Doze Radiofarmaceutice 2020
Doze Radiofarmaceutice 2020
Doze Radiofarmaceutice 2020
The American College of Radiology will periodically define new practice parameters 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 parameters and technical standards will
be reviewed for revision or renewal, as appropriate, on their fifth anniversary or sooner, if indicated.
Each practice parameter 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 and approval. The practice parameters and technical standards recognize that the safe and effective use of diagnostic and
therapeutic radiology requires specific training, skills, and techniques, as described in each document. Reproduction or modification of the published practice
parameter and technical standard by those entities not providing these services is not authorized.
2020 (Resolution 13)*
ACR–AAPM–ACNM–SNMMI PRACTICE PARAMETER FOR REFERENCE
LEVELS AND ACHIEVABLE ADMINISTERED ACTIVITY FOR NUCLEAR
MEDICINE AND MOLECULAR IMAGING
PREAMBLE
This document is an educational tool designed to assist practitioners in providing appropriate radiologic care for
patients. Practice Parameters and Technical Standards are not inflexible rules or requirements of practice and are
not intended, nor should they be used, to establish a legal standard of care1. For these reasons and those set forth
below, the American College of Radiology and our collaborating medical specialty societies caution against the
use of these documents 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
practitioner considering all the circumstances presented. Thus, an approach that differs from the guidance in this
document, 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 this
document when, in the reasonable judgment of the practitioner, such course of action is indicated by variables
such as the condition of the patient, limitations of available resources, or advances in knowledge or technology
after publication of this document. However, a practitioner who employs an approach substantially different from
the guidance in this document may consider documenting in the patient record information sufficient to explain
the approach taken.
The practice of medicine involves the science, and 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 diagnosis or to predict with certainty a particular response to treatment. Therefore, it should be
recognized that adherence to the guidance in this document 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
purpose of this document is to assist practitioners in achieving this objective.
1 Iowa Medical Society and Iowa Society of Anesthesiologists v. Iowa Board of Nursing 831 N.W.2d 826 (Iowa 2013) Iowa Supreme Court refuses to find
that the ACR Technical Standard for Management of the Use of Radiation in Fluoroscopic Procedures (Revised 2008) sets a national standard for who may
perform fluoroscopic procedures in light of the standard’s stated purpose that ACR standards are educational tools and not intended to establish a legal standard
of care. See also, Stanley v. McCarver, 63 P.3d 1076 (Ariz. App. 2003) where in a concurring opinion the Court stated that “published standards or guidelines
of specialty medical organizations are useful in determining the duty owed or the standard of care applicable in a given situation” even though ACR standards
themselves do not establish the standard of care.
This practice parameter has been revised collaboratively by the American College of Radiology (ACR), the
American Association of Physicists in Medicine (AAPM), the American College of Nuclear Medicine (ACNM),
and the Society of Nuclear Medicine and Molecular Imaging (SNMMI) to guide appropriately trained and licensed
physicians and Qualified Medical Physicists involved in nuclear medicine and molecular imaging procedures.
The establishment of reference levels (RLs) in nuclear medicine and molecular imaging requires close cooperation
and communication between the physicians responsible for the clinical management of the patient and the Qualified
Medical Physicist responsible for monitoring equipment, image quality, and estimating patient dose. Adherence to
this practice parameter should help to maximize the efficacious use of these procedures, optimize radiation dose to
patients, minimize radiation dose to staff, maintain safe conditions, and ensure compliance with applicable
standards. This is particularly important for children, who are more vulnerable than adults to the potential adverse
effects of ionizing radiation.
The goal of this practice parameter is to provide benchmark national nuclear medicine and molecular imaging
achievable administered activities (AAA) and RLs for the United States in order to help practices optimize
radiopharmaceutical administered activity while meeting the diagnostic needs of the medical imaging procedure.
RLs are used to help manage the radiation dose to the patient. The medical radiation exposure must be optimized,
avoiding unnecessary radiation that does not contribute to the clinical objective of the procedure. By the same token,
an administered activity that is significantly lower than the AAA may also be a cause for concern because it may
indicate that adequate image quality is not being achieved. The specific purpose of the RL is to provide a benchmark
for comparison, not to establish regulatory limits.
