ML20202G072
| ML20202G072 | |
| Person / Time | |
|---|---|
| Issue date: | 01/08/1998 |
| From: | Flack D NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Berk H, Deye J, Williams J NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| References | |
| NUDOCS 9802200048 | |
| Download: ML20202G072 (42) | |
Text
. _. - _ _ _.
January 8,1998 p,;.Cmy[~n I7"B,fy p; 7 UC DOcw;5y7 pggg MEMORANDUM TO: Dr. Jir1 Deye Dr. Harold Berk Dr. Janelle Williams Dr. Mike Bohan FROM:
Diane S. Flack,IMNS (orig signed by)
SU3 JECT:
Revision of Part 35, Medical Uses of Byproduct Material In follow-up to your January 7,1998, conversatioil with Cathy Haney, Chairperson of the Part 35 Working Group, I am attaching for your review and comment the Decembe' 17,1996, draft of Subpart F Medium and Low Dose Rate Manual Brachytherapy and Subr rt H -
a Therapeutic Medical Devicer, which will be discussed at the January 15th session of the January 1216, ';998, Working Group Meeting.
The meeting will be held in 03B4 of the NRC9 One Whlie Flint Building from 8:30 sm to 5:00 p.m. I have included maps that show how to reach the NRC building by Metro or h car.
The agenda for the meeting will be faxed to you as soon as it is finalized, if you have any questions about the meeting, please contact Cathy at (301) 415 6825 or me at (301) 413-5681,
Attachment:
As Stated DISTRIBUT'DN:
IMNS Central Files NRC File Center NMSS r/f DOCUMENT NAME: 1:\\ THERAPY,LTR Te veeeive e car of this sleeument. Indcate in the bout 'C' = Copy without ettschment' enclosure
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DRAFT 12/17/97 I 86:400 35.700 Use of a sealed source in a device for therapeutic medical uses 0;'.;;Ln;pj er.".,
The regulations and provisions of this subpart govern the use of sealed sources in devices for therapeutic uses as approved in the Sealed Source a Device.":gdri. tithe;;pi ur.h for modeofwthet arg;r, a nid ;;ura c' abe". SO :: nc,4Bh 12/5/97 (RAT:
Review of requircoment Indicates that teletherapy, gamana knife, and HDR could be cumbined into one inodasty, Do not want to list specific devices or radionuclides because of redundancy in requirements. Where t3quirements do not afply to all types of devices, the requirement ck.:rtyindicates this as the case. Treatment in this manner would not require rule revisions, lends itself more easily to new radionuclides (issue c f emerging uses of current devices).))
sea.ed source or sealed source in a device
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107
DRAFT 12/17/97 I 35.605 35.705 Installation, mMaintenance,-and repair reste!etkne.
(a) Only a person specifically licensed by the Commission or an Agr..
1 State to perbrm teletherapy-ttntt--maintenance, and repsir shall:
(e)(1) Install, replace, relocate, or remove a i l; therapy sealed source or source contained in a device, or remove depleted uranium contained in the device; or e4c;; therapy-timethet cont;ine ::;!cd soaree m (b) (2) Maintain, adjust, or repair the sourcc drewer, the shutter er other mechanient-of-e teletherept :tmtibet a device and associated equipment involving work on the source (s) shieloing, the source (s) driving unit, or other electronic or mechanism that could expose the source, reduce the shielding around the source, or compromise the safety of the device or the source (s) er-fesult in,ncicasedi;diatica lcyc's.
12/5/97 Would need to define " associated equipment." Need to be careful of FDA space.
ADD Record keeping requirement for maintenance 108
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DRAFT 12/17/97 (46.40643eense-emendmenter
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12/5/97 (RAT (a. d) are part 20 issue (e) covered in new 35.13(moved from 35.606 to 35.13 so all requirements for an amendment arO in one location) 109
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DRAFT 12/17/97 i
6 86444 36.710 Safety instruction.
(a) A licensee shall post instructions at the device ;bther;py unit console. To satisfy this requirement, these instructions must inform the operator of; (1) The procedure to be followed to secure the device, the console, the console keys, and the treatment room when not in use er unattended (2)(4) The procedure to be followed to ensure that only the patient or the human research subject is in the treatment room before initiating treatment with the source (s) turnbg the pr:m;ri b;;m c' 7:i;ba en to b;;b : ti;;;,nent or after a door interlock interruption; (3) The procedure to he followed to prevent the dual operation of more then.one radiation.
producing device in a treatment room if applicable; and (4) (2) The procedure to be followed if; (!) Th; the operator is unable to place the source (s) in the shielded position or remove the patient or human research subject from the radiation beam turn th; prim;ry b;; n of ;;dZtbn c'f Oh centreb outside the treatment room or any otner abnormal ooeration occurs. The procedure sht'llinclude: t-end (1) Instructions for responding to equipment fallutes and the names of the individuals responsible for implementing corrective actions; (ii) Process for restricting and posting the treatment area to minimize the risk of inadvertent exposure.
(iii)-fii) The names and telephone numbers of the authorized users, the authorized medical physicist, and Radiation Safety Officer to be immedeeWy contacted if the device or console
- b: hor;py unit-or ;;neek operates abnormally; and (b) A licensee shall provide instruction with refresher training and practice drills in the topics identified in paragraph (a) of this section to all individuals who operate the device. ;::btherepy unib (c) A licensee shall retain for three years a record of individuals receiving instruction required by paragraph (b) of this section, ; d;;;;;p;bn of the b;;ructba, the date of instructior',
individuals who received the training, and the name of the individual who gave the instruction.
12/5/97' Check record keeping requirement agalnst previous records of training.
(RAT Review of requirement indicates that teletherapy, gamma knife, and HER could be combined into one modality. Do not want to list specific devices or radionuclides because of redundancy in reqdrements. Origin of newitems are license conditions. )
[51 FR 36951, Oct.16,1980, as amended at 53 FR 19247, May 27,1988; 59 FR 61785, Dec. 2,1994) 110
t DRAFT 12/17/97 I
1 l 46:444 35.715 Safety precautions.
(a) A licensee shall control access to the treatment ti:'er;F, room by a door at each entrance.
