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\...../ I RULEMAKING ISSUE ;
February 5, 1987 (Notation Vote)
SECY-87-29 For: The Commissioners From: Victor Stello, Jr.
Executive Director for Operations
Subject:
MISADMINISTRATION ;
Purpose:
To submit for Commission consideration: (1)anAdvanceNotice of Proposed Rulemaking (ANPR), (2) a proposed rule for public comment, and (3) the staff response to issues raised by the Commission in its December 16, 1986 memorandum. !
Category: This paper covers significant policy issues concerning the '
regulation of the medical use of byproduct material.
Issues: Quality assurance in radiation therapy and certain diagnostic clinical procedures involving large radiation dosages.
Summary: On April 14, 1986, the Commission directed the staff to prepare a proposed rule by April 15, 1987 that would strengthen NRC overcight of medical licensees. Subsequently, in an SRM i
dated December 16, 1986, the Commission directed that an Advance i
Notice of Proposed Rulemaking be submitted by January 31, 1987, that included a comprehensive analysis and recommendations for improvements in NRC oversight that may be effective in reducing medical misadministration.
l The staff has prepared an Advance Notice of Proposed Rulemaking to request early public comment on the scope of a rule that would: (1) require radiation therapy licensees, and licensees using large diagnostic dosages, to implement comprehensive quality assurance programs to lessen the chance of misadministration, and (2) provide.for a regulatory standard in the medical use of byproduct material for radiation therapy. In addition, the staff has prepared a quick-turnaround i proposed rule to require licensees to implement some basic therapy quality assurance steps. This rule would go far in upgrading NRC's requirements in this area, and could probably be published in final form in September.
Contact:
Norman L. McElroy 42-74108 y2 L7 d$Yi 3hpXA
4 The Commissioners 2 This paper also contains the staff's response to the Commission's request for recommendations and options. The staff has considered various options, such as rulemaking, issuance of orders, national voluntary standards, and increased NRC presence. They are presented in the Enclosures 3, 4, and 5.
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Background:
Radiation Therapy and Diaonostic Uses Teletherapy is the application of a beam of cobalt-60 radiation to a patient for a therapeutic purpose, usually for curative, prophy-lactic, or palliative cancer therapy. (High energy x-ray machines are also used for the same purposes.) A typical therapy may be comprised of daily treatments of 200 rads to the tumor volume for five weeks, yielding a total tumor dose of 5000 rads.
Brachytherapy is. the insertion of small sealed sources of cesium-137, iridium-192, gold-198, or iodine-125 into the tumor volume for cancer therapy. A typical therapy may 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 tumor dose of 5000 rads.
Radiopharmaceutical therapy is the administration of a radioactive drug for therapeutic purposes. The most common procedure is the oral administration of liquid or gelatin-capsuled iodine-131 as sodium iodide. For hyperthyroidism, 5 to 30 millicuries are administered; for thyroid cancer, 70 to 200 millicuries are administered.
Most diagnostic clinical proccdures result in a whole body dose of about 0.1 rem and a target organ dose of about 2.0 ren.
- Occasionally, however, as much as 5 mf111 curies of iodine-131 is administered as a diagnostic dosage for patients who have been treated for thyroid cancer. If accidentally administered to a patient who has a normal thyroid, the thyroid dose may be ,
several thousand rems.
About 400 NRC and 800 Agreement State licensees offer teletherapy and brachytherapy services, and about 700 NRC and 1,400 Agreement State licensees offer radiopharmaceutical therapy services. About 2,500 NRC and 5,000 Agreement State licensees offer diagnostic nuclear medicine services.
For a more complete description of the radiation therapy process ;
see Enclosure 7.
Discussion: General In April 1986 the Commission directed the staff to "Favelop a rulemaking to require independent verification of therapeutic doses, as is done in the case of diagnostic procedures, and penalize medical licensee 3 for their negligence or that of their employees, agents or practitioners." (See Enclosure 8.)
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The Commissioners 3 4
The staff shares the Commission's desire to reduce the frequency In developing its proposals, the staff of misadministration.
has itempted to balance competing public health and safety ;
neeos.
The diagnostic and therapeutic use of byproduct material has substantially reduced deaths from a number of causes. For example, it is frequently used in place of invasive surgical procedures which carry risks associated with the administration of general anesthe:f a and the introduction of infection, either of which can prove lethal. Nuclear medicine also improves the recovery rate j for certain diseases and extends the life expectancy of patients who are terminally ill. The demonstrated benefits of the medical 4 use of byproduct material far outweigh the risks. l Therefore, in its formulation of the enclosed rulemakings, the staff _has attempted to minimize the possibility that interven- !
tion of Federal regulation in this area, could, over the long !
run, drive practitioners away from the medical use of byproduct material or provide disincentives for further research for new applications, thereby having a negative impact on public health and safety.
ANPR on Quality Assurance and Failure to Meet Regulatory _
Standards (Eaclosure 1)
The staff has developed for public comment an Advance Notice of Proposed Rulemaking (ANPR) that contains both technical ana policy questions. The staff recommends that the Commission issue an ANPR before issuing a comprehensive proposed rule because information is needed, particularly from tho medical community, before it can develop a rule that is comprehensive without inadvertently interfering with the delivery of medical care.
The staff has broadly constructed the Commission's use of the term " independent verification of therapeutic doses" because, to reduce therapy misadministration, the best approach would be to require each licensee to have a comprehensive quality assurance program that addresses each step in the radiation therapy process. However, the personnel and equipment needed to imple-ment a comprehensive quality assurance program may not be available. Consequently, information on this matter would be sought through the ANPR.
Upon the advice of the Office of the General Counsel, the staff has not provided a section on " negligence" in the ANPR. The section is not needed for several reasons. First, at present, l the NRC does not have the quality assurance requirements (envisioned in the proposed rule and the ANPR) for medical licensees under which it can take enforcement actions in cases involving therapy misadministration. Once the rules resulting i
4 The Commissioners 4 from the proposed rule and the ANPR are implemented, however, the NRC will have the requisite requirements for enforcement actions. Second, the Commission's rules set standards, but normally do not characterize licensees' actions; rather, the Commission's Enforcement Policy provides the necessary charac-terization. Thus, the current Enforcement Policy, as applied <
to the medical use of byproduct material (see 10 CFR Part 2, Appendix C, particularly Supplement VI), can be used to address 1 violations. In fact, it has been invoked ir, several enforce-ment actions involving misadministration. Explicit in the Enforcement Policy is the Commission's position that it will take enforcement actions against licensees that, for instance, ---
willfully disregard the Commission's rules, are reckless, or are -
careless, i.e., negligent, as measured against the rules. Third, l the negligence section would have introduced unnecessary contro-l versy and would have carried the Commission into uncharted waters and away from its expertire in radiation safety. Finally, it could have impeded achieving the main objective of reducing misadministration. _ _ _
The staff believes that the Commission should give clear notice $$ND*
that enforcement actions for non-compliance with NRC regulations 8PI' will continue to be applied to NRC's medical licensees. Conse- '
quently, the staff has highlighted NRC's current enforcement policy as applied to the medical use of byproduct material. - -
As an alternative to the negligence section, the staff has prepared some broad questions the ANPR could propose about NRC's establishment of a broader regulatory standard relating to medical care that would address many of the issues dis-cussed in response to the Commission's request for options and recommendations (see Enclosure 3). Appropriate enforcement penalties for failure to adhere to all aspects of such a standard could be provided. This is consistent with the >
provisions of the Atomic Energy Act, as amended, and the Administrative Procedure Act for agencies' compliance actions.
By highlighting its its enforcement policy, the NRC will give strong and clear notice of its intent to take strong enforce-ment action if a medical licensee fails to meet the standards established in the Commission's regulations. The staff believes it should proceed with the ANPR without delay.
The staff expects extensive comment and offers of assistance from professional organizations in this project because they have a clear interest in developing programs that will improve the quality of patient care. '
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- 4 The Commissioners 5 Proposed Rule on Basic Ouality Assurance (Enclosure 2)
To promptly establish basic quality assurance requirements while comments on the ANPR are submitted and analyr.d the staff has reviewed the technical and professional literature, consuited with the members of the Advisory Comittee on the Medical Use of Isotope's (ACMUI) who are specialists in radiation therapy and other medical experts, and drafted a proposed rule (Enclosure 2) that would require medical licensees to implement certain basic quality assurance steps in their radiation therapy procedures that would reduce the chance of a misadministration.
This rule would provide a clear basis for enforcement actions in many therapy misadministration cases where no basis currently exists.
The staff considered preparing this rule in final form. This was not done for three reasons: (1) appropriate safety findings would have to be made, but'there do not appear to be sufficient grounds for not following the nomal rulemaking .
process (which requires opportunity for public comment) prescribed by the Administrative Procedure Act of 1946, as amended, (2) a significant portion of the regulatory text refers to recordkeeping requirements that, although published, could not be enforced until approved by the Office of Management and Budget under the Paperwork Reduction Act of 1980, and (3) many licensees would need time to formulate and institute programs.
The staff believes a final rule based on Enclosure 2 could be I submitted to the Commission by fall of 1987. j Need for Improved NRC Oversight I In a memorandum dated December 16, 1986, the Commission requested I a comprehensive analysis of NRC % medical use regulations including I a list of elements to be addressed. The staff response to this '
directive is in Enclosure 3.
Other Actions The proposed rule (Enclosure 2) addresses therapy misadministration because this is the area where most of the problems have occurred, and where the Commission requested the staff to focus its attention. The staff notes that on January 14, 1987, the Office of Analysis and Evaluation of Operational Data (AE0D) published a study on diagnostic misadministration involving the administration of millicurie amounts of iodine-131. The l staff believes that the probism of diagnostic misadininistrations l involving large radiation dosages (similar in magnitude to some i therapy dosages) is one that should be addressed, and has done i so in the ANPR. It will continue to examine the issue. The l
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i The Commissioners 6 staff did not address this problem in the proposed rule for several reasons. First, the issue of therapy misadministration I
appeared to be of greater and more immediate concern. Second, worker training, experience, supervision, and responsibilities in diagnostic nuclear medicine are different from those in radiation therapy, and therefore require different analysis and corrective measures. And, finally, addressing this problem would have delayed the Commission's deadline for the therapy project.
If the Connission wishes to addrest the diagnostic issue at this time, the staff can revise the proposed rule or it can prepare a separnte proposed rule on this matter without awaiting public comment on the ANPR. The latter would be more efficient.
Resources Current. The current resources budgeted by NRC to regulate medical licensees are:
FY 86 FY 87 FY 88 FY 89 Progrem Development 1$Y ISY ISY 1SY Licensing 6SY 7SY 7SY 7SY Inspection 12SY 13SY 13SY 13SY Program Development. The follow-through on the actions proposed in this paper, particularly those addressed in Enclosure 3, and other actions such as a further consideration of quality assurance for diagnostic nuclear medicine, will require additional resources.
Also, resources should be devoted to keeping abreast of the evolving technology and making timely regulatory adjustments to maintain compatibility with the techn- Preliminary resource estimates for accomplishing this are:
FY 87 FY 88 FY 89 Proposed Total Program 4 FTE 4 FTE 4 FTE Development Resources $200k $200k $200k l
Licensing. The rulemaking activities proposed in this paper, if adopted, as well as others contemplated, will increase the resource needs for licensing. The resource requirements will vary somewhat depending on the alternatives. Preliminary estimates of new requirements based on the staff's recommended approach are:
FY 87 FY 88 FY 89 Proposed Total Licensing Resources--Direct Staff 9 FTE 10 FTE 10 FTE
--With Overhead 10 FTE 11 FTE 11 FTE l
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The Commissioners 7 i
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Inspection. In addition, increased inspection resources could be used to provide as'surance of licensee attention and compliance with all requirements. Current medical inspection resource allocations allow only for a one-day inspection of most hospitals each three years . As an example of resource considerations, to increase NRC inspection presence from each 3 years to each 1.5 years, and to account for inspection against additional requirements, inspection resources would have to be more than doubled: I FY 87 FY 88 FY 89 i I
Total Resources for 1.5 Year Inspection Frequency
--Direct Staff 27 FTE 28 FTE 28 FTE
--With Overhead 31 FTE 32 FTE 32 FTE Naed for Additional Resources The additional resources identified'for program development would be u+'lized at Headquarters. The additional resources identified for 1 u +'ng and for inspection would be utilized in the Regions where ths .ensing and inspection functions for the medical use of byproduct material are currently performed.
The staff notes that requests for additional resources for the materials program have been made a number of times in the past during the budget process. Except for minor increases to reduce the licensing backlog, NRC resources applied to materials have remained essentially constant over the last decade, consistent with projected casework. This has been a conscious decision of the Commission in balancing its priorities with available resources.
