CMS SOM App. A, Tag A-0535

…. If therapeutic services are also provided, they, as well as the diagnostic services, must

meet professionally approved standards for safety and personnel qualifications.]

§482.26(b) Standard: Safety for Patients and Personnel

The radiologic services, particularly ionizing radiology procedures, must be free from

hazards for patients and personnel.

Interpretive Guidelines §482.26(b)

The hospital must adopt and implement radiologic services policies and procedures that provide

safety for affected patients and hospital personnel and which are consistent with accepted

professional standards for radiologic services.

Ionizing Radiology Procedures

Radiologic services modalities that use ionizing radiation have increased the ability to detect

disease or injury early enough for a medical problem to be managed, treated, or cured. When

applied and performed appropriately, these radiologic studies or procedures can maintain or

improve health and save lives.

X-ray energy used in radiologic services also has a potential to harm living tissue. The most

significant risks are:

• Cataracts and skin damage, but only at very high levels of radiation exposure; and

• An increase in the possibility that a person exposed to x-ray energy will develop cancer later

in life. The risk of developing cancer from radiologic services radiation exposure is

generally very small, and it depends on at least three factors—the amount of the radiation

dose, the age of the person exposed, and the sex of the person exposed:

• The lifetime risk of cancer increases the larger the dose and the more x-ray studies or

procedures a patient undergoes;

• The lifetime risk of cancer is larger for a patient who received x-rays at a younger age

than for one who receives them at an older age; and.

• Women are at a somewhat higher lifetime risk than men for developing radiation-

associated cancer after receiving the same exposures at the same ages.

MRI:

MRIs are useful when a soft tissue injury or disease process is suspected and are generally

considered at low risk of causing harm to patients or staff. However, they also are not entirely

risk-free. Potential risks include projectile risk of magnetic objects being sucked into the main

magnet, thermal injury and burns, adverse effects on devices and leads implanted in patients, and

hearing damage.

Provision of services in accordance with professionally approved standards for safety

All radiological services provided by the hospital, including both diagnostic and, if offered,

therapeutic services, must be provided in accordance with acceptable standards of practice,

including standards for safety.

Professionally approved standards include maintaining compliance with applicable Federal and

State laws and regulations governing radiological services, including, but not limited to, facility

licensure and/or certification requirements.

Professionally approved standards also include the recommendations or guidelines promulgated

by expert governmental agencies, such as the U.S. Food and Drug Administration, as well as

those issued by nationally recognized professional organizations, such as the American Medical

Association, American College of Radiology, Radiological Society of North America, The

Alliance for Radiation Safety in Pediatric Imaging, American Society of Radiologic

Technologists, the American College of Cardiology, the American College of Neurology, the

American College of Physicians, etc.

Generally, there are different standards for different imaging modalities used to provide

radiologic services; there may also be different standards for diagnostic versus therapeutic uses,

as well as for pediatric versus adult patients, etc. For example, the American College of

Radiology has separate diagnostic radiology guidance documents for general radiology, CT,

MRI, and ultrasound, among others. The hospital must be able to document the source standards

that form the basis for its policies and procedures for each of its radiologic services modalities

and/or settings. For example, if one organization’s standards are used for mammography

services, another’s for CT services, another’s for MRI, and another’s for pediatric X-rays, this

must be clearly indicated.

In order to ensure safety and freedom from hazards, the hospital’s radiologic services policies

and procedures must include, but are not limited to, provisions addressing the following:

• For ionizing radiation services, application of the fundamental principle of As Low as

Reasonably Achievable or ALARA, which is defined by the U.S. Environmental Protection

Agency (EPA) as “A principle of radiation protection philosophy that requires that exposures

to ionizing radiation be kept as low as reasonably achievable, economic and social factors

being taken into account. The protection from radiation exposure is ALARA when the

expenditure of further resources would be unwarranted by the reduction in exposure that

would be achieved.” (Federal Guidance Report No. 14, Radiation Protection Guidance for

Diagnostic and Interventional X-ray Procedures, p. 100, November, 2014) Although CMS

does not interpret or enforce EPA guidance, the ALARA principle is considered an accepted

standard of practice for ionizing radiation services to which hospitals must adhere.

• Written protocols developed or approved by the radiologist responsible for the radiologic

services, in conjunction with other qualified radiologic services personnel (e.g., a medical

physicist, radiologic technologists, patient safety officers, etc.) designed to ensure that

diagnostic studies and therapeutic procedures are routinely performed in a safe manner,

utilizing parameters and specifications that are appropriate to the ordered study/procedure.