. (b) A licensee shall equip each entrance t> the treatment ti;'erwpy room with an electrical interlock system that will:
(1) Prevent the operator from initiating the treatment cycle tr v np tre pr;vcr;ry 'xm c' r;i;;;en en unless each treatment room entrance door is closed; and (2) Cause the sources to be shielded bra t'a p,- m.ri l: :, e' 7:i:ks ;"immediately -
when an entrance door is opened; and
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111
DRAFT 12/17/97 12/10/97 WG consider addressing concern contained within this LC - need to come back to review this.
(f) For licensee activities where sources are placed within the patient's or human research subject's body, a licensee shall not conduct a treatment for which a decoupled orjammed source could not be expeditiously removed.
HER and Gamma knife specific requirement: (g) A licensee shall require an authored user and a device medical physicist to be present during all treatments involving the device.
l (h) A licensee shall itave available, near each treatment room, emergency source shielding and/or recovery equipment. The emergency equipment shall include, as applicable:
(l) a device to assist in placing the source (s)in the shielded position; (ll) a shlalded sourcelapplicator storage contalnar; (iii) remote handling tools; and (iv) supplies necessary to surgically remove applicators or sources from a patient or human research subject treated Intenially with sealed sources.
(RAT:
Part 20, Indust?y standards, performance based)
(51 FR 36951, Oct.16,1986, as amended at 53 FR 19247, May 27,1988; 59 FR 61785, Dec.2,1994) 112
DRAFT 12/17/97 1
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12/10/97 (RAT:
performance based DSI12. not needed, deleted elsewhere.)
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113
DRAFI' 12/17/97 5 35.630 Dosimetry equipment.
(a) A licensee shall have a calibrated dosim,etry system available for use. To saSsfy this requirement, one of the following two conditions'must be met.
(1) The system must have been calibrated by the NationalInstitute of Standards and Technology or by a calibration laboratory accredited by the American Association of Physicists in Medicine (AAPM). The calibration must have been performed within the previous two years and after any servicing that may have affected system calibration; or (2) The system must have been calibrated within the previous four years; eighteen to thirty months after that calibration, the system must have been intercompared at an intercomparison meeting with another dosimetry system that was calibrated within the past tweniy four months by the National Institute of Standards and Technology or by a calibration laboratory accredited by the AAPM. The intercomparison meeting must be sanctioned by a calibratien laboratory or radiologic physics center accredited by the AAPM. The iesults of the intercomparison meeting must have indicated that the calibration factor of the licensee's cystem had not changed by more than 2 percent. The licensee may not use the intercomparison result to change the calibration factor. When intercomparing dos! metry systems to be used for calibrating sealed sources for therapeutic devices, the licensee shall use a comparable de" ice with beam attenuators or collimators as applicable and sources of the same radionuclide as the source used at the licensees facility, cob;!!=SO tc!ctherapy unitsribe ticenscc shall uso a iclctherapy unit with-e-cobalt-60mourcc. When intercampering4esimetry sistcms to bc used for co!;brating eesium-137 telethef apy units, the licenscc shall usc a ic!ctherepy$ nit with a cc3lum-137 eOUtce (b) The licensee shall have available for use a dosimetry system for spot-check measurements. To satisfy this requirement, the system may be compared with a system tnat has been calibrated in accordance with paragraph (a) of this section. This comparison must have been performed within the previous year and after each servicing that may have effected system calibration. The spot-check system may be the same system used to meet the requirement in paragraph (a) of this section.
(c) The licensee shall retain a record of each calibration, intercomparison, and comparison in accordance with 35.2730.,
5 35.2730 Recordkeeping for dosimetry equipment.
Each licensee shall retain a record of the calibration, intercomparison, and comparisons of its dosimetry equipment done in accordance with 35.730 for the duration of the license. For each calibration, intercomparison, or comparison, the record must include the date, the model numbers and serial numbers of the instrumants that were calibrated, intercompared, or compared as requirea by paragraphu (a) and (b) of B5-730 this+ection, the correction factor that was determined from the calibration or comparison or the apparent correction factor that was determined from an intercomparison, the names of the individuals who performed the 114
DRAFT 12/17/97 calibration, intercomparison, c; comparison, and evidence that the intercomparison meeting was sanctioned by a calibration laboratory or radiologic physics center accredited by AAPM.
[51 FR 36951. Oct.16,19t$8, as amended at 56 FR 23471, May 21,1991) 12/11/97 Question calibration frequency between dosime,try systems and survey meter calibrations. Contact ACMUl regarding any changes In froquency for dosimetry cystems. Need input from medical physicists and health physicists Question reduction of caillbration frequency here or extend frequwncy for survey meters.
AAPM TG 56 (not finalized yet) is recommending initial calibration, followed Ly annual intercomparison, and full cal'bration every two yearu. Should we make this change?
115
r DRAFT 12/17/97 I
4 6-4544P-35J32 Full calibration measurements for telethorapy units.
(s) A licensee authorized to use a teletherapy unit for medical use shall perform full calibration measurements on each teletherapy unit:
(1) Before the first medical use of the unit; and (2) Before medical use under the following cor.ditions:
(1) Whenever spot check measurements indicate that the output differs by n ore than 5 percent from tha output obtained at the last full calibration corrected mathematicolly for raolcactive decay; (ii) Following replacement of the source or following reinstallation of the telethtrapy unit in a new location; (iii) Following any repair of the teletherapy unit that includes removal of the sotcrce or major repair of the components associated with the source exposure assembly; and (3) At intervals r ot exceeding one year.
(b) To satisfy the requirement of paragraph (a) of this section, full calibration measurements must include determination of:
(1) The output within +/ 3 percent for the range of field sizes and for the distance or range of distances used for medical use; (2) The coincidence of the radiation field ind the field indicated by the light beam 10calizing l
device; L
(3) The uniformity of the radiation field and its dependence on the orientation of the useful beam; (C ' m.ar constancy and linearity over the range of use; l
(S) On-off error; and (6) The accuracy of_ all distance measuring and localization devices in medical use.
-(c) A licensee shall use the dosimetry system described in 9 35,630(a) to measure the ou'put for one set of exposure conditions. The remaining radiation measurements required in pangraph (b)(1) of this section may be made using a dosimetry system that indicates relati/e dost rates.
