Text

Tennessee Regulations 0400-20-07
	ML21301A027
Person / Time
Issue date:	10/25/2021
From:	; Office of Nuclear Material Safety and Safeguards
To:	; State of TN
	Beardsley M
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RULES OF ENVIRONMENT AND CONSERVATION DIVISION OF RADIOLOGICAL HEALTH CHAPTER 0400-20-07 USE OF RADIONUCLIDES IN THE HEALING ARTS TABLE OF CONTENTS 0400-20-07-.01 Purpose 0400-20-07-.35 Release of Individuals Containing 0400-20-07-.02 Scope Radioactive Drugs or Implants 0400-20-07-.03 Repealed 0400-20-07-.36 Provision of Mobile Medical Service 0400-20-07-.04 Repealed 0400-20-07-.37 Decay-in-Storage 0400-20-07-.05 Definitions 0400-20-07-.38 Use of Unsealed Radioactive Material for 0400-20-07-.06 Other Federal and State Requirements Uptake, Dilution, and Excretion Studies for 0400-20-07-.07 Provisions for the Protection of Human Which a Written Directive is Not Required Research Subjects 0400-20-07-.39 Training for Uptake, Dilution, and Excretion 0400-20-07-.08 Maintenance of Records Studies 0400-20-07-.09 Implementation 0400-20-07-.40 Use of Unsealed Radioactive Material for 0400-20-07-.10 License Required Imaging and Localization Studies for 0400-20-07-.11 Application for License, Amendment, or Which a Written Directive is Not Required Renewal 0400-20-07-.41 Radionuclide ContaminantsPermissible molybdenum-99, strontium-82, and strontium-85 concentrations.

0400-20-07-.12 Reserved 0400-20-07-.42 Reserved 0400-20-07-.13 License Amendments 0400-20-07-.43 Training for Imaging and Localization 0400-20-07-.14 Notifications Studies 0400-20-07-.15 Exemptions Regarding Specific Licenses 0400-20-07-.44 Use of Unsealed Radioactive Material for of Broad Scope Which a Written Directive is Required 0400-20-07-.16 License Issuance and Specific 0400-20-07-.45 Safety Instruction Exemptions 0400-20-07-.17 Authority and Responsibilities for the 0400-20-07-.46 Safety Precautions Radiation Protection Program 0400-20-07-.47 Training for Use of Unsealed Radioactive 0400-20-07-.18 Radiation Protection Program Changes Material for Which a Written Directive is 0400-20-07-.19 Supervision Required 0400-20-07-.20 Written Directives 0400-20-07-.48 Training for the Oral Administration of 0400-20-07-.21 Procedures for Administrations Requiring Sodium Iodide I-131 Requiring a Written a

Written Directive Directive in Quantities Less Than or Equal 0400-20-07-.22 Suppliers for Sealed Sources or Devices to 1.22 Gigabecquerels (33 Millicurries) for Medical Use 0400-20-07-.49 Training for the Oral Administration of 0400-20-07-.23 Training for Radiation Safety Officer Sodium Iodide I-131 Requiring a Written 0400-20-07-.24 Training for an Authorized Medical Directive in Quantities Greater Than 1.22 Physicist 0400-20-07-.25 Training for an Authorized Nuclear Gigabecquerels (33 Millicurries)

Pharmacist 0400-20-07-.50 Training for the Parenteral Administration of 0400-20-07-.26 Training for Experienced Radiation Safety Unsealed Radioactive Material Requiring a Officer, Teletherapy or Medical Physicist, Written Directive Authorized User, and Nuclear Pharmacist 0400-20-07-.51 Use of Sealed Sources for Manual 0400-20-07-.27 Recentness of Training Brachytherapy 0400-20-07-.28 Possession, Use, and Calibration of 0400-20-07-.52 Surveys After Source Implant and Removal Instruments Used to Measure the Activity 0400-20-07-.53 Brachytherapy Source Accountability of Unsealed Radioactive Material 0400-20-07-.54 Safety Instruction 0400-20-07-.29 Calibration of Survey Instruments 0400-20-07-.55 Safety Precautions for Patients or Human 0400-20-07-.30 Determination of Dosages of Unsealed Research Subjects Receiving Radioactive Material for Medical Use Brachytherapy 0400-20-07-.31 Authorization for Calibration, 0400-20-07-.56 Calibration Measurements of Transmission, Brachytherapy and Reference Sources Sources 0400-20-07-.32 Requirements for Possession of Sealed 0400-20-07-.57 Decay of s Strontium-90 sources for May, 2012 1

USE OF RADIONUCLIDES IN THE HEALING ARTS CHAPTER 0400-20-07 Sources and Brachytherapy Sources ophthalmic treatments 0400-20-07-.33 Labeling of Vials and Syringes 0400-20-07-.58 Therapy-Related Computer Systems 0400-20-07-.34 Surveys of Ambient Radiation Dose Rate 0400-20-07-.59 Training for Use of Manual Brachytherapy and Contamination Sources 0400-20-07-.60 Training for Ophthalmic Use of Strontium- 0400-20-07-.92 Records of the Release of Individuals 90 0400-20-07-.61 Use of Sealed Sources for Diagnosis Containing Unsealed Radioactive Material 0400-20-07-.62 Training for Use of Sealed Sources for or Implants Containing Radioactive Material Diagnosis 0400-20-07-.93 Records of Administrative and Technical 0400-20-07-.63 Use of a Sealed Source in a Remote Requirements That Apply to the Provisions of Mobile Services Afterloader Unit, Teletherapy Unit, or Gamma Stereotactic Radiosurgery Unit 0400-20-07-.94 Records of Decay-in-Storage 0400-20-07-.64 Surveys of Patients and Human Research 0400-20-07-.95 Records of Radionuclide Contaminants Subjects Treated With a Remote 0400-20-07-.96 Records of Safety Instruction and Training Afterloader Unit 0400-20-07-.97 Records of Radiation Surveys of Patients 0400-20-07-.37 Decay-in-Storage and Human Research Subjects 0400-20-07-.38 Use of Unsealed Radioactive Material for 0400-20-07-.98 Records of Brachytherapy Source Uptake, Dilution, and Excretion Studies for Accountability Which a Written Directive is Not Required 0400-20-07-.99 Records of Calibration Measurements of Brachytherapy Sources 0400-20-07-.66 Safety Procedures and Instructions for 0400-20-07-.100 Records of Decay of Strontium-90 Remote Afterloader Units, Teletherapy Sources for Ophthalmic Treatments Units and Gamma Stereotactic Radiosurgery Units 0400-20-07-.67 Safety Precautions for Remote Afterloader 0400-20-07-.101 Records of Installation, Maintenance, Units, Teletherapy Units, and Gamma Adjustment, and Repair of Remote Stereotactic Radiosurgery Units Afterloader Units, Teletherapy Units, and 0400-20-07-.68 Dosimetry Equipment Gamma Stereotactic Radiosurgery Units 0400-20-07-.69 Full Calibration Measurements on 0400-20-07-.102 Records of Safety Procedures Teletherapy Units 0400-20-07-.103 Records of Dosimetry Equipment 0400-20-07-.70 Full Calibration Measurements on Remote 0400-20-07-.104 Records of Teletherapy, Remote Afterloader Units Afterloader, and Gamma Stereotactic 0400-20-07-.71 Full Calibration Measurements on Gamma Radiosurgery Full Calibrations Stereotactic Radiosurgery Units 0400-20-07-.105 Records of Periodic Spot-Checks for 0400-20-07-.72 Periodic Spot-Checks for Teletherapy Teletherapy Units Units 0400-20-07-.73 Periodic Spot-Checks for Remote 0400-20-07-.106 Records of Periodic Spot-Checks for Afterloader Units Remote Afterloader Units 0400-20-07-.74 Periodic Spot-Checks for Gamma 0400-20-07-.107 Records of Periodic Spot-Checks for Stereotactic Radiosurgery Units Gamma Stereotactic Radiosurgery Unit 0400-20-07-.75 Additional Technical Requirements for 0400-20-07-.108 Records of Additional Technical Mobile Remote Afterloader Units Requirements for Mobile Remote 0400-20-07-.76 Radiation Surveys Afterloader Units 0400-20-07-.77 Five-Year Inspection for Teletherapy and 0400-20-07-.109 Records of Surveys of Therapeutic Gamma Stereotactic Radiosurgery Units Treatment Units 0400-20-07-.78 Therapy-Related Computer Systems 0400-20-07-.110 Records of Five-Year Inspection for 0400-20-07-.79 Reserved Teletherapy and Gamma Stereotactic 0400-20-07-.80 Training for Use of Remote Afterloader Radiosurgery Units Unit, Teletherapy Units and Gamma Stereotactic Radiosurgery Units 0400-20-07-.81 Other Medical Uses of Radioactive 0400-20-07-.111 Records of Leak Tests and Inventory of Material or Radiation from Radioactive Material 0400-20-07-.82 Records of Authority and Responsibilities Sealed Sources and Brachytherapy Sources for Radiation Protection Programs 0400-20-07-.112 Report of Procedures for Administrations Requiring a Written Directive 0400-20-07-.83 Records of Radiation Protection Program 0400-20-07-.113 Report of a Leaking Source Changes 0400-20-07-.84 Records of Written Directives 0400-20-07-.85 Reserved 0400-20-07-.86 Reserved 0400-20-07-.87 Records of Calibrations of Instruments May, 2012 2

USE OF RADIONUCLIDES IN THE HEALING ARTS CHAPTER 0400-20-07 Used to Measure the Activity of Unsealed Radioactive Material 0400-20-07-.88 Records of Radiation Survey Instrument Calibrations 0400-20-07-.89 Records of Dosages of Unsealed Radioactive Material for Medical Use 0400-20-07-.90 Reserved 0400-20-07-.91 Records of Surveys for Ambient Radiation Exposure Rate May, 2012 3

USE OF RADIONUCLIDES IN THE HEALING ARTS CHAPTER 0400-20-07 0400-20-07-.01 PURPOSE.

This Chapter contains the requirements and provisions for the medical use of radionuclides and for issuance of specific licenses authorizing the medical use of this material. The provisions of this Chapter are in addition to and not in substitution for other applicable provisions of these regulations.

Authority: T.C.A. §§68-202-101 et seq., 68-202-201 et seq. and 4-5-201 et seq. Administrative History:

Original rule filed February 22, 2012; effective May 22, 2012.

0400-20-07-.02 SCOPE.

Except as otherwise specifically provided, this Chapter applies to all persons who use radionuclides in the healing arts.

Authority: T.C.A. §§68-202-101 et seq., 68-202-201 et seq. and 4-5-201 et seq. Administrative History:

Original rule filed February 22, 2012; effective May 22, 2012.

0400-20-07-.03 RESERVED.

Authority: T.C.A. §§68-202-101 et seq., 68-202-201 et seq. and 4-5-201 et seq. Administrative History:

Original rule filed February 22, 2012; effective May 22, 2012.

0400-20-07-.04 RESERVED.

Authority: T.C.A. §§68-202-101 et seq., 68-202-201 et seq. and 4-5-201 et seq. Administrative History:

Original rule filed February 22, 2012; effective May 22, 2012.

0400-20-07-.05 DEFINITIONS.

When used in this Chapter, the following terms have the meanings given below unless otherwise specified:

(1) Address of use means the building or buildings that are identified on the license and where radioactive material may be received, prepared, used, or stored.

(2) Area of use means a portion of an address of use that has been set aside for the purpose of receiving, preparing, using, or storing radioactive material.

(3) Associate Radiation Safety Officer means an individual who:

(a) Meets the requirements in 0400-20-07-.23 and 0400-20-07-.27; and (b) Is currently identified as an Associate Radiation Safety Officer for the types of use of Formatted: Indent: Left: 0.75", Hanging: 0.25", Tab byproduct material for which the individual has been assigned duties and tasks by the stops: Not at 1.13" Radiation Safety Officer on Formatted: Indent: Left: 0.75", Hanging: 0.38"

1. A specific medical use license issued by the Commission or an Agreement State; or

2. A medical use permit issued by a Commission master material licensee. Formatted: Indent: Left: 1", Hanging: 0.13" Formatted: Indent: First line: 0.24" (3)(4) Authorized medical physicist means an individual who:

Formatted: Indent: Hanging: 0.01" (a) Meets the requirements in paragraph (1) of Rule 0400-20-07-.24 and Rule 0400-20 .27; or (b) Is identified as an authorized medical physicist or teletherapy physicist on:

1. A specific medical use license or permit issued by the Division, U.S. Nuclear Regulatory Commission, or Agreement State; May, 2012 4

USE OF RADIONUCLIDES IN THE HEALING ARTS CHAPTER 0400-20-07 (Rule 0400-20-07-.05, continued)

2. A medical use permit issued by a U.S. Nuclear Regulatory Commission master material licensee;

3. A permit issued by a Division, U.S. Nuclear Regulatory Commission or Agreement State broad scope medical use licensee; or

4. A permit issued by a U.S. Nuclear Regulatory Commission master material license broad scope medical use permittee.

(4)(5) Authorized nuclear pharmacist means a pharmacist who:

(a) Meets the requirements in paragraph (1) of Rule 0400-20-07-.25 and Rule 0400-20 .27; or (b) Is identified as an authorized nuclear pharmacist on:

1. A specific license or equivalent permit issued by the Division, U.S. Nuclear Regulatory Commission, or Agreement State that authorizes medical use or the practice of nuclear pharmacy;

2. A permit issued by a U.S. Nuclear Regulatory Commission master material licensee that authorizes medical use or the practice of nuclear pharmacy;

3. A permit issued by a Division, U.S. Nuclear Regulatory Commission or Agreement State broad scope medical use licensee that authorizes medical use or the practice of nuclear pharmacy; or

4. A permit issued by a U.S. Nuclear Regulatory Commission master material license broad scope medical use permittee that authorizes medical use or the practice of nuclear pharmacy; or (c) Is identified as an authorized nuclear pharmacist by a commercial nuclear pharmacy that has been authorized to identify authorized nuclear pharmacists; or (d) Is designated as an authorized nuclear pharmacist in accordance with part (10)(b)4 of Rule 0400-20-10-.13.

(5)(6) Authorized user means a physician, dentist, or podiatrist who:

(a) Meets the requirements in Rule 0400-20-07-.27 and subparagraph (1)(a) of Rule 0400-20-07-.39, subparagraph (1)(a) of Rule 0400-20-07-.43, subparagraph (1)(a) of Rule 0400-20-07-.47, subparagraph (1)(a) of Rule 0400-20-07-.48, subparagraph (1)(a) of Rule 0400-20-07-.49, subparagraph (1)(a) of Rule 0400-20-07-.59, Rule 0400-20-07-.60, subparagraph (1)(a) of Rule 0400-20-07-.62, or subparagraph (1)(a) of Rule 0400 07-.80; or (b) Is identified as an authorized user on:

1. A Division, U.S. Nuclear Regulatory Commission, or Agreement State license that authorizes the medical use of radioactive material;

2. A permit issued by a U.S. Nuclear Regulatory Commission master material licensee that is authorized to permit the medical use of radioactive material; May, 2012 5

USE OF RADIONUCLIDES IN THE HEALING ARTS CHAPTER 0400-20-07 (Rule 0400-20-07-.05, continued)

3. A permit issued by a Division, U.S. Nuclear Regulatory Commission, or Agreement State specific licensee of broad scope that is authorized to permit the medical use of radioactive material; or

4. A permit issued by a U.S. Nuclear Regulatory Commission master material license broad scope permittee that is authorized to permit the medical use of radioactive material.

(6)(7) Brachytherapy means a method of radiation therapy in which sources are used to deliver a radiation dose at a distance of up to a few centimeters by surface, intracavitary, intraluminal, or interstitial application.

(7)(8) 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.

(8)(9) Clients address means the area of use or a temporary job site for the purpose of providing mobile medical service in accordance with Rule 0400-20-07-.36.

(9)(10) Dedicated check source means a radioactive source that is used to assure the constant operation of a radiation detection or measurement device over several months or years.

(10)(11) 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.

(11)(12) 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.

(12)(13) Division means the Division of Radiological Health.

(13)(14) High dose-rate remote afterloader means a device that remotely delivers a dose rate in excess of 12 gray (1200 rads) per hour at the treatment site.

(14)(15) Low dose-rate remote afterloader means a device that remotely delivers a dose rate of less than or equal to 2 gray (200 rads) per hour at the treatment site.

(15)(16) Management means the chief executive officer or other individual having the authority to manage, direct, or administer the licensees activities, or that persons delegate or delegates.

(16)(17) Manual brachytherapy means a type of therapy in which the brachytherapy sources (e.g., seeds, ribbons) are manually placed or inserted.

(17)(18) Medical institution means an organization in which more than one medical discipline is practiced.

(18)(19) Medical use means the intentional internal or external administration of radioactive material or the radiation from radioactive material to patients or human research subjects under the supervision of an authorized user.

(19)(20) Medium dose-rate remote afterloader means a device that remotely delivers a dose rate of greater than 2 gray (200 rads), but less than or equal to 12 gray (1200 rads) per hour at the point or surface where the dose is prescribed.

May, 2012 6

USE OF RADIONUCLIDES IN THE HEALING ARTS CHAPTER 0400-20-07 (Rule 0400-20-07-.05, continued)

(20)(21) Misadministration means an event that meets the criteria in Rule 0400-20-05-.145.

(21)(22) Mobile medical service means the transportation of radioactive material to and its medical use at the clients address.

(23) Ophthalmic physicist means an individual who:

(a) Meets the requirements in 0400-20-07-.57 and 0400-20-07-.27; and (b) Is identified as an ophthalmic physicist on a (i) Specific medical use license issued by the Commission or an Agreement Formatted: Indent: Left: 1.38", Hanging: 0.5", Tab State; stops: 0.94", Left + Not at 0.75" (ii) Permit issued by a Commission or Agreement State broad scope medical use licensee; (iii) Medical use permit issued by a Commission master material licensee; or Formatted: Indent: First line: 0.62" (iv) Permit issued by a Commission master material licensee broad scope medical use permittee. Formatted: Indent: Left: 1.38", Hanging: 0.5", Tab stops: 0.94", Left + Not at 0.75" (22)(24) Output means the exposure rate, dose rate, or a quantity related in a known manner to Formatted: Font: Not Bold these rates from a brachytherapy source or a teletherapy, remote afterloader, or gamma stereotactic radiosurgery unit for a specified set of exposure conditions.

(23)(25) 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.

(24)(26) 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.

(25)(27) Physician means a doctor of medicine or doctor of osteopathy licensed by the 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.

(26)(28) 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.

(27)(29) Positron Emission Tomography (PET) radionuclide production facility is defined as a facility operating a cyclotron or accelerator for the purpose of producing PET radionuclides.

(28)(30) Preceptor means an individual who provides, directs, or verifies training and experience required for an individual to become an authorized user, an authorized medical physicist, an authorized nuclear pharmacist, or a radiation safety officer, or an associate radiation safety officer.

(29)(31) Prescribed dosage means the specified activity or range of activity of unsealed radioactive material as documented:

(a) In a written directive as specified in Rule 0400-20-07-.20; or (b) In accordance with the directions of the authorized user for procedures performed under Rules 0400-20-07-.38 and 0400-20-07-.40.

(30)(32) Prescribed dose means:

(a) For gamma stereotactic radiosurgery, the total dose as documented in the written directive; May, 2012 7

USE OF RADIONUCLIDES IN THE HEALING ARTS CHAPTER 0400-20-07 (Rule 0400-20-07-.05, continued)

(b) For teletherapy, the total dose and dose per fraction as documented in the written directive; (c) For manual brachytherapy, either the total source strength and exposure time or the total dose, as documented in the written directive; or (d) For remote brachytherapy afterloaders, the total dose and dose per fraction as documented in the written directive.

(31)(33) Pulsed dose-rate remote afterloader means a special type of remote afterloading device that uses a single source capable of delivering dose rates in the high dose-rate range, but:

(a) Is approximately one-tenth of the activity of typical high dose-rate remote afterloader sources; and (b) Is used to simulate the radiobiology of a low dose-rate treatment by inserting the source for a given fraction of each hour.

(32)(34) Radiation safety officer means an individual who meets the requirements in paragraph (1) or subparagraph (3)(a) of Rule 0400-20-07-.23 and Rule 0400-20-07-.27 or is named as a Radiation Safety Officer on a specific medical use license or equivalent permit issued by the Division, U.S. Nuclear Regulatory Commission or Agreement State or a medical use permit issued by a Commission master material licensee.

(33)(35) "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.

(34)(36) Sealed source means any radioactive material that is encased in a capsule designed to prevent leakage or escape of the radioactive material.

(35)(37) Sealed Source and Device Registry means the national registry that contains all the registration certificates, generated by both the U.S. Nuclear Regulatory Commission and the Agreement States, that summarize the radiation safety information for the sealed sources and devices and describe the licensing and use conditions approved for the product.

(36)(38) Stereotactic radiosurgery means the use of external radiation in conjunction with a stereotactic guidance device to very precisely deliver a therapeutic dose to a tissue volume.

(37)(39) Structured educational program means an educational program designed to impart particular knowledge and practical education through interrelated studies and supervised training.

(38)(40) Teletherapy, for the purpose of this Chapter, means a method of radiation therapy in which collimated gamma rays are delivered at a distance from the patient or human research subject.

(39)(41) Temporary job site means a location where mobile medical services are conducted other than those location(s) of use authorized on the license.

(40)(42) 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.

May, 2012 8

USE OF RADIONUCLIDES IN THE HEALING ARTS CHAPTER 0400-20-07 (Rule 0400-20-07-.05, continued)

(41)(43) Therapeutic dose means a radiation dose delivered from a source containing radioactive material to a patient or human research subject for palliative or curative treatment.

(42)(44) Treatment site means the anatomical description of the tissue intended to receive a radiation dose, as described in a written directive.

(43)(45) Type of use means use of radioactive material under Rule 0400-20-07-.38, 0400 07-.40, 0400-20-07-.44, 0400-20-07-.51, 0400-20-07-.61, 0400-20-07-.63 or 0400-20-07-.81.

(44)(46) Unit dosage means a dosage prepared for medical use for administration as a single dosage to a patient or human research subject without any further manipulation of the dosage after it is initially prepared.

(45)(47) Written directive means an authorized users written order for the administration of radioactive material or radiation from radioactive material to a specific patient or human research subject, as specified in Rule 0400-20-07-.20.

Authority: T.C.A. §§68-202-101 et seq., 68-202-201 et seq. and 4-5-201 et seq. Administrative History:

Original rule filed February 22, 2012; effective May 22, 2012.

0400-20-07-.06 OTHER FEDERAL AND STATE REQUIREMENTS.

Nothing in this Chapter relieves a licensee from complying with applicable Food and Drug Administration (FDA) requirements or other federal and state requirements governing radioactive drugs or devices.

Authority: T.C.A. §§68-202-101 et seq., 68-202-201 et seq. and 4-5-201 et seq. Administrative History:

Original rule filed February 22, 2012; effective May 22, 2012.

0400-20-07-.07 PROVISIONS FOR THE PROTECTION OF HUMAN RESEARCH SUBJECTS.

(1) A licensee may conduct research involving human subjects using radioactive material provided that:

(a) The research is conducted, funded, supported, or regulated by a federal agency which has implemented the Federal Policy for the Protection of Human Subjects. Otherwise, a licensee shall apply for and receive approval of a specific amendment to its license before conducting such research. In both instances, the licensees shall, at a minimum, 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 the Federal Policy for the Protection of Human Subjects; (b) The research involving human subjects authorized in subparagraph (a) of this paragraph shall be conducted using radioactive material authorized for medical use in the license; and (c) Nothing in this rule relieves licensees from complying with the other requirements in this rule.

Authority: T.C.A. §§68-202-101 et seq., 68-202-201 et seq. and 4-5-201 et seq. Administrative History:

Original rule filed February 22, 2012; effective May 22, 2012.

0400-20-07-.08 MAINTENANCE OF RECORDS.

May, 2012 9

USE OF RADIONUCLIDES IN THE HEALING ARTS CHAPTER 0400-20-07 Each record required by this Chapter must be legible throughout the retention period specified by each Division regulation. The record may be the original or a reproduced copy or a microform provided that the copy or microform is authenticated by authorized personnel and that 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. A licensee shall maintain adequate safeguards against tampering with and loss of records.

Authority: T.C.A. §§68-202-101 et seq., 68-202-201 et seq. and 4-5-201 et seq. Administrative History:

Original rule filed February 22, 2012; effective May 22, 2012.

0400-20-07-.09 IMPLEMENTATION.

(1) A licensee shall implement the provisions in this rule on March 21, 2010.

(2) When a requirement in this rule differs from the requirement in an existing license condition, the requirement in this rule shall govern.

(3) Any existing license condition that is not affected by a requirement in this rule remains in effect until there is a license amendment or license renewal.

(4) If a license condition exempted a licensee from a provision of this rule on March 21, 2010, it will continue to exempt a licensee from the corresponding provision in this rule.

(5) If a license condition cites provisions in this rule that will be deleted on March 21, 2010, then the license condition remains in effect until there is a license amendment or license renewal that modifies or removes this condition.

(6) Licensees shall continue to comply with any license condition that requires it to implement procedures required by 0400-20-07-.66, 0400-20-07-.72, 0400-20-07-.73 and 0400-20-07-.74 until there is a license amendment or renewal that modifies the license condition.

Authority: T.C.A. §§68-202-101 et seq., 68-202-201 et seq. and 4-5-201 et seq. Administrative History:

Original rule filed February 22, 2012; effective May 22, 2012.

0400-20-07-.10 LICENSE REQUIRED.

(1) A person shall only manufacture, produce, prepare, acquire, receive, possess, use, or transfer radioactive material for medical use in accordance with a specific license issued by the Division, the U.S. Nuclear Regulatory Commission, or an Agreement State or as allowed in paragraphs (2) and (3) of this rule.

