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The Honorable John B. Breaux, Chairman Subcommittee on Nuclear Regulation Committee on Environment and Public Works United States Senate Washington, D.C. 20510
Dear Mr. Chairman:
l In a few days the Nuclear Regulatory Commission will publish in the Federel Register the enclosed notices on quality assurance in the medical use of byproduct material.
Based on analyses of several misadministration events over the years, the NRC believes additional regulatory oversight is needed to reduce the chance of misadministration and provide for better patient safety. The staff has developed a two-pronged approach to this problem. First, the agency will publish a basic quality assurance rule that would impose additional quality
- assurance requirements on licensees that use materials that pose a clear i potential for hazard to the patient. This action would affect licensees that offer radiation therapy services or that use potentially hazardous diagnostic radiopharmaceuticals. Second, the agency will, at the same time, request public comment on how the NRC should implement a comprehensive quality assurance program requirement that would apply to all licensees authorized to provide any type of medical use service. This two-pronged approach provides for prompt action on easily-recognized basic problems and comprehen-sive action on more subtle problems.
These notices will be mailed to licensees and other interested individuals for comment. We expect the medical community will be very interested in these notices.
Sincerely, i
t') ?-
Hy'gh L. Thompso Jre irector 0(f'ce of Nuclear Mdter{ia' afety and Safeguards
Enclosures:
As stated cc: Senator Alan K. Simpson i
0712010287 871201 HRS 2y36942 PDR
Identical letters sent to: The Honorable Morris K. Udall, Chairman Subcommittee on Energy and the Environment Committee on Interior and Insular Affairs United States House of Representatives Washington, D.C. 20515 cc: Rep. Manuel lujan, Jr.
-and-The Honorable Philip R. Sharp, Chairman Committee on Energy and Commerce United States House of Representatives Washington, D.C. 20515 cc: Rep. Carlos J. Moorhead DISTRIBUTION IMd5 Central File IMAB R/F NMSS R/F NLMcElroy VLMiller GJSjoblom RECunningham NMSS0ffice File RBernero HThompson 1
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1 The Honorable John B. Breaux, Chairman Subcommittee on Nuclear Regulation Committee on Environment and Public Works United States Senate l Washington, D.C. 20510
Dear Mr. Chairman:
In a few days the Nuclear Regulatory Commission will publish in the Federal Register the enclosed notices on quality assurance in the medical use of byproduct material.
Based on analyses of several misadministration events over the years, the NRC believes additional regulatory oversight is needed to reouce the chance of misadministration and provide for better patient safety. The staff has i
developed a two-pronged approach to this problem. First, the agency will !
publish a basic quality assurance rule that would impose additional quality ;
assurance requirements on licensees that use materials that pose a clear potential for hazard to the patient. This action would affect licensees that offer radiation therapy services or that use potentially hazardous diagnostic radiopharmaceuticals. Second, the agency will, at the same time, request public comment on how the NRC should implement a comprehensive quality assurance program requirement that would apply to all licensees authorized to provide r.ny type of medical use service. This two-pronged approach provides for prompt action on easily-recognized basic problems and comprehen-sive action on more subtle problems.
These notices will be mailed to licensees and other interested individuals for comment. We expect the medical community will be very interested in these notices.
Sincerely, (Signed) Hugh L Thompson, k.
Hugh L. Thompson, Jr. , Director Office of Nuclear Material Safety and Safeguards
Enclosures:
As stated I
cc: Senator Alan K. Simpson
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1 0FC: IMAS :IMAD :IMN5 :IMNS :NM55 :NM55 : I NAME:NMcElroy :VMiller :GLSjoblom:RECunninghum:RBernero:HThompson:
DATE:09/ /87 :09/ /87 : 09/ /87: 09/ /87 : 09/ /87:09/ /87:
OFFICIAL RECORD COPY
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UNIT 3D STATES NUCLEAR REGULAT's .Y COMMISSION WASH WG W. .C.20555
% . . . . . ,e 1 The Honorable Philip R. Sharp, Chairman Subcommittee on Energy and Power Committee on Energy and Commerce United States House of Representatives ,
Washington, D.C. 20515 !
}
Dear Mr. Chaiman:
In a few days the Nuclear Regulatory Commission will publish in the Federal Register the enclosed notices on quality assurance in the medical use of byproduct material.
Based on analyses of several misadministration events over the years, the NRC .
believes additical regulatory oversight is needed to reduce the chance of misadministration and provide for better patient safety. The staff has <
oevelopea a two-pronged approach to this problem. First, the agency will pidlish a basic quality assurance rule that would impose additional quality assurance requirements on licensees that use materials that pose a clear potential for hazard to the patient. This action would affect licensees that offer radiation therapy services or that use potentially hazardous diagnostic radiopharmaceuticals. Second, the agency will, at the same time, request public coment on how the NRC should implement a comprehensive quality assurance program requirement that would apply to all licensees authorized to provide any type of medical use service. This two-pronged approach provides for prompt action on easily-recognized basic problems and comprehen-sive action on more subtle problems.
These notices will be mailed to licensees and other interested individuals for comment. We expect the medical community will be very interested in these notices.
Sincerely,
) %,
Hugh(L. Thompson, r. Jrector Office of Nuclear Ma e/ial '
Safety and Safegupyds
Enclosures:
As stated cc: Rep. Carlos J. Moorhead l
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Identical letters sent to: The Honorable Merris K. Udall, Chairman Subcommittee on Energy and the Environment Committee on Interior and Insular Affairs United States House of Representatives Washington, D.C. 20515 cc: Rep. Manuel Lujan, Jr.
-and-The Honorable Philip R. Sharp, Chairman Conmittee on Energy and Conant.rce United States House of Representatives Washington, D.C. 20515 cc: Rep. Carlos J. Moorhead DISTRIBUTION IMNS Central File IMAB R/F NMSS R/F NLMcElroy VLMiller GJSjoblom RECunningham NMS50ffice File RBernero HThompson i
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___________________-_____________-__a
Identical letters sent to: The Honorable Morris K. Udall, Chairman Subcommittee on Energy and the Environment Committee on Interior and Insular Affairs United States House of Representatives Washington, D.C. 20515 cc: Rep. Manuel Lujan, Jr.
.and.
The Honorable Philip R. Sharp, Chairman Committee on Energy and Commerce United States House of Representatives Washington, D.C. 20515 cc: Rep. Carlos J. Moorhead The Honorable John B. Breaux, Chairmen fon Subcommi+teeonNuclearRegula)blicWorks Committee on Environment and ::
United States Senate Washington, D.C. 20510
Dear Mr. Chairman:
In a few days the Nu ear Regulatory Commission will publish in the Federal Register the encio d notices on quality assurance in the medical use of Fyproduct materiaY.
The NRC believe'/ s additional regulatory oversight is needed to reduce the chance of mipddministrations and provide for better patient safety. The staff has developed a basic quality assurance rule that would require licensees to implement f fey elements of a qvality assurance program. The staff has also develope,d a request for public comment on how the NRC should implement a compre 'ensive quality assurance program requirement.
Thg.,e notices will be mailed to licensees and other interested individuals for cgmment.
Sincerely, DISTRIBUTION:.
IMNS Central File GLSj oblom IMAB R/F RECunningbam Hugh L. Thompson, Jr., Director N!1 VLM111er h NMSS Office File Office of Nuclear Material Safety and Safeguards
Enclosures:
As stated cc: Senator A an K. Simpson 1 0FC: IMAB :INAB :IMNS j ihMSS i[ :IM NMSS :
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, y, NAME:NMc 'oy :VMilley ._:GLSfoblom: [ECunn
__ _ _ _L _H _......_....g ha, m n : RBe rne ro : HTh omn s o n :
...........________.1., ._________________ ____ .____.. )
DATE:09/d/87 :09/lV/87: 09/\ /81: 09/H/87 09/7.1/87:09/ /87:
i ts 0FFICIAL RECORD COPY J
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l NUCLEAR REGULATORY COMMISSION )
i 10 CFR PART 35 Comprehensive Quality Assurance in Medical Use and a Standard of Care j
AGENCYr Nuclear Regulatory Commission.
ACTION: Advance Notice of Proposed Rulemaking.
SUMMARY
- The Nuclear Regulatory Commission (NRC) is considering amendments to its regulations that apply to the use of byproduct material for radia-tion therapy and diagnostic uses involving large radiation dosages. In addition to the current requirements for quality assurance, the contem-l plated amendments would require licensees that offer teletherapy or brachy-therapy services to implement a comprehensive quality assurance program to reduce the chance of misadministration. The NRC requests public comment on the extent to which additional radiopharmaceutical quality assurance requirements are needed, and invites advice and recommendations on several questions that will have to be addressed in the rulemaking process. The NRC is also requesting comments on some basic quality assurance program requirements set out in a proposed rule published elsewhere in this issue.
