ML20148K766
| ML20148K766 | |
| Person / Time | |
|---|---|
| Issue date: | 11/01/1977 |
| From: | NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | |
| References | |
| RTR-REGGD-10.XXX AA73-1, NUREG-0338, NUREG-0338-DRFT, NUREG-338, NUREG-338-DRFT, NUDOCS 7811170284 | |
| Download: ML20148K766 (111) | |
Text
n 9
NUREG-0338. Rev. 1 l
l l
{;e DRAFT i r I
l A Guide For Preparation Of Applications l
for Medical Programs l
Nuclear Regulatory Commission i
Radioisotopes Licensing Branch l
Division of Fuel Cycle i
and Materials Safety 0 1 B77 Date:
DRAFT Collation of information upon which Regulatory Guide 10xx vill be based.
7811170 M m/
o
l l
1.0 Introduction 1.1 Purpose of Guide This Guide describes the type and extent of information needed 0
by the Nuclear Regulatory Commission (NRC) Licensing staff to evaluate an application for a specific license for the posses-sion and use of byproduct material (reactor produced radio-nuclides), in or on human beings.
This type of license is provided for under Title 10, Code of Federal Regulations, Part 35, " Human Uses of Byproduct Material," (10 CFR Part 35).
The NRC will usually issue a single byproduct material license to cover the institution's entire radioisotope program, other than teletherapy.
Separate licenses, other than for teletherapy, are not normally issued to different departments of a medical institution, nor are they issued to individuals associated with the hospital.
The applicant should carefully study the regulations and this guide, and submit all information requested.
The NRC will request additional information, when necessary, to provide reasonable assurance that the applicant has established an adequate radiation safety program.
Such requests will delay final action on the application.
)
_ _ _ 1.2 Applicable Regulations In addition to 10 CFR Part 35, other regu'ations pertaining to this type of license are found in 10 CFR Part 19, " Notices, Instructions, and Reports to Workers; Inspections," 10 CFR Part 20, " Standards for Protection Against Radiation," 10 CFR 30, " Rules of General Applicability to Licensing of Byproduct Material," and 10 CFR Part 170, " Fees for Facilities and Materials Licenses."
1.3 Items Reouiring Separate Applications A separate application should be submitted for kilocurie 4
a.
sources used in teletherapy facilities.
A specific licensing guide for teletherapy applications is available upon request.
I b.
Source and Special Nuclear Materials Separate applications should be submitted for these materials in accordance with Part 40, " Licensing of Source Material," and Part 70, "Special Nuclear Material,"
of Title 10 of the Code of Federal Regulation.
Source j
material is defined in paragraph 40.4(h) of 10 CFR Part 40 as (1) uranium or thorium, or any combination thereof, in any physical or chemical form or (2) cres that contain by weight 1/20 of one percent (0.05%) or more of i
d l
I (a) uranium, (b) thorium, or (c) any combination thereof.
Source material does not include special nuclear material.
Special nuclear material is defined in paragraph 70.4(m) of 10 CFR Part 70 and includes (1) plutonium, uranium 233, uranium enriched in the isotope 233 or in the isotope 235, (2) any material artifically enriched by any one of the foregoing but does not include source material.
1.4 As Low As Is Reasonably Achievable (ALARA)
Paragraph 20.l(c) of 10 CFR states that "... persons engaged in activities under licenses issued by the Nuclear Regulatory
. Commission pursuant to the Atomic Energy Act of 1954, as amended, and the Energy Reorganization Act of 1974 should, in addition to complying with the requirements set forth in this part, make every reasonable effort to maintain radiation exposures, and releases of radioactive materials in effluents to unrestricted areas, as low as is reasonably achievable."
l Regulatory Guide 8.10, " Operating Philosophy for Maintaining Occupational Radiation Exposures as Low As is Reasonably Achievable," provides the NRC staff position on this important l
subject.
License applicants should give consideration to the ALARA philosophy, as described in Regulatory Guide 8.10, in the development of plans for work with licensed raciioactive materials.
, 1.5 Types of Material Licenses The general license provided in Section 35.31 of 10 CFR a.
Part 35 author:2cs the registrant physician to posses and use limited quantities of prepackaged individual doses of iodine-131 for measurement of thyroid up-take, iodine-125 and iodine-131 for blood and plasma volume determinations, cobalt-58 and cobalt-60 for intestinal absorption of cyanocobalamin, and chromium-51 for red blood cell volume i
and survival time determinations.
Section 35.31 explains the general license requirements and requires the physician to register with the Commission and receive a registration number prior to receiving or using the diagnostic radio-pharmaceuticals covered by the general license.
Section 31.11 of 10 CFR Part 31 establishes a general j
b.
license authorizing physicians, clinical laboratories, and hospitals to possess certain small quantities of byproduct material (iodine-125, iodine-131, carbon-14, hydrogen-3, iron-59, selenium-75, and mock iodine-125 reference sources) for in vitro clinical or laboratory tests not involving the internal or external administra-tion of byproduct material or the radiation therefrom to human beings or animals.
Section 31.11 explains the 4
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/
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t general license requirements and requires the applicant to register with the Commission and receive a registration number prior to receiving or using the byproduct material for h vitro testing.
Licenses issued to physicians for private practice specify c.
the radioisotopes and the clinical uses that may be per-formed by the physician to whom the license is issued.
Such licenses are issued to physicians who are located in private offices and not on hospital premises.
It is not required that a medical isotopes committee be formed.
l The private practice license does not permit other physi-cians to obtain clinical radioisotope trair.ing and experi-ences under it.
Section 35.12 of 10 CFR Part 35 outlines specific requirements for this type of license, d.
Specific licenses of limited scope issued to institutions specify the radioisotopes and the clinical uses that may l
be performed by physicians named on the institution's l
license.
The regulations in Section 35.ll(b) of 10 CFR i
Part 35 require an institutional licensee to have a medical isotope committee (see Appendix B) to evaluate all proposals for clinical research, diagnostic, and therapeutic uses of radioisotopes within the institution.
_ _ _ _ _ - _ _ The physicians named on the institution's license conduct their programs with the approval of the medical isotopes committee.
Institutional licenses provide a means whereby nonapproved physicians under the supervision of physicians named on the license may obtain basic and clinical radio-isotope training and experience which may enable them to qualify as individual users.
Training and experience criteria for physicians are outlined in Appendix A.
Specific licenses of broad scope for medical use, i.e.,
e.
licenses authorizing multiple quantities and types of byproduct material for unspecified users, are issued to institutions that (1) have had previous experience operating under a specific institutional license of limited scope and (2) are engaged in medical research as well as routine diagnosis and therapy using radioisotopes.
Such programs operate under the supervision of a medical isotopes committee.
Individual users are not named on the license nor are radioisotopes limited to specified uses.
Individual users and procedures are approved by the institution's medical isotope committee.
Physicians may obtain basic and clinical radioisotope training and experience in the 1
l (
use of radiopharamecuticals in such programs.
This type of license is not appropriate for most institutions using byproduct material in medical programs and is fully fiscussed in a licensing guide dealing specifically with the broad license.
- 2. 0 LICENSE FEES An application fee is required for most types of licenses.
The applicant should refer to 9 170.31, " Schedule of Fees for Materials Licenses," of 10 CFR Part 170 to determine the amount of fee that must accompany the application.
Review of the application will not begin until the proper fee is received by the NRC.
3.0 FILING AN APPLICATION A license application for specific licenses for human use should be submitted on Form NRC-313M " Application for Materials License-Medical." All items on the application form should be completed in sufficient detail for the NRC licensing staff to determine that the applicant's equipment, facilities, and radiation protection program are adequate to protect health and minimize danger to life and property.
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1
{ t Since the space provided on Form NRC-313M is limited, the applicant should append separate sheets of paper for Items 7-23 listed in the Form.
Each separate sheet should contain the item number and the application date at the bottom right hand corner of each page.
The application should be completed in triplicate.
The original and one copy should be mailed to:
Radioisotopes Licensing Branch, Division of Fuel Cycle and Material Safety, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, D.C. 20555.
One copy of the applica-tion with all attachments should be retained by the applicant, since the license will require as a condition that the licensee follow the statements and representations set forth in the application and any supplement to it.
4.0 CONTENTS OF AN APPLICATION Form NRC-313M Item 1.a.
Enter the name, mailing address and telephone number of applicant.
If the request is for a private license, enter the l
name of the physician or partnership.
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Item 1.b.
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List the addresses and locations where radioactive material will be used or stored if other than the address stated in Item 1.a.
If multiple addresses are to be used, explain the extent of use at each address and the facilities and equipment
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located at each place of use.
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Item 2 Enter the name and telephone number (including area code) of the individual to be contacted.
Item 3 Indicate whether this is an application for a new license,
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amendment or renewal.
Item 4 List the full names of all physicians who will use or directly supervise the use of byproduct material.
Item 5 State the name and title of the person designated by, and responsible to, the institution's management for the coordina-tion of the institution's radiation protection program (some-i times designated the " Radiation Safety Officer").
- if) -
Item 6.a.
For routine human use you may check the group numbers of Schedule A, Section 35.100, of 10 CFR Part 35 for which you 4
are requesting a license.
Groups I, II and III consist of the more commonly used diagnostic procedures that involve radio-pharmaceuticals; Groups IV and V consist of routine therapeutic procedures thdt involve radiopharmaceuticals; and Group VI consists of sealed sources used primarily for therapeutic d
procedures.
For Groups I, II, IV, and V, possession limits are not listed on the license.
For Group III, the possession limit will be two curies of each radioactive material listed unless a larger limit is requested in the application.
The requested possession limit for Group VI and any radioactive material listed separately from Groups I-V should be stated.
The possession limit for each radio-nuclide should include material held as radioactive waste.
Item 6.b.
For routine human use not listed in Groups I-VI and for non-human use, list each radionuclide to be used, the chemical and physical form, and the maximum quantity (in millicuries).
List the manufacturer's name, model number, and activity (in millicuries) for all sealed sources.
A specific authorization must be obtained from the NRC to perform studies invclving the use of radioactive material in animals.
Describe the intended use for each radionuclide and form listed in Item 6.6.
If the radioactive material is for human use and has not been approved for routine human use by the Food and Drug Administration (FDA), you should submit evidence that your procurement, preparation and use of the material will be in accordance with the Federal Food, Drug and Cosmetic Act and the Public Health Service Act.
If the study is conducted f
under a " Notice of Claimed Investigational Exemption for a New Drug" (IND) sponsored by the physician or institution you should state the radionuclide, chemical form, possession limit, use, and submit a copy of the IND acceptance letter from the Food and Drug Administration.