'(d) A licensee shall make full calibration measurements required by paragrcph (a) of thit -
section in accordance with either the procedures recommended by the Scientific Committee on Radiation Dosimetry of the American Association of Physicists in Medicine that are described in Physics in Medicine and Biology Vol.16, No. 3,1971, pp. 379 396, or by Task Group 21 of the Radiat'on Therapy Committee of the American Association of Physicists in Medicine that are described in Medical Physics Vol.10, No. 6,1983, pp. 741771, and Vol.11, No. 2,1984, p.
213,(Both of thm ;f;;;ne;e h;v; L;= pprev;d for ;reerper; tion by referene; by tre Bereeter ef-th; I;cr;l n;;%;n 0;pk; ci the twinct; ;;; ;;;":5b for :n;pe;;'e, et the NRC4:,bieryr445'S C;;kv:lb ";k;, neekv;lb, ";ri ad 20002-2730. Cepb; c' tre document; b
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DRAFT l
12/17/97
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i (e) A licenseo shall correct mathematically the outputs determined in paragraph (b)(1) of this section for physical decay for intervals consistent with 1% physical decay n;; ;x;;;8mg en; menth fer ;;k"rSO cr sN m;nthe4er-eeemm447-(f) Full calibration measurements required by paragraph (a) of this section and physical j
decay correctione required by paragraph (e) of this section must be nerformed by the l;;;n;;;'s i
t;l;ther;py medical physicist.
(g) A licensee shall retain a record of each calibration in accordance with 35.2732.
$ 36.2732 Records of teletherapy calibrhtlon.
The licensee must maintain a record of the calibrations required by 35.73210 ue durai;on of use of the teletherapy unit source. The record must include the date of the calibracion, the manufacturer's name, model number, and serial number for the teletherapy unit, one 9e source, the med;l numkr; :nd eer;;' numkr; cf the and instruments used to calibrats the teletherapy unit tables thc' describe the output of the unit over the range of field sizes and for I
the range of distances used in radiation therapy, a cetermination of tne coincidence of the radiation field and the field indicated by the light beam localizing device, an assessmen' oi timer I
linearity and constancy, the calculated on-off error, the estimated accuracy of each dist
- e measuring or localization device, and the signature of the medical t;'; therapy physicis' FOOTNOTE TO (d)
(Both of these references have been approved for incorporation by reference by the Director of the Federal Register. Copies of the documents are available for inspection at the NRC Library, 11545 Rockville Pike, Rockville, Maryland 20852 2738. Copies of the documents are also on file at the Ofdu of the Federal Register,800 North Capitol Street NW., suite 700, Washington, DC. A notice of any chango in the material will be published in the Federal Register.)
[51 FR 36951, Oct.16,1986, as amended at 53 FR 43420, Oct. 27,1988; 57 FR 61786, Dec.
29,1992; 59 FR 50689, Oct. 5,1994) 117
.. - - -.-. ~. _ -. _
{-
DRAFT 12/17/97 1
i g
9-45488-38.733 Full calibration measuremente of High Dose-Rate Remote Aftertoeder, (a) A linonese authorized to use a high done rate-remote afterloader for medical use shall perform.bil calibratkm measurements on each unit:
I (1) Before the first medical use of the unit; and (2) Befke medical urs. nder the followir'g conditions:
(?) 70..;?r :;;%c ;x1:;;;.-O ;-f;" 0 ; 2.; ce;d C:;. b; ms;then-6
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(ii) FUldng replacement of the source or following reinstallation of the unit in a new l
location; L (d) Following any repair of the unit that includes removal of the source or m@r repair vf the c.omponents associated with the source exposu e assembly; and (3) At intervals not exceeding one month.
(b) To satisfy the requirement of paragraph (a) of this section, full calibration measurements must include determination of:
(1) The output within +/ 5 percent; (2) Timor constancy and linearity over the range of use; (3) On-o# error; and (4) Source positioning accuiacy to within +/- 1 millimeter
($) Measurement of source guide tubes e.nd connectors;
- (6) Source retraction with backup batte:y upon power failure; ar.d
-(7) Source homogeneity.
- (c) A licensee shall use the dosimetry system described in 9 35.730(a) to measure the output.
(d) A licensee shall make full calibration measurements required by parag,aph (a),of this section in accordance with either the procedures recommended by Task Group 41 of the Radiation Therapy Committee of the American Association of Physic:ists in Medicine, May 1993.~
- (e) A licensee shall correct mathematically the outputs determinocl in paragraph (b)(1) of this section for physical decay for intervals decay for intervals consistent with 1% physical decay.
. (f) Full calibration measurements required by paragraph (a) of this section and physical-1 decay corrections required by paragraph (e) of this section must be performed by the licensee's medical physicist.
(g) A licensee shall retain a record of each calibration in accordance with 35.2733.
$ 35.2733 Records of high dose-rate remote afterioader calibration. -
Tim heensee must maintain a record of the calibrations required by 36.733 for three years.
The rooord must include the date of the calibration, the manufacturer's name, model number, and serial number for the high dose-rate remote afterloader, end-the source, the model 118
DRAFT 12/17/97 numisert; rd s,% r.;..T.M.. c';M and instruments used to calibrate the unit, source position accuracy, homogeneity, an assessment of timer linearity and constancy, the calculated on-off error, emi the signature of the medical tele #wrapy physici6t.
l J-119 e
.. -. - - _ _ - - -. ~. -. _. _ - - -
T i.
i DRAFT 12/17/97
-1
$46448-35.734 Full calibration measurements for gamma stereotactic surgery unit.
(a) A licensee authorized to use a gamma stereotactic surgery unit for medical use shall perfom) full calibration measurements on each unit:
(1) Before the first medical use of the unit; and (2) Before medical use under the following conditions:-
(1) Whenever spot check measurements indicate that the output differs by more than 5 percent from the output obtained at the last full calibration corrected mathematicaJy for-radioactive decay; l
(ii) Following replacement of the source or following reinstallation of tie gamma
+
storsotactic surgery unit in a new location; l
_ (iii) Following any repair of the gamma storsotactic surgery _ unit that includes removal of the source or major repair of the components associated with the source exposure assembly; and (3) At interval 4 not exceeding one year.