(2) An individual may receive, possess, use, or transfer radioactive material in accordance with the regulations in this rule under the supervision of an authorized user as provided in Rule 0400-20-07-.19, unless prohibited by a license condition.

(3) An individual may prepare unsealed radioactive material for medical use in accordance with the regulations in this rule under the supervision of an authorized nuclear pharmacist or authorized user as provided in Rule 0400-20-07-.19 unless prohibited by a license condition.

Authority: T.C.A. §§68-202-101 et seq., 68-202-201 et seq. and 4-5-201 et seq. Administrative History:

Original rule filed February 22, 2012; effective May 22, 2012.

0400-20-07-.11 APPLICATION FOR LICENSE, AMENDMENT, OR RENEWAL.

May, 2012 10

USE OF RADIONUCLIDES IN THE HEALING ARTS CHAPTER 0400-20-07 (Rule 0400-20-07-.11, continued)

(1) An application must be signed by the applicants or licensees management.

(2) An application for a license for medical use of radioactive material as described in Rules 0400-20-07-.38, 0400-20-07-.40, 0400-20-07-.44, 0400-20-07-.51, 0400-20-07-.61, 0400-20-07-.63, and 0400-20-07-.81 must be made by:

(a) Filing with the Division the original application in duplicate on a form prescribed by the Division that includes the facility diagram, equipment, and training and experience qualifications of the Radiation Safety Officer, Associate Radiation Safety Officer(s),

authorized user(s), authorized medical physicist(s), ophthalmic physicist(s), and authorized nuclear pharmacist(s); ; and (b) Submitting applicable procedures required by Rules 0400-20-07-.66, 0400-20-07-.72, 0400-20-07-.73, and 0400-20-07-.74.

(3) A request for a license amendment or renewal must be made by:

(a) Submitting an original in letter format to the Division; and of either-

1. Form CN 0716, Application for Radioactive Material License; or

2. A letter containing all information required by Form CN 0716; and (b) Submitting applicable procedures required by Rules 0400-20-07-.66, 0400-20-07-.72, 0400-20-07-.73, and 0400-20-07-.74.

(4) In addition to the requirements in paragraphs (2) and (3) of this rule, an application for a license or amendment for medical use of radioactive material as described in Rule 0400-20-07-.81 must also include: information regarding any radiation safety aspects of the medical use of the material that is not addressed in this Chapter.

(a) Information regarding any additional radiation safety aspects of the medical use of the Formatted: Indent: Left: 0.75", Hanging: 0.38",

material that is not addressed in this chapter. Numbered + Level: 1 + Numbering Style: a, b, c, +

Start at: 1 + Alignment: Left + Aligned at: 0.75" +

(b) Identification of and commitment to follow the applicable radiation safety program Indent at: 1", Tab stops: Not at 0.75" requirements in this chapter that are appropriate for the specific Rule 0400-20-07-.81 medical use; (a)(c) The applicant shall also provide specific information on: Any additional specific information on

1. Radiation safety precautions and instructions;

2. Training and experience of proposed users;

3. Methodology for measurement of dosages or doses to be administered to patients or human research subjects; and

4. Calibration, maintenance, and repair of instruments and equipment necessary for radiation safety.

(5)(d) An applicant or licensee shall also provide any other information requested by the Formatted: Indent: Left: 0.75", Hanging: 0.38", Tab Division in its review of the application. stops: Not at 0.75" May, 2012 11

USE OF RADIONUCLIDES IN THE HEALING ARTS CHAPTER 0400-20-07 (Rule 0400-20-07-.11, continued)

(6)(5) An applicant that satisfies the requirements specified in paragraph (4) of Rule 0400-20-10-.13 may apply for a specific license of broad scope.

Authority: T.C.A. §§68-202-101 et seq., 68-202-201 et seq. and 4-5-201 et seq. Administrative History:

Original rule filed February 22, 2012; effective May 22, 2012.

0400-20-07-.12 RESERVED.

Authority: T.C.A. §§68-202-101 et seq., 68-202-201 et seq. and 4-5-201 et seq. Administrative History:

Original rule filed February 22, 2012; effective May 22, 2012.

0400-20-07-.13 LICENSE AMENDMENTS.

(1) A licensee shall apply for and must receive a license amendment:

(a) Before the licensee receives, prepares or uses radioactive material for a type of use that is permitted under this rule, but that is not authorized on the licensees current license issued pursuant to this rule; (b) Before the licensee permits anyone to work as an authorized user, authorized nuclear pharmacist, ophthalmic physicist or an authorized medical physicist under the license, except an individual who is: -

1. For an authorized user, an individual who meets the requirements in Rule 0400-20-07-.27 and subparagraph (1)(a) of Rule 0400-20-07-.39, subparagraph (1)(a) of Rule 0400-20-07-.43, subparagraph (1)(a) of Rule 0400-20-07-.47, subparagraph (1)(a) of Rule 0400-20-07-.48, subparagraph (1)(a) of Rule 0400-20-07-.49, subparagraph (1)(a) of Rule 0400-20-07-.59, subparagraph (1)(a) of Rule 0400-20-07-.62, subparagraph (1)(a) of Rule 0400-20-07-.80;

2. For an authorized nuclear pharmacist, an individual who meets the requirements in paragraph (1) of Rule 0400-20-07-.25 and Rule 0400-20-07-.27;

3. For an authorized medical physicist, an individual who meets the requirements in paragraph (1) of Rule 0400-20-07-.24 and Rule 0400-20-07-.27;

4. Identified as an authorized user, an authorized nuclear pharmacist, or an authorized medical physicist, or an ophthalmic physicist on a U.S. Nuclear Regulatory Commission or Agreement State license or Licensing State or other equivalent permit or license recognized by the Division that authorizes the use of radioactive material in medical use in the practice of nuclear pharmacy; or

5. Identified as an authorized user, an authorized nuclear pharmacist, or an authorized medical physicist, or an ophthalmic physicist on a permit issued by a U.S. Nuclear Regulatory Commission or Agreement State or Licensing State specific licensee of broad scope that is authorized to permit the use of radioactive material in medical use or in the practice of nuclear pharmacy.

(c) Before the licensee changes Radiation Safety Officers, except as provided in paragraph (3) of Rule 0400-20-07-.17; (d) Before it permits anyone to work as an Associate Radiation Safety Officer, or before the Radiation Safety Officer assigns duties and tasks to an Associate Radiation Safety Officer that differ from those for which this individual is authorized on the license; May, 2012 12

USE OF RADIONUCLIDES IN THE HEALING ARTS CHAPTER 0400-20-07 (Rule 0400-20-07-.13, continued)

(d)(e) Before the licensee receives radioactive material in excess of the amount or in a different physical or chemical form than is authorized on the license; (e)(f) Before the licensee adds to or changes the areas of use identified in the application or on the license; (f)(g) Before the licensee changes the address(es) of use identified in the application or on the license; (h) Before it revises procedures required by Rules 0400-20-07-.66, 0400-20-07-.72, 0400-20-07-.73, and 0400-20-07-.74, as applicable, where such revision reduces radiation safety; and (g)(i) Before the licensee changes statements, representations, and procedures which are incorporated into the license; and (h)(i) Before the licensee releases licensed facilities for unrestricted use.

(k) Before it receives a sealed source from a different manufacturer or of a different model number than authorized by its license unless the sealed source is used for manual brachytherapy, is listed in the Sealed Source and Device Registry, and is in a quantity and for an isotope authorized by the license.

Authority: T.C.A. §§68-202-101 et seq., 68-202-201 et seq. and 4-5-201 et seq. Administrative History:

Original rule filed February 22, 2012; effective May 22, 2012.

0400-20-07-.14 NOTIFICATIONS.

Formatted: Indent: Hanging: 0.01" (1) A licensee shall provide to the Division a copy of the board certification, the Nuclear Regulatory Formatted: Numbered + Level: 1 + Numbering Style: a, Commission, Agreement State or Licensing State license, or the permit issued by a licensee b, c, + Start at: 1 + Alignment: Left + Aligned at:

of broad scope for each individual no later than 30 days after the date that the Licensee permits 0.75" + Indent at: 1" the individual to work as an authorized user, an authorized nuclear pharmacist or an authorized medical physicist, pursuant to subparagraph (1)(b) of Rule 0400-20-07-.13. A licensee shall Formatted: English (United States) provide the Division, no later than 30 days after the date that the licensee permits an individual Formatted: Indent: Left: 0.75", First line: 0" to work under the provisions of subparagraph (1)(b) of Rule 0400-20-07-.13 as an authorized user, authorized medical physicist, ophthalmic physicist, or authorized nuclear pharmacist the Formatted: Numbered + Level: 2 + Numbering Style: 1, following: 2, 3, + Start at: 1 + Alignment: Left + Aligned at:

1.25" + Indent at: 1.5" (a) A copy of the board certification and, as appropriate, verification of completion of:

Formatted: English (United States)

1. Training for the authorized medical physicist under Rule 0400-20-07-.24; Formatted: Numbered + Level: 2 + Numbering Style: 1, 2, 3, + Start at: 1 + Alignment: Left + Aligned at:

2. Any additional case experience required in Item 0400-20-07-.47(1)(b)1.(ii)(VI) for 1.25" + Indent at: 1.5" an authorized user under Rule 0400-20-07-.44; or Formatted: English (United States)

3. Device specific training in Subparagraph 0400-20-07-.80(1)(c) for the authorized Formatted: List Paragraph, No bullets or numbering user under Rule 0400-20-07-.63; or Formatted: Numbered + Level: 2 + Numbering Style: 1, (b) A copy of the Commission or Agreement State license, the permit issued by a Commission 2, 3, + Start at: 1 + Alignment: Left + Aligned at:

master material licensee, the permit issued by a Commission or Agreement State licensee 1.25" + Indent at: 1.5" of broad scope, the permit issued by a Commission master material license broad scope Formatted: English (United States) permittee, or documentation that only accelerator-produced radioactive materials, discrete sources of radium-226, or both, were used for medical use or in the practice of nuclear Formatted: List Paragraph, No bullets or numbering pharmacy at a Government agency or Federally recognized Indian Tribe before November Formatted: Numbered + Level: 1 + Numbering Style: a, 30, 2007, or at all other locations of use before August 8, 2009, or an earlier date as noticed b, c, + Start at: 1 + Alignment: Left + Aligned at:

0.75" + Indent at: 1" May, 2012 13

USE OF RADIONUCLIDES IN THE HEALING ARTS CHAPTER 0400-20-07 (Rule 0400-20-07-.14, continued) by the NRC for each individual whom the licensee permits to work under the provisions of this section.

(2) A licensee shall notify the Division no later than 30 days after:

(a) (a) An authorized user, an authorized nuclear pharmacist, a Rradiation Ssafety Formatted: Indent: Left: 0.75", Hanging: 0.38",

Oofficer, an Associate Radiation Safety Officer,or an authorized medical physicist, or Numbered + Level: 1 + Numbering Style: a, b, c, +

ophthalmic physicist permanently discontinues performance of duties under the license Start at: 1 + Alignment: Left + Aligned at: 0.75" +

or has a name change; Indent at: 1" (b) The licensee permits an individual qualified to be a Radiation Safety Officer under Rules 0400-20-07-.23 and 0400-20-07-.27 to function as a temporary Radiation Safety Officer and to perform the functions of a Radiation Safety Officer in accordance with Paragraph 0400-20-07-.17(3);

(b)(c) The licensees mailing address changes; (c)(d) The licensees name changes, but the name change does not constitute a transfer of control of the license as described in paragraph (2) of Rule 0400-20-10-.16; or (d)(e) The licensee has added to or changed the areas of use identified in the application or on the license where radioactive material is used under either Rule 0400-20-07-.38 or 0400-20-07-.40. if the change does not include addition or relocation of either an area where PET radionuclides are produced or a PET radioactive drug delivery line from the PET radionuclide/PET radioactive drug production area; or (f) The licensee obtains a sealed source for use in manual brachytherapy from a different manufacturer or with a different model number than authorized by its license for which it did not require a license amendment as provided in Rule 0400-20-07-.13. The notification must include the manufacturer and model number of the sealed source, the isotope, and the quantity per sealed source.

(3) The licensee shall send the documents required in this rule to the Division at the address listed in Rule 0400-20-04-.07.

Authority: T.C.A. §§68-202-101 et seq., 68-202-201 et seq. and 4-5-201 et seq. Administrative History:

Original rule filed February 22, 2012; effective May 22, 2012.

0400-20-07-.15 EXEMPTIONS REGARDING SPECIFIC LICENSES OF BROAD SCOPE.

A licensee possessing a specific license of broad scope for medical use is exempt from:

(1) The provisions of paragraph (4) of Rule 0400-20-07-.11 regarding the need to file an amendment to the license for medical use of radioactive material, as described in Rule 0400-20-07-.81; (2) The provisions of subparagraph (1)(b) of Rule 0400-20-07-.13 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; (3) The provisions of subparagraph (1)(e) of Rule 0400-20-07-.13 regarding additions to or changes in the areas of use at the addresses specified in the license; identified in the application or on the license; May, 2012 14

USE OF RADIONUCLIDES IN THE HEALING ARTS CHAPTER 0400-20-07 (Rule 0400-20-07-.14, continued)

(4) The provisions of subparagraph (2)(a) of Rule 0400-20-07-.14 regarding notification to the Division for new authorized users, new authorized medical physicists and new authorized nuclear pharmacists or an ophthalmic physicist; (5) The provisions of paragraph (1) of Rule 0400-20-07-.22 regarding suppliers for sealed sources.

Authority: T.C.A. §§68-202-101 et seq., 68-202-201 et seq. and 4-5-201 et seq. Administrative History:

Original rule filed February 22, 2012; effective May 22, 2012.

0400-20-07-.16 LICENSE ISSUANCE AND SPECIFIC EXEMPTIONS.

(1) The Division shall issue a license for the medical use of radioactive material if:

(a) The applicant has filed an application with the Division in accordance with the instructions in Rule 0400-20-07-.11; (b) The applicant has paid applicable fee under Rule 0400-20-10-.31; (c) The Division finds the applicant equipped and committed to observe the safety standards established by the Division in these regulations for the protection of the public health and safety; and (d) The applicant meets the requirements of Chapter 0400-20-10.

(2) The Division shall issue a license for mobile medical service if the applicant:

(a) Meets the requirements in paragraph (1) of this rule; and (b) Assures that individuals or human research subjects to whom unsealed radioactive material, or radiation from implants containing radioactive material, will be administered may be released following treatment in accordance with Rule 0400-20-07-.35.

(3) The Division may, upon application of any interested person or upon its own initiative, grant exemptions from this Chapter that 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.

Authority: T.C.A. §§68-202-101 et seq., 68-202-201 et seq. and 4-5-201 et seq. Administrative History:

Original rule filed February 22, 2012; effective May 22, 2012.

0400-20-07-.17 AUTHORITY AND RESPONSIBILITIES FOR THE RADIATION PROTECTION PROGRAM.

(1) In addition to the radiation protection program requirements of Rule 0400-20-05-.40, a licensees management shall approve in writing:

(a) Requests for a license application, renewal, or amendment before submittal to the Division; (b) Any individual before allowing that individual to work as an authorized user, authorized nuclear pharmacist, or authorized medical physicist; and (c) Radiation protection program changes that do not require a license amendment and are permitted under Rule 0400-20-07-.18.

(2) A licensees management shall appoint a radiation safety officer, who agrees, in writing, to be responsible for implementing the radiation protection program. The licensee, through the May, 2012 15

USE OF RADIONUCLIDES IN THE HEALING ARTS CHAPTER 0400-20-07 (Rule 0400-20-07-.17, continued) radiation safety officer, shall ensure that radiation safety activities are being performed in accordance with licensee-approved procedures and regulatory requirements. A licensees management may appoint, in writing, one or more Associate Radiation Safety Officers to support the Radiation Safety Officer. The Radiation Safety Officer, with written agreement of the licensees management, must assign the specific duties and tasks to each Associate Radiation Safety Officer. These duties and tasks are restricted to the types of use for which the Associate Radiation Safety Officer is listed on a license. The Radiation Safety Officer may delegate duties and tasks to the Associate Radiation Safety Officer but shall not delegate the authority or responsibilities for implementing the radiation protection program.

(3) For up to 60 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, under paragraph (7) of this rule, if the licensee takes the actions required in paragraphs (2), (5), (7), and (8) of this rule and notifies the Division in accordance with Paragraph 0400-20-07-.14(2).

(4) A licensee may simultaneously appoint more than one temporary radiation safety officer under paragraph (3) of this rule, if needed to ensure that the licensee has a temporary radiation safety officer that satisfies the requirements to be a radiation safety officer for each of the different types of uses of radioactive material permitted by the license.

(5) A licensee shall establish the authority, duties, and responsibilities of the radiation safety officer in writing.

(6) Licensees that are authorized for 2 or more different types of use of radioactive material under Rules 0400-20-07-.44, 0400-20-07-.51, 0400-20-07-.63, and 0400-20-07-.81, or 2 or more types of units under Rule 0400-20-07-.63 shall establish a radiation safety committee to oversee all uses of radioactive material permitted by the license. The committee must include an authorized user of each type of use permitted by the license, the radiation safety officer, a representative of the nursing service, and a representative of management who is neither an authorized user nor a radiation safety officer. The committee may include other members the licensee considers appropriate.

(7) A licensee shall provide the radiation safety officer sufficient authority, organizational freedom, time, resources, and management prerogative, to:

(a) Identify radiation safety problems; (b) Initiate, recommend, or provide corrective actions; (c) Stop unsafe operations; and (d) Verify implementation of corrective actions.

(8) A licensees Radiation Safety Committee shall meet as necessary, but at a minimum shall meet at intervals not to exceed 6 months. The licensee shall maintain minutes of each meeting in accordance with Rule 0400-20-07-.82.

(9) A licensee shall retain a record of actions taken under paragraphs (1), (2), and (5) of this rule in accordance with Rule 0400-20-07-.82.

Authority: T.C.A. §§68-202-101 et seq., 68-202-201 et seq. and 4-5-201 et seq. Administrative History:

Original rule filed February 22, 2012; effective May 22, 2012.

0400-20-07-.18 RADIATION PROTECTION PROGRAM CHANGES.

May, 2012 16

USE OF RADIONUCLIDES IN THE HEALING ARTS CHAPTER 0400-20-07 (Rule 0400-20-07-.17, continued)

(1) A licensee may revise its radiation protection program without Division approval if:

(a) The revision does not require a license amendment under Rule 0400-20-07-.13; (b) The revision is in compliance with this Chapter and the license; (c) The revision has been reviewed and approved by the radiation safety officer and licensee management; and (d) The affected individuals are instructed on the revised program before the changes are implemented.

(2) A licensee shall retain a record of each change in accordance with Rule 0400-20-07-.83.

Authority: T.C.A. §§68-202-101 et seq., 68-202-201 et seq. and 4-5-201 et seq. Administrative History:

Original rule filed February 22, 2012; effective May 22, 2012.

0400-20-07-.19 SUPERVISION.

(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 paragraph (2) of Rule 0400-20-07-.10, shall:

(a) Instruct the supervised individual in the licensees written radiation protection procedures, written directive procedures, this Chapter, and license conditions with respect to the use of radioactive material; and (b) Require the supervised individual to follow the instructions of the supervising authorized user for medical uses of radioactive material, written radiation protection procedures established by the licensee, written directive procedures, regulations of this Chapter, and license conditions with respect to the medical use of radioactive material.

(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 paragraph (3) of Rule 0400-20-07-.10, shall:

(a) Instruct the supervised individual in the preparation of radioactive material for medical use, as appropriate to that individuals involvement with radioactive material; and (b) 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, written radiation protection procedures established by the licensee, this Chapter, and license conditions.

(3) A licensee that permits supervised activities under paragraphs (1) and (2) of this rule is responsible for the acts and omissions of the supervised individual.

Authority: T.C.A. §§68-202-101 et seq., 68-202-201 et seq. and 4-5-201 et seq. Administrative History:

Original rule filed February 22, 2012; effective May 22, 2012.

0400-20-07-.20 WRITTEN DIRECTIVES.

(1) A written directive must be dated and signed by an authorized user before the administration of I-131 sodium iodide greater than 1.11 megabecquerels (MBq) (30 microcuries (µCi)), any therapeutic dosage of radioactive material or any therapeutic dose of radiation from radioactive material.

May, 2012 17

USE OF RADIONUCLIDES IN THE HEALING ARTS CHAPTER 0400-20-07 (Rule 0400-20-07-.20, continued)

If, because of the emergent nature of the patients condition, a delay in order to provide a written directive would jeopardize the patients health, an oral directive is acceptable. The information contained in the oral directive must be documented as soon as possible in writing in the patients record. A written directive must be prepared within 48 hours5.555556e-4 days 0.0133 hours 7.936508e-5 weeks 1.8264e-5 months of the oral directive.

(2) The written directive must contain the patient or human research subjects name and the following information:

(a) For any administration of quantities greater than 1.11 MBq (30 µCi) of sodium iodide I-131: the dosage; (b) For an administration of a therapeutic dosage of radioactive drug containing radioactive material other than sodium iodide I-131: the radioactive drug, dosage, and route of administration; (c) For gamma stereotactic radiosurgery: The total dose, treatment site, and values for the target coordinate settings per treatment for each anatomically distinct treatment site; (d) For teletherapy: The total dose, dose per fraction, number of fractions, and treatment site; (e) For high dose-rate remote afterloading brachytherapy: The radionuclide, treatment site, dose per fraction, number of fractions, and total dose; or (f) For permanent implant brachytherapy:

1. Before implantation: the treatment site, the radionuclide, and the total source Formatted: Indent: Left: 1.13", Hanging: 0.38", Tab strength; and stops: Not at 1.13"

2. After implantation but before the patient leaves the post-treatment recovery area:

the treatment site, the number of sources implanted, the total source strength implanted, and the date; or Formatted: Indent: Left: 1.13", Hanging: 0.38", Tab stops: Not at 1.13" (f)(g) For all other brachytherapy, including low, medium, and pulsed dose rate remote afterloaders:

1. Before implantation: Treatment site, the radionuclide, and dose; and

2. After implantation but before completion of the procedure: The radionuclide, treatment site, number of sources, and total source strength and exposure time (or the total dose).); and date.

(3) A written revision to an existing written directive may be made if the revision is dated and signed by an authorized user before the administration of the dosage of unsealed radioactive material, the brachytherapy dose, the gamma stereotactic radiosurgery dose, the teletherapy dose, or the next fractional dose.

(a) If, because of the patients condition, a delay in order to provide a written revision to an existing written directive would jeopardize the patients health, an oral revision to an existing written directive is acceptable. The oral revision must be documented as soon as possible in the patients record. A revised written directive must be signed by the authorized user within 48 hours5.555556e-4 days 0.0133 hours 7.936508e-5 weeks 1.8264e-5 months of the oral revision.

May, 2012 18

USE OF RADIONUCLIDES IN THE HEALING ARTS CHAPTER 0400-20-07 (Rule 0400-20-07-.20, continued)

(4) The licensee shall retain a copy of the written directive in accordance with Rule 0400-20 .84.

Authority: T.C.A. §§68-202-101 et seq., 68-202-201 et seq. and 4-5-201 et seq. Administrative History:

Original rule filed February 22, 2012; effective May 22, 2012.

0400-20-07-.21 PROCEDURES FOR ADMINISTRATIONS REQUIRING A WRITTEN DIRECTIVE.

(1) For any administration requiring a written directive, a licensee shall develop, implement, and maintain written procedures to provide high confidence that:

(a) The patients or human research subjects identity is verified before each administration; and (b) Each administration is in accordance with the written directive.

(2) At a minimum, the procedures required by paragraph (1) of this rule must address the following activities that are applicable to the licensees use of radioactive material:

(a) Verifying the identity of the patient or human research subject; (b) Verifying that the administration is in accordance with the treatment plan, if applicable, and the written directive; (c) Checking both manual and computer-generated dose calculations; and (d) Verifying that any computer-generated dose calculations are correctly transferred into the consoles of therapeutic medical units authorized by Rule 0400-20-07-.63 or 0400-20-07-.81.

(e) Determining if a patient or medical event, as defined in Rule 0400-20-07-.114, has occurred; and (f) Determining, for permanent implant brachytherapy, within 60 calendar days from the date the implant was performed, the total source strength administered outside of the treatment site compared to the total source strength documented in the post-implantation portion of the written directive, unless a written justification of patient unavailability is documented.

(3) A licensee shall retain a copy of the procedures required under paragraph (1) of this rule in accordance with Rule 0400-20-07-.112.

Authority: T.C.A. §§68-202-101 et seq., 68-202-201 et seq. and 4-5-201 et seq. Administrative History:

Original rule filed February 22, 2012; effective May 22, 2012.

0400-20-07-.22 SUPPLIERS FOR SEALED SOURCES OR DEVICES FOR MEDICAL USE.

For medical use, a licensee may only use:

(1) Sealed sources or devices manufactured, labeled, packaged, and distributed in accordance with a license issued under Chapter 0400-20-10 of these regulations or the equivalent requirements of the Nuclear Regulatory Commission or an Agreement State; (2) Sealed sources or devices non-commercially transferred from a Division, Nuclear Regulatory Commission or Agreement State licensee; or May, 2012 19

USE OF RADIONUCLIDES IN THE HEALING ARTS CHAPTER 0400-20-07 (3) Teletherapy sources manufactured and distributed in accordance with a license issued under Chapter 0400-20-10 of these regulations or the equivalent requirements of the Nuclear Regulatory Commission or an Agreement State; Authority: T.C.A. §§68-202-101 et seq., 68-202-201 et seq. and 4-5-201 et seq. Administrative History:

Original rule filed February 22, 2012; effective May 22, 2012.

