Section He-P 4035.03 - Definitions(a) "Address of use" means the building or buildings that are identified on the license and where byproduct material may be prepared, received, used, or stored.(b) "Area of use" means a portion of an address of use that has been set aside for the purpose of preparing, receiving, using, or storing byproduct material.(c) "Associate radiation safety officer" means an individual who:(1) Meets the requirements in He-P 4035.61 and He-P 4035.73; 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 DHHS/RHS, an agreement state, or the Nuclear Regulatory Commission; orb. A medical use permit issued by a Nuclear Regulatory Commission master material licensee.(d) "Authorized medical physicist" means an individual who:(1) Meets the requirements in He-P 4035.70 and He-P 4035.73; or(2) Is identified as an authorized medical physicist or teletherapy physicist on:a. A specific medical use license issued by DHHS/RHS, or an agreement state, or the Nuclear Regulatory Commission;b. A medical use permit issued by a Nuclear Regulatory Commission master material licensee;c. A permit issued by DHHS/RHS, or an agreement state, or the Nuclear Regulatory Commission broad scope medical use licensee; ord. A permit issued by a Nuclear Regulatory Commission master license broad scope medical use permittee.(e) "Authorized nuclear pharmacist" means a person who is a "licensed pharmacist" as defined in RSA 318:1, VII, and who: (1) Meets the requirements in He-P 4035.73, He-P 4035.74(a), and NH pharmacy board administrative rule Ph 405.03;(2) Is identified as an authorized nuclear pharmacist on:a. A specific license issued by DHHS/RHS, or an agreement state, or the Nuclear Regulatory Commission that authorizes medical use, or the practice of nuclear pharmacy;b. A permit issued by a Nuclear Regulatory Commission master material licensee that authorizes medical use or the practice of nuclear pharmacy;c. A permit issued by DHHS/RHS, or an agreement state, or the Nuclear Regulatory Commission broad scope medical use licensee that authorizes medical use or the practice of nuclear pharmacy; ord. A permit issued by a Nuclear Regulatory Commission 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 He-P 4032.05(b)(2), or by an equivalent agreement state regulation, or by the Nuclear Regulatory Commission pursuant to 10 CFR 32.72(b)(4).(f) "Authorized user" means a physician, dentist, or podiatrist who:(1) Meets the applicable requirements for an authorized user as listed in in He-P 4035.59, He-P 4035.63, He-P 4035.64, He-P 4035.65, He-P 4035.66, He-P 4035.68, or He-P 4035.69, and He-P 4035.73, or(2) Is identified as an authorized user on: a. A DHHS/RHS, or an agreement state, or Nuclear Regulatory Commission license that authorizes the medical use of byproduct material;b. A permit issued by a Nuclear Regulatory Commission master material licensee that is authorized to permit the medical use of byproduct material;c. A permit issued by DHHS/RHS, or an agreement state, or a Nuclear Regulatory Commission specific licensee of broad scope that is authorized to permit the medical use of byproduct material; ord. A permit issued by a Nuclear Regulatory Commission master material license broad scope permittee that is authorized to permit the medical use of byproduct material.(g) "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.(h) "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.(i) "Client's address" means the area of use or a temporary job site for the purpose of providing mobile medical service in accordance with He-P 4035.26.(j) "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.(k) "Dentist" means an individual licensed to practice dentistry in New Hampshire, another state or territory of the United States, the District of Columbia, or the Commonwealth of Puerto Rico.(l) "High dose-rate remote afterloader" (HDR) means a brachytherapy device that remotely delivers a dose rate in excess of 12 gray (1200 rads) per hour at the point or surface where the dose is prescribed.(m) "Low dose-rate remote afterloader" (LDR) means a brachytherapy device that remotely delivers a dose rate of less than or equal to 2 gray (200 rads) per hour at the point or surface where the dose is prescribed.(n) "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.(o) "Manual brachytherapy" means a type of brachytherapy in which the brachytherapy sources (e.g., seeds, ribbons) are manually placed topically on or inserted either into the body cavities that are in close proximity to a treatment site or implanted directly into the tissue volume.(p) "Medical event" means an event that meets the criteria in He-P 4035.14(a) or (b).(q) "Medical institution" means an organization in which more than one medical discipline is practiced.(r) "Medical use" means the intentional internal or external administration of byproduct material or the radiation from byproduct material to patients or human research subjects under the supervision of an authorized user.