ML20090J586
| ML20090J586 | |
| Person / Time | |
|---|---|
| Site: | MIT Nuclear Research Reactor |
| Issue date: | 03/10/1992 |
| From: | Bernard J MASSACHUSETTS INSTITUTE OF TECHNOLOGY, CAMBRIDGE |
| To: | NRC OFFICE OF INFORMATION RESOURCES MANAGEMENT (IRM) |
| References | |
| NUDOCS 9203170318 | |
| Download: ML20090J586 (29) | |
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,pINhkt :. rjl NUCLEAR REACTOR LABORATORY AN INTERDEPARTMENTAL CENTE R OF MASSACHUSETTS INSTITUTE OF TECHNOLOGY O.K.HARUNo 138 Albany Street camtmop. Maa 021M
.I A DE RNARD. JR.
Duector Teleta No !6th253J300 Drector of Heactor Operabots Tees No 92=1473 fST CAM 1e No (61h 253 4202 March 10,1992 U.S. Nuclear Regulatory Corimission, A'ITN: Docunent ControlDesk Washington, D.C. 20555
Subject:
Generation of Medical Herapy Facility Beam for llunun Derapy, License Wo. R 37, Docket No.-50-20 Gentlemen:
"De Massachusetts Institute of To:hnology hereby submits an application to amend its Facility Operating License No. R 37, ne requested amendment concerns the generation of the MIT-Research Reactor's McJical Herapy Facility beam for human therapy. His amendment is submitted at the request of the U.S. Nuclear Regulatory Comrrussion and reflects previous discussions and correspandence between MIT and NRC. It is requested that this amendment be given your immediate attention so as not to delay human therapy trials which are sched&d to begin late in the second quarter of 1992.
'Also enclosed, per NRC request, is a ' Quality Menapment Program' that addresses the generation of the medical therapy facility beam. His is a related itera for approval but it is not part of the aforementioned ecquested amendment to the operating license.
i his request has been reviewed and approved by the MIT Reactor Safeguards Committee, Sincerely,
(%.R-o ohn A. Bernard, Ph.D.
Director of Reactor Operations MIT Research Reactor JAD/gw L
Enclosures:
Safety Reviews #0-91-17 and #0 92-3.
I cc: : MITRSC ~ (with enclosures)
USNRC - Project Manager,
- NRR/PDNP USNRC RegionI-Chief.
Effluer'.s Radiation Protection Section (ERPS)
FRSSB/DRSS l.
USNRC - Region I-Project Scientist,
. Effluents Radiation Protection Section (ERPS)
\\
FRSSB/DRSS USNRC - Director, j
NRR/PDNP i
9203170318 920310 l
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Safety Review Form No.
0-91-17 PM 1.4 Pg 4 of 4 Technical Specification #6.5, "Ceneration of Medical Therapy racility It erc:
Beam for Human Ther y"
f Submitted by J ' J. Bernard Date 30 Sept. 1991 H-92~4 Q/A number if required Does the item change or contradict the Technical Specifications?_
X Yes No SAR7 Yes
_X No
- Attach explanation Dsscription of Change (Attach extra pages if necessary):
See attached sheet.
S3f ety Evaluation (Attach extra pages if necessary):
See attached sheet.
Summary of Reviews
- Yes, No e
a) Does the proposal i) involve an unreviewed saf ety question (10C?R50.59(a)(2))
X 11? decrease scope of requalification prograin (10CFR50.54(1-1))
X iii) decrease effectiveness of security plan (10CFR50.54(p))
X iv) decrease effectiveness of emergency plan (10CFR50.54(q))
b) Reviewer's Cotanents:
NRC Date MITRSC Ut Date_st[arh/
'I Date 3 4.q Recomend Approval
/
Yes No
[w/
Date e z /o c NL Reviewer mkh/
Date 3/M92 Reviewer Approved k.
cs A
/
bate 7
/> 9 1_
/ (Director of Reactor pherations)
~
10CFR50.59 & 50.54(p and q) changes logged for reporting to NRC, Date Copy. to Director for Operations Copies circulated to and initia11ed by all Licensed Personnel Original to Safety Review File SR#-0-80-32 OCT 21 1980
Unrrviewed Safety Question (URSQ) Determination for SR#-0 91-17 This safety review establishes a new technical specificat'r' that delineates design and procedural practices regarding the MIT Research kc ctor's medical therapy facihty beam. This new specification does not alter or in any way impact any existirg technical specification and/or its basis. No safety issue or unreviewed safety question has beeri found to exist. De basis for this negative finding is documented below as required by 10 CFR 50.59(b).
(a)
The change does not meet any of the three criteria that define an URSQ.
Als is shown below:
No increase in pmbability or consequences of an analyzed accident because the new technical specification is a concise compilation of design and procedural practices regarding the medical therapy facihty beam.
lio new type of accidents are created.
No margin of safety is reduced, again because the change is only to summarize design features and operational practices in a concise format.
I I
SR#-0-91-17 MAR 061992
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Safety Review No. 0-91,12.
Technical Soecification #6.5 - Generation of Medical %erapv Facility Beam for Human Thernoy Description of Change A new Technical Specification, #6.5, is created that addresses the generation of the MIT Research Reactor's medical therapy facility's beam for human therapy. This specification was prepared at the request of the U.S. Nuclear Regulatory Commission as specified in the letter of 02/19/92 from S.II. Weiss, Director Non Power Reactors, Decommissionin,; and Environmental Project Directorate, to O.K. liarling, Director MIT Nuclear Reactor aboratory. Dat letter hsted eight specific items for which information was requested. Seven of these are contained in the proposed technical s wification. The eighth, which concerned FDA requirements, is provided as an item c/ information. A summary of MITs resp <mse to these eight items is given in the 'ssfety analysis'section of the enclosed safety review.
