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 training, 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.

Revised 2006 (Res. 26,16g,17,36)*

ACR 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 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. I. INTRODUCTION

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 using radiopharmaceuticals. II. DEFINITION

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 unsealed radionuclide sources for diagnosis.

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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 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. 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 program that must in radiation physics, include training instrumentation, radiochemistry, radiopharmacology, radiation dosimetry, radiation biology, radiation safety and protection, and quality control. In addition, clinical training in general nuclear medicine is required which must cover technical performance, calculation of administered activity, evaluation of images, 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, provided they have been actively involved in providing nuclear medicine services. and 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). 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. 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, quality of procedures, and all aspects of patient and facility 5.

safety and compliance with applicable government and institutional regulations regarding the use of radiopharmaceuticals. 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.

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 shall include training 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 invitro use of radiopharmaceuticals and performance of imaging procedures. or Current registration by 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 Licensure, if required by state regulations. Documented regular participation in continuing education to maintain competence in the workplace. Knowledge of radiation safety and protection, handling of radiopharmaceuticals, all aspects of performing examinations, operation of equipment, handling of medical and radioactive waste, patient safety, and applicable rules and regulations.

2. 3. 4.

2.

3.

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 TECHNICAL STANDARD

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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. 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 Qualified Medical Physicist or other qualified scientist performing services in support of nuclear medicine facilities should meet all of the following criteria: 1. 2. 3. 4. Advanced training directed at the specific area of responsibility (e.g., radiopharmacy, medical physics, health physics, or instrumentation). Licensure, if required by state regulations. Documented regular participation in continuing education in the area of specific involvement to maintain competency. Knowledge of radiation safety and protection and of all rules and regulations applying to the area of practice. RADIOPHARMACY 2.

3.

4.

patients record. If specifically permitted by state or NRC regulations, 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. 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 possible in writing in the patients record. A written directive must be prepared within 48 hours of the oral directive. The identity of the radiopharmaceutical and the patient, route of administration, and the pregnancy and breast-feeding status of the patient shall be verified prior to administration. 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.

C. Elution of Generators and On-Site Preparation of Radiopharmaceutical Kits 1. 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. Radiopharmaceuticals should be prepared according to the manufacturers instructions. Documenting exceptions in the policy or procedure manual is desirable. Aseptic procedures must be followed whenever handling parenteral radiopharmaceutical preparations or their components. The first (initial) eluate after receipt of a generator shall be assayed for breakthrough of the parent isotope. No more than 0.15 microcurie (.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. Labeling efficiency of kit-prepared technetium99m radiopharmaceuticals should be evaluated periodically, such as the first vial of a new lot. Specifically, testing for free pertechnetate and hydrolyzed-reduced radiochemical impurities Radiopharmaceuticals / 3

IV.

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. Handling, preparation, and administration of radiopharmaceuticals may be delegated to qualified personnel, subject to applicable state or local laws. The qualified individual performing radiopharmaceutical tasks shares responsibility for the safety and quality of all radiopharmaceuticals with which he or she is involved. 2.

2.

3. 4.

3.

B. Radiopharmaceuticals 1. The quantity of radioactivity to be administered must be prescribed (either individually by prescription or by protocol), assayed, and recorded. Administered activity must fall within tolerances of applicable state and federal regulations and should be recorded in the 5.

TECHNICAL STANDARD

should be performed. Radiopharmaceuticals should not be administered if the total level of radiochemical impurities exceeds 10%. D. Records 1. Records of receipt, usage, administration, and disposal of all radionuclides shall be kept in compliance with license conditions and applicable medical records and radiation control regulations. All packages containing radioactive materials will 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. 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. 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. If a radionuclide dose calibrator is used on-site for the assay of radiopharmaceutical administered activity, the instrument will be checked for constancy, accuracy, linearity, and geometric dependence per manufacturers recommendation and the requirements of the appropriate regulatory agency. Records must be maintained. Material (excepting excreta, which may be released into 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. Residual activity must be stored in a shielded container or in an area that is designed for the storage of radioactive materials until 10 halflives 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. Adverse reactions attributable to any radiopharmaceutical should be reported to the

9.

2.

manufacturer and, when appropriate, to the Food and Drug Administration (FDA). There must be policies and procedures to ensure that the identity of the patient, the pharmaceutical, the administered activity, and the route of administration are correct. Errors in the 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 Nuclear Regulatory Commission, or the state regulatory agency and the referring physician must be notified. Unless medically contraindicated, the patient must also be notified. INSTRUMENT QUALITY CONTROL

V.

3.