DATE: Submit comments by (90 days). Comments yeceived after this date will be considered if it is practical to do so but assurance of considera-tion cannot be given except as to comments received on or before this date.
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ADDRESSES: Mail comments to: The Secretary of the Commission, U.S. j Nuclear Regulatory Commission, Washington, DC 20555, Attention: Docket-ing and Service Branch.
Deliver comments to: Room 1121, 1717 H Street NW., Washington, DC, between 8:15 am and 5:00 pm on Federal workdays.
Examine copies of comments received at: The NRC Public Document Room, 1717 H Street N'! , Washington, DC.
FOR FURTHER INFORMATION CONTACT: Norman L. McElroy, Office of Nuclear -
Material Safety and Safeguards, U.S. Nuclear Regulatory Comtission, -
Washington, DC 20555, telephone (301) 427-4108. )
SUPPLEMENTARY INFORMATION:
Therapy Use of Byproduct Material Teletherapy is the application of a beam of radiation emanating from !
a cobalt-60 source to a patient for a therapeutic purpose, usually cura- j tive, prophylactic, or palliative cancer therapy. (High energy x-ray l machines are also used for the same purposes.) As an example, a treatment j i
might be comprised of daily treatment.s of 200 rads to the tumor volume for i five weeks, yielding a total tumor dose of 5000 rads.
l Brachytherapy is the inse,rtion of small sealed sources such as l 1
cesium-137, iridium-192, gold-193, or iodine-125 into the tumor volume for l
J curative or prophylactic cancer therapy. As an example, a treatment might l
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require insertion of 50 millicuries for 48 to 72 hours8.333333e-4 days <br />0.02 hours <br />1.190476e-4 weeks <br />2.7396e-5 months <br />, resulting in a j tumor dose of 5000 rads.
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Radiopharmaceutical therapy is the administration of a radioactive drug for therapeutic purposes. The most common clinical procedure involves the oral administration of liquid or gelatin-capsuled iodine-131 as sodium iodide. For hyperthyroidism, 5 to 30 millicuries might be administered; for thyroid canser, 70 to 200 millicuries might be administered.
Most diagnostic uses result in whole body doses of about 0.1 rem and target organ doses of about 2.0 rem. Occasionally, however, as much as 5 millicuries of iodine-131 is administered as a diagnostic dozage for patients who have been treated for thyroid cancer. If this dosage were mistakenly administered to a patient who has no thyroid disease, the thyroid dose would be several thousand rads.
NRC'S Policy Regarding the Medical llse of Byproduct Material In a policy statement published February 9, 1979 (44 FR 8242), the NRC stated:
" 1. The NRC will continue to regulate the medical uses of radioisotopes as necessary to provide for the radiation safety of workers and the general public.
l "2. The NRC will regulate the radiation safety of patieats where justi-fied by the risk to patients and where voluntary standards, or compliance with these standards, are inadequate.
"3. The NRC will minimize intrusion into medical judgments affecting patients and into other areas traditionally considered to be a part of the practice of medicine."
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The NRC has the authority to regulate the medical use of byproduct material to protect the health and safety of patients, but also recognizes that physicians have the primary responsibility for the protection of their patients. NRC regulations are predicated on the assumption that properly trained and adequately infonned physicians will make decisions in the best interest of their patients.
NRC's Responsibilities in the Medical Use of Byproduct Material The NRC draws a line between the unavoidable risks attendant to-purposefully prescribed and properly performed clinical procedures and I the unacceptable risks of improper or careless use of byproduct material in medicine. The NRC is obliged, as part of its public health and safety 1
charge, to establish and enforce regulations that protect the public from the latter. i i
Reports of Misadministration in Radiation Therapy The NRC has published a study of the twenty-seven therapy misadministration that were reported over the period November 1980 through July 1984.1 The following NRC analysis of these events provides ;
the basis for determining that a need exists for this rulemaking.
The specific causes of the misadministration, detailed in Table 1, are, of course, related to the treatment modality. Nonetheless, three basic themes run through the reports: inadequate training, inattention to detail, and lack of redundancy.
IFor a copy of this report, write to Kathleen M. Black, Of fice for Analysis and Evaluation of Operational Data, Nuclear Regulatory Commission, Washington, DC 20555. Ask for report AE00/C505.
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Table 1. Therapy misadministration reported to NRC from November 1980 to July 1984 Teletherapy Prescription Total daily dose was delivered from each port (2)*
Oral and written prescriptions were different (1)
Boost dose of 500 rad /3 da was interpreted as 500 rad x 3'da (1)
Proper body side was not clear (1)
Treatment planning Tumor depth was incorrectly measured (1)
Tumor depth was incorrectly recorded (1)
Dosimetrist used wrong computer program (1)
Dosimetry tables for wrong unit were used (1)
Arithmetic mistakes were made (3)
Records Arithmetic mistakes were made (1)
Poor handwriting of numerals caused misunderstanding (1)
Physical measurements Wedge factors were measured incorrectly (1-53 patients affected)
Application Field blocks were not used (1)
Brachytherapy Treatment planning Dose rate was much higher than first estimated (1)
Application Wrong sources were. loaded in applicator (2)
Source fell out of applicator (1)
Source was improperly seated in applicator (1)
Radiopharmaceutical Therapy Wrong radiopharmaceutical was administered (2)
Assay date on unit dosage was not read (3)
Patient was improperiy identified (1)
- Numbers in parentheses indicate number of events of the type described.
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Improved training of medical personnel who handle and administer byproduct material can reduce the potential for error. Thorough training should also clearly impress on each individual involved in the medical use of byproduct material that a clear communication of concepts I and quantities as well as systematic checks for revealing mistakes early in the process are both essential for the delivery nf quality care. All_ i information integral to the process, whether specific to the patient or to the clinic, should be carefully examined for clarity, applicability, and correctness. Each individual involved in the process should be strongly encouraged to ask for clarification if there is any unclear or unexpected step or if an expected step is missing. !
Inattention to detail is often the medium in which a misadministra-tion event germinates. NRC recognizes that this problem is not specific to the medical use of byproduct material. Computerized radiation therapy treatment planning may reduce the chance of mistakes in sealed source treatment planning, and " record and verify" systems that check teletherapy unit orientations and settings may reduce the chance of mistakes in !
l teletherapy administration. But even these systems must ultimately rely 1 on quantities that are iaitially measured, recorded, and entered into memory by individuals.
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Lack of redundancy means that there exists no independent mechanism for detecting errors. An independent verification requires examination by a second individual of each data entry, whether a physical measurement or a number copied from a table of values, as well as a check of arithmetic operations for correctness. Redundancy requires that two separate systems produce the same result. For purposes of planning radiation therapy, the I
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best method of early detection of mistakes may be a simple independent l 6
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check. Independent verification may'also need to be incorporated into procedures for measuring radiation parameters, using those measurements for treatment planning, and applying radiation to patients. In radiation therapy or any other endeavor, an independent outside auditor can detect mistakes in both process design and process application as well as cite areas where a change in the process might reduce the chance for future error.
These observations have led the NRC to some general conclusions regarding quality assurance.
The radiation therapy process should be planned with the realization that individuals are likely to make mistakes. Some simple aids may include using tables and graphs that are clearly titled and easy to read, and use of a uniform written prescription format. NRC inspections have revealed that about ten percent of teletherapy unit calibrations and spot-checks are incomplete. Checklists could be used to assure completeness.
Independent verification must be made integral to the design of the radiation therapy process. All entries and calculations in a treat-ment plan should be checked by an individual who did not construct the treatment plan. Each patient's chart should be reviewed weekly to check for accumulated dose and implementation of prescription changes. A quality assurance program for the teletherapy unit should include a periodic check of the teletherapy unit output and an occasional detailed examination of the complete teletherapy process, including physical measurements, by an outside expert with an eye towarde systematic errors and system improvements.
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A program that requires a physical measureinent of the dose or amount of radioactivity actually administered to the individual patient would provide assurance that the given dose is the same es the prescribed dose.
Such measurements are now done for radiopharmaceutical therapy and occa-sionally for some teletherapy cases, but because of expense or unavail-ability of equipment are not commonplace in sealed source therapy.
