|
The IAC Standards
and Guidelines |
Click here for a printer-friendly PDF of the Nuclear/PET
Standards |
2.1B The
annual procedure volume must be sufficient to maintain proficiency in
examination interpretation and performance.
2.1.1B For
general nuclear medicine accreditation, a facility must be able to submit the
minimum number of cases per area required in the application process. The cases
must be performed within one year from the date of
submission.
2.2B To
ensure standardized operation the facility must have and follow site-specific
written protocols that accurately describe the details for all procedures
performed within the facility.
2.2.1B Complete
procedure manuals must be present in the facility and include corresponding
references.
2.2.2B Protocols
must be organized for easy use (such as in notebook or electronic form) with a
table of contents with sections/headings such as: clinical imaging protocols,
exercise and/or pharmacologic stress protocols, therapeutic protocols,
equipment quality control, radiation safety and radioactive materials handling,
administrative policies and facility quality assessment and improvement.
2.2.2.1B The
protocol manual must be readily accessible to appropriate staff members during
operational hours.
2.2.2.2B Where
appropriate, records must be maintained to document compliance with protocols
(e.g., radiopharmaceutical receipt/disposal records, spill records, etc.).
(See Guidelines
below for further recommendations.)
2.2.3B Clinical
protocols must be reviewed and updated at least annually by the Medical
Director or by an appropriate designee. For areas in which the Medical Director does not have
education, training and experience, a designee must be appointed to review
those protocols. This designee must be a physician whom meets the criteria
relevant to the delegated responsibility, as outlined in Standard 1.1A.
2.2.3.1B As noted in Standard 4.4.5.1A,
protocols should use the lowest radiation dose necessary to acquire a
diagnostic-quality image.
i. Myocardial Perfusion Imaging protocols
administered radiopharmaceutical dose must be within the ranges listed in the following table:
Comment: Large patient is
defined as >250 lbs or BMI >35 and (rest) denotes optional rest injection
and only performed where clinically warranted.7
Comment: Physicians
may use judgement to individualize doses for patients who should
receive doses outside the range prescribed by the facility’s protocol.
|
Current SPECT Myocardial Perfusion Imaging
Protocols: REFERENCE: ASNC Imaging Guidelines for SPECT Nuclear
Cardiology Procedures: Stress, Protocols and Tracers (February 2016) |
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|
|
First Injection |
Second Injection |
Total |
Total Dose If |
||||
|
Given at |
Activity (mCi) |
Dose (mSv) |
Given at |
Activity (mCi) |
Dose (mSv) |
Dose (mSv) |
Stress-only (mSv) |
|
|
Tc-99m
Protocols |
||||||||
|
Tc-99m One Day Stress-First/Stress-Only |
Stress |
8-12 |
2.0-3.0 |
(Rest)** |
24-36 |
7.0-10.5 |
9.0-13.5 |
2.0-3.0 |
|
Tc-99m One Day Rest/Stress |
Rest |
8-12 |
2.3-3.5 |
Stress |
24-36 |
6.1-9.1 |
8.4-12.6 |
n/a |
|
Tc-99m Two Day Stress/Rest |
Stress |
8-12 |
2.0-3.0 |
(Rest)** |
8-12 |
2.3-3.5 |
4.3-6.5 |
2.0-3.0 |
|
Tc-99m Two Day Stress/Rest - Large Patient* |
Stress |
18-30 |
4.5-7.6 |
(Rest)** |
18-30 |
5.2-8.7 |
9.8-16.3 |
4.5-7.6 |
|
Tc-99m Two Day Rest/Stress |
Rest |
8-12 |
2.3-3.5 |
Stress |
8-12 |
2.0-3.0 |
4.3-6.5 |
n/a |
|
Tc-99m Two Day Rest/Stress - Large Patient* |
Rest |
