Definitions

As used in 105 CMR 120.500, the following definitions apply: Address of Use means the building or buildings that are identified on the license and where radioactive material may be produced, prepared, received, used, or stored. Area of Use means a portion of a physical structure that has been set aside for the purpose of producing, preparing, receiving, using, or storing radioactive material. Associate Radiation Safety Officer means an individual who: (1) Meets the requirements in 105 CMR 120.524 and 105 CMR 120.529; and (2) Is currently identified as an Associate Radiation Safety Officer for the types of use of byproduct material for which the individual has been assigned duties and tasks by the Radiation Safety Officer on: (a) A specific medical use license issued by the Agency, Nuclear Regulatory Commission or an Agreement State; or (b) A medical use permit issued by a Nuclear Regulatory Commission master material licensee. Authorized Medical Physicist means an individual who: (1) Meets the requirements in 105 CMR 120.525(A) and 120.529; or (2) Is identified as a medical physicist or teletherapy physicist on: (a) A specific medical use license or equivalent permit issued by the Agency, Nuclear Regulatory Commission or Agreement State; (b) A permit issued by the Agency, Nuclear Regulatory Commission or Agreement State medical use license of broad scope that is authorized to permit the use of radioactive material; (c) A medical use permit issued by a NRC master material licensee; or (d) A permit issued by a NRC master material license broad scope medical use permittee. Authorized Nuclear Pharmacist means a pharmacist as defined in 105 CMR 120 005 who: (1) Meets the requirements in 105 CMR 120.526(A) and 120.529; or (2) Is identified as an authorized nuclear pharmacist on: (a) A specific license issued by NRC or Agreement State that authorizes medical use or the practice of nuclear pharmacy; (b) A permit issued by a NRC master material licensee that authorizes medical use or the practice of nuclear pharmacy; (c) A permit issued by a NRC or Agreement State broad scope medical use licensee that authorizes medical use or the practice of nuclear pharmacy; or (d) A permit issued by a NRC master material license broad scope medical use permittee that authorizes medical use or the practice of nuclear pharmacy; or (3) Is identified as an authorized nuclear pharmacist by a commercial nuclear pharmacy that has been authorized to identify authorized nuclear pharmacists; or (4) Is designated as an authorized nuclear pharmacist in accordance with 105 CMR 120.128(J)(2)(d). Authorized User means a physician, dentist, or podiatrist who: (1) Meets the requirements in 105 CMR 120.529 and 120.546(A), 120.551(A), 120.556(A), 120.557(A), 120.558(A), 120.566(A), 120.569(A), or 120.587(A); or (2) Identified as an authorized user on: (a) A NRC or Agreement State license that authorizes the medical use of byproduct material; (b) A permit issued by a NRC master material licensee that is authorized to permit the medical use of byproduct material; (c) A permit issued by a NRC or Agreement State specific licensee of broad scope that is authorized to permit the medical use of byproduct material; or (d) A permit issued by a NRC master material license broad scope permittee that is authorized to permit the medical use of byproduct material. Brachytherapy means a method of radiation therapy in which sources are utilized to deliver a radiation dose at a distance of up to a few centimeters, by surface, intracavitary, intraluminal or interstitial application. Brachytherapy Source means a radioactive source or a manufacturer-assembled source train or a combination of these sources that is designed to deliver a therapeutic dose within a distance of a few centimeters. Client’s Address means the address of use or a temporary jobsite for the purpose of providing mobile medical service in accordance with 105 CMR 120.541. Dedicated Check Source means a radioactive source that is used to assure the constant operation of a radiation detection or measurement device over several months or years. This source may also be used for other purposes. Dentist means an individual licensed by the Commonwealth to practice dentistry. Diagnostic Clinical Procedures Manual means a collection of written procedures that describes each method (and other instructions and precautions) by which the licensee performs diagnostic clinical procedures; where each diagnostic clinical procedure has been approved by the authorized user and includes the radiopharmaceutical, dosage, and route of administration. High Dose-rate Remote Afterloader (HDR) means a device that remotely delivers a dose rate in excess of 12 gray (1200 rads) per hour at the treatment site. Low Dose-rate Remote Afterloader (LDR) means a device that remotely delivers a dose rate of less than or equal to two gray (200 rads) per hour at the treatment site. Management means the chief executive officer or other individual having the authority to manage, direct, or administer the licensee’s activities, or those persons’ delegate or delegates. Manual Brachytherapy means a type of therapy in which brachytherapy sources are manually applied or inserted. Medical Institution means an organization in which several medical disciplines are practiced. Medical Use means the intentional internal or external administration of radioactive material, or the radiation from radioactive material to patients or human research subjects under the supervision of an authorized user. Medium Dose-rate