No. 27748 (Amendment): R313-32. Medical Use of Radioactive Material

DAR File No.: 27748
Filed: 03/11/2005, 04:34
Received by: NL

 

RULE ANALYSIS

Purpose of the rule or reason for the change:

The reason for this change is to modify Utah's Radiation Control Rules to be compatible with Federal requirements found in 10 CFR 35.

 

Summary of the rule or change:

Corrections to references to Title 19 are made. In general, the rule change allows regulated persons to have more flexibility in methods used to comply with the rule by replacing prescriptive requirements with risk informed, performance-based requirements. In addition, the changes specifically include some medical modalities that have been previously regulated through the use of license conditions and include a mechanism to regulate new medical modalities as they emerge. There is now a definition for authorized medical physicists and particular training and experience requirements for these individuals. The prescriptive requirements for a quality management program have been removed and replaced with certain essential requirements. The rule change also modifies some requirements for calibration of instrumentation used to measure actual patient doses.

 

State statutory or constitutional authorization for this rule:

Sections 19-3-104 and 19-3-108

 

This rule or change incorporates by reference the following material:

10 CFR 35

 

Anticipated cost or savings to:

the state budget:

With the adoption of risk informed, performance-based regulations, no additional regulatory requirements will need to be implemented by the state. Therefore, changes in the rules will not result in a cost or savings to the state budget.

 

local governments:

The rule modification does not affect the local governments presently licensed under the rules under R313. Therefore, there will be no cost or savings for local governments.

 

other persons:

Because the proposed changes allow affected persons more flexibility in methods used to attain compliance with the rule, overall costs or savings to most affected persons will depend on their business practices and are difficult to determine. There are approximately six affected facilities that may incur additional costs due to requirements for calibration of instrumentation used to measure the radiation output of certain radiation sources used in medical therapies, but actual costs will be determined by the method each facility uses to be compliant.

 

Compliance costs for affected persons:

Because the proposed changes allow affected persons more flexibility in methods used to attain compliance with the rules, overall costs or savings to most affected persons will depend on their business practices and are difficult to determine. There are approximately six affected facilities that may incur additional costs due to requirements for calibration of instrumentation used to measure the radiation output of certain radiation sources used in medical therapies, but actual costs will be determined by the method each facility uses to be compliant.

 

Comments by the department head on the fiscal impact the rule may have on businesses:

Overall, the increased flexibility of the rules allows businesses to determine the most cost effective way to obtain compliance with requirements. Actual costs or savings are dependant on the business practices used and therefore cannot be determined. Dianne R. Nielson, Executive Director

 

The full text of this rule may be inspected, during regular business hours, at the Division of Administrative Rules, or at:

Environmental Quality
Radiation Control
168 N 1950 W
SALT LAKE CITY UT 84116-3085

 

Direct questions regarding this rule to:

Gwyn Galloway at the above address, by phone at 801-536-4258, by FAX at 801-533-4097, or by Internet E-mail at [e-mail]

 

Interested persons may present their views on this rule by submitting written comments to the address above no later than 5:00 p.m. on:

05/02/2005

 

This rule may become effective on:

05/13/2005

 

Authorized by:

Dane Finerfrock, Director

 

 

RULE TEXT

R313. Environmental Quality, Radiation Control.

R313-32. Medical Use of Radioactive Material.

R313-32-1. Purpose and Authority.

(1) The purpose of this rule is to prescribe requirements and provisions for the medical use of radioactive material and for issuance of specific licenses authorizing the medical use of this material. These requirements and provisions provide for the protection of the public health and safety. The requirements and provisions of Rule R313-32 are in addition to, and not in substitution for, other sections of Title R313.

(2) The rules set forth herein are adopted pursuant to the provisions of Subsections 19-3-104(4) and 19-3-104(8).

 

R313-32-2. Clarifications or Exceptions.

For the purposes of Rule R313-32, 10 CFR 35.2 through 35.7; and 35.10 through 35.3067 (2004) are incorporated by reference with the following clarifications or exceptions:

(1) The exclusion of the following:

(a) In 10 CFR 35.2, exclude definitions for "Address of Use," "Agreement State," "Area of Use," "Dentist," "Pharmacist," "Physician," "Podiatrist," and "Sealed Source"; and

(b) In 10 CFR 35.3067, exclude "with a copy to the Director, Office of Nuclear Material Safety and Safeguards."

(2) The substitution of the following date references:

(a) "October 25, 2006" for "October 25, 2004";

(b) "October 24, 2006" for "October 24, 2004"; and

(c) "the effective date of this rule" for "October 24, 2002";

(3) The substitution of the following rule references:

(a) "Rule R313-15" for reference to "10 CFR Part 20" or for reference to "Part 20 of this chapter";

(b) "Rule R313-19" for reference to "Part 30 of this chapter" or for reference to "10 CFR Part 30" except for the reference to "Part 30 of this chapter" found in 10 CFR 35.65(d);

(c) "10 CFR 30" for reference to "Part 30 of this chapter" found in 10 CFR 35.65(d);

(d) "Rules R313-15 and R313-19" for reference to "parts 20 and 30 of this chapter";

(e) "Section R313-12-110" for reference to "Sec. 30.6 of this chapter" or for reference to "Sec. 30.6(a)" or for reference to "Sec. 30.6(a) of this chapter";

(f) "Section R313-15-101" for reference to "Sec. 20.1101 of this chapter";

(g) "Subsection R313-15-301(1)(a)" for reference to "Sec. 20.1301(a)(1) of this chapter";

(h) "Subsection R313-15-301(1)(c)" for reference to "Sec. 20.1301(c) of this chapter";

(i) "Section R313-15-501" for reference to "Sec. 20.1501 of this chapter";

(j) "Section R313-18-12" for reference to "Sec. 19.12 of this chapter";

(k) "Subsection R313-22-75(10) or equivalent U.S. Nuclear Regulatory Commission or Agreement State regulations" for reference to "Sec. 32.74 of this chapter," found in 10 CFR 35.65(b);

(l) "Subsection R313-22-75(10)" for reference to "10 CFR 32.74 of this chapter," or for reference to "Sec. 32.74 of this chapter" except for the reference to "Sec. 32.74 of this chapter" found in 10 CFR 35.65(b);

(m) "Rule R313-70" for reference to "Part 170 of this chapter";

(n) "Section R313-19-34(2)" for reference to "Sec. 30.34(b) of this chapter";

(o) "Rule R313-22" for reference to "Part 33 of this chapter";

(p) "Subsection R313-22-50(2)" for reference to "Sec. 33.13 of this chapter";

(q) "Subsection R313-22-75(9)(b)(iv)" for reference to "Sec. 32.72(b)(4)";and

(r) "Subsection R313-22-75(9)" for reference to "Sec. 32.72 of this chapter."

(4) The substitution of the following terms:

(a) "radioactive material" for reference to "byproduct material";

(b) "final" for "draft";

(c) "original" for "original and one copy";

(d) "[phone] or after hours, [phone]" for "[phone]";

(e) "Form DRC-02, 'Application for Medical Use of Radioactive Material License'" for reference to "NRC Form 313, 'Application for Material License'";

(f) "State of Utah radioactive materials" for reference to "NRC" in 10 CFR 35.6(c);

(g) "the Executive Secretary, the U.S. Nuclear Regulatory Commission, or an Agreement State" for reference to "the Commission or Agreement State" or for reference to "the Commission or an Agreement State";

(h) "an Executive Secretary, the U.S. Nuclear Regulatory Commission, or an Agreement State" for reference to "a Commission or Agreement State";

(i) "Equivalent U.S. Nuclear Regulatory Commission or Agreement State" for reference to "equivalent Agreement State" as found in 10 CFR 35.63(b)(2)(i), 10 CFR 35.63(c)(3), 10 CFR 35.65(a), 10 CFR 35.100(a), 10 CFR 35.200(a), and 10 CFR 35.300(a);

(j) "Executive Secretary" for reference to "NRC Operations Center" in 10 CFR 3045(c) and 10 CFR 3047(c);

(k) "Utah Division of Radiation Control" for reference to "NRC Operations Center" in Footnote 3 to 10 CFR 35.3045;

(l) "Executive Secretary" for reference to "appropriate NRC Regional Office listed in Sec. 30.6 of this chapter";

(m) "Utah Radiation Control Board" for reference to "Commission" in 10 CFR 35.18(a)(3)(second instance) and 10 CFR 35.19;

(n) "Executive Secretary" for reference to "Commission" in 10 CFR 35.12(d)(2), 10 CFR 35.14(a)(first instance), 10 CFR 35.14(b), 10 CFR 35.18(a), 10 CFR 35.18(a)(3)(first instance), 10 CFR 35.18(b), 10 CFR 35.24(a)(1), 10 CFR 35.24(c), 10 CFR 35.26(a), and 10 CFR 35.1000(b);

(o) "the Executive Secretary" for reference to "NRC" in 10 CFR 35.13(b)(4)(i), 10 CFR 35.3045(g)(1), and 10 CFR 35.3047(f)(1);

(p) "the U.S. Nuclear Regulatory Commission or an Agreement State" for reference to "an Agreement State" in 10 CFR 35.49(a) and 10 CFR 35.49(c); and

(q) "Executive Secretary, a U.S. Nuclear Regulatory Commission, or Agreement State" for reference to "NRC or Agreement State" in 10 CFR 35.63(b)(2)(ii), 10 CFR 35.100(c), 10 CFR 35.200(c), and 10 CFR 35.300(c).[(1) The purpose of this rule is to prescribe requirements and provisions for the medical use of radioactive material and for issuance of specific licenses authorizing the medical use of this material. These requirements and provisions provide for the protection of the public health and safety. The requirements and provisions of R313-32 are in addition to, and not in substitution for, other sections of R313.

(2) The rules set forth herein are adopted pursuant to the provisions of Sections 19-3-104(3) and 19-3-104(6).

 

R313-32-2. Definitions.

"Authorized nuclear pharmacist" means a pharmacist who is:

(a) board certified as a nuclear pharmacist by the Board of Pharmaceutical Specialties;

(b) identified as an authorized nuclear pharmacist on a Nuclear Regulatory Commission or Agreement State license that authorizes the use of radioactive material in the practice of nuclear pharmacy; or

(c) identified as an authorized nuclear pharmacist on a permit issued by a Nuclear Regulatory Commission or Agreement State specific licensee of broad scope that is authorized to permit the use of radioactive material in the practice of nuclear pharmacy.

"Authorized user" means a physician, dentist, or podiatrist who is:

(a) board certified by at least one of the boards listed in Paragraph (1) of R313-32-910, R313-32-920, R313-32-930, R313-32-940, R313-32-950, or R313-32-960;

(b) identified as an authorized user on a Nuclear Regulatory Commission or Agreement State license that authorizes the medical use of radioactive material; or

(c) identified as an authorized user on a permit issued by a Nuclear Regulatory Commission or Agreement State specific licensee of broad scope that is authorized to permit the medical use of radioactive material.

"Brachytherapy source" means an individual sealed source or a manufacturer-assembled source train that is not designed to be disassembled by the user.

"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.

"Dental use" means the intentional external administration of the radiation from radioactive material to human beings in the practice of dentistry in accordance with a license issued by this state.

"Dentist" means an individual licensed by this state to practice dentistry.

"Diagnostic clinical procedures manual" means a collection of written procedures that describes each method, 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.

"Management" means the chief executive officer or that person's delegate.

"Medical institution" means an organization in which several medical disciplines are practiced.

"Medical use" means the intentional internal or external administration of radioactive material, or the radiation therefrom, to patients or human research subjects under the supervision of an authorized user.

"Ministerial change" means a change that is made, after ascertaining the applicable requirements, by persons in authority in conformance with the requirements and without making a discretionary judgement about whether those requirements should apply in the case at hand.

"Misadministration" means the administration of:

(a) A radiopharmaceutical dosage greater than 1.11 MBq (30 uCi) of either sodium iodide I-125 or I-131:

(i) involving the wrong individual, or wrong radiopharmaceutical; or

(ii) when both the administered dosage differs from the prescribed dosage by more than 20 percent of the prescribed dosage and the difference between the administrated dosage and prescribed dosage exceeds 1.11 MBq (30 uCi).

(b) A therapeutic radiopharmaceutical dosage, other than sodium iodide I-125 or I-131:

(i) involving the wrong individual, wrong radiopharmaceutical, or wrong route of administration; or

(ii) when the administered dosage differs from the prescribed dosage by more than 20 percent of the prescribed dosage.

(c) A gamma stereotactic radiosurgery radiation dose:

(i) involving the wrong individual or wrong treatment site; or

(ii) when the calculated total administered dose differs from the total prescribed dose by more than ten percent of the total prescribed dose.