(b) To satisfy the requirement es paragraph (a) of this section, full calibret.on measurements must include riotermination of;
- (1) The output within +/-3 percent for the range of field sizes and for the distance or range J
of distances used for medical use;-
~ !
(2) The coincidence of the radiation field and the to within +/t1 millimeter; (3) Collimator factors; and i
(4) Relative helmet factors.
@ A licensee shall use the dosimetry system described in $ 35.760(a) to measure the output for one set of exposure conditions. The remaining radiation measurements required in
. paragraph (b)(1) of this section may be modo using a dosimetry system that indicates relative
- dose rates.
(d) A licensee 'shall make full calibration measurements required by paragraph (a) of this Section in accordance with -
(v) A licensee chall correct rnathematically the outputs determined in paragraph (b)(1) of this section for physical decay for intervals consistent with 1% physical decayr (f) Full cal 6bration measurements required by paragraph (a) of this section and physical decay corrections regiarod by paragraph (e) of this section must be performed by the medical physicist.
(g) A licensee shall retain a record of each calibration in accordance with 6 35.2734.
$ 35.2734 Records of gamma stereotactic surgery unit calibration.
- The liconoee must maintain a record of the calibrations required by 35.734 for the duration of use ((the gamma stereotactic surgery unit source. The record must includn the date c4 the calibration, the manufacturer's name, model number, cnd serial number for the gamma storectr4ctic surgery unit, en:Hhe source, % m:2%c.M.;;.t : -:# rcd:2 ;'".; and instruments uced to calibrate the gamma stereotactic surgery unit, an assessment of timer
'120 l
l-
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DRAFT 12!17/97-linearity sna constancy, the calculated cn-off error, collimator factors, helmet factor, and the signature of the medical :_:_::ar;; physicist.
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121
DRAFT 12/17/97 I 46.434 35.7xx Periodic spot checks for teletherapy units.
(a) A licensen authorized to use teletherapy units for medical use shall perform output spot-checks on each teletherapy unit once in each calendar month that include determination of; (1) Timer constancy, and timer linearity over the range of use; (2) On off error; (3) The coincidence of the radiation field and the field indicated by the light beam localizing device; (4) The accuracy of all distance measuring and localization deviens used for medical use; (5) The output for one typical set of operating conditions measured with the dosimetry system described in 9 35.630(b) of this part; and (6) The difference between the measurement rnade in paragraph (b)(5) of this section and the anticiphted output, expressed as a pe ventage of thu anticipated output (i.u., the value cbtained at last full calibration corrected mathematically for physical decay).
(b) A licensee shall perform measurements required by paragraph (a) of this section in accordance with procedures established by the monthly telethefepy physicist. That individual need not actually perform the spotcheck measurements.
O A licensee shall have the medical telethefepy physicist review the results of each spot-check within 15 days. The medical tither &py physicist shall promptly notify the licensee in writing of the results of each spot-check. The licensee shall keep a copy of each written notification for three years.
(d) A licensee authorized to use a teletherapy unit for medical use shall perform safety spot checks of each teletherapy facility once in each calendar month that assure proper operation of:
(1) Eledrical interlocks at each teletherapy room entrance; (2) Electrical or mechanical stops installed for the purpose of limiting use of the primary beam of radiation (restriction of source housing angulation or elevation, carriage or stand travel and operation of the beam on-off mechanism);
(3) Beam condition indicator lights on the teletherapy unit, on the control console, and in the facility; (4) Viewing systems; (5) Treatment room doors from inside and outside the treatment room; and (0) Electrically assisted treatment room doors with the teletherapy unit electrical power turned off, (e) A licenses shall arrange for prompt repair of any system identified in paragraph (d) of this section that is not operating properly, and shall not use the teletherapy unit following door interlock malfunction until the interlock system has been repaired.
(f) A licensee shall retain a record of each spot-check required by paragraphs (a) and (d) of this section for three years. The record must ine'ude toe date of the spot-check, the manufacturer's name, model number, and serial number for both the teletherapy unit and 122
1.
I DRAFT 12/17/97
- cource, the manufacturer's name, model number and serial number of the instrument used to measure the output of the teletherapy unit, an assessment of timer lineanty and constancy, the calculated on-off error, a determination of the coincidenco of the radiation field and the field indictied by the light beam localizing device, the calculated on-off error, the determined accurecy of each distance measuring or localization device, the difference between the anticipated output and the measured output, notations indicating the operability of each
~
entrance door electrical interlock, each electrical or mechanical stop, each beam condition indicator lignt, the viewing system and doors, and the signature of the individual who performed the periodic spot check.
[51 FR 36951, Oct.16,1986, as amended at 53 FR 19247, May 27,1988) i
'S
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==
123
DRAFT 12/17/97 t SMH 36.7xx Periodic spot checks for teletherapy units.
(a) A licensee authorized to use teletherapy units for medical use shall perform output spot-checks on each teletherapy unit once in each calendar month that include determination of:
(1) Timer constancy, and timer linearity over the range of use; (2) On-off error; (3) The coincidence of the radiation field knd the field indicated by the light beam localizing device; (4) The accuracy of all distance measuring and localization devices used for medical use; (5) The output for one typical set of operating conditions measured with the dos! metry system described in 9 35.630(b) of this part; and (0) The difference between the measurement made in paragraph (b)(5) of this section and the anticipated output, expressed as a per ntage of the anticipated output (i.e., the value obtained at last full calibration corrected n.
tematically for physical decay).
(b) A licensee shall perform measurements required by paragraph (a) of this section in accordance with procedures established by the teletherapy physicist. That individual need not actually perform the spotcheck measurements.
(c) A licensee shall have the teletherapy physicist review the results of each spot check within 15 days. The teletherapy physicist shall promptly notify the licensee in writing of the results of each spot check. The licensee shall keep a copy of each written notification for three years.
