W. Va. Code R. § 64-23-12 - Use of Radionuclides in the Healing Arts

Current through Register Vol. XXXVIII, No. 51, December 23, 2021

12.1. Scope. - The provisions of this Section apply to all registrants who use sealed sources in the healing arts and are in addition to, and not in substitution for, other applicable provisions of this rule.
12.2. Definitions. - As used in Section 12. the following definitions apply:
12.2.a. Address of Use - the building or buildings that are identified on the registration and where radioactive material may be produced, prepared, received, used, or stored.
12.2.b. Area of Use - a portion of a physical structure that has been set aside for the purpose of producing, preparing, receiving, using, or storing radioactive material.
12.2.c. Authorized User - a practitioner of the healing arts who is identified as an authorized user on an agency [or the Nuclear Regulatory Commission] registration or registration that authorizes the medical use of radioactive material.
12.2.d. Brachytherapy - a method of radiation therapy in which sealed sources are utilized to deliver a radiation dose at a distance of up to a few centimeters, by surface, intracavitary, or interstitial application.
12.2.e. Dedicated Check Source - a radioactive source that is used to assure the constant operation of a radiation detection or measurement device over several months or years. This source may also be used for other purposes.
12.2.f. Diagnostic Clinical Procedures Manual - a collection of written procedures that describes each method (and other instructions and precautions) by which the registrant 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.
12.2.g. Medical Institution - an organization in which several medical disciplines are practiced.
12.2.h. Medical Use - the intentional internal or external administration of radioactive material, or the radiation therefrom, to humans in the practice of the healing arts.
12.2.i. Misadministration - the administration of:
12.2.i.1. A radiopharmaceutical dosage greater than one and eleven one-hundredths (1.11) megabecquerels (thirty [30] :Ci) of either sodium iodide, I-125 or I-131:
12.2.i.1.A. Involving the wrong patient or wrong radiopharmaceutical; or
12.2.i.1.B. When both the administered dosage differs from the prescribed dosage by more than twenty (20) percent of the prescribed dosage and the difference between the administered dosage and prescribed dosage exceeds one and eleven one-hundredths (1.11) megabecquerels (thirty [30] :Ci);
12.2.i.2. A therapeutic radiopharmaceutical dosage, other than sodium iodide, I-125 or I-131:
12.2.i.2.A. Involving the wrong patient, wrong radiopharmaceutical, or wrong route of administration; or
12.2.i.2.B. When the administered dosage differs from the prescribed dosage by more than twenty (20) percent of the prescribed dosage;
12.2.i.3. A gamma stereotactic radiosurgery radiation dose:
12.2.i.3.A. Involving the wrong patient or wrong treatment site; or
12.2.i.1.B. When the calculated total administered dose differs from the total prescribed dose by more than ten (10) percent of the total prescribed dose;
12.2.i.4. A teletherapy radiation dose:
12.2.i.4.A. Involving the wrong patient, wrong mode of treatment, or wrong treatment site; or
12.2.i.4.B. When the treatment consists of three (3) or fewer fractions and the calculated total administered dose differs from the total prescribed dose by more than ten (10) percent of the total prescribed dose; or
12.2.i.4.C. When the calculated weekly administered dose exceeds the weekly prescribed dose by thirty (30) percent or more of the weekly prescribed dose; or
12.2.i.4.D. When the calculated total administered dose differs from the total prescribed dose by more than twenty (20) percent of the total prescribed dose;
12.2.i.5. A brachytherapy radiation dose:
12.2.i.5.A. Involving the wrong patient, wrong radionuclide, or wrong treatment site (excluding, for permanent implants, seeds that were implanted in the correct site but migrated outside the treatment site); or
12.2.i.5.B. Involving a sealed source that is leaking; or
12.2.i.5.C. When, for a temporary implant, one or more sealed sources are not removed upon completion of the procedure; or
12.2.i.5.D. When the calculated administered dose differs from the prescribed dose by more than twenty (20) percent of the prescribed dose;
12.2.i.6. A diagnostic radiopharmaceutical dosage, other than quantities greater than one and eleven one-hundredths (1.11) megabecquerels (thirty [30] :Ci) of either sodium iodide I-125 or I-131, both:
12.2.i.6.A. Involving the wrong patient, wrong radiopharmaceutical, wrong route of administration, or when the administered dosage differs from the prescribed dosage; and
12.2.i.6.B. When the dose to the patient exceeds fifty (50) millisieverts (five [5] rem) effective dose equivalent or five hundred (500) millisieverts (fifty [50] Rem) dose equivalent to any individual organ.
12.2.j. Mobile Nuclear Medicine Service - the transportation and medical use of radioactive material.
12.2.k. Output - 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.
12.2.l. Prescribed Dosage - the quantity of radiopharmaceutical activity as documented:
12.2.l.1. In a written directive; or
12.1.l.2. Either in the diagnostic clinical procedures manual or in any appropriate record in accordance with the directions of the authorized user for diagnostic procedures.
12.2.m. Prescribed Dose:
12.2.m.1. For gamma stereotactic radiosurgery, the total dose as documented in the written directive; or
12.2.m.2. For teletherapy, the total dose and dose per fraction as documented in the written directive; or
12.2.m.3. For brachytherapy, either the total source strength and exposure time, or the total dose, as documented in the written directive.
12.2.n. Recordable event - the administration of:
12.2.n.1. A radiopharmaceutical or radiation without a written directive where a written directive is required;
12.2.n.2. 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;
12.2.n.3. A radiopharmaceutical dosage greater than one and eleven one-hundredths (1.11) megabecquerels (thirty [30] :Ci) of sodium iodide I-125 or I-131 when both the administered dosage differs from the prescribed dosage by more than ten (10) percent of the prescribed dosage, and the difference between the administered dosage and the prescribed dosage exceeds five hundred fifty five (555) kilobecquerels (fifteen [15] :Ci);
12.2.n.4. 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 (10) percent of the prescribed dosage;
12.2.n.5. A teletherapy radiation dose when the calculated weekly administered dose exceeds the weekly prescribed dose by fifteen (15) percent or more of the weekly prescribed dose; or
12.2.n.6. A brachytherapy radiation dose when the calculated administered dose differs from the prescribed dose by more than ten (10) percent of the prescribed dose.
12.2.o. Teletherapy - therapeutic irradiation in which the source of radiation is at a distance from the body.
12.2.p. Visiting Authorized User - an authorized user who is not identified on the registration of the registrant being visited.
12.2.q. Written Directive - an order in writing for a specific patient, dated and signed by an authorized user prior to the administration of a radiopharmaceutical or radiation, except as specified in 12.2.q.iv., containing the following information:
12.2.q.1. For any administration of quantities greater than one and eleven one-hundredths (1.11) megabecquerels (thirty [30] :Ci) of sodium iodide I-125 or I-131: the radionuclide, and dosage; or
12.2.q.2. For a therapeutic administration of a radiopharmaceutical other than sodium iodide I-125 or I-131: the radiopharmaceutical, dosage, and route of administration; or
12.2.q.3. For gamma stereotactic radiosurgery: target coordinates, collimator size, plug pattern, and total dose; or
12.2.q.4. For teletherapy: the total dose, dose per fraction, treatment site, and overall treatment period; or
12.2.q.5. For high-dose-rate remote afterloading brachytherapy: the radionuclide, treatment site, and total dose; or
12.2.q.6. For all other brachytherapy,
12.2.q.6.A. Prior to implantation: the radionuclide, number of sources, and source strengths; and
12.2.q.6.B. 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).
12.3. Registration Required.
12.3.a. No person shall manufacture, produce, prepare, compound, acquire, receive, possess, use, or transfer radioactive material for medical use except in accordance with a registration issued pursuant to this rule.
12.3.b. Unless prohibited by registration condition, an individual may receive, possess, use, or transfer radioactive material in accordance with the rules in Section 11 under the supervision of an authorized user as provided in Subsection 11.10.
12.4. Registration Amendments. A registrant shall apply for and receive a registration amendment:
12.4.a. Before using radioactive material for a method or type of medical use not permitted by the registration issued under Section 11;
12.4.b. Before permitting anyone, except a visiting authorized user described in Section 11.11, to work as an authorized user under the registration;
12.4.c. Before changing a radiation safety officer or teletherapy physicist;
12.4.d. Before receiving radioactive material in excess of the amount authorized on the registration;
12.4.e. Before adding to or changing the areas of use or address or addresses of use identified in the application or on the registration; and
12.4.f. Before changing statements, representations, and procedures which are incorporated into the registration.
12.5. Notifications. A registrant shall notify the agency in writing within 30 days when an authorized user, radiation safety officer, or teletherapy physicist, permanently discontinues performance of duties under the registration.
12.6. ALARA Program
12.6.a. Each registrant shall develop and implement a written program to maintain radiation doses and releases of radioactive material in effluents to unrestricted areas as low as reasonably achievable (ALARA) as defined in Section 1. of this rule.
12.6.b. To satisfy the requirement of Subdivision 11.6.a.:
12.6.b.1. The management, radiation safety officer, and all authorized users shall participate in the establishment, implementation, and operation of the program as required by this rule or the radiation safety committee; or
12.6.b.2. For registrants that are not medical institutions, management and all authorized users shall participate in the program as required by the radiation safety officer.
12.6.c. The ALARA program shall include an annual review by the radiation safety committee for registrants that are medical institutions, or management and the radiation safety officer for registrants that are not medical institutions, of summaries of the types and amounts of radioactive material used, occupational dose reports, and continuing education and training for all personnel who work with or in the vicinity of radioactive material. The purpose of the review is to ensure that individuals make every reasonable effort to maintain occupational doses, doses to the general public, and releases of radioactive material as low as reasonably achievable, taking into account the state of technology, and the cost of improvements in relation to benefits.
12.6.d. The registrant shall retain a current written description of the ALARA program for the duration of the registration. The written description shall include:
12.6.d.1. A commitment by management to keep occupational doses as low as reasonably achievable;
12.6.d.2. A requirement that the radiation safety officer brief management once each year on the radiation safety program;
12.6.d.3. Personnel exposure investigational levels as established in accordance with Paragraph 11.8.b.8. that, when exceeded, will initiate an investigation by the radiation safety officer of the cause of the exposure; and
12.6.d.4. Personnel exposure action 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.
12.7. Radiation Safety Officer.
12.7.a. A registrant shall appoint a radiation safety officer responsible for implementing the radiation safety program. The registrant, 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 registrant's radioactive material program.
