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i MEMORANDUM FOR: Victor Stello, Jr. JAN 311W Executive Director for Operations l
FROM: John G. Davis, Director Office of Nuclear Material Safety and Safeguards
SUBJECT:
COMMISSION PAPER " MISADMINISTRATION OF RADIATION THERAPY" COMFB-86-3, COMFB-86-8, COMLZ-86-25 l
The enclosed Commission paper on " Misadministration of Radiation Therapy" responds to staff requirements memoranda COMFB-86-3 dated April 14, 1986, and COMFP-86-8/C0MLZ-86-25 dated December 16, 1986. The paper contains:
(1) an Advance Notice of Proposed Rulemaking (Enclosure 1) that raises ,
certain issues for public comment; (2) a notice of proposed rulemaking (Enclosure 2) that would place certain basic quality assurance requirements on radiation therapy licensees; and (3) an analysis and recommendations on methods of further reducing misadministration,s (Enclosure 3).
The paper was distributed to the Offices of Nuclear Regulatory Research, Administration, State Programs, Inspection and Enforcement, and Analysis and Evaluation of Operational Data, and the five Regional Offices. They i have concurred.
The paper was developed in coordination with the Regulations Division of the Office of the General Counsel. However, even though the Commission paper indicates OGC concurrence, the G3neral Counsel is still reviewing the Commission paper.
,. (SIGRED) Donald B. Mausshardt l
j e'g1Office JohnofG. Davis, Nuclear Material Director !
Safety and Safeguards
Enclosure:
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1 81D Cka?n W For: The Commissioners From: Victor Stello, Jr.
Executive Director for Operations
Subject:
filSADMINISTRATIONS
Purpose:
To submit for Commission consideration: (1) an Advance Notice 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 ovresight of medical licensees. Subsequently, in an SRM l
dated December 16, 1986, the Commission directed that an Advance i Notice of proposed Rulemaking be submitted by January 31, 1987, l that included a comprehensive analysis and recommendations for 1 improvements in NRC oversight that may be effective in reduc!ng medical misadministration.
The staff has prepared an Advance Notice of Proposed !
Rulemaking to request early public comment on the scope of l a rule that would: (1) require radiation therapy licensees, i 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 i therapy. In addition, the staff has prepared a quick-turnaround )
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:
l Norman L. McElroy 42-74108 t I I
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i 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. )
Background:
Radiation Therapy and Diannostic 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. (liigh 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 l 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 procedures result in a whole body do;e of about 0.1 rem and a target organ dose of about 2.0 ren.
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 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 t In April 1986 the Commission directed the staf f to " develop a ou d U2_ ',... rulemaking to require independent verification of therapeutic doses, as is done in the case of diagnostic procedures, and penalize medical licensees for their negligence or that of their employees, agents or practitioners." (See Enclosure 8.)
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The Commissioners 3
The staff shares the Commission's desire to reduce the frequency of misadministration. In developing its proposals, the staff has attempted to balance competing public health and safety needs.
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 anesthesia and the introduction of infection, either of which can prove lethal. Nuclear medicine also improves the recovery rate ntChl I6Mg J-- for certain diseases and extends the life expectancy of patients who are tenninally ill. The demonstrated benefits of the medical use of byproduct material far outweigh the risks.
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 (Enclosure 1)
The staff has developed for public comment an Advance Notice of Proposed Rulemaking (ANPR) that contains both technical and i policy questions. The staff recommends that the Commission issue an ANPR before issuing a comprehensive proposed rule !
because information is needed, particularly from the 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 he 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, the NRC does not have the quality assurance requirements (envisioned in tho proposed rule and the ANpR) for medical l
licensees under which it can take enforcement actions in cases involving therapy sisadministrations. Once the rules resulting ,
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t The Commissioners 4 i
from the proposed rule and the ANPR are implemented, however, the NRC will have the requisite requirements for enforcement actions. Second, the Commissinn'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 uced to address I violations. In fact, it has been invoked in 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, the negligence section would have introduced unnecessary contro-versy and would have carried the Commission into uncharted waters and away from its expertise in radiation safety. Finally, it could have impeded achieving the main objective of reducing l misadministration.
The staff believes that the Commission should give clear notice that enforcement actions for non-compliance with NRC regulations will continue to be applied to NRC's medical licensees. Conse-ouently, 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 1; sues 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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a The Commissioners 5 Proposed Rule on Basic Ouality Assurance (Enclosure 2)
, To promptly establish basic quality assurance requirements Md CIam(M j while comments on the ANPR are submitted and analyzed, the staff has reviewed the technical and professional literature, consulted with the members of the Advisory ' Committee on the
- l. Medical Use of Isotopes (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 the apy 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.
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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 fer not following the normal rulemaking process (which requit2s opportunity for public comment) prescribed b amended, (2)y the Administrative a significant portion of procedure the regulatory Act of text 1946, as refers to recordkeeping requirements that, although published, could not be enfcrced 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, l The staff believes a final rule based on Enclosure 2 could be submitted to the Commission by fall of 1987.
Need for Irnproved NRC Oversight In a memorandum dated December 16, 1986, the Commission requested a comprehensive analysis of NRC's medical use regulations including 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 staff believes that the problem of diagnostic misadministration involving large radiation dosages (similar in magnitude to some therapy dosages) is one that should he addressed, and has done so in the ANPR. It will continue to examine the issue. The t
4 The Commissioners 6 l
staff did not address this problem in the proposed rule for several reasons. First, the issue of therapy misadministration 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 Commission wishes to address the diagnostic issue at this time, the staff can revise the proposed rule or it can prepare a separate proposed rJle 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 Program Development ISY ISY ISY ISY 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 I:eeping abreast of the evolving technology and making timely regulatory adjustments to maintain compatibility with the technology. Preliminary resource estimates for accomplishing this are:
FY 87 F_Y _8,8 FY 89 Proposed Total Program 4 FTE 4 FTE 4 FTE Development Resources $200k $200k $P00k 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:
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FY 87 FY 88 FY 89 l Proposed Total Licensing Resources--Direct Staff 9 FTE 10 FTE 10 FTE i
--With Overhead 10 FTE 11 FTE 11 FTE t
a The Commissioners 7 Inspection. In addition, increasmi inspection resources could be i used to provide assurance 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:
FY 87 FY 88 FY 89 Total Resources for 1.5 Year Inspection Frequency
--Direct Staff 27 FTE 28 FTE 28 FTE
--With Overhead 31 FTE 32 FTE 32 FTE l Need for Additional Resources The additional resources identified for program development would be utilized at Headquarters. The additional resources identified for licensing and for inspection would be utilized in the Regions where the licensing 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 Congnission in balancing its priorities with atM 4g .f -
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, I and nuclear medicine in particular, decisions on the amount and source of resources for 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 in:pection casework. They do not, for example, take into account initiatives for improvements j stemming from the Sequoyah Fuels accident. j l
Other Commission Support !
l 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, Congnissioners can show the staff, licensees, and the public that they are as I interested in materials safety as they are in reactor safety.
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4 The Commissioners 8 ,
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. Coordination with Agreement Statec 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. l Recommendation: The Commission: '
- 1. Direct publication of the quick-turnaround proposed rule (Enclosure 2) that would require licensees to implement certain basic quality assurance steps.
- 2. Direct publication of the Advance Notice of Proposed Rulemaking (Enclosure 1) regarding the scope of a quality assurance program rule..
- 3. Approve the milestones and schedule proposed in Enclosure 6.
- 4. Agree to the staff initiatives (Enclosure 3) submitted in response to the Commission'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 Stat'e licensees have a fair (
g gf opportunity to consnent on the Proposed Rule, that j it be published for 60-day public comment period. '
If the Commission selects the 60-day comment period, appropriate adjustments will be made in the ent sed notice and schedules.
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The Commissioners 9 l
b.- The Director of the Office of Nuclear Material Safety and Safeguards has made a determination that.these actions are categorically) excluded, under sections 10 CFR 5 to perform an environmental impact assessment. This
/no c[an v 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.
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- 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 sub.iect to the Paperwork Reduction Act of 1980 (44 U.S.C. 3501 et seq.). It will be submitted to the Office of Management and Budget for review and approval of l
the paperwork requirements.
Victor Stello, Jr.
Executive Director for Operations
Enclosures:
- 1. Federal _ Register Advance Notice of Proposed Rulemaking
_2. Federal Register Notice of Proposed
-Rulemakir.g
- 3. Response to questions in December 16, 1986, staff requirements memorandum
- 4. Regulatory Analysis for Advance Notice of Proposed 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, 1 1986 (COMFB-86-3) and December 16, l 1986 (COMFB-86-8/COMLZ-86-25) t u _ . _ . _ _ _ . _ _ _ __ - _ _ _ >
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Pesponse 4. The staff addressed this issue for all licensees in SECY-86-319, " Identifying and Informing Others of Wrongdoers," October 29, 1986.
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 implenent this statute and explore methods for NRC access to the tracking system to obtain and supply information. l l
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 orovide 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 i 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 whfie minimizing structural or functional injury.)
Recommendation: The staff should explore this matter with the Advisory Committee on the Medical Use of Radioisotopes (ACMUI) to further assess the staff's preliminary views.
Question 6. A mechanism for following up on patients who have been sub.iect to reported misadministration.
- f Response 6. The need for and method of patient follow up would vary v widely depending on the nature of the misadministration. The staff believes 7 Enclosure 3
f l 4 l . .
l that this should be handled mainly as a physician-patient matter. The physician l 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 j and offering expert medical assistance through NRC medic 61 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 misadministration.
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 undertake appropriate modifications of the misadministration reporting requirement.
Question 8. The need for additional feedback mechanisms such as addi-tional NRC information notices on reported medical misadministration to I ensure that all censees can benefit from lessons learned.
Response 8. The staff is already doing this. See: I "One Year's Experience With Misadministration Reporting," L. Roche, Society of Nuclear Medicine Newsline, v7, n1, pp 4-5, March 1982.
8 Enclosure 3
pyht ll [ 7590-01]
[ g G Gc s .
p OsvV6 pyf)f'jS NUCLEAR REGULATORY COMMISSION 10 CFR PART 35 Radiation Therapy Quality Assurance and Penalties for Negligence
[or]
Radiatfon Therapy Ouality Assurance and. Standards of Care AGENCY: Nuclear Regulatory Commission.
ACTION: Advance Notice of Proposed Rulemaking.
SUMMARY
- The Nuclear. Regulatory Commission (NRC) ic considering amendments
- to its regulations that apply to the use of byproduct' material for radiation
. therapy. In addition to the current requirements for quality assurance j in radiation therapy, 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, and would also provide penalties for negligence when using byproduct material for radiation therapy. The NRC requests public comment as to whether additional radiopharmaceutical therapy 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.]
4 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-tior, cannot be given except as to comments received before this date.
1 Enclosure 1
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[7590-01]
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. i F0P 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.
i SUPPLEMENTARY INFORMATION:
NRC'S Policy Regarding the Medical Use of Byproduct Material In a policy statenent 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 I
risk to patients, and minimizes its intrusion into medical judgments affecting patients and into other areas traditionally considered 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 responsi-bility for the protection of their patients. NRC regulations are predi-cated on the assumption that properly trained and adequately informed physicians will make decisions in the best interest of their patients.
2 Enclosure 1
[7590-01]
Therapy Use of Byproduct Material Teletherapy is the application of a beam of radiation emanating from a cobalt-60 source to a patient for a therapeutic purpose, usually cura-tive, prophylactic, or palliative cancer therapy. (High energy x-ray machines are also used for the same purposes.) As an example, a treatment i might be comprised of daily treatments of 200 rads to the tumor volume for five weeks, yielding a total tu:nor dose of 5000 rads.