(d) A teletherapy radiation dose:

(i) involving the wrong individual, wrong mode of treatment, or wrong treatment site;

(ii) when the treatment consists of three or fewer fractions and the calculated total administered dose differs from the total prescribed dose by more than ten percent of the total prescribed dose;

(iii) when the calculated weekly administered dose exceeds the weekly prescribed dose by 30 percent or more of the weekly prescribed dose; or

(iv) when the calculated total administered dose differs from the total prescribed dose by more than 20 percent of the total prescribed dose.

(e) A brachytherapy radiation dose:

(i) involving the wrong individual, wrong radionuclide, or wrong treatment site (excluding, for permanent implants, seeds that were implanted in the correct site but migrated outside the treatment site);

(ii) involving a sealed source that is leaking;

(iii) when, for a temporary implant, one or more sealed sources are not removed upon completion of the procedure; or

(iv) when the calculated administered dose differs from the prescribed dose by more than 20 percent of the prescribed dose.

(f) A diagnostic radiopharmaceutical dosage, other than quantities greater than 1.11 MBq (30 uCi) of either sodium iodide I-125 or I-131, or both:

(i) involving the wrong individual, wrong radiopharmaceutical, wrong route of administration, or when the administered dosage differs from the prescribed dosage; and

(ii) when the dose to the individual exceeds 0.05 Sv (five rems) effective dose equivalent or 0.5 Sv (50 rems) dose equivalent to any individual organ.

"Mobile nuclear medicine service" means the transportation and medical use of radioactive material.

"Output" means the exposure rate, dose rate, or a quantity related in a known manner to these rates from a teletherapy unit for a specified set of exposure conditions.

"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.

"Podiatric use" means the intentional external administration of the radiation from radioactive material to human beings in the practice of podiatry in accordance with a license issued by this State.

"Podiatrist" means an individual licensed by this State to practice podiatry.

"Prescribed dosage" means the quantity of radiopharmaceutical activity as documented:

(a) in a written directive; or

(b) either in the diagnostic clinical procedures manual or in an appropriate record in accordance with the directions of the authorized user for diagnostic procedures.

"Prescribed dose" means:

(a) for gamma stereotactic radiosurgery, the total dose as documented in the written directive;

(b) for teletherapy, the total dose and dose per fraction as documented in the written directive; or

(c) for brachytherapy, either the total source strength and exposure time or the total dose, as documented in the written directive.

"Radiation Safety Officer" means the individual identified as the Radiation Safety Officer on a license issued by the Executive Secretary.

"Recordable event" means the administration of:

(a) a radiopharmaceutical or radiation without a written directive where a written directive is required;

(b) a radiopharmaceutical or radiation where a written directive is required without daily recording of each administered radiopharmaceutical dosage or radiation dose in the appropriate record;

(c) a radiopharmaceutical dosage greater than 1.11 MBq (30 uCi) of either sodium iodide I-125 or I-131 when both:

(i) the administered dosage differs from the prescribed dosage by more than ten percent of the prescribed dosage, and

(ii) the difference between the administered dosage and prescribed dosage exceed 555 kBq (15 uCi);

(d) A therapeutic radiopharmaceutical dosage, other than sodium iodide I-125 or I-131, when the administered dosage differs from the prescribed dosage by more than ten percent of the prescribed dosage;

(e) A teletherapy radiation dose when the calculated weekly administered dose exceeds the weekly prescribed dose by 15 percent or more of the weekly prescribed dose; or

(f) A brachytherapy radiation dose when the calculated administered dose differs from the prescribed dose by more than ten percent of the prescribed dose.

"Teletherapy" means therapeutic irradiation in which the source of radiation is at a distance from the body.

"Teletherapy physicist" means the individual identified as the teletherapy physicist on a license issued by the Executive Secretary.

"Visiting authorized user" means an authorized user who is not identified as an authorized user on the license of the licensee being visited.

"Written directive" means an order in writing for a specific patient or human research subject, dated and signed by an authorized user prior to the administration of a radiopharmaceutical or radiation, except as specified in paragraph (f) of this definition, containing the following information:

(a) for any administration of quantities greater than 1.11 MBq (30 uCi) of either sodium iodide I-125 or I-131: the dosage;

(b) for a therapeutic administration of a radiopharmaceutical other than sodium iodide I-125 or I-131: the radiopharmaceutical, dosage, and route of administration;

(c) for gamma stereotactic radiosurgery: target coordinates, collimator size, plug pattern, and total dose;

(d) for teletherapy: the total dose, dose per fraction, treatment site, and overall treatment period;

(e) for high-dose-rate remote afterloading brachytherapy: the radioisotope, treatment site, and total dose; or

(f) for all other brachytherapy:

(i) prior to implantation: the radionuclide, number of sources, and source strengths; and

(ii) after implantation but prior to completion of the procedure: the radionuclide, treatment site, and total source strength and exposure time, or equivalently, the total dose.

 

R313-32-6. Provisions for Research Involving Human Subjects.

A licensee may conduct research involving human subjects using radioactive material provided that 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 Utah license before conducting such research. Both types of licensees shall, at a minimum, obtain 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.

 

R313-32-7. FDA, other Federal, and State Requirements.

Nothing in R313-32 relieves the licensee from complying with applicable FDA, other Federal, and State requirements governing radioactive drugs or devices.

 

R313-32-11. License Required.

(1) A person shall not manufacture, produce, acquire, receive, possess, use, or transfer radioactive material for medical use except in accordance with a specific license issued by the Executive Secretary, the Nuclear Regulatory Commission, or an Agreement State, or as allowed in R313-32-11(2) or (3).

(2) An individual shall receive, possess, use, or transfer radioactive material in accordance with the Utah Radiation Control Rules under the supervision of an authorized user as provided in R313-32-25, unless prohibited by license condition.

(3) An individual may prepare unsealed radioactive material for medical use in accordance with R313-32 under the supervision of an authorized nuclear pharmacist or authorized user as provided in R313-32-25, unless prohibited by license condition.

 

R313-32-12. Application for License, Amendment, or Renewal.

(1) If the application is for medical use sited in a medical institution, only the institution's management may apply. If the application is for medical use not sited in a medical institution, any person may apply.

(2) An application for a license for medical use of radioactive material as described in R313-32-100, R313-32-200, R313-32-300, R313-32-400, and R313-32-500 must be made by filing of Form DRC-02, "Application for Materials License." For guidance in completing the form, refer to the instructions in the most current versions of the appropriate Regulatory Guides. A request for a license amendment or renewal may be submitted in a letter format.

(3) An applicant that satisfies the requirements specified in R313-22-50(2) may apply for a Type A specific license of broad scope.

 

R313-32-13. License Amendment.

A licensee shall apply for and receive a license amendment:

(1) before it receives or uses radioactive material for a clinical procedure permitted under R313-32 but not permitted by the license issued pursuant to R313-32;

(2) before it permits anyone to work as an authorized user or authorized nuclear pharmacist under the license, except an individual who is:

(a) an authorized user certified by the organizations specified in paragraph (1) of R313-32-910, R313-32-920, R313-32-930, R313-32-940, R313-32-950, or R313-32-960;

(b) an authorized nuclear pharmacist certified by the organization specified in paragraph (1) of R313-32-980;

(c) identified as an authorized user or an authorized nuclear pharmacist on a Nuclear Regulatory Commission or an Agreement State license that authorizes the use of radioactive material in medical use or in the practice of nuclear pharmacy, respectively, or

(d) identified as an authorized user or an authorized nuclear pharmacist on a permit issued by the Executive Secretary, the Nuclear Regulatory Commission or an Agreement 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, respectively.

(3) before it changes Radiation Safety Officers or Teletherapy Physicists;

(4) before it orders radioactive material in excess of the amount, or radionuclide or form different than authorized on the license; and

(5) before it adds to or changes the address or addresses of use identified on the license.

 

R313-32-14. Notifications.

(1) A licensee shall provide to the Executive Secretary a copy of the board certification, the Nuclear Regulatory Commission or Agreement State license, or the permit issued by a licensee of broad scope for each individual no later than 30 days after the date that the licensee permits the individual to work as an authorized user or an authorized nuclear pharmacist pursuant to R313-32-13(2)(a) through (2)(d).

(2) A licensee shall notify the Executive Secretary by letter no later than 30 days after:

(a) an authorized user, an authorized nuclear pharmacist, Radiation Safety Officer, or teletherapy physicist permanently discontinues performance of duties under the license or has a name change; or

(b) the licensee's mailing address changes.

(3) The licensee shall mail the documents required in R313-32-14 to the address identified in R313-12-110.

 

R313-32-15. Exemptions Regarding Type A Specific Licenses of Broad Scope.

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

(1) The provisions of R313-32-13(2);

(2) The provisions of R313-32-13(5) regarding additions to or changes in the areas of use only at the addresses specified in the license;

(3) The provisions of R313-32-14(1); and

(4) The provisions of R313-32-14(2)(a) for an authorized user or an authorized nuclear pharmacist.

 

R313-32-18. License Issuance.

The Executive Secretary shall issue a license for the medical use of radioactive material for a term of five years provided the following requirements are met:

(1) The applicant has filed form DRC-02 "Application for Materials License - Medical" in accordance with the instructions in R313-22-32.

(2) The applicant has paid any applicable fee as provided in R313-70.

(3) The Executive Secretary finds the applicant equipped and committed to observe the safety standards established in R313-15 for the protection of the public health and safety.

(4) In addition to the requirements set forth in R313-22-33 a specific license for human use of radioactive material in institutions will be issued if:

(a) the applicant has appointed a radiation safety committee to coordinate the use of radioactive material throughout that institution and to maintain surveillance over the institution's radiation safety program; and

(b) if the application is for a license to use unspecified quantities or multiple types of radioactive material, the applicant's staff has training and experience in the use of a variety or radioactive materials for a variety of human uses, and meets the training and experience requirements of R313-32.

(5) A specific license for the human use of radioactive material will be issued to an individual physician if the following are complied with:

(a) The applicant has access to a hospital possessing adequate facilities to hospitalize and monitor the applicant's radioactive patients whenever it is advisable.

(b) The applicant has training and experience as required by R313-32, in the handling and administration of radioactive material and, where applicable, the clinical management of radioactive patients.

(c) The application is for use in the applicant's practice in an office outside a medical institution.

(d) The Executive Secretary shall not approve an application by an individual physician or group of physicians for a specific license to receive, possess or use radioactive material on the premises of a medical institution unless:

(i) the use of radioactive material is limited to:

(A) the administration of radiopharmaceuticals for diagnostic or therapeutic purposes;

(B) the performance of diagnostic studies on patients to whom a radiopharmaceutical has been administered;

(C) the performance of in vitro diagnostic studies;

(D) the calibration and quality control checks of radioactive assay instrumentation, radiation safety instrumentation and diagnostic instrumentation;

(ii) the physician brings the radioactive material with him and removes the radioactive material when he departs. The institution cannot receive, possess or store radioactive material other than the amount of material remaining in the patient; or

(iii) the medical institution does not hold a radioactive material license issued pursuant to the provisions of R313-32-18(4).

 

R313-32-19. Specific Exemptions.

The Board may, upon application of any interested person or upon its own initiative, grant exemptions from the rules in R313-32 as it determines are authorized by law and will not endanger life or property or the common defense and security and are otherwise in the public interest. The Board will review requests for exemptions from training and experience requirements with the assistance of the Executive Secretary.

 

R313-32-20. ALARA Program.

(1) The licensee shall develop and implement a written radiation protection program that includes provisions for keeping doses ALARA.

(2) To satisfy the requirement of R313-32-20(1) one of the following shall be implemented:

(a) At a medical institution, management, the Radiation Safety Officer, and authorized users shall participate in the program as requested by the Radiation Safety Committee.

(b) For licensees that are not medical institutions, management and authorized users shall participate in the program as requested by the Radiation Safety Officer.

(3) The program shall include notice to workers of the program's existence and workers' responsibility to help keep dose equivalents ALARA, a review of summaries of the types and amounts of radioactive material used, occupational doses, changes in radiation safety procedures and safety measures, and continuing education and training for personnel who work with or in the vicinity of radioactive material. The purpose of the review is to ensure that licensees make a reasonable effort to maintain individual and collective occupational doses ALARA.

 

R313-32-21. Radiation Safety Officer.

(1) A licensee shall appoint a Radiation Safety Officer responsible for implementing the radiation safety program. The licensee, through the Radiation Safety Officer, shall ensure that radiation safety activities are being performed in accordance with approved procedures and regulatory requirements in the daily operation of the licensee's radioactive material program.