(d) A licensee authorizad to use a teletherapy unit for medical use shall perform safety spot checks of each teletherapy facility once in each calendar month that assure proper operation of:
(1) Electrical interlocks at each teletherapy room entrance; (2) Electrical or mechanical stops installed for the purpose of limiting use of the primary beam of radiation (restriction of source housing angulation or elevation, carriage or stand travel and operation of the beam on-off mechanism);
(3) Beam condition indicator lights on the teletherapy unit, on the control console, and in the facility; (4) Viewing systems; (5) Treatment room doors from inside and outside the treatment room; and (6) Electrically assisted treatment room doors with the teletherapy unit electrical power turned off.
(e) A licensee shall arrange for prompt repair of any system identified in paragraph (d) of this section that is not operating properly, and shall not use the teletherapy unit following door interlock malfunction until the interlock system has been repaired.
l (f) A licensee shall retain a record of each spot check required by paragraphs (a) and (d) of this section for three years. The record must include the date of the spot-check, the manufacturer's name, model number, and serial number for both the teletherapy unit and 124 I
. _. - ~ _ _.... _ _ _ _. _ - - _ _ _._._ _. _ _ _ ~ _ _ _ _. -
DRAFT 12/17/97 4
source, the manufacturer's name, model number an d oerial number of the instrument used to mensure the output cf the teletherapy unit, en assessment of timer linearity and constancy, the calculated on off error, a determination of the coincidence of the radiation field and the field indicatad by the light beam localizing device, the calculated on-off error, the determined avuracy of each dist9nce measuring or loedlization device, the difference between the anticipated output and the measured output, notations indicating the operability of each entrance door electrical intenock, each electrical or mechanical stop, each beam condition indicator light, the viewing system and doors, and the signature of the individual who performed the perioulc spot check.
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DRAFT 12/17/97 945466 36.736 Safety checks %;:: ;".;;g; t; ::::;;.
(a) A licensee shall promptly check all systems listed in 6 35.634(d) for proper function after each instal!stion of a teletherapy source and after making any change for which an amendment is required by $ 35,606 (a) t$ ugh (d).
(b) If the results of the checks required in paragraph (a) of this section Indicate the malfunction of any system specified in 6 35.634(d), the licensee shall lock the control console in the off position and not use the unit except as may be necessary to repair, replace; or check the 4
malfunt,iloning system.
O A licensee shall retain for three years a record of the facilit/ checks following installation of a source. The record must include notatior.s indicating the operability of each entrance door interloci., each electrical or mechanical stop, each beam condition indicator light, the viewing system, and doors, and the signature of the Radiation Safety Officer.
[51 FR 36951, Oct.16,1986, as amended at 53 FR 19247, May 27,1988)
. = _
126
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DRAFT i
12/17/97-i e
$4 M 4435.741 Radiation surveys t t'w^W.':::"--.
(a) in addition to the survey requirement in 20.1501, a licensee shall make such surveys as -
defined in the Sealed Source and Devlor Pogistry to assure that the maximum radiation levels i
and everage radiation levels from the surface of the main source safe with the souros(s) in the shielded position does not exceed the levels stated in the Registry, i
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. surveys as defined in the Sealed Source and Device Registry to assurs ;
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. radiation levels and average reiiation levels from the surface of the mair. Orce safe with the i
source (s) in the shielded position does not exceed the levels stated ki thwegistry, i
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- $ 35.2741 Records of surveys.
The licensee must maintain a record of surveys made in accordance with 35.2741 for
';";;;b ;,..':5, c'; w;;;ee 'cr the duration of the license The record
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ii must include tha date of the measurements, r : ;r,2.; ;ur;;, P rqu!rd, the manufacturer % name, model number and serial number of the treatment telethocery unit,', the 4
. source, and the instrument used to measure radiation levels, and each dose rate measured around the teletherapy source while the unit is in the off position and the average of all
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(51 FR 36951 Oct.16,1986, as amended at 56 FR 23472, May 21,1991; 58 FR 67630, Dec, 22,1993) b 128
DRAFT 12/17/97 1
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12/11/97 (RAT Part 20 covers this section, no need to cite.)
[51 FR 36951, Octi 16,1986, as amended at 56 FR 23472s May 21,1991; 58 FR 67660, Deci22,1993) 129
DRAFT 12/17/97 1
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No need to send information to NRC. Survey results would be reviewed during inspectsans. )
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DRAFT 12/17I97 6 36.647 Five year inspection for teletherapy and gamme stereotactic surgery units.
(q) A licensee shall have each teletherapy unit and gamma stereotactic surgery unit fully inspected and serviced d: ring ;l;ther;py source replaceinent or at intervals not to exceed five years, whichever comes first, to assure proper functioning of the source exposure mechanism.
(b) This inspection and servicing may only be performed by persons specifically licensed to i
do so by the Commission or an Agreement State.
(c) A licensee shall keep a record of the inspection and servicing in accordance with 35.2747, l 36.2747 Recordkeeping of five year inspection for teletherapy and gamma steroometic surgery units.
A licen;ce must maintain a record of the five-year ir spection required by 35.747 for the duration of the licensn. The record must contain the inspector's name, the inspector's radioactive materials license number, the date of inspection, the manufacturer's name and model number and serial number for both the treatment ;;l:ther;py unit and source, a list of components inspected, and a list of components serviced and the type of service,, li;t of cerapenente rep;eced; end the ;4neture of the la;pedor.
12/11/97 Look at origin of 6 year check in Sue's document was it NUREG on risk?
(RAT:
Impact is on reducing requirement from 5 to 7 years on gamma knife.
Precedenyt in hydraulic fluid checks. Risk involvedjustifies requirement. - Similal teletherapy units have been on a five year imquency. Public comment (Chicago) treat gemma knife like tele.
. Recordkeeping - if we list of components serviced, list of components replaced will be included.
Signature is not needed because the name is required.)
131
DRAFT 12/17/97 l 35.7x4 Additionalinstructions/ training.
A licenses shall ensure that operators, medical physicists, and authorized users have received training and have demonstrated pro!ciency in the use of the treatment device and treatment planning system and any associated emergency procedures. ????DRYRUN7???
