ML19256F805
| ML19256F805 | |
| Person / Time | |
|---|---|
| Issue date: | 03/31/1979 |
| From: | NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | |
| References | |
| NUREG-0339, NUREG-339, NUDOCS 7912200843 | |
| Download: ML19256F805 (16) | |
Text
NUREG4)339 DRAFT LICENSING GUIDE FOR TELETHERAPY PROGRAMS Draft Report k
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1780 021 Office of Nuclear Material Safety and Safeguards U. S. Nuclear Regulatory Commission N 912 20 0 f/g' f
NUREG4339 DRAFT LICENSING GUIDE FOR TELETHERAPY PROGRAMS Draft Report This Guide will be replaced by a Division 10 Regulatory Guide in late 1979 or early 1980.
Manuscript Completed: March 1979 Date Published: March 1979 1780 022 Division of Fuel Cycle and Material Safety Office of Nuclear Material Safety and Safeguards U. S. Nuclear Regulatory Commission Washington, D.C. 20555
TELETHERAPY LICENSING GUIDE I.
Introduction II.
Filing An Application III. Information to be Submitted A.
Physician's Qualifications B.
Teletherapy Unit 1.
Design and Construction Details 2.
Source Content 3.
Beam Stops C.
Teletherapy Facility 1.
Plan and Elevation Details 2.
Patient Viewing System 3.
Penetrations and Voids 4.
Door Interlocks 5.
Calculations of Radiation Levels D.
Radiation Safety Program 1.
Personnel Monitoring 2.
Radiation Survey and Monitoring Instrumentation 3.
Unrestricted and Restricted Areas 4.
Leak Testing 5.
Emergency Procedures E.
Relocation IV.
Service A.
Installation, Maintenance, Exchange and Removal B.
5-Year service an ! !!aintenance Insnection V.
Survey Report i780 023
TELETHERAPY LICENSING GUIDE I.
Introduction This Guide describes the types of information that should be submitted in an application for the possession and use of teletherapy sources.
Regulations pertaining to teletherapy programs are contained in Title 10, Code of Federal Regulations, Part 20, " Standards for Protection Against Radiation" (10 CFR Part 20), Part 30 " Rules of General Applicability to Licensing of Byproduct Material" (10 CFR Part 30), and Part 35, " Human Uses of Byproduct Material" (10 CFR Part 35).
The applicant should carefully study the regulations and this Guide and submit all information requested.
The Nuclear Regulatory Commission will request additional information, if necessary, in order to provide reasonable assurance that the applicant has established an adequate radiation safety program.
(See Section 30.32(b) ot IC CFR Part 30.)
Requests for additional information will delay fina) action on the application.
This, Guide is intended only for general inforration and should not be considered a substitute for the applicant's careful evaluation n"
his proposed use of byproduct material and assur.ince that the applicat ion correct iv and adequately describes the radiatiin safer,uards and procedures to be followed.
1780 024 0
ig a When an application has been received, evaluated and accepted, the Commission issues a license contair.ing certain conditions whic1 should be read and understood by the applicant.
Among other things, the license conditions require that the facility be coa-structed and operated in compliance with 10 CFR Part 20.
Section 20.105(b) is of particular importance in considering the shielding requirements for the teletherapy room.
The Commission's requirements and evaluation of information per-taining to teletherapy devices and sources are based on reco=menda-tions of the National Committee on Radiation Protection and Measure-ments as contained in NCRP Reports No. 33, " Medical X-Ray and Gamma Ray Protection for Energies up to 10 Mee - Equipment Design ai.d Use" and 34, " Medical X-Ray and Gamma Ray Protection for Eneri.ies up to 10 MeV - Structural Shielding Design and Evaluation" (available from NCRP Publication, P.O. Box 4867, Washington, D. C.
2000H).
The Commission in its evaluations does not nortolly consider occupancy factors that are established in these reports.
II.
Filing An Application The " Application for Byproduct Material License" (Form NRC-311) and all supporting documents must be submitted in duplicate to the Materials Branch, Office of Nuclear Material Safety and Safeguards, Nuclear Regulatory Comission, Washington, D.C.
