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REFERENCE COMMITTEE I
Kyle J. Antes, MS
Steven M. Cohen, MD, FACR
Beverly G. Coleman, MD, FACR
Bennett S. Greenspan, MD, FACR
Gerald M. Mulligan, MD, FACR, Chair
Matthew Hawkins, MD
COMMISSIONS, COMMITTEES & TASK FORCES:
Commission on Medical Physics
Commission on Quality & Safety
Commission on Radiation Oncology
Commission on Ultrasound
Commission on Breast Imaging
Commission on Nuclear Medicine
RESOLUTION
SPONSORED/
SUBMITTED
1.
Ten Year Extension of Policies:
(a) Computed Tomography Radiation Dose
(b) Non-Diagnostic Fetal Portraiture
(c) Multidisciplinary Evaluation of Prostate Cancer
(d) Position Statement of Non-Operative SpinalIParaspinal Ultrasound in Adults
CSC
2.
ACR Technical Standard for Medical Nuclear Physics Performance Monitoring of PET
Imaging Equipment
CSC
3.
ACR Technical Standard for Diagnostic Medical Physics Performance Monitoring of Real
Time Ultrasound Equipment
CSC
4.
ACR Technical Standard for Diagnostic Medical Physics Performance Monitoring of
Radiographic and Fluoroscopic Equipment
CSC
5.
ACR—SNM Technical Standard for Procedures Using Radiopharmaceuticals
CSC
6.
ACR—ACOG—AIUM—SRU Practice Guideline for the Performance of Sonohysterography
CSC
7.
ACR—SPR—SRU Practice Guideline for Performing and Interpreting Diagnostic Ultrasound
Examinations
CSC
8.
ACR—AIUM—SPR—SRU Practice Guideline for the Performance of an Ultrasound Examination
of the Neonatal Spine
CSC
9.
ACR—AIUM—SRU Practice Guideline for the Performance of Ultrasound Vascular Mapping
for Preoperative Planning of Dialysis Access
CSC
10.
ACR—AIUM—SRU Practice Guideline for the Performance of an Ultrasound Examination of
the Extracranial Cerebrovascular System
CSC
11.
ACR Practice Guideline for the Performance of a Breast Ultrasound Examination
12.
Extend ACR—ACS—CAP—SSO Practice Guideline for the Management of Ductal Carcinoma
In-Situ of the Breast (DCIS); and the ACR—ACS—CAP—SSO Practice Guideline for Breast
Conservation Therapy in the Management of Invasive Breast Carcinoma
13.
Nuclear Medicine Advanced Associate
14.
Refer to the North American Consensus Guidelines for Administration of Radiopharmaceutical
Activities in Children and Adolescents Paper in the Nuclear Medicine Guidelines
15.
Standardization of Relative Exposure Unit of Measure for Digital Diagnostic Radiologic
Equipment
16.
Call to Eliminate the Self-Dealing of Medical Imaging Technical Fees
17.
Support for Maryland Anti Self-Referral Legislation
CSC
CSC IBOC
SUBMITTED BY
BOC
ACR STAFF:
Director............................. Carolyn MacFarlane
Moderator ......................... Lavonne Robbins
Recorder ........................... Freda White
Assistant ........................... Ryan Thompson
Observer ........................... Brian Monzon
CSC IBOC
NYSRS
CA Rad. Soc.
Rad. Soc. of CT
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RESOLUTION NO. 1
Ten Year Extension of Policy
WHEREAS,
the ACR bylaws state that “All official actions and policies of the
Council are effective for only ten years unless extended for an additional
ten year period by the Council…,” and
WHEREAS,
the various components of the College feel that the following policy
should be extended for an additional ten year period; therefore
BE IT RESOLVED,
that the following policy of the American College of Radiology be
extended for an additional ten year period:
(a)
COMPUTED TOMOGRAPHY RADIATION DOSE
The ACR strongly encourages all radiologists to be aware of the
radiation dose in CT examinations and to take the steps necessary to
minimize optimize the dose to patients, especially pediatric patients.
The ACR shall continue to support both Image Gently and Image Wisely
initiatives to further raise this awareness. evaluate issues related to CT
radiation dosage using its existing Commission and Committee structure
to indicate areas of concern to the ACR membership, to work with
vendors to address these concerns and to respond to the Council in one
year’s time; 2001 (Res. 4).
(b) Non-Diagnostic Fetal Portraiture
The American College of Radiology (ACR) opposes the all uses of
diagnostic ultrasound equipment (including 3-D options) for nondiagnostic fetal portraiture; 2001 (Res. 25).
(c)
Multidisciplinary Evaluation of Prostate Cancer
If a diagnosis of prostate cancer is made, men should be offered
multidisciplinary consultation regarding treatment options. This should
include referral to a radiation oncologist to discuss the role of radiation
therapy (external beam, brachytherapy, or combined modality therapy) as
an option in treatment; 2001 (Res. 16).
(d)
Position Statement on Non-Operative Spinal’Paraspinal Ultrasound
in Adults
The American College of Radiology adopts the following position
statement on Non-Operative Spinal/Paraspinal Ultrasound in Adults,
dated May 2001.
Ultrasound has developed into a significant imaging modality due to its
capabilities in examining a wide variety of tissues. Research to expand
the usefulness of this non-invasive modality is ongoing in a number of
areas. In order for any medical procedure to become widely accepted it
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must be tested by appropriate research. Proven scientific methods must
be applied to any new imaging modality, or a new use of current
modality, to show its potential usefulness and establish efficacy.
Published peer-reviewed articles and data provided by multiple research
centers are used by government agencies, third party payers and the
medical community to prove the safety and efficacy of a new
procedure/modality. While there may be dissatisfaction with the costs
and time associated with such an approach, it is still the best method
currently available to medical researchers. Without appropriate
randomized clinical trials there is much danger improper scientific
conclusions may be drawn due to inherent biases, lack of reproducibility
of results and problems or side effects overlooked because of an
inadequate sampling of patients.
Over the past several years the successful application of ultrasound to the
musculoskeletal system has been documented by multiple research
studies in well-respected peer-reviewed journals. Ultrasound is useful in
diagnosing abnormalities of tendons, joints, ligaments, muscles, and
bursae. Spinal ultrasound is useful in neonates to assess for cord
abnormalities and in adults for procedures such as lumbar puncture.
However, as a diagnostic outpatient procedure in adults there is little to
support use of ultrasound for assessment of the spinal/paraspinal regions.
Due to the ubiquitous nature of back pain, there has also been interest in
developing the use of ultrasound technology to evaluate the spine and
paraspinal regions. However, this application of ultrasound technology
has not been as promising. A Medline search of the peer-reviewed
literature on spinal/paraspinal ultrasound from 1991 to 2001 uncovers
only several articles. The article by Battie, et al. in the Journal of
Occupational Medicine, December, 1994, page 1283, states “No
association was found between [spinal] canal measurements and claims
with extended work loss of greater than one month. The imprecision of
the measurements and poor predictive ability indicate that B scan
ultrasonography, as used in this study, is of dubious screening value.” An
article by Nazarian et al in the Journal of Ultrasound in Medicine 1998,
vol. 17, page 122 states that “paraspinal ultrasonography as currently
practiced is neither a sensitive nor a specific modality for evaluating
patients with back pain, and, therefore, should be considered no more
than investigational at this time”. Three articles by Hides, et al in Spine
imaged the lumbar multifidus muscle in health and disease, but as yet
their findings have not been corroborated by other investigators. Eisele,
et al in the European Journal ofUltrasound 1998, vol. 8, pp 167-175
describe ultrasonic texture analysis of the paraspinal soft tissues
but admit that “30 or 40 individuals [the size of their study group] are not
enough for any serious statistical interpretation and that their method as
of yet is “unable to validate a diagnosis.” Thus, there is currently no
documented scientific evidence of the efficacy of this modality in the
evaluation of the spine, spinal canal and paraspinal tissues. Any claims
or inferences that the use of spinal or paraspinal ultrasound is more
advantageous or has a greater diagnostic accuracy than established
procedures such as computed tomography (CT) or magnetic resonance
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imaging (MRI) cannot be made today based on recognized medical
research.
Until such time as adequate research studies have been carried out and
published in peer-reviewed journals which establish the efficacy of
ultrasound evaluation of spinal and paraspinal regions, individuals
performing these studies should be considered to be performing
investigational procedures. Such investigation procedures do not fit
under existing Physicians’ Current Procedural Terminology (CPT) codes
already established for ultrasound imaging of the musculoskeletal
system, soft tissues of the neck or general abdomen. Practitioners
performing these investigational procedures should not charge patients
directly or indirectly for these costs.
Qualified physicians should be encouraged to carry out appropriate
clinical research to prove the efficacy of ultrasound imaging on the spine
and paraspinal regions. Patients should only have these procedures
performed within the framework of clinical trials until their efficacy has
been established; 2001 (Res. 15).
Sponsored by:
ACR Council Steering Committee
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Fiscal Note
Ten Year Extension of Policy
To support the resolution for Ten Year Extension of Policy, the ACR would incur the following
estimated costs:
Costs:
De minimis
NOT FOR PUBLICATION, QUOTATION, OR CITATION
RESOLUTION NO. 2
BE IT RESOLVED,
that the American College of Radiology adopt the ACR
Technical Standard for Medical Nuclear Physics Performance
Monitoring of PET Imaging Equipment
Sponsored by:
Council Steering Committee
PET Imaging Equipment
TECHNICAL STANDARD
Resolution No. 2
NOT FOR PUBLICATION, QUOTATION, OR CITATION
The American College of Radiology, with more than 30,000 members, is the principal organization of radiologists, radiation
oncologists, and clinical medical physicists in the United States. The College is a nonprofit professional society whose primary
purposes are to advance the science of radiology, improve radiologic services to the patient, study the socioeconomic aspects of the
practice of radiology, and encourage continuing education for radiologists, radiation oncologists, medical physicists, and persons
practicing in allied professional fields.
The American College of Radiology will periodically define new practice guidelines and technical standards for radiologic
practice to help advance the science of radiology and to improve the quality of service to patients throughout the United States.
Existing practice guidelines and technical standards will be reviewed for revision or renewal, as appropriate, on their fifth anniversary
or sooner, if indicated.
Each practice guideline and technical standard, representing a policy statement by the College, has undergone a thorough
consensus process in which it has been subjected to extensive review, requiring the approval of the Commission on Quality and Safety
as well as the ACR Board of Chancellors, the ACR Council Steering Committee, and the ACR Council. The practice guidelines and
technical standards recognize that the safe and effective use of diagnostic and therapeutic radiology requires specific train ing, skills,
and techniques, as described in each document. Reproduction or modification of the published practice guideline and technical
standard by those entities not providing these services is not authorized .
ACR TECHNICAL STANDARD FOR MEDICAL NUCLEAR
PHYSICS PERFORMANCE MONITORING OF PET IMAGING
EQUIPMENT
PREAMBLE
These standards are an educational tool designed to assist practitioners in providing
appropriate radiologic care for patients. They are not inflexible rules or requirements of
practice and are not intended, nor should they be used, to establish a legal standard of
care. For these reasons and those set forth below, the American College of Radiology
cautions against the use of these standards in litigation in which the clinical decisions of a
practitioner are called into question.
The ultimate judgment regarding the propriety of any specific procedure or course of
action must be made by the physician or medical physicist in light of all the
circumstances presented. Thus, an approach that differs from the standards, standing
alone, does not necessarily imply that the approach was below the standard of care. To
the contrary, a conscientious practitioner may responsibly adopt a course of action
different from that set forth in the standards when, in the reasonable judgment of the
practitioner, such course of action is indicated by the condition of the patient, limitations
of available resources, or advances in knowledge or technology subsequent to publication
of the standards. However, a practitioner who employs an approach substantially
different from these standards is advised to document in the patient record information
sufficient to explain the approach taken.
The practice of medicine involves not only the science, but also the art of dealing with
the prevention, diagnosis, alleviation, and treatment of disease. The variety and
TECHNICAL STANDARD
Resolution No. 2
PET Imaging Equipment
NOT FOR PUBLICATION, QUOTATION, OR CITATION
complexity of human conditions make it impossible to always reach the most appropriate
diagnosis or to predict with certainty a particular response to treatment. Therefore, it
should be recognized that adherence to these standards will not assure an accurate
diagnosis or a successful outcome. All that should be expected is that the practitioner will
follow a reasonable course of action based on current knowledge, available resources,
and the needs of the patient to deliver effective and safe medical care. The sole purpose
of these standards is to assist practitioners in achieving this objective.
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I.
INTRODUCTION
All positron emission tomography (PET) imaging equipment should be tested on
installation and monitored at least annually by a Qualified Medical Physicist or other
qualified individual to ensure that it is functioning within the manufacturer’s
specifications and meets accepted performance standards. Additional or more frequent
performance monitoring may be necessary in certain situations (e.g., after major
equipment maintenance). Although it is not possible to consider all variations of
equipment performance to be monitored, adherence to this standard will maximize image
quality and help to ensure the accuracy of quantitative results in clinical procedures. Key
points to consider are performance characteristics, patient radiation dose, to be
monitored, absorbed dose to the patients scanner calibrations, qualifications of
personnel, integrity (i.e., correct scaling to standard uptake values ISUVI) of the
images presented for physician review, and follow-up procedures.
II.
GOAL
The goal is to establish performance standards to promote the production of highquality diagnostic PET images that are consistent with the clinical use of PET
imaging equipment and the clinical objectives of the examination.
III.
QUALIFICATIONS AND RESPONSIBILITIES OF A QUALIFIED
MEDICAL PHYSICIST
A Qualified Medical Physicist is an individual who is competent to
practice independently one or more of the subfields in medical physics.
The American College of Radiology (ACR) considers certification and
continuing education and experience in the appropriate subfield(s) to
demonstrate that an individual is competent to practice one or more of the
subfields in medical physics, and to be a Qualified Medical Physicist. The
ACR recommends that the individual be certified in the appropriate
subfield(s) by the American Board of Radiology (ABR), the Canadian
College of Physics in Medicine, or for MRI, by the American Board of
Medical Physics (ABMP) in magnetic resonance imaging physics.
The appropriate subfields of medical physics for this standard are Medical
Nuclear Physics and Radiological Physics.
PET Imaging Equipment
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Resolution No. 2
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A Qualified Medical Physicist should meet the ACR Practice Guideline
for Continuing Medical Education (CME). (ACR Resolution 17, 1996 —
revised in 2008, Resolution 7)
Certification in nuclear medicine physics and instrumentation by the American
Board of Science in Nuclear Medicine (ABSNM) is also acceptable.
Regardless of certification, 40 hours of practical clinical experience in PET imaging
is required.
The medical physicist must be familiar with the principles of imaging physics and
radiation protection; the guidelines of the National Council on Radiation Protection and
Measurements (NCRP); laws and regulations governing pertaining to the use of the
equipment being tested; the function, clinical uses, and performance specifications of the
imaging equipment; and calibration processes and limitations of the instruments and the
techniques used for testing performance. A medical physicist should maintain continuing
competence in medical nuclear physics, including PET
Individuals The medical physicist may be assisted by properly trained individuals in
obtaining data. for performance monitoring may assist the medical physicist. The medical
physicist These individuals must be approved by the medical physicist them in the
techniques of performing tests, the function and limitations of the imaging equipment and
test instruments, the reasons for the tests, and the importance of the test results. The
medical physicist is responsible for and must be present during initial and annual surveys
and must review, interpret, and approve all data as well as summarize the tests performed
and the indicating conclusions and must provide a signed report of the conclusions.
IV.
PERFORMANCE CHARACTERISTICS TO BE MONITORED
A. Performance Evaluation
1. Characteristics to be monitored
The medical physicist must design a quality assurance (QA) program that
includes regular testing procedures to insure proper operation on a daily basis.
The PET QA program must be reviewed at least annually, preferably
semiannually, by a medical physicist. This program should be reviewed at least
annually
The procedures should include, as a minimum, those recommended by the
manufacturer. Specific attention should be given to daily quality control (QC) for
attenuation blanks, detector operation, and any necessary normalization scans.
Additional procedures considered important by the nuclear medicine community
may be recommended
TECHNICAL STANDARD
Resolution No. 2
PET Imaging Equipment
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The following characteristics shall should be evaluated for the equipment to
which they apply on at least an annual basis [1-2]:
a. Spatial resolution (radial, tangential, and axial).
b. Count rate performance (count rate, versus activity), including count loss
correction. Specific measurements of the following may be appropriate:
including count loss correction factor
i. Total coincidences.
ii. Random coincidences.
iii. Scatter coincidences.
iv. Net true coincidences.
v. Noise equivalent count rate.
vi. System dead time
vii. Count rate versus activity
i. Prompt coincidences
ii. Random coincidences
iii. Background coincidences
iv. Net true coincidences
c. Sensitivity (cps/MBq/ml) in two-dimensional (2D) and three-dimensional
(3D) modes as applicable.
d. Image quality, accuracy of attenuation and scatter corrections.
e. Correct scaling for activity measurements (kBq/ml) and SUV scaling.
4. Uniformity (plane-by-plane in 2D and 3D modes as applicable).
5. Attenuation-correction calibration accuracy (quantification).
6. Linearity of bed motion.
7. Reproducibility of transmission rod motion (extension and retraction) as
applicable.
8. Reproducibility of lead septa motion (extension and retraction) as applicable.
9. Image contrast and full system test (phantom scan).
B. Quality Control Program
A continuous quality control (QC) program must be established for the PET system
with the assistance of a medical physicist consistent with the recommendations of
the
ACR
Technical
Standard
for
Diagnostic
Procedures
Using
Radiopharmaceuticals 131. Additional tests to evaluate quantitative parameters
should be performed. Testing of standardized uptake values, spatial resolution,
contrast detectability, and noise should be performed at least quarterly as part of
the QC program. Specific attention should be given to daily QC for attenuation
blanks (if applicable), detector operation, and any necessary normalization scans.
The medical physicist should determine the frequency of each test and who should
perform each test based on the facility and PET usage. An on-site technologist
should be identified to be responsible for conducting routine QC.
The results of the QC program must be monitored annually by the medical
physicist. If measured values of QC parameters fall outside the control limits,
PET Imaging Equipment
TECHNICAL STANDARD
Resolution No. 2
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appropriate investigative or corrective actions should be initiated as soon as
possible. A medical physicist should be available to assist in prescribing corrective
actions for unresolved problems.
C. Acceptance Testing
Initial performance testing of imaging equipment shall must be performed upon
installation and should be completed before clinical use. This testing should be more
comprehensive than periodic performance testing and shall should be consistent with
current acceptance testing practices [1,4-7].
D. Written Survey Reports and Follow-Up Procedures
The medical physicist or other qualified individual shall must report the findings to the
physician(s), to the responsible professional(s) in charge of obtaining or providing
necessary service to the equipment and, in the case of the consulting physicist(s), to the
representative of the hiring party. and If appropriate, the medical physicist should
initiate the required service. Action should be taken immediately by direct verbal
communication if there is imminent danger to patients or staff using the equipment due to
unsafe conditions. Written survey reports shall must be provided in a timely manner
consistent with the importance of any adverse findings. The medical physicist should
confirm that the unit is performing in a safe and acceptable fashion as soon as possible
after the required service is performed.
D. Organ Doses from Radiopharmaceuticals
A table of organ doses shall be prepared for all procedures that involve administration of
radiopharmaceuticals to patients. The table shall specify the dosage schedule used at the
facility. All organs that receive significant doses shall be included. Separate values for
patient size and gender shall be tabulated where applicable. The table shall be reviewed at
least annually and updated when any of the following occur: addition of new procedures
and/or pharmaceuticals, changes in dosage schedules, change in route of administration,
and availability of more accurate dosimetry data.
V.
RADIATION SAFETY IN IMAGING
Radiologists, medical physicists, imaging technologists, and all supervising physicians
have a responsibility to minimize radiation dose to individual patients, to staff, and to
society as a whole, while maintaining the necessary diagnostic image quality. This
concept is known as “as low as reasonably achievable (ALARA).”
Facilities, in consultation with the radiation safety officer, should have in place and
should adhere to policies and procedures for the safe handling and administration of
radiopharmaceuticals, in accordance with ALARA, and must comply with all applicable
radiation safety regulations and conditions of licensure imposed by the Nuclear
Regulatory Commission (NRC) [8] and by state and/or other regulatory agencies.
TECHNICAL STANDARD
Resolution No. 2
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Quantities of radiopharmaceuticals should be tailored to the individual patient by
prescription or protocol.
A table of organ doses must be prepared for all procedures that involve
administration of radiopharmaceuticals to patients. The table must specify the
dosage schedule used at the facility. All organs that receive significant doses should
be included. Separate values for patient size should be tabulated where applicable.
The table must be reviewed at least annually and updated when any of the following
occur: addition of new procedures and/or pharmaceuticals, changes in dosage
schedules, change in route of administration, and availability of more accurate
dosimetry data.
VI.
RADIATION SHIELDING CONSIDERATIONS
Special care must be exercised regarding radiation shielding requirements for PET
facility design. Appropriate shielding must be provided for patient injection/uptake
rooms, PET imaging suites, and any other areas where PET radiopharmaceuticals
are prepared, used, or stored. Due to the high energy of annihilation radiation used
in PET, the amount of shielding materials needed to protect adjacent areas is
typically much larger than that for conventional CT scanners or other diagnostic
imaging modalities. A medical physicist should be consulted early in facility design
planning stages so that shielding requirements can be determined and structural
design issues arising from the need for large amounts of shielding can be assessed.
The American Association of Physicists in Medicine Task Group #108 report “PET
and PET-CT Shielding Requirements”191 should be used as a reference in
determining PET shielding requirements.
VII.
QUALITY CONTROL AND IMPROVEMENT, SAFETY, INFECTION
CONTROL, AND PATIENT EDUCATION
Policies and procedures related to quality, patient education, infection control, and safety
should be developed and implemented in accordance with the ACR Policy on Quality
Control and Improvement, Safety, Infection Control, and Patient Education appearing
under the heading Position Statement on QC & Improvement, Safety, Infection Control,
and Patient Educ on the ACR web page (http://www.acr.org/guidelines).
ACKNOWLEDGEMENTS
This guideline was revised according to the process described under the heading The
Process for Developing ACR Practice Guidelines and Technical Standards on the ACR
web site (http://www.acr.org/guidelines) by the Guidelines and Standards Committee of
the ACR Commission on Medical Physics with assistance from the AAPM.
PET Imaging Equipment
TECHNICAL STANDARD
Resolution No. 2
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Principal Reviewer: Bruce E. Hasselquist, PhD
Paul E. Kinahan, PhD
Guidelines and Standards Committee — Medical Physics — ACR Committee
responsible for sponsoring the draft through the process
Richard A. Geise, PhD, FACR, Chair
Tariq A. Mian, PhD, FACR, Vice Chair
William K. Breeden, III, MS
Laurence E. Court, PhD
Martin W. Fraser, MS
Nicholas J. Hangiandreou, PhD
Bruce E. Hasselquist, PhD
Ralph P. Lieto, MS
Mahadevappa Mahesh, MS, PhD, FACR
James T. Norweck, MS
Janelle L. Park, MD
Doug Pfeiffer, MS
Gerald A. White, Jr., MS, FACR
James M. Hevezi, PhD, FACR, Chair, Commission
Comments Reconciliation Committee Jay A.
Harolds, MD, FACR, Co-Chair Mahadevappa
Mahesh, MS, PhD, FACR, Co-Chair Kimberly E.
Applegate, MD, MS, FACR
Howard B. Fleishon, MD, MMM, FACR
Richard A. Geise, PhD, FACR
Bruce E. Hasselquist, PhD
James M. Hevezi, PhD, FACR
Alan D. Kaye, MD, FACR
Paul E. Kinahan, PhD
Paul A. Larson, MD, FACR
Henry D. Royal, MD
Hadyn T. Williams, MD
REFERENCES
1. International Atomic Energy Agency. Quality Assurance for PET and PET/CT
Systems.
IAEA
Human
Health
Series,
No.
1
1http://wwwpub.iaea.org/MTCD/publications/PDF/Pub1393_web.pdf. Accessed April 21,
2010.
2. Performance Measurements of Positron Emission Tomographs. NEMA Standards
Publication NU 2. Rosslyn, Va: National Electrical Manufacturers Association; 2007.
3. American College of Radiology. ACR Technical Standard for Diagnostic
Procedures Using Radiopharmaceuticals.
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8.
9.
http://www.acr.org/SecondaryMainMenuCategories/quality_safety/guidelines/nu
c_med/radiopharmaceuticals.aspx. Accessed January 19, 2010.
Daube-Witherspoon ME, Karp JS, Casey ME, et al. PET performance measurements
using the NEMA NU 2-2001 standard. J Nuci Med 2002;43:1398-1409.
Erdi YE, Nehmeh SA, Mulnix T, Humm JL, Watson CC. PET performance
measurements for an LSO-based combined PET/CT scanner using the National
Electrical Manufacturers Association NU 2-2001 standard. J Nuci Med 2004;45:813821.
Kinahan P, Vesselle H, Williams J. Performance evaluation of an integrated
PET/CT scanner: Discovery STE. J Nuci Med 2006;47 (Suppl 1):392P.
Mawlawi O, Podoloff DA, Kohlmyer S, et al. Performance characteristics of a newly
developed PET/CT scanner using NEMA standards in 2D and 3D modes. J Nuci Med
2004;45:1734-1742.
Consolidated Guidance About Medical Use Licenses. Finai Report NUREG1556,. Vol 9. Washington, DC: Nuclear Regulatory Commission,; 2002.
Madsen MT, Anderson JA, Halama JR, et al. AAPM Task Group 108: PET and
PET/CT shielding requirements. Med Phys 2006;33:4-15.
*Guidelines and standards are published annually with an effective date of October 1 in
the year in which amended, revised or approved by the ACR Council. For guidelines and
standards published before 1999, the effective date was January 1 following the year in
which the guideline or standard was amended, revised, or approved by the ACR Council.
Development Chronology for this Standard
2001 (Resolution 20)
Revised 2006 (Resolution 28, 16g, 17)
Amended 2009 (Resolution 11)
PET Imaging Equipment
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RESOLUTION NO. 3
BE IT RESOLVED,
that the American College of Radiology adopt the ACR
Technical Standard for Diagnostic Medical Physics
Performance Monitoring of Real Time Ultrasound Equipment
Sponsored by:
Council Steering Committee
Ultrasound Equipment
TECHNICAL STANDARD
Resolution No. 3
NOT FOR PUBLICATION, QUOTATION, OR CITATION
The American College of Radiology, with more than 30,000 members, is the principal organization of radiologists, radiation
oncologists, and clinical medical physicists in the United States. The College is a nonprofit professional society whose primary
purposes are to advance the science of radiology, improve radiologic services to the patient, study the socioeconomic aspects of the
practice of radiology, and encourage continuing education for radiologists, radiation oncologists, medical physicists, and persons
practicing in allied professional fields.
The American College of Radiology will periodically define new practice guidelines and technical standards for radiologic
practice to help advance the science of radiology and to improve the quality of service to patients throughout the United States.
Existing practice guidelines and technical standards will be reviewed for revision or renewal, as appropriate, on their fifth anniversary
or sooner, if indicated.
Each practice guideline and technical standard, representing a policy statement by the College, has undergone a thorough
consensus process in which it has been subjected to extensive review, requiring the approval of the Commission on Quality and Safety
as well as the ACR Board of Chancellors, the ACR Council Steering Committee, and the ACR Council. The practice guidelines and
technical standards recognize that the safe and effective use of diagnostic and therapeutic radiology requires specific train ing, skills,
and techniques, as described in each document. Reproduction or modification of the published practice guideline and technical
standard by those entities not providing these services is not authorized .
ACR TECHNICAL STANDARD FOR DIAGNOSTIC MEDICAL
PHYSICS PERFORMANCE MONITORING OF REAL TIME
ULTRASOUND EQUIPMENT
PREAMBLE
These standards are an educational tool designed to assist practitioners in providing
appropriate radiologic care for patients. They are not inflexible rules or requirements of
practice and are not intended, nor should they be used, to establish a legal standard of
care. For these reasons and those set forth below, the American College of Radiology
cautions against the use of these standards in litigation in which the clinical decisions of a
practitioner are called into question.
The ultimate judgment regarding the propriety of any specific procedure or course of
action must be made by the physician or medical physicist in light of all the
circumstances presented. Thus, an approach that differs from the standards, standing
alone, does not necessarily imply that the approach was below the standard of care. To
the contrary, a conscientious practitioner may responsibly adopt a course of action
different from that set forth in the standards when, in the reasonable judgment of the
practitioner, such course of action is indicated by the condition of the patient, limitations
of available resources, or advances in knowledge or technology subsequent to publication
of the standards. However, a practitioner who employs an approach substantially
different from these standards is advised to document in the patient record information
sufficient to explain the approach taken.
The practice of medicine involves not only the science, but also the art of dealing with
the prevention, diagnosis, alleviation, and treatment of disease. The variety and
complexity of human conditions make it impossible to always reach the most appropriate
TECHNICAL STANDARD
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diagnosis or to predict with certainty a particular response to treatment. Therefore, it
should be recognized that adherence to these standards will not assure an accurate
diagnosis or a successful outcome. All that should be expected is that the practitioner will
follow a reasonable course of action based on current knowledge, available resources,
and the needs of the patient to deliver effective and safe medical care. The sole purpose
of these standards is to assist practitioners in achieving this objective.
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I.
INTRODUCTION
All ultrasound equipment should must be evaluated upon installation (acceptance
testing) and routinely at least annually thereafter to ensure that it is functioning properly.
Acceptance testing and performance evaluations are the responsibility of the should be
performed or supervised by a Qualified Medical Physicist. and should include
acceptance testing and routine quality control testing In addition, regular preventive
maintenance should be performed and documented by a qualified equipment service
engineer following the recommendations of the equipment vendor. Although it is not
possible to consider all possible variations of equipment performance to be monitored,
adherence to this standard will maximize image quality. Key points to consider are
performance characteristics to be monitored, qualifications of personnel, and follow-up
procedures.
II.
GOAL
The goal of this document is to produce establish a standard that will allow
production of the highest quality diagnostic images consistent with the clinical use of the
equipment and the information requirement of the examination. and to establish
performance standards
III.
QUALIFICATIONS AND RESPONSIBILITIES OF PERSONNEL
A Qualified Medical Physicist is an individual who is competent to
practice independently one or more of the subfields in medical physics.
The American College of Radiology (ACR) considers certification and
continuing education and experience in the appropriate subfield(s) to
demonstrate that an individual is competent to practice one or more of the
subfields in medical physics and to be a Qualified Medical Physicist. The
ACR recommends that the individual be certified in the appropriate
subfield(s) by the American Board of Radiology (ABR), the Canadian
College of Physics in Medicine, or for MRI, by the American Board of
Medical Physics (ABMP) in magnetic resonance imaging physics.
The appropriate subfields of medical physics for this standard are
Diagnostic Radiological Physics and Radiological Physics.
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A Qualified Medical Physicist should meet the ACR Practice Guideline
for Continuing Medical Education (CME). (ACR Resolution 17, 1996 —
revised in 2008, Resolution 7)
The medical physicist must be familiar with the principles of ultrasound safety and
bioeffects; regulations pertaining to the performance of the equipment being tested; the
physics, function, clinical uses, and performance specifications of the imaging
equipment; and calibration processes and limitations of the instruments methods and
equipment used for testing performance; and analysis and interpretation of test
results.
The medical physicist is responsible for:
1. The design of the overall program of performance monitoring including selection
of specific methods for acceptance testing and quality control testing.