12.7.b. The Radiation Safety Officer shall:
12.7.b.1. Investigate overexposures, misadministrations, accidents, spills, losses, thefts, unauthorized receipts, uses, transfers, and disposals, and other deviations from approved radiation safety practice and implement corrective actions as necessary;
12.7.b.2. Implement written policy and procedures for:
12.7.b.2.A. Authorizing the purchase of radioactive material;
12.7.b.2.B. Receiving and opening packages of radioactive material;
12.7.b.2.C. Storing radioactive material;
12.7.b.2.D. Keeping an inventory record of radioactive material;
12.7.b.2.E. Using radioactive material safely;
12.7.b.2.F. Taking emergency action if control of radioactive material is lost;
12.7.b.2.G. Performing periodic radiation surveys;
12.7.b.2.H. Performing checks and calibrations of survey instruments and other safety equipment;
12.7.b.2.I. Disposing of radioactive material;
12.7.b.2.J. Training personnel who work in or frequent areas where radioactive material is used or stored; and
12.7.b.2.K. Keeping a copy of all records and reports required by the agency rules, a copy of this rule, a copy of each registration request and registration and amendments and the written policy and procedures required by the rules; and
12.7.c. For medical use not sited at a medical institution, approve or disapprove radiation safety program changes with the advice and consent of management prior to submittal to the agency for registration action; or
12.7.d. For medical use sited at a medical institution, assist the radiation safety committee in the performance of its duties.
12.8. Radiation Safety Committee. Each medical institution registrant shall establish a radiation safety committee to oversee the use of radioactive material.
12.8.a. The committee shall meet the following administrative requirements:
12.8.a.1. Membership must consist of at least three (3) individuals and shall include an authorized user of each type of use permitted by the registration, 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 registrant deems appropriate;
12.8.a.2. The committee shall meet at least once each calendar quarter;
12.8.a.3. To establish a quorum and to conduct business, one-half of the committee's membership shall be present, including the radiation safety officer and the management's representative;
12.8.a.4. The minutes of each radiation safety committee meeting shall include:
12.8.a.4.A. The date of the meeting;
12.8.a.4.B. Members present;
12.8.a.4.C. Members absent;
12.8.a.4.D. Summary of deliberations and discussions;
12.8.a.4.E. Recommended actions and the numerical results of all ballots;
12.8.a.4.F. Documentation of any reviews required in Subdivision 11.6.c. and 11.8.b.;
12.8.a.4.G. The committee shall provide each member with a copy of the meeting minutes, and retain one copy until the agency authorizes its disposition.
12.8.b. To oversee the use of registered material, the committee shall:
12.8.b.1. Be responsible for monitoring the institutional program to maintain occupational doses as low as reasonably achievable;
12.8.b.2. Review, on the basis of safety and with regard to the training and experience standards of Section 11, and approve or disapprove any individual who is to be listed as an authorized user, the radiation safety officer, or teletherapy physicist before submitting a registration application or request for amendment or renewal;
12.8.b.3. Review on the basis of safety and approve or disapprove each proposed method of use of radioactive material;
12.8.b.4. Review on the basis of safety, and approve with the advice and consent of the radiation safety officer and the management representative, or disapprove procedures and radiation safety program changes prior to submittal to the agency for registration action;
12.8.b.5. Review quarterly, with the assistance of the radiation safety officer, occupational radiation exposure records of all personnel working with radioactive material;
12.8.b.6. Review quarterly, with the assistance of the radiation safety officer, all incidents involving radioactive material with respect to cause and subsequent actions taken;
12.8.b.7. Review annually, with the assistance of the radiation safety officer, the radioactive material program; and
12.8.b.8. Establish a Table of investigational and action levels for occupational dose that, when exceeded, will initiate investigations and considerations of action by the radiation safety officer.
12.9. Statement of Authorities and Responsibilities.
12.9.a. A registrant shall provide sufficient authority and organizational freedom to the radiation safety officer and the radiation safety committee to:
12.9.a.1. Identify radiation safety problems;
12.9.a.2. Initiate, recommend, or provide solutions; and
12.9.a.3. Verify implementation of corrective actions.
12.9.b. A registrant shall establish in writing the authorities, duties, responsibilities, and radiation safety activities of the radiation safety officer and the radiation safety committee.
12.10. Supervision.
12.10.a. A registrant who permits the receipt, possession, production, preparation, compounding, use, or transfer of radioactive material by an individual under the supervision of an authorized user as allowed by Subsection 11.3. shall:
12.10.a.1. Instruct the supervised individual in the principles of radiation safety appropriate to that individual's use of radioactive material and in the registrant's written quality management program;
12.10.a.2. Periodically review the supervised individual's use of radioactive material, the records kept to reflect this use, and provide reinstruction as needed;
12.10.a.3. Require an authorized user to be immediately available to communicate with the supervised individual; and
12.10.a.4. Require that only those individuals permitted under state and local rules and specifically trained, and designated by the authorized user, be permitted to administer radionuclides or radiation to patients.
12.10.b. A registrant shall require the supervised individual receiving, possessing, producing, preparing, compounding, using or transferring radioactive material under Subsection 11.3. to:
12.10.b.1. Follow the instructions of the supervising authorized user;
12.10.b.2. Follow the written radiation safety and quality management procedures established by the registrant; and
12.10.b.3. Comply with this rule conditions with respect to the use of radioactive material.
12.11. Visiting Authorized User.
12.11.a. A registrant may permit any visiting authorized user to use registered material for medical use under the terms of the registrant's registration for sixty (60) days each year if:
12.11.a.1. The visiting authorized user has the prior written permission of the registrant's management and, if the use occurs on behalf of an institution, the institution's radiation safety committee;
12.11.a.2. The registrant has a copy of an agency, agreement state, licensing state or the Nuclear Regulatory Commission registration that identifies the visiting authorized user by name as an authorized user for medical use; and
12.11.a.3. Only those procedures for which the visiting authorized user is specifically authorized by an agency, agreement state, licensing state or the Nuclear Regulatory Commission registration are performed by that individual.
12.11.b. A registrant need not apply for a registration amendment in order to permit a visiting authorized user to use registered material as described in Subdivision 11.11.a.
12.11.c. A registrant shall retain copies of the records specified in Subdivision 11.11.a. for 3 years from the date of the last visit.
12.12. Mobile Nuclear Medicine Service Administrative Requirements.
12.12.a. The agency shall register mobile nuclear medicine services or clients of such services. The mobile nuclear medicine service shall be registered if the service receives, uses or possesses radioactive material. The client of the mobile nuclear medicine service shall be registered if the client receives or possesses radioactive material to be used by a mobile nuclear medicine service.
12.12.b. Mobile nuclear medicine service registrations shall retain for the duration of service a letter signed by the management of each location where services are rendered that authorizes use of radioactive material. If the client is registered, the letter shall document procedures for notification, receipt, storage and documentation of transfer of radioactive material delivered to the client's location for use by the mobile nuclear medicine service.
12.12.c. A mobile nuclear medicine service shall not have radioactive material delivered directly from the manufacturer or the distributor to the client's address of use, unless the client has a registration. Radioactive material delivered to the client's address of use shall be received and handled in conformance with the client's registration.
12.12.d. A mobile nuclear medicine service shall inform a responsible individual, such as a representative of management in charge of the patient or the registered nurse in charge of the nursing unit, who is on site at each client's address of use at the time that radiopharmaceuticals are being administered.
12.13. Quality Management Program.
12.13.a. Each registrant shall establish and maintain a written quality management program to provide assurance that radioactive material or radiation therefrom 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:
12.13.a.1. That, prior to administration, a written directive is prepared for:
12.13.a.1.A. Any teletherapy radiation dose;
12.13.a.1.B. Any gamma stereotactic radiosurgery radiation dose;
12.13.a.1.C. Any brachytherapy radiation dose;
12.13.a.1.D. Any administration of quantities greater than one and eleven one-hundredths (1.11) megabecquerels (thirty [30] :Ci) of either sodium iodide I-125 or I-131; or
12.13.a.1.E. Any therapeutic administration of a radiopharmaceutical, other than sodium iodide I-125 or I-131;

(NOTE: 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 forty eight (48) hours of the oral revision. Also, a written revision to an existing written directive may be made for any 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. 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 twenty four (24) hours of the oral directive.)

12.13.a.2. That, prior to each administration, the patient's identity is verified by more than one method as the individual named in the written directive;
12.13.a.3. That final plans of treatment and related calculations for brachytherapy, teletherapy, and gamma stereotactic radiosurgery are in accordance with the respective written directives;
12.13.a.4. That each administration is in accordance with the written directive; and
12.13.a.5. That any unintended deviation from the written directive is identified and evaluated, and appropriate action is taken.
12.13.b. Each registrant shall:
12.13.b.1. Develop procedures for and conduct a review of the quality management program including, since the last review, an evaluation of a representative sample of patient administrations, all recordable events, and all misadministrations to verify compliance with all aspects of the quality management program; these reviews shall be conducted at intervals no greater than twelve (12) months;
12.13.b.2. Evaluate each of these reviews to determine the effectiveness of the quality management program and, if required, make modifications to meet the objectives of Subdivision 11.13.a.; and
12.13.b.3. Retain records of each review, including the evaluations and findings of the review, in an auditable form for three (3) years.
12.13.c. The registrant shall evaluate and respond to each recordable event, within thirty (30) days after discovery of the recordable event, by:
12.13.c.1. Assembling the relevant facts including the cause;
12.13.c.2. Identifying what, if any, corrective action is required to prevent recurrence; and
12.13.c.3. Retaining a record, in an auditable form, for 3 years, of the relevant facts and what corrective action, if any, was taken.
12.13.d. Each registrant shall retain:
12.13.d.1. Each written directive; and
12.13.d.2. A record of each administered radiation dose or radiopharmaceutical dosage where a written directive is required in Paragraph 11.13.a.1., in an auditable form, for three (3) years after the date of administration.
12.13.e. The registrant may make modifications to the quality management program to increase the program's efficiency provided the program's effectiveness is not decreased.
12.14. Records, Notifications, and Reports of Misadministrations.
12.14.a. For a misadministration:
12.14.a.1. The registrant shall notify the agency by telephone no later than twenty four (24) hours after discovery of the misadministration;
12.14.a.2. The registrant shall submit a written report to the agency within fifteen (15) days after discovery of the misadministration. The written report must include the registrant's name; the prescribing physicians's name; a brief description of the event; why the event occurred; the effect on the patient; what improvements are needed to prevent recurrence; actions taken to prevent recurrence; whether the registrant notified the patient, or the patient's responsible relative or guardian (this person will be subsequently referred to as "the patient"), and if not, why not, and if the patient was notified, what information was provided to the patient. The report must not include the patient's name or other information that could lead to identification of the patient;
12.14.a.3. The registrant shall notify the referring physician and also notify the patient of the misadministration not later than 24 hours after its discovery, unless the referring physician personally informs the registrant either that he or she will inform the patient or that, based on medical judgement, telling the patient would be harmful. The registrant is not required to notify the patient without first consulting the referring physician. If the referring physician or patient cannot be reached within twenty four (24) hours, the registrant shall notify the patient as soon as possible thereafter. The registrant may not delay any appropriate medical care for the patient, including any necessary remedial care as a result of the misadministration, because of any delay in notification;
12.14.a.4. If the patient was notified, the registrant shall also furnish, within fifteen (15) days after discovery of the misadministration, a written report to the patient by sending either:
12.14.a.4.A. A copy of the report that was submitted to the agency; or
12.14.a.4.B. A brief description of both the event and the consequences, as they may affect the patient, provided a statement is included that the report submitted to the agency can be obtained from the registrant.
