PART 7: USE OF RADIONUCLIDES IN THE HEALING ARTS USE OF RADIONUCLIDES IN THE HEALING ARTS 7.1 Purpose and Scope.

7.1.1 Authority [Eff 11/30/2006] 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. [Eff 11/30/2006] 7.1.2 Basis and Purpose. [Eff 11/30/2006] A statement of basis and purpose accompanies this part and changes to this part. A copy may be obtained from the Department. [Eff 11/30/2006] 7.1.3 Scope. [Eff 11/30/2006] 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. [Eff 11/30/2006] 7.1.4 Applicability. [Eff 11/30/2006] The requirements and provisions of these regulations apply to applicants and licensees subject to this part unless specifically exempted. [Eff 11/30/2006] 7.1.5 Published Material Incorporated by Reference. [Eff 11/30/2006] Published material incorporated in Part 7 by reference is available in accord with 1.4. [Eff 11/30/2006] 7.2 Definitions.

As used in this part, these terms have the definitions set forth as follows: [Eff 11/30/2006] "Accredited institution" means a teaching facility for nuclear medicine technology or radiation therapy technology whose standards are accepted by the United States Department of Education. [Eff 11/30/2006] “Address of use” means the building(s) identified on the license where radioactive material may be produced, prepared, received, used or stored. [Eff 11/30/2006] “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. [Eff 11/30/2006] "Authorized medical physicist" (AMP) means an individual who meets the requirements of Appendix 7B. [Eff 11/30/2006] "Authorized nuclear pharmacist" (ANP) means a pharmacist who meets the requirements of Appendix 7C. [Eff 11/30/2006] "Authorized user" (AU) means a physician, dentist, or podiatrist who meets the training and experience requirements for a use of radioactive material specified in the applicable appendix of Appendix 7D through Appendix 7M. [Eff 11/30/2006] “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. [Eff 11/30/2006] "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. [Eff 11/30/2006] “Client” means, for mobile medical service, the person for whom, or in conjunction with whom, medical service is provided. [Eff 11/30/2006] "Client's address" means the address of use for the purpose of providing mobile medical service in accordance with 7.27. [Eff 11/30/2006] “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. [Eff 11/30/2006] "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. [Eff 11/30/2006] "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. [Eff 11/30/2006] “HDR", see high dose-rate remote afterloader. [Eff 11/30/2006] "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. [Eff 11/30/2006] “LDR", see low dose-rate remote afterloader. [Eff 11/30/2006] "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). [Eff 11/30/2006] “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). [Eff 11/30/2006] "Manual brachytherapy" means a type of therapy in which brachytherapy sources are manually applied or inserted. [Eff 11/30/2006] “MDR", see medium dose-rate remote afterloader". [Eff 11/30/2006] “Medical institution” means an organization in which two or more medical disciplines are practiced. [Eff 11/30/2006] "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. [Eff 11/30/2006] "Medium dose-rate remote afterloader" (MDR) means a device that remotely delivers a dose rate of greater than 2 gray (200 rad), but less than, or equal to, 12 gray (1200 rad) per hour at the treatment site (at the specified distance). [Eff 11/30/2006] “Misadministration” means an event that meets the criteria in 7.21. [Eff 11/30/2006] “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. [Eff 11/30/2006] "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. [Eff 11/30/2006] "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. [Eff 11/30/2006] “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. [Eff 11/30/2006] "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. [Eff 11/30/2006] “PDR", see pulsed dose-rate remote afterloader. [Eff 11/30/2006] "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) [Eff 11/30/2006] "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. [Eff 11/30/2006] "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. [Eff 11/30/2006] "Preceptor" means an individual who provides, directs or verifies training and experience required for an individual to become an a radiation safety officer, an authorized user, an authorized medical physicist, an authorized nuclear pharmacist, a nuclear medicine technologist, or a radiation therapy technologist (see appendices 7A through 7O). [Eff 11/30/2006] "Prescribed dosage" means the specified activity or range of activity of a radioactive drug as documented in: [Eff 11/30/2006] (1) A written directive as specified in 7.11; or [Eff 11/30/2006] (2) Accordance with the directions of the authorized user for procedures performed pursuant to 7.30, 7.32, or 7.36. [Eff 11/30/2006] "Prescribed dose" means: [Eff 11/30/2006] (1) For gamma stereotactic radiosurgery, the total dose as documented in the written directive; [Eff 11/30/2006] (2) For teletherapy, the total dose and dose per fraction as documented in the written directive; [Eff 11/30/2006] (3) For manual brachytherapy, either the total source strength and exposure time or the total dose, as documented in the written directive; or [Eff 11/30/2006] (4) For remote brachytherapy afterloaders, the total dose and dose per fraction as documented in the written directive. [Eff 11/30/2006] "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: [Eff 11/30/2006] (1) Is approximately one-tenth of the activity of typical high dose-rate remote afterloader sources; and [Eff 11/30/2006] (2) Is used to simulate the radiobiology of a low dose rate treatment by inserting the source for a given fraction of each hour. [Eff 11/30/2006] "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. [Eff 11/30/2006] "Radiation therapy technologist" (RTT) means an individual who meets the requirements of Appendix 7O and is under the supervision of an authorized user to perform procedures and apply radiation emitted from sealed radioactive sources to human beings for therapeutic purposes. [Eff 11/30/2006] "Radiation therapy technology" means the science and art of applying radiation emitted from sealed radioactive sources to patients or human research subjects for therapeutic purposes. [Eff 11/30/2006] "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. [Eff 11/30/2006] "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. [Eff 11/30/2006] "Sealed Source and Device Registry" means the national registry that contains the registration certificates maintained by the Nuclear Regulatory Commission, that summarize the radiation safety information for the sealed sources and devices and describe the licensing and use conditions approved for the product. [Eff 11/30/2006] "Stereotactic radiosurgery" means the use of external radiation in conjunction with a stereotactic guidance device to precisely deliver a dose to a treatment site. [Eff 11/30/2006] "Structured educational program" means an accredited educational program designed to impart particular knowledge and practical education through interrelated studies and supervised training. [Eff 11/30/2006] "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. [Eff 11/30/2006] "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. [Eff 11/30/2006] "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. [Eff 11/30/2006] "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. [Eff 11/30/2006] "Treatment site" means the anatomical description of the tissue intended to receive a radiation dose, as described in a written directive. [Eff 11/30/2006] “Trunnion” means a support bar sometimes used as a bearing instead of a socket. [Eff 11/30/2006] "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. [Eff 11/30/2006] "Unit dosage" means a dosage that: [Eff 11/30/2006] (1) Is obtained or prepared in accordance with the regulations for uses described in 7.30, 7.32, or 7.36; and [Eff 11/30/2006] (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. [Eff 11/30/2006] "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. [Eff 11/30/2006] GENERAL REGULATORY REQUIREMENTS 7.3 License Required.

7.3.1 A person shall manufacture, produce, prepare, acquire, receive, possess, use, or transfer radioactive material for medical use only in accordance with a specific license issued by the Department, an Agreement State or NRC, or as allowed in 7.3.2 or 7.3.3. [Eff 11/30/2006] 7.3.1.1 Unless prohibited by license condition, an individual may receive, possess, use, or transfer radioactive material in accordance with the regulations in this part under the supervision of an authorized user as provided in 7.10. [Eff 11/30/2006] 7.3.1.2 Unless prohibited by license condition, an individual may prepare unsealed radioactive material for medical use in accordance with the regulations in this part under the supervision of an authorized nuclear pharmacist or authorized user as provided in 7.10. [Eff 11/30/2006] 7.3.2 Provisions for Research Involving Human Subjects. [Eff 11/30/2006] A licensee may conduct research involving human subjects using radioactive material provided that: [Eff 11/30/2006] 7.3.2.1 The research is conducted, funded, supported, or regulated by a federal agency which has implemented federal policy for the protection of human subjects; [Eff 11/30/2006] 7.3.2.2 A licensee not authorized pursuant to 3.11 shall apply for and receive approval of a specific amendment to its Department license before conducting such research; [Eff 11/30/2006] 7.3.2.3 At a minimum, the licensee shall obtain prior informed consent from the human subjects and obtain prior review and approval of the research activities by an "Institutional Review Board" in accordance with the meaning of these terms as defined and described in federal policy for the protection of human subjects; [Eff 11/30/2006] 7.3.2.4 The research involving human subjects authorized in 7.3.2.1 shall be conducted using radioactive material authorized for medical use in the license; and [Eff 11/30/2006] 7.3.2.5 Nothing in 7.3.2 relieves licensees from complying with the other requirements in Part 7. [Eff 11/30/2006] 7.3.3 Nothing in this part relieves the licensee from complying with applicable FDA, other federal, and state requirements governing radioactive drugs or devices. [Eff 11/30/2006] 7.3.4 Application for License, Amendment, or Renewal. [Eff 11/30/2006] 7.3.4.1 An application shall be signed by the applicant's or licensee's management. [Eff 11/30/2006] 7.3.4.2 An application for a license for medical use of radioactive material as described in 7.30, 7.32, 7.36, 7.40, 7.42, 7.48 or 7.62 must be made by: [Eff 11/30/2006] (1) Filing an original and one copy of Department Form R-12, and [Eff 11/30/2006] (2) Submitting procedures required by 7.12, 7.15, 7.51, 7.58, 7.59, and 7.61, as applicable. [Eff 11/30/2006] 7.3.4.3 A request for a license amendment or renewal must be made by: [Eff 11/30/2006] (1) Submitting an original and one copy in letter format. [Eff 11/30/2006] (2) Submitting procedures required by 7.12, 7.15, 7.51, 7.58, 7.59, and 7.61, as applicable. [Eff 11/30/2006] 7.3.4.4 In addition to the requirements in 7.3.4.2 and 7.3.4.3, an application for a license or amendment for medical use of radioactive material as described in 7.62 must also include information regarding any radiation safety aspects of the medical use of the material that is not addressed in 7.1 through 7.29, as well as any specific information on: [Eff 11/30/2006] (1) Radiation safety precautions and instructions; [Eff 11/30/2006] (2) Training and experience of proposed users; [Eff 11/30/2006] (3) Methodology for measurement of dosages or doses to be administered to patients or human research subjects; and [Eff 11/30/2006] (4) Calibration, maintenance, and repair of instruments and equipment necessary for radiation safety. [Eff 11/30/2006] 7.3.4.5 The applicant or licensee shall also provide any other information requested by the Department in its review of the application. [Eff 11/30/2006] 7.3.4.6 An applicant that satisfies the requirements specified in 3.11 may apply for a Type A specific license of broad scope. [Eff 11/30/2006] 7.3.5 Mobile Medical Service Administrative Requirements. [Eff 11/30/2006] 7.3.5.1 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. [Eff 11/30/2006] 7.3.5.2 Mobile medical service licensees shall obtain a letter signed by the management of each location where services are rendered that authorizes use of radioactive material at the client's address of use. This letter shall clearly delineate the authority and responsibility of both the client and the mobile medical service. If the client is licensed, the letter shall document procedures for notification, receipt, storage and documentation of transfer of radioactive material delivered to the client's address for use by the mobile medical service. [Eff 11/30/2006] 7.3.5.3 A mobile medical service shall not have radioactive material delivered directly from the manufacturer or the distributor to the client, unless the client has a license allowing possession of the radioactive material. Radioactive material delivered to the client shall be received and handled in conformance with the client's license. [Eff 11/30/2006] 7.3.5.4 A mobile medical service shall inform the client's management who is on site at each client's address of use at the time that radioactive material is being administered. [Eff 11/30/2006] 7.3.5.5 A licensee providing mobile medical services shall retain the letter required in 7.3.5.2 for 3 years after the last provision of service. [Eff 11/30/2006] 7.3.5.6 A mobile medical service licensee shall, at a minimum, maintain the following documents on each mobile unit: [Eff 11/30/2006] (1) The current operating and emergency procedures; [Eff 11/30/2006] (2) A copy of the license; [Eff 11/30/2006] (3) Copies of the letter required by 7.3.5.2; [Eff 11/30/2006] (4) Current calibration records for each survey instrument and diagnostic equipment or dose delivery device in use; and [Eff 11/30/2006] (5) Survey records covering uses associated with the mobile unit during, at a minimum, the preceding 30 calendar days. [Eff 11/30/2006] 7.3.5.7 The mobile medical service shall designate and manage each area of use in the client’s facility as a restricted area while radioactive material is present. For each location where radioactive materials will be routinely used, the licensee shall provide to the Department: [Eff 11/30/2006] (1) A diagram of the location of use, including information about the placement of required postings; and [Eff 11/30/2006] (2) Calculation(s) or survey(s) results that demonstrate compliance with applicable dose limits in 4.14 and 4.15 at the location of use. [Eff 11/30/2006] 7.3.5.8 The mobile medical service shall ensure that: [Eff 11/30/2006] (1) Supervision by an authorized user is in accordance with 7.10.1; [Eff 11/30/2006] (2) Radiation exposures to the client’s personnel working in the client facility are: [Eff 11/30/2006] (a) Below the dose limits to members of the public listed in 4.14; or [Eff 11/30/2006] (b) The client’s personnel are instructed as described in 10.3 and monitored for exposure in accordance with 4.18 unless the licensee can demonstrate that 4.18 does not apply. [Eff 11/30/2006] 7.3.5.9 A mobile medical service licensee shall maintain all records required by Parts 4 and 7 of these regulations at a location within the Department's jurisdiction that is: [Eff 11/30/2006] (1) A single address of use: [Eff 11/30/2006] (a) Identified as the records retention location; and [Eff 11/30/2006] (b) Staffed at all reasonable hours by individual(s) authorized to provide the Department with access for purposes of inspection; or [Eff 11/30/2006] (2) When no address of use is identified on the license for records retention, the mobile unit: [Eff 11/30/2006] (a) Identified in the license; and [Eff 11/30/2006] (b) Whose current client's address of use and area of use schedule is reported to the Department. [Eff 11/30/2006] 7.3.6 A licensee possessing a Type A specific license of broad scope for medical use is exempt from: [Eff 11/30/2006] 7.3.6.1 The provisions of 7.3.4.4 regarding the need to file an amendment to the license for medical uses of radioactive material as described in 7.62; [Eff 11/30/2006] 7.3.6.2 The provisions of 7.4.2 regarding the need to file an amendment before permitting anyone to work as an authorized user, an authorized nuclear pharmacist or an authorized medical physicist under the license; [Eff 11/30/2006] 7.3.6.3 The provisions of 7.4.5 regarding additions to or changes in the areas of use at the addresses specified in the license; [Eff 11/30/2006] 7.3.6.4 The provisions of 7.5.1 regarding notification to the Department for new authorized users, new authorized nuclear pharmacists and new authorized medical physicists; [Eff 11/30/2006] 7.3.6.5 The provisions of 7.14 regarding suppliers for sealed sources. [Eff 11/30/2006] 7.3.7 The Department may, upon application of any interested person or upon its own initiative, grant such exemptions from the regulations in Part 7 as it determines are authorized by law and will not endanger life or property or the common defense and security and are otherwise in the public interest. [Eff 11/30/2006] 7.4 License Amendments.

A licensee shall apply for and shall have received a license amendment before the licensee: [Eff 11/30/2006] 7.4.1 Receives, prepares, or uses radioactive material for a type of use that is permitted under this part but that is not authorized on the licensee’s current license issued pursuant to this part; [Eff 11/30/2006] 7.4.2 Permits anyone to work as an authorized user, authorized medical physicist, or an authorized nuclear pharmacist under the license in accordance with the training and experience requirements specified in: [Eff 11/30/2006] 7.4.2.1 The applicable appendix of Appendix 7D through Appendix 7M for an authorized user for a type of use of radioactive material; [Eff 11/30/2006] 7.4.2.2 Appendix 7B for an authorized medical physicist; [Eff 11/30/2006] 7.4.2.3 Appendix 7C for an authorized nuclear pharmacist; and [Eff 11/30/2006] 7.4.3 Changes a Radiation Safety Officer, except as provided in 7.7.6; [Eff 11/30/2006] 7.4.4 Receives radioactive material in excess of the amount or in a different physical or chemical form than is authorized on the license; [Eff 11/30/2006] 7.4.5 Adds to or changes the area(s) of use or address(es) of use identified in the application or on the license, except as specified in 7.5.2.4; and [Eff 11/30/2006] 7.4.6 Changes statements, representations, and procedures which are incorporated into the license; or [Eff 11/30/2006] 7.4.7 Releases licensed facilities for unrestricted use. [Eff 11/30/2006] 7.5 Notifications; Maintenance of Records.

7.5.1 A licensee shall provide to the Department required documentation of adequate radiation safety training and experience under Appendix 7B for each authorized medical physicist pursuant to 7.4.2, under Appendix 7C for each authorized nuclear pharmacist, and under the applicable appendix of Appendix 7D through Appendix 7M for each individual authorized user. [Eff 11/30/2006] 7.5.2 A licensee shall notify the Department in writing within 30 days after: [Eff 11/30/2006] 7.5.2.1 An authorized user, authorized medical physicist, authorized nuclear pharmacist, or Radiation Safety Officer permanently discontinues performance of duties under the license or has a name change; [Eff 11/30/2006] 7.5.2.2 The licensee's mailing address changes; [Eff 11/30/2006] 7.5.2.3 The licensee's name changes, but the name change does not constitute a transfer of control of the license as described in 3.15.2 of these regulations; or [Eff 11/30/2006] 7.5.2.4 The licensee has added to or changed the areas where radioactive material is used in accordance with 7.30 and 7.32. [Eff 11/30/2006] 7.5.3 Maintenance of Records. [Eff 11/30/2006] 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. [Eff 11/30/2006] 7.6 License Issuance.

7.6.1 The Department shall issue a license for the medical use of radioactive material if: [Eff 11/30/2006] 7.6.1.1 The applicant has filed Department Form R-12 in accordance with the instructions in 7.3.4; [Eff 11/30/2006] 7.6.1.2 The applicant has paid any applicable fee; [Eff 11/30/2006] 7.6.1.3 The applicant meets the requirements of Part 3 of these regulations; and [Eff 11/30/2006] 7.6.1.4 The Department finds the applicant equipped and committed to observe the safety standards established by the Department in these regulations for the protection of the public health and safety. [Eff 11/30/2006] 7.6.2 The Department shall issue a license for mobile services if the applicant: [Eff 11/30/2006] 7.6.2.1 Meets the requirements in 7.6.1, and in particular 7.3.5; and [Eff 11/30/2006] 7.6.2.2 Assures that individuals to whom radioactive drugs or radiation from implants containing radioactive material will be administered may be released following treatment in accordance with 7.26. [Eff 11/30/2006] ADDITIONAL OVERALL REQUIREMENTS 7.7 Authority and Responsibilities for the Radiation Protection Program 7.7.1 In addition to the radiation protection program requirements of 4.5 of these regulations, a licensee's management must approve in writing: [Eff 11/30/2006] 7.7.1.1 Requests for license application, renewal, or amendments before submittal to the Department; [Eff 11/30/2006] 7.7.1.2 Any individual before allowing that individual to work as an authorized user, authorized nuclear pharmacist or authorized medical physicist; and [Eff 11/30/2006] 7.7.1.3 Radiation protection program changes that do not require a license amendment and are permitted under 7.7. [Eff 11/30/2006] 7.7.2 A licensee’s management shall appoint a Radiation Safety Officer (RSO), who agrees in writing to be responsible for implementing the radiation safety program. The licensee, through the RSO, shall ensure that radiation safety activities are being performed in accordance with approved procedures and regulatory requirements. [Eff 11/30/2006] 7.7.3 A licensee shall establish in writing the authority, duties, and responsibilities of the Radiation Safety Officer, and of the Alternate RSO, if required. [Eff 11/30/2006] 7.7.4 A licensee shall provide the Radiation Safety Officer sufficient authority, organizational freedom, time, resources, and management prerogative, to: [Eff 11/30/2006] 7.7.4.1 Identify radiation safety problems; [Eff 11/30/2006] 7.7.4.2 Initiate, recommend, or provide corrective actions; [Eff 11/30/2006] 7.7.4.3 Stop unsafe operations; and [Eff 11/30/2006] 7.7.4.4 Verify implementation of corrective actions. [Eff 11/30/2006] 7.7.5 A license shall retain a record of actions taken pursuant to 7.7.1, 7.7.2 and 7.7.3 for 5 years, including: [Eff 11/30/2006] 7.7.5.1 A summary of the actions taken (and a signature of licensee management) in accordance with 7.7.1; [Eff 11/30/2006] 7.7.5.2 A signed copy of the RSO’s agreement (including the signature of the RSO and licensee management) to be responsible for implementing the radiation safety program, as required by 7.7.2; and [Eff 11/30/2006] 7.7.5.3 A current copy of the authorities, duties and responsibilities of the RSO as required by 7.7.3. [Eff 11/30/2006] 7.7.6 For up to sixty days each year, a licensee may permit an authorized user or an individual qualified to be a radiation safety officer to function as a temporary Radiation Safety Officer and to perform the functions of a Radiation Safety Officer, as provided in 7.7.4, provided the licensee takes the actions required in 7.7.2, 7.7.3, 7.7.4 and 7.7.5. A licensee may simultaneously appoint more than one temporary RSO, if needed, to ensure that the licensee has a temporary RSO that satisfies the requirements to be an RSO for each of the different uses of radioactive material permitted by the license. [Eff 11/30/2006] 7.8 Radiation Safety Committee.

7.8.1 Licensees that are authorized for two or more different types of radioactive material use under 7.36, 7.42, 7.48, 7.62 or two or more types of units under 7.48 shall establish a Radiation Safety Committee to oversee all uses of radioactive material permitted by the license. [Eff 11/30/2006] 7.8. 2 The Committee shall: [Eff 11/30/2006] 7.8.2.1 Include: [Eff 11/30/2006] (1) An authorized user of each type of use permitted by the license; [Eff 11/30/2006] (2) The Radiation Safety Officer [Eff 11/30/2006] (3) A representative of the nursing service [Eff 11/30/2006] (4) A representative of management who is neither an authorized user nor a Radiation Safety Officer; and [Eff 11/30/2006] (5) Other members as the licensee deems appropriate. [Eff 11/30/2006] 7.8.2.2 Meet as necessary, but at a minimum shall meet at intervals not to exceed 6 months. [Eff 11/30/2006] 7.8.2.3 Maintain minutes of each meeting, including: [Eff 11/30/2006] (1) The date of the meeting; [Eff 11/30/2006] (2) Members present; [Eff 11/30/2006] (3) Members absent; and [Eff 11/30/2006] (4) Summary of deliberations and discussions. [Eff 11/30/2006] 7.9 Radiation Protection Program Changes.

7.9.1 A licensee may revise its radiation protection program without Department approval if: [Eff 11/30/2006] 7.9.1.1 The revision does not require an amendment under 7.4; [Eff 11/30/2006] 7.9.1.2 The revision is in compliance with the regulations and the license; [Eff 11/30/2006] 7.9.1.3 The revision has been reviewed and approved by the Radiation Safety Officer, licensee management and licensee's Radiation Safety Committee (if applicable); and [Eff 11/30/2006] 7.9.1.4 The affected individuals are instructed on the revised program before the changes are implemented. [Eff 11/30/2006] 7.9.2 A licensee shall retain a record of each change for 5 years, including [Eff 11/30/2006] 7.9.2.1 A copy of the old and new procedures; [Eff 11/30/2006] 7.9.2.2 The effective date of the change; and [Eff 11/30/2006] 7.9.2.2 The signature of the licensee management that reviewed and approved the change. [Eff 11/30/2006] 7.10 Supervision.

