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/)$bn v HEMORANDUM FOR: Richard E. Cunningham, Director Division of Fuel Cycle and Material Safety FROM: Ross A. Scarano, Director p jy Division of Radiation Safety and Safeguards AF
SUBJECT:
REQUEST FOR COMMENT AND CONCURRENCE ON ADVANCE NOTICE OF PROPOSED RULEMAKING: " RADIATION THERAPY QUALITY ASSURANCE AND PENALTIES FOR NEGLIGENCE" ]
Thank you for the opportunity to respond to the Advanced Notice of Proposed Rulemaking which was distributed by your memo dated November 24, 1986 We would first like to offer some general comments regarding the proposed rule and then follow with more detailed information in response to the specific questions which were raised in Enclosure 1.
We support NRC's efforts in establishing quality assurance programs for brachytherapy and teletherapy. We also believe that licensees should be required to implement such a program since voluntary compliance would probably not be fully effective. The issue of qua31ty assurance as applied to radiation oncology is a very complicated one due to the complex nature of treatment planning and multip1 deity of types of patient treatments, the uncertainties in doses and dose distributions which are inherent in the therapy process, and the absence of current standards for quality assurance in radiation therapy.
High priority should be given to establishing minimum standards or model QA programs in cooperation with the American Association of Physicists in Medicine and other interested professional organizations.
QUALITY ASSURANCE Teletherapy and Brachytherapy:
- 1. It is probably true that there is a general correlation between patient caseload and level of expertise in performing radiation therapy processes.
The larger radiotherapy facilities such as those found at radiotherapy clinics and at teaching institutions ter.d to have equipment and a well trained staff which help to establish and maintain state-of-the-art capabilities. However in the case of teletherapy it would be difficult to justify a minimum caseload requirement since not all patients require j the most advanced facilities and the most qualified staff to receive adequate treatment. Most of the smaller therapeutic facilities with small caseloads (less than approximately 15 patient treated per day) are for the most part limited to palliative therapy which do not require extensive treatment planning resources. The NRC should not ilmit the permissible ratio of cases per licensee employee since such a requirement would be inflexible and not take into account expected variations in personal productivity, need for or absence of complex treatment planning l
efforts, and duration of teletherapy patient setup and treatment (which j would be a function of the number and complexity of treatment ficids).
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R. Cunningham DEC 5 INE l
.The NRC should also not require licensees to specialize in treating certain types of cases because of the inherent inflexibility and the practical difficulties associated with implementing such a requirement from the licenairg standpoint.
- 2. The question implies that the level of quality assurance and by implication quality of patient care in this respect will vary depending upon where the patient received treatment. Every patient has a right to demand, and the NRC should require that teletherapy and brachytherapy services be delivered with high expectation of accuracy and assurance that misadminis-trations will not occur. This means that all teletherapy and brachytherapy programs should be required to also have a minimally acceptabic quality assurance program regardless of staff or facility size, and that any additional elements required will depend upon the specifics of the individual case and the type of treatment prescribed. For example, weekly or more frequent patient chart reviews and checks of calculations of dose and verification of treatment machine parameters should be a necessary part of any QA program. Examples include equivalent field areas, percent depth dose or TAR, given dose, tumor dose machine time, bolus and wedges. However because of the complexity of certain types of patient treatments,' additional verification of doses received by the patient may be warrauted-through physical measurements.
- 3. A large majority of . medical licens' ees already have quality assurance programs in place although there is significant variation in its implemen-tation and effectiveness. . QA programs are normally included as part of the medical physics services rendered and consequently a cost breakdown for this service only is difficult to establish and would likely require a cost analysis study. .However it is unlikely that reimbursement for quality assurance would bc significantly impaired since commercial medical insurance programs in the past have provided coverage for specialized treatment planning services.
4 Although we are not aware of model programs which have been developed, specific information which nay be used as a starting point concerning QA programs can be obtained from the American Association of Physicists in Medicine. Recent pubidcations on this subject include AAPM Report No. 13,
" Physical Aspects of Quality Assurance Radiation Therapy" (1984) and
" Quality Assurance in Radiation Therapy: Clinical and Physical Aspects",
Proceedings of the First International Symposium on Quality Assessment in Radiation Oncology, held in Washington, D. C. June 8-10, 1983.
