ML20126M579
| ML20126M579 | |
| Person / Time | |
|---|---|
| Site: | MIT Nuclear Research Reactor |
| Issue date: | 12/30/1992 |
| From: | MASSACHUSETTS INSTITUTE OF TECHNOLOGY, CAMBRIDGE |
| To: | |
| Shared Package | |
| ML20126M565 | List: |
| References | |
| PROC-921230, NUDOCS 9301110043 | |
| Download: ML20126M579 (6) | |
Text
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Ouality Management Program' I
for
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Generation of MITR-II Medical Therapy Facility Beam t
for Human Therapy 9301120043 921230 p DR -ADOCK 03000o2o
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1 Ounlity Management Program: Generation of MITR-II MedicalJherany Facility 13 cam 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 Pacility 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. 20-03857 06.
(b) Any other medical use licensee diat has been similarly authorized by NRC to utilize the MIT Research Reactor's Medical Therapy Facility beam for human therapy.
- 3. Program Reauirements: The following requirements are established as pan of this quality management program:
(a) A written directive will, except as noted in subparagraph (iv) below, be
>repated by a physician atahorized user of the NRC-approved medical use icensee prior to th: 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:
1 (i) Name and other means ofidentifying the patient.
(ii) Name of the physician authori:cd 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 would jeopardize the patient's health, an oial 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 provioed 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 houca 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 a
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correct directive for the patient in question, a copy of that directive !
shall be hand delivered to the MfrR Str.ff by the Staff of the medical use licensee who accom)any the patient to MIT. This copy shall !
then be checked against tie 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 areprovided to the NRC approved medical use liccusee and that the radiation fluence desired in the written directive was delivered. A copy of tids signed directive shall be provided to the medical use licensee within ;
twentyfour hours ofa 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 thefollowing acceptable mellwds ofident(fIcation: ,
(i) Self identification by patients who are conscious upon arrival at the MIT Research Reactor. Information provided shallinclude name, address, date of birth, and social security number. The social.
security rmmber is to be compared to the corresponding Irformation in the patient's record.
(ii) llospital wrist band identification with the wrist band Ir/ormation to be compared to the corresponding irformation in the patient's record. >
(iii) Visual identification against photographs provided with the written directive.
(iv) Other methods as specified in U.S. Nucleir 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 -
1 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 the NRC-approved medical use licensee 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 Iluman 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 liuman Therapy."
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-.3 (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 shallbe performe:f monthlyfor any month in which hwnan 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. Program Imnlementation: 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) Ali 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 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. l (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 in this quality management program to meet the requirements of .
" paragraph (3) above. A copy of these reviews will also be provided to each medical use licensee.
(c) Records of each review, including the evaluations and findings of the review, shall be retained in an auditable form for three years.
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4 (d) The licensee (Af/T) 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 t nore effective.
- 5. Resnonse to Recordable Event: Within thirty days after the discovery of a trcordable event, the event shall be evaluated and a response made that includes:
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(a) Assembling the relevant facts, including the cause; (b) Identifying what, if any, corrective action is required to prevent recurrence; and :
(c) Retaining a record, in an auditable form, for three years, of the relevant facts and what corrective action,if any, was taken.
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 record of each administered radiation therapy where a written directive is required in paragraph (3(a)) above, in an auditable form, for three years after the date of administration.
- 7. Program Modification: Modifications may be made to this quality management 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 *
(Af/T) shall furnish the modification to the NRC (Region I) within 30 days after the modification has been made.
- 8. Report and Surveillance Freauencv: Any report or otherfunction that is required to be performed in this Quality Aianagement Program at a specifiedfrequency shall .
be performed within the specified time interval with:
(a) a maximum allowable extension not to exceed 2S% of the specified surveillance inten al, unless otherwise stated in this Quality hianagement >
Program; (b) a total maximum combined interval time for any three consecutive surveillance intervals not to exceed 3.25 times thispecified surveillance =
interval.
- 9. Definitions:
(a) The term ' physician authorized user'means a medicalphysician approved for neutron capture therapy by an NRC-approved medical use licensee. ,
(b) . The term
- certified medicalphysicist' means a medicalphysicist cert {fied in =
cither radiologicalphysics or therapeutic radiation physics by the American Board of Radiology, or in therapeutic radiation physics by the American . .
- Board of Afedical Physics and who also has specific training in neutron dosimetry ami neutron beam capture therapy.
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-Ib. Applicability: l'his Quality blanagernent Prograrn applies solely to the generation of the snedical therapyfacility bearnfor the treahnent of hurnan subjects. It does not apply to any other use of the snedical therapyfacility and/or its beam. Reports and surveillances listed in this specification are only required if haunan therapy was conducted during the referenced interval.
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