7.10.1 A licensee that permits the receipt, possession, use, or transfer of radioactive material by an individual under the supervision of an authorized user as allowed by 7.3.2 shall: [Eff 11/30/2006] 7.10.1.1 In addition to the requirements of 10.3 of these regulations, instruct the supervised individual in the licensee's written radiation protection procedures, written directive procedures, regulations of Part 7, and license conditions with respect to the use of radioactive material; and; [Eff 11/30/2006] 7.10.1.2 Require the supervised individual to follow the instructions of the supervising authorized user for medical uses of radioactive material, written radiation protection procedures, written directive procedures, regulations of Part 7, and license conditions with respect to the medical use of radioactive material. [Eff 11/30/2006] 7.10.2 A licensee that permits the preparation of radioactive material for medical use by an individual under the supervision of an authorized nuclear pharmacist or physician who is an authorized user, as allowed by 7.3.3, shall: [Eff 11/30/2006] 7.10.2.1 Instruct the supervised individual in the preparation of radioactive material for medical use, as appropriate to that individual's use of radioactive material; and [Eff 11/30/2006] 7.10.2.2 Require the supervised individual to follow the instructions of the supervising authorized user or authorized nuclear pharmacist regarding the preparation of radioactive material for medical use, the written radiation protection procedures, the regulations of Part 7, and license conditions. [Eff 11/30/2006] 7.10.3 Unless physical presence as described in other sections of Part 7 is required, a licensee who permits supervised activities under 7.10.1 and 7.10.2 shall require an authorized user to be immediately available (by telephone within ten minutes) to communicate with the supervised individual, and able to be physically present within one hour, unless otherwise authorized by the Department with prior written approval; and [Eff 11/30/2006] 7.10.4 A licensee who permits supervised activities under 7.10.1 and 7.10.2 is responsible for the acts and omissions of the supervising authorized user and supervised individual(s). [Eff 11/30/2006] 7.11 Written Directives.

7.11.1 A written directive must be dated and signed by an authorized user, including the signatory’s printed or typed name, prior to administration of: [Eff 11/30/2006] 7.11.1.1 I-131 sodium iodide greater than 1.11 MBq (30 µCi), or [Eff 11/30/2006] 7.11.1.2 Any therapeutic dosage of radioactive material, or [Eff 11/30/2006] 7.11.1.3 Any therapeutic dose of radiation from radioactive material. [Eff 11/30/2006] 7.11.2 The written directive must contain the patient or human research subject's name and the following: [Eff 11/30/2006] 7.11.2.1 For an administration of a dosage of radioactive drug containing radioactive material, the name of the radioactive drug containing radioactive material, dosage, and route of administration; [Eff 11/30/2006] 7.11.2.2 For gamma stereotactic radiosurgery, the total dose, treatment site, and number of target coordinate settings per treatment for each anatomically distinct treatment site; [Eff 11/30/2006] 7.11.2.3 For teletherapy, the total dose, dose per fraction, number of fractions, and treatment site; [Eff 11/30/2006] 7.11.2.4 For high dose rate remote afterloading brachytherapy, the radionuclide, treatment site, dose per fraction, number of fractions, and total dose; or [Eff 11/30/2006] 7.11.2.5 For all other brachytherapy including LDR, MDR, and PDR: [Eff 11/30/2006] (1) Prior to implantation: treatment site, the radionuclide, and dose; and [Eff 11/30/2006] (2) After implantation but prior to completion of the procedure: the radioisotope, treatment site, number of sources, and total source strength and exposure time (or the total dose). [Eff 11/30/2006] 7.11.3 If, because of the emergent nature of the patient's condition, a delay in order to provide a written directive would jeopardize the patient's health, an oral directive will be acceptable, provided that the information contained in the oral directive is documented as soon as possible in writing in the patient's record and a written directive is prepared within 48 hours of the oral directive. [Eff 11/30/2006] 7.11.4 A written revision to an existing written directive may be made provided that the revision is dated and signed by an authorized user prior to the administration of the dosage of radioactive drug containing radioactive material, the brachytherapy dose, the gamma stereotactic radiosurgery dose, the teletherapy dose, or the next fractional dose. [Eff 11/30/2006] 7.11.5 If, because of the patient's condition, a delay in order to provide a written revision to an existing written directive would jeopardize the patient's health, an oral revision to an existing written directive will be acceptable, provided that the oral revision is documented as soon as possible in the patient's record and a revised written directive is signed by the authorized user within 48 hours of the oral revision. [Eff 11/30/2006] 7.11.6 The licensee shall retain a copy of each written directive and/or written revision to an existing written directive for 3 years. [Eff 11/30/2006] 7.12 Procedures for Administrations Requiring a Written Directive. 7.12.1 For any administration requiring a written directive, the licensee shall develop, implement, and maintain written procedures to provide high confidence that: [Eff 11/30/2006] 7.12.1.1 The patient's or human research subject's identity is verified before each administration; and [Eff 11/30/2006] 7.12.1.2 Each administration is in accordance with the written directive. [Eff 11/30/2006] 7.12.2 The procedures required by 7.12.1 must, at a minimum, address the following items that are applicable for the licensee's use of radioactive material: [Eff 11/30/2006] 7.12.2.1 Verifying the identity of the patient or human research subject; [Eff 11/30/2006] 7.12.2.2 Verifying that the specific details of the administration are in accordance with the treatment plan, if applicable, and the written directive; [Eff 11/30/2006] 7.12.2.3 Checking both manual and computer-generated dose calculations; and [Eff 11/30/2006] 7.12.2.4 Verifying that any computer-generated dose calculations are correctly transferred into the consoles of therapeutic medical units authorized by 7.48 [Eff 11/30/2006] 7.13 Duties of Authorized User and Authorized Medical Physicist. 7.13.1 A licensee shall assure that only authorized users for the type of radioactive material used: [Eff 11/30/2006] 7.13.1.1 Prescribe the radiopharmaceutical dosage and/or dose to be administered through the issuance of a written directive or reference to the diagnostic clinical procedures manual; and [Eff 11/30/2006] 7.13.1.2 Direct, as specified in 7.10 and 7.12, or in license conditions, the administration of radioactive material for medical use to patients or human research subjects; [Eff 11/30/2006] 7.13.1.3 Prepare and administer, or supervise the preparation and administration of radioactive material for medical use, in accordance with 7.3.2, 7.3.3 and 7.10; [Eff 11/30/2006] 7.13.1.4 Perform the final interpretation of the results of tests, studies, or treatments. [Eff 11/30/2006] 7.13.2 A licensee shall assure that only authorized medical physicists perform, as applicable: [Eff 11/30/2006] 7.13.2.1 Full calibration measurements as described in 7.54, 7.55, and 7.56; [Eff 11/30/2006] 7.13.2.2 Periodic spot checks as described in 7.58, 7.59 and 7.61; and [Eff 11/30/2006] 7.13.2.3 Radiation surveys as described in 7.57. [Eff 11/30/2006] 7.14 Suppliers for Sealed Sources or Devices for Medical Use. For medical use, a licensee shall use only: [Eff 11/30/2006] 7.14.1 Sealed sources or devices initially manufactured, labeled, packaged, and distributed in accordance with a license issued pursuant to these regulation or the equivalent regulations of another Agreement State, a Licensing State or the NRC; and [Eff 11/30/2006] 7.14.2 Teletherapy sources manufactured and distributed in accordance with a license issued pursuant to these regulations, or the equivalent regulations of another Agreement State, a Licensing State, or the NRC. [Eff 11/30/2006] SPECIFIC REQUIREMENTS 7.15 Quality Control of Diagnostic Equipment.

Each licensee shall establish written quality control procedures for all diagnostic equipment used for radionuclide studies. As a minimum, quality control procedures and frequencies shall be those recommended by equipment manufacturers or procedures which have been approved by the Department. The licensee shall conduct quality control of diagnostic equipment in accordance with written procedures. [Eff 11/30/2006] 7.16 Possession, Use, and Testing of Instruments to Measure the Activity of Unsealed Radioactive Materials.

7.16.1 For direct measurements performed in accordance with 7.18, a licensee shall possess and use instrumentation to measure the activity of unsealed radioactive materials prior to administration to each patient or human research subject. [Eff 11/30/2006] 7.16.2 A licensee shall test the instrumentation required in 7.16.1 in accordance with nationally recognized standards or the manufacturer's instructions. [Eff 11/30/2006] 7.16.3 The tests required in 7.16.2 shall at a minimum include tests for constancy, linearity, accuracy and geometry dependence, as appropriate to demonstrate proper operation of the instrument. [Eff 11/30/2006] 7.16.4 A licensee shall retain a record of each instrument test required by 7.16 for 3 years. The record shall include the: [Eff 11/30/2006] 7.16.4.1 Model and serial number of the instrument; [Eff 11/30/2006] 7.16.4.2 Date of the calibration; [Eff 11/30/2006] 7.16.4.3 Results of the calibration; and [Eff 11/30/2006] 7.16.4.4 Name of the individual who performed the calibration. [Eff 11/30/2006] 7.17 Calibration of Survey Instruments.

7.17.1 A licensee shall ensure that the survey instruments used to show compliance with Part 4 and Part 7 have been calibrated before first use, annually, and following any repair that will affect the calibration. [Eff 11/30/2006] 7.17.2 To satisfy the requirements of 7.17.1 the licensee shall: [Eff 11/30/2006] 7.17.2.1 Calibrate all required scale readings up to 10 mSv (1 rem) per hour with a radiation source; [Eff 11/30/2006] 7.17.2.2 Have each radiation survey instrument calibrated as follows, or by acceptable equivalent methods: [Eff 11/30/2006] (1) At energies appropriate for use and at intervals not to exceed 12 months or after instrument servicing, except for battery changes; [Eff 11/30/2006] (2) For linear scale instruments, at 2 points located approximately one-third and two- thirds of full-scale on each scale; [Eff 11/30/2006] (3) For logarithmic scale instruments, at mid-range of each decade and at 2 points of at least one decade; [Eff 11/30/2006] (4) For digital instruments, at 3 points between 0.02 and 10 mSv (2 and 1000 mrem) per hour; and [Eff 11/30/2006] (5) For dose rate instruments, so that an accuracy within plus or minus 20 percent of the true radiation dose rate can be demonstrated at each point checked. [Eff 11/30/2006] 7.17.2.3 Conspicuously note on the instrument the date of calibration. [Eff 11/30/2006] 7.17.3 The licensee shall not use survey instruments if the difference between the indicated exposure rate and the calculated exposure rate is greater than 20 percent. [Eff 11/30/2006] 7.17.4 The licensee shall retain a record of each survey instrument calibration required by 7.17 for 3 years. The record shall include the: [Eff 11/30/2006] 7.17.4.1 Model and serial number of the instrument; [Eff 11/30/2006] 7.17.4.2 Date of the calibration; [Eff 11/30/2006] 7.17.4.3 Results of the calibration; and [Eff 11/30/2006] 7.17.4.4 Name of the individual who performed the calibration. [Eff 11/30/2006] 7.18 Determination of Dosages of Radioactive Material for Medical Use. 7.18.1 A licensee shall determine and record the activity of each dosage prior to medical use. [Eff 11/30/2006] 7.18.1.1 For photon-emitting radioactive material, this determination shall be within 30 minutes prior to medical use. [Eff 11/30/2006] 7.18.1.2 For all other radioactive material, this determination shall be within the period before medical use that is no greater than 10 percent of the physical half-life of the radioactive material. [Eff 11/30/2006] 7.18.2 For a unit dosage, the determination by 7.18.1 shall be made either by direct measurements or by a decay correction, based on the measurement made by a manufacturer or preparer licensed pursuant to Part 3 of these regulations or equivalent provisions of another Agreement State, a Licensing State or NRC. [Eff 11/30/2006] 7.18.3 For other than a unit dosage, the determination by 7.18.1 shall be made by direct measurement of radioactivity or by a combination of measurements of radioactivity and mathematical calculations or combination of volumetric measurements and mathematical calculations, based on the measurement made by a manufacturer or preparer licensed pursuant to Part 3 of these regulations or equivalent provisions of another Agreement State, a Licensing State or NRC. [Eff 11/30/2006] 7.18.4 Unless otherwise directed by the authorized user, a licensee shall not use a dosage if the dosage differs from the prescribed dosage by more than 20 percent. [Eff 11/30/2006] 7.18.5 A license shall retain a record of the each dosage determination required by 7.18.1 for 3 years. The record shall contain the: [Eff 11/30/2006] 7.18.5.1 Name of the radioactive drug; [Eff 11/30/2006] 7.18.5.2 Patient's or human research subject’s name, and identification number if one has been assigned; [Eff 11/30/2006] 7.18.3.3 Prescribed dosage; [Eff 11/30/2006] 7.18.3.4 Determined dosage; or a notation that the total activity is less than 1.1 MBq (30 µCi); [Eff 11/30/2006] 7.18.3.5 Date and time of the dosage determination; and [Eff 11/30/2006] 7.18.3.6 Name of the individual who determined the dosage. [Eff 11/30/2006] 7.19 Authorization for Calibration, Transmission and Reference Sources. Any person authorized by 7.3 for medical use of radioactive material may receive, possess, and use the following radioactive material for check, calibration and reference use: [Eff 11/30/2006] 7.19.1 Sealed sources manufactured and distributed by persons specifically licensed pursuant to Part 3 of these regulations or equivalent provisions of the another Agreement State, a Licensing State, or NRC, and that do not exceed 1.1 GBq (30 mCi) each; [Eff 11/30/2006] 7.19.2 Any radioactive material with a half-life not longer than 120 days or less in individual amounts not to exceed 0.55 GBq (15 mCi); [Eff 11/30/2006] 7.19.3 Any radioactive material with a half life greater than 120 days in individual amounts not to exceed the smaller of: [Eff 11/30/2006] 7.19.3.1 7.4 MBq (200 µCi); [Eff 11/30/2006] 7.19.3.2 1000 times the quantities in Appendix 3B; and [Eff 11/30/2006] 7.19.4 Technetium-99m in amounts as needed. [Eff 11/30/2006] 7.20 Requirements for Possession of Sealed Sources and Brachytherapy Sources. 7.20.1 A licensee in possession of any sealed source or brachytherapy source shall follow the radiation safety and handling instructions supplied by the manufacturer or equivalent instructions approved by the Department and shall maintain the instructions for the duration of source use in a legible form convenient to users. [Eff 11/30/2006] 7.20.2 A licensee in possession of a sealed source shall test the source for leakage: [Eff 11/30/2006] 7.20.2.1 In accordance with Part 4 of these regulations; and [Eff 11/30/2006] 7.20.2.2 At intervals not to exceed 6 months or at intervals approved by the Department, another Agreement State, a Licensing State or the NRC in the Sealed Source and Device Registry. [Eff 11/30/2006] 7.20.3 If the leak test reveals the presence of 0.005 microcurie (185 Bq) or more of removable contamination, the licensee shall: [Eff 11/30/2006] 7.20.3.1 Immediately withdraw the sealed source from use and store, dispose or cause it to be repaired in accordance with the requirements of these regulations; and [Eff 11/30/2006] 7.20.3.2 File a written report with the Department within 5 days of receiving the leak test result, including the model number and serial number, if assigned, of the leaking source, the radionuclide and its estimated activity, the date and results of the test, and the action taken. [Eff 11/30/2006] 7.20.4 A licensee in possession of a sealed source or brachytherapy source, except for a gamma stereotactic radiosurgery source, shall conduct a semi-annual physical inventory of all such sources. The licensee shall retain each inventory record for 3 years. The inventory records shall contain the model number of each source, and serial number if one has been assigned, the identity of each source radionuclide and its estimated activity, the location of each source, and the name of the individual who performed the inventory. [Eff 11/30/2006] 7.21 Reports and Notifications of Misadministrations.

7.21.1 Other than events that result from intervention by a patient or human research subject, a licensee shall report any event in which the administration of radioactive material or radiation from radioactive material results in: [Eff 11/30/2006] 7.21.1.1 A dose that differs from the prescribed dose by more than 0.05 Sv (5 rem) effective dose equivalent, 0.5 Sv (50 rem) to an organ or tissue, or 0.5 Sv (50 rem) shallow dose equivalent to the skin; and either [Eff 11/30/2006] (1) The total dose delivered differs from the prescribed dose by 20 percent or more; [Eff 11/30/2006] (2) The total dosage delivered differs from the prescribed dosage by 20 percent or more or falls outside the prescribed dosage range; or [Eff 11/30/2006] (3) The fractionated dose delivered differs from the prescribed dose, for a single fraction, by 50 percent or more. [Eff 11/30/2006] 7.21.1.2 A dose that exceeds 0.05 Sv (5 rem) effective dose equivalent, 0.5 Sv (50 rem) to an organ or tissue, or 0.5 Sv (50 rem) shallow dose equivalent to the skin from any of the following: [Eff 11/30/2006] (1) An administration of a wrong radioactive drug; [Eff 11/30/2006] (2) An administration of a radioactive drug containing radioactive material by the wrong route of administration; [Eff 11/30/2006] (3) An administration of a dose or dosage to the wrong individual or human research subject; [Eff 11/30/2006] (4) An administration of a dose or dosage delivered by the wrong mode of treatment; or [Eff 11/30/2006] (5) A leaking sealed source. [Eff 11/30/2006] 7.21.1.3 A dose to the skin or an organ or tissue other than the treatment site that exceeds by 0.5 Sievert (50 rem) to an organ or tissue and 50 percent of the dose expected from the administration defined in the written directive (excluding, for permanent implants, seeds that were implanted in the correct site but migrated outside the treatment site). [Eff 11/30/2006] 7.21.2 A licensee shall report any event resulting from intervention of a patient or human research subject in which the administration of radioactive material or radiation from radioactive material results, or will result in, unintended permanent functional damage to an organ or a physiological system, as determined by a physician. [Eff 11/30/2006] 7.21.3 The licensee shall notify the Agency by telephone no later than the next calendar day after discovery of the misadministration. [Eff 11/30/2006] 7.21.4 The licensee shall submit a written report to the Agency within 15 days after discovery of the misadministration. [Eff 11/30/2006] 7.21.4.1 The written report must include: [Eff 11/30/2006] (1) The licensee's name; [Eff 11/30/2006] (2) The name of the prescribing physician; [Eff 11/30/2006] (3) A brief description of the event; [Eff 11/30/2006] (4) Why the event occurred; [Eff 11/30/2006] (5) The effect, if any, on the individual(s) who received the administration; [Eff 11/30/2006] (6) Actions, if any, that have been taken, or are planned, to prevent recurrence; [Eff 11/30/2006] (7) Certification that the licensee notified the individual (or the individual's responsible relative or guardian), and if not, why not. [Eff 11/30/2006] 7.21.4.2 The report may not contain the individual's name or any other information that could lead to identification of the individual. [Eff 11/30/2006] 7.21.5 The licensee shall provide notification of the misadministration to the referring physician and also notify the individual who is the subject of the misadministration no later than 24 hours after its discovery, unless the referring physician personally informs the licensee either that he or she will inform the individual or that, based on medical judgment, telling the individual would be harmful. The licensee is not required to notify the individual without first consulting the referring physician. If the referring physician or the affected individual cannot be reached within 24 hours, the licensee shall notify the individual as soon as possible thereafter. The licensee may not delay any appropriate medical care for the individual, including any necessary remedial care as a result of the misadministration, because of any delay in notification. To meet the requirements of this paragraph, the notification of the individual who is the subject of the misadministration may be made instead to that individual's responsible relative or guardian. If a verbal notification is made, the licensee shall inform the individual, or appropriate responsible relative or guardian, that a written description of the event can be obtained from the licensee upon request. The licensee shall provide such a written description if requested. [Eff 11/30/2006] 7.21.6 Aside from the notification requirement, nothing in this section affects any rights or duties of licensees and physicians in relation to each other, to individuals affected by the misadministration, or to that individual's responsible relatives or guardians. [Eff 11/30/2006] 7.21.7 A licensee shall retain a record of a misadministration for 3 years. The record must contain: [Eff 11/30/2006] 7.21.7.1 The licensee's name; [Eff 11/30/2006] 7.21.7.1 Names of the individuals involved; [Eff 11/30/2006] 7.21.7.1 The social security number or other identification number if one has been assigned, of the individual who is the subject of the misadministration; [Eff 11/30/2006] 7.21.7.1 A brief description of the event and why it occurred; [Eff 11/30/2006] 7.21.7.1 The effect, if any, on the individual; [Eff 11/30/2006] 7.21.7.1 The actions, if any, taken, or planned, to prevent recurrence; and [Eff 11/30/2006] 7.21.7.1 Whether the licensee notified the individual (or the individual's responsible relative or guardian) and, if not, whether such failure to notify was based on guidance from the referring physician. [Eff 11/30/2006] 7.21.8 A copy of the record required under 7.21.7 shall be provided to the referring physician if other than the licensee, within 15 days after discovery of the misadministration. [Eff 11/30/2006] 7.22 Notification to the Department of Deceased Patients or Human Research Subjects Containing Radioactive Material.

7.22.1 The licensee shall notify the Department by telephone immediately upon discovery that a patient or human research subject containing radioactive material has died, and it is possible that any individual could receive exposures in excess of 4.14 as a result of the deceased's body. [Eff 11/30/2006] 7.22.2 The licensee shall submit a written report to the Department within 30 days after discovery that the patient or human research subject referenced in 7.22.1 has died. The written report must include the: [Eff 11/30/2006] 7.22.2.1 Licensee's name; [Eff 11/30/2006] 7.22.2.2 Date of death; [Eff 11/30/2006] 7.22.2.3 Radionuclide, chemical and physical form and calculated activity at time of death; and [Eff 11/30/2006] 7.22.2.4 Names (or titles) and address(es) of known individuals who might have received exposures exceeding 5 mSv (500 mrem). [Eff 11/30/2006] 7.22.3 The licensee shall retain a record of each written report required by 7.22 for 3 years. [Eff 11/30/2006] 7.23 Report and Notification of a Dose to an Embryo/Fetus or a Nursing Child. 7.23.1 A licensee shall report any dose to an embryo/fetus that is greater than 5 mSv (500 mrem) dose equivalent that is a result of an administration of radioactive material or radiation from radioactive material to a pregnant individual unless the dose to the embryo/fetus was specifically approved, in advance, by the authorized user. [Eff 11/30/2006] 7.23.2 A licensee shall report any dose to a nursing child, that was not specifically approved, in advance, by the authorized user, that is a result of an administration of radioactive material to a breast feeding individual that: [Eff 11/30/2006] 7.23.2.1 Is greater than 5 millisievert (500 mrem) total effective dose equivalent; or [Eff 11/30/2006] 7.23.2.2 Has resulted in unintended permanent functional damage to an organ or a physiological system of the child, as determined by a physician. [Eff 11/30/2006] 7.23.3 The licensee shall notify by telephone the Agency no later than the next calendar day after discovery of a dose to the embryo/fetus or nursing child that requires a report in 7.23.1 or 7.23.2. [Eff 11/30/2006] 7.23.4 The licensee shall submit a written report to the Agency within 15 days after discovery of a dose to the embryo/fetus or nursing child that requires a report in 7.23.1 or 7.23.2. [Eff 11/30/2006] 7.23.4.1 The written report must include: [Eff 11/30/2006] (1) The licensee's name; [Eff 11/30/2006] (2) The name of the prescribing physician; [Eff 11/30/2006] (3) A brief description of the event; [Eff 11/30/2006] (4) Why the event occurred; [Eff 11/30/2006] (5) The effect on the embryo/fetus or the nursing child; [Eff 11/30/2006] (6) What actions, if any, have been taken, or are planned, to prevent recurrence; and [Eff 11/30/2006] (7) Certification that the licensee notified the pregnant individual or mother (or the mother's or child's responsible relative or guardian), and if not, why not. [Eff 11/30/2006] 7.23.4.2 The report must not contain the individual's or child's name or any other information that could lead to identification of the individual or child. [Eff 11/30/2006] 7.23.5 The licensee shall notify the referring physician and also notify the pregnant individual or mother, both hereafter referred to as the mother, no later than 24 hours after discovery of an event that would require reporting under 7.23.1 or 7.23.2, unless the referring physician personally informs the licensee either that he or she will inform the mother or that, based on medical judgment, telling the mother would be harmful. The licensee is not required to notify the mother without first consulting with the referring physician. If the referring physician or mother cannot be reached within 24 hours, the licensee shall make the appropriate notifications as soon as possible thereafter. The licensee may not delay any appropriate medical care for the embryo/fetus or for the nursing child, including any necessary remedial care as a result of the event, because of any delay in notification. To meet the requirements of this paragraph, the notification may be made to the mother's or child's responsible relative or guardian instead of the mother, when appropriate. If a verbal notification is made, the licensee shall inform the mother, or the mother's or child's responsible relative or guardian, that a written description of the event can be obtained from the licensee upon request. The licensee shall provide such a written description if requested. [Eff 11/30/2006] 7.23.6 A licensee shall retain a record of a dose to an embryo/fetus or a nursing child for 3 years. The record must contain: [Eff 11/30/2006] 7.23.6.1 The licensee's name; [Eff 11/30/2006] 7.23.6.2 Names of all the individuals involved; [Eff 11/30/2006] 7.23.6.3 Social security number or other identification number if one has been assigned to the pregnant individual or nursing child who is the subject of the event; [Eff 11/30/2006] 7.23.6.4 A brief description of the event and why it occurred; [Eff 11/30/2006] 7.23.6.5 The effect, if any, on the embryo/fetus or nursing child; [Eff 11/30/2006] 7.23.6.6 The actions, if any, taken, or planned, to prevent recurrence; and [Eff 11/30/2006] 7.23.6.7 Whether the licensee notified the pregnant individual or mother (or the mother's or child's responsible relative or guardian) and, if not, whether such failure to notify was based on guidance from the referring physician. [Eff 11/30/2006] 7.23.7 A copy of the record required under 7.23.6 shall be provided to the referring physician, if other than the licensee, within 15 days after discovery of the event. [Eff 11/30/2006] 7.24 Vial Shields and Labels.