The use of beams from research reactors to treat patients is not addressed in any deall in the Code of Federal Regulations. The most relevant material is to be found in Subpan I, Teletherapy' of 10 CFR 35, " Medical Use of Byproduct Material." This safety review is structured so as to show the relation between the new MITR Technical Specification and the relevant provisions of 10 CFR 35. liowever, it is im wrtant to recognize th:t a one to-one correspondence would not be appmpriate. Subpart I concerns the use of Co 60 or Cs 137 sources for medical use. MITR Technical Specification #6.5 addresses the use of a research reactor to produce a beam of radiation. There are many differences between an operating reactor and an installed gamma radiation source. These include:
(a)
The reactor can be shut down or scrammed thereby greatly reducing the beam. This feature makes use of a research reactor to produce a beam far less hazardous than the use of a scaled gamma source. Radiation from the latter can only be halted by the use of shields. In contrast, the intensity of the reactor's beam can be greatly reduced either with shutters or by a shutdown action.
(b)
The reactor is heavily regulated and has NRC-approved quality assurance, training, and radiation protection programs in place.
(c)
The Reactor Staff is committed under the provisions of the reactor's operating license to report any instance of non compliance with its technical specifications, in contrast, medical licensees are only required to report those items that are listed in 10 CFR 35 as being reponable.
SR#-0-91-17 MAR 051992
2-Each provision of Technical Specification #6.5 is listed below together with a reference to the relevant requirement of either Subpart I of 10 CFR 35,10 CFR 35.33, or 10 CFR 35.2. Whenever a match is not appropriate, the trason for it ia listed as reactor-specific (R/S),
10 CFR H Technical Soecification #6,5 Patients are accepted only in accordance with a R/S written directive from NRC Medical Use Licensee No. 20-03857-06, which is licensed by NRC for use of the MIT Research Reactor's Medical Therapy Facility beam, or from any other medical use licensee that has h-en similarly authorized by NRC to utilize the MIT Research Reactor's Medical Therapy Facility beem for human therapy.
R/S Delineates division of responsibility between MIT and the referring m. edicallicensee. Also, establishes both the authority and protocol for initiating and tenninating a nullation therapy.
Provision to scram the reactor thereby greatly R/S reducing the beam as a somre of radiauon.
Provision (4) of the specification.
35.615(a) Access Contml Provision (5) of the specification.
35,615(b) Interlocks Subprovisions (a) and (b) of the specification correspond to subclauses (b(1)) and (b(2)) of 10 CFR 35.615. Subclause (b(3)) is not applicable because there is no 'rcset' for a tractor beam. Subpmvisions (c) and (d) of the technical specification impose design requirements on the shutters that are more conservetive than Part 35.
Pmvision (6) of the specification.
35.615(c) Indicator Lights Provision (7) of the specification. Subclauses 35.615(d) Radiation Monitor (1), (2), (3), and (5) of 10 CFR 35.615(d) are directly addressed in the subprovisions of the specification. Subclauses (4) and (6) are not so addressed because these items are covered as part of the MIT Research Reactor's radiation protection and maintenance propums.
R/S Provision (8) of the specification establishes a means for two-way communication between personnel at the medical therapy facility's local control panel and the reactor operator stationed at the reactor contml room console.
SR#-0-91-17
. " AR 061992061992
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3-Provision (9) of the specification imposes R/S requirement for manual opening of the door to the medical therapy facility. This requirement is necessary because the door also acts as a j
shield and is specially-de,igned so as to be movable without electnc power.
^
Provision (10) of the specification.
35.615(e) Patient Observation Provision (11) of the specification establishes 35.2 Clauses 4(ill) and 4(iv)of Definition of criteria for the accuracy of the radiation fluence Misadministration delivered by the medical therapy facility team.
'Ite exposure of the boronated cancer cells in the patient's tumor to this fluence will have the des red medical effect.
This provision represents another differrace between the use of a reactor beam and a sealed source for medical therapy. The reactor treatment is n two step process involving delivery of a fluence and a subsequent nuclear rucrion in the tumor based on the boron concentration in tissue. It is this nuclear reaction that generates a major pcr.Jon of the dose. In contrast, the use of a scaled source is a one step process with the dose in the tumot being that delivered by the source. Provision (11) was inserted in the specification to establish allowable limits on the delivered radiation fluence. Issues of-mis administration and recordable events as they concem generation of the medical therapy f acility beam are delineated in definitions (7) and (8) of this specification.
Provision (12) of the specification establishes R/S criteria for the testing of all interlocks and channels. (Tultj Testing of the radiation monitor is addressed separately in provision 7(b)).
Provision (13) of the specification establishes R/S criteria for testing the manual operation of the facility's shield door.
Provision (14) of the specification specifies 35.632 / 35.634 frec uencies for full characterization and calirat!on checks of the beam. These terms, which are defined in the specifications, correspond roughly to the words ' full calibration measurements' and ' periodic spot-checks' in 10 CFR 35.632 and 35.634 respectively.
However, there are major differences. A sealed somre provides one type of radiation. The rer.ctor beam has fast SR#-0-91-17 MAR 061992
f
-4 neutron, thermal neutron, and gamma components. While the reactor beam has many components, its characteristics correlate wi h the reactor's power Icvel making it relatively easy to reproduce from day to day. It should be recogmzed that the criteria listed in 10 CFR 35.632 and 10 CFR 35.634 are specific to sealed sources and can not be applied directly to a reactor produced beam.
Provision (15) of the specification provides for 35.605 the proper supervision of all maintenance and repair activities. As such, it fulfills the same function as 10 CFR 35.605.
Provision (16) of the specification provides for 35.610 the training of non-licensed personnel to operate the medical therapy facility beam.