2. Documentation of program goals, policies and procedures.
3. Documentation of the results of all performance measurements.
4. Review and approval of all measurements performed by other designated
personnel.
Properly trained individuals may assist the medical physicist in the overall program
design and documentation, and in obtaining test data for performance monitoring, as well
as other aspects of the program. These individuals must should be trained and
approved by the medical physicist in the techniques of performing the tests, the function
and limitations of the imaging equipment and test instruments, measurement methods,
the reasons for the tests, and the importance of the test results. The medical physicist
must should periodically review and approve all performance measurements and actions
taken to address any specific problems detected by the testing. If it is not possible
for a qualified medical physicist to perform the tasks designated for a medical
physicist, these tasks may be performed by other appropriately trained personnel
with experience. These individuals must be approved by the physician(s) directing
the clinical ultrasound practice.
Program documentation must include:
1.
2.
3.
4.
IV.
Program goals, policies, and responsible personnel.
Testing procedures, equipment, frequencies, and performance criteria.
Results of all performance measurements.
Actions taken to address any specific problems detected by the testing.
PERFORMANCE CHARACTERISTICS TO BE MONITORED
A. Performance Evaluation
Ultrasound system performance evaluations must be performed at least annually, in
addition to routine quality control (QC) as described below. should be evaluated
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periodically. This evaluation should include, but not be limited to, the following tests (as
applicable) (see Appendix A)
The following performance evaluation tests must be performed at least annually on
all machines and transducers:
1.
2.
3.
4.
5.
6.
Physical and mechanical inspection.
Image uniformity and artifact survey.
Geometric accuracy.
Contrast resolution.
Fidelity of the ultrasound scanner electronic image display(s).
System sensitivity.
They may also include, but not be limited to, the following tests (as applicable) 11-31
(see Appendix A):
1.
2.
3.
2.
3.
Spatial resolution.
Contrast resolution.
Fidelity of the ultrasound scanner electronic image display(s).
Fidelity of the display device(s) used for primary interpretation.
Qualitative evaluations of Doppler functionality.
All tests done as part of the routine QC program must also be performed as part of
this performance evaluation.
Either subjective visual methods or objective computer-based approaches may be used to
make these measurements [1,3-6]. If subjective methods are used, it is recommended that
the images used to perform the tests be retained for comparison with subsequent test
images.
Image-based performance measurements must be made using an ultrasound phantom.
Acceptable phantoms are available from a variety of commercial vendors. Appropriate
custom phantoms may also be fabricated by experienced personnel. Other
approaches to performance measurement not requiring ultrasound images of phantoms
have been reported, e.g., the “paper-clip test” [4] and use of the FirstCall transducer test
device from Sonora Medical Systems evaluation devices which test the electrical and
acoustic characteristics of each individual transducer array element [5]. These approaches
may be used for evaluating some performance characteristics if they are appropriately
described by the medical physicist in the overall program documentation. The topic of
display device performance assessment is discussed in the ACR Technical Standard for
Electronic Practice of Medical Imaging.
B. Quality Control Program
A continuous quality control QC program is essential to assure the proper functioning of
all ultrasound equipment. Routine QC is typically performed by appropriately
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trained sonographers or equipment service engineers. Transducers are a weak link in
the ultrasound imaging chain since they are easy to drop, their cables may be easily
kinked and stressed, they are easy to drop and the active elements are relatively fragile.
All scanners and all transducers in routine clinical use should be tested quarterly, but
must be tested at least semiannually. This should allow problems to be identified at an
early stage and before the diagnostic utility of the equipment is significantly impacted.
Quarterly These tests should must include:
1. Physical and mechanical inspection.
2. Image uniformity and artifact survey.
3. Geometric accuracy (only for mechanically scanned transducers).
All transducer ports on each scanner should be tested using at least 1 transducer.
Electronic image displays, both those on the ultrasound equipment and those used for
primary interpretation (e.g., workstation displays), should be tested according to the
recommendations in the ACR Technical Standard for Electronic Practice of Medical
Imaging, in terms of specific tests and testing frequency [7]. Test methods for hard-copy
display equipment are described in Siegel et al [8] and Goodsitt et al [2].
All scanners and transducers should be tested annually for geometric accuracy and
system sensitivity.
C. Acceptance Testing
The performance of all ultrasound imaging equipment must be extensively evaluated at
the time it is acquired. This includes purchases of new scanners and/or transducers, as
well as replacement equipment obtained under warranty or service contract. Acceptance
testing should be done following equipment repair, and may also be warranted following
major equipment upgrade. Equipment pulled from storage should also undergo
acceptance testing. These tests should provide complete performance baselines for
comparison with future test results.
1. Ultrasound scanners. Acceptance testing of a scanner alone (i.e., without testing
transducers) may be performed using a single transducer. These tests should
include:
a. Physical and mechanical inspection.
b. Image uniformity/artifact survey (each transducer port on the scanner should
be tested).
c. Geometric accuracy.
d. System sensitivity.
e. Spatial resolution.
f. Contrast resolution.
g. Fidelity of ultrasound scanner electronic image display(s).
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For those systems with tissue harmonic imaging capabilities, at minimum, tests d, e,
and f above should be repeated in this mode.
For those systems with spectral Doppler and color-flow imaging capabilities,
qualitative evaluations of these capabilities should be performed.
2. Ultrasound transducers. Acceptance tests should include:
a.
b.
c.
d.
e.
f.
Physical and mechanical inspection.
Image uniformity/artifact survey.
Geometric accuracy.
System sensitivity.
Spatial resolution.
Contrast resolution.
All tests done as part of the QC program must be included in acceptance testing.
D. Written Survey Reports and Follow-Up Procedures
If test results fall outside of the acceptable limits, corrective action should must be taken.
This is typically accomplished by an equipment service engineer. If appropriate, the
medical physicist should initiate the required service Appropriate action and notification
shall must occur immediately if there is imminent danger to patients or staff using the
equipment due to unsafe conditions. A medical physicist should be available to assist in
prescribing corrective actions for unresolved problems After a problem has been
addressed, acceptance testing should be performed to assure adequate resolution of the
problem, and these test results should be documented.
The medical physicist shall report Results of the acceptance tests and QC program testing
must be reported to the physician(s) directing the clinical ultrasound practice, the
responsible professional(s) in charge of obtaining or providing necessary service to the
equipment, and, in the case of the consulting personnel, physicist(s) to the representative
of the hiring party. This communication shall be provided in a timely manner consistent
with the importance of any adverse findings.
V.
QUALITY CONTROL AND IMPROVEMENT, SAFETY, INFECTION
CONTROL, AND PATIENT EDUCATION
Policies and procedures related to quality, patient education, infection control, and safety
should be developed and implemented in accordance with the ACR Policy on Quality
Control and Improvement, Safety, Infection Control, and Patient Education appearing
under the heading Position Statement on QC & Improvement, Safety, Infection Control,
and Patient Education on the ACR web site (http://www.acr.org/guidelines).
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ACKNOWLEDGEMENTS
This guideline was revised according to the process described under the heading The
Process for Developing ACR Practice Guidelines and Technical Standards on the ACR
web site (http://www.acr.org/guidelines) by the Guidelines and Standards Committees of
the ACR Commissions on Medical Physics and Ultrasound.
Principal Reviewer: Nicholas J. Hangiandreou, PhD
Guidelines and Standards Committee — Medical Physics — ACR Committee
responsible for sponsoring the draft through the process
Richard A. Geise, PhD, FACR, Chair
Tariq A. Mian, PhD, FACR, Vice Chair
William K. Breeden, III, MS
Laurence E. Court, PhD
Martin W. Fraser, MS
Nicholas J. Hangiandreou, PhD
Bruce E. Hasselquist, PhD
Ralph P. Lieto, MS
Mahadevappa Mahesh, MS, PhD, FACR
James T. Norweck, MS
Janelle L. Park, MD
Doug Pfeiffer, MS
Gerald A. White, Jr., MS, FACR
James M. Hevezi, PhD, FACR, Chair, Commission
Guidelines and Standards Committee — Ultrasound — ACR Committee responsible
for sponsoring the draft through the process
Mary C. Frates, MD, FACR, Chair
Debra L. Acord, MD
Sandra 0. Allison, MD
Marcela Bohm-Velez, MD, FACR
Helena Gabriel, MD
Ruth B. Goldstein, MD
Robert D. Harris, MD, MPH, FACR
Beverly E. Hashimoto, MD, FACR
Leann E. Linam, MD
Laurence Needleman, MD, FACR
Maitray D. Patel, MD
Michelle L. Robbin, MD, FACR
Robert M. Sinow, MD
Maryellen R. M. Sun, MD
Deborah Levine, MD, FACR, Chair, Commission
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REFERENCES
1. Gibson NM, Dudley NJ, Griffith K. A computerised quality control testing system for
B-mode ultrasound. Ultrasound Med Biol 2001;27:1697-1711.
2. Goodsitt MM, Carson PL, Witt S, Hykes DL, Kofler JM, Jr. Real-time B-mode
ultrasound quality control test procedures. Report of AAPM Ultrasound Task Group
No. 1. Med Phys 1998;25:1385-1406.
3. Thijssen JM, Weijers G, de Korte CL. Objective performance testing and quality
assurance of medical ultrasound equipment. Ultrasound Med Biol 2007;33:460-471.
4. Goldstein A, Ranney D, McLeary RD. Linear array test tool. J Ultrasound Med
1989;8:385-397.
5. Moore GW, Gessert A, Schafer M. The need for evidence-based quality assurance in
the modern ultrasound clinical laboratory. Ultrasound 2005;13:158-162.
6. Skolnick ML. Estimation of ultrasound beam width in the elevation (section
thickness) plane. Radiology 1991;180:286-288.
7. ACR Technical Standard for the Electronic Practice of Medical Imaging.
http://www.acr.org/SecondaryMainMenuCategories/quality_safety/guidelines/m
ed_phys/electronic_practice.aspx. Accessed January 27, 2010.
8. Siegel EL, Templeton AW, Cook LT, Eckard DA, Harrison LA, Dwyer SJ, 3rd.
Image calibration of laser digitizers, printers, and gray-scale displays. Radiographics
1992;12:329-335.
Suggested Reading (Additional articles that are not cited in the document but that the
committee recommends for further reading on this topic)
9. Specification acceptance testing and quality control of diagnostic x-ray imaging
equipment. College Park, Md: American Association of Physicists in Medicine; 1991.
AAPM Monograph 20.
10. A Guide to Continuous Quality Improvement in Medical Imaging. Reston, Va:
American College of Radiology; 1996.
11. Gray JE, Lisk KG, Haddick DH, Harshbarger JH, Oosterhof A, Schwenker R. Test
pattern for video displays and hard-copy cameras. Radiology 1985; 154:519-527.
12. Kofler JM, Groth DS. Ultrasound Quality Control: Basic Tests. Rochester, Minn:
Mayo Clinic and Foundation; 1996.
13. Lopez H. Methods for Measuring Performanceof Pulse-Echo Ultrasound Equipment,
Part II: Digital Methods (stage 1). Laurel, Md: American Institute of Ultrasound in
Medicine; 1995.
14. Madsen E. Quality Assurance Manual for GrayScale Ultrasound Scanners (stage 2).
Laurel, Md: American Institute of Ultrasound in Medicine; 1995.
15. Papp J. Quality Management in the Imaging Sciences. St. Louis, MO: Mosby; 1998.
16. van Wijk MC, Thijssen JM. Performance testing of medical ultrasound equipment:
fundamental vs. harmonic mode. Ultrasonics 2002; 40:585-591.
Appendix A
1. Physical and mechanical inspection — this assures the mechanical integrity of the
equipment, and the safety of patient and operator.
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2. Image uniformity/artifact survey — this test aims to identify the presence of artifacts,
often axial or lateral streaks in scans of uniform sections of a phantom. The use of
“in-air” images (i.e., images acquired without the use of gel or phantom) may also be
useful in detecting superficial artifacts.
3. Geometric accuracy — tests often involve use of the scanner calipers to measure
known distances between phantom test targets in the axial and lateral directions,
although other tests of geometric accuracy have been described. The use of a phantom
with a sound speed closely matching 1,540 m/s is recommended for determining
absolute performance.
4. System sensitivity — visual determination of the maximum depth of visualization of
speckle patterns or phantom targets, and quantitative measurements of signal-to-noise
ratio (SNR), have both been reported.
5. Spatial resolution — this should be measured in the axial, lateral, and elevational
directions. Various approaches have been described for making axial and lateral
resolution measurements, including visual interpretation of groups of phantom
pin/fiber targets and measurement of pin target dimensions. Similarly, various
approaches for making elevational resolution measurements have been discussed, one
requiring a special phantom, and one compatible with multipurpose phantoms [4].
The use of a phantom with a sound speed closely matching 1,540 m/s is
recommended for determining absolute performance.
6. Contrast resolution — the use of both anechoic and low contrast echogenic targets has
been suggested, as has the use of 2D cylindrical targets and 3D spherical targets. The
use of larger 2D targets emphasizes contrast resolution performance, while the use of
small targets also tests spatial resolution capabilities.
7. Fidelity of ultrasound scanner electronic image display(s) — when used for diagnostic
purposes, the electronic displays on the scanner and any modality workstations should
be considered as primary diagnostic devices. This would not necessarily be the case
for scanners used exclusively as an aid to guide procedures. Display characteristics
that are evaluated may include gray scale response, presence of pixel defects,
and overall image quality. These evaluations are typically performed using
specialize test pattern images, and may also involve the use of photometric
equipment.
8. Fidelity of display device(s) used for primary interpretation — these primary
diagnostic displays may be electronic soft-copy displays on a workstation or hardcopy films. Display characteristics that are evaluated may include gray scale
response, presence of pixel defects, and overall image quality. These evaluations
are typically performed using specialize test pattern images, and may also
involve the use of photometric equipment.
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9. Qualitative evaluations of Doppler functionality — for spectral Doppler mode, the tests
include positioning of the Doppler sampling volume, specification of Doppler angle,
Doppler spectral display, directionality of flow, and lack of velocity signal where no
flow is present. For color flow imaging mode, the tests include color map and flow
direction, and color signal superimposition on the grayscale image. As these are
visual, qualitative tests, the use of a phantom is not required.
*Guidelines and standards are published annually with an effective date of October 1 in
the year in which amended, revised or approved by the ACR Council. For guidelines and
standards published before 1999, the effective date was January 1 following the year in
which the guideline or standard was amended, revised, or approved by the ACR Council.
Development Chronology for this Standard
1999 (Resolution 18)
Revised 2004 (Resolution 17c)
Amended 2006 (Resolution 16g)
Revised 2009 (Resolution 9)
Ultrasound Equipment
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RESOLUTION NO. 4
BE IT RESOLVED,
that the American College of Radiology adopt the ACR
Technical Standard for Diagnostic Medical Physics
Performance Monitoring of Radiographic and Fluoroscopic
Equipment
Sponsored by:
Council Steering Committee
Radiographic Fluoroscopic Equipment
TECHNICAL STANDARD
Resolution No. 4
NOT FOR PUBLICATION, QUOTATION, OR CITATION
The American College of Radiology, with more than 30,000 members, is the principal organization of radiologists, radiation
oncologists, and clinical medical physicists in the United States. The College is a nonprofit professional society whose primary
purposes are to advance the science of radiology, improve radiologic services to the patient, study the socioeconomic aspects of the
practice of radiology, and encourage continuing education for radiologists, radiation oncologists, medical physicists, and persons
practicing in allied professional fields.
The American College of Radiology will periodically define new practice guidelines and technical standards for radiologic
practice to help advance the science of radiology and to improve the quality of service to patients throughout the United States.
Existing practice guidelines and technical standards will be reviewed for revision or renewal, as appropriate, on their fifth anniversary
or sooner, if indicated.
Each practice guideline and technical standard, representing a policy statement by the College, has undergone a thorough
consensus process in which it has been subjected to extensive review, requiring the approval of the Commission on Quality and Safety
as well as the ACR Board of Chancellors, the ACR Council Steering Committee, and the ACR Council. The practice guidelines and
technical standards recognize that the safe and effective use of diagnostic and therapeutic radiology requires specific train ing, skills,
and techniques, as described in each document. Reproduction or modification of the published practice guideline and technical
standard by those entities not providing these services is not authorized .
ACR TECHNICAL STANDARD FOR DIAGNOSTIC MEDICAL
PHYSICS PERFORMANCE MONITORING OF RADIOGRAPHIC
AND FLUOROSCOPIC EQUIPMENT
PREAMBLE
These standards are an educational tool designed to assist practitioners in providing
appropriate radiologic care for patients. They are not inflexible rules or requirements of
practice and are not intended, nor should they be used, to establish a legal standard of
care. For these reasons and those set forth below, the American College of Radiology
cautions against the use of these standards in litigation in which the clinical decisions of a
practitioner are called into question.
The ultimate judgment regarding the propriety of any specific procedure or course of
action must be made by the physician or medical physicist in light of all the
circumstances presented. Thus, an approach that differs from the standards, standing
alone, does not necessarily imply that the approach was below the standard of care. To
the contrary, a conscientious practitioner may responsibly adopt a course of action
different from that set forth in the standards when, in the reasonable judgment of the
practitioner, such course of action is indicated by the condition of the patient, limitations
of available resources, or advances in knowledge or technology subsequent to publication
of the standards. However, a practitioner who employs an approach substantially
different from these standards is advised to document in the patient record information
sufficient to explain the approach taken.
The practice of medicine involves not only the science, but also the art of dealing with
the prevention, diagnosis, alleviation, and treatment of disease. The variety and
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complexity of human conditions make it impossible to always reach the most appropriate
diagnosis or to predict with certainty a particular response to treatment. Therefore, it
should be recognized that adherence to these standards will not assure an accurate
diagnosis or a successful outcome. All that should be expected is that the practitioner will
follow a reasonable course of action based on current knowledge, available resources,
and the needs of the patient to deliver effective and safe medical care. The sole purpose
of these standards is to assist practitioners in achieving this objective.
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I.
INTRODUCTION
This standard was revised by the American College of Radiology (ACR) with assistance
from the American Association of Physicists in Medicine (AAPM).
The performance of all radiographic and fluoroscopic equipment shall must be evaluated
upon installation and monitored at least annually by a Qualified Medical Physicist to
ensure that the equipment is functioning properly and that patients are not exposed to
unnecessary doses of radiation. Additional or more frequent monitoring may be necessary
after repairs that might change the radiation exposure to patients or personnel or the
imaging performance of the equipment. Although it is not possible to consider all
possible variations of equipment performance to be monitored, adherence to this standard
will assist in maximizing image quality and in reducing patient radiation doses. Key
points to consider are: performance characteristics to be monitored, patient radiation
dose, qualifications of the personnel, and follow-up procedures
II.
GOAL
The goals are to produce the highest quality diagnostic image at the lowest reasonable
radiation dose consistent with the clinical use of the equipment and the information
requirement of the examination and to establish and maintain performance standards.
III.
QUALIFICATIONS AND RESPONSIBILITIES OF PERSONNEL
A Qualified Medical Physicist is an individual who is competent to
practice independently one or more of the subfields in medical physics.
The American College of Radiology (ACR) considers certification and
continuing education and experience in the appropriate subfield(s) to
demonstrate that an individual is competent to practice one or more of the
subfields in medical physics, and to be a Qualified Medical Physicist. The
ACR recommends that the individual be certified in the appropriate
subfield(s) by the American Board of Radiology (ABR), the Canadian
College of Physics in Medicine, or for MRI, by the American Board of
Medical Physics (ABMP) in magnetic resonance imaging physics.
The appropriate subfields for this standard are Diagnostic Radiological
Physics and Radiological Physics.
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A Qualified Medical Physicist should meet the ACR Practice Guideline
for Continuing Medical Education (CME). (ACR Resolution 17, 1996 —
revised in 2008, Resolution 7)
Understanding of the relationship between image quality and patient radiation dose is
essential to for proper monitoring of equipment performance. The medical physicist must
be familiar with the principles of imaging physics and radiation protection; the current
guidelines of the National Council on Radiation Protection and Measurements (NCRP);
federal and local laws and regulations pertaining to the performance of the equipment
being tested; the function, clinical uses, and performance specifications of the imaging
equipment; and calibration processes and limitations of the instruments used for testing
performance.
The medical physicist may be assisted by other properly trained individuals in obtaining
test data for performance monitoring. These individuals must be properly trained and
approved by the medical physicist in the techniques of performing the tests, the function
and limitations of the imaging equipment and test instruments, the reasons for the tests,
and the importance of the test results. The tests will be performed by or under the
general supervision of the medical physicist, who is responsible for must be available
at the facility during initial and annual surveys and must review, interpret, and approve
all data measurements and provide a signed report.
IV.
PERFORMANCE CHARACTERISTICS TO BE MONITORED
A. Performance Evaluation Equipment Characteristics to be Monitored
The performance of each radiographic and fluoroscopic unit must be evaluated at
least annually. This evaluation should include, but not be limited to, the following
tests (as applicable): following characteristics shall be evaluated for the equipment to
which they apply
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
Integrity of unit assembly.
Collimation and radiation beam alignment.
Fluoroscopic system resolution.
Automatic exposure control system performance.
Fluoroscopic automatic brightness control performance (high-dose-rate,
pulsed modes, field-of-view [FOVI variation).
Image artifacts.
Fluoroscopic phantom image quality.
kVp accuracy and reproducibility.
Linearity of exposure versus mA or mAs.
Exposure reproducibility.
Timer accuracy.
Beam quality assessment (half-value layer).
Fluoroscopic entrance exposure rates.
Image receptor entrance exposure.
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15.
16.
17.
18.
19.
Equipment radiation safety functions.
Patient dose monitoring system calibration if present.
Video and digital monitor performance.
Digital image receptor performance.
Fluoroscopic alignment test.
For further information on computed radiography ICRI and digital radiography
IDRI systems please see the ACR—AAPM—SIIM Practice Guideline for Digital
Radiography I1I.
B. Moni toring of Te chnolo gist ’s Quality Control
Program
A continuous quality control (QC) program must be implemented for all
radiographic and fluoroscopic units. The program should be established with the
assistance of the medical physicist. The medical physicist should identify the person
responsible for performing the tests and may choose to modify the frequency of
testing based on the system’s usage and performance. The QC program should
include, but not be limited to, the following tests (as applicable): The following
aspects of a technolo gist ’s quali t y control pr ogr am shall b e reviewed
as deemed applicable
1.
2.
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5.
6.
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5.
6.
7.
8.
Appropriateness of technique factors.
Visual equipment checklists.
Phantom images.
Repeat analysis.
Viewboxes, image monitors, and viewing conditions.
Laser film printer quality control.
Darkroom and screen cleanliness.
Processor quality control.
Screen film screen speed matching.
Analysis of fixer retention.
Darkroom fog.
Screen-film contact.
CR and DR system performance.
Personnel radiation monitoring
Viewboxes and viewing conditions
Phantom images
Visual equipment checklists
Repeat analysis
C. Radiation Dose and Patient Safety
Patient radiation dose shall be evaluated for radiographic and fluoroscopic equipment at
least annually. Tables of patient radiation exposure for representative examinations shall
be prepared and supplied to the facility. These tables shall be prepared using measured
radiation output data and imaging techniques provided by the facility. These results shall
be compared with appropriate guidelines or recommendations when they are available.
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The medical physicist should assist facilities in developing policies and procedures to
evaluate risks to patients, personnel, and physicians from studies and interventions
requiring prolonged radiation exposure. Electrical safety of the equipment should be
tested by appropriate personnel prior to its initial clinical use and periodically thereafter.
C. Acceptance Testing
Acceptance testing shall Initial performance testing of imaging equipment must be
performed upon installation and should be completed before clinical use. This testing
shall must be more comprehensive than periodic performance and compliance testing
and shall must be consistent with current acceptance testing practices. Electrical safety
of the equipment must also be tested by appropriate personnel prior to its initial
clinical use.
D. Written Survey Reports and Follow-Up Procedures
The medical physicist shall must provide a written report of the findings of acceptance
testing and performance evaluation to the responsible physician(s), if appropriate,
and to the professional(s) in charge of obtaining or providing necessary service to the
equipment. And If appropriate, the medical physicist should initiate the required
service. Written reports must be provided in a timely manner consistent with the
importance of any adverse findings.
Action shall be taken immediately by verbal communication if there is If use of the
equipment would pose imminent danger to patients or staff, the medical physicist must
take immediate action to prevent its use. using the equipment due to either unsafe
conditions or unacceptably poor image quality. Written reports shall be provided in a
timely manner consistent with the importance of any adverse findings. The medical
physicist shall confirm that the unit is performing in a safe or acceptable fashion as soon
as possible after the required service has been performed.
V.
RADIATION SAFETY IN IMAGING
Radiologists, medical physicists, radiologic technologists, and all
supervising physicians have a responsibility to minimize radiation dose to
individual patients, to staff, and to society as a whole, while maintaining
the necessary diagnostic image quality. This concept is known as “as low
as reasonably achievable (ALARA).”
Facilities, in consultation with the medical physicist, should have in place
and should adhere to policies and procedures, in accordance with ALARA,
to vary examination protocols to take into account patient body habitus,
such as height and/or weight, body mass index or lateral width. The dose
reduction devices that are available on imaging equipment should be
active; if not; manual techniques should be used to moderate the exposure
while maintaining the necessary diagnostic image quality. Periodically,
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radiation exposures should be measured and patient radiation doses
estimated by a medical physicist in accordance with the appropriate ACR
Technical Standard. (ACR Resolution 17, adopted in 2006 — revised in
2009, Resolution 11)
Patient radiation dose must be estimated for radiographic and fluoroscopic
equipment at least annually. Tables of patient radiation exposure for representative
examinations must be prepared and supplied to the facility. These tables must be
prepared using measured radiation output data and imaging techniques provided
by the facility. These results must be compared with appropriate guidelines or
recommendations when they are available 12-31. The medical physicist should assist
facilities in understanding and developing policies and procedures to evaluate risks
to patients, personnel, and physicians from studies and interventions requiring
prolonged radiation exposure 13-131.
ACKNOWLEDGEMENTS
This standard was revised according to the process described under the heading The
Process for Developing ACR Practice Guidelines and Technical Standards on the ACR
web site (http://www.acr.org/guidelines) by the Guideline and Standards Committee of
the ACR Commission on Medical Physics with assistance from the AAPM.
Principal Reviewer: Mahadevappa Mahesh, MS, PhD, FACR
John M. Boone, PhD, FACR
Guidelines and Standards Committee — Medical Physics — ACR Committee
responsible for sponsoring the draft through the process
Richard A. Geise, PhD, FACR, Chair
Tariq A. Mian, PhD, FACR, Vice Chair
William K. Breeden, III, MS
Laurence E. Court, PhD
Martin W. Fraser, MS
Nicholas J. Hangiandreou, PhD
Bruce E. Hasselquist, PhD
Ralph P. Lieto, MS
Mahadevappa Mahesh, MS, PhD, FACR
James T. Norweck, MS
Janelle L. Park, MD
Doug Pfeiffer, MS
Gerald A. White, Jr., MS, FACR
James M. Hevezi, PhD, FACR, Chair, Commission
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REFERENCES
1. American College of Radiology. Practice guideline for digital radiography.
http://www.acr.org/SecondaryMainMenuCategories/quality_safety/guidelines/dx
/digital_radiography.aspx. Accessed June 29, 2010.
2. American College of Radiology. Practice guideline for diagnostic reference levels
in medical x-ray imaging.
http://www.acr.org/SecondaryMainMenuCategories/quality_safety/guidelines/m
ed_phys/reference_levels.aspx. Accessed June 29, 2010.
3. Public Health Advisory: Avoidance of Serious X-Ray Induced Skin Injuries to
Patients During Fluoroscopically-Guided Procedures. Rockville, Md: Food and Drug
Administration; 1994.
4. Specification and Acceptance Testing and Quality Assurance of Diagnostic X-Ray
Imaging Equipment. College Park, Md: American Association of Physicists in
Medicine; 1994. AAPM Monograph 20.
5. Managing the Use of Fluoroscopy in Medical Institutions. College Park, Md:
American Association of Physicists in Medicine; 1998. AAPM Report 58.
6. Cardiac Catheterization Equipment Performance. College Park, Md: American
Association of Physicists in Medicine; 2001. AAPM Report 70.
7. Structural Shielding Design for Medical X-Ray Imaging Facilities. Bethesda, Md:
National Council on Radiation Protection and Measurements; 2004. NCRP Report
147.
8. Performance Standards for Diagnostic X-Ray Systems and their Major Components:
Federal Register; June 10, 2005. Final Rule 21 CFR Part 1020.30-1020.32.
9. Balter S, Hopewell JW, Miller DL, Wagner LK, Zelefsky MJ. Fluoroscopically
guided interventional procedures: a review of radiation effects on patients’ skin
and hair. Radiology 2010;254:326-341.
10. Mahesh M. Fluoroscopy: patient radiation exposure issues. Radiographics
2001;21:1033-1045.
11. Miller DL, Balter S, Wagner LK, et al. Quality improvement guidelines for
recording patient radiation dose in the medical record. J Vasc Interv Radiol
2009;20:S200-207.
12. Seibert JA, Filipow L, Andriole K, ed. Practical Digital Imaging and PACS.
Madison, Wisc: Medical Physics Publishing; AAPM Monograph 25; 1999.
13. Stecker MS, Balter S, Towbin RB, et al. Guidelines for patient radiation dose
management. J Vasc Interv Radiol 2009;20:S263-273.
Suggested Reading (Additional articles that are not cited in the document but that the
committee recommends for further reading on this topic)
2. Balter S, Shope TB. Syllabus: A Categorical Course in Physics — Physical and
Technical Aspects of Angiography and Interventional Radiology. Oak Brook, Ill:
Radiological Society of North America; 1995.
3. Barium Enema Quality Control Manual. Reston, Va: American College of
Radiology; 1998.
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5. Exposure of the US Population from Diagnostic Medical Radiation. Bethesda, Md:
National Council on Radiation Protection and Measurements; NCRP Report 100;
1989.
6. Frey GD, Sprawls P. The Expanding Role of Medical Physics in Diagnostic Imaging.
College Park, Md: American Association of Physicists in Medicine; AAPM
Monograph 23; 1997.
7. Gray JE, Winkler NT, Stears J, et al. Quality Control in Diagnostic Imaging.
Rockville, Md: Aspen Systems Corporation; 1983.
8. Import ant Information: Recordi ng Information in the Patient’s Medical
Record that Identifies the Potential for Serious X-Ray Induced Skin
Injuries Following Fluoroscopically-Guided Procedures. Rockville, Md: Food and
Drug Administration;1995.
9. Limitation of Exposure to Ionizing Radiation. Bethesda, Md: National Council on
Radiation Protection and Measurements: NCRP Report 16; 1993.
11. Managing Patient Dose in Digital Radiology. Sweden: International Commission of
Radiological Protection; Publication 93; 2003.
13. Medical X-Ray, Electron Beam and Gamma-Ray Protection for Energies up to 50
MeV. (Equipment Design, Performance, and Use). Bethesda, Md: National Council
on Radiation Protection and Measurements; NCRP Report 102; 1989.
14. Nelson RE, Stears JG, Barnes GT, et al. Acceptance testing of radiological systems:
experience in testing 129 imaging systems at two major medical facilities. Radiology
1992;183:563-567.
15. Nickoloff EL, Strauss KJ. Syllabus: A Categorical Course in Diagnostic Radiology
Physics: Cardiac Catherization Imaging. Oak Brook, Ill: Radiological Society of
North America; 1998.