0400-20-07-.23 TRAINING FOR RADIATION SAFETY OFFICER AND ASSOCIATE RADIATION Formatted: Indent: Left: 0", Hanging: 1.06" SAFETY OFFICER.

Formatted: English (United States)

Except as provided in Rule 0400-20-07-.26, a licensee shall require an individual fulfilling the responsibilities of the radiation safety officer or an individual assigned duties and tasks as an associate radiation safety officer under Rule 0400-20-07-.17 to be an individual who:

(1) Is certified by a specialty board whose certification process has been recognized by the Division, the U.S. Nuclear Regulatory Commission, or an Agreement State, and who meets the requirements of paragraphs (4) and (5)(4) of this rule. (Specialty boards whose certification processes have been recognized by the U.S. Nuclear Regulatory Commission or an Agreement State will be posted on the U.S. Nuclear Regulatory Commission's Web page.) The names of board certifications that have been recognized by the Division, the U.S. Nuclear Regulatory Commission or an Agreement State are posted on the NRCs Medical Uses Licensee Toolkit Web page. To be have its certification process recognized, a specialty board shall require all candidates for certification to:

(a) 1. Hold a bachelors 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;

2. Have 5 or more years of professional experience in health physics (graduate training may be substituted for no more than 2 years of the required experience) including at least 3 years in applied health physics; and

3. Pass an examination administered by diplomates of the specialty board, which 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; or (b) 1. Hold a masters or doctors degree in physics, medical physics, other physical science, engineering, or applied mathematics from an accredited college or university;

2. Have 2 years of full-time practical training and/or supervised experience in medical physics:

(i) Under the supervision of a medical physicist who is certified in medical physics by a specialty board recognized by the U.S. Nuclear Regulatory Commission or an Agreement State; or (ii) In clinical nuclear medicine facilities providing diagnostic and/or therapeutic services under the direction of physicians who meet the requirements for authorized users under Rule 0400-20-07-.26, 0400-20-07-.43 or 0400 07-.47; and

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; or May, 2012 20

USE OF RADIONUCLIDES IN THE HEALING ARTS CHAPTER 0400-20-07 (Rule 0400-20-07-.23, continued)

(2) (a) Has completed a structured educational program consisting of both:

1. 200 hours0.00231 days 0.0556 hours 3.306878e-4 weeks 7.61e-5 months of classroom and laboratory training in the following areas:

(i) Radiation physics and instrumentation; (ii) Radiation protection; (iii) Mathematics pertaining to the use and measurement of radioactivity; (iv) Radiation biology; and (v) Radiation dosimetry; and

2. 1 year of full-time radiation safety experience under the supervision of the individual identified as the radiation safety officer on a Division, U.S. Nuclear Regulatory Commission or Agreement State license or a permit issued by a Commission master material licensee that authorizes similar type(s) of use(s) of radioactive material. An Associate Radiation Safety Officer may provide supervision for those areas for which the Associate Radiation Safety Officer is authorized on a Division, U.S. Nuclear Regulatory Commission, or an Agreement State license or permit issued by a Commission master material licensee. The full-time radiation safety experience must involveing the following:

(i) Shipping, receiving, and performing related radiation surveys; (ii) Using and performing checks for proper operation of instruments used to determine the activity of dosages, survey meters, and instruments used to measure radionuclides; (iii) Securing and controlling radioactive material; (iv) Using administrative controls to avoid mistakes in the administration of radioactive material; (v) Using procedures to prevent or minimize radioactive contamination and using proper decontamination procedures; (vi) Using emergency procedures to control radioactive material; and (vii) Disposing of radioactive material; orand (b) This individual must obtain a written attestation, signed by a preceptor radiation safety officer or associate radiation safety officer who has experience with the radiation safety aspects of similar types of use of radioactive material for which the individual is seeking approval as a Radiation Safety Officer or an Associate Radiation Safety Officer. The written attestation must state that the individual has satisfactorily completed the requirements in paragraph (4) of this rule, and in subparagraph (1)(a), (1)(b), (2)(a),

(2)(b), (3)(a) or (3)(b) of this rule, and is able to independently fulfill the radiation safety related duties as a radiation safety officer or as an associate radiation safety officer for a medical use license; or Formatted: Indent: Left: 0.75", Hanging: 0.38", Tab stops: Not at 1.88" (3) (a) Is a medical physicist who has been certified by a specialty board whose certification process has been recognized by the Division, the U.S. Nuclear Regulatory Commission, May, 2012 21

USE OF RADIONUCLIDES IN THE HEALING ARTS CHAPTER 0400-20-07 (Rule 0400-20-07-.23, continued) or an Agreement State under paragraph (1) of Rule 0400-20-07-.24 and has experience in radiation safety for similar types of use of radioactive material for which the licensee is seeking the approval of the individual as radiation safety officer or as an associate radiation safety officer and who meets the requirements in paragraphs (4) and (5) of this rule; or (b) Is an authorized user, authorized medical physicist, or authorized nuclear pharmacist identified on the licensees license a U.S. Nuclear Regulatory Commission or an Agreement State license, a permit issued by a Commission master material licensee, a permit issued by a Commission or an Agreement State licensee of broad scope, or a permit issued by a Commission master material license broad scope permittee, and has experience with the radiation safety aspects of similar types of use of radioactive material for which the licensee seeks the approval of the individual has as the radiation safety officer responsibilities or associate radiation safety officer, and meets the requirements in paragraph (4) of this rule; andor (c) Has experience with the radiation safety aspects of the types of use of radioactive material for which the individual is seeking simultaneous approval both as the Radiation Safety Officer and the authorized user on the same new medical use license or new medical use permit issued by a Commission master material license. The individual must also meet the requirements in paragraph (4) of this rule.

(4) Has obtained written attestation, signed by a preceptor radiation safety officer, that the individual has satisfactorily completed the requirements in paragraph (5) of this rule, and in subparagraph (1)(a), (1)(b), (2)(a), (3)(a) or (3)(b) of this rule, and has achieved a level of radiation safety knowledge sufficient to function independently as a radiation safety officer for a medical use licensee; and (5)(4) Has training in the radiation safety, regulatory issues, and emergency procedures for the types of use for which a licensee seeks approval. This training requirement may be satisfied by completing training that is supervised by an authorized medical physicist, authorized user, authorized nuclear pharmacist, or radiation safety officer a radiation safety officer, an associate radiation safety officer, authorized medical physicist, authorized nuclear pharmacist, or authorized user, as appropriate, who is authorized for the type(s) of use for which the licensee is seeking approval.

Authority: T.C.A. §§68-202-101 et seq., 68-202-201 et seq. and 4-5-201 et seq. Administrative History:

Original rule filed February 22, 2012; effective May 22, 2012.

0400-20-07-.24 TRAINING FOR AN AUTHORIZED MEDICAL PHYSICIST.

Except as provided in Rule 0400-20-07-.26, the licensee shall require the authorized medical physicist to be an individual who:

(1) Is certified by a specialty board whose certification process has been recognized by the Division, the U.S. Nuclear Regulatory Commission or an Agreement State and who meets the requirements in subparagraph (2)(b) and paragraph (3) of this rule. The names of board certifications that have been recognized by the Commission or an Agreement State are posted on the NRC's Medical Uses Licensee Toolkit Web page. To be recognized To have its certification process recognized, a specialty board shall require all candidates for certification to:

(a) Hold a masters or doctors degree in physics, medical physics, other physical science, engineering, or applied mathematics from an accredited college or university; May, 2012 22

USE OF RADIONUCLIDES IN THE HEALING ARTS CHAPTER 0400-20-07 (Rule 0400-20-07-.24, continued)

(b) Have 2 years of full-time practical training and/or supervised experience in medical physics:

1. Under the supervision of a medical physicist who is certified in medical physics by a specialty board recognized by the U.S. Nuclear Regulatory Commission or an Agreement State; or

2. In clinical radiation facilities providing high energy, external beam therapy (photons and electrons with energies greater than or equal to 1 million electron volts) and brachytherapy services under the direction of physicians who meet the requirements for authorized users in Rule 0400-20-07-.26, 0400-20-07-.59 or 0400-20-07-.80; and (c) Pass an examination, administered by diplomates of the specialty board, which assesses knowledge and competence in clinical radiation therapy, radiation safety, calibration, quality assurance, and treatment planning for external beam therapy, brachytherapy, and stereotactic radiosurgery; or (2) (a) Holds a masters or doctors degree in physics, medical physics, other physical science, engineering, or applied mathematics from an accredited college or university; and has completed 1 year of full-time training in medical physics and an additional year of full-time work experience under the supervision of an individual who meets the requirements for an authorized medical physicist for the type(s) of use modalities for which the individual is seeking authorization. This training and work experience must be conducted in clinical radiation facilities that provide high energy, external beam therapy and brachytherapy services and must include:

1. Performing sealed source leak tests and inventories;

2. Performing decay corrections;

3. Performing full calibration and periodic spot checks of external beam treatment units, stereotactic radiosurgery units, and remote afterloading units as applicable; and

4. Conducting radiation surveys around external beam treatment units, stereotactic radiosurgery units, and remote afterloading units as applicable; and (b) Has obtained written attestation that the individual has satisfactorily completed the requirements in subparagraphs (1)(a) and (1)(b) and paragraph (3), or subparagraph (2)(a) and paragraph (3) of this rule, and 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. is able to independently fulfill the radiation safety-related duties as an authorized medical physicist for each type of therapeutic medical unit for which the individual is requesting authorized medical physicist status. The written attestation must be signed by a preceptor authorized medical physicist who meets the requirements in this rule, Rule 0400-20-07-.26 or equivalent U.S. Nuclear Regulatory Commission or Agreement State requirements for an authorized medical physicist for each type of therapeutic medical unit for which the individual is requesting authorized medical physicist status; and (3) Has training for the type(s) of use in the modalities for which authorization is sought that includes hands-on device operation, safety procedures, clinical use, and the operation of a treatment planning system. This training requirement may be satisfied by satisfactorily completing either a training program provided by the vendor or by training supervised by an May, 2012 23

USE OF RADIONUCLIDES IN THE HEALING ARTS CHAPTER 0400-20-07 (Rule 0400-20-07-.24, continued) authorized medical physicist authorized for the type(s) of use for which the individual is seeking authorization.

Authority: T.C.A. §§68-202-101 et seq., 68-202-201 et seq. and 4-5-201 et seq. Administrative History:

Original rule filed February 22, 2012; effective May 22, 2012.

0400-20-07-.25 TRAINING FOR AN AUTHORIZED NUCLEAR PHARMACIST.

Except as provided in Rule 0400-20-07-.26, a licensee shall require the authorized nuclear pharmacist to be a pharmacist who:

(1) Is certified by a specialty board whose certification process has been recognized by the Division, the U.S. Nuclear Regulatory Commission or an Agreement State. and who meets the requirements in subparagraph (2)(b) of this rule. The names of board certifications that have been recognized by the Commission or an Agreement State are posted on the NRC's Medical Uses Licensee Toolkit Web page.To be recognized To have its certification process recognized, a specialty board shall require all candidates for certification to:

(a) 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; (b) Hold a current, active license to practice pharmacy; (c) Provide evidence of having acquired at least 4,000 hours0 days 0 hours 0 weeks 0 months of training/experience in nuclear pharmacy practice. Academic training may be substituted for no more than 2,000 hours0 days 0 hours 0 weeks 0 months of the required training and experience; and (d) 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, research and development; or (2) (a) Has completed 700 hours0.0081 days 0.194 hours 0.00116 weeks 2.6635e-4 months in a structured educational program consisting of both:

1. 200 hours0.00231 days 0.0556 hours 3.306878e-4 weeks 7.61e-5 months of classroom and laboratory training in the following areas:

(i) Radiation physics and instrumentation; (ii) Radiation protection; (iii) Mathematics pertaining to the use and measurement of radioactivity; (iv) Chemistry of radioactive material for medical use; and (v) Radiation biology; and

2. Supervised practical experience in a nuclear pharmacy involving:

(i) Shipping, receiving, and performing related radiation surveys; (ii) Using and performing checks for proper operation of instruments used to determine the activity of dosages, survey meters, and, if appropriate, instruments used to measure alpha-or beta-emitting radionuclides; May, 2012 24

USE OF RADIONUCLIDES IN THE HEALING ARTS CHAPTER 0400-20-07 (Rule 0400-20-07-.25, continued)

(iii) Calculating, assaying, and safely preparing dosages for patients or human research subjects; (iv) Using administrative controls to avoid misadministrations in the administration of radioactive material; and (v) Using procedures to prevent or minimize radioactive contamination and using proper decontamination procedures; and (b) Has obtained written attestation, signed by a preceptor authorized nuclear pharmacist, that the individual has satisfactorily completed the requirements in subparagraphs (1)(a) through (d) or subparagraph (2)(a) of this rule and is able to independently fulfill the radiation safety-related duties has achieved a level of competency sufficient to function independently as an authorized nuclear pharmacist.

Authority: T.C.A. §§68-202-101 et seq., 68-202-201 et seq. and 4-5-201 et seq. Administrative History:

Original rule filed February 22, 2012; effective May 22, 2012.

0400-20-07-.26 TRAINING FOR EXPERIENCED RADIATION SAFETY OFFICER, TELETHERAPY OR MEDICAL PHYSICIST, AUTHORIZED MEDICAL PHYSICIST, AUTHORIZED USER, AND NUCLEAR PHARMACIST, AND AUTHORIZED NUCLEAR PHARMACIST.

(1) An individual identified as a radiation safety officer, a teletherapy physicist or medical physicist, an authorized medical physicist, or a nuclear pharmacist or authorized nuclear pharmacist on a Division, U.S. Nuclear Regulatory Commission, or Agreement State license, or a permit issued by the Division, U.S. Nuclear Regulatory Commission, or an Agreement State broad scope licensee or master material license permit, or by a master material license permittee of broad scope before March 21, 2010, need not comply with the training requirements of Rule 0400-20-07-.23, 0400-20-07-.24, or 0400-20-07-.25, respectively.

An individual identified on a Commission or an Agreement State license or a permit issued by a Commission or an Agreement State broad scope licensee or master material license permit or by a master material license permittee of broad scope as a Radiation Safety Officer, a teletherapy or medical physicist, an authorized medical physicist, a nuclear pharmacist or an authorized nuclear pharmacist on or before the effective date of these rules need not comply with the training requirements of Rule 0400-20-07-23, 0400-20-07-24, or 0400-20-07-25, respectively, except the Radiation Safety Officers and authorized medical physicists identified in this paragraph must meet the training requirements in paragraphs 0400-20-07-.23(4) or 0400-20-07-.24(3), as appropriate, for any material or uses for which they were not authorized prior to this date.

(2) Any individual certified by the American Board of Health Physics in Comprehensive Health Formatted: Indent: Hanging: 0.38" Physics; American Board of Radiology; American Board of Nuclear Medicine; American Board of Science in Nuclear Medicine; Board of Pharmaceutical Specialties in Nuclear Pharmacy; American Board of Medical Physics in radiation oncology physics; Royal College of Physicians and Surgeons of Canada in nuclear medicine; American Osteopathic Board of Radiology; or American Osteopathic Board of Nuclear Medicine on or before October 24, 2005, need not comply with the training requirements of Rule 0400-20-07-.23 to be identified as a Radiation Safety Officer or as an Associate Radiation Safety Officer on a Division, Commission, or an Agreement State license or Commission master material license permit for those materials and uses that these individuals performed on or before October 24, 2005.

May, 2012 25

USE OF RADIONUCLIDES IN THE HEALING ARTS CHAPTER 0400-20-07 (3) Any individual certified by the American Board of Radiology in therapeutic radiological physics, Roentgen ray and gamma ray physics, x-ray and radium physics, or radiological physics, or certified by the American Board of Medical Physics in radiation oncology physics, on or before October 24, 2005, need not comply with the training requirements for an authorized medical physicist described in Rule 0400-20-07-.24, for those materials and uses that these individuals performed on or before October 24, 2005.

(2)(4) Physicians, dentists, or podiatrists identified as authorized users for the medical use of radioactive material on a license issued by the Division, U.S. Nuclear Regulatory Commission, an Agreement State, a permit issued by a U.S. Nuclear Regulatory Commission master material licensee, a permit issued by the Division, U.S. Nuclear Regulatory Commission, or Agreement State broad scope licensee, or a permit issued by a U.S. Nuclear Regulatory Commission master material license broad scope permittee issued before March 21, 2010January 14, 2019, who perform only those medical uses for which they were authorized on that date need not comply with the training requirements of Rules 0400-20-07-.39, 0400-20-07-.43, 0400-20-07-.47, 0400-20-07-.48, 0400-20-07-.49, 0400-20-07-.59, 0400-20-07-.60, 0400-20-07-.62 and 0400-20-07-.80.

(5) Physicians, dentists, or podiatrists not identified as authorized users for the medical use of radioactive material on a license issued by the Division, the U.S. Nuclear Regulatory Commission or an Agreement State, a permit issued by a Commission master material licensee, a permit issued by a Commission or an Agreement State broad scope licensee, or a permit issued by a Commission master material license of broad scope on or before October 24, 2005, need not comply with the training requirements of Rules 0400-20-07-.39, 0400 07-.43, 0400-20-07-.47, 0400-20-07-.48, 0400-20-07-.49, 0400-20-07-.59, 0400-20-07-.60, 0400-20-07-.62 and 0400-20-07-.80 for those materials and uses that these individuals performed on or before October 24, 2005, as follows:

(a) For uses authorized under Rules 0400-20-07-.38 and 0400-20-07-.40, or oral Formatted: Indent: Left: 0.38", Hanging: 0.75" administration of sodium iodide I-131 requiring a written directive for imaging and localization purposes, a physician who was certified on or before October 24, 2005, in nuclear medicine by the American Board of Nuclear Medicine; diagnostic radiology by the American Board of Radiology; diagnostic radiology or radiology by the American Osteopathic Board of Radiology; nuclear medicine by the Royal College of Physicians and Surgeons of Canada; or American Osteopathic Board of Nuclear Medicine in nuclear medicine; (b) For uses authorized under Rule 0400-20-07-.44, a physician who was certified on or before October 24, 2005, by the American Board of Nuclear Medicine; the American Board of Radiology in radiology, therapeutic radiology, or radiation oncology; nuclear medicine by the Royal College of Physicians and Surgeons of Canada; or the American Osteopathic Board of Radiology after 1984; (c) For uses authorized under Rules 0400-20-07-.51 and 0400-20-07-.63, a physician who was certified on or before October 24, 2005, in radiology, therapeutic radiology or radiation oncology by the American Board of Radiology; radiation oncology by the American Osteopathic Board of Radiology; radiology, with specialization in radiotherapy, as a British Fellow of the Faculty of Radiology or Fellow of the Royal College of Radiology; or therapeutic radiology by the Canadian Royal College of Physicians and Surgeons; and (d) For uses authorized under Rule 0400-20-07-.61, a physician who was certified on or before October 24, 2005, in radiology, diagnostic radiology, therapeutic radiology, or May, 2012 26

USE OF RADIONUCLIDES IN THE HEALING ARTS CHAPTER 0400-20-07 radiation oncology by the American Board of Radiology; nuclear medicine by the American Board of Nuclear Medicine; diagnostic radiology or radiology by the American Osteopathic Board of Radiology; or nuclear medicine by the Royal College of Physicians and Surgeons of Canada.

Formatted: Indent: Left: 0.38", Hanging: 0.75" (3)(6) Individuals who need not comply with training requirements as described in this rule may serve as preceptors for, and supervisors of, applicants seeking authorization on Division or NRC licenses for the same uses for which these individuals are authorized.

Authority: T.C.A. §§68-202-101 et seq., 68-202-201 et seq. and 4-5-201 et seq. Administrative History:

Original rule filed February 22, 2012; effective May 22, 2012.

0400-20-07-.27 RECENTNESS OF TRAINING.

The training and experience specified in Rules 0400-20-07-.17 through this rule and Rules 0400-20-07-.38 through 0400-20-07-.80 must have been obtained within the 7 years preceding the date of application or the individual must have had related continuing education, and experience since the required training and experience was completed.

Authority: T.C.A. §§68-202-101 et seq., 68-202-201 et seq. and 4-5-201 et seq. Administrative History:

Original rule filed February 22, 2012; effective May 22, 2012.

0400-20-07-.28 POSSESSION, USE, AND CALIBRATION OF INSTRUMENTS USED TO MEASURE THE ACTIVITY OF UNSEALED RADIOACTIVE MATERIAL.

(1) For direct measurements performed in accordance with Rule 0400-20-07-.30, a licensee shall possess and use instrumentation to measure the activity of unsealed radioactive material before it is administered to each patient or human research subject.

(2) A licensee shall calibrate the instrumentation required in paragraph (1) of this rule in accordance with nationally recognized standards or the manufacturers instructions.

(3) A licensee shall retain a record of each instrument calibration required by this rule in accordance with Rule 0400-20-07-.87.

Authority: T.C.A. §§68-202-101 et seq., 68-202-201 et seq. and 4-5-201 et seq. Administrative History:

Original rule filed February 22, 2012; effective May 22, 2012.

0400-20-07-.29 CALIBRATION OF SURVEY INSTRUMENTS.

(1) A licensee shall calibrate the survey instruments used to show compliance with this Chapter and Chapter 0400-20-05 before first use, annually, and following a repair that affects the calibration.

(2) To satisfy the requirements of paragraph (1) of Rule 0400-20-07-.29, the licensee shall:

(a) Calibrate all required scale readings up to 10 millisieverts (1000 millirem) per hour with a radiation source; (b) Calibrate 2 separated readings on each scale or decade that will be used to show compliance; and (c) Conspicuously note on the instrument the date of calibration.

May, 2012 27

USE OF RADIONUCLIDES IN THE HEALING ARTS CHAPTER 0400-20-07 (3) A licensee shall not use survey instruments if the difference between the indicated exposure rate and the calculated exposure rate is greater than 20 percent.

(4) A licensee shall retain a record of each survey instrument calibration in accordance with Rule 0400-20-07-.88.

(5) Calibration of all survey instruments shall be in accordance with an approved procedure or preformed by persons specifically licensed to provide calibration services.

Authority: T.C.A. §§68-202-101 et seq., 68-202-201 et seq. and 4-5-201 et seq. Administrative History:

Original rule filed February 22, 2012; effective May 22, 2012.

0400-20-07-.30 DETERMINATION OF DOSAGES OF UNSEALED RADIOACTIVE MATERIAL FOR MEDICAL USE.

(1) A licensee shall determine and record the activity of each dosage before medical use.

(2) For a unit dosage, this determination must be made by:

(a) Direct measurement of radioactivity; or (b) A decay correction, based on the activity or activity concentration determined by:

1. A manufacturer or preparer licensed under paragraph (10) of Rule 0400-20-10-.13 or equivalent U.S. Nuclear Regulatory Commission or Agreement State requirements; or

2. An Agreement State or U.S. Nuclear Regulatory Commission licensee for use in research in accordance with a radioactive drug research committee-approved protocol or an investigational new drug (IND) protocol accepted by Food and Drug Administration (FDA).

3. A PET radioactive drug producer licensed under paragraph (8) of Rule 0400 10-.11 or equivalent Agreement State Requirements.

(3) For other than unit dosages, this determination must be made by:

(a) Direct measurement of radioactivity; (b) Combination of measurement of radioactivity and mathematical calculations; or (c) Combination of volumetric measurements and mathematical calculations, based on the measurement made by:

1. A manufacturer or preparer licensed under paragraph (10) of Rule 0400-20-10-.13 or equivalent U.S. Nuclear Regulatory Commission or Agreement State requirements, or

2. A PET radioactive drug producer licensed under paragraph (8) of Rule 0400 10-.11 or equivalent U.S. Nuclear Regulatory Commission or Agreement State requirements.

(4) Unless otherwise directed by the authorized user, a licensee may not use a dosage if the dosage does not fall within the prescribed dosage range or if the dosage differs from the prescribed dosage by more than 20 percent.

May, 2012 28

USE OF RADIONUCLIDES IN THE HEALING ARTS CHAPTER 0400-20-07 (5) A licensee shall retain a record of the dosage determination required by this rule in accordance with Rule 0400-20-07-.89.

Authority: T.C.A. §§68-202-101 et seq., 68-202-201 et seq. and 4-5-201 et seq. Administrative History:

Original rule filed February 22, 2012; effective May 22, 2012.

0400-20-07-.31 AUTHORIZATION FOR CALIBRATION, TRANSMISSION, AND REFERENCE SOURCES.

(1) Any person authorized by Rule 0400-20-07-.10 for medical use of radioactive material may receive, possess, and use any of the following radioactive material for check, calibration, transmission, and reference use:

(a) Sealed sources not exceeding 1.11 GBq (30 mCi) each,manufactured and distributed by persons specifically licensed pursuant under 10 CFR 32.74,to Chapter 0400-20-10 or equivalent provisions of the U.S. Nuclear Regulatory Commission or an Agreement State and that do not exceed 1.11 gigabecquerels (30 millicuries) eachregulations; (b) Sealed sources, not exceeding 1.11 GBq (30 mCi) each, redistributed by a licensee authorized to redistribute the sealed sources manufactured and distributed by a person licensed under paragraph (12) of Rule 0400-20-10-.13, or equivalent provisions of the U.S. Nuclear Regulatory Commission or Agreement State regulations, providing the redistributed sealed sources are in the original packaging and shielding and are accompanied by the manufacturer's approved instructions; (c) Any radioactive material with a half-life of not longer than 120 days or less in individual amounts not to exceed 555 megabecquerels 0.56 GBq (15 millicuries);

(d) Any radioactive material with a half-life greater longer than 120 days in individual amounts not to exceed the smaller of:

1. 7.4 megabecquerels (200 Ci ); or

2. 1000 times the quantities in Schedule RHS 8-30 Chapter 0400-20-10; and (e) Technetium-99m in amounts as needed.

