|
The IAC Standards
and Guidelines |
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Testing Standards |
3.1B Peripheral
arterial testing must be performed for appropriate clinical indications.
3.1.1B The
indication for testing must be documented prior to performing the examination.
(See Guidelines below for further recommendations.)
3.2B Equipment
must provide accurate data.
3.2.1B Imaging
Equipment – Duplex ultrasound with color flow Doppler, if used for
testing, must be provided with:
3.2.1.1B imaging
frequencies appropriate for the structures evaluated;
3.2.1.2B Doppler
frequencies appropriate for the vessels evaluated;
3.2.1.3B range-gated
spectral Doppler with the ability to adjust the depth and position of the range
gate within the area of interest;
3.2.1.4B a
Doppler angle which is measurable and adjustable;
3.2.1.5B a
visual display and a permanent recording of the image; and
3.2.1.6B a
visual display, an audible output, and a permanent recording of the Doppler
waveform and corresponding image which includes the Doppler angle.
3.2.2B Continuous
wave (CW) and pulsed wave (PW) Doppler (if used for testing) must be provided
with:
3.2.2.1B a
direction sensitive Doppler blood flow meter;
3.2.2.2B Doppler
transducer frequencies appropriate for the vessels evaluated, which must be at
least 3 MHz or greater;
3.2.2.3B Doppler
waveform display demonstrating bidirectional flow; and
3.2.2.4B an
audible output and a permanent recording of the waveform.
3.2.3B Segmental
limb plethysmography, if used for testing, must be provided with:
3.2.3.1B equipment
capable of measuring small segmental volume changes and providing permanent
recordings; and
3.2.3.2B cuffs
of varying sizes appropriate to the technique and the limb segment to be
evaluated.
3.2.4.1B Photoplethysmography
(PPG), if used for testing, must be provided with:
i. appropriate
electrical coupling for signal display;
ii. capability
of providing a permanent recording of the waveform.
3.2.4.2B Limb
air plethysmography (pulse volume recording-PVR ), if used for testing, must be
provided with:
i. appropriately
sized pneumatic cuffs;
ii. capability
of being calibrated before each examination;
iii. capability
of measuring small limb volume changes;
iv. capability
of providing a permanent recording of the data.
3.2.4.3B Treadmill
exercise/stress testing, if used for testing, must be provided with:
i. motor-driven
treadmill capable of providing constant speed and inclination.
Comment: Other forms of standardized exercise may be utilized as defined by the
facility protocol.
Comment: If additional examinations are
performed and additional testing equipment is utilized and is not listed here,
a written protocol, diagnostic criteria and quality improvement methods must be
in place and available for review upon request.
3.2.5B Equipment
Quality Control
3.2.5.1B Equipment
used for diagnostic testing must be maintained in good operating condition.
3.2.5.2B Equipment
maintenance must include, but is not necessarily limited to:
i. recording
of the method and frequency of maintenance of all imaging equipment and
non-imaging equipment;
ii. establishment
of and adherence to a policy regarding routine safety inspections and testing
of all facility electrical equipment;
iii. establishment
of and adherence to an equipment cleaning schedule that includes routine
cleaning of equipment parts, including filters and transducers, according to
specifications of the manufacturer.
(See Guidelines below for further recommendations.)
3.3B Each
examination performed in the facility must have a written protocol. The
protocol must include:
3.3.1B the
equipment to be used for each examination;
3.3.2B the elements of proper technique (also see STANDARD – Techniques);
3.3.3B anatomic
extent that constitutes a complete examination includes evaluation of the
entire course of the accessible portion of each vessel:
3.3.3.1B bilateral
testing is considered a complete examination.
3.3.3.2B variations
in technique following vascular intervention;
3.3.3.3B variations
in technique and documentation for recurring limited examinations must be
described.
3.3.4B the
performance of an ankle brachial index (ABI);
3.3.5B the
acquisition of waveforms (either CW, PW or PVR) from at least three levels;
3.3.6B the
measurement of systolic blood pressure at more than one level if indicated;
3.3.7B documentation
that must be acquired for normal examinations and the additional documentation
that must be acquired to describe abnormalities, if present (also see STANDARD – Documentation); and
3.3.8B a
description of how color Doppler or other flow imaging modes (e.g., power
Doppler) are used to supplement grayscale imaging, spectral Doppler and
velocity measurements.
(See
Guidelines below for further recommendations.)
3.4B Appropriate techniques
must be used for the evaluation of the peripheral arterial system to assess for
the presence of any abnormalities and to document their severity, location,
extent and whenever possible etiology.
3.4.1B
Examinations must include:
3.4.1.1B
Performance of an ABI.
i.
Measurement of upper extremity (brachial artery) systolic pressures must be
obtained from both arms and the higher of the two pressures used to calculate
the ABI.
ii.
