ML003771757

Further Response to Request for Additional Information Regarding Massachusetts Institute of Technology Request to Amend Technical Specification No. 6.5

ML003771757
Person / Time
Site:	MIT Nuclear Research Reactor
Issue date:	11/09/2000
From:	Bernard J, Hu L, Newton T Massachusetts Institute of Technology (MIT)
To:	Document Control Desk, Office of Nuclear Reactor Regulation
References
-RFPFR, TAC MA6134
Download: ML003771757 (26)

Text

NUCLEAR REACTOR LABORATORY AN INTERDEPARTMENTAL CENTER OF MASSACHUSETTS INSTITUTE OF TECHNOLOGY JOHN A. BERNARD 138 Albany Street, Cambridge, MA 02139-4296 Activation Analysis Telefax No. (617) 253-7300 Coolant Chemistry Director Tel. No. (617) 253-4220 Nuclear Medicine Director of Reactor Operations Reactor Engineering Principal Research Engineer November 9, 2000 Nuclear Regulatory Commission Attn: Document Control Desk Washington, D.C. 20555

Subject:

Further Response to Request for Additional Information (TAC No. MA6134),

Docket No. 50-20, License No. R-37 Gentlemen:

On June 30, 1999, the Massachusetts Institute of Technology submitted a request to amend MIT Research Reactor Technical Specification No. 6.5, "Generation of Medical Therapy Facility Beam for Human Therapy." On December 23, 1999, we received a request from NRC for additional information. That response was provided on March 17, 2000. On July 21, 2000, we received a further request for information. That response was provided on August 15, 2000. Enclosed are some additional changes that are either administrative in nature or serve to improve clarity.

Also enclosed is a copy of the proposed wording of MITR Technical Specification No. 6.5 and its associated QMP. This wording supersedes that of our submission of August 15, 2000.

Thomas H. Newton, Jr. Lin Wen Hu, Ph.D.

Reactor Engineer Reactor Relicensing Engineer a L

Jbhn A. Ber nard, Ph.D.

Director JAB/koc Enclosure cc: USNRC - Senior Project Manager, NRR/ONDD USNRC - Region I - Project Scientist ýC)ýýC)

Effluents Radiation Protection Section (ERPS)

Additional Information on Dose Estimates As part of a previous question, the Massachusetts Institute of Technology provided information on the dose to the patient in the event of a shutter failure. That answer is hereby augmented by providing information on the dose to staff who would enter the medical facility room to assist a patient in the event of a shutter failure.

If, during the course of a patient irradiation in the fission converter medical treatment facility (FCB), a shutter fails open, personnel will not enter the room until the dose rates are reduced as much as possible. Thus, entry will occur no sooner than a few minutes after the shutter failure.

(Note: A simultaneous shutter failure and a patient emergency that would necessitate immediate entry is not considered credible.) Two scenarios are possible.

(a) If the shutter involved is the CCS or water shutter, no significant doses (<5 mRem) to personnel will result.

(b) In the case of the mechanical shutter failure, both the motor drive and manual closing method would have to fail in order for dose rates to be of concern.

In this case, personnel will wait -- as is the case for all routine irradiations -- for the water shutter and CCS to be fully closed before entering the room.

This requires about 100 seconds. In addition, the reactor will be scrammed or the reactor power lowered in order to reduce dose rates to as low as possible. Again, if advantageous, personnel can wait several minutes for the dose rates to drop.

With the CCS and water shutter closed, and the reactor shut down, the dose rate in the beam after 5 minutes is approximately 1 Rem/hr. Given one minute to remove the patient and assuming personnel spent the entire minute in the beam centerline (contrary to our ALARA procedures), the total dose to personnel would be less than 20 mRem.

In summary, for any shutter failure scenario, personnel will be able to enter the medical irradiation room within a few minutes, if necessary, to remove a patient. The estimated personnel exposures are always less than 20 mrem under the most conservative assumptions.

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 primary beam of radiation on to begin a treatment; (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 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 a shutter affects reactivity (e.g., the D20 shutter for the medical room below the reactor and the converter control shutter for the fission converter beam), personnel who are not licensed on the MIT Research Reactor but who have been trained under this provision may operate that shutter provided that verbal permission is requested and received from the reactor 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 accordance with the MIT 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 made to the Headquarters Operation Center, or designate. The 15 day written reports will be sent to the NRC Document Control Desk, or designate.

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

a) Involving the wrong patient, wrong beam (basement or fission converter), or wrong treatment site; or b) When the treatment delivery is not in accordance with provision 11 of this specification.