16. Quality Assurance for Diagnostic Imaging Equipment. Bethesda, Md: National
Council on Radiation Protection and Measurements; NCRP Report 99; 1988.
19. Protocols for Radiation Safety Service of Diagnostic Radiological Equipment.
College Park, Md: American Association of Physicists in Medicine; AAPM Report
25; 1988.
*Guidelines and standards are published annually with an effective date of October 1 in
the year in which amended, revised or approved by the ACR Council. For guidelines and
standards published before 1999, the effective date was January 1 following the year in
which the guideline or standard was amended, revised, or approved by the ACR Council.
Development Chronology for this Standard
1992 (Resolution 11)
Amended (Resolution 13)
Revised 1997 (Resolution 17)
Revised 2001 (Resolution 18)
Revised 2006 (Resolution 29, 16g, 17)
Amended 2009 (Resolution 11)
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RESOLUTION NO. 5
BE IT RESOLVED,
that the American College of Radiology adopt the ACR-SNM
Technical Standard for Procedures
Using Radiopharmaceuticals
Sponsored by:
Council Steering Committee
Radiopharmaceuticals
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The American College of Radiology, with more than 30,000 members, is the principal organization of radiologists, radiation
oncologists, and clinical medical physicists in the United States. The College is a nonprofit professional society whose primary
purposes are to advance the science of radiology, improve radiologic services to the patient, study the socioeconomic aspects of the
practice of radiology, and encourage continuing education for radiologists, radiation oncologists, medical physicists, and persons
practicing in allied professional fields.
The American College of Radiology will periodically define new practice guidelines and technical standards for radiologic
practice to help advance the science of radiology and to improve the quality of service to patients throughout the United States.
Existing practice guidelines and technical standards will be reviewed for revision or renewal, as appropriate, on their fifth anniversary
or sooner, if indicated.
Each practice guideline and technical standard, representing a policy statement by the College, has undergone a thorough
consensus process in which it has been subjected to extensive review, requiring the approval of the Commission on Quality and Safety
as well as the ACR Board of Chancellors, the ACR Council Steering Committee, and the ACR Council. The practice guidelines and
technical standards recognize that the safe and effective use of diagnostic and therapeutic radiology requires specific train ing, skills,
and techniques, as described in each document. Reproduction or modification of the published practice guideline and technical
standard by those entities not providing these services is not authorized .
ACR-SNM TECHNICAL STANDARD FOR DIAGNOSTIC
PROCEDURES USING RADIOPHARMACEUTICALS
PREAMBLE
These standards are an educational tool designed to assist practitioners in providing
appropriate radiologic care for patients. They are not inflexible rules or requirements of
practice and are not intended, nor should they be used, to establish a legal standard of
care. For these reasons and those set forth below, the American College of Radiology
cautions against the use of these standards in litigation in which the clinical decisions of a
practitioner are called into question.
The ultimate judgment regarding the propriety of any specific procedure or course of
action must be made by the physician or medical physicist in light of all the
circumstances presented. Thus, an approach that differs from the standards, standing
alone, does not necessarily imply that the approach was below the standard of care. To
the contrary, a conscientious practitioner may responsibly adopt a course of action
different from that set forth in the standards when, in the reasonable judgment of the
practitioner, such course of action is indicated by the condition of the patient, limitations
of available resources, or advances in knowledge or technology subsequent to publication
of the standards. However, a practitioner who employs an approach substantially
different from these standards is advised to document in the patient record information
sufficient to explain the approach taken.
The practice of medicine involves not only the science, but also the art of dealing with
the prevention, diagnosis, alleviation, and treatment of disease. The variety and
complexity of human conditions make it impossible to always reach the most appropriate
TECHNICAL STANDARD
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diagnosis or to predict with certainty a particular response to treatment. Therefore, it
should be recognized that adherence to these standards will not assure an accurate
diagnosis or a successful outcome. All that should be expected is that the practitioner will
follow a reasonable course of action based on current knowledge, available resources,
and the needs of the patient to deliver effective and safe medical care. The sole purpose
of these standards is to assist practitioners in achieving this objective.
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I.
INTRODUCTION
This standard was revised collaboratively by the American College of Radiology
(ACR) and the Society of Nuclear Medicine (SNM).
This standard was developed by the American College of Radiology (ACR) to cover key
aspects pertinent to the performance of nuclear imaging, and in-vivo nonimaging
diagnostic studies, and therapy using radiopharmaceuticals.
II.
DEFINITION
Radiopharmaceuticals are drugs that are intended for use in the diagnosis, therapy,
or monitoring of a disease or a manifestation of a disease in humans and that exhibit
spontaneous disintegration of unstable nuclei with the emission of nuclear particles
or photons, or any nonradioactive reagent kit or radionuclide generator that is
intended to be used in the preparation of such articles. (FDA definition of
radiopharmaceutical: 21CFR315.2, 1997 FDAMA section 122(b) I11.)
Radiopharmaceuticals are unsealed radioactive agents used for diagnostic or therapeutic
purposes. They may demonstrate different pharmacokinetic characteristics in normal and
abnormal body tissues or fluids. Static images and dynamic, time-related information are
obtained with special equipment which records the spatial and, frequently, the temporal
pattern of the administered radiopharmaceutical. Altered pharmacokinetics of the
administered agent induced by physiological and pharmacological intervention can be
studied as well.
This standard is intended to be antecedent to all guidelines and standards covering the use
of radiopharmaceuticals for diagnosis or therapy. unsealed radionuclide sources for
diagnosis
III.
QUALIFICATIONS OF PERSONNEL
A. Physician
The physician providing nuclear medicine services must meet all of the following
criteria:
1. Certification in Radiology, Diagnostic Radiology, Nuclear Radiology, or Nuclear
Medicine by one of the following organizations: the American Board of
Radiology (ABR), the American Board of Nuclear Medicine, the American
Radiopharmaceuticals
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Osteopathic Board of Radiology, the Royal College of Physicians and Surgeons
of Canada, Le College des Medecins du Quebec, the American Board of Nuclear
Medicine and/or the American Osteopathic Board of Nuclear Medicine. In
addition, the physician should have appropriate training and experience in
specific examinations or therapy as defined in procedure specific guidelines
when applicable.
or
At a minimum, completion of a formal Accreditation Council for Graduate
Medical Education (ACGME) approved general nuclear medicine program or an
American Osteopathic Association (AOA) approved nuclear medicine program
that must meet all Nuclear Regulatory Commission (NRC) requirements as
cited in 10 CFR 35.290(c)(1)(i) 121. include training in radiation physics,
instrumentation, radiochemistry, radiopharmacology, radiation dosimetry,
radiation biology, radiation safety and protection, and quality control In addition,
clinical training in general nuclear medicine is required. The training must cover
technical performance, calculation of administered activity, evaluation of images,
and correlation with other diagnostic modalities, interpretation, and formal
reporting. Physicians trained prior to the availability of formal instruction in
nuclear medicine-related sciences may be exempted from this paragraph
requirement, provided they have been actively involved in providing nuclear
medicine services.
and
2. Have documented regular participation in continuing medical education (CME)
specifically related to diagnostic procedures using radiopharmaceuticals, in
accordance with the ACR Practice Guideline for Continuing Medical Education
(CME) [3]. In addition, expertise should be maintained on a continual basis
to ensure the quality and safety of patient care through ongoing experience
as defined in procedure specific guidelines and maintenance of certification
as appropriate.
3. Be listed as an authorized user on the radioactive materials license of his or her
institution. When required by the NRC or by the state, at least one physician
member of the facility must be a participating member of the committee that deals
with radiation safety.
4. Have a thorough understanding of each procedure with which he or she is
involved. The physician is further responsible for ensuring appropriate utilization
of services, for the quality of procedures, for all aspects of patient and facility
safety, and for compliance with applicable government and institutional
regulations regarding the use of radiopharmaceuticals.
5. Be responsible for developing and maintaining a program of quality control and
continued quality improvement (see sections IV and V) or accept responsibility
for adhering to such an established program.
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The physician may also be required to hold current Advanced Cardiac Life Support
(ACLS) certification if monitoring patients undergoing cardiac stress studies.
B. Nuclear Medicine Technologist
The technologist performing nuclear medicine services should meet all of the following
criteria:
1. Successful completion of an accredited training program in nuclear medicine
technology. This program must include training education in the basic and
medical sciences as they apply to nuclear medicine technology and practical
experience in performing nuclear medicine procedures. The technologist must
satisfy all state and federal regulations that pertain to the in vivo and in vitro use
of radiopharmaceuticals and performance of imaging procedures.
or
Hold current registration by with the American Registry of Radiologic
Technologists (ARRT) (N) or equivalent body as recognized by the American
College of Radiology, or certification by the Nuclear Medicine Technology
Certification Board (NMTCB).
and
2. Licensure, if required by state regulations.
3. Documented regular participation in continuing education to maintain competence
in the workplace.
4. Knowledge of radiation safety and protection, handling the compounding,
preparing, and administration of radiopharmaceuticals, all aspects of
performing examinations, operation of equipment, handling of medical and
radioactive waste, patient safety, and applicable rules and regulations.
C. Qualified Medical Physicist or Other Qualified Scientist
A Qualified Medical Physicist is an individual who is competent to
practice independently one or more of the subfields in medical physics.
The ACR considers certification and continuing education and experience
in the appropriate subfield(s) to demonstrate that an individual is
competent to practice one or more of the subfields in medical physics and
to be a Qualified Medical Physicist. The ACR recommends that the
individual be certified in the appropriate subfield(s) by the American
Board of Radiology (ABR), the Canadian College of Physics in Medicine,
or for MRI, by the American Board of Medical Physics (ABMP) in
magnetic resonance imaging physics.
The appropriate subfields of medical physics for this standard are
Radiological Physics and Medical Nuclear Physics.
Radiopharmaceuticals
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A Qualified Medical Physicist should meet the ACR Practice Guideline
for Continuing Medical Education (CME). (ACR Resolution 17, 1996 —
revised in 2008, Resolution 7)
Certification in Nuclear Medicine Physics and Instrumentation by the
American Board of Science in Nuclear Medicine (ABSNM) is also
acceptable.
D. Radiation Safety Officer (RSO)
The Radiation Safety Officer (RSO) must meet applicable NRC requirements for
training as specified in 10 CFR 35.50, or equivalent state regulations 141.
The Qualified Medical Physicist or other qualified scientist performing services in
support of nuclear medicine facilities should meet all of the following criteria:
1. Advanced training directed at the specific area of responsibility (e.g.,
radiopharmacy, medical physics, health physics, or instrumentation).
2. Licensure, if required by state regulations.
3. Documented regular participation in continuing education in the area of specific
involvement to maintain competency.
4. Knowledge of radiation safety and protection and of all rules and regulations
applying to the area of practice.
E. Nuclear Pharmacist
The Nuclear Pharmacist must meet applicable NRC requirements for training as
specified in 10 CFR 35.55, or equivalent state regulations 151.
IV.
RADIOPHARMACY
A. Responsibility
1. The nuclear medicine physician is ultimately responsible for the safety and
appropriate utilization of all radiopharmaceuticals prepared and/or used under his
or her direction.
2. Handling, aseptic preparation, and administration of radiopharmaceuticals may be
delegated to qualified personnel, subject to applicable federal, state or local
regulations. laws The nuclear medicine physician remains responsible for
supervising those persons to whom tasks are delegated.
3. The qualified individual performing radiopharmaceutical tasks shares
responsibility for the safety and quality of all radiopharmaceuticals with which he
or she is involved.
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B. Radiopharmaceuticals
1. Prescription: The quantity of radioactivity to be administered must be prescribed
(either individually by prescription or by protocol). When the
radiopharmaceutical and dose are such that a written directive is required,
such a directive must be signed by an authorized user. In an emergent
situation, an oral directive is acceptable. The information contained in the
oral directive must be documented as soon as possible in writing in the
patient’s record. A written directive must be prepared within 48 hours of the
oral directive. assayed, and recorded. Administered activity must fall within
tolerances of applicable state and federal regulations and should be recorded in
the pati ent’s re cord. If specificall y p ermitt ed b y state or NRC
re gulations ,
facilities receiving diagnostic radiopharmaceutical unit
administered activity need not perform direct measurement of the radioactivity
but may perform a decay correction, based on the activity or the activity
concentration determined by the manufacturer or preparer licensed by the state or
federal agency
2. Assay: The quantity of radioactivity to be administered must be assayed. If
specifically permitted by state or NRC regulations, facilities receiving
diagnostic radiopharmaceuticals as unit administered activity (“unit dose”)
need not perform direct measurement of the radioactivity but may perform a
decay correction, based on the activity or the activity concentration
determined by the manufacturer or preparer licensed by the state or federal
agency. However, it is desirable that administered activity still be assayed on
site at the medical facility prior to administration. When unit administered
activities are obtained from commercial radiopharmacies, quality control
need not be repeated. Administered activity must fall within tolerances of
applicable state and federal regulations. Under normal circumstances,
prescriptions must be in writing and signed by the prescribing physician, who
must be an authorized user. In an emergent situation, an oral directive is
acceptable. The information contained in the oral directive must be documented
as soon as possi ble in writ ing in the pati ent’s reco rd. A writ ten directi
ve m ust be
prepared within 48 hours of the oral directive
3. Administration: Administered activity must fall within tolerances of
applicable state and federal regulations. The identity of the
radiopharmaceutical and the patient, route of administration, and the pregnancy
and breastfeeding status of the patient shall must be verified prior to
administration.
4. Recording: The radiopharmaceutical and the administered activity must be
documented in the patient’s record. When unit administered activities are
obtained from commercial radiopharmacies, quality control need not be repeated.
It is desirable, however, that administered activity still be assayed on site at the
medical facility prior to administration
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C. Elution of Generators and On-Site Preparation of Radiopharmaceutical Kits
1. Care must be taken to minimize radiation exposure to personnel at all steps
in setting up, eluting, and assaying the eluate. The volume and radioactivity of
the generator eluate must be measured and recorded. Care must be taken to
minimize exposure to personnel at all steps in setting up, eluting, and assaying the
eluate
2. Radiopharmaceuticals should be prepared according to the manufacturer’s
instructions package insert. Exceptions should be documented in the policies
and procedures manual. Documenting exceptions in the policy or procedure
manual is desirable
3. Aseptic handling procedures must be followed whenever preparing, dispensing,
administering, or otherwise handling radiopharmaceuticals that are intended
to be sterile in accordance with USP General Chapter <797> Pharmaceutical
Compounding —
Sterile
Preparations
161.
handling
parenteral
radiopharmaceutical preparations or their components
4. Generator eluates must be assayed for the presence of parent or other
radionuclide contaminants. Required testing is specified in 10 CFR 35.204
171. Eluates testing positive for contaminants of greater concentration than
specified above may not be used for patient doses. The first (initial) eluate after
receipt of a generator shall be assa ye d for “bre a kthrough ” of the p arent
isot ope. No more than 0.15 microcuries 006 MBq) of molybdenum-99 per
millicurie (37
MBq) of the administered activity of technetium-99m is permitted. The eluates
can also be checked for aluminum ion breakthrough, although law does not
require this.
5. Radiopharmaceuticals prepared on site should be subjected to quality
control testing, especially radiochemical purity. Radiopharmaceuticals should
not be administered if the total level of radiochemical impurities impurity
exceeds package insert or USP monograph specifications 161. 10%. Labeling
efficiency of kit-prepared technetium-99m radiopharmaceuticals should be
evaluated periodically, such as the first vial of a new lot. Specifically, testing for
free pertechnetate and hydrolyzed-reduced radiochemical impurities should be
performed
6. Radiopharmaceuticals prepared by radiolabeling kits should be used by the
expiration time recommended in the package insert.
D. Records
1. Records of receipt, usage, administration, and disposal of all radionuclides shall
radioactive materials must be kept in compliance with license conditions and
applicable medical records and radiation control regulations. For
radiopharmaceuticals prepared on site, records must document the date and
time of preparation, amount of radioactivity used, reagent lot numbers,
results of quality control tests, and subsequent disposition or disposal with an
identifying signature of the person performing the task.
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2. All packages containing radioactive materials will must be inspected upon receipt
for physical damage and tested for external contamination, as required by the
appropriate regulatory agency. The label and contents must agree. Any
discrepancies must be reported to the manufacturer and to regulatory agencies, as
required.
3. For radiopharmaceuticals prepared on site, records must reflect the date and time
of preparation, amount of radioactivity used, reagent lot numbers, results of
quality control tests, and how all radioactivity was used or disposed of
3. For all radiopharmaceuticals, the amount of radioactivity administered, patient
identity, technologist identity, route of administration, date and time of use, and,
if unused, date of disposal must be recorded.
4. If a radionuclide dose calibrator is used on site for the assay of
radiopharmaceutical administered activity, the instrument will must be checked
for constancy, accuracy, linearity, and geometric dependence per manufacturer’s
recommendation and the requirements of the appropriate regulatory agency.
Records must be maintained.
5. Material (excepting patient excreta, which may be released into a sanitary sewer)
with radiation levels greater than background cannot be discarded into regular
trash containers. and the labels must be destroyed or defaced before disposal. All
containers should be checked for the presence of radioactivity. Disposal must be
in accordance with license conditions and applicable federal, state, and local
regulations
6. The radiation labels on empty packages must be destroyed or defaced before
disposal. All containers should be surveyed to determine that levels of
radiation do not exceed background. Residual activity must be stored in a
shielded container or in an area that is designed for the storage of radioactive
materials until radiation levels do not exceed background, which generally
approximates storing them for at least 10 half lives. Radioactive gaseous
wastes must be stored or ventilated in accordance with federal, state, and
local regulations. Disposal must be in accordance with license conditions and
applicable federal, state, and local regulations. Records must be maintained.
6. Residual activity must be stored in a shielded container or in an area that is
designed for the storage of radioactive materials until 10 half-lives have passed
and it is at the level of background, or until it can be shipped out as radioactive
waste. Radioactive gaseous wastes must be stored or ventilated in accordance
with federal, state, and local regulations
7. Adverse reactions attributable to any radiopharmaceutical, or defects in any
radiopharmaceutical product, should be reported to the manufacturer and, when
appropriate, to the Food and Drug Administration (FDA).
8. There must be policies and procedures to ensure that the identity of the patient,
the radiopharmaceutical, the administered activity, and the route of
administration are correct. Exceptional care in proper identification of patient
and product is required when handling and administering radiolabeled blood
components. Policies and procedures must be in place to ensure the
traceability of autologous blood components whenever radiolabeled blood
labeling procedures are performed. Errors in Medical events related to the
Radiopharmaceuticals
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administration of radiopharmaceuticals must be reported within the specified time
frame as required by the appropriate regulatory agencies. Where required, the
radiation safety office, the NRC, or the state regulatory agency and the referring
physician must be notified. Unless medically contraindicated, the patient must
also be notified.
V.
INSTRUMENT QUALITY CONTROL
A qualified medical physicist should be responsible for overseeing the equipment quality
control program and for monitoring performance upon installation and routinely
thereafter. (See the ACR Technical Standard for Medical Nuclear Physics Performance
Monitoring of Gamma Cameras [8].) Daily Routine testing and evaluation of nuclear
medicine equipment may be performed by the technologists under the supervision of the
responsible physician. A quality control program for the routine assessment of
cameras performance must be maintained in accordance with the manufacturer’s or
physicist’s recommendations.
A. For All Scintillation Standard, Single-Crystal Gamma Cameras
1. Test field uniformity daily using either a uniform sheet flood source and
collimator or a point source and no collimator.
2. Use a resolution test pattern (e.g., a bar phantom) designed to test linearity,
spatial resolution, distortion, and field of view weekly or according to the
manufacturer’s recommendations. Comparison with prior test images is advisable.
Retention of these images may be required by state or federal regulations. is
recommended
3. Inspect collimators regularly for damage. Test with a very high-count flood image
annually or when collimator damage is suspected.
4. Inspect systems regularly for mechanical or electrical hazards. If a system is
malfunctioning in a manner that would compromise safety or patient care, do
not use it until it is repaired.
5. Maintain a log of all quality control testing and problems identified and ascertain
if any trends exist.
6. Maintain all service records.
B. For Single Photon Emission Computed Tomography
section V.A.1-6 above)
(SPECT) (in
addition
to
1. Assess center of rotation according to the manufacturer’s or physicist’s
recommendations.
2. Assess flood uniformity according to the manufacturer’s or physicist’s
recommendations. This will require often requires a 30-million-count flood for a
64 x 64-pixel matrix and a 120-million-count flood for a 128 x 128-pixel matrix.
3. Assess system uniformity, spatial resolution, and contrast resolution using a threedimensional phantom according to the manufacturer’s recommendations.
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Resolution No. 5
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C. For SPECT Cameras Utilizing Solid State Detectors or Other Dedicated SPECT
Devices
1. A quality control program for the routine assessment of cameras
performance must be performed and documented in accordance to the
manufacture’s or physicist’s recommendation.
2. Maintain a log of all quality control testing and problems identified and
ascertain if any trends exist.
3. Inspect system regularly for mechanical or electrical hazards. If a system is
malfunctioning in a manner that would compromise safety or patient care,
do no use it until it is repaired.
4. Maintain all service records.
D. For Xenon or DTPA Aerosol Delivery System
Assure proper function according to the manufacturer’s specifications and within
applicable federal or state regulations.
E. Hard-Copy Imaging Image Output Device
Quality control testing should be performed according to the manufacturer’s
recommendations, with comparison of current results to baseline results obtained in
acceptance testing.
F. Film Processors
l. Chemical (wet) systems
a. Perform daily sensitometric checks.
b. Perform periodic cleaning and maintenance.
c. Perform chemical checks.
2. Nonchemical (dry) systems
Perform periodic calibration and maintenance as recommended by the
manufacturer.
For information on picture archiving and communication systems (PACS), see the
ACR Technical Standard for Electronic Practice of Medical Imaging 191.
G. Radiation Detectors and Radiation Survey Instruments Geiger Counters, Well
Counters, Ionization Chambers
Each instrument must be calibrated before first use and following repair, in
accordance with local regulations. Each instrument must be checked for proper
operation with a dedicated check source before each use, if required by state or local
regulations. Test for precision (constancy), accuracy, and linearity with energy and
photon flux as specified by state regulations or license conditions, as well as after any
equipment repair
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Resolution No. 5
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H. Radionuclide Dose Calibrators
A licensee shall test the instrumentation required for determining administered activity of
unsealed byproduct material for medical use in accordance with nationally recognized
standards or the manufacturer’s instructions. The following tests and frequencies are
provided as recommendations:
1.
2.
3.
4.
Test for precision (constancy) each day of use and after equipment repair.
Test for linearity at installation, quarterly, and after equipment repair.
Test for accuracy at installation, annually, and after equipment repair.
Test for geometry upon at installation, and after replacement or repair after
equipment repair, and whenever the chamber is moved. of the chamber
accuracy annually and after equipment repair
5. An assessment must be made of the radionuclide’s emission spectrum
characteristics and a determination made as to whether correction factors
are required for measurement of containers with different composition or
geometry configuration, if this geometry has not been previously established.
Records of these tests must be maintained for 3 years or as otherwise required by
applicable regulations.
H. Daily Instrument Notes
Notes on technique for various radionuclides, collimators, and count rate combinations
may be helpful to the technologist. It is not necessary to save these notes
I. A daily patient log should be maintained and include patient name, hospital or office,
patient identification number, procedure, radiopharmaceutical dose requested, and
administered activity, and comments.
J. For each study, the following information should be recorded: instrument, collimator,
pulse height analyzer (window) setting, acquired views, number of counts in each image,
start time of procedure, and duration of image acquisition. (These may be part of a
standard protocol (section VII.B) and need be recorded only if different from the protocol
in the procedure manual.) This information should be retrievable as long as the images
are kept.
K. For SPECT, one should also record: matrix size, number of stops, time per image,
type of rotation, and type of filter used. (These may be part of a standard protocol
[section VII.B] and need be recorded only if different from the protocol in the procedure
manual.) This information should be retrievable as long as the images are kept.
L. All equipment manuals must be available.
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Resolution No. 5
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VI.
PATIENT AND PERSONNEL SAFETY
A. The facility must comply with all applicable radiation safety regulations and
conditions of licensure imposed by the NRC, state, and/or other regulatory agencies.
B. Sufficient numbers of syringe shields and shielded containers must be available in
good condition and be used unless contraindicated for a specific patient. Any shield that
has been in contact with a patient or used in a patient care area must be properly
sanitized before being returned to any radiopharmaceutical dose preparation area
or used for another patient dose.
C. Under no circumstances may Pipetting of any materials by mouth be is never
permitted.
D. Under no circumstances may makeup cosmetics or lip balm be applied, nor may
food, or drink, or chewing gum be brought into, stored, or consumed in areas where
radionuclides radioactive materials are prepared, used, or stored. Gloves and
appropriate apparel and footwear should be worn which, in case of a spill, would
prevent direct contact of radioactive material with skin.
E. In accordance with applicable federal and state regulations, there must be a policy on
administration of radiopharmaceuticals to pregnant or potentially pregnant patients and to
female patients who are breastfeeding. If the patient is known to be pregnant, the
potential radiation risks to the fetus and clinical benefits of the procedure should be
considered. The patient should be counseled before proceeding with the study, and this
counseling must be documented in writing. Similarly, if the patient is known to be
breastfeeding, the potential radiation risks to the breastfeeding child should be
considered and guidance given to the mother regarding discontinuation of
breastfeeding. There should be signs posted requesting that patients inform the staff
if they are or could be pregnant or if they are breastfeeding.
F. There must be a policy of weekly surveys of removable contamination and daily
surveys of ambient dose rate in all areas where radionuclides are used and stored in
accordance with state or federal regulations. A policy must exist for routine daily
radiation surveys of all areas where radionuclides are used or stored, according to state or
federal regulatory requirements
G. There must be a policy on containment and cleanup of radioactive spills. Radioactive
gases should only be used in rooms with appropriate airflow and exhaust rate according
to state or federal regulatory requirements.
H. Personnel who routinely handle radionuclides must be monitored for radiation
exposure. Records of exposure must be made available to individuals, as per regulations
of the NRC or state regulatory agency.
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I. All professional and technical staff in nuclear medicine are responsible for
maintaining radiation exposures at ALARA (as low as reasonably achievable) levels for
both patients and staff.
J. There must be a written policy for the handling of radiolabeled autologous blood
products that will ensure that all samples are positively identified as to source and that
reinjection of these agents occurs only into the correct patient.
K. There should must be documented policies on:
1.
2.
3.
4.
5.
6.
Hazardous biological or chemical materials (if any are present in the workplace).
Electrical and mechanical safety.
Fire safety and evacuation.
Handling of infectious wastes and patients with communicable diseases.
Handling of “sharps.”
Procedures for safe use of medical equipment.
L. There shall should be posting of:
1. Information placards required by regulatory agencies.
2. Radiation precaution signs in areas where radioactive agents are used or stored.
3. Warnings to patients Signs requesting patients to inform the staff if they are or
could be pregnant or if they are breastfeeding.
VII.
PROCEDURE MANUAL
A. A policy and procedure manual must be prepared and maintained. The physician(s)
responsible for nuclear medicine procedures must review and update it at least annually.
B. Detailed information about the performance of each examination on each instrument
must be developed to include: type of study, radiopharmaceutical, administered activity,
route of administration, preparation of patient, nonradioactive drugs and dosages,
required views, timing, preset counts or time, and any contraindications. Pediatric
dosages will be derived from appropriate guidelines or standards (e.g., body surface area
or weight or other accepted dosing formulas).
C. There must be standard operating procedures with detailed information about
performance, recording, and action regarding all radiopharmaceutical and instrument
quality control.
D. There must be standard operating procedures with detailed information on
appropriate aspects of radiation safety, including emergency procedures.
E. There must be standard operating procedures in place with detailed information
on appropriate aspects of the aseptic preparation of sterile radiopharmaceuticals
and sterile pharmaceuticals used in nuclear medicine procedures.
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Resolution No. 5
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VIII. RECORDS
A. Information on how to request procedures should be available to referring physicians.
B. Generic technical data on procedures should be retrievable from the policy and
procedure manual.
C. Procedures should be traceable to the technologist performing them.
D. Calculations or raw data for quantitative studies should be retrievable.
E. Appropriate technical data must appear in the report of the procedure. These include,
at a minimum, the radiopharmaceutical, dosage, route of administration, and views
obtained. Pharmacologic enhancement and other interventions should be documented.
The reporting of nuclear medicine procedure interpretations should be in accordance with
the ACR Practice Guideline for Communication of Diagnostic Imaging Findings [10].
F. Studies, data, and reports must be archived for a time consistent with the mandates of
state regulatory agencies, license conditions, or radiation protection regulations.
IX.
RADIATION SAFETY IN IMAGING
Radiologists, medical physicists, radiologic technologists, and all
supervising physicians have a responsibility to minimize radiation dose to
individual patients, to staff, and to society as a whole, while maintaining
the necessary diagnostic image quality. This concept is known as “as low
as reasonably achievable (ALARA).”
Facilities, in consultation with the medical physicist, should have in place
and should adhere to policies and procedures, in accordance with ALARA,
to vary examination protocols to take into account patient body habitus,
such as height and/or weight, body mass index or lateral width. The dose
reduction devices that are available on imaging equipment should be
active; if not; manual techniques should be used to moderate the exposure
while maintaining the necessary diagnostic image quality. Periodically,
radiation exposures should be measured and patient radiation doses
estimated by a medical physicist in accordance with the appropriate ACR
Technical Standard. (ACR Resolution 17, adopted in 2006 — revised in
2009, Resolution 11)
X.
QUALITY CONTROL AND IMPROVEMENT, SAFETY, INFECTION
CONTROL, AND PATIENT EDUCATION
Policies and procedures related to quality, patient education, infection control, and safety
should be developed and implemented in accordance with the ACR Policy on Quality
Control and Improvement, Safety, Infection Control, and Patient Education appearing
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Resolution No. 5
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under the heading Position Statement on QC & Improvement, Safety, Infection Control,
and Patient Education on the ACR web site (http://www.acr.org/guidelines).
Equipment performance monitoring should be in accordance with the ACR Technical
Standard for Medical Nuclear Physics Performance Monitoring of Gamma Cameras.
ACKNOWLEDGEMENTS
This guideline was revised according to the process described under the heading The
Process for Developing ACR Practice Guidelines and Technical Standards on the ACR
web site (http://www.acr.org/guidelines) by the Guidelines and Standards Committee of
the ACR Commission on Nuclear Medicine in collaboration with SNM.
Collaborative Committee — members represent their societies in the initial and final
revision of this guideline
ACR
Robert E. Henkin, MD, FACR, Chair
Lorraine M. Fig, MD, MB, ChB, MPH
Bennett S. Greenspan, MD, FACR
Christopher J. Palestro, MD
Ronald C. Walker, MD
SNM
Stephen C Dragotakes, RPh, BCNP, FAPhA
Pradeep Garg, PhD
Neil A. Petry, MS, RPh, BCNP, FAPhA
James A. Ponto, MS, RPh, BCNP
Guidelines and Standards Committee — Nuclear Medicine — ACR committee
responsible for sponsoring the draft through the process.
