHz) (5–8 MHz)
ATL HDI 3500 1 2000 2000 C8-5 1 0 – –
C9-5 1 0 – –
C4-2 1 0 – –
ATL HDI 5000 1 1998 1998 C8-5 1 0 – –
C7-4 1 0 – –
C5-2 1 0 – –
P3-2 1 0 – –

Siemens Acuson X300 1 2009 2009 VF13-5 1 1 7.3 11.4


P4-2 1 1 2.5 4.6
Sonoline G40 1 2005 2005 VF10-5 1 1 6.2 10.0
CH5-2 1 1 2.5 5.0
Acuson 1 2001 2001 15L8 1 1 8.0 14.0
SEQUOIA 512
8L5 1 1 5.0 8.0
10V4 1 1 5.0 10.0
8V5 1 0 – –

Sonosite Micromaxx 1 2006 2006 L38e 1 1 pena resa


(5–10 MHz) (5–10 MHz)
C60e 1 1 pena resa
(2–5 MHz) (2–5 MHz)

Toshiba Aplio XG 3 2008 2008 PLT-1204AX 1 1 7.2 14.0


PLT-1204BX 2 2 7.2 14.0
O. Sipilä et al. / European Journal of Radiology 80 (2011) 519–525

PLT-805AT 1 0 – –
PLT-704SBT 2 2 4.8 11.0
PVT-375BT 3 3 1.9 6.0
PVT-674BT 1 1 3.6 9.2
PVT-382BT 2 2 1.8 5.5
Aplio/Aplio 80 3 2002–2004 2003 PLT-1204AT 2 2 7.2 14.0
PLT-704AT 1 1 5.0 11.0
PLT-805AT 1 1 5.0 12.0
PVT-375BT 3 3 1.9 6.0
PST-37CT 2 2 2.5 5.5
PST-25AT 1 1 2.0 4.0
Nemio 20 1 2002 2002 PLM-805 AT 1 1 6.0 12.0
PVM-375 AT 1 1 3.0 6.0
a
In some transducers, the user can choose only between three frequency ranges: penetration, general and resolution. The total frequency ranges of these transducers, specified by the manufacturers, are given in parentheses.
O. Sipilä et al. / European Journal of Radiology 80 (2011) 519–525 523

Fig. 1. Sensitivity drops (upper image) and lower capacitance values (lower image) in elements 1–23 of a defective transducer are shown in a test result from the Sonora
FirstCall aPerioTM system. Also a sensitivity drop in the middle of the transducer is evident.

Fig. 2. (a) An example of signal drop in the left edge of an image (white arrow) from a CIRS General Purpose Phantom, Model 040, scanned with a defective linear transducer.
Note the gradual drop of intensities towards the left edge of the image, especially in the upper part of the field of view, when compared to the right edge of the image.
(b) Another example of imaging the phantom with a defective linear transducer. The two vertical streaks with signal drop in the homogenous region of the phantom are
indicated with white arrows. The bright spots in (a) and (b) and the small anechoic elliptic structure in the right edge of (a) are structures belonging to the phantom.

Fig. 3. (a) The air image with the same defective transducer as in Fig. 2a. Non-uniform reverberation pattern can be seen in the left upper corner of the image (white arrow).
(b) An example of vertical streaks in the reverberation pattern of a convex transducer in the air image (white arrows).
524 O. Sipilä et al. / European Journal of Radiology 80 (2011) 519–525

