ML20128P437

Safety Evaluation Supporting Amend 27 to License R-37

ML20128P437
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Site:	MIT Nuclear Research Reactor
Issue date:	02/16/1993
From:	Office of Nuclear Reactor Regulation
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NUDOCS 9302240300
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SAFETY EVALUal10N BY THE OFFICE OF NUCLEAR REACTOR REGULATION IllPPORTING AMENDMENT NO. 27 TO

[ACILITY OPERATING LICENSE NO. R-37 DOCKET NO. 50-20 MASSACHUSETTS INSTITUTE OF TECHNOLOGY 1.0 BTRODUCTION By letter dated March 10, 1992, as supplemented on July 30, 1992, August 31, 1992, September 23, 1992, December 22, 1992, December 30, 1992, and January 22, 1993, the Massachusetts Institute of Technology (MIT) requested '.

changes to the Technical Specifications (TS) of Facility Operating License No. R-37 for the MIT Research Reactor (MITR-II). The requested changes would add requirements to the TS concerning the use of the MITR-II Medical Therapy beam (beam) for human therapy.

2.0 BACKGROVND The Atomic Energy Act of 1954, as amended (the Act) authorizes the issuance of class 104 licenses for medical therapy (Section 104(a) of the Act) and for research and development facilitics (Section 104(c) of the Act). All non-power reactors (NPRs) currently licensed by the U. S. Nuclear Regulatory Commission (NRC or the Cocnission) hold class 104c licentes in <ccordance with 10 CFR 50.21(c). MIT also holds a 104a license in accordance with 10 CFR 50.2)(a). MIT is the only NPR licensee to hold a 104a license. This license was issued in 1958 when the original MIT reactor was licensed by the Atomic Energy Commission.

A potential medical therapy use for NPRs that was identified in the 1950s is the use of neutron beams to treat the cancers glioblastoma multiform and metastasized melanoma. Called Boron Neutron Capture Therapy (BNCT), the treatment consists of a patient ingesting a boron compound that concentrates boron in the tumors. The patient is then exposed to a neutron beam from the NPR which causes the boron to fission into lithium and an alpha particle, which are heavy charged particles. These particles cause secondary ionization that kills the tumor cells.

MIT conducted patient trials during 1960-1962 with no success. Apparently, the boron drugs available at that time did not concentrate enough boron in the tumor and the use of thermal neutron beams did not allow neutrons to reach deep enough into the brain for successful treatment.

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Since those early trials, improved boron compounds have been developed that are thought to increase concentrations of boron in the cancer cells. Also, MIT has focused on the use of an epithermal neutron beam that will allow neutrons to reach any part of the brain. These two developments have. led researchers to believe that another attempt should be made to treat cancers using BNCT.

In letters to the NRC staff dated April 3, April 16, and June 6,1991, MIT outlined the current >ro)osed practice and procedures for using neutron beams in patient therapy, tie .11 story of the 1960-1962 patient trials, and historical information on the procedures for the medical beam therapy facility at MIT. MIT also expressed the opinion that they satisfy all NRC regulations concerning the use of neutron beams for the treatment of human subjects. The existing regulations authorize the issuance of licenses for human therapy but places no requirements or restrictions on the irradiation of huiaans with neutron beams from NPRs.

During the thirty years since the MIT patient trials, NRC has issued no other lu a license for NPR medical therapy. Thus, the NRC has not developed regulations for the use of special nuclear material for medical therapy at NPRs. However, regulations for the medical use of byproduct material have been developed in 10 CFR Part 35, " Medical Use of Byproduct Material."

Although 10 CFR Part 35 may be used as a guide to regulate BNCT, it is not directly applicable to BNCT and the use of special nuclear material for human therapy.

The use of neutron beams for medical therapy has many similarities to-teletherapy. Because of this, the NRC staff decided to use the criteria of 10 CFR Part 35, Subpart I, Teletherapy, as a model for the regulation of neutron beams for the treatment of human patients. The requirements of Part 35 were modified to account for the differences between teletherapy and BNCT.

For regulatory purposes, BNC1 is divided into two components: beam generation and beam use. MIT is responsible for the regulatory aspects of beam generation and the hospital providing treatment to the patient is responsible for the regulatory aspects of beam use. A February 19, 1992, letter to MIT from NRC outlined the commitments and information that MIT was requested to submit to NRC. Because no 10 CFR Part 50 regulations that parallel 10 CFR Part 35 exist, the commitments made by MIT for the conduct of human therapy would be captured in the facility Technical Specifications. The license amendment request from MIT evaluated by the staf f in this safety evaluation report (GER) is in response to the February 19, 1992, NRC letter.