If the Commission makes a determination that it is in the interest of the public health and safety to intensify its materials program, and nuclear medicine in particular, decisions on the amount and source of resources fer the enhanced program must also be made. The staff cannot in good conscience re-allocate existing materials resources to the medical use of materials. These resources are at a bare mini-mun and are based largely on licensing and inspection casewcrk. They do not, for example, take into account initiatives for improvements stemming from the Sequoyah Fuels accident.
Other Commission Support The Commission's expression of interest in the materials area can have a salutary effect on licensees' quality assurance, safety, and compliance programs. By participating in regional meetings with staff and licensees and making other public demonstrations of interest, such as the visits to medical facilities that were recently made, Commissioners can show the staff, licensees, and the public that they are as interested in materials safety as they are in reactor safety.
The Commissioners 8 ,
Coordination with Agreement States The staff believes that the purpose of quality assurance rules requires that they be made a matter of compatibility with the Agreement States. Thus, State regulatory agencies may be expected to comment, and should be consulted on the proper role of a regulatory organization in the delivery of medical care.
The schedule has not allowed for the customary interactions with the Agreement States before submitting this rulemaking.
We believe this interaction is particularly important where compatibility is required. We will work with the Agreement States on this during the comment period. Note that NRC guidelines allow Agreement States three years to adopt compatible regulations.
Coordination: The Office of the General Counsel has reviewed this paper and has no legal objection to it. .
Recommendation: The Commission:
- 1. _ Direct publication of the quick-turneround proposed rule (Enclosure 2) that would require licensees to implement certain basic quality assurance steps.
- 2. Direct publication of the Advance Notice cf Pmposed Rulemaking (Enclosure 1) regarding the scope of a quality l
assurance program rule.
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- 3. Approve the milestones and schedule preposed in Enclosure 6.
- 4. Agree to the staff initiatives (Enclocure 3) submitted in response to the Commicsion's December 16, 1986 memorandum on medical regulations.
- 5. Note
- a. The Advance Notice of Proposed Rulemaking, with a 90-day public comment period, and the Proposed Rule, with a 30-day public comment period, could be published in the Federal Register for public comment; however, the staff recommends that, to assure that Agreement State licensees have a fair opportunity to comment on the Proposed Rule, that
, it be published for 60-day public comment period.
l If the Commission selects the 60-day comment I period, appropriate adjustments will be made in i the enclosed notice and schedules, o
The Commissioners 9
- b. The Director of the Office of Nuclear Material Safety l and Safeguards has made a determination that these actions are categorically) excluded, under sections 10 CFR 51 to perform an environmental impact assessment. This provides the basis in Enclosure 1 for the Commission's determination not to prepare an environmental impact statement for the action.
- c. Regulatory analyses (Enclosures 4 and 5) have been developed for these notices.
- d. A public announcement and congressional letter will ,
be drafted and issued when the notices are filed with the Office of the Federal Register.
- e. Copies of the Federal Register notices will be distributed to all affected Commission specific licensees, all States, and other interested ,
organizations and individuals,
- f. The proposed rule in Enclosure 2 amends information collection requirements that are subject to the Paperwork Reduction Act of 1980 (44 U.S.C. 3501 etseq.). It will be submitted to the Office of I Management and Budget for review and approval of the paperwork requirements.
( Gd,[
ctor Stello, Ar Executive Dir6,ctor for Operations
Enclosures:
- 1. Federal Register Advance Notice of Proposed Rulemaking
- 2. Federal Register Notice of Proposed Rulemaking
- 3. Response to questions in December 16, 1986, staff requirements memorandum
- 4. Regulatory Analysis for Advance Notice of Propo;ed Rulemaking
- 5. Regulatory Analysis for Proposed Rule
- 6. Draft Schedule
- 7. Description of the radiation therapy process
- 8. Memos Chilk to Stello dated April 14, 1986 (COMFB-86-3) and December 16, j 1986 (COMFB-86-8/COMLZ-86-25) 1
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Commissioners' comments or consent should be provided directly to the Office of the Secretary by c.o.b. Friday, February 20, l 1987.
Commission Staff office comments, if any, should be submitted to the Commissioners NLT Wednesday, February 11, 1987, with an information copy to the Office of the Secretary. If the paper is of such a nature that it requires additional time for analytical review and comment, the Commissioners and the Secretariat should be apprised of when comments may be expected.
. DISTRIBUTION:
Cominissioners OGC (H Street)
OI OCA OIA 09A REGIONAL OFFICES EDO OGC (MNBB) ,
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NUCLEAR REGULATORY COMMISSION 10 CFR PART 35 Comprehensive Quality Assurance in Medical Use and a Standard of Care AGENCY: 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 radiation therapy and diagnostic uses involving large radiation dosages. In addition to the current requirements for quality assurance, the contemplated amendments would require licensees that offer teletherapy or brachytherapy services to implement a comprehensive quality assurance program to reduce the chance of-misadministration. The NRC requests public comment as to whether 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. [ Note: a cross-reference to the proposed rule will be inserted.] .,
DATE: Submit comments by (90 days). Comments received 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 before this date.
1 Enclosure 1
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-ADDRESSES: Mail comments to: The Secretary of the Commission, U.S.
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 NW., Washington, DC. ,
FOR FURTHER INFORMATION CONTACT: Norman L. McElroy, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555, telephone (301) 427-4108. '
SUPPLEMENTARY INFORMATION:
I NP.C'S Policy Regarding the Medical Use 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.
"2. The NRC will regulate the radiation safety of patients 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 f patients and into other areas traditionally considered to be a part of the practice of medicine."
2 Enclosure 1
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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 l regulations are predicated on the assumption that properly trained and adequately informed physicians will make decisions in the best interest of their patients.
l Therapy Use of Byproduct Material 1 1
Teletherapy is the application of a beam of radiation emanating from a cobalt-60 source to a patient for a therapeutic purpose, usually cura-tive, prophylactic, or palliative cancer therapy. (High energy x-ray I q
machines are also used for the same purposes.) As an example, a treatment might be comprised of daily treatments of 200 rads to the tumor volume for five weeks, yielding a total tumor dose of 5000 rads.
Brachytherapy is the insertion of small sealed sources such as cesium-137, iridium-192, gold-198, or iodine-125 into the tumor volume for curative or prophylactic cancer therapy. As an example, a treatment might reouire insertion of 50 mil 11 curies 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 tumor dose of 5000 rads.
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 mil 11 curies might be administered; for thyroid cancer, 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 dosage for patients who have been treated for thyroid cancer. If this dosage were mistakenly 3 Enclosure 1
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4 ed7 1nistered to a patient who has no thyroid disease, the thyroid dose would ,
be several thousand rems.
Therapy Misadministration The NRC recently mailed to all licensees a report about therapy misadministration (" Case Study Report on the Therapy Misadministration Reported to the NRC Pursuant to 10 CFR 35.32," NRC report AE0D/C505)l . .
Although the specific cause of each event was different, three basic themes were apparent: inadequate training, inattention to detail, and lack of redundancy.
In most of the reported events the 'atient was given much more radiation than prescribed by the physician authorized user. In a recent case that occurred after the report was published, a physician authorized user prescribed a radiation dose for a patient who had not been referred for radiation therapy.
These events make it apparent that at least some licensees do not have adequate quality assurance programs to prevent misadministration.
Under current regulations and licensing practice, a misadministration of radiation to a patient does not specifically constitute a violation .
of NRC regulations.
To begin rulemaking on this matter, it is important to frame the issues. Realizing that there will be considerable public interest, the NRC is taking this opportur.ity to request early public comment.
I See also, "AE0D Engineering Evaluation Report on Diagnostic Misadminis-trations Involvina ~
the Administration of Millicurie Amounts of Iodine-131,"
AE0D/N701. Single copies of each report are avai?able from Kathy Black, Offica for Analysis and Evaluation of Operational Data, U.S. Nuclear Regulatory Commission., Washington, D.C. 20555.
4 Enclosure 1
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Effect on the Ag-eement State Program l
Twenty-eight 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 do not have to respond l
to these questions alone; other related topics or alternatives may be described j if the commenter believes this will help to rusolve issues related to I this rulemaking. -
Quality _ Assurance l
General l l
The following questions apply to the provision of all types of thera-peutic medical use, and large diagnostic dosages.
- 1. Should the Connission require that each licensee implement a comprehensive quality assurance program without specifying its content, or should the NRC list certain ouality assurance steps that must be performed?
5 Enclosure 1
- 2. Should the definition of misadministration in 10 CFR 35.41 (the sarne definition that appears in 10 CFR 35.2 that was published on October 20, 1986 at 51 FR 36932) 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 h some more descriptive term be used?
- 3. The NRC knovs 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 I
physician before prescribing radiation or deciding that radiation is not needed?
- 4. What methods are available that provide reliable assurance that the patient who is administered radiation is the patient for whom radiation was intended?
- 5. Should NRC require certification or specific training criteria for technologists, dosimetrists, and others who participate in the applica-tion of radiation to patients, or assume that licensees will provide each individual whatever training is necessary? Should the NRC require licensees to administer written examinations to workers and evaluate them before allowing the workers 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? Are these examinations considered perfunctory or exhaustive?
6 Enclosure 1
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Teletherapy and Brachytherapy The following questions apply to the provision of teletherapy and brachytherapy services.
- 1. To assure quality of patient care, some organizations recommend that certain surgical or test-tube procedures only be performed if the practitioner has a sufficient case-load to cssure that dexterity and famil-1arity with the procedure are not lost. 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? Should NRC limit the permissible ratio of cases per employee to assure that licensee employees are not rushed in their work?
Should NRC require licensees to specialize in treating certain kinds or stages of disease rather than allowing them to treat all kinds of disease?
Should differing training or certification requirements be imposed based on case load?
- 2. Should smaller licensees with fewer staff and equipment resources be required to meet different quality assurance requirements than those for larger licensees?
- 3. What fraction of licensees already have a quality assurance progran?
- 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? If more staff were needed to meet quality assurance requirements, are the requisite individuals readily available or would a lengthy lead-in time be needed?
7 Enclosure 1
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- 5. Are there complete model quality assurance programs already available that address every step of the radiation 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 ]
l should be, covered in a complete quality assurance program? q
- 6. Are the staff and equipment th'at are needed to implement a i
complete quality assurance program available in the marketplace, or would new training programs and equipment development be needed?
- 7. What 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 administration, and have a measurement quality assurance program for the dose calibrator used to make that measurement. These requirements appear to comprise all 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.
i The NRC expects that all licensees have policy requirements for clear statements of prescription and verification before administration of any pharmaceutical. The NRC would appreciate suggestions on methods to assure that tha clinical procedure (including radiopharmaceutical, dosage, and 8 Enclosure 1
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l route of administration) intended by the authorized user is prescribed, and that the prescribed clinical procedure is the clinical procedure that l.
is performed. 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 I
The NRC presently has, in 10 CFR Part 2, Appendix C, particularly 'i Supplement VI, an enforcement policy that it can apply to the medical use l i
of byproduct material.
The following questions apply to the provision of teletherapy, brachytherapy, and radiopharmaceutical services, and to the Commission's Enforcement Policy.
- 1. Is there a clear, generally accepted standard of care that the NRC can adopt? If yes, please describe it. If not, please describe a standard that NRC could adopt. Is a standard needed if NRC has comprehensive prescriptive requirements?
- 2. What kinds of penalties should be imposed on licensees, their 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 be changed, and if so, how?
- 3. What effect would such a standard or comprehensive, prescriptive requirements have on provisions of radiation therapy care?
9 Enclosure 1
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List of Subjects in 10 CFR Part 35 Byproduct material, Drugs, Health facilities, Health professions, Incorporation by reference, Medical devices, Nuclear materials, Occupa-tional safety and health, Penalty, Radiation protection, Reporting and recordkeeping requirements.
The authority citation for this document is:
AUTHORITY: 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 , 1987.
FOR THE NUCLEAR REGULATORY COMMISSION, Samuel J. Chilk, Secretary of the Commission.
I 10 Enclosure 1
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NUCLEAR REGULATORY COMMISSION 10 CFR Part 35 Basic Quality Assurance in Radiation Therapy l
AGENCY: Nuclear Regulatory Comission. l I
i ACTION: Proposed Rule, i
SUMMARY
- The Nuclear Regulatory Comission (NRC) is revising its regulations to require its medical licensees to implement certain quality assurance steps j that will reduce the chance of therapy misadministration. This 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 and severity of therapy misadministration. The regulations will primarily affect hospitals, clinics, and individual physicians. [ Note: A l cross-reference to the Advance Notice of Proposed Rulemaking will be inserted.]