Reports of Diagnostic Misadministration That Result in 00ses in the Therapy Range The NRC has also published a report on misadministration of diagnostic dosages of iodine-131 that lead to doses in the therapy range.2 The~ report was a review of fourteen recent misadministration events in which patients were administered one to ten millicuries of iodine-131 with a resulting thyroid dose of several thousand rads. Many of the events demonstrated that the physician authorized user failed to review I the medical history of the referred patient to determine the suitability of a particular clinical procedure. In many cases the referring physician, i who is not a nuclear medicine expert, and the nuclear medicine technologist, who is not a medical expert, determine which radiopharmaceutical should be 1 administered. Furthermore, in some events technologists unfamiliar with the clinical procedure prescribed by the authorized user mistakenly administered a dosage that was not requested. It is apparent, therefore, j that whenever radiopharmaceuticals capable of producing therapy doses are uced, clear nomenclature, independent verification, and adequate l
training are essential. l "For a single copy, submit a request for report number AE0D/N701 to the address in footnote 1. l 8 l i
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Earlier NRC Efforts This is not the first time the NRC has examined the matter of quality assurance in the medical use of byproduct material. In 1979 the NRC issued some basic quality assurance requirements for teletherapy (sce 10 CFR 35.632 and 10 CFR 35.634). This rulemaking was precipitated by the inaction of a single licensee. The output of a teletherapy unit was incorrectly calculated and the licensee made no physical measurements to determine whether the calculation was correct. This inaction resulted in cobalt-60 teletherapy being misadministered to 400 patients. The 1979 rule addressed the circumstances surrounding that event but did not critically examine tne entire radiation therapy process.
Voluntary Initiatives f
The Commission is aware of voluntary initiatives to improve quality assurance. A notable example is the Patterns of Care study managed by the American College of Radiology. In addition to comparing prescriptions, methods of applying radiation, and survival rates for certain diseases at various therapy facilities across the nation, methods of calculating and measuring applied dose rates are examined for accuracy. Such an examina-tion can detect whatever procedural flaws may be present as well as l determine the precision and accuracy of day-to-day service.
It is NRC's position that voluntary programs alone many not provide adequate assurance of public health and safety. Serious. misadministration 1
i continue to occur. The NRC would be remiss in its responsibilities were it to fail to thoroughly examine all avenues available to reduce unnecessary exposure from licensed material.
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Summary The NRC believes many misadministration could reasonably be avoided if certain quality assurance steps were included in the radiation therapy process.
Other Actions The NRC recognizes that the medical use of byproduct material is a complex field, and that preparing regulations to reduce the likelihood of misadministration must be done carefully. However, the NRC cannot allow the complexity of medical use to prevent it from taking regulatory action when patients are harmed by the incorrect application of byproduct material. The NRC has balanced these competing desiderata by preparing two rulemaking actions for contemporary publication.
This Advance Notice of Proposed Rulemaking (ANPR) will provide the foundation for a comprehensive quality assurance program requirement that will address each source of error that can lead to a misadm'nistration.
The NRC elected to prepare the ANPR because of the complexity of medical use. Elsewhere in this issue of the Federal Register, the NRC has 1
published a Notice of Proposed Rulemaking (NPR) that provides the l foundation for a basic quality assurance program that addresses some simple sources of error that have come to light under NRC's misadministra-tion reporting program.
The NRC believes this two pronged aoproach to the problem of misadministration provides the best balance between the need to assure public health and safety without inadvertently interfering in the delivery of quality medical carc.
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Effect on the Agreement States Program Many States, known as Agreement States, have assumed responsibility for regulating certain radioactive materials within their respective borders by agreement with the NRC. (This kind of agreement is authorized by the Atomic Energy Act.) They issue licenses for the use of byproduct material, and currently regulate about 5,000 medical licensees. Because the NRC will request the Agreement States, as a matter of compatibility, to implement regulations equivalent to those that it implements on this matter, state regulatory agencies are asked to comment, Request For Comments The NRC has prepared the following questions to elicit comments on methods of preventing misadministration. Comments need not be confined to these questions alone; discussion of other related topics or alter-natives is welcome if the commenter believes this will help to resolve i
issues related to this rulemaking.
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Quality Assurance General The following questi,ons apply to the provision of all types of medical use:
- 1. How can the Commission most effectively implement requirements for comprehensive quality assurance? The Commission has the authority to adopt existing national standards. The Commission, in concert with 1nedical experts, could identify and adopt by rulemaking the key elements in a quality assurance program. The Commission could impose a performance ,
requirement under which licensees would be required to implement a quality 11
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assurance program that would provide absolute assurance that there would be no misadministration. What other mechanisms should be considered?
2.
Should the definition of misadministration in 10 CFR 35.2 be changed? Is it clear and complete? Is the definition sufficiently broad to include all appropriate activities? Is it so broad as to include inappropriate activities? Is the term " misadministration" appropriately descriptive of the activities? Should some more descriptive term be used?
3.
The NRC knows of one instance in which radiation was administered to a patient without a request from the primary care physician. Should the NRC require that the authorized user actively consult with the primary care physician before prescribing radiation or deciding that radiation is not needed? How can the chance of miscommur.ication be reduced? What improve-ments can be made in terminology, prescription format, and orders?
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What methods should be considered to provide assurance that the patient to whom radiation is administered is the patient for whom radiation was intended?
5.
What current standards exist to ensure the adequacy arid uniformity of training of all individuals who participate in the administration of radiation to patients? Should NRC require certification or prescribe l
specific training criteria for technologists, dosimetrists, and others l I
who participate in the application of radiation to patients, or shot.ld 1 NRC have a performance requirement that requires licensees to provide I
each individual whatever training is necessary? In either case, how can l NRC'onsure the adequacy and consistency of this training throughout the '
radiation therapy community? Should the NRC require licensees to I l
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administer written examinations to workers and evaluate them before allowing the worurs to participate in radiation therapy? Should periodic retraining and re-examination be required?
- 6. What other regulatory, certifying, accrediting, or inspecting organizations examine medical quality assurance programs? Describe tne purpose, objectives, and rigor of these examinations.
- 7. Should the NRC require physicians to provide patients, upon request, a record of the radiation dose prescribed and/or given? What information should or should not be provided?
- 8. Apart from increased NRC oversight, i~60 changes in industry practice or standards could improve the quality of performance and mini-mize human error?
Teletherapy and Brachytherapy The following questions apply to the provision of teletherapy and brachytherapy services.
- 1. What performance criteria could be adcpted to assure appropriate care, minimize the chance of human error, and mitigate the consequences of potential error?
- 2. To assure adequacy of continued experience, some organizations recommend that certain surgical or test-tube procedures only be performed if the practitioner has a sufficient case-load to assure that dexterity and familiarity with the procedure are retained. Should NRC require that licensees have a certain minimum case-load to assure that their employees retain their expertise in performing radiation therapy clinical and quality assurance procedures?
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- 3. What fraction of licensees already have a quality assurance program? What are its key elements?
- 4. The Regulatory Flexibility Act requires that regulatory agencies examine the cost of compliance with regulations. How much does a quality assurance program cost per patient or per year? What fraction of staff time, including physicians, physicists, dosimetrists, technologists, and nurses, is currently budgeted for quality assurance work?
- 5. Are there templete model quality assurance programs already available that address every step of the radiat. ion therapy process, or will model programs have to be developed? Should physical measurements, redundant calculations, or both be required to assure-that the dose given is the same as the dose prescribed? What other areas are, or should be, covered in a complete quality assurance program?
- 6. Are the staff and equipment that are needed to implement a com-plete quality assurance program available in the marketplaces or would new training programs and equipment development be needed?
- 7. Computers are used in radiation therapy to calculate dose distributions and to control th' operation of equipment. How could quality assurance of sof tware accuracy and validity be improved? Should licensees be required to verify them? How can user skill and knowledge of the inherent assumptions and limitations of a computer program be assured? Should additional quality assurance requirements be developed to ensure that users understand the algorithms on which the programs are based?
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- 8. What additional methods are available for reducing the frequency or impact of human error?
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Radiopharmaceutical Therapy The NRC requires that licensees use only certain radiopharmaceuticals for specified therapy clinical procedures, measure the radioactivity in radiopharmaceutical dosages before acainistration, and have a measurement quality assurance program for the dose calibrator used to make that measurement. These requirements appear to encompass the steps in a radiopharmaceutical therapy physical quality assurance program. However, the NRC invites public comment on this position.
There have been cases in which, due to procedural failure, a radio-pharmaceutical other than that intended has been ordered and administered.
Many of these cases began with miscommunication between the referring physician and the licensee. Some began with miscommunication between the physician's authorized user and the nuclear medicine technologist. The NRC expects that all licensees have procedural requirements for clear state-mants of prescription and verification before administration of any phar-l maceutical. The NRC would appreciate suggestions on methods to assure that the clinical procedure (including radiopharmaceutical, dosage, and route of administration) intended by the autherized user is prescribed, and that the prescribed clinical procedure is the clinical procedure that is performed. The NRC has observed several cases of miscommunication of the referring physician's request. What improvements can be made to minimize such errors? Are there special needs regarding patient identification in radiopharmaceutical therapy that go beyond the information regarding patient identification that was requested in question 4 of the General subsection?
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Standards of Care The following questions apply to the medical use of byproduct material.