20555.
1780 025 The applicant named in item 1(a) of Form NRC-313 is the organiza-tion or person (hospital, corporation, partnership, ind i v idua l,
etc.) who will be responsible, as the licensee, for assuring that the teletherapy source is used in compliance with the conditions of the license and with the Commission's regulations.
For institutions such as hospitals, the applicant will usually be the hospital, clinic, etc.
A physician who owns a private therapy facility should be the applicant and place his name in Item 1(a).
The name of the applicant must be entered in both Items 1(a) and 16 of Form NRC-313, and the application must be signed by the applicant,
or, if the applicant is an institution, by an individual to whom this responsibility is delegated.
When a hospital is the applicant, the hospital administrator is normally the individual who signs the application.
An applicat ion fee should be submitted with an application for most types of licenses.
The applicant should refer to 10 CFR Part 170, Section 170.31 " Schedule of Fees f o r Ma t er ia l L icenser,," te detemine what fee, if any, should accoapany the application.
No action will be taken on an application filed without the proper fee.
1780 026 III. Information To Be Submitted The information contained in an application must be suf ficient to allow the Commission to determine that the applicant's proposed equipment, facilities, procedures, and the training and experience of personnel are such that the therapy program will not constitute an unreasonable risk to the health and safety of employees and the public.
If the application is for amendment or renewal of an existing license, the applicant may incorporate, by refc.ence, information contained in applications, statements, and reports previously filed with the Commission's Materials Branch.
The references should cicarly indicate the date, page, paragraph, and name of the docu-ment and how such information is applicable to the license application.
Items 1 through 7, and 16 of Form flRC-313 cust be completed.
The remaining items need not be completed if adequate information with respect to the following is submitted on supplementary pages attached t o Form !!RC-313:
A.
Physic ians's Qualifications Each user must be a physician who is liccnsed to dispense s t,4 t e o r. t e r r i t o r:. of drugs in the practice of medicine by t he United States, the Dist ric t of Columbia, ir the Co::wnw alth
' Y li li 'P Puer t o Rico.
d.
1780 027 e
If the proposed user is certified by the American Board of Radiology in Radiology or Therapeutic Radiology, a statement to this effect, giving the branch of radiology and the year in which certification was received, will be suf ficient.
If not certified as indicated above, the physician's training and experience qualifications will be reviewed with the aid of the Commission's Advisory Committee on Medical Uses of Isotopes.
In such cases, the applicant should submit (1) signed preceptor statements (page 3 of application Form NRC-313(a)) and (2) additional statements from each physician under whom he received training and experience in the use of a teletherapy unit.
The latter statements should describe the scope and extent of his training and experience and include an appraisal of his competency to independently use a teletherapy unit.
B.
Teletherapy Unit 1.
Design and Construction Details Design and construction details of the source and tele-therapy device are required for evaluation.
A description of the source and device sho..ld be submitted to the Commission or a State licensing agency (if the manufacturer 1780 028 r..
o is located in an Agreement State) by the manufacturer prior to customer use.
The applicant then must submit only the manufacturer's name and model number of the source and teletherapy device for licensing purposes.
2.
Source content The type and quantity of radioactive material contained in the source must be identified.
The identification should include the maximum number of curias and the associatad RHM value (roentgens per hour at 1 meter) for the specific source intended.
3.
Beam Stops It is usually necessary to restrict the use of the teletherapy machine's primary beam of radiction becau:;e portions of the treatment room walls, floor or ceiling do not adequately shield adjacent are.is from direct or scattered radiction.
Tt.e use of mechanical and/or electrical stops that will be used to restrict beam orientation must he spec ified and the angles subtended by such beam limitations should be described.
C.
Teletherapy Facility 1.
Plan and Elevation Details i
1780 029
_ 7_
Plan and elevation drawings or sketches of the teletherapy room (including thickness, density and type of shielding material used) are required. The drawing or sketch should specify distances from the source location to areas adjacent to the shielding facility, and denote the walls that are backed by earth.