Item 7 Medical Isotopes Committee In accordance with Section '5.ll(b), 10 CFR Part 35, an insti-tution applying for a byproduct material license for human use shall establish a medical isotopes committee.
This comittee
)
- _ _ _ _ _ _ _ _ _ _ _ _ should contain at least three (3) members to evaluate all proposals for research, diagnosis and therapeutic use of radioisotopes.
Membership of the committee should include:
Physicians expert in internal medicine, hematology, a.
I therapeutic radiology.
b.
A person with special competence in radiation safety, c.
A representative of the institution's management.
The following information should be submitted, a.
The responsibility and duties of the committee, b.
The meeting frequency of the committee (at least quarterly).
The name and specialty of each member of the committee.
c.
Apper. dix B contains an example of typical responsibilities and duties for a medical isotopes committee.
In response to Item 7 you may state that the responsibilities, duties and meeting frequency will be as described in Appendix B to this
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guide.
1 f T If the responsibilities, duties, or meeting frequency will be
. different from those described, submit a complete description.
Item 8 Training and Experience a.
Authorized User (s)
{
If the physician has been previously authorized to use the radioactive material requested in this application, it is necessary to submit only the previous license number (if issued by the AEC or 14RC) or a copy of the license (if issued by an Agreement State).
If the physician has not been previously authorized to use the radioactive material being requested, state where he is licensed to practice medicine and submit a complete description of his training and experience.
Criteria for acceptable training and experience are contained in Appendix A.
Supplements A and B to NRC Form-313M are forms that may be used for the description of the physi-cian's training and experience.
b.
Radiation Safety Officer If the radiation safety officer is not one of the physi-cians named in Item 4, submit a complete description of g
his training and experience.
Supplement A to NRC Form-313M
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i may be used for the description of the radiation safety I
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officer's training and experience.
Item 9 Instrumentation Instruments required in a typical nuclear medicine laboratory are:
a.
Survey Instruments (1) A low level survey meter capable of detecting 0.1 i
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milliroentgen per hour to perform contamination surveys.
(2) A high level survey meter such as an ionization type capable of reading up to 1 roentgen per hour to measure radiation exposure rates that may exist in j
the vicinity of Mo-99/Tc-99m generators and thera-peutic quantities of radioactive material.
b.
Dose calibrators and other instruments to assay radio-pharmaceuticals.
t c.
Diagnostic instruments for all procedures (e.g., gamma camera, well counter, thyroid probe).
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d.
Other pertinent instrumentation (e.g., liquid scintil-lation counter, area monitor).
Appendix C contains a form that may be used to describe your instruments.
If you do not use this form, attach equiva-lent information.
Item 10 Methods, Freouencies and Standards Used for Calibrating Instruments Listed in Item 9 a.
Survey Instruments Aa adequate calibration of survey instruments cannot be performed with built-in check sources.
Electronic calibra-tions that do not involve a source of radiation are also not adequate to determine the proper functioning and response of all components of an instrument.
Daily constancy checks of survey instruments should be supplemented every 12 months with a two point calibration on each scale of the instrument such that (1) one point is in each half of the scale, and (2) the two points are separated by 35-50% of full scale.
Survey instruments should also be calibrated after repair.
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A survey instrument may be considered properly calibrated at one point when the exposure rate measured by the l
instrument differs from the true exposure rate by less 1
than 10% of full scale.
If you propose to calibrate your own radiation survey and i
monitoring instruments, you should submit a detailed dercription of your planned calibration procedures.
The description of calibration procedures should include, as a minimum-a.
The manufacturer's name and model number of the source (s) to be used.
b.
The nuclide and activity (in millicuries) of radioactive material contained in the source.
l c.
The accuracy of the source (s).
Traceability of the source to a primary standard should be provided, d.
The step-by-step procedures, including associated radiation safety procedures.
These procedures should include a two-
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point calibration of each scale of each instrument with the points separated by 35-50% of full scale.
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. - _ _ _ If a consultant or outside firm will perform the calibration of your radiation survey and monitoring instruments you should specify his name, address, and the license number.
You should contact the firm or consultant that will provide the calibra-tion to determine if information concerning calibration proce-dures has been filed with the Commission.
If this information has not been filed, you should submit it with your application.
Appendix D contains a description of an acceptable calibration procedure for survey instruments and a form that may be used to supply the information required in Item 10 of the applica-tion form.
b.
Dose Calibrator All radiopharmaceuticals should be assayed for activity to an accuracy of 10% prior to being administered to patients.
The usual method for performing assays is with f
a dose calibrator.
Upon installation and periodically thereafter dose calibrators should be tested for accuracy of response for the energies commonly used, for geometrical variation, for linearity of response over the entire range of activities to be used, and for day-to-day constancy of operation.
l
_ _ _ _ _ _ _ _ _ - You should submit a descriptinn of your calibration procedures.
These should include as a minimum:
(1) The manufacturer's name and model number of any sealed sources to be used (unless authorized by Section 35.14(d), 10 CFR Part 35).
(2) The nuclide and activity (in millicuries) of radio-active material in the standards.
(3) The accuracy of the standard.
Traceability of the i
source to a primary standard should be provided.
(4) The step-by-step procedures used for calibration.
If an instrument other than a dose calibrator is used to assay patient doses, submit a complete description of:
(1) The assay method.
(2) The method of calibration.
(3) The frequency of calibration.
(4) The standards to be used for calibration (radio-nuclide, activity, accuracy.)
Appendix D contains a description of acceptable calibra-tion procedures for dose calibrators and a form that may be used to supply the information required in Item 10 of o
i this application form.
I c.
Diagnostic Instruments Manuf acturer's directions should be followed for calibra-tion and maintenance of diagnostic instrumentation.
l Item 11 Facilities and Equipment Describe the available facilities and equipment (e.g., remote handling equipment, storage containers, shielding, fume hoods) at each location where radioactive material will be used.
Include a description of the area (s) assigned for the receipt, l
storage (including waste), preparation, and measurement of radioactive material.
l i
A diagram should be submitted showing the locations of shield-t l
ing, the proximity of radiation sources to unrestricted areas, and other items related to radiation safety.
Any wall shield-ing, special storage area shielding, or movable shielding around storage areas, generators, kit preparation areas, etc.
j should be indicated.
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l l 1 For facilities in which radioactive material may become airborne, the diagrams should also include schematic descrip-tions of the ventilation system, with pertinent airflow rates, pressures, filtration equipment, and monitoring instruments.
Diagrams should be drawn to a specified scale, or dimensions should be indicated.
Examples of acceptable f acility and equipment descriptions are attached.
Item 12 Personnel Training Program Submit a description of training required for all personnel who work with or in the vicinity of radioactive materials.
The description should include the form of training (e.g.,
formal course work, lectures), the duration of training and the subject matter included.
The training program should be of sufficient scope to ensure that all personnel, including clerical, nursing, housekeeping, and security personnel, receive proper instruction in the items specified in Section 19.12 of 10 CFR Part 19, including:
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Potential hazards associated with radioactive material.
c.
Radiological safety procedures appropriate to their respective duties.
d.
Pertinent NRC regulations.
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The rules and regulations.of the licensee.
f.
The pertinent terms of the license.
g.
Their obligation to report unsafe conditions.
h.
Appropriate response to emergencies or unsafe conditions.
i.
Their right to be informed of their radiation exposure and bioassay results.
)
You should verify that personnel will be properly instructed:
i a.
Before assuming their duties with or in the vicinity of radioactive materials.
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' b.
During annual refresher training.
Whenever there is a significant change in duties, regula-c.
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tions, or the terms of the license.
2 Item 13 Procedures for Ordering and Receiving Radioactive Materials Submit a copy of written procedures for ordering radioactive materials, for receipt of materials during off-duty hours, and for notification of responsible persons upon receipt of radio-active materials.
These procedures should be adequate to ensure that possession limits are not exceeded, that radioactive materials are secured at all times against unauthorized removal i
and that radiation levels in unrestricted areas do not exceed the limits specified in 920.105 of 10 CFR Part 20.
i Security personnel, nursing personnel or anybody else who receives packages during off-duty hours, should be issued written instructions as to procedures to be followed for receiving, examining and securing the package and for notifica-4 tion procedures if the package is found or suspected to be leaking and immediate steps to be taken to prevent spread of 3
contaminction.
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_ _ - _ _ - _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ 1 Appendix E contains sample procedures and instructions for the receipt of packages containing radioactive material.
Item 14 Procedures for Safely Opening Packages Containing Radioactive Material
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Describe your procedures for examining incoming packages for leakage, contamination or damage, and for safely opening packages in accordance with Section 20.205 of 10 CFR Part 20.
The monitoring should be performed as soon as practicable after receipt of the package of radioactive material.
The procedures may vary depending on the quantity of radioactive material received, but should, at a minimum include instruc-tions for surveying packages, wearing gloves while opening packages and checking packing material for contamination after opening.
Even though Section 20.205 exempts certain packages from immediate monitoring, procedures must be established for 5
safely opening all packages containing radioactive material.
Appendix F contains a description of an acceptable procedure e
for safely opening packages.
In response to Item 14, you may state that you will follow the procedures described in Appendix F or you may submit a copy of equivalent procedures.
- 1 i
Item 15 Laboratory Rules for Use of Radioactive Material 1
Submit a copy of general instructions to be followed by physi-cians and technicians while working with radioactive materials.
An acceptable example of such instructions is listed in Appendix G of this guide.
The instruction should:
Outline control procedures for obtaining permission to a.
use radioactive material at the institution.
b.
Explain what laboratory apparel to wear and what equipment to use, e.g., wearing of lab coats, the use of disposal i
gloves, trays, etc.
Prescribe limitations and conditions relative to handling c.
liquid or loose radioactive materials and what laboratory equipment to use in working with them.
For example, explain which materials and operations should be confined to radiochemical fume hoods or gloveboxes.
d.
Explain what shielding or remote handling equipment is to be used when hard beta and/or gamma emitting materials f
are handled.
Preparation of radiopharmaceuticals from reagent kits should be done behind shielding.
Syringe shields should be used for the preparation and administra-L tion of patient doses.
_ _ _ _ _ _ _. e.
Give instructions for preparation and assay of patient doses.
f.
Give instructions concerning movement of material between rooms, halls, or in corridors if applicable, g.
Explain requirements for storage of materials, labeling of containers, and identification of areas where radio-active materials are used.
You should describe the shielding used for areas where large amounts of byproduct material are stored.
h.
Specify personnel monitoring devices to be used, where to obtain them, and instructions for recording exposure
)
results or properly turning in personnel monitoring a
devices for processing at appropriate intervals.
i.
Instruct the user in waste disposal procedures to follow for each type of waste, (e.g., liquids, gases, solids, long-lived, short-lived).