10. The term 'written directive' means an order in writing for a specific patient, dated and signed by a BNCT physician authorized user prior to the administration of radiation and which specifies the treatment site, the total radiation fluence, radiation fluence per fraction, the medical facility (basement medical therapy facility beam or fission converter medical therapy facility beam) and collimator, if any, to be used, and overall treatment period.

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

12. The term 'BNCT physician authorized user' means a medical physician authorized by the medical use licensee's radiation safety committee to act as an authorized user for BNCT on humans.

13. 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 Medical Physics and who also has specific training in neutron dosimetry and neutron capture therapy.

14. The term 'BNCT Principal Investigator' means a person who holds an advanced in degree in science or engineering and who has two or more years of experience BNCT.

15. The term 'basement medical therapy facility beam' means the beam emanating from the MIT Research Reactor into the medical therapy room that is physically located below the reactor on the building's lower level.

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Quality Management Program: Generation of MITR Medical Therapy Facility Beams for Human Therapy 1.

Purpose:

The objective of this quality management program is to ensure that radiation treatments provided by the MIT Research Reactor's (MITR) Medical Therapy Facility beams will be administered as directed by a BNCT physician authorized user.

2. Authorized Medical Use Licensees: Use of the MIT Research Reactor's Medical Therapy Facility beams, for the treatment of human subjects, is limited to the BNCT physician authorized users from medical centers with an NRC or Agreement State medical use license that contains BNCT specific conditions and commitments for BNCT treatment on humans conducted at the Massachusetts Institute of Technology Research Reactor's Medical Therapy Facilities.

3. Program Requirements: The following requirements are established as part of this quality management program:

a) A written directive will, except as noted in subparagraph (iv) below, be prepared by a BNCT physician authorized user of either the NRC or Agreement State medical use licensee prior to the administration of any radiation therapy. This directive shall be written, signed, and dated by the BNCT physician authorized user and it shall include the following information:

(i) Name and other means of identifying the patient.

(ii) Names of the BNCT physician authorized user and certified medical physicist in charge of the therapy.

(iii) The medical facility (basement medical therapy facility beam or fission converter medical therapy facility beam) to be used and the collimator, if any, the total radiation fluence to be administered, the radiation fluence per fraction, the treatment site, and the overall treatment period.

(iv) If, because of the patient's condition, a delay in order to provide a written revision to an existing written directive would jeopardize the patient's health, an oral revision to an existing written directive will be acceptable, provided the oral revision is documented immediately in the patient's record and a revised written directive is signed by a BNCT physician authorized user within 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 any therapeutic procedure provided that the revision is dated and signed by a BNCT physician authorized user prior to the administration of the next fraction.

If, because of the emergency nature of the patient's condition, a delay in order 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.

a 6.5 Generation of Medical Therapy Facility. Beams for Human Therapy This specification applies solely to the generation of medical therapy facility beams use of the medical therapy for the treatment of human patients. It does not apply to any other are only required if facilities and/or their beams. Surveillances listed in this specification However, in the event of a human therapy is planned for the interval of the surveillance.

that surveillance shall be hiatus in the scheduled performance of any given surveillance, the interval in question.

performed prior to the initiation of human therapy during Objective by ensuring that patients To provide for the protection of the public health and safety by the BNCT physician are treated in accordance with the treatment plan established for all non-therapeutic radiation authorized user and that the ALARA principle is observed exposures.

Speific-ation directive from a

1. Patients accepted for treatment shall have been referred by written with an NRC or Agreement BNCT physician authorized user from a medical center and commitments State medical use license that contains BNCT specific conditions Institute of for BNCT treatment on humans conducted at the Massachusetts Technology Research Reactor's Medical Therapy Facilities.

analyses of the neutron capture

2. All medical treatments, including irradiations and authorized user in agents in the patients, are the responsibility of the BNCT physician NRC-licensed or charge of the therapy and the medical physicists from the Institute of Technology Agreement State-licensed medical center. The Massachusetts parameters is only responsible for providing ciurrent and accurate beam characteristic radiation fluence as to the medical use licensee and for delivery of the desired both the certified requested in the written directive. Before the start of a therapy, must agree that medical physicist and the BNCT Principal Investigator, or designate, user is responsible for the therapy can be initiated. The BNCT physician authorized 6-21

Because MIT is responsible for monitoring the therapy and can direct its termination.