12.14.b. Each registrant shall retain a record of each misadministration for five (5) years. The record shall contain the names of all individuals involved (including the prescribing physician, allied health personnel, the patient, and the patient's referring physician), the patient's social security number or identification number if one has been assigned, a brief description of the misadministration, why it occurred, the effect on the patient, what improvements are needed to prevent recurrence, and the actions taken to prevent recurrence.
12.14.c. Aside from the notification requirement, nothing in Subdivisions 11.14.a. and 11.14.b. shall affect any rights or duties of registrants and physicians in relation to each other, patients, or the patient's responsible relatives or guardians.
12.15. Suppliers. A registrant shall use for medical use only:
12.15.a. Radioactive material manufactured, produced, labeled, prepared, compounded, packaged, and distributed in accordance with a registration issued pursuant to this rule or the equivalent rules of an agreement state, a licensing state or the Nuclear Regulatory Commission; and
12.15.b. Reagent kits, radiopharmaceuticals, or radiobiologics that have been manufactured, labeled, packaged, and distributed in accordance with an approval issued by the food and drug administration; or
12.15.c. Radiopharmaceuticals compounded from a prescription in accordance with the rules of the State Board of Pharmacy.
12.15.d. Teletherapy and brachytherapy sources manufactured and distributed in accordance with a registration issued pursuant to this rule, or the equivalent rules of an agreement state, a licensing state, or the Nuclear Regulatory Commission.
12.16. Quality Control of Diagnostic Equipment. Each registrant shall establish written quality control procedures for all diagnostic equipment used for radionuclide studies. As a minimum, quality control procedures and frequencies shall be those recommended by equipment manufacturers or procedures which have been approved by the agency. The registrant shall conduct quality control procedures in accordance with written procedures.
12.17. Possession, Use, Calibration, and Check of Dose Calibrators.
12.17.a. A medical use registrant authorized to administer radiopharmaceuticals shall possess a dose calibrator and use it to measure the amount of activity administered to each patient. In the case where the ionization type dose calibrator cannot be used effectively to verify administered activity, the registrant shall use an alternative method. Any alternative method to the use of a dose calibrator shall be approved by the agency in writing. Any alternative method shall provide for acceptable verification of constancy, accuracy, linearity, and geometry dependence as applicable.
12.17.b. Each registrant shall establish written quality control procedures for all dose calibrators used for measuring the amount of activity administered to a patient. As a minimum, quality control procedures and frequencies shall be those recommended by the American National Standards Institute in ANSI N42.13-1986 or the registrant shall:
12.17.b.1. Check each dose calibrator for constancy with a dedicated check source at the beginning of each day of use. The check shall be done on a frequently used setting with a sealed source of not less than one and eighty five one-hundredths (1.85) megabecquerels (fifty [50] :Ci) of any photon-emitting radionuclide with a half-life greater than 90 days;
12.17.b.2. Test each dose calibrator for accuracy upon installation and at intervals not to exceed 12 months thereafter by assaying at least two (2) sealed sources containing different radionuclides with activities of at least one and eighty five one-hundredths (1.85) megabecquerels (fifty [50] :Ci) each. The activity of one source shall be determined by the manufacturer to be within five (5) percent of the stated activity. All other sources used for this test shall be within ten (10) percent of the stated activity. All sources used to satisfy the accuracy test shall be calibration sources traceable to the national institute of standards and technology or other standards recognized as being equivalent by the national institute of standards and technology;
12.17.b.3. Test each dose calibrator for linearity upon installation and at intervals not to exceed three (3) months thereafter over the range of use between three hundred seventy (370) kilobecquerels (ten [10] :Ci) and the highest dosage that will be assayed; and
12.17.b.4. Test each dose calibrator for geometry dependence upon installation over the range of volumes and volume configurations for which it will be used. The registrant shall keep a record of this test for the duration of the use of the dose calibrator.
12.17.c. A registrant shall mathematically correct dosage readings for any geometry or linearity error that exceeds ten (10) percent if the dosage is greater than three hundred seventy (370) kilobecquerels (ten [10] :Ci) and shall repair or replace the dose calibrator if the accuracy or constancy error exceeds ten (10) percent.
12.17.d. A registrant shall also perform checks and tests required by Subdivision 11.17.b. following adjustment or repair of the dose calibrator.
12.17.e. A registrant shall retain a record of each check and test required by Subsection 11.17. or three (3) years. The records required by Subdivision 11.17.b. shall include:
12.17.e.1. For Paragraph 11.17.b.1., the model and serial number of the dose calibrator, the identity and calibrated activity of the radionuclide contained in the check source, the date of the check, the activity measured, the instrument settings, and the initials of the individual who performed the check;
12.17.e.2. For Paragraph 11.17.b.2., the model and serial number of the dose calibrator, the model and serial number of each source used and the identity of the radionuclide contained in the source and its activity, the date of the test, the results of the test, the instrument settings, and the signature of the individual who performed the test;
12.17.e.3. For Paragraph 11.17.b.3., the model and serial number of the dose calibrator, the calculated activities, the measured activities, the date of the test, and the signature of the individual who performed the test; and
12.17.e.4. For Paragraph 11.17.b.4., the model and serial number of the dose calibrator, the configuration and calibrated activity of the source measured, the activity of the source, the activity measured and the instrument setting for each volume measured, the date of the test, and the signature of the individual who performed the test.
12.18. Calibration and Check of Survey Instruments.
12.18.a. A registrant shall ensure that the survey instruments used to show compliance with Section 12. have been calibrated before first use, annually, and following repair.
12.18.b. To satisfy the requirements of Subdivision 11.18.a. registrant shall:
12.18.b.1. Calibrate all required scale readings up to ten (10) millisieverts (one thousand [1000] mRem) per hour with a radiation source;
12.18.b.2. For each scale that shall be calibrated, calibrate two (2) readings separated by at least fifty (50) percent of scale rating; and
12.18.b.3. Conspicuously note on the instrument the apparent dose rate from a dedicated check source as determined at the time of calibration, and the date of calibration.
12.18.c. To satisfy the requirements of Subdivision 11.18.b., the registrant shall consider a point as calibrated if the indicated exposure rate differs from the calculated exposure rate by not more than ten (10) percent; and consider a point as calibrated if the indicated exposure rate differs from the calculated exposure rate by not more than twenty (20) percent if a correction chart or graph is conspicuously attached to the instrument.
12.18.d. A registrant shall check each survey instrument for proper operation with the dedicated check source before each use. The registrant is not required to keep records of these checks.
12.18.e. The registrant shall retain a record of each calibration required in Subdivision 11.18.a. for three (3) years. The record shall include:
12.18.e.1. A description of the calibration procedure; and
12.18.e.2. A description of the source used and the certified dose rates from the source, and the rates indicated by the instrument being calibrated, the correction factors deduced from the calibration data, the signature of the individual who performed the calibration, and the date of calibration.
12.18.f. To meet the requirements of Subdivisions 11.18.a., b., and c., the registrant may obtain the services of individuals registered by the agency, the Nuclear Regulatory Commission, an agreement state, or a licensing state to perform calibrations of survey instruments. Records of calibrations which contain information required by Subdivision 11.18.e. shall be maintained by the registrant.
12.19. Assay of Radiopharmaceutical Dosages. A registrant shall:
12.19.a. Assay, [within 30 minutes] before medical use, the activity of each radiopharmaceutical dosage that contains more than three hundred seventy (370) kilobecquerels (ten [10] :Ci) of a photon-emitting radionuclide;
12.19.b. Assay, before medical use, the activity of each radiopharmaceutical dosage emitting alpha and beta radiation or alpha or beta radiation as the radiation of principal interest, unless such radiopharmaceutical has been obtained:
12.19.b.1. In unit dose form, calibrated by the supplier for individual patients; and
12.19.b.2. From a supplier which participates in a measurement quality assurance program with the national institute of standards and technology, and which is designed to ensure that unit doses have a calibration traceable to a national standard;
12.19.c. Retain a record of the assays or calibrations required by Subdivision 11.19.a. and b., for three (3) years. To satisfy this requirement, the record shall contain the:
12.19.c.1. Radiopharmaceutical, or the radionuclide administered;
12.19.c.2. Patient's name, and identification number if one has been assigned;
12.19.c.3. Prescribed dosage and measured activity of the dosage at the time of assay, or a notation that the total activity was determined by a calibration traceable to a national standard;
12.19.c.4. Date and time of the assay or calibration and the date and time of the administration; and
12.19.c.5. Initials of the individual who performed the assay or documentation of the supplier's participation in the measurement quality assurance program specified in Subdivision 11.18.b.
12.20. Authorization for Calibration and Reference Sources. Any person authorized by Subsection 11.3. for medical use of radioactive material may receive, possess, and use the following radioactive material for check, calibration and reference use:
12.20.a. Sealed sources manufactured and distributed by persons specifically registered pursuant to Section 11. of this rule or equivalent provisions of the Nuclear Regulatory Commission, agreement state or licensing state and that do not exceed five hundred fifty five (555) megabecquerels (fifteen [15] mCi) each;
12.20.b. Any radioactive material [listed in Subsections 12.31. or 11.33.] with a half-life of one hundred (100) days or less in individual amounts not to exceed five hundred fifty five (555) megabecquerels (fifteen [15] mCi);
12.20.c. Any radioactive material[listed in Subsections 12.31. or 12.33.] with a half-life greater than one hundred (100) days in individual amounts not to exceed seven and four-tenths (7.4) megabecquerels (two hundred [200] :Ci) each; and
12.20.d. Technetium-99m in individual amounts not to exceed one and eighty five one-hundredths (1.85) gigabecquerels (fifty [50] mCi).
12.21. Requirements for Possession of Sealed Sources and Brachytherapy Sources.
12.21.a. A registrant in possession of any sealed source or brachytherapy source shall follow the radiation safety and handling instructions supplied by the manufacturer or equivalent instructions approved by the agency and shall maintain the instructions for the duration of source use in a legible form convenient to users.
12.21.b. A registrant in possession of a sealed source shall assure that:
12.21.b.1. The source is tested for leakage before its first use unless the registrant has a certificate from the supplier indicating that the source was tested within six (6) months before transfer to the registrant; and
12.21.b.2. The source is tested for leakage at intervals not to exceed six (6) months or at intervals approved by the agency, another agreement state, a licensing state or the Nuclear Regulatory Commission.
12.21.c. To satisfy the leak test requirements of Subdivision 12.21.b., the registrant shall assure that:
12.21.c.1. Leak tests are capable of detecting the presence of one hundred eighty five (185) becquerels (five one-thousandths [0.005] :Ci) of radioactive material on the test sample, or in the case of radium, the escape of radon at the rate of thirty seven (37) becquerels (one one-thousandth [0.001] :Ci) per twenty four (24) hours;
12.21.c.2. Test samples are taken from the source or from the surfaces of the device in which the source is mounted or stored on which radioactive contamination might be expected to accumulate; and
12.21.c.3. Test samples are taken when the device containing the source is in the "off" position.
12.21.d. A registrant shall retain leak test records for 5 years. The records shall contain the model number, and 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 (:Ci), a description of the method used to measure each test sample, the date of the test, and the signature of the individual who performed the test.