Brachytherapy is the inscetion of small sealed sources such as cesium-137, ;
)
iridium-192, gold-198, or fodine-125 into the tumor volume for curative or. !
prophylactic cancer therapy. As an example, a treatment might require j 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 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.
Therapy Misadministration The NRC recently mailed to all licensee:: 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)I .
I Single copies are available from Kathy Black, Office for Analysis and Evaluation of Operational Data, U.S. Nuclear Regulatory Commission, Washington, D.C. 20555.
3 Enclosure 1
17590-01].
Although the specific cause of each event was different, three basic themes were apparent: inadequate training, inattention to detail, and
- j. lack of redundancy.
In most of the reported events the patient was given much'more radiation than prescribed by the physician authorized user. In a recent ,
l case that occurred after the report was published, a physician authorized user prescribed a radiation dose for a patient who had not i
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
- in of NRC regulations. The Commission nts.to.we/ ends prepare a rule that would require independent verification of therapy doses and penalize medical
! licensees for their negligence or that of their employees, agents, or i practitioners. l To begin rulemaking on this matter, it is important to frame the issues. Realizing that there will be considerable public interest, l
the NRC is taking this opportunity to request early public comment.
Effect on the Agreement State Program 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 I
authorized by the Atomic Energy Act.) They issue licenses for the use of ;
i p 4 Enclosure 1 l-E _ _ _ _ . _ _ _ _ . _ _ _ . ___ __ _ l
, [7590-01]
1 byproduct material, and currently regulate about 5,000 medical licensees.
Because the NPC 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.
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Recuest For Comments The NRC has prepared the following questions to elicit comments on
.3 methods of preventing misadministration. Comments do not have to respond to these questions elone; other related topics or alternatives may be described if +he commenter believes this will help to resolve issues related to this rulemaking.
1' Quality Assurance i
General The following questions apply to the provision of all types of thera-peutic medical use.
- 1. Should the Commission require that each licensee implement a l n;M n/ .rpecify hy H3 on /enh \
comprehensive quality assurance program, or should the NRC list certain !
h quality assurance steps that must be performed?
- 2. Should the definition of misadministration in 10 CFR 35.41 (the same 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? We-NRG-has.
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tk NRC trse a term'othEr'than~" misadministration"~to rbfsFto these' events?
- 3. The NRC knows of one instance in which radiation was administered-to a patient without a request from the primary care physician. Should the NRC require that the authorized user actively consult with the primary care physician before prescribing radiation or deciding that radiation is not needed? g4 gg
- 4. fr thm methods e p;regreliable 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 e .rs 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? jam /d A*#
d y,h & <d da m inct& & k i -?
Teletherapy and Brachytherapy The following questions apply to the provision of teletherapy and brachytherapy services.
- 1. Should NRC require that licensees have a certain minimum case-load to' assure that their employees retain their expei'tise 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? :4 m /A' p$dSj-'Mnef-ba$t5 . es;- etr6fMA$*W Aljtwthm61tZ2 l4 ontyoftd SwA
.4 d AM / dad .# 6 Enclosure 1 i i a i
e =, . .- .
[7590-01]
i:
l 2 .Should smaller licensees with fewer staff and ecuipment resources '
k ,upu.Asdtb mtuZ Aquohneh use
- d fferent quality assurance pregr e than t ' ane + hat i: M d'M
/ Lose f
used-by larger licensees? l
- 3. What fraction of licensees already have a quality assurance program?
//ea a Momeer aJ//ity 4
- 4. 4 Will current reimbursement methods Kfeet eq%1amantatinn Mdrt' e orn p 4 w > $e4-e-quality
,u o fuafa'fy oaouwhprofnd i cep43ers?assuran&mk How much does g M cost per patient or per year? What fraction of staff time, including physicians, physicists, dosimetrists, technologists, and, nurses, is currently budgeted for quality o assurance work? h ,,a0 jf ,.a amM A .sust gu.tu~7' wom" - .
I ,vpanw&, au & <upap4 msv'kb nddy m<b.60 'u '" & A'y N ')'
- 5. Are there complete model quality assurance programs already L./% 4 r,a.-
available that address every step of the radiation therapy process, or S ""
will model programs have to be developed? Should physical measurements, I redundant calculations, or both he required to assure that the dose given is the same as the dose prescribed? What other arear are, or L should be, covered in a complete quality assurance program?
I .
- 6. Are the staff and equipment that are needed to implement a com-l l plete quality assurance program available in the marketplace, or would i
new training programs and equipment development be needed?
- 7. What methods are available for reducing the frequency or impact l.
! of human error?
Radiopharmaceutical Therapy l
The NRC requires that licensees use only certain radiopharmaceuticals ;
I for specified therapy clinical proceddres, measure the radioactivity in radio- j i
pharmaceutical dosages before administration, and have a measurement quality assurance program for the dose calibrator used to make that 7 Enclosure 1 i 1
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p measurement.. These requirements a'ppeak te boarQ W e al1 the steps in a '
E f ra,diopharmaceutica therapy physice! qual'ityf4 rano) program. However, H , s 'sF' s
,( ,
. N the Mips invites publit.\com'm ent On tiq ,is positioni
S, p y i 1' ...
Thbre have' been cases in which, due 'to procedura'l failurn, th #
n,1 i ; %
rad) oph.nhaceutibal other than t!iat intended'has been ordertk a'nd - <
). 1 33 y'e <
i 6 t,
,. U. administered. The NF.C ' expects that all licensees have policy requirements n 3
[j, for clear statements of prescription and ' verification before administra-tion of any pharmaceutical. /7he NRC would appn ciate suggestions on
't J) '
methods to assure that the clinical procedure (including radiopharmaceutical,
]/
dosage, and route of administration) intended by tha authorized user is prescribed, an' d that the prescribed cifvical procedure is the clinical
, a ..
da 4hc a Ke4 5,y procedurethatispe/ formed.
ik Obahu d,4;iu:d,sph m,a aaA J y 9ged/ muc/vsj;ang/dj
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([ t/c gf;.$yJSf&L t' v 4 k p h r y Negligonce)
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- j. so, &, ikk3 sch& asuu %d ypra O A Hs 9@af,O g vA4%d.]
The 1 ,11ouing questions apply to the< provision of teletherapy, u, ,
)' \ ,
brachytherapy, and rbdiopharmaceutical therapy services.
- 1. Is there a clear, generally accepteU[finition of negligence
,\
thattheNPCc.jnuse? Should the NRC t/d: ,existinchlegal definf tions or - i develop its cwrij,s definition? What. level of. negligence should trigger a penalty--the licensee's willful action, the licensee's ree'<1ess di;. egard for " generally accepted patient care prncedures," or the ,
ifccrace's simple inadvertent error? Should there be actual, clinically i
diso rnible harm to pr.itient or simply radiation dose above a certain-level, or should preserqe:or absence of actual patient harm not be e? consideration tu making a finding of negligence?
L
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i 8 Enclosure 1 e ,
} _
e 3- . . ,
[7590-01) e 2.- Should negligence penalties be imposed on licensees, on their employees or both? Should the State Board of Medical Examiners be invited q
to participate in proceedings regarding physicians? What kinds of negligence penalties should be imposed en licensees? Employees? Both?
Should the penalty, or the standard for negligence, be related to the amount or kind of byproduct material that was used or misusedI Should in & e nd, n pthap s lo lh mow >/: ud Lhh o Lygodac/ nwh.4.1 pe:wndd NRC institute a system to assure that an individd{al who precipitates undn &
misadministration or commits a violation does not simply leave and go to jaw another licensee, either an NRC or Agreement State licensee, and continue to engage in similar activities?
- 3. What effect would a rule on negligence have on liability insurance rates and availability of insurance?
- 4. Would issuance of penalties impact licensees, their employees, or both in any lawsuits?
- 5. The NRC is aware that in other medical specialties such as obstetrics, legal and insurance issues have been cited as reasons for l physicians electing to move to another medical specialty. Would the risk to medical professionals of NRC-imposed penalties reduce the willingness of licensees to provide radiation therapy services? I l
hlternativeinplaceof" Negligence"Section] {
fM atufuL%%4.%,bapy dau The NRC presently has, in 10 CFR Part 2, Appendix C, particularly Supplement VI, an enforcement policy that it can apply to the medical use of byproduct material.
l -
l l
L 9 Enclosure 1 is
[7590-01]
l The following questions apply to the provision of teletherapy, brachytherapy, and radiopharnaceutical services, and to the Commission's Enforcement Policy.
- 1. Should NRC adopt some kind of "due care" regulatory standard?
Or instead, should NRC set comprehensive, prescriptive qu.ality assurance I requirements?
- 2. Is there a clear, generally accepted standard of radiation therapy care that the NRC can adopt? If yes, please describe it. If not, please describe the standard that NRC should adopt.
- 3. What kinds of penalties should be imposed on licensees, their employees, or both, if the standard pp the comprehensive, prescriptive requirements pare not met? How should NRC's Enforcement Policy be changed in this regard? -
- 4. What effect would such a standar e comprehensive, prescriptive requirements have on provisions of radiation therapy care?
End of Alternative Text
+ + + + v 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 pratection, Reporting and recordkeeping requirements.
10 Enclosure 1
t.' , a . ,
[7590-01]
The authority citation'for this document is:
AUTHORITY: Sec. 161, 68 Stat. 948, as amended (42 U.S.C. 2201);
l sec. 201, 88 Stat. 1242, as amended (42 U.S.C. 5841).
l l
Dated at Washington, DC, this day of , 1987.
- FOR THE NUCLEAR REGULATORY COMMISSION Samuel J. Chilk, Secretary of the Commission i
l l
11 Enclosure 1 l 1
, ._--_ _______-- _ _ _ _ _ _ a
.. 4 . . ,
h E- [{j$;n7- a;$%j UNITED STATES NUCLEAR REGULATORY COMMISSION ghag p#/ /[
3 E, WASHINGTON, D. C. 20555 M, W. "
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MEMORANDUM FOR: Victor Stello, Jr.
Executive Director for Operations FROM: . John G. Davis, Director Office of. Nuclear Material Safety and Safeguards
SUBJECT:
CCtiMISSION PAPER " MISADMINISTRATION OF RADIATION THERAPY" COMFB-86-3, COMFB-86-8, COMLZ-86-?5
'The enclosed Commission paper on " Misadministration of Padiation Therapy"'
responds to staff requirements memoranda COMFB-86-3 dated April.14, 1986, and COMFB-86-8/COMLZ-86-25 dated December 16, 1986. The paper contains:
'(1) an Advance Notice of Proposed Rulemaking (Enclosure 1) that raises certain issues for public comment; (2) a notice of proposed rulemaking
-(Enclosure 2) that would place certain basic quality assurance requirements on radiation therapy licensees; and (3) an analysis and recommendations on methods of further reducing misadministration (Enclosure 3).
The paper was distributed to the Offices of Nuclear Pegulatory Research, Administration, State Programs, Inspection and Enforcement, and Analysis and Evaluation of Operational Data, and the five Regional Offices. They have concurred. .
The paper was developed in coordination with the Regulations Division of the Office of the General Counsel. However, even though the Commission paper indicates OGC concurrence, the General Counsel is still reviewing the Commission paper.
John G. Davis, Director Office of Nuclear Material Safety and Safeguards
Enclosure:
Consnission paper w/ enclosures
MEMORANDUM FOR: Victor Stello, Jr.
Executive Director for Operations FROM: John G. Davis, Director Office of Nuclear Material Safety and Safeguards FUBJECT: COMMISSION PAPER " MISADMINISTRATION OF RADIATION THERAPY" COMFB-86-3, COMFB-86-8, COMLZ-86-25 The enclosed Commission paper on " Misadministration of Radiation Therapy" responds to staff requirements nemoranda CONFB-86-3 dated April it., 1986, and COMFF-86-8/COMLZ-86-25 dated December 16, 1986. The paper contains:
(1) an Advance Potice of Proposed Rulemaking (Enclosure 1) that raises certain issues for public comment; (2) a notice of proposed rulemaking (Enclosure 2) that would place certain basic quality assurance requirements on radiation therapy licensees; and (3) an analysis and recommendations on nethods of further reducing misadministration (Enclosure 3).