Principal Investigator, or designate, delivery of the prescribed fluence, the BNCT irradiation whenever the prescribed will under normal circumstances terminate the can also be terminated at any time if fluence is attained. However, a radiation therapy or the BNCT Principal Investigator, or either the BNCT physician authorized user should be terminated.

their designates, judge that the therapy of the reactor from a control panel located

3. It shall be possible to initiate a minor scram in each medical therapy facility area.

shall be controlled by means of the shield

4. Access to each medical therapy facility door located at its entrance.

shall be operable:

5. The following features and/or interlocks that control beam delivery a) An interlock shall prevent opening of the shutters door is closed.

unless the medical therapy facility's shield shall be interlocked to close b) The shutters that control beam delivery therapy facility's shield door.

automatically upon opening of the medical shutter, the shutters that control c) Except for the fission converter mechanical automatically either upon failure of beam delivery shall be designed to close if the shutter is operated electric power, or upon reduced air pressure mechanical shutter, the reactor will pneumatically. For the fission converter electric power to that shutter.

be scrammed automatically upon loss of that are normally pneumatically d) Shutters that control beam delivery and for manual closure.

operated shall, in addition, be designed that control beam delivery from e) It shall be possible to close the shutters within the medical therapy facility.

which is normally operated f) The fission converter mechanical shutter, electrically, shall also allow manual closure.

that delivery shall be equipped with a light

6. Each of the shutters that controls beam lights shall be visible at each medical indicates the status of the shutter. These 6-22

light malfunction, it therapy facility's local control panel. In the event of a status alternate means of shall be acceptable to use the affected shutter provided that an verifying position is available. Use of this alternate means of shutter position days.

verification is limited to seven consecutive working a monitor that provides a visual

7. Each medical therapy facility shall be equipped with indicates both within the indication of the radiation level within the facility, that alarm both within facility and at the local control panel, and that provides an audible the facility and at the local control panel.

supply such as a) This radiation monitor shall be equipped with a backup power the reactor emergency power system or a battery.

by means of a b) This radiation monitor shall be checked for proper operation irradiation.

check source on the calendar day of and prior to any patient c) This radiation monitor shall be calibrated quarterly.

This monitor and/or its d) The audible alarm shall be set at or below 50 mR/hr.

searched and alarm may be disabled once the medical therapy room has been patient therapy. If secured, such as is done immediately prior to initiation of so that they this is done, the monitor and/or its alarm shall be interlocked facility's shield door.

become functional upon opening of the medical therapy the medical e) In the event that this monitor is inoperable, personnel entering or audible alarm therapy facility shall use either portable survey instruments provision. These personal dosimeters as a temporary means of satisfying this MIT Research instruments/dosimeters shall be in calibration as defined by the daily Reactor's radiation protection program and shall be source-checked Use of prior to use on any day that they are used to satisfy this provision.

satisfying this these instruments/dosimeters as a temporary means of days.

provision is limited to seven consecutive working shall be operable both

8. An intercom or other means of two-way communication the reactor control room, and between each medical therapy facility control panel and 6-23

panel and the interior of the also between each medical therapy facility control facility. The latter is for the monitoring of patients.

patient to open each medical therapy

9. It shall be possible for personnel monitoring a facility's shield door manually.

both a viewing port and by means

10. It shall be possible to observe the patient through of patient visualization shall be of a closed-circuit TV camera. Both methods the irradiation. Should either fail during operable at the outset of any patient the discretion of the BNCT physician irradiation, the treatment may be continued at viewing shall be assured by the authorized user. Adequate lighting to permit such provision of emergency lighting.

therapy facility beam as measured

11. The total radiation fluence delivered by the medical in the patient treatment plan by on-line beam monitors shall not exceed that prescribed delivered in fractions in accordance by more than 20%. The treatment is normally 20% criterion applies to the sum of with standard practice for human therapy. The in a given treatment plan. A the radiation fluences associated with all fractions the administered and prescribed criterion of 30% applies to the difference between days). Finally, if the treatment fluence for any given week (seven consecutive criterion of 10% shall apply.

consists of three or fewer fractions, then a be tested at least monthly and prior to

12. The following interlocks or channels shall or channel has been repaired or treatment of human patients if the interlock deenergized:

Surveillance Interlock or Channel Scram test a) Medical therapy facility minor scram Operational test b) Shutters will not open unless shield door is closed and Operational test c) Shutters close upon both manual door automatic opening of shield 6-24

d) Shutters close or the reactor is Operational test automatically scrammed on loss of electrical power, and shutters close upon reduction of pressure to pneumatic operators, if applicable Operational test e) Manual closure of pneumatic shutters Operational test f) Shutters can be closed manually from within the facility Operational test g) Shutter status lights Operational test h) Radiation monitor alarm Operational test i) Radiation monitor and/or alarm enabled upon opening of shield door Operational test j) Intercoms Operational test k) Manual closure of fission converter mechanical shutter Operational test