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j.
Describe contamination control procedures including pro-
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hibitions against smoking,. eating or the consumption of f
beverages in restricted areas and instruction for indivi-duals who prepare doses and radiopharmaceuticals to moni--
I tor their hands after each pror.edure and at the end of i
the day.
i Appendix G contains an acceptable set of laboratory rules for use of radioactive material.
In response to Item 15, you may state that you will follow the laboratory rules described in Appendix G or you may submit a copy of equivalent rules.
Item 16 Emergency Procedures Submit a copy of emergency instructions to be posted in all laboratory areas where radioactive materials are used. These instructions should (1) describe immediate action to be taken in order to prevent contamination of personnel and work areas (e.g., turning off the ventilation, evacuation of the area,
(
containment of the spill), (2) state the names and telephone numbers of the responsible persons.to be notified in case of an emergency,-and (3) instruct personnel on appropriate methods for reentering, decontaminating, and recovering facilities N
that may have been accidentally contaminated.
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. An acceptable set ~of Emergency Procedures is contained in Appendix H.
In response to Item 16, you may refer to Appendix H or submit a copy of equivalent procedures.
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Item 17 Area Survey Procedures Submit a description of the routine survey program, including the areas to be surveyed, the levels of contamination considered to be acceptable and provisions for maintaining records of surveys.
If the application is to cover multiple users and areas of use, the individual user should supplement the surveys performed by the radiation safety staff.
Acceptable procedures and fre-quencies for routine surveys are described in Appendix I to a
this guide.
In response to It'm 17, you may either refer to Appendix I or submit equivalent procedures.
Item 18 Waste Disposal Procedures Submit a complete description of specific methods used for disposal of waste byproduct material.
A licensee may dispose of waste by:
a.
Transfer to a person properly licensed to receive such waste, e.g., commercial waste disposal firms.
(See Section 20.301 of 10 CFR Part 20.) Submit the name and NRC or Agreement State license number of the commercial i
firm selected.
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b.
Release into a sanitary sewer in conformance with Section 20.303, 10 CFR Part 20.
You should describe your methods for controlling the sewage disposal of radioactive wastes in order to ensure that disposals do not exceed the limits specified in Section 20.303 of 10 CFR Part 20.
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c.
Burial in soil in conformance with Section 20.304, 10 CFR
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Part 20.
d.
Release into the air in conformance with Section 20.106, i
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Other methods specifically approved by the Commission e.
pursuant to Section 20.302, 10 CFR Part 20.
i l
NOTE:
No licensee may dispose of byproduct material waste by incineration unless specifically authorized by the Commission.
(See Section 20.305 of 10 CFR Part 20.)
h
. L Appendix J contains a form that may be used to supply the information required in Item 18 of the application form.
Item 19 Therapeutic Use of Radiopharmaceuticals i
Describe special precautions for patients treated with byproduct l
l material listed in Groups IV and V, Schedule A, Section 35.100 of 10 CFR Part 35.
Although Groups IV procedures are often performed on an out patient basis, these patients sometimes require hospitalization.
1 l
Appropriate p*ocedures should be established for all patients i
treated with byproduct material and should include:
i a.
Method for preparation and administration of therapeutic doses of iodine-131.
b.
Methods for contamination control:
i (1) assignment to private room I
i (2) use of disposable items (e.g., dishes, utensils, etc.).
c.
Procedures for surveys of:
(1) unrestricted areas l
)
(2) linens and other items removed from patient's room (3) patient's room before it is reassigned to another patient.
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Instructions to nursing staff.
e.
Procedures for disposal of waste:
(1) patient excreta (2) surgical dressings (3) disposable items.
f.
Procedures to be followed in case of emergency surgery or
- death, g.
Procedures for release of patients:
(1) criteria for release of patients (2) instructions to patient and family.
i l
Guidance for the management of therapy patients can be found in National Council on Radiation Protection and Measurements (NCRP) Report No. 37, "Precaut os in the Management of Patients Who Have Received Therapeutic Amounts of Radionuclides," (NCRP Reports are available from:
NCRP Publications, P.O. Box 30175, Washington, DC 20014).
I s
Appendix K contains a description of precautions to be followed for patients treated with iodine-131, gold-198 and phosphorus-32 In response to Item 19, you may state that you will follow the procedures described in Appendix K or submit a copy of equiv-alent procedures.
Item 20 Therapeutic Use of Sealed Sources Describe special procedures for patients treated with byproduct materials listed in Group VI, Schedule A, Section 35.100 of 10 CFR Part 35.
These procedures should include descriptions of:
a.
The areas where sealed sources will be stored, including (1) placement and thickness of shielding and (2) proximity of the storage area to unrestricted areas.
b.
Special precautions to be used while handling sealed sources.
c.
Special instructions for nursing care of patients who are treated with sealed sources.
(Appendix L contains a description of procedures to be followed for patients treated with sealed sources).
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d.
Your method'for determining-the radiation doses to the
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extremities of personnel handling sealed sources.
The equipment and shielding available for transporting i
e.
sources from storage sites to the place of use.
l f.
Your method for maintaining source' accountability at all
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times. This should include a description of your sign-in i
and sign-out procedures, periodic invento'y, and your r
method for determining that all sources are accounted for
-l and returned to storage following treatment.
)
g.
Surveys to be performed during the course of treatment and at the conclusion of treatment.
Your dismissal i
survey should be adequate to determine that all temporary implant sources have been removed from the patient and from all areas that the patient occupied.
You should submit detailed responses to Items Nos. 20.a.,
20.b., 20.d., 20.e., 20.f., and 20.g.
In response to Item 20.c.,
you may either state that you will follow the procedures
]
described in Appendix L or you may submit equivalent procedures.
D ei
! Item 21 Information to be Submitted-for the Use of Radioactive Gases (e.g., Xenon-133) o The use of radioactive gases (e.g., xenon-133 gas or gas in saline) requires attention not only to the standard radiation safety considerations but also to an evaluation of expected air concentrations of the radioactive gas in restricted and unrestricted areas.
The NRC requires that each applicant make such determinations for his own unique situation and submit sufficient evidence to the Commission in support of his request.
Appendix M contains sample procedures and instructions for submitting an application to use xenon-133.
Item 22 Procedures and Precautions for use of Radioactive Material in Animals Describe procedures to be followed if radioisotopes will be used in animals including (1) a description of the animal housing facilities, (2) a copy of instructions provided to animal caretakers for the handling of animals, animal waste and carcasses, (3) instructions for cleaning and decontam-inating animal cages, and (4) procedures for ensuring that animal rooms will be locked or otherwise secured unless attended by authorized users of radioactive material.
w Item 23 Procedures and Precautions for Use of Radioactive Materials Specified in Item 6.b.
Any additional radiation safety procedures to be followed while individuals are using these materials listed in Item 6.b. should be clearly stated, e.g., air sampling, other special surveys, bioassays.
Bioassays may be required when individuals work with millicurie quantities of hydrogen-3, iodine-125 or iodine-131 (depending on the chemical and physical form, the procedures followed, and the equipment used).
Bioassays may also be required for other radionuclides if the chemical or physical form or proce-dures and equipment used make it likely that the radioactive material will be ingested, inhaled, or absorbed into the body.
i The applicant should show in his application that the need for bioassays has been thoroughly considered and that the p-oposed bioassay program is appropriate for his intended use of radio-active material.
Item 24 State the name of the organization furnishing film badge or thermoluminescent dosimeter (TLD) service.
Specity the frequency with which the badges are changed and evaluated, and give a description of the type, e.g., whole body, or finger badge.
I 1
( Item 25.a.
(For Private Practice Licenses Only)
State the name and address of the hospital that has agreed to admit patients containing radioactive material.
I Item 25.b.
Submit a copy of the letter of authorization, signed by the adtainistrator, from the hospital that has agreed to admit patients containing radioactivity.
Item 25.c.
If patients treated with therapeutic quantities under this license are admitted to the hospital, you should (1) describe the radiation detection instruments available at the hospital and (2) submit a copy of radiation safety procedures to be followed.
- 5. 0 AMENDMENTS TO LICENSES Licensees are required to conduct their programs in accordance with statements, representations, and procedures contained in the license application and supportive documents.
The license must therefore be amended if the licensee plans to make any changes in the facilities, equipment (including monitoring and survey instruments), procedures, personnel, or byproduct material to be used.
.-.s.-
m 6.m
' ?
Applications for license amendments may be filed either on the application form or in letter form.
The application should identify the license by number and should clearly describe the exact nature of the changes, additions, or deletions.
Refer-ences to previously submitted information and documents should be clear and specific and should identify the pertinent informa-tion by date, page, and paragraph.
6.0 RENEWAL OF A LICENSE An application for renewal of a license should be filed at least 30 days prior to the expiration date.
This will ensure that the license does not expire until final action on the application has been taken by the NRC as provided for in paragraph 30.37(b) of 10 CFR Part 30.
Renewal applications should be filed on Form NRC-313M appro-oriately supplemented, and should contain complete and up-to-date information about the applicant's current program.
In order to facilitate the review process, the application for renewal should be submitted without reference to previously submitted documents and information.
If such references cannot be avoided, they should be clear and specific and should identify the pertinent information by date, page, and paragraph.
I The application should be completed in triplicate.
The original and one copy should be mailed to:
Radioisotopes Licensing Branch, Division of Fuel Cycle and Material Safety, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, D.C. 20555.
One copy of the applica-tion, with all attachments, should be retained by the applicant, i
since the license will require, as a condition, that the institution follow the statements and representations set forth in the application and any supplement to it.
I
l Appendices Order Appendix Title l
A Acceptable Training and Experience for Medical Uses of Byproduct Material B
Medical Isotopes Committee C
Instrumentation 0
Instrumentation Calibration j
Section 1 - Methods for Calibration of Survey Meters, Including Procedures, Standards and Frequency Section 2 - Methods of Calibration for a Dose Calibrator E
Procedures for Ordering and Receiving Radioactive Materials F
Procedures for Openirg Packages Containing Radioactive Materials G
Laboratory Rules for the Use of Radioactive Material H
Emergency Procedures I
Survey Procedures J
Waste Disposal Procedures K
Procedures for Use of Groups IV and V Radiopharma-ceuticals for Treatment of Patients L
Procedures for Use of Group VI sources for Treatment of Patients M
Information to be Submitted for the Use of Radioactive l
Gases (e.g., xenon-133) h
(
I APPENDIX A ACCEPTABLE TRAINING AND EXPERIENCE FOR MEDICAL USES OF BYPRODUCT MATERIAL Section 35.11 (d) of 10 CFR 35 provides that the Commission will approve l
i a license application by an institution for medical use of byproduct material if it determines, among other things, that the physician designated as the individual user is adequately trained and experienced in (a) basic radioisotope handling techniques and (b) the clinical use of byproduct material proposed in the application.