Table 2 statistical comparison. Also, the number of transducers by some


The percentage of transducers with defective results in the measurements using
manufacturers was small.
the Sonora FirstCall aPerioTM system (FirstCall), a CIRS General Purpose Phantom
Model 040 (Phantom) and visual assessment of physical condition of the transducer A major drawback in the FirstCall system was the lack of an
(Visual). Also, the percentages of transducers with concurrent defects using two of adapter or a correct definition file for some manufacturers’ newest
these measurements or all three are listed. All three measurements were available transducers. The classification of a transducer to be functional or
for 135 transducers. The FirstCall tests were available with a total number of 151 defective was based in Mårtensson et al. [16]. However, the num-
transducers.
ber of weak or dead elements required to have significant impact
Test type Number of transducers Defective result (%) on the quality of diagnostic ultrasound with different transducer
FirstCall 151 17 types and active apertures should be studied more closely, although
FirstCall 135 16 Weigang et al. [15] have shown as an example that two consec-
Phantom 135 15 utive dead elements in a linear array were enough to have an
Visual 135 25
effect on Doppler studies. Also, in our experience, an occasional
FirstCall + phantom 135 7
FirstCall + visual 135 8 dead element with a very low capacitance value in the test should
Phantom + visual 135 4 always be checked again: In 11 transducers out of 32 transducers,
FirstCall + phantom + visual 135 2 re-tested about one year later by the medical engineering center
of our hospital, occasional dead elements had disappeared. One
of the re-tested transducer had four occasional dead elements,
which disappeared in the second measurement, thus changing
transducer test and also a physical fault, (3) a defective result in
the classification of the transducer from defective to fully func-
the phantom measurements and also a physical fault, and (4) a
tional. One possible reason for the changes in the results could be
defective result in both the transducer test and the phantom mea-
occasional bad connections between the FirstCall adapter and the
surements and also a physical fault.
transducer.
The functionality of the transducer obviously has a crucial
3. Results impact on the image quality, and verifying it is an important step
in image QA. However, checking the transducer is not necessarily
In the transducer tests, 117 (78%) of the 151 transducers were enough to ensure the quality of the whole chain of image forma-
considered fully functional and 26 (17%) defective. For 8 transduc- tion. For example, three transducers utilized in the same scanner
ers (5%), the results were unambiguous. Out of the 135 transducers were found fully functional in the transducer test, but they all gave
with phantom measurements available, 21 (16%) had a defective similar defective results in the phantom measurements. This led to
result in the transducer test and 3 (2%) had an unambiguous result. the conclusion that the scanner itself had a fault, which was unno-
For the 135 transducers, defective image quality was detected ticeable with only the transducer tests. Although phantom based
in 20 (15%) during phantom measurements. QA has been claimed even to be a major step backward in US QA
A physical fault was found in 34 out of the 135 transducers (25%). [14], at the current there is no other validated method, at least to
In eight scanners out of 51 (16%), a fault elsewhere than in the the authors’ knowledge, for checking the image quality through the
transducer was found. whole imaging chain.
For the 135 transducers with the transducer test, phantom mea- In the phantom measurements, defective image quality was
surements and visual checks, the following concurrent defects were detected with 15% of the 135 transducers. A general purpose phan-
found: (1) transducers with a defect in the phantom measurements tom with manual analysis was utilized, since this is still the most
and a defect in the transducer test added up to 10 (7%). In three straight forward approach for US QA, with existing standards and
transducers (2%), a defect in the phantom measurements and an recommendations [1,2]. A weak point in utilizing phantom based
unambiguous result in the transducer test were detected. (2) A QA is the possible dependence of the results on the experience of
physical fault and a defect in the transducer test were discovered the user. Automatic estimation of the QA parameters could result in
in 11 transducers (8%). In one transducer (1%), a physical fault and more repeatable and less subjective analysis [6–10], although con-
an unambiguous result in the transducer test were found. (3) The sistent scanning of the images or a less practical transducer holder
number of transducers with both a physical fault and a defect in [9] would still be needed.
the phantom measurements was 5 (4%). (4) Three transducers (2%) In this study, only the homogeneity measurement and the air
had a physical fault and defective transducer test and phantom image were utilized. Most of the other results from the phantom
measurements. measurements would have required a baseline to compare the
The main results for the transducers are collected in Table 2. results with. The baseline parameters were not available from the
manufacturers, and we did not have several consecutive measure-
4. Discussion ments for all transducers nor a large set of transducers of the same
model for all the models. Comparing the results from transduc-
Different methods for technical QA in diagnostic US were com- ers for similar purposes (e.g. low-frequency convex transducers)
pared. Transducer tests, phantom measurements and visual checks but from different models or manufacturers was not an option,
for physical faults were performed for 51 US scanners in a large due to the differences in user selectable parameters in different
radiological imaging center. equipment.
Sixteen percent of the 135 transducers were found defective The comparison of the results from different tests indicated that
in the transducer tests. In Mårtensson et al. [16], 48% of 40 trans- none of these methods was adequate alone. There were defec-
ducers in radiological use were defective. The results cannot be tive phantom measurements with 20 transducers. For ten of these
compared with our results, since the age, the frequency of use and (50%), also the transducer test indicated a fault. For three trans-
the amount of mobile use of the scanners might differ. In Mårtens- ducers (15%), an unambiguous transducer test was found. Three
son et al. [16], statistically significant variations in the amount transducers (15%) were used with the same scanner and the scan-
of defective transducers between the manufacturers were found, ner itself was suspected to be faulty. With four transducers (20%),
when including all 676 transducers utilized in different clinics in the bad quality of the phantom image was left unanswered, at least
the comparison. In our study, the mean ages of the transducers by not relating directly to the classification criteria of the transduc-
different manufacturers varied considerably, not allowing unbiased ers in the FirstCall tests. On the other hand, when considering the
O. Sipilä et al. / European Journal of Radiology 80 (2011) 519–525 525

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