ML20098B297

Forwards Second Draft of Changes Licensee Proposing to TS Order to Provide Medical Therapy Team

ML20098B297
Person / Time
Site:	Washington State University
Issue date:	09/25/1995
From:	Tripard G WASHINGTON STATE UNIV., PULLMAN, WA
To:	Mendonca M NRC
References
NUDOCS 9510030146
Download: ML20098B297 (13)

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. Washington StateUniversity Nuclear Rajiation Center Pullman, WA 991641300 509-335-8641 FAX 509 335-4433 Monday, September 25,1995 Marvin M. Mendonca ' l I

- Senior Project Manager .

U.S. Nuclear Regulatory Commission MS OWFN 11-B-20 Washington, D.C.' 20555 Ref: Docket 50-27

Dear Mr. Mendonca:

Please find enclosed the second draft of changes we are proposing to our WSU reactor Technical Specifications in order to provide a medical therapy beam. We have tried to use the MIT Technical Specifications as a model. We have placed side bars next to those

c. sections that differ slightly fmm the MIT version. Some of these changes are simply a change of name from MIT to WSU.

~ What I consider to be the one substantive change is our use of the reactor bridge movement as equivalent to what MIT refers to as a shutter. Both the WSU bridge movement and the

- MIT object or liquid insertion serve the same function namely, to place shielding between -

the reactor core and the treatment room. The BNCI' consortium would appreciate getting an early assessment from the NRC on these proposed changes to our Technical Specifications.

Sincerely.

I

{ Gerald E. Tripard .

Dimetor i

enclosure: Draft-2 of the Proposed Technical Specification Changes to Accommodate a Medical Therapy Facility at Washington State University cc: J. M. Ryskamp, INEL D.W. Nigg, INEL R.J. Wiersema, Ionix D.E. Hagge, Ionix W.R. Rayburn, WSU P.R. Gavin, WSU .-

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4 , DRAFT-2 i 3.15 GhNERATION OF MEDICAL THERAPY FACILITY BEAM FOR HUMAN THERAPY -

Applicability ,

This specification applies solely to the generation of the medical therapy facility beam for the treatment of human patients. It does not apply to any other use of the medical therapy facility and/or its beam. Surveillances listed in this specification am only required if human therapy is planned for 'he interval of the surveillance. However, in the ever.t of a hiatus in the scheduled performance of any given surveillance, that surveillance shall be performed prior to the initiation of human therapy during the interval in question.

' Obiective To provide for the protection of the public health and safety by ensuring that patients are 1

-treated in accordance with the treatment plan established by the physician authorized user and that the ALARA principle is observed for all non-therapeutic radiation exposures. I Specification l 1

l 1. Patients accepted for tmatment shall have been referred by written directive from a

! l physician authorized user of NRC Medical Use Licensee No. 20-03857-06 or of any other -

medical use licensee that has been similarly authorized by NRC to utilize the WSU Research Reactor's Medical Therapy Facility beam for neutron capture therapy for humans.

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2. All medical treatments, including irradiations and analyses of the neutron capture agents in i the patients, are the responsibility of the physician authorized user in charge of the therapy

} and the medical physicists from the NRC-licensed medical center. Washington State j University is only responsible for providing current and accurate beam characteristic

, parameters to the medical use licensee and for delivery of the desired radiation fluence as requested in the written directive. Before the start of a therapy, both the certified medical

. physicist and the Director of the Nuclear Radiation Center, or his designate, must agree that f

the therapy can be initiated. The physician authorized user is responsible for monitoring i

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". . DRAFT-2 th'etherapy and for directing its termination. However, a radiation therapy cr.n also be terminated at any time if either the physician authorized user or the facility Director, or their designates, judge that the therapy should be terminated.

3. It shall be possible to initiate a scram of the reactor from a control panel located in the I

medical therapy facility area. In the event that the medical facility 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 provision. Use of this temporary provision is limited to seven consecutive working days.  !