Measurement of ankle systolic pressures must be obtained bilaterally from the
distal posterior tibial (PT) artery and distal anterior tibial (AT)/dorsalis
pedis (DP) artery and the higher of the two pressures on each side used to
calculate the ABI.
3.4.1.2B
Additional information regarding the presence of disease may be obtained by
recording toe waveforms and toe systolic pressures, particularly in cases when
the ABI may be non-diagnostic.
3.4.2B
Elements of proper technique include, but are not limited to:
3.4.2.1B
performance of an examination according to the facility specific, written
protocol;
3.4.2.2B
proper patient positioning;
3.4.2.4B
appropriate equipment and transducer selection;
3.4.2.5B
appropriate transducer positioning;
3.4.2.6B
proper sample volume size and positioning;
3.4.2.7B
optimization of equipment gain and display settings;
3.4.2.8B
a spectral Doppler angle of 60 degrees or less with respect to the vessel wall and/or
direction of blood flow when measuring velocities;
3.4.2.9B
proper measurement of spectral velocities as required by the protocol;
3.4.2.10B
identification of vessels by imaging and Doppler.
3.5B
Each examination performed in the facility must provide documentation as
required by the protocol that is sufficient to allow proper interpretation,
including but not limited to:
3.5.1B
Ankle brachial index (ABI):
3.5.1.1B
Duplex ultrasound used to evaluate arteries and/or bypass grafts must include
measurement and documentation of the ankle brachial indices that is generally
performed at the time of the examination. Previous ABI measurements may only be
used if:
i. the ABI
is performed within two weeks prior to the duplex examination;
ii. was performed in
the same facility;
iii. there has been no
change in the patient’s symptoms;
iv. the results and
date of the previous ABI must be included in the final report.
3.5.1.2B
CW Doppler or PW Doppler or PVR waveforms.
3.5.6B
other images if used and waveforms as required by the protocol;
3.5.7B
other measurements as required by the protocol.
3.6B
Abnormalities will require additional images and waveforms that demonstrate the
severity, location, extent and whenever possible etiology of the abnormality
present.
3.6.1B
Areas of suspected stenosis or obstruction must include representative Doppler
waveforms and velocity measurements recorded at and distal to the stenosis or
obstruction.
3.7B Peripheral
Arterial Documentation
3.7.1B
Duplex ultrasound of lower extremity arteries (if performed) must include:
3.7.1.1B
Long axis grayscale images
and/or color Doppler images must be documented as required by the
protocol and must include at a minimum:
i.
common femoral artery;
ii.
superficial femoral artery;
iii.
proximal deep femoral artery;
iv.
popliteal artery;
v.
aorta, common and external iliac arteries and tibial arteries (when
appropriate);
vi.
bypass graft(s) when present including anastomoses.
3.7.1.2B
Stent(s) when present,
including proximal and distal ends.
3.7.1.3B
Spectral Doppler waveforms
and velocity measurements must be documented as required by the protocol
and must include at a minimum:
i.
common femoral artery;
ii.
superficial femoral artery;
iii.
proximal deep femoral artery;
iv.
popliteal artery;
v.
tibial arteries;
vi.
aorta, common and external iliac arteries (when appropriate);
vii.
bypass graft when present, including proximal and distal anastomoses, inflow
and outflow arteries.
viii. stent(s) when present.
· native artery at the proximal end of
the stent;
· proximal stent;
· mid stent;
· distal stent;
· native artery at the distal end of the
stent.
3.7.1.4B
Abnormalities require additional images, waveforms and velocity measurements.
3.7.2B
Duplex ultrasound of upper extremity arteries (if performed) must include:
3.7.2.1B
Long axis grayscale images and/or color Doppler images must be documented as
required by the protocol and must include at a minimum:
i.
subclavian artery;
ii.
axillary artery;
iii.
brachial artery;
iv.
innominate and forearm arteries (when appropriate);
v.
bypass graft(s) when present including anastomoses;
vi
stent(s) when
present, including proximal and distal ends.
3.7.2.2B
Spectral Doppler waveforms and velocity measurements must be documented as
required by the protocol and must include at a minimum:
i.
subclavian artery;
ii.
axillary artery;
iii.
brachial artery;
iv.
radial and ulnar arteries;
v.
innominate artery (when appropriate);
vi.
bypass graft when present, including proximal and distal anastomoses, inflow
and outflow arteries.
viii. stent(s) when present must
include:
· native artery at the proximal end of
the stent;
· proximal stent;
· mid stent;
· distal stent;
· native artery at the distal end of the
stent.
3.7.2.3B
Abnormalities require additional images, waveforms and velocity measurements.
Comment: Long stents (e.g.,
femoral-to-popliteal covered stent graft) may require multiple mid stent images
to localize stenosis when present.
Comment: Limitation of the study
must be documented in the report.