Also,it provides for the postmg ofinstructions to be followed in the event of an abnormality.
' Itis provision is similar in many respects to 10 CFR 35.610.
Provision (17) of the specification provides for 35.33 the recording of ' recordable events' and the itporting of 'misadministrations.'
Definition (7).
35.2 Misadminis' ration 35.2 Recordable Event-Definition (8).
35.2 Written Directive Definition (9).
Safety Analysis The issuance of Technical Specification #6.5 will have no impact on reactor safety because it does not entail any design or procedural changes to the reactor or its o>cration.
Rather it delineates des.gn requirements end operational practices for the medica therapy facility beam. Similarly, its issuance will have no effect on patient safety because the provisions in Technical Specification #6.5 that pertain to panent treatment are already contained in various medical pmtocols.
The significance of Technical Specification #6.5 is that it provides a concise summary of the various requirements that are to be observed in the generation of a reactor-produced beam to treat patients. This is, of course, the principal purpose of a technical specification. Namely, relevant material is culled from the reactor's safety analy, sis report and other pertinent documents to provide a set of readily implementable enteria for operation of the facility.
In its letter of 02/19/92 from S.H. Weas to O.K. Ilarling, the U S. Nuclear P.cgulatory Commission requested that MIT "subtrit an amendment to NRC Facility SR#-0-91-17 MAR 061002
Operating License No. R 37 to add requirem:nts to the technical specifications that are equivalent to the regulations of Subpart I cf 10 CFR Part 35." ne amendment contained herein is submitted un response to that requc.;t. In addition, NRC requested information on eight specific items. MITs respouse to that request is pmvided below:
(1)
Provision (1) of the specification is a commitment to limit the therapeutic delivery of neutrons to human subjects pursuant to a written directive from NRC Medical Use Licensee No. 20-03857-06 or from any other medical use licensee that has been similarly authorized by NRC to utilize the MIT Research Reactor's Medical nerapy Facility beam for human therapy. De term ' written directive'is defined in definition (9) of the specification.
(2)
Provision (17) of the specification is a commitment to record events equivalent to 'recortlable events' in 10 CFR 35.2 and to re wrt events equivalent to 'misadministrations'in 10 CFR 35.2. De criteria For defining a recordable event and a misadministration are given in definitions (7) and (8) of the specification. A ' Quality Management Program' which follows 10 CFR 35.32 is enclosed.
(3)
Provision (11) of the specification establishes allowable limits on the radiation fluence for the treatment as a whole and for any given fraction.
Provision (14) of the specification in conjunction vdth definitions (3), (4),
ard (6) provide a methodology to ensure that the neutron flux and spectrum are as requested.
(4)
Virtually all of the provisions contained in the proposed specification address the issue of patient and user safety. nose that are specific to some aspect of the medicaJ therapy facility beam delivery system irclude:
Provision #
Bnpose Capability to reduce beam intensity by 3
initiation of a reactor scram.
5 Functional description of the shutters and shutter interlocks that control beam delivery. (Also see definition (1).)
Indication lights for shutter position.
6 Radiation nanitor for the medical therapy 7
facility.
Methods for patient observation during 10 treatment.
11 On line beam monitors for determining the delivered fluence.
Surveillance requirements.
12/13 SR#4)-91-17 MAR 061992
14 Provision for periodic characterizations and calibration checks of the beam. (Also see definitions (3) and (4).)
Proper maintenance of the beam oclivery 15/16 system and proper training of those using it.
l Each of the above provisions is pan of the proposed technical specification.
Ilence, once they are approved by the U.S. Nuclear Regulatory Commission, they cannot be changed without a funher license anwndnwnt.
Note however that MIT has reserved the right to make certain modifications.
For example, it might be desirable to modify the beam design as new developrnents occur in both medicine and reactor physics. This is allowed provided that, as provided by provision (14), the beam is fully characterized upon completion of the modification. S'milarly, under definition (1),it is permitted to alter the shutter configuratica provided that the net effectiveness of the shutters is not reduced.
(5)
Provision (2) specifies the protocol for both initiating and terminating the treatment exposures. Provision (8) specifies the means of communication.
(6)
'Ihe only activity that will alter the beam's characteristics is a change in one or more of the neutmn filter components. Other activities such as a terations in the medical thera py facility and reactor refuelings have little or no effect on the beam. In ord er to be cenain that no change occurs without its being detected, definition (5) defines a ' design tr.odification' as any change that alters the " dose versus depth profile of the fast neutrons, thermal neutrons, or gamma rays in the beam as sensed by the calibration check." Pmvision of the specification requires that calibration checks be done "at least (14)kly for any week that the beam will be used for human therapy."
wee Definition (4) describes the possible methods for doing a calibration check.
(7)
Many provisions of the specification address the use of interlock systems and safety precautions. Some of these overlap with those listed in response to NRC pstion #4 on design aspects of the medical therapy facility beam delNery system. Ponions of the technical specification that are specific to imcrlocks include provision (3) on the scram capability, provision (4) on access control to the medical therapy facility, provision (5) on shutter interlocks, provision (6) on shutter position indicator lights, provision (7) on the radiation monitor that is located in the medical therapy facility, provision (9) on manual operation of the facility's shielded door, provisions (12) and (13) on surveillance requirements, and provisions (15) and (16) on the qualification of personnel authorized to maintain and use the facility.