(2) The Radiation Safety Officer shall:

(a) investigate overexposures, accidents, spills, losses, thefts, unauthorized receipts, uses, transfers, disposals, misadministrations, and other deviations from approved radiation safety practices and implement corrective actions as necessary;

(b) establish, collect in one binder or file, and implement written policy and procedures for:

(i) authorizing the purchase of radioactive material;

(ii) receiving and opening packages of radioactive material;

(iii) storing radioactive material;

(iv) keeping an inventory record of radioactive material;

(v) using radioactive material safely;

(vi) taking emergency action if control of radioactive material is lost;

(vii) performing periodic radiation surveys;

(viii) performing checks of survey instruments and other safety equipment;

(ix) disposing of radioactive material;

(x) training personnel who work in or frequent areas where radioactive material is used or stored;

(xi) keeping a copy of all records and reports required by the Utah Radiation Control Rules, a copy of these rules, a copy of each licensing request, license and amendment, and written policy and procedures required by the rules;

(c) brief management once a year on the radioactive material program;

(d) establish personnel exposure investigational levels that, when exceeded, will initiate an investigation by the Radiation Safety Officer of the cause of the exposure;

(e) establish personnel exposure investigational levels that, when exceeded, will initiate a prompt investigation by the Radiation Safety Officer of the cause of the exposure and a consideration of actions that might be taken to reduce the probability of recurrence;

(f) for medical use not at a medical institution, approve or disapprove radiation safety program changes with the advice and consent of management; and

(g) for medical use at a medical institution, assist the Radiation Safety Committee in the performance of its duties.

 

R313-32-22. Radiation Safety Committee.

The medical institution licensee shall establish a Radiation Safety Committee to oversee the use of radioactive material.

(1) The Committee shall meet the following administrative requirements:

(a) Membership shall consist of at least three individuals and shall 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. Other members may be included as the licensee deems appropriate.

(b) The Committee shall meet at least quarterly.

(c) To establish a quorum and to conduct business, at least one-half of the Committee's membership shall be present, including the Radiation Safety Officer and the management's representative.

(d) The minutes of each Radiation Safety Committee meeting shall include:

(i) the date of the meeting;

(ii) members present;

(iii) members absent;

(iv) summary of deliberations and discussions;

(v) recommended actions and the numerical results of all ballots; and

(vi) ALARA program reviews described in R313-32-20.

(e) The Committee shall promptly provide the members with copies of the meeting minutes, and retain one copy for the duration of the license.

(2) To oversee the use of licensed material, the Committee shall:

(a) review recommendations on ways to maintain individual and collective doses ALARA;

(b)(i) review, on the basis of safety and with regard to the training and experience standards in R313-32-900 through R313-32-981, and approve or disapprove any individual who is to be listed as an authorized user, an authorized nuclear pharmacist, the Radiation Safety Officer, or a Teletherapy Physicist before submitting a license application or request for amendment or renewal; or

(ii) review, pursuant to R313-32-13(2)(a) through (2)(d), on the basis of the board certification, the license, or the permit identifying an individual, and approve or disapprove any individual prior to allowing that individual to work as an authorized user or authorized nuclear pharmacist;

(c) review on the basis of safety, and approve with the advice and consent of the Radiation Safety Officer and the management representative, or disapprove minor changes in radiation safety procedures that are not potentially important to safety and are permitted under R313-32-31;

(d) review quarterly, with the assistance of the Radiation Safety Officer, a summary of the occupational radiation dose records of personnel working with radioactive material;

(e) review quarterly, with the assistance of the Radiation Safety Officer, incidents involving radioactive material with respect to cause and subsequent actions taken; and

(f) review annually, with the assistance of the Radiation Safety Officer, the radiation safety program.

 

R313-32-23. Statements of Authority and Responsibilities.

(1) A licensee shall provide the Radiation Safety Officer, and at a medical institution the Radiation Safety Committee, sufficient authority, organizational freedom, and management prerogative, to:

(a) identify radiation safety problems;

(b) initiate, recommend, or provide corrective actions; and

(c) verify implementation of corrective actions.

(2) A licensee shall establish and state in writing the authorities, duties, responsibilities, and radiation safety activities of the Radiation Safety Officer, and at a medical institution the Radiation Safety Committee, and retain the current edition of these statements as a record until the Executive Secretary terminates the license.

 

R313-32-25. 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 R313-32-11(2) shall:

(a) instruct the supervised individual in the principles of radiation safety appropriate to that individual's use of radioactive material and in the licensee's written quality management program;

(b) require the supervised individual to follow the instructions of the supervising authorized user, follow the written radiation safety and quality management procedures established by the licensee, and comply with the Utah Radiation Control Rules and the license conditions with respect to the use of radioactive material; and

(c) periodically review the supervised individual's use of radioactive material and the records kept to reflect this use.

(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 R313-32-11(3), shall:

(a) instruct the supervised individual in the preparation of radioactive material for medical use and the principles of and procedures for radiation safety and in the licensee's written quality management program, as appropriate to that individual's use of radioactive material;

(b) require the supervised individual to follow the instructions given pursuant to R313-32-25(2)(a) and to comply with these rules and license conditions; and

(c) require the supervising authorized nuclear pharmacist or physician who is an authorized user to periodically review the work of the supervised individual as it pertains to preparing radioactive material for medical use and the records kept to reflect that work.

(3) A licensee that supervises an individual is responsible for the acts and omissions of the supervised individual.

 

R313-32-29. Administrative Requirements that Apply to the Providers of Mobile Nuclear Medicine Service.

(1) The Executive Secretary will license mobile nuclear medicine service only in accordance with R313-32-100, R313-32-200, and R313-32-500.

(2) Mobile nuclear medicine service licensees shall obtain a letter signed by the management of each client for which services are rendered that authorizes use of radioactive material at the client's address of use. The mobile nuclear medicine service licensee shall retain the letter for three years after the last provision of service.

(3) If a mobile nuclear medicine service provides services that the client is also authorized to provide, the client is responsible for assuring that services are conducted in accordance with the rules while the mobile nuclear medicine service is under the client's direction.

(4) A mobile nuclear medicine service shall not order radioactive material to be delivered directly from the manufacturer or distributor to the client's address of use.

 

R313-32-31. Radiation Safety Program Changes.

(1) A licensee may make minor changes in radiation safety procedures that are not potentially important to safety, i.e., ministerial changes, that were described in the application for license, renewal, or amendment except for those changes in R313-32-13 and R313-32-606. A licensee is responsible for assuring that any change made is in compliance with the requirements of the rules and the license.

(2) A licensee shall retain a record of each change until the license has been renewed or terminated. The record shall include the effective date of the change, a copy of the old and new radiation safety procedures, the reason for the change, a summary of radiation safety matters that were considered before making the change, the signature of the Radiation Safety Officer, and the signatures of the affected authorized users and of management or, in a medical institution, the Radiation Safety Committee's chairman and the management representative.

 

R313-32-32. Quality Management Program.

(1) The applicant or licensee shall establish and maintain a written quality management program to provide high confidence that radioactive material or radiation from radioactive material will be administered as directed by the authorized user. The quality management program shall include written policies and procedures to meet the following specific objectives:

(a) that, prior to administration, a written directive is prepared for:

(i) teletherapy radiation doses;

(ii) gamma stereotactic radiosurgery radiation doses;

(iii) brachytherapy radiation doses;

(iv) administration of quantities greater than 1.11 MBq (30 uCi) of either sodium iodide I-125 or I-131;

(v) therapeutic administration of a radiopharmaceutical, other than sodium iodide I-125 or I-131;

(b) that the following are exceptions to the written directive:

(i) if, because of the patient's condition, a delay in order to provide a written revision to an existing written directive would jeopardize the patient's health, an oral revision to an existing written directive will be acceptable, provided that the oral revision is documented immediately in the patient's record and a revised written directive is signed by the authorized user within 48 hours of the oral revision;

(ii) also, a written revision to an existing written directive may be made for a diagnostic or therapeutic procedure provided that the revision is dated and signed by an authorized user prior to the administration of the radiopharmaceutical dosage, the brachytherapy dose, the gamma stereotactic radiosurgery dose, the teletherapy dose, or the next teletherapy fractional dose; or

(iii) if, because of the emergent nature of the patient's condition, a delay in order to provide a written directive would jeopardize the patient's health, an oral directive will be acceptable, provided that the information contained in the oral directive is documented immediately in the patient's record and a written directive is prepared within 24 hours of the oral directive;

(c) that, prior to each administration, the patient's or human research subject's identity is verified by more than one method as the individual named in the written directive;

(d) that final plans of treatment and related calculations for brachytherapy, teletherapy, and gamma stereotactic radiosurgery are in accordance with the respective written directives;

(e) that each administration is in accordance with the written directive; and

(f) that each unintended deviation from the written directive is identified and evaluated, and appropriate action is taken.

(2) The licensee shall:

(a) develop procedures for and conduct a review of the quality management program including, since the last review, an evaluation of:

(i) a representative sample of patient and human research subject administrations,

(ii) all recordable events, and

(iii) all misadministrations to verify compliance with each aspect of the quality management program; these reviews shall be conducted at intervals no greater than 12 months;

(b) evaluate these reviews to determine the effectiveness of the quality management program and, if required, make modifications to meet the objectives of R313-32-32(1); and

(c) retain records of the review, including the evaluations and findings of the review, in an auditable form for three years.

(3) The licensee shall evaluate and respond, within 30 days after discovery of the recordable event, to each recordable event by:

(a) assembling the relevant facts including the cause;

(b) identifying what, if applicable, corrective action is required to prevent recurrence; and

(c) retaining a record, in an auditable form, for three years, of the relevant facts and what corrective action, if applicable, was taken.

(4) The licensee shall retain:

(a) a written directive; and

(b) a record of each administered radiation dose or radiopharmaceutical dosage where a written directive is required in R313-32-32(1)(a), in an auditable form, for three years after the date of administration.

(5) The licensee may make modifications to the quality management program to increase the program's efficiency provided the program's effectiveness is not decreased. The licensee shall furnish the modification to the Executive Secretary within 30 days after the modification has been made.

(6)(a) Applicants for a new license, as applicable, shall submit to the Executive Secretary in accordance with R313-12-110 a quality management program as part of the application for a license and implement the program upon issuance of the license by the Executive Secretary.

(b) Existing licensees, as applicable, shall submit to the Executive Secretary in accordance with R313-12-110, prior to March 1, 1995, a written certification that the quality management program has been implemented along with a copy of the program.

 

R313-32-33. Notifications, Reports and Records of Misadministrations.

(1) For a misadministration:

(a) the licensee shall notify the Executive Secretary by telephone no later than the next calendar day after discovery of the misadministration.

(b) the licensee shall submit a written report to the Executive Secretary within 15 days after discovery of the misadministration. The written report shall include the licensee's name; the prescribing physician's name; a brief description of the event; why the event occurred; the effect on the individual who received the misadministration; what improvements are needed to prevent recurrence; actions taken to prevent recurrence; whether the licensee notified the individual (or the individual's responsible relative or guardian), and if not, why not; and if there was notification, what information was provided. The report must not include the individual's name or any other information that could lead to identification of the individual. To meet the requirements of R313-32-33, the notification of the individual receiving the misadministration may be made instead to that individual's responsible relative or guardian, when appropriate.

(c) the licensee shall notify the referring physician and also notify the individual receiving the misadministration of the misadministration no later than 24 hours after its discovery, unless the referring physician personally informs the licensee either that he will inform the individual or that, based on medical judgment, telling the individual would be harmful. The licensee is not required to notify the individual without first consulting the referring physician. If the referring physician or the individual receiving the misadministration cannot be reached within 24 hours, the licensee shall notify the individual as soon as possible thereafter. The licensee may not delay any appropriate medical care for the individual, including any necessary remedial care as a result of the misadministration, because of any delay in notification.

(d) if the individual was notified, the licensee shall also furnish, within 15 days after discovery of the misadministration, a written report to the individual by sending either:

(i) a copy of the report that was submitted to the Executive Secretary; or

(ii) a brief description of both the event and the consequences as they may affect the individual, provided a statement is included that the report submitted to the Executive Secretary can be obtained from the licensee.

(2) The licensee shall retain a record of each misadministration for five years. The record shall contain the names of all individuals involved (including the prescribing physician, allied health personnel, the individual who received the misadministration, and that individual's referring physician, if applicable), the individual's social security number or other identification number if one has been assigned, a brief description of the misadministration, why it occurred, the effect on the individual, improvements needed to prevent recurrence, and the actions taken to prevent recurrence.

