10A NCAC 15 .0351         SPECIFIC LICENSES: MOBILE NUCLEAR MEDICINE SERVICES

(a)  Provided that mobile nuclear medicine services shall be limited to clients who do not have a specific radioactive material license for the same services, unless the client's specific license specifically authorizes the use of such mobile services, the agency will license a mobile nuclear medicine service for the following services:

(1)           uptake, dilution and excretion;

(2)           imaging and localization;

(3)           sealed sources for diagnosis; and

(4)           certain in vitro clinical or laboratory testing.

(b)  The mobile nuclear medicine service licensee shall:

(1)           obtain a letter signed by the management of each client for which services are rendered that authorizes the licensee to use radioactive material at the client's address of use;

(2)           retain the letter for two years after the last provision of service;

(3)           not order radioactive material to be delivered directly from the manufacturer or distributor to the client's address of use;

(4)           transport to each address of use only syringes or vials containing prepared radiopharmaceuticals or radiopharmaceuticals that are intended for reconstitution of radiopharmaceuticals kits;

(5)           bring into each address of use of all radioactive material to be used and before leaving, remove all unused radioactive material and all associated waste;

(6)           secure or keep under constant surveillance and immediate control all radioactive material when in transit or at an address of use;

(7)           check survey instruments, dose calibrators and all other transported equipment for proper function before medical use at each address of use;

(8)           carry a radiation detection survey meter in each vehicle that is being used to transport radioactive material and, before leaving a client address of use, survey all radiopharmaceutical areas of use with a radiation detection survey meter to ensure that all radiopharmaceuticals and all associated waste have been removed; and

(9)           retain a record of each survey required in Subparagraph (b)(8) of this Rule for two years, where such records shall include:

(A)          the date of the survey,

(B)          a plan of each area that was surveyed,

(C)          the measured dose rate at several points in each area of use expressed in millirem per hour,

(D)          the instrument used to make the survey; and

(E)           the initials of the individual who performed the survey.

History Note:        Filed as a Temporary Amendment Eff. August 20, 1994 for a period of 180 days or until the

permanent rule becomes effective, whichever is sooner;

Authority G.S. 104E‑7(a)(2); 104E‑10(b);

Eff. June 1, 1989;

Amended Eff. May 1, 1995;

Transferred and Recodified from 15A NCAC 11 .0351 Eff. February 1, 2015.