Formatted: Indent: Hanging: 0.75" (2) Byproduct material in sealed sources authorized by this provision shall not be:

(a) Used for medical use as defined in Paragraph 0400-20-07-.05(19) except in accordance with the requirements in Rule 0400-20-07-.61; or (b) Combined (i.e., bundled or aggregated) to create an activity greater than the maximum activity of any single sealed source authorized under this rule.

Formatted: Indent: Hanging: 0.75" (3) A licensee using calibration, transmission, and reference sources in accordance with the requirements in Paragraphs (1) or (2) of this rule need not list these sources on a specific Formatted: Left, Indent: Left: 0.38", Hanging: 0.38" medical use license.

Authority: T.C.A. §§68-202-101 et seq., 68-202-201 et seq. and 4-5-201 et seq. Administrative History:

Original rule filed February 22, 2012; effective May 22, 2012.

0400-20-07-.32 REQUIREMENTS FOR POSSESSION OF SEALED SOURCES AND BRACHYTHERAPY SOURCES.

May, 2012 29

(1) A licensee in possession of any sealed source or brachytherapy source shall follow the radiation safety and handling instructions supplied by the manufacturer.

(2) A licensee in possession of a sealed source shall:

(a) Test the source for leakage before its first use unless the licensee has a certificate from the supplier indicating that the source was tested within 6 months before transfer to the licensee; and (b) Test the source for leakage at intervals not to exceed 6 months or at other intervals approved by the Division, the U.S. Nuclear Regulatory Commission, or an Agreement State in the sealed source and device registry.

(3) If the leak test reveals the presence of 185 Bq (0.005 µCi) or more of removable contamination, the licensee shall:

(a) Immediately withdraw the sealed source from use and store, dispose, or cause it to be repaired in accordance with the requirements in Chapters 0400-20-05 and 0400-20-10; and (b) File a report within 5 days of the leak test in accordance with Rule 0400-20-07-.113.

(4) A licensee need not perform a leak test on the following sources:

(a) Sources containing only radioactive material with a half-life of less than 30 days; (b) Sources containing only radioactive material as a gas; (c) Sources containing 3.7 MBq (100 µCi) or less of beta or gamma-emitting material or 0.37 MBq (10 µCi) or less of alpha-emitting material; (d) Seeds of iridium-192 encased in nylon ribbon; and (e) Sources stored and not being used. However, the licensee shall test each such source for leakage before any use or transfer unless it has been leak tested within 6 months before the date of use or transfer.

(5) A licensee in possession of sealed sources or brachytherapy sources, except for gamma stereotactic radiosurgery sources, shall conduct a semi-annual physical inventory of all such sources. The licensee shall retain each inventory record in accordance with Rule 0400-20 .111.

Authority: T.C.A. §§68-202-101 et seq., 68-202-201 et seq. and 4-5-201 et seq. Administrative History:

Original rule filed February 22, 2012; effective May 22, 2012.

0400-20-07-.33 LABELING OF VIALS AND SYRINGES.

Each syringe and vial that contains unsealed radioactive material must be labeled to identify the radioactive drug. Each syringe shield and vial shield must also be labeled unless the label on the syringe or vial is visible when shielded.

Authority: T.C.A. §§68-202-101 et seq., 68-202-201 et seq. and 4-5-201 et seq. Administrative History:

Original rule filed February 22, 2012; effective May 22, 2012.

0400-20-07-.34 SURVEYS OF AMBIENT RADIATION DOSE RATE AND CONTAMINATION.

May, 2012 30

(1) Except as provided in paragraph (2) of this rule, a licensee shall survey with a radiation detection survey instrument at the end of each day of use all areas where radioactive drugs were prepared for use or administered.

(2) A licensee shall survey with a radiation detection survey instrument at least once each week all areas where radioactive drugs or radioactive wastes are stored.

(3) A licensee shall conduct the surveys required by paragraphs (1) and (2) of this rule so as to able to measure dose rates as low as 1 microsievert (0.1 millirem) per hour.

(4) A licensee shall establish dose rate action levels for the surveys required by paragraphs (1) and (2) of this rule and shall require that the individual performing the survey immediately notify the Radiation Safety Officer if a dose rate exceeds an action level.

(5) A licensee shall survey for removable contamination at the end of each day of use all areas where generators and bulk radioactive drugs are prepared for use or administered and each week where radioactive materials are stored.

(6) A licensee shall conduct the surveys required by paragraph (5) of this rule so as to be able to detect contamination on each wipe sample of 33.3 becquerels (2000 dpm).

(7) A licensee shall establish removable contamination action levels for the surveys required by paragraph (5) of this rule and shall require that the individual performing the survey immediately notify the Radiation Safety Officer if contamination exceeds action levels.

(8) A licensee does not need to perform the surveys required by paragraph (1) of this rule in area(s) where patients or human research subjects are confined when they cannot be released pursuant to Rule 0400-20-07-.35.

(9) A licensee shall retain a record of each survey in accordance with Rule 0400-20-07-.91.

Authority: T.C.A. §§68-202-101 et seq., 68-202-201 et seq. and 4-5-201 et seq. Administrative History:

Original rule filed February 22, 2012; effective May 22, 2012.

0400-20-07-.35 RELEASE OF INDIVIDUALS CONTAINING RADIOACTIVE DRUGS OR IMPLANTS.

(1) A licensee may authorize the release from its control of any individual who has been administered radioactive drugs or 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 millisieverts (0.5 rem).1 (2) A licensee shall provide the released individual, or the individual's parent or guardian, with instructions, including written instructions, on actions recommended to maintain doses to other individuals as low as is reasonably achievable if the total effective dose equivalent to any other individual is likely to exceed 1 mSv (0.1 rem). If the total effective dose equivalent to a nursing infant or child could exceed 1 mSv (0.1 rem) assuming there were no interruption of breast-feeding, the instructions must also include:

(a) Guidance on the interruption or discontinuation of breast-feeding; and 1

The current revision of NUREG-1556, Vol. 9, Consolidated Guidance about Materials Licenses: Program-Specific Guidance about Medical Licenses describes methods for calculating doses to other individuals and contains tables of activities not likely to cause doses exceeding 5 mSv (0.5 rem).

May, 2012 31

USE OF RADIONUCLIDES IN THE HEALING ARTS CHAPTER 0400-20-07 (Rule 0400-20-07-.34, continued)

(b) Information on the potential consequences, if any, of failure to follow the guidance.

(3) A licensee shall maintain a record of the basis for authorizing the release of an individual in accordance with Rule 0400-20-07-.92.

(4) A licensee shall maintain a record of instructions provided to breast-feeding women in accordance with Rule 0400-20-07-.92.

Authority: T.C.A. §§68-202-101 et seq., 68-202-201 et seq. and 4-5-201 et seq. Administrative History:

Original rule filed February 22, 2012; effective May 22, 2012.

0400-20-07-.36 PROVISION OF MOBILE MEDICAL SERVICE.

(1) A licensee providing mobile medical service shall:

(a) Obtain a letter signed by the management of each client for which services are rendered that permits the use of radioactive material at the client's address and clearly delineates the authority and responsibility of the licensee and the client; (b) Check instruments used to measure the activity of unsealed radioactive material for proper function before medical use at each clients address or on each day of use, whichever is more frequent. At a minimum, the check for proper function shall include a constancy check; (c) Check survey instruments for proper operation with a dedicated check source before use at each clients address; and (d) Before leaving a clients address, survey all areas of use, to ensure compliance with Chapter 0400-20-05; and (2) A mobile medical service may not have radioactive material delivered 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 must be received and handled in conformance with the client's license.

(3) A licensee providing mobile medical services shall retain the letter required in subparagraph (1)(a) of this rule and the record of each survey required in subparagraph (1)(d) of this rule in accordance with paragraphs (1) and (2) of Rule 0400-20-07-.93, respectively.

Authority: T.C.A. §§68-202-101 et seq., 68-202-201 et seq. and 4-5-201 et seq. Administrative History:

Original rule filed February 22, 2012; effective May 22, 2012.

0400-20-07-.37 DECAY-IN-STORAGE.

(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 to its radioactivity if it:

(a) Monitors radioactive material at the surface before disposal and determines that its Radioactivity cannot be distinguished from the background radiation level with an appropriate calibrated radiation detection survey meter set on its most sensitive scale and with no interposed shielding; (b) Removes or obliterates all radiation labels, except for radiation labels on materials that are within containers and that will be managed as biomedical waste after they have been released from the licensee; and May, 2012 32

USE OF RADIONUCLIDES IN THE HEALING ARTS CHAPTER 0400-20-07 (Rule 0400-20-07-.34, continued)

(2) A licensee shall retain a record of each disposal permitted under paragraph (1) of this rule in accordance with Rule 0400-20-07-.94.

Authority: T.C.A. §§68-202-101 et seq., 68-202-201 et seq. and 4-5-201 et seq. Administrative History:

Original rule filed February 22, 2012; effective May 22, 2012.

0400-20-07-.38 USE OF UNSEALED RADIOACTIVE MATERIAL FOR UPTAKE, DILUTION, AND EXCRETION STUDIES FOR WHICH A WRITTEN DIRECTIVE IS NOT REQUIRED.

(1) Except for quantities that require a written directive under paragraph (2) of Rule 0400-20 .20, a licensee may use any unsealed radioactive material, prepared for medical use for uptake, dilution, or excretion that is:

(a) Obtained from:

1. A manufacturer or preparer licensed under paragraph (10) of Rule 0400-20-10-.13 or equivalent U.S. Nuclear Regulatory Commission or Agreement State requirements; or

2. A PET radioactive drug producer licensed under paragraph (8) of Rule 0400 10-.11 or equivalent Agreement State requirements; or (b) Excluding production of PET radionuclides, prepared by:

1. An authorized nuclear pharmacist;

2. A physician who is an authorized user and who meets the requirements specified in Rule 0400-20-07-.43, or Rule 0400-20-07-.47 and item (1)(c)1(ii)(VII) of Rule 0400-20-07-.43; or

3. An individual under the supervision, as specified in Rule 0400-20-07-.19, of the authorized nuclear pharmacist in part 1 of this subparagraph or the physician who is an authorized user in part 2 of this subparagraph; or (c) Obtained from and prepared by an Agreement State or U.S. Nuclear Regulatory Commission licensee for use in research in accordance with a radioactive drug research committee-approved protocol or an investigational new drug (IND) protocol accepted by Food and Drug Administration (FDA); or (d) Prepared by the licensee in accordance with a Radioactive Drug Research Committee approved application or an Investigational New Drug (IND) protocol accepted by Food and Drug Administration (FDA) for use in research.

Authority: T.C.A. §§68-202-101 et seq., 68-202-201 et seq. and 4-5-201 et seq. Administrative History:

Original rule filed February 22, 2012; effective May 22, 2012.

0400-20-07-.39 TRAINING FOR UPTAKE, DILUTION, AND EXCRETION STUDIES.

(1) Except as provided in Rule 0400-20-07-.26, a licensee shall require an authorized user of unsealed radioactive material for the uses authorized under Rule 0400-20-07-.38 to be a physician who:

(a) Is certified by a medical specialty board whose certification process has been recognized by the Division, the U.S. Nuclear Regulatory Commission or an Agreement State and who meets the requirements of part (c)2 of this paragraph. The names of board certifications that have been recognized by the Commission or an Agreement State are May, 2012 33

USE OF RADIONUCLIDES IN THE HEALING ARTS CHAPTER 0400-20-07 (Rule 0400-20-07-.39, continued) posted on the NRC's Medical Uses Licensee Toolkit Web page. To be have its certification process recognized, a specialty board shall require all candidates for certification to:

1. Have completed 60 hours6.944444e-4 days 0.0167 hours 9.920635e-5 weeks 2.283e-5 months of training and experience in basic radionuclide handling techniques and radiation safety applicable to the medical use of unsealed radioactive material for uptake, dilution, and excretion studies as described in subparts (1)(c)1(i) and (ii) of this rule; and

2. Pass an examination, administered by diplomates of the specialty board, which assesses knowledge and competence in radiation safety, radionuclide handling, and quality control; or (b) Is an authorized user under Rule 0400-20-07-.43 or 0400-20-07-.47 or equivalent Agreement State or U.S. Nuclear Regulatory Commission requirements; or (c) 1. Has completed 60 hours6.944444e-4 days 0.0167 hours 9.920635e-5 weeks 2.283e-5 months of training and experience, including a minimum of 8 hours9.259259e-5 days 0.00222 hours 1.322751e-5 weeks 3.044e-6 months of classroom and laboratory training, in basic radionuclide handling techniques applicable to the medical use of unsealed radioactive material for uptake, dilution, and excretion studies. The training and experience must include:

(i) Classroom and laboratory training in the following areas:

(I) Radiation physics and instrumentation; (II) Radiation protection; (III) Mathematics pertaining to the use and measurement of radioactivity; (IV) Chemistry of radioactive material for medical use; and (V) Radiation biology; and (ii) Work experience, under the supervision of an authorized user who meets the requirements in Rule 0400-20-07-.26, this rule, Rule 0400-20-07-.43, or 0400-20-07-.47 or equivalent U.S. Nuclear Regulatory Commission or agreement State requirements, involving:

(I) Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys; (II) Performing quality control procedures on instruments used to determine the activity of dosages and performing checks for proper operation of survey meters; (III) Calculating, measuring, and safely preparing patient or human research subject dosages; (IV) Using administrative controls to prevent a misadministration involving the use of unsealed radioactive material; (V) Using procedures to contain spilled radioactive material safely and using proper decontamination procedures; and (VI) Administering dosages of radioactive drugs to patients or human research subjects; and May, 2012 34

USE OF RADIONUCLIDES IN THE HEALING ARTS CHAPTER 0400-20-07 (Rule 0400-20-07-.39, continued)

2. Has obtained written attestation, signed by a preceptor authorized user who meets the requirements in Rule 0400-20-07-.26, this rule, Rule 0400-20-07-.43, or 0400-20-07-.47 or equivalent Agreement State or U.S. Nuclear Regulatory Commission requirements, that the individual has satisfactorily completed the requirements in parts (1)(a)1 or (1)(c)1 of this rule and has achieved a level of competency sufficient to function independently as an authorized user for the medical uses authorized under Rule 0400-20-07-.38. Has obtained written attestation that the individual has satisfactorily completed the requirements in Part 0400-20 .39(1)(c)1 of this rule and is able to independently fulfill the radiation safety-related duties as an authorized user for the medical uses authorized under Rule 0400 07-.38. The attestation must be obtained from either:

(i) A preceptor authorized user who meets the requirements in Rules 0400 Formatted: Indent: Left: 1.13", Hanging: 0.75" 07-.26, 0400-20-07-.39, 0400-20-07-.43, or 0400-20-07-.26, equivalent Agreement State requirements or U.S. Nuclear Regulatory Commission requirements; or (ii) A residency program director who affirms in writing that the attestation represents the consensus of the residency program faculty where at least one faculty member is an authorized user who meets the requirements in Rules 0400-20-07-.26, 0400-20-07-.39, 0400-20-07-.43, or 0400-20-07-.26, equivalent Agreement State requirements or U.S. Nuclear Regulatory Commission requirements, and concurs with the attestation provided by the residency program director. The residency training program must be approved by the Residency Review Committee of the Accreditation Council for Graduate Medical Education or the Royal College of Physicians and Surgeons of Canada or the Council on Postdoctoral Training of the American Osteopathic Association and must include training and experience specified in Part 0400-20-07-.39(1)(c)1.

Authority: T.C.A. §§68-202-101 et seq., 68-202-201 et seq. and 4-5-201 et seq. Administrative History:

Original rule filed February 22, 2012; effective May 22, 2012.

0400-20-07-.40 USE OF UNSEALED RADIOACTIVE MATERIAL FOR IMAGING AND LOCALIZATION STUDIES FOR WHICH A WRITTEN DIRECTIVE IS NOT REQUIRED.

(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 paragraph (2) of Rule 0400-20-07-.20 that is:

(a) Obtained from:

1. A manufacturer or preparer licensed under paragraph (10) of Rule 0400-20-10-.13 or equivalent regulations of another Agreement State or U.S. Nuclear Regulatory Commission requirements; or

2. A PET radioactive drug producer licensed under paragraph (8) of Rule 0400 10-.11 or equivalent Agreement State requirements; or (b) Excluding production of PET radionuclides prepared by an authorized nuclear pharmacist, a physician who is an authorized user and who meets the requirements specified in Rule 0400-20-07-.43, or Rule 0400-20-07-.47 and item (1)(c)1(ii)(VII) of Rule 0400-20-07-.43, or an individual under the supervision of either as specified in Rule 0400-20-07-.19; or May, 2012 35

USE OF RADIONUCLIDES IN THE HEALING ARTS CHAPTER 0400-20-07 (Rule 0400-20-07-.40, continued)

(c) Obtained from and prepared by an Agreement State or U.S. Nuclear Regulatory Commission licensee for use in research in accordance with a radioactive drug research committee-approved protocol or an investigational new drug (IND) protocol accepted by Food and Drug Administration (FDA); or (d) Prepared by the licensee for use in research in accordance with a radioactive drug research committee-approved application or an investigational new drug (IND) protocol accepted by Food and Drug Administration (FDA).

Authority: T.C.A. §§68-202-101 et seq., 68-202-201 et seq. and 4-5-201 et seq. Administrative History:

Original rule filed February 22, 2012; effective May 22, 2012.

0400-20-07-.41 RADIONUCLIDE CONTAMINANTS. PERMISSIBLE MOLYBDENUM-99, STRONTIUM-82, AND STRONTIUM-85 CONCENTRATIONS.

(1) A licensee shall not administer to humans a radiopharmaceutical that contains:

(a) More than 0.15 kilobecquerel of molybdenum-99 per megabecquerel of technetium-99m (0.15 Ci of Mo-99 per mCi of Tc-99m); or (b) More than 0.02 kilobecquerel of strontium-82 per megabecquerel of rubidium-82 chloride injection (0.02 Ci of Sr-82 per mCi of Rb-82 chloride), or more than 0.2 kilobecquerel of strontium-85 per megabecquerel of rubidium-82 chloride injection (0.2 Ci of Sr-85 per mCi of Rb-82).

(2) To demonstrate compliance with paragraph (1) of this rule, a licensee preparing radioactive drugs from radionuclide generators shallA licensee that uses molybdenum-99/technetium-99m generators for preparing a technetium-99m radiopharmaceutical shall measure the molybdenum-99 concentration in each eluate from a generator to demonstrate compliance with paragraph (1) of this rule:

(a) Measure the concentration of radionuclide contaminant in the first eluate after receipt of a molybdenum-99/technetium-99m generator; and (b) Measure the concentration of radionuclide contaminant in each eluate or extract, as appropriate for other generator systems.

(3) A licensee who must measure radionuclide contaminant concentration shall retain a record of each measurement in accordance with Rule 0400-20-07-.95.

(4) A licensee shall report immediately to the Division each occurrence of radionuclide contaminant concentration exceeding the limits specified in paragraph (1) of this rule at the time of generator elution, in accordance with Rule 0400-20-07-.114.

Authority: T.C.A. §§68-202-101 et seq., 68-202-201 et seq. and 4-5-201 et seq. Administrative History:

Original rule filed February 22, 2012; effective May 22, 2012.

0400-20-07-.42 RESERVED.

Authority: T.C.A. §§68-202-101 et seq., 68-202-201 et seq. and 4-5-201 et seq. Administrative History:

Original rule filed February 22, 2012; effective May 22, 2012.

May, 2012 36

USE OF RADIONUCLIDES IN THE HEALING ARTS CHAPTER 0400-20-07 0400-20-07-.43 TRAINING FOR IMAGING AND LOCALIZATION STUDIES.

(1) Except as provided in Rule 0400-20-07-.26, a licensee shall require an authorized user of unsealed radioactive material for the uses authorized under Rule 0400-20-07-.40 to be a physician who:

(a) Is certified by a medical specialty board whose certification process has been recognized by the Division, the U.S. Nuclear Regulatory Commission or an Agreement State and who meets the requirements in part (c)2 of this paragraph. The names of board certifications that have been recognized by the Commission or an Agreement State are posted on the NRC's Medical Uses Licensee Toolkit Web page. To be have its certification process recognized, a specialty board shall require all candidates for certification to:

1. Complete 700 hours0.0081 days 0.194 hours 0.00116 weeks 2.6635e-4 months of training and experience in basic radionuclide handling techniques and radiation safety applicable to the medical use of unsealed radioactive material for imaging and localization studies as described in subparts (c)1(i) and (ii) of this paragraph; and

2. Pass an examination, administered by diplomates of the specialty board, which assesses knowledge and competence in radiation safety, radionuclide handling, and quality control; or (b) Is an authorized user under Rule 0400-20-07-.47 and meets the requirements in item (c)1(ii)(VII) of this paragraph or equivalent Agreement State or U.S. Nuclear Regulatory Commission requirements; or (c) 1. Has completed 700 hours0.0081 days 0.194 hours 0.00116 weeks 2.6635e-4 months of training and experience, including a minimum of 80 hours9.259259e-4 days 0.0222 hours 1.322751e-4 weeks 3.044e-5 months of classroom and laboratory training, in basic radionuclide handling techniques applicable to the medical use of unsealed radioactive material for imaging and localization studies. The training and experience must include, at a minimum:

(i) Classroom and laboratory training in the following areas:

(I) Radiation physics and instrumentation; (II) Radiation protection; (III) Mathematics pertaining to the use and measurement of radioactivity; (IV) Chemistry of radioactive material for medical use; (V) Radiation biology; and (ii) Work experience, under the supervision of an authorized user, who meets the requirements in this rule, Rule 0400-20-07-.26, or item (VII) of this subpart and Rule 0400-20-07-.47 or equivalent Agreement State or U.S.

Nuclear Regulatory Commission requirements, . involving An authorized nuclear pharmacist who meets the requirements in Rule 0400-20-07-.25 or 0400-20-07-.26 may provide the supervised work experience for Item 0400-20-07-.43(1)(c)1(ii)(VII). Work experience must involve:

(I) Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys; May, 2012 37

USE OF RADIONUCLIDES IN THE HEALING ARTS CHAPTER 0400-20-07 (Rule 0400-20-07-.43, continued)

(II) Performing quality control procedures on instruments used to determine the activity of dosages and performing checks for proper operation of survey meters; (III) Calculating, measuring, and safely preparing patient or human research subject dosages; (IV) Using administrative controls to prevent a misadministration involving the use of unsealed radioactive material; (V) Using procedures to safely contain spilled radioactive material and using proper decontamination procedures; (VI) Administering dosages of radioactive drugs to patients or human research subjects; and (VII) Eluting generator systems appropriate for preparation of radioactive drugs for imaging and localization studies, measuring and testing the eluate for radionuclidic purity, and processing the eluate with reagent kits to prepare labeled radioactive drugs; and

2. Has obtained written attestation, signed by a preceptor authorized user who meets the requirements in this rule, Rule 0400-02-07-.26, or Rule 0400-20-07-.47 and item 1(ii)(VII) of this subparagraph or equivalent Agreement State or U.S. Nuclear Regulatory Commission requirements, that the individual has satisfactorily completed the requirements in parts (a)1 or (c)1 of this paragraph and has achieved a level of competency sufficient to function independently as an authorized user for the medical uses authorized under Rules 0400-20-07-.38 and 0400-20-07-.40. Has obtained written attestation that the individual has satisfactorily completed the requirements in Part (1)(c) 1 of this rule and is able to independently fulfill the radiation safety-related duties as an authorized user for the medical uses authorized under Rules 0400-20-07-.38 and 0400-20-07-.40.

The attestation must be obtained from either:

(i) A preceptor authorized user who meets the requirements in Rules 0400 07-.26, 0400-20-07-.43, or 0400-20-07-.47 and Item 0400-20 .43(1)(c)1(ii)(VII), or equivalent Agreement State requirements or U.S.

Nuclear Regulatory Commission requirements; or (ii) A residency program director who affirms in writing that the attestation Formatted: Indent: Hanging: 0.38", Tab stops: 1.88",

represents the consensus of the residency program faculty where at least Left one faculty member is an authorized user who meets the requirements in Rules 0400-20-07-.26, 0400-20-07-.43, or 0400-20-07-.47 and Item 0400-20-07-.43(1)(c)1(ii)(VII), or equivalent Agreement State requirements or U.S. Nuclear Regulatory Commission requirements, and concurs with the attestation provided by the residency program director. The residency training program must be approved by the Residency Review Committee of the Accreditation Council for Graduate Medical Education or the Royal College of Physicians and Surgeons of Canada or the Council on Postdoctoral Training of the American Osteopathic Association and must include training and experience specified in Part 0400-20-07-.43(1)(c)1 of this rule.

Formatted: 1.,2.,3.,etc.1, Left, Indent: First line: 0", Line Authority: T.C.A. §§68-202-101 et seq., 68-202-201 et seq. and 4-5-201 et seq. Administrative History: spacing: single Original rule filed February 22, 2012; effective May 22, 2012.

May, 2012 38

USE OF RADIONUCLIDES IN THE HEALING ARTS CHAPTER 0400-20-07 (Rule 0400-20-07-.43, continued) 0400-20-07-.44 USE OF UNSEALED RADIOACTIVE MATERIAL FOR WHICH A WRITTEN DIRECTIVE IS REQUIRED.