(3) Aside from the notification requirement, nothing in R313-32-33 affects any rights or duties of licensees and physicians in relation to each other, to individuals receiving misadministrations, or to that individual's responsible relative or guardian.

 

R313-32-49. Suppliers for Sealed Sources or Devices for Medical Use.

A licensee may use for medical use only:

(1) Sealed sources or devices manufactured, labeled, packaged, and distributed in accordance with a license issued pursuant to the rules in R313-22 and R313-22-75(10) or the equivalent requirements of the Nuclear Regulatory Commission or an Agreement State; or

(2) Teletherapy sources manufactured and distributed in accordance with a license issued pursuant to R313-22 or the equivalent requirements of the Nuclear Regulatory Commission or an Agreement State.

 

R313-32-50. Possession, Use, Calibration, and Check of Dose Calibrators.

(1) A licensee shall possess and use a dose calibrator to measure the activity of dosages of photon-emitting radionuclides prior to administration to each patient or human research subject.

(2) A licensee shall:

(a) check each dose calibrator for constancy with a dedicated check source at the beginning of each day of use. To satisfy this requirement, the check shall be done on a frequently used setting with a sealed source of not less than 370 kBq (ten uCi) of radium-226 or 1.85 MBq (50 uCi) for a photon-emitting radionuclide;

(b) test each dose calibrator for accuracy upon installation and at least annually thereafter by assaying at least two sealed sources containing different radionuclides whose activity the manufacturer has determined within five percent of its stated activity, whose activity is at least 370 kBq (ten uCi) for radium-226 and 1.85 MBq (50 uCi) for a photon-emitting radionuclide, and at least one of which has a principal photon energy between 100 keV and 500 keV;

(c) test each dose calibrator for linearity upon installation and at least quarterly thereafter over a range from the highest dosage that will be administered to a patient or human research subject to 1.1 MBq (30 uCi); and

(d) test each dose calibrator for geometry dependence upon installation over the range of volumes and volume configurations for which it will be used. The licensee shall keep a record of this test for the duration of the use of the dose calibrator.

(3) A licensee shall also perform appropriate checks and tests required by R313-32-50 following adjustment or repair of the dose calibrator.

(4) A licensee shall mathematically correct dosage readings for geometry or linearity errors that exceed ten percent if the dosage is greater than 370 kBq (ten uCi) and shall repair or replace the dose calibrator if the accuracy or constancy error exceeds ten percent.

(5) A licensee shall retain a record of each check and test required by R313-32-50 for three years unless directed otherwise. The records required in R313-32-50(2)(a) through (2)(d) shall include:

(a) for R313-32-50(2)(a), the model and serial number of the dose calibrator, the identity of the radionuclide contained in the check source, the date of the check, the activity measured, and the initials of the individual who performed the check;

(b) for R313-32-50(2)(b), the model and serial number of the dose calibrator, the model and serial number of each source used, the identity of the radionuclide contained in the source and its activity, the date of the test, the results of the test, and the identity of the individual performing the test;

(c) for R313-32-50(2)(c), the model and serial number of the dose calibrator, the calculated activities, the measured activities, the date of the test, and the identity of the individual performing the test; and

(d) for R313-32-50(2)(d), the model and serial number of the dose calibrator, the configuration of the source measured, the activity measured for each volume measured, the date of the test, and the identity of the individual performing the test.

 

R313-32-51. Calibration and Check of Survey Instruments.

(1) A licensee shall calibrate the survey instruments used to show compliance with R313-32 before first use, annually, and following repair. The licensee shall:

(a) calibrate all scales with readings up to ten mSv (1000 mrem) per hour with a radiation source;

(b) calibrate two separated readings on each scale that shall be calibrated. The readings shall be separated by 50 percent of the scale reading; and

(c) conspicuously note on the instrument the apparent exposure rate from a dedicated check source as determined at the time of calibration, and the date of calibration.

(2) When calibrating a survey instrument, the licensee shall consider a point as calibrated if the indicated exposure rate differs from the calculated exposure rate by not more than 20 percent, and shall conspicuously attach a correction chart or graph to the instrument.

(3) A licensee shall check each survey instrument for proper operation with the dedicated check source each day of use. A licensee is not required to keep records of these checks.

(4) A licensee shall retain a record of each survey instrument calibration for three years. The record shall include:

(a) a description of the calibration procedure; and

(b) the date of the calibration, a description of the source used and the certified exposure rates from the source, and the rates indicated by the instrument being calibrated, the correction factors deduced from the calibration data, and the signature of the individual who performed the calibration.

 

R313-32-52. Possession, Use, Calibration, and Check of Instruments to Measure Dosages or Alpha- or Beta-emitting Radionuclides.

(1) R313-32-52 does not apply to unit dosages of alpha- or beta-emitting radionuclides that are obtained from a manufacturer or preparer licensed pursuant to R313-22-75(9) or equivalent requirements of the Nuclear Regulatory Commission or an Agreement State.

(2) For other than unit dosages obtained pursuant to R313-32-52(1), a licensee shall possess and use instrumentation to measure the radioactivity of alpha- or beta-emitting radionuclides. The licensee shall have procedures for use of the instrumentation. The licensee shall measure, by direct measurement or by combination of measurements and calculations, the amount of radioactivity in dosages of alpha- or beta-emitting radionuclides prior to administration to each patient or human research subject. In addition, the licensee shall:

(a) perform tests before initial use, periodically, and following repair, on each instrument for accuracy, linearity, and geometry dependence, as appropriate for the use of the instrument; and make adjustments when necessary; and

(b) check each instrument for constancy and proper operation at the beginning of each day of use.

 

R313-32-53. Measurement of Dosages of Unsealed Radioactive Material for Medical Use.

A licensee shall:

(1) measure the activity of each dosage of a photon-emitting radionuclide prior to medical use;

(2) measure, by direct measurement or by combination of measurements and calculations, the activity of each dosage of an alpha- or beta-emitting radionuclide prior to medical use, except for unit dosages obtained from a manufacturer or preparer licensed pursuant to R313-22-75(9) or equivalent requirements of the Nuclear Regulatory Commission or an Agreement State; and

(3) retain a record of the measurements required by R313-32-53 for three years. To satisfy this requirement, the record shall contain the following:

(a) generic name, trade name, or abbreviation of the radiopharmaceutical, its lot number, and expiration dates and the radionuclide;

(b) patient's or human research subject's name, and identification number if one has been assigned;

(c) prescribed dosage and activity of the dosage at the time of measurement, or a notation that the total activity is less than 1.1 MBq (30 uCi);

(d) date and time of the measurement; and

(e) initials of the individual who made the record.

 

R313-32-57. Authorization for Calibration and Reference Sources.

Persons authorized by R313-32-11 for medical use of radioactive material may receive, possess, and use the following radioactive material for check, calibration, and reference use:

(1) sealed sources manufactured and distributed by a person licensed pursuant to R313-22-75(10) or equivalent Nuclear Regulatory Commission or Agreement State regulations and that do not exceed 555 MBq (15 mCi) each;

(2) radioactive material listed in R313-32-100 or R313-32-200 with a half-life not longer than 100 days in individual amounts not to exceed 555 MBq (15 mCi);

(3) radioactive material listed in R313-32-100 or R313-32-200 with a half-life longer than 100 days in individual amounts not to exceed 7.4 MBq (200 uCi); and

(4) technetium-99m in individual amounts not to exceed 1.85 GBq (50 mCi).

 

R313-32-59. Requirements for Possession of Sealed Sources and Brachytherapy Sources.

(1) A licensee in possession of sealed sources or brachytherapy sources shall follow the radiation safety and handling instructions supplied by the manufacturer, and shall maintain the instructions for the duration of source use in a legible form convenient to users.

(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 six months before transfer to the licensee; and

(b) test the source for leakage at intervals not to exceed six months or at other intervals approved by the Executive Secretary, the Nuclear Regulatory Commission or an Agreement State and described in the label or brochure that accompanies the source.

(3) To satisfy the leak test requirements of R313-32-59, the licensee must:

(a) take a wipe sample from the sealed source or from the surfaces of the device in which the sealed source is mounted or stored on which radioactive contamination might be expected to accumulate or wash the source in a small volume of detergent solution and treat the entire volume as the sample;

(b) take teletherapy and other device source test samples when the source is in the "off" position; and

(c) measure the sample so that the leakage test can detect the presence of 185 Bq (0.005 uCi) of radioactive material on the sample.

(4) A licensee shall retain leakage test records for five years. The records shall contain the model number, the serial number if assigned, of each source tested, the identity of each source radionuclide and its estimated activity, the measured activity of each test sample expressed in becquerels or microcuries, a description of the method used to measure each test sample, the date of the test, and the signature of the Radiation Safety Officer.

(5) If the leakage test reveals the presence of 185 Bq (0.005 uCi) or more of removable contamination, the licensee shall:

(a) immediately withdraw the sealed source from use and store it in accordance with the requirements in R313-15; and

(b) file a report within five days of the leakage test with the Executive Secretary describing the equipment involved, the test results, and the action taken.

(6) A licensee need not perform a leakage 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 uCi) or less of beta or gamma-emitting material or 370 kBq (ten uCi) or less of alpha-emitting material;

(d) sources stored and not being used. The licensee shall, however, test each source for leakage before use or transfer unless it has been leakage-tested within six months before the date of use or transfer; and

(e) seeds of iridium-192 encased in nylon ribbon.

(7) A licensee in possession of a sealed source or brachytherapy source shall conduct a quarterly physical inventory of all sources in its possession. The licensee shall retain inventory records for five years. The inventory records shall contain the model number of each source, and serial number if one has been assigned, the identity of each source radionuclide and its nominal activity, the location of each source, and the signature of the Radiation Safety Officer.

(8) A licensee in possession of a sealed source or brachytherapy source shall measure the ambient dose rates quarterly in all areas where sources are stored. This does not apply to teletherapy sources in teletherapy units or sealed sources in diagnostic devices.

(9) A licensee shall retain a record of each survey required in R313-32-59(8) for three years. The record shall include the date of the survey, a plan of each area that was surveyed, the measured dose rate at several points in each area expressed in microsieverts or millirem per hour, the survey instrument used, and the signature of the Radiation Safety Officer.

 

R313-32-60. Syringe Shields and Labels.

(1) A licensee shall keep syringes that contain radioactive material to be administered in a radiation shield.

(2) To identify its contents, a licensee shall conspicuously label each syringe or syringe radiation shield that contains a syringe with a radiopharmaceutical. The label shall show the radiopharmaceutical name or its abbreviation, the clinical procedure to be performed, or the patient's or the human research subject's name.

(3) A licensee shall require each individual who prepares a radiopharmaceutical kit to use a syringe radiation shield when preparing the kit and shall require each individual to use a syringe radiation shield when administering a radiopharmaceutical by injection unless the use of the shield is contraindicated for that patient or human research subject.

 

R313-32-61. Vial Shields and Labels.

(1) A licensee shall require each individual preparing or handling a vial that contains a radiopharmaceutical to keep the vial in a vial radiation shield.

(2) To identify its contents, a licensee shall conspicuously label each vial radiation shield that contains a vial of a radiopharmaceutical. The label shall show the radiopharmaceutical name or its abbreviation.

 

R313-32-70. Surveys for Contamination and Ambient Radiation Exposure Rate.

(1) A licensee shall survey with a radiation detection survey instrument at the end of each day of use all areas where radiopharmaceuticals are routinely prepared for use or administered.

(2) A licensee shall survey with a radiation detection survey instrument at least once each week all areas where radiopharmaceuticals or radiopharmaceutical waste is stored.

(3) A licensee shall conduct the surveys required by R313-32-70(1) and (2) so as to be able to detect dose rates as low as one uSv (0.1 mrem) per hour.

(4) A licensee shall establish radiation dose rate trigger levels for the surveys required by R313-32-70(1) and (2). A licensee shall require that the individual performing the survey immediately notify the Radiation Safety Officer if a dose rate exceeds a trigger level.

(5) A licensee shall survey for removable contamination once each week all areas where radiopharmaceuticals are routinely prepared for use, administered, or stored.

(6) A licensee shall conduct the survey required by R313-32-70(5) so as to be able to detect contamination on each wipe sample of 2200 disintegrations per minute, (0.001 uCi or 37 Bq).

(7) A licensee shall establish removable contamination trigger levels for the surveys required by R313-32-70(5). A licensee shall require that the individual performing the survey immediately notify the Radiation Safety Officer if contamination exceeds the trigger level.

(8) A licensee shall retain a record of each survey for three years. The record shall include the date of the survey, a plan of each area surveyed, the trigger level established for each area, the detected dose rate at several points in each area expressed in microsieverts or millirem per hour or the removable contamination in each area expressed in disintegrations per minute (becquerels or curies) per 100 square centimeters, the instrument used to make the survey or analyze the samples, and the initials of the individual who performed the survey.