The safety precautions to be followed beforc, during, and after treatment to limit occupational exposure to ionizing radiation are addressed by (a) mandatory training in radiation safety given to all pmspective vers of the MIT Research Reactor, (b) the traimng requirements of provison (16) of the proposed s pecification, and (c) the posted procedures that are required by provision (16).
i (8)
The U.S. Food and Drug Administration (FDA) requirements that are applicable to the use of boron nuclear capture therapy (NCT) for the SR#-0-91 17 MAR 061992 l
treatment of human patients arc addressed in Investigatory New Drug Application #32,559 (FDA IND #32,559) as amended. These concern the toucity of the boronated drug that is used in the therapy end the combined toxicity of this drug and neutron radiation. The primary sponsors for this IND are Allen G. hieck, hi.D. and Juan hiadariaga, hi.D., both of the State University of New York at Stony Brook. Background on this document is as follows:
(a)
As originally conceived by Dr. hicek, IND #32,559 addressed "the collection, and in vitro analysis of tumor, skin, urine, and blood tissues [from humanfatients] after administration of a drug called BPA to the patient.
This research is referred to as s ' Phase I Biodistribution/ Toxicity Study.' (Hom: BPA stands for p-Boror o-phenylalanine. It is an amino acid and a tyrosine analog that was areviously shown in animal studies to have low (if any) toxicity and 11gh tumor to blood and tumor-to normal tissue concentrations.
These propenics make it ideal for NCT.) Samples were to be 1
collected from melanoma patients. The maximum allowed dose of IsBPA was 189 mg/kg. (Holt: BPA is available la either of two isomeric forms. Only the 'L' form is used for NCT.) Also, no tient treatment was requested under the original IND. 'Ihe original b.h was submitted to the FDA by Dr. Meek on behalf of several research institutions on 3 February 1989. FDA subsequently approved it.
(b)
On 13 December 1989, Dr. Meek submitted an amendment to the original IND that allowed the Massachusetts Institute of Technology and the Tufts - New England Medical Center to become collaborating institutions. Also, the study was extended to include the collection of samples from glioblastoma and breast carcinoma natients. FDA approved this request on 13 January 1990. (Helg:
This request was submitted to Dr. John F. Palmer, M.D., Director, Division of Oncology and Radiopharmaceutical Drug Products, Office of Drug Evaluation I, Center for Drug Evaluation &
Research, Dept. of Health and Human Services, USFDA.)
(c)
On 29 January 1992, Dr. Meek submitted another amendment. It requested (1) that approval be given to increase the administered dose of L-BPA from 189 mg/kg to 500 mg/kg and (2) that a
" concurrent Phase I toxicity study of BPA with neutron radiation" be initiated. It is this latter request that addresses the irradiation of humans for the study of NCT. This research is referred to as a
' Phase I Combined BPA/ Neutron Radiation Toxicity Study' and, as the name implies, its objective is to investigate the toxicity associated with the combined effects of BPA and neutron radiation. The arotocol calls for a stepwise escalation in radiation fluence from
.evels that are expected to produce no toxicity to levels where the appearance of toxicity is anticipated. The patients participating in this Phase I study will probably not derive any benefit from it. Once the Phase I study is complete and, assuming it to be successful, a further amendment will be prepared for the use of NCT with therapeutic ir. tent (a Phase 11 study). The 01/29/92 amendment is now in effect pursuant to Federal Register Vol. 52, No. 53; l
I SR#-0-91-17 MAR 061992
8-4 Thursday March 19, 1987; Rules and the Regulations, Section 312.30. (Npat: The 01/29/92 amendment was submitted to Ms.
Susan Lange, Consumer Safety Officer, Division of Medical Imaging, Surgical and Dental Prnlucts, USFDA. Earlier repons on this topic were submitted to Ms. lange's immediate predecessor, Mr. Mark Anderson.)
(d)
An amendment to IND #32,559 is currently being prepared for submission to the USFDA for the purpose of designating the MIT Research Reactor's medical therapy facility beam as an approved
' device.' Submission is expected in about a month.
The FDA is, as noted above, concemed with issues of toxicity relative to both the drug (L BPA) and the combination of the drug with neutron radiation. Other issues are also involved including patient selection criteda, right to privacy, informed consent, etc. These issues as v. ell as the ones that are of concern to either the FDA or NRC are reviewed by several internal committees. At MIT, these are the Ccmmitiee on Reactor Safeguards, the Committee on the Use of Humans as Experimental Subjects, the Committee on Radiation Exposure to lluman Subjects, and the Radiation Protection Committee. At NEMC, these include the Human Investigational Review Committee, the Radiation Safety Committee, and the Clinical Study Unit Scientific Advisory Committee. All of the above committees have been provide s U+h information on the proposed use of NCT for human therapy. T; 11T Reactor Safeguards Committee approved the proposal as it concerns the generation of the medical therapy facility beam on 11/25/91. Submission for approval from the other MIT committees is scheduled. All of the NEMC committees lave given approval for the Phase I study.
Finally, it should be noted that the above information on FDA approval of NCT at the MIT Research Reactor is provided to the U.S. Nuclear Regulatory Commission only as an item of information. Changes, such as the use of a drug other than L-BPA, are conceivable. Please be assured that any such changes will be subject to the appropdate USFDA reviews.
SR#4)-91-17 MAR 061992
1 hEt 6.
EXPERIMENTS 6.1 General Experiment Criteria..................................................... 6-1 6.2 In-Core Cryostat.................................................................. 6 8 03 Sodium Subassembly for Fast Neutron Spectrum Facility.................. 614 6.4 Closed loop Con trol S ys tems................................................. 6-17 6.5 Generation of Medical'1herapy Facility Beam for11uman Therapy....... 6 21 7.
ADMINISTRATIVE CONTROLS 7.1 Respon sibility..................................................................... 7 1 7.2 Reactor Staff Organization....................................................... 7 4 7.3 Reactor Sta ff Qualifications..................................................