The paper was distributed to the Offices of Nuclear Regulatory Research, Administration, State Programs, Inspection and Enforcement, and Analysis and Evaluation of Operational Data, and the five Regional Offices. They have concurred.
The paper was developed in coordination with the Regulations Division of the Office of the General Counsel. However, even though the Commission paper indicates OGC concurrence, the General Counsel is still reviewing the Commission paper.
Jchn G. Davis, Director Office of Nuclear Material Safety and Safeguards
Enclosure:
Coramissicr paper w/ enclosures DISTRIBUTI0f!:
FC Central File NMSS r/f FC File NMcElroy JHickey VMiller RECunrirgham DMausshardt JGDavis EHeumann
! G l OFC: FCML pF :FCML :FCML :FC :NHSS :NMSS j
.4----------......---------------------------------------------------
NAME:Mfic'Elroy/cr:JHickey :VMiller :RECunninahan:DBMausshardt:JGDavis ;
DATE:01/rl//87 :01/ /87:01/ /87:01/ /87 :01/ /87 :01/ /87 0FFICIAL RECORD COPY l
l j
, ,. s- . .
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For: The Commissioners From: Victor Stello, Jr.
Executive Director for Operations Sub,1ect: MISADMINISTRATION OF RADIATION THERAPY
Purpose:
To submit for Commission consideration: (1) an Advance Notice of Proposed Rulemaking, (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 penalties for negligence or for not meeting a regulatory standard.
Summary: On April 14, 1986, the Commission directed the staff to prepare and submit a proposed rule by April 15, 1987 that would strengthen NRC oversight of medical licensees.
Subsequently, in an SRM dated. December 16, 1986, the Commission directed that an Advance Notice of Proposed Rulemaking be submitted by January 31, 1987, that included l a comprehensive analysis and recommendations for improvements !
in NRC oversight that may be effective in reducing medical {
misadministration. 2 i
The staff has prepared an Advance Notice of Proposed i Rulemaking to reauest early public comment on the scope of {
a rule that would: (1) require radiation therapy licensees {
l to implement comprehensive quality assurance programs
to lessen the chance of misadministration, and (2) provide for penalties for negligence or for not meeting a regulatory sjandapt in the use of byproduct material for radiation therapy. TTh DJ>Ndm3 staff has u#so prepared a, proposed rule that would require implementation of some basic radiation therapy quality su $5wmuc.uub l l \
Ccntact:
Forman L. McElroy i 4?-74108 l
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- The Commissioners y ara u, 9 ws x eje d a . g_,.y;anw nun /n/
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- This paper also %
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contains the staff's assurance response to steps',Comission's the recuest for recommendations and options. The staff has considered various options, such ,
as rulemaking, issuance of orders, national voluntary I standards, and increased NRC presence. They are presented in the Enclosures 3, 4, and 5.
Background:
Padiation Therapy Teletherapy is the application of a beam of cobalt-60 radiation to a patient for a therapeutic purpose, usually for curative, prophylactic, 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 mil 11 curies for 48 tu 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 radio-active drug for therapeutic purposes. The most common p"ocedure 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.
About 400 NRC and 800 Agreement State licenrees offer teletherapy and brachytherapy services, and about 700 NRC and 1,400 Agreement State licensees offer radiopharmaceutical therapy services.
For a nore complete description of the radiation therapy process see Enclosure 7.
Discussion: ANPR on Ouality Assurance and Penalties for Negligence or for Failure to Meet Reculatory Standards (Enclosure 1) feMowing-severfrl-therapy mi36diiiffrfstrai.iun e v ents-over-the-veerst in April 1986 the Commission directed the staff to " develop a rulemaking to require independent verification of therapeutic i doses...and penalize medical licensees for their negligence or l that of their employees, agents or practitioners." The staff has developed for public comment an Advarre Notice of Proposed Rulemaking (ANPR) that contains both technical and polfry questions. The staff recommends that the Comission issue i
L___ - - _
The Commissioners 3 hwM an ANPR before issuing a co prehensive proposed rule because the-staff-ceeds-information, particularly from the medical j community, before it can develop a rule that is comprehensive /
~Wd yet-wi44-not inadvertently interferGwith the delivery of medical care. "J' The staff has broadly constructed the term " independent verifica-tion" because, to reduce therapy misadministration, the best 1 approach would be to require each licensee to have a comprehen- '
sive quality assurance program that addresses each step in the radiation therapy process. However, the personnel and equipment needed to implement a comprehensive quality assurance program nay not be available,in the ceketplacer Consequently, informa-tion on this matter would be sought through the ANpR.
rn euen.
Thestafffelievestherearemanyissuestoconsiderwhen !
addressing acgligence cr-en appropriate reguletery-srtadardr- l (These issues include: NRC'.s medical policy statement,
- /"""" # -NRO*s-handHng of reactor " operator error L'ryunTity and ##'
availability of medical care, state regulation of medical services, methods of reimbursement for medical care, legal and insurarce issues, coordination with other Federal agencies, and NRC resources. See Enclosure 5.) Therefore, early public comment on this matter is essential.
__ x #
/_S Mud /a #4-khe staff has provided the- reWesWd~"N6'gTTgence" ctNF7~
A///Luina4'/xthe Advance Notice of Proposed Rulemaking. However, use of.>'/h~'h " ~
/7 1 LuAW lg;g,A),the word rand "hoJpitalspi" negligence"not-huve-e-sehtery-.effect in a rulemaking that applies *T5 physicians on NRC's relation- '
e [s}iIfwith professional organizations that can assist NRC in iny heca its missiont On 9 speciaL-puniMyee-m4 ht-a4sn-infer-that-NRC-is-planning-to-apply',
actions-to-medica 14icensees-that-arc act~
amAu.%,,b b ,appHed-to-other-licenseet Theg negligence section 4s like4y--ar i 6 d4 Luc agjpg gintroduce unnecessary controversy-and may-impede achTeiTing7f,yp.fd r '
- )the main objective of reducing misadministration.
Ppuv&:fi pdm ew.
js ,rigsa%a. Nd
- gy 4r ma4ternat4ver-adhe-Commission wants-to-give clear notice
~
i' ' "g _ thatJ4peMF enforcement actions for non-compliance with NRC regulations are under consideration for medical licensees, hgg, the Commission may wish to airect the staff to replace the o negligence section with a review of NRC's v enforceniErit~ pow 6P""#
as applied to the medical use of byproduct material.fsee-OfP-Part-ErAppendix-C, particularly-Supplement 4).-The-
-current-enforcement-policy-clearly addresses-violations
-involving-therapy-misadministrationsrand-has.been invoked-
-in ~ enforcement-actions:
As requested by the Commission, the staff has.provided a section on " negligence" b' /T.
in the "f;r:0 "!ctice The staff believes, however, that the section should be deleted for several reasons. First, at presentyside-from-the7nisadministratierr sreporting._ requirement,- the NRC does not have the ki-d of qu&lity assurance requirements (envisioned in the proposed rule and the AWAA advenu) notice for medical licensees sof.w -
- 2 nt which it can take enforcement actions in cases involving therapy misadministration.
Once the rules resulting from the proposed rule and the ANPR are implemented, however, the NRC will have the requisite requirements for enforcement actions. Second, the 6d Commission's rules set standards,and normally do not characterize licensees' actions; rather, the Commission's 'e_nforcement glicy provides the necessary characterization.
Thus,(Lcurrent enforcementgolicy, as applied to the medical use of byproduct material (see 10 CFR Part 2, Appendix C, particularly Supplement VI), can be used to address v.nh ing ma a nuniskku violations. In fact, it has been invoked in several enforcement actions,. 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, the s neg-ligence sec t.en may--
hftEht n $ / 3 l
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The Commissioners 4 l w nsJ.hanaln &
As another alternative the ANPR could propose to establish a j lum %eorembroaAregulatory standard relating to the special ;p=nf i medical care that would address many of the issues discussed {
st gg <</, in Enclosure __3. Appropriate enforcement penalties for )
' i faTlure to adhere tdVsuch a standard could be provided. J'
/ ,gm y VThTs~iFc~oisTitentlith~the* Ator.iic Energy Act, as amended,and the Adm '
compliance actions. The Commission may wish to couple this action with the preceding alternative in order to insure that 4 it has given strong and clear notice of its intent to take i strong enforcement action if a medical licensee fails to I maf prov4de the standardsef-eace established in the Commission's l regulations. This would require more time and effort to i develop than is needed for the ANPR in Enclosure 1. However, the delay and extra expenditure of resources might be !
worthwhile in view of the fact that Enclosure 2 contains a proposed rule for basic quality assurance in radiation therapy.
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,and-ceduce -nenbersl-vtrinerabfHty----
-to 4awsu4ts; Proposed Rule on Basic Quality Assurance (Enclosure 2) p/- //y .. en:orw L .m /Is Mk
. To, establish basic quality assurance requirements while ayMding au voon;M lengthy-tfeiemonnected-with-the-ANPR process 7 the staff ms au/y>p/>
has reviewed the technical and professional literature, consulted with the members of the Advisory Committee on the i Medical Use of Isotopes (ACMUI) who are specialists in radiation therapy and other medical experts, and drafted a proposed rule (Enclosure 2) that would reovire medical licensees to bd TmplenFerft7ertsTnv guality assurance steps in their radiation therapy procedures that would reduce the chance of a misadminis-tration. This rule would provide a clear basis for erforcemen actions in many therapy misadminf stration casef pas asi uhu 9b F'c,urrent)f~ib~sTritTeyaus7!~t E onlyfRRC~Bi~Epy .0ali .y a spbrance'requ)remenJCthat re noy'in the regul , tion de 1 p'M.
cPh I pith ppfiodig' calibration of telftherap unit .'
The staff considered preparing this rule in final form. This was not done for three reasons: (1) appropriate safety findings would have to te made, but there do not appear to be sufficient grounds for not following the normal rulemakinc process (which requires opportunity for public comment) prescribed by the Administrative Procedures Act of 1946, as amended, (2) a significant portion of the regulatory text refers i
_3 The Commissioners 5 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 i licenstei_wpuld_n.e_edst- bud;-t-additionel secrs +and :k - -
/im. /a mmbd r. % sines % rre s ts-t -meet- -and t --
g g g' ru might , ave ~unf eTee ' adverse,the impac. ree s on frement
- th -availah. lity_.,_
o _therap -for pat entsr ptegwmA '
The staff believes a final rule based on Enclosure 2 could be submitted to the Commission by August 1987.
Need for Improved NRC Oversicht
/
h In a nemnrandum dated December 16, 1986, the Commission requested 4 a comprehensive analysis of NRC's tredical use regulatfors including
-a list of elements to be addressed. The staff response to this directive is in Enclosure 3.