7.24.1 A licensee shall require each individual preparing or handling a vial that contains a radiopharmaceutical to keep the vial in a vial radiation shield. [Eff 11/30/2006] 7.24.2 Each syringe and vial that contains a radioactive drug shall be labeled to identify the radioactive drug, to include the isotope and amount of radioactivity. Each syringe shield and vial shield shall also be labeled unless the label on the syringe or vial is visible when shielded. [Eff 11/30/2006] 7.25 Surveys for Contamination and Ambient Radiation Dose Rate. 7.25.1 Except as provided in 7.25.2, at the end of each day of use, a licensee shall survey, with a radiation detection instrument, all areas where radioactive drugs containing radioactive material requiring a written directive were prepared for use or administered. [Eff 11/30/2006] 7.25.2 At least once each week, a licensee shall survey, with a radiation detection instrument, all areas where radioactive drugs or radioactive wastes are stored. [Eff 11/30/2006] 7.25.3 A licensee shall conduct the surveys required by 7.25.1 and 7.25.2 using an instrument capable of measuring dose rates as low as 1 µSv (0.1 mrem) per hour. [Eff 11/30/2006] 7.25.4 A licensee shall establish dose rate action levels for the surveys required by 7.25.1 and 7.25.2 and shall require that the individual performing the survey immediately notify the Radiation Safety Officer if a dose rate exceeds an action level. [Eff 11/30/2006] 7.25.5 Each day of use a licensee shall survey for removable contamination all areas where generators and bulk radioactive drugs are prepared for use. [Eff 11/30/2006] 7.25.6 Each week the licensee shall perform removable contamination surveys in all areas where radioactive materials other than sealed sources as defined in Part 7 are stored. [Eff 11/30/2006] 7.25.7 For the surveys required by 7.25.5 and 7.25.6, the licensee shall: [Eff 11/30/2006] 7.25.7.1 Use instrumentation capable of detecting contamination on each wipe sample of 33.3 Bq (2000 disintegrations per minute); [Eff 11/30/2006] 7.25.7.2 Establish removable contamination action levels; and [Eff 11/30/2006] 7.25.7.3 Require that the individual performing the survey immediately notify the Radiation Safety Officer if contamination exceeds action levels. [Eff 11/30/2006] 7.25.8 A licensee does not need to perform the surveys required by 7.25.1 in an area where patients or human research subjects are confined when they cannot be released pursuant to 7.26. [Eff 11/30/2006] 7.25.9 A licensee shall retain a record of each survey required by 7.25.1, 7.25.2 and 7.25.5 for 3 years. The record must include the date of the survey, the results of the survey, the instrument used to make the survey (including, if applicable, that the instrument was checked for consistent response with a dedicated check source prior to each daily use), and the name of the individual who performed the survey. [Eff 11/30/2006] 7.26 Release of Individuals Containing Radioactive Drugs or Implants. 7.26.1 A licensee may authorize the release from the licensee’s control of any individual who has been administered radioactive drugs or permanent implants containing radioactive material if the total effective dose equivalent to any other individual from exposure to the released individual is not likely to exceed 5 mSv (0.5 rem). [Eff 11/30/2006] 7.26.2 Instructions to Individuals: [Eff 11/30/2006] 7.26.2.1 A licensee shall provide the released individual, or the individual's parent or guardian, with oral and written safety instructions on actions recommended to maintain doses to other individuals as low as is reasonably achievable. [Eff 11/30/2006] 7.26.2.2 If a breast-feeding infant or child could receive a radiation dose as a result of the release of the patient, the instructions shall also include: [Eff 11/30/2006] (1) Guidance on the interruption or discontinuation of breast-feeding; and [Eff 11/30/2006] (2) Information on the consequences of failure to follow the guidance. [Eff 11/30/2006] 7.26.3 Release of the patient must be approved by an individual listed as an authorized user on the license from the Department who is approved for the type of radioactive material use in the patient being released. [Eff 11/30/2006] 7.26.4 The licensee shall maintain a record, signed by the authorized user, for 3 years after the date of release, of: [Eff 11/30/2006] 7.26.4.1 The basis for authorizing the release of an individual; and [Eff 11/30/2006] 7.26.4.2 Instructions that were provided to a breast-feeding woman. [Eff 11/30/2006] 7.26.5 Reports of Patient Departure Prior to Authorized Release. [Eff 11/30/2006] 7.26.5.1 The licensee shall notify the Department by telephone immediately upon discovery that a patient or human research subject has departed from the licensee's facility without authorization under 7.26. [Eff 11/30/2006] 7.26.5.2 The licensee shall submit a written report to the Department within 30 days after discovery of the unauthorized departure. The written report must include: [Eff 11/30/2006] (1) The licensee's name; [Eff 11/30/2006] (2) The date and time of the unauthorized departure; [Eff 11/30/2006] (3) The projected date and time when release would have occurred; [Eff 11/30/2006] (4) The address of the patient's or human research subject's home or anticipated destination following departure; [Eff 11/30/2006] (5) The radionuclide, chemical and physical form and calculated activity at time of release; [Eff 11/30/2006] (6) The apparent reason(s) for the departure prior to authorized release; and [Eff 11/30/2006] (7) A description of any changes in the licensee's patient release criteria or patient instructions that are designed to avoid a recurrence of such an event. [Eff 11/30/2006] 7.27 Mobile Nuclear Medicine Service Technical Requirements. A licensee providing mobile nuclear medicine service shall: [Eff 11/30/2006] 7.27.1 Transport to each client’s address of use only syringes or vials containing prepared drugs or radioactive materials that are intended for reconstitution of radioactive drug kits; [Eff 11/30/2006] 7.27.2 Bring into each client’s address of use all radioactive material to be used and, before leaving, remove all unused radioactive material and associated radioactive waste; [Eff 11/30/2006] 7.27.3 Secure or keep under constant surveillance and immediate control all radioactive material when in transit or at a client’s address of use; [Eff 11/30/2006] 7.27.4 Check instruments used to measure the activity of unsealed radioactive material 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 shall include a constancy check; [Eff 11/30/2006] 7.27.5 Check survey instruments for consistent response with a dedicated check source before use at each client's address; [Eff 11/30/2006] 7.27.6 Prior to leaving a client’s address of use, perform area surveys and survey for removable contamination in all areas of use, to ensure compliance with Part 4 of these regulations; [Eff 11/30/2006] 7.27.7 Use radioactive gases only in areas of use and under conditions which have been evaluated and approved by the Department for compliance with airborne release standards; and [Eff 11/30/2006] 7.27.8 Retain a record of each survey required by 7.27.6 for 3 years. The record must include the date of the survey, the results of the survey, the instrument used to make the survey, and the name of the individual who performed the survey. [Eff 11/30/2006] 7.28 Storage of Volatiles and Gases.

7.28.1 A licensee shall store volatile radioactive materials and radioactive gases in a radiation shield and container. [Eff 11/30/2006] 7.28.2 A licensee shall store and use a multi-dose container in a properly functioning fume hood. [Eff 11/30/2006] 7.28.3 A licensee who administers radioactive aerosols or gases shall do so with a system that will keep airborne concentrations within the limits prescribed in Part 4 of these regulations. [Eff 11/30/2006] 7.28.3.1 The system shall either be directly vented to the atmosphere through an air exhaust or provide for collection and decay or disposal of the aerosol or gas in a shielded container. [Eff 11/30/2006] 7.28.3.2 A licensee shall check the operation of collection systems monthly. Records of these checks shall be maintained for 3 years. [Eff 11/30/2006] 7.29 Decay-In-Storage.

7.29.1 A licensee may hold radioactive material with a physical half-life of less than 120 days for decay- in-storage before disposal without regard for its radioactivity if the licensee: [Eff 11/30/2006] 7.29.1.1 Monitors radioactive material at the container surface before disposal and determines that its radioactivity cannot be distinguished from the background radiation level with a radiation detection survey instrument set on its most sensitive scale and with no interposed shielding; [Eff 11/30/2006] 7.29.1.3 Removes or obliterates all radiation labels, except for material that will be handled as biomedical waste after release; and [Eff 11/30/2006] 7.29.1.4 Separates and monitors each generator column individually with all radiation shielding removed to ensure that its contents have decayed to background radiation level before disposal. [Eff 11/30/2006] 7.29.2 Records of Decay-in-Storage. [Eff 11/30/2006] For radioactive material disposed in accordance with 7.29.1, the licensee shall retain a record of each disposal for 3 years. The record must include the date of the disposal, the survey instrument used, the background radiation level, the radiation level measured at the surface of each waste container, and the name of the individual who performed the survey. [Eff 11/30/2006] SPECIFIC REQUIREMENTS FOR THE USE OF RADIOACTIVE MATERIAL FOR UPTAKE, DILUTION, AND EXCRETION STUDIES 7.30 Use of Unsealed Radioactive Material for Uptake, Dilution, and Excretion Studies for which a Written Directive is Not Required.

7.30.1 A licensee may use any unsealed radioactive material, in quantities that do not require a written directive, as described in 7.11, for a diagnostic use involving measurements of uptake, dilution, or excretion that is: [Eff 11/30/2006] 7.30.1.1 Obtained from a manufacturer or preparer licensed pursuant to 3.12.10 or equivalent regulations of another Agreement State, a Licensing State, or NRC; or; [Eff 11/30/2006] 7.30.1.2 Prepared by an authorized nuclear pharmacist, a physician who is an authorized user and who meets the requirements specified in 7.30.2, or an individual under the supervision of either as specified in 7.10; [Eff 11/30/2006] 7.30.1.3 Obtained from and prepared by a Department, Agreement State, Licensing State or NRC licensee for use in research in accordance with a Radioactive Drug Research Committee-approved protocol or an Investigational New Drug (IND) protocol accepted by FDA; or [Eff 11/30/2006] 7.30.1.4 Prepared by the licensee in accordance with a Radioactive Drug Research Committee- approved application or an Investigational New Drug (IND) protocol accepted by FDA for use in research. [Eff 11/30/2006] 7.30.2 Authorized User Training For Uptake, Dilution, And Excretion Studies. [Eff 11/30/2006] The licensee shall require an authorized user of an unsealed radioactive material for the uses authorized under 7.30 to meet the requirements of Appendix 7D. [Eff 11/30/2006] 7.31 Possession of Survey Instrument.

A licensee authorized to use radioactive material for uptake, dilution, and excretion studies shall possess a portable radiation detection survey instrument capable of detecting dose rates over the range 1.0 µSv (0.1 mrem) per hour to 500 µSv (50 mrem) per hour. The instrument shall be operable and calibrated in accordance with 7.17. [Eff 11/30/2006] SPECIFIC REQUIREMENTS FOR THE USE OF UNSEALED RADIOACTIVE MATERIAL - WRITTEN DIRECTIVE NOT REQUIRED 7.32 Use of Unsealed Radioactive Material for Imaging and Localization Studies for which a Written Directive is Not Required.

7.32.1 A licensee may use, for imaging and localization studies, any radioactive material prepared for medical use, in quantities that do not require a written directive, as described in 7.11, that is: [Eff 11/30/2006] 7.32.1.1 Obtained from a manufacturer or preparer licensed pursuant to 3.12.10 or equivalent regulations of another Agreement State, a Licensing State, or NRC; or; [Eff 11/30/2006] 7.32.1.2 Prepared by an authorized nuclear pharmacist, a physician who is an authorized user and who meets the requirements specified in 7.32.2, or an individual under the supervision of either as specified in 7.10; [Eff 11/30/2006] 7.32.1.3 Obtained from and prepared by a Department, Agreement State, Licensing State or NRC licensee for use in research in accordance with a Radioactive Drug Research Committee-approved protocol or an Investigational New Drug (IND) protocol accepted by FDA; or [Eff 11/30/2006] 7.32.1.4 Prepared by the licensee in accordance with a Radioactive Drug Research Committee- approved application or an Investigational New Drug (IND) protocol accepted by FDA for use in research. [Eff 11/30/2006] 7.32.2 Authorized User Training for Imaging and Localization Studies for which a Written Directive is Not Required. [Eff 11/30/2006] The licensee shall require an authorized user of an unsealed radioactive material for the uses authorized under 7.32 to meet the requirements of Appendix 7E. [Eff 11/30/2006] 7.33 Radionuclide Contaminants.

7.33.1 A licensee shall not administer to humans a radioactive drug containing: [Eff 11/30/2006] 7.33.1.1 More than 0.15 kBq of molybdenum-99 per MBq of technetium-99m (0.15 µCi of 99 Mo per mCi of 99m Tc). [Eff 11/30/2006] 7.33.1.2 More than 0.02 kBq of strontium-82 per MBq of rubidium-82 chloride injection (0.02 µCi of 82 Sr per mCi of 82 Rb chloride); [Eff 11/30/2006] 7.33.1.3 More than 0.2 kBq of strontium-85 per MBq of rubidium-82 chloride injection (0.2 µCi of 85 Sr per mCi of 82 Rb). [Eff 11/30/2006] 7.33.2 To demonstrate compliance with 7.33.1, the licensee preparing radioactive drugs from radionuclide generators shall measure the concentration of radionuclide contaminant in: [Eff 11/30/2006] 7.33.2.1 The first eluate after receipt of a molybdenum-99/technetium-99m generator; [Eff 11/30/2006] 7.33.2.2 Each eluate or extract, as appropriate for other than molybdenum-99/technetium-99m generator systems. [Eff 11/30/2006] 7.33.3 Records of Radionuclide Purity. [Eff 11/30/2006] A licensee who must measure radionuclide contaminant concentration shall retain a record of each radionuclide contaminant test for 3 years. The record shall include, for each measured elution of radionuclide used to prepare a radioactive drug, the ratio of the measures expressed as kBq of contaminant per MBq of desired radionuclide (µCi/ mCi), the time and date of the test, and the name of the individual who made the measurement. [Eff 11/30/2006] 7.33.4 Immediate Report. [Eff 11/30/2006] A licensee shall report immediately to the Department each occurrence of radionuclide contaminant concentration exceeding a limit specified in 7.33.1. [Eff 11/30/2006] 7.34 Aerosols and Gases.

Provided the conditions of 7.28 are met, a licensee shall use radioactive aerosols or gases only if specific application is made to and approved by the Department. [Eff 11/30/2006] 7.35 Radiation Detection Capability.

A licensee authorized to use radioactive material pursuant to 7.32, 7.36, or 7.42 shall possess portable radiation detection survey instrumentation capable of detecting dose rates over the range 1.0 µSv (0.1 mrem) per hour to 500 µSv (50 mrem) per hour and over the range of 10 µSv (1 mrem) per hour to 10 mSv (1 rem) per hour. Each instrument shall be operable and calibrated in accordance with 7.17. [Eff 11/30/2006] SPECIFIC REQUIREMENTS FOR THE USE OF UNSEALED RADIOACTIVE MATERIAL - WRITTEN DIRECTIVE REQUIRED 7.36 Use of Unsealed Radioactive Material for Which A Written Directive Is Required. 7.36.1 A licensee may use any unsealed radioactive material for diagnostic or therapeutic medical use for which a written directive is required that has been: [Eff 11/30/2006] 7.36.1.1 Obtained from a manufacturer or preparer licensed pursuant to 3.12.10 or equivalent regulations of another Agreement State, a Licensing State, or NRC; or [Eff 11/30/2006] 7.36.1.2 Prepared by an authorized nuclear pharmacist, a physician who is an authorized user and who meets the requirements specified in 7.36.2, 7.36.3 or 7.36.4, or an individual under the supervision of either as specified in 7.10; [Eff 11/30/2006] 7.36.1.3 Obtained from and prepared by a Department, Agreement State, Licensing State or NRC licensee for use in research in accordance with a Radioactive Drug Research Committee-approved protocol or an Investigational New Drug (IND) protocol accepted by FDA; or [Eff 11/30/2006] 7.36.1.4 Prepared by the licensee in accordance with a Radioactive Drug Research Committee- approved application or an Investigational New Drug (IND) protocol accepted by FDA for use in research. [Eff 11/30/2006] 7.36.2 Authorized User Training For Use Of Any Unsealed Radioactive Material For Diagnostic Or Therapeutic Medical Use For Which A Written Directive Is Required. [Eff 11/30/2006] The licensee shall require an authorized user of an unsealed radioactive material for diagnostic or therapeutic medical use for which a written directive is required under 7.36 to meet the requirements of Appendix 7F. [Eff 11/30/2006] 7.36.3 Authorized User Training For Oral Administration Of < / = 1.22 GBq 131 I (33 mCi) Sodium Iodide Requiring A Written Directive. [Eff 11/30/2006] The licensee shall require an authorized user of an unsealed radioactive material for oral administration of < / = 1.22 GBq 131 I (33 mCi) sodium iodide requiring a written directive under 7.36 to meet the requirements of Appendix 7G. [Eff 11/30/2006] 7.36.4 Authorized User Training For Oral Administration Of > 1.22 GBq 131 I (33 mCi) Sodium Iodide Requiring A Written Directive. [Eff 11/30/2006] The licensee shall require an authorized user of an unsealed radioactive material for oral administration of > 1.22 GBq 131 I (33 mCi) sodium iodide requiring a written directive under 7.36 to meet the requirements of Appendix 7H. [Eff 11/30/2006] 7.36.5 Authorized User Training For Parenteral Administration Requiring A Written Directive. [Eff 11/30/2006] The licensee shall require an authorized user of an unsealed radioactive material for parenteral administration requiring a written directive under 7.36 to meet the requirements of Appendix 7I. [Eff 11/30/2006] 7.37 Safety Instruction.

In addition to the requirements of Part 10 of these regulations: [Eff 11/30/2006] 7.37.1 The licensee shall provide radiation safety instruction, initially and at least annually, to personnel caring for patients or human research subjects that have received therapy with a radioactive drug, and cannot be released in accordance with 7.26. [Eff 11/30/2006] 7.37.2 The instruction required by 7.37.1 shall be appropriate for the duties of the personnel and include: [Eff 11/30/2006] 7.37.2.1 Patient or human research subject control; [Eff 11/30/2006] 7.37.2.2 Visitor control, to include the following; [Eff 11/30/2006] (1) Routine visitation to hospitalized individuals in accordance with Part 4 of these regulations; [Eff 11/30/2006] (2) Contamination control; [Eff 11/30/2006] (3) Waste control; and [Eff 11/30/2006] (4) Notification of the RSO, or his or her designee, and the authorized user if the patient or the human research subject dies or has a medical emergency. [Eff 11/30/2006] 7.37.3 A licensee shall keep a record of individuals receiving instruction required by 7.37.1 and maintain such records for 3 years. The record shall include a list of the topics covered, the date of instruction, the names(s) of the attendee(s), and the name(s) of the individual(s) who gave the instruction. [Eff 11/30/2006] 7.38 Safety Precautions.

7.38.1 For each patient or human research subject receiving radiopharmaceutical therapy and hospitalized for compliance with 7.26, a licensee shall: [Eff 11/30/2006] 7.38.1.1 Quarter the patient or the human research subject either in: [Eff 11/30/2006] (1) A private room with a private sanitary facility; or [Eff 11/30/2006] (2) A room, with a private sanitary facility, with another individual who also has received similar radiopharmaceutical therapy and who cannot be released in accordance with 7.26; and [Eff 11/30/2006] 7.38.1.2 Visibly post the patient's or the human research subject’s door with a "Caution: Radioactive Material" sign and note on the door or on the patient's or the human research subject’s chart where and how long visitors may stay in the patient's or the human research subject’s room; [Eff 11/30/2006] 7.38.1.3 Either monitor material and items removed from the patient's or the human research subject’s room to determine that their radioactivity cannot be distinguished from the natural background radiation level with a radiation detection survey instrument set on its most sensitive scale and with no interposed shielding, or handle such materials and items as radioactive waste. [Eff 11/30/2006] 7.38.2 A licensee shall notify the RSO , or his or her designee, and the authorized user immediately if the hospitalized patient dies or has a medical emergency and notify the Department as required by 7.39. [Eff 11/30/2006] 7.39 Emergency Notification.

The licensee shall notify the Department in accordance with 7.22 if it is possible that any individual could receive exposures in excess of 4.14 as a result of a deceased's body. [Eff 11/30/2006] SPECIFIC REQUIREMENTS FOR THE USE OF SEALED SOURCES FOR DIAGNOSIS 7.40 Use of Sealed Sources for Diagnosis.

7.40.1 A licensee shall use for diagnostic medical uses only sealed sources: [Eff 11/30/2006] 7.40.1.1 Approved in the Sealed Source and Device Registry; and [Eff 11/30/2006] 7.40.1.2 Handled in accordance with the manufacturer's radiation safety and handling instructions: [Eff 11/30/2006] 7.40.2 Authorized User Training For Use Of Sealed Sources For Diagnosis. [Eff 11/30/2006] The licensee shall require an authorized user under 7.40 to meet the requirements of Appendix 7J. [Eff 11/30/2006] SPECIFIC REQUIREMENTS FOR THE USE OF SEALED SOURCES FOR MANUAL BRACHYTHERAPY 7.41 Calibration Measurements of Brachytherapy Sealed Sources. 7.41.1 Prior to the first medical use of a brachytherapy sealed source on or after October 25, 2005, a licensee shall perform the following: [Eff 11/30/2006] 7.41.1.1 Determine the source output or activity using a dosimetry system that meets the requirements of 7.53; [Eff 11/30/2006] 7.41.1.2 Determine source positioning accuracy within applicators; and [Eff 11/30/2006] 7.41.1.3 Use published protocols accepted by nationally recognized bodies to meet the requirements of 7.41.1.1 and 7.41.1.2. [Eff 11/30/2006] 7.41.2 A licensee may use measurements provided by the source manufacturer or by a calibration laboratory accredited by the American Association of Physicists in Medicine that are made in accordance with 7.41.1. [Eff 11/30/2006] 7.41.3 A licensee shall mathematically correct the outputs or activities determined in 7.41.1 for physical decay at intervals consistent with 1.0 percent physical decay. [Eff 11/30/2006] 7.41.4 An authorized medical physicist shall perform or review the measurements and calculations made pursuant to 7.41.1, 7.41.2, or 7.41.3. [Eff 11/30/2006] 7.41.5 Only an authorized medical physicist shall calculate the activity of each strontium-90 source that is used to determine the treatment times for ophthalmic treatments. The actual source output shall consider decay based on the activity determined in accordance with paragraphs 7.41.1, 7.41.2, or 7.41.3. [Eff 11/30/2006] 7.41.6 A licensee shall retain a record of each calibration on brachytherapy sources required by 7.41.1 for 3 years after the last use of the source. The record must include the date of the calibration; the manufacturer's name, model number, and serial number for the source and the instruments used to calibrate the source; the source output or activity; source positioning accuracy within applicators; and the signature of the authorized medical physicist. [Eff 11/30/2006] 7.41.7 A licensee shall retain a record of decay calculations required by 7.41.5 for the life of the source. The record must include the date and initial activity of the source as determined under 7.41, and for each decay calculation, the date, the source activity and the signature of the authorized medical physicist. [Eff 11/30/2006] 7.42 Use of Sealed Sources For Manual Brachytherapy.

