Florida Regulations 64E-5.610: Mobile Medical Service Requirements
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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 Fl. Admin. Code R. 64E-5.621, 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 Fl. Admin. Code R. 64E-5.622
(11) A licensee authorized to use mobile remote afterloaders for medical use shall follow the requirements specified in Fl. Admin. Code R. 64E-5.6423
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. History-New 8-25-91, Formerly 10D-91.716, Amended 2-11-10.
(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 Fl. Admin. Code R. 64E-5.621, 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 Fl. Admin. Code R. 64E-5.622
(11) A licensee authorized to use mobile remote afterloaders for medical use shall follow the requirements specified in Fl. Admin. Code R. 64E-5.6423
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. History-New 8-25-91, Formerly 10D-91.716, Amended 2-11-10.