- 1. Is there a clear, generally accepted standard of care that the NRC can adopt? If yes, please t' scribe it. If not, please describe a standard that NRC could adopt. Is a standard needed if NRC has comprehensive prescriptive requirements?
- 2. What effect would such a standard or comprehensive, prescriptive requirements have on provisions of radiation therapy care?
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- 3. What kinds of penalties should be imposed on licensees, their 1
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employees, or both, if the standard or the comprehensive, prescriptive requirements are not met? Should penalties be imposed on employees?
Should NRC's Enforcement Policy (see 10 CFR Part 2, Appendix C) be changed, and if so, how?
List of Subjects in 10 CFR Part 35 Byproduct material, Drugs, Health facilities, Health professions, Incorporation by reference, Medical devices, Nuclear materials, Occupational safety and health, Penalty, Radiation protection, Reporting and recordkeeping requirements.
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'I The authority citation for this document is:
AUTFIORITY: Sec. 161, 68 Stat.' 948, as amended (42 U.S.C. 2201);
sec. 201, 88 Stat. 1242, as amended (42 U.S.C. 5841). .;
Dated at Washington, DC, this day of , 1907. ,
For the Nuclear Regulatory Commission.
Samuel J. Chiik, Secretary of the Commission.-
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1 Document Name:
10 CFR 35 TRER HISAD RULE 1 Requestor's ID:
JPK Author's Name:
McELROY N Document Comments:
9/11/87 -. revisions etpb i
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t NUCLEAR REGULATORY COMMISSION 10 CFR Part 35 Basic Quality Assurance in Radiation Therapy AGENC : Nuclear M gulatory Commission.
ACTION: Proposed Rule.
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SUMMARY
The Nuclear Regulatory Commission (NRC) is proposing to amend its regulations concerning the medical use of byproduct material to require its medical licensees to implement certain quality assurance steps that will reduce the chance of therapy misadministration. This. proposed action is necessary to provide better patient safety and a basis for enforcement action in cases of therapy misadministration. The amendment is intended to reduce the chance anc' severity of therapy misadministra-tions.
The proposed regulations would primarily affect hospitals, clinics, and individual physicians.
In an advance notice of proposed rulemaking published elsewhere in this issue of the Federal Register, the NRC is.also requesting comments on the need for a comprehensive quality assurance program requirement.
COMMENTS:
Comments must be received by (60 days). Comments received after this date will be considered if it is practical to do so, but assurance of consideration cannot be given except as to comments received on or before this date.
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ADDRESSES: Submit written comments and suggestions to the Secretary of the Commission, U.S. Nuclear Regulatory Commission, Washington, DC 20555, Attention: Docketing and Service Branch.
Copies of the regulatory analysis and the comments received on this rule may be examined at the Commission's Public Document Room at 1717 N Street NW., Washington, DC. Single copies of the regulatory analysis are avail-able from Norman L. McElroy, Of fice of Nuclear Material Safety and Safe-i guards, U.S. Nuclear Regulatory Commission, Washington, DC 20555, Telephone: (301) 427-4108.
FOR FURTHER INFORMATION CONTACT: Norman L. McElroy, Of fice of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555, Telephone: (301) 427-4108.
SUPPLEMENTARY INFORMATION:
- 1. BYPRODUCT MATERIAL IN MEDICINE Use for Patient Care Radioactive materials are used in drugs in the field of nuclear medicine. Drugs labeled with radioisotopes are known as radiopharmaceu-ticals. In diagnostic nuclear medicine, patients receive these materials i i
by injection, inhalation, or oral administrator Physicians use radia-tion detection equipment to visualize the distribution of a radioactive drug within the patient. Using this technology, it is possible to locate tumors, assess organ function, or monitor the effectiveness of a treatment. 1 An estimated 10 million diagnostic nuclear medicine procedures are per-formed in this country annually. In therapeutic nuclear medicine, larger 09/09/87 2
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i quantities of radiopharmaceuticals are administered to treat hyperactive thyroid conditions and certain forms of cancer. An estimated 30,000 pro-cedures are performed each year.
q Sealed radioactive sources that produce high radiation fields are
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used in radiation therapy primarily to treat cancer. A radioactive source in a teletherapy machine can be adjusted to direct a radiation beam to the part of the patient's body to be treated. An estimated 100,000 patients receive cobalt-60. teletherapy treatments from NRC and Agreement State licensees each year.
Smaller sealed sources with less radioactivity are designed to be implanted directly into a tumor area or applied on the surface of an area to be treated. This procedure is known as brachy-therapy. Licensees perform approximately 50,000 brachytherapy treatments annually.
Sealed radioactive sources can also be used in machines that are used for diagnostic purposes. The source provides a beam of radiation that is projected through the patient. A device on the other side of the patient detects the amount or spatial distribution of radiation that goes through the patient.
This can provide information about tissues within the patient.
This is a relatively new development in the field of medicine and the NRC has no estimate of the number of these diagnostic procedures performed annually.
State and Federal Regulation Many states, known as Agreement States, have assumed responsibility for regulating certain radioactive materials within their respective borders by agreement with the NRC. (This kind of agreement is authorized 09/09/87 3
[7590-012 by the Atomic Energy Act.) They issue licenses for the medical use of byproduct material, and currently regulate about 5,000 licensees. In i I
non-Agreement States, the NRC has licensed 2,200 medical institutions
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l (mostly hospitals and clinics) and 300 physicians in private practice.
These licenses authorize certain diagnostic and therapeutic uses of radioactive materials.
II. HRC'S REGULATORY PROGRN4 NRC's Policy Regarding the Medical Use of Byproduct Material j In a policy statement published February 9, 1979 (44 FR 8242), the i NRC stated:
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I "1. The NRC will continue to regulate the medical uses of radioisotopes as necessary to provide for the radiation safety of workers and the general public.
"?. The NRC will regulate the radiation safety of patients where justified by the risk to patients and where volun- i i
tary standards, or compliance with these standards, are inadequate.
1 "3. The NRC will minimize intrusion into medical judgments affecting patients and into other areas traditionally i l
considered to be a part of the practice of medicine." i l
The NRC has the authority to regulate the medical use of byproduct material to protect the health and safety of patients, but also recognizes I that physicians have the primary responsibility for the protection of their patients. NRC regulations are predicated on the assumption that 09/09/87 4
[7590-01) properly trained and adequately informed physicians will make decisions in the best interest of their patients.
NRb'sResponsibilitiesintheMedicalUseofByproductMaterial i
The NRC draws a line between the unavoidable risks attendant to purposefully prescribed and properly performed clinical procedures and the unacceptable risks of improper or careless use of byproduct material in medicine.
The NRC is obliged, as part of its public health and safety charge, to establish and enforce regulations that protect the public from the latter.
Reports of Misadministration in Radiation Therapy The NRC has published a study of the twenty-seven therapy misadministration that were reported over the period November 1980 through July 1984.1 The following NRC analysis of these events provides the basis for determining that a need exists for this rulemaking.
The specific causes of the misadministration, detailed in Table 1, are, of course, related to the treatment modality. Nonetheless, three '
basic themes run through the reports: inadequate training, inattention to detail, and lack of reaundancy.
Improved training of medical personnel who. handle and administer byproduct material can reduce the potential for error. Thorough training should also clearly impress on each individual involved in the medical use of byproduct material that a clear communication of concepts l.
1For a copy of this report, write to Kathleen M. Black , Office for Analysis and Evaluation Washington, DCof Operational Data, Nuclear Regulatory Commission, 20555. Ask for report AE00/C505.
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i Table 1. Therapy misadministration reported to NRC from November 1980 to July 1984 Teletherapy Prescription Total daily dose was delivered from each port (2)*
Oral and written prescriptions were different (1)
Boost dose of 500 rad /3 da was interpreted as 500 rad x 3 da (1)
Proper body side was not clear (1)
Treatment planning Tumor depth was incorrectly measured (1)
Tumor depth was incorrectly recorded (1)
Dosimetrist used wrong computer program (1)
Dosimetry tables for wrong unit were used (1)
Arithmetic mistakes were made (3)
Records Arithmetic mistakes were made (1)
Poor handwriting of numerals caused misunderstanding (1)
Physical measurements Wedge factors were measurod incorrectly (1-53 patients affected)
Application Field blocks were not used (1)
Brachytherapy Treatment planning Dose rate was much higher than first estimated (1)
Application Wrong sources were loaded in applicator (2)
Source fell out of applicator (1)
Source was improperly seated in applicator (1)
Radiopharmaceutical Therapy Wrong radiopharmaceutical was administered (2)
' Assay date on unit dosage was not read (3)
Patient was improperly identified (1)
- Numbers in parentheses indicate number of events of the type described.