2.
Patient Viewing System A system for providing continuous patient viewing from outside the treatment room during therapy is required.
If a shielded viewing window is used, specify the thickness, density and type of material used.
If a TV viewing system is used, specify the back-up system that is used if the TV system malf unctions or confirm that patient t reatments will be suspended imtil the TV syst em i.
repaired and functioning again.
3.
Penetrations and Voids Entrance ways, ventilation docts, patient viewing window:.,
pipes, conduits, and all other penetrations and voids in the treatment room walls, ceiling or floor should be indicated on the drawings or sketches.
The description of the shielding used to com,iensite for the v o i d r. shi.n l o include the type of matorial used, :te density.ind t hickne: s 1780 030 4.
Door Interlocks Each door leading into the teletherapy room must be provided with an interlock to control the "'n-off" mechanism of the teletherapy unit. The interlock must cause the source to move to the "off" condition if the door is opened during source exposure. The mechanism must be so wired that the source cannot be returned to the "on" condition until the system is reset at the control panel.
5.
Calculations of Radiation Levels Calculations of the maximum radiation levels that will exist in each area adjacent to the shielded facility are required.
The calculations should include the contribu-tions due to primary, leakage, and scattered radiation and should clearly indicate all paraceters used in the calculations.
Such parameters inc lude beam orientation, scatter angle, treatment distince, scatter ratio. distance between source and area of concern, and beam attentating factor of the shield material.
The type of use intended for each area should be speci:'ied.
The radiation levels will be evaluated with respect to the requirements of 10 CFR Part 20 and specif ically Sect ion 20.105.
Occupancy factors will not normally be :onsiaered f or t hese evaluation.,.
1780 031
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st D.
Radiation Safety Program 1.
Personnel Monitoring The name and address of the supplier furnishing film badges or equivalent personnel monitoring devices (please specify) and the frequency for changing such monitoring devices should be stated.
If pocket chambers or pocket dosimeters are to be used as additional monitoring devices, state the useful range, frequency for reading the devices, and the procedures f or their calibration and maintenance.
2.
Radiation Survey and Monitoring Instrumentation State the manufacturer's name and codel number of each survey and monitoring instrument to be used and describe the minimum specifications and aperating char.icteristics of each. The description should include the type of radiation detected, range (mr/hr), window thickness (mg/cm ) and type of use for whic h each instrument is designed. The frequency, method, and standards used iri calibrating such instrumentation must be described.
If such calibrations are to be performed by an outside firm, its calibration procedures and cethods cust be descr: bed if not previously furnished to, and accepted by, the Commission or a State licensing agency.
1780 032 c
An area radiation monitor should be installed within the teletherapy room as an cid in early detection of ca. hine malfunctions and accompanying hazardous radiation is vels.
3.
Unrestricted and Restricted Areas There may exist in certain areas adjacent to the teletherapy f acility radiation levels higher than those permitted for unrestricted areas, as defined by Section 20.105(b) of 10 CFR Part 20.
If the radiation level in an unrestricted area exceeds 2 mR/hr, it must be shown that, in keeping with Section 20.105(b) of 10 CFR Part 20, an individual contin'iously present fa the area would not receive more than 2 millirems in any one hour or 100 millirems in any seven consecutive days.
If these criteria cannot be met, the applicant may request authorization for higher radiat.on levels in the unrestricted area pursuant to Section 20.105(a).
If the above criteria cannot be met, the Commission may require additional ;,hielding or restrict orientation of the primary beam of radiation.
In certain cases, following the radiation surv y described in Item V, scue areas with mary,inal shielding; :ay be designated as res t r i t. Led a r eas,
1780 033 provided the methods used to control access to such restricted areas are delineated in detail and the nanner in which the areas are posted is described.
Refer to Section 20.203 of 10 CFR Part 20 for the Cc= mission's requirements concerning posting and controlling of access to high radiation areas.
4.