(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 A licensee may use any unsealed byproduct material identified in Item 0400-20-07-.47(1)(b)1(ii)(VI) prepared for medical use and for which a written directive is required that is (a) Obtained from:

1. A manufacturer or preparer licensed under paragraph (10) of Rule 0400-20-07-.10 or equivalent Agreement State or U.S. Nuclear Regulatory Commission requirements; or

2. A PET radioactive drug producer licensed under paragraph (8) of Rule 0400 10-.11 or equivalent Agreement State requirements; or (b) Excluding production of PET radionuclides prepared by an authorized nuclear pharmacist, a physician who is an authorized user and who meets the requirements specified in Rule 0400-20-07-.43, Rule 0400-20-07-.47, or an individual under the supervision of either as specified in Rule 0400-20-07-.19; or (c) Obtained from and prepared by an Agreement State or U.S. Nuclear Regulatory Commission licensee for use in research in accordance with an investigational new drug (IND) protocol accepted by Food and Drug Administration (FDA) for use in research; or (d) Prepared by the licensee for use in research in accordance with an investigational new drug (IND) protocol accepted by Food and Drug Administration (FDA).

Authority: T.C.A. §§68-202-101 et seq., 68-202-201 et seq. and 4-5-201 et seq. Administrative History:

Original rule filed February 22, 2012; effective May 22, 2012.

0400-20-07-.45 SAFETY INSTRUCTIONS.

(1) In addition to the requirements of Rule 0400-20-04-.12:

(a) A 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 under Rule 0400-20-07-.35. The instruction must be appropriate to the personnels assigned duties and include the following:

1. Patient or human research subject control; and

2. Visitor control to include the following:

(i) Routine visitation to hospitalized individuals in accordance with Chapter 0400-20-05; (ii) Contamination control; (iii) Waste control; and May, 2012 39

USE OF RADIONUCLIDES IN THE HEALING ARTS CHAPTER 0400-20-07 (Rule 0400-20-07-.44, continued)

(iv) Notification of the radiation safety officer, or their designee, and the authorized user if the patient or the human research subject has a medical emergency or dies.

(b) A licensee shall retain a record of individuals receiving instruction in accordance with Rule 0400-20-07-.96.

Authority: T.C.A. §§68-202-101 et seq., 68-202-201 et seq. and 4-5-201 et seq. Administrative History:

Original rule filed February 22, 2012; effective May 22, 2012.

0400-20-07-.46 SAFETY PRECAUTIONS.

(1) For each patient or human research subject receiving radiopharmaceutical therapy and hospitalized for compliance with Rule 0400-20-07-.35, a licensee shall:

(a) Quarter the patient or the human research subject either in:

1. A private room with a private sanitary facility; or

2. A room, with a private sanitary facility, with another individual who also has received radiopharmaceutical therapy and who also cannot be released under Rule 0400-20-07-.35; (b) Visibly post the patients or the human research subjects room with a Caution Radioactive Materials sign; (c) Note on the door or in the patients or human research subjects chart where and how long visitors may stay in the patients or the human research subjects room; and (d) Either monitor material and items removed from the patients or the human research subjects 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 the material and items as radioactive waste.

(2) The Radiation Safety Officer, or his or her designee, and the authorized user shall be notified immediately if the hospitalized patient or human research subject dies or has a medical emergency.

Authority: T.C.A. §§68-202-101 et seq., 68-202-201 et seq. and 4-5-201 et seq. Administrative History:

Original rule filed February 22, 2012; effective May 22, 2012.

0400-20-07-.47 TRAINING FOR USE OF UNSEALED RADIOACTIVE MATERIAL FOR WHICH A WRITTEN DIRECTIVE IS REQUIRED.

(1) Except as provided in Rule 0400-20-07-.26, a licensee shall require an authorized user of unsealed radioactive material for the uses authorized under Rule 0400-20-07-.44 to be a physician who:

(a) Is certified by a medical specialty board whose certification process has been recognized by the Division, the U.S. Nuclear Regulatory Commission an Agreement State and who meets the requirements in item (1)(b)1(ii)(VI) and part (1)(b)2 of this rule. (Specialty boards whose certification processes have been recognized by the U.S. Nuclear Regulatory Commission or an Agreement State will be posted on the U.S. Nuclear Regulatory Commissions Web page.) The names of board certifications that have been recognized by the Commission or an Agreement State are posted on the NRCs Medical May, 2012 40

USE OF RADIONUCLIDES IN THE HEALING ARTS CHAPTER 0400-20-07 (Rule 0400-20-07-.47, continued)

Uses Licensee Toolkit Web page. To be recognized, a specialty board shall require a candidate for certification to:

1. Successfully complete a residency training in a radiation therapy or nuclear medicine training program or a program in a related medical specialty that includes 700 hours0.0081 days 0.194 hours 0.00116 weeks 2.6635e-4 months of training and experience as described in subpart (b)1(i) through item (b)1(ii)(V) of this paragraph. 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 Postgraduate Training Council on Postdoctoral Training of the American Osteopathic Association; and

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 by-product material; or (b) 1. Have completed 700 hours0.0081 days 0.194 hours 0.00116 weeks 2.6635e-4 months of training and experience, including a minimum of 200 hours0.00231 days 0.0556 hours 3.306878e-4 weeks 7.61e-5 months of classroom and laboratory training, in basic radionuclide handling techniques applicable to the medical use of unsealed radioactive material requiring a written directive. The training and experience must include:

(i) Classroom and laboratory training in the following areas:

(I) Radiation physics and instrumentation; (II) Radiation protection; (III) Mathematics pertaining to the use and measurement of radioactivity; (IV) Chemistry of radioactive material for medical use; and (V) Radiation biology; and (ii) Work experience, under the supervision of an authorized user who meets the requirements of this rule, Rule 0400-20-07-.26, or equivalent U.S.

Nuclear Regulatory Commission or Agreement State requirements. A supervising authorized user, who meets the requirements in this subparagraph, must also have experience in administering dosages in the same dosage category or categories (i.e., item (VI) of this subpart) as the individual requesting authorized user status. The work experience must involve:

(I) Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys; (II) Performing quality control procedures on instruments used to determine the activity of dosages and performing checks for proper operation of survey meters; (III) Calculating, measuring, and safely preparing patient or human research subject dosages; (IV) Using administrative controls to prevent a misadministration involving the use of unsealed radioactive material; May, 2012 41

USE OF RADIONUCLIDES IN THE HEALING ARTS CHAPTER 0400-20-07 (Rule 0400-20-07-.47, continued)

(V) Using procedures to contain spilled radioactive material safely and using proper decontamination procedures; and (VI) Administering dosages of radioactive drugs to patients or human research subjects involving a minimum of 3 cases in each of the following categories for which the individual is requesting authorized user status: Administering dosages of radioactive drugs to patients or human research subjects from the three categories in this paragraph.

Radioactive drugs containing radionuclides in categories not included in this paragraph are regulated under Rule 0400-20-07-.81. This work experience must involve a minimum of three cases in each of the following categories for which the individual is requesting authorized user status I. Oral administration of less than or equal to 1.22 gigabecquerels (33 millicuries) of sodium iodide I-131, for which a written directive is required; II. Oral administration of greater than 1.22 gigabecquerels (33 millicuries) of sodium iodide I-131. Experience with at least three cases in this also satisfies the requirement in subitem I of this item; 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/orParenteral administration of any radioactive drug that contains a radionuclide that is primarily used for its electron emission, beta radiation characteristics, alpha radiation characteristics, or photon energy of less than 150 keV, for which a written directive is required; and IV. Parenteral administration of any other radionuclide for which a written directive is required; and

2. Have obtained written attestation that the individual has satisfactorily completed the requirements in part (a)1 and item (b)1(ii)(VI) of this paragraph or part 1 of this subparagraph and has achieved a level of competency sufficient to function independently as an authorized user for the medical uses authorized under Rule 0400-20-07-.44 for which the individual is requesting authorized user status. The attestation must be obtained from either:. The written attestation must be signed by a preceptor authorized user who meets the requirements in this rule, Rule 0400-20-07-.26, or equivalent U.S. Nuclear Regulatory Commission or Agreement State requirements. The preceptor authorized user, who meets the requirements in this subparagraph, must have experience in administering dosages in the same dosage category or categories (i.e., item 1(ii)(VI) of this subparagraph) as the individual requesting authorized user status.

(i) A preceptor authorized user who meets the requirements in this rule or Rule Formatted: Indent: Left: 1.5", Hanging: 0.38", Tab 0400-20-07-.26, or equivalent Agreement State or equivalent U.S. Nuclear stops: Not at 1.5" Regulatory Commission requirements and has experience in administering dosages in the same dosage category or categories as the individual requesting authorized user status; or (ii) A residency program director who affirms in writing that the attestation represents the consensus of the residency program faculty where at least May, 2012 42

USE OF RADIONUCLIDES IN THE HEALING ARTS CHAPTER 0400-20-07 (Rule 0400-20-07-.47, continued) one faculty member is an authorized user who meets the requirements in this rule or Rule 0400-20-07-.26, or equivalent Agreement State or equivalent U.S. Nuclear Regulatory Commission requirements, has experience in administering dosages in the same dosage category or categories as the individual requesting authorized user status, and concurs Formatted: Indent: First line: 0" with the attestation provided by the residency program director. The residency training program must be approved by the Residency Review Committee of the Accreditation Council for Graduate Medical Education or the Royal College of Physicians and Surgeons of Canada or the Council on Postdoctoral Training of the American Osteopathic Association and must include training and experience specified in part (b)1 of this rule.

Formatted: Indent: Left: 1.5", Hanging: 0.38", Tab stops: Not at 1.5" Authority: T.C.A. §§68-202-101 et seq., 68-202-201 et seq. and 4-5-201 et seq. Administrative History: Formatted: Indent: Hanging: 0.01" Original rule filed February 22, 2012; effective May 22, 2012.

0400-20-07-.48 TRAINING FOR THE ORAL ADMINISTRATION OF SODIUM IODINE I-131 REQUIRING A WRITTEN DIRECTIVE IN QUANTITIES LESS THAN OR EQUAL TO 1.22 GIGABECQUERELS (33 MILLICURRIES).

(1) Except as provided in Rule 0400-20-07-.26, a licensee shall require an authorized user for the oral administration of sodium iodide I-131 requiring a written directive in quantities less than or equal to 1.22 gigabecquerels (33 millicuries), to be a physician who:

(a) Is certified by a medical specialty board whose certification process includes all of the requirements in Ssubparagraph (c) of this paragraph and whose certification has been recognized by the Division, the U.S. Nuclear Regulatory Commission or an Agreement State and who meets the requirements in part (c)3 of this paragraph; (The names of board certifications which have been recognized by the U.S. Nuclear Regulatory Commission or an Agreement State will be posted on the U.S. Nuclear Regulatory Commission's Web page); or. The names of board certifications that have been recognized by the Commission or an Agreement State are posted on the NRC's Medical Uses Licensee Toolkit Web page.; or (b) Is an authorized user under Rule 0400-20-07-.47 for uses listed in subitem (1)(b)1(ii)(VI)I or II of Rule 0400-20-07-.47, Rule 0400-20-07-.49, or equivalent Agreement State or U.S. Nuclear Regulatory Commission requirements; or (c) 1. Has successfully completed 80 hours9.259259e-4 days 0.0222 hours 1.322751e-4 weeks 3.044e-5 months of classroom and laboratory training, applicable to the medical use of sodium iodide I-131 for procedures requiring a written directive. The training must include:

(i) Radiation physics and instrumentation; (ii) Radiation protection; (iii) Mathematics pertaining to the use and measurement of radioactivity; (iv) Chemistry of radioactive material for medical use; and (v) Radiation biology; and

2. Has work experience, under the supervision of an authorized user who meets the requirements in Rule 0400-20-07-.26, 0400-20-07-.47, 0400-20-07-.48, 0400 May, 2012 43

USE OF RADIONUCLIDES IN THE HEALING ARTS CHAPTER 0400-20-07 (Rule 0400-20-07-.48, continued) 07-.49, or equivalent Agreement State or U.S. Nuclear Regulatory Commission requirements. A supervising authorized user who meets the requirements in subparagraph (1)(b) of Rule 0400-20-07-.47, must also have experience in administering dosages as specified in subitem (1)(b)1(ii)(VI)I or II of Rule 0400 07-.47. The work experience must involve:

(i) Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys; (ii) Performing quality control procedures on instruments used to determine the activity of dosages and performing checks for proper operation of survey meters; (iii) Calculating, measuring, and safely preparing patient or human research subject dosages; (iv) Using administrative controls to prevent a misadministration involving the use of radioactive material; (v) Using procedures to contain spilled radioactive material safely and using proper decontamination procedures; and (vi) Administering dosages to patients or human research subjects, that includes at least 3 cases involving the oral administration of less than or equal to 1.22 gigabecquerels (33 millicuries) of sodium iodide I-131; and

3. Has obtained written attestation that the individual has satisfactorily completed the requirements in parts 1 and 2 of this subparagraph and has achieved a level of competency sufficient to function independently as an authorized user for medical uses authorized under Rule 0400-20-07-.44. The written attestation must be signed by a preceptor authorized user who meets the requirements in Rule 0400-20-07-.26, 0400-20-07-.47, 0400-20-07-.48, 0400-20-07-.49, or equivalent Agreement State or U.S. Nuclear Regulatory Commission requirements. A preceptor authorized user, who meets the requirement in subparagraph (1)(b) of Rule 0400-20-07-.47, must also have experience in administering dosages as specified in subitem (1)(b)1(ii)(VI)I or II of Rule 0400-20-07-.47.

(d) Has obtained written attestation that the individual has satisfactorily completed the Formatted: Indent: Left: 0.75", Hanging: 0.38" requirements in Parts (c)1 and (c)2 of this paragraph, and is able to independently fulfill the radiation safety-related duties as an authorized user for oral administration of less than or equal to 1.22 gigabecquerels (33 millicuries) of sodium iodide I-131 for medical uses authorized under Rule 0400-20-07-.44. The attestation must be obtained from either:

1. A preceptor authorized user who meets the requirements in Rule 0400-20-07-.26, Formatted: Indent: Left: 1.13", Hanging: 0.38" 0400-20-07-.47, 0400-20-07-.48, 0400-20-07-.49, or equivalent Agreement State or U.S. Nuclear Regulatory Commission requirements and has experience in administering dosages as specified in Subitem 0400-20-07-.47(1)(b)1(ii)(VI)I or 0400-20-07-.47(1)(b)1(ii)(VI)II; or

2. A residency program director who affirms in writing that the attestation represents the consensus of the residency program faculty where at least one faculty member is an authorized user who meets the requirements in Rule 0400-20-07-.26, 0400-20-07-.47, 0400-20-07-.48, 0400-20-07-.49, or equivalent Agreement State requirements, has experience in administering dosages as specified in Subitem 0400-20-07-.47(1)(b)1(ii)(VI)I or 0400-20-07-.47(1)(b)1(ii)(VI)II, and concurs with the attestation provided by the residency program director. The residency training May, 2012 44

USE OF RADIONUCLIDES IN THE HEALING ARTS CHAPTER 0400-20-07 (Rule 0400-20-07-.48, continued) program must be approved by the Residency Review Committee of the Accreditation Council for Graduate Medical Education or the Royal College of Physicians and Surgeons of Canada or the Council on Postdoctoral Training of the American Osteopathic Association and must include training and experience specified in Parts (c)1 and (c)2 of this paragraph.

Authority: T.C.A. §§68-202-101 et seq., 68-202-201 et seq. and 4-5-201 et seq. Administrative History: Original rule filed February 22, 2012; effective May 22, 2012.

0400-20-07-.49 TRAINING FOR THE ORAL ADMINISTRATION OF SODIUM IODINE I-131 REQUIRING A WRITTEN DIRECTIVE IN QUANTITIES GREATER THAN 1.22 GIGABECQUERELS (33 MILLICURRIES).

(1) Except as provided in Rule 0400-20-07-.26, a licensee shall require an authorized user for the oral administration of sodium iodide I-131 requiring a written directive in quantities greater than 1.22 gigabecquerels (33 millicuries), to be a physician who:

(a) Is certified by a medical specialty board whose certification process includes all of the requirements in Pparts (c)1 and 2 of this paragraph and whose certification process has been recognized by the Division, the U.S. Nuclear Regulatory Commission or an Agreement State. , and who meets the requirements in part (1)(c)3 of this rule (The names of board certifications which have been recognized by the U.S. Nuclear Regulatory Commission or an Agreement State will be posted on the U.S. Nuclear Regulatory Commission's Web page); or The names of board certifications that have been recognized by the Commission or an Agreement State are posted on the NRC's Medical Uses Licensee Toolkit Web page.; or (b) Is an authorized user under Rule 0400-20-07-.47 for uses listed in subitem (1)(b)1(ii)(VI)II of Rule 0400-20-07-.47, or equivalent Agreement State or U.S. Nuclear Regulatory Commission requirements; or (c) 1. Has successfully completed 80 hours9.259259e-4 days 0.0222 hours 1.322751e-4 weeks 3.044e-5 months of classroom and laboratory training, applicable to the medical use of sodium iodide I-131 for procedures requiring a written directive. The training must include:

(i) Radiation physics and instrumentation; (ii) Radiation protection; (iii) Mathematics pertaining to the use and measurement of radioactivity; (iv) Chemistry of radioactive material for medical use; and (v) Radiation biology; and

2. Has work experience, under the supervision of an authorized user who meets the requirements in Rule 0400-20-07-.26, 0400-20-07-.47, this rule, or equivalent Agreement State or U.S. Nuclear Regulatory Commission requirements. A supervising authorized user, who meets the requirements in subparagraph (1)(b) of Rule 0400-20-07-.47, must have experience in administering dosages as May, 2012 45

USE OF RADIONUCLIDES IN THE HEALING ARTS CHAPTER 0400-20-07 (Rule 0400-20-07-.49, continued) specified in subitem (1)(b)1(ii)(VI)II of Rule 0400-20-07-.47. The work experience must involve:

(i) Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys; (ii) Performing quality control procedures on instruments used to determine the activity of dosages and performing checks for proper operation of survey meters; (iii) Calculating, measuring, and safely preparing patient or human research subject dosages; (iv) Using administrative controls to prevent a misadministration involving the use of radioactive material; (v) Using procedures to contain spilled radioactive material safely and using proper decontamination procedures; and (vi) Administering dosages to patients or human research subjects, that includes at least 3 cases involving the oral administration of greater than 1.22 gigabecquerels (33 millicuries) of sodium iodide I-131; and

3. Has obtained written attestation that the individual has satisfactorily completed the requirements in parts 1 and 2 of this subparagraph and has achieved a level of competency sufficient to function independently as an authorized user for medical uses authorized under Rule 0400-20-07-.44. The written attestation must be signed by a preceptor authorized user who meets the requirements in Rule 0400-20-07-.26, 0400-20-07-.47, this rule, or equivalent Agreement State or U.S.

Nuclear Regulatory Commission requirements. A preceptor authorized user, who meets the requirements in Rule subparagraph (1)(b) of Rule 0400-20-07-.47, must have experience in administering dosages as specified in subitem (1)(b)1(ii)(VI)II of Rule 0400-20-07-.47.

(d) Has obtained written attestation that the individual has satisfactorily completed the Formatted: Indent: Left: 0.75", Hanging: 0.38", Tab requirements in Parts (c)1 and (c)2 of this paragraph, and is able to independently fulfill stops: 1.13", Left the radiation safety-related duties as an authorized user for oral administration of less than or equal to 1.22 gigabecquerels (33 millicuries) of sodium iodide I-131 for medical uses authorized under Rule 0400-20-07-.44. The attestation must be obtained from either:

1. A preceptor authorized user who meets the requirements in Rule 0400-20-07-.26, 0400-20-07-.47, 0400-20-07-.48, 0400-20-07-.49, or equivalent Agreement State requirements and has experience in administering dosages as specified in Subitem 0400-20-07-.47(1)(b)1(ii)(VI)I or 0400-20-07-.47(1)(b)1(ii)(VI)II; or

2. A residency program director who affirms in writing that the attestation represents the consensus of the residency program faculty where at least one faculty member is an authorized user who meets the requirements in Rule 0400-20-07-.26, 0400-20-07-.47, 0400-20-07-.48, 0400-20-07-.49, or equivalent Agreement State requirements, has experience in administering dosages as specified in Subitem 0400-20-07-.47(1)(b)1(ii)(VI)I or 0400-20-07-.47(1)(b)1(ii)(VI)II, and concurs with the attestation provided by the residency program director. The residency training program must be approved by the Residency Review Committee of the Accreditation Council for Graduate Medical Education or the Royal College of Physicians and Surgeons of Canada or the Council on Postdoctoral Training of the May, 2012 46

USE OF RADIONUCLIDES IN THE HEALING ARTS CHAPTER 0400-20-07 (Rule 0400-20-07-.49, continued)

American Osteopathic Association and must include training and experience specified in Parts (c)1 and (c)2 of this paragraph.

Authority: T.C.A. §§68-202-101 et seq., 68-202-201 et seq. and 4-5-201 et seq. Administrative History:

Original rule filed February 22, 2012; effective May 22, 2012.

0400-20-07-.50 TRAINING FOR THE PARENTERAL ADMINISTRATION OF UNSEALED RADIOACTIVE MATERIAL REQUIRING A WRITTEN DIRECTIVE.

(1) Except as provided in Rule 0400-20-07-.26, a licensee shall require an authorized user for the parenteral administration requiring a written directive, to be a physician who:

(a) Is an authorized user under Rule 0400-20-07-.47 for uses listed in subitem (1)(b)1(ii)(VI)III or IV of Rule 0400-20-07-.47, or equivalent Agreement State or U.S.

Nuclear Regulatory Commission requirements; or (b) Is an authorized user under Rule 0400-20-07-.59 or 0400-20-07-.80, or equivalent Agreement State or U.S. Nuclear Regulatory Commission requirements and who meets the requirements in subparagraph (d) of this paragraph; or (c) Is certified by a medical specialty board whose certification process has been recognized by the U.S. Nuclear Regulatory Commission or an Agreement State under Rule 0400-20-07-.59 or 0400-20-07-.80, and who meets the requirements in subparagraph (d) of this paragraph.

(d) 1. Has successfully completed 80 hours9.259259e-4 days 0.0222 hours 1.322751e-4 weeks 3.044e-5 months of classroom and laboratory training, applicable to parenteral administrations listed in Subitem 0400-20 .47(1)(b)1(ii)(VI)III. , for which a written directive is required, of any beta emitter or any photon-emitting radionuclide with a photon energy less than 150 keV, and/or parenteral administration of any other radionuclide for which a written directive is required. The training must include:

(i) Radiation physics and instrumentation; (ii) Radiation protection; (iii) Mathematics pertaining to the use and measurement of radioactivity; (iv) Chemistry of radioactive material for medical use; and (v) Radiation biology; and

2. Has work experience, under the supervision of an authorized user who meets the requirements in Rule 0400-20-07-.26, 0400-20-07-.47 or this rule, or equivalent Agreement State or U.S. Nuclear Regulatory Commission requirements, in the parenteral administration listed in Subitem 0400-20-07-.47(1)(b)1(ii)(VI)III., for which a written directive is required, of any beta emitter or any photon-emitting radionuclide with a photon energy less than 150 keV, and/or parenteral administration of any other radionuclide for which a written directive is required. A supervising authorized user who meets the requirements in Rule 0400-20-07-.47, 0400-20-07-.50, or equivalent Agreement State or U.S. Nuclear Regulatory Commission requirements, must have experience in administering dosages as specified in subitems (1)(b)1(ii)(VI)III and/or IV of Rule 0400-20-07-.47 in the same category or categories as the individual requesting authorized user status. The work experience must involve:

May, 2012 47

USE OF RADIONUCLIDES IN THE HEALING ARTS CHAPTER 0400-20-07 (Rule 0400-20-07-.50, continued)

(i) Ordering, receiving, and unpacking radioactive materials safely, and performing the related radiation surveys; (ii) Performing quality control procedures on instruments used to determine the activity of dosages, and performing checks for proper operation of survey meters; (iii) Calculating, measuring, and safely preparing patient or human research subject dosages; (iv) Using administrative controls to prevent a misadministration involving the use of unsealed radioactive material; (v) Using procedures to contain spilled radioactive material safely, and using proper decontamination procedures; and (vi) Administering dosages to patients or human research subjects, that include at least 3 cases involving the parenteral administrations, for which a written directive is required, of any beta emitter or any photon-emitting radionuclide with a photon energy less than 150 keV and/or at least 3 cases involving the parenteral administration of any other radionuclide, for which a written directive is required as specified in Subitem 0400-20-07-.47(1)(b)1(ii)(VI)III; and

3. Has obtained written attestation that the individual has satisfactorily completed the requirements in Ssubparagraphs (b) or (c) of this paragraph, and has achieved a level of competency sufficient to function independently as an authorized user for the parenteral administration of unsealed radioactive material requiring a written directive. The written attestation must be signed by a preceptor authorized user who meets the requirements in Rule 0400-20-07-.26, 0400-20-07-.47, this rule, or equivalent Agreement State or U.S. Nuclear Regulatory Commission requirements. A preceptor authorized user, who meets the requirements in Rule 0400-20-07-.47, must have experience in administering dosages as specified in subitems (1)(b)1(ii)(VI)III and/or IV of Rule 0400-20-07-.47. must be obtained from either:

(i) A preceptor authorized user who meets the requirements in Rule 0400 Formatted: Indent: Left: 1.5", Hanging: 0.38", Tab 07-.26, 0400-20-07-.47, 0400-20-07-.50, or equivalent Agreement State or stops: 1.56", Left + Not at 1.5" U.S. Nuclear Regulatory Commission requirements. A preceptor authorized user who meets the requirements in Rules 0400-20-07-.47, 0400-20-07-.50, or equivalent Agreement State or U.S. Nuclear Regulatory Commission requirements, must have experience in administering dosages in the same category or categories as the individual requesting authorized user status; or (ii) A residency program director who affirms in writing that the attestation represents the consensus of the residency program faculty where at least one faculty member is an authorized user who meets the requirements in Rule 0400-20-07-.26, 0400-20-07-.47, 0400-20-07-.50, or equivalent Agreement State or U.S. Nuclear Regulatory Commission requirements, has experience in administering dosages in the same dosage category or categories as the individual requesting authorized user status, and concurs with the attestation provided by the residency program director. The residency training program must be approved by the Residency Review Committee of the Accreditation Council for Graduate Medical Education or May, 2012 48

USE OF RADIONUCLIDES IN THE HEALING ARTS CHAPTER 0400-20-07 (Rule 0400-20-07-.50, continued) the Royal College of Physicians and Surgeons of Canada or the Council on Postdoctoral Training of the American Osteopathic Association and must include training and experience specified in Parts 0400-20-07-.50(1)(d) 1 and 2.