4. Access to the treatment room of the medical therapy facility shall be controlled by means of  ;

i the shield door located at its entrance. )

5. The following features and/or interlocks shall be operable:

1 (a) An interlock shall prevent moving the bridge from the retracted position unless the j treatment room's shield door is closed.

(b) The bridge shall be interlocked to move to the retracted position automatically upon opening of the treatment room's shield door.

(c) The bridge shall be designed to move to the retracted position automatically upon failure of facility electric power or low voltage on the backup batteries that power the bridge motor.

(d) Bridge movement that controls beam delivery shall be designed for manual

moument to the retracted position. l (e) It shall be possible to move the bridge to the retracted position from the medical therapy facility control area. .

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6. Bridge shall be equipped with a position readout that indicates the status of the bridge. A l

, bridge position readout shall be visible at the medical therapy facility's local control panel.

In the event of a bridge position readout malfunction,it shall be acceptable to use an alternate means of verifying position such as a video camera in the pool room providing a 2

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signal to a monitor at the medical therapy facility's local control panel. Use of this alternate means of bridge position verification is limited to seven consecutive working days.

7. The medical therapy facility shall be equipped with a monitor that provides a visual indication of the radiation level within the treatment room, that indicates both within the tn:atment room and at the local medical therapy facility's control panel, and that provides an

_ audible alann both within the treatment room and at the local control 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 on the calendar day of and prior to any patient irradiation.  ;

(c) This radiation monitor shall be calibrated quarterly.

(d) The audible alarm shall be set at or below 50 mR/hr. This monitor and/or its alarm may be disabled once the treatment room has been searched and secured, such as is done immediately prior to initiation of patient therapy. If this is done, the monitor and/or its alaim shall be interlocked so that they become functional upon opening of the medical therapy facility shield door.

(e) . In the event that this monitor is inoperable, personnel entering the treatment room l

shall use either portable survey instruments or audible alarm personal dosimeters as a i 1 l temporary means of satisfying this provision. These instruments /dosirneters shall be i j in calibration as defined by the WSU Research Reactor's radiation protection

!. program and shall be source-checked daily prior to use on any day that they are used 1 .

l to satisfy this provision. Use of these instruments / dosimeters as a temporary means i of satisfying this provision is limited to seven consecutive working days.

8. An intercom or other means of two-way communication shall be operable both between the i

medical therapy facility control panel and the reactor control room, and also between the ,

medical therapy facility control panel and the treatment room. This latter is for the

, ' monitoring of patients.

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- . ,. DRAFT-2 l 9.', It'shall be'possible for personnel monitoring a patient to open the treatment room shield i door manually.

10. It shall be possible to observe the patient by means of two independent closed-circuit TV j cameras. Both cameras providing patient visualization shall be operable at the outset of any i

patient irradiation. Should either fail during the irradiation, the treatment may be continued >

I at the discretion of the physician authorized user. Adequate lighting to permit such viewing shall be assumd by the provision of emergency lighting.

11. The total radiation fluence delivered by the medical therapy facility beam as measured by l on-line beam monitors shall not exceed that pmscribed in the patient treatment plan by more 4

j than 20%. The treatment is normally delivered in fractions in accordance with standard i 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 the difference between the administered and prescribed fluence for any given week (seven consecutive days). Finally,if the treatment consists of three or fewer fractions, then a criterion of 10% shall apply.

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12. The following interlocks or channels shall be tested at least monthly and prior to treatment i of human patients if the interlock or channel has been repaired or deenergized:

Interlock or Channel Surveillance i

a) Medical therapy facility scram Scram test p -

b) Bridge will not move from the retracted Operational test position unless shield door is closed i c) The bridge moves toward the retracted Operational test position upon both manual and automatic j opening of treatment room shield door

. d) The bridge moves toward the retracted Operational test

position on loss of electrical power ,

and low voltage on the bridge motor 4

. DRAFT-2 batteries e) Manual movement of bridge Operational test f) Bridge can be moved manually Opemtional test from within the facility g) Bridge position indicator and status Opemtional test lights h) Radiation monitor alarm Operational test i) Radiation monitor and/or alarm Opemtional test enabled upon opening of shield door j) Intercoms Opemtional test In addition to the above, the medical therapy facility scram shall be tested prior to reactor startup if the reactor has been shut down for more than sixteen hours.