COMMENTS: Coments must be received by (30 days). Coments received after this date will be considered if it is practical to do so, but assurance of consideration cannot be given except as to coments received on or before this date.
ADDRESSES: Submit written coments and suggestions to the Secretary of I the Comission, U.S. Nuclear Regulatory Comission, l!ashington, DC 20555, Attention: Docketing and Service Branch.
1 Enclosure 2 l
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Copies of the regulatory analysis and the comments received on this rule may be examined at the Commission's Public Document Room at 1717 H Street NW.,
Washington, DC. ' Single copies of the regulatory analysis are available from Norman L. McElroy, Office of Nuclear Material Safety and Safeguards, U.S.
Nuclear Regulatory Commission, Washington, DC 20555, Telephone: (301)427-4108.
l 4
FOR FURTHER INF0PRATION CONTACT: Norman L. McElroy, Office of Nuclear ,'
Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, j Washington, DC 20555, Telephone: (301)427-4108.
SUPPLEMENTARY INFORMATION:
h I. 8yproduct 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 '
by injection, inhalation, or oral administration. Physicians use radiation detection equipment to visualize the distribution of a radioactive drug within the natient, using this technology, it is possible to locate tumors, assess organ function, or monitor the effectiveness of a treatment. An estimated 10 million diagnostic nuclear medicine procedures are performed in this country annually. In therapeutic nuclear medicine, larger quantities of radiopharmaceuticals are administered to treat hyperactive thyroid conditions and certain forms of cancer. An estimated 30,000 procedures
~
are performed each year.
2 Enclosure 2 i
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Sealed radioactive sources that produce high radiation fields are h 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 brachytherapy.
Licensees perform approximately 50,000 brachytherapy treatments annually.
1 Sealed radioactive sources can also be used in machines that are used for diagnostic purposes. The source provides a beam of radiation that is pro,fected 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 Twenty-eight 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 medicel use of byproduct material, nd currently regulate about 5,000 licensees.
In non-Agreement States, the NPC has licensed 2,200 medical institutions (mostly hospitals and clinics) and 300 physicians in private practice.
These licenses authorize certain diagnostic and therapeutic uses of radioactive materials.
3 Enclosure 2
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II. PRC'S Regulatory T+) ram Policy Regardiag the Medical Use of Byproduct Material In a policy statement published February 9, 1979 (44 FR 8242), the NRC noted that it regulates the medical use of byproduct material as necessary to provide for the radiation safety of workers and the general
\
public, regulates the radiation safety of patients where justified by the risk to patients, and minimizes its intrusion into medical ,1udgments affecting patients and into other areas t additionally conJidered to be the practice of medicine. The NRC has the authority to regulate the medical use of byproduct material to protect the health and safety of l patients, but also recognizes that physicians have the primary responsibility for the protection of their patients. NRC regulations have been predicated on the assumption that properly trained and adequately informed physicians will make decisions in the best interest of their patients.
Reports of Therapy Misadministration The NRC continues to receive reports of therapy misadministration. In a recently published study, the NRC noted that one half of reported therapy misadministration resulted in doses that were 20 percent to as much as 200 percent greater than prescribed. In one event, 53 patients did not receive as much radiation as prescribed because the effect of certain beam modifying devices on the dose rate from a teletherapy unit had been improperly measured.
(See Case Study Report on the Therapy Misadministration Reported to the NRC Pursuant to 10 CFR 35.42, NRC Report Number AE0D/C505.)I The NRC believes I Single copies are available from Kathy Black, Office for Analysis and Evaluation of Operational Data, U.S. Fuclear Regulatory Comission, Washington, DC 20555 4 Enclosure 2
[7590-01]
these misadministration of radiation pose a clear risk to patients because, as noted in a recent report, "The dose response curve in radiation therapy is quite steep in certain cases, and there is evidence that a'7-10 percent change'in the dose to the target volume may result in a significant change in tumor control probability. Similarly, such a dose change may also result in a sharp change in the incidence and severity of radiation induced morbidity." (See Physical Aspects of Quality Assurance in Radiation Therapy, American Association of Physicists in Medicine Report Number 13, published 1984.)2 Thus, administration of less radiation than prescribed may be of little therapeutic value; administration of more radiation than prescribed ;
may prove unnecessarily harmful to the patient's healthy tissue. The NRC believes many misadministration could reasonably be avoided if certain basic quality assurance steps were included in the radiation therapy process.
The NRC staff has examined literature on the radiatien therapy process and consulted with experts practicing in the field of radiation therapy to-discuss the need for these quality assurance steps. The NRC believes that the steps are basic to the radiation therapy process.
The regulations that would require implementation of these steps will provide guidance for improved patient safety and will also provide a basis for NRC enforcement. action if not followed.
The NRC is examining the need for a requirement to implement a more complete quality assurance program and may take further actions in this a ree. .
2 Copies of reports may be purchased by contactino the Executive Secretary, American Association of Physichts in Medicine, 335 E. 45 Street, New York, NY 10017.
5 Enclosure 2
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. III. Discussion of Regulatory Text
, 6 35.2 Definitions.
l The NRC has added several definitions to the regulations to ensure that the regulatory requirements are clear. The definitions are intended to be similar to those already in use in radiation therapy.
9 35.43 Prescriptions and records of medical use for therapy.
The NRC has received one therapy misadministration report in which l
radiation was administered to a patient who had not been referred for medical use of byproduct material. The NRC believes that a physician with special training and experience is needed to consult with the I
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
- chart that includes information about the care provided for the patient. The chart is made for medical and legal reasons. All charts contain the patient'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) diagrams of physical measurements of the patient, portal arrangements used to administer the radiation dose, and devices used to modify the radiation 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 6 Enclosure 2
L -
[7590-01]
of each daily application of rediation made at the time of application; and (4) records'of any physical measurements of radiation or portal verification films made specifically for the patient.- Charts for brachytherapy patients include the same type of information, but the diagrams and calculations refer to implanted radiation sources rather 1
than externally applied radiation beams. Each entry in a chart is dated and signed or initialed.
The NRC considered preparing prescriptive recordkeeping requirements for the application of therapeutic amounts of radiation, but believes that the patient charts and calibration records that licensees make and retain j usually contain the information needed to demonstrate that the. licensee has' implemented a quality assurance program. There would be no benefit gained by imposing additional recordkeeping requirements. However, the i
NRC would appreciate public comment on this matter. l Several therapy misadministration have been precipitated by unclear prescriptions. In radiation therapy, a different dose is prescribed for l I
each patient, depending on the type and extent of the malady. Therefore, j requiring a legible, handwritten, or typed prescription on the patient's 1
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 to deliver 1
the prescribed dose. :
I The NRC believes that it is possible that some dosimetrists or )
technologists may be disinclined to request clarification of instructions and this may lead to misadministration. Therefore, the NRC would require
~
licensees to specifically instruct workers to request clarification in cases where there may be ambiguity or error.
7 Enclosure 2
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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.)3 Manufacturers usual,1y provide source strength information with sources, but the NRC believes that an independent measurement is needed to ensure that the information relates specifically l 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 lice re must be free to use the source strength that it believes is the most ccurate.
95 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-ments of the patient that are needed for dosimetry purposes, and believes that such a requirement may reduce the chance of misadministration.
However, because there are a finite number of individuals trained to do 3
Copies of reports may be purchased by contacting NCRP Publications, P.O. Box 30175, Washington, DC 20014.
8 Enclosure 2
i
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these tasks, such a requirement could negatively impact the delivery of j medical care. Therefore, no requirement has been included. However, the NRC will continue to examine tnis matter.
9 35.454 Check of dose calculations, and s 35.654 Checks and )
i measurements of dose. I Dose calculations are made for each teletherapy and brachytherapy patient before radiation is administered to determine how long the source ]
must be used to deliver the prescribed radiation dose to the treatment volume. Several therapy misadministration have been precipitated by )
arithmetic mistakes or incorrect assumptions in dose calculations. An independent check will likely uncover many of these mistakes.
Ideally, teletherapy dose calculations should be checked before radiation is administered, and the NRC expects that n'est licensees already 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 to be made before 20 percent of the dose has been administered provides a proper balance between patient safety and administrative flexibility for the licensee.
For most brachytherapy cases, final dose calculations cannot be performed until the sources are implanted ir the patient because the exact locatinn 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 after the sources are implanted. Thus, the NRC has selected a dose calculation check criterien of 50 percent.
9 Enclosure 2
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Public comments are invited oh 1e workability of 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 calculation and then a second individual can tick each entry and arithmetic operation after verifying its accuracy.
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-generated dose calculations pose difficult problems. It is not clear whether nomograms or manual algorithms are available that can be used to check the accuracy of computer-generated dose calculations. Many computer programs that are used contain steps for calculating the effect on the dose caused by tissue density differences, organ a M tissue contours, and radiation field contours. The NRC believes tha a manual check of a computer calculation with that many physical correction factors may be beyond the reasonably expected means of many licensees, and may adversely affect the delivery of medical care.
Therefore, the NRC has only 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, ticking each relevant piece of information en the calculation printout, and then initialing it.
Regarding the concept of " independent check," the NRC would particularly appreciate comments on whether a second individual should 1
f i
10 Enclosure 2 l
[7590-01]
begin with only the prescription, independently calculate the dosimetry
. and treatment plan, and then compare those results with those of the
- first 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 have been summed correctly. In contrast, brachytherapy is administered continuously until the prescribed dose has been given; thus, there j is no need for a comparable requirement.
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 unconnon 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 J
if the teletherapy unit settings or beam modifying devices used for a e patient fall outside the ranges examined during the last set of full calibration measurements.
f The NRC considered requiring physical measurements for brachytherapy but believes the methodology (comprised of a comparison of calculated and measured dose rates) that is needed to make such measurements has not been fully developed. The NRC also considered requiring that two
' 11 Enclosure 2 l
[7590-01] '
individuals verify that the correct sources were being implanted. Thi
]
would clearly add to workers' radiation dose, but it is not clear that this would reduce the number of brachytherapy misadministration.
The NRC knows that 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, er severe vaginal bleeding. In such cases, it may not be possible for the licensee to perform an independent check of calculations.
The NRC believes the prescribing physician is best situated to determine whether the time needed to make normal quality assurance checks might jeopardize the patient's health. This provision is not intended to give licensees a basis for not providing the required quality assurance steps in a timely fashion.
% 35.632 Full calibration measurements.
In one misadministration event, 53 patients received doses of radiation 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 NRC believes the revalidation of the effect of these devices on the output is just as important as the annual full calibration itself.
9 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 calibration. If a mistake were made in that measurement, all dose
[7590-01]
calculations would be incorrect. Therefore, the NRC believes there should be an independent check of the output that was determined during the full calibration.
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 tenn " measuring system" is used in a broad sense here to inean not just the dosimetry equipment, but the personnel, 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 comment on this matter.) l The device used to make the output measurement could be one described in 5 35.630 "Dosinetry 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 ,
1 device made of " tissue-equivalent" material. The licensee irradiates the j device, calculates the given dose, and returns the dosimeters to the l I
organization by mail. By processing the thermoluminescent dosimeters, the organization can measure the given dose and compare that measure to the I l
calculated given dose. This provides assurance that the output has been I correctly rneasured.
l l
}
13 Enclosure 2
[7590-01],
IV. Administrative Statements Environmental Impact: Categorical Exclusion
}
The NRC has determined that this regulation is the type of action )
i described in categorical exclusion 10 CFR 51.22(c)(3) and (c)(.14).
Therefore, neither an environments.1 impact statement nor an environmental assessment has been prepared for this proposed regulation.
Paperwork Reduction Act Statement This proposed rule would amend information collection requirements
\
that are subject to the Paperwork Reduction Act of 1980 (44 U.S.C. 3501 etseq.). This rule has been submitted to the Office of Management and Budget for review and approvel of the paperwork requirements.
Regulatory Analysis The Commission has prepared a regulatory analysis on this regulation.
The analysis examines the costs and benefits of the alternatives considered by the Commission. 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 FURTHER INF0PMATION CONTACT" heading).
Regulatory Flexibility 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 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 14 Enclosure 2
[7590-01]
are held by institutions, and approximately 300 physicians in private practice. Post of the institutional 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.
UnCer these size standards, some NRC medic.al licensees could be considered !
"snall entities" for purposes of the Regulatory Flexibility Act.
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 radfation 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 provisicn 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 1
for the Commission's belief that the regulation will not result in significant additional costs to any licensees. It is available for !
I public inspection in the NRC Public Document Room,1717 H Street NW, l Washington, DC. Single copies are available from Mr. McElroy.