3.0 [VALVAT!03 The commitments and information requested by NRC of MIT to be included in the ,

request fer license amendment are as follows:

(1} A commitment to limit the delivery of neutrons only to human subjects pursuant to a written directive from a physician authorized user who is specifically authorized to perform boron neutron capture therapy by NRC medical use licensee No. 20-03857-06 (New Engla-d Medical Center).

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(2) A commitment to record events equivalent to " recordable events' in-10 CFR 35.2, report events equivalent to "misadministrations" in 10 CFR 35.2, and establish a written quality management program using the criteria specified in 10 CFR Part 35 for teletherapy (the neutron j beam). l (3) The methodology to ensure that the neutron flux, fluence, and spectrum delivered to the patient are as requested by the physician authorized ,

user. J (4) The design aspects of the neutron beam delivery system that are important to patient or user safety such that these aspects cannot be  ;

changed without license amendment.

(5) The reactor operator and physician communication system and the method for terminating the treatment exposures.

(6) A list of the anticipated activities that may alter beam characteristics and may require spot-checks before the beam use ar.d the spet-checks that will be performed in these situations.

(7) The interlock systems and safety precautions used to prevent personnel from being accidentally exposed to the beam in the treatment room and the safety precautions to be fnllowed before, during, and after treatment exposures to limit occupational exposure to ionizing radiation. include information on surveillances, if required.

Each of these areas have been addressed by the licensee in their amendment request.

A new section to the TS, Section 6.5, has been proposed by the licensee to place limits and conditions on the generation of a neutron beam for human therapy. These TS will ensure that patients are treated in accordance with the treatment pla, established by tne physician authorized user, that the as low as reasonably achievable (ALARA) princhie is observed for all non-therapeutic radiation exposures, and that tie medical therapy treatment room-design features operate properly.

The licensee is not seeking approval of the details of beam design. Except for the initial facility design, and the review of changes to the facility, experiments, and procedures conducted under 10 CFR 50.59 for the beam and '

submitted to NRC, the NRC staff has not reviewed the specific design of the beam filter system or the gamma and neutron fluxes and energies of the beam.

The ability to place filters in the beam to control beam characteristics is allcwed in the existing license and is not unique to medical therapy. The filter construction and materials must be in accordance with the license and safety analysis report or changes approved under 10 CFR 50.59. The charac-teristics of the beam necessary to conduct treatment are decisions that are medical in nature and are the responsibility of the physician authorized user.

The NRC staff is also reviewing an amendment to the medical use of byproduct material license for New England Medical Center to regulate beam use.

TS 6.5.1 requires that patients be referred by a written directive of the physician authorized user from a medical use licensee authorized by NRC to utilize the MITR-II. TS 6.5.2 clearly defines that treatment is the responsibility of the physician authorized user in charge of the therapy and that delivery of the requested radiation fluence is the responsibility of MIT.

These TS are responsive to item (1) above. ,;

TS 6.5.2 also assigns responsibility to medical and MIT personnel for the initiation, monitoring, and termination of treatment. TS 6.5.10 requires that -

the patient be observed through both a viewing port in the medical therapy facility and by a closed-circuit TV camera. Thergy may continue at the-discretion of the physician Luthorized user if one of the viewing methods fails during the treatment. These TS are responsive to. item (5) above. The staff cencludes that patients will be properly referred for treatment and that the responsibility for the treatment will be properly controlled. This is acceptable to the staff.

TS 6.5.3 recuires that it be possible to initiate a minor scram of the reactor from the mecical therapy room control panel and provides a temporary provision of communicating with the control room operator to scram the reactor if the minor scram button on the medical therapy room control panel is out of service. This temporary measure is limited to seven consecutive working days.

TS 6.5.8 requires that an intercom or other means of two-way communication exist between the medical therapy facility control panel and the control room and between the medical therapy facility control panel and the inside of the therapy room. This will allow the reactor, which is the source of neutrons, to be rapidly shut down h an emergency. These TS are responsive to items (5) and (7) above. The staff concludes that therapy can be rapidly terminated if the need arises. This is acceptable to the staff.