Jay A. Harolds, MD, FACR, Co-Chair
Darlene F. Metter, MD, FACR, Co-Chair
Richard K.J. Brown, MD
Robert F. Carretta, MD
Gary L. Dillehay, MD, FACR
Mark F. Fisher, MD
Lorraine M. Fig, MD, MB, ChB, MPH
Leonie Gordon, MD
Bennett S. Greenspan, MD, FACR
Milton J. Guiberteau, MD, FACR
Robert E. Henkin, MD, FACR
Warren R. Janowitz, MD, JD
Homer A. Macapinlac, MD
Gregg A. Miller, MD
Christopher J. Palestro, MD
Eric M. Rohren, MD, PhD
Henry D. Royal, MD
Paul D. Shreve, MD
William G. Spies, MD, FACR
Manuel L. Brown, MD, FACR, Chair, Commission
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REFERENCES
1. US
Food
and
Drug
Administration.
21CFR315.6.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=315.
6. Accessed June 17, 2010.
2. United States Nuclear Regulatory Commission. 10 CFR 35.290 Training for
imaging and localization studies.
http://www.nrc.gov/reading-rm/doccollections/cfr/part035/part035-0290.html. Accessed June 17, 2010.
3. American College of Radiology. ACR Practice Guideline for Continuing Medical
Education
(CME).
http://www.acr.org/SecondaryMainMenuCategories/quality_safety/guidelines/c
me/cme.aspx. Accessed June 17, 2010.
4. United States Nuclear Regulatory Commission. 10 CFR 35.50 Training for
Radiation
Safety
Officer.
http://www.nrc.gov/reading-rm/doccollections/cfr/part035/part035-0050.html. Accessed June 17, 2010.
5. United States Nuclear Regulatory Commission. 10 CFR 35.55 Training for an
authorized nuclear
pharmacist.
http://www.nrc.gov/reading-rm/doccollections/cfr/part035/part035-0055.html. Accessed June 17, 2010.
6. The United States Pharmacopeial Convention (USP). USP <797> Guidebook to
Pharmaceutical
Compounding—
Sterile
Preparations.
http://www.usp.org/products/797Guidebook/. Accessed June 17, 2010.
7. United States Nuclear Regulatory Commission. 10 CFR 35.204 Permissible
molybdenum-99,
strontium-82,
and
strontium-85
concentrations.
http://www.nrc.gov/reading-rm/doc-collections/cfr/part035/part035-0204.html.
Accessed June 17, 2010.
8. American College of Radiology. ACR Technical Standard for Medical Nuclear
Physics
Performance
Monitoring
of
Gamma
Cameras.
http://www.acr.org/SecondaryMainMenuCategories/quality_safety/guidelines/m
ed_phys/nuc_med_equipment.aspx. Accessed June 17, 2010.
9. American College of Radiology. ACR Technical Standard for Electronic
Practice
of
Medical
Imaging.
http://www.acr.org/SecondaryMainMenuCategories/quality_safety/guidelines/m
ed_phys/electronic_practice.aspx. Accessed June 17, 2010.
10. American College of Radiology. ACR Practice Guideline for Communication of
Diagnostic
Imaging
Findings.
http://www.acr.org/SecondaryMainMenuCategories/quality_safety/guidelines/dx
/comm_diag_rad.aspx. Accessed June 17, 2010.
1. Bushberg JT, Mettler FA. Radiation protection and health effects. In: Gottschalk A,
Hoffer PB, Potchen EJ, eds. Diagnostic Nuclear Medicine. 2nd edition. Baltimore,
Md: Williams and Wilkins; 1988:164-186.
2. Comprehensive Accreditation Manual for Hospitals. Oakbrook Terrace, Ill: Joint
Commission on Accreditation of Healthcare Organizations; 1997. (Updates were
issued in January and May 1997 and will be issued on a quarterly basis.)
3. Eckelman WC, Steigman J, Paik C. Radiopharmaceuticals, radiation protection, and
dosimetry. In: Sandler et al, eds. Diagnostic Nuclear Medicine. 3rd edition.
Baltimore, Md: Williams and Wilkins; 1996:199-216.
Radiopharmaceuticals
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5. Eshima D, Fauconnier T, Eshima L, et al. Radiopharmaceuticals for
lymphoscintigraphy, including dosimetry and radiation considerations. Semin Nucl
Med 2000;30:25-32.
6. Gonzalez AJ, Radiation safety standards and their application: international policies
and current issues. Health Phys 2004;87:258-272.
7. Graham LS, Muehllehner G. Anger scintillation camera. In: Sandler et al, eds.
Diagnostic Nuclear Medicine. 3rd edition. Baltimore, Md: Williams and Wilkins;
1996:81-91.
8. Mettler FA, Guiberteau MJ. Essentials of Nuclear Medicine Imaging. 3rd edition.
Philadelphia, Pa: WB Saunders; 1991:27-36.
9. Practice Certification Manual. Reston, Va: American College of Nuclear Physicians;
1997.
10. Procedure Guidelines Manual. Reston, Va: Society of Nuclear Medicine; 1999.
11. Radiation Protection Code of Federal Regulations. District of Columbia, DC: United
States Nuclear Regulatory Commission, Volume 10, chapter 20, 10 CFR 20.
12. Radiation Protection Code of Federal Regulations. District of Columbia, DC: United
States Nuclear Regulatory Commission, Volume 10, chapter 35, 10 CFR 35.
*Guidelines and standards are published annually with an effective date of October 1 in
the year in which amended, revised or approved by the ACR Council. For guidelines and
standards published before 1999, the effective date was January 1 following the year in
which the guideline or standard was amended, revised, or approved by the ACR Council.
Development Chronology for this Standard
1994 (Resolution 17)
Amended 1995 (Resolution 24, 54)
Revised 1998 (Resolution 18)
Revised 2001 (Resolution 21)
Revised 2006 (Resolution 26, 16g, 17, 36)
Amended 2009 (Resolution 11)
TECHNICAL STANDARD
Resolution No. 5
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RESOLUTION NO. 6
BE IT RESOLVED,
that the American College of Radiology adopt the
ACR— ACOG—AIUM—SRU Practice Guideline for the
Performance of Sonohysterography
Sponsored by:
Sonohysterography
Council Steering Committee
PRACTICE GUIDELINE
Resolution No. 6
NOT FOR PUBLICATION, QUOTATION, OR CITATION
The American College of Radiology, with more than 30,000 members, is the principal organization of radiologists, radiation
oncologists, and clinical medical physicists in the United States. The College is a nonprofit professional society whose primary
purposes are to advance the science of radiology, improve radiologic services to the patient, study the socioeconomic aspects of the
practice of radiology, and encourage continuing education for radiologists, radiation oncologists, medical physicists, and persons
practicing in allied professional fields.
The American College of Radiology will periodically define new practice guidelines and technical standards for radiologic
practice to help advance the science of radiology and to improve the quality of service to patients throughout the United States.
Existing practice guidelines and technical standards will be reviewed for revision or renewal, as appropriate, on their fifth anniversary
or sooner, if indicated.
Each practice guideline and technical standard, representing a policy statement by the College, has undergone a thorough
consensus process in which it has been subjected to extensive review, requiring the approval of the Commission on Quality and Safety
as well as the ACR Board of Chancellors, the ACR Council Steering Committee, and the ACR Council. The practice guidelines and
technical standards recognize that the safe and effective use of diagnostic and therapeutic radiology requires specific train ing, skills,
and techniques, as described in each document. Reproduction or modification of the published practice guideline and technical
standard by those entities not providing these services is not authorized .
ACR-ACOG-AIUM-SRU PRACTICE GUIDELINE FOR THE
PERFORMANCE OF SONOHYSTEROGRAPHY
PREAMBLE
These guidelines are an educational tool designed to assist practitioners in providing
appropriate radiologic care for patients. They are not inflexible rules or requirements of
practice and are not intended, nor should they be used, to establish a legal standard of
care. For these reasons and those set forth below, the American College of Radiology
cautions against the use of these guidelines in litigation in which the clinical decisions of
a practitioner are called into question.
The ultimate judgment regarding the propriety of any specific procedure or course of
action must be made by the physician or medical physicist in light of all the
circumstances presented. Thus, an approach that differs from the guidelines, standing
alone, does not necessarily imply that the approach was below the standard of care. To
the contrary, a conscientious practitioner may responsibly adopt a course of action
different from that set forth in the guidelines when, in the reasonable judgment of the
practitioner, such course of action is indicated by the condition of the patient, limitations
of available resources, or advances in knowledge or technology subsequent to publication
of the guidelines. However, a practitioner who employs an approach substantially
different from these guidelines is advised to document in the patient record information
sufficient to explain the approach taken.
The practice of medicine involves not only the science, but also the art of dealing with
the prevention, diagnosis, alleviation, and treatment of disease. The variety and
complexity of human conditions make it impossible to always reach the most appropriate
PRACTICE GUIDELINE
Resolution No. 6
Sonohysterography
NOT FOR PUBLICATION, QUOTATION, OR CITATION
diagnosis or to predict with certainty a particular response to treatment. Therefore, it
should be recognized that adherence to these guidelines will not assure an accurate
diagnosis or a successful outcome. All that should be expected is that the practitioner will
follow a reasonable course of action based on current knowledge, available resources,
and the needs of the patient to deliver effective and safe medical care. The sole purpose
of these guidelines is to assist practitioners in achieving this objective.
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I.
INTRODUCTION
The clinical aspects contained in specific sections of this guideline (Introduction,
Indications and Contraindications, Specifications of the Examination, and Equipment
Specifications) were developed collaboratively by the American College of Radiology
(ACR), the American Institute of Ultrasound in Medicine (AIUM), the American College
of Obstetricians and Gynecologists (ACOG), and the Society of Radiologists in
Ultrasound (SRU). Recommendations for physician qualifications, written request for the
examination, procedure documentation, and quality control may vary among the four
organizations and are addressed by each separately.
This guideline has been developed to assist qualified physicians performing
sonohysterography. Properly performed sonohysterography can provide information
about the uterus, endometrium, and fallopian tubes. Additional studies may be necessary
for complete diagnosis. Adherence to the following guideline serves to will maximize the
diagnostic benefit of sonohysterography.
Sonohysterography is the evaluation of the endometrial cavity using the
transcervical injection of sterile fluid. Various terms such as saline infusion
sonohysterography or simply sonohysterography have been used to describe this
technique. The primary goal of sonohysterography is to visualize the endometrial
cavity in more detail than is possible with routine endovaginal ultrasound 111.
Sonohysterography can also be used to access tubal patency 121.
II.
DEFINITION
Most clinical experience and medical literature to date have focused on the sonographic
imaging of the uterus, and specifically the endometrial cavity, using the transcervical
injection of sterile fluid. Thus, terms such as saline infusion sonohysterography or simply
sonohysterography have been used to describe this technique. More recently, fluids other
than saline have been used for intrauterine injection. Also, emerging research is being
developed in assessing tubal patency using uterine infusion of fluid.
III.
GOAL
The goal of sonohysterography is to visualize the endometrial cavity in more detail than
is possible with routine endovaginal ultrasound.
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II.
INDICATIONS AND CONTRAINDICATIONS
A. Indications [3-11]
The most common indication for sonohysterography is abnormal uterine bleeding in both
premenopausal and postmenopausal women. Other Indications include but are not limited
to evaluation of:
1. Abnormal uterine bleeding.
2. Assessment of Uterine cavity, especially with regard to uterine myomas, polyps,
and synechiae.
3. Abnormalities detected on endovaginal sonography, including focal or diffuse
endometrial or intracavitary abnormalities.
4. Congenital abnormalities of the uterus. uterine cavity
5. Infertility. and habitual abortion
6. Recurrent pregnancy loss.
5. Endometrium suboptimally imaged by endovaginal sonography
B. Contraindications
Sonohysterography should not be performed in a woman who is pregnant or who could
be pregnant. This is usually avoided by scheduling the examination in the follicular phase
of the menstrual cycle, after menstrual flow has essentially ceased, but before the patient
has ovulated. In a patient with regular cycles, sonohysterography should not in most
cases be performed later than the tenth day of the menstrual cycle. Sonohysterography
should not be performed in patients with a pelvic infection or unexplained pelvic
tenderness, which could be due to pelvic inflammatory disease. Active vaginal bleeding
is not a contraindication to the procedure but may make the interpretation more
challenging.
III.
QUALIFICATIONS AND RESPONSIBILITIES OF THE PHYSICIAN
Each organization addresses this requirement individually. ACR language is as
follows:
See the ACR—SPR—SRU Practice Guideline for Performing and Interpreting Diagnostic
Ultrasound Examinations.
In addition, the physician must have spent a minimum of 3 months in documented formal
training in the performance, interpretation, and reporting of examinations of the female
reproductive system. Additionally, the physician should supervise and interpret
examinations of the female reproductive system on a regular basis and The physician
should be familiar with techniques of cervical cannulation.
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IV.
WRITTEN REQUEST FOR THE EXAMINATION
Each organization addresses this requirement individually. ACR language is as
follows:
The written or electronic request for sonohysterography should provide
sufficient information to demonstrate the medical necessity of the
examination and allow for its proper performance and interpretation.
Documentation that satisfies medical necessity includes 1) signs and
symptoms and/or 2) relevant history (including known diagnoses).
Additional information regarding the specific reason for the examination
or a provisional diagnosis would be helpful and may at times be needed to
allow for the proper performance and interpretation of the examination.
The request for the examination must be originated by a physician or other
appropriately licensed health care provider. The accompanying clinical
information should be provided by a physician or other appropriately
licensed health care provider familiar with the patient’s clinical problem or
question and consistent with the state’s scope of practice requirements.
(ACR Resolution 35, adopted in 2006)
V.
SPECIFICATIONS FOR INDIVIDUAL EXAMINATIONS
A. Patient Preparation
Pelvic organ tenderness should be assessed during the preliminary endovaginal
sonogram. If adnexal tenderness or pain suspicious for active pelvic infection is found
prior to fluid infusion, the examination should be deferred until after an appropriate
course of treatment. In the presence of nontender hydrosalpinges, consideration may be
given to administering antibiotics at the time of the examination; in this case it is prudent
to discuss the antibiotic regimen with the referring physician. A pregnancy test is advised
when clinically indicated. Patients should be questioned about latex allergy prior to use of
a latex sheath. The optimal time to perform this test in a menstruating woman is after the
bleeding ends but prior to ovulation.
B. Procedure
Preliminary routine endovaginal sonography with measurements of endometrium and
evaluation of the uterus, and ovaries, and pelvic free fluid should be performed prior to
sonohysterography. A speculum is used to allow visualization of the cervix. The presence
of unusual pain, lesions, or purulent vaginal or cervical discharge may require
rescheduling the procedure pending further evaluation. Prior to insertion, the catheter
should be flushed with sterile fluid to avoid introducing air during the study. After
cleansing the external os, the cervical canal and/or uterine cavity should be catheterized
using aseptic technique, and appropriate sterile fluid should be instilled slowly by means
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of manual injection under real-time sonographic imaging. Imaging should include realtime scanning of the endometrial and cervical canal [12].
C. Contrast Agent
Appropriate sterile fluid such as normal saline or water should be used for
sonohysterography.
D. Images
Appropriate images Precatheterization images should be obtained and recorded, in at
least two planes, using a high-frequency endovaginal ultrasound probe should be
produced and recorded to demonstrate normal and abnormal findings. Precatheterization
images should be obtained; including These images should include the thickest bi-layer
endometrial measurement on a sagittal image when possible.
Once the uterine cavity is filled with fluid, representative images with a complete survey
of the uterine cavity should be performed and representative images obtained to
document normal and abnormal findings. are obtained as necessary for diagnostic
evaluation If a balloon catheter is used for the examination, images should be obtained at
the end of the procedure with the balloon deflated to fully evaluate the endometrial
cavity, particularly the cervical canal and lower portion of the endometrial cavity.
uterine segment
Additional techniques such as color Doppler and 3D imaging may be helpful in
evaluating both normal and abnormal findings 113-141.
VI.
DOCUMENTATION
Each organization addresses this requirement individually. ACR language is as
follows:
Adequate documentation is essential for high quality in patient care. There should be a
permanent record of the ultrasound examination and its interpretation. Comparison with
prior relevant imaging studies may prove helpful. Images of all appropriate areas, both
normal and abnormal, should be recorded. Variations from normal size should generally
be accompanied by measurements. Images should be labeled with the patient
identification, facility identification, examination date, and image orientation The initials
of the operator should be accessible on the images or electronically on PACS.
Images should be labeled with the patient identification, facility identification,
examination date, and image orientation. An official interpretation (final report) of the
ultrasound examination should be included in the patient’s medical record. Retention of
the ultrasound examination images should be consistent both with based on clinical need
and with relevant legal and local health care facility requirements.
Reporting should be in accordance with the ACR Practice Guideline for Communication
of Diagnostic Imaging Findings.
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VII.
EQUIPMENT SPECIFICATIONS
Sonohysterography is usually conducted with a high-frequency an endovaginal
transducer. In cases of an enlarged uterus, additional transabdominal images during
infusion may be required to fully evaluate the endometrium. The transducer should be
adjusted to operate at the highest clinically appropriate frequency under the ALARA (as
low as reasonably achievable) principle.
VIII. QUALITY CONTROL AND IMPROVEMENT, SAFETY, INFECTION
CONTROL, AND PATIENT EDUCATION
Each organization addresses this requirement individually. ACR language is as
follows:
All transducers should be cleaned after use Vaginal transducers should be covered by a
protective sheath prior to insertion. Sterile Coupling gel should be used. Following the
examination, the sheath should be disposed of and the transducer cleaned in an
antimicrobial solution. The type of solution and amount of time for cleaning should
follow manufacturer and infectious disease control recommendations.
Policies and procedures related to quality, patient education, infection control, and safety
should be developed and implemented in accordance with the ACR Policy on Quality
Control and Improvement, Safety, Infection Control, and Patient Education appearing
under the heading Position Statement on QC & Improvement, Safety, Infection Control,
and Patient Education on the ACR web site (http://www.acr.org/guidelines).
Equipment performance monitoring should be in accordance with the ACR Technical
Standard for Diagnostic Medical Physics Performance Monitoring of Real Time
Ultrasound Equipment.
ACKNOWLEDGEMENTS
This guideline was revised according to the process described under the heading The
Process for Developing ACR Practice Guidelines and Technical Standards on the ACR
web site (http://www.acr.org/guidelines) by the Guidelines and Standards Committee of
the ACR Commission on Ultrasound in collaboration with the AIUM, the ACOG, and the
SRU.
Collaborative Committee — members represent their societies in the initial and final
revision of this guideline
ACR
Marcela Bohm-Velez, MD, FACR, Chair
Debra L. Acord, MD
Helena Gabriel, MD
Ruth B. Goldstein, MD
Sonohysterography
AIUM
Mert Bahtiyar, MD
Kevin J. Doody, MD
Daniel Skupski, MD
Brad Van Voorhis, MD
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ACOG
Daniel Breitkopf, MD
Steven R. Goldstein, MD
SRU
Robert L. Bree, MD, FACR
Theodore Dubinsky, MD
Faye C. Laing, MD
Guidelines and Standards Committee — Ultrasound — ACR Committee responsible
for sponsoring the draft through the process
Mary C. Frates, MD, FACR, Chair
Debra L. Acord, MD
Sandra O. Allison, MD
Marcela Bohm-Velez, MD, FACR
Helena Gabriel, MD
Ruth B. Goldstein, MD
Robert D. Harris, MD, MPH, FACR
Beverly E. Hashimoto, MD, FACR
Leann E. Linam, MD
Laurence Needleman, MD, FACR
Maitray D. Patel, MD
Michelle L. Robbin, MD, FACR
Robert M. Sinow, MD
Maryellen R. M. Sun, MD
Deborah Levine, MD, FACR, Chair, Commission
REFERENCES
1. Bree RL, Bowerman RA, Bohm-Velez M, et al. US evaluation of the uterus in
patients with postmenopausal bleeding: A positive effect on diagnostic decision
making. Radiology 2000;216:260-264.
2. Hajishafiha M, Zobairi T, Zanjani VR, Ghasemi-Rad M, Yekta Z, Mladkova N.
Diagnostic value of sonohysterography in the determination of fallopian tube
patency as an initial step of routine infertility assessment. J Ultrasound Med
2009;28:1671-1677.
3. Becker E, Jr., Lev-Toaff AS, Kaufman EP, Halpern EJ, Edelweiss MI, Kurtz AB. The
added value of transvaginal sonohysterography over transvaginal sonography alone in
women with known or suspected leiomyoma. J Ultrasound Med 2002;21:237-247.
4. Breitkopf DM, Frederickson RA, Snyder RR. Detection of benign endometrial
masses by endometrial stripe measurement in premenopausal women. Obstet Gynecol
2004;104:120-125.
5. Doubilet PM. Society of Radiologists in Ultrasound Consensus Conference statement
on postmenopausal bleeding. J Ultrasound Med 2001;20:1037-1042.
6. Dubinsky TJ, Stroehlein K, Abu-Ghazzeh Y, Parvey HR, Maklad N. Prediction of
benign and malignant endometrial disease: hysterosonographic-pathologic
correlation. Radiology 1999;210:393-397.
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7. Goldstein RB, Bree RL, Benson CB, et al. Evaluation of the woman with
postmenopausal bleeding: Society of Radiologists in Ultrasound-Sponsored
Consensus Conference statement. J Ultrasound Med 2001;20:1025-1036.
8. Goldstein SR. Use of ultrasonohysterography for triage of perimenopausal patients
with unexplained uterine bleeding. Am J Obstet Gynecol 1994;170:565-570.
9. Laifer-Narin S, Ragavendra N, Parmenter EK, Grant EG. False-normal appearance of
the endometrium on conventional transvaginal sonography: comparison with saline
hysterosonography. AJR 2002;178:129-133.
10. Laifer-Narin SL, Ragavendra N, Lu DS, Sayre J, Perrella RR, Grant EG.
Transvaginal saline hysterosonography: characteristics distinguishing malignant and
various benign conditions. AJR 1999;172:1513-1520.
11. Mihm LM, Quick VA, Brumfield JA, Connors AF, Jr., Finnerty JJ. The accuracy of
endometrial biopsy and saline sonohysterography in the determination of the cause of
abnormal uterine bleeding. Am J Obstet Gynecol 2002;186:858-860.
12. Lindheim SR, Sprague C, Winter TC, 3rd. Hysterosalpingography and
sonohysterography: lessons in technique. AJR 2006;186:24-29.
13. Benacerraf BR, Shipp TD, Bromley B. Improving the efficiency of gynecologic
sonography with 3-dimensional volumes: a pilot study. J Ultrasound Med
2006;25:165-171.
14. Ghate SV, Crockett MM, Boyd BK, Paulson EK. Sonohysterography: do 3D
reconstructed images provide additional value? AJR 2008;190:W227-233.
Suggested Reading (Additional articles that are not cited in the document but that the
committee recommends for further reading on this topic)
9. Hann LE, Gretz EM, Bach AM, Francis SM. Sonohysterography for evaluation of the
endometrium in women treated with tamoxifen. AJR 2001;177:337-342.
12. Lev-Toaff AS, Toaff ME, Liu JB, Merton DA, Goldberg BB. Value of
sonohysterography in the diagnosis and management of abnormal uterine bleeding.
Radiology 1996;201:179-184.
15. Parsons AK, Lense JJ. Sonohysterography for endometrial abnormalities: preliminary
results. J Clin Ultrasound 1993;21:87-95.
16. Schwartz LB, Snyder J, Horan C, Porges RF, Nachtigall LE, Goldstein SR. The use
of transvaginal ultrasound and saline infusion sonohysterography for the evaluation of
asymptomatic postmenopausal breast cancer patients on tamoxifen. Ultrasound
Obstet Gynecol 1998;11:48-53.
*Guidelines and standards are published annually with an effective date of October 1 in
the year in which amended, revised or approved by the ACR Council. For guidelines and
standards published before 1999, the effective date was January 1 following the year in
which the guideline or standard was amended, revised, or approved by the ACR Council.
Development Chronology for this Guideline
2002 (Resolution 28)
Amended 2006 (Resolution 35)
Revised 2007 (Resolution 26)
Sonohysterography
PRACTICE GUIDELINE
Resolution No. 6
NOT FOR PUBLICATION, QUOTATION, OR CITATION
RESOLUTION NO. 7
BE IT RESOLVED,
that the American College of Radiology adopt the ACR—
SPR— SRU Practice Guideline for Performing and
Interpreting Diagnostic Ultrasound Examinations
Sponsored by:
Council Steering Committee
Performing and Interpreting Ultrasound
PRACTICE GUIDELINE
Resolution No. 7
NOT FOR PUBLICATION, QUOTATION, OR CITATION
The American College of Radiology, with more than 30,000 members, is the principal organization of radiologists, radiation
oncologists, and clinical medical physicists in the United States. The College is a nonprofit professional society whose primary
purposes are to advance the science of radiology, improve radiologic services to the patient, study the socioeconomic aspects of the
practice of radiology, and encourage continuing education for radiologists, radiation oncologists, medical physicists, and persons
practicing in allied professional fields.
The American College of Radiology will periodically define new practice guidelines and technical standards for radiologic
practice to help advance the science of radiology and to improve the quality of service to patients throughout the United States.
Existing practice guidelines and technical standards will be reviewed for revision or renewal, as appropriate, on their fifth anniversary
or sooner, if indicated.
Each practice guideline and technical standard, representing a policy statement by the College, has undergone a thorough
consensus process in which it has been subjected to extensive review, requiring the approval of the Commission on Quality and Safety
as well as the ACR Board of Chancellors, the ACR Council Steering Committee, and the ACR Council. The practice guidelines and
technical standards recognize that the safe and effective use of diagnostic and therapeutic radiology requires specific train ing, skills,
and techniques, as described in each document. Reproduction or modification of the published practice guideline and technical
standard by those entities not providing these services is not authorized .
ACR-SPR-SRU PRACTICE GUIDELINE FOR PERFORMING AND
INTERPRETING DIAGNOSTIC ULTRASOUND EXAMINATIONS
PREAMBLE
These guidelines are an educational tool designed to assist practitioners in providing
appropriate radiologic care for patients. They are not inflexible rules or requirements of
practice and are not intended, nor should they be used, to establish a legal standard of
care. For these reasons and those set forth below, the American College of Radiology
cautions against the use of these guidelines in litigation in which the clinical decisions of
a practitioner are called into question.
The ultimate judgment regarding the propriety of any specific procedure or course of
action must be made by the physician or medical physicist in light of all the
circumstances presented. Thus, an approach that differs from the guidelines, standing
alone, does not necessarily imply that the approach was below the standard of care. To
the contrary, a conscientious practitioner may responsibly adopt a course of action
different from that set forth in the guidelines when, in the reasonable judgment of the
practitioner, such course of action is indicated by the condition of the patient, limitations
of available resources, or advances in knowledge or technology subsequent to publication
of the guidelines. However, a practitioner who employs an approach substantially
different from these guidelines is advised to document in the patient record information
sufficient to explain the approach taken.
The practice of medicine involves not only the science, but also the art of dealing with
the prevention, diagnosis, alleviation, and treatment of disease. The variety and
complexity of human conditions make it impossible to always reach the most appropriate
PRACTICE GUIDELINE
Resolution No. 7
Performing and Interpreting Ultrasound
NOT FOR PUBLICATION, QUOTATION, OR CITATION
diagnosis or to predict with certainty a particular response to treatment. Therefore, it
should be recognized that adherence to these guidelines will not assure an accurate
diagnosis or a successful outcome. All that should be expected is that the practitioner will
follow a reasonable course of action based on current knowledge, available resources,
and the needs of the patient to deliver effective and safe medical care. The sole purpose
of these guidelines is to assist practitioners in achieving this objective.
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I.
INTRODUCTION
This guideline was revised collaboratively by the American College of Radiology (ACR),
the Society for Pediatric Radiology (SPR), and the Society of Radiologists in Ultrasound
(SRU).
Diagnostic ultrasound is an established, effective diagnostic imaging technique that uses
high-frequency ultrasound sound waves for both anatomic (grayscale) and
Color/Power/Spectral Doppler (anatomic and hemodynamic) evaluation. imaging
and Doppler examinations The applications of diagnostic ultrasound technology include,
but are not limited to:
1.
2.
3.
4.
Obstetrical and gynecological ultrasound.
Thoracic, abdominal, and pelvic ultrasound.
Renal and retroperitoneal ultrasound.
Vascular ultrasound (carotid, abdominal, intracranial, peripheral arterial, and
peripheral venous studies, including pulsed, power, and color Doppler).
5. Neurosonography.
6. Guidance of interventional biopsy and therapeutic procedures.
7. Intraoperative ultrasound.
8. Evaluation of superficial structures such as breast, thyroid, testicle, skin.
9. Endoluminal ultrasound.
10. Ophthalmologic ultrasound.
11. Echocardiography.
12. Musculoskeletal ultrasound.
Extensive experience has shown that ultrasound is a safe and effective diagnostic
procedure. While no harmful effects of ultrasound have been demonstrated at power
levels used for diagnostic studies, quality assurance dictates that it is necessary to use this
imaging technique in the most appropriate and indicated fashion and that studies be
performed by qualified and knowledgeable physicians and/or sonographers using
appropriate equipment and techniques. Diagnostic ultrasound examinations should be
performed only when there is a valid medical reason. The lowest possible ultrasonic
exposure power settings should be used to gain the necessary diagnostic information.
These guidelines apply to all ultrasound examinations in all clinical situations. Diagnostic
ultrasound examinations should be supervised and interpreted by trained and qualified
physicians.
Performing and Interpreting Ultrasound
PRACTICE GUIDELINE
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II.
QUALIFICATIONS AND RESPONSIBILITIES OF PERSONNEL
A. Physician
Physicians who supervise, perform, and/or interpret diagnostic ultrasound examinations
should be licensed medical practitioners who have a thorough understanding of the
indications for ultrasound examinations as well as a familiarity with the basic physical
principles and limitations of the technology of ultrasound imaging. They should be
familiar with alternative and complementary imaging and diagnostic procedures and
should be capable of correlating the results of these other procedures with the
sonographic findings. They should have an thorough understanding of ultrasound
technology and instrumentation, ultrasound power output, equipment calibration, and
safety. Physicians responsible for diagnostic ultrasound examinations should be able to
demonstrate familiarity with the anatomy (including normal growth and development),
physiology, and pathophysiology of those organs or anatomic areas that are being
examined. These physicians should provide evidence of the training and competence
needed to perform diagnostic ultrasound examinations successfully.
The physicians should be familiar with interpretation and documentation in accordance
with the ACR Practice Guideline for Communication of Diagnostic Imaging Findings
Physicians performing and/or interpreting diagnostic ultrasound examinations should
meet at least one of the following criteria:
Certification in Radiology or Diagnostic Radiology by the American Board of
Radiology, the American Osteopathic Board of Radiology, the Royal College of
Physicians and Surgeons of Canada, or Le College des Medecins du Quebec, and
involvement with the supervision and/or performance, interpretation, and reporting of
300 ultrasound examinations within the last 36 months.1
or
Completion of an Accreditation Council for Graduate Medical Education (ACGME)
approved diagnostic radiology residency program or an American Osteopathic
Association (AOA) approved diagnostic radiology residency program and
involvement with the supervision and/or performance, interpretation, and reporting of
500 ultrasound examinations in the past 36 months.1
or
Physicians not board certified in radiology or not trained in a diagnostic radiology
residency program, and who assume these responsibilities for sonographic imaging
exclusively in a specific anatomical area should meet the following criteria:
Completion of an ACGME approved residency program in specialty practice plus 200
hours of Category I CME in the subspecialty where ultrasound reading occurs; and
supervision and/or performance, interpretation, and reporting of 500 cases relative to
1Completion of an accredited radiology residency in the past 24 months will be presumed to be satisfactory experience
for the performance, reporting, and interpreting requirement.