RLs for nuclear medicine and molecular imaging should be based on administered activity (dosage2). RLs are based
on published surveys from professional organizations or representative groups performing nuclear medicine and
molecular imaging procedures [1-4].
An RL in nuclear medicine is an investigational (action) level that, when it is exceeded, indicates the use of a higher
than typical administered activity for a routine nuclear medicine and molecular imaging procedure [5-8]. A
procedure RL is set at around the 75th percentile of the range of the available administered activity data. The
International Commission on Radiological Protection (ICRP) Publication 135 on Diagnostic Reference Levels
(DRL) in Medical Imaging provides the current guidance on how to develop RLs [8]. RLs are derived thresholds
from radiation metric data that are obtained locally and collected nationally or regionally. If a facility or practice
consistently exceeds an RL, it should review its procedures and equipment to determine if acceptable image quality
can be achieved with a lower administered activity.
AAA is a concept that can be used with RLs to assist in optimization of image quality and dose to the patient. The
AAA is based on the median value (the 50th percentile) of the distribution of a DRL quantity, which, for nuclear
medicine and molecular imaging, is the administered activity [3]. The AAA provides a goal that facilities should
strive to achieve through the optimization of image quality and patient absorbed doses.
Further information on RLs and AAAs in nuclear medicine and molecular imaging is available in ICRP Publication
135 [8] and the National Council on Radiation Protection and Measurements (NCRP) Report 172 [3].
2 Dosage is the term used by the U.S. Nuclear Commission and other agencies that regulate radioactive materials to describe the patient administered activity
and differentiate it from absorbed dose.
A. Physician
See the ACR-ACNM-SNMMI-SPR Practice Parameter for the Use of Radiopharmaceuticals in Diagnostic
Procedures [9].
A Qualified Medical Physicist is an individual who is competent to practice independently in one or more of the
subfields in medical physics. The ACR considers certification, 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 strongly recommends that the individual be
certified in the appropriate subfield(s) by the American Board of Radiology (ABR), the Canadian College of
Physicists in Medicine, the American Board of Science in Nuclear Medicine (ABSNM), or the American Board of
Medical Physics (ABMP).
A Qualified Medical Physicist should meet the ACR Practice Parameter for Continuing Medical Education (CME)
[10].
The appropriate subfields of medical physics for this practice parameter is Nuclear Medical Physics (including
medical physics certification categories of Radiological Physics, Medical Nuclear Physics, and Nuclear Medicine
Physics). (ACR Resolution 17, adopted in 1996 – revised in 2008, 2012, 2022, Resolution 41f)
The Qualified Medical Physicist must be familiar with the principles of imaging physics and radiation protection;
the guidance of the NCRP; the laws and regulations pertaining to nuclear medicine; the function, clinical uses, and
performance specifications of nuclear medicine imaging equipment; and the calibration processes and limitations
of the equipment. The Qualified Medical Physicist must also be familiar with the relevant clinical procedures.
The RL can be a practical tool in nuclear medicine. Achieving acceptable diagnostic information, consistent with
the medical imaging task, is the overriding clinical objective. The quantity that is recommended for RLs and AAAs
is the administered activity (dosage) [8]. Administered activity RLs (in MBq or MBq/kg of body mass) are then
used to help manage the radiation dose to patients.
Determining RLs for nuclear medicine procedures in the United States has previously been difficult because of the
limited amount of available survey data, the large number of radiopharmaceuticals that are used, and variability in
procedures among practitioners. In the absence of survey data for adults, other guidance has been used. For adults,
manufacturers recommend a standard administered activity based on a standard 70-kg person in their package insert
as required by the US Food and Drug Administration (FDA). Guidance for minimum and maximum administered
activities for adults and children is available from various sources [3,11-21].
The individual(s) listed as an authorized user(s) on the regulatory license or permit is ultimately responsible for the
supervision and appropriate use of all radiopharmaceuticals received, prepared, or administered under the user’s
direction [22].
It is strongly recommended that each administered dosage be assayed onsite at the medical facility prior to
administration to verify the prescribed activity [9].
Table 1 summarizes the RLs and AAAs for some radiopharmaceuticals that are commonly administered to adults.