18-30 |
5.2-8.7 |
Stress |
18-30 |
4.5-7.6 |
9.8-16.3 |
n/a |
|
Tl-201
Protocols |
||||||||
|
Tl-201 Stress/Redistribution Rest |
Stress |
2.5-3.5 |
10.9-15.3 |
n/a |
n/a |
n/a |
10.9-15.3 |
10.9-15.3 |
|
Tl-201 Stress/Redistribution Rest/Reinjection |
Stress |
2.5-3.5 |
10.9-15.3 |
Rest |
1-2 |
4.4-8.8 |
15.3-24.1 |
n/a |
|
Tl-201 Rest/Redistribution |
Rest |
2.5-3.5 |
1.9-15.3 |
n/a |
n/a |
n/a |
10.9-15.3 |
n/a |
|
Dual Isotope Tl-201 Rest/Tc-99m Stress |
Rest |
2.5-3.5 |
10.9-15.3 |
Stress |
8-12 |
2.0-3.0 |
13.0-18.3 |
n/a |
|
Dual Isotope Tl-201 Rest/Tc-99m Stress - Large Patient* |
Rest |
3.0-3.5 |
13.1-15.3 |
Stress |
18-30 |
4.5-7.6 |
17.7-22.9 |
n/a |
|
I-123
Protocol |
||||||||
|
MIBG |
Rest |
10 |
4.6 |
n/a |
n/a |
n/a |
4.6 |
n/a |
(See Guidelines
below for further recommendations.)
2.2.3.2B All protocols and/or
revisions must be dated and initialed/signed by the Medical Director or the designated person.
Comment: It is acceptable
for the Medical Director to sign a summary page to indicate he/she has approved
the entire protocol manual.
Comment: The Radiation Safety Program must also be reviewed annually (see Standard
4.2.1A).
2.2.4B Personnel
must have read, be appropriately trained in and have current competence
documented to perform/comply with relevant protocols. Documentation is
typically found as initial training/orientation and annual training records.
2.2.5B The
protocols and the facility’s performance must be in compliance with:
2.2.5.1B All
applicable federal, state and local requirements, including Nuclear Regulatory
Commission (NRC) regulations or, in Agreement States, with state regulations
for medical use of radioisotopes.
2.2.5.2B Accepted
practices such as those in published guidelines.1-16
2.3B The
clinical procedure manual must include every clinical procedure performed at
the facility, even those performed only occasionally.
2.3.1B All
procedures that are performed must have detailed, site-specific written
instructions.
2.3.2B All clinical
procedures must be performed under conditions that ensure patient and staff
safety.
2.3.3B Protocols
must be sufficiently detailed to enable recreation of the protocol in the event
of staffing or software change.
(See Guidelines
below for further recommendations.)
2.4B Diagnostic
imaging protocols and their implementation must result in an accurate depiction
of the distribution of the radiopharmaceutical(s) within the patient and
provide data (images and/or quantitation) that is interpretable by the
responsible physician. This includes following accepted practices6, 7
(or providing published justification for variance) and performing optimal
acquisition, processing and display of data as well as minimization of distortion
due to such factors as motion and artifacts.
2.4.1B Clinical
protocols must include, as appropriate:
2.4.1.1B clinical
indications and contraindications;
2.4.1.2B patient
preparation and education/instructions such as food/diet restrictions, if any,
withholding or non-withholding of medications or other relevant information. If there are no patient
preparations or restrictions, the protocol must specifically state this.
Comment: Other patient
instruction/preparation may include skin preparation, wound care, changing or
removal of dressings or casts.
Comment: For myocardial perfusion imaging protocols, the indications,
contraindications and patient preparation for exercise and pharmacologic stress
testing must also be listed in the relevant stress protocols, as applicable.