Remote Afterloader (MDR) means a device that remotely delivers a dose rate of greater than two gray (200 rads), but less than, or equal to, 12 gray (1200 rads) per hour at the treatment site. Mobile Medical Service means the transportation of radioactive material and its medical use at the client’s address. Ophthalmic Physicist means an individual who: (1) Meets the requirements in 105 CMR 120.564A(A)(2) and 105 CMR 120.529; and (2) Is identified as an ophthalmic physicist on a: (a) Specific medical use license issued by the Agency, Nuclear Regulatory Commission or an Agreement State; (b) Permit issued by the Agency, Nuclear Regulatory Commission or Agreement State broad scope medical use licensee; (c) Medical use permit issued by a Nuclear Regulatory Commission master material licensee; or (d) Permit issued by a Nuclear Regulatory Commission master material licensee broad scope medical use permittee. Output means the Exposure rate, dose rate, or a quantity related in a known manner to these rates from a brachytherapy source or a teletherapy, remote afterloader, or gamma stereotactic radio- surgery unit for a specified set of exposure conditions. Patient Intervention means actions by the patient or human research subject, whether intentional or unintentional, such as dislodging or removing treatment devices or prematurely terminating the administration. Preceptor means an individual who provides, directs, or verifies the training and experience required for an individual to become an authorized user, an authorized medical physicist, an authorized nuclear pharmacist, a Radiation Safety Officer, or an Associate Radiation Safety Officer. Prescribed Dosage means the quantity of a radiopharmaceutical activity as documented: (1) In a written directive as specified in 105 CMR 120.521; or (2) In accordance with the directions of the authorized user for procedures performed pursuant to 105 CMR 120.544, 120.547 and 120.552. Prescribed Dose means: (1) For gamma stereotactic radiosurgery, the total dose as documented in the written directive; or (2) For teletherapy, the total dose and dose per fraction as documented in the written directive; or (3) For manual brachytherapy, either the total source strength and exposure time, or the total dose, as documented in the written directive; or (4) For remote brachytherapy afterloaders, the total dose and dose per fraction as documented in the written directive. Pulsed Dose-rate Remote Afterloader (PDR) means a special type of remote afterloading device that uses a single source capable of delivering dose rates in the “high dose-rate” range, but: (1) Is approximately one-tenth of the activity of typical high dose-rate remote afterloader sources; and (2) Is used to simulate the radiobiology of a low dose rate treatment by inserting the source for a given fraction of each hour. Radiation Safety Officer means an individual who: (1) Meets the requirements in 105 CMR 120.524(A) or (C)(1) and 120.529; or (2) Is identified as a Radiation Safety Officer on: (a) A specific medical use license issued by NRC or Agreement State; or (b) A medical use permit issued by NRC master material license. Sealed Source means any radioactive material that is encased in a capsule designed to prevent leakage or escape of the radioactive material. Sealed Source and Device Registry means the national registry that contains all the registration certificates, generated by both Nuclear Regulatory Commission and the Agreement States, that summarize the radiation safety information for the sealed sources and devices and describe the licensing and use conditions approved for the product. Stereotactic Radiosurgery means the use of external radiation in conjunction with a stereotactic guidance device to precisely deliver a dose to a tissue volume. Structured Educational Program means an educational program designed to impart particular knowledge and practical education through interrelated studies and supervised training. Teletherapy as used in 105 CMR 120.500, means a method of radiation therapy in which collimated gamma rays are delivered at a distance from the patient or human research subject. Temporary Jobsite means a location where mobile medical services are conducted other than those location(s) of use authorized on the license. Therapeutic Dosage means a dosage of unsealed radioactive material that is intended to deliver a radiation dose to a patient or human research subject for palliative or curative treatment. Therapeutic Dose means a radiation dose delivered from a sealed source containing radioactive material to a patient or human research subject for palliative or curative treatment. Treatment Site means the anatomical description of the tissue intended to receive a radiation dose, as described in a written directive. Type of Use means use of radioactive material as specified under 105 CMR 120.544, 120.547, 120.552, 120.559, 120.569, 120.570 or 120.589. Unit Dosage means a dosage that: (1) Is obtained or prepared in accordance with 105 CMR 120.544, 120.547, 120.552; and (2) Is to be administered as a single dosage to a patient or human research subject without any further manipulation of the dosage after it is initially prepared. Visiting Authorized User means an authorized user who is not identified on the license of the licensee being visited. Written Directive means an authorized user’s written order for the administration of radioactive material or radiation from radioactive material to a specific patient or human research subject, as specified in 105 CMR 120.521.