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and quantities as well- as systematic checks for revealing mistakes early' in the process are both essential for the delivery of quality care. All information integral to the process, whether specific,to the patient or to the clinic, should be carefully examined for clarity, applicability, and correctness. Each individual involved in the process.should be strongly encouraged to ask_for clarification if there is any unclear or unexpected step or if an expected step is missing.
Inattention to detail is often.the medium in which a misadministra-tion event germinates. NRC recognizes that this problem is not specific to the medical use of byproduct material. Computerized ?adiation therapy treatment planning may reduce the chance of mistakes in sealed source treatment planning, and " record and verify" systems that check teletherapy unit orientations and settings may reduce the chance of mistakes in teletherapy administration. But even these systems must ultimately rely on quantities that are initially measured, recorded, and entered into memory by individuals.
Lack of redundancy means that there exist no independent mechanism for detecting errors. An independent verification requires examination by a second individual of each data entry, whether a physical measure-ment or a number copied from a table of values, as well as a check of arithmetic operations for correctness. Redundancy requires that two
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separate systems produce the same result. For purposes of planning radiation therapy, the best method of early detection of mistakes may be a simple independent check. Independent verification may also need to be incorporated into procedures for measuring radiation parameters, using those measurements for treatment planning, and applying radiation to patients. In radiation therapy or any other endeavor, an independent 09/11/87 7 i
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[7590-01) outside auditor can detect' mistakes in both process design and process application as well as cite areas where a change in the process might reduce the chance for future errors.
These observations have led the NRC to some general conclusions regarding quality assurance.
i The radiation therapy process should be planned with the realization that individuals are likely to make mistakes. Some simple aids may include using tables and graphs that are clearly titled and easy to read, and use of a uniform written prescription format. NRC inspections have t
revealed that about ten percent of teletherapy unit calibrations and '
spot checks are incomplete.
Checklists could be used to assure completeness.
Independent verification must be made integral to the design of the l radiation therapy process.
All entries and calculations in a treatment !
plan should be checked by an individual who did not construct the treat-ment plan.
Each patient's chart should be reviewed weekly to check for accumulated dose and implementation of prescription changes. A quality assurance program for the teletherapy unit should include a periodic check of the teletherapy unit output and an occasional detailed examina-tion of the complete teletherapy process, including physical measurements,
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by an outside expert with an eye towards systematic errors and system !
improvements. I I
A prograa that requires a physical measurement of the dose or amount of radioactivity actually administered to the individual patient would-provide assurance that the given dose is the same as the prescribed dose. l' 1
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l Such measurements are now done for radiopharmaceutical therapy and occa-sionally for some teletherapy cases, but because of expense or unavail-ability of equipment are not commonplace in sealed source therapy.
Reports of Diagnostic Misadministration That Result in Doses in the Therapy Range The NRC has also published a' report on misadministration of diag-nostic dosages of iodine-131 that lead to doses in the therapy range.2 The report was a review of fourteen recent misadministration events in which patients were administered one to ten millicuries of iodine-131 with a resulting thyroid dose of severai thc.usand rads. Many of the events demonstrated that the physician authorized user failed to review the medical history of the referred patient to determine the suitability of a particular clinical procedure. In many cases the referring physi-cian, who is not a nuclear medicine expert, and the nuclear medicine technologist, who is not a medical expert, determine which radiophar-maceutical should be administered. Furthermore, in some events tech-nologists unfamiliar with the clinical precedura prescribed by the authorized user mistakenly administered a dosage that was not requested.
It is apparent, therefore, that whenever radiopharmaceuticals capable of producing therapy doses are used, clear nomenclature, independent l
verification, and adequate training are essential.
Earlier NRC Efforts This is not the ' est time the NRC has examined the matter of quality assurance in the medical use of byproduct material. In 1979 the NRC issued some basic quality assurance requirements for teletherapy (see 44 FR 1722, 09/21/87 9
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published January 8,1979).
This rulemaking was precipitated by the inaction of a single licensee.
The output of a teletherapy unit wss incorrectly calculated and the licensee made no physical measurements to determine whether the calculation was correct. This inaction resulted in 1
cobalt-60 teletherapy being misadministered to 400 patients. The 1979 rule addressed the circumstances surrounding that event but did not critically examine the entire radiation therapy process.
Voluntary Initiatives The Commission is aware of voluntary initiatives to improve quality assurance.
A notable example is the Patterns of Care study managed by the American College of Radiology. In addition to comparing prescriptions, methods of applying radiation, and survival rates for certain diseases at various therapy facilities across the nation, methods of calculating and measuring applied dose rates are examined for accuracy. Such an examination can delect whatever procedural flaws may be present as well as determine the precision and accuracy of day-to-day service.
It is NRC's position that voluntary programs alone may not provide adequate assurance of public health and safety. Serious misadministration I continue to occur. The NRC would be remiss in its responsibilities were it to fail to examine thoroughly all avenues available available to-reduce unnecessary exposure from licensed material.
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Summary The NRC believes many misadministration could reasonably be avoided
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( if certain basic quality assurance steps were included in the radiation 1
therapy process. \
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l Other Actions The NRC recognizes that the medical use of byproduct material is a complex field, ar.d that preparing regulations to reduce the likelihood cf misadministration must be done carefully. liowever, the NRC cannot allow the complexity of medical use to prevent it from taking regulatory action when patients are hermed by the incorrect application of byproduct material.
The NRC has balanced these competing desiderata by preparing i two rulemaking actions for contemporary publication.
This Notice of Propose Rulemaking (NPR) will provide the foundation for a basic quality assurance program that addresses some simple sources of error that have come to light under NRC's misadministration reporting program.
Elsewhere in this issue of the Federal Register, the NRC has published an Advance Notice of Proposed Rulemaking (ANPR) that provides the foundation for a comprehensive quality assurance program requirement that addresses' broad areas where error can lead to a misadministration.
The NRC believes this two pronged approach to the problem of misadministration provides the best balance between the need to assure public health and safety without inadvertently interfering in the delivery of quality medical care.
III.
DISCUSSION OF P.R0 POSED REGULATORY TEXT The NRC staff has examined literature on the radiation therapy process and consulted with experts practicing in the field of radiation
. therapy to discuss these quality assurance steps. The NRC believes that the following steps are basic to the radiation therapy process. The 09/11/87 11 f
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i regulations that would require implementation of these steps will provide I L
guidance for improved patient safety and will also provide a basis for '
NRC enforcement action should these steps not be followed, j.
l S 35.2 Definitions.
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The NRC has added s v eral definitions to the regulations to ensure l
that the regulatory requirements are clear. The definitions are intended to be similar to those already in use in radiation therapy.
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S 35.39 Ordering, prescribing, and administering certain radiopharmaceuticals There have been a number of misadministration in which an unclear >
oral prescription by the authorized user resulted in the licensee ordering the wrong radiopharmaceutical. Confusing colloidal and soluble phosphorus-32 is a common mistako. The NRC is particularly concerned with the medical use of iodine-131 because of the high thyroid dose that results when a patient with a normal thyroid is misadministered an iodine-131 dosage intended for a patient whose thyroid has been removed.
These misadministration appear to be precipitated by unclear instructions. This section would require close participation of the nuclear medicine physician in those cases involving the use of radio-pharmaceuticals that are clearly hazardous to the patient if l misadministered, {
1 In drafting this section the Commission considered applying these l' requirements to all licensees when using any diagnostic radiopharmaceu-i tical, For the following reasons the scope of the section was limited to l therapy radiopharmaceuticals and radiopharmaceuticals of iodine.
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L l There is a clear history of misadministration of these two groups of radiopharmaceuticals, and medical experts generally agree that there is i
clear potential for harm to patients that receive these misadministra-tions. For the other radiopharmaceuticals identified in 35.100 and 35.200, the record shows that most misadministration involve either the conventional administration of a radiopharmaceutical to the wrong patient' or the conventional administration of the wrong radiopharmaceu-l tical to the patient (see "f1RC Reports on Misadministration and Unannounced Safety inspections," Journal of Nuclear Medicine, v27, n7, pliO2, July 1986). Neither of these types of misadministration pose a
' clear hazard to the patient. To misadminister a diagnostic radiopharmaceutical other than iodine in a manner that would pose -a hazard to the patient would, in the most likely circumstance, require administration of at least a full day's inventory of the radiopharmaceutical to the patient.
l However, the absence of additional quality assurance requirements for diagnostic radiopharmaceuticals other than iodine should not be interpreted as Commission lack of interest in this matter. The Commission would appreciate public comment on how it might address future diagnostic applications of radioisotopes which, if misadministered, could produce doses in the therapy range.