Because of the widely differing conditions under which licensees covered by this proposed regulation operate, the Commission specifically seeks public comment from small entities. Any small entity subject to 15 Enclosure 2
[7590-01] ,
b this regulation which determines that, because of its size, it is likely
- to bear a disproportionate adverse economic impact should notify the Commission of this in a comment that indicates
- (1) The licensee's size in terms of annual income or revenue, number of employees and, if the licensee is a treatment center, the number of beds and patients treated annually; (2) how the regulation would result in a significant economic !
I 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 I 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, y- 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, dosimetrists, and radiation therapy physicists) are readily availaole in h
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, Occupational 5
safety and health, Penalty, Radiation protection, Reporting and recordkeeping requirements.
16 Enclosure 2
1 l I
[7590-01]
)
l j Under the authority of the Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of 1954, as amended, and 5 U.S.C. 553 the NRC is adopting the following revision of 10 CFR Part 35. I VI. Text of Final Regulations Part 3'5 - 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 amended (42 U.S.C. 5841).
For the purposes of rec. 223, 68 Stat. 958, as amended (42 U.S.C. 2273);
9935.11,35.13,35.20(a)and(b),35.22,35.23,35.25,35.27(a),(c) and(d),35.31(a),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 f5 35.14, 35.21(b),
35.22(b),35.23(b),35.27(a)and(c),35.29(b),35.33(a)-(d),35.36(b),
35.43(b) and (d), 35.50(e), 35.51(d), 35.53(c), 35.59(d) and (e)(2),
35.59(g) and (i), 35.70(g), 35.80(f), 35.92(b), 35.204(c), 35.310(b), I i
17 Enclosure 2
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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. 1610 68 Stat. 950 as amended (42 U.S.C. 2201(o)).
- 2. In Subpart A--General Information, 6 35.2, the following terms are added in alphabetical order: .
6 35.2 Definitions.
" Beam modifying devices" means items such as trays, wedges, i
compensators, boluses, and blocks that are used to change the radiation dose profile within the patient.
" Computer-generated dose calculation" means a dose calculation that f I
has been made by a computer program with no human action necessary j i
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.
- * *
- I I
" Patient chart" means a record of the diagnosis and radiation treatment applied to a patient. It may be part of the hospital admission chart prepared for each patient and kept with the 18 Enclosure 2
[7590-01]
patient, or a chart prepared primarily as a result of radiation treatment and kept in the clinic.
l
" Prescription" means the written instruction to make medical use of byproduct material for the benefit of a specific patient.
" Source strength" neans the exposure rate at a specified distance 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 that produces the same dose rate (usually expressed as milligrams of radiumequivalent).
- 3. In Subpart B--General Administrative Requirements, 6 35.43 is added to read as follows:
6 35.43 ' descriptions, records, and checks of medical use for therapy.
I .) The authorized user or a physician under supervision of the au+ .orized user shall ensure that, if there is a primary care physician,
.ne 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 assure that the authorized user or a physician working under supervision of the authorized user has personally made, dated, and signed a written ,
l prescription in the patient's chart that identifies the body part to be l l treated. Changes in the prescription must also be made by being written in the patient's chart, dated, and signed.
1 l
3 19 Enclosure 2 l I - - - - - _ - - _ _ _ _ - - - -
I
[7590-01], l (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 us,ed, the prescribed dose, and the trea,tment plan.
(c) Prescriptions and other records made regarding the medical use of byproduct material must be legible and unambiguous.
(d) To demonstrate compliance with requirements for independent checks of data transfer and calculations, the licensee may have the individual who performs the check tick the appropriate data in the record and then initial the record.
(e) 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 prescription or other record is unclear, ambiguous, or apparently erroneous.
- 4. In Subpart F--Radiopharmaceuticals for Therapy, 6 35.302 is added to read as follows:
9 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.
- 5. In Subpart G--Sources for Brachytherapy, 6 35.432 is added to read l as follows:
20 Enclosure 2
[7590-01] f 9 35.432 Sou'rce 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 may be selected rather than 4
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.
- 6. In Subpart G--Sources for Brachytherapy, 5 35.452 is added to read as folicws:
9 35.452 Physical measurements of patient.
[ Reserved] i
- 7. In Subpart G--Sources for Brachytherapy, s 35.454 is added to read as follows:
6 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.
(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 21 Enclosure 2
[7590-01) ,
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 )
treatment in order to perform the checks of dose calculations required i
by this section would jeopardize the patient's health because of the l emergent nature of the patient's condition, the licensee may provide the I
prescribed treatment without performing the checks. The prescribing physician shall make a notation of this determination on the patient's chart. The licensee shall perform the checks as soon as practicable.
1
- 8. In Subpart I--Teletherapy, 9 35.632, paragraph (b)(1) is revised to read as follows:
J 35.632 Full calibration measurements.
I (b) To satisfy the requirement of paragraph (a) of this section, full calibration measurements must include determination of:
(1) The output within 3 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;
- 9. In Subpart I--Teletherapy, 6 35.633 is added to read as follows: !
6 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 5 35.632 of this Part.
22 Enclosure 2
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(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 5 35.630 of this Part, or ,
it may be another system that provides a similar level of accuracy and precision.
- 10. In Subpart I--Teletherapy, 6 35.652 is added to read as follows:
5 35.652 Physical measurements of patient.
[ Reserved] 4
- 11. In Subpart I--Teletherapy, 5 35.654 is added to read as follows:
5 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 provide assurance that the final treatment plan will provide the dose prescribed in the patient's chart.
1 (a) Manual dose calculations must be checked for accuracy by an i j
individual who did not make the calculations.
I (b) Computer-generated dose calculations must be checked by l I
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 l l
into the computer.
l l
l l
23 Enclosure 2 l
[7590-01] ,
(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 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 been administered.
(e) If the prescribing physician makes a determination that to delay treatment in order to perform the checks of dose calculations or physical measurements 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 of dose calculations or physical measurements. The prescribing physician shall make a notation of this determination on the patient's chart. The 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.
24 Enclosure 2
l RESPONSE T0 QUESTIONS IN DECEMBER 16, 1986 STAFF REQUIREMENTS MEMORANDUM Introduction In a follow-up memorandum on medical misadministration dated December 16, i 1986,'the Commission directed the staff to give priority attention to the development of a proposed rule that would strengthen NRC oversight of medical licensees. The staff has provided an Advance Notice of Proposed Rulemaking in Enclosure 1 as well as a proposed rule in Enclosure 2.
The Commission also directed the staff to prepare a comprehensive analysis of NRC's regulations and other initiatives that may reduce the frequency of misadministration, and specifically raised ten elements to be considered.
Various options, such as rulemaking, issuance of orders, na.ional voluntary standards, and increased FRC presence are discussed here an0 in Enclosures 4 and 5.
Analysis Continuing Evolution of the Medical Use of Byproduct Material In diagnostic nuclear medicine we have witnessed in the last few years the development of devices that contain radioactivity and that can be used by physicians and paramedic personnel who have never before had an NRC license. In conventional nuclear medicine, in which radiopharmaceuticals are administered to patients for diagnostic or therapeutic purpose, the development of new radiopharmaceuticals and clinical procedures has raised new technical problems for staff analysis as well as attracting new practitioners who were never before NRC licensees. The most dramatic example of this is the development of diagnostic nuclear cardiology. As little as ten years ago, this speciality was only briefly mentioned in the closing chapter's of nuclear medicine science textbooks. Now, nuclear cardiology clinical procedures are employed in many cardiology departments as well as nuclear medicine departments.
1 Enclosure 3
t i
The NRC will also likely have to deal with the development of new technologies..
If research with alpha-emitter labels or radio-labelled monoclonal antibodies for ,
diagnostic and therapeutic use is successful, the staff will have to address a whole new plethora of worker and public radiation safety issues and technical issues associated with alpha-emitting radioisotopes, which are new to nuclear medicine. The use of teletherapy, although not evolutionary in and of itself, will be complicated by its application with hyperthermic and chemotherapy. Thus, NRC's medical use regulations will likely have to be modified to address new areas as new treatment regimens are developed. ,
Impact on the Delivery of Medical Care In considering changes to the regulatory program governing the medical use of byproduct material that would improve public health and safety, the staff is faced with several dilemmas.
Diagnostic and therapeutic procedures save lives and reduce human suffering. - '
For example, one diagnostic procedure alone, the detection and localization !
of pulmonary embolisms, has reduced this as a cause of death in hospitals from ;
about 200 to 300 per week to essentially zero. There are other potentially life-saving diagnostic procedures such as those for gastro-intestinal bleeding and hepato-biliary dysfunction. In the case of therapy, which involves large radiation doses, there is often a fine line drawn between providing sufficient radiation to destroy a lethal tumor while attempting to avoid damage to vital healthy tissues. Such therapy often involves risks which must be balanced by the physician.
Our objective is to improve the regulatory regime covering nuclear medicine, while avoiding unintentionally impeding the delivery of medical care by imposing unworkable regulatory requirements or making regulatory control so enerous, and the professional risk so great, that the availability of nuclear medicine for those in need is curtailed. The issue is clearly not how rules affect physicians who have alternatives in the field in which they choose to practice, but rather how the rules affect patients who have few alternatives for methods and locations of treatment.
In a similar vein, we must develop regulations that do not influence physicians' decisions as to what medical actions they believe to be in the best i
2 Enclosure 3
_ _ _ _ - _ _ - __O
o interest of their patients. There is oftsn not time for a physician to seek clarification of rulec or seek exceptions as applied to a particular case before treatment decisions must be made.
Need for Resources NRC resources are an important issue in increasing the effectiveness of '
the NRC's niedical use regulatory programs. The staff presently has essentially only one FTE budgeted to keep its regulatory. practices abreast of evolving technology and to work with the medical community on development of safe practices and procedures. The staff believes more effort in this area is essential for maintaining a viable and effective regulatory program.
Given competing demands for NRC resources, staff resources that are devoted to medical use, and the materials program as a whole, have been reduced to a bare minimum. During FY86, NRC budgeted about 60 staff-years for licensing and inspection in the materials program, which includes approximately 9000 medical, .
academic, and commercial licensees. Of these, about 19 staff-years were used for medical licensing and inspection. The resource allocation for medical licensing and inspection is based on the application workload and the priority assigned to inspections.
In the case of misadministration, we are attempting to further reduce an already very small reported incidence rate. To accomplish this objective, additional resources will be needed to review quality assurance programs in the licensing process and to inspect for compliance. Also, more frequent inspections than are provided for in the current budget (every three years for almost all medical licensees) are needed if our goal is prevention of misadministration rather than reactions to them.
Given these constraints, however, the staff does believe there is j opportunity for improvement in the regulatory program for medica: use. l l
(
Response to Elements !
I l
Initiatives are discussed in the staff response to each of the elements )
raised by the Commission in its December 16, 1986 memorandum as follows:
3 Enclosure 3
puestion1. Whether the rulemaking under development in response to the April 14, 1986 SRM goes far enough in strengthening NRC regulations?
Response 1. There are two parts to the April 14, 1986 SRM: quality l assurance for radiation therapy and standards of medical care. The staff believes that the April 14, 1986 SRM provides the staff ample guidance to initiate a strengthening of NRC regulations in these two areas. Compliance with the basic quality assurance steps in Enclosure 2 would have eliminated about three-fourths of the misadministration reported in AE00/C505. More can be done, but is not clear how much quality assurance is in place now and how much can be realistically required without negatively impacting the delivery of medical care. Therefore, the advance notice in Enclosure 1 poses certain policy and technical questions for public comment.
Recommendation: The staff should address this matter in the context of the proposed rule that evolves from the ANPR on this suoject.
Questien 2. What additional measures are needed, including improvement in the regulations or inspection proaram? Should there be chances to the content or an increased frequency of NRC inspections of Part 35 licensees?
Response 2. In addition to rules that might be needed to address the elements raised t,f the Commission, there are other matters that need to be con W ered. For example, the Office for Analysis and Evaluation of Operational Data (AE0D) recently published a study en diagnostic misadministration that have led to doses in the therapy range (AE0D/N701). Depending on the staff analysis of that stur'y, further rulemaking might be indicated for diagnostic quality assurance.
The new 10 CFR Part 35 was recently issued. As experience is gained with the new rule, further adjustments or additional guidance related to implementa-tion might be indicated.
The staff also believes that the term " misadministration report" has had a detrimental effect on NRC's ability to participate in voluntary industry improvement programs that are under way and tends to undermine cooperation with the medical community which the staff seeks. The staff notes that at the Food 4 Enclosure 3
and Drug Administration, which regulates manufacturers but not end' users, the programs to collect information about potentially faulty products and devices are entitled, " Problem Reporting Programs." The two programs are endorsed by over 80 regional and national organizations. Each year about 7,000 reports are submitted by individuals that result in about 200 recalls or. corrective actions.
