|
The IAC Standards
and Guidelines |
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Testing Standards |
3.1A Provisions
must exist for the generation and retention of examination records of all
studies performed.
3.1.1A Essential
portions of all examinations must be documented on media appropriate for
long-term storage.
Comment: Final submission of representative case studies to the IAC must be in
a digital format (e.g., CD, DVD or flash drive; no videotape recordings will be
accepted).
3.1.2A A
complete, accurate and signed final report must be generated as outlined in STANDARD: Examination Interpretation and
Reports, as part of the record of examination.
3.1.3A All
records of the examination, including a signed dated final report must be
retained in accordance with applicable state or federal guidelines for medical
records, generally five to seven years for adult patients.
3.2A Noninvasive
vascular examinations are interpreted and reported by the Medical Director or a
member of the medical staff of the vascular testing facility.
Comment: The report represents the final interpretation of the noninvasive
vascular examination and is part of the patient’s legal medical record.
As such, the report must be in the form of a document that is retrievable
and/or reproducible for review by health care personnel. In general, the report
must contain
3.2.1A All
reporting must be standardized.
3.2.2A All
physicians interpreting noninvasive vascular examinations in the facility must
agree on and utilize uniform diagnostic criteria and a standardized report
format.
3.2.3A Interpretation
must include review of all examination data including measurements, images and
recordings by the Medical Director or a member of the medical staff.
3.2.4A The
report must accurately reflect the content and results of the examination.
3.2.5A The
final report must be verified and signed by the Medical Director or a member of
the medical staff of the facility.
3.2.6A The
final report must be typed and must include but is not limited to:
3.2.6.1A patient identification;
3.2.6.2A date
of the examination;
3.2.6.3A appropriate clinical indications leading to the
performance of the examination;
3.2.6.4A an
adequate description of the examination performed and must include the name of
the examination and its integral parts;
3.2.6.5A description
of pertinent positive and negative findings, including veocity measurements;
3.2.6.6A if
disease is present it must be characterized according to its location, extent,
severity and etiology whenever possible;
3.2.6.8A reasons
for a technically limited, suboptimal or incomplete examination;
3.2.6.9A summary
(impression/conclusion) of the examination findings;
3.2.6.10A comparison
with previous related studies when available;
3.2.6.11A interpreting
physician typed name and signature and/or electronic verification;
3.2.6.12A date
of interpreting physician signature or verification.
(See Guidelines below for further recommendations.)
3.2.7A The
interpretation by the Medical Director or a member of the medical staff must be
available within two working days of the examination.
Comment: An interpretation can be in the form of paper, digital storage or
voice system. The final verified signed report must be available in a timely
fashion, generally within four business days.
3.2.8A Identification
of the technologist performing the examination must appear as part of the
permanent record.
3.2.9A If
preliminary findings are provided, the preliminary nature must be clearly
indicated.
3.2.9.1A A
policy for communication of any significant changes must be defined for those
situations in which the final interpretation differs substantially from the
preliminary findings.
3.2.10A A
policy must be defined whereby the results of the examination that demonstrate
urgent or life threatening findings are communicated to the appropriate health
care professionals in a timely fashion.
3.3A Interpretation
using the documented findings and the diagnostic criteria must be performed by
the Medical Director or a member of the medical staff to indicate the absence
or presence of abnormalities in the sites and vessels that were examined.
3.3.1A Disease,
if present, must be characterized according to:
3.3.1.4A etiology
whenever possible.
Comment: For the requirements of
interpretation/final report, refer to STANDARD – Examination
Interpretation and Reports.
3.4A Each
examination performed in the facility must have a single set of written,
validated diagnostic criteria to interpret the presence of disease and to
document its severity, location, extent and whenever possible etiology.
3.4.1A Diagnostic
criteria must be based on published reports or internally generated and
internally validated as outlined in Part C: Quality
Improvement.
3.5A Extracranial
Cerebrovascular
3.5.1A For
each extracranial cerebrovascular examination performed there must be
diagnostic criteria for the interpretation of:
i. Plaque
morphology, when reported.
3.5.1.2A spectral
Doppler waveforms;
3.5.1.3A spectral
Doppler velocities;
3.5.1.4A color
Doppler images;
3.5.1.5A stent(s) (when present).