???? PERIODIC REFRESHER?????
copies of instructions arid requirernsr.ts required by 35 operating and emergency procedures completed exam covering material unit operst'on, inspection associated equipment, survey instruments
}
demo understanding of use of operation,.. practical exam (dryrun)
Physicist /au copies ofinstructions use of unit and treatment planning system demo use of unit, treatment planning, assoc. oquip, emergency procedures by dryrun Annual refresher 12/11/97 WG try to incorporate bulletin requirements on HDRs and make more generic. We want to be sure that they have device training.-
132
DRAFT 12/17/97-8 36.7xx Thorapy related computer systems.
TN !bensee shall assure that the computer treatment planning systems and computerized operating systems associated with he therapy device are operating appropriately.
- 2/11/97 WG added this in, not reviewed yet.
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133
DRAFT 12/17/97
$ 35.960 Training for teletherapy.
Except as provided in 9 35.970, the licensee sha!I require the authorizec user of a sealed source listed in 9 35.600 in a teletherapy unit to be a physician who:
(a) is cartified by a specialty board whose certification process includes all of the training and exporlence requirements in 9 35.900(b) of this section and whose certification has been accepted by the NRC; W g
(1)]ad;clcgy, therapeutic radblcgy, ci radstbn encology4y the Amcdcon Ocard of 3
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w" (3) Radiclcgy, wlth apccbll;:ar;cn in radbthcrapy, as a Sdtish 'Tc!lcw of the i aculty of Radic!cgy" or 'Tclicw cf4hc Royal Oc"cgo of Radblcgy"; cr i-(4) Therapeutic rad lclcgy by :he Canadbn Royal Ocllcgc of Physic lans and Surgeons; or (b) is in the active practice of therapeutic radiology, and has had classroom and laboratory
~
training in basic.adioisotope techniques applicable t, the use of a sealeo souru in a E
teletherapy unit, supervised work experience, and supervised clinical experience as follows:
Ei (1) 200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br /> of classroom and laboratory training thet includes; (1) Radiation physics and instrumentation; (ii) Radiation protection; (iii) Mathematics pertaining to the use and measurement of raoioactivity; and (iv) Radiation biology; (2) 500 hours0.00579 days <br />0.139 hours <br />8.267196e-4 weeks <br />1.9025e-4 months <br /> of supervised work experience under the supervision of an authorized user at a medical institution that includes:
('1 Review of the full calibration measurements and periodic spot checks; (ii) Preparing treatment plans and calculating treatment times; (iii) Using administrative controls to prevent misadministrations; (iv) Implementing emergency procedures to be followed in the event of the abnormal operation of a teletherapy unit or console; and (v) Checking and using survey meters; and (3) Three years of supervised clinical experience that includes ono year in a formal training orogram approved by the Resit ocy Review Committee for Radiology of the Accreditation Council for Graduate Medical Education or the Committee u,1 Postdoctoral Training of the American Osteopathic Association and an additional two years of clinical experience in therapeutic radiology under the supervision of an cuthorized user at a medicalinstitut;on that includes:
(1) Examining individuals and reviewing their case istories to determine their suitability for teletherapy treatment, and any limitations or contraindications; (ii) Selecting the proper dose and how it is to be administered; (iii) Calculating the teletherapy doses and collabotating with the authorized user in the review of patients' or human research subjects' progress and consideration of the need to modify odginally prescribed doses as warranted by patients' or human research subjects' reaction to radiation; and 134
' O.
.o DRAFT 12/17/97 i
(iv) Post administration follow up and review of case h) stories.
- (3) Has demonatrated sufficient knowledge in radiation safety commensurate with the use requested by passing an examination given by the Commission or an organization or entity i
approvided by the Commission; 1
l 135 c
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- k DRAFT 12/17/97 Subpett43-Ocurce; for Stechytherepy SUBPART F - MEDIUM AND LOW OOSE RATE MANUAL BRACHYTHERAPY 12/1/97 - WG will need to define terms 92
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DRAFT 12/17/97 1
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$ 35,400 Use of sources for brach,' therapy.
y A heensee 6 'l use sealed the f;;;;wlng sources for therapeutic medical uses as approved in the Sealed Source and Device Registry. iet ;;nide,0; wi'th th; manuf;;turcr's red;;tbn safet end h;nd ;ng it.e'ruetbne:
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(c) Ot,;nt;um-00 ;s ; x;'.d scure; in en ;pp'beter for tr;;; ment of up;;t;bl y;
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(') led;nc-125 es ; =;bd sourc; in x;d-for intefetitial tratment of cr.;;r-(g) P;lbd;um-103 es ; x;kd ;;ure; in =;ds f:r inter;tltb' truim;'
' encer.
12/1/97 Need to either footnote or at least discuss in SOC what Sealed Source Registry (RAT:
Solves TARS on whetherpalladium andirra.um can be usedintercavitary orintersti'ial. No need to distinguish between types of uses.
Burden is on manufacturer to state whether thh source meets requirements for types of use intercavitary vs. Intersitial.)
(51 FR 36951, Oct.16,1986, as amended at 54 FR 41821, Oct.12,1989) 93
DRAFT 12/17/97 9
5 35,404 Radiation surveys. RelemeeH+;;;;;..t. or h;;;; rn:::;h ;d'nt..sted v. :J,
" ;;;;;.i :=;::./.
In addit!on to the requirements of Part 20.
(a) Immediately after implanting sources in a patient or a human research subject the 4
- licensee shall make a radiation survey of the patient or the human research suLject and the immediate t.rea of use i; ;;ntrm th;; ne ecures; L;v; bna m ;p';;ed. The li;ensee shall make a record of each sur/ey.
(b) Immediately after removing the last temporary implant source from a patient c, a human research subject, the licensee shall make a radiation survey of the patient or the human research subject with a radiation detection survey instrument to confirm that all sources have been removed. The-i cenn; m;y not r;';n; f;;m ;;n5nement for m;d;;;l cer; ; p;tl=t er ;
humemex;rch cubic;t tre,;;;d by temper; y ;mplenW4;;urc;; h;;; b;;n rem;ved.
(c) a licensee shall retain a record of patient or human research subject surveys for three years. Each record must include the date af the survey, the name of the patient or the human research subject, the dose rate from the patient or the human research subject expressect as millirem per hour and measurad at 1 meter from the patient or the human research subject, the survey instrunient used, and the initials of the individual who made the survey.