12.21.e. If the leak test reveals the presence of one hundred eighty five (185) becquerels (five one-thousandths [0.005] :Ci) or more of removable contamination, the registrant shall:
12.21.e.1. Immediately withdraw the sealed source from use and store, repair or dispose of it in accordance with the requirements of Section d of this rule; and
12.21.e.2. File a report with the agency within five (5) days of receiving the leak test results with the agency describing the equipment involved, the test results, and the action taken.
12.21.f. A registrant need not perform a leak test on the following sources:
12.21.f.1. Sources containing only radioactive material with a half-life of less than thirty (30) days;
12.21.f.2. Sources containing only radioactive material as a gas; and
12.21.f.3. Sources containing three and seven-tenths (3.7) megabecquerels (one hundred [100] :Ci) or less of beta- or photon-emitting material or three hundred seventy (370) kilobecquerels (ten [10] :Ci) or less of alpha-emitting material.
12.21.g. A registrant in possession of a sealed source or brachytherapy source shall conduct a physical inventory of all such sources at intervals not to exceed 3 months. The registrant shall retain each inventory record for five (5) years. The inventory records shall contain the model number of each source, and serial number if one has been assigned, the identity of each source radionuclide and its estimated activity, the location of each source, date of the inventory, and the signature of the individual who performed the inventory.
12.21.h. A registrant in possession of a sealed source or brachytherapy source shall survey with a radiation survey instrument at intervals not to exceed 3 months all areas where such sources are stored. This does not apply to teletherapy sources in teletherapy units or sealed sources in diagnostic devices.
12.21.i. A registrant shall retain a record of each survey required in Subdivision 12.21.h. for 3 years. The record shall include the date of the survey, a sketch of each area that was surveyed, the measured dose rate at several points in each area expressed in microsieverts (mRem) per hour, the model number and serial number of the survey instrument used to make the survey, and the signature of the individual who performed the survey.
12.22. Syringe Shields.
12.22.a. A registrant shall keep syringes that contain radioactive material to be administered in an appropriate radiation shield or shielded area.
12.22.b. A registrant shall require each individual who prepares or administers radiopharmaceuticals to use an appropriate syringe radiation shield unless the use of the shield is contraindicated for that patient.
12.23. Syringe Labels. Unless utilized immediately, a registrant shall conspicuously identify each syringe, or syringe radiation shield as to contents or intended patient.
12.24. Vial Shields. A registrant shall require each individual preparing or handling a vial that contains a radiopharmaceutical to keep the vial in a vial radiation shield.
12.25. Vial Shield Labels. A registrant shall conspicuously label each vial radiation shield that contains a vial of a radiopharmaceutical with the radiopharmaceutical name or its abbreviation.
12.26. Surveys for Ambient Radiation Dose Rate and Contamination.
12.26.a. A registrant shall survey with a radiation detection survey instrument at the end of each day of use all areas where radiopharmaceuticals are prepared for use or administered.
12.26.b. A registrant shall survey with a radiation detection survey instrument at least once each week all areas where radiopharmaceuticals or radioactive wastes are stored.
12.26.c. A registrant shall conduct the surveys required by Subdivision 12.26.a. and b. so as to able to measure dose rates as low as one (1) microsievert (one-tenth [0.1] mRem) per hour.
12.26.d. A registrant shall establish dose rate action levels for the surveys required by Subdivision 12.26.a. and b. and shall require that the individual performing the survey immediately notify the radiation safety officer if a dose rate exceeds an action level.
12.26.e. A registrant shall survey for removable contamination each day of use all areas where radiopharmaceuticals are prepared for use or administered and each week where radioactive materials are stored.
12.26.f. A registrant shall conduct the surveys required by Subdivision 12.26.e. so as to be able to detect contamination on each wipe sample of thirty three and three-tenths (33.3) becquerels (two thousand [2000] dpm).
12.26.g. A registrant shall establish removable contamination action levels for the surveys required by Subdivision 12.26.e. and shall require that the individual performing the survey immediately notify the radiation safety officer if contamination exceeds action levels.
12.26.h. A registrant shall retain a record of each survey required by Subdivision 12.26.a., b., and e. for three (3) years. The record must include the date of the survey, a sketch of each area surveyed, action levels established for each area, the measured dose rate at several points in each area expressed in microsieverts (mRem) per hour or the removable contamination in each area expressed in becquerels (dpm) per one hundred (100) square centimeters, the serial number and the model number of the instrument used to make the survey or analyze the samples, and the initials of the individual who performed the survey.
12.27. Release of Patients Containing Radiopharmaceuticals or Permanent Implants.
12.27.a. A registrant shall not authorize release from confinement for medical care any patient administered a radiopharmaceutical until either:
12.27.a.1. The dose rate from the patient is less than fifty (50) :Sv (five [5] millirems) per hour at a distance of one (1) meter; or
12.27.a.2. The activity in the patient is less than one and eleven one-hundredths (1.11) GBq (thirty [30] millicuries).
12.27.b. A registrant shall not authorize release from confinement for medical care any patient administered a permanent implant until the dose rate from the patient is less than fifty (50) :Sv (five [5] millirems) per hour at a distance of one (1) meter.
12.28. Mobile Nuclear Medicine Service Technical Requirements. A registrant providing mobile nuclear medicine service shall:
12.28.a. Transport to each address of use only syringes or vials containing prepared radiopharmaceuticals or radiopharmaceuticals that are intended for reconstitution of radiopharmaceutical kits;
12.28.b. Bring into each area of use all radioactive material to be used and, before leaving, remove all unused radioactive material and associated radioactive waste;
12.28.c. Secure or keep under constant surveillance and immediate control all radioactive material when in transit or at an area of use;
12.28.d. In addition to complying with Subsection 12.17. and 12.18., check survey instruments and dose calibrators for constancy and response, and check all other transported equipment for proper function before medical use at each area of use;
12.28.e. Carry a survey meter calibrated in accordance with Subsection 12.18. in each vehicle that is being used to transport radioactive material, and, before leaving a client area of use, survey all areas of radiopharmaceutical use with a radiation detection survey instrument, including a survey for removable contamination, to ensure that all radiopharmaceuticals and all associated radioactive waste have been removed;
12.28.f. Retain a record of each survey required by Subdivision 12.28.e. for 3 years. The record must 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 (mRem) per hour, the removable contamination in each area expressed in becquerels (dpm) per one hundred (100) square centimeters, the model and serial number of the instrument used to make the survey, and the initials of the individual who performed the survey; and
12.28.g. Use radioactive gases only in areas of use and under conditions which have been evaluated and approved by the agency for compliance with airborne release standards.
12.29. Storage of Volatiles and Gases.
12.29.a. A registrant shall store volatile radiopharmaceuticals and radioactive gases in the shippers' radiation shield and container.
12.29.b. A registrant shall store and use a multidose container in a properly functioning fume hood.
12.30. Decay-In-Storage.
12.30.a. Before disposal in ordinary trash, a registrant shall hold radioactive material for decay-in-storage and is exempt from the waste disposal requirements of section 6. of this rule if the registrant:
12.30.a.1. Holds radioactive material for decay a minimum of ten (10) half-lives;
12.30.a.2. 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 an appropriate radiation detection survey instrument set on its most sensitive scale and with no interposed shielding;
12.30.a.3. Removes or obliterates all radiation labels; and
12.30.a.4. Separates and monitors each generator column individually with all radiation shielding removed to ensure that its contents have decayed to background radiation level before disposal.
12.30.b. For radioactive material disposed in accordance with Subdivision 12.30.a., the registrant shall retain a record of each disposal for three (3) years. The record must include the date of the disposal, the date on which the radioactive material was placed in storage, the radionuclides disposed, the model and serial number of the survey instrument used, the background dose rate, the radiation dose rate measured at the surface of each waste container, and the name of the individual who performed the disposal.
12.31. Use of Radiopharmaceuticals for Uptake, Dilution, or Excretion Studies.
12.31.a. A registrant may use any radioactive material in a radiopharmaceutical for a diagnostic use involving measurements of uptake, dilution, or excretion:
12.31.a.1. Which has been granted acceptance or approval by the Food and Drug Administration; or
12.31.a.2. Which is prepared and compounded in accordance with the rules of the State Board of Pharmacy.
12.32. Possession of Survey Instrument. A registrant authorized to use radioactive material for uptake, dilution, and excretion studies shall possess a portable radiation detection survey instrument capable of detecting dose rates over the range one (1) microsievert (one-tenth [0.1] mRem) per hour to five hundred (500) microsieverts (fifty [50] mRems) per hour. The instrument shall be operable and calibrated in accordance with Subsection 12.18.
12.33. Use of Radiopharmaceuticals, Generators, and Reagent Kits for Imaging and Localization Studies. A registrant may use any radioactive material in a diagnostic radiopharmaceutical (except aerosol or gaseous forms) or any generator or reagent kit for preparation and diagnostic use of a radiopharmaceutical containing radioactive material:
12.33.a. Which has been granted acceptance or approval by the Food and Drug Administration; or
12.33.b. Which has been prepared and compounded in accordance with the rules of the State Board of harmacy;
12.33.c. A registrant shall elute generators in compliance with Subsection 12.34.;
12.33.d. Provided the conditions of Subsection 12.35. are met, a registrant shall use radioactive aerosols or gases only if specific application is made to and approved by the agency.
12.34. Radionuclide Contaminants.
12.34.a. A registrant shall not administer a radiopharmaceutical containing:
12.34.a.1. More than fifteen one-hundredths (0.15) kilobecquerel of Molybdenum-99 per megabecquerel of Technetium-99m (fifteen one-hundredths [0.15] :Ci of Mo-99 per mCi of Tc-99m);
12.34.a.2. More than two one-hundredths (0.02) kilobecquerel of Strontium-82 per megabecquerel of Rubidium-82 chloride injection (two one-hundredths (0.02) :Ci of Sr-82 per mCi of Rb-82 chloride);
12.34.a.3. More than two-tenths (0.2) kilobecquerel of Strontium-85 per megabecquerel of Rubidium-82 chloride injection (two-tenths [(0.2] :Ci of Sr-85 per mCi of Rb-82).
12.34.b. A registrant preparing radiopharmaceuticals from radionuclide generators shall measure the concentration of radionuclide contaminant in each eluate or extract, as appropriate for the generator system, to determine compliance with the limits specified in Subdivision 12.34.a.
12.34.c. A registrant who must measure radionuclide contaminant concentration shall retain a record of each measurement for three (3) years. The record shall include, for each elution or extraction tested, the measured activity of the radiopharmaceutical expressed in megabecquerels (mCi), the measured activity of contaminant expressed in kilobecquerels (:Ci), the ratio of the measures expressed as kilobecquerels (:Ci) of contaminant per megabecquerel (mCi) of radiopharmaceutical, the date of the test, and the initials of the individual who performed the test.
12.34.d. A registrant shall report immediately to the agency each occurrence of radionuclide contaminant concentration exceeding the limits specified in Subdivision 12.4.a.
12.35. Control of Aerosols and Gases.
12.35.a. A registrant who administers radioactive aerosols or gases shall do so with a system that will keep airborne concentrations within the limits prescribed in Section 6. of this rule.
12.35.b. 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.