 

R313-32-75. Release of Individuals Containing Radiopharmaceuticals or Permanent Implants.

(1) The licensee may authorize the release from its control of any individual who has been administered radiopharmaceuticals or permanent implants containing radioactive material if the total effective dose equivalent to any other individual from exposure to the released individual is not likely to exceed 5 mSv (0.5 rem).

NOTE: The Nuclear Regulatory Commission Regulatory Guide 8.39, "Release of Patients Administered Radioactive Materials," describes methods for calculating doses to other individuals and contains tables of activities not likely to cause doses exceeding 5 mSv (0.5 rem).

(2) The licensee shall provide the released individual 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 dose to a breast-feeding infant or child could exceed 1 mSv (0.1 rem) assuming there were no interruption of breast-feeding, the instructions shall also include:

(a) guidance on the interruption or discontinuation of breast-feeding, and

(b) information on the consequences of failure to follow the guidance.

(3) The licensee shall maintain a record of the basis for authorizing the release of an individual, for three years after the date of release, if the total effective dose equivalent is calculated by:

(a) using the retained activity rather than the activity administered,

(b) using an occupancy factor less than 0.25 at 1 meter,

(c) using the biological or effective half-life, or

(d) considering the shielding by tissue.

(4) The licensee shall maintain a record, for three years after the date of release, that instructions were provided to a breast-feeding woman if the radiation dose to the infant or child from continued breast-feeding could result in a total effective dose equivalent exceeding 5 mSv (0.5 rem).

 

R313-32-80. Technical Requirements that Apply to the Providers of Mobile Nuclear Medicine Service.

A licensee providing mobile nuclear medicine service shall:

(1) transport to each address of use only syringes or vials containing prepared radiopharmaceuticals or radiopharmaceuticals that are intended for reconstitution of radiopharmaceutical kits;

(2) bring into each address of use all radioactive material to be used and, before leaving, remove all unused radioactive material and all associated waste;

(3) secure or keep under constant surveillance and immediate control all radioactive material when in transit or at an address of use;

(4) check survey instruments and dose calibrators as described in R313-32-50 and R313-32-51 and check all other transported equipment for proper function before medical use at each address of use;

(5) carry a radiation detection survey meter in each vehicle that is being used to transport radioactive material, and, before leaving a client address of use, survey all radiopharmaceutical areas of use with a radiation detection survey meter to ensure that all radiopharmaceuticals and all associated waste have been removed; and

(6) retain a record of each survey required in R313-32-80(5) for three years. The record shall include the date of the survey, a plan of each area that was surveyed, the measured dose rate at several points in each area of use expressed in microsieverts or millirems per hour, the instrument used to make the survey, and the initials of the individual who performed the survey.

 

R313-32-90. Storage of Volatiles and Gases.

A licensee shall store volatile radiopharmaceuticals and radioactive gases in the shipper's radiation shield and container. A licensee shall store a multi-dose container in a fume hood after drawing the first dosage from it.

 

R313-32-92. Decay-In-Storage.

(1) A licensee may hold radioactive material with a physical half-life of less than 65 days for decay-in-storage before disposal in ordinary trash and is exempt from the requirements of R313-15-1001 if it:

(a) holds radioactive material for decay a minimum of ten half-lives;

(b) monitors radioactive material at the container surface before disposal as ordinary trash and determines that its radioactivity cannot be distinguished from the background radiation level with a radiation detection survey meter set on its most sensitive scale and with no interposed shielding;

(c) removes or obliterates all radiation labels; and

(d) separates and monitors each generator column individually with radiation shielding removed to ensure that it has decayed to background radiation level before disposal.

(2) A licensee shall retain a record of each disposal permitted under R313-32-92(1) for three years. The record shall include the date of the disposal, the date on which the radioactive material was placed in storage, the radionuclides disposed, the survey instrument used, the background dose rate, the dose rate measured at the surface of each waste container, and the name of the individual who performed the disposal.

 

R313-32-100. Use of Unsealed Radioactive Material for Uptake, Dilution, and Excretion Studies.

A licensee may use for uptake, dilution, or excretion studies any unsealed radioactive material prepared for medical use that is either:

(1) obtained from a manufacturer or preparer licensed pursuant to R313-22-75(9) or equivalent requirements of the Nuclear Regulatory Commission or an Agreement State; or

(2) prepared by an authorized nuclear pharmacist, a physician who is an authorized user and who meets the requirements specified in R313-32-920, or an individual under the supervision of either as specified in R313-32-25.

 

R313-32-120. Possession of Survey Instrument.

A licensee authorized to use radioactive material for uptake, dilution, and excretion studies shall have in its possession a portable radiation detection survey instrument capable of detecting dose rates over the range one uSv (0.1 mrem) per hour to one mSv (100 mrem) per hour.

 

R313-32-200. Use of Unsealed Radioactive Material for Imaging and Localization Studies.

A licensee may use for imaging and localization studies any unsealed radioactive material prepared for medical use that is either:

(1) obtained from a manufacturer or preparer licensed pursuant to R313-22-75(9) or equivalent requirements of the Nuclear Regulatory Commission or an Agreement State; or

(2) prepared by an authorized nuclear pharmacist, a physician who is an authorized user and who meets the requirements specified in R313-32-920, or an individual under the supervision of either as specified in R313-32-25.

 

R313-32-204. Permissible Molybdenum-99 Concentration.

(1) A licensee shall not administer to humans a radiopharmaceutical containing more than 5.55 kBq (0.15 uCi) of molybdenum-99 per 37.0 MBq (one mCi) of technetium-99m.

(2) A licensee that uses molybdenum-99/technetium-99m generators for preparing a technetium-99m radiopharmaceutical shall measure the molybdenum-99 concentration in each elute or extract.

(3) A licensee that is required to measure molybdenum concentration shall retain a record of each measurement for three years. The record shall include, for each elution or extraction of technetium-99m, the measured activity of the technetium expressed in megabecquerels or millicuries, the measured activity of the molybdenum expressed in kilobecquerels or microcuries, the ratio of the measures expressed as kilobecquerels or microcuries of molybdenum per megabecquerels or millicuries of technetium, the time and date of the measurement, and the initials of the individual who made the measurement.

 

R313-32-205. Control of Aerosols and Gases.

(1) A licensee that administers radioactive aerosols or gases shall do so in a room with a system that will keep airborne concentrations within the limits prescribed in R313-15-201(4) and R313-15-301. The system shall either be directly vented to the atmosphere through an air exhaust or provide for collection and decay or disposal of the aerosol or gas in a shielded container.

(2) A licensee shall administer radioactive gases in rooms that are at negative pressure compared to surrounding rooms.

(3) Before receiving, using, or storing a radioactive gas, the licensee shall calculate the amount of time needed after a spill to reduce the concentration in the room to the occupational limit as specified in R313-15-201. The calculation shall be based on the highest activity of gas handled in a single container, the air volume of the room, and the measured available air exhaust rate.

(4) A licensee shall make a record of the calculations required in R313-32-205(3) that includes the assumptions, measurements, and calculations made and shall retain the record for the duration of use of the area. A licensee shall also post the calculated time and safety measures to be instituted in case of a spill at the area of use.

(5) A licensee shall check the operation of reusable collection systems each month, and measure the ventilation rates available in areas of radioactive gas use each six months. Records of the measurement shall be kept for three years.

 

R313-32-220. Possession of Survey Instruments.

A licensee authorized to use radioactive material for imaging and localization studies shall have in its possession a portable radiation detection survey instrument capable of detecting dose rates over the range of one uSv (0.1 mrem) per hour to one mSv (100 mrem) per hour, and a portable radiation measurement survey instrument capable of measuring dose rates over the range ten uSv (one mrem) per hour to ten mSv (1000 mrem) per hour.

 

R313-32-300. Use of Unsealed Radioactive Material for Therapeutic Administration.

A licensee may use for therapeutic administration any unsealed radioactive material prepared for medical use that is either:

(1) obtained from a manufacturer or preparer licensed pursuant to R313-22-75(9) or equivalent requirements of the Nuclear Regulatory Commission or an Agreement State; or

(2) prepared by an authorized nuclear pharmacist, a physician who is an authorized user and who meets the requirements specified in R313-32-920, or an individual under the supervision of either as specified in R313-32-25.

 

R313-32-310. Safety Instruction.

(1) A licensee shall provide radiation safety instruction for all personnel caring for the patient or the human research subject receiving radiopharmaceutical therapy and hospitalized for compliance with R313-32-75. To satisfy this requirement, the instruction shall describe the licensee's procedures for:

(a) patient or human research subject control;

(b) visitor control;

(c) contamination control;

(d) waste control; and

(e) notification of the Radiation Safety Officer in case of the patient's or the human research subjects's death or medical emergency.

(2) A licensee shall keep for three years a list of individuals receiving instruction required by R313-32-310(1), a description of the instruction, the date of instruction, and the name of the individual who gave the instruction.

 

R313-32-315. Safety Precautions.

(1) For each patient or human research subject receiving radiopharmaceutical therapy and hospitalized for compliance with R313-32-75, a licensee shall:

(a) provide a private room with a private sanitary facility;

(b) post the patient's or the human research subject's door with a "Radioactive Materials" sign and note on the door or in the patient's or the human research subject's chart where and how long visitors may stay in the patient's or the human research subject's room;

(c) authorize visits by individuals under age 18 only on a case-by-case basis with the approval of the authorized user after consultation with the Radiation Safety Officer;

(d) promptly after administration of the dosage, measure the dose rates in contiguous restricted and unrestricted areas with a radiation measurement survey instrument to demonstrate compliance with the requirements of R313-15, and retain for three years a record of each survey that includes the time and date of the survey, a plan of the area or list of points surveyed, the measured dose rate at several points expressed in microsieverts or millirem per hour, the instrument used to make the survey, and the initials of the individual who made the survey;

(e) either monitor material and items removed from the patient's or the human research subject's room to determine that their radioactivity cannot be distinguished from the natural background radiation level with a radiation detection survey instrument set on its most sensitive scale and with no interposed shielding, or handle them as radioactive waste;

(f) survey the patient's or the human research subject's room and private sanitary facility for removable contamination with a radiation detection survey instrument before assigning another patient or human research subject to the room. The room shall not be reassigned until removable contamination is less than 200 disintegrations per minute per 100 square centimeters; and

(g) measure the thyroid burden of each individual who helped prepare or administer a dosage of iodine-131 within three days after administering the dosage, and retain for the period required by R313-15-1107 a record of each thyroid burden measurement, its date, the name of the individual whose thyroid burden was measured, and the initials of the individual who made the measurements.

(2) A licensee shall notify the Radiation Safety Officer immediately if the patient or the human research subject dies or has a medical emergency.

 

R313-32-320. Possession of Survey Instruments.

A licensee authorized to use radioactive material for radiopharmaceutical therapy shall have in its possession a portable radiation detection survey instrument capable of detecting dose rates over the range one uSv (0.1 mrem) per hour to one mSv (100 mrem) per hour, and a portable radiation measurement survey instrument capable of measuring dose rates over the range ten uSv (one mrem) per hour to ten mSv (1000 mrem) per hour.

 

R313-32-400. Use of Sources for Brachytherapy.

A licensee shall use the following sources in accordance with the manufacturer's radiation safety and handling instructions:

(1) Cesium-137 as a sealed source in needles and applicator cells for topical, interstitial, and intracavitary treatment of cancer;

(2) Cobalt-60 as a sealed source in needles and applicator cells for topical, interstitial, and intracavitary treatment of cancer;

(3) Gold-198 as a sealed source in seeds for interstitial treatment of cancer;

(4) Iridium-192 as seeds encased in nylon ribbon for interstitial and intracavitary treatment of cancer and as seeds for topical treatment of cancer;

(5) Strontium-90 as a sealed source in an applicator for treatment of superficial eye conditions;

(6) Iodine-125 as a sealed source in seeds for topical, interstitial and intracavitary treatment of cancer;

(7) Palladium-103 as a sealed source in seeds for interstitial treatment of cancer.

 

R313-32-404. Release of Patients or Human Research Subjects Treated With Temporary Implants.

(1) Immediately after removing the last temporary implant source from a patient or a human research subject, the licensee shall make a radiation survey of the patient or the human research subject with a radiation detection survey instrument to confirm that all sources have been removed. The licensee shall not release from confinement for medical care a patient or a human research subject treated by temporary implant until all sources have been removed.