13. Manual operation of the treatment room's shield door in which the door is opened fully shall be verified semi-annually.

14. Use of the medical therapy facility beam shall be subject to the following:

a) A calibration check of the beam and a functional check of the beam monitors that are described in provision 11 of this specification shall be made weekly for any week j i that the beam will be used for human therapy. These checks shall be made prior to  !

any patient irradiation for a given week. In addition, a calibration check shall be performed prior to any patient irradiation in the event that any component of a given I

beam design has been replaced. Finally, a calibration and a functional check shall be performed prior to any patient irradiation in the event of a design modification.

b) A characterization of the beam shall be performed every six months for any six-month interval that the beam will be used for human therapy. This six-month I j

characterization shall be made prior to any patient irradiation for a given six-month I interval. A characterization shall also be performed prior to any patient irradiation in the event of a design modification. As part of the characterization process, the I

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. DRAFF-2 proper response of the beam monitors that are described in provision 11 of this specification shall be verified.

c) A calibration of the beam monitors that are described in provision 11 of this specification shall be performed at least once every two years for any two-year interval that the beam will be used for human therapy. The two-year calibration shall be made prior to any patient irradiation during any given two-year interval.

15. Maintenance, repair, and modification of the medical therapy facility shall be performed under the supervision of a senior mactor operator who is licensed by the U.S. Nuclear Regulatory Commission to operate the WSU Research Reactor. The ' medical therapy facility' includes the beam, bridge moving system, beam monitoring equipment, treatment room shielding, shield door, and patient viewing equipment. All modifications will be reviewed pursuant to the requirements of 10 CFR 50.59. The operating 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, except insofar as radiation safety (i.e., activation and/or contamination)is concerned.

16. Personnel who are not licensed to operate the WSU Research Reactor but who are i

! msponsible 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:

f (a) Training has been provided and proficiency satisfactorily demonstrated on the

[ design of the facility,its controls, and the use of those controls. Proficiency shall l be demonstrated annually.

(b) Instructions are posted at the medical therapy facility's local control panel that specify the procedure to be followed:

(i) to ensure that only the patient is in the treatment room before turning the i

. primary beam of radiation on to begin a treatment;

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. (ii) if the operator is unable to tum the primary beam of radiation off with controls outside the medical therapy facility, or if any other abnormal condition occurs. A directive shall be included with these instructions to notify the reactor console operator in the event of any abnormality.

-(c) In the event that bridge movement affects reactivity, personnel who are not licensed on the WSU Research Reactor but who have been trained under this provision may initiate bridge movement provided that verbal permission is requested and received from the n: actor console operator immediately prior to such action. Emergency  ;

closures are an exception and may be made without first requesting permission.

Records of the training provided under subparagraph (a) above shall be retained in acconiance with the WSU Research Reactor's training program or at least for three years.

A list of personnel so qualified shall be maintained in the reactor control room.

17. Events defined as ' recordable' under definition 8 of this specification shall be recorded and the record maintained for five years. Events defined as 'misadministrations' under definition 9 of this specification shall be reported 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). The 24 hour2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> verbal reports will be .

1 made to the Regional Administrator, Region IV, or his designate. The 15 day written reports will be sent to the NRC Document Control Desk with a copy to the Regional j Administration, Region IV or his designate.

18. The requirements of the Quality Management Program (QMP) for the Generation of Medical Therapy Facility Beam for Human Therapy at Washington State University

Research Reactor shall be observed for any human therapy. (N_qte

The presence of this  !

commitment to observe the QMP in these specifications does not preclude modifying the QMP as provided in that document. Any such modifications are not considered to be a change to the WSU Reactor Technical Specifications.)

