|
The IAC Standards
and Guidelines |
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Standards |
3.1A All
patient records must be confidentially maintained and be retained. They must be
accessible for the appropriate period of time as prescribed by state,
institution or other rules/regulations.
3.1.1A Any
retained hard copy images must be of high quality and reflect the findings
described in the final interpretation.
3.1.2A Technical
data that are not included as part of the final report (e.g., worksheets, calculations) must be
maintained as part of the facility records. The specific imaging and processing
parameters used should be retrievable for each clinical study.
3.1.3A Data from
non-imaging studies (e.g.,
thyroid uptake) must be maintained as part of the facility records, if not included in the final
report.
3.1.4A The
facility must be able to transmit current or archived patient studies to an
outside, non-affiliated entity in a format that is of interpretable quality.
(See Guidelines below for further recommendations.)
3.2A Examinations
must be interpreted and a final report provided by the Medical Director or
qualified members of the medical staff as defined in 1.1A and 1.3A.
3.2.1A All
dynamic studies (e.g., gated, flow, etc.) must be interpreted on a computer.
For SPECT studies, raw data images must be reviewed.
(See Guidelines below for further
recommendations.)
3.2.2A An
interpretation must be available within one working day of the examination. An
interpretation may be in the form of paper, digital storage or accessible voice
system.
3.2.3A Results
of examinations with critical findings must be communicated to the referring
physicians as quickly as clinically indicated. A record of the communication must
be maintained.
3.2.4A The final report must be reviewed, signed and dated
manually or electronically by the interpreting qualified member of the medical
staff. Stamped signatures
or signing by non-physician staff is unacceptable. In the unusual circumstance that
the interpreting physician is not available, another qualified member of the
medical staff may sign for them, if they choose to take such responsibility.
3.2.4.1A If the report is signed manually, the
date signed must also be manually recorded with the signature.
3.2.4.2A If the report is signed electronically,
the signatures must be password protected with sign off only by an interpreting
physician. The signature must indicate it is electronically recorded and be
electronically date/time stamped.
3.2.5A The
final signed report must be transmitted to the referring health care provider
within two working days.
3.2.6A There
must be a system for identification and retrieval of a patient’s prior relevant studies for comparison.
3.3A Final
interpretation of examinations must be based on quality images/data as well as
relevant clinical information. This includes, but is not limited to:
3.3.1A relevant
clinical information and clinical indication/question;
3.3.2A relevant
patient response to exercise or pharmacologic stress, including but not limited
to symptoms, rest/stress heart rate, rest/stress blood pressure and rest/stress
ECG findings. This information must be included in the final report as noted in
Standard 3.4A.
3.3.3A relevant patient response to other
pharmacologic intervention (e.g., Lasix, morphine, ACE inhibitors, sincalide);
3.3.4A acceptable
quality radionuclide images and/or derived quantitative data including
acceptable:
3.3.4.2A processing/filtering;
3.3.4.3A data
display [includes image data (slice line-up, normalization, color,
standardization, as relevant) and quantitative data (including ROI display,
graphs, raw data and calculated values, as relevant)];
3.3.4.4A lack of
artifacts (e.g., patient motion, attenuation, subdiaphragmatic activity).
3.3.5A other
relevant imaging modalities (e.g., echo/ultrasound, CT, MRI, etc.), if
available;
3.3.6A comparison
with relevant prior nuclear medicine examinations, when available;
3.3.7A the
integration of imaging and non-imaging information into a final impression that
resolves any potential inconsistencies.
3.4A The
final report must be typed or computer generated and must accurately reflect
the content and results of the study. The report must include:
3.4.1A identification
of the name, address and phone number of the facility;
3.4.2A name of the procedure [type of
examination(s)];
3.4.3.1A patient’s
first and last name;
3.4.3.3A date of
birth or age;
3.4.3.4A height and weight or BMI (not applicable to general nuclear medicine).
3.4.4A requesting
health care provider’s name;
3.4.5A interpreting
physician name;
3.4.6A date of
the examination;
3.4.7A clinical indications and pertinent history leading to the performance of the examination
Comment: For cardiac stress studies, this includes current symptoms, current medications and cardiac history with pertinent risk factors.
