CMS SOM App. A, Tag A-1027

The organization of the nuclear medicine service must be appropriate to the scope

and complexity of the services offered.

(1) There must be a director who is a doctor of medicine or osteopathy qualified in

nuclear medicine.

(2) The qualifications, training, functions and responsibilities of the nuclear

medicine personnel must be specified by the service director and approved by the

medical staff.

Interpretive Guidelines §482.53(a)

The scope of nuclear medicine services offered by the hospital, including which types of

diagnostic studies and/or therapeutic procedures are provided, where they are provided in

the hospital, and the appropriately-trained staff and equipment needed to provide these

services must be specified in writing. Hospitals may choose to provide nuclear medicine

services in one location or at several different locations in the hospital, including, but not

limited to, inpatient and outpatient locations of the radiology, cardiology, and oncology

departments. The organization of the nuclear medicine service must encompass the full

scope and complexity of nuclear services offered throughout the hospital.

Nuclear Medicine Director

The hospital is required to have a director responsible for nuclear medicine services

offered throughout the hospital. The director must be a doctor of medicine (MD) or

osteopathy (DO) and must demonstrate through education, experience and specialized

training that he/she is qualified in nuclear medicine. Nuclear medicine physicians utilize

radioactive materials to diagnose and treat disease either by interpreting the images

created by radioisotopes or by prescribing and evaluating therapeutic interventions

involving radiopharmaceuticals. Typically these MDs/DOs initially specialize in

radiology or internal medicine and then complete subspecialty training in nuclear

medicine.

The hospital must describe in writing the qualifications it requires for the director of

nuclear medicine services.

Other Nuclear Medicine Personnel

Although not mentioned specifically in the regulation, there are several different

categories of personnel that may typically be involved in the provision of nuclear

medicine services, including (but not limited to):

• Nuclear medicine pharmacists: these individuals are pharmacists who specialize in

preparing, dispensing, and distributing radiopharmaceuticals;

• Nuclear medicine technologists: these individuals are trained to administer

radioactive materials and perform the specific imaging procedures and often process

the images for interpretation; and

• Nuclear medicine physicists.

The hospital must specify in writing the qualifications, training, functions and

responsibilities of each category of personnel used by the hospital, whether personnel are

employees or contractors, in the delivery of nuclear medicine services. The written

specifications must be developed by the Director and approved by the hospital’s medical

staff. Qualifications include at a minimum, job title, education, experience, specialized

training, and licensure/certification, consistent with any applicable Federal and State law.

The specifications must also address ongoing training for personnel.

Survey Procedures §482.53(a)

• Determine whether the scope of the nuclear medicine services offered is specified in

writing.

• Determine whether there are nuclear medicine policies developed by the director of

nuclear medicine governing provision of these services in every part of the hospital

offering nuclear medicine services.

• Verify that the hospital has a written description of the qualifications of the nuclear

medicine services director.

• Review the service director’s file to verify that he/she is a MD or DO and has the

necessary education, experience and specialized training in nuclear medicine, per the

hospital’s written policies.

• Verify that the qualifications, training, functions and responsibilities of the various

categories of nuclear medicine staff the hospital uses are specified by the director and

approved by the medical staff.

• Review personnel files for a sample of nuclear medicine staff to determine if they

meet the prescribed qualifications and have received ongoing training as required in

the hospital’s policies and procedures.