1) Availability of emergency power for beam monitor systems facility minor scram shall be tested In addition to the above, each medical therapy shut down for more than twenty-four prior to reactor startup if the reactor has been hours.

is facility's shield door in which the door

13. Manual operation of each medical therapy opened fully shall be verified semi-annually.

facility beam shall be subject to the

14. a) Use of the basement medical therapy following:

are described in provision (i) A functional check of the beam monitors that for any week that the 11 of this specification shall be made weekly check shall be made prior beam will be used for human therapy. This In addition, a functional to any patient irradiation for a given week.

irradiation in the event of a check shall be performed prior to any patient component replacement or a design modification.

every six months for (ii) A calibration check of the beam shall be performed be used for human therapy.

any six-month interval that the beam will 6-25

This six-month calibration check shall be made prior to any patient In addition, a calibration irradiation for a given six-month interval.

in the event of a check shall be performed prior to any patient irradiation component replacement or a design modification.

every twelve months (iii) A characterization of the beam shall be performed will be used for human for any twelve-month interval that the beam be made prior to any therapy. This twelve-month characterization shall interval. A characterization patient irradiation for a given twelve-month in the event of a shall also be performed prior to any patient irradiation process, the proper design modification. As part of the characterization in provision 11 of this response of the beam monitors that are described specification shall be established.

chamber and either a graphite (iv) The instruments (e.g., tissue-equivalent equivalent) that are to be or a magnesium wall ionization chamber or the of the beam used to perform both calibration checks and characterization laboratory. This shall be calibrated by a secondary calibration two years for any two calibration shall be performed at least once every human therapy. The two year interval that the beam will be used for irradiation during any year calibration shall be made prior to any patient (e.g., foil activation) other given two-year interval. (Not.e: If a method and or the characterization, than these checks is used for the calibration shall either be traceable then the devices (e.g., foils) used in that method or be selected in to the National Institute of Standards and Technology accordance with the relevant ANSI/ANS standards.)

beam monitors to (v) There shall be a minimum of two neutron-sensitive a patient irradiation may be initiate a patient irradiation. Once initiated, medical physicist and the continued at the discretion of both the certified 6-26

Director of the Nuclear Reactor Laboratory, or designate, provided that at least one neutron-sensitive beam monitor is operable.

beam shall be subject to b) Use of the fission converter medical therapy facility the following:

above.

(i) Functional checks: the same requirements as provision 14(a)(i) 14(a)(ii) above (ii) Calibration checks: the same requirements as provision except that all frequencies are weekly instead of six months.

14(a)(iii) above (iii) Characterization: the same requirements as provision twelve months.

except that all frequencies are six months instead of provision 14(a)(iv).

(iv) Instrument calibration: the same requirements as 14(a)(v).

(v) Beam monitors: the same requirements as provision the medical therapy facilities shall be

15. Maintenance, repair, and modification of operator who is licensed by the performed under the supervision of a senior reactor Research Reactor. The U.S. Nuclear Regulatory Commission to operate the MIT

'medical therapy facility' includes the beam, beam shutters, beam monitoring shield door, and patient viewing equipment, medical therapy facility shielding, to the requirements of 10 equipment. All modifications will be reviewed pursuant medical CFR 50.59. The operating couch, patient positioning equipment, medical support of the patient instruments, and other equipment used for the direct of this provision, are not considered part of the medical therapy facility for purposes contamination) is concerned.

except insofar as radiation safety (i.e., activation and/or Research Reactor but who are

16. Personnel who are not licensed to operate the MIT design including construction responsible for either the medical therapy or the beam's the corresponding medical therapy and/or modification may operate the controls for facility beam provided that:

demonstrated on the a) Training has been provided and proficiency satisfactorily controls. Proficiency design of the facility, its controls, and the use of those shall be demonstrated annually.

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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 primary beam of radiation on to begin a treatment; (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 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 a shutter affects reactivity (e.g., the D2 0 shutter for the medical room below the reactor and the converter control shutter for the fission converter beam), personnel who are not licensed on the MIT Research Reactor but who have been trained under this provision may operate that shutter provided that verbal permission is requested and received from the reactor 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 accordance with the MiT 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 made to the Headquarters Operation Center, or designate. The 15 day written reports will be sent to the NRC Document Control Desk, or designate.