(2) A licensee shall retain a record of patient or human research subject surveys for three years. Each record shall include the date of the survey, the name of the patient or the human research subject, the dose rate from the patient or the human research subject expressed as microsieverts per hour or millirem per hour and measured at one meter from the patient or the human research subject, the survey instrument used, and the initials of the individual who made the survey.

 

R313-32-406. Brachytherapy Sources Inventory.

(1) Promptly after removing them from a patient or a human research subject, a licensee shall return brachytherapy sources to the storage area, and count the number returned to ensure that all sources taken from the storage area have been returned.

(2) A licensee shall make a record of brachytherapy source use which shall include:

(a) the names of the individuals permitted to handle the sources;

(b) the number and activity of sources removed from storage, the patient's or the human research subject's name and room number, the time and date they were removed from storage, the number and activity of the sources in storage after the removal, and the initials of the individual who removed the sources from storage; and

(c) the number and activity of sources returned to storage, the patient's or the human research subject's name and room number, the time and date they were returned to storage, the number and activity of sources in storage after the return, and the initials of the individual who returned the sources to storage.

(3) Immediately after implanting sources in a patient or a human research subject the licensee shall make a radiation survey of the patient or the human research subject and the area of use to confirm that no sources have been misplaced. The licensee shall make a record of each survey.

(4) A licensee shall retain the records required in R313-32-406(2) and (3) for three years.

 

R313-32-410. Safety Instruction.

(1) The licensee shall provide radiation safety instruction to all personnel caring for the patient or the human research subject undergoing implant therapy. To satisfy this requirement, the instruction shall describe:

(a) size and appearance of the brachytherapy sources;

(b) safe handling and shielding instructions in case of a dislodged source;

(c) procedures for patient or human research subject control;

(d) procedures for visitor control; and

(e) procedures for notification of the Radiation Safety Officer if the patient or the human research subject dies or has a medical emergency.

(2) A licensee shall retain for three years a record of individuals receiving instruction required by R313-32-410(1), a description of the instruction, the date of instruction, and the name of the individual who gave the instruction.

 

R313-32-415. Safety Precautions.

(1) For each patient or human research subject receiving implant therapy and not released from licensee control pursuant to R313-32-75, a licensee shall:

(a) not quarter the patient or the human research subject in the same room with an individual who is not receiving radiation therapy;

(b) post the patient's or human research subject's door with a "Radioactive Materials" sign and note on the door or in the patient's or human research subject's chart where and how long visitors may stay in the patient's or human research subject's room;

(c) authorize visits by individuals under age 18 only on a case-by-case basis with the approval of the authorized user after consultation with the Radiation Safety Officer;

(d) promptly after implanting the material, survey the dose rates in contiguous restricted and unrestricted areas with a radiation measurement survey instrument to demonstrate compliance with the requirements of R313-15, and retain for three years a record of each survey that includes the time and date of the survey, a plan of the area or list of points surveyed, the measured dose rate at several points expressed in microsieverts or millirem per hour, the instrument used to make the survey, and the initials of the individual who made the survey; and

(e) provide the patient or the human research subject with radiation safety guidance that will help to keep radiation dose to household members and the public as low as reasonably achievable before releasing the individual if the individual was administered a permanent implant.

(2) A licensee shall notify the Radiation Safety Officer immediately if the patient or the human research subject dies or has a medical emergency.

 

R313-32-420. Possession of Survey Instrument.

A licensee authorized to use radioactive material for implant therapy shall have in its possession a portable radiation detection survey instrument capable of detecting dose rates over the range one uSv (0.1 mrem) per hour to one mSv (100 mrem) per hour, and a portable radiation measurement survey instrument capable of measuring dose rates over the range ten uSv (one mrem) per hour to ten mSv (1000 mrem) per hour.

 

R313-32-500. Use of Sealed Sources for Diagnosis.

A licensee shall use the following sealed sources in accordance with the manufacturer's radiation safety and handling instructions:

(1) iodine-125, americium-241, or gadolinium-153 as a sealed source in a device for bone mineral analysis; and

(2) iodine-125 as a sealed source in a portable imaging device.

 

R313-32-520. Availability of Survey Instrument.

A licensee authorized to use radioactive material as a sealed source for diagnostic purposes shall have available for use a portable radiation detection survey instrument capable of detecting dose rates over the range one uSv (0.1 mrem) per hour to one mSv per hour to (100 mrem) per hour or a portable radiation measurement survey instrument capable of measuring dose rates over the range ten uSv (one mrem) per hour to ten mSv (1000 mrem) per hour. The instrument shall be calibrated in accordance with R313-32-51.

 

R313-32-600. Use of a Sealed Source in a Teletherapy Unit.

The rules and provisions of R313-32-600 through R313-32-647 govern the use of teletherapy units for medical use that contain a sealed source of cobalt-60 or cesium-137.

 

R313-32-605. Maintenance and Repair Restrictions.

Only a person specifically licensed by the Executive Secretary, the Nuclear Regulatory Commission, or an Agreement State to perform teletherapy unit maintenance and repair shall:

(1) install, relocate, or remove a teletherapy sealed source or a teletherapy unit that contains a sealed source; or

(2) maintain, adjust, or repair the source drawer, the shutter or other mechanism of a teletherapy unit that could expose the source, reduce the shielding around the source, or result in increased radiation levels.

 

R313-32-606. License Amendments.

In addition to the changes specified in R313-32-13, a licensee shall apply for and shall receive a license amendment before:

(1) making any change in the treatment room shielding;

(2) making any change in the location of the teletherapy unit within the treatment room;

(3) using the teletherapy unit in a manner that could result in increased radiation levels in areas outside the teletherapy treatment room;

(4) relocating the teletherapy unit; or

(5) allowing an individual not listed on the licensee's license to perform the duties of the teletherapy physicist.

 

R313-32-610. Safety Instruction.

(1) A licensee shall post instructions at the teletherapy unit console. To satisfy this requirement, these instructions shall inform the operator of:

(a) the procedure to be followed to ensure that only the patient or the human research subject is in the treatment room before turning the primary beam of radiation on to begin a treatment or after a door interlock interruption; and

(b) the procedure to be followed if:

(i) the operator is unable to turn the primary beam of radiation off with controls outside the treatment room or any other abnormal operation occurs; and

(ii) the names and telephone numbers of the authorized users and Radiation Safety Officer to be immediately contacted if the teletherapy unit or console operates abnormally.

(2) A licensee shall provide instruction in the topics identified in R313-32-610(1) to individuals who operate a teletherapy unit.

(3) A licensee shall retain for three years a record of individuals receiving instruction required by R313-32-610(2), a description of the instruction, the date of instruction, and the name of the individual who gave the instruction.

 

R313-32-615. Safety Precautions.

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

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

(a) prevent the operator from turning the primary beam of radiation on unless each treatment room entrance door is closed;

(b) turn the primary beam of radiation off immediately when an entrance door is opened; and

(c) prevent the primary beam of radiation from being turned on following an interlock interruption until all treatment room entrance doors are closed and the beam on-off control is reset at the console.

(3) A licensee shall equip each entrance to the teletherapy room with a beam condition indicator light.

(4) A licensee shall install in each teletherapy room a permanent radiation monitor capable of continuously monitoring beam status.

(a) A radiation monitor shall provide visible notice of a teletherapy unit malfunction that results in an exposed or partially exposed source, and shall be observable by an individual entering the teletherapy room.

(b) A radiation monitor shall be equipped with a backup power supply separate from the power supply to the teletherapy unit. This backup power supply may be a battery system.

(c) A radiation monitor shall be checked with a dedicated check source for proper operation each day before the teletherapy unit is used for treatment of patients or human research subjects.

(d) A licensee shall maintain a record of the check required by R313-32-615(4)(c) for three years. The record shall include the date of the check, notation that the monitor indicates when its detector is and is not exposed, and the initials of the individual who performed the check.

(e) If a radiation monitor is inoperable, the licensee shall require individuals entering the teletherapy room to use a survey instrument or audible alarm personal dosimeter to monitor for malfunction of the source exposure mechanism that may result in an exposed or partially exposed source. The instrument or dosimeter shall be checked with a dedicated check source for proper operation at the beginning of each day of use. The licensee shall keep a record as described in R313-32-615(4)(d).

(f) A licensee shall promptly repair or replace the radiation monitor if it is inoperable.

(5) A licensee shall construct or equip each teletherapy room to permit continuous observation of the patient or the human research subject from the teletherapy unit console during irradiation.

 

R313-32-620. Possession of Survey Instrument.

A licensee authorized to use radioactive material in a teletherapy unit shall have in its possession either a portable radiation detection survey instrument capable of detecting dose rates over the range one uSv (0.1 mrem) per hour to one mSv (100 mrem) per hour or a portable radiation measurement survey instrument capable of measuring dose rates over the range ten uSv (one mrem) per hour to ten mSv (1000 mrem) per hour.

 

R313-32-630. Dosimetry Equipment.

(1) A licensee shall have a calibrated dosimetry system available for use. To satisfy this requirement, one of the following two conditions shall be met:

(a) The system shall be calibrated by the National Institute of Standards and Technology or by a calibration laboratory accredited by the American Association of Physicists in Medicine (AAPM). The calibration shall have been performed within the previous two years and after any servicing that may have affected system calibration.

(b) The system shall have been calibrated within the previous four years; eighteen to thirty months after that calibration, the system shall have been intercompared at an intercomparison meeting with another dosimetry system that was calibrated within the past twenty-four months by the National Bureau of Standards or by a calibration laboratory accredited by the AAPM. The intercomparison meeting shall be sanctioned by a calibration laboratory or radiologic physics center accredited by the AAPM. The results of the intercomparison meeting shall have indicated that the calibration factor of the licensee's system had not changed by more than two percent. The licensee shall not use the intercomparison result to change the calibration factor. When intercomparing dosimetry systems to be used for calibrating cobalt-60 teletherapy units, the licensee shall use a teletherapy unit with a cobalt-60 source. When intercomparing dosimetry systems to be used for calibrating cesium-137 teletherapy units, the licensee shall use a teletherapy unit with a cesium-137 source.

(2) The licensee shall have available for use a dosimetry system for spot-check measurements. To satisfy this requirement, the system may be compared with a system that has been calibrated in accordance with R313-32-630(1). This comparison shall have been performed within the previous year and after each servicing that may have affected system calibration. The spot-check system may be the same system used to meet the requirement in R313-32-630(1).

(3) The licensee shall retain a record of each calibration, intercomparison, and comparison for the duration of the license. For each calibration, intercomparison, or comparison, the record shall include the date, the model numbers and serial numbers of the instruments that were calibrated, intercompared, or compared as required by R313-32-630(1) and (2), the correction factor that was determined from the calibration or comparison or the apparent correction factor that was determined from an intercomparison, the names of the individuals who performed the calibration, intercomparison, or comparison, and evidence that the intercomparison meeting was sanctioned by a calibration laboratory or radiologic physics center accredited by AAPM.

 

R313-32-632. Full Calibration Measurements.

(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:

(i) whenever spot-check measurements indicate that the output differs by more than five percent from the output obtained at the last full calibration corrected mathematically for radioactive decay;

(ii) following replacement of the source or following reinstallation of the teletherapy unit in a new location; or

(iii) 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 one year.

(2) To satisfy the requirement of R313-32-632(1), full calibration measurements shall include determination of:

(a) the output within plus or minus three percent for the range of field sizes and for the distance or range of distances used for medical use;

(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 constancy 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 R313-32-630(1) to measure the output for one set of exposure conditions. The remaining radiation measurements required in R313-32-632(2)(a) may be made using a dosimetry system that indicates relative dose rates.

(4) A licensee shall make full calibration measurements required by R313-32-632(1) in accordance with either the procedures recommended by the Scientific Committee on Radiation Dosimetry of the American Association of Physicists in Medicine that are described in Physics in Medicine and Biology Vol. 16, No. 3, 1971, pp. 379-396, or by Task Group 21 of the Radiation Therapy Committee of the American Association of Physicists in Medicine that are described in Medical Physics Vol. 10, No. 6, 1983, pp. 741-711, and Vol. 11, No. 2, 1984, p. 213.

(5) A licensee shall correct mathematically the outputs determined in R313-32-632(2)(a) for physical decay for intervals not exceeding one month for cobalt-60 or six months for cesium-137.

(6) Full calibration measurement required in R313-32-632(1) and physical decay corrections required by R313-32-632(5) shall be performed by the licensee teletherapy physicist.