(RAT:
35.404(a), last sentence - Can release patient without remcval of temporary implants
' 12/1/97 in 36.75 go back and delete permarant from title and text.12/16 done (RAT:
acknowledge that patients are released under 35.75 that contain sealed sources. Purpose of this requimment is to make sure that when the physician directs that the sources be removed
-they are actually removed.)
[59 FR 61785, Dec. 2,.1994) j l
94 c
s DPAFT 12/17/97
$ 35.406 Brat.: /tnerapy sources inventory.
(a) Promptly after removing them from a patient or a human research subject, a licensee shall retum brachytherapy sources to the storage area and ensure that all sources taken from the storage area are returned., and count the number retumed to cnsure that all Ocurecs takca ficm th; storag; arca hava beca rcturncd.
(b) A licensee shall make a record of brachytnerapy source use which must include:
(1) The norncs of the individuals pcrmlticd to hand'c the sources; (2) The number and avlivity of sources removed from storapt the patient's cr-thc4nimen rcscccch subject's name and room numbci, the hme-end date they were removed from storage, the number and activity-cf th; sourcca in storagc a'tcr the remove l, and th; ;nitia's of the individunl who remcVed the sourcca from stcragc; (3) The number and activity of sources returned to storage, the patient's or the human icscacch subject's name and recm numbci, the hme-and date they were retumed to storage:
the nurnbcr and activity of sourcca in storag; aitt the retum, and the in;tials of the individual who rctumed the sourcca to storage.
(c) Immcd:stcly a'tcr lmp'enting sources in a patient er a human rescarch subject the liccascc shnll make a radiation suracy of the pat l cat or the human res;;rch subject and the arca of use to ccafm that nc sources have boca mispl aced. Thc !!ccascc shall mak; a record of cach suracy.
(d) A licensee shall retain the records required in paragraphs (b) end-@ of this section for three years.
[51 FR 36951, Oct.16,1986, as amended at 53 FR 19247, May 27,1988; 59 FR 61785, Dec.2,1994) 95
DRAFT l
12/17/97 i
I 35.410 Safety instruction, in addition to the requirements of 19.12,
. (a) The licensee shall provide radiation safety instruction to all personnel caring for the patient or the human research subject undergoing implant therapy. To satisfy this requirement, i
the instruction must describe:
l (1) Size and appearance of the brachytherapy sources; (2) Safe handling and shielding instructions in ccx cf ; d: lcdged ;curec; l
(3) F ocedures for patient or human research subject control; (4) Procedures for visitor control; and (3)(6) Procedures for notification of the Radiation Safety Officer if the patient or the human research subject d es or has a medical emergency.
l (b) A licensee shall retain for threc y;;r; a record of individuals receiving instruction in l
accordance with 35.2410.
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$ 35.2410 Recoros of safety instruction.
l The licensee must maintain a record of instructions required by 9 35.410 for three years. The reccid shall contain required by peregrcph (c) of thl: nctlca, ; d;;;ription of th; ln;;ructica, the date of instruction, and the name(s) of the individual (s) who attended the training and who gave the instruction.-
l 12/2/97 Consider whether there r.hould be a recordkeeping requiremer't for 19.12. Why wasn't this required before. M:sterial licensees are being required in license space to keep the rer,ord.
12/5/97 Revisited area of patient control and visitor control. Group belief that it should be required. Maintain consistency with 35.310.
RAT:
These training requirements are in addition to 19.12. Given possibility of higher dosas from improper handling of sources, WG believes it;at it is important that the section contain more specific instruction on what else needs to be provided to personnel. llctnc 3 cad 4 crc dclclcd boccuce thcy crc ccvcrcd by rcet 10.12 (rcicicacc rc;i 20 rcquirc;nant lc dcmlp proccdurcc
- ;%44&F)
[51 FR 36C51, Oct.16,1986, as amended at 53 FR 19247, May 27,1988; 59 FR 61785, Dec.2,1994)
(RATfornrcordkeeping:
It is important to know who attended the training. The description of the instruction is not needed since we can assume that the training matches that of 35.410.)
i 96
DRAFT l
12/17/97 l
I 35.415 Safety precautions.
(c) For each patient or human research subject receiving implant therapy and not released from licensee control pursuant to 9 35.75 of this part, a licensee shall:
(1) N;t qu;;1;r the p;tient er the hum;n r;xerch ;ubject in th; am; reem ;; an int caiduci vehe i; not Tex vlng red ;t!;n ther;py.
(2) Post the patient's or human research subject's door with a " Radioactive Materials" sign and note on the door or in the patient's or human research subject'r, : hart where and how long visitors may stay in the patient's or human research subject's room; (3) Permit visits by individuals only on a case-by-case basis, if the authortred user after consultation with the Radiation Safety Offk*r determines that it is appropriate, provided these individuals do not exceed the radiation dose limit of 0.5 rem (5 mSv) for visitors in 20,1301(a)(3),
(3) Authori;; visit; by indheidud; under ;g; iS city on ; ;;x by-;;x b;;;; veith th; epprevr.; cf the ;uthori;;d ux; ;'tcr cen;u!:;tlcn ve;th ;n; H;d;; tion 0;fety O";;;r; and (4) Iromptly r^;r lmpient np the m;tcri;l, ;urs;y the d;;; r;tc; in ;;ntiguou; r;;trlcted l
- nd unrati;;ted ;;;x..lth ; ren;tlcn m;;;urement ;urscy in;;rument to d; men;;r;;;
- mpll
- nee viith the requir;ments of I;;t 20 of th;; chopter, ;nd r;;;in for thr;; y;;r; ; re;;rd of ;;;h ;uricy th4ln;lud;; the tlm; ;nd d;'; cf th; ;uricy, ; pl;n of th; ore; 07 li;t of p;lnt;
- ur;;yed, the m;;;ured de;; r;t; ;t ;;v;r;l point; cxpre;;;d in m!lll rem per hour, "h; in;trument u;;d to md; th; ;urvey, ;nd th; inlt!;l; cf 'h; lndts!Ou;l Veh; m;d; th; ;uNcy
(5) [ Removed 62 FR 4120.).