Formatted: Indent: Hanging: 0.01" Authority: T.C.A. §§68-202-101 et seq., 68-202-201 et seq. and 4-5-201 et seq. Administrative History:

Original rule filed February 22, 2012; effective May 22, 2012.

0400-20-07-.51 USE OF SEALED SOURCES FOR MANUAL BRACHYTHERAPY.

(1) A licensee shall use only brachytherapy sources for therapeutic medical uses:

(a) As approved in the Sealed Source and Device Registry for manual brachytherapy medical use. The manual brachytherapy sources may be used for manual brachytherapy uses that are not explicitly listed in the Sealed Source and Device Registry, but must be used in accordance with the radiation safety conditions and limitations described in the Sealed Source and Device Registry ; or (b) In research to deliver therapeutic doses for medical use in accordance with an active investigational device exemption (IDE) application accepted by the Food and Drug Administration (FDA) provided the requirements of Rule 0400-20-07-.22 are met.

Authority: T.C.A. §§68-202-101 et seq., 68-202-201 et seq. and 4-5-201 et seq. Administrative History:

Original rule filed February 22, 2012; effective May 22, 2012.

0400-20-07-.52 SURVEYS AFTER SOURCE IMPLANTS AND REMOVAL.

(1) Immediately after implanting sources in a patient or a human research subject, a licensee shall make a survey to locate and account for all sources that have not been implanted.

(2) Immediately after removing the last temporary implant source from a patient or a human research subject, a licensee shall make a survey of the patient or the human research subject with a radiation detection survey instrument to confirm that all sources have been removed.

(3) A licensee shall retain a record of the surveys in accordance with Rule 0400-20-07-.97.

Authority: T.C.A. §§68-202-101 et seq., 68-202-201 et seq. and 4-5-201 et seq. Administrative History:

Original rule filed February 22, 2012; effective May 22, 2012.

0400-20-07-.53 BRACHYTHERAPY SOURCE ACCOUNTABILITY.

(1) A licensee shall maintain accountability at all times for all brachytherapy sources in storage or use.

(2) As soon as possible after removing sources from a patient or a human research subject, a licensee shall return brachytherapy sources to a secure storage area.

(3) A licensee shall maintain a record of the brachytherapy source accountability in accordance with Rule 0400-20-07-.98.

Authority: T.C.A. §§68-202-101 et seq., 68-202-201 et seq. and 4-5-201 et seq. Administrative History:

Original rule filed February 22, 2012; effective May 22, 2012.

0400-20-07-.54 SAFETY INSTRUCTIONS.

May, 2012 49

USE OF RADIONUCLIDES IN THE HEALING ARTS CHAPTER 0400-20-07 (Rule 0400-20-07-.53, continued)

(1) In addition to the requirements of Rule 0400-20-04-.12:

(a) A licensee shall provide radiation safety instruction, initially and at least annually, to personnel caring for patients or human research subjects who are receiving brachytherapy and cannot be released under Rule 0400-20-07-.35. Instruction must be commensurate with the duties of the personnel and include the:

1. Size and appearance of the brachytherapy sources;

2. Safe handling and shielding instructions;

3. Patient or human research subject control;

4. Visitor control, including both:

(i) Routine visitation of hospitalized individuals in accordance with subparagraph (1)(a) of Rule 0400-20-05-.60; and (ii) Visitation authorized in accordance with paragraph (2) of Rule 0400-20 .60; and

5. Notification of the radiation safety officer, or his or her designee, and an authorized user if the patient or the human research subject has a medical emergency or dies.

(b) A licensee shall retain a record of individuals receiving instruction in accordance with Rule 0400-20-07-.96.

Authority: T.C.A. §§68-202-101 et seq., 68-202-201 et seq. and 4-5-201 et seq. Administrative History:

Original rule filed February 22, 2012; effective May 22, 2012.

0400-20-07-.55 SAFETY PRECAUTIONS FOR PATIENTS OR HUMAN RESEARCH SUBJECTS RECEIVING BRACHYTHERAPY.

(1) For each patient or human research subject who is receiving brachytherapy and cannot be released under Rule 0400-20-07-.35, a licensee shall:

(a) Not quarter the patient or the human research subject in the same room as an individual who is not receiving brachytherapy; (b) Visibly post the patients or human research subjects room with a Caution- Radioactive Materials sign; and (c) Note on the door or in the patients or human research subjects chart where and how long visitors may stay in the patients or human research subjects room.

(2) A licensee shall have emergency response equipment available near each treatment room to respond to a source:

(a) Dislodged from the patient; and (b) Lodged within the patient following removal of the source applicators.

(3) The radiation safety officer, or their designee, and an authorized user shall be notified immediately if the patient or human research subject has a medical emergency or dies.

May, 2012 50

USE OF RADIONUCLIDES IN THE HEALING ARTS CHAPTER 0400-20-07 (Rule 0400-20-07-.55, continued)

Authority: T.C.A. §§68-202-101 et seq., 68-202-201 et seq. and 4-5-201 et seq. Administrative History:

Original rule filed February 22, 2012; effective May 22, 2012.

0400-20-07-.56 CALIBRATION MEASUREMENTS OF BRACHYTHERAPY SOURCES.

(1) Before the first medical use of a brachytherapy sealed source on or after March 21, 2010, a licensee shall have:

(a) Determined the source output or activity using a dosimetry system that meets the requirements of Rule 0400-20-07-.68; (b) Determined source positioning accuracy within applicators; and (c) Used published protocols currently accepted by nationally recognized bodies to meet the requirements of subparagraphs (a) and (b) of this paragraph.

(2) Instead of a licensee making its own measurements as required in paragraph (1) of this rule, the 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 paragraph (1) of this rule.

(3) A licensee shall mathematically correct the outputs or activities determined in paragraph (1) of this rule for physical decay at intervals consistent with 1 percent physical decay.

(4) A licensee shall retain a record of each calibration in accordance with Rule 0400-20-07-.99.

Authority: T.C.A. §§68-202-101 et seq., 68-202-201 et seq. and 4-5-201 et seq. Administrative History:

Original rule filed February 22, 2012; effective May 22, 2012.

0400-20-07-.57 DECAY OF STRONTIUM-90 SOURCES FOR OPHTHALMIC TREATMENTS.

(1) 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 decay must be based on the activity determined under Rule 0400-20-07-.56.

Formatted: Font: Arial, 10 pt (2) A licensee shall retain a record of the activity of each strontium-90 source in accordance with Rule 0400-20-07-.100. Formatted: Indent: First line: 1" Formatted: Font: Arial, 10 pt (1) Licensees who use strontium-90 for ophthalmic treatments must ensure that certain activities as specified in Paragraph (2) of this rule are performed by either: Formatted: Font: Arial, 10 pt Formatted: Indent: First line: 1" (a) An authorized medical physicist; or Formatted: Font: Arial, 10 pt (b) An individual who: Formatted: Font: Arial, 10 pt

1. is identified as an ophthalmic physicist on a specific medical use license Formatted: Indent: Left: 1.5", Hanging: 0.5" issued by the Commission or an Agreement State; permit issued by a Formatted: Font: Arial, 10 pt Commission or Agreement State broad scope medical use licensee; medical use permit issued by a Commission master material licensee; or Formatted: Font: Arial, 10 pt permit issued by a Commission master material licensee broad scope Formatted: Font: Arial, 10 pt medical use permittee; and Formatted: Indent: Left: 1.5", Hanging: 0.5"

2. holds a masters or doctors degree in physics, medical physics, other Formatted: Font: Arial, 10 pt physical sciences, engineering, or applied mathematics from an accredited college or university; and Formatted: Font: Arial, 10 pt Formatted: Font: Arial, 10 pt May, 2012 51

USE OF RADIONUCLIDES IN THE HEALING ARTS CHAPTER 0400-20-07 (Rule 0400-20-07-.55, continued)

3. has successfully completed 1 year of full-time training in medical physics Formatted: Indent: Left: 1.5", Hanging: 0.5" and an additional year of full-time work experience under the supervision of a medical physicist; and Formatted: Font: Arial, 10 pt Formatted: Font: Arial, 10 pt

4. Has documented training in:

Formatted: Font: Arial, 10 pt (i) The creation, modification, and completion of written directives; Formatted: Font: Arial, 10 pt (ii) Procedures for administrations requiring a written directive; and Formatted: Font: Arial, 10 pt Formatted: Font: Arial, 10 pt (iii) Performing the calibration measurements of brachytherapy sources as detailed in Rule 0400-20-07-.56. Formatted: Indent: First line: 1.5" Formatted: Font: Arial, 10 pt (2) The individuals who are identified in paragraph (a) of this section must:

Formatted: Font: Arial, 10 pt (a) Calculate the activity of each strontium-90 source that is used to determine the Formatted: Font: Arial, 10 pt treatment times for ophthalmic treatments. The decay must be based on the activity determined under 0400-20-07-.56; and Formatted: Indent: First line: 2" Formatted: Font: Arial, 10 pt (b) Assist the licensee in developing, implementing, and maintaining written procedures to provide high confidence that the administration is in accordance with Formatted: Font: Arial, 10 pt the written directive. These procedures must include the frequencies that the Formatted: Font: Arial, 10 pt individual meeting the requirements in paragraph (a) of this section will observe treatments, review the treatment methodology, calculate treatment time for the Formatted: Indent: First line: 2" prescribed dose, and review records to verify that the administrations were in Formatted: Font: Arial, 10 pt accordance with the written directives.

Formatted: Font: Arial, 10 pt (3) Licensees must retain a record of the activity of each strontium-90 source in accordance Formatted: Font: Arial, 10 pt with Rule 0400-20-07-.100.

Formatted: Font: Arial, 10 pt Authority: T.C.A. §§68-202-101 et seq., 68-202-201 et seq. and 4-5-201 et seq. Administrative History:

Formatted: Indent: Left: 2", Hanging: 0.5" Original rule filed February 22, 2012; effective May 22, 2012.

Formatted: Font: Arial, 10 pt 0400-20-07-.58 THERAPY-RELATED COMPUTER SYSTEMS.

Formatted: Font: Arial, 10 pt (1) The licensee shall perform or shall verify and maintain documentation of acceptance testing on Formatted: Indent: First line: 0.5" the treatment planning system of therapy-related computer systems in accordance with Formatted: Font: Arial, 10 pt published protocols accepted by nationally recognized bodies. At a minimum, the acceptance testing must include, as applicable, verification of: Formatted: Font: Arial, 10 pt Formatted: Font: Arial, 10 pt (a) The source-specific input parameters required by the dose calculation algorithm; Formatted: Font: Arial, 10 pt (b) The accuracy of dose, dwell time, and treatment time calculations at representative Formatted: Indent: Left: 1", Hanging: 0.5" points; Formatted: Font: Arial, 10 pt (c) The accuracy of isodose plots and graphic displays; and Formatted: Font: Arial, 10 pt (d) The accuracy of the software used to determine sealed source positions from Formatted: Font: Arial, 10 pt radiographic images.

Formatted: Indent: Left: 1", Hanging: 0.5" Authority: T.C.A. §§68-202-101 et seq., 68-202-201 et seq. and 4-5-201 et seq. Administrative History: Formatted: Font: Arial, 10 pt Original rule filed February 22, 2012; effective May 22, 2012.

Formatted: Font: Arial, 10 pt Formatted: Font: Arial, 10 pt Formatted ... [1]

May, 2012 52

USE OF RADIONUCLIDES IN THE HEALING ARTS CHAPTER 0400-20-07 (Rule 0400-20-07-.58, continued) 0400-20-07-.59 TRAINING FOR USE OF MANUAL BRACHYTHERAPY SOURCES.

(1) Except as provided in Rule 0400-20-07-.26, a licensee shall require an authorized user of a manual brachytherapy source for the uses authorized under Rule 0400-20-07-.51 to be a physician who:

(a) Is certified by a medical specialty board whose certification process has been recognized by the Division, the U.S. Nuclear Regulatory Commission, or an Agreement State, and who meets the requirements in part (b)3 of this paragraph. (The names of board certifications which have been recognized by the U.S. Nuclear Regulatory Commission or an Agreement State will beare posted on the U.S. Nuclear Regulatory Commission's Web pageNRCs Medical Uses Licensee Toolkit Web page.) To have its certification process be recognized, a specialty board shall require all candidates for certification to:

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 Postgraduate Training Council on Postdoctoral Training of the American Osteopathic Association; and

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 manual brachytherapy; or (b) 1. Has completed a structured educational program in basic radionuclide handling techniques applicable to the use of manual brachytherapy sources that includes:

(i) 200 hours0.00231 days 0.0556 hours 3.306878e-4 weeks 7.61e-5 months of classroom and laboratory training in the following areas:

(I) Radiation physics and instrumentation; (II) Radiation protection; (III) Mathematics pertaining to the use and measurement of radioactivity; and (IV) Radiation biology; and (ii) 500 hours0.00579 days 0.139 hours 8.267196e-4 weeks 1.9025e-4 months of work experience, under the supervision of an authorized user who meets the requirements in this rule, Rule 0400-20-07-.26, or equivalent Agreement State or U.S. Nuclear Regulatory Commission requirements at a medical institution facility authorized to use radioactive materials under, Rule 0400-20-07-.51, involving:

(I) Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys; (II) Checking survey meters for proper operation; (III) Preparing, implanting, and removing brachytherapy sources; (IV) Maintaining running inventories of material on hand; May, 2012 53

USE OF RADIONUCLIDES IN THE HEALING ARTS CHAPTER 0400-20-07 (Rule 0400-20-07-.59, continued)

(V) Using administrative controls to prevent a misadministration involving the use of radioactive material; (VI) Using emergency procedures to control radioactive material; and

2. Has completed 3 years of supervised clinical experience in radiation oncology, under an authorized user who meets the requirements in this rule, Rule 0400 07-.26, or equivalent U.S. Nuclear Regulatory Commission or Agreement State requirements, as part of a formal training program approved by the Residency Review Committee for Radiation Oncology of the Accreditation Council for Graduate Medical Education or the Royal College of Physicians and Surgeons of Canada or the Committee Council on Postdoctoral Training of the American Osteopathic Association. This experience may be obtained concurrently with the supervised work experience required by subpart 1(ii) of this subparagraph; and

3. Has obtained written attestation, signed by a preceptor authorized user who meets the requirements in this rule, Rule 0400-20-07-.26, or equivalent Agreement State or U.S. Nuclear Regulatory Commission requirements, that the individual has satisfactorily completed the requirements in part (a)1, or parts (b)1 and 2 of this paragraph and has achieved a level of competency sufficient to function independently is able to independently fulfill the radiation safety-related duties as an authorized user of manual brachytherapy sources for the medical uses authorized under Rule 0400-20-07-.51. The attestation must be obtained from either:

(i) A preceptor authorized user who meets the requirements in this rule, Rule 0400-20-07-.26, or equivalent Agreement State or U.S. Nuclear Regulatory Commission requirements; or (ii) A residency program director who affirms in writing that the attestation represents the consensus of the residency program faculty where at least one faculty member is an authorized user who meets the requirements in this rule, Rule 0400-20-07-.26, or equivalent Agreement State or U.S.

Nuclear Regulatory Commission requirements, and concurs with the attestation provided by the residency program director. The residency training program must be approved by the Residency Review Committee of the Accreditation Council for Graduate Medical Education or the Royal College of Physicians and Surgeons of Canada or the Council on Postdoctoral Training of the American Osteopathic Association and must include training and experience specified in parts (b)1 and (b)2 of this paragraph.

Authority: T.C.A. §§68-202-101 et seq., 68-202-201 et seq. and 4-5-201 et seq. Administrative History:

Original rule filed February 22, 2012; effective May 22, 2012.

0400-20-07-.60 TRAINING FOR OPHTHALMIC USE OF STRONTIUM-90.

(1) Except as provided in Rule 0400-20-07-.26, a licensee shall require the authorized user of strontium-90 for ophthalmic uses authorized under Rule 0400-20-07-.51 to be a physician who:

(a) Is an authorized user under Rule 0400-20-07-.59 or equivalent Agreement State or U.S.

Nuclear Regulatory Commission requirements; or (b) 1. Has completed 24 hours2.777778e-4 days 0.00667 hours 3.968254e-5 weeks 9.132e-6 months of classroom and laboratory training applicable to the medical use of strontium-90 for ophthalmic radiotherapy. The training must include:

May, 2012 54

USE OF RADIONUCLIDES IN THE HEALING ARTS CHAPTER 0400-20-07 (Rule 0400-20-07-.60, continued)

(i) Radiation physics and instrumentation; (ii) Radiation protection; (iii) Mathematics pertaining to the use and measurement of radioactivity; and (iv) Radiation biology; and

2. Supervised clinical training in ophthalmic radiotherapy under the supervision of an authorized user at a medical institution, clinic, or private practice that includes the use of strontium-90 for the ophthalmic treatment of 5 individuals. This supervised clinical training must involve:

(i) Examination of each individual to be treated; (ii) Calculation of the dose to be administered; (iii) Administration of the dose; and (iv) Follow up and review of each individuals case history; and

3. Has obtained written attestation, signed by a preceptor authorized user who meets the requirements in Rule 0400-20-07-.26, 0400-20-07-.59, this rule, or equivalent Agreement State or U.S. Nuclear Regulatory Commission requirements, that the individual has satisfactorily completed the requirements in subparagraph (b) of this paragraph and has achieved a level of competency sufficient to function independently as an authorized user of strontium-90 for ophthalmic use is able to independently fulfill the radiation safety-related duties as an authorized user of strontium-90 for ophthalmic use.

Authority: T.C.A. §§68-202-101 et seq., 68-202-201 et seq. and 4-5-201 et seq. Administrative History:

Original rule filed February 22, 2012; effective May 22, 2012.

0400-20-07-.61 USE OF SEALED SOURCES AND MEDICAL DEVICES FOR DIAGNOSIS.

A licensee shall use only sealed sources for diagnostic medical uses as approved in the sealed source and device registry.

(1) A licensee must use only sealed sources that are not in medical devices for diagnostic medical uses if the sealed sources are approved in the Sealed Source and Device Registry for diagnostic medicine. The sealed sources may be used for diagnostic medical uses that are not explicitly listed in the Sealed Source and Device Registry but must be used in accordance with the radiation safety conditions and limitations described in the Sealed Source and Device Registry.

(2) A licensee must only use medical devices containing sealed sources for diagnostic medical uses if both the sealed sources and medical devices are approved in the Sealed Source and Device Registry for diagnostic medical uses. The diagnostic medical devices may be used for diagnostic medical uses that are not explicitly listed in the Sealed Source and Device Registry but must be used in accordance with the radiation safety conditions and limitations described in the Sealed Source and Device Registry.

May, 2012 55

USE OF RADIONUCLIDES IN THE HEALING ARTS CHAPTER 0400-20-07 (Rule 0400-20-07-.60, continued)

(3) Sealed sources and devices for diagnostic medical uses may be used in research in accordance with an active Investigational Device Exemption (IDE) application accepted by the U.S. Food and Drug Administration provided the requirements of Paragraph 0400 07-.22(1) are met.

Authority: T.C.A. §§68-202-101 et seq., 68-202-201 et seq. and 4-5-201 et seq. Administrative History:

Original rule filed February 22, 2012; effective May 22, 2012.

0400-20-07-.62 TRAINING FOR USE OF SEALED SOURCES AND MEDICAL DEVICES FOR DIAGNOSIS.

(1) Except as provided in Rule 0400-20-07-.26, a licensee shall require the authorized user of a diagnostic sealed source for use in or a device authorized under Rule 0400-20-07-.61 to be a physician, dentist, or podiatrist who:

(a) Is certified by a specialty board whose certification process includes all of the requirements in subparagraphs (bc) and (cd) of this paragraph and whose certification has been recognized by the Division, the U.S Nuclear Regulatory Commission, or an Agreement State (The names of board certifications which have been recognized by the U.S. Nuclear Regulatory Commission or an Agreement State will beare posted on the U.S. Nuclear Regulatory Commission'sNRCs Medical Uses Licensee Toolkit Web page); or (b) Is an authorized user for uses listed in Rule 0400-20-07-.40 or equivalent Agreement State requirements, U.S. Nuclear Regulatory Commission requirements; or (b)(c) Has completed 8 hours9.259259e-5 days 0.00222 hours 1.322751e-5 weeks 3.044e-6 months of classroom and laboratory training in basic radionuclide handling techniques specifically applicable to the use of the device. The training must include:

1. Radiation physics and instrumentation;

2. Radiation protection;

3. Mathematics pertaining to the use and measurement of radioactivity;

4. Radiation biology; and (c)(d) Has completed training in the use of the device for the uses requested.

Authority: T.C.A. §§68-202-101 et seq., 68-202-201 et seq. and 4-5-201 et seq. Administrative History:

Original rule filed February 22, 2012; effective May 22, 2012.

0400-20-07-.63 USE OF SEALED SOURCE IN A REMOTE AFTERLOADER UNIT, TELETHERAPHY UNIT, OR GAMMA STEREOTACTIC RADIOSURGERY UNIT.

(1) A licensee shall use sealed sources in photon emitting remote afterloader units, teletherapy units, or gamma stereotactic radiosurgery units for therapeutic medical uses:

(a) As approved in the sealed source and device registry; or (b) In research in accordance with an active investigational device exemption (IDE) application accepted by the Food and Drug Administration (FDA) provided the requirements in paragraph (1) of Rule 0400-20-07-.22 are met.

(1) A licensee must only use sealed sources:

May, 2012 56

USE OF RADIONUCLIDES IN THE HEALING ARTS CHAPTER 0400-20-07 (Rule 0400-20-07-.62, continued)

(a) Approved and as provided for in the Sealed Source and Device Registry in photon emitting remote afterloader units, teletherapy units, or gamma stereotactic radiosurgery units to deliver therapeutic doses for medical uses: or (b) In research involving photon-emitting remote afterloader units, teletherapy units, or gamma stereotactic radiosurgery units in accordance with an active Investigational Device Exemption (IDE) application accepted by the U.S. Food and Drug Administration provided the requirements of Paragraph (1) of Rule 0400 07-.22 are met.

(2) A licensee must use photon-emitting remote afterloader units, teletherapy units, or gamma stereotactic radiosurgery units:

(a) Approved in the Sealed Source and Device Registry to deliver a therapeutic dose for medical use. These devices may be used for therapeutic medical treatments that are not explicitly provided for in the Sealed Source and Device Registry, but must be used in accordance with radiation safety conditions and limitations described in the Sealed Source and Device Registry; or (b) In research in accordance with an active Investigational Device Exemption (IDE) application accepted by the FDA provided the requirements of Paragraph (1) of Rule 0400-20-07-.22 are met.

Authority: T.C.A. §§68-202-101 et seq., 68-202-201 et seq. and 4-5-201 et seq. Administrative History:

Original rule filed February 22, 2012; effective May 22, 2012.

0400-20-07-.64 SURVEYS OF PATIENTS AND HUMAN RESEARCH SUBJECTS TREATED WITH A REMOTE AFTERLOADER UNIT.

(1) Before releasing a patient or a human research subject from licensee control, a licensee shall survey 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.

(2) A licensee shall retain a record of these surveys in accordance with Rule 0400-20-07-.97.

Authority: T.C.A. §§68-202-101 et seq., 68-202-201 et seq. and 4-5-201 et seq. Administrative History:

Original rule filed February 22, 2012; effective May 22, 2012.

0400-20-07-.65 INSTALLATION, MAINTENANCE, ADJUSTMENT, AND REPAIR.

(1) Only a person specifically licensed by the Division, the U.S. Nuclear Regulatory Commission, or an Agreement State 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).

(2) Except for low dose-rate remote afterloader units, only a person specifically licensed by the Division, the U.S. Nuclear Regulatory Commission, or an Agreement State shall install, replace, relocate, or remove a sealed source or source contained in other remote afterloader units, teletherapy units, or gamma stereotactic radiosurgery units.

May, 2012 57

USE OF RADIONUCLIDES IN THE HEALING ARTS CHAPTER 0400-20-07 (Rule 0400-20-07-.65, continued)

(3) For a low dose-rate remote afterloader unit, only a person specifically licensed by the Division, the U.S. Nuclear Regulatory Commission, or an Agreement State or an authorized medical physicist shall install, replace, relocate, or remove a sealed source(s) contained in the unit.

(4) A licensee shall retain a record of the installation, maintenance, adjustment, and repair of remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units in accordance with Rule 0400-20-07-.101.

Authority: T.C.A. §§68-202-101 et seq., 68-202-201 et seq. and 4-5-201 et seq. Administrative History:

Original rule filed February 22, 2012; effective May 22, 2012.

0400-20-07-.66 SAFETY PROCEDURES AND INSTRUCTIONS FOR REMOTE AFTERLOADER UNITS, TELETHERAPY UNITS, AND GAMMA STEREOTACTIC RADIOSURGERY UNITS.