Item (7) above focuses on interlocks and safety precautions to prevent accidental personnel exposure and surveillances on these interlocks. TS 6.5.4, 6.5.5, 6.5.6, and 6.5.9 describe the operation and interlocks on the -

medical therapy facility doors that allow access into the facility and on the shutters that control beam delivery and, when closed, shield the inside of the

medical therapy facility room from the reactor. TS 6.5.4 requires that eccess to the facility be controlled by a shield door- TS 6.5.5 requires that an interlock prevent the shutters from opening unkss the facility shield door is closed. If the shutters are open and the shield door is opened, the shutters.

are interlocked to automatically close. The shutters will also close automatically if electric power fails. If tha shutters are pneumatically powered and air pressure becomes low, the shutters will-automatically close.

The shutters are also designed to be manually closed. TS 6.5.5 also requires that the shutters are able to be closed manually from within the medical therapy facility. TS 6.5.6 requires that the status of the shutters be indicated by lights. A temporary alternate means of indicating shutter position may be used for up to seven consecutive working days if the light system fails. TS 6.5.9 requires that the facil Hy shield door be able to be l opened manually.

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0 TS 6.5.12 and 6.5.13 requires surveillance tests of the above interlocks and the medical therapy facility minor reactor scram. When the facility is in use for human therapy, the surveillances are conducted monthly with the exception of the full opening manual operation of the shield door which is semi-annual.

These surveillances will also be conducted if repairs have occurred or the system has been deenergized. In addition, if the reactor has been shut down for more than sixteen hours, the medical therapy facility minor scram shall be tested.

The staff has determined that these TS requiremenh t1sure that adecuate safety precautions exist to prevent accidental exposure from the mecical therapy facility beam and that surveillances exist to test the interlocks and scram. This is acceptable to the staff.

TS 6.5.7 concerns the requirements for radiation safety and monitoring of the medical therapy facility. This TS is also responsive to item (7) above. The TS requires a radiation monitor in the medical therapy facility with visual readout and local alarm. The primary purpose of this monitor is to warn the MIT staff if the shutters are not properly closed. The TS also encompasses requirements for backup power, checks for proper operation and quarterly calibration. The TS places the monitor setpoint at or below 50 mr/hr. This radiation setpoint is above the radiation levels in the room immediately after termination of treatment, but is low enough to provide warning if the shutters are not properly closed. The licensee has the ability, in accordance with the TS, to disable the monitor during therapy. This will prevent alarming of the monitor during therapy sesslons which would be a distraction to the patient and the treatment staff. If the monitor is disabled, it shall be interlocked to automatically become functional again upon opening of the shield door.

This TS also allows for temporary means of meeting the monitor requirements for up to seven consecutive working days with portable survey meters or audible dosimeters if the monitor is inoperable. Surveillance requirements for quarterly calibration of the radiation monitor are included in the TS.

The staff concludes that the medical therapy facility will be adequately monitored for radiation levels. This is acceptable to the staff.

TS 6.5.11 concerns the accuracy of the radiation fluence delivered by the medical therapy facility beam. This is responsive to item (2) above. The total fluence delivered shall not exceed the prescribed amount by more than 20 percent. There are also criteria for the administered and prescribed fluence not to exceed 30 percent for any given week (seven consecutive days) and a 10 percent criteria if the treatment consists of three or fewer fractions. Recordable events and misadministrations are defined in the definitions section of TS 6.5. TS 5.5.17 has the requirements for maintaining records of recordable events and for reporting misadministrations to the NRC.

Recordable events records shall be maintained for five years. Hisadministra-tions shall be verbally reported to NRC within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> and in writing within 15 days. The definitions of recordable events and misadministrations agree with the definitions given in 10 CFR Part 35 for teletherapy. This section of the is is acceptable to the staff.

TS 6.5.14 has the requirements for calibration checks, characterization, and calibration of the beam monitors for the medical therapy facility beam. The beam is calibration checked and the beam monitors are functional checked weekly when the beam is in use for treatment arior to treatment for that week.

The beam will be characterized every six montis for any six month interval that the beam will be used for human therapy p-lor to patient irradiation for the six month interval. If beam design modification occurs, the beam shall be calibration checked, functional checked, and characterized before patients are irradiated. In addition, a calibration check will be performed in the event of a beam component replacement.

The beam shall be calibrated sgainst dose measuring instruments that have been calibrated by a secondary laboratory at least once every two years for any two year interval that the beam will be used for human thera)y prior to patient irradiation for the two year interval. Calibration chects, characterization, functional checks, and calibration are defined in the definition section of-TS 6.5. These provisions of the TS are responsive to items (3 and (6) above and will ensure that the beam characteristics remain stable ove)r time.

