ML20138L199

Requests for Adjustment of License R-37 for Massachusetts Institute of Technology Research Reactor

ML20138L199
Person / Time
Site:	MIT Nuclear Research Reactor
Issue date:	02/18/1997
From:	Bernar J NUCLEAR REACTOR LABORATORY
To:	NRC OFFICE OF INFORMATION RESOURCES MANAGEMENT (IRM)
References
NUDOCS 9702210140
Download: ML20138L199 (21)

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h# 'I f NUCLEAR REACTOR LABORATORY AN INTERDEPARTMENTAL CENTER OF %hJ b)

MASSACHUSETTS INSTITUTE OF TECHNOLOGY 138 Albany Street, Cambndge, MA 02139-4296 Activation Analysts JOHN A BERNARD Telefax No. (617) 253-7300 Coolant Chemistry Director Duector of Aeactor Operatons Nuclear Medone Tel. No. (617) 253-4202 Reactor Engineenng  ;

Pnropal Research Engineer February 18,1997 t

U.S. Nuclear Regulatory Commission  !

Washington, D.C. 20555 l Attn: Document Control Desk  ;

Subject:

Request for Adjustment of Facility Operating License No. R-37 for the Massachusetts  :

Institute of Technology Research Reactor (MITR); Docket No. 50-20.

Gentlemen:

On 22 March 1997, the Commonwealth of Massachusetts is scheduled to become an NRC-approved Agreement State. Under that arrangement, nuclear reactor facilities will continue to be regulated by the U.S. Nuclear Regulatory Commission. However, other activities, such as those governed by medical use licenses now held by hospitals will be regulated by the State. This creates an administrative issue for the Massachusetts Institute of Technology Research Reactor (MITR) because our program on neutron capture therapy involves participation by both MIT and affiliated hospitals. Provision No. 6.5 of Facility Operating License No. R-37 concerns this program. That provision is entitled, " Generation of Medical Therapy Facility Beam for Human Therapy." The purpose of this request is to modify provision no. 6.5 so that the government-imposed transition from NRC regulation to State regulation of medical use licensees will not cause any dismption of our on-going research program. That program is currently in human trials and it would be desirable that administrative issues not be allowed to cause a disruption.

A potential problem is that language is present in several of the provisions of MITR Technical Specification No. 6.5 and its associated Quality Management Program that limits patient referrals to the MITR to "NRC medical use licensees that have been authorized by NRC to utilize j i the MIT Research Reactor's Medical Therapy Facility for neutron capture therapy." It is proposed iI .

to amend this language to read "either NRC-approved or Agreement State-approved medical use  !

licensees that have been authorized by either NRC or an Agreement State to utilize the MIT g; Research Reactor's Medical Therapy Facility for neutron capture therapy." The rationale for this request is as follows:

k< l (i) Provision No. 6.5 to Facility Operating License No. R-37 was originally submitted to NRC on 10 March 1992. It was issued in final form on 10 February 1993. At that time, therc was no discussion (or at least no public discussion) of the intent of the Commonwealth of Massachusetts to become an Agreement State. That eventuality was simply not foreseen. Accordingly, the limitation of patient referrals to NRC approved >

medical use licensees was an oversight.

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Page 2 (ii). The neutron capture therapy program is in place and functional at the MITR and at two NRC-approved medical use licensees, both in Massachusetts. The request submitted

- herein is purely administrative. No substantive changes of any type will result.

Enclosed is a copy of MITR Technical Specification No. 6.5 and its associated Quality Management Program. The modified language is denoted by margin marks. Your earliest approval of this request would be most appreciated. Please refer any questions to the undersigned.

This request has been approved by the MIT Reactor Safeguards Committee.

Sincerely,

,w 4' ohn A. Bernard, Ph.D.

Director -

MIT Nuclear Reactor Laboratory JAB /CRM cc: USNRC - Region I- Project Scientist Radiation Safety Branch USNRC - Region I- Senior Project Manager Nuclear Power Reactor and Decommissioning Projects Directorate i

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6.5 Generation of Medical Therapy Facility Beam for Human Theraov 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 are only required if human therapy is planned for the interval of the surveillance. However,in the event 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 r

, To provide for the protection of the public health and safety by ensuring that patients are 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.