Other Work in Progress
%p Ib Y,d* U " .
fice for Analysis and aluation of Operational Data (AE0D)f.d 4 A l
/'/he 5hmduku stw urDe &"mvafdu 1s studyiddiagnostic misadministration. eat-4ead tc deses-4n-
-the therapy-rar,geri-he-tesehs-of-eat-studymay require arr ynm" 'jb //Dxpansion-of-the-scope of-this-project: The staff did not address this problem in these enclosures because the-study-
.r.eeults wre not-availablerthe-quality-assurance-steps-needed-
-to-a vo i d-t hose-k i nd s-o f- m i s a dmi n i s t ra ti on s-a re- no t- a s -cl earcutr
, and-the worker training, experience, supervision, and responsi-3 g,g.,m A u g h bilities in diagnostic nuclear medicine are different from
"& Av.c aAg ti ' se hi-~Fa~didtiUn~therap6V The staff will continue to examine e this mattar.wher, the AEOD-repuri, is evaitatite-for-the-sta9
- J &q rp -t+-+tedyw Mced--fer Resources The staff' believes that,E high level of C,omnifssion concern reg [rding thes atters, as inpitfated by the directive to begin rulemaking, b- / is inconsistent w Ah the NRC budge 6r regulation of.me' dical
[/7%2 J censees. /
t,brrent resource allocations only allow for most ospitals l
to be irlsbected approximately once each three years. Because
! of the'high turnover rate among technologists, many never sey an NRC inspector / An increased NPC' presence coupled with d Nje requirements.pf the proposed rul,e'may improve licensees l attention to mgtters of cuality and lead to a reduction'in the misadminfs'tration rate. Additional resources.,.will also be needed for both the licensing and inspectioyfunctions to 1
< )
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, lk $ f h u- aa, DRAFT #1 3gg ,ff, ,tf . fi.9, JGDavis:bsp g 1/15/87 Resources The current resources budgeted by NRC to regulate medical licensees are: j FY 87 FY 88- FY 89 r y / ,v
-Standards i' ,o- O m A,me . 6 Y #,V Licensing 6 4'/
Inspection ^#
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The rulemaking activities proposed in this paper, if adopted, will increase the resource needs for licensing. The resource requirements will vary somewhat de-pending on the alternatives. Preliminary estimates of new requirements based on the staffirecommended approach are:
FY 87 FY 88 FY 89 Additional Licensing __
Resurces-trnacsn . ~
~5In addition, increased inspection resources should improve licensee attention
, ,,,q u r u w:a ,m .O and per4omancc against all requirements. Currenteinspection resource allocations y s ou ny ; ch act gw. .,ts n .
allow mos-t-hospita s_to e_ inspected,-for-a_per.iod_of_aboutone_ day.. once_each_
\
estimates to increase the frequency bof an annual three years: Preliminary inspection are: p i FY 87 FY 88 FY 89 Additional Inspection 77 9'v 9'O l Resources ,
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/' 0'7 The current resources budgeted by NRC to regulate medical licensees are: )
1 FY 87 FY 88 FY 89 I
~
p,,9 w m Ac hlg d stand W s-Licensing- 7 7 (f
/ Inspection. /4 /3 l5 I3 )
JW/ The rulemaking activities proposed in this paper, if adopted, will increase the
\
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a resource needs for licensing. The resource requirements will vary somewhat de-pending on the alternatives. Preliminary estimates of new requirements based on the staff recommended approach are:
FY 87 FY 88 FY 89 Additional Licensing 3 7 7 Resources In addition, increased inspection resources should improve licensee attention and performance against all requirements. Current inspection resource allocations allow most hospitals to be inspected, for a period of about one day, once each three years. Preliminary estimates to increase the frequency of an annual inspection are:
FY 87 FY 88 FY 89 j Additional Inspection Resources I
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The Cenmissioners 6 proper address (regulations 3-qudityassurarceand ne gence. Th xtent of reso i J ' ill depe o the natur be madethe finalavailch, s. Additf or3Yresources should al le to keeprule,pece requ rey fations currp t remen s-w with a nces in nucled medicine techtf61ogy.
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 Le expected to comment, and shculd be consulted on the proper role of a regulatory organization in the delivery of medical care.
v&uuwa r The accelerated schedule ,
allowed for the customary (and-complexity-of-this-. f project ha rulemaking, eich the staff-believes'is 4, where compatibility is required. Note partTcuTFrly importdiit]ow that NRC guidelines all g gjy Agreement States three years .o adopt compatible regulations. I Public Rssponse
~
pwl."" "f Th taff cautionsA t these rulemaki$gs, particularly'y whatever Janguage is used in the " Negligence" or standard.of care section of the ANPR,,will likely be yery contentious, and might have far-reachjnp impacts on p costs.f The staff expegts'gtient care to receive and medical requests insurance for extensions of comment periods,,arfd expects that,many individual usersi professional associations, liability insurance carriers, and daw firms wf!1 ,c6mment.
/
/ g/
Although,th,ey endorse the, purpose of this ptofe,ct, the medical expertjVconsulted by the' staff were unanimous in expressino/
their'cencern about puflity of serviges,th'is apparent Feder61 inter rendered. The comply with the/fouirementjv in Enclosured are reasonably M ailable to many 1 mall licepsfes.
Coordination: The Office of the General Counsel has reviewed this material and concurs in it.
Recommendation: The Commiss mn: f4 ,, j
- 1. Direct publication of the# proposed rule (Enclosure 2) that '
would require licensees to implement certain basic quality assurance steps.
, ,s .
.The Commissioners 7
- 2. Direc_t publication of the Advance Notice of Proposed Rulemaking (Enclosure 1) regarding the scope of a cuality assurance program rule after removing the section entitled " Negligence" or-A/fd's e.oud g ~~and 1nserting
/ about a~ statement regulatory 3
~about' standards) enforcement policy,M n /,[4'
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- 3. Approve the milestones and schedule proposed in Enclosure 6.
4 Agree to the staff initiatives (Enclosure 3) submitted in response to the Commission'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, would be published in the Federal Register for public comment;
- b. The Director of the Office of Nuclear Material Safety and Safeguards has made a determination that these actions are categorically excluded, under sections 10 CFR 51.22(c)(3) and (c)(14), from the requirement I
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 et seq.). It'
)
i
t &
The~ Connissioners 8 will be submitted to the Office of Management and Budget for review and approvc1 of the paperwork requirements.
Victor Stello, Jr.
Executive Director for Operations {
Enclosures:
- 1. Federal Register Advance Notice of Proposed Rulemaking
- 2. Federal Register Notice of Final Rulemaking 3.- Response to questions..in December 16, 1986, staff requirements memorandum
- 4. Regulatory Analysis for Advance Notice of Proposed Rulemaking
- 5. Regulatory Analysis for Quality Assurance Rule
- 6. Draft Schedule
- 7. Description of the radiation therapy-process
- 8. Memos Chilk to Stello dated April 14, 1986(COMFB-86-3)andDecember16, .
1986(COMFB-86.8/C0MLZ-86-25) ;
l 3
l
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ -. J
The Commissioners 8 i
i will be submitted to the Office of Management and Budget for reviow and approval of the paperwork '
requirements.
Victor Stello, Jr.
Executive Director .
for Operations l
Enclosures:
- 1. Federal Register Advance Notice of Proposed Rulemaking I
- 2. Federal Register Notice of Final ;
Rulemaking
- 3. Response to questions in December 16, 1986, staff requirements memorandum
- 4. Regulatory Analysis for Advance ,
Notice of Proposed Rulemaking
- 5. Regulatory Analysis for Quality Assurance 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, 1986 (COMFB 86-8/COMLZ.86 25) 0FC: : FCML : FCFL : D/FC : DD/NM55 : D/NM55 :
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For: The Commissioners i
From: Victor Stello, Jr. l Executive Director fc,r Operations
Subject:
MISADMINISTRATION 4P-RADIATt0N-THERApV-AWPL)
- purpose
- To submit for Commissioj6(consideration: (1) an Advance Notice l of Proposed Rulemaking7 (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 regulaticn of the medical use of byproduct material.
w f&., m a n /u v ur m / m 1 % Aud en hn Issues: Quality assurance in radiation therarly and, penal-t4es-4ee-eegMgence-or-for-motet 4ng-a regulatory-standardr
> Summary: On April 14, 1986, the Commission directed the staff to prepare and submit a proposed, rule by April 15, 1987 that '
l-would strengthen NRC oversight of medical licensees.
l Subsequently, in an SRM dated December 16, 1986, the !
Commission directed that an Advance Notice of Proposed Rulemaking be submitted by January 31,~1987, that included i a comprehensive analysis and recommendations for improvements l
in NRC oversight that may be effective in reducing medical l
misadministration.
The staff has prepared an Advance Notice of Proposed Rulemaking to request early public comment on the scope of a rule that would:
to implement comprehensive (1)requireradiationtherapylicenseesgpf>g'ly, quality assurance programs tf> '
j to lessen the chance of misadministration, and (2) provide for penalt4ss-Jor-negMgence-or-for- not meeting. a regulatory standard .
in the l additi,use n, the of staff byproduct material.for has prepared radiation therapyr a quick-turnaround proposed. In ,.
N' l% ^^*
Contact:
g,u t rA b of a' '
l t
Norman L. McElroy
! 42-74108 .. -.
.. . 1
. _ _ _ _ ____ _ ______ _ ________ _ _________ ___ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ __ _J
r i'
The Commissioners 2
- e6 o LL. -, s - "f therapy quality assurance steps,that would far in upgrading NRC'srequirementsinthisarea;,this-. rule [couldprobak published in final form this Se'ptember. 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 l presented in the Enclosures 3, 4, and 5.
Background:
Radiation Therapy g p g M M 1 Teletherapy is the application nf a beam of cobalt-60 radiation J/i/ /y le w yw/g 7, , to a patient for a therapeutic purpose, usually for curative, l
~ s n / /, 4 ,;.$p o!> m. 0./ prophylactic, or palliative cancer therapy. (High energy x-ray h a,st/cyay 4m machines are also used for the same purposes.) A typical 6 Mm / ;o %,s ' .wo.;//.,' therapy may be comprised of daily treatments of 200 rads to the tumor volume for five weeks, yielding a total tumor dose i Am a nya x r,c/ " of 5000 rads.
9' us a - isi ,s s,~,,, maf
. .u ; A. puw a , y gr Brachytherapy is the insertion of small sealed sources of cesium-137,
" -* -~'s '
iridium-192, gold-198, or iodine-125 into the tumor volume for p-u/ 5 m, Aw m mmf cancer therapy. A typical therapy may require insertion of i
/A Op a v a ,, u . , ;I ,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
, . s # 'of 5000 rads.
[ /" ' '
Radiopharmaceutical therapy is the administration of a radio-active 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.
N/>-
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. A'
- w sa c o x w o w n .. r ; o m -.- p p,w c e .~ . - " + , -
For a more complete description of the radiation therapy process see Enclosure 7.
Discussion: ANPR on Quality Assurance and Renaltias for. Negligence-- --
-or-for Failure to Meet Regulatory Standards (Enclosure 1)
In April 1986 the Commission directed the staff to " develop a rulemaking to require independent verification of therapeutic doses and penalize medical licensees for their negligence or
, - ,m ,
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that of their employees, agents or practitioners." The staff l
has developed for Rulemaking (ANPR) public both that contains commenttechnicalan and Advance policy Notice of Propo questions. The staff recommends that the Commission issue y an ANPR before issuing a comprehensive proposed rule because information is needed, particularly from the medical community, before it can develop a rule that is comprehensive without i, inadvertently interfering with the delivery of medical care. 3 The staff has broadly constructed the term " independent verifica- ,
tion" because, to reduce therapy misadministration, the best !
approach would be to require each licensee to have a comprehen-sive quality assurance program that addresses each step in the radiation therapy process. However, the personnel and equipment f needed to implement a comprehensive quality assurance program h may not be available. Consequently, 'information~~~ on this matter would be sought through the ANPR. -
t/g /f
/
fuim A m gA h-
/ Th h issues-to-consider when * *"1 L ~
addr~eiising-sanctions. (These4ssues-includes-NRCJs-mediEcal : "
[ t,7y (4W,
- #l/6 M standards,-quality-and h)N "," ,po+e staff believes icy-statementrenforcement of reactor ~" operator-error"---
availability'of medical care, state' regulation o,f medical services, methods of reimbursement for t ere hw ',
'- m9 dical ca
/Therefore, ral agenciearly p /s, and NRC/ resources.o l
(Aw th & sj &gblichm commenf on C//h this matter I g f is essential.
si c'w.afh
-ArTd40ested bTthe Cumissionr the staff has,provided a ,
4 section on " negligence" in the ANPR. The-staf N 4 eves r - i howess.r-r-that-the section shodd-bc deleted 3 Tor several~ " ""j "Ag !
reasons. Firsf, at present, the NRC does not have the quality I assurance requirements (envisioned in the proposed rule and the l ANPR) for medical licensees under which it can take enforcement
- actions in cases involving therapy misadministration. Once the rules resulting 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 characterization. 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 violations. In fact, it has been invoked in several enforcement actions involving misadministration.