3.4.8A an
adequate description of the procedure, as performed. The elements of the procedure description include:
3.4.8.1A technique (e.g., rest/stress vs.
stress/rest, one-day vs. two-day, gated, first pass, red cell labeling method,
3-phase, flow, blood pool, attenuation correction method, etc.);
3.4.8.2A pertinent laboratory results (e.g.,
blood glucose level for F18-FDG imaging, TSH prior to I131 whole body imaging);
3.4.8.3A administered
radiopharmaceutical:
i. specific
identity – radionuclide and chemical form (e.g., Tc99m sestamibi, Tc99m
pertechnetate, I131 sodium iodide);
ii. exact
amount (i.e., XX.X mCi);
iii. route of
administration (e.g., intravenous, oral, inhaled, subdermal);
iv. uptake time (e.g., F18-FDG time from
injection to imaging, I123 or I131 oral dose to thyroid uptake measurement).
3.4.8.4A administered
pharmaceutical (non-radioactive):
i. specific
identity (e.g., regadenoson, sincalide, furosemide, sedation);
ii. exact
amount;
iii. route of
administration (e.g., intravenous, oral, inhaled, subdermal);
iv. time of pharmaceutical administration relative
to tracer administration;
v. time over which dose administered
(e.g., regadenoson over 10-15 seconds, sincalide over 60 minutes).
3.4.8.5A anatomic area(s) imaged (e.g., kidney,
abdomen, skull base to mid-thigh);
3.4.8.6A views obtained (e.g., planar, anterior,
posterior, whole body, SPECT, SPECT/CT);
3.4.8.7A CT procedure, if applicable:
i. CT technique (e.g., anatomic
localization and attenuation correction vs. diagnostic intent);
ii. administered contrast;
iii. identity (not required for GI contrast);
iv. volume (not required for GI contrast);
v. route of administration (e.g., oral,
intravenous);
vi. adverse reaction to contrast material
(e.g., signs, symptoms and treatment), if applicable.
3.4.9A description
of the results of the examination including pertinent positive and negative
findings
3.4.9.1A Nuclear Cardiology (Myocardial Perfusion
Imaging including SPECT and PET)
i. Stress test procedure and results including:
· type of stress (e.g., exercise or pharmacologic);
· stress protocol (e.g., Bruce, modified Bruce, regadenoson);
o Low level exercise performed in conjunction with pharmacologic stress must be documented.
· timing of radiopharmaceutical administration;
· stress
duration (e.g., total exercise/infusion time);
· percent
of the maximum predicted heart rate or pressure-rate product;
· reason
for termination of stress;
· rest and
peak stress heart rate;
· rest and
peak stress blood pressure;
· stress
symptoms or lack thereof;
· rest and
peak stress ECG finding (rest rhythm, AV conduction, arrhythmias and repolarization/STT abnormalities).
ii. Myocardial Perfusion Imaging results including:
· description
of the image quality (e.g., excellent, good, poor, uninterpretable or other)
including identification of suboptimal or limited studies (e.g., soft tissue
attenuation [breast or diaphragm], patient/organ motion, activity in non-target
organs [subdiaphragmatic activity] or other artifacts);
· deviation from facility’s protocol, if any;
· qualitative left ventricular perfusion results including:
o size/extent
[e.g., small/medium/large or semi quantitatively (small (<10% of the left
ventricle (LV))/medium (10-20% of the LV)/large (>20% of the LV)];
o severity/intensity (e.g., mild, moderate, severe);
o location using the 17-segment model to specify involved segment (e.g. apical to basal, inferior)
· individual perfusion defect clinical interpretation (e.g., ischemia, infarction, probable ischemia, probable artifact, artifact).
Comment:
when “probable” is used to describe perfusion, a defect’s clinical
interpretation justification is required (e.g., ischemia vs inferior
wall attenuation).
· Transient ischemic dilatation (if present).
iii. Gated left ventricular function results:
· quantitative left ventricular ejection fraction;
· overall left ventricular function (e.g., normal, reduced [mild, moderate or severe] or hyperdynamic);
· regional wall motion abnormalities (e.g., normal, hypokinesis [mild, moderate, severe], akinesis or dyskinesis).
iv. Overall impression
· LV perfusion summary (e.g., normal, equivocal, abnormal, ischemia, infarction);
· LV summary of global function (e.g., normal, equivocal, abnormal);
· suggestions for additional studies based on the results of the procedure being reported must be provided as appropriate.
3.4.9.2A Equilibrium Radionuclide Gated Angiography (ERNA)
i. Gated left ventricular function results;
· left ventricular volume (e.g., normal, mildly enlarged, moderately enlarged, severely enlarged);
· quantitative left ventricular ejection fraction including normal values;
· overall left ventricular function (e.g., normal, reduced [mild, moderate, severe],or hyperdynamic);
· regional wall motion abnormalities (e.g., normal, hypokinesis [mild, moderate, severe], akinesis or dyskinesis;
· regional wall motion abnormality location (e.g., none, 17 segment model).
ii. Impression:
· Summary of global function (e.g., normal, abnormal).
i. Findings must include:
· image quality;
· visual scan interpretation;
· semi quantitative (visual grade) interpretation in relation to rib uptake.