7.42.1 A licensee shall use for manual brachytherapy only sealed sources: [Eff 11/30/2006] 7.42.1.1 Approved in the Sealed Source and Device Registry; or [Eff 11/30/2006] 7.42.1.2 In research in accordance with an effective Investigational Device Exemption (IDE) application accepted by the FDA provided the requirements of 7.14.1 are met. [Eff 11/30/2006] 7.42.2 Authorized User Training For Use Of Sealed Sources For Manual Brachytherapy. [Eff 11/30/2006] The licensee shall require an authorized user under 7.42 to meet the requirements of Appendix 7K. [Eff 11/30/2006] 7.42.3 Authorized User Training For Use Of Strontium-90 Sealed Sources For Ophthalmic Uses. [Eff 11/30/2006] The licensee shall require an authorized user of strontium-90 sealed sources for ophthalmic uses under 7.42 to meet the requirements of Appendix 7L. [Eff 11/30/2006] 7.43 Safety Instruction.

7.43.1 The licensee shall provide radiation safety instruction, initially and at least annually, to personnel caring for patients or human research subjects that are undergoing implant therapy and cannot be released in accordance with 7.26. [Eff 11/30/2006] 7.43.2 The instruction required by 7.43.1 shall be commensurate with the duties of the personnel and include: [Eff 11/30/2006] 7.43.2.1 Size and appearance of the brachytherapy sources; [Eff 11/30/2006] 7.43.2.2 Safe handling and shielding instructions in case of a dislodged source; [Eff 11/30/2006] 7.43.2.3 Patient or human research subject control; [Eff 11/30/2006] 7.43.2.4 Visitor control, including both; [Eff 11/30/2006] (1) Routine visitation to hospitalized individuals in accordance with 4.14.1.1; and [Eff 11/30/2006] (2) Visitation authorized in accordance with 4.14.3; and [Eff 11/30/2006] 7.43.2.5 Notification of the RSO, or his or her designee, and the authorized user if the patient or the human research subject dies or has a medical emergency . [Eff 11/30/2006] 7.43.3 A licensee shall keep a record of individuals receiving instruction required by 7.43.1 and maintain such records for 3 years. The record shall include a list of the topics covered, the date of instruction, the names(s) of the attendee(s), and the name(s) of the individual(s) who gave the instruction. [Eff 11/30/2006] 7.44 Safety Precautions.

7.44.1 For each patient or the human research subject that is receiving brachytherapy and cannot be released in accordance with 7.26, a licensee shall: [Eff 11/30/2006] 7.44.1.1 Not place the patient or the human research subject in the same room with a patient who is not receiving radiation therapy; [Eff 11/30/2006] 7.44.1.2 Visibly post the patient's or human research subject’s door with a "Caution: Radioactive Material" sign and note on the door or on the patient's or human research subject’s chart where and how long visitors may stay in the patient's or human research subject’s room. [Eff 11/30/2006] 7.44.2 A licensee shall have emergency response equipment available near each treatment room to respond to a source that inadvertently becomes: [Eff 11/30/2006] 7.44.2.1 Dislodged from the patient; or [Eff 11/30/2006] 7.44.2.2 Lodged within the patient following removal of the source applicators. [Eff 11/30/2006] 7.44.3 A licensee shall notify the RSO , or his or her designee, and the authorized user immediately if the hospitalized patient dies or has a medical emergency and notify the Department as required by 7.39. [Eff 11/30/2006] 7.45 Brachytherapy Sources Inventory.

7.45.1 A licensee shall maintain accountability at all times for all brachytherapy sources in storage or use. [Eff 11/30/2006] 7.45.2 Promptly after removing brachytherapy sources from a patient, a licensee shall return brachytherapy sources to a secure storage area and count or otherwise verify the number returned to ensure that all sources taken from the storage area have been returned. [Eff 11/30/2006] 7.45.3 A licensee shall maintain a record of brachytherapy source accountability for 3 years. [Eff 11/30/2006] 7.45.3.1 For temporary implants, the record must include the number and activity of sources: [Eff 11/30/2006] (1) Removed from storage, the time and date they were removed from storage, the name of the individual who removed them from storage, and the location of use; and [Eff 11/30/2006] (2) Not implanted, the time and date they were returned to storage, and the name of the individual who returned them to storage. [Eff 11/30/2006] 7.45.3.2 For permanent implants, the record must include the number and activity of sources: [Eff 11/30/2006] (1) Removed from storage, the date they were removed from storage, and the name of the individual who removed them from storage; [Eff 11/30/2006] (2) Returned to storage, the date they were returned to storage, and the name of the individual who returned them to storage; and [Eff 11/30/2006] (3) Permanently implanted in the patient or human research subject. [Eff 11/30/2006] 7.46 Surveys After Source Implant and Removal.

7.46.1 Immediately after implanting sources in a patient or a human research subject, the licensee shall perform a survey to locate and account for all sources that have not been implanted. [Eff 11/30/2006] 7.46.2 Immediately after removing the last temporary implant source from a patient or a human research subject, the licensee shall perform a radiation survey of the patient with a radiation detection survey instrument to confirm that all sources have been removed. The licensee shall not release from confinement for medical care a patient treated by temporary implant until all sources have been removed. [Eff 11/30/2006] 7.46.3 A licensee shall maintain a record of patient surveys which demonstrate compliance with 7.46.1 and 7.6.2 for 3 years. Each record shall include the date and results of the survey, the survey instrument used, and the name of the individual who made the survey. [Eff 11/30/2006] 7.47 Therapy-related Computer Systems.

7.47.1 The licensee shall perform acceptance testing on the treatment planning system in accordance with published protocols accepted by nationally recognized bodies. [Eff 11/30/2006] 7.47.2 At a minimum, the acceptance testing required by 7.47.1 shall include, as applicable, verification of: [Eff 11/30/2006] 7.47.2.1 The source-specific input parameters required by the dose calculation algorithm; [Eff 11/30/2006] 7.47.2.1 The accuracy of dose, dwell time, and treatment time calculations at representative points; [Eff 11/30/2006] 7.47.2.1 The accuracy of isodose plots and graphic displays; and [Eff 11/30/2006] 7.47.2.1 The accuracy of the software used to determine radioactive source positions from radiographic images. [Eff 11/30/2006] SPECIFIC REQUIREMENTS FOR PHOTON-EMITTING REMOTE AFTERLOADER UNITS, TELETHERAPY UNITS, AND GAMMA STEREOTACTIC RADIOSURGERY UNITS 7.48 Use of a Sealed Source in a Remote Afterloader Unit, Teletherapy Unit, or Gamma Stereotactic Radiosurgery Unit.

7.48.1 A licensee shall use sealed sources in remote afterloader units, teletherapy units, or gamma stereotactic radiosurgery units for therapeutic medical uses: [Eff 11/30/2006] 7.48.1.1 Approved in the Sealed Source and Device Registry; and [Eff 11/30/2006] 7.48.1.2 In research in accordance with an effective Investigational Device Exemption (IDE) application accepted by the FDA provided the requirements of 7.14.1 are met. [Eff 11/30/2006] 7.48.2 Authorized User Training For Use of a Remote Afterloader Unit, Teletherapy Unit, or Gamma Stereotactic Radiosurgery Unit. [Eff 11/30/2006] The licensee shall require an authorized user under 7.48 to meet the requirements of Appendix 7M. [Eff 11/30/2006] 7.49 Installation, Maintenance, Adjustment, and Repair. 7.49.1 Only a person specifically licensed by the Department, another Agreement State, or the NRC shall install, maintain, adjust, or repair a remote afterloader unit, teletherapy unit, or gamma stereotactic radiosurgery unit that involves work on the source(s) shielding, the source(s) driving unit, or other electronic or mechanical component that could expose the source(s), reduce the shielding around the source(s), or compromise the radiation safety of the unit or the source(s). [Eff 11/30/2006] 7.49.2 Except for low dose-rate remote afterloader units, only a person specifically licensed by the Department, another Agreement State, a Licensing State, or the NRC shall install, replace, relocate, or remove a sealed source or source contained in other remote afterloader units, teletherapy units, or gamma stereotactic radiosurgery units. [Eff 11/30/2006] 7.49.3 For a low dose-rate remote afterloader unit, only a person specifically licensed by the Department, another Agreement State, a Licensing State, or the NRC, or an authorized medical physicist shall install, replace, relocate, or remove a sealed source(s) contained in the unit. [Eff 11/30/2006] 7.49.4 A licensee shall retain a record of the installation, maintenance, adjustment and repair done on remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units for 3 years. The record shall include the date, description of the service, and name(s) of the individual(s) who performed the work. [Eff 11/30/2006] 7.50 Surveys of Patients and Human Research Subjects Treated with a Remote Afterloader Unit. 7.50.1 Before releasing a patient or a human research subject from licensee control, a licensee shall make a survey of the patient or the human research subject and the remote afterloader unit with a portable radiation detection survey instrument to confirm that the source(s) has been removed from the patient or human research subject and returned to the safe, shielded position. [Eff 11/30/2006] 7.50.1 A licensee shall maintain a record of patient surveys which demonstrate compliance with 7.50.1 for 3 years. Each record shall include the date and results of the survey, the survey instrument used, and the name of the individual who made the survey. [Eff 11/30/2006] 7.51 Safety Procedures and Instructions for a Remote Afterloader Unit, Teletherapy Unit, or Gamma Stereotactic Radiosurgery Unit.

7.51.1 A licensee shall: [Eff 11/30/2006] 7.51.1.1 Secure the unit, the console, the console keys, and the treatment room when not in use or unattended; [Eff 11/30/2006] 7.51.1.2 Permit only individuals approved by the authorized user, RSO, or authorized medical physicist to be present in the treatment room during treatment with the source(s), if such presence is necessary and justified; [Eff 11/30/2006] 7.51.1.3 Prevent dual operation of more than one radiation producing device in a treatment room, if applicable; and [Eff 11/30/2006] 7.51.1.4 Develop, implement, and maintain written procedures for responding to an abnormal situation when the operator is unable to place the source(s) in the shielded position, or remove the patient or human research subject from the radiation field with controls from outside the treatment room. This procedure must include: [Eff 11/30/2006] (1) Instructions for responding to equipment failures and the names of the individuals responsible for implementing corrective actions; [Eff 11/30/2006] (2) The process for restricting access to and posting of the treatment area to minimize the risk of inadvertent exposure; and [Eff 11/30/2006] (3) The names and telephone numbers of the authorized users, the authorized medical physicist, and the RSO to be contacted if the unit or console operates abnormally. [Eff 11/30/2006] 7.51.2 A copy of the procedures required by 7.51.1.4 shall be physically located at the unit console. [Eff 11/30/2006] 7.51.3 A licensee shall conspicuously post instructions at the unit console to inform the operator of the names and telephone numbers of the authorized users, the authorized medical physicist, and the RSO to be contacted if the unit or console operates abnormally. [Eff 11/30/2006] 7.51.4 A licensee shall provide instruction, initially and at least annually, to all individuals who operate a unit, as appropriate to the individual's assigned duties, in: [Eff 11/30/2006] 7.51.4.1 The procedures identified in 7.51.1.4; and [Eff 11/30/2006] 7.51.4.2 The operating procedures for the unit. [Eff 11/30/2006] 7.51.5 A licensee shall ensure that operators, authorized medical physicists, and authorized users participate in drills of the emergency procedures, initially and at least annually. [Eff 11/30/2006] 7.51.6 A licensee shall keep a record of individuals receiving instruction required by 7.51.4 and maintain such records for 3 years. The record shall include a list of the topics covered, the date of instruction, the names(s) of the attendee(s), and the name(s) of the individual(s) who gave the instruction. [Eff 11/30/2006] 7.52 Doors, Interlocks, and Warning Systems.

7.52.1 A licensee shall control access to the treatment room by a door at each entrance. [Eff 11/30/2006] 7.52.2 A licensee shall equip each entrance to the treatment room with an electrical interlock system that shall: [Eff 11/30/2006] 7.52.2.1 Prevent the operator from initiating the treatment cycle unless each treatment room entrance door is closed; [Eff 11/30/2006] 7.52.2.2 Cause the source(s) to be shielded promptly when an entrance door is opened; and [Eff 11/30/2006] 7.52.2.3 Prevent the source(s) from being exposed following an interlock interruption until all treatment room entrance doors are closed and the source(s)’ on/off control is reset at the console. [Eff 11/30/2006] 7.52.3 A licensee shall require any individual entering the treatment room to assure, through the use of appropriate radiation monitors, that radiation levels have returned to ambient levels. [Eff 11/30/2006] 7.52.4 Except for low-dose remote afterloader units, a licensee shall construct or equip each treatment room with viewing and intercom systems to permit continuous observation of the patient or the human research subject from the treatment console during irradiation. [Eff 11/30/2006] 7.52.5 For licensed activities where sources are placed within the patient's or human research subject's body, a licensee shall only conduct treatments which allow for expeditious removal of a decoupled or jammed source. [Eff 11/30/2006] 7.52.6 In addition to the requirements specified in 7.52.1 through 7.52.5, a licensee shall: [Eff 11/30/2006] 7.52.6.1 For low dose-rate, medium dose-rate, and pulsed dose-rate remote afterloader units, require: [Eff 11/30/2006] (1) An authorized medical physicist and either an authorized user or a physician, under the supervision of an authorized user, who has been trained in the operation and emergency response for the unit, to be physically present during the initiation of all patient treatments involving the unit; and [Eff 11/30/2006] (2) An authorized medical physicist and either an authorized user or an individual, under the supervision of an authorized user, who has been trained to remove the source applicator(s) in the event of an emergency involving the unit, to be immediately available during continuation of all patient treatments involving the unit. [Eff 11/30/2006] 7.52.6.2 For high dose-rate remote afterloader units, require: [Eff 11/30/2006] (1) An authorized user and an authorized medical physicist to be physically present during the initiation of all patient treatments involving the unit; and [Eff 11/30/2006] (2) An authorized medical physicist and either an authorized user or a physician, under the supervision of an authorized user, who has been trained in the operation and emergency response for the unit, to be physically present during continuation of all patient treatments involving the unit. [Eff 11/30/2006] 7.52.6.3 For gamma stereotactic radiosurgery units, require an authorized user and an authorized medical physicist to be physically present throughout all patient treatments involving the unit. [Eff 11/30/2006] 7.52.6.4 If a patient or research subject suffers a medical emergency during radiation therapy: [Eff 11/30/2006] (1) Cease the therapy immediately; [Eff 11/30/2006] (2) Remove the source(s); and [Eff 11/30/2006] (3) Provide appropriate care to the patient or research subject. [Eff 11/30/2006] 7.52.6.5 If the patient expires during treatment, remove the source(s) before further actions are taken. [Eff 11/30/2006] 7.52.6.6 Notify the RSO, or his or her designee, and an authorized user as soon as possible, if the patient or human research subject has a medical emergency and, immediately, if the patient dies. [Eff 11/30/2006] 7.52.7 A licensee shall have emergency response equipment available near each treatment room, to respond to a situation in which a source inadvertently: [Eff 11/30/2006] 7.52.7.1 Remains in the unshielded position; or [Eff 11/30/2006] 7.52.7.2 Lodges within the patient following completion of the treatment. [Eff 11/30/2006] 7.53 Dosimetry Equipment.

7.53.1 Except for low dose-rate remote afterloader sources where the source output or activity is determined by the manufacturer, a licensee shall have a calibrated dosimetry system available for use. To satisfy this requirement, one of the following two conditions shall be met: [Eff 11/30/2006] 7.53.1.1 The system shall have been calibrated using a system or source traceable to the National Institute of Standards and Technology and published protocols accepted by nationally recognized bodies, or by a calibration laboratory accredited by the American Association of Physicists in Medicine. The calibration shall have been performed within the previous 2 years and after any servicing that may have affected system calibration; or [Eff 11/30/2006] 7.53.1.2 The system shall have been calibrated within the previous 4 years; 18 to 30 months after that calibration, the system shall have been intercompared with another dosimetry system that was calibrated within the past 24 months by the National Institute of Standards and Technology or by a calibration laboratory accredited by the American Association of Physicists in Medicine. The results of the intercomparison must have indicated that the calibration factor of the licensee's system had not changed by more than 2 percent. The licensee shall not use the intercomparison result to change the calibration factor. When intercomparing dosimetry systems to be used for calibrating sealed sources for therapeutic units, the licensee shall use a comparable unit with beam attenuators or collimators, as applicable, and sources of the same radionuclide as the source used at the licensee's facility. [Eff 11/30/2006] 7.53.2 The licensee shall have available for use a dosimetry system for spot-check output measurements. To meet this requirement, the system may be compared with a system that has been calibrated in accordance with 7.53.1. This comparison shall have been performed within the previous year and after each servicing that may have affected system calibration. The spot- check system may be the same system used to meet the requirement in 7.53.1. [Eff 11/30/2006] 7.53.3 The licensee shall maintain a record of each calibration, intercomparison, and comparison for the duration of the license. For each calibration, intercomparison, or comparison, the record shall include: [Eff 11/30/2006] 7.53.3.1 The date; [Eff 11/30/2006] 7.53.3.2 The manufacturer’s name, the model numbers and serial numbers of the instruments that were calibrated, intercompared, or compared as required by 7.53.1 and 7.53.2; [Eff 11/30/2006] 7.53.3.3 The correction factor that were determined from the calibration or comparison or the apparent correction factor that was determined from an intercomparison; [Eff 11/30/2006] 7.53.3.4 The names of the individuals who performed the calibration, intercomparison, or comparison. [Eff 11/30/2006] 7.54 Full Calibration Measurements on Teletherapy Units. 7.54.1 A licensee authorized to use a teletherapy unit for medical use shall perform full calibration measurements on each teletherapy unit: [Eff 11/30/2006] 7.54.1.1 Before the first medical use of the unit; [Eff 11/30/2006] 7.54.1.2 Before medical use under the following conditions: [Eff 11/30/2006] (1) Whenever spot-check measurements indicate that the output differs by more than 5 percent from the output obtained at the last full calibration corrected mathematically for radioactive decay; [Eff 11/30/2006] (2) Following replacement of the source or following reinstallation of the teletherapy unit in a new location; and [Eff 11/30/2006] (3) Following any repair of the teletherapy unit that includes removal of the source or major repair of the components associated with the source exposure assembly; and [Eff 11/30/2006] 7.54.1.3 At intervals not exceeding 1 year. [Eff 11/30/2006] 7.54.2 To satisfy the requirement of 7.54.1, full calibration measurements shall include determination of: [Eff 11/30/2006] 7.54.2.1 The output within +/- 3 percent for the range of field sizes and for the distance or range of distances used for medical use; [Eff 11/30/2006] 7.54.2.2 The coincidence of the radiation field and the field indicated by the light beam localizing device; [Eff 11/30/2006] 7.54.2.3 The uniformity of the radiation field and its dependence on the orientation of the useful beam; [Eff 11/30/2006] 7.54.2.4 Timer accuracy, constancy, and linearity; [Eff 11/30/2006] 7.54.2.5 "On off" error; and [Eff 11/30/2006] 7.54.2.6 The accuracy of all distance measuring and localization devices in medical use. [Eff 11/30/2006] 7.54.3 A licensee shall use the dosimetry system described in 7.53 to measure the output for one set of exposure conditions. The remaining radiation measurements required in 7.54.2.1 may then be made using a dosimetry system that indicates relative dose rates. [Eff 11/30/2006] 7.54.4 A licensee shall make full calibration measurements required by 7.54.1 in accordance with published protocols accepted by nationally recognized bodies. [Eff 11/30/2006] 7.54.5 A licensee shall correct mathematically the outputs determined in 7.54.2.1 for physical decay for intervals not exceeding 1 month for cobalt 60, 6 months for cesium 137, or at intervals consistent with 1 percent decay for all other nuclides. [Eff 11/30/2006] 7.54.6 Full calibration measurements required by 7.54.1 and physical decay corrections required by 7.54.5 shall be performed by the authorized medical physicist. [Eff 11/30/2006] 7.54.7 A licensee shall maintain a record of each calibration for the duration of the license. The record shall include: [Eff 11/30/2006] 7.54.7.1 The date of the calibration; [Eff 11/30/2006] 7.54.7.2 The manufacturer's name, model number, and serial number for the teletherapy unit, source(s), and instruments used to calibrate the teletherapy unit; [Eff 11/30/2006] 7.54.7.3 The results and assessments of the full calibrations; and [Eff 11/30/2006] 7.54.7.4 The signature of the authorized medical physicist who performed the full calibration. [Eff 11/30/2006] 7.55 Full Calibration Measurements on Remote Afterloader Units. 7.55.1 A licensee authorized to use a remote afterloader unit for medical use shall perform full calibration measurements on each unit: [Eff 11/30/2006] 7.55.1.1 Before the first medical use of the unit; [Eff 11/30/2006] 7.55.1.2 Before medical use under the following conditions: [Eff 11/30/2006] (1) Following replacement of the source or following reinstallation of the unit in a new location outside the facility; and [Eff 11/30/2006] (2) Following any repair of the unit that includes removal of the source or major repair of the components associated with the source exposure assembly; and [Eff 11/30/2006] 7.55.1.3 At intervals not exceeding one (1) calendar quarter for high dose-rate, medium dose- rate, and pulsed dose-rate remote afterloader units with sources whose half-life exceeds 75 days; and [Eff 11/30/2006] 7.55.1.4 At intervals not exceeding 1 year for low dose-rate remote afterloader units. [Eff 11/30/2006] 7.55.2 To satisfy the requirement of 7.55.1, full calibration measurements must include, as applicable, determination of: [Eff 11/30/2006] 7.55.2.1 The output within +/- 5 percent; [Eff 11/30/2006] 7.55.2.2 Source positioning accuracy to within +/- 1 millimeter; [Eff 11/30/2006] 7.55.2.3 Source retraction with backup battery upon power failure; [Eff 11/30/2006] 7.55.2.4 Length of the source transfer tubes; [Eff 11/30/2006] 7.55.2.5 Timer accuracy and linearity over the typical range of use; [Eff 11/30/2006] 7.55.2.6 Length of the applicators; and [Eff 11/30/2006] 7.55.2.7 Function of the source transfer tubes, applicators, and transfer tube-applicator interfaces. [Eff 11/30/2006] 7.55.3 In addition to the requirements for full calibrations for low dose-rate remote afterloader units in 7.55.2, a licensee shall perform an autoradiograph of the source(s) to verify inventory and source(s) arrangement at intervals not exceeding one quarter. [Eff 11/30/2006] 7.55.4 A licensee shall use the dosimetry system described in 7.53 to measure the output. [Eff 11/30/2006] 7.55.5 A licensee shall make full calibration measurements required by 7.55.1 of this section in accordance with published protocols accepted by nationally recognized bodies. [Eff 11/30/2006] 7.55.6 For low dose-rate remote afterloader units, a licensee may use measurements provided by the source manufacturer that are made in accordance with 7.55.1 through 7.55.5. [Eff 11/30/2006] 7.55.7 A licensee shall mathematically correct the outputs determined in 7.55.2.1 for physical decay at intervals consistent with 1 percent physical decay. [Eff 11/30/2006] 7.55.8 Full calibration measurements required by 7.55.1 and physical decay corrections required by 7.55.7 must be performed by the authorized medical physicist. [Eff 11/30/2006] 7.55.9 A licensee shall retain a record of each calibration for the duration of the license. The record shall include: [Eff 11/30/2006] 7. 55.9.1 The date of the calibration; [Eff 11/30/2006] 7. 55.9.2 The manufacturer's name, model number, and serial number for the remote afterloader unit, source(s), and instruments used to calibrate the remote afterloader unit; [Eff 11/30/2006] 7. 55.9.3 The results and assessments of the full calibrations; [Eff 11/30/2006] 7. 55.9.4 The results of the autoradiograph required for low dose-rate remote afterloader units; and [Eff 11/30/2006] 7. 55.9.5 The signature of the authorized medical physicist who performed the full calibration. [Eff 11/30/2006] 7.56 Full Calibration Measurements on Gamma Stereotactic Radiosurgery Units. 7.56.1 A licensee authorized to use a gamma stereotactic radiosurgery unit for medical use shall perform full calibration measurements on each unit: [Eff 11/30/2006] 7.56.1.1 Before the first medical use of the unit; [Eff 11/30/2006] 7.56.1.2 Before medical use under the following conditions: [Eff 11/30/2006] (1) Whenever spot-check measurements indicate that the output differs by more than 5 percent from the output obtained at the last full calibration corrected mathematically for radioactive decay; [Eff 11/30/2006] (2) Following replacement of the sources or following reinstallation of the gamma stereotactic radiosurgery unit in a new location; and [Eff 11/30/2006] (3) Following any repair of the gamma stereotactic radiosurgery unit that includes removal of the sources or major repair of the components associated with the source assembly; and [Eff 11/30/2006] 7.56.1.3 At intervals not exceeding 1 year, with the exception that relative helmet factors need only be determined before the first medical use of a helmet and following any damage to a helmet. [Eff 11/30/2006] 7.56.2 To satisfy the requirement of 7.56.1, full calibration measurements must include determination of: [Eff 11/30/2006] 7.56.2.1 The output within +/-3 percent; [Eff 11/30/2006] 7.56.2.2 Relative helmet factors; [Eff 11/30/2006] 7.56.2.3 Isocenter coincidence; [Eff 11/30/2006] 7.56.2.4 Timer accuracy and linearity over the range of use; [Eff 11/30/2006] 7.56.2.5 On-off error; [Eff 11/30/2006] 7.56.2.6 Trunnion centricity; [Eff 11/30/2006] 7.56.2.7 Treatment table retraction mechanism, using backup battery power or hydraulic backups with the unit off; [Eff 11/30/2006] 7.56.2.8 Helmet microswitches; [Eff 11/30/2006] 7.56.2.9 Emergency timing circuits; and [Eff 11/30/2006] 7.56.2.10 Stereotactic frames and localizing devices (trunnions). [Eff 11/30/2006] 7.56.3 A licensee shall use the dosimetry system described in 7.53 to measure the output for one set of exposure conditions. The remaining radiation measurements required in 7.56.2.1 may be made using a dosimetry system that indicates relative dose rates. [Eff 11/30/2006] 7.56.4 A licensee shall make full calibration measurements required by 7.56.1 in accordance with published protocols accepted by nationally recognized bodies. [Eff 11/30/2006] 7.56.5 A licensee shall mathematically correct the outputs determined in 7.56.2.1 at intervals not exceeding 1 month for cobalt-60 and at intervals consistent with 1 percent physical decay for all other radionuclides. [Eff 11/30/2006] 7.56.6 Full calibration measurements required by 7.56.1 and physical decay corrections required by 7.56.5 must be performed by the authorized medical physicist. [Eff 11/30/2006] 7.56.7 A licensee shall retain a record of each calibration for the duration of the license. The record shall include: [Eff 11/30/2006] 7. 56.7.1 The date of the calibration; [Eff 11/30/2006] 7. 56.7.2 The manufacturer's name, model number, and serial number for the gamma stereotactic radiosurgery unit, source(s), and instruments used to calibrate the gamma stereotactic radiosurgery unit; [Eff 11/30/2006] 7. 56.7.3 The results and assessments of the full calibrations; [Eff 11/30/2006] 7. 56.7.4 The signature of the authorized medical physicist who performed the full calibration. [Eff 11/30/2006] 7.57 Radiation Surveys of Therapeutic Treatment Units.