3.5.2A There must
be diagnostic criteria for the interpretation of:
3.5.2.1A Internal
Carotid Artery (ICA) Stenosis/Disease – These criteria must state how
velocity measurements, spectral Doppler waveform analysis and imaging are used
to document the severity, location, extent and whenever possible etiology.
i. When interpreted, there must
be diagnostic criteria for the interpretation of:
§ Common Carotid
Artery (CCA) and External Carotid Artery (ECA), vertebral artery and subclavian
disease – These criteria must state how velocity measurements, spectral
Doppler waveform analysis and imaging are used to document the severity,
location, extent and whenever possible etiology.
(See Guidelines below for
further recommendations.)
3.6A Intracranial
Cerebrovascular
3.6.1A For
each intracranial cerebrovascular examination performed, there must be
diagnostic criteria for the interpretation of:
3.6.1.1A grayscale
images (if used);
3.6.1.2A spectral
Doppler waveforms;
3.6.1.3A spectral
Doppler velocities;
3.6.1.4A color
Doppler images (if used).
3.7A Peripheral
Arterial Report Components
3.7.1A For
each peripheral arterial examination (if performed), there must be diagnostic
criteria for the interpretation of:
3.7.1.2A spectral
Doppler waveforms;
3.7.1.3A spectral
Doppler velocities;
3.7.1.4A color
Doppler images (if used);
3.7.1.5A stent(s) (when present).
3.7.2A For
each of the following peripheral arterial non-imaging examinations (if
performed), there must be diagnostic criteria for the interpretation of:
3.7.2.1A ankle
brachial index (ABI);
3.7.2.2A segmental
limb pressures (if used);
3.7.2.3A continuous
wave and/or pulsed wave Doppler waveforms;
3.7.2.4A air
plethysmographic waveforms (PVR);
3.7.2.5A supplemental
testing:
i. photoplethysmography
signal amplitude and waveform;
ii. treadmill
exercise/stress testing;
iii. abdominal
aorta examination for aneurysm and/or stenosis.
3.8.1A For
each peripheral venous examination performed there must be diagnostic criteria
for the interpretation of:
3.8.1.2A spectral
Doppler waveforms;
3.8.1.3A color
Doppler images.
3.8.2A There
must be diagnostic criteria for interpretation of:
3.8.2.1A thrombosis
and thrombus aging;
3.8.2.4A venous reflux in seconds/time;
3.8.2.5A arteriovenous
fistula (AVF) or dialysis access grafts.
3.9.1A For
each visceral vascular examination performed there must be vessel specific
diagnostic criteria for the interpretation of:
3.9.1.2A plaque
morphology (when reported);
3.9.1.3A spectral
Doppler waveforms;
3.9.1.4A spectral
Doppler velocities (when required by the protocol);
3.9.1.5A color
Doppler images (if used).
3.9.1.6A stent(s) (when present).
3.10.1A For
each screening examination performed there must be diagnostic criteria for the
interpretation of:
3.10.1.2A spectral
Doppler waveforms;
3.10.1.3A spectral
Doppler velocities;
3.10.1.4A color
Doppler images (if used).
3.10.2A Each
screening examination must have specific reporting criteria.
3.10.2.1A Extracranial
cerebrovascular screening:
i.
absence of disease, normal;
ii.
presence of disease with no overall significance;
iii.
presence of disease with overall significance;
iv.
occlusion
3.10.2.2A Carotid
intima-media thickness screening (CIMT):
i.
age, gender and race associated risk according to a standardized table of CIMT
measurements should be used to generate a cardiovascular risk assessment
report;
ii.
plaque characteristics and dimensions should be reported separately;
iii.
the report should include standard deviations or prediction ranges for the
measurements based on age and gender. Specific measurement values (i.e., mean,
maximum, mean maximum) used for the risk prediction report should be the same
as those used in the study(s) providing the basis for the risk prediction
reporting.
3.10.2.3A Peripheral
arterial screening:
i.
absence of disease;
ii.
presence of disease;
iii.
non-diagnostic ABI.
3.10.2.4A Abdominal
aorta aneurysm screening:
i.
absence of aneurysmal disease;
ii.
presence of aneurysmal disease;
iii.
aneurysmal status not defined due to non-visualization.
3.2.6A
The final interpretation should address the clinical indications for the
examination.
3.2.6.10A
Comment: The use of a signature stamp is strongly discouraged. The use of the signature
stamp provides the potential for inappropriate use by personnel other than the
physician whose signature appears on the stamp.