Explicit in the Enforcement Policy is the Commission's position I
t
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The Commissioners 4 / (
yJpubY IM that it will take enforcement actions against licensees that, ) ,
for instance, willfully disregard the Commission's rules, ary' )
reckless, or are cafeless, i.e., negligent, as measured against i the rules. Third,*the negligence section-may I'iftroduce/ unnecessary j controversy and may impede (achieving the main objective of reducing '
misadministration.g c '/ w The staff believes that the Commission'should give c1 ear notice that increased enforcement actions for non-compliance with NRC regulations are under consideration for medical licensees. .,
Consequently, ph~e-66mmission may-wish-to-direct- the replace-the-negl.igence-sect 4on-with-a review of- NRC's current j enforcement po)jcy as applied to the medical use of byproduct I meteria1. u/ C p J , n *, f 9 " '"
- h.u 3j w ! L 4 14 m/ya x % _ b **))
n As an alternativejer addit 4onal-act4cnr the ANPR could propose I
- "j 'y; ,jem / 9 to-estehh- care a broader that regulatory would address manystandard relating of the issues to medical discussed in Enclosure 3.
l j
Appropriate enforcement penalties for failure to adhere to all I aspects of such a standard could be provided. This is consistent !
with the provisions of the Atomic Energy Act, as amended, and l
~ ~ ' " ' " " '
,the Administrative ProcedureK Act for agencies' compliance actions. l
%!a>.- -The-Commission _may_wish_tn enupla_thisstT5h-with-the-preceding-b4.h, d,,$ ,t ". "" y /)notice p4teenat-ite-in ordettodnswe-that ii, he givegstrong and clear of its intent to take strong enforcement action if a medical
/g/cI g/ A/ A C M licensee fails to meet the standards established in the Commission's
/ regulations. This-would-requirs mnro timp and effort-to-develep_
than de nonded for_ the-ANPR-4n-Enclosure-h.-Howevery the staff believes it shou 1d proceed with the ANPR f+r-therapy-qtiality.
assurance- without de1ay, and -treat-theee =tters- unralated-to--
therapy-quaki-ty-assurance-es-edditiona4-actions-to be foMowed.
1+ter-4n-the-process of upgrading-the-standard oLmedicaLcate.
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.
Proposed Rule on Basic Quality Assurance (Enclosure 2)
To promptly establish basic quality assurance requirements while comments on the ANPR are submitted and analyzed, the staff has reviewed the technical and professional literature, consulted with the members of the Advisory Committee on the Medical Use of Isotopes (ACMUI) who are specialists in radiation therapy and other medical experts, and drafted a proposed rule (Enclosure 2) that would require medical lice,nsees to
The Commissioners 5
_ 4 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 t where no basis currently exists.
The staff considered preparing this rule in final form. This '
j was not done for three reasons: (1)appropriatesafety findings would have to be made, but there do not appear to be sufficient grounds for not following the normal rulemaking j process (which requires opportunity for public comment) i prescribedbytheAdministrativeProcedurepActof1946,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 j Budget under the Paperwork Reduction Act of 1980, and (3) many licensees would need time to formulate ar.d. institute prcgrams.
}
The staff believes a final rule based on Enclosure 2 cou'd be 'l submitted to the Commission by August 1987, e---- -- Need for Improved NRC Oversight In a memorandum dated December 16, 1986, the Commission requested a comprehensive analysis of NRC's medical use regulations including a list of elements to be addressed. The staff response to this directive is in Enclosure 3.
Nm- >
Other Med--4*-Progress-The proposed actions a dres therapy misadministration. The
~
staff notes that on Jan ar 14, 1987, the Office for Analysis g
fI and Evaluation of Opera i nal Data (AE00) published a study of q
l p' diagnostic misadministra ions. The staff did not address this I k.@problemintheseenclosth}esbecausetheworker' supervision, and resp /ts bilities in diagnostic nuclear training, medicine experien f'
y [d aredifferentfromthse(inradiationtherapy. To address these problemswouldhavepelayedthistherapyproject. The staff willcontinuetoexaminetlismatter.
Resources J Current. The current resources budgeted by NRC to regulate medical licensees are:
FY 86 FY 87 FY 88 FY 89 l
Program Development 15Y 1SY ISY ISY 1 l '
l Licensing 6SY 7SY 7SY 7SY l Inspection 12SY '13SY 135Y 135Y I
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s L. Program Development. The follow-through on the actions proposed 9 T in this paper, particularly th.ne addressed in Enclosure 3, and other actions such as'a furthed consideration of quality assurance for diagnostic nuclear medicind,'will require additional resources. Also,1 Nsources eficuld be devoted to keeping abreast of the evolvHg tect:r. ology and making timely regulatory adjustments i to raintain compatibility with the technology. Preliminary rest,urce. estimates for accomplishing this are: ~3 FY 87 M8, , FY 89 Proposed ' Total Program 4 FTE l4 FTE 4 FTE s '
',y Deve16pment Resources $200k 5200k $200k I .
,1 s Licensing. The rulemaking activities proposed in this paper, if adopted, as well as others contemplated, will increase the U
resourceneedsforlicenhing. The resource requirements will
, vary somewhat deptiiding on the alternatives. Preliminary estimates of new requirements based on the staff's recommended approach are:
t FY 87 FY 88 FY 89
-o
'}
Pruossed Total Licensing .
.4 FesoUrces--Direct Staff 9 FTE 10 FTE 10 frg
' ' 11 FIE
--Witn Overhead 10 FTE 11 FTE Inspectfo% In addition, increased inspr:ction resources should improveTTeensee attention and compliance with all requirements.
Current w dfcal inspection resource allocations allow for a one-: lay'inspectionofmosthospitalseach,threeyears. Preliminary estimates to increase the frequency to an annual inspection and to account for inspection against additional requirements are: FY 87 FY 88 , FY 89 lt-Proposed Total Inspection
> Resources--Direct Staff 39 FTE 40 FTE 40 FTE
--With Overhead 44 FTE 45 FTE 45 FTE i
t 4 2 s - 1
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_ _ _ _ _ _ _ _ _ _ _ _ . . . _ 1
- a i
The Commissioners 7 ( Source of Additional Resources. If we are to proceed with this initiative, additional resources will be required. The additional resources identified for program development, 3 FTE
- q. over those currently budgeted, would be utilized at Headquarters.
.j The additional resources identified for licensing, 4 FTE per f year, and for inspection, 32 FTE per year, would be utilized in the Regions where the. licensing and inspection functions for the medical use of byproduct material are currently performed. / Major impacts would result in'both Headquarters and the Regions 3" if these additional resources were diverted from existing programs. In the proposed' agency-wide reorganization, a potential resource saving of approximately 68 FTE has been identified. The staff
'. considers the resource saving identified in the proposed reorga-3 nization to'be a possible source of tho additional resources needed for this new initiative. The identified dollar resources ,
d for program development, $200K per year, could be reprogrammed l from funds currently budgeted for the materials program with little or no impact. Coordination with Agreement States J 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 1 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 ' d\ States on this during the comment period. Note that NRC guide- ;
- lines allow Agreement States three years to adopt compatible '
regulations.
/'/"# 1 Coordination:- The Office of the General Counsel has reviewed this eaterial-. ;
and concurs in 4t- lov#a &cd ol'ccBcw h it I 1 1
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* . ,^ ~
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a
' The Commissioners 8 Recommendation: The Commission:
- 1. Direct publication of the quick-turnaround proposed rule (enclosure 2) that would require licensees to implement certain basic quality assurance steps.
- 2. Direct publication of the Advance Notice of Proposed Rulemaking l
(Enclosure 1) regardirg the scope of a quality assurance r program rule.after removing tha sectinn entitind_"Negl.igence!!-- T.. and-insenting-e-statement. about-.NRCis-current,. Enforcement-6\ Policy-and-its-application to-.medicallicensees,-a-statement _ deut-broad-regulatety-standards. or_.both.
- 3. Approve the milestones and schedule proposed in Enclosura 6.
- 4. Agree to the staff initiatives (Enclosure 3) submitted in response to the Commission's December 16, 1986 memorandum on medical regulations.
- 5. Note
' - - * - - a. The Advance Notice of Proposed Rulem King, with a 90-day public comment period, and the Proposed Rule, with a 30-day public comment period, would be published in the Federal Register for public comment; The Director of the Office of Nuclear Material Safety b.
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 j the Office of the Federal Register. ! I
- e. Copies of the Federal Register notices will be distributed i to all affected Commission specific licensees, all States, and other interested organizations and individuals.
The Commissioners' 9
- f. The proposed rule in Enclosure 2 amends infor. nation collection requirements that are subject to the Paperwork Reduction Act of 1980 (44 U.S.C. 3501 et seq.). It will be submitted to the Office of Management and-Budget for review and approval of the paperwork requirements.
Victor Stello, Jr. Executive Director for Operations
Enclosures:
- 1. Federal Register Advance. Notice of Proposed Rulemaking f) /
- 2. . Federal Register Notice of Mfte4- /"y)//ME Rulemaking
- 3. Response to questions in December 16,
'- * * * '1986, staff requirements memorandum
- 4. Regulatory Analysis for Advance hotice.of Proposed Rulemaking 5.- Regulatory Analysis for Qua uty- /A#/#3
// ,
f v' Assurence-Rul e--
- 6. Draft Schedule
- 7. Description of the radiation therapy process
- 8. Memos Chilk to Stello dated April 14, 2986 (COMFB-86-3) and December 16, 1586 (COMFB-86-8/C0MLZ-86-25) y e d. a e he g ["
. _ _ _ _ . . . _ _ _ _ _ . _ _ _ . _ _ _ _ _ ______._________w
lE ww[s Aan' / A 9 The Commissioners 6 Resources i Current. The current resources budgeted by NRC to regulate l medical licensees are: FY 86 FY 87 FY 88 FY 89 j Program Development ISY ISY ISY ISY , Licensing 6SY 7SY 7SY 7SY ! Inspection 12SY 13SY 13SY 13SY Program Development. The follow-through on the actions proposed j 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 technology. Preliminary resource estimates for accomplishing this are: ; H 81 FY 88 FY 89 ; 1 Proposed Total Program 4 FTE 4 FTE 4 FTE Development Resources $200k $200k $200k 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 udtle w/
, Inspection. In addition, increased inspection resources shottM-a.mia u / 4epeeve- licensee attention and compliance with all requirements.