Administered activity information that was recently provided by thousands of U.S. nuclear medicine facilities to
accreditation programs during the accreditation process [1,2,4] has updated or added to the limited survey data of
nine academic facilities that were available for NCRP 172 [3]. The RLs and AAAs for the specific
radiopharmaceutical in Table 1 were determined using the 75th percentile and 50th percentile, respectively of the
ACR accreditation data or the NCRP 172 survey data. NCRP 172 values for RLs are based on the 75th percentile
of the maximum administered activities, and AAAs are based on the median value of routine administered activities
from the survey.
TABLE 1
Radiopharmaceutical Achievable Administered Activities and Reference Levels for Adults
B. Pediatric Examinations
ICRP 135 [8] specifies that the quantities collected to develop RLs for pediatric nuclear medicine studies should
be based on administered activity with adjustments for the size or weight of the child.
Because of limited accreditation or survey data for pediatric nuclear medicine, development of AAAs or RLs that
are linked to pediatric size or weight is not practical at this time. However, applicable guidance is available from
the 2016 Update: North American Consensus Guidelines for Pediatric Administered Radiopharmaceutical
Activities [21]. These guidelines were developed as a result of surveys and consensus workshops by nuclear
medicine experts in North America and Europe. Conforming to the North American Consensus Guidelines is the
recommendation of NCRP 172. Availability of the North American Consensus Guidelines has been shown to reduce
the variability of pediatric radiopharmaceutical administration in the United States [25-27].
RLs and AAAs are part of the optimization process for both adult and pediatric examinations. It is essential to
ensure that image quality appropriate for the diagnostic purpose is maintained when modifying administered
activity. Optimization must balance image quality and patient absorbed dose (ie, image quality must be maintained
Internal absorbed dose can be estimated from anthropomorphic computer models and used for comparison of
radiation doses among procedures. Although dose estimates are available for children of various ages, adult
individuals , as well as pregnant patients at different gestational stages, they are based on generic body-size
estimates and tracer kinetics, which may be very different from those of any individual patient [26,28-30].
On occasion, it may be necessary to estimate the dose delivered to an individual patient because of a specific
situation (eg, pregnancy or the request of a referring physician). In these situations, it is recommended that the
physician have a written medical physics consult with a Qualified Medical Physicist. Using the information about
the patient’s weight, administered activity, and the radiopharmaceutical, the Qualified Medical Physicist can
estimate the dose to tissue and organs. The consultation request and the Qualified Medical Physicist’s report should
be duly signed by the requesting physician and the Qualified Medical Physicist and should be incorporated into the
patient’s medical record.
Radiologists, medical physicists, non-physician radiology providers, radiologic technologists, and all supervising
physicians have a responsibility for safety in the workplace by keeping radiation exposure to staff, and to society
as a whole, "as low as reasonably achievable” (ALARA) and to assure that radiation doses to individual patients
are appropriate, taking into account the possible risk from radiation exposure and the diagnostic image quality
necessary to achieve the clinical objective. All personnel who work with ionizing radiation must understand the
key principles of occupational and public radiation protection (justification, optimization of protection,
application of dose constraints and limits) and the principles of proper management of radiation dose to patients
(justification, optimization including the use of dose reference levels). https://www-
pub.iaea.org/MTCD/Publications/PDF/PUB1775_web.pdf
Facilities and their responsible staff should consult with the radiation safety officer to ensure that there are
policies and procedures for the safe handling and administration of radiopharmaceuticals in accordance with
ALARA principles. These policies and procedures must comply with all applicable radiation safety regulations
and conditions of licensure imposed by the Nuclear Regulatory Commission (NRC) and by applicable state, local,
or other relevant regulatory agencies and accrediting bodies, as appropriate. Quantities of radiopharmaceuticals
should be tailored to the individual patient by prescription or protocol, using body habitus or other customized
method when such guidance is available.
Nationally developed guidelines, such as the ACR’s Appropriateness Criteria®, should be used to help choose the
most appropriate imaging procedures to prevent unnecessary radiation exposure.
Additional information regarding patient radiation safety in imaging is available from the following websites –
Image Gently® for children (www.imagegently.org) and Image Wisely® for adults (www.imagewisely.org).
These advocacy and awareness campaigns provide free educational materials for all stakeholders involved in
imaging (patients, technologists, referring providers, medical physicists, and radiologists).