7.4 Retiaining and Replacement Tralning......................................... 7 8 7.5 Review.............................................................................79 7.6 Action to be Taken in the Event of an Abnormal 0;currence............... 7-18 7.7 Action to be Taken if a Safety Limit is Exceeded............................. 7-19 7
Operating Pmcodures............................................................ 7-20 7.9 Experiment Approval Procedures.............................................. 7 22 7.10 Radia tion Protection Progmm.................................................. 7 24 7.11 S ec u rity Program................................................................ 7-25 7.12 Records R e t e n tion.........................................................
7.13 Plan t Reportin g Requirements.................................................. 7-2 8 SR#-0-91-17 MAR 061992
6.5 Generation of Medical hrapv Facility Beam for Hunun herapy Aonlicability This specification applies solely to the generation of the medical therapy facility beam for the treatment of human patiena. It does not apply to any other use of the medical therapy facility and/or its beam.
Ohicclin To provide for the protection of the public health and safety by ensuring that patients are treated in ar.cordance with the treatment plan established by their physician and that the ALARA principle 18 observed for all nor. therapeutic radiation exposures.
Specification 1.
Patients accepted for treatnient shall have been referred by written directive from NRC Medical Use Licensee No. 20-03857 06 or from any other medical use licensee that has been similarly authorized by NRC to utilize the MIT Research Reactor's Medical'Iherapy Facility beam for human therapy.
2.
All medical treatments, including irradiations and analyses of the neutmn capture 4
agents in the patients, are the responsibility of the licensed physician in charge of the therapy and the medical physicists from the NRC licensed medical center. The Massachusetts Institute of Technalogy is only responsible for delivery of the desired radiation fluence as requested by the medical physicist in charge of the therapy. Before the start of a therapy both a certified medical physicist and the Director of the Nuclear Reactor Laboratory, or his designate, must agree that the therapy can be initiated. A certified medical physicist is responsible for monitoring the therapy and for directing its termination. However, a radiation therapy can also be terminated at any time if either the physician or the NRL Director, or their designates, judge that the therapy should be terminated.
3.
It shall be possible to initiate a minor scram of the reactor from a control panel located m the medical therapy facility area. In the event that the medical facility 6-21 l
SR#-0 91-17 MAR % 1992
(
minor scram is inoperable, it shall be acceptable to use one of the control room scrams via communication with the reactor operator as a temporary means of satisfying this pmvision.
4.
Access to the medical therapy facility shall be controlled by means of the shield doorlocated at its entrance.
5.
He following features and/or interlocks shall be operable:
(a)
An interlock shall prevent opening of the :hutten that contml beam delivery unless the medical therapy facility's shieM door is closed.
(b)
The shutters that control beam delivery shall be interlocked to close automeically upon opening of the medical therapy facility's shield door.
(c)
The shutters that control beam delivery shall be designed to close automatically upon failure of electric power or on low air pressure if the shutter is operated pneumatically.
(d)
Shutters that contml beam delivery and which alt. normally pneumatically-operated can be closed manually.
6.
Each of the shutters that controls beam delivery shall be equipped with a light that
+ icates the status of the shutter. These lights shall be visible at the medical
, ierapy facility's local control panel. In the event of a status light malfunction,it shall be acceptable to use the affected shutter pmvided that an alternate means of verifying position is available.
7.
He medical therapy facility shall be equipped with a monitor that provides a visual indication of the radiation level within the facility and which indicates at the local contml panel.
(a)
This radiation monitor shall be equipped with a backup power supply such as the reactor emergency power system or a battery.
(b)
This radiation monitor shall be checked for proper operation by means of a check source within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> prior to any patient inadiation.
l 6-22 SR#-0-91-17 MAR 061992
l (c)
In the event that this monitor is inoperable, personnel entering the medical therapy facility shall use either portable survey instruments or audible alarm personal doshneters, nese instruments / dosimeters thall be in calibration as defined by the MIT Research Reactor's radiation protection program.
8.
An intercom or other means of two-way communication shall be operable between the medical therapy facility and the reactor control room.
9.
It shall be possible for personnel monitoring a patient to open the medical therapy facility's shield door manually.
10.
It shall be possible to observe the patient thmugh both a viewing port and by means of a closed-circuit TV camera. Both methods of patient visualization shall be operable at the outset of any patient irradiation. Should either fait during the irradiation, the treatment can be continued at the discretion of either the patient's physician or medical physicist. Adequate lighting to permit such viewing shall be assured by the provision of emergency lighting.
I1.
The total radiation fluence delivered by the medical therapy facility beam as measured by on line beam monitors shall not exceed that prescribed in the patient treatment plan by more than 20%. De tiratment is normally delivered in fractions in accordance with standard practice for human therapy. The 20% criterion applies to the sum of the radiation fluences associated with all fractions in a given treatment plan. A criterion of 30% applies to any given fraction.
12.
The following interlocks or channels will be tested at least monthly and prior to treatment of human patients if the interlock or channel has been repaired or l
deenergized:
l l
l fr23 SR#-0-91 17 MAR 061992 l
Interlock or annnel Surveillance a)
Medical therapy facility minor scram Scram test b)
Shutters clow upon opening of Operational test shield dccr c)
Shutters close on loss of electrical Operatkul test power and/or reduction of pn:ssure in pneumatic operatort d)
Manual closure of pneumatic shutters Operational test e)
Beam moaltoring instmmentation Functional check 13.
Manual opemtion of the medical therapy facility's shield door shall be verified sen6 annually. (Note: Opembility of the interlock for automatic closure of the shutters upon manual opening of the shield door is verified monthly as part of provision 12(b) of this technkal specification.)
14.
'Ihe medical therapy facility beam shall be clorecterized dosimetrically prior to the initiation of patient irradiations. Similarly, a characterization shall be performed prior to patient irradiations following design modifications to the beam. In the event that components of a given design are replaced as opposed to modified, then a calibration check as opposed to characterization shall be performed. Calibration checks of the beam shall be made at least weekly for any week that the beam will be used for human therapy. A characterization shall have been done not less than six months prior to any patient irradiation.