(s) "Medium dose-rate remote afterloader" (MDR) means a brachytherapy device that remotely delivers a dose rate of greater than 2 gray (200 rads) per hour, but less than or equal to 12 gray (1200 rads) per hour at the point or surface where the dose is prescribed.(t) "Mobile medical service" means the transportation of byproduct material to, and its medical use at, the client's address.(u) "Ophthalmic physicist" means an individual who: (1) Meets the requirements in He-P 4035.32(f)(2) and He-P 4035.73; and(2) Is identified as an ophthalmic physicist on a:a. Specific medical use license issued by DHHS/RHS, an agreement state, or the Nuclear Regulatory Commission;b. Permit issued by DHHS/RHS, an agreement state, or a Nuclear Regulatory Commission broad scope medical use licensee;c. Medical use permit issued by a Nuclear Regulatory Commission master material licensee; ord. Permit issued by a Nuclear Regulatory Commission master material licensee broad scope medical use permittee.(v) "Output" means the exposure rate, dose rate, or a quantity related in a known manner to these rates from a brachytherapy source, teletherapy unit, remote afterloader, or gamma stereotactic radiosurgery unit for a specified set of exposure conditions.(w) "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.(x) "Podiatrist" means an individual licensed to practice podiatry in New Hampshire, another state or territory of the United States, the District of Columbia, or the Commonwealth of Puerto Rico.(y) "Positron emission tomography (PET) radionuclide production facility" means a facility operating a cyclotron or accelerator for the purpose of producing PET radionuclides.(z) "Preceptor" means an individual who provides, directs, or verifies 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.(aa) "Prescribed dosage" means the specific activity or range of activity of unsealed byproduct material as documented:(1) In a written directive; or(2) In accordance with the directions of the authorized user for procedures pursuant to He-P 4035.27 and He-P 4035.31.(ab) "Prescribed dose" means: (1) For gamma stereotactic radiosurgery, the total dose as documented in the written directive;(2) For teletherapy, the total dose and dose per fraction as documented in the written directive;(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.(ac) "Pulsed dose-rate remote afterloader" means a special type of remote afterloading brachytherapy 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.(ad) "Radiation Safety Officer" means an individual who:(1) Meets the requirements in He-P 4035.61(a) or (c) and He-P 4035.73; or(2) Is identified as a radiation safety officer on a specific medical use license issued by DHHS/RHS, or an agreement state, or the Nuclear Regulatory Commission, or a medical use permit issued by a Nuclear Regulatory Commission master material licensee.(ae) "Stereotactic radiosurgery" means the use of external radiation in conjunction with a stereotactic guidance device to very precisely deliver a therapeutic dose to a tissue volume.(af) "Structured educational program" means an educational program designed to impart particular knowledge and practical education through interrelated studies and supervised training.(ag) "Teletherapy" means a method of radiation therapy in which collimated gamma rays are delivered at a distance from the patient or human research subject.(ah) "Temporary job site" means a location where mobile medical services are conducted other than those location(s) of use authorized on the license.(ai) "Therapeutic dosage" means a dosage of unsealed byproduct material that is intended to deliver a radiation dose to a patient or human research subject for palliative or curative treatment.(aj) "Therapeutic dose" means a radiation dose delivered from a source containing byproduct material to a patient or human research subject for palliative or curative treatment.(ak) "Treatment site" means the anatomical description of the tissue intended to receive a radiation dose, as described in a written directive.(al) "Unit dosage" means a dosage prepared for medical use for administration as a single dosage to a patient or human research subject without any further manipulation of the dosage after it is initially prepared.(am) "Written directive" means an authorized user's written order for the administration of byproduct material or radiation from byproduct material to a specific patient or human research subject, as specified in He-P 4035.13.N.H. Admin. Code § He-P 4035.03
(See Revision Note at part heading for He-P 4035) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07
New. #8959, eff 8-7-07
Amended by Volume XXXV, Number 32 Filed August 13, 2015, Proposed by #10897, Effective 7/22/2015, Expires1/18/2016.Amended by Volume XXXVI Number 01, Filed January 7, 2016, Proposed by #11011, Effective 1/15/2016, Expires 1/15/2026.Amended by Volume XL Number 24, Filed June 11, 2020, Proposed by #13048, Effective 6/2/2020, Expires 6/2/2030.Amended by Volume XLII Number 45, Filed November 10, 2022, Proposed by #13473, Effective 10/25/2022, Expires 10/25/2032