12.35.c. A registrant shall only administer radioactive gases in rooms that are at negative pressure with respect to surrounding rooms.
12.35.d. Before receiving, using, or storing a radioactive gas, the registrant shall calculate the amount of time needed after a release to reduce the concentration in the area of use to the occupational limit listed in Table 64-23 F of this rule. The calculation shall be based on the highest activity of gas handled in a single container and the measured available air exhaust rate.
12.35.e. A registrant shall post the time calculated in Subdivision 12.35.d. at the area of use and require that, in case of a gas spill, individuals evacuate the room until the posted time has elapsed.
12.35.f. A registrant shall check the operation of collection systems monthly and measure the ventilation rates in areas of use at intervals not to exceed six (6) months. Records of these checks and measurements shall be maintained for three (3) years.
12.35.g. A copy of the calculations required in Subdivision 12.35.d. shall be recorded and retained for the duration of the registration.
12.36. Possession of Survey Instruments. A registrant authorized to use radioactive material for imaging and localization studies shall possess a portable radiation detection survey instrument capable of detecting dose rates over the range of one (1) microsievert (one-tenth [0.1] mRem) per hour to five hundred 500 microsieverts (fifty [50] mRems) per hour, and a portable radiation measurement survey instrument capable of measuring dose rates over the range ten (10) microsieverts (one [1] mRem) per hour to ten (10) millisieverts (one thousand [1000] mRems) per hour. The instruments shall be operable and calibrated in accordance with Subsection 12.18.
12.37. Use of Radiopharmaceuticals for Therapy. A registrant may use any radioactive material in a radiopharmaceutical and for a therapeutic use:
12.37.a. Which has been granted acceptance or approval by the Food and Drug Administration; or
12.37.b. Which has been prepared and compounded in accordance with the rules of the State Board of Pharmacy.
12.38. Safety Instruction.
12.38.a. A registrant shall provide oral and written radiation safety instruction for all personnel caring for patients undergoing radiopharmaceutical therapy. Refresher training shall be provided at intervals not to exceed one (1) year.
12.38.b. To satisfy Subdivision 12.38.a., the instruction shall describe the registrant's procedures for:
12.38.b.1. Patient control;
12.38.b.2. Visitor control;
12.38.b.3. Contamination control;
12.38.b.4. Waste control;
12.38.b.5. Notification of the radiation safety officer or authorized user in case of the patient's death or medical emergency; and
12.38.b.6. Training for workers as required by Section 13. of this rule.
12.38.c. A registrant shall keep a record of individuals receiving instruction required by Subdivision 12.38.a., a description of the instruction, the date of instruction, and the name of the individual who gave the instruction. Such record shall be maintained for inspection by the agency for three (3) years.
12.39. Safety Precautions.
12.39.a. For each patient receiving radiopharmaceutical therapy and hospitalized for compliance with Subsection 12.27., a registrant shall:
12.39.a.1. Provide a private room with a private sanitary facility;
12.39.a.2. Post the patient's door with a "Caution: Radioactive Material" sign and note on the door or on the patient's chart where and how long visitors may stay in the patient's room;
12.39.a.3. Authorize visits by individuals under eighteen (18) years of age only on a case-by-case basis with the approval of the authorized user after consultation with the radiation safety officer;
12.39.a.4. 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 Section d of this rule and retain for three (3) 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 (mRem) per hour, the instrument used to make the survey, and the initials of the individual who made the survey;
12.39.a.5. Either monitor material and items removed from the patient's room to determine that any contamination 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 these materials and items as radioactive waste;
12.39.a.6. Instruct the patient and, where appropriate, the patient's family, orally and in writing concerning radiation safety precautions that will help to keep radiation dose to household members and the public as low as reasonably achievable before authorizing release of the patient;
12.39.a.7. Survey the patient's room and private sanitary facility for removable contamination with a radiation detection survey instrument before assigning another patient to the room. The room must not be reassigned until removable contamination is less than three and thirty three one-hundredths (3.33) becquerels (two hundred [200] dpm) per one hundred (100) square centimeters; and
12.39.a.8. Measure the thyroid burden of each individual who helped prepare or 0administer a dosage of I-131 within three (3) days after administering the dosage, and retain for the period required by Section 6. of this rule a record of each thyroid burden measurement, date of measurement, the name of the individual whose thyroid burden was measured, and the initials of the individual who made the measurements. Other procedures acceptable to the agency may be used for individuals who only prepare, but do not administer, doses of stabilized I-131.
12.39.b. For each non-hospitalized patient receiving radiopharmaceutical therapy, the registrant shall instruct the patient and, where appropriate, the patient's family, orally and in writing concerning radiation safety precautions that will help to keep radiation doses to the household members and the public as low as reasonably achievable.
12.39.c. The radiation safety officer or the authorized user shall be notified immediately if the hospitalized patient dies or has a medical emergency.
12.40. Possession of Survey Instruments. A registrant authorized to use radioactive material for radiopharmaceutical therapy shall possess a portable radiation detection survey instrument capable of detecting dose rates over the range one (1) microsievert (one-tenth [0.1] mRem) per hour to five hundred (500) microsieverts (fifty [50] mRems) per hour, and a portable radiation measurement survey instrument capable of measuring dose rates over the range ten (10) microsieverts (one [1] mRem) per hour to ten (10) millisieverts (one thousand [1000] mRems) per hour. The instruments shall be operable and calibrated in accordance with Subsection 12.18.
12.41. Use of Sealed Sources for Diagnosis. A registrant shall use the following sealed sources in accordance with the manufacturer's radiation safety and handling instructions:
12.41.a. Iodine-125 as a sealed source in a device for bone mineral analysis;
12.41.b. Americium-241 as a sealed source in a device for bone mineral analysis;
12.41.c. Gadolinium-153 as a sealed source in a device for bone mineral analysis or in a portable device for imaging; and
12.41.d. Iodine-125 as a sealed source in a portable device for imaging.
12.42. Availability of Survey Instrument. A registrant 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 (1) microsievert (one-tenth [0.1] mRem) per hour to five hundred (500) microsieverts (fifty [50] mRems) per hour or a portable radiation measurement survey instrument capable of measuring dose rates over the range ten (10) microsieverts (one [1] mRem) per hour to ten (10) microsieverts (one thousand [1000] mRems) per hour. The instrument shall be operable and calibrated in accordance with Subsection 12.18.
12.43. Use of Sources for Brachytherapy. A registrant shall use the following sources in accordance with the manufacturer's radiation safety and handling instructions:
12.43.a. Cesium-137 as a sealed source in needles and applicator cells for topical, interstitial, and intracavitary treatment of cancer;
12.43.b. Cobalt-60 as a sealed source in needles and applicator cells for topical, interstitial, and intracavitary treatment of cancer;
12.43.c. Gold-198 as a sealed source in seeds for interstitial treatment of cancer;
12.43.d. Iodine-125 as a sealed source in seeds for interstitial treatment of cancer;
12.43.e. Iridium-192 as seeds encased in nylon ribbon for interstitial treatment of cancer;
12.43.f. Strontium-90 as a sealed source in an applicator for treatment of superficial eye conditions; and
12.43.g. Palladium-103 as a sealed source in seeds for the interstitial treatment of cancer.
12.44. Safety Instruction.
12.44.a. The registrant shall provide oral and written radiation safety instruction to all personnel caring for a patient receiving implant therapy. Refresher training shall be provided at intervals not to exceed one (1) year.
12.44.b. To satisfy Subdivision 12.44.a., the instruction shall describe:
12.44.b.1. Size and appearance of the brachytherapy sources;
12.44.b.2. Safe handling and shielding instructions in case of a dislodged source;
12.44.b.3. Procedures for patient control;
12.44.b.4. Procedures for visitor control;
12.44.b.5. Procedures for notification of the radiation safety officer or authorized user if the patient dies or has a medical emergency; and
12.44.b.6. Training for workers as required by Section 13. of this rule.
12.44.c. A registrant shall maintain a record of individuals receiving instruction required by Subdivision 12.44.a., a description of the instruction, the date of instruction, and the name of the individual who gave the instruction for three (3) years.
12.45. Safety Precautions.
12.45.a. For each patient receiving implant therapy a registrant shall:
12.45.a.1. Not place the patient in the same room with a patient who is not receiving radiation therapy unless the registrant can demonstrate compliance with the radiation dose limits for individual members of the public as specified in Section 6. of this rule at a distance of one (1) meter from the implant;
12.45.a.2. Post the patient's door with a "Caution: Radioactive Materials" sign and note on the door or the patient's chart where and how long visitors may stay in the patient's room;
12.45.a.3. Authorize visits by individuals under 18 years of age only on a case-by-case basis with the approval of the authorized user after consultation with the radiation safety officer;
12.45.a.4. Promptly after implanting the sources, survey the dose rates in contiguous restricted and unrestricted areas with a radiation measurement survey instrument to demonstrate compliance with Section 6 of this rule and retain for three (3) years a record of each survey that includes the time and date of the survey, a sketch of the area or list of points surveyed, the measured dose rate at several points expressed in microsieverts (mRems) per hour, the instrument used to make the survey, and the initials of the individual who made the survey; and
12.45.a.5. Before authorizing the release of a patient administered a permanent implant, instruct the patient, and where appropriate, the patient's family, orally and in writing concerning radiation safety precautions that will help keep the radiation dose to household members and the public as low as reasonably achievable.
12.45.b. The radiation safety officer or authorized user shall be notified immediately if the hospitalized patient dies or has a medical emergency.
12.46. Brachytherapy Sources Inventory.
12.46.a. Each time brachytherapy sources are returned to an area of storage from an area of use, the registrant shall immediately count or otherwise verify the number returned to ensure that all sources taken from the storage area have been returned.
12.46.b. A registrant shall make a record of brachytherapy source utilization which includes:
12.46.b.1. The names of the individuals permitted to handle the sources;
12.46.b.2. The number and activity of sources removed from storage, the room number of use and patient's name, the time and date they were removed from storage, the number and activity of sources in storage after the removal, and the initials of the individual who removed the sources from storage; and
12.46.b.3. The number and activity of sources returned to storage, the room number of use and patient's name, 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.
12.46.c. Immediately after implanting sources in a patient and immediately after removal of sources from a patient, the registrant shall make a radiation survey of the patient and the area of use to confirm that no sources have been misplaced. The registrant shall make a record of each survey.
12.46.d. A registrant shall maintain the records required in Subdivision 12.46.b. and c. for three (3) years.
12.47. Release of Patients Treated With Temporary Implants.
12.47.a. Immediately after removing the last temporary implant source from a patient, the registrant shall perform a radiation survey of the patient with a radiation detection survey instrument to confirm that all sources have been removed. The registrant shall not release from confinement for medical care a patient treated by temporary implant until all sources have been removed.
12.47.b. A registrant shall maintain a record of patient surveys which demonstrate compliance with Subdivision 12.47.a. for three (3) years. Each record shall include the date of the survey, the name of the patient, the dose rate from the patient expressed as microsieverts (mRems) per hour and measured within 1 meter from the patient, and the initials of the individual who made the survey.