Leak Test ing The Commission requires that teletherapy sources be tested for leakage at intervals not to exceed six months.
The tests shall be suf ficiently sensit ive to detect 0.05 microcurie of contamination on the test sample.
If a service organization is to perform the leak tests on the teletherapy source, specify the nane and address of the organization.
If the le;k test is to be conducted by the applicant, describe the nanner in which the test samples are taken, the specific radiation detection instrumenta-tion (i.e., manufacturer's name and model number) that will be used in the analysis, and the method of analysis.
5.
Emergency Procedures The applicant must establish and submit a set of emergency procedures to be folle ed in the event that the cierator is unable to turn off the teletherapy ur.it at the console.
1780 034
12 -
These procedures shall be posted at the taletherapy machine console and indicate to the operator:
a.
If the patient is ambulatory, instruct him to get off the table and leave the room.
b.
If the patient is not ambula tory :
(1)
If the patient can be removed from the room, enter the room and avoiding exposure to the useful beam, pull the treatment table as far away from the useful beam as possible, transfer the patient to a stretcher and remove him f ram the room.
(2)
If the patient cannot be removed from the room:
(a)
Operate the teletherapy unit from the console and direct the primary beam of radiation away fre= the patient toward a safe barrier.
(b)
If the primary beam of radiation cannot be moved off the patient, en t e:' the room, e
s 1780 035 locate the device for manually turning off the primary beam of radiation and turn the unit off.
c.
Close the door and uccure the room against unauthorizeil entry.
d.
Notify the responsible physician or radiation pro-tection of ficer fcr remedial action to be taken.
if the trouble cannot be corrected immediately, the manufacturer may also have to be contacted.
E.
Relocation In the event that a licenset desires to move his teletherapy unit to a new location, he must submit to the Commission for review and evaluation the information required by items A-D above prior to receiving approval for the new tacility.
I V, Service A.
Installation, Maintenance, 1;.. change and Removal All persons or organizations performing service operations on a teletherapy source must be licensed by the Commission or a State Licensing agency to do so.
Service operations include (1) i nst a llat ion. exc h.i n ge and removal of sources in a tele-therapy unit son: ce ho.ning, (21 any maintenance or repair operations perfirnen on 1 t e l e t h e r a p.' unit involving wc,rk ni, the son cr t r.twe r, ihe 'but
<r, tuer rr.ec h in i sm t h.i t,0011 1780 036~
e> pose the source, reduce the shielding around the source, or compromise the safety of the unit and result in increased radiation levels, and (3) the installation, relocation, or removal of a teletherapy unit containing a source leaded in the head. The applicant should indicate the name and address of the organization performing such service operations.
B.
5 Year Service and Maintenance Inspections The Commission requires "Each teletherapy machine to be fully inspected and serviced during source replacement or at interval?.
not to exceed five (5) years, whichever comes first, to assure proper functioning of the source exposure mechanism".
" Fully inspected and serviced" means inspection and servicing of the teletherapy machine's components with the source removed from the head. Such operations must be performed by persons or organizations specifically licensed to do so by the Commiss hm or a State licensing agency.
V.
Survey Report Prior to initiation of a treatoer.t program, and subsequent to each installation of a teletherapy source, each licensee must p e r f o r.1, or have performed, radiation surveys and operational tests and furnish a copy of the results in a radiation survey report to the Commission for evaluation.
The survey report must include a head survey, a
1780 037 source output messu--r en t, ope stis tal test s on interlocks and safety devices, anc an ca survey of the maximum radiation levels that exist
.n each area adjacent to the teletherapy facility.
The survey report is required to be submitted to the Co= mission no later than thirty (30) days following each installation of a teletherapy source.
The surveys and tests to be conducted must be performed in accordance with the following:
A.
A radiation survey shall be made of:
(i) The teletherapy source housing, with the teletherapy source in the "off" position.
The maximum and average radiation levels at one meter from the teletherapy source in the "off" position shall not exceed 10 milli-roentgens per hour aad 2 milliroentgens per hour, respectively.