15.
Maintenance, repair, and modification of the medical therapy facility shall be performed under the supervision of a senior reactor operator who is licensed by the U.S. Nuclear Regulatory Commission to operate the MIT Research Reactor. The
' medical therapy facility' includes the beam, beam shutters, beam monitoring equipment, medical therapy facility shielding, shield door, and patient viewing 6-24 SR#4)-91-17 MAR 061992
1 equipment. The op rating couch, patient positioning equipment, medical instruments, and other equipment used for the direct medical support of the patient are not considered part of the medical therapy facility for purposes of this provision.
16.
Personnel who are not licensed to operate the MIT Research Reactor but who are responsible for either the medical therapy or the beam's design including construction and/or modification may operate the controls for the medical therapy facility beam provided that:
1 (a)
Tmining has been provided and proficiency satisfactorily demonstrated on the design of the facility, its controls, and the use of those controls.
Proficiency shall be demonstrated annually.
(b)
Instructions are posted at the medical therapy facility's local control panel that specify the pmcedure to be followed:
(i) to ensure that only the patient is in the treatment room before tuming the prinury beam of radiation on to begin a tiratment; (ii) if the operator is unable to turn the primary beam of radiation off with controls outside the medical therapy facility, or if any other abnom al condition occurs. A directive shall be included with these instructions to notify the reactor console operator in the event of any almomulity.
(c)
In the event that a shutter affects reactivity (e.g., the D 0~ shutter),
2 personnel who are not licensed on the MIT Research Reactor but who have been trained under this provision may operate that shuttet provided that verbal permission is requested and received from the reactor console l-operator immediately prior to such action. Emergency closures are an
(
exception and may be made withcut first requesting permission.
Records of the training provided under subparagraph (a) above should be irtained in acconiance with the MIT Research Reactor's training program or at least for three 6-25 SR# 0-91-17 MAR 061992 l
~
years. A list of personnel so qualified shall be maintained in die reactor control room.
17.
Events defined as ' recordable' under definition 7 of this specification shall be recorded and the record maintained for five years, Events defined as
'misadministrations' under definition 8 of this specification shall be reponed to the U.S. Nuclear Regulatory Commission (24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> verbal,15 day written report).
Dermitions 1.
The medical therapy facility is equipped with shutters that are used (i) to control beam delivery and (ii) to adjust the neutron energy spectrum of the beam. The former currently include lead, boral, and light we.ter shutters as described in Reference 6.5-1. The heavy water blister tank, which is also described in Reference 6.51, is an example of the latter, it is conceivable that these designations msy change should it be found desirable to alter the beam configuration. Accordingly, the phrase " shutters that control beam delivery" refers either to the aforementioned three existing shutters or to any future shutter or group thereof which provides an equivalent or greater reduction in beam intensity.
Shutter effect analyses shall be documented through the standard safety review process including where appropriate an SAR revision and submission to NRC under 10 CFR 50.59.
2.
The functional check listed as the surveillance requirement for the beam monitoring instrumentation shall consist of verifying that the system output is consistent (i 10%) with previously measured values upon normalization to a common reactor neutronic power level.
3.
The term ' characterization' refers to the proc:ss of obtaining the dose versus depth profile in phantoms as described in Reference 6.5 2 or an equivalent process. The dose versus depth profile from the surface of the phantom to a depth at least l
equivalent to the total thickness of the body part to be treated on a central axis is 6-26 SR#-0-91-17 MAR 061992 L
deemed adequate for a characterization. Fast neutron, thermal neutmn, and gamma ray components are determined in a full characterization and monitors are j
nomutilzed by this characterization.
4.
The term ' calibration check' refers to the process of checking the beam intensity and quality via one or more of the foll. wing: foil activation; use of a fission chamber, use of an ion chamber, or an equivalent process. De purpose of a calibration check is to ensure that the beam has not changed in a significant way (e.g., energy spectrum or intensity) from the beam that was characterized.
5.
He term ' design modification' r.s applied to the medical therapy facility beam refers to a change that is shown to alter the dose versus depth profile of the fast neutrons, thermal neutmns, or gamma rays in the beam as sensed by the calibration check.
6.
The term ' radiation Guence' means the total Duence of neutrons and gamma radiation that is emitted in the medical therapy facility beam. He detennination of the ratios of gemma, fast neutmn, and thennal neutron fluences is part of the beam characterization Knowledge of these ratios allows the total radiation fluence to be monitored by the on line detectors, which are neutron sensi ive. Compliance with t
the limits specified on radiation fluence by this specification is determined by reference to the Duence monitored by these detectors.
7.
The term ' recordable event' means the administration of:
(a)
A radiation treatment without a written directive where a written directive is reqaired and where the treatment is appropriate; (b)
A radiation uratment where a written directive is required without die per treatment recording of administered radiation fluence in the appropriate record; (c)
A treatment delivery for which the administered radiation Duence for any given fraction is 15% greater than prescribed.
8.
%e term ' misadministration' means the administration of a radiation therapy:
6-27 SR#-0-91-17 MAR 061992
4 (a)
Involving the wmng patient, wrong mode of treatment, or wrong treatment site; (b)
When the treatment delivery is not in accordance with provision 11 of this specification.
9.
The term ' written directive' means an order in writing for a specific patient, dated and signed by an authorized user prior to the administration of radiation and which specifies the total radiation fluence, radiation fluence per fraction, treatment site, and overall treatment period.
10.
The term ' human therapy' means radiation treatments that are of direct therapeutic benefit to the patient and/or part ofinvestigatory studies that involve humans.
I 1.
The term ' certified medical physicist' means a medical physicist certified in either radiological physics or therapeutic radiation physics by the American Board of Radiology, or in therapeutic radiation physics by the American Board of hiedical Physics.