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Program (QMP) for the Generation of

18. The requirements of the Quality Management Therapy at the Massachusetts Institute of Medical Therapy Facility Beams for Human for any human therapy. (Note: The Technology Research Reactor shall be observed the QMP in these specifications does not presence of this commitment to observe in that document. Any such modifications preclude modifying the QMP as provided the MITR Technical Specifications.)

are not considered to be a change to for the determination of boron concentration

19. Reactor facilities (e.g., prompt gamma measurements associated with the conduct in blood or tissue) that are used to perform every twelve months for any twelve-month of medical therapy shall be calibrated therapy. This twelve-month calibration interval that the beam will be used for human This for a given twelve-month interval.

shall be made prior to any patient irradiation a series of standards that span the anticipated calibration could be done by measuring a single point check, (e.g.,

range of boron in blood or tissue. In addition, be that a single standard is measured +/-10% of its true value) shall verification performed prior to any patient irradiation.

be available for the beam monitor systems.

20. An emergency power source shall 6-29

Definitions that are used (i) to control

1. The medical therapy facilities are equipped with shutters energy spectrum of the beam. The beam delivery and (ii) to adjust the neutron water shutters as described in former currently include lead, boral, and light which is also described in Reference Reference 6.5-1. The heavy water blister tank, convener, the shutters that control 6.5-1, is an example of the latter. For the fission a fast-acting mechanical shutter. It is beam delivery are a water shutter and should it be found desirable to alter conceivable that these designations may change "shutters that control beam the beam configuration. Accordingly, the phrase existing shutters or to any future shutter delivery" refers either to the aforementioned greater reduction in beam intensity.

or group thereof that provides an equivalent or through the standard safety review Shutter-effect analyses shall be documented revision and submission to NRC process including, where appropriate, an SAR under 10 CFR 50.59.

and process of checking the beam intensity

2. The term 'calibration check' refers to the foil activation; use of a fission chamber; quality via one or more of the following:

check process. The purpose of a calibration use of an ion chamber; or an equivalent in a significant way (e.g., energy is to ensure that the beam has not changed characterized.

spectrum or intensity) from the beam that was that

'functional check of the beam monitors' shall consist of verifying

3. The term previously measured values upon system output is consistent (+/- 10%) with power level.

normalization to a common neutronic process of obtaining the dose-versus-depth

4. The term 'characterization' refers to the 6.5-2 or an equivalent process. The profile in phantoms as described in Reference of the phantom to a depth at least dose.versus-depth profile from the surface part to be treated on a central axis is equivalent to the total thickness of the body neutron, thermal neutron, and gamma deemed adequate for a characterization. Fast 6-30

and monitors are normalized by ray components are determined in a characterization this characterization.

the replacement of a component in the

5. The term 'component replacement' means a component in the beam for beam with an identical unit or the re-installation of For example, the latter may be which a characterization has already been performed.

a change of collimators.

(a) to a medical therapy facility beam refers

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

fluence of neutrons and gamma radiation

7. The term 'radiation fluence' means the total beam. The determination of the ratios of that is emitted in a medical therapy facility fluences is part of the beam gamma, fast neutron, and thermal neutron allows the total radiation fluence to be characterization. Knowledge of these ratios Compliance with monitored by the on-line detectors, which are neutron-sensitive.

this specification is determined by the limits specified on radiation fluence by detectors.

reference to the fluence monitored by these administration of:

8. The term 'recordable event' means the or a) A radiation treatment without a written directive; A radiation treatment where a written directive is required without reporting to b) given within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> of the the medical use licensee in writing each fluence treatment; or radiation fluence for any c) A treatment delivery for which the administered given fraction is 15% greater than prescribed.

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

a) Involving the wrong patient, wrong beam (basement or fission converter), or wrong treatment site; or b) When the treatment delivery is not in accordance with provision 11 of this specification.

10. The term 'written directive' means an order in writing for a specific patient, dated and signed by a BNCT physician authorized user prior to the administration of radiation and which specifies the treatment site, the total radiation fluence, radiation fluence per fraction, the medical facility (basement medical therapy facility beam or fission converter medical therapy facility beam) and collimator, if any, to be used, and overall treatment period.

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

12. The term 'BNCT physician authorized user' means a medical physician authorized by the medical use licensee's radiation safety committee to act as an authorized user for BNCT on humans.

13. 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 Medical Physics and who also has specific training in neutron dosimetry and neutron capture therapy.

14. The term 'BNCT Principal Investigator' means a person who holds an advanced degree in science or engineering and who has two or more years of experience in BNCT.

15. The term 'basement medical therapy facility beam' means the beam emanating from the MIT Research Reactor into the medical therapy room that is physically located below the reactor on the building's lower level.