The staff believes that the deletion of the term " misadministration" can be coupled with closer NRC-medical industry cooperation, thereby providing greater assurance of public health and safety. The staff recommends that NRC's reporting requirement be retitled " Medical Use Event Report" if the medical industry demonstrates a cooperative attitude.
With the reorganization, the staff anticipates a closer coupling of licensing and inspection policy and procedures. Changes in the rules neces-sarily result in changes in licensing and liarection content. These will be !
re-examined. The staff anticipates that licensins standard review plans and inspection modules will need to be modified. .
Imposition of quality assurance regulations would require training of NRC
' staff because radiation therapy quality assurance is different from radiation sa fety. There is little overlap. Inspections of quality assurance programs would be time consuming--at least an entire day for each licensee.
The amount of resources devoted to medical licensing and inspection is a critical issue. As regulations become more comprehensive, additional resources will be required for both. Approximately 0.5 percent of NRC's total resources are applied to medical licensing and inspections. Inspection is a key issue.
Of the 2,500 NRC medical licenses, 749 were inspdcted in 1985. NRC " presence" in nuclear medicine is limited. An increased NRC presence coupled with the requirements of the proposed rule may improve licensees' attention to matters of quality and lead to a reduction in the misadministration rate.
If our objective is to prevent misadministration rather than investigate after an incident occurs, the staff needs to assess compliance with quality assurance rules and identify licensee programmatic weaknesses before failures lead to a misadministration rather than later. This would require redirection of the medical licensee inspection program. The staff also believes that coupling more frequent inspections, perhaps every eighteen months, with the proposed rule is important to meet the Commission's goal of reducing misadmin- )
istrations, and to better assure compliance with all its regulations.
5 Enclosure 3 i
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Recommendation: The staff should consider in the next budget cycle adding resources to cover new rule development, increased licensing and inspection effort to evaluate licensee QA programs, and a modest increase in inspection frequency to provide a greater NRC " presence" at medical licensees.
Question 3. Whether the training, guidance, and supervision of technologists is adequate?
Response 3. The staff believes there is room for improvement. However, the issues are complex and improvements may prove difficult. The staff estimates there are about 12,000 diagnostic nuclear medicine technologists and 2,400 radiation therapy technologists working under NRC and Agreement State licenses. The licensees' training criteria vary widely depending on the patient load and the responsibilities assigned by the supervising physician.
There is a chronic, nationwide shortage of therapy technologists and dosimetrists (specially trained technologists who calculate treatment plans based on the physician's prescription). The departure of incumbents from these occupations is higher than for other occupations because of the difficult physical and emotional work environment. Experienced workers are not readily available in the marketplace. When these concerns are applied to the entire field of medical use of byproduct material, the dimensions of the issues expand considerably.
Recommenda tion: Examine the ANPR responses to this issue, and include, in the FY88 budget, funds for a contract study that would: (a) provide information about patterns of technologists' duties and responsibilities; (b) assess the adequacy of training, guidance, and supervision of technologists; (c) identify weaknesses in training, supervision, and the workplace; and (d) make recommenda-tions for improvement either through the regulatory process or complia n e with voluntary standards prepared by the medical community.
Question 4. Development of a mechanism to track practitioners known to have willfully violated NRC regulations so that such information is considered in any subseouent licensing; also an assessment of the adequacy of the feedback of information on individuals who repeatedly violate NRC regulations.
Response 4. The staff addressed this issue for all licensees in-SECY-86-319, " Identifying and Informing Others of Wrongdoers," October 29, 1986. I However, the staff notes that the President recently signed Public Law 99-660, which, among other things, establishes a tracking system for physicians who have been disciplined or defeated in malpractice cases. The Department of Health and Human Services (HHS) is charged with implementing this law.
Recommendation: The staff should ascertain HHS plans to implement this statute and explore methods for NRC access to the tracking system to obtain and supply information.
Question 5. A_ requirement that all licensees maintain, and provide to patients upon request, a record of the anticipated and actual radiation doses received by patients as a result of all licensed procedures.
Response 5. The staff believes that physicians, upon request, already provide information on the amount of radiation used and the method of treatment, and does not believe this is a significant issue. A simple requirement to provide a statement of dose prescribed and dose given would not violate physician confidentiality considerations and may be worthwhile. However, specific, detailed medical or technical information is easily subject to misunderstanding, and may be counterproductive.
A rule governing availability of specific, detailed dose information would not explain the basis of the physician's prescription for the condition being treated, or the expected results. (See, for example, Enclosure 7, which discusses the problem of compromise in radiation dose to eradicate a tumor while minimizing structural or functional injury.)
Recornmendation: The staff should explore this matter ;fith the Advisory Committee on the Medical Use of Radioisotopes (ACMUI) to further assess the staff's preliminary views.
Question 6. A mechanism for followina up on patients who have been sub.iect to reported misadministration.
Response 6. The need for and method of patient follow up would vary l widely depending on the nature of the misadministration. The staff believes 7 Enclosure 3
that this should be handled mainly as a physician-patient matter. The physician must make decisions based on detailed knowledge of the patient's medical condition and the patient must make personal decisions. Assuming continuation of the standing regulatory practice of investigating the cause of the misadministration and offering expert medical assistance through NRC medical consultants, as appropriate, it is not clear how further regulatory intervention would benefit the patient.
Recommendation: The staff should further explore with the ACMUI possible follow-up mechanisms that might benefit patients who have received therapy misadministi ations.
Question 7. A procedure to verify that referring physicians and patients are indeed notified of misadministration, as currently required by NRC regulations.
Response 7. Item 2 above identified the misadministration reporting requirement as a rule that might be modified. If modified, the rule could also require written confirmation that the referring physician or patient has been notified. Also, inspectors could check during routine inspections that notification was accomplished. Alternatively, a complete inspection manual for follow-up of misadministration could be developed.
Recommendation: The staff should Jndertake appropriate modifications of the misadministration reportino requirement.
Question 8. The need for edditional feedback mechanisms such as addi-tional NRC information notices on reported medical misadministration to ensure that all licensees can benefit from lessons learned.
Response 8. The staff is already doing this. See:
"One Year's Experience With Misadministration Reporting," L. Roche, Society of Nuclear Medicine Newsline, v7, nl, pp 4-5, March 1982.
8 Enclosure 3
"NRC Reports on Misadministration and Unannounced Safety Inspections,"
N.L. McElroy, and " Physician Removed from NRC License for Failure to Report Misadministration," J. E. Frohman, Journal of Nuclear Medicine, Vol. 27, pp 1102-1107, July 1986.
"NRC Reports on Therapy Misadministration," N.L. McElroy, accepted for January 1987 publication in newsletters of the American College of Radiology and American Association of Physicists in Medicine.
" Case Study Report on the Therapy Misadministration Reported to the NRC Pursuant to 10 CFR 35.42," S. Pettijohn, was distributed to all medical licensees.
IN 86-85 Enforcement Actions Against Medical Licensees for Wilfull Failure to Report Misadministration .
IN 86-84 Rupture of a Nominal 40-millicurie Iodine-125 Brachytherapy Seed Causing Significant Spread of Radioactive Contamination Bulletin 86-04 Defective Teletherapy Timer that May Not Terminate Treatment Dose IN 86-95 Leak Testing Iodine-125 Sealed Sources in Lixi, Inc. Imaging Devices and Bone Mineral Analyzers IN 85-61 Misadministration to Patients Undergoing Thyroid Scans
-IN 85-85 Molybdenum Breakthrough from Technetium-99m Generators IN 84-62 Therapy Misadministration to Patients Undergoing Cobalt-60 Teletherapy Treatments 9 Enclosure 3 i
The staff notes that medical organizations have been very willing to publish NRC-authored articles in their journals and newsletters.
Recommendation: The staff should continue to inform the medical ,
community of misadministration events and enforcement actions through NRC notices and publications in professional journals.
Ouestion 9. Whether, apart from increased NRC oversight, there are any changes in industry practice or standards that could substantially improve the quality of performance and minimize human error.
Response 9. The staff believes responses to the Advance Notice of Proposed Rulemaking in Enclosure 1 may provide insights on this matter.
Recommendation: During the course of developing rules that evolve from the ANPR, the staff should identify and consider other changes in industry practice that could substantially improve the quality of performance and minimize human error.
Ouestion 10. What interactions do we have with industry organizations and what initiatives do they have in progress which could help?
Response 10. The American College of Radiology (ACR) and the American Association of Physicists in Medicine (AAPM) are the two key organizations.
The ACR has developed quality assurance programs for delivery of radiation therapy, and has also operated the Patterns of Care study, which is apparently the first medical study in any medical specialty to provide long-term, follow-up of patients to develop a prospective data base that will allow the determination of the optimum treatment for patients with certain diseases.
The AAPM has been active in assisting in the development of quality l assurance programs, and instrumental in the development and management of a certification program for dosinetry equipment calibration laboratories. The following task groups are working on quality assurance projects that apply to sealed source therapy: Regional Calibration Laboratory, Computer Applications, l Radiotherapy Port Film Quality, Total and Half-Body Irradiation, Radiotherapy i
l 10 Enclosure 3
l Quality Assurance in Clinical Trials: Treatment Specification & Review, Specification and Calibration of Brachytherapy Sources, Lung Corrections, and Evaluation of Models for Dose Response in Radiation Oncology. This is in addition to twenty-one other committees working on quality assurance programs for medical use of radiation that is not under NRC jurisdiction.
The staff has already had informal meetings with the ACR and the AAPM and intends to fully utilize the resources of all these organizations once the public is given formal notice of NRC's intent to initiate rulemaking on these matters.
Recommendation: The staff should continue communicating with affected professional organizations to inform them of NRC plans regarding safety in nuclear medicine and radiation therapy, and work with these organizations to {
establish industry solutions to the extent practicable.
II Enclosure 3
REGULATORY ANALYSIS FOR THE ADVANCE NOTICE OF PROPOSED RULEMAKING
" COMPREHENSIVE QUALITY ASSURANCE IN MEDICAL USE AND A STANDARD OF CARE" At this early phase of the rulemaking process, the staff is not able to !
project any public, licensee, or Agency costs or benefits. However, the following general issues have been identified.
- 1. Medical Policy Statement In its medical policy statement published February 9, 1979 (44 FR 8242), ,
NRC said, "1. The NRC will continue to regulate the medical uses of radioisotopes i as necessary to provide for the radiation safety of workers and the general public.
"2. The NRC will regulate the radiation safety of patients 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."
It cannot be argued that there have not been mishaps in radiation therapy.
Although the medical community has implemented many radiation therapy quality assurance programs, it is not clear whether any combination of available pro-grams completely examines the radiation therapy process. However, the medical community may take issue with the assertion that voluntary standards and com-pliance with then is inadequate.
- 2. Human Error 1
Should NRC treat human error in the materials area the same way it treats ,
operator error? The NRC issues licenses to hospitals and lists physician !
l 1 Enclosure 4
l s
duthorized users on that license. The NRC does not individually license '
physicians, physicists, dosimetrists, or technologists and does not normally take action against them as individuals. Enforcement Actions are taken against the licensee. On the other hand, reactor operators must meet specific training requirements and are individually examined and licensed.
NRC does not normally take punitive action against reactor operators who make errors similar to those that might be made in a misadministration. Rather, NRC may order licensees to temporarily remove and retrain reactor operators who make such mistakes. Then additionally, some licensees invoke their own punitive measures.
How should human error in medical use be treated?
- 3. Quality and Availability of Medical Care NRC's implementation of regulations that result in a significant increase in licensees' resources expended, or professional risks, could have a negative impact on the delivery of medical service to some portions of the population, and may cause some licensees to stop providing radiation services. Small licensees may not have enough patients to warrant the purchase of quality assurance equipment, to hire the staff needed to independently verify measure-ments and calculations, or to assume large risks.
There are about 1200 cobalt-60 units in the U.S. used to treat about 100,000 patients each year. About 300,000 patients are treated in the U.S.
each year with high energy x-ray machines, linear accelerators, that are not under NRC jurisdiction. However, the entire radiation therapy process is very similar. Some States apply no quality assurance requirements to the use of linear accelerators for teletherapy. The NRC notes that a stringent quality assurance program requirement for cobalt teletherapy might be inconsistent with some States' regulation of linear accelerator teletherapy, and will have to I resolve any resulting confusion.
l
- 4. State Regulation of Medical Services Although the Federal government regulates the quality of drugs and devices ,
sold for use in medical service, the States are responsible for regulating l
l 2 Enclosure 4
i l
medical services. Though the NRC clearly has statutory authority with respect I to medical use of byproduct material, this rulemaking may be considered by some States as an intrusion on their prerogatives to regulate medical services.