Ilasis The stipulation that patients only be accepted fmm NRC Medical Use Licensee No.
20-03857-06 or from any other medical use licenste that has been similarly authorized by NRC to utilize the MIT Researth Reactor's Medical Therapy Facility beam for human therapy, ensures that medical criteria imposed by NRC on such licensees for the use of the MIT Research Reactor's medical therapy facility beam for human thenpy will be fulfilled.
The second pmvision delineates the division of responsibilities between the Massachasetts Institute of Technology and the medical licensee which refers the patient. Also, it establishes administrative authority and protocol for initiating and terminating a radiation therapy.
The requirement that it be possible to initiate a minor scram from a control panel located in the medical therapy facility area assurrs the attending physician and/or medical physicist of the capability to terminate the treatment immediately should the need arise. The 6-28 SRr S91 17 MAR 061992
pmvision that access to the medical thenpy facility be limited to r. single door ensures that there will be no inadvertent entries. The various interlocks for the shutters that control beam delivery ensure that exposure levels in the medical therapy facility will te minimal prior to entry by personnel who are attending the patient. The shutter-indication lights serve to notify personnel of the beam's status. The provision for a radiation monitor ensures that personnel will have information available on radie. tion levels in the medical therapy facility prior to entry. The intercom provides a means for the prompt exchange of information between medical personnel and the reactor operator (s).
The provision for manual operation of the medical therapy facility's shield door ensures access to any patient in the event of a loss of electrical power. He presence of the viewing window and a closed-circuit TV camera provide the attending physician and/or medical physicist with the opportunity to monitor the patient visually as well as thmugh the use of various instruments. The viewing window will function even during an electric power failure because of the provision for emergency lighting.
The spec.ification that the total radiation fluence for a therapy (i.e., the radiation fluences for the sum of all fract ons specified in a given treatment plan) not exceed that prescribed in the patient treatment plan by 20% establishes an allowable upper limit on the delivered fluence, he 20% criterion is tased on the definition of misadministration (clause 4(iv)) as given in 10 CFR 35.2. ne criterion for any single fraction is set at 30%. His is also in accordance with the definition of misadministration (clause 4(iii)) as given in 10
('FR 35.2.
The various surveillance requirements as well as those for beam characterization and/or calibration checks provide a mechanism for ensuring that the medical therapy facility and its beam will perform as originally designed.
De specification on maintenance and repair of the medical therapy facility ensures that all such activities art performed under the supervision of personnel cognizant of quality I
assurance and other requirements such as radiation safety. The provision on the training and proficiency of non-licensed personnel ensures that all such personnel will receive 6 29 SR#491-17 MAR 061992 l
l
l instruction equivalent to that given to licensed reactor operators as regards use of the medical therapy facility beam. (Note: Licensed personnel may, of course, operate the medical therapy facility beam.) Also, this provision pmvides for the posting ofinstructions to be followed in the event of an abnormality.
The specification on ' recordable events' and 'misadministrations' pmvides for the documentation and reponing to the U.S. Nuclear Regulatory Commission of impmper events regarding the generation of the medical therapy facility beam.
jleferences 6.5 1 MrIR Staff, " Safety Analysis Repon for the MIT Research Reactor (MITR II),"
Report No. MITNE-115,22 (kt.1970, Section 10.1.3.
6.5-2 Choi, R.J.," Development and Characterization of an Epithermal Beam for Boron Neutron Capture Therapy at the MITR-Il Reseamh Reactor," ph.D. Thesis, Nuclear Engineering Department, Massachusetts Institute of Technology, April 1991.
6-30 SR#-0-91-17 MAR 061992
0-92-3 pg 1,4 Safety Review Form No.
Pg 4 of 4 i
Quality 11anagement Program for Generation of liedical Therapy Facility Bes n Item:
for lluman Therapy Submitted by Date February 21, 1992 J. Bernard Q/A number if required M-92-4 l
Docs the item change or contradict the Technical Specifications?
Yes X
No SAR7 Yes X
No
- Attach explanation D:scription of Change (Attach extra 1 ages if necessary):
See attached sheets.
Safety Evaluation (Attach extra pages if necessary):
See attached sheets.
Summary of Review:
c) Does the proposal Yes No
- 1) involve an unreviewed saf ety question (10CFR50.59(a)(2))
X
- 11) decrease scope of requalification program (10CFR50.54(1-1))
X iii) decrease effectiveness of security plan (10CrR50.54(p))
X iv) decrease effectiveness of emergency plan (10CFR50.54(q))
X b) Reviewer's Cotanents:
NRC Date MITRSC d
Date I//st/f/
Reconsnend Approval Yes N
MIT RPO f,
Date L QL.
Rsviewer M ih/I Date Mlgt/h Reviewer fn, _. _
-,A Date 3 /d /
1-b.L
/h, _ /
Date
?. t - 9
- a. -
Approved et
~
' (Director 'of'Reactoryperations) 10CFR50.59 & 50.54(p and q) changes logged for reporting to NRC, Date Copy to Director for Operations Copies circulated to and initia11ed by all Licensed Personnel Original to Safety Review File
-- S R # 80- 3 2 OCT 21 1980
Unreviewed Safety Question (URSQ) Determination for SR#-0 92 3
'Ihis safety review establishes a quality management program conceming the generation of MIT Research Reactor's medical therapy facility beam for human therapy. This new aro ; ram does not alter or in any,way impact any existing technical specification and/or its xts s. No safety issue or unreviewed safety question has been found to exist. The basis for this negative finding is documented below as required by 10 CFR 50.59(b).
(a)
The change does not meet any of the three criteria that define an URSQ.
This is shown below:
No increase in pmbability or consequences of an analyzed accident because the new program does not affect the reactor's design or operating procedures. It concems only the use made of the medical therapy facility beam.