(ii) All areas adjacent to the treatment room, with the teletherapy source in the "on" position.
The survey, except item (c), shall be perfcrmed vith a phantem in the primary beam of radiation and shall clearly establish:
(a)
That radiation levels in restricted areas are not likelv to cauce perse v '. exposures in excess of 1780 038 the limits specified in Section 20.101 of Title 10, Part 20, Code of Federal Regulations, Chapter 1,
" Standards for Prctection Against Radiation" (10 CFR Part 20), and (b)
That quantities of radiation in unrestricted areas do not exceed the limits specified in Section 20.105(b) of 10 CFR 20.
(c) The intensity or the primary beam of radiation at a specified distance from the teletherapy source.
B.
Tests shall be made to determine proper operation of:
(i) Electrical interlocks on entrance doors to the teletherapy treatment room.
(ii) The t eletherapy source "on-of f" indicators, both at the source housing and on the teletherapy machine control panel.
(iii) Electrical or mechanical stops installed for the purpose of limiting use of the primary beaa of radiation (restric-tion of source housing angulation or elevation, carriage or stand travel, and operation of the beam "on-off" ncchanism).
(iv) The teletherapy treatment timing device.
x.
1780 U39
17 APPMDIX "/.*'
TELETi(ERAPY SURVEY R.:.7_0RT5 The radiation survey shall be conducted by a person ubo is goalified by training mod experience to measure ionizing radiation, to evaluate safety techniques, and to advise regarding protection needs and has good inculedge and understanding of the operating characteristics, incleding the limitations, of the radiation detection instru=entation and measuring devices that are used in the survey.
The following items can be used as a guide in fulfilling the requirec:ent for reporting the results of the radiation survey to the Cor:sission.
1.
The name, address, and licer se nuabar of the institution possessing and using the so.irce.
2.
The name and address of the person conducting the survey.
3.
The name of the manufacturer and codel number of the teletherapy unit and source.
4.
The date of source installation.
5.
The date of the survey.
6.
The name of the manufacturer and cc::et number of the radiation detection instrumentation and measuring devices that are used in the survey.
Also, state the last date of calibration and the method usrel for the calibr.ition.
1780 040
18 7.
The number of curies the source coacained at the time of installation.
s 8.
Tne measured output in PJii1 or R/M at X ca after the source is installed in the teletherapy head.
9.
A report of the mximum and average radiation levels measured at one meter from che source with the teletherapy source in the "off" position.
The ayerage radiation level may be obtained by averaging measure-meats-taken at 14 points on the surface of a sphere one meter in radius centered on the source. Please refer to the.
enclosed diagram for location of the 14 primary points.
Up to 25 points may be measured in accordance with t;CRP Report
- 33.
10.
A description of the limits of beam orientation permitted by electrical or mechanical stops installed on the teletherapy unit.
Please specify each directicn in which the teletherapy head can be coved and the naximu.
engle involved in each direction.
11.
For rotational units, please deternir.e the rotational position of the teletherapy unit causig the maximum radiation level in each area adjacent to the teletheresy 1780 041
19 facility, including above and belcw, with a phanton in the primary beam and report the maximum levels measured and the corresponding rotational positions (i.e., specify the angulation toward each area).
If the unit is to be used with the primary beam directed away from the integral beam absorber, then sp2cify the limits of such beam orientatica (sce Itc:10 above) and report the maximum radiation levels that are measured in ca.ch area adjacent to the teletherapy facility, including above and below.
12.
For vertical units, please report the maximun radiation levels that are measured in each area adjacent to the teletherapy facility, including above and below,and specify the orientations producing such radiation levels.
13.
A report describing the type of tests that were conducted and the tests results to determine:
The teletherapy treatment room door interlock (s) a.
function properly.
b.
The teletherapy source "on-off" indicators function properly.
1780 042
_ ao_
c.
The teletherapy unit's beaa stoos function properly, d.
The teletherapy treatment tiair.g device functions properly.
u 1780 043
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1780 044
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