3.8B
Non-imaging (physiologic) examinations (if performed) must include bilateral
sampling from three or more levels. Only one type of waveform is required (CW
Doppler or PW Doppler or PVR).
3.8.1B
Doppler waveforms (either CW or PW) must be documented as required by the
protocol and must include at a minimum:
3.8.1.1B
common femoral artery;
3.8.1.3B
distal tibial arteries at the level of the ankle.
3.8.2B
Plethysmographic waveforms must be documented from:
3.8.2.4B
toe waveforms (if indicated);
3.8.2.5B
toe systolic pressures (if indicated).
3.9B
Supplemental testing (if performed) may include:
Comment: Supplemental testing techniques
are inadequate for use alone to diagnose and grade the severity of peripheral
arterial disease.
3.9.1B
Photoplethysmography (if performed) must be documented as required by the
protocol and must include at a minimum:
3.9.1.1B
documentation of the digital waveforms.
3.9.2B
Treadmill exercise/stress testing, if performed, must be documented as required
by the protocol and must include at a minimum:
3.9.2.1B
pressures obtained at rest;
3.9.2.2B
pressures obtained at timed intervals immediately after exercise;
3.9.2.3B
for treadmill-based protocols, the time of onset of claudication and maximal
walking time.
3.9.3B
Abdominal aorta examinations (if performed) must be documented as required by
the protocol and must include at a minimum:
Comment: The facility can include
abdominal aorta examinations as part of the peripheral arterial application
only if the facility performs other peripheral arterial examinations. If the
facility does not perform any other peripheral arterial examinations, abdominal
aorta examinations can be included in the visceral vascular testing
section.
3.9.3.1B
Transverse view (defined as perpendicular to the long axis of the aorta)
grayscale images with the single widest outer wall to outer wall diameter
measurement must be documented as required by the protocol and must include at
a minimum:
i.
proximal aorta;
ii.
mid aorta;
iii.
distal aorta;
iv.
common iliac arteries at the bifurcation.
3.9.3.2B
Long axis grayscale images must be documented as required by the protocol and
must include at a minimum:
i.
proximal aorta;
ii.
mid aorta;
iii.
distal aorta;
iv.
documentation of aneurysms (if present) must include the widest size of the
aorta measured outer wall to outer wall;
v.
additional images proximal and distal to the aneurysm.
3.9.3.3B
Spectral Doppler waveforms and velocity measurements must be documented as
required by the protocol and must include at a minimum:
i.
aorta at/or proximal to the renal artery origins;
ii.
mid aorta;
iii.
distal aorta;
iv.
right common iliac artery;
v.
left common iliac artery.
(See Guidelines below for further recommendations.)
3.9.3.4B
Abnormalities require additional images, waveforms and velocity measurements.
3.9.4B Arteriovenous fistula
(AVF)/dialysis access grafts, if performed, must be documented as
required by the protocol and must include at a minimum:
3.9.4.1B A description of
the type of fistula or graft.
3.9.4.2B Long axis
grayscale and/or color Doppler images must be documented as required by the
protocol and must include at a minimum:
i. inflow artery
proximal to graft or fistula;
ii. anastomotic
site(s);
iii. outflow vein;
iv. axillary and
subclavian veins (when appropriate).
3.9.4.3B Spectral Doppler
waveforms and velocity measurements must be documented as required by the
protocol and must include at a minimum:
i. inflow artery;
ii. proximal and
distal anastomoses (graft);
iii. anastomosis site
(fistula);
iv. outflow vein
beyond anastomosis.
3.9.4.4B Blood flow volume
must be documented from at least one site.
3.9.4.5B If evaluation
includes provocative maneuvers for steal phenomenon, digital image
documentation of findings with and without maneuvers.
Comment:
Spectral Doppler imaging of the ipsilateral axillary and subclavian veins
should be obtained to document proximal patency.
3.9.4.6B Abnormalities
require additional images, waveforms and velocity measurements.
3.10B Records must be maintained that permit
evaluation of annual procedure volumes. These records must include:
3.10.1B indication for the
examination;
3.10.2B technologist
performing the examination;
3.10.3B examination(s)
performed;
3.10.5B physician
interpreting the examination.
(See
Guidelines below for further recommendations.)
3.1B
When available, appropriateness criteria published by medical professional
organizations should be utilized.
Comment: An accepted indication is generally written by the referring health
care provider. In some instances it can only be assessed at the time of the
examination.
3.2.5.2B
The cleaning schedule for each
system will depend on the degree of use and should be frequent enough to allow
for accurate collection of data.
3.3B
The protocol should include the indications for a limited examination and the
descriptions of the limited examination. Separate limited examination protocols
may also be written.
3.9.3.3B
Color Doppler images may supplement grayscale imaging but does not substitute
for it.
3.10B
The annual procedure volume should be sufficient to maintain proficiency in
exam techniques and interpretation.
•
In general, a facility should perform a minimum of 100 complete examinations
annually.