Similar criteria are established in Section 35.12 (c) of 10 CFR 35 for approval of licenses for medical use of radiopharmaceuticals by individual physicians.
Out-lined below are training and experience criteria that the Commission, with the assistance of its Advisory Committee on the Medical Uses of Isotopes, has found acceptable for physicians who use radiopharma-cauticals.
Each physician's training and experience are examined on a case-by-case basis.
if a physician wishes to use radiopharmaceuticals but does not have the training and experience described, he may submit an appication listing his specific qualifications and this will be reviewed by the Commission with the assistance of the Medical Advisory Committee.
)
I.
GENERAL TRAINING To qualify as adequately trained to use or directly supervise the use of
~
byproduct material listed in Groups I, II and/or III, Section 35.100 of 10 CFR Part 35, a physician should have:
A.
Training in basic radioisotope handling techniques (200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br />) consisting of lectures, laboratory sessions, discus-sion groups or supervised experience in a nuclear medicine laboratory in the following areas:
1.
Radiation physics and instrumentation (100 hours0.00116 days <br />0.0278 hours <br />1.653439e-4 weeks <br />3.805e-5 months <br />) 2.
Radiation Protection
( 30 hours3.472222e-4 days <br />0.00833 hours <br />4.960317e-5 weeks <br />1.1415e-5 months <br />)
)
3.
Mathematics pertaining to the use and measure-ment of radioactivity
( 20 hours2.314815e-4 days <br />0.00556 hours <br />3.306878e-5 weeks <br />7.61e-6 months <br />) 4.
Radiation biology
( 20 hours2.314815e-4 days <br />0.00556 hours <br />3.306878e-5 weeks <br />7.61e-6 months <br />) 5.
Radiopharmaceutical chemistry
( 30 hours3.472222e-4 days <br />0.00833 hours <br />4.960317e-5 weeks <br />1.1415e-5 months <br />)
(The hours listed next to each of the five subjects above are suggested values and should not be interpreted as specific requirements.)
B.
Experience with the types and quantities of byproduct material for which the application is being made, or equivalent (500 hours0.00579 days <br />0.139 hours <br />8.267196e-4 weeks <br />1.9025e-4 months <br />).
!, 1 l
4 C.
Supervised clinical training in an institutional nuclear medicine
(
program (500 hours0.00579 days <br />0.139 hours <br />8.267196e-4 weeks <br />1.9025e-4 months <br />).
The clinical training should cover all appropriate types of diagnostic procedures and include:
j i
1.
Supervised examination of patients to determine the suitability for radioisotope diagnosis and recommendation on dosage to be prescribed.
2.
Collaboration in calibration of the dose and the actual 1
administration of the dose to the patient, including calculation f
of the radiation dose, related measurement and plotting data.
d 3.
Follow-up of patients when required.
4.
Study and discussion with preceptor of case histories to
(
establish most appropriate diagnostic procedures, limitation, contraindication, etc.
Note:
The require:nents specified in Sections A, B and C may be satisfied i
f concurrently in a three month training program IF all three areas are integrated into the program.
4 i
Note:
(
For each physician named in Item 4 of Form NRC-313M complete Supplements A and B of Form NRC-313M (Preceptor Statement and the statement of a
l
(
l
l 1 training in basic radioisotope handling techniques).
For each subject covered in basic training, state where the training was obtained, the
~
dates, total number of hours and type of training (e.g., lectures, labo-
)
ratory sessions).
Alternative:
Certification by the American Board of Nuclear Medicine will be accepted as evidence that a physician has had adequate training and experience to use Groups I, II and III.
Certification by the American Board of Radiology in Diagnostic Radiology with Special Competence in Nuclear Radiology will be accepted as evidence j
l that a physician has had adequate training in basic radioisotope handling techniques and has had adequate clinical experience to use Groups II and i
f III.
TRAINING REQUIREMENTS FOR SPECIFIC DIAGNOSTIC PROCEDURES II.
A physician who wishes to be authorized for only one or two specific diagnostic procedures should have training in basic radioisotope handling techniques and clinical procedures commensurate with the procedures and quantities of byproduct material being requested.
Such requests will be examined on a case-by-case basis by the Commission with the assistance of the Advisory Committee on the Medical Uses of Isotopes.
____________ _. III. TRAINING REQUIREMENTS FOR THERAPY PROCEDURES INVOLVING-RADI0 PHARMACEUTICALS To qualify as adequately trained to use or directly supervise the use of byproduct material listed in Groups IV and/or, V, Section 35.100 of 10 CFR Part 35, a physician should have:
A.
Training in basic radioisotope handling techniques (80 hours9.259259e-4 days <br />0.0222 hours <br />1.322751e-4 weeks <br />3.044e-5 months <br />) including:
1.
Radiation physics and instrumentation (25 hours2.893519e-4 days <br />0.00694 hours <br />4.133598e-5 weeks <br />9.5125e-6 months <br />) 2.
Radiation protection (25 hours2.893519e-4 days <br />0.00694 hours <br />4.133598e-5 weeks <br />9.5125e-6 months <br />) 3.
Mathematics pertaining to the use and measurement of radioactivity (10 hours1.157407e-4 days <br />0.00278 hours <br />1.653439e-5 weeks <br />3.805e-6 months <br />) 4.
Radiation biology (20 hours2.314815e-4 days <br />0.00556 hours <br />3.306878e-5 weeks <br />7.61e-6 months <br />)
(These requirements are in lieu of, not in addition to, those specified in Section I.A., above.)
8.
Clinical training in specific therapy procedures:
For Group IV (i)
Iodine-131 for treatment of hyperthyroidism and/or cardiac conditions:
- Clinical experience in the diagnosis of thyroid function and active participation in the treatment of ten patients.
j
i (ii) Phosphorus-32 for treatment of polycythemia vera, leukemia and/or bone metastases:
- Treatment of three patients with any combination of these three conditions.
(iii) Colloidal phosphorus-32 intracavitary treatment:
- Active participation in the treatment of three patients.
For Group V (1)
Iodine-131 for treatment of thyroid carcinoma:
- Clinical experience in diagnosis of thyroid function and treatment of hyperthyroidism and/or cardiac dysfunction, and active participation in the treatment of three patients with thyroid carcinoma.
g (ii)
Colloidal gold-198 for intracavitary treatment:
- Active participation in the treatment ~ of three patients.
IV.
TRAINING REQUIREMENTS FOR THERAPY PROCEDURES INVOLVING SEALE0 SOURCES To qualify as adequately trained to use or directly supervise the use of byproduct material listed in Group VI, Section 35.100 of 10 CFR Part 35, a physician should have:
A.
Training in basic radioisotope handling techniques (200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br />) as described in Section I.A. of this Appendix.
)
l
} B.
Clinical training in specific therapy procedures:
(1) Radiation sources for interstitial, intracavitary, or surface treatment of cancer:
- Active practice in therapeutic radiology with a minimum of three years experience.
(ii) Beta ray applicators for the treatment of superficial eye disease:
- Active practice in therapeutic radiology or opthalomology i
and experience in the therapeutic use of beta rays or soft X-rays.
(Evidence of certification by the American Board of Radiology in Radiology or Therapeutic Radiology may be submitted in lieu of the information requested in Subsections A and B, above.)
l i
I l
APPENDIX B MEDICAL IS0 TOPES COMMITTEE
\\
l Responsibility:
The Committee is responsible for:
l 1.
Ensuring that all individuals who work with or in the vicinity of radioactive material have sufficient training and experience to enable them to perform their duties safely and in accordance with NRC regulations and the conditions of the license.
2.
Ensuring that all use of radioactive material is conducted in a i
safe manner and in accordance with NRC regulations and the conditions of the license.
l l
Duties:
The Committee shall:
t 1.
Be familiar with all pertinent NRC regulations, the terms of the l
license, and information submitted in support of the request for t
i the license and its amendments.
2.
Review the training and experience of any individual who uses radioactive material (including physicians, technologists, physicists, and pharmacists) and determine that the qualifications are' sufficient
i l
i 2
to enable them to perform their duties safely and in accordance
]
with NRC regulations and the conditions of the license.
3.
Establish a program to ensure that all individuals whose duties may require them to work in the vicinity of radioactive material
]
(e.g., nursing, security and housekeeping personnel) are properly instructed as required by Section 19.12, of 10 CFR Part 19.
1 4.
Review and approve all requests for use of radioactive material within the institution.
)
5.
Prescribe special conditions that will be required during a proposed use of radioactive material such as requirements for bioassays, physical examinations of users and special monitoring procedures.
6.
Review the entire radiation safety program at least annually to determine that all activities are being conducted safely and in accordance with NRC regulations and the conditions of the license.
The review shall include an examination of all records, reports l
from the radiation safety officer, results of NRC inspection.
written safety procedures and managemen. control system.
1 i
- i i.
7.
Recommend remedial action to ' correct any deficiencies identified in the radiation safety program.
)
l 8.
Maintain written records of all committee meetings, actions, recommendations, and decisions.
9.
Ensure that the byproduct material license is amended, when necessary, j
prior to any changes in facilities, equipment, policies, procedures, I
and personnel.
Meeting Frequent,y; The medical isotopes committee shall meet as often as necessary to conduct its business, but not less than once in each calendar quarter.
r t
f.
APPENDIX C INSTRUMENTATION 1.
Survey meters a.
Manufacturer's name:
Manufacturer's model number:
Number of instruments available:
Minimum range:
mr/hr to mr/hr Maximum range:
mr/hr to mr/hr b.
Manufacturer's name:
Manufacturer's model number:
Number of instruments available:
ranges:
Minimum range mr/hr to mr/hr Maximum range mr/hr to mr/hr
__. 2.
Dose calibrator Manufacturer's name:
Manufacturer's model number:
Number of instruments available:
3.
Diagnostic instruments Manufacturer's Type of Instrument Name Model No.
4.
Other i
I
i APPENDIX D Section 1 METHODS FOR CALIBRATION OF SURVEY METERS, INCLUDING PROCEDURES, STANDARDS AND FREQUENCY A.
Calibration of survey meters shall be performed with radionuclide sources.
I 1.
The sources shall be approximate point sources.
l 2.
The source activities shall be traceable within 5% accuracy to I
the U.S. National Bureau of Standards (NBS) calibrations.
3.
The frequency shall be at least annually.
4.
Each scale of the instrument shall be calibrated at approximately 1/3 and 2/3 of full. scale.
5.
The exposure rate measured by the instrument shall differ from the true exposure rate by less than 10% of full scale (read appropriate section of the instrument manual to determine how to make necessary adjustments to bring instrument into calibra-tion).
