CMS SOM App. W, Tag C-1030

Radiology services furnished by the CAH are

provided by personnel qualified under State law, and do not expose CAH patients

or personnel to radiation hazards.

Interpretive Guidelines §485.635(b)(3)

Radiologic services encompass many different modalities used for the purpose of medical

imaging. Each type of technology gives different information about the area of the body

being studied or treated, related to possible disease, injury, or the effectiveness of medical

treatment. All the modalities use some form of radiation, such as ionizing radiation

(radiography, computed tomography, fluoroscopy), which has enough energy to

potentially cause damage to DNA, and other forms of radiation (ultrasound, magnetic

resonance imaging) to view the human body in order to diagnose, monitor, or treat

medical conditions.

Radiological services furnished by the CAH may be provided by CAH staff or under

arrangement. The CAH must maintain and have available diagnostic radiological

services to support the services the CAH provides to meet the needs of its patients. These

services must be available at all times the CAH provides services, including emergency

services. The CAH has the flexibility to choose the types and complexity of radiologic

services offered. They may offer only a minimal set of services or a more complex range

of services (including nuclear medicine).

All radiological services provided by the CAH, including diagnostic, therapeutic, and

nuclear medicine, must be provided in accordance with acceptable standards of practice

and must meet professionally approved standards for safety. The scope and complexity

of radiological services offered should be specified in writing and approved by the

governing body (or responsible individual).

Acceptable standards of practice include maintaining compliance with appropriate

Federal and State laws, regulations and guidelines governing radiological services,

including facility licensure and/or certification requirements, as well as any standards and

recommendations promoted by nationally recognized professions such as the American

Medical Association, Radiological Society of North America, Alliance for Radiation

Safety in Pediatric Imaging, American Society of Radiologic Technologists, American

College of Cardiology, American College of Neurology, American College of

Physicians, American College of Radiology, etc.

Qualified Radiologic Personnel

There must be written policies that are developed and approved by the governing body or

responsible individual and are consistent with State law, that designate which personnel

are qualified to use the radiological equipment and administer procedures.

When telemedicine is used to provide teleradiology services, radiologists who interpret

radiological tests must satisfy the telemedicine privileging requirements §485.616(c)(3).

In addition to radiologists, there are other types of healthcare personnel who, depending

on State law and the scope and complexity of the CAH’s radiologic services, may be

involved in the delivery of radiologic services in the CAH, including radiologic

technologists and medical physicists. Radiologic technologists perform diagnostic

imaging examinations and administer radiation therapy treatments. They are educated in

anatomy, patient positioning, examination techniques, equipment protocols, radiation

safety, radiation protection and basic patient care.

For Information Only – Not Required/Not to be Cited

Well-designed radiologic services include a medical physicist, who, in conjunction

with the person responsible for radiologic services, performs or supervises the pertinent

procedures necessary to assure the safe and effective delivery of radiation to achieve a

diagnostic or therapeutic result. The responsibilities of the medical physicist include:

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

establishment of adequate protocols to ensure accurate patient dosimetry; the

measurement and characterization of radiation; the determination of delivered dose;

advancement of procedures necessary to ensure image quality; development and

direction of quality assurance programs; and assistance to other health care

professionals in optimizing the balance between the beneficial and deleterious effects

of radiation (www.aapm.org). CAHs are encouraged to involve a medical physicist in

the calibration of the imaging equipment and monitoring of radiation dosage

exposures.

Safety from Radiation Hazards

The CAH must adopt and implement policies and procedures that ensure safety from

radiation hazards for patients and personnel. The CAH must implement and ensure

compliance with its established safety standards. The policies must address at least the

following:

• Adequate radiation shielding for patients, personnel and facilities, which includes:

• Shielding built into the CAH’s physical plant, as appropriate;

• Types of personal protective shielding to be used, under what circumstances,

for patients, including high risk patients as identified in radiologic services

policies and procedures, and CAH personnel;

• Types of containers to be used for various radioactive materials, if applicable,

when stored, in transport, in use, and when disposed;

• Clear signage identifying hazardous radiation areas;

• Labeling of all radioactive materials, including waste, with clear identification of

all material(s);

• Transportation of radioactive materials between locations within the CAH;

• Security of radioactive materials, including determining who may have access to

radioactive materials and controlling access to radioactive materials;

• Periodic testing of equipment for radiation hazards;

• Periodic checking of staff regularly exposed to radiation for the level of radiation

exposure, via exposure meters or badge tests;

• Storage of radio nuclides and radio pharmaceuticals as well as radioactive waste;

and

• Disposal of radio nuclides, unused radio pharmaceuticals, and radioactive waste.

Radiologic Equipment Maintenance

The CAH must have policies and procedures in place to ensure that periodic inspections

of radiology equipment are conducted, and that problems identified are corrected in a

timely manner. The CAH must ensure that equipment is inspected and maintained in

accordance with Federal and State laws and regulations, as applicable, and the

manufacturer’s recommendations. The CAH must have a system in place to correct

identified problems. The CAH must have evidence of its inspections and corrective

actions.

Radiology Records

The CAH radiology records are to be treated in the same manner as any other part of a

medical record. The medical records CoP at §485.638(a)(4)(ii) requires that the CAH

maintain reports of physical examinations, diagnostic and laboratory test results, and

consultative findings.

Survey Procedures §485.635(b)(3)

• Interview the person responsible for radiologic services.

• Ask what radiologic services the CAH offers at its main campus. At off-site

locations ask how the CAH ensures patient needs for radiologic services are

met, if applicable.

• Ask how the CAH ensures that radiologic services are provided consistent

with acceptable standards of practice.

• Safety:

• Determine if the radiologic services staff is familiar with the policies and

procedures related to safety.

• Verify that patient shielding (aprons, etc.) are properly maintained and

routinely inspected by the CAH.

• Observe areas where radiologic testing is done and check for safety problems.

• Verify that hazardous materials are clearly labeled. Review records to verify

that they are tracked, handled and stored properly in a safe manner with the

requisite containers.

• Review records to verify that periodic tests of radiology personnel by

exposure meters or test badges are performed.

• Equipment maintenance:

• Review the inspection records to verify that periodic inspections and

maintenance are conducted in accordance with the manufacturer’s

recommendations.

• Determine whether any problems identified are properly corrected in a

timely manner and the correction is maintained over time.

• Qualified Personnel:

• Are studies interpreted only by qualified staff approved to do so by the CAH’s

governing body or responsible individual?

• Determine which staff are using various pieces of radiological equipment

and/or administering patient procedures. Review their personnel folders to

determine if they meet the qualifications for tasks they perform, as established

in the CAH’s policies and consistent with state law.

• Ask staff to explain the protocol for the procedures/studies they administer.

Ask to see the CAH’s written protocols and verify that the staff is adhering to

them.