National laws and regulations
There are numerous U.S. laws that apply to radiation emitting products sold in the United States and to providers of radiology and imaging services. There are also overlapping enforcement authorities for radiation-emitting products provided for by the Federal Food, Drug, and Cosmetic Act, (Chapter V, Medical Devices); Radiation Control for Health and Safety Act of 1968 (now part of the Federal Food, Drug and Cosmetic Act as Chapter V, Subpart 3), Electronic product radiation control; and the Mammography Quality Standards Act of 1992.
FDA Safety Communications
- FDA Safety Communication: Safety Concerns with Implantable Infusion Pumps in the Magnetic Resonance (MR) Environment January 10, 2016
- FDA Radiation Safety: Interference between CT and Electronic Medical Devices April 12,2016
- FDA website on Radiation Emitting Products
- Visit our Safety Resource section for additional FDA information
Nuclear Regulatory Commission – NRC
The U.S. Nuclear Regulatory Commission (NRC), created as an independent agency by Congress in 1974, oversees the safe use of radioactive materials for beneficial civilian purposes while ensuring that people and the environment are protected. The NRC regulates uses of nuclear materials, such as in nuclear medicine, through licensing, inspection and enforcement of its requirements. NRC also has formal agreements with 37 states that have assumed regulatory responsibility and jointly with NRC develop new regulations and guidance.
Mammography Quality Standards Act (MQSA)
The MQSA was passed on October 27, 1992, to establish national quality standards for mammography. The MQSA required that to provide mammography services legally after October 1, 1994, all facilities, except facilities of the Department of Veterans Affairs, must be accredited by an approved accreditation body and certified by the Secretary of Health and Human Services (the Secretary). The authority to approve accreditation bodies and to certify facilities was delegated by the Secretary to the FDA. Current FDA-approved accreditation bodies are:
- American College of Radiology (ACR)
- Arkansas Department of Health Division of Health-Radiation Control Section
- Iowa Department of Public Health Bureau of Radiological Health
For more information visit the FDA Website on MQSA:
Medicare Improvements for Patients and Providers Act of 2008 (MIPPA)
As required by the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA), all suppliers of the technical component (TC) of advanced imaging must be accredited by an accreditation organization designated by the Secretary of Health and Human Services. Existing entities had until Jan. 1, 2012 to become accredited. The accreditation requirement applies to physicians, non-physician practitioners, and physician and non-physician organizations that are paid for providing the technical component of advanced imaging services under the Medicare Physician Fee Schedule. The accreditation requirement applies only to the suppliers furnishing the imaging services, and not to the physician’s interpretation of the images.
MIPPA specifically defines advanced diagnostic imaging procedures as including diagnostic magnetic resonance imaging (MRI), computed tomography (CT), and nuclear medicine imaging such as positron emission tomography (PET).
This requirement applies for Medicare Part B payments to be made under the Physician Fee Schedule.
On behalf of the Secretary of Health and Human Services, the Centers for Medicare and Medicaid Services CMS designated three national accreditation organizations – the American College of Radiology (ACR), the Intersocietal Accreditation Commission (IAC), and The Joint Commission (TJC) – to accredit suppliers furnishing the technical component (TC) of advanced diagnostic imaging procedures.
State laws and regulations
Hundreds of state laws addressing radiology and imaging services are introduced in state legislatures each year. The ACR is one of many organizations that tracks the legislation. The bills relate to a range of issues including scope of practice, licensure, telemedicine, self-referral, patient safety, and more. States have typically assumed the lead in developing regulations that assure that patients are receiving safe levels of radiation and that the providers of services are qualified.
California was the first state to pass a law related to reporting of radiation dose levels. The law was passed in September 2010, was effective January 1, 2012, and was revised further in 2013. Texas has similar regulations in place, and Connecticut recently considered legislation, although it did not pass.
- California The new 2012 law (originally A.B. 150) revises some provisions from the original 2010 legislation (originally S.B. 1237) to require accreditation, allow for certain exemptions, and specify error reporting procedures.
Bill 6423 was introduced in early 2013 and was working its way to the Connecticut General Assembly; however, the bill did not make it through the hearing committee.
The regulations in California, Connecticut and Texas have the following in common:
- Requirements for dose exposure levels on patient reports
- Mandates or the establishment of mandates on specific dose thresholds
- Requirements for reporting to state authorities when thresholds are surpassed
Even though the bill in Connecticut did not become law, the trend is pointing toward similar legislation passing in other states.
American College of Radiology (ACR)
The ACR mission is to serve patients and society by maximizing the value of radiology, radiation oncology, interventional radiology, nuclear medicine and medical physics. The organization’s 36,000 members include radiologists, radiation oncologists, medical physicists, interventional radiologists, nuclear medicine physicians and allied health professionals. ACR accredits more than 35,000 facilities in 10 imaging modalities. The ACR offers accreditation programs in CT, MRI, breast MRI, nuclear medicine and PET as mandated under the Medicare Improvements for Patients and Providers Act (MIPPA) as well as for modalities mandated under the Mammography Quality Standards Act (MQSA).
Intersocietal Accreditation Commission (IAC)
The Intersocietal Accreditation Commission (IAC) is dedicated to improving health through accreditation. Formerly the Intersocietal Commission for the Accreditation of Vascular Laboratories, the IAC today works with more than 12,000 sites throughout the U.S. and Canada to provide accreditation programs for carotid stenting,dental CT, diagnostic CT,echocardiography, MRI,nuclear/PET, vascular testing, and vein center
The Joint Commission (TJC) is an independent, not-for-profit organization, that accredits and certifies more than 20,000 health care organizations and programs in the United States. The standards by which organizations are accredited and certified are developed via a consensus building process by leading professional organizations in the health care field. The Joint Commission is one of three organizations that accredits suppliers of the technical components of advanced imaging services.
TJC announced new and revised Diagnostic Imaging Standards for accredited hospitals, critical access hospitals, and ambulatory health care organizations that provide diagnostic imaging services, including ambulatory organizations that have achieved Advanced Diagnostic Imaging certification. The initial effective date was July 1, 2014. However, on May 21, 2014, TJC announced that they are postponing the implementation date and adding additional requirements with the goal of a new implementation date of July 2015.
As noted in the sections above, various State Departments of Health also develop performance standards relating to radiology and imaging safety.