The staff has dctermined that the calibrations, beam characterizations, functional checks, and calibration checks required by the TS are acceptable.

TS 5.6.15 controls maintenance, repair, and modification of the medical therapy facility. These changes to the facility will be made under the direction of an NRC licensed senior reactor operator. The TS confinns that changes to the facility will be reviewed pursuant to 10 CFR 50.59. The TS also states that certain items such as 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 the purposes of maintenance, repair or. modification.

These are the responsibility of the medical provider. However, MIT is responsible for the radiation safety aspects (activation and/or contamination control) of this equipment.

This TS responds to item (4) above. The staff concludes that maintenance, repair, and modification of the medical therapy facility will be adequately controlled, the NRC will be involved at the appropriate times through compliance with 10 CFR 50.59, and that MIT will be responsible for radiation safety of equipment in the medical therapy facility. The staff finds this TS to be acceptable.

TS 5.6.16 has the requirements for the training of personnel who are not .

reactor operators but who are responsible for medical therapy, beam design, or construction and/or modification of the beam. Instructions shall be provided to ensure that only the pat,ent is in the therapy facility prior-to the initialization of treatment, and for the steps to be taken if abnormal conditions occur or if the medical therapy facility controls fnil to turn off the beam. Training records will be maintained for three years or in accordance with the reactor training program, and a list of qualified personnel will be maintained in the reactor control room. There is a

requirement that, except in emergences, manipulating shuttert that could affect 'he reactivity of the reactor must be authorized in advance by the reactor console operator.

The staff has determined that personnel that operate the medical therapy .

facility will be )roperly trained in the use of the facility and that except in emergencies, tie reactivity of the reactor will only be manipulated witn ,

the permission of the control room operator. .

TS 5.6.18 requires that the Quality Management Program (QMP) for the Generation of Medical Therapy facility Beam for Human Therapy at the Massachusetts Institute of Technology Research Reactor (Attachment 1) be observed for human therapy. The program parallels the requirements of 10 CFR 35.32, Quality Management Program. The program meets objectives similar to-those of 10 CFR 35.32 for having a written direttive prior to administration of treatment, for verification of the patient's identity by more than one method prior to treatment, that the treatment plan and related calculations are in accordance with the written directive, that the treatment is in accordance with the written directive, that unintended deviations from the written directive are identified and evaluated, and that appropriate action is taken.

Although the QMP is a requirement of the TS, the QMP is not part of the TS and may be changed by the licensee without license amendment. The requirements for QMP modifications are given in the QMP.

The licensee will develop written procedures for the conduct of therapy and will provide them to the NRC at least thirty days prior to the start of human irradiations, lhe staff has reviewed the QMP and finds that there is assurance that the objectives discussed above will be met by HIT. This section of the is is acceptable to the staff.

TS 7.13.5 on reporting requirements is amended to add a requirement that a summary of the use of the medical therapy facility for human therapy be included in the annual report of the MITR-II. The staff finds this addition to the annual report tc be acceptable.

3.0 [NVIRONMENTAL CONSIDERATION This amendment involves changes in the installation or use of facility-components located within the restricted area as defined in 10 CFR Part 20 and changes in inspe: tion and surveillance requfrcments. The staff has determined that the amendment involves no significant increase in the amounts, and no significant change in the types, of any effluents that may be released offsite, and there is no significant increase in individual or cumulative

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,. occupational radiation exposure. Accordingly, this amendment meets the-eligibility criteria for categorical exclusion set forth-in 10 CFR- I St.22(c)(9).-

or environmental assessment need be a pre (p) red in connection-wit) the issuancePursuant to 1 of this amendment.

4.0 CONCLUSION

The staff has concluded that there is assurance that the use of the MIT. -i medical therapy facility and beam for human therapy will be in accordance with '

the treatment-plan established by the physician authorized user, that non-therapeutic. radiation exposures will be ALARA, and that the medical therapy f acility will function as designed.

The staff has also concluded, based on the considerations discussed above, that: (1 probabil)ity or consequences of reactor. accidents previously; evaluated, or create the possibility of a new or different kind of reactor accident from any reactor accident previously evaluated. and does not involve a significant-reduction in a margin of safety,- the amendment does not involve a significant_

reactor hazards consideration, (2)-there is reasonable assurance that the health and safety of the public will not be endangered by.the proposed . . ,

activities, and '

Commission's regu(3) lationssuch and the activities issuance willof-this be conducted amendment in compliance will not be with the:

inimical to the common defense and security or the; health and safety of the.

public. _

Principal contributors: - Alexander Adams, Jr.