(b) A l;;;nx; ;hdlactifj the Red: don 0;f;;y 0"lar immed ;t; y if the p;'l cat ;- th; hum;n r;n;;;h ;ubj;;t d;;; er h;; ; med;;e cmcrgency.
(b) A licensee shall viotify the Radiation Safety Officer as soon as possible:
(1) if the patient or the human research subject dies or (2) after attending to the patient or human research subject for a medical emergency. has a mtsdical emergency.
12/2/97 Discuss with Barry reason for change
- (RAT:
Removal of (1) and (3). Part 20 is limiting, prescriptiveness is not needed.
Keeping (2) because of risk associated with dose, Removsl of(4) This section is covered under Part 20 Removal of(b): Clarify that notification of the RSO does not take precedencu over emergency medicalcare.)
[51 FR 36951, Oct.16,1986, as amended at 53 FR 1924' May 27,1988; 59 FR 61785, Dec. 2,1994; 59 FR 65244, Dec.19,1994]
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DRAFT 12/17/97 Nn of nre;y instrument:
A liecan ;utherked t; u;; byproduct m;t rb; f;r imebnt ther;py ;he ' h;v; in it; penneba ; perteb;; red;;tbn d;;;;;;;n eure;y lnetrument ;;peb;; cf d; tat;ng d;,; r;ta ev;r the teng; 0.1 m"'; rem per hcur i; 100 m;",; rem per hcur, end a pertebk redbt;;n inn;urernent ;urs;y netrument ;;pubb cf mn;uring d;;; r;;;; cver the teng; i m!ll rem per hcur i; 1000 m;;;; rem per hour.
12/2/97 (RAT: Requirements are not needed in rule. Part 20.1501 requires that licensee shall make or cause to be made surveys that..show compliance with Part 20... ensure that instruments and cquipment for compliance are periodically calibrated. Part 30.33(a)(2? requisas licensee to have adequate instrumentation. Information on types ofinstruments available could be foundin guidsnce.)
t 98
- D DRAFT 12/17/97
$ 35,940 Training for use of brachytherapy sources.
Except as provided in 9 35.970, the licensee shall require the authorized user of a brachytherapy source listed in S 35.400 for therapy to be a physician who:
(a) is certified by a spacialty board whose certification process includes all of the training and experience requirements in $ 35.900(b) of this section and whose certification has been accepted by the NRC;im (1) R;dbb;y, thereputic redbb;y, ;* redutbn en;;bgy by the ?,med;;n 0;;;d of
- Radhkgy, (2) R;db;kn ence';;y by th; ?,rnedsen 0:;tepthk 2;;rd of Redbb;y; (3) Redbbgy, J;h ep;bNtlen in redbth; mpy, ;; ; Odtbh "I;lbw of the F;;uity of R;dbbgy" er "I;llcw of the R;y;' 0;";;; cf Redbbgy", er (4) Thcreputic redbbgy by th; 0;n; dun R;y;; 0;";;; cf "hy;bbn; and Surg;;n;; or (b) is in the active practice of therapeutic radiology, has hao classroom and laboratory training,n radioisotope handling techniques app" cable to the therapeutic use of brachytherapy sources, supervised work experience, and supe. vised clinical experiance as todows:
(1) 200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br /> of classroom and laboratory trr'ining that includes:
(1) Radiatior ohysics and instrumentation; (ii) Radiation protection; (iii) Mathematics pertaining to the use and measurement of radioactivity; and (iv) Radiation biology; (2) 500 hours0.00579 days <br />0.139 hours <br />8.267196e-4 weeks <br />1.9025e-4 months <br /> of supervised work experience under the supervision of an authorized user at a medicalinstitution that includes:
(1) Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys; (h) Checking survey meters for proper operation; (iii) Preparing, implanting, and removing sealed sources; (iv) Maintaining runninc inventories of material on hand; (v) Using administrative controls to prevent the misadministration of byproduct material; and (vi) Using emergency procedures to cortrol byproduct mate ial; and (3) Han demonstrated sufficient knowledge in rad?ation safety commensurate with the use requested by passing an examination given by the Ccmmission or an organization or entity
- appovided by the Commission; (3) Three years of supervised clinical experience that includes one year in a formal training prgram approved by the Residency Review Committee for Radiology of the Accreditation Council for Graduate Medical Education or the Committee on Postdoctoral Training of the American Osteopathic Association. and an additional two years of clinical experience in therapeutic radiology under the supervit, ion of an authorized rser at a medical institu; ion that includes:
(1) Examining individuals and reviewing their case histories to determine their suitability for brachytherapy treatment, and any limitations or contraindications; (ii) Selecting the proper brachytherapy sources and dose and method of edministration:
99
l;.
i DRAFT 12" 7/97 (iii) Calculating the dose; and i.
_. (iv) Post administration follow up and review of case hit, tories in collaboration with the l
authorized user.
[51 FR 36951, Oct.16,1986, as amended at 59 FR 61788, Dec. 2,1994)
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O DRAFT 12/17/97
$ 35.941 Training for ophthalmic use of strontium 90.
Except es provided in [; 35.970, the licensee shall require the authcrized user of only strontium 90 for ophthalmic radiotherapy to be a physician who is in the active practice of therapeutic radiology or uphthalmology, and has had classroom and laboratory training in basic radioisotope handling techniques applicable to the use of strontium-90 for ophthalmic radiotherapy, and a period of supervised clinical training in ophthalmic radUtherapy as follows:
I (a) 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> of classroom and laboratory training that includes:
(1) Radiation physics and instrumentation; (2) Radiation protection; (3) Mathematics pertaining to the use and measurement of radioactivity; and (4) Radiation biology; (b) Supervised clinical training in ophthalmic radiotherapy under the supervision of an authorized user at a medical institution that includes the use of strontium-90 for the ophthalmic treatment of five individuals that includes:
(1) Examination of each individual to ve treated; (2) Calculation of the dose to be administered; l
(3) Administration of the dose; and (4) Follow up and review of each individual's case history.
(c) Has demonstrated sufficient knowledge in radiation safety commensurate with the use requested by passing en examination given by the Commission or an organization or entity approvided by the Commission; 101
.