The department shall license mobile medical services or
clients of such services. The mobile medical service shall be licensed if the
service receives, uses or possesses radioactive material. The client of the
mobile medical service shall be licensed if the client receives or possesses
radioactive material to be used by a mobile medical service.
(1) The mobile medical licensee shall obtain
a letter signed by the management of each client for which services are
rendered that permits the use of radioactive materials at the client's address
and clearly delineates the authority and responsibility of the licensee and the
client. A licensee providing mobile medical services shall retain this letter
for 3 years after the provision of service.
(2) Mobile medical service licensees shall
secure or keep under constant surveillance and immediate control all
radioactive material when in transit or at a location of use.
(3) The mobile medical licensee shall check
instruments used to measure the activity of unsealed or sealed radioactive
materials for proper function before medical use at each client's address or on
each day of use, whichever is more frequent. At a minimum, the check for proper
function required by this paragraph must include a constancy check and shall
perform all daily quality control tests on all equipment used to obtain images
or information from radionuclide studies before medical use at each location of
use.
(4) Before leaving a client
location,
mobile medical service licensees shall perform a
survey of all areas
where radioactive materials are used with a
radiation survey instrument in
order to ensure that they have complied with the requirements in Rule
64E-5.621,
F.A.C., that
radiation dose rates are at background levels, and that removable
contamination is below 2000 disintegrations per minute per 100 square
centimeters sampled. A licensee shall check each survey instrument for proper
operation with a
dedicated check source before each use at each location. The
licensee is not required to keep records of these dedicated source survey
instrument checks.
(5) Mobile
medical service licensees shall retain a record of each survey required for 3
years. The record must include the date of the survey, a diagram of each area
that was surveyed, the measured dose rate at several points in each area of use
in millirems (microsieverts) per hour, the model and serial number of the
instrument used to make the survey, and the initials of the individual who
performed the survey.
(6) A
physician shall be on site at each client's address at the time radioactive
materials are administered. An authorized user shall be immediately available
to communicate with the supervised individuals or individuals under their
direction.
(7) Radioactive material
will be received at the permanent location of the mobile medical service or
delivered directly to an authorized individual in the vehicle at a place of
use. A mobile medical service may not have radioactive materials delivered from
the manufacturer or the distributor to the client unless the client has a
radioactive materials license allowing possession of the radioactive material.
Radioactive material delivered to the client must be received and handled in
conformance with the client's license.
(8) Restrooms contained in mobile vehicles
shall not routinely be used by patients who have been administered radioactive
material.
(9) Radioactive gases or
aerosols shall not be used by mobile medical service licenses.
(10) Prior to administration, the
mobile
medical service
licensee shall assure that individuals or human research
subjects meet the patient release criteria specified in Rule
64E-5.622,
F.A.C.
(11) A
licensee authorized
to use mobile remote afterloaders for medical use shall follow the requirements
specified in Rule
64E-5.6423,
F.A.C.
Notes
Fla. Admin. Code Ann. R.
64E-5.610
Rulemaking Authority
404.022,
404.051,
404.061,
404.071,
404.081,
404.141 FS. Law
Implemented
404.022,
404.051(1),
(4), (5), (6), (8), (9), (10), (11),
404.061(2),
(3),
404.071(1),
404.081,
404.141
FS.
New 8-25-91, Formerly
10D-91.716, Amended 2-11-10.