7.57.1 A licensee authorized to use radioactive material in remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units shall possess a portable radiation detection survey instrument capable of detecting dose rates over the range of 1 µSv (0.1 mrem) per hour to 500 µSv (50 mrem) per hour, and a portable radiation measurement survey instrument capable of measuring dose rates over the range of 10 µSv (1 mrem) per hour to 10 mSv (1 rem) per hour. The instruments shall be operable and calibrated in accordance with 7.17. [Eff 11/30/2006] 7.57.2 In addition to the survey requirements in Part 4 of these regulations, a person licensed pursuant to Part 7 shall make surveys to ensure that the maximum radiation levels and average radiation levels from the surface of the main source safe with the source(s) in the shielded position does not exceed the levels stated in the Sealed Source and Device Registry. [Eff 11/30/2006] 7.57.3 The licensee shall make the survey required by 7.57.2 at installation of a new source and following repairs to the source(s) shielding, the source(s) driving unit, or other electronic or mechanical component that could expose the source, reduce the shielding around the source(s), or compromise the radiation safety of the unit or the source(s). [Eff 11/30/2006] 7.57.4 A licensee shall retain a record of the radiation surveys required by 7.57.2 for the duration of use of the unit. The record must include: [Eff 11/30/2006] 7.57.4.1 The date of the measurements; [Eff 11/30/2006] 7.57.4.2 The manufacturer's name, model number and serial number of the treatment unit, source, and instrument used to measure radiation levels; [Eff 11/30/2006] 7.57.4.3 Each dose rate measured around the source while the unit is in the off position and the average of all measurements; and [Eff 11/30/2006] 7.57.4.4 The signature of the authorized medical physicist who performed the test. [Eff 11/30/2006] 7.58 Periodic Spot Checks for Teletherapy Units.

7.58.1 A licensee authorized to use teletherapy units for medical use shall perform output spot checks on each teletherapy unit once in each calendar month, including determination of: [Eff 11/30/2006] 7.58.1.1 Timer accuracy and timer linearity over the range of use; [Eff 11/30/2006] 7.58.1.2 "On off" error; [Eff 11/30/2006] 7.58.1.3 The coincidence of the radiation field and the field indicated by the light beam localizing device; [Eff 11/30/2006] 7.58.1.4 The accuracy of all distance measuring and localization devices used for medical use; [Eff 11/30/2006] 7.58.1.5 The output for one typical set of operating conditions measured with the dosimetry system described in 7.53; and [Eff 11/30/2006] 7.58.1.6 The difference between the measurement made in 7.58.1.5 and the anticipated output, expressed as a percentage of the anticipated output (i.e., the value obtained at last full calibration corrected mathematically for physical decay). [Eff 11/30/2006] 7.58.2 A licensee shall perform spot checks required by 7.58.1 in accordance with procedures established by the authorized medical physicist. That individual need not actually perform the output spot-check measurements. [Eff 11/30/2006] 7.58.3 A licensee shall have the authorized medical physicist review the results of each spot check within 15 days. The authorized medical physicist shall promptly notify the licensee in writing of the results of each spot check. [Eff 11/30/2006] 7.58.4 A licensee authorized to use a teletherapy unit for medical use shall perform safety spot checks of each teletherapy facility once in each calendar month and after each source installation to assure proper operation of: [Eff 11/30/2006] 7.58.4.1 Electrical interlocks at each teletherapy room entrance; [Eff 11/30/2006] 7.58.4.2 Electrical or mechanical stops installed for the purpose of limiting use of the primary beam of radiation restriction of source housing angulation or elevation, carriage or stand travel, and operation of the beam "on off" mechanism; [Eff 11/30/2006] 7.58.4.3 Source exposure indicator lights on the teletherapy unit, on the control console, and in the facility; [Eff 11/30/2006] 7.58.4.4 Viewing and intercom systems; [Eff 11/30/2006] 7.58.4.5 Treatment room doors from inside and outside the treatment room; and [Eff 11/30/2006] 7.58.4.6 Electrically assisted treatment room doors with the teletherapy unit electrical power turned "off". [Eff 11/30/2006] 7.58.5 If the results of the checks required in 7.58.4 indicate the malfunction of any system, a licensee shall lock the control console in the "off" position and not use the unit except as may be necessary to repair, replace, or check the malfunctioning system. [Eff 11/30/2006] 7.58.6 A licensee shall maintain a record of each spot check required by 7.58.1 and 7.58.5 for 3 years. The record shall include: [Eff 11/30/2006] 7.58.6.1 The date of the spot check; [Eff 11/30/2006] 7.58.6.2 The manufacturer's name, model number, and serial number for the teletherapy unit, source, and instrument used to measure the output of the teletherapy unit; [Eff 11/30/2006] 7.58.6.3 An assessment of timer linearity and constancy; [Eff 11/30/2006] 7.58.6.4 The calculated "on off" error; [Eff 11/30/2006] 7.58.6.5 A determination of the coincidence of the radiation field and the field indicated by the light beam localizing device [Eff 11/30/2006] 7.58.6.6 The determined accuracy of each distance measuring or localization device; [Eff 11/30/2006] 7.58.6.7 The difference between the anticipated output and the measured output; [Eff 11/30/2006] 7.58.6.8 Notations indicating the operability of each entrance door electrical interlock, each electrical or mechanical stop, each source exposure indicator light, and the viewing and intercom system and doors; and [Eff 11/30/2006] 7.58.6.9 The name of the individual who performed the periodic spot check and the signature of the authorized medical physicist who reviewed the record of the spot check. [Eff 11/30/2006] 7.59 Periodic Spot Checks for Remote Afterloader Units. 7.59.1 A licensee authorized to use remote afterloader units for medical use shall perform spot checks of each remote afterloader facility and on each unit: [Eff 11/30/2006] 7.59.1.1 At the beginning of each day of use of a high dose-rate, medium dose-rate or pulsed dose-rate remote afterloader unit; [Eff 11/30/2006] 7.59.1.2 Prior to each patient treatment with a low dose-rate remote afterloader unit; and [Eff 11/30/2006] 7.59.1.3 After each source installation. [Eff 11/30/2006] 7.59.2 The licensee shall have the authorized medical physicist establish written procedures for performing the spot checks required in 7.59.1 The authorized medical physicist need not actually perform the spot-check measurements. [Eff 11/30/2006] 7.59.3 A licensee shall have the authorized medical physicist review the results of each spot check within 15 days. The authorized medical physicist shall notify the licensee as soon as possible in writing of the results of each spot check. [Eff 11/30/2006] 7.59.4 To satisfy the requirements of 7.59.1, spot checks must, at a minimum, assure proper operation of: [Eff 11/30/2006] 7.59.4.1 Electrical interlocks at each remote afterloader unit room entrance; [Eff 11/30/2006] 7.59.4.2 Source exposure indicator lights on the remote afterloader unit, on the control console, and in the facility; [Eff 11/30/2006] 7.59.4.3 Viewing and intercom systems in each high dose-rate, medium dose-rate and pulsed dose-rate remote afterloader facility; [Eff 11/30/2006] 7.59.4.4 Emergency response equipment; [Eff 11/30/2006] 7.59.4.5 Radiation monitors used to indicate the source position; [Eff 11/30/2006] 7.59.4.6 Timer accuracy; [Eff 11/30/2006] 7.59.4.7 Clock (date and time) in the unit's computer; and [Eff 11/30/2006] 7.59.4.8 Decayed source(s) activity in the unit's computer. [Eff 11/30/2006] 7.59.5 If the results of the checks required in 7.59.4 indicate the malfunction of any system, a licensee shall lock the control console in the off position and not use the unit except as may be necessary to repair, replace, or check the malfunctioning system. [Eff 11/30/2006] 7.59.6 A licensee shall retain a record of each check required by 7.59.4 for 3 years. The record must include, as applicable: [Eff 11/30/2006] 7.59.6.1 The date of the spot check; [Eff 11/30/2006] 7.59.6.2 The manufacturer's name, model number, and serial number for the remote afterloader unit and source; [Eff 11/30/2006] 7.59.6.3 An assessment of timer accuracy; [Eff 11/30/2006] 7.59.6.4 Notations indicating the operability of each entrance door electrical interlock, radiation monitors, source exposure indicator lights, viewing and intercom systems, and clock and decayed source activity in the unit's computer; and [Eff 11/30/2006] 7.59.6.5 The name of the individual who performed the periodic spot check and the signature of the authorized medical physicist who reviewed the record of the spot check. [Eff 11/30/2006] 7.60 Additional Technical Requirements for Mobile Remote Afterloader Units. 7.60.1 A licensee providing mobile remote afterloader service shall: [Eff 11/30/2006] 7.60.1.1 Check survey instruments for consistent response before medical use at each address of use or on each day of use, whichever is more frequent; and [Eff 11/30/2006] 7.60.1.2 Account for all sources before departure from a client's address of use. [Eff 11/30/2006] 7.60.2 In addition to the periodic spot checks required by 7.59, a licensee authorized to use mobile afterloaders for medical use shall perform checks on each remote afterloader unit before use at each address of use. At a minimum, checks must be made to verify the operation of: [Eff 11/30/2006] 7.60.2.1 Electrical interlocks on treatment area access points; [Eff 11/30/2006] 7.60.2.2 Source exposure indicator lights on the remote afterloader unit, on the control console, and in the facility; [Eff 11/30/2006] 7.60.2.3 Viewing and intercom systems; [Eff 11/30/2006] 7.60.2.4 Applicators, source transfer tubes, and transfer tube-applicator interfaces; [Eff 11/30/2006] 7.60.2.5 Radiation monitors used to indicate room exposures; [Eff 11/30/2006] 7.60.2.6 Source positioning (accuracy); and [Eff 11/30/2006] 7.60.2.7 Radiation monitors used to indicate whether the source has returned to a safe shielded position. [Eff 11/30/2006] 7.60.3 In addition to the requirements for checks in 7.60.2, a licensee shall ensure overall proper operation of the remote afterloader unit by conducting a simulated cycle of treatment before use at each address of use. [Eff 11/30/2006] 7.60.4 If the results of the checks required in 7.60.2 indicate the malfunction of any system, a licensee shall lock the control console in the off position and not use the unit except as may be necessary to repair, replace, or check the malfunctioning system. [Eff 11/30/2006] 7.60.5 A licensee shall retain a record of each check required by 7.60.2 for 3 years. The record must include: [Eff 11/30/2006] 7.60.5.1 The date of the check; [Eff 11/30/2006] 7.60.5.2 The manufacturer's name, model number, and serial number of the remote afterloader unit; [Eff 11/30/2006] 7.60.5.3 Notations accounting for all sources before the licensee departs from a facility; [Eff 11/30/2006] 7.60.5.4 Notations indicating the operability of each entrance door electrical interlock, radiation monitors, source exposure indicator lights, viewing and intercom system, applicators and source transfer tubes, and source positioning accuracy; and [Eff 11/30/2006] 7.60.5.5 The signature of the individual who performed the check. [Eff 11/30/2006] 7.61 Periodic Spot Checks for Gamma Stereotactic Radiosurgery Units. 7.61.1 A licensee authorized to use a gamma stereotactic radiosurgery unit for medical use shall perform spot checks of each gamma stereotactic radiosurgery facility and on each unit: [Eff 11/30/2006] 7.61.1.1 Monthly; [Eff 11/30/2006] 7.61.1.2 At the beginning of each day of use; and [Eff 11/30/2006] 7.61.1.3 After each source installation. [Eff 11/30/2006] 7.61.2 The licensee shall have the authorized medical physicist: [Eff 11/30/2006] 7.61.2.1 Establish written procedures for performing the spot checks required in 7.61.1; and [Eff 11/30/2006] 7.61.2.2 Review the results of each spot check required by 7.61.1.1 within 15 days of the check. The authorized medical physicist need not actually perform the spot-check measurements. The authorized medical physicist shall notify the licensee as soon as possible, in writing, of the results of the spot check. [Eff 11/30/2006] 7.61.3 To satisfy the requirements of 7.61.1.1 spot checks must, at a minimum: [Eff 11/30/2006] 7.61.3.1 Assure proper operation of: [Eff 11/30/2006] (1) Treatment table retraction mechanism, using backup battery power or hydraulic backups with the unit off; [Eff 11/30/2006] (2) Helmet microswitches; [Eff 11/30/2006] (3) Emergency timing circuits; and [Eff 11/30/2006] (4) Stereotactic frames and localizing devices (trunnions). [Eff 11/30/2006] 7.61.3.2 Determine: [Eff 11/30/2006] (1) The output for one typical set of operating conditions measured with the dosimetry system described in 7.53.2; [Eff 11/30/2006] (2) The difference between the measurement made in 7.61.3.2(1) and the anticipated output, expressed as a percentage of the anticipated output (i.e., the value obtained at last full calibration corrected mathematically for physical decay); [Eff 11/30/2006] (3) Source output against computer calculation; [Eff 11/30/2006] (4) Timer accuracy and linearity over the range of use; [Eff 11/30/2006] (5) On-off error; and [Eff 11/30/2006] (6) Trunnion centricity. [Eff 11/30/2006] 7.61.4 To satisfy the requirements of 7.61.1.2 and 7.61.1.3, spot checks must assure proper operation of: [Eff 11/30/2006] 7.61.4.1 Electrical interlocks at each gamma stereotactic radiosurgery room entrance; [Eff 11/30/2006] 7.61.4.2 Source exposure indicator lights on the gamma stereotactic radiosurgery unit, on the control console, and in the facility; [Eff 11/30/2006] 7.61.4.3 Viewing and intercom systems; [Eff 11/30/2006] 7.61.4.4 Timer termination; [Eff 11/30/2006] 7.61.4.5 Radiation monitors used to indicate room exposures; and [Eff 11/30/2006] 7.61.4.6 Emergency off buttons. [Eff 11/30/2006] 7.61.5 A licensee shall arrange for prompt repair of any system identified in 7.61.3 that is not operating properly. [Eff 11/30/2006] 7.61.6 If the results of the checks required in 7.61.4 indicate the malfunction of any system, a licensee shall lock the control console in the off position and not use the unit except as may be necessary to repair, replace, or check the malfunctioning system. [Eff 11/30/2006] 7.61.7 A licensee shall retain a record of each check required by 7.61.3 and 7.61.4 for 3 years. The record must include: [Eff 11/30/2006] 7.61.7.1 The date of the spot check; [Eff 11/30/2006] 7.61.7.2 The manufacturer's name, model number, and serial number for the gamma stereotactic radiosurgery unit and the instrument used to measure the output of the unit; [Eff 11/30/2006] 7.61.7.3 An assessment of timer linearity and accuracy; [Eff 11/30/2006] 7.61.7.4 The calculated on-off error; [Eff 11/30/2006] 7.61.7.5 A determination of trunnion centricity; [Eff 11/30/2006] 7.61.7.6 The difference between the anticipated output and the measured output; [Eff 11/30/2006] 7.61.7.7 An assessment of source output against computer calculations; [Eff 11/30/2006] 7.61.7.8 Notations indicating the operability of radiation monitors, helmet microswitches, emergency timing circuits, emergency off buttons, electrical interlocks, source exposure indicator lights, viewing and intercom systems, timer termination, treatment table retraction mechanism, and stereotactic frames and localizing devices (trunnions); and [Eff 11/30/2006] 7.61.7.9 The name of the individual who performed the periodic spot check and the signature of the authorized medical physicist who reviewed the record of the spot check. [Eff 11/30/2006] 7.62 Other Medical Uses of Radioactive Material or Radiation From Radioactive Material. 7.62.1 A licensee may use radioactive material or a radiation source approved for medical use that is not specifically addressed in Part 7 if: [Eff 11/30/2006] 7.62.1.1 The applicant or licensee has submitted the information required by 7.3.4.2, 7.3.4.3, and 7.3.4.4; and [Eff 11/30/2006] 7.62.1.2 The applicant or licensee has received written approval from the an Agreement State, Licensing State, or NRC in a license and uses the material in accordance with the regulations and specific conditions that the Agreement State, Licensing State, or NRC considers necessary for the medical use of the material. [Eff 11/30/2006] 7.63 Five Year Inspection.