No new type of accidents an: created.
No margin of safety is reduced, again because the change is only to establish a quality management program for generation of the medical therapy facility's neutron beam for patient use.
l l
l l
SR#-0-92-3 MAR 061992
._ _ _ _ _. -. _ _ _._ _._ _.__ __ _ _..-_. _ _ _.._ _._.. _m._ _ _ _._
i Safety Review No. 0-92 3 1
Ouality Manneenent Prorram for Generatinn of Medical Thernov Benm for Human Therany Descrintinn of (%mnue A quality management program for generation of MTIR.Il medical therapy facility beam for human therapy is established pursuant to 10 CFR 35.32(f)(1). The stmeture of the program conforms to 10 CFR 35.32(a)-(e).
Saferv Annivsis The establishment of this quality management program has no effect on reactor safety because it applies solely to generation of the medical thcrapy facility beam for patient I!se.
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SR#-0-92 3 MAR 061992
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Purposn: 'Ihe objective of this quality management program is to ensure that radiation treatments provided by the MIT Research Reactor's (MITR-II) Medical
%entpy Facility beam will be administered as directed by an authorized user.
,c N' igd Users: Use of the MIT Research Reactor's Medical'liwapy Facility for the treatment of human sttjects,is litrdted to the following.
x NRC Medical Use Ucensee No. 20-03857 06.
Any other m: dical use licensee that has been sitnilarly authorized by hTC to utilize the MIT Research Reactor's Medical Therapy Facility beam for human therapy.
3 Prouam Requirements: The following requirements are estabhshed as part of this quality management pmgram:
(a)
A written directive will, except as noted in subparagraph (iv) below, be prepamd by an authorized user prior to the administrauon of any radiation therapy. This directive st.all include the following information:
(i)
Name and other means of identifying the patient.
~
(ii)
Name f the licensed physician and certified medical physicist in cha'n of the therupy.
(iii)
The total radiation fluenct to be administered, the radiation fluence per fraction, the treatment site, and the overall treatment pedod.
(iv)
If, because of the patient's condition, a delay in order tu provide a written revision to an existing written directive would jeopardize the aatient's health, an oral revision to an existing written directive will x acceptable, provided the cral revision is documented immedir.tely in the patient's record and a revised written directive is signed by an authonzed user witnin 48 hours5.555556e-4 days <br />0.0133 hours <br />7.936508e-5 weeks <br />1.8264e-5 months <br /> of the oral revision.
Also, a written revision to an existing written directive may be made for sny diagnostic or therapeutic procedure provided that the revisiui is dated and signed by an authorized user prior to the adminiscation of the next fraction.
If, because of the emergent nature of the patient's condition, a delay in onier to provide a written directive would jeopardize the patient's health, an oral directive will be acceptable, provided that the information contained in the oral directive is documented immediately in the patient's record and a written directive is prepared within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> of the oral directive.
(b)
Prior to each administration of any radiation. the patient's identity will be verified by more than one method as the individual named in the written SR#-0-92-3 MAR 061992
O 2-dimetive. Acceptable methods of identification include, but are not limited to:
(i)
Self-identification by patients who are conscious upon arrival at the MIT Research Reactor. Information provided shall include name, address, date of birth and/or social security number.
(ii)
Hospital wrist band identification.
(iii)
Visual identification against photographs provided with the written directive.
(iv)
Identification by attending medical personnel.
(c)
The patient treatment plan is certified by the medical physicist to be in accordance with the written directive.
(d)
Each administration of radiation is in accordance with the written directive subject to tolerances of 20% in total radiation fluence and 30% for any given fraction.
(c)
Any unintended deviations frorn the written directive shall be identified and evaluated, and appropriate action taken.
4.
Procram Implementation: ne following practices shall be observed in order to ensure proper implementation of the quality management program:
-(a)
A review shall be conducted of the quality management program. His review shall include, since the last review, an evaluation of:
(i)
A representative sample of patient administrations, (ii)
Allreconlable events, and (iii)
Allmindministrations, i
The objective of this review is to verify compliance with all aspects of the quality management pmgram.
_ b)
He procedure for conducting the above review is as follows:
(
(i)
He review shall be performed by the Director of the MIT Radiation Protection Program or his designate.
(ii) ne review shall be performed annually.
(iii)-.
Patient administrations selected for review shall be audited to determine compliance with each of the requirements listed in paragraph (3) above.
l (iv) - The review shall be wrdten and any item, that require further action sh J1 be so desigrmted. Copies of the review shall be provided to the l
NRL Director and to the MIT Reactor Safeguards Committee who will evaluate each review and, if required, recommend modifications SR#-0-92-3 MAR 061992
!~
, 4 in this quality management program to meet the requiremente of paragraph (3) above.
(c)
Records of each review, !ncluding the evaluations and findings of the review, shall be retained in an auditable form for thn;c years.
5.
B.csponse to Recordable Event: Within thirty days after the discovery of a recordable event, the v :nt shall be evaluated and a response made that includes:
(a)
Assembling the relevant facts, including :he cause; (b)
Llentifying what, if any, corrective action is required to prevent recurrence; and (c)
Retaining a record, in an auditable form, for three years, of the relevant facts and what corrective action, if any, was taken.
6.
Reconis Retention: The following records shall be retained:
(a)
Each written ducctive; and i
(b)
A record of each administered radiation therapy where a written directive is required in paragraph (3(a)) above, it ar. 2.uditable fonn, for three years after the date of administration.
7.
Procram Modificatinn: Modifications may be made to this quality management program to increase the program's efficiency provided that the program's effectiveness is not decreased. The licensee shall I urnish the modification to the NRC (Region 1) within 30 days after the modification has been made.
SR#4-92-3 MAR 061992