4 # ;u,4 Current medical inspection resource allocations allow f N n i one-day inspection of most hospitals each three years. C' A c~ M*7, g ,f P~'-4 ner;' estimate: to -iacrcase the -fregttency-to-an-enntraf 4 /#"L. m'/9 d -w j (
'w a c.-admd',"">/4s5pecduw,and requirements wet wjic to account
%w nua.;for inspection i.wW M k l' against pu m additiona fen" i tw M.w knw/ , & ! ' Y '" "_
FY 87 FY 88 FV 89 ud /4y aw l c f, M gw Proposed--Total Inspect 4on- f,
/M "'T Resetteses--Direct Staff 39 FTE (Q FTE 40:FTE g ju AA
! "' " 'I / --With Overhead M)FTE '45 FTE 4 FTE 27 27 n l
3I 3L M. I l a
The. Commissioners 7 , Source of Additional Resources. If we are to proceed with this initiative, additional resources will be required. The additional resources identified for program development, a mr m -- ~ 7,ygmtyy gnage+=d e would be utilized at Headquarters. The additier.al resources identified for licensingf4-RF per p and for inspections 52 TTE gr-m would be utilized in the Regions where the licensing and. inspection functions for the medical use of byproduct material are currently performed. ff, g h a mn Heu duwkd d& 5d". ^[ j4 p,g6 Major impacts if these. would additional result in}were diverted from existing pro-both Headqu resources g, m u g /iej 6 @ .4 gin the proposed resource saving ofagency-wide reorganization, approximately 68 FTE has been identified. a potential
~ - [n/ cw/e ed ^#'"';j# The staff considers the resource saving' identified in the proposed reorganization to be a possible source of the additional /,f [ o j g;// -
resources needed for this new initiative. The identified dollar jl
'ddW au6 n, resources for program development, $200K per year, could be reprogrammed from funds currently budgeted for the materials 1 ra/ J % Mdj'j / program with little or no impact.
MM Coordination with Agreement States 1 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. l The schedule has not allowed for the customary interactions j with the Agreement States before submitting this rulemaking, i 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 i guidelines a110w Agreement States three years to adopt ! compatible regulations. Coordination: The Office of the General Counsel has reviewed this paper and has no legal objections to it. t _ . . _ . . _ __ _ _ _______________________
. ~
[7590-01] NUCLEAR REGULATORY COMMISSICN 10 CFR PART 35
-" ad;6 Uun T ^
cory y u,hei6py u a l i t.,7 Assuponge and Fenai u m TorNEgTTg'elft'r m av av, a y Radp.ation-Theapy Quality Assurance and Standard of Care AGENCY: Nuclear Regulatory Commission. /]/fg/Q/ /k ACTION: Advance Notice of Proposed Rulemaking.
SUMMARY
- The Nuclear Regulatory Commission (NRC) is considering amendments to its regulations that apply to the use of bypr,oduct material for radiatien a , a! = 4 pa h use s w /olor '.u~!t n&+ run d;;s u V .
therapy. In addition to the curr;ent r' requirements for quality assurance, 0 u _o."-
^ 9py,.the contemplated amendments would require licensees that offer teletherapy or brachytherapy services to implement a comprehensive quality assurance program to reduce the chance of misadministrationst_ead would-alsn pcovide-pena 4 ties-for negl.igence when using byRraduct mater _ial.--
f.c.r_.r.adiation-therapy..-The NRC requests public ccmment as to whether additional radiopharmaceutical the.rapy quality assurance requirements are needed, and invites advice and recommendations on several cuestions that will have to be addressed in the rulemaking process. [ Note: a cross-reference to the proposed rule will be inserted.] CATE: Submit comments by (90 days). Comments received after this date w1115e considered if it is practical to do so but assurance of considera-tion cannet be given except as to comments received before this date. 1 Enclosure 1
( I , [7590-01] ADDRESSES: Mail comments to: The Secretary of the Commission, U.S. I 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 Roott, 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:
\
se" k i e NRC'S Policy Regarding the Medical Use of Byproduct Material pp , In a policy statement published February 9, 1979 (44 FR 8242), the F 1, ) NRC:4Gd: me ted ',"'"'acgtde+es4he-medioa4- ttse of b [ ig eduet-tae* erie 4-es**- p (g) ucestetwts.prowide for theJadiation.safaty-of workecs.-and-the genertT I pubHc, reguletes-the~r.ad4ation 4afaty.4f-patierttsJhemjAtitied.by, the-tgfI"
? *i-sk-to patients,-ar.d minimizes its.JntrusionJnto.redirahdudgments a l
.a24ecti n gget;i e n t r a h~d' Thro ~6Thie f'#P Aa Y~t ra d i ti o n ai4y-cens 4 dered-to-bs the-practice,oLmedicine The NRC has the authority to ragulate the medical use of byproduct material to protect the health and safety of natients , but also recognizes that physicians have the primary responsi-bility for the protection cf their patients. NRC regulations are predi-cated on the assumption that properly trained and adeouately informed physicians will make decisions in the best interest of their patients.
2 Enclosure 1
[7590-01] Therapy Use of Byproduct Material Teletherapy is the application of a beam of radiation emanating from a cobalt-60 source to a patient for a therapeutic purpose, usually cura-tive, prophylactic, or palliative cancer therapy. (High energy x-ray 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 tha 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 nicht require insertion of 50 millicuries for 48 to 72 hours, 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-capsuleo iodine-131 as sodium lodide. For hyperthyroidism, 5 to 30 millicuries night be administered; j for thyroid cancer, 70 to 200 millicuries night be administered. t
$f f Therapy Misadministration The NRC recently maileo to all licensees a report about therapy misadministration (' Case Study Report on the Therapy Misacministrations Reported to the NRC Pursuant to 10 CFR 35.32," hRC report AE00/C505)1 .
! ffSingle copies are available from Kathy Black, Office for Analysis and
/ Evaluation of Operational Data U.S. Nuclear Ragulatory Commissior,
Washington, D.C. 20555.
.uk, ',May w , ew m ." A b'b % i'* ' ' ~ ' " " ' "
l $ o lvi .t. % G .x A .', c h', , s- ' A N*3 'E U '' d Y1 'f # '5 I' ' l l
> .nclosure .
[7590-01] 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 patient 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 authnrized 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 violatier of NRC regulations Jho en=4 rr4ce-inted3-- tc=ppare a ruie-thatwould-raquire-independent-verification f-therapy dosas-andepenalizeemedical.
-licensees-for-their-negligence orThat~of*thh1Pempl'0yees s agents ror--*
-practitioners - ~ m 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 opportunity to request early public commer.t.
Effect on the Agreement State Program Twenty-eight States, known as Agreement States, have assumed resocrsibility for reguiating 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 4 l { 4 Enclosure 1 '
[7590-01] l 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 tht.t it : implements on this matter, state regulatory agencies are asked to comment. Request For Comments The NRC has prepared the following questions to elicit ccmments on methods of preventing misadministration. Comments do not have to respond to these questions alona; other related topics or alternatives may be described if the commenter believes this will help to resolve issues related to this rulemaking. Quality Assurance J General The following questions apply to tt.e provision of all types of thera-peutic medical use j onI (c d'd j Aos /" # 0 W f i S.
- 1. Should the Commission require that each licensee implement a comprehensive quality assurance program without specifying its content, or should the NRC list certain quality assurance steps that must be q
performed?
- 2. Should the definition of misadministration in 10 CFR 35.d' l (the same cefinition that appears in 10 CFR 35.2 that was published en October 20, 1986 at 51 FR 36932) be chanced? Is it clear and complete? 3 t
Is the definition sufficiently bread to incluoe all appropriate activities? i Is it so broad as to include inappropriate activities? Is the tern
)
l 5 Enclosure 1 ) i
)
[7590-01]
" misadministration" appropriately descriptive of the activities? Should some more descriptive term be used?
- 3. The NRC knows of one instance in which radiation was administered to a patient without a request from the primary care physician. Should the NRC require that the authorized user activily consult with the primary care physician before prescribing radiation or deciding that radiation is not needed?
- 4. What methods are available that provide reliable as'urance 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 assune that licensees will provide each individual whatever training is necessary? Should the NRC require licensees to acminister written examinations to workers and evaluate them i before allowing the workers to participate in radiation t;ierapy'? Should periodic retraining and re-examination te required?
- 6. What other regulatory, certifying accrediting, or inspecting !
l organizations examine medical quality assurance programs? Are these ! l examinations censidered perfunctory or exhaustive? ) Teletherapy and Brachytherapy The following questions apply to the provisior of teletherapy anc brachytherapy services. l { 6 Enciosure 1 1
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,p' ' ;i1LJ4 '~ yN'*
~
)
[7590-01] ' , Jo awn pdA q'lAcJjm, nn nyni arin mawmed Nd cu% weicd' l - n hi k p,, w k a 'm
/, un !$n,tsw of kyynff & paM>.h JJawit,a.ity A th ,:wJm +' mt b. k. ;W sw M
- 1. g Should NkC require that licensees have a certain minimum case-load to assure that their employees retain their expertise in performing l; radiation therapy clinical and quality assurance procedures? Should NRC limit the permissible ratio of cases per employee to assure that licensee ,
1 employees are not rushed in their work? Should NRC require licensees to specialize in treating cert'ain 'inds or stages of disease rather than allowing them to treat all kinds of disease? Should differing training , nr certification requirements be imposed based on case load?
- 2. Should smaller licensees with fewer staff anc equipment resources l be required to meet different quality assurance requirements than those for larger licensees?
- 3. What fraction of licensees already have a quality assurance program?
.h h,yda D y 66 ,0,/,ty &/ Jniw.o I'd upnrqn a y ,, c;,: S m mad gJ !
4, -lbi viilixtinent-reimbursement methods attem,,tteenreedtrtitty- i car / af any/uw &AL .ugun AwJ. te-eemp4y-with-quam-ty-assurance.-requirements.?- 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 woulf a lengthy lead-in time be needed?
- 5. Are there complete medel 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 recuired to assure that the dose ,
given is the sane as the dose proscribed? What other areas are, or ; i shculd be, covered in a ccmplete qt.aiity assurance program?
- 6. Are the staff and equipment that are needed to implement a complete quality assurance orogram available in the marketplace, or ,
would new training programs and equirment development be needed? 7 Enclosure 1
r [7590-01]
- 7. What methods are available for reducing the frecuency or impact of human error?
Radiopharmaceutical Therapy The NRC requires that licensees use only certain radiopharmaceuticals for specified therapy clinical procedures, measure the radioactivity in radiopharmaceutical dosages be fore 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. The NPC expects that all licensees have policy requirements for clear statements of prescription and verification before administration of any p ha rnaceuti cal . The NRC would appreciate suggestions on methods to assure that the clinical procedure (including radiopharmaceutical, dosage, and rcute of administration) intended by the authorized user is prescribed, and that the prescribed clinical procedure is the clinical precedure that is perforced. Are there special needs regarding patient identification in radiopharmaceut4 cal therapy that go beyond the information regarding patient identification that was requested in question 4. of the General subsection? [ Note: If the Ccmmission accepts staff recommendation 2. in the Commission : Paper, the following section would not appear in the Federal Recister Notice.] l i 8 Enclosure 1
' M -Q i fio?);V,7-A3 g
() s }1
- 1
"?' i G 1 The following ques ns apply tc the provisiogofte herapy, brachytherapy, and ra '1 pharmaceutical therapy service .
- 1. Is there a clear, generally accepted defi tion of negligence that the NRC c rt use? Should the NRC use existin legal definitions or develop its wn definition? What level of n.eg.1gence should trigger apenalty-thelicensee'swillfulaction,th licensee's reckless disrega'rd for " generally accepted patient care procedures," or the lic,e/ nsee's simple inadvertent error? S ould there be actual, clinically ,
d cernible harm to a patient or sim y radiation dose above a certain level, or should presence or absence of actual patient harm not be a consideration in making a find'ng of negligence?
- 2. Should negligence pe.alties be imposed on licensees, on their employees or both? Should the State Board of Medical Examiners be invited
/
toparticipate'inproceed;ngsregardingphysicians? What kinds of negligence penalties should be impos/ed on licensees? Employees? Both? Should the j ' penalty or the standa d for negligence, be related to the amount pr'liin
/
of byproduct materia that was used or misused in the eventfor perhaps to
/
the amounts and kinds of byproduct material authorized'under the license? Should NRC institute a system te assure that aneindividual who precipitates
? misadminisrbtionorcommitsaviolation7 s not simply leave and gn to ~
another licensee, either an NRC or Agree / ment State licensee, and continue to engage,in similar activities? e
- a / What ef#ect would a rule on neglhence have en liability insurance i j i rates and availability of insu -nee?
t 9 Enclosure 1
-__-__-_7--
[7590-01]
//
- 4. Would issuance of,peNil es impact licensees, their employees, or both in any lawsuits? /
/
- 5. The NRC j is aware that in cther medical special. ties such as /
obstetrics, leg'ai and insurance issues have been cited as reasons for physicians' ecting to move to another medical specialty. W T e
/
risk t.o" medical professierals of NRC-inposed peralties re uce the
/
wi>lingness of licensees to provide radiation therap services?