7.63.1 A licensee shall have each teletherapy unit and gamma stereotactic radiosurgery unit fully inspected and serviced during source replacement or at intervals not to exceed 5 years, whichever comes first, to assure proper functioning of the source exposure mechanism. [Eff 11/30/2006] 7.63.2 This inspection and servicing shall only be performed by persons specifically licensed to do so by the Department, another Agreement State, a Licensing State, or the NRC. [Eff 11/30/2006] 7.63.3 A licensee shall keep a record of the inspection and servicing for the duration of the license. The record shall contain: [Eff 11/30/2006] 7.63.3.1 The inspector's radioactive materials license number; [Eff 11/30/2006] 7.63.3.2 The date of inspection; [Eff 11/30/2006] 7.63.3.3 The manufacturer's name and model number and serial number of both the treatment unit and source; [Eff 11/30/2006] 7.63.3.4 A list of components inspected and serviced; [Eff 11/30/2006] 7.63.3.5 A list of components inspected and serviced, and the type of service; [Eff 11/30/2006] 7.63.3.6 A list of components replaced; and [Eff 11/30/2006] 7.63.3.7 The signature of the inspector. [Eff 11/30/2006] PART 7, APPENDIX 7A: RADIATION SAFETY OFFICER (RSO) ADEQUATE RADIATION SAFETY TRAINING AND EXPERIENCE The licensee shall require the individual fulfilling the responsibilities of the Radiation Safety Officer (RSO) as provided in 7.7 to be an individual who: [Eff 11/30/2006] 7A1 Has provided: [Eff 11/30/2006] 7A1.1 Evidence of current certification in health physics or medical physics by a recognized specialty board (see 7A5); and [Eff 11/30/2006] 7A1.2 Written attestation(s), signed by a preceptor RSO, that the individual has achieved a level of radiation safety knowledge sufficient to function independently as an RSO for a medical use licensee; [Eff 11/30/2006] (1) Each preceptor RSO supervising the training required by Appendix 7A shall meet the requirements for an RSO for the type(s) of use for which the individual is seeking authorization; and [Eff 11/30/2006] 7A1.3 Evidence of documented experience with the radiation safety aspects of the type(s) of use or similar type(s) of use of radioactive material for which the individual is seeking to have RSO responsibilities. [Eff 11/30/2006] (1) For a new type of use under 7.62, acceptable training under 7A2.2 is sufficient, unless the Department determines otherwise; [Eff 11/30/2006] or [Eff 11/30/2006] 7A2 Has satisfied the following criteria: [Eff 11/30/2006] 7A2.1 Has provided written attestation(s), signed by a preceptor RSO, that the individual has completed a structured educational program that includes: [Eff 11/30/2006] (1) 200 hours of classroom and laboratory training in the following areas: [Eff 11/30/2006] (a) Radiation physics and instrumentation; [Eff 11/30/2006] (b) Radiation protection; [Eff 11/30/2006] (c) Mathematics pertaining to the use and measurement of radioactivity; [Eff 11/30/2006] (d) Radiation biology; and [Eff 11/30/2006] (e) Radiation dosimetry; and [Eff 11/30/2006] (2) 1 year of full-time radiation safety experience, under the supervision of an RSO, authorized medical physicist, authorized nuclear pharmacist, or authorized user, as appropriate, on an Agreement State or NRC license that authorizes similar type(s) of use of radioactive material, involving the following: [Eff 11/30/2006] (a) Shipping, receiving, and performing related radiation surveys; [Eff 11/30/2006] (b) Using and performing checks for proper operation of dose calibrators, survey meters, and, if appropriate, instruments used to measure radionuclides; [Eff 11/30/2006] (c) Securing and controlling radioactive material; [Eff 11/30/2006] (d) Using administrative controls to avoid mistakes in the administration of radioactive material; [Eff 11/30/2006] (e) Using procedures to prevent or minimize radioactive contamination and using proper decontamination procedures; [Eff 11/30/2006] (f) Using emergency procedures to control radioactive material; and [Eff 11/30/2006] (g) Disposing of radioactive material; and [Eff 11/30/2006] 7A2.2 Has experiential training in the radiation safety, regulatory issues, and emergency procedures for the type(s) of use for which the licensee is seeking approval, for example, training supervised by an RSO, authorized medical physicist, authorized nuclear pharmacist, or authorized user on an Agreement State or NRC license that authorizes similar type(s) of use of radioactive material; and [Eff 11/30/2006] 7A2.3 Has provided written attestation(s), signed by a preceptor RSO, that the individual has achieved a level of radiation safety knowledge sufficient to function independently as an RSO for a medical use licensee; [Eff 11/30/2006] or [Eff 11/30/2006] 7A3 Has demonstrated adequate prior experience as: [Eff 11/30/2006] 7A3.1 An experienced medical physicist who has provided written attestation(s), signed by a preceptor RSO, that the medical physicist: [Eff 11/30/2006] (1) Is certified by a specialty board whose certification process has been recognized under 7A5.2; and [Eff 11/30/2006] (2) Has satisfied 7A1.2, 7A2.2 and 7A2.3; [Eff 11/30/2006] or [Eff 11/30/2006] 7A3.2 An authorized user, authorized medical physicist, or authorized nuclear pharmacist who: [Eff 11/30/2006] (1) Is identified on the licensee's current license; and [Eff 11/30/2006] (2) Has satisfied 7A1.2, 7A2.2 and 7A2.3; [Eff 11/30/2006] or [Eff 11/30/2006] 7A3.3 An experienced RSO who was identified before October 25, 2005 (and thus need not comply with 7A1, 7A2.1 or 7A2.2) either on: [Eff 11/30/2006] (1) An Agreement State or NRC license that authorizes medical use; or [Eff 11/30/2006] (2) A permit issued by an Agreement State or NRC broad scope licensee that authorizes medical use; or on [Eff 11/30/2006] (3) An equivalent permit or license recognized by the Department for similar types and uses of radioactive material. [Eff 11/30/2006] 7A4 Training and experience required by Appendix 7A shall have been obtained: [Eff 11/30/2006] 7A4.1 Within the 7 years preceding the date of license application; or [Eff 11/30/2006] 7A4.2 Through documented subsequent continuing education and experience. [Eff 11/30/2006] 7A5 To be recognized by an Agreement State or the U.S. Nuclear Regulatory Commission (posted by NRC at http://www.nrc.gov/materials/miau/med-use-toolkit/spec-board-cert.html) a specialty board shall require that each candidate for certification: [Eff 11/30/2006] 7A5.1 With a health physics background: [Eff 11/30/2006] (1) Hold a bachelor's or graduate degree from an accredited college or university in physical science or engineering or biological science with a minimum of 20 college credits in physical science; and [Eff 11/30/2006] (2) Have 5 or more years of professional experience in health physics, provided: [Eff 11/30/2006] (a) At least 3 years are in applied health physics; and [Eff 11/30/2006] (b) Graduate training may be substituted for no more than 2 years of the required 5 years of experience; and [Eff 11/30/2006] (3) Pass an examination administered by diplomates of the specialty board that evaluates knowledge and competence in radiation physics and instrumentation, radiation protection, mathematics pertaining to the use and measurement of radioactivity, radiation biology, and radiation dosimetry; [Eff 11/30/2006] 7A5.2 With a medical physics background: [Eff 11/30/2006] (1) Hold a master's or doctor's degree in physics, medical physics, other physical science, engineering, or applied mathematics from an accredited college or university; and [Eff 11/30/2006] (2) Have 2 years of full-time practical training and/or supervised experience in medical physics; [Eff 11/30/2006] (a) Under the supervision of a medical physicist who is certified in medical physics by a specialty board recognized by an Agreement State or NRC; or [Eff 11/30/2006] (b) In clinical nuclear medicine facilities providing diagnostic and / or therapeutic services under the general supervision of physicians who meet the requirements of Appendix 7F or Appendix 7G; and [Eff 11/30/2006] (3) Pass an examination administered by diplomates of the specialty board that assesses knowledge and competence in clinical diagnostic radiological or nuclear medicine physics and in radiation safety. [Eff 11/30/2006] PART 7, APPENDIX 7B: AUTHORIZED MEDICAL PHYSICIST (AMP) ADEQUATE RADIATION SAFETY TRAINING AND EXPERIENCE The licensee shall require each authorized medical physicist to be an individual who: [Eff 11/30/2006] 7B1 Has provided: [Eff 11/30/2006] 7B1.1 Evidence of current certification by a recognized specialty board (see 7B5); and [Eff 11/30/2006] 7B1.2 Written attestation(s), signed by a preceptor medical physicist, that the individual has achieved a level of competency sufficient to function independently as an authorized medical physicist for each type of therapeutic medical unit for which the individual is requesting authorized medical physicist status; [Eff 11/30/2006] (1) Each preceptor medical physicist supervising the training required by Appendix 7B shall meet the requirements for an authorized medical physicist for the type(s) of use for which the individual is seeking authorization; [Eff 11/30/2006] (2) The Department may, upon application or upon its own initiative, accept as being adequate: [Eff 11/30/2006] (a) Documentation that the equivalent component of an Agreement State or NRC requirement has been met; or [Eff 11/30/2006] (b) Equivalent approval by another state or agency; and [Eff 11/30/2006] 7B1.3 Written attestation(s), signed by a preceptor medical physicist, that the individual has adequate training for the type(s) of use for which authorization is sought: [Eff 11/30/2006] (1) Including: [Eff 11/30/2006] (a) Hands-on device operation; [Eff 11/30/2006] (b) Safety procedures; [Eff 11/30/2006] (c) Clinical use, and [Eff 11/30/2006] (d) Treatment planning system operation; and [Eff 11/30/2006] (2) Provided by either: [Eff 11/30/2006] (a) Satisfactorily completing a vendor training program; or [Eff 11/30/2006] (b) Being supervised by an authorized medical physicist authorized for the type(s) of use for which the individual is seeking authorization; and [Eff 11/30/2006] or [Eff 11/30/2006] 7B2 Has provided written attestation(s), signed by a preceptor medical physicist, that the individual: [Eff 11/30/2006] 7B2.1 Holds a master’s or doctor’s degree in physics, medical physics, other physical science, engineering, or applied mathematics from an accredited college or university; [Eff 11/30/2006] 7B2.2 Has satisfactorily completed 2 years of training and work experience that: [Eff 11/30/2006] (1) Include one-year of full-time training in medical physics; and [Eff 11/30/2006] (2) Include an additional year of full-time practical experience; [Eff 11/30/2006] (3) Are conducted in clinical radiation facilities that provide high energy, external beam (photons or electrons =/ > 1 MeV) therapy and brachytherapy services; [Eff 11/30/2006] (4) And include: [Eff 11/30/2006] (a) Performing sealed source leak tests and inventories; [Eff 11/30/2006] (b) Performing decay corrections; [Eff 11/30/2006] (c) Performing full calibration and periodic spot checks of external beam treatment units, stereotactic radiosurgery units, and remote afterloading units as applicable; and [Eff 11/30/2006] (d) Conducting radiation surveys around external beam treatment units, stereotactic radiosurgery units, and remote afterloading units as applicable; and [Eff 11/30/2006] 7B2.3 Has also satisfied 7B1.1 and 7B1.2. [Eff 11/30/2006] or [Eff 11/30/2006] 7B3 Has demonstrated adequate prior experience as: [Eff 11/30/2006] 7B3.1 An authorized medical physicist identified on a current license or permit, either on: [Eff 11/30/2006] (1) A specific medical license or equivalent permit issued by the Department, another Agreement State, a Licensing State, or NRC; or [Eff 11/30/2006] (2) A permit issued by a Department, Agreement State, Licensing State, or NRC specific medical use licensee of broad scope that is authorized to permit the use of radioactive material; or [Eff 11/30/2006] 7B3.2 An experienced medical physicist who was identified before October 25, 2005 (and thus need not comply with the training and experience requirements of 7B1 or 7B2) either on: [Eff 11/30/2006] (1) An NRC or Agreement State license; or [Eff 11/30/2006] (2) A permit issued under an NRC or Agreement State broad scope license that authorizes medical use; or [Eff 11/30/2006] 7B3.3 An experienced medical physicist who has demonstrated to the Department experience in the type(s) of use for which the individual is requesting authorized medical physicist status (and thus need not comply with the specific training and experience requirements of 7B1 or 7B2): [Eff 11/30/2006] (1) Having been certified before October 25, 2005 by the American Board of Radiology in: [Eff 11/30/2006] (a) Therapeutic radiological physics; [Eff 11/30/2006] (b) Roentgen ray and gamma ray physics; [Eff 11/30/2006] (c) X-ray and radium physics; or [Eff 11/30/2006] (d) Radiological physics; or [Eff 11/30/2006] (2) Having been certified before October 25, 2005 by the American Board of Medical Physics in radiation oncology physics; [Eff 11/30/2006] (3) And having sufficient work experience that includes the tasks listed in 7.13.2 and/or other sections of these regulations related to medical physics, as applicable (having also satisfied 7B2.1 and being trained in therapeutic radiological physics). [Eff 11/30/2006] 7B4 Training and experience required by Appendix 7B shall have been obtained: [Eff 11/30/2006] 7B4.1 Within the 7 years preceding the date of license application; or [Eff 11/30/2006] 7B4.2 Through documented subsequent continuing education and experience. [Eff 11/30/2006] 7B5 To be recognized by an Agreement State or the U.S. Nuclear Regulatory Commission (posted by NRC at http://www.nrc.gov/materials/miau/med-use-toolkit/spec-board-cert.html), a specialty board shall require that each candidate for certification: [Eff 11/30/2006] 7B5.1 Hold a master's or doctor's degree in physics, medical physics, other physical science, engineering, or applied mathematics from an accredited college or university; and [Eff 11/30/2006] 7B5.2 Have 2 years of full-time practical training and/or supervised experience in medical physics; [Eff 11/30/2006] (1) Under the supervision of a medical physicist who is certified in medical physics by a specialty board recognized by an Agreement State or NRC; or [Eff 11/30/2006] (2) In clinical radiation facilities providing high energy, external beam therapy and brachytherapy services under the direction of physicians who meet the requirements for authorized users in Appendix 7K or Appendix 7M; and [Eff 11/30/2006] 7B5.3 Pass an examination administered by diplomates of the specialty board, that assesses knowledge and competence in clinical radiation therapy, radiation safety, calibration, quality assurance and treatment planning for external beam therapy, brachytherapy, and stereotactic radiosurgery. [Eff 11/30/2006] PART 7, APPENDIX 7C: AUTHORIZED NUCLEAR PHARMACIST (ANP) ADEQUATE RADIATION SAFETY TRAINING AND EXPERIENCE The licensee shall require each authorized nuclear pharmacist to be a pharmacist who has a current active Colorado State Board of Pharmacy license and who: [Eff 11/30/2006] 7C1 Has provided: [Eff 11/30/2006] 7C1.1 Evidence of: [Eff 11/30/2006] (1) Current Board of Pharmaceutical Specialties Certification as a Nuclear Pharmacist; or [Eff 11/30/2006] (2) Current certification by a recognized specialty board (see 7C5); and [Eff 11/30/2006] 7C1.2 Written attestation(s), signed by a preceptor nuclear pharmacist, that the individual has achieved a level of competency sufficient to function independently as a nuclear pharmacist; [Eff 11/30/2006] (1) Each preceptor nuclear pharmacist supervising the experiential training required by Appendix 7C shall meet the requirements for an authorized nuclear pharmacist; [Eff 11/30/2006] or [Eff 11/30/2006] 7C2 Has satisfied the following criteria: [Eff 11/30/2006] 7C2.1 Has provided written attestation(s), signed by a preceptor nuclear pharmacist, that the individual has completed 700 hours in a structured educational program that includes: [Eff 11/30/2006] (1) 200 hours of classroom and laboratory training in the following areas: [Eff 11/30/2006] (a) Radiation physics and instrumentation; [Eff 11/30/2006] (b) Radiation protection; [Eff 11/30/2006] (c) Mathematics pertaining to the use and measurement of radioactivity; [Eff 11/30/2006] Chemistry of radioactive material for medical use; and [Eff 11/30/2006] Radiation biology; and [Eff 11/30/2006] (2) Supervised practical experience in nuclear pharmacy involving: [Eff 11/30/2006] (a) Shipping, receiving, and performing related radiation surveys; [Eff 11/30/2006] (b) Using and performing checks for proper operation of instruments to determine the activity of dosages, survey meters, and, if appropriate, instruments used to measure alpha or beta-emitting radionuclides; [Eff 11/30/2006] (c) Calculating, assaying, and safely preparing dosages for patients or human research subjects; [Eff 11/30/2006] (d) Using administrative controls to avoid misadministrations in the administration of radioactive material; and [Eff 11/30/2006] (e) Using procedures to prevent or minimize radioactive contamination and using proper decontamination procedures; and [Eff 11/30/2006] 7C2.2 Has provided written attestation(s), signed by a preceptor nuclear pharmacist, that the individual has achieved a level of competency sufficient to function independently as a nuclear pharmacist. [Eff 11/30/2006] or [Eff 11/30/2006] 7C3 Has demonstrated adequate prior experience as: [Eff 11/30/2006] 7C3.1 An authorized nuclear pharmacist identified on a current facility license or permit, either on: [Eff 11/30/2006] (1) A specific license or equivalent permit that authorizes medical use or the practice of pharmacy issued by the Department, an Agreement State, Licensing State, or NRC; or [Eff 11/30/2006] (2) A permit issued under a Department, Agreement State, Licensing State, or NRC specific license of broad scope that is authorized to permit the use of radioactive material; [Eff 11/30/2006] or [Eff 11/30/2006] 7C3.2 Is an experienced nuclear pharmacist who was identified before October 25, 2005 (and thus need not comply with the requirements of 7C2) either on: [Eff 11/30/2006] (1) An NRC or Agreement State license; or [Eff 11/30/2006] (2) A permit issued under an NRC or Agreement State broad scope license that authorizes the practice of nuclear pharmacy. [Eff 11/30/2006] 7C4 Training and experience required by Appendix 7C shall have been obtained: [Eff 11/30/2006] 7C4.1 Within the 7 years preceding the date of license application; or [Eff 11/30/2006] 7C4.2 Through documented subsequent continuing education and experience. [Eff 11/30/2006] 7C5 To be recognized by an Agreement State or the U.S. Nuclear Regulatory Commission (posted by NRC at http://www.nrc.gov/materials/miau/med-use-toolkit/spec-board-cert.html), a specialty board shall require that each candidate for certification: [Eff 11/30/2006] 7C5.1 Have graduated from a pharmacy program accredited by the American Council on Pharmaceutical Education (ACPE) or have passed the Foreign Pharmacy Graduate Examination Committee (FPGEC) examination; [Eff 11/30/2006] 7C5.2 Hold a current, active license to practice pharmacy; [Eff 11/30/2006] 7C5.3 Provide evidence of having acquired at least 4000 hours of training/experience in nuclear pharmacy practice (academic training may be substituted for no more than 2000 hours of the required training and experience); and [Eff 11/30/2006] 7C5.4 Pass an examination, in nuclear pharmacy administered by diplomates of the specialty board, which assesses knowledge and competency in procurement, compounding, quality assurance, dispensing, distribution, health and safety, radiation safety, provision of information and consultation, monitoring patient outcomes, and research and development. [Eff 11/30/2006] PART 7, APPENDIX 7D: AUTHORIZED USER FOR UPTAKE, DILUTION AND EXCRETION STUDIES (7.30) ADEQUATE RADIATION SAFETY TRAINING AND EXPERIENCE The licensee shall require an authorized user of an unsealed radioactive material for the uses authorized under 7.30 to be a physician who has a current active State of Colorado license and: [Eff 11/30/2006] 7D1 Has provided: [Eff 11/30/2006] 7D1.1 Evidence of current certification by a recognized specialty board (see 7D5); and [Eff 11/30/2006] 7D1.2 Written attestation(s), signed by a preceptor authorized user, that the individual has achieved a level of competency sufficient to function independently as an authorized user for the medical uses authorized under 7.30; [Eff 11/30/2006] (1) Each preceptor authorized user supervising the experiential training required by Appendix 7D shall meet the requirements of Appendix 7D, Appendix 7E or Appendix 7F, or equivalent Agreement State or NRC requirements. [Eff 11/30/2006] or [Eff 11/30/2006] 7D2 Has satisfied the following criteria: [Eff 11/30/2006] 7D2.1 Has provided written attestation(s), signed by a preceptor authorized user, that the individual has satisfactorily completed 60 hours in basic radionuclide handling techniques applicable to the medical use of unsealed radioactive materials for uptake, dilution, and excretion studies, including: [Eff 11/30/2006] (1) 8 hours of classroom and laboratory training in the following areas: [Eff 11/30/2006] (a) Radiation physics and instrumentation; [Eff 11/30/2006] (b) Radiation protection; [Eff 11/30/2006] (c) Mathematics pertaining to the use and measurement of radioactivity; [Eff 11/30/2006] Chemistry of radioactive material for medical use; and [Eff 11/30/2006] Radiation biology; and [Eff 11/30/2006] (2) Work experience involving: [Eff 11/30/2006] (a) Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys; [Eff 11/30/2006] (b) Performing quality control procedures on instruments used to determine the activity of dosages and performing checks for proper operation of survey meters; [Eff 11/30/2006] (c) Calculating, measuring, and safely preparing patient or human research subject dosages; [Eff 11/30/2006] (d) Using administrative controls to prevent a misadministration involving the use of unsealed radioactive material; [Eff 11/30/2006] (e) Using procedures to contain spilled radioactive material safely and using proper decontamination procedures; and [Eff 11/30/2006] (f) Administering dosages to patients or human research subjects; [Eff 11/30/2006] 7D2.2 Has provided written attestation(s), signed by a preceptor authorized user, that the individual has achieved a level of competency sufficient to function independently as an authorized user for the medical uses authorized under 7.30. [Eff 11/30/2006] or [Eff 11/30/2006] 7D3 Has demonstrated adequate prior experience as: [Eff 11/30/2006] 7D3.1 An authorized user identified on a current facility license or permit under Appendix 7E or Appendix 7F (and also meets the requirements specified in 7E3.1.7), or under equivalent Agreement State or NRC requirements, and has achieved a level of competency sufficient to function independently as an authorized user for the medical uses authorized under 7.30; [Eff 11/30/2006] or [Eff 11/30/2006] 7D3.2 An experienced authorized user for uptake, dilution and excretion studies who: [Eff 11/30/2006] (1) Was identified before October 25, 2005 (and thus need not comply with the requirements of 7D2) either on: [Eff 11/30/2006] (a) An NRC or Agreement State license; or [Eff 11/30/2006] (b) A permit issued under an NRC or Agreement State broad scope license that authorizes medical use or the practice of nuclear pharmacy; [Eff 11/30/2006] (2) Performs only those medical uses for which the authorized user identified in accord with 7D3.2(1) was authorized on October 25, 2005. [Eff 11/30/2006] 7D4 Training and experience required by Appendix 7D shall have been obtained: [Eff 11/30/2006] 7D4.1 Within the 7 years preceding the date of license application; or [Eff 11/30/2006] 7D4.2 Through documented subsequent continuing education and experience. [Eff 11/30/2006] 7D5 To be recognized by an Agreement State or the U.S. Nuclear Regulatory Commission (posted by NRC at http://www.nrc.gov/materials/miau/med-use-toolkit/spec-board-cert.html), a specialty board shall require that each candidate for certification: [Eff 11/30/2006] 7D5.1 Complete 60 hours in basic radionuclide handling techniques applicable to the medical use of unsealed radioactive materials for uptake, dilution, and excretion studies (including the topics specified in 7D2.1); and [Eff 11/30/2006] 7D5.2 Pass an examination, administered by diplomates of the specialty board, which assesses knowledge and competence in radiation safety, radionuclide handling, and quality control. [Eff 11/30/2006] PART 7, APPENDIX 7E: AUTHORIZED USER FOR IMAGING AND LOCALIZATION STUDIES (7.32) ADEQUATE RADIATION SAFETY TRAINING AND EXPERIENCE The licensee shall require an authorized user of an unsealed radioactive material for the uses authorized under 7.32 to be a physician who has a current active State of Colorado license and: [Eff 11/30/2006] 7E1 Has provided: [Eff 11/30/2006] 7E1.1 Evidence of current certification by a recognized specialty board (see 7E5); and [Eff 11/30/2006] 7E1.2 Written attestation(s), signed by a preceptor authorized user, that the individual has achieved a level of competency sufficient to function independently as an authorized user for the medical uses authorized under 7.30 and 7.32; [Eff 11/30/2006] (1) Each preceptor authorized user supervising the experiential training required by Appendix 7E shall meet the requirements of this Appendix 7E, or Appendix 7F, and also the requirements specified in 7E2.1(2)(g), or equivalent Agreement State or NRC requirements. [Eff 11/30/2006] or [Eff 11/30/2006] 7E2 Has satisfied the following criteria: [Eff 11/30/2006] 7E2.1 Has provided written attestation(s), signed by a preceptor authorized user, that the individual has satisfactorily completed 700 hours in basic radionuclide handling techniques applicable to the medical use of unsealed radioactive materials for imaging and localization studies, including: [Eff 11/30/2006] (1) At least 80 hours of classroom and laboratory training in the following areas: [Eff 11/30/2006] (a) Radiation physics and instrumentation; [Eff 11/30/2006] (b) Radiation protection; [Eff 11/30/2006] (c) Mathematics pertaining to the use and measurement of radioactivity; [Eff 11/30/2006] (d) Chemistry of radioactive material for medical use; and [Eff 11/30/2006] (e) Radiation biology; and [Eff 11/30/2006] (2) Work experience involving: [Eff 11/30/2006] (a) Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys; [Eff 11/30/2006] (b) Performing quality control procedures on instruments used to determine the activity of dosages and performing checks for proper operation of survey meters; [Eff 11/30/2006] (c) Calculating, measuring, and