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each subspecialty area interpreted (e.g., pelvic, obstetrical, breast, thyroid, vascular)
during the past 36 months in a supervised situation.
The physicians should be familiar with interpretation and documentation in
accordance with the ACR Practice Guideline for Communication of Diagnostic
Imaging Findings.
Maintenance of Competence
All physicians performing ultrasound examinations should demonstrate evidence of
continuing competence in the interpretation and reporting of those examinations.
1f competence is assured primarily based on continuing experience, a minimum of
100 examinations per year is recommended in order to maintain the physician’s
skills.
Bec ause a ph ysician ’s practi c e or lo cati on ma y p reclud e thi s met
hod
Continued competency can also be assured through monitoring and
evaluation that indicates acceptable should be monitored for technical success,
accuracy of interpretation, and appropriateness of evaluation.
Continuing Medical Education
The physician’s continuing education should be in accordance with the ACR Practice
Guideline for Continuing Medical Education (CME) and should include CME in
ultrasonography as is appropriate to his/her practice.
B. Registered Radiologist Assistant
A registered radiologist assistant is an advanced level radiographer who is
certified and registered as a radiologist assistant by the American Registry
of Radiologic Technologists (ARRT) after having successfully completed
an advanced academic program encompassing an ACR/ASRT (American
Society of Radiologic Technologists) radiologist assistant curriculum and
a radiologist-directed clinical preceptorship. Under radiologist
supervision, the radiologist assistant may perform patient assessment,
patient management and selected examinations as delineated in the Joint
Policy Statement of the ACR and the ASRT titled “R adiol ogist Assis
tant:
R oles and R esponsi bil it ies” and as all owed b y st ate law. The
radiol o gist assistant transmits to the supervising radiologists those
observations that have a bearing on diagnosis. Performance of
diagnostic interpretations remains outside the scope of practice of the
radiologist assistant. (ACR Resolution 34, adopted in 2006)
B. Diagnostic Medical Sonographer
When a sonographer performs the examination, that person should be qualified by
appropriate training to do so. This qualification can be demonstrated by certification or
eligibility for certification by a nationally recognized certifying body (e.g., ARDMS or
ARRT). The sonographer should have ongoing continuing education in ultrasound.
Performing and Interpreting Ultrasound
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III.
SPECIFICATIONS OF THE EXAMINATION
The written or electronic request for ultrasound examinations should
provide sufficient information to demonstrate the medical necessity of the
examination and allow for its proper performance and interpretation.
Documentation that satisfies medical necessity includes 1) signs and
symptoms and/or 2) relevant history (including known diagnoses).
Additional information regarding the specific reason for the examination
or a provisional diagnosis would be helpful and may at times be needed to
allow for the proper performance and interpretation of the examination.
The request for the examination must be originated by a physician or other
appropriately licensed health care provider. The accompanying clinical
information should be provided by a physician or other appropriately
licensed health care provider familiar with the patient’s clinical problem or
question and consistent with the state’s scope of practice requirements.
(ACR Resolution 35, adopted in 2006)
Quality may be enhanced by having the ultrasound practice undergo an
accreditation process.
images are to be labeled with the following: a) patient identification, b) facility
identification, c) examination date, d) the side (right or left) of the anatomic site imaged,
if appropriate, e) patient position if other than supine, f) transducer orientation, and g)
initials of operator.
IV.
DOCUMENTATION
Adequate documentation is essential for high-quality patient care. There should be a
permanent record of the ultrasound examination and its interpretation. Comparison with
prior relevant imaging studies may prove helpful. images of all appropriate areas, both
normal and abnormal, should be recorded. Variations from normal size should generally
be accompanied by measurements. images should be labeled with the patient
identification, facility identification, examination date, and image orientation. The
initials of the operator should be accessible on the images or electronically on PACS.
Images should be labeled with the patient identification, facility identification,
examination date, and image orientation. An official interpretation (final report) of the
ultrasound examination should be included in the patient’s medical record. Retention of
the ultrasound examination images should be consistent both with based on clinical need
and with relevant legal and local health care facility requirements.
Reporting should be in accordance with the ACR Practice Guideline for Communication
of Diagnostic imaging Findings.
PRACTICE GUIDELINE
Resolution No. 7
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V.
QUALITY CONTROL AND IMPROVEMENT, SAFETY, INFECTION
CONTROL, AND PATIENT EDUCATION
Policies and procedures related to quality, patient education, infection control, and safety
should be developed and implemented in accordance with the ACR Policy on Quality
Control and improvement, Safety, infection Control, and Patient Education appearing
under the heading Position Statement on QC & Improvement, Safety, Infection Control,
and Patient Education on the ACR web site (http://www.acr.org/guidelines).
Equipment performance monitoring should be in accordance with the ACR
Technical Standard for Diagnostic Medical Physics Performance Monitoring of
Real Time Ultrasound Equipment.
ACKNOWLEDGEMENTS
This guideline was revised according to the process described under the heading The
Process for Developing ACR Practice Guidelines and Technical Standards on the ACR
web site (http://www.acr.org/guidelines) by the Guidelines and Standards Committees of
the ACR Commissions on Ultrasound and Pediatric Radiology in collaboration with the
SPR and the SRU.
Collaborative Committee — members represent their societies in the initial and final
revision of this guideline
ACR
Robert D. Harris, MD, MPH, FACR, Chair
Helena Gabriel, MD
Marta Hernanz-Schulman, MD, FACR
Robert M. Sinow, MD
SPR
Caroline T. Carrico, MD
Lynn A. Fordham, MD
Martha M. Munden, MD
SRU
Teresita L. Angtuaco, MD, FACR
Barbara S. Hertzberg, MD, FACR
Jill E. Langer, MD
Guidelines and Standards Committee — Pediatric — ACR Committee responsible
for sponsoring the draft through the process
Marta Hernanz-Schulman, MD, FACR, Chair
Sara J. Abramson, MD, FACR
Taylor Chung, MD
Brian D. Coley, MD
Kristin L. Crisci, MD
Wendy Ellis, MD
Eric N. Faerber, MD, FACR
Kate A. Feinstein, MD, FACR
Performing and Interpreting Ultrasound
PRACTICE GUIDELINE
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Lynn A. Fordham, MD
S. Bruce Greenberg, MD
J. Herman Kan, MD
Beverley Newman, MB, BCh, BSc, FACR
Marguerite T. Parisi, MD
Sudha P. Singh, MB, BS
Donald P. Frush, MD, FACR, Chair, Pediatric Commission
Guidelines and Standards Committee — Ultrasound — ACR Committee responsible
for sponsoring the draft through the process
Mary C. Frates, MD, FACR, Chair
Debra L. Acord, MD
Sandra 0. Allison, MD
Marcela Bohm-Velez, MD, FACR
Helena Gabriel, MD
Ruth B. Goldstein, MD
Robert D. Harris, MD, MPH, FACR
Beverly E. Hashimoto, MD, FACR
Leann E. Linam, MD
Laurence Needleman, MD, FACR
Maitray D. Patel, MD
Michelle L. Robbin, MD, FACR
Robert M. Sinow, MD
Maryellen R. M. Sun, MD
Deborah Levine, MD, FACR, Chair, Commission
Comments Reconciliation Committee
Beverly G. Coleman, MD, FACR, Chair
Teresita L. Angtuaco, MD, FACR
Kimberly E. Applegate, MD, MS, FACR
Douglas L. Brown, MD
Caroline T. Carrico, MD
Howard B. Fleishon, MD, MMM, FACR
Lynn A. Fordham, MD
Mary C. Frates, MD, FACR
Donald P. Frush, MD, FACR
Helena Gabriel, MD
Robert D. Harris, MD, MPH, FACR
Marta Hernanz-Schulman, MD, FACR
Barbara S. Hertzberg, MD, FACR
Alan D. Kaye, MD, FACR
Jill E. Langer, MD
Paul A. Larson, MD, FACR
Deborah Levine, MD, FACR
Martha M. Munden, MD
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Laurence Needleman, MD, FACR
Robert M. Sinow, MD
Morlie L. Wang, MD
REFERENCES
1. Hertzberg BS, Kliewer MA, Bowie JD, et al. Physician training requirements in
sonography: how many cases are needed for competence? AJR 2000;174:1221-1227.
2. Kasales CJ, Coulson CC, Mauger D, Chertoff JD, Matthews A. Training in obstetric
sonography for radiology residents and fellows in the United States. AJR
2001;177:763-767.
3. Rose JS, Mandavia D, Tayal V, Blaivas M. Physician sonography training
competency. AJR 2001;176:813-814.
Suggested Reading (Additional articles that are not cited in the document but that the
committee recommends for further reading on this topic)
1. ACR ASRT joint statement. Radiologist assistant roles and responsibilites. in: Digest
of Council Actions. Reston, VA: American College of Radiology; 2008:147.
1. Boote EJ. AAPM/RSNA physics tutorial for residents: topics in US: Doppler US
techniques: concepts of blood flow detection and flow dynamics. Radiographics
2003;23:1315-1327.
2. DeCara JM, Lang RM, Koch R, et al. The use of small personal ultrasound devices by
internists without formal training in echocardiography. Eur J Echocardiogr
2003;4:141-147.
5. Reynolds PR, Dale RC, Cowan FM. Neonatal cranial ultrasound interpretation: a
clinical audit. Arch Dis Child Fetal Neonatal Ed 2001;84:F92-F95.
6. 7. Tessler FN, Tublin ME, Peters JC, et al. Value of selective second-look
sonography by radiologists. Radiology 1996;199:551-553.
*Guidelines and standards are published annually with an effective date of October 1 in
the year in which amended, revised or approved by the ACR Council. For guidelines and
standards published before 1999, the effective date was January 1 following the year in
which the guideline or standard was amended, revised, or approved by the ACR Council.
Development Chronology for this Guideline
1992 (Resolution 9)
Amended 1995 (Resolution 53)
Revised 1995 (Resolution 22)
Revised 2000 (Resolution 36)
Revised 2006 (Resolution 37, 34, 35, 36)
Performing and Interpreting Ultrasound
PRACTICE GUIDELINE
Resolution No. 7
NOT FOR PUBLICATION, QUOTATION, OR CITATION
RESOLUTION NO. 8
BE IT RESOLVED,
that the American College of Radiology adopt the
ACR— AIUM—SPR—SRU Practice Guideline for the
Performance of an Ultrasound Examination of the Neonatal
Spine
Sponsored by:
Neonatal Spine US
Council Steering Committee
PRACTICE GUIDELINE
Resolution No. 8
NOT FOR PUBLICATION, QUOTATION, OR CITATION
The American College of Radiology, with more than 30,000 members, is the principal organization of radiologists, radiation
oncologists, and clinical medical physicists in the United States. The College is a nonprofit professional society whose primary
purposes are to advance the science of radiology, improve radiologic services to the patient, study the socioeconomic aspects of the
practice of radiology, and encourage continuing education for radiologists, radiation oncologists, medical physicists, and persons
practicing in allied professional fields.
The American College of Radiology will periodically define new practice guidelines and technical standards for radiologic
practice to help advance the science of radiology and to improve the quality of service to patients throughout the United States.
Existing practice guidelines and technical standards will be reviewed for revision or renewal, as appropriate, on their fifth anniversary
or sooner, if indicated.
Each practice guideline and technical standard, representing a policy statement by the College, has undergone a thorough
consensus process in which it has been subjected to extensive review, requiring the approval of the Commission on Quality and Safety
as well as the ACR Board of Chancellors, the ACR Council Steering Committee, and the ACR Council. The practice guidelines and
technical standards recognize that the safe and effective use of diagnostic and therapeutic radiology requires specific train ing, skills,
and techniques, as described in each document. Reproduction or modification of the published practice guideline and technical
standard by those entities not providing these services is not authorized .
ACR-AIUM-SPR-SRU PRACTICE GUIDELINE FOR THE
PERFORMANCE OF AN ULTRASOUND EXAMINATION OF THE
NEONATAL SPINE
PREAMBLE
These guidelines are an educational tool designed to assist practitioners in providing
appropriate radiologic care for patients. They are not inflexible rules or requirements of
practice and are not intended, nor should they be used, to establish a legal standard of
care. For these reasons and those set forth below, the American College of Radiology
cautions against the use of these guidelines in litigation in which the clinical decisions of
a practitioner are called into question.
The ultimate judgment regarding the propriety of any specific procedure or course of
action must be made by the physician or medical physicist in light of all the
circumstances presented. Thus, an approach that differs from the guidelines, standing
alone, does not necessarily imply that the approach was below the standard of care. To
the contrary, a conscientious practitioner may responsibly adopt a course of action
different from that set forth in the guidelines when, in the reasonable judgment of the
practitioner, such course of action is indicated by the condition of the patient, limitations
of available resources, or advances in knowledge or technology subsequent to publication
of the guidelines. However, a practitioner who employs an approach substantially
different from these guidelines is advised to document in the patient record information
sufficient to explain the approach taken.
The practice of medicine involves not only the science, but also the art of dealing with
the prevention, diagnosis, alleviation, and treatment of disease. The variety and
PRACTICE GUIDELINE
Resolution No. 8
Neonatal Spine US
NOT FOR PUBLICATION, QUOTATION, OR CITATION
complexity of human conditions make it impossible to always reach the most appropriate
diagnosis or to predict with certainty a particular response to treatment. Therefore, it
should be recognized that adherence to these guidelines will not assure an accurate
diagnosis or a successful outcome. All that should be expected is that the practitioner will
follow a reasonable course of action based on current knowledge, available resources,
and the needs of the patient to deliver effective and safe medical care. The sole purpose
of these guidelines is to assist practitioners in achieving this objective.
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I.
INTRODUCTION
The clinical aspects contained in specific sections of this guideline (Introduction,
Indications, Specifications of the Examination, and Equipment Specifications) were
developed collaboratively by the American College of Radiology (ACR) the American
Institute of Ultrasound in Medicine (AIUM), the Society for Pediatric Radiology (SPR),
and the Society of Radiologists in Ultrasound (SRU). Recommendations for physician
requirements, written request for examination, procedure documentation, and quality
control vary between the four organizations and are addressed by each separately.
This guideline has been developed to assist practitioners performing a sonographic
examination of the neonatal and infant spine. In some cases, an additional or specialized
examination may be necessary. While it is not possible to detect every abnormality,
following this guideline will maximize the detection of abnormalities of the infant spine.
Sonographic examination of the pediatric spinal canal is accomplished by scanning
through the normally incompletely ossified posterior elements. Therefore, it is most
successful in the newborn period and in early infancy. In infants above 6 months of
age, the examination can be very limited, although the level of termination of the
cord may be identified.
In experienced hands, ultrasound of the infant spine has been demonstrated to be an
accurate and cost-effective examination that is comparable to MRI for evaluating
congenital or acquired abnormalities in the neonate and young infant.
II.
QUALIFICATIONS AND RESPONSIBILITIES OF PERSONNEL
Each organization addresses this requirement individually. ACR language is as
follows:
See the ACR Practice Guideline for Performing and Interpreting Diagnostic Ultrasound
Examinations.
III.
INDICATIONS/CONTRAINDICATIONS
A. Indications
The indications for ultrasonography of the neonatal spinal canal and its contents
include, but are not limited to 11-81:
Neonatal Spine US
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1. Lumbosacral stigmata known to be associated with spinal dysraphism,
including but not limited to:
a. Midline or paramedian masses.
b. Skin discolorations.
c. Skin tags.
d. Hair tufts.
e. Hemangiomas.
f. Pinpoint midline dimples.
g. Paramedian deep dimples.
2. The spectrum of caudal regression syndrome, including patients with sacral
agenesis and patients with anal atresia or stenosis.
3. Evaluation of suspected defects such as cord tethering, diastematomyelia,
hydromyelia, syringomyelia.
4. Detection of sequelae of injury, such as:
a. Hematoma following spinal tap or birth injury.
b. Sequelae of prior instrumentation, infection or hemorrhage.
c. Post-traumatic leakage of cerebrospinal fluid (CSF).
5. Visualization of fluid with characteristics of blood products within the spinal
canal in patients with intracranial hemorrhage.
6. Guidance for lumbar puncture 191.
7. Postoperative assessment for cord retethering 1101.
Infants with simple, low-lying sacrococcygeal dimples typically have normal spinal
contents, for them the examination has a low diagnostic yield 13,71. On the other
hand, atypical dimples, such as those larger than 5 mm, located greater than 2.5 cm
above the anus, or seen in combination with other lesions, are at higher risk of
occult spinal dysraphism 131. A sacral dimple or congenital sinus that is leaking CSF
will need further assessment with MRI, and sonography is therefore not a
mandatory first examination in this circumstance.
B. Contraindications
1. Preoperative examination in patients with open spinal dysraphism.
2. Examination of the contents of a closed neural tube defect if the skin
overlying the defect is thin or no longer intact.
The indications for ultrasonography of the neonatal spinal canal and its contents include
visible stigmata known to be associated with congenital cord anomalies that lead to
dysraphic anomalies and tethering of the cord such as midline masses, skin
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discolorations, skin tags, hair tufts, or hemangiomas; or pinpoint midline or paramedian
deep dimples. often associated with hyperpigmentation or hypertrichosis indicative of
dorsal dermal sinus tract. The spectrum of caudal regression syndrome, including anal
atresia..and cloacal extrophy, may be associated with cord anomalies and constitutes an
established indication for sonography. Ultrasonography is also used to detect sequelae of
injury, such as hematoma following spinal tap or birth injury, or leakage of central spinal
fluid (CSF). Ultrasound can also visualize blood products within the spinal canal in
patients with intracranial hemorrhage. Ultrasound is not indicated to visualize the neural
placode and meninges in patients with spina bifida aperta and meningocele or
meningomyelocele, due to the risk of injury and infection. However it may be useful
post-operatively in evaluation of cord retethering and associated defects, such as
diastematomyelia, hydromyelia, and syringomyelia. Other than evaluation of spina bifida
aperta, there are no contraindications to this examination. Infants with simple, low-lying
sacrococcygeal dimples typically have normal spinal contents, and in this group of
patients the examination is of low yield.
IV.
WRITTEN REQUEST FOR THE EXAMINATION
Each organization addresses this requirement individually. ACR language is as
follows:
The written or electronic request for a neonatal and infant spine ultrasound
examination should provide sufficient information to demonstrate the
medical necessity of the examination and allow for its proper performance
and interpretation.
Documentation that satisfies medical necessity includes 1) signs and
symptoms and/or 2) relevant history (including known diagnoses).
Additional information regarding the specific reason for the examination
or a provisional diagnosis would be helpful and may at times be needed to
allow for the proper performance and interpretation of the examination.
The request for the examination must be originated by a physician or other
appropriately licensed health care provider. The accompanying clinical
information should be provided by a physician or other appropriately
licensed health care provider familiar with the patient’s clinical problem or
question and consistent with the state scope of practice requirements.
(ACR Resolution 35, adopted in 2006)
V.
SPECIFICATIONS OF THE EXAMINATION
The examination should be performed with the infant preferably lying in the prone
position, although the study can also be done with the patient lying on his or her side
when necessary. A small bolster, such as a rolled blanket, may be placed under the
lower abdomen/pelvis to help position and immobilize the patient. The knees may be
flexed to the abdomen to allow adequate spacing of the spinous processes and
visualization of the spinal canal contents. An infant who has previously recently been
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fed will generally lie quietly during the examination. If feeding is not possible, a pacifier
dipped in glucose solution will often be helpful in keeping an infant still attaining an
appropriately still infant for an optimal examination. If there is difficulty placing the child
prone, the examination can also be performed with the infant on his or her side. It is
important to note that babies infants, particularly if not full term, have difficulty
maintaining normal body temperature. Therefore, the examination should be performed
in a warm room, and the coupling agent should be warmed. The child can be covered
by warm blankets, and the transducer placed under the blankets. Use of a radiant lamp
can also be considered. The sonographic gel should be warmed. If in the neonatal
intensive care unit, the examination can be performed under the warmer
The cord should be assessed in the longitudinal and transverse planes, with right
and left labeled on transverse images. The examination may be limited to the
lumbosacral region in specific cases, such as in patients being evaluated for a
sacrococcygeal dimple, or in those patients being scanned to look for the presence of
hematoma after an unsuccessful or traumatic spinal tap. The entire spinal canal, from
the craniocervical junction to the coccyx, may be included in appropriately selected
cases. The cord should be assessed in the longitudinal and transverse planes, with image
documentation
A stand-off pad may be used, if needed, to follow a tract from the skin surface. The entire
spinal canal, from the craniocervical junction to the coccyx, may be included in selected
cases. However, this may not be feasible in older infants
The normal cord morphology and the level of termination of the conus should be
assessed and documented. In order to do this, the vertebral body levels need to be
accurately identified and numbered. Accurate labeling or numbering of vertebral
bodies needs to be accomplished Once the vertebral bodies are clearly numbered,
labeled, the level of termination of the conus can be determined. The configuration and
level of termination of the conus should be documented, as well as any deviations from
normal In normal patients, the conus should lie at or above the L2 to L3 interspace disc
space 18,11-141. or above although occasionally the normal cord may extend midway to
L3, particularly in preterm infants [13-16] In fetuses and extremely preterm infants
the normal conus medullaris may be caudal to the superior endplate of L3 1141. In a
preterm infant with a conus that terminates at the L3 midvertebral body, a follow
up sonogram after age correction of 40 weeks gestation but before age correction of
6 months is warranted 181. The level of termination of the conus and its
configuration should be documented, as well as any deviations from normal.
The vertebral level can be determined in a number of ways [15-16]. These include:
. After assessment of the normal lumbosacral curvature to locate the last lumbar
vertebra or L5, the vertebral level of the conus is determined by counting
the cephalad. This method tends to be more reproducible than the other
methods described below, which rely on counting the number of rib-bearing
vertebrae or the number of ossified sacral and coccygeal segments and can
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lead to less reliable results. determining the last lumbar vertebra or L5, and
counting cephalad to the level of the conus
Counting the five sacral segments to S1 The first coccygeal segment has variable
ossification at birth but, if ossified, can be distinguished by its more rounded
shape compared with the square or rectangular shape of the sacral bodies.
Counting cephalad from S1 again can help determine the vertebral level of the
conus.
The last rib-bearing vertebra can be presumed to be T12 and the sequential
lumbar level can be thus determined.
When the level of the conus cannot be definitively assessed as normal or
abnormal, correlation with previous plain films, if available, is helpful. A
radiopaque marker can be placed on the skin at the level of the conus under
sonographic guidance, followed by and correlated with a spine radiograph.
The last rib-bearing vertebra can be identified as T12 and the sequential lumbar
level determined.
In equivocal cases, a radiopaque marker can be placed on the skin and correlated
with a spine radiograph.
The level of termination of the cord is important in assessment of tethering. Cord
position within the spinal canal and motion of cord and nerve roots are also helpful
parameters in assessment for cord tethering. The normal position of the cord within
the spinal canal, and deviation from normal, such as apposition to the dorsal aspect of the
spinal canal as seen in tethering, should be documented. Cine evaluation can be helpful
both in demonstrating anatomy and in showing movement of the distal cord and
nerve roots in conjunction with cardiac-related pulsations of the spinal CSF. Mmode can also be very helpful in documenting motion of the cord and nerve roots.
The normal nerve roots pulsate freely with cardiac and respiratory motion, layer
dependently with variable patient positioning, and are not adherent to each other.
Cine can also document changes that occur with head flexion and extension. A
stand-off pad or a thick layer of coupling gel may be used, if needed, to follow a
tract from the skin surface.
The integrity of the cord should be documented. Also, Areas of abnormal fluid
accumulation, such as hydromyelia or syringomyelia, should be documented and their
level identified hydromyelia or syringomyelia, anterior, lateral or posterior
meningoceles or pseudomeningoceles, or arachnoid cysts, should be documented
and their level identified. Transverse images are essential to identify and document
diastematomyelia, with off-center scanning for confirmation to avoid the potential pitfall
of duplication a reverberation artifact creating a lateral duplication, or ghost image
117-181.
Normal motion of the cord and nerve roots of the cauda equina should be evaluated, and
documented on M-mode or cine images where available.
The subarachnoid space should be evaluated for a normal anechoic appearance,
interrupted by normal hyperechoic linear nerve roots and dentate ligaments. The
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subarachnoid space, dura, and epidural space should be evaluated, and abnormalities such
as hematoma, lipoma, or other masses should be documented.
In addition to the termination of the conus, the termination of the thecal sac, typically
located at S2, should be documented. and an The normal filum measures less than 2
mm in thickness. If the filum is abnormally echogenic hyperechoic or appears
thickened, filum terminale identified it should be and measured and documented. The
nerve roots of the cauda equina should be delineated within the thecal sac. In cases of
failed lumbar puncture, additional imaging with the child supported in a seated position,
bending forward, may be useful to allow gravity to distend the lower thecal sac with
CSF.
Upright positioning can be used for image guidance of lumbar puncture or to
demonstrate meningoceles or pseudomeningoceles in some patients. Anterior
meningoceles or presacral masses should also be scanned from an anterior position.
The vertebral bodies and posterior elements should be evaluated for deformities.
including the posterior elements Dysraphic defects with open posterior elements should
be documented on transverse views.
Sonographic examination of the infant spinal canal is accomplished by scanning through
the as yet posterior ossified posterior elements. Therefore, it is most successful in the
newborn period. In older infants above 6 months of age, the examination can be very
limited, although the level of termination of the cord may be identified. Imaging may be
enhanced with supplemental paramedian scans.
VI.
DOCUMENTATION
Each organization addresses this requirement individually. ACR language is as
follows:
Adequate documentation is essential for high-quality patient care. There should be a
permanent record of the ultrasound examination and its interpretation. Comparison with
prior relevant imaging studies may prove helpful. Images of all appropriate areas, both
normal and abnormal, should be recorded. Variations from normal size should generally
be accompanied by size measurements and/or vertebral level when applicable. Images
should be labeled with the patient identification, facility identification, examination date,
and image orientation. The initials of the operator should be accessible on the images
or electronically on PACS. Images should be labeled with the patient identification,
facility identification, examination date, and image orientation. An official
interpretation (final report) of the ultrasound examination should be included in the
patient’s medical record. Retention of the ultrasound examination images should be
consistent both with based on clinical need and with the relevant legal and local health
care facility requirements.
Reporting and communication efforts should be in accordance with the ACR Practice
Guideline for Communication of Diagnostic Imaging Findings.
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VII.
EQUIPMENT SPECIFICATIONS
Ultrasound of the infant spine should be performed with real-time scanners using highfrequency linear array transducers, typically 7 MHz to 10 MHz or higher in neonates
1191. Center frequencies between 7 and 10 MHz are usually best. Where available and
When possible, panoramic views of the entire spinal canal are very helpful in providing
an overview of the anatomy and termination of the cord and thecal sac. Images of the
craniocervical junction often may need to be performed with a small vector or tightly
curved array transducer. operating at 5 to 8 MHz frequency, in order to obtain adequate
detail
VIII. QUALITY CONTROL AND IMPROVEMENT, SAFETY, INFECTION
CONTROL, AND PATIENT EDUCATION
Each organization addresses this requirement individually. ACR language is as
follows:
Policies and procedures related to quality, patient education, infection control, and safety
should be developed and implemented in accordance with the ACR Policy on Quality
Control and Improvement, Safety, Infection Control, and Patient Education appearing
under the heading Position Statement on QC & Improvement, Safety, Infection Control,
and Patient Education on the ACR web site (http://www.acr.org/guidelines).
Equipment performance monitoring should be in accordance with the ACR Technical
Standard for Diagnostic Medical Physics Performance Monitoring of Real Time
Ultrasound Equipment.
ACKNOWLEDGEMENTS
This guideline was revised according to the process described under the heading The
Process for Developing ACR Practice Guidelines and Technical Standards on the ACR
web site (http://www.acr.org/guidelines) by the Guidelines and Standards Committees of
the ACR Commissions on Pediatric Radiology and Ultrasound in collaboration with the
AIUM, the SPR, and the SRU.
Collaborative Committee — members represent their societies in the initial and final
revision of this guideline
ACR
Marta Hernanz-Schulman, MD, FACR, Chair
Lori L. Barr, MD, FACR
Leann E. Linam, MD
AIUM
Harris L. Cohen, MD, FACR
Judy A. Estroff, MD
Charlotte Henningsen, MS, RDMS, RVT, FSDMS
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David A. Bloom, MD
Caroline T. Carrico, MD
Lynn A. Fordham, MD
Martha M. Munden, MD
SRU
Dorothy I. Bulas, MD, FACR
Brian D. Coley, MD
Harriet J. Paltiel, MD
Guidelines and Standards Committee — Pediatric — ACR Committee responsible
for sponsoring the draft through the process
Marta Hernanz-Schulman, MD, FACR, Chair
Sara J. Abramson, MD, FACR
Taylor Chung, MD
Brian D. Coley, MD
Kristin L. Crisci, MD
Wendy Ellis, MD
Eric N. Faerber, MD, FACR
Kate A. Feinstein, MD, FACR
Lynn A. Fordham, MD
S. Bruce Greenberg, MD
J. Herman Kan, MD
Beverley Newman, MB, BCh, BSc, FACR
Marguerite T. Parisi, MD
Sudha P. Singh, MB, BS
Donald P. Frush, MD, FACR, Chair, Pediatric Commission
Guidelines and Standards Committee — Ultrasound — ACR Committee responsible
for sponsoring the draft through the process
Mary C. Frates, MD, FACR, Chair
Debra L. Acord, MD
Sandra 0. Allison, MD
Marcela Bohm-Velez, MD, FACR
Helena Gabriel, MD
Ruth B. Goldstein, MD
Robert D. Harris, MD, MPH, FACR
Beverly E. Hashimoto, MD, FACR
Leann E. Linam, MD
Laurence Needleman, MD, FACR
Maitray D. Patel, MD
Michelle L. Robbin, MD, FACR
Robert M. Sinow, MD
Maryellen R. M. Sun, MD
Deborah Levine, MD, FACR, Chair, Commission
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Comments Reconciliation Committee
Richard N. Taxin, MD, FACR, Chair
Kimberly E. Applegate, MD, MS, FACR
Lori L. Barr, MD, FACR
David A. Bloom, MD
Dorothy I. Bulas, MD, FACR
Caroline T. Carrico, MD
Harris L. Cohen, MD, FACR
Brian D. Coley, MD
Judy Estroff, MD
Howard B. Fleishon, MD, MMM, FACR
Lynn A. Fordham, MD
Mary C. Frates, MD, FACR
Donald P. Frush, MD, FACR
Charlotte Henningsen, MS
Marta Hernanz-Schulman, MD, FACR
Alan D. Kaye, MD, FACR
Paul A. Larson, MD, FACR
Deborah Levine, MD, FACR
Leann E. Linam, MD
Martha M. Munden, MD
Harriet J. Paltiel, MD
David M. Paushter, MD, FACR
REFERENCES
1. Guggisberg D, Hadj-Rabia S, Viney C, et al. Skin markers of occult spinal
dysraphism in children: a review of 54 cases. Arch Dermatol 2004;140:1109-1115.
2. Izci Y, Gonul M, Gonul E. The diagnostic value of skin lesions in split cord
malformations. J Clin Neurosci 2007;14:860-863.
3. Kriss VM, Desai NS. Occult spinal dysraphism in neonates: assessment of highrisk cutaneous stigmata on sonography. AJR 1998;171:1687-1692.
4. Ozturk E, Sonmez G, Mutlu H, et al. Split-cord malformation and
accompanying anomalies. J Neuroradiol 2008;35:150-156.