/
/ /
/ * *
[ Alternative in place of'" Negligence" Section.] 4. Sta nda rds -SeeRed i e t. . un Thecapy Care
/f The NRC presently has, in 10 CFR Part 2, Appendix C, particularly Supplement VI, an enforcement policy that it can apply to the medical use of byproduct material.
The following questions apply to the provision of teletherapy, brachytherapy, and radiopharmaceutical services, and to the Commission's Enforcement Policy. 1. Should NRC adopt some kjrd of "due care" regulatory / standard?
/ /
Or inste,id, should NRC set coyp/rehensive, prescriptive cuafity assurance
./
requirements? j f. Is there a clear, generally accepted standard of ra44et4ctr deepy care that the NRC can adopt? If yes, please describe it. If not, please describe $ standard that NRC ould adopt. 85
- M"#^ ##
,g y C h e c u j a h n so d e , u w ,y /, v e p9,ys,nJ4 ?
g A. What kinds of penalties should be imposed on licensees, their l ., enp yees, or both, if the standarc or the comprehensive, prescriptive
;k!)pb/Ns i pq;.c) m o,j/syee s ? ,
i requirements are not net? Hex.should f NRC's Enforcement Policy be I changea n th;s asaed L ,
) \
God!l 5s, ka ai . > 10 Enclesure 1 ___-- - - l
[7590-01]
- h. Wnat effect would such a standard or comprehensive, prescriptive l
requirements have en provisions of radiation therapy care?
-End o + E !*,emai. i v e Tex t --
,_ __ ,_ __ _ _ _.y _ _,,_ _ _. ,
l List of Subjects in 10 CFR Part 35 Byproduct ma.terial, 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 Sta t. 1242, as amended (42 U.S.C. 5841). Dated at Washington, DC, this day of , 1987. FOR THE NUCLEAR REGULATORY COMMISSION) A Samuel J. Chilk, Secreta r:e of the Commission, n 11 Enclosure 1
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n January 14, 1987 AE00/N701 ( t MEMORANDUM FOR: John G. Davis, Director Office of Nuclear Material Safety and Safeguards James M. Taylor, Director Office of Inspection and Enforcement j i FROM: C. J. Heltemes, Jr. , Director Office for Analysis and Evaluation of Operational Data i
SUBJECT:
AE0D ENGINEERING EVALUATION REPORT: DIAGNOSTIC MISADMINISTRATION INVOLVING THE ADMINISTRATION
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OF MILLICURIE AN0UNTS 0F~10DINEU31 ~ Attached is the AE0D Engineering Eval'ation Report on Diagnostic Misadminis-trations Involving the Administration of Millicurie Amounts of Icdine-131 (Attachment 1). This report documents our review and evaluation of 14 diagnostic misadministration, each of which involved the administration of a 1-10 millicurie dosage of iodine-131 to a patient, whereas the prescribed radiopharmaceutical was either iodine-131 (6-300 microcuries), iodine-123 1 (150-400 microcuries), technetium-99m (0.1-10 millicuries), or technetium-99m methylenediphosphonate (20 millicuries). These misadministration were -) reported to NRC between January 1982 and June 1986. From our evaluation of these events we found, among other things, that while I ten of the 14 misadministration occurred as a result of either the referring physician's orders being misinterpreted by or miscommunicated to the tech-nologist or the technologist not knowing the correct dosage to administer for the prescribed thyroid scan, the underlying cause of 11 of the 14 (79%) misadministration was that licensees did not exercise adequate control over the administratit,n of millicurie amounts of iodine-131 to patients. That is, most of the misadministration could have been prevented, despite the errors of-misinterpretation or miscomunication if the prescription for the iodine-131 dosage had been verified before the iodine-131 was administered to the patient. We believe that the overall data highlight the need for better quality assurance practices to ensure the accuracy of radiophannaceutical dosages of iodine-131 that, although administered for diagnostic purposes, fall in the
' cosage range normally used for therapy. 1 AE0D issued a case study report in December 1985, AE0D/C505, " Therapy Misadministration Reported to the NRC Pursuant to 10 CFR 35.42," that docu-ments an analysis of 16 teletherapy and two brachytherapy misadministration.
! A significant finding of the case study was that: Although professional f medical groups involved with radiotherapy and related government agencies
- encourage quality assurance programs in radiotherapy facilities, no government i
A 3 W '0ffT}& l
4
. Multiple Addressees 2 ,
agency or nongovernmental accrediting body requires that radiotherapy facili-ties have quality assurance programs that conform to the programs recommended by professional medical groups. Thus, many facilities may not have quality assurance programs .that are consistent with recommendations of medical profes-sional groups involved with radiation therapy. We believe that this finding likely applies equally to NRC licensed facilities which may administer millicurie amounts of iodine-131 for diagnostic and therapeutic purposes. - Since undertaking the engineering evaluation study, we have received three additional. reports of diagnostic misadministrctions involving the adminis- i tration of millicurie amounts of iodine-131 to patients (a summary of each report is 9 ven 1 in Attachment 2). The cause of these misadministration was the misinterpretation by or miscommunication to the technologist o.' the referring physician's order. These events further support the findt qs, conclusions, and suggestions contained in this report. We have suggested in our engineering evaluation report that: (1) The Office of Inspection and Enforcement send an update to Information Notice IN-85-61 (Misadministration to Patients (Jndergoing Thyroid Scans) to the.affected licensees informing them of the more recent misadministration events involving iodine-131. (2) NMSS assess the proposed regulatory changes to 10 CFR 35 to determine whether the requirements for quality assurance procedures for radiotherapy facilities should be expanded to include a requirement for cuality assurance procedures for the administration of radiopharmaceuticals for therapy or for diagnosis in which the dosage of the radiopharmaceutical administered is in the therapy dosage range for the radio-pharmaceutical. We understand that an ANPRM is being developed in regard to amendments to Part 35 involving misadministration. We suggest that consideration be given to incorporating item 2 into this ANPRM. If we can be of further assistance in this regard or if you have questions on other matters regarding the report, please contact Samuel L. Pettijohn of this office on X28348. I C. Heltemes Sr. Director Off for Analysis and Evaluation of Operational Data
Attachment:
As Stated cc: See next page
Multiple Addressets 3 cc: D. Ross, RES G. Wayne Kerr, SP T. Murley, R-I J. Nelson Grace, R-II
'J. Keppler, R-III R. Martin, R-IV l J. Martin, R-V l 0. Humanansky, OCM V. Stello, ED0 T. Rehm, A0/E00 J. Sniezek, DEDR0GR M. Beaumont, Westinghouse Electric Corporation C. Brinkman, Combustion Engineering Company.
R. Borsum, Babcock & Wilcox L. Gifford, Generai Electric Company
)
i
AE0D ENGINEERING EVALUATION REPORT ; 1 1 I LICENSEES: Various EE REPORT NO.: AE0D/ N701 EVENT DATES: Various DATE: 01/14/87 4
REFERENCES:
See Footnotes EVALUATOR / CONTACT: S. Pettijohn X28348
SUBJECT:
DIAGNOSTIC MISADMINISTRATION INVOLVING THE ADMINISTRATION OF MILLICURIE AMOUNTS OF 10 DINE-131 INTRODUCTION As a result of a number of serious mis: administrations involving radiation therapy in the 1970s, and to assure the complete and consistent reporting of such events, in 1980 the NRC promulgated regulations (10 CFR 35.41 through 35.45) to require the reporting of diagnostic and therapy misadministration involving nuclear medicine studies or radiation therapy, although the regula-tions did not define the occurrence of a misadministration to be a violation of any NRC regulation. Nuclear medicine is defined as that speciality in the practice of medicine dealing with the diagnostic, therapeutic (exclusive of sealed sources), and investigative use of radionuclides. Therapeutic radiology (radiation therapy) is that branch of radiology which deals with the therapeutic application of icnizing radiation, including Roentgen and gamma rays, as well as particulate radiation from whatever source, including artificially and naturally radio-active, as well as X-ray generators and particle accelerators. Diagnostic misadministration, as used in NRC regulations, refers to the misadministration of radioisotopes during diagnostic procedures (e.g., thyroid scans, bone scans,etc.). Therapy misadministration, as used in the regulations, refers to the misadministration of radiation during therapeutic procedures. The regulations, which became effective on November 10, 1980, define a misadministration to mean the administration of: (a) a radiopharmaceutical* or radiation from a sealed source other than the one intended; (b) a radiopharmaceutical or radiation to the wrong patient; (c) a radiopharmaceutical or radiation by a route of administration other than that intended by the prescribing physician; (d) a diagnostic dose of a radiopharmaceutical differing from the prescribed dose by more than 50%; (e) a therapeutic dose of a radiopharmaceutical differing from the prescribed dose by more than 10%; or
- Definition from Nuclear Medicine Therapy and Techniques, Edited by Donald R. Bernier, C.N.M.T. , James K. Langan, C.N.M.T. , and L. David Wells, ;
C.N.M.T. , The C.V. Mosby Company, St. Louis, Toronto, London 1981. f N p.
n 2 ( (f) a therapeutic radiation dose from a sealed source such that errors in the source calibration, time of exposure, and treat-ment geometry result in a calculated total treatment dose l differing from the final prescribed total treatment dose by ) more than 10%, i Items (a), (b), (c), (e), and (f) apply to therapy misadministration, and (a), (b), (c), and (d) apply to diagnostic misadministration. The Office of Inspection and Enforcement (IE) issued an Information Notice (IN-85-61) dated July 22, 1985, titled " Misadministration to Patients Undergoing Thyroid Scans," that addressed the occurrence of diagnostic misadministration involving the administration of millicurie amounts of iodine-131 to patients. The IN was developed from inform & tion compiled by us and forwarded informally to them. Following our tracking and review of reports of several additional misadministration of this type over the last year, AE0D decided to evaluate the safety implications of this type of misadministration ; and assess whether action should be taken to minimize the occurrence of this type of misadministration. This engineering evaluation report documents our review of 14 reports of diagnostic misadministration, each of which involved the administration of a 1-10 millicurie dosage of iodine-131 to a patient, whereas the prescribed radiopharmaceutical was either iodine-131 (6-300 microcuries), iodine-123 (150-400 microcuries), technetium-99m (0.1-10 millicuries), or technetium-99m methylenedisphosphonate (20 millicuries). The average radiation dose (calculated) to the thyroid (critical organ) of the patient involved in a 1 misadministration was over 80 times the average radiation dose (calculated) that the patient would have received if the correct radiopharmaceutical and/or dosage had been administered. The 14 diagnostic misadministration evaluated in this report were received by NRC during the period January 1982 through June 1986, a 41/2-year period.* ' This represents an annual rate of three misadministration of this gype. The error rate for these misadministration is calculated to be 6 x 10- based on an estimate of 500,000 thyroid scans per year.** This error rate is about a factor of 100 smaller than the error rate found for diagnostic misadminis-trations*** reported to NRC. However, similar to therapy misadministration, the significance of diagnostic misadministration involving the administration
*The 14 reports were-identified from a search of the AE0D misadministra-tion database for all reports of diagnostic misadministration that involved the administration of iodine-131 where the administered amount exceeded the prescribed amount by greater than 50%.