Radiation exposures or other dose indices should be periodically measured by a Qualified Medical Physicist in
accordance with the applicable ACR Technical Standards. Monitoring or regular review of dose indices from
patient imaging should be performed by comparing the facility’s dose information with national benchmarks, such
as the ACR Dose Index Registry and relevant publications relying on its data, applicable ACR Practice
Parameters, NCRP Report No. 172, Reference Levels and Achievable Doses in Medical and Dental Imaging:
For the purpose of this practice parameter, the radiation dose index that is used is the administered activity of the
radiopharmaceutical.
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 ACR Position Statement on Quality Control and Improvement,
Safety, Infection Control and Patient Education on the ACR website (https://www.acr.org/Advocacy-and-
Economics/ACR-Position-Statements/Quality-Control-and-Improvement).
Performance evaluation, quality control, acceptance testing, written survey reports, and follow-up procedures of all
nuclear medicine and PET imaging systems and support equipment should be in accordance with the appropriate
ACR Medical Physics Technical Standards (http://www.acr.org/Quality-Safety/Standards-Guidelines/Technical-
Standards-by-Modality/Medical-Physics).
The Qualified Medical Physicist should annually review the common nuclear medicine and PET protocols for
adults and pediatric patients performed at the facility and report the results of that review. The report should include
estimates of radiation dose based on administered activity and a comparison of these estimates with the current RLs.
It should recommend means of improvement if the dose estimates or administered activity exceeds the RLs.
ACKNOWLEDGEMENTS
This practice parameter was revised according to the process described under the heading The Process for
Developing ACR Practice Parameters and Technical Standards on the ACR website (https://www.acr.org/Clinical-
Resources/Practice-Parameters-and-Technical-Standards) by the Committee on Practice Parameters and Technical
Standards – Medical Physics of the ACR Commission on Medical Physics and the Committee on Practice
Parameters and Technical Standards – Nuclear Medicine and Molecular Imaging of the ACR Commission on
Nuclear Medicine and Molecular Imaging in collaboration with the AAPM, the ACNM, and the SNMMI.
Collaborative Committee – members represent their societies in the initial and final revision of this practice
parameter
ACR AAPM
Priscilla F. Butler, MS, FACR, Chair Osama Mawlawi, PhD, FACR, FAAPM
Murray D. Becker, MD, PhD, FACR Jonathon A. Nye, PhD
Loretta M. Johnson, PhD Richard E. Wendt III, PhD
Ralph P. Lieto, MS, FACR
Thomas G. Ruckdeschel, MS
ACNM SNMMI
Mark Tulchinsky, MD Warren R. Janowitz, MD, JD, FACR
Christopher J. Palestro, MD
Darko Pucar, MD, PhD
Rathan M. Subramaniam, MD, PhD, MPH
Mary Ann Keenan, DMP, Vice Chair Lijun Ma, PhD, FAAPM
Priscilla F. Butler, MS, FACR Tariq A. Mian, PhD, FACR
Heidi A. Edmonson, PhD Anshuman Panda, PhD
Samuel A. Einstein, PhD Douglas E. Pfeiffer, MS, FACR
Per H. Halvorsen, MS, FACR Premavathy Rassiah, PhD
Loretta M. Johnson, PhD Thomas G. Ruckdeschel, MS
Committee on Practice Parameters and Technical Standards – Nuclear Medicine and Molecular Imaging
(ACR Committee responsible for sponsoring the draft through the process)
REFERENCES
1. Alessio AM, Farrell MB, Fahey FH. Role of Reference Levels in Nuclear Medicine: A Report of
the SNMMI Dose Optimization Task Force. J Nucl Med 2015;56:1960-4.
2. Becker MD, Butler PF, Bhargavan-Chatfield M, et al. Adult Gamma Camera Myocardial
Perfusion Imaging: Diagnostic Reference Levels and Achievable Administered Activities Derived
From ACR Accreditation Data. J Am Coll Radiol 2016;13:688-95.
*Practice parameters and technical 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 practice parameters and technical standards
published before 1999, the effective date was January 1 following the year in which the practice parameter or
technical standard was amended, revised, or approved by the ACR Council.