5. Robinson AJ, Russell S, Rimmer S. The value of ultrasonic examination of the
lumbar spine in infants with specific reference to cutaneous markers of occult
spinal dysraphism. Clin Radiol 2005;60:72-77.
6. Long FR, Hunter JV, Mahboubi S, Kalmus A, Templeton JM, Jr. Tethered cord
and associated vertebral anomalies in children and infants with imperforate
anus: evaluation with MR imaging and plain radiography. Radiology
1996;200:377-382.
7. Medina LS, Crone K, Kuntz KM. Newborns with suspected occult spinal
dysraphism: a cost-effectiveness analysis of diagnostic strategies. Pediatrics
2001;108:E101.
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8. Beek FJ, de Vries LS, Gerards LJ, Mali WP. Sonographic determination of the
position of the conus medullaris in premature and term infants. Neuroradiology
1996; 38 Suppl 1:S174-177.
9. Coley BD, Shiels WE, 2nd, Hogan MJ. Diagnostic and interventional
ultrasonography in neonatal and infant lumbar puncture. Pediatr Radiol
2001;31:399-402.
10. Gerscovich EO, Maslen L, Cronan MS, et al. Spinal sonography and magnetic
resonance imaging in patients with repaired myelomeningocele: comparison of
modalities. J Ultrasound Med 1999;18:655-664.
11. DiPietro MA. The conus medullaris: normal US findings throughout childhood.
Radiology 1993;188:149-153.
12. Kesler H, Dias MS, Kalapos P. Termination of the normal conus medullaris in
children: a whole-spine magnetic resonance imaging study. Neurosurg Focus
2007;23:1-5.
13. Wilson DA, Prince JR. John Caffey award. MR imaging determination of the
location of the normal conus medullaris throughout childhood. AJR
1989;152:1029-1032.
14. Zalel Y, Lehavi O, Aizenstein O, Achiron R. Development of the fetal spinal
cord: time of ascendance of the normal conus medullaris as detected by
sonography. J Ultrasound Med 2006;25:1397-1401; quiz 1402-1393.
15. Deeg KH, Lode HM, Gassner I. Spinal sonography in newborns and infants-Part I: method, normal anatomy and indications. Ultraschall Med 2007;28:507517.
16. Lowe LH, Johanek AJ, Moore CW. Sonography of the neonatal spine: part 1,
Normal anatomy, imaging pitfalls, and variations that may simulate disorders.
AJR 2007;188:733-738.
17. Hedrick WR, Hykes, DL, Starchman DE. Ultrasound Physics and
Instrumentation. 4th ed. St. Loius, Mo: Elsevier Mosby; 2004.
18. Kremkau FW. Diagnostic Ultrasound; Principles and Instruments. 7th ed. St.
Louis, Mo: Saunders Elsevier; 2006.
19. Unsinn KM, Geley T, Freund MC, Gassner I. US of the spinal cord in newborns:
spectrum of normal findings, variants, congenital anomalies, and acquired
diseases. Radiographics 2000;20:923-938.
Suggested Reading (Additional articles that are not cited in the document but that the
committee recommends for further reading on this topic)
1. Austin MJ, Gerscovich EO, Fogata M, Gillen MA, Bijan B. Sonographic duplication
artifact of the spinal cord in infants and children. J Ultrasound Med 2004;23:799-803.
2. Henriques JG, Pianetti G, Henriques KS, Costa P, Gusmao S. Minor skin lesions as
markers of occult spinal dysraphisms: prospective study. Surg Neurol 2005;63:S8S12.
3. Hill CA, Gibson PJ. Ultrasound determination of the normal location of the conus
medullaris in neonates. AJNR 1995;16:469-472.
4. Kriss VM, Desai NS. Occult spinal dysraphism in neonates: assessment of high-risk
cutaneous stigmata on sonography. AJR 1998;171:1687-1692.
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5. Kriss VM, Kriss TC, Babcock DS. The ventriculus terminalis of the spinal cord in the
neonate: a normal variant on sonography. AJR 1995;165:1491-1493.
6. Robinson AJ, Russell S, Rimmer S. The value of ultrasonic examination of the
lumbar spine in infants with specific reference to cutaneous markers of occult spinal
dysraphism. Clin Radiol 2005;60:72-77.
7. Rudas G, Almassy Z, Papp B, Varga E, Meder U, Taylor GA. Echodense spinal
subarachnoid space in neonates with progressive ventricular dilatation: a marker of
noncommunicating hydrocephalus. AJR 1998;171:1119-1121.
8. Rudas G, Varga E, Meder U, Pataki M, Taylor GA. Changes in echogenicity of spinal
subarachnoid space associated with intracranial hemorrhage: new observations.
Pediatr Radiol 2000;30:739-742.
9. Unsinn KM, Geley T, Freund MC, Gassner I. US of the spinal cord in newborns:
spectrum of normal findings, variants, congenital anomalies, and acquired diseases.
Radiographics 2000;20:923-938.
*Guidelines and standards are published annually with an effective date of October 1 in
the year in which amended, revised or approved by the ACR Council. For guidelines and
standards published before 1999, the effective date was January 1 following the year in
which the guideline or standard was amended, revised, or approved by the ACR Council.
Development Chronology for this Guideline
2007 (Resolution 30)
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RESOLUTION NO. 9
BE IT RESOLVED,
that the American College of Radiology adopt the
ACR— AIUM—SRU Practice
Guideline for
the
Performance
of
Ultrasound
Vascular Mapping for Preoperative Planning of Dialysis
Access
Sponsored by:
Council Steering Committee
Preoperative Dialysis Access
PRACTICE GUIDELINE
Resolution No. 9
NOT FOR PUBLICATION, QUOTATION, OR CITATION
The American College of Radiology, with more than 30,000 members, is the principal organization of radiologists, radi ation
oncologists, and clinical medical physicists in the United States. The College is a nonprofit professional society whose primary
purposes are to advance the science of radiology, improve radiologic services to the patient, study the socioeconomic aspects of the
practice of radiology, and encourage continuing education for radiologists, radiation oncologists, medical physicists, and persons
practicing in allied professional fields.
The American College of Radiology will periodically define new practice guidelines and technical standards for radiologic
practice to help advance the science of radiology and to improve the quality of service to patients throughout the United States.
Existing practice guidelines and technical standards will be reviewed for revision or renewal, as appropriate, on their fifth anniversary
or sooner, if indicated.
Each practice guideline and technical standard, representing a policy statement by the College, has undergone a thorough
consensus process in which it has been subjected to extensive review, requiring the approval of the Commission on Quality and Safety
as well as the ACR Board of Chancellors, the ACR Council Steering Committee, and the ACR Council. The practice guidelines and
technical standards recognize that the safe and effective use of diagnostic and therapeutic radiology requires specific train ing, skills,
and techniques, as described in each document. Reproduction or modification of the published practice guideline and technical
standard by those entities not providing these services is not authorized .
ACR-AIUM-SRU PRACTICE GUIDELINE FOR THE
PERFORMANCE OF ULTRASOUND VASCULAR MAPPING FOR
PREOPERATIVE PLANNING OF DIALYSIS ACCESS
PREAMBLE
These guidelines are an educational tool designed to assist practitioners in providing
appropriate radiologic care for patients. They are not inflexible rules or requirements of
practice and are not intended, nor should they be used, to establish a legal standard of
care. For these reasons and those set forth below, the American College of Radiology
cautions against the use of these guidelines in litigation in which the clinical decisions of
a practitioner are called into question.
The ultimate judgment regarding the propriety of any specific procedure or course of
action must be made by the physician or medical physicist in light of all the
circumstances presented. Thus, an approach that differs from the guidelines, standing
alone, does not necessarily imply that the approach was below the standard of care. To
the contrary, a conscientious practitioner may responsibly adopt a course of action
different from that set forth in the guidelines when, in the reasonable judgment of the
practitioner, such course of action is indicated by the condition of the patient, limitations
of available resources, or advances in knowledge or technology subsequent to publication
of the guidelines. However, a practitioner who employs an approach substantially
different from these guidelines is advised to document in the patient record information
sufficient to explain the approach taken.
The practice of medicine involves not only the science, but also the art of dealing with
the prevention, diagnosis, alleviation, and treatment of disease. The variety and
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complexity of human conditions make it impossible to always reach the most appropriate
diagnosis or to predict with certainty a particular response to treatment. Therefore, it
should be recognized that adherence to these guidelines will not assure an accurate
diagnosis or a successful outcome. All that should be expected is that the practitioner will
follow a reasonable course of action based on current knowledge, available resources,
and the needs of the patient to deliver effective and safe medical care. The sole purpose
of these guidelines is to assist practitioners in achieving this objective.
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I.
INTRODUCTION
The clinical aspects contained in specific sections of this guideline (Introduction,
Indications, Specifications of the Examination, and Equipment Specifications) were
developed collaboratively by the American College of Radiology (ACR), the American
Institute of Ultrasound in Medicine (AIUM), and the Society of Radiologists in
Ultrasound (SRU). Recommendations for physician requirements, written request for the
examination, procedure documentation, and quality control vary between the three
organizations and are addressed by each separately.
Mapping of arm vessels prior to surgical placement creation of dialysis access has been
shown to be useful in helping achieve a higher percentage of arteriovenous fistula (AVF)
placements, as well as increased fistula success rate [1-4].
This guideline is intended to help physicians in the performance of preoperative mapping,
to guarantee a high quality examination, and to help promote successful placement of the
most preferred types of dialysis access. Kidney Disease Outcomes Quality Initiative
(K/DOQI) guidelines [5] define an order of preference for placement of vascular access
in patients with kidney failure who will become hemodialysis dependent:
1. The nondominant arm is usually preferable for dialysis access placement, and
is usually evaluated first. A forearm AVF is preferred over an upper arm
AVF, although a dominant forearm AVF is generally preferred over a
nondominant upper arm AVF.
2. A forearm cephalic vein AVF (radial artery-cephalic vein), followed by an upper
arm cephalic vein AVF (brachial artery-cephalic vein), is preferred.
3. If it is not possible to create either of these fistulae, access may be established
using a transposed basilic vein fistula (brachial artery-basilic vein), or other AVF
configuration.
4. If the vascular anatomy is not suitable for any AVF placement, a graft of synthetic
material (e.g., polytetrafluoroethylene, abbreviated PTFE) may be placed. A
forearm loop graft (brachial artery to antecubital vein) is preferred over an upper
arm straight graft (brachial artery to basilic vein). If no other upper extremity
access is possible, an upper arm loop graft (axillary artery to axillary vein) may be
placed, if the anatomy is suitable.
5. Thigh grafts (common superficial femoral artery to great saphenous vein or
common femoral vein) are the next usual site for access placement [6].
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6. Placement of an upper extremity AVF or an arm or thigh graft is preferred to
catheter-based hemodialysis, due to increased catheter infection rates and often
lower catheter flow rates as compared to a graft or fistula [7].
II.
INDICATIONS/CONTRAINDICATIONS
Indications for vascular mapping for preoperative planning of dialysis access include
planning of vascular access for hemodialysis. There are no absolute contraindications for
this examination.
III.
QUALIFICATIONS AND RESPONSIBILITIES OF PERSONNEL
Each organization addresses this requirement individually. ACR language is as
follows:
See the ACR Practice Guideline for Performing and Interpreting Diagnostic Ultrasound
Examinations.
IV.
WRITTEN REQUEST FOR THE EXAMINATION
Each organization addresses this requirement individually. ACR language is as
follows:
The written or electronic request for a dialysis access ultrasound
examination should provide sufficient information to demonstrate the
medical necessity of the examination and allow for its proper performance
and interpretation.
Documentation that satisfies medical necessity includes 1) signs and
symptoms and/or 2) relevant history (including known diagnoses).
Additional information regarding the specific reason for the examination
or a provisional diagnosis would be helpful and may at times be needed to
allow for the proper performance and interpretation of the examination.
The request for the examination must be originated by a physician or other
appropriately licensed health care provider. The accompanying clinical
information should be provided by a physician or other appropriately
licensed health care provider familiar with the patient’s clinical problem or
question and consistent with the state’s scope of practice requirements.
(ACR Resolution 35, adopted in 2006)
V.
SPECIFICATIONS OF THE EXAMINATION
The ultrasound examination for dialysis access planning is designed to gather information
about both the arterial system and the venous system. It is important to understand the
procedure and surgical techniques to be used by the local dialysis access surgeon(s) in
order to obtain information tailored to the technique. Both arms can be mapped in their
entirety, or a more focused preoperative mapping can be performed that concludes
when vessels adequate for AVF formation are found.
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A. Arterial Examination
The examination is done either on both arms or only on one arm, depending on
laboratory preference. If a unilateral examination is chosen, the nondominant arm
is examined first unless there is a known contraindication to the use of this arm. The
artery used must be of sufficient size (diameter > 0.20 cm) 141 to construct the fistula
and to have adequate flow for maturation. This size may vary according to surgical
preference. The artery is first evaluated with grayscale and spectral Doppler
imaging. The internal luminal diameter of the artery is measured at the level of
expected fistula creation. The presence of calcification is recorded and reported,
since the surgical anastomosis can be difficult if significant concentric calcification is
present. Arterial spectral waveforms should be assessed to screen for inflow or
outflow disease.
For a forearm AVF the diameter, presence of calcification, and peak systolic/end
diastolic velocities of the radial artery are assessed at the wrist. Ulnar arteries may
be similarly assessed. For either AVF or graft creation the brachial artery is
assessed at the antecubital fossa for diameter, presence of calcification, and peak
systolic/end diastolic velocities. An artery in the antecubital fossa that is smaller
than expected, or the presence of two arteries at this site, is a clue that there is a
high bifurcation of the brachial artery (high radial artery) takeoff. This vascular
anomaly occurs in 5% to 10% of patients. This anatomic variant should be
confirmed by imaging the radial and ulnar arteries to determine at what level they
arise from the brachial artery. If noted, it should be reported, as some surgeons will
place an AVF, but not a graft, below a high radial artery takeoff.
A modified duplex Allen test may be performed to evaluate flow to the hand
(patency of the deep palmar arch). This is done by identifying the radial artery at
the wrist and/or at the dorsum of the hand (posteriorly between the bases of the first
and second metacarpals). The radial artery is compressed proximal to this site to
occlude flow during insonation with spectral and color Doppler. Reversal of blood
flow distal to the proximal occlusion confirms patency of the palmar arch 181.
B. Venous Examination
The nondominant arm is examined first unless there is a known to be a contraindication
to the use of this that arm. The examination is focused first towards finding a vein
suitable for AVF creation. If no suitable vein is found, veins suitable for graft creation are
sought.
The vein mapped to receive the arterial anastomosis should be measured after it is
dilated. This measurement will more closely approximate the size of the arterialized vein
that will be seen after following fistula formation. The vein is generally dilated by use of
sequential tourniquet placement or an inflated blood pressure cuff on the arm [9].
Percussion in the region of the wrist after tourniquet placement for 2 to 3 minutes
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can increase the size of the veins, similar to starting an IV. Other suitable dorsal or
volar caudal forearm veins may be identified with this technique. It can also be
dilated by letting the arm hang below the level of the heart, by rubbing or tapping the
vein, or by wrapping the forearm with a warm compress for several minutes
The forearm vein most commonly used for AVF creation is the cephalic vein. The
anastomosis is usually created at the wrist, or in the lower one-third of the forearm. The
cephalic vein is insonated imaged at the site of the expected anastomosis at the wrist. It is
assessed for compressibility, thrombus, and for size. Measurements are obtained with a
minimal diameter of O.25 cm for all veins used for an AVF. However There may
be variations in the diameter used based on clinical factors or surgical preference.
Vein diameter is measured at the caudal, mid and cranial forearm; at the antecubital
fossa; and at the caudal, mid, and cranial upper arm, as applicable. The sites and length
of any vein venous stenosis are noted. Veins that are borderline in size (within O.O5 cm
of the desired size) are measured again after more focused percussion, or after
application of a warm compress for several minutes. If a sclerotic or thick walled vein
is seen, the diameter measured should be the inner luminal diameter, and the
abnormality noted.
The cephalic vein should be evaluated throughout the entire arm to its insertion into
the subclavian vein. Note that the forearm cephalic vein may drain preferentially
via a large antecubital vein into the basilic or brachial veins if the upper arm
cephalic vein is too small or thrombosed. In this case, placement of a forearm fistula
is still possible as long as diameter thresholds are maintained.
Veins must be relatively superficial to be easily cannulated after placement of a fistula.
Depending on local practices and surgical preferences The depth from the skin surface
of to the cephalic veins of adequate diameter may be measured if of adequate diameter
to assess the need for a subsequent superficialization procedure [10].
If the cephalic vein in the forearm is inadequate for fistula creation, other veins in
the forearm may be examined to determine whether they are adequate. These veins
in general will need to be transposed to a more easily accessible position in the
anterior surface of the forearm. If no suitable vein is found in the forearm, the veins
in the upper arm should be evaluated.
The upper arm cephalic vein should be examined for upper arm fistula creation. If
it is too small or thrombosed, the basilic vein is evaluated. The basilic vein needs to
be of adequate size for at least 4 cm in length, caudal to the antecubital fossa so
there is enough vein length to create a basilic vein transposition AVF in the upper
arm. If no suitable upper arm vein for AVF creation is found, the largest brachial
vein and the axillary vein should be measured for potential graft placement as
previously described. A vein with a diameter of at least 0.4 cm is needed for grafts.
Similar assessment techniques should be used for all veins (i.e., vein dilatation prior
to insonation, demonstration of adequate size and normal venous compressibility,
and determination of adequate venous drainage).
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Large branches of veins near the site of a fistula can result in nonmaturation of the fistula
[11-12]. Depending on local practices The sites and sizes of vein branches and the sizes
of those branches may be noted.
The cephalic vein should be evaluated central to its draining vein to verify a wide
connection to the upper arm. The examination should be continued to include the main
draining vein for the fistula to the axillary vein. If the cephalic vein drains via a large
antecubital vein into the basilic or brachial veins, note should be made that the vein is
suitable for AVF creation even if the upper arm cephalic vein is too small
The internal jugular and subclavian veins should be examined bilaterally for to
document symmetric respiratory phasicity and transmitted cardiac pulsatility, as well as
to exclude out-flow stenosis. These veins should generally be evaluated by duplex color
sonography including grayscale with compression if possible, with grayscale, spectral,
and color Doppler. Unilateral or bilateral monophasic waveforms or low peak systolic
velocity venous waveforms are abnormal [13-14]. Abnormal waveforms in the jugular
veins or subclavian veins should prompt further evaluation of the brachiocephalic veins
and/or superior vena cava (SVC) by magnetic resonance imaging (MRI), computed
tomography (CT) or conventional venography if access placement on that side is
desired.
If the cephalic vein in the forearm is not adequate for fistula creation, then other veins in
the forearm may be examined to determine whether they may be adequate. These veins in
general will need to be transposed to an easier accessible position in the anterior surface
of the forearm, typically a basilic or other vein. If no suitable vein is found in the
forearm, the veins in the upper arm should be evaluated.
The upper arm cephalic vein should be examined for upper arm fistula creation. If it is
too small or thrombosed, the basilic vein is evaluated. There needs to be 2 cm of
adequately sized basilic vein caudal to the antecubital fossa to create a basilic vein
transposition AVF. If no suitable upper arm vein for AVF creation is found, the largest
brachial vein and axillary vein should be measured for potential graft placement as
previously described. An even larger vein is needed for grafts, with a minimum diameter
of 0.4 cm.
Similar assessment techniques should be used in all these veins (i.e., vein dilatation prior
to insonation, demonstration of adequate size and normal venous compressibility, and
determination of adequate venous drainage).
B. Arterial Examination
The artery used must be of sufficient size (0.20 cm) [1,7] to construct the fistula and for it
to have adequate flow for maturation. The artery is evaluated with grayscale. The
presence of calcifications is recorded and reported since the surgical anastomosis can be
difficult to perform if significant concentric calcifications are present. The luminal
diameter of the artery is measured at the level of expected fistula creation. Arterial
spectral waveforms should be assessed for normalcy, to screen for inflow disease.
For a forearm AVF the radial and ulnar arteries are assessed for diameter, peak
systolic/end diastolic velocity, and the presence of calcification at the wrist. For either
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AVF or graft creation the brachial artery is assessed for diameter, peak systolic/end
diastolic velocity, waveform and the presence of calcification at the antecubital fossa. An
artery at this location that is smaller than expected can be a clue to the patient having a
high bifurcation of the brachial artery (high radial artery takeoff), a vascular anomaly
occurring in 5% to 10% of patients. When suspected, the anomaly should be confirmed
by insonating the radial and ulnar arteries to determine whether they arise from the
brachial artery. If noted, it should be reported, as some surgeons will place an AVF, but
not a graft, below the high radial artery takeoff.
A duplex Allen test may be performed. This is often most easily done by identifying the
radial artery at the wrist and/or at the dorsum of the hand (posteriorly between the bases
of the first and second metacarpals to become the deep palmar arch). The radial artery is
compressed proximal to this site during insonation with spectral and color Doppler to
occlude its flow. Reversal of blood flow distal to the proximal occlusion confirms
patency of a palmar arch [11].
VI.
DOCUMENTATION
Each organization addresses this requirement individually. ACR language is as
follows:
Adequate documentation is essential for high-quality patient care. There should be a
permanent record of the ultrasound examination and its interpretation. Comparison with
prior relevant imaging studies may prove helpful. Images of all appropriate areas, both
normal and abnormal, should be recorded. Variations from normal size should generally
be accompanied by measurements. Images should be labeled with the patient
identification, facility identification, examination date, and image orientation The initials
of the operator should be accessible on the images or electronically on PACS.
Images should be labeled with the patient identification, facility identification,
examination date, and image orientation. An official interpretation (final report) of the
ultrasound examination should be included in the patient’s medical record. Retention of
the ultrasound examination images should be consistent both with based on clinical need
and with relevant legal and local health care facility requirements.
Reporting should be in accordance with the ACR Practice Guideline for Communication
of Diagnostic Imaging Findings.
VII.
EQUIPMENT SPECIFICATIONS
Real-time imaging should be conducted at the highest clinically appropriate frequency,
realizing that there is a trade-off between resolution and beam penetration. This should
usually be at a frequency of 10 to 12 MHz or greater, with the occasional need for a
lower frequency transducer. A linear transducer should be used. Flow analyses are
performed with duplex sonography, using pulsed Doppler. Evaluation of the flow signals
originating from within the lumen of the vessels should be conducted with a carrier
frequency of 2.5 MHz or above. A lower frequency sector transducer placed in the
sternal notch may be useful to look for venous stenosis in the brachiocephalic veins
or SVC, if a central stenosis is suspected from abnormal subclavian and internal
jugular vein waveforms. Images of the relevant grayscale, color, and spectral Doppler
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waveforms should be recorded and archived. Color Doppler should be used for relevant
portions of the procedure.
VIII. QUALITY CONTROL AND IMPROVEMENT, SAFETY, INFECTION
CONTROL, AND PATIENT EDUCATION
Each organization addresses this requirement individually. ACR language is as
follows:
Policies and procedures related to quality, patient education, infection control, and safety
should be developed and implemented in accordance with the ACR Policy on Quality
Control and Improvement, Safety, Infection Control, and Patient Education appearing
under the heading Position Statement on QC & Improvement, Safety, Infection Control,
and Patient Education on the ACR web site (http://www.acr.org/guidelines).
Equipment performance monitoring should be in accordance with the ACR Technical
Standard for Diagnostic Medical Physics Performance Monitoring of Real Time
Ultrasound Equipment.
ACKNOWLEDGEMENTS
This guideline was revised according to the process described under the heading The
Process for Developing ACR Practice Guidelines and Technical Standards on the ACR
web site (http://www.acr.org/guidelines) by the Guidelines and Standards Committee of
the ACR Commission on Ultrasound in collaboration with the AIUM, and the SRU.
Collaborative Committee — members represent their societies in the initial and final
revision of this guideline
ACR
Michelle L. Robbin, MD, FACR, Chair
Raymond E. Bertino, MD, FACR
Laurence Needleman, MD, FACR
AIUM
Julia Drose, MD
Jill E. Langer, MD
Carl C. Reading, MD, FACR
SRU
Mark E. Lockhart, MD, MPH
John S. Pellerito, MD, FACR
Guidelines and Standards Committee — Ultrasound — ACR Committee responsible
for sponsoring the draft through the process
Mary C. Frates, MD, FACR, Chair
Debra L. Acord, MD
Sandra 0. Allison, MD
Marcela Bohm-Velez, MD, FACR
Helena Gabriel, MD
Ruth B. Goldstein, MD
Robert D. Harris, MD, MPH, FACR
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Beverly E. Hashimoto, MD, FACR
Leann E. Linam, MD
Laurence Needleman, MD, FACR
Maitray D. Patel, MD
Michelle L. Robbin, MD, FACR
Robert M. Sinow, MD
Maryellen R. M. Sun, MD
Deborah Levine, MD, FACR, Chair, Commission
REFERENCES
1. Allon M, Lockhart ME, Lilly RZ, et al. Effect of preoperative sonographic mapping
on vascular access outcomes in hemodialysis patients. Kidney Int 2001;60:2013-2020.
2. Allon M, Robbin ML. Increasing arteriovenous fistulas in hemodialysis patients:
problems and solutions. Kidney Int 2002;62:1109-1124.
3. Robbin ML, Gallichio MH, Deierhoi MH, Young CJ, Weber TM, Allon M. US
vascular mapping before hemodialysis access placement. Radiology 2000;217:83-88.
4. Silva MB, Jr., Hobson RW, 2nd, Pappas PJ, et al. A strategy for increasing use of
autogenous hemodialysis access procedures: impact of preoperative noninvasive
evaluation. J Vasc Surg 1998;27:302-307; discussion 307-308.
5. Clinical practice guidelines for vascular access. Am J Kidney Dis 2006; 48 Suppl
1:S176-247.
6. Khadra MH, Dwyer AJ, Thompson JF. Advantages of polytetrafluoroethylene
arteriovenous loops in the thigh for hemodialysis access. Am J Surg 1997;173:280283.
7. Lee T, Barker J, Allon M. Tunneled catheters in hemodialysis patients: reasons
and subsequent outcomes. Am J Kidney Dis 2005;46:501-508.
8. Zimmerman P, Chin E, Laifer-Narin S, Ragavendra N, Grant EG. Radial artery
mapping for coronary artery bypass graft placement. Radiology 2001;220:299-302.
9. Lockhart ME, Robbin ML, Fineberg NS, Wells CG, Allon M. Cephalic vein
measurement before forearm fistula creation: does use of a tourniquet to meet
the venous diameter threshold increase the number of usable fistulas? J
Ultrasound Med 2006;25:1541-1545.
10. Robbin ML, Chamberlain NE, Lockhart ME, et al. Hemodialysis arteriovenous fistula
maturity: US evaluation. Radiology 2002;225:59-64.
11. Beathard GA, Arnold P, Jackson J, Litchfield T. Aggressive treatment of early fistula
failure. Kidney Int 2003;64:1487-1494.
12. Singh P, Robbin ML, Lockhart ME, Allon M. Clinically immature arteriovenous
hemodialysis fistulas: effect of US on salvage. Radiology 2008;246:299-305.
13. Chin EE, Zimmerman PT, Grant EG. Sonographic evaluation of upper extremity deep
venous thrombosis. J Ultrasound Med 2005;24:829-838; quiz 839-840.
14. Patel MC, Berman LH, Moss HA, McPherson SJ. Subclavian and internal jugular
veins at Doppler US: abnormal cardiac pulsatility and respiratory phasicity as a
predictor of complete central occlusion. Radiology 1999;211:579-583.
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4. Kidney and Urologic Diseases Statistics for the United States. 2001. National Kidney
and Urologic Diseases Information Clearinghouse Web site. Available at:
http://kidney.niddk.nih.gov/kudiseases/pubs/kustats/index.htm. Accessed June 16,
2005.
5. National Kidney Foundation. K/DOQI clinical practice guidelines for vascular access:
update 2000. Am J Kidney Dis 2001;37:S137-S181.
*Guidelines and standards are published annually with an effective date of October 1 in
the year in which amended, revised or approved by the ACR Council. For guidelines and
standards published before 1999, the effective date was January 1 following the year in
which the guideline or standard was amended, revised, or approved by the ACR Council.
Development Chronology for this Guideline
2006 (Resolution 38, 35)
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RESOLUTION NO. 10
BE IT RESOLVED,
that the American College of Radiology adopt the
ACR— AIUM—SRU
Practice
Guideline for the
Performance
of
an Ultrasound Examination of the
Extracranial Cerebrovascular System
Sponsored by:
Council Steering Committee
Extracranial Cerebrovascular US
PRACTICE GUIDELINE
Resolution No. 10
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The American College of Radiology, with more than 30,000 members, is the principal organization of radiologists, radi ation
oncologists, and clinical medical physicists in the United States. The College is a nonprofit professional society whose primary
purposes are to advance the science of radiology, improve radiologic services to the patient, study the socioeconomic aspects of the
practice of radiology, and encourage continuing education for radiologists, radiation oncologists, medical physicists, and persons
practicing in allied professional fields.
The American College of Radiology will periodically define new practice guidelines and technical standards for radiologic
practice to help advance the science of radiology and to improve the quality of service to patients throughout the United States.
Existing practice guidelines and technical standards will be reviewed for revision or renewal, as appropriate, on their fifth anniversary
or sooner, if indicated.
Each practice guideline and technical standard, representing a policy statement by the College, has undergone a thorough
consensus process in which it has been subjected to extensive review, requiring the approval of the Commission on Quality and Safety
as well as the ACR Board of Chancellors, the ACR Council Steering Committee, and the ACR Council. The practice guidelines and
technical standards recognize that the safe and effective use of diagnostic and therapeutic radiology requires specific train ing, skills,
and techniques, as described in each document. Reproduction or modification of the published practice guideline and technical
standard by those entities not providing these services is not authorized .
ACR-AIUM-SRU PRACTICE GUIDELINE FOR THE
PERFORMANCE OF AN ULTRASOUND EXAMINATION OF THE
EXTRACRANIAL CEREBROVASCULAR SYSTEM
PREAMBLE
These guidelines are an educational tool designed to assist practitioners in providing
appropriate radiologic care for patients. They are not inflexible rules or requirements of
practice and are not intended, nor should they be used, to establish a legal standard of
care. For these reasons and those set forth below, the American College of Radiology
cautions against the use of these guidelines in litigation in which the clinical decisions of
a practitioner are called into question.
The ultimate judgment regarding the propriety of any specific procedure or course of
action must be made by the physician or medical physicist in light of all the
circumstances presented. Thus, an approach that differs from the guidelines, standing
alone, does not necessarily imply that the approach was below the standard of care. To
the contrary, a conscientious practitioner may responsibly adopt a course of action
different from that set forth in the guidelines when, in the reasonable judgment of the
practitioner, such course of action is indicated by the condition of the patient, limitations
of available resources, or advances in knowledge or technology subsequent to publication
of the guidelines. However, a practitioner who employs an approach substantially
different from these guidelines is advised to document in the patient record information
sufficient to explain the approach taken.
The practice of medicine involves not only the science, but also the art of dealing with
the prevention, diagnosis, alleviation, and treatment of disease. The variety and
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complexity of human conditions make it impossible to always reach the most appropriate
diagnosis or to predict with certainty a particular response to treatment. Therefore, it
should be recognized that adherence to these guidelines will not assure an accurate
diagnosis or a successful outcome. All that should be expected is that the practitioner will
follow a reasonable course of action based on current knowledge, available resources,
and the needs of the patient to deliver effective and safe medical care. The sole purpose
of these guidelines is to assist practitioners in achieving this objective.