(7) A licensee shall retain a record of each calibration for the duration of the teletherapy unit source. The record shall include the date of the calibration, the manufacturer's name, model number, and serial number for both the teletherapy unit and the source, the model numbers and serial numbers of the instruments used to calibrate the teletherapy unit, tables that describe the output of the unit over the range of field sizes and for the range of distances used in radiation therapy, a determination of the coincidence of the radiation field and the field indicated by the light beam localizing device, an assessment of timer linearity and constancy, the calculated on-off error, the estimated accuracy of each distance measuring or localization device, and the signature of the teletherapy physicist.

 

R313-32-634. Periodic Spot-Checks.

(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 constancy, 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 R313-32-630(2); and

(f) the difference between the measurement made in R313-32-634(2)(e) and the anticipated output, expressed as a percentage of the anticipated output (the value obtained at last full calibration corrected mathematically for physical decay).

(2) A licensee shall perform measurements required by R313-32-634(1) in accordance with procedures established by the teletherapy physicist. That individual need not actually perform the spot-check measurements.

(3) A licensee shall have the teletherapy physicist review the results of each spot-check within 15 days. The teletherapy physicist shall promptly notify the licensee in writing of the results of each spot-check. The licensee shall keep a copy of each written notification for three years.

(4) A licensee authorized to use a teletherapy unit for medical use shall perform safety spot-checks for each teletherapy facility once in each calendar month that 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) beam condition indicator lights on the teletherapy unit, on the control console, and in the facility;

(d) viewing 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) A licensee shall arrange for prompt repair of any system identified in R313-32-634(4) that is not operating properly, and shall not use the teletherapy unit following door interlock malfunction until the interlock system has been repaired.

(6) A licensee shall retain a record of each spot-check required by R313-32-634(1) and (4) for three years. The record shall include the date of the spot-check, the manufacturer's name, model number, and serial number for both the teletherapy unit and source, the manufacturer's name, model number and serial number of the instrument used to measure the output of the teletherapy unit, an assessment of linearity and constancy, the calculated on-off error, a determination of the coincidence of the radiation field and the field indicated by the light beam localizing device, the calculated on-off error, the determined accuracy of each distance measuring or localization device, the difference between the anticipated output and the measured output, notations indicating the operability of each entrance door electrical interlock, each electrical or mechanical stop, each beam condition indicator light, the viewing system and doors, and the signature of the individual who performed the periodic spot-check.

 

R313-32-636. Safety Checks for Teletherapy Facilities.

(1) A licensee shall promptly check all systems listed in R313-32-634(4) for proper function after each installation of a teletherapy source and after making any change for which an amendment is required by R313-32-606(1) through (4).

(2) If the results of the checks required in R313-32-636(1) indicate the malfunction of a system specified in R313-32-634(4), the 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.

(3) A licensee shall retain for three years a record of the facility checks following installation of a source. The record shall include notations indicating the operability of each entrance door interlock, each electrical or mechanical stop, each beam condition indicator light, the viewing system, and doors, and the signature of the Radiation Safety Officer.

 

R313-32-641. Radiation Surveys for Teletherapy Facilities.

(1) Before medical use, after each installation of a teletherapy source, and after making any change for which an amendment is required by R313-32-606(1) through (4), the licensee shall perform radiation surveys with a portable radiation measurement survey instrument calibrated in accordance with R313-32-51 to verify that:

(a) the maximum and average dose rates at one meter from the teletherapy source with the source in the off position and the collimators set for a normal treatment field do not exceed 100 uSv (ten mrem) per hour and 20 uSv (two mrem) per hour, respectively;

(b) with the teletherapy source in the on position with the largest clinically available treatment field and with a scattering phantom in the primary beam of the radiation, that:

(i) radiation dose rates in restricted areas are not likely to cause any occupationally exposed individual to receive a dose in excess of the limits specified in R313-15-201; and

(ii) radiation dose rates in controlled or unrestricted areas are not likely to cause any individual member of the public to receive a dose in excess of the limits specified in R313-15-301.

(2) If the results of the surveys required in R313-32-641(1) indicate any radiation dose quantity per unit time in excess of the respective limit specified in R313-32-641(1), the licensee shall lock the control in the off position and not use the unit:

(a) except as may be necessary to repair, replace, or test the teletherapy unit shielding or the treatment room shielding; or

(b) until the licensee has received a specific exemption pursuant to R313-12-54.

(3) A licensee shall retain a record of the radiation measurements made following installation of a source for the duration of the license. The record shall include the date of the measurements, the reason the survey is required, the manufacturer's name, model number and serial number of the teletherapy unit, the source, the instrument used to measure radiation levels, each dose rate measured around the teletherapy source while in the off position and the average of all measurements, a plan of the areas surrounding the treatment room that were surveyed, the measured dose rate at several points in each area expressed in microseverts or millirem per hour, the calculated maximum quantity of radiation over a period of one week for each restricted and unrestricted area, and the signature of the Radiation Safety Officer.

 

R313-32-643. Modification of Teletherapy Unit or Room Before Beginning a Treatment Program.

(1) If the survey required by R313-32-641 indicates that an individual member of the public is likely to receive a dose in excess of the limits specified in R313-15-301, the licensee shall, before beginning the treatment program:

(a) either equip the unit with stops or add additional radiation shielding to ensure compliance with R313-15-301(3);

(b) perform the survey required by R313-32-641 again; and

(c) include in the report required by R313-32-645 the results of the initial survey, a description of the modification made to comply with R313-32-643(1)(a), and the results of the second survey.

(2) As an alternative to the requirements set out in R313-32-643(1), a licensee may request a license amendment under R313-15-301(3) that authorizes radiation levels in unrestricted areas greater than those permitted by R313-15-301(1). A licensee shall not begin the treatment program until the license amendment has been issued.

 

R313-32-645. Reports of Teletherapy Surveys, Checks, Tests and Measurements.

A licensee shall mail a copy of the records required in R313-32-636, R313-32-641, R313-32-643, and the output from the teletherapy source expressed as coulombs/kilogram (roentgens) or gray (rad) per hour at one meter from the source and determined during the full calibration required in R313-32-632 to the Executive Secretary within thirty days following completion of the action that initiated the record requirement.

 

R313-32-647. Five-Year Inspection.

(1) A licensee shall have each teletherapy unit fully inspected and serviced during teletherapy source replacement or at intervals not to exceed five years, whichever comes first, to assure proper functioning of the source exposure mechanism.

(2) This inspection and servicing shall only be performed by persons specifically licensed to do so by the Executive Secretary, the Nuclear Regulatory Commission, or an Agreement State.

(3) A licensee shall keep a record of the inspection and servicing for the duration of the license. The record shall contain the inspector's name, the inspector's license number, the date of inspection, the manufacturer's name and model number and serial number for both the teletherapy unit and source, a list of components inspected, a list of components serviced and the type of service, a list of components replaced, and the signature of the inspector.

 

R313-32-900. Radiation Safety Officer.

Except as provided in R313-32-901, the licensee shall require an individual fulfilling the responsibilities of the Radiation Safety Officer as provided in R313-32-21 to be an individual who:

(1) is certified by:

(a) American Board of Health Physics in comprehensive health physics;

(b) American Board of Radiology;

(c) American Board of Nuclear Medicine;

(d) American Board of Science in nuclear medicine;

(e) Board of Pharmaceutical Specialties in nuclear pharmacy;

(f) American Board of Medical Physics in radiation oncology physics;

(g) Royal College of Physicians and Surgeons of Canada in nuclear medicine;

(h) American Osteopathic Board of Radiology; or

(i) American Osteopathic Board of Nuclear Medicine; or

(2) has had classroom and laboratory training and experience as follows:

(a) 200 hours of classroom and laboratory training that includes:

(i) radiation physics and instrumentation;

(ii) radiation protection;

(iii) mathematics pertaining to the use and measurement of radioactivity;

(iv) radiation biology; and

(v) radiopharmaceutical chemistry; and

(b) one year of full time experience as a radiation safety technologist at a medical institution under the supervision of the individual identified as the Radiation Safety Officer on a license issued by the Executive Secretary, Nuclear Regulatory Commission or Agreement State license that authorizes the medical use of radioactive material; or

(3) be an authorized user identified on the licensee's license.

 

R313-32-901. Training for Experienced Radiation Safety Officer.

An individual identified as a Radiation Safety Officer on a license issued by the Executive Secretary, Nuclear Regulatory Commission or Agreement State before January 1, 1989, need not comply with the training requirements of R313-32-900.

 

R313-32-910. Training for Uptake, Dilution, and Excretion Studies.

Except as provided in R313-32-970 and R313-32-971, the licensee shall require the authorized user of a radiopharmaceutical in R313-32-100(1) to be a physician who:

(1) is certified in:

(a) nuclear medicine by the American Board of Nuclear Medicine;

(b) diagnostic radiology by the American Board of Radiology;

(c) diagnostic radiology or radiology by the American Osteopathic Board of Radiology;

(d) nuclear medicine by the Royal College of Physicians and Surgeons of Canada; or

(e) American Osteopathic Board of Nuclear Medicine in nuclear medicine; or

(2) has had classroom and laboratory training in basic radioisotope handling techniques applicable to the use of prepared radiopharmaceuticals, and supervised clinical experience as follows:

(a) 40 hours of classroom and laboratory training that includes:

(i) radiation physics and instrumentation;

(ii) radiation protection;

(iii) mathematics pertaining to the use and measurement of radioactivity;

(iv) radiation biology; and

(v) radiopharmaceutical chemistry; and

(b) 20 hours of supervised clinical experience under the supervision of an authorized user and that includes:

(i) examining patients or human research subjects and reviewing their case histories to determine their suitability for radioisotope diagnosis, limitations, or contraindications;

(ii) selecting the suitable radiopharmaceuticals and calculating and measuring the dosages;

(iii) administering dosages to patients or human research subjects and using syringe radiation shields;

(iv) collaborating with the authorized user in the interpretation of radionuclide test results; and

(v) patient or human research subject follow-up; or

(3) has successfully completed a six-month training program in nuclear medicine as part of a training program that has been approved by the Accreditation Council for Graduate Medical Education and that included classroom and laboratory training, work experience, and supervised clinical experience in the topics identified in R313-32-910(2).

 

R313-32-920. Training for Imaging and Localization Studies.

Except as provided in R313-32-970 or R313-32-971, the licensee shall require the authorized user of a radiopharmaceutical, generator, or reagent kit in R313-32-200(1) to be a physician who:

(1) is certified in:

(a) nuclear medicine by the American Board of Nuclear Medicine;

(b) diagnostic radiology by the American Board of Radiology;

(c) diagnostic radiology or radiology by the American Osteopathic Board of Radiology;

(d) nuclear medicine by the Royal College of Physicians and Surgeons of Canada; or

(e) American Osteopathic Board of Nuclear Medicine in nuclear medicine; or

(2) has had classroom and laboratory training in basic radioisotope handling techniques applicable to the use of prepared radiopharmaceuticals, generators, and reagent kits, supervised work experience, and supervised clinical experience as follows:

(a) 200 hours of classroom and laboratory training that includes:

(i) radiation physics and instrumentation;

(ii) radiation protection;

(iii) mathematics pertaining to the use and measurement of radioactivity;

(iv) radiopharmaceutical chemistry; and

(v) radiation biology; and

(b) 500 hours of supervised work experience under the supervision of an authorized user that includes:

(i) ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys;

(ii) calibrating dose calibrators and diagnostic instruments and performing checks for proper operation of survey meters;

(iii) calculating and safely preparing patient or human research subject dosages;

(iv) using administrative controls to prevent the misadministration of radioactive material;

(v) using procedures to contain spilled radioactive material safely and using proper decontamination procedures; and

(vi) eluting technetium-99m from generator systems, measuring and testing the elute for molybdenum-99 and alumina contamination, and processing the elute with reagent kits to prepare technetium-99m labeled radiopharmaceuticals; and

(c) 500 hours of supervised clinical experience under the supervision of the authorized user that includes:

(i) examining patients or human research subjects and reviewing their case histories to determine their suitability for radioisotope diagnosis, limitations, or contraindications;

(ii) selecting the suitable radiopharmaceuticals and calculating and measuring the dosages;

(iii) administering dosages to patients or human research subjects and using syringe radiation shields;

(iv) collaborating with the authorized user in the interpretation of radioisotope test results; and

(v) patient or human research subject follow-up; or

(3) has successfully completed a six-month training program in nuclear medicine that has been approved by the Accreditation Council for Graduate Medical Education and that included classroom and laboratory training, work experience, and supervised clinical experience in the topics identified in R313-32-920(2).

 

R313-32-930. Training for Therapeutic Use of Unsealed Radioactive Material.