12.48. Possession of Survey Instruments. A registrant authorized to use radioactive material for implant therapy shall possess a portable radiation detection survey instrument capable of detecting dose rates over the range one (1) microsievert (one-tenth [0.1] mRem) per hour to five hundred (500) microsieverts (fifty [50] mRems) per hour, and a portable radiation measurement survey instrument capable of measuring dose rates over the range ten (10) microsieverts (one [1] mRem) per hour to ten (10) millisieverts (one thousand [1000] mRems) per hour. The instruments shall be operable and calibrated in accordance with Subsection 12.18.
12.49. Use of a Sealed Source in a Teletherapy Unit. A registrant shall use Cobalt-60 or cesium-137 as a sealed source in a teletherapy unit for medical use in accordance with the manufacturer's radiation safety and operating instructions.
12.50. Maintenance and Repair Restrictions. Only a person specifically licensed by the Nuclear Regulatory Commission, or an agreement state to perform teletherapy unit maintenance and repair shall install, relocate, or remove a teletherapy sealed source or a teletherapy unit that contains a sealed source or 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.
12.51. Amendments. In addition to the requirements specified in Subsection 12.4, a registrant shall apply for and receive a registration amendment before:
12.51.a. Making any change in the treatment room shielding;
12.51.b. Making any change in the location of the teletherapy unit within the treatment room;
12.51.c. Using the teletherapy unit in a manner that could result in increased radiation levels in areas outside the teletherapy treatment room;
12.51.d. Relocating the teletherapy unit; or
12.51.e. Allowing an individual not listed on the registrant's registration to perform the duties of the teletherapy physicist.
12.52. Safety Instruction.
12.52.a. A registrant shall conspicuously post written instructions at the teletherapy unit console. These instructions shall inform the operator of:
12.52.a.1. The procedure to be followed to ensure that only the patient is in the treatment room before turning the primary beam of radiation "on" to begin a treatment or after a door interlock interruption;
12.52.a.2. The procedure to be followed if 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
12.52.a.3. 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.
12.52.b. A registrant shall provide instruction in the topics identified in Subdivision 12.52.a. to all individuals who operate a teletherapy unit and shall provide appropriate refresher training to individuals at intervals not to exceed one (1) year.
12.52.c. A registrant shall maintain a record of individuals receiving instruction required by 12.52.b., a description of the instruction, the date of instruction, and the name of the individual who gave the instruction for three (3) years.
12.53. Doors, Interlocks, and Warning Systems.
12.53.a. A registrant shall control access to the teletherapy room by a door at each entrance.
12.53.b. A registrant shall equip each entrance to the teletherapy room with an electrical interlock system that shall:
12.53.b.1. Prevent the operator from turning the primary beam of radiation "on" unless each treatment room entrance door is closed;
12.53.b.2. Turn the beam of radiation "off" immediately when an entrance door is opened; and
12.53.b.3. 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.
12.53.c. A registrant shall equip each entrance to the teletherapy room with a conspicuously visible beam condition indicator light.
12.54. Possession of Survey Instrument. A registrant authorized to use radioactive material in a teletherapy unit shall possess either a portable radiation detection survey instrument capable of detecting dose rates over the range one (1) microsievert (one-tenth [0.1] mRem) per hour to five hundred (500) microsieverts (fifty [50] mRems) per hour or a portable radiation measurement survey instrument capable of measuring dose rates over the range 10 microsieverts (1 mRem) per hour to ten (10) microsieverts (one thousand [1000] mRems) per hour. The instruments shall be operable and calibrated in accordance with Subsection 12.18.
12.55. Radiation Monitoring Device.
12.55.a. A registrant shall have in each teletherapy room a permanent radiation monitor capable of continuously monitoring beam status.
12.55.b. Each radiation monitor shall be capable of providing visible notice of a teletherapy unit malfunction that results in an exposed or partially exposed source. The visible indicator of high radiation levels shall be observable by an individual entering the teletherapy room.
12.55.c. Each 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.
12.55.d. 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.
12.55.e. A registrant shall maintain a record of the check required by Subdivision 12.55.d. for 3 years. The record shall include the date of the check, notation that the monitor indicates when the source is exposed, and the initials of the individual who performed the check.
12.55.f. If a radiation monitor is inoperable, the registrant shall require any individual entering the teletherapy room to use a survey instrument or audible alarm personal dosimeter to monitor for any malfunction of the source exposure mechanism. The instrument or dosimeter shall be checked with a dedicated check source for proper operation at the beginning of each day of use. The registrant shall keep a record as described in Subdivision 12.55.e.
12.55.g. A registrant shall promptly repair or replace the radiation monitor if it is inoperable.
12.56. Viewing System. A registrant shall construct or equip each teletherapy room to permit continuous observation of the patient from the teletherapy unit console during irradiation.
12.57. Dosimetry Equipment.
12.57.a. A registrant shall have a calibrated dosimetry system available for use. To satisfy this requirement, one of the following two conditions shall be met:
12.57.a.1. The system shall have been calibrated by the national institute of standards and technology or by a calibration laboratory accredited by the American Association of Physicists in Medicine. The calibration shall have been performed within the previous two (2) years and after any servicing that may have affected system calibration; or
12.57.a.2. The system shall have been calibrated within the previous four (4) years; eighteen (18) to thirty (30) months after that calibration, the system shall have been intercompared at an intercomparison meeting with another dosimetry system that was calibrated within the past 24 months by the national institute of standards and technology or by a calibration laboratory accredited by the American Association of Physicists in Medicine. The intercomparison meeting shall be sanctioned by a calibration laboratory or radiologic physics center accredited by the American Association of Physicists in Medicine. The results of the intercomparison meeting must have indicated that the calibration factor of the registrant's system had not changed by more than two (2) percent. The registrant 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 registrant shall use a teletherapy unit with a Cobalt-60 source. When intercomparing dosimetry systems to be used for calibrating Cesium-137 teletherapy units, the registrant shall use a teletherapy unit with a Cesium-137 source.
12.57.b. The registrant shall have available for use a dosimetry system for spot-check measurements. To meet this requirement, the system may be compared with a system that has been calibrated in accordance with Subdivision 12.57.a. This comparison shall have been performed within the previous year and after each servicing that may have affected system calibration. The spot-check system shall be the same system used to meet the requirement in Subdivision 12.57.a.
12.57.c. The registrant shall maintain a record of each calibration, intercomparison, and comparison for the duration of the registration. 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 Subdivision 12.57.a. and b., the correction factors that were determined, 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 the American Association of Physicists in Medicine.
12.58. Full Calibration Measurements.
12.58.a. A registrant authorized to use a teletherapy unit for medical use shall perform full calibration measurements on each teletherapy unit:
12.58.a.1. Before the first medical use of the unit;
12.58.a.2. Before medical use under the following conditions:
12.58.a.2.A. Whenever spot-check measurements indicate that the output differs by more than five (5) percent from the output obtained at the last full calibration corrected mathematically for radioactive decay;
12.58.a.2.B. Following replacement of the source or following reinstallation of the teletherapy unit in a new location; and
12.58.a.2.C. 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
12.58.a.3. At intervals not exceeding 1 year.
12.58.b. To satisfy the requirement of Subdivision 12.58.a., full calibration measurements shall include determination of:
12.58.b.1. The output within three (3) percent for the range of field sizes and for the distance or range of distances used for medical use;
12.58.b.2. The coincidence of the radiation field and the field indicated by the light beam localizing device;
12.58.b.3. The uniformity of the radiation field and its dependence on the orientation of the useful beam;
12.58.b.4. Timer accuracy, constancy, and linearity;
12.58.b.5. "On-off" error; and
12.58.b.6. The accuracy of all distance measuring and localization devices in medical use.
12.58.c. A registrant shall use the dosimetry system described in Subsection 12.57. to measure the output for 1 set of exposure conditions. The remaining radiation measurements required in Paragraph 12.58.b.1. may then be made using a dosimetry system that indicates relative dose rates.
12.58.d. A registrant shall make full calibration measurements required by Subdivision 12.58.a. in accordance with the measurements required for annual calibration by "Comprehensive QA for Radiation Oncology: Report of AAPM Radiation Therapy Committee Task Group 40," Medical Physics, vol. 21, no. 4, 1994, pp. 581-618.
12.58.e. A registrant shall correct mathematically the outputs determined in Paragraph 12.58.b.1. for physical decay for intervals not exceeding one (1) month for Cobalt-60 and intervals not exceeding six (6) months for cesium-137.
12.58.f. Full calibration measurements required by Subdivision 12.58.a. and physical decay corrections required by Subdivision 12.58.e. shall be performed by a teletherapy physicist named on the registrant's registration or authorized by a registration issued by the Nuclear Regulatory Commission or an agreement state to perform such services.
12.58.g. A registrant shall maintain a record of each calibration for the duration of the registration. 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, the measured timer accuracy for a typical treatment time, the calculated "on-off" error, the estimated accuracy of each distance measuring or localization device, and the signature of the teletherapy physicist.
12.59. Periodic Spot Checks.
12.59.a. A registrant authorized to use teletherapy units for medical use shall perform output spot checks on each teletherapy unit at intervals not to exceed one (1) month.
12.59.b. To satisfy the requirement of Subdivision 12.59.a., spot checks shall include determination of:
12.59.b.1. Timer constancy and timer linearity over the range of use;
12.59.b.2. "On-off" error;
12.59.b.3. The coincidence of the radiation field and the field indicated by the light beam localizing device;
12.59.b.4. The accuracy of all distance measuring and localization devices used for medical use;
12.59.b.5. The output for 1 typical set of operating conditions; and
12.59.b.6. The difference between the measurement made in Paragraph 12.59.b.5. and the anticipated output, expressed as a percentage of the anticipated output (i.e., the value obtained at last full calibration corrected mathematically for physical decay).
12.59.c. A registrant shall use the dosimetry system described in Subsection 12.57. to make the spot check required in Paragraph 12.59.b.5.
12.59.d. A registrant shall perform spot checks required by Subdivision 12.59.a. in accordance with procedures established by the teletherapy physicist. The teletherapy physicist does not need to actually perform the output spot-check measurements.
12.59.e. A registrant shall have the teletherapy physicist review the results of each output spot check within fifteen (15) days. The teletherapy physicist shall promptly notify the registrant in writing of the results of each output spot check. The registrant shall keep a copy of each written notification for two (2) years.
12.59.f. A registrant authorized to use a teletherapy unit for medical use shall perform safety spot checks of each teletherapy facility at intervals not to exceed one (1) month.
12.59.g. To satisfy the requirement of Subsection 12.59.f., safety spot checks shall assure proper operation of:
12.59.g.1. Electrical interlocks at each teletherapy room entrance;
12.59.g.2. Electrical or mechanical stops installed for the purpose of limiting use of the primary beam of radiation restriction of source housing angulation or elevation, carriage or stand travel, and operation of the beam "on-off" mechanism;
12.59.g.3. Beam condition indicator lights on the teletherapy unit, on the control console, and in the facility;
12.59.g.4. Viewing systems;
12.59.g.5. Treatment room doors from inside and outside the treatment room; and
12.59.g.6. Electrically assisted treatment room doors with the teletherapy unit electrical power turned "off."