- 5. Methods of Reimbursement for Medical Care )
The Federal government no longer pays for patient care under Medicare on a fee-for-service basis. Now the' government makes a lump sum payment based on the diagnosis made at the time of admission. There is a chart of several hundred " diagnosis related groups" (DRG's) that identifies the amount paid for each malady. Thus, contrary to the fee-for-service reimbursement scheme, a hospital now reduces its profit, rather than increasing it, by providing addi-tional services for each patient.
- 6. ~ Lawsuits and Insurance Rates .
A regulation that increases the chances of lawsuits would likely increase malpractice insurance rates and, therefore, the cost of medical care.
- 7. Coordination with Other Federal Acencies There are three agencies under the Department of Health and Human Services that are active in medical affairs. The Center for Devices and Radiologic Health regulates the quality of devices sold for use in medical service. The National Cancer Institute has special expertise in radiation therapy. The Health Care Financing Administration is responsible for setting reimbursement
' amounts for medical services provided under Medicare. These agencies should
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{
have the opportunity to comment on this rulemaking.
- 8. NRC Resources The NRC will have to modify its inspection procedures and inspector training program. The time devoted to inspection will require additional resources, the amount depending on the kind of quality assurance program deve% ped.
3 Enclosure 4
f 4
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1 1
REGULATORY ANALYSIS FOR PROPOSED RULE !
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" BASIC QUALITY ASSURANCE IN RADIATION THERAPY" l
1.- STATEMENT OF PROBLEM
. Some medical licensees that provida radiation therapy services do not have adequately defined or properly executed quality assurance programs to assure that the dose administered is the same as the dose prescribed. This has resulted, on occasion, in the misadministration of radiation. Some of these misadministration have had deleterious effects on patients, i.e., members of the public who are within NRC's regulatory responsibility. Under its current rules, the NRC has no regulatory basis for enforcement action against licensees -
that, due to inadequate quality assurance programs, misadminister radiation.
The problem, therefore, is use of inadequate quality assurance programs by some licensees, and lack of authority to take enforcement action against medical licensees that fail to implement adequate quality assurance programs. A quality assurance program requirement would allow NRC to take action in accordance with !
the existing Enforcement Policy.
I
- 2. OBJECTIVES l 1
The purpose of this rulemaking is to require medical licensees that provide radiation therapy services to implement a basic quality assurance program. As a parallel project, NRC will work with the radiation therapy community to develop a more comprehensive quality assurance program. An Advance Notice of Proposed i Rulemaking (ANPR) will be issued in connection with this project. The ANPR will I also examine NRC's actions in response to radiation therapy misadministration. !
! 3. ALTERNATIVES The NRC could do nothing, could provide quality assurance guidance and request voluntary implementation, or could require implementation and provide penalties for either noncompliance or program failure due to human error.
1 Enclosure 5
The no-action alternative is not acceptable because some patients have been harmed by improper use of radiation, and it does not respond to the Commission's directive.
The staff believes that most licensees already have some kind of quality assurance program in place, albeit perhaps informal or incomplete, to assure quality care and avoid lawsuits. However, due to cost containment measures (see Enclosure 4), licensees may be disinclined to provide more resources unless a regulatory requirement is placed on them.
The staff has prepared a rule (see Enclosure 2) that would require implementation of a basic quality assurance program.
- 4. CONSEQUENCES General NRC has about 400 cobalt teletherapy licensees and the Agreement States have about 800. About 35,000 patients are treated by NRC licensees each j year, and about 65,000 are treated by Agreement State licensees. l NRC has about 700 radiopharmaceutical therapy licensees and the Agreement State.s have about 1,400. The staff estimates that each licensee treats about 12 patients each year.
NRC has about 400 implant therapy licensees and the Agreement States have about 800. The staff estimates that each licensee treats about 25 patients i each year.
Section 35.43 Prescriptions and records of medical use for therapy.
The staff does not expect licensees to be subjected to increased costs due to this requirement because maintenance of clear and complete records of all medical care is a common practice for business and legal reasons.
Section 35.432 Source strength measurements.
Licensees may use a nuclear medicine dose calibrator or an ionization-type survey meter to make this measurement. The staff estimates it will take one hour of professional time to measure a set of long-lived, reusable sources and one hour to sample and measure a set of short-lived sources.
2 Enclosure 5 l _ _ _ _ _ - _ _ _ _ _ _ _ - _ _ -
Section 35.454 Check of calculations, and 35.654 Checks of dose calculations and measurements of dose.
A requirement under which each dose calculation would be checked by a separate individual would recuire one hour for each patient. Based on costs )
for similar precision dosimetry services, the staff estimates that a physical l measurement of a single teletherapy treatment.given to one patient would cost
$50. This assumes the measurement would be made with a few carefully calibrated i thermoluminescent dosimeters.
Section 35.632 Full Calibration measurements.
The staff believes the additional required measurements will consume about one hour of professional time each year.
l Section 35.633 Independent check of full calibration measurements.
Single independent measurements of output using precision thermoluminescence dosimetry are available for $35.
- 5. DECISION RATIONALE The staff believes that certain basic radiation therapy quality assurance measures are needed to assure public health and safety and has consolidated them here.
- 6. IMPLEMENTATION After publication of this rulemaking, the staff will begin working with professional organizations to develop a comprehensive quality assurance program.
l The program will be available for public comment.
I Based on the comments received, the staff will develop a rule that requires implementation of a comprehensive quality assurance program and provides a basis for enforcement action in cases of noncompliance.
I 3 Enclosure 5
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DRAFT SCHEDULE QUALITY ASSURANCE IN RADIATION THERAPY Submit this Commission Paper 1/87 Publish proposed rule on basic quality assurance (Enclosure 2) for 30-day comment 3/87 Publish advance notice on complete quality assurance (Enclosure 1) for comment 4/87 Submit final rule on basic quality assurance to Commission (this step may be delayed if there are requests for extension of the comment period) 8/87 Publish final rule on basic quality assurance 9/87 Submit proposed rule on complete quality assurance to Commission 1/88 Publish proposed rule on complete quality assurance for 60-day comment 3/88 Submit final rule on complete quality assurance to Commission 11/88 Publish final rule on complete quality assurance 11/88 1
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l Enclosure 6
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DESCRIPTION OF THE RADIATION THERAPY PROCESS The Following Text is from Clinical Oncology for Medical Students and Physicians, Sixth Edition, Philip Rubin, M.D., Editor American Cancer Society, 1983 Explanatory notes inserted by the staff are set off in [...].
l I
Enclosure 7
1
.. i OVERVIEW The ideal in radiation therapy of malignant disease is achieved when the tumor is completely eradicated and the surrounding normal tissues show minimal evi-dence of structural or functional injury. This ideal has been described as the selective effect of irradiation. In clinical practice, this ideal selective effect is obtained infrequently; consequently, as,a compromise, one accepts a certain degree of permanent residual damage as a sequel to the destruction of a lethal tumor. The acceptable extent of such alteration of nomal structures varies in different settings, but the integrity of vital tissues must always be maintained. .
This ability to eradicate the tumor without undue complication or destruction of normal tissues is the essential factor in tumor radiocurability. Therefore, it is necessary to either: (1) destroy the tumor cells more readily than vital .
normal tissues in the treatment field for the same dose absorbed; or, (2) focus the radiation beam so that a differential dose between the tumor volume and the normal surrounding tissue is achieved. Such improvements in therapy will result from research advances in biology for the former, and radiation physics in the latter circumstance. [page 58]
TELETHERAPY TREATMENT
- 1. Staging of cancer: The staging of cancer is the first step in the treat-ment decision. Radiation treatment is usually designed to treat a tumor i i
volume; this volume is often defined by the site or structure of origin 1 and its local spread to contiguous structures and regional lymph nodes.
The extent of metastatic disease also requires definition, as do all fields that extend beyond the sites of obvious involvement.
1
- 2. Precise definition of the tumor volume: Oncologic imaging has become more precise with computerized tomography (CT) and other diagnostic procedures.
The ability to reconstruct the tumor volume in different planes, i.e., trans-verse or cross-sectional, sagittal and coronal has allowed for 3-dimensional viewing.... Surgical clips left by the surgeon at the time of resection can identify residual disease. A cross-sectional contcar of the patient with 1 Enclosure 7
the " tumor volume" drawn in and a surrounding margin for suspected micro-scopic extensions and some normal tissue completes this step by defining the " target volume."
l
- 3. Identification of critical normal structures: The need to identify dose-limiting vital normal tissues that will be included in the treatment fields is an essential part of the treatment plan. The dose to the tumor needs j to be given uniformly, but vital tissues and organs should receive as mini-
. mal a dose as is consistent with the prescription for the tumor. The normal dose-limiting vital tissues are then added to the patient contour, i.e., kidneys, spinal cord, and liver.
- 4. Dosimetry: Radiation treatment planning is generally done by computers.
This is accomplished by having complete isodose curves for different energy beams, different field sizes, and commonly used wedges [ teletherapy unit accouterments used to slant the contour of the radiation beam] available in computer programs. The tumor and target volume and the volume of normal organs are added to the patient's contour, and the treatment beams are then selected. The entire process can be followed on a video screen. Within minutes, different arrangements of isodose curves can be combined and displayed. The "best" individualized plan for each patient is chosen in consultation between the radiation physicist and radiation oncologist.
- 5. Simulation films: Simulation films are obtained on a radiographic unit that has identical geometrical factors to the negavoltage treatment unit.
Fields are marked and shields [ teletherapy unit accouterments used to customize the contour of the treatment beam, which is normally rectangular with continuously adjustable length and width] are cast to block exposure of vital organs, i.e., lung shields or spinal cord shields. Beam films under the treatment unit are obtained to verify proper positioning of the patient and shields by the technician.
- 6. Quality assurance and reproducibility of daily treatment are essential since usually 25-30 treatments are required for a curative course of radia-tion therapy. [ Treatments are typically administered 5 times each week for 2 Enclosure 7
r_______--_ _--__ _
)
5 weeks. The total treatment dose is typically 5,000 rad.] The aim of most treatment is to reduce the variation in dose to less than 5% at most. Radiation therapy quality control procedures have been developed through cooperative group studies. Weekly chart and beam film reviews are conducted by radiation oncologists, and machine calibrations as well i as phantom and in vivo dosimetry are checked by radiation physicists to
~
assure accuracy and consistency of dose. Quality assurance procedures j and reproducibility are essential for precise treatment. [pages 73 to 75] l l
l BRACHYTHERAPY OR IMPLANT TREATMENT USING CERVICAL CANCER AS AN EXAMPLE Treatment plans are individually designed for each patient, based upon the clinical (and surgical) stage of disease. Intracavitary irradiation delivers high doses to the central tumor, while supervoltage external beam treatment i assures adequate dosage to the node-bearing areas and also can be extended to include the periaortic nodes when indicated. Computerized treatment planning allows for 3-dimensional reconstruction of internal and external irradiation.
Cesium sources have replaced radium, since they require less shielding and can be miniaturized for afterloading, as a result, cesium sources are safer and easier to handle. When placed in a closed metal cylinder (tandem) and inserted into the cervical canal and uterus, these intracavitary sources are held in place by attachment to the vaginal colpostats that deliver additional irradia-tion to the vaginal fornices. [The implant is typically comprised of 515-mci tubes 0.1 in dia x 0.8 in each.] The resultant dose distribution is in the form of a pear-shaped isodose curve, with greatest coverage in the upper vagina, cervix, parametria, and uterine isthmus.
Intracavitary cesium is more effective when the volume of the cancer in the cervix is smaller. The larger the cervical tumor, the greater the reliance on external beam therapy to shrink the cervical cancer to a size that can be satis-factorily controlled by intracavitary treatment after completion of external therapy.
Optimum doses for carcinoma of the cervix are determined by the tolerance of the surrounding organs, particularly the rectuu, bladder, and small intestine.
3 Enclosure 7
i Radiation tolerance of the cervix, endocervix, endometrium, and my6metrium is high, however, so that doses ranging from 15,000-25,000 rad may be absorbed by cervical stroma in the course of radiation treatment.
Radiation doses in cervix cancer are usually reported at " point A" and ' point B."