A 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.) Daily testing and evaluation of nuclear medicine equipment may be performed by the technologists under the supervision of the responsible physician. A. For All Scintillation Cameras 1. 2. Test field uniformity daily using either a uniform sheet flood source and collimator or a point source and no collimator. Use a resolution test pattern (e.g., a bar phantom) to test linearity, spatial resolution, distortion, and field of view weekly or according to manufacturers recommendations. Comparison with prior test images is advisable. Retention of these images is recommended. Inspect collimators regularly for damage. Test with a very high-count flood image annually or when collimator damage is suspected. Inspect systems regularly for mechanical or electrical hazards; if malfunctioning, do not use until repaired. Maintain a log of all quality control testing and problems identified; ascertain if any trends exist. Maintain all service records.

4.

5.

3. 4. 5. 6.

6.

7.

B. For Single Photon Emission Computed Tomography (SPECT) (in addition to section V.A.1-6 above) 1. 2. Assess center of rotation according to the manufacturers or physicists recommendations. Assess flood uniformity according to the manufacturers or physicists recommendations. This will require 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. TECHNICAL STANDARD

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3.

Assess system uniformity, spatial resolution, and contrast resolution using a three-dimensional phantom according to the manufacturers recommendations.

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 number, procedure, radiopharmaceutical and administered activity, and comments. J. For each study, the following information should be recorded: instrument, collimator, pulse height analyzer setting, acquired views, number of counts in each image, start time of procedure, and duration of images. (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. VI. PATIENT AND PERSONNEL SAFETY

C. For Xenon or DTPA Aerosol Delivery System Assure proper function according to the manufacturers specifications and within applicable federal or state regulations. D. Hard-Copy Imaging Device Quality control testing should be performed according to the manufacturers recommendations, with comparison of current results to baseline results obtained in acceptance testing. E. Film Processors 1. Chemical (wet) systems a. Perform daily sensitometric checks. b. Perform periodic cleaning and maintenance. c. Perform chemical checks. Nonchemical (dry) systems Perform periodic calibration and maintenance as recommended by the manufacturer. Well Counters, Ionization

2.

F. Geiger Counters, Chambers

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. G. 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 manufacturers 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 quarterly and after equipment repair. Test for accuracy annually and after equipment repair. Test for geometry upon installation and after replacement or repair of the chamber.

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 shall be used unless contraindicated for a specific patient. C. Under no circumstances may pipetting of any materials by mouth be permitted. D. Under no circumstances may makeup be applied or food or drink be brought into, stored, or consumed in areas where radionuclides are prepared, used, or stored. 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 breast-feeding. If the patient is known to be pregnant, the potential radiation risks to the fetus and clinical benefits of the procedure should be considered before proceeding with the study. F. A policy must exist for routine daily radiation surveys of all areas where radionuclides are used or

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stored, according requirements.

to

state

or

federal

regulatory

dosages will be derived from appropriate guidelines or standards (e.g., body surface area or weight). C. There must be detailed information about performance, recording, and action regarding all radiopharmaceutical and instrument quality control. D. There must be detailed information on appropriate aspects of radiation safety, including emergency procedures. VIII. RECORDS

G. There must be a policy on containment and cleanup of radioactive spills. Radioactive gases should only be used in rooms with appropriate airflow 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. 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 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.

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 shall 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. F. Studies, data, and reports shall be archived for a time consistent with the mandates of state regulatory agencies, license conditions, or radiation protection regulations. IX. RADIATION SAFETY IN IMAGING

L. There shall be posting of: 1. 2. 3. Information placards required by regulatory agencies. Radiation precaution signs in areas where radioactive agents are used or stored. Warnings to patients to inform the staff if they are or could be pregnant or if they are breastfeeding. PROCEDURE MANUAL

VII.

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 TECHNICAL STANDARD

A. A policy and procedure manual must be prepared and maintained. The physician 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 6 / Radiopharmaceuticals

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 under the heading Position Statement on QC & Improvement, Safety, Infection Control, and Patient Education on the ACR web page (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 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 page (http://www.acr.org/guidelines) by the Guidelines and Standards Committees of the Commissions on Nuclear Medicine. Principal Reviewers: Alice M. Scheff, MD James W. Fletcher, MD

Alice M. Scheff, MD, Co-Chair James W. Fletcher, MD, Co-Chair Rodney R. Bowman, MD Leonie Gordon, MD L. Stephen Graham, PhD Michael M. Graham, MD, PhD Ronald L. Korn, MD Massoud Majd, MD Sara M. OHara, MD Christopher J. Palestro, MD Paul D. Shreve, MD Manuel L. Brown, MD, Chair, Commission Suggested Reading (Additional articles that are not cited in the document but that the committee recommends for further reading on this topic) 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.

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. 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)

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