Readings within + 20% will be considered acceptable if a calibration chart or graph is prepared and attached to the instrument.
NOTE:
Sources of Cs-137, Ra-226, or Co-60 are appropriate for the performance of calibration.
The activity of the calibration standard should be sufficient to calibrate the survey meters on all ranges, or at least up to 1 R/ hour.
n
- _ _ B.
A reference check source of long half-life, e.g. Cs-137 or Ra 0 and E, shall also be read at the +dme of the above calibration. The i
readings shall be taken with the check source placed in specific geometry relative to the detector.
A reading of this reference check source should be taken:
1.
Before each use.
l 2.
After each maintenance and/or battery change.
3.
At least quarterly.
If any reading with the same geometry is not within +20% of the reading measured immediately after calibration.
The instrument i
should be recalibrated (see Step A).
C.
The instrument must be calibrated at iower energies if its response is energy dependent and it is to be used to measure in the 1-125, Xe-133, or Tc-99m energy ranges.
This calibration may be done either:
1.
As in A. above with calibrated standards of radionuclides at or near the desired energies, or 2.
As a relative intercomparison with an energy independent instrument and uncalibrated radionuclides.
l t l
D.
Records of the above, A, B-2, B-3, and C must be maintained.
?
E.
Use of Inverse Square Law and Radioactive Decay Law l.
A calibrated source will have a calibration certificate giving l
its output at a given distance measured on a specified date by l
I the manufacturer or NBS.
a.
The Inverse Square Law may be used with any point source to calculate the exposure rate at other distance.
l i
b.
The Radioactive Decay Law may be used to calculate the output at other times after the specified date.
I 2.
INVERSE SQUARE LAW l
S (R))
(R )
2
- _.p
_ _p ExposurepateatP 2 2 = (P))
X R) l R
where (a) S is the point source j
(p)2
\\
c (b) R and R2 are in the same l
3 l
units (mR/h or R/h)
(c) P) and P are in the same 2
units (cm, meter, feet etc.)
1 3.
RADIOACTIVE DECAY LAW:
Exposure rate t units of time af:er specified calibration date:
r R
=R x e ~[0 693 x t]
where (a) R and Rt are in the t
g o
1/2 units (mR/h or R/h):
(b)R is exposure rate g
on specified calibration date i
(c)R is exposure rate t t
unit of time later (d) T and t are in the 1/2 same units (years, months, days,etc.)
(e)T is radionuclide 1/2 half-life (d)tisnumberofunitsof time elapsed between calibration and present time 4
Example:
Source output is given by calibration certificate as 100 mR/h at i foot on 10 March 1975.
Radionuclide half-life is 5.27 years.
1 Question: What is the output at 3 feet on 10 March 1977 (2.0 years)?
(
- - - - Output at.1 foot, 2.0 years after calibration date:
~
a.
- }=100x0.77=77mR/hr R = 100 mR/hr x e ~M 5.3 at 1 foot on 10 March 1977.
b.
Output at 3 feet, 2.0 years after calibration date:
feet =f3 x77mR/hr=hx77=8.6mR/hrat 2
R 3
3 feet, 2.0 years after calibration.
i F
^
l CALIBRATION OF SURVEY INSTRUMENTS f
Check appropriate items 1.
Survey instruments will be calibrated at least annually and following repair.
2.
Calibration will be performed at two points on each scale.
The two points will be approximately 1/3 and 2/3 of full scale. A survey instrument may be considered properly calibrated when the instrument readings are within + 10%
of the calculated or known values for each point chiicked.
Readings within i 20% are considered acceptable if a calibration chart or graph is prepared and attached to the instrument.
3.
Survey instruments will be calibrated a.
By the manufacturer b.
At the licensee's facility (i) Calibration source Manufacturer's name Model no.
Activity in millicuries Accuracy Traceability to primary standard (ii) The calibration procedures in Appendix D,Section I will be used.
or (iii) The step-by-step procedures, including radiation safety procedures are attached, c.
By a consultant or outside firm (1) Name lii) location (iii) Procedures and sources have been approved by NRC and are on file in License No.
are attached
(
\\
l APPENDIX D Section 2 METHODS FOR CALIBRATION OF DOSE CALIBRATOR All radiopharmaceuticals must be assayed for activity to an accuracy of 10%. The most common instrument for accomplishing this is an ionization type dose calibrator. The instrument must be checked for accurate operation. at the time of installation and periodically thereafter.
A.
Test for the following:
1.
Instrument linearity (at installation and quarterly) 2.
Geometrical variation (at installation) 3.
Instrument accuracy (at installation and annually).
B.
After repair or adjustment of the dose calibrator, repeat all of the appropriate tests listed above (dependent upon the nature of the repairs).
C.
Daily or before each use of the the instrument:
1.
Measure and record the activity of at least one reference source (e.g.,1-2mCiofCo-57). This check should be repeated during the day whenever sample readings are not within 10% of the anticipated assay.
Variation greater than 5% in this test will indicate the need for instrument repair, adjustment or recalibration.
w
- -l 2.
Measure and record the apparent activity of a long-lised standard radionuclide such as Cs-137 or Radium-226 at all of the i
commonly used radionclide settings (when the unit was first calibrated against NBS-traceable standards).
Choose a source l
with activity in the 100 pCi range 4
D.
Inspect the instrument on a quarterly basis to ascertain that the
]
measurement chamber liner is in place and that instrument zero is properly set (see manufactuer's instructions).
E.
Test of Instrument Linearity
(
The linearity of a-dose calibrator should-be ascertained over the entire range of activities employed. This test will utilize-a vial of Tc-99m whose activity is equivalent to the maximum anticipated 1
activity to be assayed (e.g., the first elution from a new generator).
1.
Assay the Tc-99m vial in the dose calibrator and subtract i
background level to obtain net activity in millicuries.
i i
2.
Repeat step l'at time intervals of 6, 24, 30, and 48 hours5.555556e-4 days <br />0.0133 hours <br />7.936508e-5 weeks <br />1.8264e-5 months <br /> after the initial assay.
1
____- 3.
Using the 30 hour3.472222e-4 days <br />0.00833 hours <br />4.960317e-5 weeks <br />1.1415e-5 months <br /> activity measurement as a starting point calculate the predicted activities at 0, 6, 24, and 48 hours5.555556e-4 days <br />0.0133 hours <br />7.936508e-5 weeks <br />1.8264e-5 months <br /> e
using the following table:
Assay Time (hrs.)
Correction Factor 0
32 6
16 24 2
30 1
48 0.125 Example:
if the net activity measured at 30 hrs was 15.625 millicuries, then the predicted activity for 6 and 48 hours5.555556e-4 days <br />0.0133 hours <br />7.936508e-5 weeks <br />1.8264e-5 months <br /> would be 15.625 mci x 16 = 250 mci and 15.625 mci x 0.125 - 1.95 mci respectively.
4.
Plot the measured net activity for each time interval versus the predicted activity on log-log graph paper.
5.
The activities plotted should be within + 5% of the predicted curve if the instrument is linear and functioning properly.
Errors greater than i 5% indicate the need for repair or adjustment of the instrument.
6.
If instrument linearity cannot be corrected, it will be necessary in routine assays to reither assay an aliquot of the eluate that can be accurately measured, or to use the graph constructed in step 4 to relate measured activities to true activities.
G.
Test for Geometrical Variation There may be significant geometrical variation in activity measured as a function of sample volume or configuration, depending on the volume and size of the ionization chamber used in the dose calibrator.
The extent of geometrical variation should be ascertained for commonly used radionuclides and appropriate correction factors computed if variations are significant, i.e., greater than + 2%
(even though correction factors may be provided by the manufacturer, the accuracy of these should be checked).
To measure variation with volume of liquid, a 30 cc vial containing 2 mci of Co-57 or other appropriate radionuclide in a volume of 1 m1 will be used.
1.
Assay vial at the appropriate instrument setting and subtract background level to obtain net activity.
2.
Increase the volume of liquid in the vial in steps to 2, 4, 8, l
10, 20 and 25 mi by adding the appropriate amount of water or saline. After each addition, gently shake vial to mix contents and assay as in step 1.
3.
Select one volume as a standard (such as the volume of reference standard used in performing the test for instrument accuracy)
I and calculate the ratio of measured activities for each volume to the reference volume activity.
This represents the volume I
correction factor.
5 Example:
if activities of 2.04, 2.02, and 2.00 mC are measured for 4, 8, and 10 mi volumes and 10 m1 is the reference volume selected, then
= %
= 0.98 4 ml Volume CF l
l 4.
Plot the correction factors against the volume on linear graph paper.
Use this graph to select the proper volume correction factors for routine assay of that radionuclide.
5.
The true activity of a sample is calculated as follows:
True Activity = Measured Activity x CF Where the CF used is for the same volume and geometrical configuration as the sample measured.
6.
Similarly, the same activity of Co-57 in a syringe may be compared with that of 10 m1 in a 30 cc vial and a correction factor calculated.
7.
It should be noted that differences of 200% in dose calibrator readings between glass and plastic syringes have been observed for lower energy radionuclides such as I-125.
Hence adequate correction factors must be established for this type of syringe.
An alternate to providing syringe calibration factors is to simply assay the stock vial before and after filling the syringe.
The activity in the syringe is then the difference in the two readings (with a volume correction if significant).
H.
Test For Instrument Accuracy The accuracy of the dose calibrator should checked for several radionuclides such as Cs-137, Co-57, and Ba-133 using appropriate reference standards whose activity is traceable to NBS.
The
~
_. (
activity levels of the reference sources used should approximate those levels normally encountered, giving adequate attention to source configuration. The lower energy reference standards (Tc-99m, Xe-133, I-125) must be in vials with the same thickness of glass as the actual samples to be measured for best accuracy.
1.
Assay the reference standard in the dose calibrator at the appropriate setting and subtract the background level to obtain the net activity.
2.
Repeat step 1 for a total of 3 determinations and average results.
3.
The average activity determined in step 2 should agree with the certified activity of the reference source within 15%
after decay corrections.
I 4.
Repeat the above steps for other commonly used radionuclides for which adequate reference standards are available, i
5.
Keep a log of these calibration checks.
6.
Calibration checks which do not agree within 1 5% indicate that the instrument should be repaired or adjusted.
If this t
is not possible a calibration factor should be calculated for i
use during routine assays of radionuclides.
7.
At the same time the instrument is being initially calibrated with the NBS traceable standards, place a long-lived source in the calibrator, set the instrument, in turn, at the various radionuclide settings used (Cs-137, I-131, Tc-99m, I-125, etc.) and record the readings.