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emanating

16. The term 'fission converter medical therapy facility beam' means the beam from the MIT Research Reactor's fission converter into the medical therapy facility that is physically located adjacent to the reactor on the building's main floor.

B asi__._s that has an The stipulation that patients only be accepted from a medical use licensee specific conditions and NRC or an Agreement State medical use license that contains BNCT Institute of commitments for BNCT treatment of humans conducted at the Massachusetts that medical criteria Technology Research Reactor's Medical Therapy Facilities ensures use of the M1T Research imposed by NRC or the Agreement State on such licensees for the The second Reactor's medical therapy facility beams for human therapy will be fulfilled.

Institute of provision delineates the division of responsibilities between the Massachusetts Technology and the medical licensee that refers the patient. Also, it establishes a radiation therapy.

administrative authority and protocol for initiating and terminating panels The requirement that it be possible to initiate a minor scram from control and/or medical located in the medical therapy facility areas assures the attending physician the need arise. The physicist of the capability to terminate the treatment immediately should door ensures that provision that access to each medical therapy facility be limited to a single control beam there will be no inadvertent entries. The various interlocks for the shutters that be minimal prior to delivery ensure that exposure levels in the medical therapy facility will lights serve to notify entry by personnel who are attending the patient. The shutter-indication that personnel personnel of the beam's status. The provision for a radiation monitor ensures facility prior to will have information available on radiation levels in the medical therapy to the presence of entry. The purpose of this monitor's audible alarm is to alert personnel delivery are open.

elevated radiation levels, such as exist when the shutters that control beam facility has been This monitor and/or its alarm may be disabled once the medical therapy distract attending searched and secured so that it will (1) not disturb a patient and (2) not door so that they are personnel. The monitor and/or its alarm are interlocked with the shield 6-33

to the medical made functional upon opening that door, and hence prior to any possible entry of information therapy facility. One intercom provides a means for the prompt exchange second intercom is for between medical personnel and the reactor operator(s). The monitoring the patient.

shield door The provision for manual operation of each medical therapy facility's The presence of a ensures access to any patient in the event of a loss of electrical power.

BNCT physician viewing window and a closed-circuit TV camera provide the attending the patient visually authorized user and/or medical physicist with the opportunity to monitor will function even as well as through the use of various instruments. The viewing window lighting.

during an electric power failure because of the provision for emergency radiation The specification that the total radiation fluence for a therapy (i.e., the plan) not exceed that fluences for the sum of all fractions specified in a given treatment limit on the delivered prescribed in the patient treatment plan by 20% establishes a trigger The 20% criterion is fluence above which NRC has to be notified of a misadministration.

in 10 CFR 35.2. The based on the definition of misadministration (clause 4(iv)) as given for any seven criterion that the difference between the administered and prescribed fluence the definition of consecutive days is set at 30%. This is also in accordance with a treatment involves misadministration (clause 4(iii)) as given in 10 CFR 35.2. Finally, if the difference three or fewer fractions, then a more stringent criterion, 10%, applies to treatment plan (10 between the total radiation fluence for a therapy and that prescribed in the as well as those for CFR 35.2(4ii)). The surveillance requirements for the functional checks for ensuring that each the beam calibration checks and characterizations provide a mechanism Similarly, the medical therapy facility and its beam will perform as originally designed.

these checks and surveillance requirements on the instruments used to perform traceable to the characterizations ensure that these instruments are calibrated by a means National Institute of Standards and Technology. The chambers specified (tissue-equivalent, as opposed to and graphite or magnesium-wall) were chosen because they measure dose 6-34

monitors is in keeping with fluence. Finally, the requirement on the number of beam standard practice for gamma-ray sources.

facilities ensures The specification on maintenance and repair of the medical therapy of personnel cognizant of quality that all such activities are performed under the supervision provision on the training and assurance and other requirements such as radiation safety. The will receive instruction proficiency of non-licensed personnel ensures that all such personnel use of the medical therapy equivalent to that given to licensed reactor operators as regards of course, operate the medical facility beams. (Note: Licensed reactor operators may, posting of instructions to be therapy facility beams.) Also, this provision provides for the followed in the event of an abnormality.

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

are used to measure the The specification on calibration of reactor facilities that measurements are accurate.

concentration of boron in blood or tissue ensures that these References Reactor (MITR-II),"

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

an Epithermal Beam for Boron 6.5-2 Choi, R.J., "Development and Characterization of Thesis, Nuclear Neutron Capture Therapy at the MITR-ll Research Reactor," Ph.D.