Previous studies of the frequency of errors in treatment plannicg and irradiation of patients have shown that excluding tumor localization, the most common causes of error are mistakes which are made in calculatjans and in the use of information presented in graphs, scales or charts.(1)
We believe that redundant calculations should form part of the basis for any quality assurance program in teletherapy or brachytherapy. For most
- routine teletherapy, a reasonably high expectation cf accuracy of dose l
delivered to the tumor volume can be realized on the basis of calculations cud checks of prescriptions and patient charts without the need to use physical measurement where simple or few treatment fields are involved.
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l R. Cunningham- bob Although in vivo dosimetry measurements can in theory provide an ultimate check of accuracy of patfeut treatments, technical limitations and practical difficulties (e.g. patient anatomy or brachytherapy using interstitial sources) in making physical measurements will probably make it difficult to impose a broad regulatory requirement which is applicable to all types of patient treatments.
- 5. The answer to this question depends .upon the extent to which licensees will be required to implement a quality assurance program and upon the size of the clinic. The larger radiatior, oncology programs will ifkely possess the resources required to develop and run a high quality QA program since adequate medical physics staffing and modern dosimetry equipment already exist. Small oncology programs will be impacted the most, especially if there are extensive QA requirements. Although even small therapy' programs usually have some medical physics coverage on at least a weekly or bi-weekly basis, periodic checks of treatment parameters and dose calculations may not be performed in a redundant fashion until several daily treatments have elapsed. 1his is further complicated by staffing in many small programs of only a single physician and one or two technologists who often share diagnostic radiology responsibilities.
Under these circumstances, redundant calculations prior to initial patient treatment would need to be performed by the physician or technologist.
If physical measurements are required, most small to moderate size therapy programs would likely contract with outside consultants for increased medical physics coverage since thf u would be far less expensive than purchasing the needed equipment. In any case substantial additional costs would be incurred because of the specialized services required.
- 6. Errors can be reduced by such methods as:
- a. Redundant and frequent checks of the prescription and treatment charts
- b. Use of therapy verification films throughout the treatment course
- c. In vivo dosimetry on certain occasions and for certain types of treatments
- d. Computer' or automated systems for recording daily patient treatment parameters
- e. Frequent checka for presence and correct placement of accessory devices (e.g. bolus, wedges) used in daily treatments
- f. Periodic checks of patient parameters (crosa section thickness measurements, CAT, NMR or other diagnostic procedures, etc) to evaluate any changes in position of tumor volumes within the patient
- g. Use of equipment to aid in the accurate and reproducibic positioning of patients _ undergoing teletherapy (e.g. bite blocks, positioning lights, body braces, vacuum posinf oning bags)
- h. Routine observation of treatments at randoma to verjfy correct positioning of patients and the proper use of teletherapy equipment
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. 1 R. Cunningham DEC 5 E86 Radiopharmaceutical Therapy:
We agree that current regulatory requirements to measure the radioactivity in radiopharmaceutical dosages prior to administration and to calibrate the dose calibrator used to make the measurements are probably adequate for a radiopharmaceutical therapy QA program.
NEGLIGENCE
- 1. We believe that the level of negligence that would trigger a " penalty" should definitely be one involving a licensee's willful action or failure to conduct a quality assurance program in compliance with the license.
The decision to impose penalties should be made on a case by case basis and should be commensurate with the consequences of the error. An error that results in serious clinical harm to the patient should result in escalated enforcement action with consideration given for civil penalty or revocation of the NRC license, whereas an error which results in no clinical harm should be handled as a violation of moderate severity. In any diccussion regarding " penalties" or triggering levels, it must be realized however that the occurrence of errors can only be held to low rate levels; errors probably cannot be eliminated completely even in optimal quality assurance programs.
- 2. Negligence penalties should only be imposed on licensees. The penalty should be related to the degree of harm suffered and not on the amount of byproduct material involved.
- 3. It is difficult to know what effect a negligence penalty rule would have on insurance rates.
- 4. A negidgence penalty would probably make it more difficult for the Ideensee to defend against a lawsuit.
- 5. If insurance rates increase significantly, small radiation oncology ,
programs might be forced to withdraw from providing these services.
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Ross A. Scarano, ir a
Division of Radiation Safety I and Safeguards (
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(1) Determination of Absorbed Dose in a Patient Irradiated by Beams of X or Gamma Rays in Radiotherapy Procedures, ICRU Report 24, September 15, 1976.