1 S 35.43 Prescriptions and records of medical use for therapy.
The NRC has received one therapy misadministration report in which radiation was administered to a patient who had not been referred for medical use of byproduct material. The NRC 'oelieves that a physician 09/09/97 13
[7590-01) with special training and experience is needed to consult with the primary care physician in cases of referral, and make a determination that a clinical procedure that requires radiation dose to the patient is indicated.
When a decision has been made to treat a patient for any malady, whether with radiation, surgery, or drugs, a physician makes a patient l
chart that includes information about the care provided for. the patient.
The chart is made for medical and legal reasons. All charts contain the patlent's name, the results of laboratory tests and physical examinations, a statement of diagnosis, and a prescription. Charts for teletherapy patients usually include: (1) photographs of the patient's face and the treatment area; (2) the treatment plan (which is comprised of: (a) dia-grams of physical measurements of the patient, portal arrangements used to administer the radiation dose, and devices used to modify the radia-tion beam, (b) calculations made to determine how long the beam must be applied each day to deliver the prescribed dose, and (c) the number of days radiation is to be administered); (3) a record of each daily appli-cation of radiation made at the time of application; and (4) records of j
any physical measurements of radiation or portal verification films made specifically for the patient. Charts for brachytherapy patients include I l
i the same type of information, but the diagrams and calculations refer to !
implanted radiation sources rather than externally applied radiation beams.
Each entry in a chart is dated and signed or initialed. I i
The NRC considered preparing prescriptive recordkeeping requirements
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for the application of therapeutic amounts of radiation, but believes that J l
the patient charts and calibration records that licensees make and retain
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usually contain the information needed to demonstrate that the licensee l
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has implemented a quality assurance program. However, the NRC would appreciate public comment on this matter.
i Several therapy misadministration have been precipitated by unclear prescriptions.
In radiation therapy, a different dose is prescribed for each patient, depending on the type and extent of the malady. Therefore, i
requiring a legible handwritten or typed prescription on the patient's .
chart appears to be the most efficient way of ensuring clear communication between the prescribing physician and the dosimetrist who makes the calculations to determine how long radiation must be applied te deliver i the prescribed dose.
The NRC believes that it is possible that some dosimetrists or tech-I nologists may be disinclined to request clarification of instructions and this may lead to misadmini.strations.
Therefore, the NRC would require licensees to specifically instruct workers to request clarification in i cases where there may be ambiguity or error. l The NRC is considering prescribing what documentation is needed to demonstrate that an independent check of data transfers and calculations had been made.
The NRC has not included such a requirement in the
. proposed rule, but would appreciate comment on this matter.
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S 35.65 Discrepancies in records and observations.
On occasion licensees have complied with required safety measures, such as performing surveys, yet not taken mitigating or corrective actions that the NRC believes were obviously necessary to assure public health and safety.
The purpose of this section is to clearly require licensees I to resolve discrepancies in records and observations, i i
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l The NRC foresees the possibility of many kinds of discrepancies.
The licensee's measurement of the source strength of a brachytherapy source may differ from the manufacturer's reported source strength. A .
l thin patient may present a surface lesion, yet the patient's record may !
refer to.a deep seated lesion with extensive overlying tissue. A post-mastectomy patient may be referred for a prophylactic treatment with no clear statement prescribing whether the tissue surrounding the site of i surgery or the remaining breast tissue is to be treated. The prescrip-tion in the chart may not be in accord with the prescription agreed to by j the physician, physicist, technologist, and dosimetrist during a treatment planning meeting. Daily tallies of administered dose may not agree with projections made by multiplying the daily dose by the number of treatment days.
If, when faced with an ebvious discrepancy, a licensee, physician, physicist, technologist, dosimetrist or other individual fails to take reasonable clarifying, mitigating, or corrective action and the dis-crepancy results in a misadministration, then a citation will issue under this section.
S 35.432 Source strength measurements.
The radiation dose rate from a sealed source, which is known as source strength, depends on the amount of radioactivity in the source and the material used to encapsulate it. (See National Council on Radiation Protection and Measurements Report Number 41, " Specification of Gamma-Ray Brachytherapy Sources," Chapter 4.)a Manufacturers usually provide source aCopies of this report may be purchased by contacting NCRP Publications, P.O. Box 30175, Washington, DC 20014.
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i 1 strength information with sources, but the NRC believes that an independent l measurement is needed to ensure that the information relates specifically to the source under consideration.
However, the NRC would not require licensees to use these measurements in dose calculations. In some cases, manufacturers are able to provide more accurate measurements of source strength than licensees; the licensee must be free to use the source strength that it believes is the most accurate.
SS 35.452 and 35.652 Physical measurements of patients.
The NRC knows that dose rates depend to some extent on the tissue volume to be treated and its depth within the patient. These parameters may be determined by physical examination or examination of images such as radiographs, 'or images from computerized tomography, ultrasound, nuclear medicine, or nuclear magnetic resonance. The NRC considered requiring that two individuals independently make the physical measure-mots of the patient 'that are needed for dosimetry purposes, and believes that such a requirement may reduce the chance of misadministration.
The NRC would like comment on this matter.
S 35.454 Check of dose calculations, and S 35.654 Checks and measurements of dose Dose calculations are made for each teletherapy and brachytherapy patient before radiation is administered to determine how long the source must be used to deli,er the prescribed radiation dose to the treatment volume. Several therapy misadministration have been precipitated by arithmetic mistakes or incorrect assumptions io dose calculations. An l
. independent check will likely uncover many of these mistakes.
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Ideally, teletherapy dose calculations should be checked before radiation is administered, and the NRC expects that most licensees do this.
However, a second person may not always be available to check the dose calculations before therapy begins.
The NRC believes that requiring the check te be made before 20 percent of the dose has been administere provides a proper balance betweea patient safety and administrative flexibility for the licensee.
For most brachytherapy cases, final dose calculations cannot be performed until the sources are implanted in the patient because the exact location of the sources with respect to certain tissues cannot be predetermined.
Brachytherapy sources are typically left in place for two to three days.
Thus, a 20 percent criterion may be difficult to meet in many cases, because the check would have to be made within hours af the sources are implanted.
Thus, the NRC has selected a dose calculation check criterion of Su percent.
Public con"nents are invited on the workability c1 these 20 percent and 50 percent criteria.
There are two usual methods for performing checks of manual dose calculation.
Two individuals may independently calculate treatment times and compare results.
Alternatively, one individual may make the calcula-tion and then a second individual can examine each entry and arithmetic operation to verify its accuracy, i
The NRC considered requiring that licensees perform a manual check of the dose to a single point in the treatment volume predicted by computer generated dose calculations.
However, checks of computer-
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generated dose cal:ulations pose difficult problems.
It is not clear !
whether nomograms or manual algorithms are available that can be used to 09/09/87 18
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[7590-01) check the accuracy of computer generated dose calculations. fiany computer programs that are used contain steps for calculating the effect on the dose caused by tissue density differences, organ and tissue contours, and radiation field contours.
The NRC believes that a manual check nf a computer calculation with that many physical correction factors may be bayond the reasonably expected means of many licensees, and may adver affect the delivery of medical care. Therefore, the NRC has oni,y drafted a requirement that a second individual assure that the correct parameters, such as radionuclides, dose, and physical measurements of patients , were used in the computer generated dose calculation printout to information in the patient's chart, and examining each relevant piece of information on the calculation printout.
The NRC would appreciate comments on the best method for documenting that these checks have been made.
Regarding the concept of " independent check," the NRC would parti-cularly appreciate comments on whether a second individual should begin with only the prescription, independently calculate the dosimetry and treatment plan, and then compare those results with those of the first i
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individual.
In teletherapy, the arithmetic that sums the daily administration of radiation must also be checked. Radiation is usually administered in daily doses over several days or weeks and each dose is recorded in the patient's chart.
A weekly check will assure the daily doses i I
have been summed correctly, In contrast, brachytherapy is administered continuously until the prescribed dose has been given; thus, there i is no need for a comparable requirement.
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One recent teletherapy misadministration occurred in a case in which an unusual treatment configuration of the teletherapy unit, the beam collimators, and the patient was required.
Whereas an arithmetic mistake would likely be obvious in a commonly used configuration because certain calculated values for patients usually fall within small ranges, an unexpected treatment time in an uncommon configuration would likely be attributed to the uncommonness of the configuration rather than triggering an examination of calculations for a dosimetry mistake. Therefore, the NRC believes that a physical measurement of the dose rate should be made if the teletherapy unit settings or beam modifying devices used for a patient fall outside the ranges examined during the last set of full calibration measurements.
The NRC considered requiring physical measurements fue brachytherapy but believes the methodology (comprised 'of a comparison of calculated and '
measured dose rates) that is needed to make such measuretrents has not been fully developed.
The NRC also considered requiring that two indi-viduals verify that the correct sources were being implanted. This would clearly add to workers' radiation dose, but it is not clear that this would reduce the number of brachytherapy misadministration.