The hospital must ensure that protocols for the various types of ionizing radiation diagnostic

or therapeutic imaging modalities are designed to minimize the amount of radiation while

maximizing the yield and producing diagnostically acceptable image quality. Existing

protocols must be reviewed periodically and updated as needed. The rationale and details for

changes to technical parameters must be documented.

For Information Only – Not Required/Not to be Cited

Hospitals are encouraged to follow the recommendation in the EPA’s Guidance

Report No. 14 concerning patient radiation dosage. The report says “As the ICRP

[International Commission on Radiological Protection] has stated, ‘Provided that the

medical exposures of patients have been properly justified and that the associated doses are

commensurate with the medical purpose, it is not appropriate to apply dose limits or dose

constraints to the medical exposure of patients, because such limits or constraints would

often do more harm than good’ (ICRP 2007b). While dose limits do not apply to medical

exposures, radiation doses to patients should always be optimized. All responsible parties

should always strive to minimize patient irradiation to the dose that is necessary to perform

the procedure with adequate image quality. The recommendation against establishing

absolute dose limits should not discourage a facility from implementing diagnostic

reference levels for imaging and interventional procedures. Exceeding these levels

should prompt a review of practice at the facility as a quality assurance measure.

Dose notification and alert values for CT, notification levels for use during

interventional procedures, and trigger levels for follow-up after interventional

procedures are also appropriate QA measures [emphasis added]...(EPA Guidance

Report No. 14, p.6)

• Policies and protocols to identify patients at high risk for adverse events for whom the

radiologic study or procedure might be contraindicated, e.g., pregnant women, individuals

with known allergies to contrast agents, individuals with implanted devices, etc. Policies

would address the steps to be taken, and by which personnel, if an order is written for a

radiologic study or procedure for an individual identified in the radiologic services policies

as potentially at high risk (e.g., notify the ordering physician, cancel the procedure

personally, etc.).

• Specific requirements related to procedures to mitigate radiation hazards are discussed in the

guidance for §482.26(b)(1).

• Procedures to address risks associated with modalities that do not use ionizing radiation. For

example, with respect to MRI:

• Measures to prevent magnetic materials from being closer than is safe to the MRI suite,

per nationally recognized guidelines;

• If equipment and supplies, such as fire extinguishers and oxygen tanks, are located in

the MRI area, they are MR-safe, i.e., they are non-ferromagnetic;

• Provision of adequate and effective hearing protection to patients, staff and others who

might be in the MRI suite while the scans are taking place; and

• Measures to reduce the risk of thermal injuries/burns during MRI. This would include,

but is not limited to, screening patients to identify those who may have metallic tattoos or

metal in them, proper patient positioning, ensuring implants are MR Conditional,

checking for electrically conductive materials that might be in close proximity to the

patient and taking the appropriate precautions, and instructing the patient to immediately

report any burning sensations experienced during the scan.

• Training required by personnel permitted to enter areas where radiologic services are

provided.

• Training and, as applicable, qualifications, required for personnel who perform diagnostic

imaging studies or therapeutic procedures utilizing radiologic services equipment. This

includes proper operation of equipment per manufacturer’s instructions and hospital policy.

• Areas where radiologic services are provided must be equipped with the necessary equipment

or materials to immediately respond to potential adverse events. This could include, but is

not limited to, things like a crash cart, emergency stop mechanisms, cleaning and

decontamination agents if applicable, etc.

For Information Only – Not Required/Not to be Cited

Hospitals are encouraged to also address the following in their Radiologic Services:

• Encouraging physicians and other practitioners with privileges to order radiologic studies

or procedures that utilize ionizing radiation to consider both the benefits and risks of the

procedures.

• Recording and tracking the dosing patients receive. There are several nationally

recognized quality assurance programs designed to assist health care providers in

developing and maintaining this data, including, but not limited to:

• The Alliance for Safety in Pediatric Imaging (www.Imagegently.org)

• The Conference of Radiation Control Program Directors

• The American College of Radiology data registry (http://nrdr.acr.org)

• The Nationwide Evaluation of X-ray Trends (NEXT program)

Further, although the EPA’s Guidance Report No. 14 was developed by an Interagency

Working Group on Medical Radiation specifically to provide guidance to Federal facilities that

use diagnostic and interventional X-ray equipment, it should also be useful to non-Federal

medical facilities and hospitals are encouraged to review it. The Guidance Report addresses

the following topics:

• Radiation Safety Standards and General Concerns

• Structural Shielding and Door Interlock Switches

• Requesting and Performing Studies Involving X-rays

• Technical Quality Assurance

• General Guidelines for Clinical Imaging, organized into separate sections for Medical and

Dental, and further broken down by modality

• Imaging Informatics

• Recommendations for Facility Action

Medical Physicists

According to the American Association of Physicists in Medicine, the practice of Medical

Physics means the use of principles and accepted protocols of physics to ensure the correct

quality, quantity, and placement of radiation during the performance of a radiological procedure.