Theoretically, point A represents a paracervical area at the crossing of the uterine artery and ureter; point B represents the pelvic sidewall and iliac lymph nodes. In general, 5,000-5,500 rad are delivered to the pelvic. sidewalls (pointB)>and 7,500-8,500 rad are delivered to point A [by implanting 75 milli-curies for 48 hour5.555556e-4 days <br />0.0133 hours <br />7.936508e-5 weeks <br />1.8264e-5 months <br />s]. [page464]
RADI0 PHARMACEUTICAL TREATMENT USING RADI0 ACTIVE IODINE THERAPY AS AN EXAMPLE The principle involved in iodine-131 treatment of local and distant metastases is to induce avidity for fodine in tumor tissue utilizing the endogenous thyroid stimulating hormone (TSH) stimulus that develops after the ablation of all func-tioning tissue.
In view of the increasing competitive effects of stable iodine in the diet, a 5-day low iodine diet combined with a loop diuretic has resulted in significant increased tumor uptake.
After " total or radical subtotal thyroidectomy" has been attempted surgically, en ablative dose of 30-50 mil 11 curies of iodine-131 is usually given postopera-tively [ orally by capsule or liquid dosage] on the basis of tracer evidence of small nests of residual tissue at the thyroid site. However, repeat ablative doses are often required....
If the criteria for ablation are not met, high-dose radioactive treatment is begun and continues until criteria are in conformity.
l Treatment usually ranges from 75-200 mci of iodine-131 given at 3-4 week intervals until retention ceases. Total dosage acave 500 mC1 is not advised.
[page 331]
f 4 Enclosure 7
(
STAFF REQUIREMENTS MEMORANDA
- 1. COMFB-86-3 dated April 14, 1995,
- 2. COMFB-86-8/C0MLZ-86-25 dated December 16, 1986.
l l
l l
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1
)
t l
l Enclosure 8
, . n
. /'pns eauq*o UNITED STATES
' ACTION - Davis._.
! o NUCLEAR REGULATORY COMMISSION Cys: Stollo
,d
- i W .SHINOTON, D.C. 20553 Roe o ?
'%EWl,p# >
Rehm Sniezek
- ...a April 14, 1986 Minogue OFFICE OF THE GCunningham SECRETARY COMFB-86-3 Philips
...//
MEMORANDUM FOR: Victor Stello, Jr.
Executive Director for O rations FROM: Samuel J. Chilk, Secrete y V j
SUBJECT:
MEDICAL MISADMINISTRATION (; OF RADIATION )
THERAPY f The Commission (with all Commissioners agreeing) reauests that j the staff review the authority currently possessed by the Commission in the area of medical licensee regulation. The staff is to prepare and submit to the Commission a rulemaking ,
package which would_ provide the authority needed to-j (1) require independent verification of therapeutic doses, as is done in the case of diagnostic procedures, and (2) penalize medical licensees for their negligence or j that of their employees, agents or practitioners.
(EDO/NMSS) (SECY -SUSPENSE: 4/15/87) cc: Chairman Palladino Commissioner Roberts Commissioner Asselstine Commissioner Bernthal Cc:rmissioner ::ech OGC OPE '
- / G - h' u L.: ?$ b l
i I
l Enclosure 5 (1.) 1
F .
. ]j
- h4 UNITED STATES 5
.' ! NUCLEAR REGULATORY COMMISSION
'5 ) b :% E WASHINGTON, D.C. 20555 . ellO I
l Y
- d' m December 16, 1986 Sniezek l OFFICE OF THE 8eckjord l SECRETARY IaylOr.
f Denton- '
Murray . d COMFB-86-8 "_0y COMLZ _S6-25 MEMORANDUM FOR: [ Victor Stello, Jr.
- Executive Director for Operations l
FROM: , h amuel J. Chilk, Secretary
SUBJECT:
MEDICAL MISADMINISTRATION - NEED FOR IMPROVED OVERSIGHT On April 14, 1986, the Commission directed the staff to.
prepare and submit to the Commissions by April 15, 1987, a -
rulemaking package that would strengthen NRC oversight of' medical. licensees.
In the ensuing months, additional serious medical misadministration involving both diagnostic and therapeutic doses of licensed radioisotopes have been brought to the Comission's attention.
In view of the foregoing, the Commission requests'that the-development of a proposed rule be given priority attention-and be accelerated to the greatest extent practicable. To this end, the staff is requested to provide, for Commission review, the Advanced Notice of Proposed Rulemaking (currently in' draft) no later than January 31, 1987.
In addition, the Commission requests that you prepare and discuss with the Commission a comprehensive analysis and list of recommendations with options for improvements in administering URC's regulations under Part 35 and other initiatives that may be . effective in reducing medical misadministration. At a minimum, the following elements should be discussed and considered:
- 1. Whether the rulemaking under development in response to the April 14, 1986 SEM goes far enough in strengthing NRC regulations?
- 2. What additional measures are needed, including .
improvement in the regulations or inspection 1 program? Should there be changes to the content or an increased frequency of NRC inspections of Part 35 licensees? . -..
-._ _/ .:. - / 1 - f% _
g,_. rr._.
Enclosure 3 (2.' _
r- - %
e 5 *
/
4 Victor Stello, Jr. !
- 3. Wheuher the training, guidance, and supervision of technologists is adequate; 4
- 4. Development of a mechanism to track practitioners 1 known to have willfully violated NRC regulations so that such information is considered in any subsequent licensing; also an assessment of the adequacy of the feedback of information on individuals who repeatedly violate NRC regulations;
. 5. A requirement that.all licensees maintain, and provide to patients upon request, a record of the anticipated and actual radiation doses received by patients as a result of all licensed procedures; i
- 6. A mechanism for following up on patients who have been subject to reported misadministration.
- 7. A procedure to verify that referring physicians and patients are indeed notified of misadministration, as currently required by NRC 1 regulations; j
- 8. The need for additional feedback mechanisms such as additional NRC'information notices on reported medical misadministration to ensure that all licensees can benefit from lesscns learned;
- 9. Whether, apart from increased NRC oversight, there are any changes in industry practice or '!
standards that could substantially improve the !
quality of performance and minimize human error; and !
- 10. What interactions do we have with industry organizations and what initiatives do they have in progress which could help?
In' regard to item 10, the staff should identify appropriate professional organizations such as the American College of Radiology and the American College of Nuclear Physicians with which the Commicsion could arrange to meet to discuss the role of industry initiatives which could be effective !
in preventing medical misadministration.
Enclosure 8 (2.)
p_ -
l . .
Victor Stello, Jr. The Commission requests that the paper discussing the above elements be provided by February 16, 3987. Following review of the draft ANPR and the requested paper, the Commission will provide additional guidance toward a goal of having a proposed rula prepared and published for comment by July 1, 1987. -
The Commission has also agreed that it should take appro-priate actions to strengthen the material licensing / medical programs during the current reorganization initiatives.
Commissioner Carr believes that item 6 above is of secondary importance and that the emphasin should be on prevention of misadministration.
Copies:
Chairman Zech Commissioner Roberts Commissioner Asselstine Commissioner Bernthal Commissioner Carr OGC (H Street) 9 Enclosure 3 l2.)
~ -
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PDA 8['m'o,,
g UNITED $TATES NUCLEAR REGULATORY COMMISSION 7, p WASHING TON, D. C. 20555
\ ***o/ NOV 131987 MEMORANDUM FOR: Vandy Miller, Chief Medical, Academic & Commercial Use Branch, NMSS FROM: Kathleen Black, Chief Nonreactor Assessnient Staff, AEOD
SUBJECT:
AE0D TECHNICAL REVIEW REPORT: REVIEW 0F DATA ON THE TELETHERAPY MISADMINISTRATION REPORTED TO THE STATE OF NEW YORK Enclosed is the subject Technical Review (TR) report that documents our review of the data on the misadministration that were reported to the State of New York and that were the subject of PN0 I-87-74 The review was performed in response to the memorandum dated August 26, 1987 from V. Miller to K. Black, requesting AE0D to review the above data.
I Based on our review of the available data we found that:
- 1. The misadministration essentialy resulted from random errors in dose calculations made by a consulting dosimetrist, and that all of the errors were made on patient treatment plans where data was generated by computer (computer treatment plans).
- 2. In relating the causes of the misaministrations to requirements in the l
proposed rule, " Basic Quality Assurance in Radiation Therapy," the require-ment for a check of dose calculations by an individual who did not perform the calculations and the requirement for weekly accuracy checks of daily arithmetic calculations contained in the proposed rule appear to address the primary causes identified for the misaoministrations. Therefore, we do not believe that any changes to the proposed rule are occasioned as a result of our findings regarding the causes of the misadministration.
- 3. The conclusien in item 2 notwithstanding, the facts of the misadministration hignlight several general issues that we will address in a future TR:
- a. Training requirements for personnel involved in radiotherapy.
l l b. Definition of the relationship between radiotherapy consultants, licensees and NRC in regard to training and other regulatory requirements.
- c. Definitive requirements for periodic patient chart reviews to detect errors in the patient treatment plan.
& S 5.L L -}~ Gb l Y> b f-L______._____-_-__
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Vandy Miller NOV 131987
- d. Requireatent for an annual audit of patient treatment records.
- e. Standardization of computer treatment plans.
- f. Expanded d,efinition of a misadministration,
- g. Quality assurance for linear accelerators.
The above findings are primarily based on our review of date provided by the State of New York Department of Health. The data was compiled by a consulting physicist retained by the hospitals subsequent to the discovery of the misadministration.
The New York Department of Health advised us that the Radiological Health Advisory Committee to the State has been requested to review the data on the misadmini-stratiens; and that a radiological physics consultant under contract to NRC has been retained to review the data. Findings from the above reviews were not available for inclusion in our report.
Our TR that addresses the general issues listed above will allow the findings of the TR to be considered in the development of the proposed rule for comprehensive quality assurance.
Sould you have any questions on the above, please contact Sam Pettijohn on extension 28348.
N ds Kathleen M. Black, Chief Nonreactor Assessment Staff Division of Safety Programs Office for Analysis and Evaluation of Operational Data l
Enclosure:
As stated cc: A. Tse, RES
- - .__.______---__.__.__m.______.___ __._.__.___-__.._.m_._._.-_-_____
AE00 TECHNICAL REVIEW REPORT UNIT: N/A TR REPORT NO.: AE0D/T711 DOCKET NO.: N/A DATE:
LICENSEE: N/A EVALUATOR / CONTACT: S. Pettijohn
SUBJECT:
REVIEW 0F DATA ON TELETHERAPY MISADMINISTRATION REPORTED TO THE STATE OF NEW YORK THAT WERE THE SUBJECT OF PN0-I-87-74A Introduction The State of New York Bureau of ErWonmental Padiation Protection in early August informed NRC (RI) by teleph6.e of the discovery that 22 or more therapy misadministration involving teletherapy treatment had occurred at several hosp.lals in the State. The State of New York does not have a specific requirement for hospitals to report misadministration *. The Bureau of Environmental Radiation Protection learned of the misadministration through another state agency, the Office at Walth Systems Manage'nent, to which the misadministration were reported.** Most of the misadministration met the criteria set forth in 10 CFR 35.2 " Misadministration."
In follow-up reports to NRC the State of New York revesled that three hospitals were involved. The misadministration that occurred at each of the hospitals were found to I: ave resulted from errors made by a single dosimetriW during various phases of dose calcv!ation for patient treatmenn , lhe cosimetsist was employed by a consulting fird that provided radiologia0 ' physics servPjes including " treatment planning" to the hospitals involved. Most of the errer<. y appeared rardom exceot th6t the errors involved treatment plMd that were generated by g eccoutir treatment planning system. There ws ho indication that the treatment platinith system was not functioning properly or other ,
indications of difficulties with the system. Instead it appears that the dosimetrist was not sufficiently familiar with the use of the system to obtain consistent results.
Our review of these events is prima'rily based on information on the events compiledsby the State cf New York, Department of Health, Bureau of Environmental Racietion Protection. Tt u information includes:
Treatment records.for 22 patients who received misadministered doses at one of the hospitels. The records were reviewed and annotated by a ,
consulting radiokgical physicist who was engaged by the hospital to l review patient records for errors subseawnt to the discovery of the n ' !
mi sadmini strations'. /
- The requirement to report medical misadministration involving licensed m'a terial l was made an item of compatibility for Agreement States. The effective date of the requirement was April 1,1987; howevkr, states hake three years from the i effective date in which te implement the requirement. ]
- The misadministration apparenti" were reported to this agency under a requirement to report unusual events. l f ,] r////(/7 CY -- >
0 /
^
1 .
l . .
Summaries of findings on the causes of misadministration for the three hospitals involved prepared by the same consulting radiological physicist.
Information obtained from discussions with Ms. Rita Aldrich, Chief, Radioactive Materials Section, Bureau of Environmental Radiation Protection, New York Department of Health.