12.59.h. A registrant shall lock the control console in the "off" position if any door interlock malfunctions. No registrant shall use the unit until the interlock system is repaired unless specifically authorized by the agency.
12.59.i. A registrant shall promptly repair any system identified in Subdivision 12.59.g. that is not operating properly. The teletherapy unit shall not be used until all repairs are completed.
12.59.j. A registrant shall maintain a record of each spot check required by Subdivision 12.59.a. and f. for three (3) 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, the timer constancy and linearity, 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 timer constancy and linearity for a typical treatment time, the calculated "on-off" error, the estimated 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.
12.60. Radiation Surveys for Teletherapy Facilities.
12.60.a. Before medical use, after each installation of a teletherapy source, and after making any change for which an amendment is required by Subsection 12.51., the registrant shall perform radiation surveys with an operable radiation measurement survey instrument calibrated in accordance with Subsection 12.18. to verify that:
12.60.a.1. The maximum and average radiation levels at 1 meter from the teletherapy source with the source in the "off" position and the collimators set for a normal treatment field do not exceed one hundred (100) microsieverts (ten [10] mRems) per hour and twenty (20) microsieverts (two [2] mRems) per hour, respectively; and
12.60.a.2. 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 radiation, that:
12.60.a.2.A. Radiation levels in restricted areas are not likely to cause personnel exposures in excess of the limits specified in Section 6. of this rule; and
12.60.a.2.B. Radiation levels in unrestricted areas do not exceed the limits specified in Section 6. of this rule.
12.60.b. If the results of the surveys required in Subdivision 12.60.a. indicate any radiation levels in excess of the respective limit specified in that Paragraph, the registrant shall lock the control in the "off" position and not use the unit:
12.60.b.1. Except as may be necessary to repair, replace, or test the teletherapy unit, the teletherapy unit shielding, or the treatment room shielding; or
12.60.b.2. Until the registrant has received a specific exemption from the agency.
12.60.c. A registrant shall maintain a record of the radiation measurements made following installation of a source for the duration of the registration. 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, and 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 microsieverts (mRems) per hour, the calculated maximum level of radiation over a period of one (1) week for each restricted and unrestricted area, and the signature of the radiation safety officer.
12.61. Safety Spot Checks for Teletherapy Facilities.
12.61.a. A registrant shall promptly check all systems listed in Subdivision 12.59.g. for proper function after each installation of a teletherapy source and after making any change for which an amendment is required by Subsection 12.51.
12.61.b. If the results of the safety spot checks required in Subdivision 12.61.a. indicate the malfunction of any system specified in Subsection 12.59., the registrant 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.
12.61.c. A registrant shall maintain a record of the safety spot checks following installation of a source for three (3) years. 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, doors, and the signature of the radiation safety officer.
12.62. Modification of Teletherapy Unit or Room Before Beginning a Treatment Program. If the survey required by Subsection 12.60. indicates that an individual in an unrestricted area may be exposed to levels of radiation greater than those permitted by Section 6 of this rule, before beginning the treatment program the registrant shall:
12.62.a. Either equip the unit with stops or add additional radiation shielding to ensure compliance with Section 6. of this rule;
12.62.b. Perform the survey required by Subsection 12.60. again; and
12.62.c. Include in the report required by Subsection 12.63. the results of the initial survey, a description of the modification made to comply with Subdivision 12.62.a., and the results of the second survey; or
12.62.d. Request and receive a registration amendment under Section 6. of this rule that authorizes radiation levels in unrestricted areas greater than those permitted by Section 6. of this rule.
12.63. Reports of Teletherapy Surveys, Checks, Tests, and Measurements. A registrant shall furnish a copy of the records required in Subsections 12.60.,.12.61., and 12.62., and the output from the teletherapy source expressed as grays (Rads) per hour at 1 meter from the source as determined during the full calibration required in Subsection 12.58. to the agency within thirty (30) days following completion of the action that initiated the record requirement.
12.64. Five-Year Inspection.
12.64.a. A registrant shall have each teletherapy unit fully inspected and serviced during teletherapy source replacement or at intervals not to exceed five (5) years, whichever comes first, to assure proper functioning of the source exposure mechanism.
12.64.b. This inspection and servicing shall only be performed by persons specifically registered to do so by an agreement state, or the Nuclear Regulatory Commission.
12.64.c. A registrant shall maintain a record of the inspection and servicing for the duration of the registration. The record shall contain the inspector's name, the inspector's registration 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.
12.65. Training Requirements for Radiation Safety Officers. Except as provided in Subsection 12.66., an individual fulfilling the responsibilities of the radiation safety officer as provided in Section 12.7. shall:
12.65.a. Be certified by the:
12.65.a.1. American Board of Health Physics in Comprehensive Health Physics; or
12.65.a.2. American Board of Radiology in Radiological Physics, Therapeutic Radiological Physics, or Medical Nuclear Physics; or
12.65.a.3. American Board of Nuclear Medicine; or
12.65.a.4. American Board of Science in Nuclear Medicine; or
12.65.a.5. Board of Pharmaceutical Specialties in Nuclear Pharmacy or Science; or
12.65.a.6. American Board of Medical Physics in Radiation Oncology Physics; or
12.65.a.7. Royal College of Physicians and Surgeons of Canada in Nuclear Medicine; or
12.65.a.8. American Osteopathic Board of Radiology; or
12.65.a.9. American Osteopathic Board of Nuclear Medicine; or
12.65.b. Have had two hundred (200) hours of classroom and laboratory training covering:
12.65.b.1. Radiation physics and instrumentation;
12.65.b.2. Radiation protection;
12.65.b.3. Mathematics pertaining to the use and measurement of radioactivity;
12.65.b.4. Radiation biology;
12.65.b.5. Radiopharmaceutical chemistry; and
12.65.b.6. Have had one (1) year of full-time experience in radiation safety at a medical institution under the supervision of the individual identified as the radiation safety officer on an agency, agreement state, licensing state, or the Nuclear Regulatory Commission registration or registration that authorizes the medical use of radioactive material; or
12.65.c. Be an authorized user for those radioactive material uses that come within the radiation safety officer's responsibilities.
12.66. Training for Experienced Radiation Safety Officer. An individual identified as a radiation safety officer on an agency, agreement state, licensing state, or Nuclear Regulatory Commission registration or registration on July 1, 2001 who oversees only the use of radioactive material for which the registrant was authorized on that date need not comply with the training requirements of Subsection 12.65.
12.67. Training for Uptake, Dilution, or Excretion Studies. Except as provided in Subsection 12.75. and 12.76., the registrant shall require the authorized user of a radiopharmaceutical listed in Subsection 12.31. to be a physician who:
12.67.a. Is certified in:
12.67.a.1. Nuclear medicine by the American Board of Nuclear Medicine; or
12.67.a.2. Diagnostic Radiology by the American Board of Radiology; or
12.67.a.3. Diagnostic radiology or radiology by the American Osteopathic Board of Radiology; or
12.67.a.4. Nuclear medicine by the American Osteopathic Board of Nuclear Medicine; or
12.67.a.5. Nuclear medicine by the Royal College of Physicians and Surgeons of Canada; or
12.67.b. Has completed forty (40) hours of instruction in basic radionuclide handling techniques applicable to the use of prepared radiopharmaceuticals, and twenty (20) hours of supervised clinical experience.
12.67.b.1. To satisfy the basic instruction requirement, forty (40) hours of classroom and laboratory instruction shall include:
12.67.b.1.A. Radiation physics and instrumentation;
12.67.b.1.B. Radiation protection;
12.67.b.1.C. Mathematics pertaining to the use and measurement of radioactivity;
12.67.b.1.D. Radiation biology; and
12.67.b.1.E. Radiopharmaceutical chemistry.
12.67.b.2. To satisfy the requirement for twenty (20) hours of supervised clinical experience, training must be under the supervision of an authorized user at a medical institution and shall include:
12.67.b.2.A. Examining patients and reviewing their case histories to determine their suitability for radionuclide diagnosis, limitations, or contraindications;
12.67.b.2.B. Selecting the suitable radiopharmaceuticals and calculating and measuring the dosages;
12.67.b.2.C. Administering dosages to patients and using syringe radiation shields;
12.67.b.2.D. Collaborating with the authorized user in the interpretation of radionuclide test results; and
12.67.b.2.E. Patient followup; or
12.67.b.2.F. 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 all the topics identified in Subdivision 12.67.b.
12.68. Training for Imaging and Localization Studies. Except as provided in Subsection 12.75. or 12.76. the registrant shall require the authorized user of a radiopharmaceutical, generator, or reagent kit specified in Subsection 12.33. to be a physician who:
12.68.a. Is certified in:
12.68.a.1. Nuclear medicine by the American Board of Nuclear Medicine; or
12.68.a.2. Diagnostic radiology by the American Board of Radiology; or
12.68.a.3. Diagnostic radiology or radiology by the American Osteopathic Board of Radiology; or
12.68.a.4. Nuclear medicine by the American Osteopathic Board of Nuclear Medicine; or
12.68.a.5. Nuclear medicine by the Royal College of Physicians and Surgeons of Canada; or
12.68.b. Has completed two hundred (200) hours of instruction in basic radionuclide handling techniques applicable to the use of prepared radiopharmaceuticals, generators, and reagent kits, 500 hours of supervised work experience, and five hundred (500) hours of supervised clinical experience.
12.68.b.1. To satisfy the basic instruction requirement, two hundred (200) hours of classroom and laboratory training shall include:
12.68.b.1.A. Radiation physics and instrumentation;
12.68.b.1.B. Radiation protection;
12.68.b.1.C. Mathematics pertaining to the use and measurement of radioactivity;
12.68.b.1.D. Radiopharmaceutical chemistry; and
12.68.b.1.E. Radiation biology.
12.68.b.2. To satisfy the requirement for five hundred (500) hours of supervised work experience, training shall be under the supervision of an authorized user at a medical institution and shall include:
12.68.b.2.A. Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys;
12.68.b.2.B. Calibrating dose calibrators and diagnostic instruments and performing checks for proper operation of survey meters;
12.68.b.2.C. Calculating and safely preparing patient dosages;
12.68.b.2.D. Using administrative controls to prevent the misadministration of radioactive material;
12.68.b.2.E. Using emergency procedures to contain spilled radioactive material safely and using proper decontamination procedures; and
12.68.b.2.F. Eluting Technetium-99m from generator systems, assaying and testing the eluate for molybdenum-99 and alumina contamination, and processing the eluate with reagent kits to prepare Technetium-99m labeled radiopharmaceuticals.
12.68.b.3. To satisfy the requirement for five hundred (500) hours of supervised clinical experience, training shall be under the supervision of an authorized user at a medical institution and shall include:
12.68.b.3.A. Examining patients and reviewing their case histories to determine their suitability for radionuclide diagnosis, limitations, or contraindications;
12.68.b.3.B. Selecting the suitable radiopharmaceuticals and calculating and measuring the dosages;
12.68.b.3.C. Administering dosages to patients and using syringe radiation shields;
12.68.b.3.D. Collaborating with the authorized user in the interpretation of radionuclide test results; and
12.68.b.3.E. Patient followup; or
12.68.c. 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 all the topics identified in Subdivision 12.68.b.