Comment: SPECT imaging must be performed for all studies.
ii. Conclusions must include:
· overall interpretation of findings (e.g., not suggestive, equivocal, or strongly suggestive of ATTR cardiac amyloidosis);
· a statement addressing that appropriate laboratory testing to rule out AL amyloidosis must be performed for the accurate interpretation of PYP testing.
Comment:
Not suggestive: A semi-quantitative visual Grade of 0. 20
Equivocal: If diffuse
myocardial uptake of 99mTc-PYP/DPD/HMDP is visually confirmed and the
semi-quantitative visual grade is 1 or there is interpretive
uncertainty of grade 1 versus grade 2 on visual grading.20
Strongly suggestive: If diffuse myocardial uptake of 99mTc-PYP/DPD/HMDP is visually confirmed, a semi-quantitative visual grade of 2 or 3.20
3.4.9.4A General Nuclear Medicine
i. description of suboptimal or limited studies (e.g.,
artifacts, dose infiltration, poor count density, patient motion, metal attenuation
or urine contamination);
ii. deviation from facility’s
protocol, if any;
iii. description
of the image results including:
· pertinent
positive findings (e.g., intensity/size/location, inhomogeneity, pattern,
change over time);
· pertinent
negative findings;
· quantitative data with normal values;
· correlative imaging results, if
applicable (e.g., CT portion of SPECT/CT).
iv. description
of non-imaging data with normal values (e.g., radioiodine uptake);
v. comparison
to previous and/or other imaging or non-imaging studies (e.g., x-ray,
ultrasound, laboratory results), as appropriate. It is preferable that
“no previous studies” be stated to document that there was none.
i. description
of suboptimal or limited studies (e.g., artifacts, dose infiltration, poor
count density, patient motion, metal, urine contamination, excessive muscle
uptake or misregistration);
ii. deviation from facility’s protocol,
if any;
iii. description
of the image results including:
· pertinent
positive findings (e.g., intensity/size/location, inhomogeneity, pattern,
change over time);
· pertinent
negative findings;
· quantitative data with reference values
(e.g., SUV compared with liver activity and/or mediastinal activity; size
measurement of nodules/masses; and density measurements from CT);
· correlative imaging results, if
applicable (e.g., CT portion of PET/CT).
iv. comparison
to previous and/or other imaging or non-imaging studies (e.g., x-ray,
ultrasound, laboratory results), as appropriate. It is preferable that
“no previous studies” be stated to document that there was none.
3.4.10A a succinct impression, which clearly communicates the results of the study and
answers the clinical question that was the indication for the examination. This
must include an interpretation of significant abnormalities and/or indicate
when results are normal. This must also include a clear summary of any
significant changes from prior studies. This also includes recommendations for
additional studies based on results of the procedure being reported, as
appropriate.
3.4.10.1A General Nuclear Medicine
i. diagnosis or summary list of
differential diagnoses with likelihood.
i. diagnosis or summary list of
differential diagnoses with likelihood;
ii. for oncologic studies, response
assessment (e.g., complete response, partial response, stable disease,
progressive disease). Both the metabolic response and anatomic response may be
reported.
3.4.11A Report
finalization to include:
3.4.11.1A identification
and manual or electronic signature (password protected) of the interpreting
physician as described in Standard 3.2.4A;
3.4.11.2A date
report finalized and signed by the interpreting physician;
3.4.11.3A if the report is amended, the original
report content, author and date of signature must be retained. The content of
the amendment, author and date of amendment must be clearly recorded.
3.1A It
is strongly recommended that raw digital image data be retained for a minimum
of three years.
If images are transmitted to another (affiliated) location for remote
interpretation, a method of validating the quality of the transmitted image
should be done to assure that it is of comparable diagnostic quality (e.g.,
SMPTE or similar patterns).
3.2.1A Although
static images may be interpreted from film or other hard copy, it is preferable
that they be interpreted on the computer.
3.4A The
final report should include:
· Unique patient identifier (e.g., unique identification number or sufficient demographic information to identify patient)16
For
nuclear cardiology studies, a standardized report is recommended (e.g., The
American Society of Nuclear Cardiology Guidelines on Standardized Reporting of
Radionuclide Myocardial Perfusion and Function).