Donna-Beth Howe >

James A. Smith

Attachment:

As stated Date: February 16, 1993

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Quality Management Pro. gram l for Generation of MITR-II Medical Therapy Facility Beam l

for Human Therapy l

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ATTAOMNT 1

1 Quality Management Pmernm: Generation of MrrR II Medical *Iherapy Facility B. gam ,

for Iluman Therapv

l. Eurpose: The objective of this quality management program is to ensure that radiation treatments provided by the MIT Research Reactor's (MITR II) hiedical 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 authonzed users authorized under:

(a) NRC Medical Use Licensee No. 204)3857-06.

(b) Any other medical use licensee that has been similarly authorized by NRC to utilize the MIT Research Reactor's Medical Therapy Facility beam for  ;

human therapy. i

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

tu) A written directive will, except as noted in subparagraph (iv) below, be prepared by a physician authorized user of the NRC approved medical use  :

licensee pnor 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 infomution:

(i) Name and other means ofidentifying the patient.

(ii) Name of the physician authorized user and certified rnedical 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 would jeopardize the

,atient's health, an oral revision to an existing wriaen directive will x acceptable, provided the oral revision is document:d 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.

(v) In order to ensure that the Staff of the MIT Researth Reactor has the most recent written directive from the medical use licensee and the

correct dirstive 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 i then be checked against tie most recent previous transmission. Any i discrepancy shall be resolved by the medical use licensee prior to the initianon 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 pmvided to the NRC approved medical use licensee 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 Rcactor Laboratory will use any two or more of the following acceptable methods ofid:ntification:

(i) Self identification by patients who are comeious upon arrival at the MIT Rescaich Reactor. Information provided by the patient shall include any two of the following: name, address, date of binh, 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 wTitten directive.

(iv) Other methods as sxcified in U.S. Nuclear Regulatory Commission Regulatory Guide E.33, " Quality Management Program."

(c) The plan of treatment is certified by the cenified 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 y central axis dose versus depth profile. This information will t:1en be used -

by personnel at the NRC-approved medical use licensee to generate a plan of ticatment. 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 be used for human therapy (provision 14(a)).

(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."

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(e) Any unintended deviations from the written directive shall be identified and

' evaluated, and appropriate action taken. Such action shallintlude informing i

the medical use licensee of the deviation. Rese 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 t eatment 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. Rese actions may include new or revised policies, new or : .ted procedures, additional training, increased i

' supervisory review of work, or other measures as deemed appropriate, Corrective actions shall be implemented as soon as practicable.

i 4. Procram 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. His review shall include, since the last Irview, an evaluation of:

i (i) A representative sample of patient administrations, )

(ii) All recordable events, r.nd (ni) All misadministrations.

The objective of th's 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 c efimed 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 eliminate 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 determine compliance with each of the requirements listed in paragraph (3) above.

(iv) ne review shall be wntten and any items that requite further action '

shall be so designated. Copies of the review shall be pmvided to the NRL Director and to the MIT Reactor Safeguards Committee who will evaluate each review and,if required, recommend modifications in this quality mana paragraph (3) above.gement program A copy of these reviewsto willmeet theprovided also be requirements of to each medical use licensee.

(c) Records of each review, inch'iing the evaluations and findings of the review, shall be retained in an c ditable form for three years.

, 4 (d) The licensee (Mir) 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 progarn more effective.

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

(a) Assembling the relevant facts, including the cause; (b) Identifyir.g what, if any, corrective action is required to prevent recunence; and (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 recordable event shall be provided to the affected medical use licensee.

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

(a) Each written directive for three years; and (b) A recced of each administered radiation therapy where a written directive is required in puagraph (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 managemem program to increase the program's efficiency provided that the prograrr's effectiveness is not decreased. All medical use licensees shall be notined of uy modifications and provided with a copy of the revised program. The liccasce (MIT) shall furnish the rr.odification to the NRC (Region I) within 30 days after the modification has been made.

8. Report and Surveillance Frequenev: Any repon or other function that is required to be performed in this Quality Management Program at a specified frequency shall

- be performed within the specified time interval with:

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

9. Definitions:

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

(b) The term 'cenified medical physicist' means a medical physicist certified in either radiolocical physics or therapeutic radiation physier 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.

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10. Anglicability: This Quality Management Program app!'ics 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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