safely preparing patient or human research subject dosages; [Eff 11/30/2006] (d) Using administrative controls to prevent a misadministration involving the use of unsealed radioactive material; [Eff 11/30/2006] (e) Using procedures to contain spilled radioactive material safely and using proper decontamination procedures; and [Eff 11/30/2006] (f) Administering dosages to patients or human research subjects; [Eff 11/30/2006] (g) Eluting generator systems appropriate for preparation of radioactive drugs for imaging and localization studies, measuring and testing the eluate for radiochemical purity, and processing the eluate with reagent kits to prepare labeled radioactive drugs; and [Eff 11/30/2006] 7E2.2 Has provided written attestation(s), signed by a preceptor authorized user, that the individual has achieved a level of competency sufficient to function independently as an authorized user for the medical uses authorized under 7.30 and 7.32. [Eff 11/30/2006] or [Eff 11/30/2006] 7E3 Has demonstrated adequate prior experience as: [Eff 11/30/2006] 7E3.1 An authorized user identified on a current facility license or permit under Appendix 7F (and also meets the requirements specified in 7E2.1(2)(g)), or under equivalent Agreement State or NRC requirements, and has provided written attestation(s), signed by a preceptor authorized user, that the individual has achieved a level of competency sufficient to function independently as an authorized user for the medical uses authorized under 7.30 and 7.32; or [Eff 11/30/2006] 7E3.2 An experienced authorized user for imaging and localization studies who: [Eff 11/30/2006] (1) Was identified before October 25, 2005 (and thus need not comply with the requirements of 7E2) either on: [Eff 11/30/2006] (a) An NRC or Agreement State license; or [Eff 11/30/2006] (b) A permit issued under an NRC or Agreement State broad scope license that authorizes medical use or the practice of nuclear pharmacy; [Eff 11/30/2006] (2) Performs only those medical uses for which the authorized user identified in accord with 7E3.2(1) was authorized on October 25, 2005. [Eff 11/30/2006] 7E4 Training and experience required by Appendix 7E shall have been obtained: [Eff 11/30/2006] 7E4.1 Within the 7 years preceding the date of license application; or [Eff 11/30/2006] 7E4.2 Through documented subsequent continuing education and experience. [Eff 11/30/2006] 7E5 To be recognized by an Agreement State or the U.S. Nuclear Regulatory Commission (posted by NRC at http://www.nrc.gov/materials/miau/med-use-toolkit/spec-board-cert.html), a specialty board shall require that each candidate for certification: [Eff 11/30/2006] 7E5.1 Complete 700 hours in basic radionuclide handling techniques applicable to the medical use of unsealed radioactive materials for imaging and localization studies (including the topics specified in 7E2.1); and [Eff 11/30/2006] 7E5.2 Pass an examination, administered by diplomates of the specialty board, which assesses knowledge and competence in radiation safety, radionuclide handling, and quality control. [Eff 11/30/2006] PART 7, APPENDIX 7F: AUTHORIZED USER FOR DIAGNOSTIC OR THERAPEUTIC USE OF UNSEALED RADIOACTIVE MATERIAL REQUIRING A WRITTEN DIRECTIVE (7.36) ADEQUATE RADIATION SAFETY TRAINING AND EXPERIENCE The licensee shall require an authorized user of an unsealed radioactive material for the uses authorized under 7.36 to be a physician who has a current active State of Colorado license and: [Eff 11/30/2006] 7F1 Has provided: [Eff 11/30/2006] 7F1.1 Evidence of current certification by a recognized specialty board (see 7F5); and [Eff 11/30/2006] 7F1.2 Written attestation(s), signed by a preceptor authorized user, that the individual has achieved a level of competency sufficient to function independently as an authorized user for the medical uses authorized under 7.36; [Eff 11/30/2006] (1) Each preceptor authorized user supervising the experiential training required by Appendix 7F shall meet the requirements of this Appendix 7F, including experience in administering dosages in the same dosage category or categories listed in 7F2.1(3), or equivalent Agreement State or NRC requirements. [Eff 11/30/2006] or [Eff 11/30/2006] 7F2 Has satisfied the following criteria: [Eff 11/30/2006] 7F2.1 Has provided written attestation(s), signed by a preceptor authorized user, that the individual has satisfactorily completed 700 hours in basic radionuclide handling techniques applicable to the medical use of unsealed radioactive material requiring a medical directive, including: [Eff 11/30/2006] (1) At least 200 hours of classroom and laboratory training in the following areas: [Eff 11/30/2006] (a) Radiation physics and instrumentation; [Eff 11/30/2006] (b) Radiation protection; [Eff 11/30/2006] (c) Mathematics pertaining to the use and measurement of radioactivity; [Eff 11/30/2006] (d) Chemistry of radioactive material for medical use; and [Eff 11/30/2006] (e) Radiation biology; and [Eff 11/30/2006] (2) Work experience involving: [Eff 11/30/2006] (a) Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys; [Eff 11/30/2006] (b) Performing quality control procedures on instruments used to determine the activity of dosages and performing checks for proper operation of survey meters; [Eff 11/30/2006] (c) Calculating, measuring, and safely preparing patient or human research subject dosages; [Eff 11/30/2006] (d) Using administrative controls to prevent a misadministration involving the use of unsealed radioactive material; [Eff 11/30/2006] (e) Using procedures to contain spilled radioactive material safely and using proper decontamination procedures; and [Eff 11/30/2006] (3) Has administered dosages of radioactive drugs to patients or human research subjects: [Eff 11/30/2006] (a) That include a minimum of 3 cases in each of the following categories for which the individual is requesting authorized user status; [Eff 11/30/2006] (i) Oral administration of less than or equal to 1.22 GBq (33 mCi) of Na I- 131 for which a written directive is required; and [Eff 11/30/2006] (ii) Oral administration of greater than 1.22 GBq (33 mCi) of Na I-131 for which a written directive is required [experience with at least 3 cases in 7F2.1(3)(a)(ii) also satisfies the requirement in category 7F2.1(3)(a)(i)]; and [Eff 11/30/2006] (iii) Parenteral administration of any beta emitter or a photon-emitting radionuclide with a photon energy less than 150 keV for which a written directive is required; and/or [Eff 11/30/2006] (iv) Parenteral administration of any other radionuclide for which a written directive is required; and [Eff 11/30/2006] (b) Provided that the experience required by 7F2.1(3) may be obtained concurrently with the supervised work experience required by 7F2.1(2); [Eff 11/30/2006] 7F2.2 Has provided written attestation(s), signed by a preceptor authorized user, that the individual has achieved a level of competency sufficient to function independently as an authorized user for the medical uses authorized under 7.36. [Eff 11/30/2006] or [Eff 11/30/2006] 7F3 Has demonstrated adequate prior experience as: [Eff 11/30/2006] 7F3.1 An authorized user identified on a current facility license or permit under Appendix 7F for uses listed in Appendix 7F, or under equivalent Agreement State or NRC requirements, and has provided written attestation(s), signed by a preceptor authorized user, that the individual has achieved a level of competency sufficient to function independently as an authorized user for the medical uses authorized under 7.36; [Eff 11/30/2006] or [Eff 11/30/2006] 7F3.2 An experienced authorized user for use of unsealed radioactive material who: [Eff 11/30/2006] (1) Was identified before October 25, 2005 (and thus need not comply with the requirements of 7F2) either on: [Eff 11/30/2006] (a) An NRC or Agreement State license; or [Eff 11/30/2006] (b) A permit issued under an NRC or Agreement State broad scope license that authorizes medical use or the practice of nuclear pharmacy; [Eff 11/30/2006] (2) Performs only those medical uses for which the authorized user identified in accord with 7F3.2(1) was authorized on October 25, 2005. [Eff 11/30/2006] 7F4 Training and experience required by Appendix 7F shall have been obtained: [Eff 11/30/2006] 7F4.1 Within the 7 years preceding the date of license application; or [Eff 11/30/2006] 7F4.2 Through documented subsequent continuing education and experience. [Eff 11/30/2006] 7F5 To be recognized by an Agreement State or the U.S. Nuclear Regulatory Commission (posted by NRC at http://www.nrc.gov/materials/miau/med-use-toolkit/spec-board-cert.html), a specialty board shall require that each candidate for certification: [Eff 11/30/2006] 7F5.1 Successfully complete residency training in a radiation therapy or nuclear medicine training program or a program in a related medical specialty that includes 700 hours of training and experience as described in 7F2.1. Eligible training programs must be approved by the Residency Review Committee of the Accreditation Council for Graduate Medical Education or Royal College of Physicians and Surgeons of Canada, or the Committee on Post-Graduate Training of the American Osteopathic Association; and [Eff 11/30/2006] 7F5.2 Pass an examination, administered by diplomates of the specialty board, which tests knowledge and competence in radiation safety, radionuclide handling, quality assurance, and clinical use of unsealed byproduct material. [Eff 11/30/2006] PART 7, APPENDIX 7G: AUTHORIZED USER FOR ORAL ADMINISTRATION (7.36) OF LESS THAN OR EQUAL TO 1.22 Gbq I-131 (33 mCi) SODIUM IODIDE ADEQUATE RADIATION SAFETY TRAINING AND EXPERIENCE The licensee shall require an authorized user of the oral administration of less than or equal to 1.22 GBq (33 mCi) of Na I-131 for which a written directive is required to be a physician who has a current active State of Colorado license and: [Eff 11/30/2006] 7G1 Has provided: [Eff 11/30/2006] 7G1.1 Evidence of current certification by a recognized medical specialty board (see 7G5); and [Eff 11/30/2006] 7G1.2 Written attestation(s), signed by a preceptor authorized user, that the individual has achieved a level of competency sufficient to function independently as an authorized user for the medical uses of unsealed radioactive materials using Na I-131 authorized under 7.36; [Eff 11/30/2006] (1) Each preceptor authorized user supervising the experiential training required by Appendix 7G shall meet the requirements of Appendix 7G, or Appendix 7F (including experience in administering dosages in the same dosage category or categories listed in 7F2.1(3)), or Appendix 7H, or equivalent Agreement State or NRC requirements. [Eff 11/30/2006] or [Eff 11/30/2006] 7G2 Has satisfied the following criteria: [Eff 11/30/2006] 7G2.1 Has provided written attestation(s), signed by a preceptor authorized user, that the individual has satisfactorily completed training in basic radionuclide handling techniques applicable to the medical use of sodium iodide for procedures requiring a written directive, including: [Eff 11/30/2006] (1) At least 80 hours of classroom and laboratory training in the following areas: [Eff 11/30/2006] (a) Radiation physics and instrumentation; [Eff 11/30/2006] (b) Radiation protection; [Eff 11/30/2006] (c) Mathematics pertaining to the use and measurement of radioactivity; [Eff 11/30/2006] (d) Chemistry of radioactive material for medical use; and [Eff 11/30/2006] (e) Radiation biology; and [Eff 11/30/2006] (2) Work experience involving: [Eff 11/30/2006] (a) Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys; [Eff 11/30/2006] (b) Performing quality control procedures on instruments used to determine the activity of dosages and performing checks for proper operation of survey meters; [Eff 11/30/2006] (c) Calculating, measuring, and safely preparing patient or human research subject dosages; [Eff 11/30/2006] (d) Using administrative controls to prevent a misadministration involving the use of unsealed radioactive material; [Eff 11/30/2006] (e) Using procedures to contain spilled radioactive material safely and using proper decontamination procedures; and [Eff 11/30/2006] (3) Has administered dosages of radioactive drugs to patients or human research subjects: [Eff 11/30/2006] (a) That include a minimum of 3 cases involving the oral administration of less than or equal to 1.22 GBq (33 mCi) of Na I-131; and [Eff 11/30/2006] (b) Provided that the experience required by 7G2.1(3) may be obtained concurrently with the supervised work experience required by 7G2.1(2); [Eff 11/30/2006] 7G2.2 Has provided written attestation(s), signed by a preceptor authorized user, that the individual has achieved a level of competency sufficient to function independently as an authorized user for the medical uses of unsealed radioactive materials using Na I-131 authorized under 7.36. [Eff 11/30/2006] or [Eff 11/30/2006] 7G3 Has demonstrated adequate prior experience as: [Eff 11/30/2006] 7G3.1 An authorized user identified on a current facility license or permit under Appendix 7F for uses listed in 7F2.1(3), under Appendix 7H for uses listed in 7H2.1(3), or under equivalent Agreement State or NRC requirements, and has provided written attestation(s), signed by a preceptor authorized user, that the individual has achieved a level of competency sufficient to function independently as an authorized user for the medical uses of unsealed radioactive materials using Na I-131 authorized under 7.36; [Eff 11/30/2006] or [Eff 11/30/2006] 7G3.2 An experienced authorized user for the medical use of unsealed radioactive materials using Na I-131 who: [Eff 11/30/2006] (1) Was identified before October 25, 2005 (and thus need not comply with the requirements of 7G2) either on: [Eff 11/30/2006] (a) An NRC or Agreement State license; or [Eff 11/30/2006] (b) A permit issued under an NRC or Agreement State broad scope license that authorizes medical use or the practice of nuclear pharmacy; and [Eff 11/30/2006] (2) Performs only those medical uses for which the authorized user identified in accord with 7G3.2(1) was authorized on October 25, 2005. [Eff 11/30/2006] 7G4 Training and experience required by Appendix 7G shall have been obtained: [Eff 11/30/2006] 7G4.1 Within the 7 years preceding the date of license application; or [Eff 11/30/2006] 7G4.2 Through documented subsequent continuing education and experience. [Eff 11/30/2006] 7G5 To be recognized by an Agreement State or the U.S. Nuclear Regulatory Commission (posted by NRC at http://www.nrc.gov/materials/miau/med-use-toolkit/spec-board-cert.html), for purposes of Appendix 7G, a medical specialty board shall require that each candidate for certification to meet all of the requirements of 7G2. [Eff 11/30/2006] PART 7, APPENDIX 7H: AUTHORIZED USER FOR ORAL ADMINISTRATION (7.36) OF GREATER THAN 1.22 GBq 1-131 (33 mCi) SODIUM IODIDE ADEQUATE RADIATION SAFETY TRAINING AND EXPERIENCE The licensee shall require an authorized user of the oral administration of greater than 1.22 GBq (33 mCi) of Na I-131 for which a written directive is required to be a physician who has a current active State of Colorado license and: [Eff 11/30/2006] 7H1 Has provided: [Eff 11/30/2006] 7H1.1 Evidence of current certification by a recognized medical specialty board (see 7H5); and [Eff 11/30/2006] 7H1.2 Written attestation(s), signed by a preceptor authorized user, that the individual has achieved a level of competency sufficient to function independently as an authorized user for the medical uses of unsealed radioactive materials using Na I-131 in activities greater than 1.22 GBq (33 mCi) authorized under 7.36; [Eff 11/30/2006] (1) Each preceptor authorized user supervising the experiential training required by Appendix 7H shall meet the requirements of Appendix 7H, or Appendix 7F (including experience in administering dosages in the same dosage category or categories listed in 7F2.1(3)), or equivalent Agreement State or NRC requirements. [Eff 11/30/2006] or [Eff 11/30/2006] 7H2 Has satisfied the following criteria: [Eff 11/30/2006] 7H2.1 Has provided written attestation(s), signed by a preceptor authorized user, that the individual has satisfactorily completed training in basic radionuclide handling techniques applicable to the medical use of sodium iodide for procedures requiring a written directive, including: [Eff 11/30/2006] (1) At least 80 hours of classroom and laboratory training in the following areas: [Eff 11/30/2006] (a) Radiation physics and instrumentation; [Eff 11/30/2006] (b) Radiation protection; [Eff 11/30/2006] (c) Mathematics pertaining to the use and measurement of radioactivity; [Eff 11/30/2006] (d) Chemistry of radioactive material for medical use; and [Eff 11/30/2006] (e) Radiation biology; and [Eff 11/30/2006] (2) Work experience involving: [Eff 11/30/2006] (a) Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys; [Eff 11/30/2006] (b) Performing quality control procedures on instruments used to determine the activity of dosages and performing checks for proper operation of survey meters; [Eff 11/30/2006] (c) Calculating, measuring, and safely preparing patient or human research subject dosages; [Eff 11/30/2006] (d) Using administrative controls to prevent a misadministration involving the use of unsealed radioactive material; [Eff 11/30/2006] (e) Using procedures to contain spilled radioactive material safely and using proper decontamination procedures; and [Eff 11/30/2006] (3) Has administered dosages of radioactive drugs to patients or human research subjects: [Eff 11/30/2006] (a) That include a minimum of 3 cases involving the oral administration of greater than 1.22 GBq (33 mCi) of Na I-131; and [Eff 11/30/2006] (b) Provided that the experience required by 7H2.1(3) may be obtained concurrently with the supervised work experience required by 7H2.1(2); [Eff 11/30/2006] 7H2.2 Has provided written attestation(s), signed by a preceptor authorized user, that the individual has achieved a level of competency sufficient to function independently as an authorized user for the medical uses of unsealed radioactive materials using Na I-131 in activities greater than 1.22 GBq (33 mCi) authorized under 7.36; or [Eff 11/30/2006] 7H3 Has demonstrated adequate prior experience as: [Eff 11/30/2006] 7H3.1 An authorized user identified on a current facility license or permit under Appendix 7H, under Appendix 7F for uses listed in 7F2.1(3), or under equivalent Agreement State or NRC requirements, and has provided written attestation(s), signed by a preceptor authorized user, that the individual has achieved a level of competency sufficient to function independently as an authorized user for the medical uses of unsealed radioactive materials using Na I-131 in activities greater than 1.22 GBq (33 mCi) authorized under 7.36; [Eff 11/30/2006] or [Eff 11/30/2006] 7H3.2 An experienced authorized user for the medical use of unsealed radioactive materials using Na I-131 in activities greater than 1.22 GBq (33 mCi) who: [Eff 11/30/2006] (1) Was identified before October 25, 2005 (and thus need not comply with the requirements of 7H2) either on: [Eff 11/30/2006] (a) An NRC or Agreement State license; or [Eff 11/30/2006] (b) A permit issued under an NRC or Agreement State broad scope license that authorizes medical use or the practice of nuclear pharmacy; and [Eff 11/30/2006] (2) Performs only those medical uses for which the authorized user identified in accord with 7H3.2(1) was authorized on October 25, 2005. [Eff 11/30/2006] 7H4 Training and experience required by Appendix 7H shall have been obtained: [Eff 11/30/2006] 7H4.1 Within the 7 years preceding the date of license application; or [Eff 11/30/2006] 7H4.2 Through documented subsequent continuing education and experience. [Eff 11/30/2006] 7H5 To be recognized by an Agreement State or the U.S. Nuclear Regulatory Commission (posted by NRC at http://www.nrc.gov/materials/miau/med-use-toolkit/spec-board-cert.html) for purposes of Appendix 7H, a medical specialty board shall require that each candidate for certification to meet all of the requirements of 7H2. [Eff 11/30/2006] PART 7, APPENDIX 7I: AUTHORIZED USER FOR PARENTERAL ADMINISTRATION (7.36) OF UNSEALED RADIOACTIVE MATERIAL REQUIRING A WRITTEN DIRECTIVE ADEQUATE RADIATION SAFETY TRAINING AND EXPERIENCE The licensee shall require an authorized user for parenteral administration of unsealed radioactive material for which a written directive is required to be a physician who has a current active State of Colorado license and: [Eff 11/30/2006] 7I1 Has provided: [Eff 11/30/2006] 7I1.1 Evidence of current certification by a recognized medical specialty board (see 7I5); and [Eff 11/30/2006] 7I1.2 Written attestation(s), signed by a preceptor authorized user, that the individual has achieved a level of competency sufficient to function independently as an authorized user for parenteral administration of unsealed radioactive material for which a written directive authorized under 7.36; [Eff 11/30/2006] (1) Each preceptor authorized user supervising the experiential training required by Appendix 7I shall meet the requirements of Appendix 7I, or Appendix 7F (including experience in administering dosages in the same dosage category or categories listed in 7F2.1(3)), or equivalent Agreement State or NRC requirements. [Eff 11/30/2006] or [Eff 11/30/2006] 7I2 Has satisfied the following criteria: [Eff 11/30/2006] 7I2.1 Has provided written attestation(s), signed by a preceptor authorized user, that the individual has satisfactorily completed training in basic radionuclide handling techniques applicable to parenteral administrations requiring a written directive, including: [Eff 11/30/2006] (1) At least 80 hours of classroom and laboratory training in the following areas: [Eff 11/30/2006] (a) Radiation physics and instrumentation; [Eff 11/30/2006] (b) Radiation protection; [Eff 11/30/2006] (c) Mathematics pertaining to the use and measurement of radioactivity; [Eff 11/30/2006] (d) Chemistry of radioactive material for medical use; and [Eff 11/30/2006] (e) Radiation biology; and [Eff 11/30/2006] (2) Work experience involving: [Eff 11/30/2006] (a) Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys; [Eff 11/30/2006] (b) Performing quality control procedures on instruments used to determine the activity of dosages and performing checks for proper operation of survey meters; [Eff 11/30/2006] (c) Calculating, measuring, and safely preparing patient or human research subject dosages; [Eff 11/30/2006] (d) Using administrative controls to prevent a misadministration involving the use of unsealed radioactive material; [Eff 11/30/2006] (e) Using procedures to contain spilled radioactive material safely and using proper decontamination procedures; and [Eff 11/30/2006] (3) Has administered dosages of radioactive drugs to patients or human research subjects: [Eff 11/30/2006] (a) Parenteral administration, for which a written directive is required, of any beta emitter or a photon-emitting radionuclide with a photon energy less than 150 keV; and/or [Eff 11/30/2006] (b) Parenteral administration of any other radionuclide for which a written directive is required; and [Eff 11/30/2006] 7I2.2 Has provided written attestation(s), signed by a preceptor authorized user, that the individual has achieved a level of competency sufficient to function independently as an authorized user for the parenteral administration of unsealed radioactive materials authorized under 7.36. [Eff 11/30/2006] or [Eff 11/30/2006] 7I3 Has demonstrated adequate prior experience as: [Eff 11/30/2006] 7I3.1 An authorized user identified on a current facility license or permit under Appendix 7I, Appendix 7F for uses listed in 7F2.1(3), Appendix 7K, or Appendix 7M, or under equivalent Agreement State or NRC requirements, and has provided written attestation(s), signed by a preceptor authorized user, that the individual has achieved a level of competency sufficient to function independently as an authorized user for the parenteral administration of unsealed radioactive materials authorized under 7.36; [Eff 11/30/2006] or [Eff 11/30/2006] 7I3.2 An experienced authorized user for the parenteral administration of unsealed radioactive materials who: [Eff 11/30/2006] (1) Was identified before October 25, 2005 (and thus need not comply with the requirements of 7I2) either on: [Eff 11/30/2006] (a) An NRC or Agreement State license; or [Eff 11/30/2006] (b) A permit issued under an NRC or Agreement State broad scope license that authorizes medical use or the practice of nuclear pharmacy; and [Eff 11/30/2006] (2) Performs only those medical uses for which the authorized user identified in accord with 7I3.2(1) was authorized on October 25, 2005. [Eff 11/30/2006] 7I4 Training and experience required by Appendix 7I shall have been obtained: [Eff 11/30/2006] 7I4.1 Within the 7 years preceding the date of license application; or [Eff 11/30/2006] 7I4.2 Through documented subsequent continuing education and experience. [Eff 11/30/2006] 7I5 To be recognized by an Agreement State or the U.S. Nuclear Regulatory Commission (posted by NRC at http://www.nrc.gov/materials/miau/med-use-toolkit/spec-board-cert.html) for purposes of Appendix 7I, a medical specialty board shall require that each candidate for certification to meet all of the requirements of 7I2. [Eff 11/30/2006] PART 7, APPENDIX 7J: AUTHORIZED USER FOR USE OF SEALED SOURCES FOR DIAGNOSIS (7.40) ADEQUATE RADIATION SAFETY TRAINING AND EXPERIENCE The licensee shall require an authorized user of a diagnostic sealed source for use in a device authorized under 7.40 to be a physician, dentist or podiatrist who has a current active State of Colorado license and: [Eff 11/30/2006] 7J1 Has provided evidence of current certification by a recognized medical specialty board (see 7J5); [Eff 11/30/2006] or [Eff 11/30/2006] 7J2 Has satisfied the following criteria: [Eff 11/30/2006] 7J2.1 Has satisfactorily completed training in basic radionuclide handling techniques specifically applicable to the use of the device, including: [Eff 11/30/2006] (1) At least 8 hours of classroom and laboratory training in the following areas: [Eff 11/30/2006] (a) Radiation physics and instrumentation; [Eff 11/30/2006] (b) Radiation protection; [Eff 11/30/2006] (c) Mathematics pertaining to the use and measurement of radioactivity; [Eff 11/30/2006] (d) Radiation biology; and [Eff 11/30/2006] (2) Training in the use of the device for the uses requested. [Eff 11/30/2006] 7J2.2 Has provided written attestation(s), signed by a preceptor authorized user, that the individual has achieved a level of competency sufficient to function independently as an authorized user of a diagnostic sealed source for use in a device authorized under 7.40. [Eff 11/30/2006] (1) Each preceptor authorized user supervising the experiential training required by Appendix 7J shall meet the requirements of Appendix 7K or Appendix 7L, or equivalent Agreement State or