These values may later be used to check instrument calibration at each settings (after correcting for decay of the long lived source), without requiring more NBS traceable standards.
Keep a log of these initial and subsequent readings.
I.
Test for Instrument Constancy Two reference sources such as Cs-137 and Co-57 should be assayed using a reproducible geometry before each daily use of the instru-ment.
1.
Assay each reference source using the appropriate instrument setting (i.e., Cs-137 setting for Cs-137).
2.
Measure background level at same instrument setting.
d i
i 1
l
i 1 !
3.
Calculate net activity of each source subtracting out back-ground level.
4.
For each source plot net activity versus the day of.the year on semi-log graph paper.
5.
Log the background levels.
6.
Indicate the predicted activity of each source based upon decay calculations and the 15% limits on the graph as
)
illustrated.
7.
Repeat the procedure for the Cs-137 source for all of the commonly used radionuclide settings.
8.
Variations greater than 1 5% from the predicted activity indicate the need for instrument repair or adjustment.
i I
9.
Higher than normal background levels should be investigated to determine their origin and eliminated if possiale by decontamination, relocation, etc.
)
1 l
CALIBRATION OF DOSE CALIBRATOR A.
Sources Used for Linearity Test:
Check as appropriate First elution from new Mo-99/Tc-99m generator or other* (specify)
B.
Sources Used for Instrument Accuracy and Constancy Tests:
(
Radionuclide Activity Accuracy (mci)
/
57 Co 133 Ba 137 Cs 1
other l
C.
The procedures described in Appendix D Section 2 will be
)
used for calibration of the dose calibrator, or Equivalent procedure are attached.
- Must be equivalent to the highest activity used.
Item Nc. 10 Date:,_
I 4
APPENDIX E PROCEDURES FOR ORDERING AND RECEIVING RADI0 ACTIVE MATERIAL 1.
The Chief Nuclear Medicine Technologist will place all orders for radioactive material and will ensure that the requested materials 5
and quantities are authorized by.the license and that possession
^
limits are not exceeded.
2.
During normal working hours carriers will be instructed to deliver radioactive packages directly to the Nuclear Medicine Department.
3.
During off-duty hours security personnel will accept delivery of radioactive packages in accordance with the procedures outline in Mr. Jones' memorandum (attached).
Item No. 13 Date:
t 1
MEMORANDUM FOR: Security Personnel FROM:
John Jones, Administrator
SUBJECT:
RECEIPT OF PACKAGES CONTAINING RADI0 ACTIVE MATERIAL Any packages containing radioactive material that arrive between 4:30 P.M. and 7 A.M. or on Sundays shall be signed for by the Security guard on duty and taken immediately to the Nuclear Medicine Department.
Unlock the door, place the package on top of the counter immediately j
to the right of the door, and relock the door.
If the package is wet or appears to be damaged, immediately contact the hospital Radiation Safety Officer. Ask the carrier to remain at the hospital until it can be determined that neither he nor the delivery vehicle is contaminated.
RADIATION SAFETY OFFICER:
OFFICE PHONE:
HOME PHONE:
t l
l l
Item No. 13 Date:
/
/
RADI0 ACTIVE SHIPMENT RECEIPT REPORT 1.
P.O.#
SURVEY DATE TIME SURVEYOR 2.
CONDITION OF PACKAGE:
_ 0.K.
PUNCTURED STATUS WET CRUSHED OTHER 3.
RADIATION UNITS OF LABEL:
UNITS (mR/hr) 4.
MEMEASURED RADIATION LEVELS:
a.
Package surface mR/hr b.
3' from surface mR/hr 5.
DO PACKING SLIP AND VIAL CONTENTS AGREE?
a.
Radionuclide yes no difference b.
Amount yes no difference c.
Chem Form yes no difference 6.
WIPE RESULTS FROM:
a.
Outer CPM =
DPM eff = (
)
b.
Final source container CPM =
DPM eff=(
)
8.
SURVEY RESULTS OF PACKING MATERIAL AND CARTONS mR/hr, CPM 9.
DISPOSITION OF PACKAGE AFTER INSPECTION 10.
IF NRC/ CARRIER NOTIFICATION REQUIRED, GIVE TIME, DATE AND PERSONS NOTIFIED.
Item No.13 Date:
(. '.
l l
l l
l APPENDIX F PROCEDURES FOR OPENING PACKAGES CONTAINING RADI0 ACTIVE MATERIAL
)
1.
Visually inspect package for any sign of damage (e.g., wetness, crushed).
If damage is noted stop procedure and notify Radiation l
l Safety Officer.
l 2.
Measure exposure rate at 3 feet from package surface--record.
If
>10 mR/hr--stop procedure and notify Radiation Safety Offier.
i 3.
Measure surface exposure rate and record.
If >200 mR/hr--stop procedure and notify Radiation Safety Officer.
4.
Put on gloves.
t 5.
Open the outer package (following manufacturer's directions, if l
supplied) and remove packing slip.
Open inner package to verify contents (compare requisition, packing slips, and label on bottle) check integrity of final source container (inspect for breakage of l
seals or vials, loss of liquid, discoloration of packing material).
Check also that shipment does not exceed possession limits.
Item No. 14 Date:
l i
6.
Wipe external surface of final source container with moistened cotton swab or filter paper held with forceps, assay and record.
7.
Monitor the packing material and packages for contamination before discarding:
a.
if contaminated, treat as radioactive waste.
b.
if not, obliterate radiation labels before discarding in regular trash.
c-Item No. 14 Date:
l APPENDIX G LABORATORY' RULES FOR THE USE OF a
-Y RADI0 ACTIVE MATERIAL 1.
Wear laboratory. coats, or other protective clothing at all times in areas where radioactive materials are used.
'2.
Wear disposable gloves at all times while handling radioactive materials.
3.
Monitor hands and clothing for' contamination after each procedure or before leaving the area.
t 4.
Use syringe shields for prepuration of patient doses and admini-stration to patients except in circumstances, such as pediatric cases, where their use would canpromise the patient's well-being.
5.
Do not eat, drink, smoke or apply cosmetics in any area where radioactive material is stored or used.
6.
Assay each patient dose in the dose calibrator prior to admini-s tration. Do not use any doses that differ from the prescribed dose by more than 10%.
Item flo. 15 Date:
i 7.
Wear personnel monitoring devices (Film badge or TLD) at all times while in areas where radioactive materials are used or stored. These should be worn at chest or waist level.
8.
Wear TLD finger badges during elution of generator and preparation, assay, and injection of radiopharmaceuticals.
9.
Dispose of radioactive waste only in specially designated receptacles.
10.
Never pipette by mouth.
- 11. Survey generator, kit preparation, and injection areas for contamina-tion after each procedure or at the end of the day. Decontaminate if necessary, 12.
Confine radioactive solutions in covered containers plainly identified and labelled with name of compound, radionuclide, date, activity, and radiation level if applicable.
- 13. Always transport radioactive material in shielded containers.
Item No.15 Date:
l APPENDIX H f
EMERGENCY PROCEDURES Minor Spills:
1.
NOTIFY: Notify persons in the area that a spill has occurred.
1 2.
PREVENT THE SPREAD: Cover the spill with absorbent paper.
3.
CLEAN UP: Use disposable gloves and remote handling tongs.
Carefully fold the absorbent paper and pad.
Insert into a plastic bag and dispose of in the radioactive waste container.
Include all other contaminated materials such as disposable gloves.
i 4.
SURVEY: With a G.M. Survey Meter, check the area around the spill, your hands and clothing for contamination.
S.
REPORT: Report incident to the Radiation Safety Officer.
Major Spills _:
1.
CLEAR THE AREA: Notify all persons not involved in the spill to vacate the room.
2.
PREVENT THE SPREAD. Cover the spill with absorbent pads, but do not attempt to clean it up. Confine the movement of all personnel potentially contaminated to prevent the spread.
Item No. 16 Date:
2-3.
SHIELD THE SOURCE.
If possible, the spill should be shielded, but
't only if it can be done without further contamination or without significantly increasing your radiation exposure.
4.
CLOSE THE ROOM.
Leave the room and lock the door (s) to prevent entry.
5.
CALL FOR HELP. Notify the Radiation Safety Officer immcdiately.
6.
PERSONNEL DECONTAMINATION.
Contaminated clothing should be removed and stored for further evaluation by the Radiation Safety Officer.
If the spill is on the skin, flush thoroughly and then wash with mild soap and lukewarm water.
RADIATION SAFETY OFFICER:
OFFICE PHONE:
HOME PHONE:
l l
Item No. 16 l
Date:
APPENDIX I SURVEY PROCEDURES j
i A.
All elution, preparation and injection areas will be surveyed daily with a G-M survey meter and decontaminated if necessary.
B.
Laboratory areas where only small quantities of radioactive material are used (less than 100901) will be surveyed monthly.
C.
All other laboratory areas will be surveyed weekly.
D.
The weekly and monthly survey will consist of:
1.
A measurement of radiation levels with a survey meter sufficiently sensitive to detect 0.1 mR/hr.
2.
A series of wipe tests to measure contamination levels.
The method for performing wipe tests will be sufficiently sensitive to detect 100 dpm.
E.
A permanent record will be kept of all survey results, including negative results. The record will include:
1.
Location, date, and type of equipment used.
2.
Name of person conducting the survey.
3.
Drawing of area surveyed, identifying relevant features such as active storage areas, active Waste areas, etc.
1 4.
Measured expo;ure rates, keyed to location on drawing (point out rates that require corrective action).
5.
Detected contamination levels, keyed to locations on drawing.
i 6.
Corrective action taken in the case of contamination or excessive exposure rates, reduced contamination levels or exposure rates after corrective action, and any appropriate comments.
F.
Area will be cleaned if the contamination level exceeds 100 dpm/
2 100 cm,
NOTE:
For daily surveys where no abnormal exposures are found, only the date, the identification of the person performing the survey, and the survey reports will be recorded.
h APPENDIX J WASTE DISPOSAL PROCEDURES l
1.
Liquid Waste will be disposed of Check as appropriate By commercial waste disposal service (See also No. 4 below)
In the sanitary sewer system in accordance with Section 20.303 of 10 CFR Part 20.
Other (specify):
1 2.
Mo-99/Tc-99m generators will be:
(Check as appropriate)
Returned to the manufacturer for disposal Held for decay until radiation levels as measured with a low-level survey meter and with all shielding removed, have reached background levels. All radiation labels will be removed or obliterated and the generators disposed of aSnormal trash.
(Note:
this method of disposal may not be practical for generators containing long-lived radioactive contaminants)
Disposed of by commercial waste disposal service (See also No. 4 below)
Other (specify):
l l
3.