(1) A licensee shall:

(a) Secure the unit, the console, the console keys, and the treatment room when not in use or unattended; (b) Permit only individuals approved by the authorized user, radiation safety officer, or authorized medical physicist to be present in the treatment room during treatment with the source(s);

(c) Prevent dual operation of more than one radiation producing device in a treatment room if applicable; and (d) 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. These procedures must include:

1. Instructions for responding to equipment failures and the names of the individuals responsible for implementing corrective actions;

2. The process for restricting access to and posting of the treatment area to minimize the risk of inadvertent exposure; and

3. The names and telephone numbers of the authorized users, the authorized medical physicist, and the radiation safety officer to be contacted if the unit or console operates abnormally.

(2) A copy of the procedures required by subparagraph (1)(d) of this rule must be physically located at the unit console.

(3) A licensee shall post instructions at the unit console to inform the operator of:

(a) The location of the procedures required by subparagraph (1)(d) of this rule; and (b) The names and telephone numbers of the authorized users, the authorized medical physicist, and the radiation safety officer to be contacted if the unit or console operates abnormally.

(4) A licensee shall provide instruction, initially and at least annually, to all individuals who operate the unit, as appropriate to the individuals assigned duties, in:

(a) The procedures identified in subparagraph (1)(d) of this rule; and May, 2012 58

USE OF RADIONUCLIDES IN THE HEALING ARTS CHAPTER 0400-20-07 (Rule 0400-20-07-.66, continued)

(b) The operating procedures for the unit.

(4) (a) Prior to the first use for patient treatment of a new unit or an existing unit with a manufacturer upgrade that affects the operation and safety of the unit, a licensee shall ensure that vendor operational and safety training is provided to all individuals who will operate the unit. The vendor operational and safety training must be provided by the device manufacturer or by an individual certified by the device manufacturer to provide the operational and safety training.

(b) A licensee shall provide operational and safety instructions initially and at least annually to all individuals who operate the unit at the facility, as appropriate to the individual's assigned duties. The instructions shall include instruction in:

1. The procedures identified in Subparagraph (1)(d) of this rule; and

2. The operating procedures for the unit.

(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.

(6) A licensee shall retain a record of individuals receiving instruction required by paragraph (4) of this rule, in accordance with Rule 0400-20-07-.96.

(7) A licensee shall retain a copy of the procedures required by sSubparagraphs (1)(d) and Part (4)(b)2 of this rule in accordance with Rule 0400-20-07-.102.

Authority: T.C.A. §§68-202-101 et seq., 68-202-201 et seq. and 4-5-201 et seq. Administrative History:

Original rule filed February 22, 2012; effective May 22, 2012.

0400-20-07-.67 SAFETY PRECAUTIONS FOR REMOTE AFTERLOADER UNITS, TELETHERAPY UNITS, AND GAMMA STEREOTACTIC RADIOSURGERY UNITS.

(1) A licensee shall control access to the treatment room by a door at each entrance.

(2) A licensee shall equip each entrance to the treatment room with an electrical interlock system that will:

(a) Prevent the operator from initiating the treatment cycle unless each treatment room entrance door is closed; (b) Cause the source(s) to be shielded when an entrance door is opened; and (c) 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.

(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.

(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.

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USE OF RADIONUCLIDES IN THE HEALING ARTS CHAPTER 0400-20-07 (Rule 0400-20-07-.67, continued)

(5) For licensed activities where sources are placed within the patients or human research subjects body, a licensee shall only conduct treatments which allow for expeditious removal of a decoupled or jammed source.

(6) In addition to the requirements specified in paragraphs (1) through (5) of this rule, a licensee shall:

(a) For low dose rate, medium dose-rate, and pulsed dose-rate remote afterloader units, require:

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

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.

(b) For high dose-rate remote afterloader units, require:

1. An authorized user and an authorized medical physicist to be physically present during the initiation of all patient treatments involving the unit; and

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.

(c) 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.

(d) Notify the radiation safety officer, or their designee, and an authorized user as soon as possible if the patient or human research subject has a medical emergency or dies.

(7) A licensee shall have emergency response equipment available near each treatment room to respond to a source that inadvertently:

(a) Remains in the unshielded position; or (b) Lodges within the patient following completion of the treatment.

Authority: T.C.A. §§68-202-101 et seq., 68-202-201 et seq. and 4-5-201 et seq. Administrative History:

Original rule filed February 22, 2012; effective May 22, 2012.

0400-20-07-.68 DOSIMETRY EQUIPMENT.

(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 must be met:

(a) The system must have been calibrated using a system or source traceable to the National Institute of Science and Technology (NIST) and published protocols accepted May, 2012 60

USE OF RADIONUCLIDES IN THE HEALING ARTS CHAPTER 0400-20-07 (Rule 0400-20-07-.68, continued) by nationally recognized bodies; or by a calibration laboratory accredited by the American Association of Physicists in Medicine (AAPM). The calibration must have been performed within the previous 2 years and after any servicing that may have affected system calibration; or (b) The system must have been calibrated within the previous 4 years. 18 to 30 months after that calibration, the system must have been intercompared with another dosimetry system that was calibrated within the past 24 months by NIST or by a calibration laboratory accredited by the AAPM. The results of the intercomparison must have indicated that the calibration factor of the licensees system had not changed by more than 2 percent. A licensee may 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 licensees facility.

(2) A licensee shall have available for use a dosimetry system available for use for spot-check output measurements, if applicable. To satisfy this requirement, the system may be compared with a system that has been calibrated in accordance with paragraph (1) of this rule. This comparison must 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 paragraph (1) of this rule.

(3) A licensee shall retain a record of each calibration, intercomparison, and comparison in accordance with Rule 0400-20-07-.103.

Authority: T.C.A. §§68-202-101 et seq., 68-202-201 et seq. and 4-5-201 et seq. Administrative History:

Original rule filed February 22, 2012; effective May 22, 2012.

0400-20-07-.69 FULL CALIBRATION MEASUREMENTS ON TELETHERAPY UNITS.

(1) A licensee authorized to use a teletherapy unit for medical use shall perform full calibration measurements on each teletherapy unit:

(a) Before the first medical use of the unit; and (b) Before medical use under the following conditions:

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;

2. Following replacement of the source or following reinstallation of the teletherapy unit in a new location;

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 (c) At intervals not exceeding 1 year.

(2) To satisfy the requirement of paragraph (1) of this rule, full calibration measurements must include determination of:

(a) The output within +/-3 percent for the range of field sizes and for the distance or range of distances used for medical use; May, 2012 61

USE OF RADIONUCLIDES IN THE HEALING ARTS CHAPTER 0400-20-07 (Rule 0400-20-07-.69, continued)

(b) The coincidence of the radiation field and the field indicated by the light beam localizing device; (c) The uniformity of the radiation field and its dependence on the orientation of the useful beam; (d) Timer accuracy and linearity over the range of use; (e) On-off error; and (f) The accuracy of all distance measuring and localization devices in medical use.

(3) A licensee shall use the dosimetry system described in paragraph (1) of Rule 0400-20-07-.68 to measure the output for one set of exposure conditions. The remaining radiation measurements required in subparagraph (2)(a) of this rule may be made using a dosimetry system that indicates relative dose rates.

(4) A licensee shall make full calibration measurements required by paragraph (1) of this rule in accordance with published protocols accepted by nationally recognized bodies.

(5) A licensee shall mathematically correct the outputs determined in subparagraph (2)(a) of this rule 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.

(6) Full calibration measurements required by paragraph (1) of this rule and physical decay corrections required by paragraph (5) of this rule must be performed by the authorized medical physicist.

(7) A licensee shall retain a record of each calibration in accordance with Rule 0400-20-07-.104.

Authority: T.C.A. §§68-202-101 et seq., 68-202-201 et seq. and 4-5-201 et seq. Administrative History:

Original rule filed February 22, 2012; effective May 22, 2012.

0400-20-07-.70 FULL CALIBRATION MEASUREMENTS ON REMOTE AFTERLOADER UNITS.

(1) A licensee authorized to use a remote afterloader unit for medical use shall perform full calibration measurements on each unit:

(a) Before the first medical use of the unit; (b) Before medical use under the following conditions:

1. Following replacement of the source or following reinstallation of the unit in a new location outside the facility; and

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 (c) At intervals not exceeding 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 (d) At intervals not exceeding 1 year for low dose-rate remote afterloader units.

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USE OF RADIONUCLIDES IN THE HEALING ARTS CHAPTER 0400-20-07 (Rule 0400-20-07-.70, continued)

(2) To satisfy the requirement of paragraph (1) of this rule, full calibration measurements must include, as applicable, determination of:

(a) The output within +/-5 percent; (b) Source positioning accuracy to within +/-1 millimeter; (c) Source retraction with backup battery upon power failure; (d) Length of the source transfer tubes; (e) Timer accuracy and linearity over the typical range of use; (f) Length of the applicators; and (g) Function of the source transfer tubes, applicators, and transfer tube-applicator interfaces.

(3) A licensee shall use the dosimetry system described in paragraph (1) of Rule 0400-20-07-.68 to measure the output.

(4) A licensee shall make full calibration measurements required by paragraph (1) of this rule in accordance with published protocols accepted by nationally recognized bodies.

(5) In addition to the requirements for full calibrations for low dose-rate remote afterloader units in paragraph (2) of this rule, a licensee shall perform an autoradiograph of the source(s) to verify inventory and source(s) arrangement at intervals not exceeding 1 calendar quarter.

(6) For low dose-rate remote afterloader units, a licensee may use measurements provided by the source manufacturer that are made in accordance with paragraphs (1) through (5) of this rule.

(7) A licensee shall mathematically correct the outputs determined in subparagraph (2)(a) of this rule for physical decay at intervals consistent with 1 percent physical decay.

(8) Full calibration measurements required by paragraph (1) of this rule and physical decay corrections required by paragraph (7) of this rule must be performed by the authorized medical physicist.

(9) A licensee shall retain a record of each calibration in accordance with Rule 0400-20-07-.104.

Authority: T.C.A. §§68-202-101 et seq., 68-202-201 et seq. and 4-5-201 et seq. Administrative History:

Original rule filed February 22, 2012; effective May 22, 2012.

0400-20-07-.71 FULL CALIBRATION MEASUREMENTS ON GAMMA STEREOTACTIC RADIOSURGERY UNITS.

(1) A licensee authorized to use a gamma stereotactic radiosurgery unit for medical use shall perform full calibration measurements on each unit:

(a) Before the first medical use of the unit; (b) Before medical use under the following conditions:

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; May, 2012 63

USE OF RADIONUCLIDES IN THE HEALING ARTS CHAPTER 0400-20-07 (Rule 0400-20-07-.71, continued)

2. Following replacement of the sources or following reinstallation of the gamma stereotactic radiosurgery unit in a new location; and

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 (c) 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.

(2) To satisfy the requirements of paragraph (1) of this rule, full calibration measurements must include determination of:

(a) The output within +/-3 percent; (b) Relative helmet factors; (c) Isocenter coincidence; (d) Timer accuracy and linearity over the range of use; (e) On-off error; (f) Trunnion centricity; (g) Treatment table retraction mechanism, using backup battery power or hydraulic backups with the unit off; (h) Helmet microswitches; (i) Emergency timing circuits; and (j) Stereotactic frames and localizing devices (trunnions).

(3) A licensee shall use the dosimetry system described in paragraph (1) of Rule 0400-20-07-.68 to measure the output for one set of exposure conditions. The remaining radiation measurements required in subparagraph (2)(a) of this rule may be made using a dosimetry system that indicates relative dose rates.

(4) A licensee shall make full calibration measurements required by paragraph (1) of this rule in accordance with published protocols accepted by nationally recognized bodies.

(5) A licensee shall mathematically correct the outputs determined in subparagraph (2)(a) of this rule at intervals not exceeding 1 month for cobalt-60 and at intervals consistent with 1 percent physical decay for all other radionuclides.

(6) Full calibration measurements required by paragraph (1) of this rule and physical decay corrections required by paragraph (5) of this rule must be performed by the authorized medical physicist.

(7) A licensee shall retain a record of each calibration in accordance with Rule 0400-20-07-.104.

Authority: T.C.A. §§68-202-101 et seq., 68-202-201 et seq. and 4-5-201 et seq. Administrative History:

Original rule filed February 22, 2012; effective May 22, 2012.

May, 2012 64

USE OF RADIONUCLIDES IN THE HEALING ARTS CHAPTER 0400-20-07 (Rule 0400-20-07-.71, continued) 0400-20-07-.72 PERIODIC SPOT-CHECKS FOR TELETHERAPY UNITS.

(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 that include determination of:

(a) Timer accuracy, and timer linearity over the range of use; (b) On-off error; (c) The coincidence of the radiation field and the field indicated by the light beam localizing device; (d) The accuracy of all distance measuring and localization devices used for medical use; (e) The output for one typical set of operating conditions measured with the dosimetry system described in paragraph (2) of Rule 0400-20-07-.68; and (f) The difference between the measurement made in subparagraph (e) of this paragraph 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).

(2) A licensee shall perform measurements required by paragraph (1) of this rule in accordance with written procedures established by the authorized medical physicist. That individual need not actually perform the spot-check measurements.

(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 as soon as possible in writing of the results of each spot-check.

(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:

(a) Electrical interlocks at each teletherapy room entrance; (b) 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);

(c) Source exposure indicator lights on the teletherapy unit, on the control console, and in the facility; (d) Viewing and intercom systems; (e) Treatment room doors from inside and outside the treatment room; and (f) Electrically assisted treatment room doors with the teletherapy unit electrical power turned off.

(5) If the results of the checks required in paragraph (4) of this rule 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.

(6) A licensee shall retain a record of each spot-check required by paragraphs (1) and (4) of this rule, in accordance with Rule 0400-20-07-.105.

May, 2012 65

USE OF RADIONUCLIDES IN THE HEALING ARTS CHAPTER 0400-20-07 (Rule 0400-20-07-.72, continued)

Authority: T.C.A. §§68-202-101 et seq., 68-202-201 et seq. and 4-5-201 et seq. Administrative History:

Original rule filed February 22, 2012; effective May 22, 2012.

0400-20-07-.73 PERIODIC SPOT-CHECKS FOR REMOTE AFTERLOADER UNITS.

(1) A licensee authorized to use a remote afterloader unit for medical use shall perform spot-checks of each remote afterloader facility and on each unit:

(a) At the beginning of each day of use of a high dose-rate, medium dose-rate, or pulsed dose-rate remote afterloader unit; (b) Before each patient treatment with a low dose-rate remote afterloader unit; and (c) After each source installation.

(2) A licensee shall have the authorized medical physicist establish written procedures for performing the spot-checks required in paragraph (1) of this rule. The authorized medical physicist need not actually perform the spot-check measurements.

(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.

(4) To satisfy the requirements of paragraph (1) of this rule, spot-checks must, at a minimum, assure proper operation of:

(a) Electrical interlocks at each remote afterloader unit room entrance; (b) Source exposure indicator lights on the remote afterloader unit, on the control console, and in the facility; (c) Viewing and intercom systems in each high dose-rate, medium dose-rate, and pulsed dose-rate remote afterloader facility; (d) Emergency response equipment; (e) Radiation monitors used to indicate the source position; (f) Timer accuracy; (g) Clock (date and time) in the units computer; and (h) Decayed source(s) activity in the units computer.

(5) If the results of the checks required in paragraph (4) of this rule 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.

(6) A licensee shall retain a record of each check required by paragraph (4) of this rule in accordance with 0400-20-07-.106.

Authority: T.C.A. §§68-202-101 et seq., 68-202-201 et seq. and 4-5-201 et seq. Administrative History:

Original rule filed February 22, 2012; effective May 22, 2012.

0400-20-07-.74 PERIODIC SPOT-CHECKS FOR GAMMA STERIOTACTIC RADIOSURGERY UNITS.

May, 2012 66

USE OF RADIONUCLIDES IN THE HEALING ARTS CHAPTER 0400-20-07 (Rule 0400-20-07-.74, continued)

(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:

(a) Monthly; (b) At the beginning of each day of use; and (c) After each source installation.

(2) A licensee shall have the authorized medical physicist:

(a) Establish written procedures for performing the spot-checks required in paragraph (1) of this rule; and (b) Review the results of each spot-check required by paragraph (1) of this rule 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.

(3) To satisfy the requirements of subparagraph (1)(a) of this rule, spot-checks must, at a minimum:

(a) Assure proper operation of:

1. Treatment table retraction mechanism, using backup battery power or hydraulic backups with the unit off;

2. Helmet microswitches;

3. Emergency timing circuits; and

4. Stereotactic frames and localizing devices (trunnions).

(b) Determine:

1. The output for one typical set of operating conditions measured with the dosimetry system described in paragraph (2) of Rule 0400-20-07-.68;

2. The difference between the measurement made in part 1 of this subparagraph 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);

3. Source output against computer calculation;

4. Timer accuracy and linearity over the range of use;

5. On-off error; and

6. Trunnion centricity.

(4) To satisfy the requirements of subparagraphs (1)(b) and (c) of this rule, spot-checks must assure proper operation of:

(a) Electrical interlocks at each gamma stereotactic radiosurgery room entrance; May, 2012 67

USE OF RADIONUCLIDES IN THE HEALING ARTS CHAPTER 0400-20-07 (Rule 0400-20-07-.74, continued)

(b) Source exposure indicator lights on the gamma stereotactic radiosurgery unit, on the control console, and in the facility; (c) Viewing and intercom systems; (d) Timer termination; (e) Radiation monitors used to indicate room exposures; and (f) Emergency off buttons.

(5) A licensee shall arrange for the repair of any system identified in paragraph (3) of this rule that is not operating properly as soon as possible.

(6) If the results of the checks required in paragraph (4) of this rule 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.

(7) A licensee shall retain a record of each check required by paragraphs (3) and (4) of this rule in accordance with 0400-20-07-.107.

Authority: T.C.A. §§68-202-101 et seq., 68-202-201 et seq. and 4-5-201 et seq. Administrative History:

Original rule filed February 22, 2012; effective May 22, 2012.

0400-20-07-.75 ADDITIONAL TECHNICAL REQUIREMENTS FOR MOBILE REMOTE AFTERLOADER UNITS.

(1) A licensee providing mobile remote afterloader service shall:

(a) Check survey instruments before medical use at each address of use or on each day of use, whichever is more frequent; and (b) Account for all sources before departure from a clients address of use.

(2) In addition to the periodic spot-checks required by Rule 0400-20-07-.73, 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:

(a) Electrical interlocks on treatment area access points; (b) Source exposure indicator lights on the remote afterloader unit, on the control console, and in the facility; (c) Viewing and intercom systems; (d) Applicators, source transfer tubes, and transfer tube-applicator interfaces; (e) Radiation monitors used to indicate room exposures; (f) Source positioning (accuracy); and (g) Radiation monitors used to indicate whether the source has returned to a safe shielded position.

May, 2012 68

USE OF RADIONUCLIDES IN THE HEALING ARTS CHAPTER 0400-20-07 (3) In addition to the requirements for checks in paragraph (2) of this rule, 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.

(4) If the results of the checks required in paragraph (2) of this rule 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.

(5) A licensee shall retain a record of each check required by paragraph (2) of this rule in accordance with Rule 0400-20-07-.108.

Authority: T.C.A. §§68-202-101 et seq., 68-202-201 et seq. and 4-5-201 et seq. Administrative History:

Original rule filed February 22, 2012; effective May 22, 2012.

0400-20-07-.76 RADIATION SURVEYS.

(1) In addition to the survey requirement in Rule 0400-20-05-.70, a person licensed under this Chapter 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 do not exceed the levels stated in the sealed source and device registry.

(2) A licensee shall make the survey required by paragraph (1) of this rule 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 round the source(s), or compromise the radiation safety of the unit or the source(s).

(3) A licensee shall retain a record of the radiation surveys required by paragraph (1) of this rule in accordance with Rule 0400-20-07-.109.

Authority: T.C.A. §§68-202-101 et seq., 68-202-201 et seq. and 4-5-201 et seq. Administrative History:

Original rule filed February 22, 2012; effective May 22, 2012.

0400-20-07-.77 FIVE YEAR FULL-INSPECTION SERVICING FOR TELETHERAPY UNITS AND GAMMA STEREOTACTIC RADIOSURGERY UNITS.

(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.

A licensee shall have each teletherapy unit and gamma stereotactic radiosurgery unit fully inspected and serviced during each source replacement to assure proper functioning of the source exposure mechanism and other safety components. The interval between each full-inspection servicing shall not exceed 5 years for each teletherapy unit and shall not exceed 7 years for each gamma stereotactic radiosurgery unit.

(2) This inspection and servicing may only be performed by persons specifically licensed to do so by the Division, the U.S. Nuclear Regulatory Commission or an Agreement State.

(3) A licensee shall keep a record of the inspection and servicing in accordance with Rule 0400-20-07-.110.

Authority: T.C.A. §§68-202-101 et seq., 68-202-201 et seq. and 4-5-201 et seq. Administrative History:

Original rule filed February 22, 2012; effective May 22, 2012.

0400-20-07-.78 THERAPY-RELATED COMPUTER SYSTEMS.

May, 2012 69

USE OF RADIONUCLIDES IN THE HEALING ARTS CHAPTER 0400-20-07 (1) A licensee shall perform or shall verify and maintain documentation of acceptance testing on the treatment planning system in accordance with published protocols accepted by nationally recognized bodies. At a minimum, the acceptance testing must include, as applicable, verification of:

(a) The source-specific input parameters required by the dose calculation algorithm; (b) The accuracy of dose, dwell time, and treatment time calculations at representative points; (c) The accuracy of isodose plots and graphic displays; (d) The accuracy of the software used to determine sealed source positions from radiographic images; and (e) The accuracy of electronic transfer of the treatment delivery parameters to the treatment delivery unit from the treatment planning system.

Authority: T.C.A. §§68-202-101 et seq., 68-202-201 et seq. and 4-5-201 et seq. Administrative History:

Original rule filed February 22, 2012; effective May 22, 2012.

0400-20-07-.79 RESERVED.

Authority: T.C.A. §§68-202-101 et seq., 68-202-201 et seq. and 4-5-201 et seq. Administrative History:

Original rule filed February 22, 2012; effective May 22, 2012.

0400-20-07-.80 TRAINING FOR USE OF REMOTE AFTERLOADER UNITS, TELETHERAPY UNITS, AND GAMMA STEREOTACTIC RADIOSURGERY UNITS.

(1) Except as provided in Rule 0400-20-07-.26, a licensee shall require an authorized user of a sealed source for a use authorized under Rule 0400-20-07-.63 to be a physician who:

(a) Is certified by a medical specialty board whose certification process has been recognized by the Division, the U.S. Nuclear Regulatory Commission, or an Agreement State and who meets the requirements in part (b)3 and subparagraph (c) of this paragraph. To be recognized, a specialty board shall require all candidates for certification The names of board certifications that have been recognized by the Commission or an Agreement State are posted on the NRC's Medical Uses Licensee Toolkit web page. To have its certification process recognized, a specialty board shall require all candidates for certification to:

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 Council on Postdoctoral Training of the American Osteopathic Association; and

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; or (b) 1. Has completed a structured educational program in basic radionuclide techniques applicable to the use of a sealed source in a therapeutic medical unit that includes:

(i) 200 hours0.00231 days 0.0556 hours 3.306878e-4 weeks 7.61e-5 months of classroom and laboratory training in the following areas:

May, 2012 70

USE OF RADIONUCLIDES IN THE HEALING ARTS CHAPTER 0400-20-07 (Rule 0400-20-07-.80, continued)

(I) Radiation physics and instrumentation; (II) Radiation protection; (III) Mathematics pertaining to the use and measurement of radioactivity; and (IV) Radiation biology; and (ii) 500 hours0.00579 days 0.139 hours 8.267196e-4 weeks 1.9025e-4 months of work experience, under the supervision of an authorized user who meets the requirements in this rule, Rule 0400-20-07-.26, or equivalent Agreement State or U.S. Nuclear Regulatory Commission requirements at a medical institution facility that is authorized to use radioactive materials in, Rule 0400-20-07-.63, involving:

(I) Reviewing full calibration measurements and periodic spot-checks; (II) Preparing treatment plans and calculating treatment doses and times; (III) Using administrative controls to prevent a misadministration involving the use of radioactive material; (IV) Implementing emergency procedures to be followed in the event of the abnormal operation of the medical unit or console; (V) Checking and using survey meters; and (VI) Selecting the proper dose and how it is to be administered; and

2. Has completed 3 years of supervised clinical experience in radiation therapy, under an authorized user who meets the requirements in this rule, Rule 0400 07-.26, or equivalent U.S. Nuclear Regulatory Commission or Agreement State requirements, as part of a formal training program approved by the Residency Review Committee for Radiation Oncology of the Accreditation Council for Graduate Medical Education or Royal College of Physicians and Surgeons of Canada or the Committee Council on Postdoctoral Training of the American Osteopathic Association. This experience may be obtained concurrently with the supervised work experience required by subpart 1(ii) of this subparagraph; and

3. Has obtained written attestation that the individual has satisfactorily completed the requirements in part (a)1 of this paragraph or part 1 of this subparagraph, and part 2 of this subparagraph and subparagraph (c) Parts (1)(a)1, (1)(b)1, (1)(b)2, and Subparagraph (1)(c) of this rule paragraph; and has achieved a level of competency sufficient to function independently is able to independently fulfill the radiation safety-related duties as an authorized user of each type of therapeutic medical unit for which the individual is requesting authorized user status. The written attestation must be signed by a preceptor authorized user who meets the requirements in this rule, Rule 0400-20-07-.26, or equivalent U.S. Nuclear Regulatory Commission or Agreement State requirements for an authorized user for each type of therapeutic medical unit for which the individual is requesting authorized user status; and The attestation must be obtained from either:

(i) A preceptor authorized user who meets the requirements in this rule, Rule 0400-20-07-.26, or equivalent U.S. Nuclear Regulatory Commission or Agreement State requirements for an authorized user for each type(s) of May, 2012 71

USE OF RADIONUCLIDES IN THE HEALING ARTS CHAPTER 0400-20-07 (Rule 0400-20-07-.80, continued) therapeutic medical unit for which the individual is requesting authorized user status; or (ii) A residency program director who affirms in writing that the attestation represents the consensus of the residency program faculty where at least one faculty member is an authorized user who meets the requirements this rule, Rule 0400-20-07-.26, or equivalent U.S. Nuclear Regulatory Commission or Agreement State requirements, for the type(s) of therapeutic medical unit for which the individual is requesting authorized user status, and concurs with the attestation provided by the residency program director.