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I.
INTRODUCTION
The clinical aspects contained in specific sections of this guideline (Introduction,
Indications, Specifications of the Examination, and Equipment Specifications) were
developed collaboratively by the American College of Radiology (ACR), the American
Institute of Ultrasound in Medicine (AIUM), and the Society of Radiologists in
Ultrasound (SRU). Recommendations for physician requirements, written request for the
examination, procedure documentation, and quality control vary between the three
organizations and are addressed by each separately.
Ultrasound, using grayscale imaging, Doppler spectral analysis, and color Doppler
imaging (CDI), is a proven and useful procedure for evaluating the extracranial
cerebrovascular system. While it is not possible to detect every abnormality, adherence to
the following guidelines will maximize the probability of detecting most extracranial
cerebrovascular abnormalities. Occasionally, an additional and/or specialized
examination may be necessary.
II.
INDICATIONS
Indications for an ultrasound examination of the extracranial carotid and vertebral arteries
include, but are not limited to:
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
Evaluation of patients with hemispheric neurologic symptoms, including stroke,
transient ischemic attack, and amaurosis fugax [1-4].
Evaluation of patients with a cervical bruit.
Evaluation of pulsatile neck masses.
Preoperative evaluation of patients scheduled for major cardiovascular surgical
procedures.
Evaluation of nonhemispheric or unexplained neurologic symptoms.
Follow-up of patients with proven carotid disease.
Evaluation
of
postoperative
patients
following
cerebrovascular
revascularization, including carotid endarterectomy, revascularization,
including stenting, or carotid to subclavian bypass.
Intraoperative monitoring of vascular surgery.
Evaluation of suspected subclavian steal syndrome [5].
Evaluation for suspected carotid artery dissection [61, arteriovenous fistula
or pseudoaneurysm.
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11.
III.
Patients with carotid reconstruction after ECMO (extracorporeal membrane
oxygenation) bypass.
QUALIFICATIONS AND RESPONSIBILITIES OF THE PHYSICIAN
Each organization addresses this requirement individually. ACR language is as
follows:
See the ACR Practice Guideline for Performing and Interpreting Diagnostic Ultrasound
Examinations.
IV.
WRITTEN REQUEST FOR THE EXAMINATION
Each organization addresses this requirement individually. ACR language is as
follows:
The written or electronic request for extracranial cerebrovascular
ultrasound should provide sufficient information to demonstrate the
medical necessity of the examination and allow for its proper performance
and interpretation.
Documentation that satisfies medical necessity includes 1) signs and
symptoms and/or 2) relevant history (including known diagnoses).
Additional information regarding the specific reason for the examination
or a provisional diagnosis would be helpful and may at times be needed to
allow for the proper performance and interpretation of the examination.
The request for the examination must be originated by a physician or other
appropriately licensed health care provider. The accompanying clinical
information should be provided by a physician or other appropriately
licensed health care provider familiar with the patient’s clinical problem or
question and consistent with the state’s scope of practice requirements.
(ACR Resolution 35, adopted in 2006)
V.
SPECIFICATIONS OF THE EXAMINATION
A. Technique
Extracranial cerebrovascular ultrasound evaluation consists of assessment of the
accessible portions of the common and internal carotid arteries, and basic
assessment of the external carotid and vertebral arteries. All arteries should be
scanned using appropriate grayscale and Doppler techniques and proper patient
positioning [2-3,71. Grayscale imaging of the common carotid artery, its bifurcation,
and both the internal and external carotid arteries should be performed in
longitudinal and transverse planes. The internal carotid and common carotid
arteries should be imaged as completely as possible with caudad angulation of the
transducer in the supraclavicular area and cephalad angulation at the level of the
mandible [3-41.
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CDI should be used to detect areas of narrowing and abnormal flow to select areas
for Doppler spectral analysis. CDI should also be used to clarify the cause of
image/pulsed Doppler mismatches and to detect narrow flow channels seen in highgrade (near occlusive) stenoses 181. Power Doppler evaluation may be helpful to
search for a narrow channel of residual flow in suspected occlusion or nearocclusion.
Spectral Doppler with angle-corrected blood-flow velocity measurements should be
obtained at representative sites in the vessels. Additionally, scanning in areas of
stenosis or suspected stenosis must be adequate to determine the maximal peak
systolic velocity associated with the stenosis and to document disturbances in the
waveform distal to the stenosis.
Consistent angle correction is essential for determining blood-flow velocity 121. All
angle corrected spectral Doppler waveforms must be obtained from longitudinal
images.
Angle correction should be applied in a consistent manner for all measurements
(typically either parallel to the vessel wall or in line with the color lumen but not
both). The angle between the direction of flowing blood and the applied Doppler
ultrasound signal (angle θ 1theta1, the Doppler angle) should not exceed 60 degrees.
The reliability of velocity measurements decreases significantly at angles above 60
degrees, and the use of velocity measurements obtained at angles above 60 degrees is
discouraged 131. Deviations from protocol may be unavoidable (e.g., with a very
tortuous vessel) but should be minimized. Gain should be appropriate for the vessel
scanned (undergaining or overgaining may affect velocity measurements).
B. Recording
1. Grayscale image: At a minimum, for each normal side evaluated, grayscale
images must be obtained at each of the following levels:
a. Long axis common carotid artery.
b. Long axis at carotid artery bifurcation.
c. Long axis internal carotid artery.
d. Short axis proximal internal carotid artery.
If abnormalities are found, additional images must be recorded:
a. If atherosclerotic plaques are present, their extent, location, and
characteristics should be documented with grayscale imaging in both the
longitudinal and transverse planes.
b. Other vascular or significant perivascular abnormalities should be
documented.
2. Color Doppler: Color images may be recorded using appropriate color
technique to demonstrate filling of the normal lumen and/or flow
disturbances associated with stenoses. In cases of occlusion, a color and/or
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power Doppler image of the abnormal vessel should be obtained to confirm
that it is occluded.
3. Spectral Doppler: For each normal side evaluated, spectral Doppler
waveforms and maximal peak systolic velocities must be recorded at each of
the following levels:
a. Proximal common carotid artery.
b. Mid or distal common carotid artery (generally 2 to 3 cm below the
bifurcation).
c. Proximal internal carotid artery.
d. Distal internal carotid artery.
e. Proximal external carotid artery.
f. Vertebral artery (in neck or near origin).
If a significant stenosis is found or suspected, additional images must be recorded
and the location of the stenosis determined:
a. At the site of maximum velocity due to the stenosis.
b. Distal to the site of maximal velocity to document the presence or absence
of disturbed flow.
Diastolic velocities and velocity ratios may also be calculated as warranted
depending on the laboratory interpretation criteria.
The peak systolic velocity and flow direction in each of the vertebral arteries should
be recorded.
Stents require additional images. Indwelling stents should be sampled within,
proximal, and distal to each stent, and the site of highest velocity should be
determined and recorded.
C. Interpretation
The interpretation of cerebrovascular ultrasound requires careful attention to
protocol and interpretation criteria.
1. Each laboratory must have interpretation criteria that are used by all
members of the technical and physician staff.
2. Diagnostic criteria must be derived from the literature from internal
validation based on correlation with other imaging modalities or from
surgical and/or pathological correlation 12-3,6,9-111.
3. The report must indicate internal carotid artery stenosis categories that are
clinically useful and nationally accepted 11-31. Stenosis above 50% should be
graded as a range (e.g., 50% to 69%, 70% to near occlusion) or a numerical
grade (e.g., 60% ±10%) to provide adequate information for clinical
decision-making. Numerous factors affect interpretation criteria, (e.g.,
contralateral severe disease or occlusion, ipsilateral near occlusion) 17,12-141.
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4. The report must indicate vertebral artery flow direction and should indicate
abnormal waveform shape 15,151.
5. The report may indicate plaque characterization as warranted depending on
the laboratory interpretation criteria 116-201.
6. The report should indicate other significant nonvascular abnormalities.
7. The criteria for common and external carotid artery stenosis differ from
internal carotid artery criteria 121-221.
8. Stents require different criteria than native vessels 123-261.
When available, modalities, parameters, and tests other than duplex ultrasound
may add valuable information to the cerebrovascular Doppler ultrasound
examination.
Grayscale imaging of the common carotid artery, its bifurcation, and both the internal and
external carotid arteries should be performed in longitudinal and transverse planes, with
representative images recorded. Additionally, if atherosclerotic plaques are present, their
extent, location, and characteristics should be documented with grayscale imaging in both
the longitudinal and transverse planes. Other vascular or perivascular abnormalities
should be documented as well.
The vessels should be imaged as completely as possible with caudad angulation of the
transducer in the supraclavicular area and cephalad angulation at the level of the
mandible.
CDI should be used to detect areas of narrowing and abnormal flow and to select areas
for Doppler spectral analysis. It may also be used to clarify the cause of apparent
image/pulsed Doppler mismatches and to detect narrow flow channels seen in high-grade
(near occlusive) stenoses. Power Doppler evaluation may also be helpful in searching for
a narrow channel of residual flow in suspected occlusion or near occlusion.
Blood-flow velocity measurements should be recorded at a minimum of one site in the
common carotid artery, external carotid artery, and vertebral artery, and two sites in the
internal carotid artery. If there are significant stenoses, Doppler spectra should be
sampled within and distal to each stenosis and the highest velocity determined and
recorded. The location of each stenosis should be documented.
Indwelling stents should be sampled within, proximal, and distal to each stent and the
highest velocity determined and recorded.
Maximal peak systolic and diastolic velocities should be recorded for the common and
internal carotid arteries bilaterally. Velocity ratios may be calculated.
The vertebral artery should be imaged in the longitudinal plane, and the velocity
spectrum and flow direction in each of the vertebral arteries should be recorded.
Consistent angle correction is essential for determining blood-flow velocity. Angle
corrected spectral Doppler is obtained from longitudinal images. The angle between the
directi on of flowing blood and the appli ed Dopple r ult rasound si gnal ( an gl e
θ [ theta] , the Doppler angle) should not exceed 60 degrees whenever possible.
The reliability of velocity measurements decreases significantly at angles above 60
degrees, and the use of velocity measurements obtained at angles above 60 degrees is
discouraged.
The interpretation of cerebrovascular ultrasound requires careful attention to protocol and
interpretation criteria. Angle correction should be applied in a consistent manner for all
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measurements. Deviations from protocol may be unavoidable (e.g., with a very tortuous
vessel) but should be minimized.
Each laboratory should have interpretation criteria that are used by all members of the
technical and physician staff. Diagnostic criteria may be derived from the literature or
based on internal validation from correlation with other imaging or from surgical or
pathological correlation. National interpretation criteria have not been validated when
applied to the evaluation of stented carotid arteries.
The report should indicate carotid stenosis categories that are clinically useful and
nationally accepted. Stenosis above 50% should be graded in a numerical grade (e.g.,
60%) or a degree of stenosis within a range (e.g., 50% to 69%), to provide adequate
information for clinical decision making.
When available, modalities, parameters, and tests other than duplex ultrasound may add
valuable information to the cerebrovascular examination.
VI.
DOCUMENTATION
Each organization addresses this requirement individually. ACR language is as
follows:
Adequate documentation is essential for high quality in patient care. There should be a
permanent record of the ultrasound examination and its interpretation. Comparison with
prior relevant imaging studies may prove helpful. Images of all appropriate areas, both
normal and abnormal, should be recorded. Variations from normal size should generally
be accompanied by measurements. Images are to be labeled with the patient
identification, facility identification, examination date, vessel name, and image
orientation. The initials of the operator should be accessible on the images or
electronically on PACS. Images should be labeled with the patient identification,
facility identification, examination date, and image orientation. An official
interpretation (final report) of the ultrasound examination should be included in the
patient’s medical record. Retention of the ultrasound examination should be consistent
both with based on clinical need and with relevant legal and local health care facility
requirements.
Reporting should be in accordance with the ACR Practice Guideline for Communication
of Diagnostic Imaging Findings.
VII.
EQUIPMENT SPECIFICATIONS
The examination should be conducted with a real-time scanner with Doppler capability,
preferably using a linear transducer. The examination should use the highest clinically
appropriate frequency, realizing that there is a trade-off between resolution and beam
penetration. Imaging frequencies should be 5.0 MHz or greater. Doppler flow analysis
should be conducted with a carrier frequency of 3.0 MHz or greater. Lower frequencies
are occasionally appropriate in patients with a large body habitus or densely calcified
vessels. Examination using lower frequency transducers can also be useful when the
vessels are not adequately imaged at higher frequencies. CDI can be used to localize
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blood-flow abnormalities for range gate placement for the Doppler spectral analysis, thus
facilitating the examination.
VIII. QUALITY CONTROL AND IMPROVEMENT, SAFETY, INFECTION
CONTROL, AND PATIENT EDUCATION
Each organization addresses this requirement individually. ACR language is as
follows:
Policies and procedures related to quality, patient education, infection control, and safety
should be developed and implemented in accordance with the ACR Policy on Quality
Control and Improvement, Safety, Infection Control, and Patient Education appearing
under the heading Position Statement on QC & Improvement, Safety, Infection Control,
and Patient Education on the ACR web site (http://www.acr.org/guidelines).
Equipment performance monitoring should be in accordance with the ACR Technical
Standard for Diagnostic Medical Physics Performance Monitoring of Real Time
Ultrasound Equipment.
ACKNOWLEDGEMENTS
This guideline was revised according to the process described under the heading The
Process for Developing ACR Practice Guidelines and Technical Standards on the ACR
web site (http://www.acr.org/guidelines) by the ACR Guidelines and Standards
Committee of the ACR Commission on Ultrasound in collaboration with the AIUM and
the SRU.
Collaborative Committee — members represent their societies in the initial and final
revision of this guideline
ACR
Laurence Needleman, MD, FACR, Chair
Beverly E. Hashimoto, MD, FACR
Michelle L. Robbin, MD, FACR
AIUM
Julia Drose, RDMS, RDCS, RVT
David M. Paushter, MD, FACR
Leslie M. Scoutt, MD
SRU
Edward I. Bluth, MD, FACR
Edward G. Grant, MD, FACR
Deborah J. Rubens, MD
Guidelines and Standards Committee — Ultrasound — ACR Committee responsible
for sponsoring the draft through the process
Mary C. Frates, MD, FACR, Chair
Debra L. Acord, MD
Sandra 0. Allison, MD
Marcela Bohm-Velez, MD, FACR
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Helena Gabriel, MD
Ruth B. Goldstein, MD
Robert D. Harris, MD, MPH, FACR
Beverly E. Hashimoto, MD, FACR
Leann E. Linam, MD
Laurence Needleman, MD, FACR
Maitray D. Patel, MD
Michelle L. Robbin, MD, FACR
Robert M. Sinow, MD
Maryellen R. M. Sun, MD
Deborah Levine, MD, FACR, Chair, Commission
REFERENCES
1. Eliasziw M, Rankin RN, Fox AJ, Haynes RB, Barnett HJ. Accuracy and
prognostic consequences of ultrasonography in identifying severe carotid artery
stenosis. North American Symptomatic Carotid Endarterectomy Trial
(NASCET) group. Stroke 1995;26:1747-1752.
2. Grant EG, Benson CB, Moneta GL, et al. Carotid artery stenosis: gray-scale and
Doppler US diagnosis--Society of Radiologists in Ultrasound Consensus
Conference. Radiology 2003;229:340-346.
3. Oates CP, Naylor AR, Hartshorne T, et al. Joint recommendations for reporting
carotid ultrasound investigations in the United Kingdom. Eur J Vasc Endovasc
Surg 2009;37:251-261.
4. Polak JF. Carotid ultrasound. Radiol Clin North Am 2001;39:569-589.
5. Kliewer MA, Hertzberg BS, Kim DH, Bowie JD, Courneya DL, Carroll BA.
Vertebral artery Doppler waveform changes indicating subclavian steal
physiology. AJR 2000;174:815-819.
6. Steinke W, Rautenberg W, Schwartz A, Hennerici M. Noninvasive monitoring of
internal carotid artery dissection. Stroke 1994;25:998-1005.
7. Horrow MM, Stassi J, Shurman A, Brody JD, Kirby CL, Rosenberg HK. The
limitations of carotid sonography: interpretive and technology-related errors.
AJR 2000;174:189-194.
8. Griewing B, Morgenstern C, Driesner F, Kallwellis G, Walker ML, Kessler C.
Cerebrovascular disease assessed by color-flow and power Doppler
ultrasonography. Comparison with digital subtraction angiography in internal
carotid artery stenosis. Stroke 1996;27:95-100.
9. Grant EG, Duerinckx AJ, El Saden S, et al. Doppler sonographic parameters for
detection of carotid stenosis: is there an optimum method for their
selection?AJR 1999;172:1123-1129.
10. Heijenbrok-Kal MH, Buskens E, Nederkoorn PJ, Van Der Graaf Y, Hunink
MG. Optimal peak systolic velocity threshold at duplex US for determining the
need for carotid endarterectomy: a decision analytic approach. Radiology
2006;238:480-488.
11. Moneta GL, Edwards JM, Chitwood RW, et al. Correlation of North American
Symptomatic Carotid Endarterectomy Trial (NASCET) angiographic definition
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of 70% to 99% internal carotid artery stenosis with duplex scanning. J Vasc
Surg 1993;17:152-157; discussion 157-159.
12. El-Saden SM, Grant EG, Hathout GM, Zimmerman PT, Cohen SN, Baker JD.
Imaging of the internal carotid artery: the dilemma of total versus near total
occlusion. Radiology 2001;221:301-308.
13. Heijenbrok-Kal MH, Nederkoorn PJ, Buskens E, Van Der Graaf Y, Hunink
MG. Diagnostic performance of duplex ultrasound in patients suspected of
carotid artery disease: the ipsilateral versus contralateral artery. Stroke
2005;36:2105-2109.
14. Romero JM, Lev MH, Chan ST, et al. US of neurovascular occlusive disease:
interpretive pearls and pitfalls. Radiographics 2002;22:1165-1176.
15. Kim ES, Thompson M, Nacion KM, Celestin C, Perez A, Gornik HL. Radiologic
importance of a high-resistive vertebral artery Doppler waveform on carotid
duplex ultrasonography. J Ultrasound Med 2010;29:1161-1165.
16. Biasi GM, Froio A, Diethrich EB, et al. Carotid plaque echolucency increases the
risk of stroke in carotid stenting: the Imaging in Carotid Angioplasty and Risk
of Stroke (ICAROS) study. Circulation 2004;110:756-762.
17. Bluth EI. Evaluation and characterization of carotid plaque. Semin Ultrasound
CT MR 1997;18:57-65.
18. Kwee RM. Systematic review on the association between calcification in carotid
plaques and clinical ischemic symptoms. J Vasc Surg 2010;51:1015-1025.
19. Mayor I, Momjian S, Lalive P, Sztajzel R. Carotid plaque: comparison between
visual and grey-scale median analysis. Ultrasound Med Biol 2003;29:961-966.
20. Polak JF, Shemanski L, O’Leary DH, et al. Hypoechoic plaque at US of the
carotid artery: an independent risk factor for incident stroke in adults aged 65
years or older. Cardiovascular Health Study. Radiology 1998;208:649-654.
21. Lee VS, Hertzberg BS, Workman MJ, et al. Variability of Doppler US
measurements along the common carotid artery: effects on estimates of internal
carotid arterial stenosis in patients with angiographically proved disease.
Radiology 2000;214:387-392.
22. Slovut DP, Romero JM, Hannon KM, Dick J, Jaff MR. Detection of common
carotid artery stenosis using duplex ultrasonography: a validation study with
computed tomographic angiography. J Vasc Surg 2010;51:65-70.
23. Aburahma AF, Abu-Halimah S, Bensenhaver J, et al. Optimal carotid duplex
velocity criteria for defining the severity of carotid in-stent restenosis. J Vasc
Surg 2008;48:589-594.
24. Fleming SE, Bluth EI, Milburn J. Role of sonography in the evaluation of
carotid artery stents. J Clin Ultrasound 2005;33:321-328.
25. Stanziale SF, Wholey MH, Boules TN, Selzer F, Makaroun MS. Determining instent stenosis of carotid arteries by duplex ultrasound criteria. J Endovasc Ther
2005;12:346-353.
26. Zhou W, Felkai DD, Evans M, et al. Ultrasound criteria for severe in-stent
restenosis following carotid artery stenting. J Vasc Surg 2008;47:74-80.
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Suggested Reading (Additional articles that are not cited in the document but that the
committee recommends for further reading on this topic)
1. Bluth El. Evaluation and characterization of carotid plaque. Semin Ultrasound CT
MR 1997;18:57-65.
2. Eliasziw M, Rankin RN, Fox AJ, Haynes RB, Barnett HJ. Accuracy and prognostic
consequences of ultrasonography in identifying severe carotid artery stenosis. North
America Symptomatic Carotid Endarterectomy Trial (NASCET) Group. Stroke
1995;26:1747-1752.
3. El-Saden SM, Grant EG, Hathout GM, Zimmerman PT, Cohen SN, Baker JD.
lmaging of the internal carotid artery: the dilemma of total versus near total
occlusion. Radiology 2001;221:301-308.
4. Fleming SE, Bluth El, Milburn J. Role of sonography in the evaluation of carotid
artery stents. J Clin Ultrasound 2005;33:321-328.
5. Grant EG, Benson CB, Moneta GL, et al. Carotid artery stenosis: gray-scale and
Doppler US diagnosis —
Society of Radiologists in Ultrasound
Consensus Conference. Radiology 2003;229:340-346.
6. Grant EG, Duerinckx AJ, El Saden S, et al. Doppler sonographic parameters for
detection of carotid stenosis: is there an optimum method for their selection? AJR
1999;172:1123-1129.
7. Griewing B, Morgenstern C, Driesner F, Kallwellis G, Walker ML, Kessler C.
Cerebrovascular disease assessed by color-flow and power Doppler ultrasonography:
comparison with digital subtraction angiography in internal carotid artery stenosis.
Stroke 1996;27:95-100.
8. Heijenbrok-Kal MH, Buskens E, Nederkoorn PJ, van der Graaf Y, Hunink MG.
Optimal peak systolic velocity threshold at duplex US for determining the need for
carotid endarterectomy: a decision analytic approach. Radiology 2006;238:480-488.
9. Moneta GL, Edwards JM, Papanicolaou G, et al. Screening for asymptomatic internal
carotid artery stenosis: duplex criteria for discriminating 60% to 99% stenosis. J Vasc
Surg 1995;21:989-994.
10. Polak JF. Carotid ultrasound. Radiol Clin North Am 2001;39:569-589.
11. P olak J F, S hemanski L, 2‘ Lea r y D H, et al. H yp oechoic pl aque at US
of the c arotid artery: an independent risk factor for incident stroke in adults aged
65 years or older. Cardiovascular Health Study. Radiology 1998;208:649-654.
*Guidelines and standards are published annually with an effective date of October 1 in
the year in which amended, revised or approved by the ACR Council. For guidelines and
standards published before 1999, the effective date was January 1 following the year in
which the guideline or standard was amended, revised, or approved by the ACR Council.
Development Chronology for this Guideline
1994 (Resolution 24)
Revised 1998 (Resolution 32)
Revised 2002 (Resolution 30)
Amended 2006 (Resolution 35)
Revised 2007 (Resolution 27)
PRACTICE GUIDELINE
Resolution No. 10
Extracranial Cerebrovascular US
NOT FOR PUBLICATION, QUOTATION, OR CITATION
RESOLUTION NO. 11
BE IT RESOLVED,
that the American College of Radiology adopt the ACR
Practice Guideline for the Performance of a Breast Ultrasound
Examination
Sponsored by:
Breast Ultrasound
Council Steering Committee
PRACTICE GUIDELINE
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NOT FOR PUBLICATION, QUOTATION, OR CITATION
The American College of Radiology, with more than 30,000 members, is the principal organization of radiologists, radiation
oncologists, and clinical medical physicists in the United States. The College is a nonprofit professional society whose primary
purposes are to advance the science of radiology, improve radiologic services to the patient, study the socioeconomic aspects of the
practice of radiology, and encourage continuing education for radiologists, radiation oncologists, medical physicists, and persons
practicing in allied professional fields.
The American College of Radiology will periodically define new practice guidelines and technical standards for radiologic
practice to help advance the science of radiology and to improve the quality of service to patients throughout the United States.
Existing practice guidelines and technical standards will be reviewed for revision or renewal, as appropriate, on their fifth anniversary
or sooner, if indicated.
Each practice guideline and technical standard, representing a policy statement by the College, has undergone a thorough
consensus process in which it has been subjected to extensive review, requiring the approval of the Commission on Quality and Safety
as well as the ACR Board of Chancellors, the ACR Council Steering Committee, and the ACR Council. The practice guidelines and
technical standards recognize that the safe and effective use of diagnostic and therapeutic radiology requires specific train ing, skills,
and techniques, as described in each document. Reproduction or modification of the published practice guideline and technical
standard by those entities not providing these services is not authorized .
ACR PRACTICE GUIDELINE FOR THE PERFORMANCE OF A
BREAST ULTRASOUND EXAMINATION
PREAMBLE
These guidelines are an educational tool designed to assist practitioners in providing
appropriate radiologic care for patients. They are not inflexible rules or requirements of
practice and are not intended, nor should they be used, to establish a legal standard of
care. For these reasons and those set forth below, the American College of Radiology
cautions against the use of these guidelines in litigation in which the clinical decisions of
a practitioner are called into question.
The ultimate judgment regarding the propriety of any specific procedure or course of
action must be made by the physician or medical physicist in light of all the
circumstances presented. Thus, an approach that differs from the guidelines, standing
alone, does not necessarily imply that the approach was below the standard of care. To
the contrary, a conscientious practitioner may responsibly adopt a course of action
different from that set forth in the guidelines when, in the reasonable judgment of the
practitioner, such course of action is indicated by the condition of the patient, limitations
of available resources, or advances in knowledge or technology subsequent to publication
of the guidelines. However, a practitioner who employs an approach substantially
different from these guidelines is advised to document in the patient record information
sufficient to explain the approach taken.
The practice of medicine involves not only the science, but also the art of dealing with
the prevention, diagnosis, alleviation, and treatment of disease. The variety and
complexity of human conditions make it impossible to always reach the most appropriate
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Resolution No. 11
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diagnosis or to predict with certainty a particular response to treatment. Therefore, it
should be recognized that adherence to these guidelines will not assure an accurate
diagnosis or a successful outcome. All that should be expected is that the practitioner will
follow a reasonable course of action based on current knowledge, available resources,
and the needs of the patient to deliver effective and safe medical care. The sole purpose
of these guidelines is to assist practitioners in achieving this objective.
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I.
INTRODUCTION
This guideline has been developed to assist practitioners performing ultrasound
examination of the breast. When ultrasound is used as guidance for interventional
procedures or biopsy, relevant ACR guidelines should be consulted.
II.
INDICATIONS
Appropriate indications for breast sonography include, but are not limited to:
1. Evaluation and characterization of palpable masses and other breast cancer
related signs and/or symptoms [1-4].
2. Evaluation of suspected or apparent abnormalities detected on other imaging
studies, such as mammography or magnetic resonance imaging (MRI) [5].
3. Initial imaging evaluation of palpable masses in women under 30 years of age and
who are not at high risk for development of breast cancer, and in lactating
and pregnant women.
4. Evaluation of problems associated with breast implants [6].
5. Evaluation of breasts with microcalcifications and/or architectural distortion
suspicious for malignancy or highly suggestive of malignancy in a setting of
dense fibroglandular tissue, for detecting an underlying mass that may be
obscured on the mammogram [6].
6. Guidance of breast biopsy and other interventional procedures [7].
7. Treatment planning for radiation therapy [6].
8. As a supplement to mammography, screening for occult cancers in certain
populations of women (such as those with dense fibroglandular breasts who
are also at elevated risk of breast cancer or with newly suspected breast
cancer) who are not candidates for MRI 18-91 or have no easy access to MRI.
9. Identification and biopsy guidance of abnormal axillary lymph node(s), for
example in patients with newly diagnosed or recurrent breast cancer 110-111
or with findings highly suggestive of malignancy or other significant etiology.
Evaluation of the axilla for occult lymph node metastasis in patients with newly
diagnosed breast cancer is an area of research.
The efficacy of ultrasound as a screening study for occult masses in dense fibroglandular
breasts of high risk women or women with newly diagnosed or suspected breast cancer is
an area of research.
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III.
QUALIFICATIONS AND RESPONSIBILITIES OF THE PHYSICIAN
A. Physician
Physicians who supervise, perform, and/or interpret diagnostic breast ultrasound
examinations should be licensed medical practitioners who have a thorough
understanding of the indications for ultrasound examinations as well as a familiarity with
the basic physical principles and limitations of the technology of ultrasound imaging.
They should be familiar with alternative and complementary imaging and diagnostic
procedures and should be capable of correlating the results of these other procedures with
the sonographic findings. They should have a thorough understanding of ultrasound
technology and instrumentation, ultrasound power output, equipment calibration, and
safety. Physicians responsible for diagnostic breast ultrasound examinations should
demonstrate familiarity with breast anatomy, physiology, and pathology. These
physicians should provide evidence of the training and competence needed to perform
diagnostic breast ultrasound examinations successfully.
Physicians performing and/or interpreting diagnostic breast ultrasound examinations
should meet at least one of the following criteria:
Certification in Radiology or Diagnostic Radiology by the American Board of
Radiology, the American Osteopathic Board of Radiology, the Royal College of
Physicians and Surgeons of Canada, or Le College des Medecins du Quebec, and
involvement with the supervision and/or performance, interpretation, and reporting of
300 breast ultrasound examinations within the last 36 months.1
or
Completion of an Accreditation Council for Graduate Medical Education (ACGME)
approved diagnostic radiology residency program and involvement with the
supervision and/or performance, interpretation, and reporting of 300 breast ultrasound
examinations in the past 36 months.1
or
Physicians not board certified in radiology or not trained in a diagnostic radiology
residency program, and who assume these responsibilities for sonographic imaging of
the breast, should meet the following criteria: completion of an ACGME approved
residency program in specialty practice plus 200 hours of Category I continuing
medical education (CME) in breast ultrasound; and supervision and/or performance,
interpretation, and reporting of 500 breast ultrasound examinations during the past 36
months in a supervised situation.
Maintenance of Competence
All physicians performing ultrasound examinations should demonstrate evidence of
continuing competence in the interpretation and reporting of those examinations. If
1Completion of an accredited radiology residency in the past 24 months will be presumed to be satisfactory experience
for the performance, reporting, and interpreting requirement.
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competence is assured primarily based on continuing experience, a minimum of 100
examinations per year is recommended in order to maintain the physician’s skills.
Because a physician’s practice or location may preclude this method, continued
competency can also be assured through monitoring and evaluation that indicates
acceptable technical success, accuracy of interpretation, and appropriateness of
evaluation.
Continuing Medical Education
The physician’s continuing education should be in accordance with the ACR Practice
Guideline for Continuing Medical Education (CME) and should include CME in
ultrasonography as is appropriate to his or her practice.
B. Diagnostic Medical Sonographer
When a sonographer performs the examination, he or she should be qualified by
appropriate training to do so. This qualification can be demonstrated by certification or
eligibility for certification by a nationally recognized certifying body.
IV.