Except as provided in R313-32-970, the licensee shall require the authorized user of radiopharmaceuticals in R313-32-300 to be a physician who:

(1) is certified by:

(a) the American Board of Nuclear Medicine;

(b) the American Board of Radiology in radiology, therapeutic radiology, or radiation oncology;

(c) nuclear medicine by the Royal College of Physicians and Surgeons of Canada; or

(d) the American Osteopathic Board of Radiology after 1984; or

(2) has had classroom and laboratory training in basic radioisotope handling techniques applicable to the use of therapeutic radiopharmaceuticals, and supervised clinical experience as follows:

(a) 80 hours of classroom and laboratory training that includes:

(i) radiation physics and instrumentation;

(ii) radiation protection;

(iii) mathematics pertaining to the use and measurement of radioactivity; and

(iv) radiation biology; and

(b) supervised clinical experience under the supervision of an authorized user at a medical institution that includes:

(i) use of iodine-131 for diagnosis of thyroid function and the treatment of hyperthyroidism or cardiac dysfunction in ten individuals; and

(ii) use of iodine-131 for treatment of thyroid carcinoma in three individuals.

 

R313-32-932. Training for Treatment of Hyperthyroidism.

Except as provided in R313-32-970, the licensee shall require the authorized user of only iodine-131 for the treatment of hyperthyroidism to be a physician with special experience in thyroid disease who has had classroom and laboratory training in basic radioisotope handling techniques applicable to the use of iodine-131 for treating hyperthyroidism, and supervised clinical experience as follows:

(1) 80 hours of classroom and laboratory training that includes:

(a) radiation physics and instrumentation;

(b) radiation protection;

(c) mathematics pertaining to the use and measurement of radioactivity; and

(d) radiation biology; and

(2) Supervised clinical experience under the supervision of an authorized user that includes the use of iodine-131 for diagnosis of thyroid function, and the treatment of hyperthyroidism in ten individuals.

 

R313-32-934. Training for Treatment of Thyroid Carcinoma.

Except as provided in R313-32-970, the licensee shall require the authorized user of only iodine-131 for the treatment of thyroid carcinoma to be a physician with special experience in thyroid disease who has had classroom and laboratory training in basic radioisotope handling techniques applicable to the use of iodine-131 for treating thyroid carcinoma, and supervised clinical experience as follows:

(1) 80 hours of classroom and laboratory training that includes:

(a) radiation physics and instrumentation;

(b) radiation protection;

(c) mathematics pertaining to the use and measurement of radioactivity; and

(d) radiation biology; and

(2) Supervised clinical experience under the supervision of an authorized user that includes the use of iodine-131 for the treatment of thyroid carcinoma in three individuals.

 

R313-32-940. Training for Use of Brachytherapy Sources.

Except as provided in R313-32-970 the licensee shall require the authorized user of a brachytherapy source listed in R313-32-400 for therapy to be a physician who:

(1) is certified in:

(a) radiology, therapeutic radiology, or radiation oncology by the American Board of Radiology;

(b) radiation oncology by the American Osteopathic Board of Radiology;

(c) radiology, with specialization in radiotherapy, as a British "Fellow of the Faculty of Radiology" or "Fellow of the Royal College of Radiology"; or

(d) therapeutic radiology by the Canadian Royal College of Physicians and Surgeons; or

(2) is in the active practice of therapeutic radiology, has had classroom and laboratory training in radioisotope handling techniques applicable to the therapeutic use of brachytherapy sources, supervised work experience, and supervised clinical experience as follows:

(a) 200 hours of classroom and laboratory training that includes:

(i) radiation physics and instrumentation;

(ii) radiation protection;

(iii) mathematics pertaining to the use and measurement of radioactivity; and

(iv) radiation biology;

(b) 500 hours of supervised work experience under the supervision of an authorized user at a medical institution that includes:

(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 sealed sources;

(iv) maintaining running inventories of material on hand;

(v) using administrative controls to prevent the misadministration of radioactive material; and

(vi) using emergency procedures to control radioactive material; and

(c) three years of supervised clinical experience that includes one year in a formal training program approved by the Residency Review Committee for Radiology of the Accreditation Council for Graduate Medical Education or the Committee on Postdoctoral Training of the American Osteopathic Association, and an additional two years of clinical experience in therapeutic radiology under the supervision of an authorized user at a medical institution that includes:

(i) examining individuals and reviewing their case histories to determine their suitability for brachytherapy treatment, and any limitations or contraindications;

(ii) selecting the proper brachytherapy sources and dose and method of administration;

(iii) calculating the dose; and

(iv) post-administration follow-up and review of case histories in collaboration with the authorized user.

 

R313-32-941. Training for Ophthalmic Use of Strontium-90.

Except as provided in R313-32-970, the licensee shall require the authorized user of only strontium-90 for ophthalmic radiotherapy to be a physician who is in the active practice of therapeutic radiology or ophthalmology, and has had classroom and laboratory training in basic radioisotope handling techniques applicable to the use of strontium-90 for ophthalmic radiotherapy, and a period of supervised clinical training in ophthalmic radiotherapy as follows:

(1) 24 hours of classroom and laboratory training that includes:

(a) radiation physics and instrumentation;

(b) radiation protection;

(c) mathematics pertaining to the use and measurement of radioactivity; and

(d) radiation biology.

(2) Supervised clinical training in ophthalmic radiotherapy under the supervision of an authorized user at a medical institution that includes the use of strontium-90 for the ophthalmic treatment of five individuals that includes:

(a) examination of each individual to be treated;

(b) calculation of the dose to be administered;

(c) administration of the dose; and

(d) follow-up and review of each individual's case history.

 

R313-32-950. Training for Use of Sealed Sources for Diagnosis.

Except as provided in R313-32-970, the licensee shall require the authorized user of a sealed source in a device listed in R313-32-500 to be a physician, dentist, or podiatrist who:

(1) is certified in

(a) radiology, diagnostic radiology, therapeutic radiology, or radiation oncology by the American Board of Radiology;

(b) nuclear medicine by the American Board of Nuclear Medicine;

(c) diagnostic radiology or radiology by the American Osteopathic Board of Radiology; or

(d) nuclear medicine by the Royal College of Physicians and Surgeons of Canada; or

(2) has had eight hours of classroom and laboratory training in basic radioisotope handling techniques specifically applicable to the use of the device that includes:

(a) radiation physics, mathematics pertaining to the use and measurement of radioactivity, and instrumentation;

(b) radiation biology;

(c) radiation protection; and

(d) training in the use of the device for the uses requested.

 

R313-32-960. Training for Teletherapy.

Except as provided in R313-32-970, the licensee shall require the authorized user of a sealed source listed in R313-32-600 in a teletherapy unit to be a physician who:

(1) is certified in:

(a) radiology, therapeutic radiology, or radiation oncology by the American Board of Radiology;

(b) radiation oncology by the American Osteopathic Board of Radiology;

(c) radiology, with specialization in radiotherapy, as a British "Fellow of the Faculty of Radiology" or "Fellow of the Royal College of Radiology"; or

(d) therapeutic radiology by the Canadian Royal College of Physicians and Surgeons; or

(2) is in the active practice of therapeutic radiology, and has had classroom and laboratory training in basic radioisotope techniques applicable to the use of a sealed source in a teletherapy unit, supervised work experience, and supervised clinical experience as follows:

(a) 200 hours of classroom and laboratory training that includes:

(i) radiation physics and instrumentation;

(ii) radiation protection;

(iii) mathematics pertaining to the use and measurement of radioactivity; and

(iv) radiation biology;

(b) 500 hours of supervised work experience under the supervision of an authorized user at a medical institution that includes:

(i) review of the full calibration measurements and periodic spot checks;

(ii) preparing treatment plans and calculating treatment times;

(iii) using administrative controls to prevent misadministrations;

(iv) implementing emergency procedures to be followed in the event of the abnormal operation of a teletherapy unit or console; and

(v) checking and using survey meters; and

(c) three years of supervised clinical experience that includes one year in a formal training program approved by the Residency Review Committee for Radiology of the Accreditation Council for Graduate Medical Education or the Committee on Postdoctoral Training of the American Osteopathic Association and an additional two years of clinical experience in therapeutic radiology under the supervision of an authorized user at a medical institution that includes:

(i) examining individuals and reviewing their case histories to determine their suitability for teletherapy treatment, and any limitations or contraindications;

(ii) selecting the proper dose and how it is to be administered;

(iii) calculating the teletherapy doses and collaborating with the authorized user in the review of patients' or human research subjects' progress and consideration of the need to modify originally prescribed doses as warranted by patients' or human research subjects' reaction to radiation; and

(iv) post-administration follow-up and review of case histories.

 

R313-32-961. Training for Teletherapy Physicist.

The licensee shall require the teletherapy physicist to be an individual who:

(1) is certified by the American Board of Radiology in:

(a) therapeutic radiological physics;

(b) roentgen ray and gamma ray physics;

(c) x-ray and radium physics; or

(d) radiological physics; or

(2) is certified by the American Board of Medical Physics in radiation oncology physics; or

(3) holds a master's or doctor's degree in physics, biophysics, radiological physics, or health physics, and has completed one year of full time training in therapeutic radiological physics and an additional year of full time work experience under the supervision of a teletherapy physicist at a medical institution that includes the tasks listed in R313-32-59, R313-32-632, R313-32-634 and R313-32-641.

 

R313-32-970. Training for Experienced Authorized Users.

Physicians, dentists, or podiatrists identified as authorized users for the medical, dental, or podiatric use of radioactive material on a license issued by the Executive Secretary, Nuclear Regulatory Commission, or Agreement State license issued before January 1, 1989, who perform only those methods of use for which they were authorized on that date need not comply with the training requirements of R313-32-900 to R313-32-961.

 

R313-32-971. Physician Training in a Three Month Program.

A physician who, before October 1, 1988, began a three month nuclear medicine training program approved by the Accreditation Council for Graduate Medical Education and has successfully completed the program need not comply with the requirements of R313-32-910 or R313-32-920.

 

R313-32-972. Recentness of Training.

The training and experience specified in R313-32-900 through R313-32-981 shall have been obtained within the seven years preceding the date of application or the individual shall have had related continuing education and experience since the required training and experience was completed.

 

R313-32-980. Training for an Authorized Nuclear Pharmacist.

The licensee shall require the authorized nuclear pharmacist to be a pharmacist who:

(1) has current board certification as a nuclear pharmacist by the Board of Pharmaceutical Specialties, or

(2)(a) has completed 700 hours in a structured educational program consisting of both:

(i) didactic training in the following areas:

(A) radiation physics and instrumentation;

(B) radiation protection;

(C) mathematics pertaining to the use and measurement of radioactivity;

(D) chemistry of radioactive material for medical use; and

(E) radiation biology; and

(ii) supervised experience in a nuclear pharmacy involving the following:

(A) shipping, receiving, and performing related radiation surveys;

(B) using and performing checks for proper operation of dose calibrators, survey meters, and, if appropriate, instruments used to measure alpha- or beta-emitting radionuclides;

(C) calculating, assaying, and safely preparing dosages for patients or human research subjects;

(D) using administrative controls to avoid mistakes in the administration of radioactive material;

(E) using procedures to prevent or minimize contamination and using proper decontamination procedures; and

(b) has obtained written certification, signed by a preceptor authorized nuclear pharmacist, that the above training has been satisfactorily completed and that the individual has achieved a level of competency sufficient to independently operate a nuclear pharmacy.

 

R313-32-981. Training for Experienced Nuclear Pharmacists.

A licensee may apply for and must receive a license amendment identifying an experienced nuclear pharmacist as an authorized nuclear pharmacist before it allows this individual to work as an authorized nuclear pharmacist. A pharmacist who has completed a structured educational program as specified in R313-32-980(2)(a) before January 1, 1998 and who is working in a nuclear pharmacy would qualify as an experienced nuclear pharmacist. An experienced nuclear pharmacist need not comply with the requirements on preceptor statement (See R313-32-980(2)(b)) and recentness of training (See R313-32-972) to qualify as an authorized nuclear pharmacist.

 

R313-32-999. Resolution of Conflicting Requirements During Transition Period.

If the rules in R313-32 conflict with the licensee's radiation safety program as identified in its license, and if that license was approved by the Bureau of Radiation Control, Department of Health, before January 1, 1989, and has not been renewed since January 1, 1989, then the requirements in the license will apply. However, if the licensee exercises its privilege to make minor changes in its radiation safety procedures that are not potentially important to safety under R313-32-31, the portion changed shall comply with the requirements of R313-32. At the time of license renewal and thereafter, these amendments to R313-32 shall apply.]

 

KEY: radioactive material, radiopharmaceutical, brachytherapy, nuclear medicine

[September 14, 2001]2005

Notice of Continuation October 10, 2001

19-3-104

19-3-108