The NRC knows
- t. hat some treatments must be administered within hours after a decision has been made to administer radiation therapy. These cases usually involve. compression of the spinal cord or superior vena cava, respiratory distress, brain metastases, or severe vaginal bleeding. In such cases, it may not be possibic for the licensee to perform an inde-pendent check of calculations.
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The NRC believes the prescribing physician is best situated to deter-mine whether the time needed to make normal quality assurance checks might 09/09/87 20
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- i. jeopardize the patient's health.
This provision is not intended to.give licensees a basis. for not providing the requircd quality assurance steps in a timely fashion.
S 35.632 Full calibration measurements In one misadministration event, 53 patients received doses of radia-tion different from the doses that were prescribed because a mistake was made when measuring the effect of certain beam modifying devices on the teletherapy unit output.
The NPC believes the revalidation of the effect of these devices on the output is just as important as the annual full calibration itself.
S 35.633 Independent check of full calibration measurements All teletherapy dose calculations are based on the output of the teletherapy unit, which is measured each year as part of the full calibra-tion. If a mistake were made in that measurement, all dose calculations would be incorrect. Therefore, the NRC believes there should be an inde-pendent check of the output that was determined during the full calibra-tion. The check should be made by a teletherapy physicist because that individual has special training and experience in the measurement of therapeutic radiation.
The check should be made using a measuring system other than the system used in the full calibration. This will better assure that any mistake made in the methodology or the calibration of dosimetry equipment will not go unnoticed. (The term " measuring system" is used in a broad sense here to mean not just the dosimetry equipment, but the personnel, 09/09/87 21
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records, site specific methodology, and even origin of dosimetry equipment calibration when possible. However, the NRC is not certain that this would be available to all licensees and requests corament on this matter.)
The device used to make the output measurement could be one described in S 35.630 " Dosimetry equipment." Alternatively, it could be made using a specialized dosimetry service available by mail. Some organizations supply licensees with precisely calibrated thermoluminescent dosimeters within a '
device made of " tissue-equivalent" materiel.
The licensee irradiates the device, calculates the given dose, and returns the dosimeters to the organization by mail. By processing the thermoluminescent dosimeters, the i'
organization can measure the given doce and compare that measure to the calculated given dose. This p,avides assurance that the output has been correctly measured.
IV. ADMINISTRATIVE STATEMENTS Environmental Impact: Categorical Exclusion l The NRC has aetermined that this regulation is the type of action described in categorical exclusion 10 CFR 51.22(c)(3) and (c)(14).
Therefore, neither an environmental impact statement nor an environmental assessment has been prepared for this proposed regulation.
Paperwork Reduction Act Statement This proposed rule does not contain a new or amended information t
collection requirement subject to the Paperwork Reduction Act of 1980 1
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(44 U.S.C. 3501, et seq.). Existing requirements were approved by the Office of Management and Budget under approval nunter 3150-0010.
Regulatory Analysis The Comission has prepared a regulatory analysis oa this regulation.
The analysis examines the costs and benefits of the alternatives considered by the Cimmission.
The analysis is available for inspection in the NRC Public Document Room, 1717 H Street NW., Washington, DC. Single copies may be obtained from Mr. McElroy (see "FOR FURTilER INFORMATION CONTACT" heading).
Regulatory F?exibility Certification Based on the information available to date, in accordance with the Regulatory Flexibility Act of 1980 (5 U.S.C. 605(b)), the Commission certifies that this rule, if promulgated, will not have a significant economic impact on a substantial number of small entities. The NRC has issued approximately 2,500 medical licenses under 10 CFR Part 35. Of these, approximately 2,200 are held by institutions, and approximately 300 physicians in private practice. Most of the inst 'ational licensees are community hospitals. The size standards adopted by the NRC (50 FR 50241, December 9,1985) classify a hospital as a small entity if its average gross annual receipts do not exceed $3.5 million, and a private practice physician as a small entity if the physician's annual gross receipts do not exceed $1 million. Under these size standards, so;ae NRC 09/0..'87 23
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medical licensees could be considered "small entities" for purposes of the'Regulato'ry Flexibility Act. i The number of medical licensees that would fall into the small entity category does not constitute a substantial number for purposes of the Regulatory Flexibility Act.
The primary objective'of the rule is to require licensees that provide radiation therapy service to implement certain quality assurance
' steps that will reduce the chance of therapy misadministration. The NRC believes that most licensees already perform these steps in order to assure the provision of quality medical care. Therefore, there should not be a significant economic impact on these small entities.
The Commission'has prepared a preliminary regulatory analysis for this regulation which contains information concerning the anticipated economic effect of this regulation on licensees and presents the basis-for the Commission's belief that the regulation will not result in significant_ additional costs to any licensees. It is available for public inspection in the NRC Public Document Room, 1717 H Street N.W.,
Washington, DC. Single copies are available from Mr. McElroy.
Because of the widely differing. conditions under which licensees l
covered by this proposed regulation operate, the Commission specifically i seeks public comment from small entities. Any small entity subject to this regulation which determines that, because of its size, it is likely to bear a disproportionate adverse economic impact should notify the Ccmmission of this in a comment that indicates: (1) The licensee's size in terms of annual income or revenue, numDer of employees and, if the 1
licensee is a treatment center, the number of beds and patients treated annually; (2) how the regulat ion would result in a significant economic l 09/09/87 24 1 i
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burden on the licensee as compared to that on a large licensee; (3) how the regulations could be modified to take into account the licensee's differing needs or capabilities; (4) the benefits that would be gained or the detriments that would be avoided to the licensee, if the regulations were modified as suggested by the Commenter; and (5) how the regulation, as modified, would still adequately protect public health and safety.
The Commission is particularly interested in comments on whether individ-uals with special training and experience (such as treatment technologists, dosimetristr, and radiation therapy physicists) are readily available in the marketplace, either as full-time employees or as a contract service, Backfit Analysis The staff has determined that a backfit analysis is not required for this rule because these amendments do not apply to 10 CFR Part 50 licensees.
V. LIST OF SUBJECTS IN 10 CFR PART 35 Byproduct material, Drugs, Health devices, Health professions, Incorporation by reference, Medical devices, Nuclear materials, Occupa-tional safety and health, Penalty, Radiation protection, Reporting and recordkeeping requirements.
l VI. TEXT OF PROPOSED REGULATIONS Under the authority of the Atomic Energy Act of 1954, as amended, the Energy Reo ganization Act of 1954, as amended, and 5 U.S.C. 553 the NRC is proposing to adopt the following amendments to 10 CFR Part 35.
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Part 35 - Medical Use of Byproduct Material
- 1. The authority citation for Part 35 is revised to read as follows:
Authority: Secs. 81, 161, 182, 183, 68 Stat. 935, 948, 953, 954,'as amended (42 U.S.C. 2111, 2201, 2232, 2233); sec. 201, 88 Stat. 1242, as l
amended (42 U.S.C. 5841).
For the purposes of sec. 223, 68 Stat. 958, as amended (42 U.S.C.
2273): SS 35.11, 35.13, 35.20(a) and (b), 35.21(a) and (b), 35.22, 35.23, 35.25, 35.27(a), (c) and (d), 35.31(a), 35.39, 35.43, 35.49, 35.50(a)-(d),
35.51(a)-(c), 35.53(a) and (b), 35.59(a)-(c), (e)(1), (g) and (h), 35.60, 35.61, 35.70(a)-(f), 35.75, 35.80(a)-(e), 35.90, 35.92(a), 35.'120, 35.200(b), 35.204(a) and (b), 35.205, 35.220, 35.302, 35.310(a), 35.315, 35.320, 35.400, 35.404(a), 35.406(a) and (c), 35.410(a), 35.415, 35.420, 35.432, 35.454, 35.500, 35.520, 35.605, 35.606, 35.610(a) and (b),
35.615, 35.620, 35.630(a) and (b), 35.632(a)-(f), 35.633, 35.634(a)-(i),
35.636(a) and (b), 35.641(a) and (b), 35.643(a) and (b), 35.645(a) and (b),35.654,35.900,35.910,35.920,35.930,35.932,35.934,35.940, 35.941, 35.950, 35.960, 35.961, 35.970, and 35.971 are issued under sec.
161b., 68 Stat. 948 as amended (42 U.S.C. 2201(b)); and SS 35.14, 35.21(b), 35.22(b), 35.23(b), 35.27(a) and (c), 35.29(b), 35.33(s)-(d), j 35.36(b), 35.39, 35.43(b) and (d), 35.50(e), 35.51(d), 35.53(c), 35.59(d) !
i and (e)(2), 35.59(g) and (i), 35.70(g), 35.80(f), 35.92(b), 35.204(c), ;
35.310(b), 35.315(b), 35.404(b), 35.406(b) and (d), 35.410(b), 35.415(b), '
35.610(c),35.615(d)(4),35.630(c),35.632(g),35.634(j),35.636(c),
35.641(c), 35.643(c), 35.645, and 35.647(c) are issued under sec. 161o.,
68 Stat. 950, as amended (42 U.S.C. 2201(o)).
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- 2. In Subpart A--General Information, S 35.2, the following terms are added in alphabetical order:
- S 35.2 Definitions.
