6 Colo. Code Regs. § 1007-1-7-A
Rules and regulations set forth herein are adopted pursuant to the provisions of sections 25-1-108, 25-1.5-101(1)(l), and 25-11-104, CRS.
A statement of basis and purpose accompanies this part and changes to this part. A copy may be obtained from the Department.
This part establishes requirements and provisions for the production, preparation, compounding and use of radionuclides in the healing arts and for issuance of licenses authorizing the medical use of this material. These requirements and provisions provide for the protection of the public health and radiation safety of workers, the general public, patients, and human research subjects. The requirements and provisions of this part are in addition to, and not in substitution for, others in these regulations.
The requirements and provisions of these regulations apply to applicants and licensees subject to this part unless specifically exempted.
U.S. Department of Health & Human Services
200 Independence Avenue, S.W.
Washington, D.C.20201
Phone: 1-877-696 -6775.
U.S. Nuclear Regulatory Commission
Washington, DC 20555-0001
Phone: 1-800-368 -5642.
As used in this part, these terms have the definitions set forth as follows:
"Address of use" means the building(s) identified on the license where radioactive material may be produced, prepared, received, used or stored.
"Area of use" means a portion of an address of use that has been set aside for the purpose of producing, preparing, receiving, using, or storing radioactive material.
"Associate Radiation Safety Officer" means, for the purposes of Part 7, an individual who:
"Authorized medical physicist" (AMP) means an individual who meets the requirements of Appendix 7B; or
"Authorized nuclear pharmacist" (ANP) means a pharmacist who meets the requirements of Appendix 7C; or
"Authorized user" (AU) means a physician, dentist, or podiatrist who meets the applicable requirements of Appendix 7D through Appendix 7M; or
"Brachytherapy" means a method of radiation therapy in which plated, embedded, activated, or sealed 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" means, for mobile medical service, the person for whom, or in conjunction with whom, medical service is provided.
"Client's address" means the address of use for the purpose of providing mobile medical service in accordance with 7.27.
"Dedicated check source" means a radioactive source that is used to assure the consistent response of a radiation detection or measurement device over several months or years.
"Dentist" means an individual licensed by a State or Territory of the United States, the District of Columbia or the Commonwealth of Puerto Rico 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, or in the case of sealed sources for diagnosis, the procedure.
"HDR", see high dose-rate remote afterloader.
"High dose-rate remote afterloader" (HDR) means a device that remotely delivers a dose rate in excess of 12 gray (1200 rad) per hour at the treatment site.
"LDR", see low dose-rate remote afterloader.
"Low dose-rate remote afterloader" (LDR) means a device that remotely delivers a dose rate of less than or equal to 2 gray (200 rad) per hour at the treatment site (at the specified distance).
"Management" means the chief executive officer, or other individual having the authority to manage, direct, or administer the licensee's activities, or such person's' delegate(s).
"Manual brachytherapy" means a type of therapy in which brachytherapy sources are manually applied or inserted.
"MDR", see medium dose-rate remote afterloader".
"Medical institution" means an organization in which two or more medical disciplines are practiced.
"Medical event" means an event that meets the criteria in 7.21.1 or 7.21.2.
"Medical use" means, for the purposes of Part 7, 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 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.
"Mobile medical service" means the transportation of radioactive material to, or its medical use at, the client's address and/or a temporary job site.
"Nuclear medicine technologist" (NMT) means an individual who meets the requirements of Appendix 7N and who under the supervision of an authorized user prepares or administers radioactive drugs to patients or human research subjects, or performs in vivo or in vitro measurements for medical purposes.
"Nuclear medicine technology" means the science and art of in vivo and in vitro detection and measurement of radioactivity and the administration of radioactive drugs to patients or human research subjects for diagnostic and therapeutic purposes.
"Ophthalmic physicist" means an individual who:
"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 radiosurgery 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.
"PDR", see pulsed dose-rate remote afterloader.
"Pharmacist" means an individual licensed by a State or Territory of the United States, the District of Columbia or the Commonwealth of Puerto Rico to practice pharmacy. (See also Authorized nuclear pharmacist)
"Physician" means an individual licensed by a State or Territory of the United States, the District of Columbia or the Commonwealth of Puerto Rico to prescribe drugs in the practice of medicine.
"Podiatrist" means an individual licensed by a State or Territory of the United States, the District of Columbia or the Commonwealth of Puerto Rico to practice podiatry.
"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, an Associate Radiation Safety Officer (see appendices 7A through 7M, and 7P).
"Prescribed dosage" means the specified activity or range of activity of a radioactive drug as documented in:
"Prescribed dose" means:
"Pulsed dose-rate remote afterloader" (PDR) means a special type of remote afterloading device that uses a single source capable of delivering dose rates (at the specified distance) in the "high dose-rate" range, but:
"Radiation safety officer" (RSO) means, for the purposes of Part 7, an individual who has demonstrated sufficient knowledge to apply radiation protection regulations appropriately, who in accord with 7.7 has been assigned such responsibility by the licensee, and who meets the requirements in Appendix 7A; or
"Radioactive drug" means any chemical compound containing radioactive material that may be used on or administered to patients or human research subjects as an aid in the diagnosis, treatment, or prevention of disease or other abnormal condition.
"Sealed source" means radioactive material that is permanently bonded or fixed in a capsule or matrix designed to prevent release and dispersal of the radioactive material under the most severe conditions which are likely to be encountered in normal use and handling.
"Sealed Source and Device Registry" means the national registry that contains all the registration certificates, generated by both the 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 treatment site.
"Structured educational program" means an accredited educational program designed to impart particular knowledge and practical education through interrelated studies and supervised training.
"Teletherapy", as used in this part, means a method of radiation therapy in which collimated gamma rays are delivered at a distance from the patient or human research subject.
"Temporary job site", as used in Part 7, means a location where mobile medical services are confined to the mobile unit not at a licensed address of use.
"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.
"Trunnion" means a support bar sometimes used as a bearing instead of a socket.
"Type of use" means use of radioactive material as specified under 7.30, 7.32, 7.36, 7.40, 7.42, 7.48 or 7.62.
"Unit dosage" means a dosage that:
"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 7.11.
GENERAL REGULATORY REQUIREMENTS
A licensee may conduct research involving human subjects using radioactive material under the following conditions:
A licensee shall apply for and must receive a license amendment:
Each record required by this part must be legible throughout the retention period specified by each Department regulation. The record may be the original, a reproduced copy, or a microform provided that the copy or microform is authenticated by authorized personnel and the microform is capable of producing a clear copy throughout the required retention period. The record may also be stored in electronic media with the capability for producing legible, accurate, and complete records during the required retention period. Records such as letters, drawings, and specifications must include all pertinent information such as stamps, initials, and signatures. The licensee shall maintain adequate safeguards against tampering with and loss of records.
6 CCR 1007-1-7-A