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f, Definitioris

1. The medical therapy facility is equipped with a bridge moving system that is used to control i beam delivery. Bridge movement analyses shall be documented through the standard I 1

safety review process including, wheir appropriate, an SAR revision and submission to -

NRC under 10 CFR 50.59. I 1

2. The term ' treatment room' refers to that portion of the medical therapy facility consisting of

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. the shielded room in which the actual exposure of patients to the neutron beam takes place. I

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3. The term ' medical therhpy facility' refers to the entire system and equipment related to 2

i. conducting neutrc n therapy including the treatment room, facility control panel, and all associated central and monitoring systems.

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! 4. The term ' calibration check' refers to the process of checking the beam intensity and quality.

via one or more of the following: foil activation; use of a fission chamber; use of an ion chamber; or an equivalent process. The purpose of a calibration check is to ensure that the i beam has not changed in a significant way (e.g., energy spectrum or intensity) from the -

beam that was characterized.

5. He tem 1 ' functional check of the beam monitors' shall consist of verifying that system  :

output is consistent (i 19%) with previously measured values upon normalization to a common reactor neutronic power level.

6. The term ' characterization' refers to the process of obtaining the dose-versus-depth profile  !

in phantoms. The dose-versus depth profile from the surface of the phantom to a depth at l

least equivalent to the total thickness of the body part to be treated on a central axis is deemed adequate for a characterization. Fast neutron, thermal neutron, and gamma ray components are determined in a characterization and monitors are normalized by this characterization.

7. He term ' calibration of the beam monitors' refers to the process wheitby the beam monitors that are described in provision 11 of this specification are calibrated against

' instruments that measure dose including a tissue equivalent chamber and a graphite or 8

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. m'agnesium wall ionization chamber ( or the equivalent to any of these three) that have in tum been calibrated by a secondary calibration laboratory.

8 The tenn ' design modification' as applied to the medical therapy facility beam refers (a) to a change that is shown to alter the dose-versus-depth profile of the fast neutrons, thennal neutrons, or gamma rays in the beam as sensed by the calibration check and (b) to a change that has the potential to increase significantly the amount of activation products in the medical therapy facility when the beam is to be used for the treatment of human patients.

9. The term ' radiation fluence' means the total fluence of neutrons and gam.na radiation that is emitted in the medical therapy facility beam. The determination of the ratios of gamma, fast neutron, and thermal 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 sensitive. Compliance with the limits specified on radiation fluence by this specification is determined by reference to the fluence monitored by these detectors.

10. The tenn 'remrdable event' means the administration of:

(a) A radiation treatment without a written directive; or (b) A radiation treatment where a written directive is required without reporting to the i

i medical use licensee in writing each fluence given within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> of the treatment; l or (c) A treatment delivery for which the administered radiation Fuence for any given i

fraction is 15% greater than prescribed.

I1. The term ' misadministration' means the administration of a radiation therapy:

(a) Involving the wrong patient, wrong mode of treatment, or wrong treatment site; or

(b) When the delivery is not in accordance with provision 11 of this specification.

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12. The term ' written directive' means an order in writing for a specific patient, dated and l signed by a physician authorized user prior to the administration of radiation and which l

specifies the treatment site, the total radiation fluence, radiation fluence per fraction, and l

overall treatment period.

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13. The term 'humsa therapy' means radiation treatments that are of direct therapeutic benefit to the patient and/or part of investigatory studies that involve humans.

14. The term ' physician authorized user' means a medical physician approved for neutron capture therapy by an NRC-approved medical use licensee.

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15. The term ' certified medical physicist' means a medical physicist cenified in either J radiological physics or therapeutic radiation physics by the American Board of Radiology, or in therapeutic radiation physics by the American Board of Medical Physics and who also j has specific training in neutron dosimetry and neutron beam capture therapy.

Basis The stipulation that patients only be accepted 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 WSU Research Reactor's Medical Therapy Facility beam for human therapy, ensures that medical criteria imposed by NRC on such licensees for the use of the WSU Research 4

Reactor's medical therapy facility beam for human therapy will be fulfilled. The second provision A

i delineates the division of responsibilities between Washington State University and the medical licensee that refers the patient. Also, it establishes administrative authority and protocol for initiating and terminating a radiation therapy.