April 1991.

Engineering Department, Massachusetts Institute of Technology, 6-35

Oualitv Management Program for Generation of MITR Medical Therapy Facility Beams I for Human Therapy

-1 Quality Management Program: Generation of MITR Medical Therapy Facility Beams for Human Therapy 1.

Purpose:

The objective of this quality management program is to ensure that radiation treatments provided by the MI1T Research Reactor's (MITR) Medical Therapy Facility beams will be administered as directed by a BNCT physician authorized user.

2. Authorized Medical Use Licensees: Use of the MIT Research Reactor's Medical Therapy Facility beams, for the treatment of human subjects, is limited to the BNCT physician authorized users from medical centers with an NRC or Agreement State medical use license that contains BNCT specific conditions and commitments for BNCT treatment on humans conducted at the Massachusetts Institute of Technology Research Reactor's Medical Therapy Facilities.

3. Program Requirements: The following requirements are established as part of this quality management program:

a) A written directive will, except as noted in subparagraph (iv) below, be prepared by a BNCT physician authorized user of either the NRC or Agreement State medical use licensee prior to the administration of any radiation therapy. This directive shall be written, signed, and dated by the BNCT physician authorized user and it shall include the following information:

(i) Name and other means of identifying the patient.

(ii) Names of the BNCT physician authorized user and certified medical physicist in charge of the therapy.

(iii) The medical facility (basement medical therapy facility beam or fission converter medical therapy facility beam) to be used and the collimator, if any, the total radiation fluence to be administered, the radiation fluence per fraction, the treatment site, and the overall treatment period.

(iv) If, because of the patient's condition, a delay in order to provide a written revision to an existing written directive would jeopardize the patient's health, an oral revision to an existing written directive will be acceptable, provided the oral revision is documented immediately in the patient's record and a revised written directive is signed by a BNCT physician authorized user within 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 any therapeutic procedure provided that the revision is dated and signed by a BNCT physician authorized user prior to the administration of the next fraction.

If, because of the emergency nature of the patient's condition, a delay in order 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.

(v) In order to ensure that the Staff of the MIT Research Reactor has the most recent written directive from the medical use licensee and the correct directive for the patient in question, a copy of that directive shall be hand-delivered to the MITR Staff by the Staff of the medical use licensee who accompany the patient to MIT. This copy shall then be checked against the most recent previous transmission. Any discrepancy shall be resolved by the medical use licensee prior to the initiation of patient irradiation.

(vi) The BNCT Principal Investigator, or designate, will date and sign the written directive to verify that current and accurate beam characteristic parameters were provided to the NRC or Agreement State medical use licensee as appropriate and that the radiation fluence desired in the written directive was delivered. A copy of this signed directive shall be provided to the medical use licensee within twenty-four hours of a treatment.

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 directive. The MIT Nuclear Reactor Laboratory will use any two or more of the following acceptable methods of identification:

(i) Self-identification by patients who are conscious upon arrival at the MIT Research Reactor. Information provided by the patient shall include any two of the following: name, address, date of birth, or social security number. The information provided by the patient is to be compared to the corresponding information in the patient's record.

(ii) Hospital wrist band identification with the wrist band information to be compared to the corresponding information in the patient's record.

(iii) Visual identification against photographs provided with the written directive.

(iv) Other methods as specified in U.S. Nuclear Regulatory Commission Regulatory Guide 8.33, "Quality Management Program."

c) The plan of treatment is certified by the certified medical physicist to be in accordance with the written directive. In this regard, the Massachusetts Institute of Technology is responsible for calibrating the output of the beam monitoring instrumentation versus dose in phantom and for providing a central axis dose versus depth profile for the identified beam. This information will then be used by personnel at either the NRC or the Agreement State medical use licensee as appropriate to generate a plan of treatment. Conformance of the beam to its design characteristics is confirmed through the measurements specified in M1TR Technical Specification #6.5, "Generation of Medical Therapy Facility Beams for Human Therapy." Functional checks are made of the beam monitors at least weekly for any week that the beam will be used for human therapy (provisions 14(a)(i) and 14(b)(i)). Calibration checks are performed every six months for any six-month interval that the basement medical beam will be used for human therapy (provision 14(a)(ii)) and every week for any week that the fission converter medical beam will be used for human therapy (provision 14(b)(ii)). The basement medical beam is characterized

dosimetrically every twelve months (provision 14(a)(iii)). The fission converter medical beam is characterized dosimetrically every six months (provision 14(b)(iii)). The instruments that are used to perform calibration checks and characterizations of the beams are calibrated every two years by a secondary calibration laboratory (provisions 14(a)(iv) and 14(b)(iv)).