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SUBJECT:
REQUEST FOR COMMENT AND CONCURRENCE ON ADVANCE NOTICE OF PROPOSED RULEMAKING: " RADIATION THERAPY QUALITY ASSURANCE
-AND PENALTIES FOR NEGLIGENCE" 1
This is in. response to your November 24, 1986 memorandum to Mr.sJames Keppler.
requesting comments and concurrence.on the subject advance notice'. We concur with the approach of publishing an' advanced notice on qu'ality assurance, however, we have several suggestions we would like to have incorporated. They are presented in.the enclosure.
We feel that Immediate Effective Orders should be issued to all licensees authorized for human uses of byproduct' material (10 CFR 35) except medical users of the Lixi Scope or Bone Mineral Analyzer. Prompt interim measures will help prevent serious therapeutic or diagnostic misadministration.s. Some form-of interim regulatory action is clearly warranted now rather than waiting one or possibly'two years for a QA/QC regulation. The Orders'should require, as a minimum,-the following:
- 1. All prescriptions for nuclear medicine procedures (therapeutic and diagnostic) should be in written form.
- 2. All written diagnostic and radiopharmaceutical therapy prescriptions should be reviewed for accuracy by a nuclear medicine physician v' (authorized user) and verified by the technologist prior to administration of doses to patients.
- 3. Before beginning' the first treatment of any teletherapy procedure 'or x' implantation of brachytherapy sources, the prescribed dose calculation should be independently performed by two qualified individuals and the
, results compared to ensure accuracy. Further, prior to the first teletherapy treatment, the technologist will verify, by patient chart review, that exposures parameters were based on two independent
' calculations.
- 4. Any of the above requirements may be relaxed if the attending or referring i j physician (s) deem the therapy or diacrostic procedure to be a medical emergency requiring immediate medical attention, i
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i Richard E. Cunningham 2 DEC 0 51986
/ 5. Records should be maintained for all of the above activities. i
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Regarding " penalizing licensees for their negligence or that or their l employees, agent or practitioners," we believe this is inconsistent with any current enforcement practices. The word " negligence" itself will only create ,
unneeded controversy and likely distract the agency effort to achieve its main goal which is to improve the quality assurance of radiation therapy. We recommend that section be modified to indicate that appropriate enforcement action will be considered by the NRC.if the licensee fails to adequately implement its QA/QC program. We have further comments on this issue in the '
enclosure.
If you have any questions or require clarification on any of our comments or !
suggestions, please contact Bruce S. Mallett of my staff at FTS 388-5742.
l v1Jac A. H1 , ir c Division of Radiation Safety and Safeguards
Enclosure:
Comments - Advanced Notice of Proposed Rulemaking i
cc w/ enclosure: l W. C. Parler, 0GC i E. Beckford, RES
.P. G. Norry, ADM G. W. Kerr, OSP J. M. Taylor, 01E Regional Administrators i 1 1
- Is 8 J Enclosure Comments
- 1. We recommend that the method of addressing the Commissioner's request for a rule,to penalize negligence, as suggested in page 3 of the proposed
. memorandum from Mr. Stello'and in Enclosure 1, be changed. As. suggested
'by.the questions.in'page 6 of Enclosure 1, the term, negligence, is.too ambiguous and controversial to use as a' basis for penalties. In addition,
.no other,NRC enforcement.is based on this, but on procedures or performance.. We recommend the NRC propese the procedures'necessary to ensure accuracy-in delivering a therapeutic dose as a basis for enforcement and penalties. Negligence due to careless disregard can'be dealt'with by. enforcement related to these. procedures. For example, recent therapeutic misadministration in Region III were caused by human
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error due to improper calculation of dose to be delivered. If the licensee,.in each case, would have been required to independently double verify dose calculations, enforcement action would have been taken for not following this procedure.
- 2. The Summary section'in page 1 of Enclosure.1 would be less confusing if the fourth sentence concerning radiopharmaceutical therapy is moved to the y end of the section and modified to say "In addition, the NRC is requesting public comment. . . ."
- 3. Question 4, page 5 of Enclosure l'should be modified since there are Quality Assurance Programs available and the NRC is aware of some of these (e.g. , AAPM Report No.13, May 1984 eniMtled " Physical Aspects of Quality (l Assurance in Radiation Therapy," ACR, 1962 manual entitled " Quality Assurance in Radiation Therapy a Manual for Technologists").
- 4. The emphasis of the section on Quality Assurance in Enclosure 1 should be-changed to indicate the NRC is eliciting public comments on the topics j that should be included.in a quality assurance program. The proposed
. enclosure appears to emphasize instead whether we need a quality assurance program.
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