WRITTEN REQUEST FOR THE EXAMINATION
The written or electronic request for a breast ultrasound examination
should provide sufficient information to demonstrate the medical necessity
of the examination and allow for its proper performance and
interpretation. Documentation that satisfies medical necessity includes 1)
signs and symptoms and/or 2) relevant history (including known
diagnoses). Additional information regarding the specific reason for the
examination or a provisional diagnosis would be helpful and may at times
be needed to allow for the proper performance and interpretation of the
examination.
The request for the examination must be originated by a physician or other
appropriately licensed health care provider. The accompanying clinical
information should be provided by a physician or other appropriately
licensed health care provider familiar with the patient’s clinical problem or
question and consistent with the state’s scope of practice requirements.
(ACR Resolution 35, adopted in 2006)
V.
SPECIFICATIONS FOR INDIVIDUAL EXAMINATIONS
A. Image labeling should include a permanent identification label that contains:
1.
2.
3.
4.
Facility name and location.
Examination date.
Patient’s first and last name.
Identifying number and/or date of birth.
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5. Designation of right or left breast.
6. Anatomic location using clock face notation or a labeled diagram of the breast.
Transducer orientation and distance from the nipple to the abnormality, if
present, are required. or the area being scanned are required
7. Sonographer’s and/or physician’s identification number, initials, or other
symbol.
B. Lesion Characterization and Technical Factors [3]
1. The breast sonogram should be correlated with clinical signs and/or symptoms
and with mammographic and other appropriate breast imaging studies. If
sonography has been performed previously, the current examination should be
compared with prior sonograms, as appropriate. A lesion or any area of the breast
being studied should be viewed in 2 perpendicular projections, and real-time
scanning by the interpreter is encouraged. should be considered
2. The size of a lesion should be determined by recording its maximal dimensions in
at least 2 planes; orthogonal planes are recommended. At least 1 set of images of
a lesion should be obtained without calipers.
3. The images should be labeled as to right or left breast, location of lesions, and the
orientation of the transducer with respect to the breast (e.g., transverse or
longitudinal, radial or antiradial). The location of the lesion should be recorded
using clock face notation and distance from the nipple, and/or shown on a
diagram of the breast. The length of the transducer face (footprint), usually
between 3.5 cm and 5 cm, can be used to estimate the distance from the nipple.
Measurements should not be made from the and not the edge of the areola, as
areolar width is widely variable.
4. Sonographic features are helpful in characterizing breast masses. These features
feature categories and their descriptors are listed and exemplified in the ACR
Breast Imaging Reporting and Data System® (BI-RADS®). The BI-RADS
sonographic categories include size, shape, orientation, margin, echogenicity,
lesion boundary, attenuation (e.g., shadowing or enhancement), special cases,
vascularity, and surrounding tissue [3].
5. Elastography, or tissue stiffness assessment, is among the new feature
categories applicable to sonographic analysis of masses, to be included in the
Associated Findings section in BI-RADS — Ultrasound, edition 2. To
minimize errors in communication or interpretation, if elastography is
performed, the color scales should be annotated to denote hardness or
softness.
6. Mass characterization with ultrasonography is highly dependent on technical
factors.
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Breast ultrasound should be performed with a high-resolution scanner (see section
VII). Gain settings, focal zone selections, and fields of view should be optimized
to obtain high-quality images. The patient should be positioned to minimize the
thickness of the portion of the breast being evaluated. For evaluation of lesions in,
on, or just beneath the skin, a stand-off device or thick layer of gel may be
helpful.
C. Guidance of Interventional Procedures
(See the ACR Practice Guideline for the Performance of Ultrasound-Guided
Percutaneous Breast Interventional Procedures.)
When ultrasound guidance is used to assist in needle placement for interventional
procedures, care should be taken to ensure that scanning geometry and transducer
placement permit adequate visualization of the needle and the needle tip.
VI.
DOCUMENTATION
Images of all important findings, including, in the case of interventional procedures, the
relationship of the needle to the lesion, should be recorded in a retrievable and reviewable
image storage format. It is recommended that documentation of a negative targeted
or whole breast ultrasound examination be performed.
Adequate documentation is essential for high-quality patient care. There should be a
permanent record of the ultrasound examination and its interpretation. Comparison with
prior relevant imaging studies may prove helpful. Images of all appropriate areas, both
normal and abnormal, should be recorded. Variations from normal size should generally
be accompanied by measurement. Images should be labeled with the patient
identification, facility identification, examination date, and image orientation. The
initials of the operator should be accessible on the images or electronically on PACS.
Images should be labeled with the patient identification, facility identification,
examination date, and image orientation. An official interpretation (final report) of the
ultrasound examination should be included in the patient’s medical record. It is
recommended that the report include a description of the area scanned. Retention of
the ultrasound examination images should be consistent both with based on clinical need
and with relevant legal and local health care facility requirements.
If the ultrasound is performed for evaluating clinical signs and/or symptoms or a finding
on mammography, MRI, or other breast imaging modality, the finding(s) should be
referred to in the report. Reporting of lesions should generally include measurements.
Use of an accepted reporting system, such as BI-RADS® US, is recommended.
Reporting should be in accordance with ACR Practice Guideline for Communication of
Diagnostic Imaging Findings.
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VII.
EQUIPMENT SPECIFICATIONS
Breast ultrasound should be performed with a high-resolution real-time linear array
scanner operating at a center frequency of at least 10 MHz and preferably higher. Other
transducers may be utilized in special circumstances. Focal zones should be electronically
adjustable. In general, the highest frequency capable of adequate penetration to the depth
of interest should be used. For evaluating superficial lesions, scanning through a thin
stand-off device or thick layer of gel may be helpful in offsetting the transducer face
from the uppermost layer of skin, to bring it into the focal zone of the transducer.
VIII. QUALITY CONTROL AND IMPROVEMENT, SAFETY, INFECTION
CONTROL, AND PATIENT EDUCATION
Policies and procedures related to quality, patient education, infection control, and safety
should be developed and implemented in accordance with the ACR Policy on Quality
Control and Improvement, Safety, Infection Control, and Patient Education appearing
under the heading Position Statement on QC & Improvement, Safety, Infection Control,
and Patient Education on the ACR web site (http://www.acr.org/guidelines).
Equipment performance monitoring should be in accordance with the ACR Technical
Standard for Diagnostic Medical Physics Performance Monitoring of Real Time
Ultrasound Equipment.
ACKNOWLEDGEMENTS
This guideline was revised according to the process described under the heading The
Process for Developing ACR Practice Guidelines and Technical Standards on the ACR
web site (http://www.acr.org/guidelines) by the Joint Committee on Breast Imaging for
Appropriateness Criteria and Guidelines of the ACR Commission on Breast Imaging and
by the Guidelines and Standards Committee of the ACR Commission on Ultrasound.
Principal Reviewer:
Ellen B. Mendelson, MD, FACR
Committee on Breast Imaging — ACR Committee responsible for sponsoring the draft
through the process
Mary C. Mahoney, MD, FACR, Chair
Lawrence W. Bassett, MD, FACR
Elizabeth S. Burnside, MD, MPH
Robyn L. Birdwell, MD, FACR
Carl J. D’Orsi, MD, FACR
Jennifer A. Harvey, MD, FACR
Mary K. Hayes, MD
Phan T. Huynh, MD, FACR
Peter M. Jokich, MD
Stuart S. Kaplan, MD
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Constance D. Lehman, MD, PhD, FACR
Martha B. Mainiero, MD
Mary S. Newell, MD
Samir B. Patel, MD
Eric L. Rosen, MD
M. Linda Sutherland, MD
Carol H. Lee, MD, Chair, Commission
Guidelines and Standards Committee — Ultrasound — ACR Committee responsible
for sponsoring the draft through the process
Mary C. Frates, MD, FACR, Chair
Debra L. Acord, MD
Sandra 0. Allison, MD
Marcela Bohm-Velez, MD, FACR
Helena Gabriel, MD
Ruth B. Goldstein, MD
Robert D. Harris, MD, MPH, FACR
Beverly E. Hashimoto, MD, FACR
Leann E. Linam, MD
Laurence Needleman, MD, FACR
Maitray D. Patel, MD
Michelle L. Robbin, MD, FACR
Robert M. Sinow, MD
Maryellen R. M. Sun, MD
Deborah Levine, MD, FACR, Chair, Commission
Comments Reconciliation Committee
Beverly G. Coleman, MD, FACR, Chair
Kimberly E. Applegate, MD, MS, FACR
Wendie A. Berg, MD, PhD, FACR
Steven M. Cohen, MD, FACR
Carl J. D’Orsi, MD, FACR
Howard B. Fleishon, MD, MMM, FACR
Mary C. Frates, MD, FACR
Phan T. Huynh, MD, FACR
Stuart S. Kaplan, MD
Alan D. Kaye, MD, FACR
Paul A. Larson, MD, FACR
Carol H. Lee, MD, FACR
Constance D. Lehman, MD, PhD, FACR
Deborah Levine, MD, FACR
James W. Lockard, MD
Mary C. Mahoney, MD, FACR
Ellen B. Mendelson, MD, FACR
Debra L. Monticciolo, MD, FACR
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Edward A. Sickles, MD, FACR
Mitchell E.F. Travis, MD
REFERENCES
1. Hilton SV, Leopold GR, Olson LK, Willson SA. Real-time breast sonography:
application in 300 consecutive patients. AJR 1986;147:479-486.
2. Hong AS, Rosen EL, Soo MS, Baker JA. BI-RADS for sonography: positive and
negative predictive values of sonographic features. AJR 2005;184:1260-1265.
3. Mendelson EB, Baum JK, Berg WA, Merritt CB, Rubin E. Breast Imaging
Reporting and Data System BI-RADS: Ultrasound. In: D’Orsi CJ, Mendelson
EB, Ikeda DM, et al, ed. Breast Imaging Reporting and Data System. 1st ed.
Reston, Va: American College of Radiology; 2003.
4. Soo MS, Rosen EL, Baker JA, Vo TT, Boyd BA. Negative predictive value of
sonography with mammography in patients with palpable breast lesions. AJR
2001;177:1167-1170.
5. Berg WA, Gutierrez L, NessAiver MS, et al. Diagnostic accuracy of mammography,
clinical examination, US, and MR imaging in preoperative assessment of breast
cancer. Radiology 2004;233:830-849.
6. Mendelson EB. Problem-solving ultrasound. Radiol Clin North Am 2004;42:909-918,
vii.
7. Parker SH, Jobe WE, Dennis MA, et al. US-guided automated large-core breast
biopsy. Radiology 1993;187:507-511.
8. Berg WA, Blume JD, Cormack JB, et al. Combined screening with ultrasound
and mammography vs mammography alone in women at elevated risk of breast
cancer. JAMA 2008;299:2151-2163.
9. Gordon PB. Ultrasound for breast cancer screening and staging. Radiol Clin North
Am 2002;40:431-441.
10. Alvarez S, Anorbe E, Alcorta P, Lopez F, Alonso I, Cortes J. Role of sonography
in the diagnosis of axillary lymph node metastases in breast cancer: a systematic
review. AJR 2006;186:1342-1348.
11. Esen G, Gurses B, Yilmaz MH, et al. Gray scale and power Doppler US in the
preoperative evaluation of axillary metastases in breast cancer patients with no
palpable lymph nodes. Eur Radiol 2005;15:1215-1223.
Suggested Reading (References need to be embedded into the document — Suggested
Reading will go away beginning in 2011)
1. Bassett LW, Kimme-Smith C. Breast sonography. AJR 1991;156:449-455.
2. Bassett LW, Kim CH. Breast imaging: mammography and ultrasonography. Magn
Reson Imaging Clin N Am 2001;9:251-571.
3. Berg WA. Rationale for a trial of screening breast ultrasound: American College of
Radiology Imaging Network (ACRIN) 6666. AJR 2003;180:1225-1228.
5. Feig SA. The role of ultrasound in a breast imaging center. Semin Ultrasound CT MR
1989;10:90-105.
6. Fornage BD. Ultrasonography of the breast. Ultrasound 1993;11:1-39.
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10. Jackson VP. The role of US in breast imaging. Radiology 1990;177:305-311.
11. Kuhl CK, Kun W, Schild H. Management of women at high risk for breast cancer:
new imaging beyond mammography. Breast 2005;14:480-486.
12. Mehta TS. Current uses of ultrasound in the evaluation of the breast. Radiol Clin
North Am 2003;41:841-856.
13. Mendelson EB, Baum JK, Berg WA, Merritt CB, Rubin E. Breast Imaging Reporting
and Data System BI-RADS: Ultrasound, 1st edition. Reston, Va: American College of
Radiology; 2003.
16. Parker SH, Stavros AT. Interventional breast ultrasound. In: Parker SH, Jobe WE,
eds. Percutaneous Breast Biopsy. New York, NY: Raven Press; 1993:129-146.
17. Rubin E, Miller VE, Berland LL, Han SY, Koehler RE, Stanley RJ. Hand-held realtime breast sonography. AJR 1985;144:623-627.
19. Stavros AT, Thickman D, Rapp CL, Dennis MA, Parker SH, Sisney GA. Solid breast
nodules: use of sonography to distinguish between benign and malignant lesions.
Radiology 1995;196:123-134.
*Guidelines and standards are published annually with an effective date of October 1 in
the year in which amended, revised or approved by the ACR Council. For guidelines and
standards published before 1999, the effective date was January 1 following the year in
which the guideline or standard was amended, revised, or approved by the ACR Council.
Development Chronology for this Guideline
1994 (Resolution 22)
Revised 1998 (Resolution 33)
Revised 2002 (Resolution 31)
Amended 2006 (Resolution 35)
Revised 2007 (Resolution 34)
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RESOLUTION NO. 12
Extend ACR—ACS—CAP—SSO Practice Guideline for the Management of Ductal Carcinoma In-Situ
of the Breast (DCIS); and the ACR—ACS—CAP—SSO Practice Guideline for Breast Conservation
Therapy in the Management of Invasive Breast Carcinoma
WHEREAS,
the ACR—ACS—CAP—SSO Practice Guideline for the Management of Ductal
Carcinoma In-Situ of the Breast (DCIS) and the ACR—ACS—CAP—SSO Practice
Guideline for Breast Carcinoma were last reviewed by the Council in 2006 and
were to be reviewed by the Council in 2011; and
WHEREAS,
since this guideline is directed to radiologists, the Joint Committee on Breast
Imaging for Appropriateness Criteria and Practice Guidelines decided to focus on
the imaging management and not include the treatment and pathologic diagnosis
and correlation; and
WHEREAS,
the Joint Committee on Breast Imaging for Appropriateness Criteria and Practice
Guidelines are developing a new ACR Practice Guideline for the Imaging
Management of DCIS and Invasive Breast Carcinoma that will be presented at
the 2012 AMCLC for adoption; and
WHEREAS,
this new practice guideline, if adopted is intended to replace the existing DCIS
and Invasive Breast Carcinoma Practice Guidelines; therefore
BE IT RESOLVED,
that based on the recommendation of the Joint Committee on Breast
Imaging for Appropriateness Criteria and Practice Guidelines of the
Commission on Breast Imaging, the ACR—ACS—CAP—SSO Practice
Guideline for the Management of Ductal Carcinoma In-Situ of the Breast
(DCIS) and the ACR—ACS—CAP—SSO Practice Guideline for Breast
Carcinoma are hereby recommended to be extended until both practice
guidelines can be sunset when the new ACR Practice Guideline for the
Imaging Management of DCIS and Invasive Breast Carcinoma is adopted at
the 2012 AMCLC.
Submitted by:
Sponsored by:
Board of Chancellors
ACR Council Steering Committee
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Fiscal Note
Extend ACR—ACS—CAP—SSO Practice Guideline for the Management of Ductal Carcinoma In-Situ
of the Breast (DCIS); and the ACR—ACS—CAP—SSO Practice Guideline for Breast Conservation
Therapy in the Management of Invasive Breast Carcinoma
To support the resolution to Extend ACR—ACS—CAP—SSO Practice Guideline for the Management of
Ductal Carcinoma In-Situ of the Breast (DCIS); and the ACR—ACS—CAP—SSO Practice Guideline for
Breast Conservation Therapy in the Management of Invasive Breast Carcinoma, the ACR would incur the
following estimated costs:
Costs:
De minimis
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RESOLUTION NO. 13
Nuclear Medicine Advanced Associate (NMAA)
WHEREAS,
the American College of Radiology is dedicated to providing quality radiological
care to patients; and
WHEREAS,
NMAA’s will be advanced-level nuclear medicine technologists (NMT) who,
working under the supervision of a licensed physician and authorized user of
radioactive materials, enhance patient care in diagnostic imaging and
radiotherapy; and
WHEREAS,
the NMAA would improve departmental quality and management efficiency; and
WHEREAS,
trained and certified nuclear medicine advanced associates performing welldefined tasks would enable nuclear medicine physicians to use their patient care
time more efficiently; and
WHEREAS,
the NMAA would be compensated at a level higher than the NMT commensurable with additional education and responsibilities, however there
would be no additional costs to the patient, government agencies, or third party
payers for the services of the NMAA; and
WHEREAS,
the SNM Board of Directors supports the creation and implementation of the
NMAA position; and
WHEREAS,
the NMAA will not perform interpretations (preliminary, final or otherwise) of
any nuclear medicine procedure nor will he or she transmit observations other
than to the supervising nuclear medicine physician or radiologist; and
WHEREAS,
nuclear medicine physicians and nuclear medicine technologists would be better
enabled to provide quality patient care; and
WHEREAS,
the Nuclear Medicine Technologist Certification Board (NMTCB) passed a
resolution stating the NMTCB will create the NMAA certification exam with a
goal of having it available within six (6) months of the first graduating class; and
WHEREAS,
the first program, a consortium between the University of Arkansas, St. Louis
University, and the University of Missouri, Columbia, received final approval
from the Department of Education in Arkansas in November 2008, with the first
class beginning Fall 2009; and
WHEREAS,
the Joint Review Committee on Nuclear Medicine Technology (JRCNMT) is
currently considering the NMAA program for accreditation; and
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WHEREAS,
the American College of Radiology (ACR) Commission on Nuclear Medicine
and the ACR Commission on Human Resource support the statement Nuclear
Medicine Advanced Associate — Roles and Responsibilities; therefore
BE IT RESOLVED,
that the American College of Radiology accepts and endorses the statement
“Nuclear Medicine Advanced Associate — Roles and Responsibilities”
Submitted by:
Board of Chancellors
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Fiscal Note
Nuclear Medicine Advanced Associate (NMAA)
To support the resolution for the Nuclear Medicine Advanced Associate, the ACR would incur the
following estimated costs:
Costs:
De minimis
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Nuclear Medicine Advanced Associate (NMAA)
Roles and Responsibilities
A Nuclear Medicine Advanced Associate (NMAA) is an advanced-level nuclear medicine technologist
working under the supervision of a licensed physician, who is also an authorized user of radioactive
materials, to enhance patient care in the diagnostic imaging and radiotherapy environments.
The Nuclear Medicine Advanced Associate is an NMTCB- or ARRT-certified nuclear medicine
technologist who has successfully completed an advanced academic program encompassing a nationally
recognized NMAA curriculum and a nuclear medicine physician-, nuclear cardiologist-, or radiologistdirected clinical preceptorship.
Under physician supervision, the NMAA performs patient assessment, patient management and selected
nuclear medicine procedures as summarized below.
Perform and document a review of clinical information, such as pertinent lab work, including blood,
urine and other tissue samples and pathology studies, as well as correlative imaging studies to facilitate
optimal performance and interpretation of the nuclear medicine procedure by the supervising physician.
Perform, update, and document a ‘history and physical’ in the medical record, obtaining a relevant
clinical history from the patient or medical record and a targeted physical exam to optimize the clinical
value of the requested nuclear medicine procedure.
Assist the supervising physician in obtaining informed consent for invasive and/or therapeutic
procedures, as well as procedures involving more than minimal risk, as defined by state law and
institutional policy.
Administer medications that enhance diagnostic imaging and therapeutic procedures, as defined by state
regulations and institutional policy.
Educate the patient undergoing invasive procedures, therapeutic procedures, and procedures involving
more than minimal risk regarding pre-procedural preparation and post-procedural care, as defined by state
law and institutional policy and documenting appropriately in the patient’s medical record.
Perform pre- and post-procedure assessment and monitoring in patients undergoing invasive and
therapeutic procedures, as well as procedures involving more than minimal risk, as defined by state law
and institutional policy.
Monitor cardiac exercise or pharmacologic stress testing in association with diagnostic nuclear medicine
imaging procedures as recognized through institutional policy and defined by state and federal law.
Assess imaging studies for appropriateness and quality, acquire additional views as necessary, and
suggest additional diagnostic procedures to the supervising physician as necessary to provide additional
information to optimize the nuclear medicine imaging studies.
Analyze the imaging, correlative and laboratory data provided and prepare a preliminary description of
findings for use by the supervising physician when he/she interprets the results and formulates the written
report.
Communicate report findings in the physician’s finalized and authenticated reports to the referring
physician and provide necessary documentation.
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The NMAA will not perform interpretations (preliminary, final or otherwise) of any nuclear medicine
procedure nor will he or she transmit observations other than to the supervising nuclear medicine
physician or radiologist.
The NMAA should actively participate in practice-based improvement activities as well as facility quality
assurance programs. They should be competent in overseeing compliance with all local, state, regional,
and federal requirements for laboratory operations and accreditation, and provide education for
technologists, students, and staff. They will be expected to participate in maintenance of certification
(MOC) activities and be credentialed by the institution in which they practice.
The education of the nuclear medicine advanced associate is granted through nationally accredited
academic programs offered at the master’s degree level and that lead to certification through the
ARRT/NMTCB. Advisory committees to such programs should include representation from the nuclear
medicine medical community.
The nuclear medicine medical community should be represented in any formal national or state
certification or licensure process and be actively involved in facility NMAA credentialing. In addition,
with the practice of medicine rapidly changing, the SNMTS leadership will work with the SNM
Leadership, the ACR and other appropriate stakeholders to assess new procedures that the NMAA may
perform.
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RESOLUTION NO. 14
Refer to the North American Consensus Guidelines for Administration of
Radiopharmaceutical Activities in Children and Adolescents Paper in the Nuclear Medicine
Practice Guidelines
WHEREAS,
the North American Consensus Guidelines for Administration of
Radiopharmaceutical Activities in Children and Adolescents was
recently published; and
WHEREAS,
this document was developed collaboratively with SNM, SPR and ACR
and it has been reviewed and endorsed by the Executive Committee of
the Board of Chancellors; and
WHEREAS,
this paper contains specific pediatric dose information for radionuclides;
and
WHEREAS,
based on the recommendations of ACR’s nuclear medicine experts, the
information should be included in the nuclear medicine practice
guidelines and technical standards; therefore
BE IT RESOLVED,
that the American College of Radiology will revise the paragraph on
pediatric radionuclides dose currently included in the appropriate
nuclear medicine practice guidelines as follows (new language shown
in bold):
Administered activity for children should be determined based on body
weight and should be as low as reasonably achievable for diagnostic
image quality. For more specific guidance on pediatric dosing, please
refer to the North American Consensus Guidelines for Administration
of Radiopharmaceutical Activities in Children and Adolescents.
Submitted by:
Sponsored by
ACR Board of Chancellors
ACR Council Steering Committee
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Fiscal Note
Refer to the North American Consensus Guidelines for Administration of
Radiopharmaceutical Activities in Children and Adolescents paper in the Nuclear Medicine
Practice Guidelines
To support the insertion of the sentence, “For more specific guidance on pediatric dosing please
refer to the North American Consensus Guidelines for Administration of Radiopharmaceutical
Activities in Children and Adolescents,“ the ACR would incur the following estimated costs:
Costs:
De minimis
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RESOLUTION NO. 15
Standardization of Relative Exposure Unit of Measure for Digital Diagnostic Radiologic Equipment
WHEREAS,
the unit of measure of radiation dose from digital radiologic equipment is highly
variable from one type of unit to another; and
WHEREAS,
there is currently no easy way to compare exposures from radiation equipment
that uses differing units of measure; and
WHEREAS,
technologists and other users of digital diagnostic radiologic imaging equipment
are often confused by the relative exposure results from the exams they have
performed which can lead to variability in exposure settings and potential over
radiation; and
WHEREAS,
there has recently been an enlightened emphasis to increase awareness to the
effects and risks of exposure to medical radiation; therefore
BE IT RESOLVED,
that the ACR encourage radiology equipment vendors to develop a
standardized unit of measure of radiation exposure from digital radiologic
imaging equipment.
Sponsored by:
New York State Radiological Society
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Fiscal Note
Standardization of Relative Exposure Unit of Measure for Digital Diagnostic Radiologic Equipment
To support the resolution for the Standardization of Relative Exposure Unit of Measure for Digital
Diagnostic Radiologic Equipment, the ACR would incur the following estimated costs:
Costs:
De minimis
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RESOLUTION NO. 16
Call to Eliminate the Self-dealing of Medical Imaging Technical Fees
WHEREAS,
the ACR and its members seek to eliminate wasteful and hazardous healthcare
policies and practices; and
WHEREAS,
“self-dealing medical imaging technical fees” is defined as the business practice
wherein a business entity directing a patient to a medical imaging provider
receives a financial interest in the technical component payment; or a physician
ordering a medical imaging examination (fluoroscopic examination, CT, MRI,
nuclear imaging, PET, ultrasound, or mammogram) or medical image-guided
procedure has a financial interest in the technical component payment, except for
radiographs, cardiac ultrasound, obstetrical ultrasound, screening exams
performed in patient populations and at intervals supported by the preponderance
of scientific literature, and the case of group practices considered exempt from
financial self-interest by federal or state law; and
WHEREAS,
“self-dealing medical imaging technical fees” has been proven in studies
published in respected peer review journals to result in inappropriate medical
imaging procedures, increased public radiation exposure, and higher costs; and
WHEREAS,
common sense indicates that a patient in a physician’s examination room or
consultation office is in no position to cross-exam his or her personal physician
with regard to alternative convenient imaging locations, relative costs, and the
relative expertise of other imaging providers in his or her community; and
WHEREAS,
“self-dealing medical imaging technical fees” circumvents the normal
competitive process of independent referral wherein personal physicians refer to
imaging locations based on the technical quality, professional quality, service
quality, and price available at the independent or hospital-based imaging facility;
and
WHEREAS,
patients should be entitled to the best advice of their personal physicians with
regard to selection of imaging consultants and procedures, unburdened by their
physician’s economic conflict-of-interest; and
WHEREAS,
physicians not specializing in medical imaging are increasingly investing in
medical imaging technology driven by their need to increase revenues in
response to various economic pressures, including declining reimbursement for
direct patient care; and
WHEREAS,
MEDPAC has recently encouraged Congress to explore reforms of the current
exemption to “technical component self-channeling in medical imaging” in the
in-office setting; and
WHEREAS,
the federal Stark laws and similar restrictions in the laws of many states have
already legally restricted “self-dealing medical imaging technical fees” in
recognition of all of these facts; and
WHEREAS,
“self-dealing medical imaging technical fees” nevertheless continues to grow in
most states because of legal loopholes; therefore
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BE IT RESOLVED,
that the ACR condemns “self-dealing medical imaging technical fees”
(defined as the business practice wherein a business entity directing a
patient to a medical imaging provider receives a financial interest in the
technical component payment; or the medical practice wherein the
physician ordering a medical imaging fluoroscopic examination, CT, MRI,
nuclear imaging, PET, ultrasound, mammogram, or medical image-guided
procedure has a financial interest in the technical component payment,
except for radiographs, cardiac ultrasound, obstetrical ultrasound,
screening exams performed in patient populations and at intervals
supported by the preponderance of scientific literature, and the case of
group practices considered exempt from financial self-interest by federal or
state law); and
BE IT FURTHER RESOLVED,
that the ACR provides a voluntary mechanism for each of its members to
disclose if he or she does not participate in “self-dealing medical imaging
technical fees,” and the list of those so disclosing shall by published by the
ACR on its website; and
BE IT FURTHER RESOLVED,
that the ACR focus its efforts on sponsoring legislation toward regulatory
abolition of “self dealing medical imaging technical fees;” and
BE IT FURTHER RESOLVED,
that savings resulting from elimination of “self-dealing medical imaging
technical fees,” be reallocated toward patient care, preventive care, and the
general pool of physician payments.
Sponsored by:
California Radiological Society
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Fiscal Note
Call to Eliminate the Self-dealing of Medical Imaging Technical Fees
To support the Call to Eliminate the Self-dealing of Medical Imaging Technical Fees, the ACR would
incur the following estimated costs:
Costs:
TBD
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RESOLUTION NO. 17
Support for Maryland Anti Self-Referral Legislation
WHEREAS,
the ACR and its members support the concept that self-referral in medical imaging results
in inappropriate overutilization of resources; and
WHEREAS,
the ACR and its members have lobbied the Federal Government on numerous occasions
in an effort to educate representatives on the untoward effects of self-referral; and
WHEREAS,
self-referral has been proven in studies published in respected peer review journals to
result in inappropriate medical imaging procedures, increased public radiation exposure,
and higher costs; and
WHEREAS,
past legislation was enacted (The Stark Laws) to obviate such self-referral, but did not
account for evolving technologies, and therefore was passed with a significant loophole
(the In-Offices Ancillary Services Exemption or IOASE) that permitted self-referral to
continue; and
WHEREAS,
federal legislation was introduced but not passed (HR 2962, the Integrity in Medicare
Advanced Diagnostic Imaging Act of 2009) to prevent such self-referral; and
WHEREAS,
anti self-referral legislation may also be undertaken on the state level to address this
behavior; and
WHEREAS,
the state of Maryland successfully passed anti self-referral legislation that closed the
IOASE of the Stark Laws; and
WHEREAS,
the Maryland legislation is a model for successful implementation of a law to prevent
self-referral, and is a model for similar legislation at both the federal and state levels; and
WHEREAS,
certain physician groups in Maryland who wish to engage in the practice of self-referral
have mounted legal challenges to the Maryland statute in an attempt to have this
repealed; and
WHEREAS,
the Maryland Court of Appeals has upheld the statute in their recent ruling that noted that
the intent of the existing statute was to prevent self-referrals; and
WHEREAS,
the Maryland Chapter of the ACR has asked other chapters and the ACR for financial
support of its ongoing defense against expected future attempts to repeal their model
legislation, in anticipation that significant financial resources may be necessary to do so;
and
WHEREAS, the Connecticut chapter of the ACR has pledged to contribute $1,000 to the legal fund of
the Maryland chapter to defend the Maryland statute, and is willing increase that to
$2,500, which equates to $8! state chapter member, if the ACR will match it; and
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WHEREAS,
dues paid by the members of the ACR should be used for important and worthy causes
that benefit the profession and specialty of radiology, and our patients; therefore
BE IT RESOLVED,
that the ACR supports efforts to defend the Maryland statute with both consultative
input and financial support; and
BE IT FURTHER RESOLVED,
that the ACR will match contributions from the individual states, and will
contribute a minimum of $25,000 to the Maryland defense fund; and
BE IT FURTHER RESOLVED,
that the ACR will challenge all state chapters to make a similar $8/ per capita
contribution to the Maryland defense fund; and
BE IT FURTHER RESOLVED,
that the ACR continues to make it a priority that self-referral in medicine remains a
target for elimination because of its deleterious effects on patients, and for its
inappropriate utilization of economic resources.
Sponsored by: Radiological Society of Connecticut
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Fiscal Note
Support for Maryland Anti Self-Referral Legislation
To support the resolution to Support for Maryland Anti Self-Referral Legislation, the ACR would
incur the following estimated costs:
Costs:
TBD