d) Each administration of radiation is in accordance with the written directive subject to the tolerances established in provision 11 of MITR Technical Specification #6.5, "Generation of Medical Therapy Beams for Human Therapy."

e) Any unintended deviations from the written directive shall be identified and evaluated, and appropriate action taken. Such action shall include informing the medical use licensee of the deviation. These reviews shall be performed monthly for any month in which human therapy was conducted. For each patient case reviewed, it shall be determined whether the administered total or fluence, fluence per fraction, treatment site, treatment beam (basement the fission converter), and overall treatment period were as specified in written directive. In the event of any deviation from the written directive, the licensee (MIT) shall identify its cause and the action required to prevent recurrence. These actions may include new or revised policies, new or of revised procedures, additional training, increased supervisory review be work, or other measures as deemed appropriate. Corrective actions shall implemented as soon as practicable.

in order to

4. Program Implementation: The following practices shall be observed ensure proper implementation of the quality management program:

a) A review shall be conducted of the quality management program. This review shall include, since the last review, an evaluation of:

(i) A representative sample of patient administrations, (ii) All recordable events, and (iii) All misadministrations.

The objective of this review is to verify compliance with all aspects of the quality management program. For purposes of this review, the term

'representative' in statement (i) above is defined as 100% sampling up to twenty patients; a sample of twenty for twenty-one to one hundred order patients, sampling for more than one hundred patients. In to and 20%

should be eliminate any bias in the sample, the patient cases to be reviewed selected randomly.

b) The procedure for conducting the above review is as follows:

(i) The review shall be performed by the Director of the MIT Radiation Protection Program or designate.

(ii) The 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.

(iv) The review shall be written and any items that require further action shall be so designated. Copies of the review shall be provided to the NRL Director and to the MIT Reactor Safeguards Committee who will evaluate each review and, if required, recommend modifications of in this quality management program to meet the requirements paragraph (3) above. A copy of these reviews will also be provided to each medical use licensee.

of the c) Records of each review, including the evaluations and findings review, shall be retained in an auditable form for three years.

Program's d) The licensee (MiT) shall reevaluate the Quality Management whether the policies and procedures after each annual review to determine the program program is still effective or to identify actions required to make more effective.

after the discovery of a

5. Response to Recordable Event: Within thirty days that includes:

recordable event, the event shall be evaluated and a response made a) Assembling the relevant facts, including the cause; recurrence; b) Identifying what, if any, corrective action is required to prevent and the relevant c) Retaining a record, in an auditable form, for three years, of facts and what corrective action, if any, was taken.

the affected medical use A copy of any recordable event shall be provided to licensee.

6. Records Retention: The following records shall be retained:

a) Each written directive for three years; and directive is b) A record of each administered radiation therapy where a written for three years required in paragraph (3(a)) above, in an auditable form, after the date of administration.

quality management

7. Program Modification: Modifications may be made to this that the program's program to increase the program's efficiency provided be notified of any effectiveness is not decreased. All medical use licensees shall The licensee modifications and provided with a copy of the revised program.

Control Desk within 30 (MIT) shall furnish the modification to the NRC Document days after the modification has been made.

8. Report and Surveillance Frequency: Any report or other function that is required frequency shall to be performed in this Quality Management Program at a specified be performed within the specified time interval with:

specified a) a maximum allowable extension not to exceed 25% of the surveillance interval, unless otherwise stated in this Quality Management Program; consecutive b) a total maximum combined interval time for any three surveillance surveillance intervals not to exceed 3.25 times the specified interval.

9. Definitions:

a) The term 'BNCT physician authorized user' means a medical physician as authorized by the medical use licensee's radiation safety committee to act an authorized user for BNCT on humans.

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

The term 'BNCT Principal Investigator' means a person who holds an c) years advanced degree in science or engineering and who has two or more of experience in BNCT.

the beam d) The term 'basement medical therapy facility beam' means room emanating from the MIT Research Reactor into the medical therapy level.

that is physically located below the reactor on the building's lower the beam e) The term 'fission converter medical therapy facility beam' means into the emanating from the MIT Research Reactor's fission converterreactor on medical therapy facility that is physically located adjacent to the the building's main floor.

to the generation

10. Applicability: This Quality Management Program applies solely It does not subjects.

of medical therapy facility beams for the treatment of human their beams. Reports apply to any other use of the medical therapy facilities and/or if human therapy was and surveillances listed in this specification are only required conducted during the referenced interval.