NRC requirements. [Eff 11/30/2006] or [Eff 11/30/2006] 7J3 Has demonstrated adequate prior experience as: [Eff 11/30/2006] 7J3.1 An authorized user identified on a current facility license or permit under this Appendix 7J for uses listed in Appendix 7J, or under equivalent Agreement State or NRC requirements, and has provided written attestation(s), signed by a preceptor authorized user, that the individual has achieved a level of competency sufficient to function independently as an authorized user of a diagnostic sealed source for use in a device authorized under 7.40; [Eff 11/30/2006] or [Eff 11/30/2006] 7J3.2 An experienced authorized user of a diagnostic sealed source for use in a device authorized under 7.40 who: [Eff 11/30/2006] (1) Was identified before October 25, 2005 (and thus need not comply with the requirements of 7J2) either on: [Eff 11/30/2006] (a) An NRC or Agreement State license; or [Eff 11/30/2006] (b) A permit issued under an NRC or Agreement State broad scope license that authorizes medical use or the practice of nuclear pharmacy; and [Eff 11/30/2006] (2) Performs only those medical uses for which the authorized user identified in accord with 7J3.2(1) was authorized on October 25, 2005. [Eff 11/30/2006] 7J4 Training and experience required by Appendix 7J shall have been obtained: [Eff 11/30/2006] 7J4.1 Within the 7 years preceding the date of license application; or [Eff 11/30/2006] 7J4.2 Through documented subsequent continuing education and experience. [Eff 11/30/2006] 7J5 To be recognized by an Agreement State or the U.S. Nuclear Regulatory Commission (posted by NRC at http://www.nrc.gov/materials/miau/med-use-toolkit/spec-board-cert.html) for purposes of Appendix 7J, a medical specialty board shall require that each candidate for certification to meet all of the requirements of 7J2.1(1). [Eff 11/30/2006] PART 7, APPENDIX 7K: AUTHORIZED USER FOR MANUAL BRACHYTHERAPY SOURCE USE (7.42) ADEQUATE RADIATION SAFETY TRAINING AND EXPERIENCE The licensee shall require an authorized user of an manual brachytherapy source for the uses authorized under 7.42 to be a physician who has a current active State of Colorado license and: [Eff 11/30/2006] 7K1 Has provided: [Eff 11/30/2006] 7K1.1 Evidence of current certification by a recognized specialty board (see 7K5); and [Eff 11/30/2006] 7K1.2 Written attestation(s), signed by a preceptor authorized user, that the individual has achieved a level of competency sufficient to function independently as an authorized user of an manual brachytherapy source for the uses authorized under 7.42; [Eff 11/30/2006] (1) Each preceptor authorized user supervising the experiential training required by Appendix 7K shall meet the requirements of Appendix 7K, or equivalent Agreement State or NRC requirements. [Eff 11/30/2006] or [Eff 11/30/2006] 7K2 Has satisfied the following criteria: [Eff 11/30/2006] 7K2.1 Has provided written attestation(s), signed by a preceptor authorized user, that the individual has satisfactorily completed 700 total hours in a structured educational program in radionuclide handling techniques applicable to the medical use of manual brachytherapy sources, including: [Eff 11/30/2006] (1) At least 200 hours of classroom and laboratory training in the following areas: [Eff 11/30/2006] (a) Radiation physics and instrumentation; [Eff 11/30/2006] (b) Radiation protection; [Eff 11/30/2006] (c) Mathematics pertaining to the use and measurement of radioactivity; [Eff 11/30/2006] (d) Radiation biology; and [Eff 11/30/2006] (2) 500 hours of supervised work experience, involving: [Eff 11/30/2006] (a) Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys; [Eff 11/30/2006] (b) Checking survey meters for proper operation; [Eff 11/30/2006] (c) Preparing, implanting, and removing brachytherapy sources; [Eff 11/30/2006] (d) Maintaining running inventories of material on hand; [Eff 11/30/2006] (e) Using administrative controls to prevent a misadministration involving the use of unsealed radioactive material; [Eff 11/30/2006] (f) Using emergency procedures to control radioactive material; [Eff 11/30/2006] (3) Or has 3 years of supervised clinical experience in radiation oncology, under the supervision of an authorized user who meets the requirements of this Appendix 7K, or equivalent Agreement State or NRC requirements, provided that the experience: [Eff 11/30/2006] (a) Is part of a formal training program approved by the Residency Review Committee of the Accreditation Council for Graduate Medical Education or Royal College of Physicians and Surgeons of Canada or the Council on Postdoctoral Training of the American Osteopathic Association; and [Eff 11/30/2006] (b) May be obtained concurrently with the supervised work experience required by 7K2.1(2). [Eff 11/30/2006] 7K2.2 Has provided written attestation(s), signed by a preceptor authorized user, that the individual has achieved a level of competency sufficient to function independently as an authorized user of manual brachytherapy sources for the medical uses authorized under 7.42. [Eff 11/30/2006] or [Eff 11/30/2006] 7K3 Has demonstrated adequate prior experience as: [Eff 11/30/2006] 7K3.1 An authorized user identified on a current facility license or permit under Appendix 7K for uses listed in Appendix 7K, or under equivalent Agreement State or NRC requirements, and has provided written attestation(s), signed by a preceptor authorized user, that the individual has achieved a level of competency sufficient to function independently as an authorized user of an manual brachytherapy source for the uses authorized under 7.42; [Eff 11/30/2006] or [Eff 11/30/2006] 7K3.2 An experienced authorized user of an manual brachytherapy source for the uses authorized under 7.42 who: [Eff 11/30/2006] (1) Was identified before October 25, 2005 (and thus need not comply with the requirements of 7K2) either on: [Eff 11/30/2006] (a) An NRC or Agreement State license; or [Eff 11/30/2006] (b) A permit issued under an NRC or Agreement State broad scope license that authorizes medical use or the practice of nuclear pharmacy; [Eff 11/30/2006] (2) Performs only those medical uses for which the authorized user identified in accord with 7K3.2(1) was authorized on October 25, 2005. [Eff 11/30/2006] 7K4 Training and experience required by Appendix 7K shall have been obtained: [Eff 11/30/2006] 7K4.1 Within the 7 years preceding the date of license application; or [Eff 11/30/2006] 7K4.2 Through documented subsequent continuing education and experience. [Eff 11/30/2006] 7K5 To be recognized by an Agreement State or the U.S. Nuclear Regulatory Commission (posted by NRC at http://www.nrc.gov/materials/miau/med-use-toolkit/spec-board-cert.html), a specialty board shall require that each candidate for certification: [Eff 11/30/2006] 7K5.1 Successfully complete a minimum of 3 years of residency training in a radiation oncology program approved by the Residency Review Committee of the Accreditation Council for Graduate Medical Education or Royal College of Physicians and Surgeons of Canada, or the Committee on Post-Graduate Training of the American Osteopathic Association; and [Eff 11/30/2006] 7K5.2 Pass an examination, administered by diplomates of the specialty board, which tests knowledge and competence in radiation safety, radionuclide handling, quality assurance, and clinical use of manual brachytherapy. [Eff 11/30/2006] PART 7, APPENDIX 7L: AUTHORIZED USER FOR OPHTHALMIC USE OF STRONTIUM-90 (7.42) ADEQUATE RADIATION SAFETY TRAINING AND EXPERIENCE The licensee shall require an authorized user of an Strontium-90 source for ophthalmic radiotherapy authorized under 7.42 to be a physician who has a current active State of Colorado license and: [Eff 11/30/2006] 7L1 Is an authorized user under Appendix 7K and has provided written attestation(s), signed by a preceptor authorized user, that the individual has achieved a level of competency sufficient to function independently as an authorized user of strontium-90 for ophthalmic radiotherapy uses authorized under 7.42; [Eff 11/30/2006] (1) Each preceptor authorized user supervising the experiential training required by Appendix 7L shall meet the requirements of Appendix 7K or Appendix 7L, or equivalent Agreement State or NRC requirements. [Eff 11/30/2006] or [Eff 11/30/2006] 7L2 Has satisfied the following criteria: [Eff 11/30/2006] 7L2.1 Has satisfactorily completed training in basic radionuclide handling techniques specifically applicable to the use of strontium-90 for ophthalmic radiotherapy, including: [Eff 11/30/2006] (1) At least 24 hours of classroom and laboratory training in the following areas: [Eff 11/30/2006] (a) Radiation physics and instrumentation; [Eff 11/30/2006] (b) Radiation protection; [Eff 11/30/2006] (c) Mathematics pertaining to the use and measurement of radioactivity; [Eff 11/30/2006] (d) Radiation biology; and [Eff 11/30/2006] (2) Supervised clinical training that includes the use of strontium-90 for the ophthalmic treatment of five individuals, that includes: [Eff 11/30/2006] (a) Examination of each individual to be treated; [Eff 11/30/2006] (b) Calculation of the dose to be administered; [Eff 11/30/2006] (c) Administration of the dose; and [Eff 11/30/2006] (d) Follow-up and review of each individual’s case history; [Eff 11/30/2006] 7L2.2 Has provided written attestation(s), signed by a preceptor authorized user, that the individual has achieved a level of competency sufficient to function independently as an authorized user of strontium-90 for ophthalmic radiotherapy uses authorized under 7.42. [Eff 11/30/2006] or [Eff 11/30/2006] 7L3 Has demonstrated adequate prior experience as: [Eff 11/30/2006] 7L3.1 An authorized user identified on a current facility license or permit under this Appendix 7L for uses listed in Appendix 7L, or under equivalent Agreement State or NRC requirements, and has provided written attestation(s), signed by a preceptor authorized user, that the individual has achieved a level of competency sufficient to function independently as an authorized user of strontium-90 for ophthalmic radiotherapy uses authorized under 7.42; [Eff 11/30/2006] or [Eff 11/30/2006] 7L3.2 An experienced authorized user of strontium-90 for ophthalmic radiotherapy uses authorized under 7.42 who: [Eff 11/30/2006] (1) Was identified before October 25, 2005 (and thus need not comply with the requirements of 7L2) either on: [Eff 11/30/2006] (a) An NRC or Agreement State license; or [Eff 11/30/2006] (b) A permit issued under an NRC or Agreement State broad scope license that authorizes medical use or the practice of nuclear pharmacy; and [Eff 11/30/2006] (2) Performs only those medical uses for which the authorized user identified in accord with 7L3.2(1) was authorized on October 25, 2005. [Eff 11/30/2006] 7L4 Training and experience required by Appendix 7L shall have been obtained: [Eff 11/30/2006] 7L4.1 Within the 7 years preceding the date of license application; or [Eff 11/30/2006] 7L4.2 Through documented subsequent continuing education and experience. [Eff 11/30/2006] PART 7, APPENDIX 7M: AUTHORIZED USER FOR USE OF SEALED SOURCES IN REMOTE AFTERLOADER UNITS, TELETHERAPY UNITS, AND GAMMA STEREOTACTIC RADIOSURGERY UNITS (7.48) ADEQUATE RADIATION SAFETY TRAINING AND EXPERIENCE The licensee shall require an authorized user of a sealed source for use in a device authorized under 7.48 to be a physician who has a current active State of Colorado license and: [Eff 11/30/2006] 7M1 Has provided: [Eff 11/30/2006] 7M1.1 Evidence of current certification by a recognized specialty board (see 7M5); and [Eff 11/30/2006] 7M1.2 Written attestation(s), signed by a preceptor authorized user, that the individual has achieved a level of competency sufficient to function independently as an authorized user for each type of the therapeutic medical unit for which the individual is requesting authorized user status for the medical uses authorized under 7.48; [Eff 11/30/2006] (1) Each preceptor authorized user supervising the experiential training required by Appendix 7M shall meet the requirements of this Appendix 7M, or equivalent Agreement State or NRC requirements. [Eff 11/30/2006] or [Eff 11/30/2006] 7M2 Has satisfied the following criteria: [Eff 11/30/2006] 7M2.1 Has provided written attestation(s), signed by a preceptor authorized user, that the individual has satisfactorily completed 700 total hours in a structured educational program in radionuclide handling techniques applicable to the medical use of sealed sources in remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units, including: [Eff 11/30/2006] (1) At least 200 hours of classroom and laboratory training in the following areas: [Eff 11/30/2006] (a) Radiation physics and instrumentation; [Eff 11/30/2006] (b) Radiation protection; [Eff 11/30/2006] (c) Mathematics pertaining to the use and measurement of radioactivity; [Eff 11/30/2006] (d) Radiation biology; and [Eff 11/30/2006] (2) 500 hours of supervised work experience, involving: [Eff 11/30/2006] (a) Reviewing full calibration measurements and periodic spot checks; [Eff 11/30/2006] (b) Preparing treatment plans and calculating treatment doses and times; [Eff 11/30/2006] (c) Using administrative controls to prevent a misadministration involving the use of unsealed radioactive material; [Eff 11/30/2006] (d) Implementing emergency procedures to followed in the event of the abnormal operation of the medical unit or console; [Eff 11/30/2006] (e) Checking and using survey meters; and [Eff 11/30/2006] (f) Selecting the proper dose and how it is to be administered; [Eff 11/30/2006] 7M2.2 Has provided written attestation(s), signed by a preceptor authorized user, that the individual has satisfactorily completed training for the type(s) of use for which authorization is sought, that: [Eff 11/30/2006] (1) Includes: [Eff 11/30/2006] (a) Hands-on device operation; [Eff 11/30/2006] (b) Safety procedures; [Eff 11/30/2006] (c) Clinical use, and [Eff 11/30/2006] (d) Treatment planning system operation; and [Eff 11/30/2006] (2) Is provided by either: [Eff 11/30/2006] (a) Satisfactorily completing a vendor training program; or [Eff 11/30/2006] (b) Being supervised by an authorized medical physicist authorized for the type(s) of use for which the individual is seeking authorization; [Eff 11/30/2006] 7M2.3 Or has completed 3 years of supervised clinical experience in radiation therapy, under the supervision of an authorized user who meets the requirements of this Appendix 7M, or equivalent Agreement State or NRC requirements, provided that the experience: [Eff 11/30/2006] (1) Is part of a formal training program approved by the Residency Review Committee of the Accreditation Council for Graduate Medical Education or Royal College of Physicians and Surgeons of Canada, or the Committee on Post-Graduate Training of the American Osteopathic Association; and [Eff 11/30/2006] (2) May be obtained concurrently with the supervised work experience required by 7M2.1(2); and [Eff 11/30/2006] 7M2.4 Has provided written attestation(s), signed by a preceptor authorized user, that the individual has achieved a level of competency sufficient to function independently as an authorized user for each type of the therapeutic medical unit for which the individual is requesting authorized user status for the medical uses authorized under 7.48. [Eff 11/30/2006] or [Eff 11/30/2006] 7M3 Has demonstrated adequate prior experience as: [Eff 11/30/2006] 7M3.1 An authorized user identified on a current facility license or permit under Appendix 7M for uses listed in Appendix 7M, or under equivalent Agreement State or NRC requirements, and has provided written attestation(s), signed by a preceptor authorized user, that the individual has achieved a level of competency sufficient to function independently as an authorized user for each type of the therapeutic medical unit for which the individual is requesting authorized user status for the medical uses authorized under 7.48; [Eff 11/30/2006] or [Eff 11/30/2006] 7M3.2 An experienced authorized user of the therapeutic medical unit authorized under 7.48 who: [Eff 11/30/2006] (1) Was identified before October 25, 2005 (and thus need not comply with the requirements of 7M2) either on: [Eff 11/30/2006] (a) An NRC or Agreement State license; or [Eff 11/30/2006] (b) A permit issued under an NRC or Agreement State broad scope license that authorizes medical use or the practice of nuclear pharmacy; [Eff 11/30/2006] (2) Performs only those medical uses for which the authorized user identified in accord with 7M3.2(1) was authorized on October 25, 2005. [Eff 11/30/2006] 7M4 Training and experience required by Appendix 7M shall have been obtained: [Eff 11/30/2006] 7M4.1 Within the 7 years preceding the date of license application; or [Eff 11/30/2006] 7M4.2 Through documented subsequent continuing education and experience. [Eff 11/30/2006] 7M5 To be recognized by an Agreement State or the U.S. Nuclear Regulatory Commission (posted by NRC at http://www.nrc.gov/materials/miau/med-use-toolkit/spec-board-cert.html), a specialty board shall require that each candidate for certification: [Eff 11/30/2006] 7M5.1 Successfully complete a minimum of 3 years of residency training in a radiation therapy program approved by the Residency Review Committee of the Accreditation Council for Graduate Medical Education or Royal College of Physicians and Surgeons of Canada, or the Committee on Post-Graduate Training of the American Osteopathic Association; [Eff 11/30/2006] 7M5.2 Pass an examination, administered by diplomates of the specialty board, which tests knowledge and competence in radiation safety, radionuclide handling, treatment planning, quality assurance, and clinical use of stereotactic radiosurgery, remote afterloaders and external beam therapy. [Eff 11/30/2006] PART 7, APPENDIX 7N: NUCLEAR MEDICINE TECHNOLOGIST (NMT) ADEQUATE RADIATION SAFETY TRAINING AND EXPERIENCE The licensee shall require the nuclear medicine technologist using radioactive materials under the supervision of an authorized user to be an individual who: [Eff 11/30/2006] 7N1 Has provided: [Eff 11/30/2006] 7N1.1 Evidence of: [Eff 11/30/2006] (1) Current registration with The American Registry of Radiologic Technologists with competency in Nuclear Medicine (ARRT(N)); or [Eff 11/30/2006] (2) Current certification by The Nuclear Medicine Technology Certification Board in Nuclear Medicine (CNMT); or [Eff 11/30/2006] (3) Being board-eligible to take the CNMT or ARRT(N) examination; or [Eff 11/30/2006] (4) Current certification by a recognized specialty board (see 7N5); and [Eff 11/30/2006] 7N1.2 Has provided written attestation(s), signed by a preceptor authorized user, that the individual has achieved a level of competency sufficient to function independently as a nuclear medicine technologist; [Eff 11/30/2006] (1) Each preceptor authorized user supervising the experiential training required by Appendix 7N shall meet the requirements of Appendix 7N, or equivalent Agreement State or NRC requirements. [Eff 11/30/2006] or [Eff 11/30/2006] 7N2 Has satisfied the following criteria: [Eff 11/30/2006] 7N2.1 Has provided written attestation(s), signed by a preceptor authorized user, that the individual has satisfactorily completed 80 hours in a structured educational program in basic radionuclide handling techniques applicable to the medical use of unsealed radioactive materials, including: [Eff 11/30/2006] (1) Classroom and laboratory training in the following areas: [Eff 11/30/2006] (a) Radiation physics and instrumentation; [Eff 11/30/2006] (b) Radiation protection; [Eff 11/30/2006] (c) Mathematics pertaining to the use and measurement of radioactivity; [Eff 11/30/2006] (d) Chemistry of radioactive material for medical use; and [Eff 11/30/2006] (e) Radiation biology; and [Eff 11/30/2006] (2) Work experience, involving: [Eff 11/30/2006] (a) Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys; [Eff 11/30/2006] (b) Quality Control checking of instruments used to determine the activity of dosages and performing checks for proper operation of survey meters; [Eff 11/30/2006] (c) Calculating, measuring, and safely preparing patient or human research subject dosages; [Eff 11/30/2006] (d) Using administrative controls to prevent a misadministration involving the use of unsealed radioactive material; [Eff 11/30/2006] (e) Using procedures to contain spilled radioactive material safely and using proper decontamination procedures; and [Eff 11/30/2006] (f) Administering dosages to patients or human research subjects; [Eff 11/30/2006] 7N2.2 Has provided written attestation(s), signed by a preceptor authorized user, that the individual has achieved a level of competency sufficient to function independently as a nuclear medicine technologist; [Eff 11/30/2006] or [Eff 11/30/2006] 7N3 Has demonstrated adequate prior experience as: [Eff 11/30/2006] 7N3.1 A full-time nuclear medicine technologist for a minimum of two years performing during the past five-year period under the supervision of an authorized user and has provided written attestation(s), signed by a preceptor authorized user, that the individual has achieved a level of competency sufficient to function independently as a nuclear medicine technologist; [Eff 11/30/2006] or [Eff 11/30/2006] 7N3.2 An experienced nuclear medicine technologist working at a facility holding a Department license before October 25, 2005 (and thus need not comply with the requirements of 7N2); [Eff 11/30/2006] 7N4 Training and experience required by Appendix 7N shall have been obtained: [Eff 11/30/2006] 7N4.1 Within the 7 years preceding the date of license application; or [Eff 11/30/2006] 7N4.2 Through documented subsequent continuing education and experience. [Eff 11/30/2006] 7N5 To be recognized by the Department, a specialty board shall require that each candidate for certification as a nuclear medicine technologist satisfactorily complete a certification process that includes all of the training requirements in 7N2.1. [Eff 11/30/2006] PART 7, APPENDIX 7O: RADIATION THERAPY TECHNOLOGIST (RTT) ADEQUATE RADIATION SAFETY TRAINING AND EXPERIENCE The licensee shall require the radiation therapy technologist using radioactive materials under the supervision of an authorized user to be an individual who: [Eff 11/30/2006] 7O1 Has provided: [Eff 11/30/2006] 7O1.1 Evidence of: [Eff 11/30/2006] (1) Current registration with The American Registry of Radiologic Technologists with competency in Radiation Therapy; or [Eff 11/30/2006] (2) Current certification by a recognized specialty board (see 7O5); or [Eff 11/30/2006] (3) Being board-eligible to take the ARRT(T) examination; or [Eff 11/30/2006] (4) Having successfully completed a training program in radiation therapy which has resulted in a certificate, associate degree, or baccalaureate degree in a radiologic technology program that complies with the requirements of the Joint Review Committee on Education in Radiologic Technology (consult the Essentials and Guidelines of an Accredited Educational Program for the Radiation Therapy Technologist , Joint Review Committee on Education in Radiologic Technology, 1988); and [Eff 11/30/2006] 7O1.2 Written attestation(s), signed by a preceptor authorized user, that the individual has achieved a level of competency sufficient to function independently as a radiation therapy technologist; [Eff 11/30/2006] (1) Each preceptor authorized user supervising the experiential training required by Appendix 7O shall meet the requirements of Appendix 7O, or equivalent Agreement State or NRC requirements. [Eff 11/30/2006] or [Eff 11/30/2006] 7O2 Has satisfied the following criteria: [Eff 11/30/2006] 7O2.1 Has provided written attestation(s), signed by a preceptor authorized user, that the individual has satisfactorily completed 80 hours in a structured educational program in basic radionuclide handling techniques applicable to the medical use of unsealed radioactive materials, including: [Eff 11/30/2006] (1) Classroom and laboratory training in the following areas: [Eff 11/30/2006] (a) Radiation physics and instrumentation; [Eff 11/30/2006] (b) Radiation protection; [Eff 11/30/2006] (c) Mathematics pertaining to the use and measurement of radioactivity; [Eff 11/30/2006] (d) Radiation biology; and [Eff 11/30/2006] (2) Work experience, involving: [Eff 11/30/2006] (a) Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys; [Eff 11/30/2006] (b) Assisting the authorized user in simulating the patient for treatment; [Eff 11/30/2006] (c) Preparing the patient for treatment; [Eff 11/30/2006] (d) Implementing treatment plans as prescribed by the authorized user; [Eff 11/30/2006] (e) Providing written documentation of treatment setup and patient treatments; [Eff 11/30/2006] (f) Quality control checks to determine that devices used to deliver the radiation doses are in compliance with institutional standards and performing checks for proper operation of survey meters; [Eff 11/30/2006] (g) Preparing or assisting in the preparation of sources, and implantation and removal of sealed sources; [Eff 11/30/2006] (h) Delivering doses to patients or human research subjects under the supervision of the authorized user; [Eff 11/30/2006] (i) Maintaining running inventories of radioactive material on hand; [Eff 11/30/2006] (j) Using administrative controls to prevent a misadministration involving the use of radioactive material; and, [Eff 11/30/2006] (k) Properly implementing emergency procedures; [Eff 11/30/2006] 7O2.2 Has provided written attestation(s), signed by a preceptor authorized user, that the individual has achieved a level of competency sufficient to function independently as a radiation therapy technologist; [Eff 11/30/2006] or [Eff 11/30/2006] 7O3 Has demonstrated adequate prior experience as: [Eff 11/30/2006] 7O3.1 A full-time radiation therapy technologist for a minimum of two years performing during the past five-year period under the supervision of an authorized user and has provided written attestation(s), signed by a preceptor authorized user, that the individual has achieved a level of competency sufficient to function independently as a radiation therapy technologist; [Eff 11/30/2006] or [Eff 11/30/2006] 7O3.2 An experienced radiation therapy technologist working at a facility holding a Department license before October 25, 2005 (and thus need not comply with the requirements of 7O2); [Eff 11/30/2006] 7O4 Training and experience required by Appendix 7O shall have been obtained: [Eff 11/30/2006] 7O4.1 Within the 7 years preceding the date of license application; or [Eff 11/30/2006] 7O4.2 Through documented subsequent continuing education and experience. [Eff 11/30/2006] 7O5 To be recognized by the Department, a specialty board shall require that each candidate for certification as a radiation therapy technologist satisfactorily complete a certification process that includes all of the training requirements in 7O2.1. [Eff 11/30/2006]