Sneci6 cation

1. Patients accepted for treatment shall have been referred by written directive from a physician authorized user of either an NRC-approved or an Agreement State-approved rnedical use licensee that has been authorized by either NRC or an j Agreement State to utilize the MIT Research Reactor's Medical Therapy Facility beam ,

I for neutron capture therapy for humans.

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

of the therapy and the medical physicists from the NRC-licensed or Agreement State- 1 licensed medical center. The Massachusetts Institute of Technology is only l

responsible for providing current and accurate beam characteristic parameters to the j l

medical use licensee and for delivery of the desired radiation fluence as requested m 1 tiie written directive. Before the start of a therapy, both the certified medical physicist and the Director of the Nuclear Reactor Laboratory, or his designate, must agree that the therapy can be initiated. The physician authorized user is responsible ,

l for monitoring the therapy and for directing its termination. However, a radiation )

l Amendment No. 27 l 6-21

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therapy can also be terminated at any time if either the physician authorized user 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 in the medical therapy facility area. In the event that the medical facility 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 provision. Use of this temporary provision is limited to seven consecutive working days.

4. Access to the medical therapy facility shall be controlled by means of the shield door located at its entrance.

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

(a) An interlock shall prevent opening of the shutters that control beam delivery unless the medical therapy facility's shield door is closed.

(b) The shutters that control beam delivuy shall be interlocked to close automatically 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 either electric power or on low air pressure if the shutter is operated pneumatically.

(d) Shutters that control beam delivery and that are normally pneumatically-operated shall, in addition, be designed for manual closure.

(e) It shall be possible to close the shutters that control beam delivery from within the medical therapy facility.

6. Each of the shutters that controls beam delivery shall be equipped with a light that indicates the status of the shutter. These lights shall be visible at the medical therapy facility's local control panel. In the event of a status light malfunction, it shall be acceptable to use the affected shutter provided that an alternate means of verifying position is available. Use of this alternate means of shutter position verification is limited to seven consecutive working days.

Amendment No. 27 6-22

7. The medical therapy facility shall be equipped with a monitor that provides a visual indication of the radiation level within the facility, that indicates both within the facility and at the local control panel, and that provides an audible alarm both within the facility 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 somce on the calendar day of and prior to any patient irradiation.

i (c) This rr.Jiation 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 medical therapy 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 alarm shall be interlocked so that they become functional upon opening of the medical therapy facility's shield door.

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

The latter is for the monitoring of patients.

9. It shall be possible for personnel monitoring a patient to open the medical therapy facility's shield door manually.

Amendment No. 27 6-23

10. It shall be possible to observe the patient through 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 fail during the irradiation, the treatment may be continued at the discretion of the physician authorized user. Adequate lighting to permit such viewing shall be assured by the provision of emergency lighting.

I 1. 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%. The treatment 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 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.

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

Interlock or Channel Surveillance a) Medical therapy facility minor scram Scram test b) Shutters will not open unless Operational test shield door is closed c) Shutters close upon both manual and Operational test i automatic opening of shield door d) Shutters close on loss of electrical Operational test power and reduction of pressure in pneumatic operators,if applicable c) Manual closure of pneumatic shutters Operational test Amendment No. 27 6-24

f) Shutters can be closed manually Operational test from within the facility g) Shutter status lights Operational test h) Radiation monitor alarm Operational test i) Radiation monitor and/or alarm Operational test enabled upon opening of shield door j) Intercoms Operational test in addition to the above, the medical therapy facility minor 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 medical therapy facility'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 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 beam design has been replaced. Finally, a calibration and a functional check shall be performed prior to any patient irradiation in the 1 event of a design modification.

b) A characterization of the beam shall be performed every six months for any six-1 month interval that the beam will be used for human therapy. This six-month '

characterization shall be made prior to any patient irradiation for a given six-

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month 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 proper response of the beam monitors that are described in provision iI of this specification shall be verified.

Amendment No. 27 6-25 j

c) A caiibration of the beam monitors that are described in provision 11 of this i 1

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 f I

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 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 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 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:

(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 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 tuming 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 Amendment No. 27 6-26

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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), 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 th; 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 repons will be made to the Regional Administrator, Region I, or his designate. The 15 day written reports will be sent to the NRC Document Control Desk with a copy to the Regional Administrator, Region I, or his designate.

I8. The requirements of the Quality Management Program (QMP) for the Generation of Medical Therapy Facility Beam for Human Therapy at the Massachusetts Institute of Technology Research Reactor shall be observed for any human therapy. (Note 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 MITR Technical Specifications.)