Other Solid Waste will be:
1 (Check as appropriate) l Held for decay until radiation levels as measured with a low-level survey meter and with all shielding removed) have reached background levels.
All radiation labels will be removed or obliterated and the waste will be disposed of in normal trash.
Item No. 18 Date:
< l Disposed of by commerical waste disposal service (See also No. 4 belcw)
Other (Specify):
4.
The commerical waste dispos &1 service used will be:
(Name)
(City, State) j NRC/ Agreement State License No.
l i
Item No. 18 Date:
l l
l
)
APPENDIX K PROCEDURES FOR USE OF GROUPS IV AND V RADI0 PHARMACEUTICALS FOR TREATMENT OF PATIENTS
)
f 1.
All patients treated with iodine-131 or gold-198 will be placed in a private room with a toilet.
2.
The patient's room will be properly posted in accordance with i
Section 20.203, 10 CFR Part 20.
3.
Surveys of the patient's room and surrounding areas will be con-ducted as soon as practicable after administration of the treatment i
dose.
Exposure rates will be measured at the patient's bedside, three feet away and the entrance to the room.
The Radiation Safety Officer or his designate will then determine how long a person may remain at these positions and will post these times in the patient's chart and on his door.
The results of daily surveys will be used to recalculate permitted times which will be posted on the patient's chart and on his door.
4.
The form, Nursing Instructions for Patients Treated with Phosphous-32, Gold-198, or Iodine-131, will be completed immediately after administration of the treatment dose. A copy will be posted in the patient's chart.
i 1
i
i l
I 5.
Radiation levels in unrestricted areas will be maintained less than the limits specified in Section 20.105(b),10 CFR Part 20.
1 6.
All linens will be surveyed for contamination before being removed from the patient's room and will, if necessary, be held for decay.
l 7.
Disposable plates, cups, eating utensils, tissue, surgical dressings, 1
and other similar waste items will be placed in a specially designated container. The material will be collected daily by the Radiation I
Safety Officer (or his designate) checked for contamination, and disposed of as normal or radioactive waste, as appropriate.
i I
8.
Non-disposable items used for these patients will be held in plastic I
f bags in the patient's room, and checked for contamination by the Radiation Safety Officer or his designate.
Items may be returned l
for normal use, held for decay or decontaminated, as appropriate.
l l
9.
Urine and vomitus, from iodine-131 therapy patients will be stored j
for decay in our radioactive waste storage area. When it has reached background levels as measured with a low-level survey meter, it will be released to the sanitary sewer system.
_ _ _ _ 10. Befora a therapy patient's room is reassigned to another patient, the room will be surveyed for contamination (and decontaminated if L
necessary) and all radioactive waste and waste containers will be removed.
- 11. Nursing Instructions a.
Nurses should spend only that amount of time near the patient required for ordinary nursing care.
Special restrictions may be noted on the precaution sheet in the patient's chart.
Nurses should read these instructions before administering to the patients.
Call the Nuclear Medicine Department if you have any questions about the care of these patients.
b.
Visitors will be limited to those 18 years of age or over, unless other instructions are noted on the precautions sheet in the patient's chart.
c.
patients must remain in bed while visitors are in the room i
and visitors should remain at least three feet from the patient.
d.
Radioactive patients are to te confined to their rooms except for special medical or nursing purposes approved by the Nuclear Medicine Department.
___ e.
No nurse, visitor or attendant who is pregnant should be per-mitted in the room of a patient who has received a therapeutic amount of radioactivity until the patient no longer presents a radiation hazard.
Female visitors should be asked whether they are pregnant.
f.
Attending personnel must wear rubber or disposable plastic gloves when handling urinals, bedpans, emesis basins or other containers having any material obtained from the body of the patient. Wash gloves before removing and then wash hands.
The gloves must be left in the patient's room in the designated waste container. These gloves need not be sterile or surgical in type.
g.
Disposable items should be used in the care of these patients, whenever possible. These items should be placed in the designated waste container. Contact the Nuclear Medicine Department for proper disposal of the contents of the designated waste container.
h.
All clothes and bed linens used by the patient should be placed in the laundry bag provided and left in the patient's room to be checked by a member of the Nuclear Medicine Department.
-__ 1.
All non-disposable items should be placed in a plastic bag and I
left in the patient's room to be checked by a member of the Nuclear Medicine Department.
j.
Surgical dressings should be changed only as directed by physician.
Gold-198 leaking from a puncture wound will stain the dressings dark red or purple.
Such dressings should not be discarded but should be collected in plastic bags and turned over to the Nuclear Medicine Department.
Handle these dressings only with tongs or tweezers. Wear disposable gloves, k.
For iodine-131 patients:
(1) Urine from iodine-131 patients will be collected in special containers provided by the Nuclear Medicine Department.
The patient should be encouraged to collect his own urine in the container.
If the patient is bedridden, a separate urinal or bed pan should be provided.
The urinal or bed pan should be flushed several times with hot soapy water after use.
(2)
If the nurse helps to collect the excreta, she should wear disposable gloves.
Afterwards she should wash her
M hands with the gloves on and again after the gloves are removed.
The gloves should be placed in the designated waste container for disposal by the Nuclear Medicine Department.
(3) Disposable plates, cups, and eating utensils will be used by patients who are treated with iodine-131.
(4)
Vomiting within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> after oral administration, urinary incontinence, or excessive sweating within the first 48 hours5.555556e-4 days <br />0.0133 hours <br />7.936508e-5 weeks <br />1.8264e-5 months <br /> may result in contamination of linen and/or floor.
In any such situations or if radicactive urine and/or feces is spilled during collection, call the Nuclear Medicine Department, Ext.
Meanwhile, handle all contaminated material with disposable gloves and avoid spreading contamination.
(5) All vomitus must also be kept in the patient's room for disposal by the Nuclear Medicine Department.
Feces need not be routinely saved, unless ordered on the chart. The same toilet should be used by the patient at all times and it should be well flushed (3 times).
. 1.
Utmost precautions must be taken to see that no urine or
(
vomitus, is spilled on the floor or the bed.
If any part of the patient's room is suspected to be contaminated, notify the Nuclear Medicine Department.
m.
If a nurse, attendant or anyone else knows or suspects that his skin, or clothing, including shoes, is contaminated, notify the Nuclear Medicine Department immediately.
This person should remain in the patient's room and not walk about the hospital.
If the hands become contaminated, wash immediately with soap and water.
n.
If a therapy patient should need emergency surgery or should die, notify the Nuclear Medicine Department immediately.
o.
When the patient is discharged call the Nuclear Medicine Department and request that the room be surveyed for con-tamination before remaking the room.
Date:,
NURSING INSTRUCTIONS FOR PATIENTS TREATED WITH PHOSPHOUS-32, GOLD-198, or 10 DINE-131 Patient's Name:
Room No.:
Physician's Name:
Radioisotope Administered:
Date and Time of Administration:
Dose Received:
Method of Administration:
Exposure Rates in MR/hr Date 3 feet from bed 10 feet from bed (Comply with all Check Items) 1.
Visting time permitted:
2.
Vistors must remain from patient.
3.
Patient may not leave room 4.
Vistors under 18 not perrmitted.
5.
Pregnant visitors not permitted.
6.
Film badges must be worn.
7.
Use and complete the following tags:
door bed chart wrist
- 8.
Gloves must be worn while attending patient.
9.
Patient must use disposable utensils.
- 10. All items must remain in romm until OK'd by Radiation Safety.
l 11.
Smoking is not permitted.
12.
Do not release room to admitting until OK'd by Radiation Safety.
- 13. Other instructions In case of an emergency contact:
/
RSO on/off duty telephone no.
name F
F
(
1 I
APPENDIX L PROCEDURES FOR USE OF GROUP VI SOURCES FOR J
TREA,TMENT OF PATIENTS l
1.
All patients treated with brachytherapy sources will be placed in a private room with toilet.
2.
The patient's room will be properly posted in accordance with Section 20.203, 10 CFR Part 20.
3.
Surveys of the patient's room and surrounding areas will be conducted as soon as practicable af ter sources are implanted.
Exposure rate measurements will be taken at the patient's bedside, three feet away and at the entrance to the room. The Radiation Safety Officer I
cr his designate will then determine how long a person may remain at these positions and will post these times in the patient's chart.
4.
The form, Nursing instructions for Patients Treated with Brachy-therapy Sources, will be completed immediately after sources are implanted and placed in the patient's chart.
1 0
_ 5.
Radiation levels in unrestricted areas will be maintained less than the limits specified in Section 20.105(b),10 CFR Part 20.
4 6.
Nurses caring for brachytherapy patients will be assigned film badges. TLD finger badges will also be assigned to nurses who must provide extended personal care to the patient.
7.
At the conclusion of treatment, a survey will be performed to ensure that all sources have been removed from the patient and that no sources remain in the patient's room or any other area occupied by the patient. At the same time all radiation signs will be removed and all film and TLD badges assigned to nurses will be collected.
8.
Instructions to Nurses a.
Special restrictions may be noted on the precaution sheet in the patient's chart.
Nurses should read these instructions before administering to the patient.
Call the Nucelar Medicine Department if you have any questions about the care of these patients.
- _ _ _ _ - _ _ - _ _.. b.
Nurses should spend only the minimum necessary time near a patient for routine nursing care, but must obtain and wear a film badge.
t When a nurse receives an assignment to a therapy patient, a c.
film or TLD badge should be obtained immediately from the Nuclear Medicine Department. The badge shall be worn only by the nurse to whom it is issued and shall not be exchanged between nurses.
d.
Pregnant nurses should not be assigned to the personal care of these patients.
Never touch needles, capsules or containers holding brachy-e.
therapy sources.
If a source becomes dislodged use.long forceps and put it in the corner of the room or in the shielded container provided; contact the Nuclear Medicine Department at once.
f.
Bed bath given by the nurse should be omitted while the sources are in place.
[
L---
l g.
Perineal care is not given during gynecologic treatment; the perineal pad may be changed when necessary, unless orders to the contrary have been written.
h.
Surgical dressings and bandages used to cover the area of needle insertion may be changed only by the attending physician or or radiologist, and MAY NOT BE DISCARDED until directed by the rad' ologist.
Dressings should be kept in a basin urtil checked by the radiologist or member of the Nuclear Medicine Department.
Special orders will be written for oral hygiene for patients with oral implants.
i.
No special precautions are needed for sputum, urine, vomitus, stools, dishes, instruments, utensils or bedding unless speci-fically ordered.
j.
These patients must stay in bed unless orders to the contrary are written.
k.
Visitors will be limited to those 18 years of age or over, unless other instructions are noted on the precaution sheet in the patient's chart.
f 1.