12.69. Training for Therapeutic Use of Radiopharmaceuticals. Except as provided in Subsection 12.75., the registrant shall require the authorized user of a radiopharmaceutical listed in Subsection 12.37. for therapy to be a physician who:
12.69.a. Is certified in:
12.69.a.1. Nuclear medicine by the American Board of Nuclear Medicine; or
12.69.a.2. Radiation oncology, therapeutic radiology, or radiology by the American Board of Radiology; or
12.69.a.3. Nuclear medicine or radiation oncology by the American Osteopathic Board of Radiology after 1984; or
12.69.a.4. Nuclear medicine by the Royal College of Physicians and Surgeons of Canada; or
12.69.b. Has completed eighty (80) hours of instruction in basic radionuclide handling techniques applicable to the use of therapeutic radiopharmaceuticals, and has had supervised clinical experience.
12.69.b.1. To satisfy the requirement for instruction, eighty (80) hours of classroom and laboratory training shall include:
12.69.b.1.A. Radiation physics and instrumentation;
12.69.b.1.B. Radiation protection;
12.69.b.1.C. Mathematics pertaining to the use and measurement of radioactivity; and
12.69.b.1.D. Radiation biology;
12.69.b.2. To satisfy the requirement for supervised clinical experience, training shall be under the supervision of an authorized user at a medical institution and shall include:
12.69.b.2.A. Use of Iodine-131 for diagnosis of thyroid function and the treatment of hyperthyroidism or cardiac dysfunction in ten (10) individuals;
12.69.b.2.B. Use of soluble Phosphorus-32 for the treatment of ascites, polycythemia vera, leukemia, or bone metastases in three individuals;
12.69.b.2.C. Use of Iodine-131 for treatment of thyroid carcinoma in three (3) individuals;
12.69.b.2.D. Use of colloidal chromic Phosphorus-32 or of colloidal Gold-198 for intracavitary treatment of malignant effusions in three individuals; and
12.69.b.2.E. Use of strontium-89 as strontium chloride for the treatment of pain associated with bone metastases in three individuals.
12.70. Training for Therapeutic Use of Brachytherapy Sources. Except as provided in Subsection 12.75., the registrant shall require the authorized user using a brachytherapy source specified in Subsection 12.43. for therapy to be a physician who:
12.70.a. Is certified in:
12.70.a.1. Radiology, therapeutic radiology, or radiation oncology by the American Board of Radiology; or
12.70.a.2. Radiation oncology by the American Osteopathic Board of Radiology; or
12.70.a.3. Radiology, with a specialization in radiotherapy, as a British "Fellow of the Faculty of Radiology" or "Fellow of the Royal College of Radiology"; or
12.70.a.4. Therapeutic radiology by the canadian royal college of physicians and surgeons; or
12.70.b. Is in the active practice of therapeutic radiology, has completed two hundred (200) hours of instruction in basic radionuclide handling techniques applicable to the therapeutic use of brachytherapy sources and five hundred (500) hours of supervised work experience and a minimum of three (3) years of supervised clinical experience.
12.70.b.1. To satisfy the requirement for instruction, two hundred (200) hours of classroom and laboratory training shall include:
12.70.b.1.A. Radiation physics and instrumentation;
12.70.b.1.B. Radiation protection;
12.70.b.1.C. Mathematics pertaining to the use and measurement of radioactivity; and
12.70.b.1.D. Radiation biology.
12.70.b.2. To satisfy the requirement for five hundred (500) hours of supervised work experience, training shall be under the supervision of an authorized user at a medical institution and shall include:
12.70.b.2.A. Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys;
12.70.b.2.B. Checking survey meters for proper operation;
12.70.b.2.C. Preparing, implanting, and removing sealed sources;
12.70.b.2.D. Using administrative controls to prevent the misadministration of radioactive material; and
12.70.b.2.E. Using emergency procedures to control radioactive material.
12.70.b.3. To satisfy the requirement for a period of supervised clinical experience, training shall include one (1) 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 (2) years of clinical experience in therapeutic radiology under the supervision of an authorized user at a medical institution. The supervised clinical experience shall include:
12.70.b.3.A. Examining individuals and reviewing their case histories to determine their suitability for brachytherapy treatment, and any limitations or contraindications;
12.70.b.3.B. Selecting the proper brachytherapy sources, dose, and method of administration;
12.70.b.3.C. Calculating the dose; and
12.70.b.3.D. Post-administration followup and review of case histories in collaboration with the authorized user.
12.71. Training for Ophthalmic Use of Strontium-90. Except as provided in Subsection 12.75., the registrant shall require the authorized user using only Strontium-90 for ophthalmic radiotherapy to be a physician who:
12.71.a. Is certified in radiology, therapeutic radiology, or radiation oncology by the American Board of Radiology; or
12.71.b. Is in the active practice of therapeutic radiology or ophthalmology, and has completed twenty four (24) hours of instruction in basic radionuclide handling techniques applicable to the use of Strontium-90 for ophthalmic radiotherapy, and a period of supervised clinical training in ophthalmic radiotherapy.
12.71.b.1. To satisfy the requirement for instruction, the classroom and laboratory training shall include:
12.71.b.1.A. Radiation physics and instrumentation;
12.71.b.1.B. Radiation protection;
12.71.b.1.C. Mathematics pertaining to the use and measurement of radioactivity; and
12.71.b.1.D. Radiation biology.
12.71.b.2. To satisfy the requirement for a period of supervised clinical training in ophthalmic radiotherapy, training shall be under the supervision of an authorized user at a medical institution and shall include the use of strontium-90 for the ophthalmic treatment of five (5) individuals that includes:
12.71.b.2.A. Examination of each individual to be treated;
12.71.b.2.B. Calculation of the dose to be administered;
12.71.b.2.C. Administration of the dose; and
12.71.b.2.D. Followup and review of each individual's case history.
12.72. Training for Use of Sealed Sources for Diagnosis. Except as provided in Subsection 12.75., the registrant shall require the authorized user using a sealed source in a device specified in Subsection 12.41. to be a physician, dentist, or podiatrist who:
12.72.a. Is certified in:
12.72.a.1. Radiology, diagnostic radiology with special competence in nuclear radiology, therapeutic radiology, or radiation oncology by the American Board of Radiology; or
12.72.a.2. Nuclear medicine by the American Board of Nuclear Medicine; or
12.72.a.3. Diagnostic radiology or radiology by the American Osteopathic Board of Radiology; or
12.72.a.4. Nuclear medicine by the Royal College of Physicians and Surgeons of Canada; or
12.72.b. Has completed eight (8) hours of classroom and laboratory instruction in basic radionuclide handling techniques specifically applicable to the use of the device.
12.72.b.1. To satisfy the requirement for instruction, the training shall include:
12.72.b.1.A. Radiation physics, mathematics pertaining to the use and measurement of radioactivity, and instrumentation;
12.72.b.1.B. Radiation biology; and
12.72.b.1.C. Radiation protection and training in the use of the device for the purposes authorized by the registration.
12.73. Training for Teletherapy. Except as provided in Subsection 12.75., the registrant shall require the authorized user of a sealed source specified in Subsection 12.49. in a teletherapy unit to be a physician who:
12.73.a. Is certified in:
12.73.a.1. Radiology, therapeutic radiology, or radiation oncology by the American Board of Radiology; or
12.73.a.2. Radiation oncology by the American Osteopathic Board of Radiology; or
12.73.a.3. Radiology, with specialization in radiotherapy, as a British "Fellow of the Faculty of Radiology" or "Fellow of the Royal College of Radiology"; or
12.73.a.4. Therapeutic radiology by the Canadian Royal College of Physicians and Surgeons; or
12.73.b. Is in the active practice of therapeutic radiology, and has completed two hundred (200) hours of instruction in basic radionuclide techniques applicable to the use of a sealed source in a teletherapy unit, five hundred (500) hours of supervised work experience, and a minimum of three (3) years of supervised clinical experience.
12.73.b.1. To satisfy the requirement for instruction, the classroom and laboratory training shall include:
12.73.b.1.A. Radiation physics and instrumentation;
12.73.b.1.B. Radiation protection;
12.73.b.1.C. Mathematics pertaining to the use and measurement of radioactivity; and
12.73.b.1.D. Radiation biology.
12.73.b.2. To satisfy the requirement for five hundred (500) hours of supervised work experience, training shall be under the supervision of an authorized user at an institution and shall include:
12.73.b.2.A. Review of the full calibration measurements and periodic spot checks;
12.73.b.2.B. Preparing treatment plans and calculating treatment times;
12.73.b.2.C. Using administrative controls to prevent misadministrations;
12.73.b.2.D. Implementing emergency procedures to be followed in the event of the abnormal operation of a teletherapy unit or console; and
12.73.b.2.E. Checking and using survey meters.
12.73.b.3. To satisfy the requirement for a period of supervised clinical experience, training shall include 1 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 (2) years of clinical experience in therapeutic radiology under the supervision of an authorized user at a medical institution. The supervised clinical experience shall include:
12.73.b.3.A. Examining individuals and reviewing their case histories to determine their suitability for teletherapy treatment, and any limitations or contraindications;
12.73.b.3.B. Selecting the proper dose and how it is to be administered;
12.73.b.3.C. Calculating the teletherapy doses and collaborating with the authorized user in the review of patients' progress and consideration of the need to modify originally prescribed doses as warranted by patients' reaction to radiation; and
12.73.b.3.D. Post-administration followup and review of case histories.
12.74. Training for Teletherapy Physicist. The registrant shall require the teletherapy physicist to:
12.74.a. Be certified by the American Board of Radiology in:
12.74.a.1. Therapeutic radiological physics;
12.74.a.2. Roentgen-ray and gamma-ray physics;
12.74.a.3. X-ray and radium physics; or
12.74.a.4. Radiological physics; or
12.74.b. Be certified by the American Board of Medical Physics in Radiation Oncology Physics; or
12.74.c Hold a master's or doctor's degree in physics, biophysics, radiological physics, or health physics, and have completed 1 year of full time training in therapeutic radiological physics and also one (1) year of full time work experience under the supervision of a teletherapy physicist at a medical institution. To meet this requirement, the individual shall have performed the tasks listed in Subsection 12.21., 12.58., 12.59., and 12.60. under the supervision of a teletherapy physicist during the year of work experience.
12.75. Training for Experienced Authorized Users. Practitioners of the healing arts identified as authorized users for the human use of radioactive material on an agency, the Nuclear Regulatory Commission or agreement state or licensing state registration or registration on July 1, 2001 who perform only those methods of use for which they were authorized on that date need not comply with the training requirements of Subsections 12.65 through 12.77.
12.76. Physician Training in a Three-Month Program. A physician who, before July 1, 1984, began a three-month nuclear medicine training program approved by the accreditation council for graduate medical education and has successfully completed the program, is exempted from the requirements of Subsections 12.67 or 12.68.
12.77. Recentness of Training. The training and experience specified in Subsection 12.65. through 12.74. shall have been obtained within the five (5) years preceding the date of application or the individual shall have had continuing applicable experience since the required training and experience was completed.

Notes

W. Va. Code R. § 64-23-12

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