The residency training program must be approved by the Residency Review Committee of the Accreditation Council for Graduate Medical Education or the Royal College of Physicians and Surgeons of Canada or the Council on Postdoctoral Training of the American Osteopathic Association and must include training and experience specified in Subparagraph (1)(b) of this rule.

(c) Has received training in device operation, safety procedures, and clinical use for the type(s) of use for which authorization is sought. This training requirement may be satisfied by satisfactory completion of a training program provided by the vendor for new users or by receiving training supervised by an authorized user or authorized medical physicist, as appropriate, who is authorized for the type(s) of use for which the individual is seeking authorization.

Authority: T.C.A. §§68-202-101 et seq., 68-202-201 et seq. and 4-5-201 et seq. Administrative History:

Original rule filed February 22, 2012; effective May 22, 2012.

0400-20-07-.81 OTHER MEDICAL USES OF RADIOACTIVE MATERIAL OR RADIATION FROM RADIOACTIVE MATERIAL.

(1) A licensee may use radioactive material or a radiation source approved for medical use that is not specifically addressed in this rule if:

(a) The applicant or licensee has submitted the information required by paragraphs (2), (3),

and (4) of Rule 0400-20-07-.11; and (b) The applicant or licensee has received written approval from the Division in a license or license amendment and uses the material in accordance with the regulations and specific conditions the Division considers necessary for the medical use of the material.

Authority: T.C.A. §§68-202-101 et seq., 68-202-201 et seq. and 4-5-201 et seq. Administrative History:

Original rule filed February 22, 2012; effective May 22, 2012.

0400-20-07-.82 RECORDS OF AUTHORITY AND RESPONSIBILITIES FOR RADIATION PROTECTION PROGRAMS.

(1) A licensee shall retain a record of actions taken by the licensees management in accordance with paragraph (1) of Rule 0400-20-07-.17 for 5 years. The record must include a summary of the actions taken and a signature of licensee management.

(2) A licensee shall retain a copy of both authority, duties, and responsibilities of the radiation safety officer as required by paragraph (5) of Rule 0400-20-07-.17, and a signed copy of each radiation safety officers agreement to be responsible for implementing the radiation safety program, as required by paragraph (2) of Rule 0400-20-07-.17. The records must include the signature of the radiation safety officer and licensee management.

May, 2012 72

USE OF RADIONUCLIDES IN THE HEALING ARTS CHAPTER 0400-20-07 (3) The minutes of each Radiation Safety Committee meeting held in accordance with paragraph (8) of Rule 0400-20-07-.17 shall include:

(a) The date of the meeting; (b) Members present; (c) Members absent; and (d) Summary of deliberations and discussions.

(4) For each Associate Radiation Safety Officer appointed under Paragraph 0400-20-07-.17(2), Formatted: Underline, Font color: Red the licensee shall retain, for 5 years after the Associate Radiation Safety Officer is removed from the license, a copy of the written document appointing the Associate Radiation Safety Formatted: Font: Arial, Underline, Font color: Red Officer signed by the licensee's management. Formatted: Underline, Font color: Red Authority: T.C.A. §§68-202-101 et seq., 68-202-201 et seq. and 4-5-201 et seq. Administrative History:

Original rule filed February 22, 2012; effective May 22, 2012.

0400-20-07-.83 RECORDS OF RADIATION PROTECTION PROGRAM CHANGES.

A licensee shall retain a record of each radiation protection program change made in accordance with paragraph (1) of Rule 0400-20-07-.18 for 5 years. The record must include a copy of the old and new procedures; the effective date of the change; and the signature of the licensee management that reviewed and approved the change.

Authority: T.C.A. §§68-202-101 et seq., 68-202-201 et seq. and 4-5-201 et seq. Administrative History:

Original rule filed February 22, 2012; effective May 22, 2012.

0400-20-07-.84 RECORDS OF WRITTEN DIRECTIVES.

A licensee shall retain a copy of each written directive as required by Rule 0400-20-07-.20 for 3 years.

Authority: T.C.A. §§68-202-101 et seq., 68-202-201 et seq. and 4-5-201 et seq. Administrative History:

Original rule filed February 22, 2012; effective May 22, 2012.

0400-20-07-.85 RESERVED.

Authority: T.C.A. §§68-202-101 et seq., 68-202-201 et seq. and 4-5-201 et seq. Administrative History:

Original rule filed February 22, 2012; effective May 22, 2012.

0400-20-07-.86 RESERVED.

Authority: T.C.A. §§68-202-101 et seq., 68-202-201 et seq. and 4-5-201 et seq. Administrative History:

Original rule filed February 22, 2012; effective May 22, 2012.

0400-20-07-.87 RECORDS OF CALIBRATIONS OF INSTRUMENTS USED TO MEASURE THE ACTIVITY OF UNSEALED RADIOACTIVE MATERIAL.

A licensee shall maintain a record of instrument calibrations required by Rule 0400-20-07-.28 for 3 years.

The records must include the model and serial number of the instrument, the date of the calibration, the results of the calibration, and the name of the individual who performed the calibration.

May, 2012 73

USE OF RADIONUCLIDES IN THE HEALING ARTS CHAPTER 0400-20-07 Authority: T.C.A. §§68-202-101 et seq., 68-202-201 et seq. and 4-5-201 et seq. Administrative History:

Original rule filed February 22, 2012; effective May 22, 2012.

0400-20-07-.88 RECORDS OF SURVEY INSTRUMENT CALIBRATIONS.

A licensee shall maintain a record of radiation survey instrument calibrations required by Rule 0400-20 .29 for 3 years. The record must include the model and serial number of the instrument, the date of the calibration, the results of the calibration, and the name of the individual who performed the calibration.

Authority: T.C.A. §§68-202-101 et seq., 68-202-201 et seq. and 4-5-201 et seq. Administrative History:

Original rule filed February 22, 2012; effective May 22, 2012.

0400-20-07-.89 RECORDS OF DOSAGES OF UNSEALED RADIOACTIVE MATERIAL FOR MEDICAL USE.

A licensee shall maintain a record of dosage determinations required by Rule 0400-20-07-.30 for 3 years.

The record must contain the radioactive drug; the patients or human research subjects name, or identification number if one has been assigned; prescribed dosage; the determined dosage, or a notation that the total activity is less than 1.1 megabecquerel (30 Ci); the date and time of the dosage determination; and the name of the individual who determined the dosage.

Authority: T.C.A. §§68-202-101 et seq., 68-202-201 et seq. and 4-5-201 et seq. Administrative History:

Original rule filed February 22, 2012; effective May 22, 2012.

0400-20-07-.90 RESERVED.

Authority: T.C.A. §§68-202-101 et seq., 68-202-201 et seq. and 4-5-201 et seq. Administrative History:

Original rule filed February 22, 2012; effective May 22, 2012.

0400-20-07-.91 RECORDS OF SURVEYS FOR AMBIENT RADIATION EXPOSURE RATE.

A licensee shall retain a record of each survey required by Rule 0400-20-07-.34 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.

Authority: T.C.A. §§68-202-101 et seq., 68-202-201 et seq. and 4-5-201 et seq. Administrative History:

Original rule filed February 22, 2012; effective May 22, 2012.

0400-20-07-.92 RECORDS OF THE RELEASE OF INDIVIDUALS CONTAINING UNSEALED RADIOACTIVE MATERIAL OR IMPLANTS CONTAINING RADIOACTIVE MATERIAL.

(1) A licensee shall retain a record, signed by the authorized user, of the basis for authorizing the release of an individual, for 3 years after the date of release.

(2) A licensee shall retain a record, for 3 years after the date of release, that the instructions required by paragraph (2) of Rule 0400-20-07-.35 were provided to a breast-feeding woman.

Authority: T.C.A. §§68-202-101 et seq., 68-202-201 et seq. and 4-5-201 et seq. Administrative History:

Original rule filed February 22, 2012; effective May 22, 2012.

0400-20-07-.93 RECORDS OF MOBILE MEDICAL SERVICES.

(1) A licensee shall retain a copy of each letter that permits the use of radioactive material at a clients address, as required by subparagraph (1)(a) of Rule 0400-20-07-.36, Each letter must clearly delineate the authority and responsibility of the licensee and the client and must be retained for 3 years after the last provision of service.

May, 2012 74

USE OF RADIONUCLIDES IN THE HEALING ARTS CHAPTER 0400-20-07 (2) A licensee shall retain the record of each survey required by subparagraph (1)(d) of Rule 0400-20-07-.36 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.

Authority: T.C.A. §§68-202-101 et seq., 68-202-201 et seq. and 4-5-201 et seq. Administrative History:

Original rule filed February 22, 2012; effective May 22, 2012.

0400-20-07-.94 RECORDS OF DECAY-IN-STORAGE.

A licensee shall maintain records of the disposal of licensed materials, as required by Rule 0400-20 .37, 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.

Authority: T.C.A. §§68-202-101 et seq., 68-202-201 et seq. and 4-5-201 et seq. Administrative History:

Original rule filed February 22, 2012; effective May 22, 2012.

0400-20-07-.95 RECORDS OF RADIONUCLIDE CONTAMINANTS.

A licensee shall maintain a record of the radionuclide contaminant concentration tests required by Rule 0400-20-07-.41 for 3 years. The record must include, for each measured elution of radionuclide used to prepare a radioactive drug, the ratio of the measures expressed as kilobecquerel of contaminant per megabecquerel of desired radionuclide (microcuries/millicurie), or microgram of contaminant per megabecquerel of desired radionuclide (microgram/millicurie), the time and date of the measurement, and the name of the individual who made the measurement.

Authority: T.C.A. §§68-202-101 et seq., 68-202-201 et seq. and 4-5-201 et seq. Administrative History:

Original rule filed February 22, 2012; effective May 22, 2012.

0400-20-07-.96 RECORDS OF SAFETY INSTRUCTION AND TRAINING.

A licensee shall maintain a record of safety instructions and training required by Rules 0400-20-07-.45, 0400-20-07-.54, and paragraph (4) of Rule 0400-20-07-.66 for 3 years. The record must include a list of the topics covered, the date of the instruction, the name(s) of the attendee(s), and the name(s) of the individual(s) who provided the instruction.

Authority: T.C.A. §§68-202-101 et seq., 68-202-201 et seq. and 4-5-201 et seq. Administrative History:

Original rule filed February 22, 2012; effective May 22, 2012.

0400-20-07-.97 RECORDS OF RADIATION SURVEYS OF PATIENTS AND HUMAN RESEARCH SUBJECTS.

A licensee shall maintain a record of the surveys required by Rules 0400-20-07-.52 and 0400-20-07-.64 for 3 years. Each record must include the date and results of the survey, the survey instrument used, and the name of the individual who made the survey.

Authority: T.C.A. §§68-202-101 et seq., 68-202-201 et seq. and 4-5-201 et seq. Administrative History:

Original rule filed February 22, 2012; effective May 22, 2012.

0400-20-07-.98 RECORDS OF BRACHYTHERAPY SOURCE ACCOUNTABILITY.

(1) A licensee shall maintain a record of brachytherapy source accountability required by Rule 0400-20-07-.53 for 3 years.

May, 2012 75

USE OF RADIONUCLIDES IN THE HEALING ARTS CHAPTER 0400-20-07 (Rule 0400-20-07-.97, continued)

(2) For temporary implants, the record must include:

(a) The number and activity of sources 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 (b) The number and activity of sources returned to storage, the time and date they were returned to storage, and the name of the individual who returned them to storage.

(3) For permanent implants, the record must include:

(a) The number and activity of sources removed from storage, the date they were removed from storage, and the name of the individual who removed them from storage; (b) The number and activity of sources not implanted, the date they were returned to storage, and the name of the individual who returned them to storage; and (c) The number and activity of sources permanently implanted in the patient or human research subject.

Authority: T.C.A. §§68-202-101 et seq., 68-202-201 et seq. and 4-5-201 et seq. Administrative History:

Original rule filed February 22, 2012; effective May 22, 2012.

0400-20-07-.99 RECORDS OF CALIBRATION MEASUREMENTS OF BRACHYTHERAPY SOURCES.

A licensee shall maintain a record of the calibrations of brachytherapy sources required by Rule 0400 07-.56 for 3 years after the last use of the source. The record must include the date of the calibration; the manufacturers name, model number, and serial number for the source and the instruments used to calibrate the source; the source output or activity; the source positioning accuracy within the applicators; and the signature of the authorized medical physicist.

Authority: T.C.A. §§68-202-101 et seq., 68-202-201 et seq. and 4-5-201 et seq. Administrative History:

Original rule filed February 22, 2012; effective May 22, 2012.

0400-20-07-.100 RECORDS OF DECAY OF STRONTIUM-90 SOURCES FOR OPHTHALMIC TREATMENTS.

A licensee shall maintain a record of the activity of a strontium-90 source required by Rule 0400-20-07-.56 for the life of the source. The record must include the date and initial activity of the source as determined under Rule 0400-20-07-.56, and for each decay calculation, the date, the source activity, and the signature of the authorized medical physicist.

Authority: T.C.A. §§68-202-101 et seq., 68-202-201 et seq. and 4-5-201 et seq. Administrative History:

Original rule filed February 22, 2012; effective May 22, 2012.

0400-20-07-.101 RECORDS OF INSTALLATION, MAINTENANCE, ADJUSTMENT, AND REPAIR OR REMOTE AFTERLOADER UNITS, TELETHERAPY UNITS, AND GAMMA STEREOTACTIC RADIOSURGERY UNITS.

A licensee shall retain a record of the installation, maintenance, adjustment, and repair of remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units as required by Rule 0400-20-07-.65 for 3 years. For each installation, maintenance, adjustment and repair, the record must include the date, description of the service, and name(s) of the individual(s) who performed the work.

Authority: T.C.A. §§68-202-101 et seq., 68-202-201 et seq. and 4-5-201 et seq. Administrative History:

Original rule filed February 22, 2012; effective May 22, 2012.

May, 2012 76

USE OF RADIONUCLIDES IN THE HEALING ARTS CHAPTER 0400-20-07 0400-20-07-.102 RECORDS OF SAFETY PROCEDURES.

A licensee shall retain a copy of the procedures required by subparagraphs (1)(d) and (4)(b) of Rule 0400-20-07-.66 until the licensee no longer possesses the remote afterloader, teletherapy unit, or gamma stereotactic radiosurgery unit.

Authority: T.C.A. §§68-202-101 et seq., 68-202-201 et seq. and 4-5-201 et seq. Administrative History:

Original rule filed February 22, 2012; effective May 22, 2012.

0400-20-07-.103 RECORDS OF DOSIMETRY EQUIPMENT.

(1) A licensee shall retain a record of the calibration, intercomparison, and comparisons of its dosimetry equipment done in accordance with Rule 0400-20-07-.68 for the duration of the license.

(2) For each calibration, intercomparison, or comparison, the record must include:

(a) The date; (b) The manufacturers name, model numbers and serial numbers of the instruments that were calibrated, intercompared, or compared as required by paragraphs (1) and (2) of Rule 0400-20-07-.68; (c) The correction factor that was determined from the calibration or comparison or the apparent correction factor that was determined from an intercomparison; and (d) The names of the individuals who performed the calibration, intercomparison, or comparison.

Authority: T.C.A. §§68-202-101 et seq., 68-202-201 et seq. and 4-5-201 et seq. Administrative History:

Original rule filed February 22, 2012; effective May 22, 2012.

0400-20-07-.104 RECORDS OF TELETHERAPY, REMOTE AFTERLOADER, AND GAMMA STEREOTACTIC RADIOSURGERY FULL CALIBRATIONS.

(1) A licensee shall maintain a record of the teletherapy unit, remote afterloader unit, and gamma stereotactic radiosurgery unit full calibrations required by Rules 0400-20-07-.69, 0400-20 .70, and 0400-20-07-.71 for 3 years.

(2) The record must include:

(a) The date of the calibration; (b) The manufacturers name, model number, and serial number of the teletherapy, remote afterloader, and gamma stereotactic radiosurgery unit(s), the source(s), and the instruments used to calibrate the unit(s);

(c) The results and an assessment of the full calibrations; (d) The results of the autoradiograph required for low dose-rate remote afterloader units; and (e) The signature of the authorized medical physicist who performed the full calibration.

May, 2012 77

USE OF RADIONUCLIDES IN THE HEALING ARTS CHAPTER 0400-20-07 (Rule 0400-20-07-.104, continued)

Authority: T.C.A. §§68-202-101 et seq., 68-202-201 et seq. and 4-5-201 et seq. Administrative History:

Original rule filed February 22, 2012; effective May 22, 2012.

0400-20-07-.105 RECORDS OF PERIODIC SPOT-CHECKS FOR TELETHERAPY UNITS.

(1) A licensee shall retain a record of each periodic spot-check for teletherapy units required by Rule 0400-20-07-.72 for 3 years.

(2) The record must include:

(a) The date of the spot-check; (b) The manufacturers name, model number, and serial number of the teletherapy unit, source and instrument used to measure the output of the teletherapy unit; (c) An assessment of timer linearity and constancy; (d) The calculated on-off error; (e) A determination of the coincidence of the radiation field and the field indicated by the light beam localizing device; (f) The determined accuracy of each distance measuring and localization device; (g) The difference between the anticipated output and the measured output; (h) 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 (i) 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.

Authority: T.C.A. §§68-202-101 et seq., 68-202-201 et seq. and 4-5-201 et seq. Administrative History:

Original rule filed February 22, 2012; effective May 22, 2012.

0400-20-07-.106 RECORDS OF PERIODIC SPOT-CHECKS FOR REMOTE AFTERLOADER UNITS.

(1) A licensee shall retain a record of each spot-check for remote afterloader units required by Rule 0400-20-07-.73 for 3 years.

(2) The record must include, as applicable:

(a) The date of the spot-check; (b) The manufacturers name, model number, and serial number for the remote afterloader unit and source; (c) An assessment of timer accuracy; (d) 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 units computer; and (e) 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.

May, 2012 78

USE OF RADIONUCLIDES IN THE HEALING ARTS CHAPTER 0400-20-07 (Rule 0400-20-07-.106, continued)

Authority: T.C.A. §§68-202-101 et seq., 68-202-201 et seq. and 4-5-201 et seq. Administrative History:

Original rule filed February 22, 2012; effective May 22, 2012.

0400-20-07-.107 RECORDS OF PERIODIC SPOT-CHECKS FOR GAMMA STEREOTACTIC RADIOSURGERY UNITS.

(1) A licensee shall retain a record of each spot-check for gamma stereotactic radiosurgery units required by Rule 0400-20-07-.74 for 3 years.

(2) The record must include:

(a) The date of the spot-check; (b) The manufacturers name, model number, and serial number for the gamma stereotactic radiosurgery unit and the instrument used to measure the output of the unit; (c) An assessment of timer linearity and accuracy; (d) The calculated on-off error; (e) A determination of trunnion centricity; (f) The difference between the anticipated output and the measured output; (g) An assessment of source output against computer calculations; (h) 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 (i) 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.

Authority: T.C.A. §§68-202-101 et seq., 68-202-201 et seq. and 4-5-201 et seq. Administrative History:

Original rule filed February 22, 2012; effective May 22, 2012.

0400-20-07-.108 RECORDS OF ADDITIONAL TECHNICAL REQUIREMENTS FOR MOBILE REMOTE AFTERLOADER UNITS.

(1) A licensee shall retain a record of each check for mobile remote afterloader units required by Rule 0400-20-07-.75 for 3 years.

(2) The record must include:

(a) The date of the check; (b) The manufacturers name, model number, and serial number of the remote afterloader unit; (c) Notations accounting for all sources before the licensee departs from a facility; (d) Notations indicating the operability of each entrance door electrical interlock, radiation monitors, source exposure indicator lights, viewing and intercom system, applicators, May, 2012 79

USE OF RADIONUCLIDES IN THE HEALING ARTS CHAPTER 0400-20-07 (Rule 0400-20-07-.108, continued) source transfer tubes, and transfer tube applicator interfaces, and source positioning accuracy; and (e) The signature of the individual who performed the check.

Authority: T.C.A. §§68-202-101 et seq., 68-202-201 et seq. and 4-5-201 et seq. Administrative History:

Original rule filed February 22, 2012; effective May 22, 2012.

0400-20-07-.109 RECORDS OF SURVEYS OF THERAPEUTIC TREATMENT UNITS.

(1) A licensee shall maintain a record of radiation surveys of treatment units made in accordance with Rule 0400-20-07-.76 for the duration of use of the unit.

(2) The record must include:

(a) The date of the measurements; (b) The manufacturers name, model number and serial number of the treatment unit, source, and instrument used to measure radiation levels; (c) Each dose rate measured around the source while the unit is in the off position and the average of all measurements; and (d) The signature of the individual who performed the test.

Authority: T.C.A. §§68-202-101 et seq., 68-202-201 et seq. and 4-5-201 et seq. Administrative History:

Original rule filed February 22, 2012; effective May 22, 2012.

0400-20-07-.110 RECORDS OF FIVE-YEARFULL- INSPECTION FOR TELETHERAPY AND GAMMA STEREOTACTIC RADIOSURGERY UNITS.

(1) A licensee shall maintain a record of the 5-year inspectionsfull-inspection servicing for teletherapy and gamma stereotactic radiosurgery units required by Rule 0400-20-07-.77 for the duration of use of the unit.

(2) The record must contain:

(a) The inspectors radioactive materials license number; (b) The date of inspection; (c) The manufacturers name and model number and serial number of both the treatment unit and source; (d) A list of components inspected and serviced, and the type of service; and (e) The signature of the inspector.

Authority: T.C.A. §§68-202-101 et seq., 68-202-201 et seq. and 4-5-201 et seq. Administrative History:

Original rule filed February 22, 2012; effective May 22, 2012.

0400-20-07-.111 RECORDS OF LEAK TESTS AND INVENTORY OF SEALED SOURCES AND BRACHYTHERAPY SOURCES.

(1) A licensee shall retain records of leak tests required by paragraph (2) of Rule 0400-20-07-.32 for 3 years. The records must include the model number, and serial number if one has been May, 2012 80

USE OF RADIONUCLIDES IN THE HEALING ARTS CHAPTER 0400-20-07 (Rule 0400-20-07-.110, continued) assigned, of each source tested; the identity of each source by radionuclide and its estimated activity; the results of the test; the date of the test; and the name of the individual who performed the test.

(2) A licensee shall retain records of the semi-annual physical inventory of sealed sources and brachytherapy sources required by paragraph (5) of Rule 0400-20-07-.32 for 3 years. The inventory records must contain the model number of each source, and serial number if one has been assigned, the identity of each source by radionuclide and its nominal activity, the location of each source, and the name of the individual who performed the inventory.

Authority: T.C.A. §§68-202-101 et seq., 68-202-201 et seq. and 4-5-201 et seq. Administrative History:

Original rule filed February 22, 2012; effective May 22, 2012.

0400-20-07-.112 RECORDS FOR PROCEDURES FOR ADMINISTRATIONS REQUIRING A WRITTEN DIRECTIVE.

A licensee shall retain a copy of the procedures required by paragraph (1) of Rule 0400-20-07-.21 for the duration of the license.

Authority: T.C.A. §§68-202-101 et seq., 68-202-201 et seq. and 4-5-201 et seq. Administrative History:

Original rule filed February 22, 2012; effective May 22, 2012.

0400-20-07-.113 REPORT OF A LEAKING SOURCE.

A licensee shall file a report within 5 days if a leak test required by Rule 0400-20-07-.32 reveals the presence of 185 Bq (0.005 µCi) or more of removable contamination. The report must be filed with the Division, and sent to the Division at the address listed in subparagraph (1)(c) of Rule 0400-20-04-.07. The written report must include the model number and serial number if assigned, of the leaking source; the radionuclide and its estimated activity; the results of the test; the date of the test; and the action taken.

Authority: T.C.A. §§68-202-101 et seq., 68-202-201 et seq. and 4-5-201 et seq. Administrative History:

Original rule filed February 22, 2012; effective May 22, 2012.

0400-20-07-.114 REPORT AND NOTIFICATION FOR AN ELUATE EXCEEDING PERMISSIBLE MOLYBDENUM-99, STRONTIUM-82, AND STRONTIUM-85 CONCENTRATIONS.

(1) The licensee shall notify by telephone the Division and the distributor of the generator within 7 calendar days after discovery that an eluate exceeded the permissible concentration listed in Paragraph 0400-20-07-.41(1) at the time of generator elution. The telephone report to the Division must include the manufacturer, model number, and serial number (or lot number) of the generator; the results of the measurement; the date of the measurement; whether dosages were administered to patients or human research subjects, when the distributor was notified, and the action taken.

(2) By an appropriate method listed in Rule 0400-20-04-.07, the licensee shall submit a written report to the Division within 30 calendar days after discovery of an eluate exceeding the permissible concentration at the time of generator elution. The written report must include the action taken by the licensee; the patient dose assessment; the methodology used to make this dose assessment if the eluate was administered to patients or human research subjects; and the probable cause and an assessment of failure in the licensee's equipment, procedures or training that contributed to the excessive readings if an error occurred in the licensee's breakthrough determination; and the information in the telephone report as required by Paragraph (1) of this rule.

Authority: T.C.A. §§68-202-101 et seq., 68-202-201 et seq. and 4-5-201 et seq.

May, 2012 81

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ML21301A027

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