Visitors should sit at least three feet from the patient and should remain no longer than the times specified on the form I
posted on the patient's door and in his chart.
i No nurse, visitor or attendent who is pregnant should be per-i m.
mitted in the room of a patient while brachytherapy sources are implanted in the patient.
Female visitors should be asked whether they are pregnant.
t n.
Emergency Procedures (1)
If an implanted source becomes loose or separated from the patient, or_
(2)
If the patient dies, or_
(3)
If the patient requires emergency surgery, immediately call Phone No. (days)
(nights) o.
At the conclusion of treatment, call the Radiation Safety Officer and request that the patient and room be surveyed to be sure all radioactive sources have been removed.
)
E
- _ _ _ _ _ _ _ _ _ _ _ NURSING INSTRUCTIONS FOR PATIENTS TREATED WITH BRACHYTHERAPY 50URCES Patient's Name:
Room Number:
Physiciar.'s Name:
Isotope Activity:
Date and Time of Administration:
Date and Time Sources are to be removed:
Isotope:
Exposure Rates in mR/hr Bedside 3 feet from bed 10 feet from bed (Complete checked items) 1.
Wear film badge.
2.
Wear rubber gloves 3.
Place laundry in linen bag and save.
1 1
4.
Housekeeping may not enter the room.
5.
Patient may not have visitors.
6.
No pregnant visitors.
7.
No visitors under 18 years of age.
8.
A dismissal survey must be performed before pattient is discharged.
9.
Patient must have a private room.
- 10. Other Instructions RS0
/
name on duty /off duty telephone number
l f
APPENDIX M l
INFORMATION TO BZ SUBMITTED FOR THE USE OF RADI0 ACTIVE GASES (e.g., XEXON-133) h.
The following information should be submitted in support of requests i
to use xenon-133:
a.
Quantitites to be U ed:
(1) Patient information 1
(a) Number of studies expected per week (b) Average activity per patient I
(2) State the desired possession limit. This should be sufficient to provide for shipments whose calibration date is several days after receipt, b.
Use and Storage Areas:
(1) Describe the area (s) in which you plan to use and store xenon-133.
Include a diagram indicating the availability of shielding materials and the proximity to unrestricted areas.
(2) Describe the ventilation in all areas where xexon-133 is used and stored:
You should indicate the location of supply and i
I
- exhaust vents, the measured air flow rates for each vent and the fraction of air that is recirculated by the system.
(3) All areas where xenon is used should be under negative pressure. State how you will ensure that all airflow rates are maintained as specified in this application.
c.
Procedures for Routine Use (1) Describe the procedures to be followed for routine use of xenon-133, giving particular attention to radiological safety factors.
(2)
If you plan to use a special apparatus for administration and collection of xenon-133, specify the manufacturer's name and model number and include a description of its design characteristics.
(Inclusion of a brochure would be helpful.)
(3) Describe any special procedures that you plari to employ to reduce leakage, e.g., use of nose clamps or special enclosures.
d.
Emergency Procedures Describe the emergency procedures to be used in case of an accidental release of xenon-133.
This should include such considerations as temporary evacuation of the area or increasing the ventilation of the area.
Air Concentrations of xenon-133 in Restricted Areas e.
No licensee shall permit any individual in a restricted area to
=
inhale a quantity of radioactive material in any period of one calendar quarter greater than the quantity which would result from t
inhalation for 40 hours4.62963e-4 days <br />0.0111 hours <br />6.613757e-5 weeks <br />1.522e-5 months <br /> per week for 13 weeks at uniform concentrations of radioactive material greater than 1 x 10-5 uCi/ml.
,I You may evaluate your situation by making actual measurements of xenon-133 concentrations or by means of calculations.
If you choose g
the latter approach, you may make simplifying assumptions, PROVIDING they are reasonable, conservative and stated explicitly in your
(
request.
In actual use and storage, some xenon-133 will be released into the room from the storage and administration devices, rebreathing apparatus, collection systems, and escape from the patient. All sources of loss must be considered when estimating the fraction of xenon-133 that is lost.
The following prccedures may be used to calculate the air con-t centration of xenon-133 in restricted areas:
1 4
(1) Estimate the maximum amount of activity to be used per week (A).
f t
)
(2)
Estimate the fraction of xenon-133 that is lost dering use and storage (f).
This fractional loss must include ALL sources of loss, e.g., during patient administration, storage, and e
disposal.
l (3) Determine the measured airflow rate in the area (s) of interest and calculate the volume of air available per week for dilution of the xenon-133 (V).
t (4)
For restricted areas, Section 20.103 of 10 CFR Part 20 requires that:
5 A
f < 1x10 V
uCi/ml.
-x (5)
Sample Problem A nuclear medicine laboratory plans to use 10 mci xenon-133 per patient and will perform a maximum of 10 studies per week.
What ventilation rate is required to ensure compliance with Section 20.103 of 10 CFR Part 20?
(a) Maximum activity used per week:
3 5
lx10 uCi = 1x10 uCi A = 10 mci x 10 patients x patient week mci week
l (b) Assume a lose rate of 20% (f)
I (c)
V=
5 uCi/ml 5
, lx10 uCi/ week x 0.20 lx10-5 uCi/ml 9
= 2.0x10 ml/ week.
The required ventilation rate is 1
9 6
30 cfm 2.0x10 ml/ week 1.7x10 cfm
=
40 hrs / week ml/hr The answer shows that, in order to meet the requirements of Section 20.103 of 10 CFR Part 20, the imaging room (RESTRT.CTED AREA) must have a ventilation rate of at least 30 cfm with no recirculation of air. Where practical, the ventilation rate should be greater than that shown necessary by the calculations.
You must also consider every alternative in order to maintain the air concentration of xenon-133 as low as reasonably achievable in accordance with Section 20.1(c) of 10 CFR Part 20.
If the ventilation rate is inadequate to meet the requirements of Section 20.103, 10 CFR Part 20, you should consider methods of increasing ventilation or reducing the patient load.
\\
t
- _ _ _ - _ _ _ _ _ The following table gives the amount of xenon-133 that can be released per week without exceeding the permissible levels for xenon-133 in restricted areas.
c 133 Maximum Xe Released Ventilation Rate (cfm) per 40 hour-week (mci) 100 67.9 500 339.7 1,000 679.4 f.
Methods of Xenon-133 Disposal (1 ) Dilution through Exhaust Systems (least desirable)
One method for disposal of xenon-133 is by release to the atmosphere through an air exhaust system.
Licensees are required to perform surveys (measurements or calculations) to ensure that they are in compliance with Section 20.l(c) and 20.106 of 10 CFR Part 20.
Section 20.l(c) requires that the 1
I concentrations of xenon-133 in effluents to unrestricted areas be as low as is reasonably achievable by the current state of technology, and Section 20.106 requires that the concentrations, averaged over a period of one (1) year, shall not exceed 3x10-7 uCi/ml.
Many facilities do not have sufficient air flow to achieve the necessary dilution.
The following procedure may be used to estimate the concentrations of xenon-133 in effluents to unrestricted areas.
l (a) Estimate the maximum amount of xenon-133 to be released peryear(A).
This should include all anticipated losses during administration, storage and disposal.
(b) Determine the flow rate of your exhaust system and describe the methods and equipment used for measuring the air flow rates.
(c) Calculate the air flow per year (V).
(d) Calculate the average concentrations for unrestricted i
areas.
Section 20.106 of 10 CFR Part 20 requires that:
C = f 1 x10'7 Ci/ml 3
(e) Sample Problems A nuclear medicine laboratorj plans to use 10 mci per patient and will perform a maximum of 10 studies per week. A fume hood is available for 133 disposal of Xe, and has a measured air flow of 2
168 ft/ min with an opening of 8 ft.
What is the
\\
l average concentration of xenon-133 at the point of release from the fume hood exhaust?
(NOTE: All xenon that has been released, e.g., collection bags, filters, t
mustbeconsidered.)
3 A = 10 patients 10 mci 10 uCi 52 weeks weeks
- patient
- mci year 6
A = 5.2x10 Ci/ year 2
10 V=168hn x 8 ft x 1.49x10 n
V = 1344 O x 1.49x1010 ml/ year m1n ftd/ min 13 V = 2.01x10 ml/ year 6
C = 5.2x10 uCi/ year 2.0lx10'd ml/ year 7
C = 2.6x10 pCi/ml The following table gives the amount of xenon-133 that m
can be released per week without exceeding and average 7
concentration of 3x10 pCi/ml.
9-Average Release of 133Xe per week (mci)
Exhaust rate (cfm) 100 8.6 500 42.8 1,000 85.6 1,500 128.4 If the exhaust is released to a restricted area, e.g., a roof to which access is controlled, or from a tall stack, you may use Sutton's equation (Refs.1,2) to calculate the concentrations at the nearest unrestricted area.
If this approach is used, you should describe the location of the exhaust system outlet, including proximity to unrestricted areas, air intakes, and open windows.
You should also describe your methods for controlling access 1.0 the area where the exhaust is located.
(2) Adsorption onto Charcoal Traps This is the disposal method of choice. The advantage of this disposal method is that xenon-133 is trapped onto charcoal or other adsorbing medium.
Filters containing xenon-133 are then stored for decay.
t One difficulty with this approach is that charcoal is not 100% efficient for trapping xenon-133.
If this is your method of disposal, you should consider the following points.
_ (ik -Describe how you will handle the problem of leakage from such trapping devices.
If the exhaust is vented to the outdoors (UNRESTRICTED AREA), show t
that air concentrations of xenon-]33, averaged over one (1) year, do not exceed 3x10-7 Ci/ml.
(See example in Item F-1.)
(ii) Describe how you will ensure that collection and trapping devices are performing according to specifi-cations, both initially and on a continuing basis.
Include in your description how you will monitor traps to determine when saturation occurs and filter must be replaced.
(iii) Describe your procedures for handling saturated fil ters.
Your discussion should include a description of the area (a diagram would be useful), available shielding, proximity to restricted areas, ventilation and an evaluation of average concentrations of xenon-133 in air.
(See example in Item e(5)).
.. l REFERENCES l
1.
Blatz, Hanson, Radiatior. Hygiene Handbook. McGraw-Hill (New York, 1
1959), pp. 22-7.
2.
Cember, Herman, Introduction to Health Physics, Pergamon Press (New York, 1969), pp. 334-9.
USEFUL CONVERSIONS 3
10 pCi 1 mci
=
3 2.832x10-2 3 = 2.832x104
=
m ml 1 ft 3
6 1 ft / min = 1.699x10 ml/hr l cfm
=
7 6.797x10 ml/40 hr wk
=
10 le484x10 ml/yr
=
168 hr 1 week
=
eu.S. GOVE RNMENT PRINTING 0FFICE; 1978 120 387/8 1-3 i
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