Amendment No. 27 6-27

Definitions l.

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 water shutters as described in Reference 6.5-1. The heavy water blister tank, which is also described in Reference 6.5-1, is an example of the latter. It is conceivable that these designations may 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 that 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 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 beam has not changed in a significant way (e.g., energy spectmm or intensity) from the beam that was characterized.

3. The term ' functional check of the beam monitors'shall consist of verifying that system output is consistent (i 10%) with previously measured values upon normalization to a common reactor neutronic power level.

4. The term ' characterization' refers to the process 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 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 l l

ray components are determined in a characterization and monitors are normalized by 1

this characterization.

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5. The term ' calibration of the beam monitors' refers to the process whereby 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  :

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

6. The term ' 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, thermal 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.

7. The term ' radiation fluence' means the total fluence of neutrons and gamma 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.

8. The term ' recordable 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 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; or (c) A treatment delivery for which the administered radiation fluence for any given fraction is 15% greater than prescribed.

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

(a) Involving the wrong patient, wrong mode of treatment, or wrong treatment site; or Amendment No. 27 6-29

(b) When the treatment delivery is not in accordance with provision i1 of this specification.

10. The term ' written directive' means an order in writing for a specific patient, dated and signed by a physician authorized user prior to the administration of radiation and which specifies the treatment site, the total radiation fluence, radiation fluence per fraction, and overall treatment period.

I 1. 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 ' physician authorized user' means a medical physician approved for neutron capture therapy by either an NRC or an Agreement State-approved medical l f

use licensee.

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 beam capture therapy.

Basis The stipulation that patients only be accepted from a medical use licensee that has been authorized either by NRC or by an Agreement State to utilize the MIT Research Reactor's Medical Therapy Facility beam for human therapy, ensures that medical criteria imposed by NRC or by the Agreement State en such licensees for the use of the MIT Research Reactor's medical therapy facility beam for human therapy will be fulfilled. The second provision delineates the division of responsibilities between the Massachusetts Institute of Techrology and the medical licensee that refers the patient. Also,it establishes administrative authority and protocol for initiating and terminating a radiation therapy. ,

1 The requirement that it be possible to initiate a minor 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 l l

Amendment No. 27 6-30 1

. I 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 shutters that control 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 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 radiation levels in the medical therapy facility prior to entry. The purpose 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.

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. The presence of the viewing window and a closed-circuit TV camera 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 for a thuapy (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 Buence above which NRC has to be notified of a misadministration. The 20% criterion is l I

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 consecutive days is set at 30%. This is also in accordance with the definition of i 1

Amendment No. 27 6-31 )

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misadministration (clause 4(iii)) as given in 10 CFR 35.2. Finally, if a treatment involves

' hree t or fewer fractions, then a more stringent criterion,10%, appines 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 checks and characterizations provide a mechanism for ensuring that the medical therapy facility and its  !

beam will perform as originally designed. Similarly, the surveillance requirements on the beam monitors ensure that these instruments are calibrated by a means traceable to the National Institute of Standards and Technology. The chambers specified (tissue-equivalent, and graphite or magnesium wall) were chosen because they measure dose as opposed to fluence.

The specification on maintenance and repair of the medical therapy facility ensures that all such activities are performed under the supervision of peconnel 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.) Alsc, this provision provides for the posting of instmctions to be followed in the event of an abnormality. i 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 provided by the medical therapy facility beam will be administered as directed by 3 the physician authorized user.

Amendment No. 27 6-32

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

J 6.5-2 Choi, R.J., " Development and Characterization of an Epithermal Beam for Boron j t

Neutron Capture Therapy at the MITR-Il Research Reactor," Ph.D. Thesis, Nuclear .j t

Engineering Department, Massachusetts Institute of Technology, April 1991.

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1 Ouality Manacement Procram: Generation of MITR-ll Medical Theracy Facihty Bnm 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-II) Medical Therapy Facility beam will be administered as directed by a physician authorized user.

2. Authorized Medical Use Licensees: Use of the MIT Research Reactor's Medical Therapy Facility beam, for the treatment of human subjects, is limited to the physician authorized users authorized under:

(a) Any medical use licensee that has been authorized by NRC to utilize the MIT Research Reactor's Medical Therapy Facility beam for human therapy.

(b) Any medical use licensee that has been authorized by an NRC-approved Agreement State to utilize the MIT Research Reactor's Medical Therapy Facility beam for human therapy.