" Beam modifying devices" means items such as trays, wedges, compensators, boluses, and blocks that are used to change the radiation dos? profile within the patient.
" Computer generated dose calculation" means a dose calculation that has been made by a computer program with no human action necessary other than the input of patient data, selection of a certain computer program, and the instruction to the computer to begin calculation.
" Manual dose calculation" means a calculation made by an individual i using patient data, tabulated data or graphs, nomograms, and a calculator that was not specifically designed or programmed for radiation therapy calculations.
" Patient chart" means a record of the diagnosis and radiation treatment applied to a patient. It may be part of the hospital j I
admission chart prepared for each patient and kept with the 1 l
patient, or a chart prepared primarily as a result of radiation treatment and kept in the clinic. l l
A * * * *
" Prescription" means the written instruction to make medical use of byproduct material for the benefit of a specific patient.
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" Source strength" means the exposure rate at a specified distance ,
I from a source (usually expressed as roentgens per hour at one meter), the amount of radioactivity in a source (usually expressed as millicuries), or the amount of a different radionuclides + hat produces the same dose rate (usually expressed as milligrams of radium equivalent).
- 3. In Subpart B--General Administrative Requirements, S 35.39 is added to read as follows:
S 35.39 Ordering, prescribing, and administering certain radiopharmaceuticals, i (a) A licensee may not order any radiopharmaceutical of iodine for diagnosis or therapy or any radiopharmaceutical for therapy without the approval of the authorized user. '
(b) A physician may not prescribe administration of a radio-pharmaceutical of iodine for diagnosis or therapy or any radiopharmaceut- 1
(
ical for therapy without personally examining the r.:tient and the patient's .
chart, and consulting with the referring physician if reasonably available. l
.q Prescriptions for these byproduct materials must be in writing, and must l include the patient's name, the radiopharmaceutical, dosage, and route j of administration.
(c) A licensee may not administer a radiopharmaceutical of iodine for diagnosis or therapy or any radiopharmaceutical for therapy without comparing the radiopharmaceutical label and dosage on hand with the physician's prescription. )
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- 4. In Subpart B--General Administrative Requirements, S 35.43 is l
l added to read as follows:
l S 35.43 Prescriptions, records, and checks of _ medical use for therapy.
j (a) The authorized user or a physician under supervision of the authorized user shall ensure that, if there is a primary care physician, the patient has been referred for a therapeutic clinical procedure that requires the medical use of byproduct material.
(b) Before beginning a patient's treatment, the licensee shall verify that the authorized user or a physician working under supervision of the authorized user has personally made, dated, and signed a written prescrip-tion in the patient's chart that identifies the body part to be treated.
Any change in the prescription must also be made in writing in the patient's chart, and must be dated and signed.
(1) For radiopharmaceutical therapy, the prescription must also identify the radiopharmaceutical', the amount of activity to be administered, and the route of administration.
(2) For brachytherapy, the prescription must also identify the sources of radiation and the total tumor dose.
(3) For teletherapy, the prescription must also identify the teletherapy unit to be used, the prescribed dose, and the treatment i
plan.
(c) Prescriptions and other records made regarding the medical use of byproduct material must i e legible and unambiguous.
(d) The licensee shall instruct all workers involved in the radiation therapy process orally and in writing to request clarification from the prescribing physician if any element of a prescript. ion or other record is l
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- 5. In Subpart C--General Technical Requirements, S 35.65 is added to read as follows:
S 35.65 Discrepancies in records and observations.
A licensee may not use byproduct material for medical use on a.
patient if there is a discrepancy in records, observations, or physical measurements that may result in a misadministration. A licensee may resume use after resolving the discrepancy.
- 6. In Subpart F--Radiopharmaceuticals for Therapy, 6 35.302 is added to read as follows: l S 35.302 Administration of radiopharmaceutical dosages.
A licensee shall verify that the prescribed radiopharmaceutical is being administered by comparing the written prescription and the container label.
- 7. In Subpart G--Sources for Brachytherapy, S 35.432 is added to read as.follows:
S 35.432 Source strength measurements.
(a) A licensee shall measure the source strength of sources before first use and annually thereafter. Sources that are in storage and not being used do not have to be measured; they must be measured before they are placed in service again. For sources manufactured and supplied in lots of nominally identical sources, a sample from each lot may be selected rather than measuring each source.
(b) When performing dose calculations, a licensee may use the source strength reported by the manufacturer rather than using the source strength measured by the licensee.
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- 8. In Subpart G--Sources for Brachytherapy, S 35.452 is added to ;
i read as follows: '
S 35.452 Physical measurements of patient.
[ Reserved]
- 9. In Subpart G--Sources for Brachytherapy, S 35.454 is added to read as follows:
S 35.454 Check of dose calculations.
A licensee shall check dose calculations for accuracy before 50 percent !
of the prescribed dose has been administered. The check must provide assurance that the final treatment plan will provide the dose prescribed in the patient's chart. .
l (a) Manual dose calculations must be checked for accuracy by an individual who did not make the calculations.
(b) Computer generated dose calculations must be checked by examining the calculation printout to assure that the correct parameters and parameter values were used in the calculation. The check must be made by an individual who did not enter the patient data or prescription into the computer.
(
(c) If the prescribing physician makes a determination to delay j i
treatment in order to perform the checks of case calculations required by this section would jeopardize the patient's health because of the emergent nature of the patient's condition, the licensee may provide the prescribed treatment without performing the checks; the prescribing 1 physician shall make a notation of this determination on the patient's chart, and the licen,ee shall perform the checks as soon as practicable.
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- 10. In Subpart I--Teletherapy, S 35.632, the introductory text of paragraph (b) and paragraph (b)(1) are revised to read as follows:
S 35.632 Full calibration measurements.
l
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- a (b) To satisfy the requirement of paragraph (a) of this section, full calibration measurements must include determination of:
(1) The output within 13 percent for the range of field sizes, range of distances, and selection of beam modifying devices (for example:
trays, wedges, and the stock material that is used for making compensators and boluses) used for medical use; A A A A *
- 11. In Subpart I--Teletherapy, S 35.633 is added to read as follows: ,
S 35.633 Independent check of full calibration measurements.
(a) A licensee shall have an independent check of the output determined within one month after completion of the full calibration required by 6 35.632.
(b) The independent check must be performed by a teletherapy physicist who did not perform the full calibration and made using a dosimetry system other than the one used to measure the output during the full calibration. The teletherapy physicist does not have to be listed as a teletherapy physicist on an NRC or Agreement State license.
The dosimetry system may be one described in S 35.630, or it may be ;
another system that provides a similar level of accuracy and precision.
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( 12. In Subpart I--Teletherapy, S 35.652 is added to read as follows:
S 35.652 Physical measurements of patient.
[ Reserved]
- 13. In Subpart I--Teletherapy, S 35.654 is added to read as follows:
S 35.654 Checks of dose calculations and measurements of dose.
A licensee shall check dose calculations for accuracy before 20 percent of the prescribed dose has been administered. The check must 'i i
provide assurance that the final treatment plan will provide the dose prescribed in the patient's chart.
(a) Manual dose calculations must be checked for accuracy by an i individual who did not make the calculations.
(b) Computer generated dose calculations must be checked by examining the calculation printout to assure that the correct parameters I
and parameter values were used in the calculation. The check must be 1 made by an individual who did not enter the patient data or prescription into the computer.
(c) A licensee shall make a weekly accuracy check of daily arithmetic calculations that have been made in patient's charts.
(d) -If the patient's dose calculations include parameters or parameter values that fall outside the range of those measured in i i
calibrating the teletherapy unit, the licensee shall make a physical measurement of the dose rate to be administered to the patient. This measurement must be made before 20 percent of the prescribed dose has i
been administered.
(e) If the prescribing physician makes a determination that to delay treatment in order to perform the checks of dose calculations or 09/09/87 33 i i
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I physical' measurements required by this section would jeopardize the i patient's health because of the emergent nature of the patient's con'dition, the licensee may provide the prescribed treatment without 1 performing the checks of dose calculations or physical measurements; the prescribing physician shall make a notation of this determination on the patient's chart, and tne licensee shall perform the checks of calculations or physical measurements as soon as practicable.
Dated at Washington, DC, this day of , 1987 For the Nuclear Regulatory Commission, Samuel J. Chilk, Secretary of the Commission.
I.
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