The New York State Department of Health Bureau of Environmental Radiation Protection (R. Aldrich) advised us that the Radiological Health Advisory Committee to the state has been requested to review the patient records referenced above, and that a NRC consultant on radiological physics has also been retained to review the data. As of the date of this report, results from the above reviews are not available for our consideration in completing this report. We expect that the findings resulting from the above reviews will be available for consideration in an analysis to be performed by AE0D/NAS at a later date (described below).
This TR was undertaken in response to the memorandum dated August 26, 1987 from V. Miller to X. Black, " Request for AE0D Study," that requested AE00 to review data on the occurrence of 22 or more teletherapy misadministration at several hospitals in the state of New York (subject of PN0-I-87-74).
Background
Teletherapy treatment involves delivering a radiation dose to a tumor by directing a beam of ionizing radiation from an external source toward the tumor region. The prescribed radiation dose is delivered in a series of ,
treatments (fractions), usually one per weekday for several weeks. Teletherapy (
treatment is a complex procedure that involves several professionals and many i steps. Figure 1 is a simplified flow chart showing the key staff functions in )
radiation therapy. The teletherapy misadministration reviewed.in this report resulted from errors made during the treatment planning (dosimetry) phase of therapy.
Determining distribution prescribed the treatment plantherapist by the (dosimetry (phase) is physician) to normally produce the the radiation tumor dose task of the radiotherapy physicist or dosimetrist. Treatment plans are developed manually or by computer treatment planning systems that may involve some manual calculations.
The treatment plan defines the parameters used for the actual treatment of the .l patient by the therapy technologist in the treatment phase. Typical parameters are source to skin distance (SSD); treatment time; beam modifying device, if any, to be' used (e.g. , beam blocks, wedge filters, etc.); the number and angle of beams to use; or any special treatment method to be employed (for example, the 1~ use of skip-scan treatment procedures). Small changes in these parameters 4 can lead to a large variation in the dose to the patient.
~'
While these pc*ameters can be computed manually or with aid of computer treatment i planning software, computer treatment planning systems vary between vendors both
- i _ 3 in the input parameter requirements and the output produced. In one case the 1 actual time that the source is to be exposed may be the output of the treatment plan whereas in another case some intermediate value may be generated that is x then used in a hand calculation to produce the actual time that the machine is 1tobeon, i
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s, m M i . .-. . _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
Just as treatment planning methods vary between institutions, the make up of the staffs' that. perform the above task also vary (see Figure 1). In some cases, all personnel are employed by the institution; in others, such as the events that are the subject of this review, itinerant personnel may be involved in treatment planning.
Most treatment regimes are modified after weekly examination of the patient.
One method of modifying treai, ment regimes as well as detecting errors _is tc have important calculations and measurements (e. g., dose calculations, tumor depth measurements, etc.) checked by a cualified individual who did not do the original calculations or measurements. Another method of treatment modification and detecting errors is through periodic reviews of the patient treatment chart.
Description of the Events Three hospitals (designated hospital A, hospital B and hospital C) were identified where the dosimetrist prepared treatment plans. The current information available indicates that he prepared the treatment plans without assistance from or supervision of other members of the radiological physics consulting group. The consulting radiological physicist retained by the
_ hospitals to review patient records subsequent to the discovery of the misadministration of misadministration -reported the following at the involved findings hospitals regarding)the (see table 1 : occurrence for hospital A, 22 of 249 patient treatment plans (about 9%) reviewed contained errors in calculations or in dose administration (e.g., incorrect beam geometry). In 21 of these cases, the errors led to the patient being treated with a dose that different from the prescribed dose by more than .
10% (the maximum difference was 138% and 10 of the 22 patients were !
treated with doses that differed from the prescribed dose by more than 40%). Twenty one of the 22 patients received a dose that differed from the prescribed dose by greater than 10% (criteria for reportable i misadministration under 10 CFR 35.2).
for hospital B. 13 of 30 patient treatment plans (about 43%) reviewed contained significant errors in calculations and or in dose administration.
However, in only two cases did treatment doses resulting fror.,
the errors meet the criteria for a misadministration. This was not a reflection of the relative seriousness of the errors but rather the treatments involved generally were for " boosting doses" where the bulk of the treatment had been given so that even a 50 percent error in the
" boosting" part of the treatment would not in all cases result in a 10 % difference between the prescribed and administered dose to the patient (criteria for reportable misadministration). Also, in one of the cases the dosimetrist made a second error that reduced the severity of the first error.
, t 1
Figure 1 Key Staff Functions in Radiation Therapy
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for hospital C, one out of eight patient treatment plans (about 12%) reviewed was found to contain errors in calculations that leo to the patient being treated in a way not prescribed. For example, one prescribed treatment plan called for treatment with two beams weighted by different factors.
The patient was treated with both beams weighted the sane; although the correct prescribed dose was administered , it was not administered in the way indicated in the treatment plan.
TABLE 1 Hospital No. of Records No. of Records Percent No of Reviewed W/ Errors Misadministration
- A 249 22 9 21*
B 30 13 43 2 C 8 1 12 0
- as defined in 10 CFR 35.2. Another event, considered by New York to be a misadministration, did not meet the criteria of 10CFR 35.2.
Causes of Events The report of the consulting radiological physicist who reviewed patient treatment records at the involved hospitals characterized the type of errors that led to the misadministration as follows:
As far as could be ascertained from the treatment record, all errors resulting from incorrect calculations were made by the dosimetrist. In no case did the technologist deliver a df fferent time from that calculated, or in a different manner. j l
The dose per fraction and point, or isodose level, at which the dose was l prescribed was, in most cases, clearly written by the radiation therapist '
on the treatment plan, and written again by the dosimetrist at the top I of the calculation sheet. Therefore the errors were not caused by miscommunication between the therapist and the dosimetrist, or ;
misunderstanding of the prescription.
---.m---,---_--.------
l In a group of about 7 patients treated with " skip-scan" rotation, the
! dosimetrist calculated the time for one arc, and' failed to multiply by i- two, which would be.the correct machine setting for treating two lateral arcs in the " skip-scan" mode. This resulted in delivery of half the desired dose. However, because this type of treatment is t normally used as a boost delivering only part of the patient's total l
trtatment this reduced the percent underdose.
l l A large proportion of the patient. charts conteined the type of errors l which demonstrated a misunderstanding of the meaning of beam weighting in j the treatment planning system being used.
l- In some -calculations the " wedge transmission factor" was wrongly included in the timer setting equation. In the computer treatment planning system being used this factor was already included.
In some calculations the numbers used in the timer setting equation were taken from the wrong part of the computer printout.
In general, it appears that the errors that led to the misadministration were random errors made by the dosimetrist in various phase of dose calculations.
While the type of errors appeared to be random all of the errors were associated with treatment plans that used computer treatment planning systems. The plans that were dona manually were done correctly.
No specific reasons were determined for the dosimetrist making the number and type of errors identified except that the dosimetrist appeared to lack sufficient ,
knowledge of the operation of the computer treatment plan beino used to produce consistent accurate results. The consulting radiological hj icist who reviewed.
the salient treatment plans for errors following.the discovery of the misadministration summarized her findings regarding the errors that were made by the dosimetrist as follows: "The mistakes were of different kinds, and were not made consistently. They seem to demonstrate a fundamental lack of understanding of the MDDCS computer system."
Hospital therapists appeared not to have checked on the accuracy of the treatment planning being done by this dosimetrist. In the opinion of the radiological physicist who reviewed the patient treatment plans for errors, independent checks of the dose calculations would likely have prevented most of the errors.
While the errors that led to the misadministration generally can be ascribed to a dosimetrist niaking random errors involving dose calibrations, the facts of the misadministration highlight several general issues that we believe should be considered for further review. These issues are:
- . Training requirements for personnel involved in treatment planning, dose ~
calculations, dose delivery, etc., in radiotherapy facilities. Lack of appropriate training appeared to be the root cause of the misadmini-strations that were the subject of our review.
- Definition of the relationship between radiotherapy consultants, licensees and NRC in regard to training and other regulatory requirements. The dosimetrist who made the errors that led to the misadministration, a member of. a consulting group retained by the hospitals, would not be prohibited by any NRC regulations from continuing to prepare treatment plans, although the nature of the errors indicated that the individual j appeared to lack a fundamental understanding of the work that he was performing.
- Definitive requirements for periodic patient chart reviews to detect errors in the patient treatment alan. While.the proposed rule on basic quality assurance addresses a wee <ly accuracy check of daily arithmetic calculations, it appears that more extensive checks such as a check of correction factors and patient setup, the use of beam modifying devices, etc. may also be callea for to assure a high probability of detecting errors before they lead to misadministration. For the misadministration that were the subject of our review (23 events) none were detected by radiotherapy personnel- reviewing patient treatment progress. !
Annual audit of patient treatment records. One significant fact concerning the 22 teletherapy misadministration is that none of the misadministration were detected by hospital radiotherapy personnel, or personnel of the consulting physics group during the normal implementation of treatment protocols. This failure to detect errors continued over a five year period in which the average annual error rate (misadministration per patients treated) for one hospital was about 8%. The annual error rate per patient given in AE00 report AE0D/N505, Therapy Miscdministrations Reported to the NRC Pursuant to 10 CFR 35.42," is .02% a factor of 400 less. An annual
. audit that detected errors the first year could have prevented the
! misadministration that occurred in the later years.
Standardization of computer treatment plans. The consulting radiological
- physicist who reviewed the salient treatment plans for errors following 9 the discovery of the misadministration, summarized her findings regarding 7 the errors that were made by the dosimeters as follows
- "The mistakes were
, of cjifferent kinds, and were not made consistently. They seem to demonstrate
- a fundamental lack of understanding of the MDDCS computer system." The
{' individual whose errors led to the misadministration may have been using
, several computer treatment plans, and may have confused some of the y parameters used in the different plans. Standardization of computer treatment plans, or user-friendly interfaces, could make working with different computer treatment plans less likely to lead to errors.
- Definition of a misadministration. In six out of the 22 misadministration at hospital A (21 of the 22 met the criteria of a misadministration given in 10 CFR 35.2), in addition to the administered dose differing from the prescribed dose, the distribution of the dose to the tumor was found to be different than what was prescribed. While most (5 out of 6) of the events met the criteria for misadministration reporting based on the prescribed and administered dose differing by greater than 10%, the primary error for one of the events was the maldistribution of the dose. Maldistribution of the dose may be as significant as a 10% difference in the prescribed and administered dose in regard to the effect on the patient.
L_ =____ _ _ - _ - _ _ _ _ _ _ . _ _ _
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Linear Accelerators. Several of the misadministration that occurred involved radiation therapy protocols using linear accelerators. Census data on demographics of radiation therapy in areas such as staffing, equipment, and new patient load found in the Patterns of Care Studies conducted by the American College of Radiology show that the number of teletherapy machines in use declined from 970 in 1975 to 744 in 1983 (equivalent to about a 3% drop per year) whereas the number of linear accelerators / betatrons increased from 407 to 1018 (equivalent to about a 19% increase per year) during the same period. The data show a definite trend toward the use of linear accelerators. Consequently, to be effective in preventing all misadministration, quality assurance procedure requirements for radiotherapy facilities should be applied to therapy protocols using !
linear accelerators as well as to therapy protocols using cobalt 60 teletherapy machines. Although NRC has no authority to regulate linear accelerators, should we, or can we work to have some group or groups undertake the regulation of accelerators in this regard.
Conclusions Based on our review of the data currently available we found that the misadmini-strations essentially resulted from random errors made by a consulting dosimetrist in calculating patient doses. All of the errors were made on patient treatment plans involving data generated by computer (computer treatment plans). Further, we found that the type of errors that were made (e.g., errors in dose calculation, use of wrong beam modifying factors) likely could have been detected if the treatment plans had been checked for accuracy by another individual. We believe that, in most cases, such checks could have detected errors sufficiently early to have prevented the misadministration. A review of the data also revealed that many of the over- or under-treatments likely could have been detected by prudent patient chart reviews. These also could have prevented the misadmini-strations if the over- or under-treatment had been identified sufficiently early to adjust the treatment plan.
In relating the causes of the 22 misadministration events to the proposed rule
" Basic Quality Assurance in Radiation Therapy," we found that the requirement for a check of dose calculations by an individual who did not perform the calculations and the requirement for weekly accuracy checks of daily arithmetic calculations contained in the proposed rule appear to address the primary causes identified for the misadministration. Therefore, we do not believe that any changes to the proposed rule are occasioned by our findings regarding the causes of the misadministration.
In regard to the " general issues" discussed above, we will develop a technical review (TR) of these general issues. Our schedule for completion of this additional TR will allow this information to be considered in the development of the proposed rule for comprehensive quality assurance.
i
. - _ - _ - _ -