3. Procram 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 physician authorized user of either the NRC- or Agreement State-approved medical use licensee prior to the administration of any radiation therapy. This directive shall be written, signed, and dated by the physician authorized user and it shall include the following information:

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

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

(iii) 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 wouldjeopardize 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 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 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.

g 2-J (v) In order to ensure that the Staff of the MIT Research Reactor has be 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 Director of the MIT Nuclear Reactor Laboratory, or his designate, will date and sign the written directive to verify that current and accurate beam characteristic parameters were provided to the NRC-approved or Agreement State-approved 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 Mi t' Nuclear Reactor Laboratory will use any two or more of the following acceptable methods ofidentification:

(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." l (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. This information will then be used by personnel at either the NRC- or the Agreement State-approved 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 MITR Technical Specification #6.5, " Generation of Medical Therapy Facility Beam for Human Therapy." The beam is characterized dosimetrically every six months (provision 14(b)), the beam monitors are calibrated every two years by a secondary calibration laboratory and their proper operation is verified semi-annually (provision 14(c)), and calibration checks are made of the beam at least weekly for any week that the beam will i be used for human therapy (provision 14(a)).

• • , 3-(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 Beam for Human Therapy."

(e) Any unintended deviations from the written directive shall be identified and evaluated, and appropriate action taken. Such action shallinclude 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 fluence, fluence per fraction, treatment site, and overall treatment period were as specified in the 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 revised procedures, additional training, increased supervisory review of work, or other measures as deemed appropriate.

Corrective actions shall be implemented as soon as practicable.

4. Erogram Implementation: The 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. 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 pur)oses of this review, the term

' representative' in statement (i) above is cefined as 100% sampling up to twenty patients; a sample of twenty for twenty-one to one hundred patients, and 20% sampling for more than one hundred patients. In order to eiiminate any bias in the sample, the patient cases to be reviewed should be 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 his designate.

(ii) The review shall be performed annually.

(iii) Patient administrations selected for review shall be audited to l determine compliance with each of the requirements listed in 1 paragraph (3) above. )

1 (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 l will evaluate each review and, if required, recommend modifications I in this quality management program to meet the requirements of paragraph (3) above. A copy of these reviews will als' be provided to each medical use licensee.

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

t (d) The licensee (MIT) shall reevaluate the Quality Management Program's policies and procedures after each annual review to determine whether the program is still effective or to identify actions required to make the program  ;

more effective.

5. Response to Recordable Event: Within thirty days after the discovery of a recordable event, the event shall be evaluated and a response made that includes:

(a) Assembling the relevant facts, including the cause; l (b) Identifying what, if any, corrective action is required to prevent recurrence; and  ;

i (c) Retaining a record, in an auditable form, for three years, of the relevant facts and what corrective action,if any, was taken.  ;

, A copy of any rt.cordable event shall be provided to the affected medical use  !

licensee.  ;

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

i (a) Each written directive for three years; and (b) A record of each administered radiation therapy where a written directive is ,

i required in paragraph (3(a)) above, in an auditable form, for three years

after the date of administration.

7. Procram Modification: Modifications may be made to this quality management  ;

i program to increase the program's efficiency provided that the program's  !

effectiveness is not decreased. All medical use licensees shall be notified of any modifications and provided with a copy of the revised program. The licensee (MIT) shall furnish the modification to the NRC (Region I) within 30 days after the  ;

modification has been made.

8. Report and Surveillance Frecuency: Any report or other function that is required j to be performed in this Qur.lity Management Program at a specified frequency shall  ;

be performed within the specified time interval with:

(a) a maximum allowable extension not to exceed 25% of the specified  ;

surveillance interval, unless otherwise stated in this Quality Management Program; ,

l (b) a total maximum combined interval time for any three consecutive surveillance intervals not to exceed 3.25 times the specified surveillance interval. l

9. Definitions:

(a) The term ' physician authorized user' means a medical physician approved for neutron capture therapy by either an NRC- or an Agreement State-approved medical use licensee.

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's, (b) 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 }

dosimety and neutron beam capture therapy.

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10. Applicability: This Quality Management Program applies solely to the generation of the medical therapy facility beam for the treatment of human subjects. It does not apply to any other use of the medical therapy facility and/or its beam. Reports and surveillances listed in this specification are only required if human therapy was conducted during the referenced interval.

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