The requireraent that it be possible to initiate a scram from a control panel located in the

. medical therapy facility area assures the attending physician and/or medical physicist of the

capability to terminate the treatment immediately should the need arise. The provision that access to the medical therapy facility be limited to a single door ensures that there will be no inadvertent entries. The various interlocks for the bridge movement system that controls beam delivery ensure that exposure levels in the medical therapy facility will be minimal prior to entry by personnel who are attending the patient. The bridge position indicator and status lights serve to notify personnel

of the beam's status. The provision for a radiation monitor ensures that personnel will have information available on radiation levels in the medical therapy facility prior to entry. The purpose 10

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• . DRAFT-2 of this monitor's audible alarm is to alert personnel to the presence of elevated radiation levels, such as exist when the shutters that control beam delivery are open. This monitor and/or its alarm .

may be disabled once the medical therapy facility has been searched and secured so that it will (1) not disturb a patient and (2) not distract attending personnel. The monitor and/or its alarm are interlocked with the shield door so that they are made functional upon opening that door, and hence prior to any possible entry to the medical therapy facility. One intercom provides'a means for the prompt exchange of information between medical personnel and the reactor operator (s). The second intercom is for monitoring the patient, a The provision for manual operation of the medical therapy facility's shield door ensums

' access to any patient in the event of a loss of electrical power. The presence of the closed-circuit TV cameras provide the attending physician authorized user and/or medical physicist with the opportunity to monitor the patient visually as well as through the use of various instruments. The viewing window will function even during an electric power failure because of the provision for emergency lighting.

The specification that the total radiation fluence fcr a therapy (i.e., the radiation fluences for the sum of all fractions specified in a given treatment plan) not exceed that prescribed in the patient

. treatment plan by 20% establishes a trigger limit on the delivered fluence above which the NRC has to be notified of a misadministration. The 20% criterion is based on the definition of misadministration (clause 4(iv)) as given in 10 CFR 35.2. The criterion that the difference between the administered and prescribed fluence for any seven conse-cutive days is set at 30%. l 1

, This is also in accordance with the definition of misadministration (clause 4(iii)) as given in 10 CFR 35.2. Finally, if a treatment involves three or fewer fractions, then a more stringent criterion, 10%, applies to the difference between the total radiation fluence for a therapy and that prescribed in the treatment plan (10 CFR 35.2(4ii)). The surveillance requirements for beam calibration

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, checks and characterizations provide a mechanism for ensuring that the medical therapy facility and L . its beam will perform as originally designed. Similarly, the surveillance requirements on the beam j monitors ensure that these instruments are calibrated by a means traceable to the National Institute l l

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. ofStandbds and Technology. The chambers specified (tissue-equivalent, and graphite or magnesium-wall) were chosen because they measure dose as opposed to fluence.

The specifications on maintenance and repair of the medical therapy facility ensures that all such activities are performed under the supervision of personnel cognizant of quality 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 instruction equivalent to that given to licensed reactor operators as regards use of the medical therapy facility beam. (Note: Licensed

- reactor operators may, of course, operate the medical therapy facility beam.) Also, this provision ,

provides for the posting of instructions to be followed in the event of an abnormality.

, The specification on ' recordable events' and 'misadministrations' provides for the documentation and reporting to the U.S. Nuclear Regulatory Commission of improper events regarding the generation and use of the medical therapy facility beam. The requirement that the Quality Management Program (QMP) be observed ensures that radiation treatments providcd by the medical therapy facility beam will be administered as directed by the physician authorized user.

References l l

6.5-1 MITR Staff," Safety Analysis Report for the MIT Research Reactor (MITR-II)," Report No. MITNE-115,22 Oct.1970, Section 10.1.3.

6.5-2 Choi, RJ.," Development and Characterization of an Epithermal Beam for Boron Neutron Capture Therapy at the MITR-II Research Reactor," Ph.D. Thesis, Nuclear Engineering f Department, Massachusetts Institute of Technology, April 1991.

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