Hospitals are not required under the regulations to have a medical physicist on staff or under

contract. However, since radiologic services are required to be free from hazards to patients and

hospital personnel, hospitals must ensure that qualified personnel, whether or not they are

medical physicists, develop and carry out protocols and test, calibrate, and maintain radiologic

services equipment and that there is a reliable means to validate the results.

For Information Only - Not Required/Not to be Cited

Definition of a Medical Physicist

An example of a definition of and qualifications for a medical physicist is provided by the

American Association of Physicists in Medicine:

“For the purpose of providing clinical professional services, a Qualified Medical Physicist

(QMP) is an individual who is competent to independently provide clinical professional

services in one or more of the subfields1 of medical physics. The subfields of medical physics

are:

• Therapeutic Medical Physics

• Diagnostic Medical Physics

• Nuclear Medicine Physics

• Medical Health Physics

…. A Qualified Medical Physicist meets each of the following credentials:

• Has earned a master’s and/or doctoral degree in physics, medical physics, biophysics,

radiological physics, medical health physics, or equivalent disciplines from an accredited

college or university; and

• Has been granted certification in the specific subfield(s) of medical physics with its

associate medical health physics aspects by an appropriate national certifying body and

abides by the certifying body’s requirements for continuing education.”

http://www.aapm.org/org/default.asp

For Information Only - Not Required/Not to be Cited

The responsibilities of the medical physicist in a hospital may include:

• protection of the patient and others from potentially harmful or excessive radiation;

• establishment, with the approval of the Director of Radiologic Services, of adequate

protocols to ensure accurate patient dosimetry;

• measurement and characterization of radiation;

• determination of delivered dose;

• promotion of procedures necessary to ensure image quality;

• development and direction of quality assurance programs; and assistance to other

healthcare professionals in optimizing the balance between the beneficial and deleterious

effects of radiation.

Hospitals are also encouraged to involve a medical physicist in the calibration of the radiologic

services equipment and monitoring of radiation dosage exposures to staff.

Consistent with the requirements under the Quality Assessment and Performance Improvement

(QAPI) CoP at 42 CFR 482.21, the hospital must monitor the quality and safety of radiologic

services.

Examples of indicators of potential quality and safety problems could include, but are not limited

to:

• Improper patient preparation, such as inadequate intravenous access or lack of pre-medication, such that procedures must be cancelled or reordered;

• Repeats of the same studies in the hospital for the same patient within a short time span,

which may be an indicator of poor image quality; or

• Diagnostic imaging studies or therapeutic procedures performed in a manner inconsistent

with the applicable hospital written protocol.

Under the QAPI CoP, hospitals are required to undertake improvement activities in areas that

represent high risk, high volume, or problem-prone areas. Problems identified in radiologic

services may meet these criteria. In addition, adverse events related to radiologic services must

be analyzed for their causes, and preventive actions must then be undertaken. Deficiencies

identified related to tracking, analyzing, and addressing adverse event and quality indicator data

and performance improvement activities must be cited under the applicable QAPI standards.

Survey Procedures §482.26(b)

• Verify that there are written hospital policies and procedures and protocols for specific

radiologic services modalities that are based on identified professionally approved standards,

and which address the ALARA principle as well as the other safety and risk-reduction

measures discussed in the guidance.

• Ask for evidence that safety protocols are reviewed periodically and, if applicable,

updated.

• Determine if the radiologic services staff are familiar with the policies and procedures related

to safety in general and specific clinical protocols.

• Observe whether the policies and procedures are followed when radiologic services are

delivered to patients. Ask for the protocol(s) for one or more studies/procedure(s) you

observed and check if they were followed.

• Verify that radiologic services staff are trained at appropriate intervals to ensure that they are

operating the equipment according to manufacturer’s instructions and hospital policy

• Verify that radiologic services staff know how to respond to adverse events.

• Confirm that areas where radiologic services are provided are equipped with the equipment

or materials to immediately respond to an adverse event.

• Ask the radiologist who supervises ionizing radiologic services how the hospital monitors the

quality and safety of radiologic services.

• Verify that adverse events are analyzed for their causes and that preventive actions are taken

(deficiencies to be cited both here and under the applicable QAPI citation).