2.4.1.3B radiopharmaceutical
identity, dosage and route of administration (e.g., intravenous, oral,
inhaled, subdermal) (See Standard 4.4.5A for additional protocol dosage
requirements):
2.4.1.4B non-radioactive
drugs (e.g., pharmacologic stress agents, pyrophosphate (PYP), sincalide,
cholecystokinin, morphine sulfate, furosemide, captopril, aminophylline,
metoclopramide, pentagastrin, Lugol’s solution) used in the procedure
including dosage, timing, route of administration, patient instruction, patient
monitoring and any precautions or restrictions;
2.4.1.5B camera
setup (e.g., collimator, energy window setting, orbit and orbit type, acquisition
type [static, dynamic, planar, SPECT, SPECT/CT, PET, PET/CT, PET/MR, PEM, step and
shoot, continuous], gating, matrix size, zoom, etc.);
2.4.1.6B patient
position (e.g., supine, prone, posterior, anterior, head in, head out, arms up,
arms down) and camera position (e.g., starting angle, detector configuration,
caudal tilt, detector to patient distance);
2.4.1.7B camera/computer
specific acquisition instructions including views, timing of views, time/counts
per view and number of views as well as SPECT/PET specific parameters,
pre-filtering (reconstruction) and attenuation correction if used;
2.4.1.8B camera/computer
specific processing protocols including such parameters as filtering,
reconstruction parameters, reconstruction algorithms, attenuation correction,
motion correction, curve generation, reformatting and quantitative analysis
requirements;
2.4.1.9B camera/computer
specific instructions regarding the images and data to be displayed for
physician interpretation (screen shots and examples are acceptable forms of
documentation);
2.4.1.10B instructions
for how image will be labeled to include: facility name, patient name, date of
birth, patient identifier, date of study, time interval (as appropriate), view
or projection, laterality and anatomical markers (as appropriate);
Comment: Screen shots and
examples are acceptable forms of documentation.
Comment: If
acquisition/processing/display protocols are in the computer software, they
must be listed in the protocol manual by the name of the protocol as on the
computer. If the computer protocol has any portions that allow or require
site/user selection/interaction (e.g., choosing filters, drawing ROI’s),
the protocol manual must document the proper choices/technique (may elect to
“print screen” showing selections and location in manual).
2.4.1.11B protocols
utilizing new (emerging) technologies and other novel imaging approaches not
included in guidelines published by the professional societies must have
supporting documentation, that demonstrates adherence to manufacturer's QC specifications.
2.4.2B Exercise
and/or Pharmacologic Stress Testing – All exercise/pharmacologic
protocols must follow accepted practices1-5 (or have published
justification for variance) and include the following:
Comment: Exercise stress is the preferred stress testing protocol in patients
who are physically able to exercise to an adequate workload. Exercise protocols
differ in the speed and incline and can be varied based on individual patient
characteristics.
2.4.2.1B detailed
description of graded protocols (e.g., charts showing speed, incline and
workload) and/or infusion protocols used;
i. If low-level exercise is used with any
infusion protocol, this must be described in detail (e.g., type of exercise,
speed/incline if treadmill used, duration of exercise, and timing of exercise
in relation to pharmaceutical and tracer administration).
2.4.2.2B instructions
for time of measurement of symptoms, heart rate, blood pressure and
electrocardiographic tracings during stress;
2.4.2.3B injection
criteria and exercise/testing end points including any specific events that are
reasons for stopping the stressing activity (e.g., duration of pharmaceutical
administration or specific symptoms at peak exercise).
Comment: Protocol must
specifically state when the tracer is injected either by time or other criteria
relative to the stress type. Exercise stress tests must be symptom-limited
unless indications for stopping the test early are achieved. Achievement of 85%
of maximum, age-adjusted, predicted heart rate is not sufficient an indication
for termination of the test.
2.4.2.4B reasons
for early termination of exercise stress or pharmacologic stress (e.g.,
moderate to severe angina, marked dyspnea, ST segment depression > 2 mm);
2.4.2.5B instructions
for post stress monitoring including time of symptoms, measurement of heart
rate, blood pressure and electrocardiographic tracings as well as criteria for
terminating post stress monitoring (i.e., minimum duration of post stress monitoring
and acceptable reasons for stopping);
2.4.2.6B identification
and treatment of common adverse effects for both exercise and/or pharmaceutical
stress (e.g., hypertension, dyspnea, chest pain).
