ML20113H727
| ML20113H727 | |
| Person / Time | |
|---|---|
| Site: | MIT Nuclear Research Reactor |
| Issue date: | 03/06/1992 |
| From: | MASSACHUSETTS INSTITUTE OF TECHNOLOGY, CAMBRIDGE |
| To: | |
| Shared Package | |
| ML20113H722 | List: |
| References | |
| PROC-920306, NUDOCS 9208050213 | |
| Download: ML20113H727 (5) | |
Text
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1 Quality Management Program
, for Generation of Medical Therapy Facility Beam for Human Therapy !
at the Massachusetts Institute of Technology Research Reactor SR#-0-92 3 MAR Ua 1992 4
78AS188!R8!888820 P PDR l
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Ouality Mnnacement Procnun: Generation of MITR-Il Medical Therapy Facility lleam fpWuman Therapy
- 1. L'prpose: The objective of this quality management program is to ensure that radiation treatments provided by the MIT Research Rea: tor's (MITR.II) Medical Therapy Facility beam will be administered as directed by an authorized user.
- 2. Authorized Medient 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) NRC Medical Use Licensee No. 20-03857 06.
(b) Any other medical use licensec that has been similarly authorized by NRC to utilize the MIT Research Reactor's Medical Therapy Facility beam for human therapy.
- 3. Pro 2 ram Requirements: The following rc41uirements are established as part of this qua ity management program:
(a) A written directive will, except as noted in subparagraph (iv) below, be prepared by an authorized medical use licensee prior to the administration of any radiation therapy. Thu dir:ctive shall include the following infonnation:
(i) Name and other means of identifying the patient.
(ii) Name of the licensed physician and certined medical physicist in charge of the therapy.
I (iii) The total radiation fluence to be administered, the radiation fluence !
I per fraction, the treatment site, and the overall treatment period.
(iv) If, because of the patient's condition, a celey in order to provide a ,
written revision to an exist ing written directive would jeopardize the latient's health, an oral revision to an existing written directive will
>e acceptable, provided the oral revision is documented immediately in the patient's record and a revised written directive is signed by an authonzed 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 fc,r any diagnostic or therapeutic procedure provided that the revision is dated and signed by an authodzed user prior to the administration of the next fractio.i.
If, because of the emergent nature of the patient's condition, a delay '-
in order to provide a writtea directive would jeopardire the patient's health, an oral directive will be acceptable, provided that the information containeJ 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.
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(v) In order to ensure that the Staff of the MIT Research !
Reactor has the most recent written directin from the !
medical use licensee and the correct directive for the i 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. l 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 l initiation of patient irradiation. '
(b) Prior to each administration of any radiation, the patin:nt's identity will be verified by more than one method as the inclividual named in the written directive. Acceptable methods ofidentification incle'ie, but are not limited to:
(i) Self identification by patients who are conscious upon arrival at the MIT Research Reactor. Infonnation provided shallinclude name, address, date of birth, and social security number.
(ii) llospital wrist band identincation.
(iii) Visual identification against photographs provided with the written directive.
(iv) - Ider? ation by attending medical personnel.
(v) Other methods as specified in U.S. Nuclear Regulatory Commission Regulatory Guide 8.33, " Quality Management Program."
(c) The patient treatment plan is curtified by the 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 is then used by the l
1edical physicist, together with the radiation oncologist, to generate the patient treatment plan. 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 lleam for iluman Therapy." The beam is characterized dosimetrically every six months (provision 14), the beam monitors are calibrated every two years by a secondary calibration laboratory and their proper operation is verified semi annually (provision 19), 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).
(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 llearn for lluman Therapy."
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l (c) Any unintendt ' deviations from the written directive shall be identified and evaluated, rnd appropriate action taken. Such action shall include informing the medical use licensee of the deviation. For each patient case reviewed, it shall be determined whether the administered total dose, dose per fraction, treatment site, aod overall treatment period were as specified in the written directive. in the event of any deviatien from the written directive, the licensee 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. Procram implementation: The following practicos shall be observed in order to ensure proper implementation of the quality management program:
(a) A revieve shall be conducted of the quality management program. 'lWs review shall include, since the last review, an evaluation of:
(i) A representative sample of patient adminisuations, (ii) All recordable events, and (iii) All misadministrations.
' ae objective of this review is to verify compliance with all aspects of the quality management program. For purposes of this review, the term l- ' representative' in statement (1) above is defined as 100 %
l sampling up to tv;enty 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 Prote " inn Program or his designate.
(ii) The review shall be i erfomied 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 Reacmr Safeguards Committee who will evaluate each review and, if required, recommend modifications m this quality management program to meet the requirements of paragraph (3) above. A copy of these reviews will also be prmided to each menical use licensee.
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1 (c) Records of each review, including the evaluations and findings of the review, shall be retained in an auditable form for dirce yavs.
(d) The licensee shall reevaluate the Quality Management Program's policies and procedures after each annual review to determine whether the program is still e rf ective or to identify actions required to me.ke the program more effective.
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- 5. Resoonse to Recordable Event: Within thirty days after the discovery of a I 1
recordable event, the event shall be evaluated and a response made that includes:
(a) Assembling the relevant facts, including the cause; (b) Identifying what,if any, corrective action is required to prevent recurrence; ar,d (c) Retaining a record, in an auditsble form, for three years, of the relevet facts and what corrective action,ilany, was taken.
~ A copy of any recordable event shall be provided to the affected medical use lleensee.
- 6. Records Retention: The following records shall be retained:
(a) Each written directive for three years; and to) 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 I program to increase the program's efficiency provided that the program's effectiveness is not decreased. All medical use licensees shall he notified of- any modifications and provided with a copy of the revisco program. The licensee shall furnish the modification to the NRC (Region 1) within 30 days after the modification has been made.
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