2.1B Procedure
Volumes - It is recommended that a facility should perform a minimum of 600
nuclear medicine patient procedures annually.
2.2.2B Availability
of protocols in digital format is desirable.
2.2.5B Sample
protocol information is available on the IAC Nuclear/PET website at intersocietal.org/nuclear.
References are listed in the Bibliography.
2.3B Some
components of clinical protocols, such as patient identification or image
labeling, may apply to a group of procedures and, therefore, may be established
separately from the individual procedure protocols. In such cases, the blanket
policy does not need to be fully reproduced in each individual procedure
protocol.
2.2.3.1B It is strongly recommended
against the routine use of a dual isotope protocol for myocardial perfusion
imaging except during extraordinary circumstances (i.e., technetium shortage)
or for use with Newer Technology combined with the Reduced-Dose Protocols above.
It is strongly recommended for
obese patients undergoing two-day myocardial perfusion imaging protocols or
patients with a low pretest probability should have stress imaging performed
first and rest imaging performed only if stress imaging is abnormal.
2.4.1.3B Radiation dosimetry: Effective
dose and critical organ dose for each radiopharmaceutical given should be
included. If relevant, pediatric exposures should be included.8,9
|
Current SPECT Myocardial Perfusion Imaging
Protocols: REFERENCE: ASNC Imaging Guidelines for SPECT Nuclear
Cardiology Procedures: Stress, Protocols and Tracers (February 2016) |
||||||||
|
|
First Injection |
Second Injection |
Total |
Total Dose If |
||||
|
Given at |
Activity (mCi) |
Dose (mSv) |
Given at |
Activity (mCi) |
Dose (mSv) |
Dose (mSv) |
Stress-only (mSv) |
|
|
Newer
Technology Reduced-Dose Protocols |
||||||||
|
Tc-99m One Day Stress-First/Stress-Only |
Stress |
4-6 |
1.0-1.5 |
(Rest)** |
12-18 |
3.5-5.2 |
4.5-6.7 |
1.0-1.5 |
|
Tc-99m One Day Rest/Stress |
Rest |
4-6 |
1.2-1.7 |
Stress |
12-18 |
3.0-4.5 |
4.2-6.3 |
n/a |
|
Tc-99m Two Day Stress/Rest |
Stress |
4-6 |
1.0-1.5 |
(Rest)** |
4-6 |
1.2-1.7 |
2.2-3.3 |
1.0-1.5 |
|
Tc-99m Two Day Stress/Rest - Large Patient* |
Stress |
9-15 |
2.3-3.8 |
(Rest)** |
9-15 |
2.6-4.4 |
4.9-8.1 |
2.3-3.8 |
|
Tc-99m Two Day Rest/Stress |
Rest |
4-6 |
1.2-1.7 |
Stress |
4-6 |
1.0-1.5 |
2.2-3.3 |
n/a |
|
Tc-99m Two Day Rest/Stress - Large Patient* |
Rest |
9-15 |
2.6-4.4 |
Stress |
9-15 |
2.3-3.8 |
4.9-8.1 |
n/a |
|
Tl-201 Stress/Redistribution Rest |
Stress |
1.3-1.8 |
5.7-7.9 |
n/a |
n/a |
n/a |
5.7-7.9 |
5.7-7.9 |
|
Dual Isotope Tl-201 Rest/Tc-99m Stress |
Rest |
1.3-1.8 |
5.7-7.9 |
Stress |
4-6 |
1.0-1.5 |
6.7-9.4 |
n/a |
|
Dual Isotope Tl-201 Stress/Tc99m Rest |
Stress |
1.3-1.8 |
5.7-7.9 |
Rest |
4-6 |
1.2-1.7 |
6.9-9.6 |
5.7-7.9 |