**From a survey of data on the in vivo use of radioisotopes for the third qucrter of 1984 compiled by Medical Marketing, Inc.
***AE0D report AE0D/C505, dated December 1985, which documents an AE0D Case Study on Therapy Misadministration Reported to NRC Pursuant to 10 CFR 35.42, shows (on page the error rate per patient for therapy misadminis-trations to be 2 x 10~
_ _ _ - - _ - _ _ - _ _ _ _ _ _. i
4 3 l of millicurie amounts of iodine-131 to patients stems from the fact that each ! misadministration had the potential to result in severe health effects on the patient involved. Acditional factors that contribute to the significance of the reported misadministration are that: l Six* of the 14 misadministration cases involved a substantial degradation to the protection of public health and safety as defined in the Commission's criteria for abnormal occurrences related to misadministration and thus, were reported in the Quarterly Report to Congress on Abnonnal Occurrences. The types of errors that led to most of the misadministration are similar to errors found for diagnostic misadministration _ in general, indicating that there may be a significant potential ! for these types of errors to occur and thus continue to occur in the future. ANALYSIS OF THE EVENTS i Ba ckaround For diagnostic nuclear medicine studies,** the technologist in general uses a radiopharmaceutical/ dosage schedule approved by the nuclear medicine physician in determining the correct dosage of a radiopharmaceutical to administer for a particular nuclear medicine study. This is in contrast to procedures normally used in radiation therapy, whereby the radiation therapy dose is calculated specifically for each patient. The dosage schedule normally provides for a l range of doses to account for variations in a patient's age, weight, etc. For l example, a typical dosage for a thyroid uptake study may be specified as 20 microcuries of iodine-131 if the patient is an adult; however, if the patient is a child the dosage specified would generally be less. Adosage(i.e.,the ar.ount of the radionuclides in microcuries, millicuries, etc.) may not be explicitly specified.by the dosage schedule for each patient type but rather a formula may be specified for use in determining the dosage for a particular patient type.
*0nly six of the misadministration were reported as abnormal occurrences because eight of the misadministration occurred before the adoption of the present criteria for determining whether a misadministration is an abnormal occurrence. These eight misadministration meet the present abnormal occurrenco reporting criteria for misadministration.
** Diagnostic neclear medicine studies as used in this report refers to the type of diagnostic procedure involving the investigative use of radio-nuclides (i.e., bone scans, thyroid scans, etc.).
4 The referring physician generally specifies the particular diagnostic study to be performed. The required dosage to be administered to the patient is then determined from the schedule for the prescribed diagnostic nuclear medicine study. As noted above, the schedule usually specifies both the radiopharmaceutical and the dosage of the radiopharmaceutical to be adminis-tered. This means that the technologist can perform the administration and imaging part of most diagnostic nuclear medicine studies without the direct intervention of a nuclear medicine physician. The interpretation of the nuclear medicine study results is performed by the nuclear medicine physician. Table 1 shows the radiation dose to a patient that results from several common , diagnostic nuclear medicine studies. From the table, we see that the radiation dose to a patient's thyroid (the critical organ) from an " iodine-131 whole body scan,"* 800-8000 rad, is substantially greater than the critical organ dose from other diagnostic studies (e.g., liver *can or lung scan). Generally, the radiation dose to a patient (critical organ) that results from a misadministration caused by the administration of the wrong diagnostic study, say a lung scan rather than liver scan, is generally of the order of I-2 rads. The radiation dose to a patient's thyroid that results from a misadministration involving a " iodine-131 whole body scan" instead of a thyroid scan can be several thousand rads. From Table 1, we see that the radiation dose to a patient's thyroid undergoing an iodine-131 whole body scan is in the same dose ranne as for a patient undergoing therapy for hyperthyroidism (state of increased thyroid function) where the radiation dose can range from 4000 rads to 24000 rads.
- Iodine-131 whole body (or total) scans are performed on patients with diagnosed thyroid cancer for the purpose of searching for metastatic deposits of functional thyroid cancers throughout the body. The dosage l of iodine-131 administered for whole body scans for the misadministration l included in this report ranged from 1 to 10 millicuries.
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,,- TABLE 1 ,
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Typical Administered Activity and. Corresponding Radiation Dose to the ~ Patient for Several Conmon Nuclear Medicine Studies *
~~
Radiation Estimated l .
// L Dose to Radiation?
/ Critical Dose to Nuclear Medicine ,9 g Administrated Critical ' Organ (mrad /. Critical l~ Study ' Ac,tivity (mC4) Organ microcurie) Organ (Rads) ,
1i , Bone Scan '
'< '/
Technetium-99m .r
)>I 3 >
methylene-diphosphonate (MDP) 15-20 Bladder Wall 0.051 0.76-1.02
,l.iver/ Spleen Scan /
n Technetium-99m sulfur colloid 4-6 Liverf.; , /0.340 1.36-2.04 Luna Scan ! Technetium-99m ' ' macroaggregated 'r - & , J albumin a lung ' O.290 1.16 cr Xenon-131 gas 25 Lung 0.016 '
.24 /;
d i [ Thyroid Uptake i
. Iodine-123e(iodide) .010 .020 Thyroid 7.5 .075-c15 Iodine-131 (icdide)- .006 h Thyroid 800( '
4.8;' ' j - i' ,. ./
, / Thyroid Scan i/f. !
Technetium-99m . (Sodium Pertechnetate) 5-10 ", Stomach Wall &,025 .125 .25 Iodine-123 (iodide) .100 .400:- Thyroid 7.4 .75-3 '
,v (Pyroid Iodine-131 (iodide) .030
(.03.2)** 80&- , 24k (24}}E0) j
,/j "
Iodine-131 if
}f Whole Body Scan Iodine-131 (iodide) 1-10 Thyroid ,800 800-8000
,r ,
Hyperthyroidism Treatment *** [- .
, j Iodine-131 (iodide) 5-30 - Thyroid '800 4000-24000 l f' ;r p -.- ,(
- Data derived from the National Counell on Mdiation Protection and Measurements. ~q (NCRP). Report 70 issued June 1,1982; and Nuclear Medicine Technology and 7:
Techniques Edited by Donald R. Bernier, C.N.M.T. , James K. Langan, C.N.M.T. , 5 and L., David Wells, C.N.M.T. , The C,V. Mosby Company, St. Louis, Toronto, C f' London [981. , t **Although data from th$ 3bove reference shovithe/ iodJne-131 dosage for a l ' thyroid scan to be 30 microcuries', the dosacfs administered in the misadministration cases ranged from 30-200'incrocuries. ' N *** Included for cdz,parison. b (j
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,!- lbscription'of the Events The-14 misadministration events invclved the administration to patients sched-uled for diagnostic nuclear medicine studies (thyroid scan, thyroid uptake,
# and bone scan), amounts of iodine-131 that normally would be administered for 9 , the diagnostic study "whole body iodine scan." Table 2 shows the prescribed and administered radiopharmaceutical and dosage for each of the misadminis-
'/'I' trations. Froni the table we see that the misadministered dosage of iodine-131 c-
'r renged from 1 millicurie to 10 millicuries.. with an average dosage of 4.7 I > millicuries. The estimated radiation dose to the thyroid of patients ranged p from 800-8000 rads, with the average dose being 3760.* The estimates of the
'L' radiation dose in ICRP Report No. 70 are based on a maximum thyroid uptake of 15%. The actual- radiation dose to individual patients will vary depending on a number of factors such as, the accuracy of the assay of the administered iodine-131 dosage, the weight of'the thyroid,** thyroid condition that might affect the uptake of iodine-131,*** and whether thyroid blocking agerits are y administered to the patient after the discovery of the misadministration, etc.
We are not able in this report to make a quantitative assessment of the health
~
effects on the specific patients involved in the misadministration, since we did not have available for review the medical evaluations for the patient, f
- International Connission on Radiological Protection (ICRP) Report No. 70, issued June 1982 (see Table 1 above) shows that the radiation dose to the thyroid from iodine-131 is approximately 800 millirads/ microcurie of
/,~ iodine-131 administered.
**The weight of the thyroid and consequently the iodine uptake varies with age and between different patients.
*** Thyroid uptake of iodine of over 55% is suggestive of hyperthyroidism (state of increased thyroid function) values of less th~ na 20% are indicative of hypothyroidism (state of decreased thyroid function).
L Handbook of Radiation Measurement and Protection, Editor. Allen Brodsky, i i CRC Press, Inc., Boca Raton, Florida. I hj 1. Ijl 5
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TABLE 2
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is, Prescribed and Administered Radiopharmaceutical'and Dosace for Each Misadministration
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l '. Prescribed Study Dosage ' AdM nistered Study Dosage , H Case # RadiopTamaceutical (mC1) _ Raid @ pharmaceutical (mci) I 31 , N ., ., s rf < '6 1 thyroid sc'an 0.40 Ele 1317whole body scan 10.0 ) I-Til T~~~
~
~' l-123 2' thyroid scan- 0.10 1-131 whole body ccg __
5.0-g Tc-99m I-131 n ' 3i thyroid uptake scan 0.08 I-131 who'le body _ scan 5.6' I-131 I-131 4L, thyrofd uptake scan 0.15 I-131 whole body ~ scan ' ~~~ 5.0
%~ I-TT3 'I-131 i i
/ .
. x
$> -whole body bo'ne scan 20.0 1-131 whole'~ body scan 10.0 S ; ,. Tc-99m MDP I-131
'l 6+ - thyroid scan 0.05 not specified 3.09 I-131 I-131 ;
7 thyroid uptake 0.015 not specified 4.9x N l-131 1-131 [ thyroid scan (inclydi_n3 0.,10 thyroid scan (including ' s
~
3 8f 4.9 ,' J . the chest area) ? the chest area) j I-131 I-131 4 9 thyroid scan (including '0.03 thyroid scan (including 2.0 i
- the chest area) the chest area)
,' I-131 ,
I-131 i g 10 thyroid scan (including 0l10
; thyboid scan (including 1.0 the CI1est area) y IIii chest area) s I-131 1-131 r: '
I-131 whole body scan
;11' thyroid scan N/A* 5.0 Tc-99m I-131 13.f, ~thyroid stan 0.20 thyroid scan 1.0 I-13I I-131 ,
t 1?/. 1-131 whole body scan 6.0 I-131 whole body scan 6.0 e, I-131 I-131 s 14 thyroid scan 0.03 not specified 5.6 y 1431 I-131 8 s \ u 7 *Information not available. The normal dosa9e is 5-10 mil 11 curies. i y .,
8 s We have tabulated in Table 3 the information provided by licensees on the estimated effect of the misadministration on the patient. The estimated health effects documented in Table 3 suggest that some patients could be expected to suffer some deleterious effects from the misadministration includino partial icss of thyroid function. _Causes of the Misadministration Table 4 lists the primary cause and applicable contributing factor (s) for 13 of the 14 misadministration. For one misadministration (14)* the licensee's report did not specify the cause of the misadministration. From a review of Table 4 we see that: The cause of seven (1,2,3,4,5,6,7) of the 14 misadministration (50%) can be ascribed to the referring physician's order being misinterpreted by or miscommunicated to the technologist. The cause of three (8,9,10) of the 14 misadministration (21%) can be ascribed to the technologist not being familiar with the iodine-131 dosage requirements for thyroid scan procedures that involve scanning the chest area. The cause of three (11,12,13) of the 14 misadministration (21%) t can be ascribed to miscellaneous causes: a patient's identity was not verified before administering the iodine dosage; the technologist picked up the wrong iodine-131 capsule and did not assay it prior to administering it to the patient; and the nuclear medicine physician or radiologist was not aware that part of the patient's thyroid was intact before prescribing the amount of iodine to administer to the patient for a whole body iodine-131 scan. These causes are discussed in more detail below.
- 1. Misinterpretation /Miscommunication of the Referring Physician's Orders.
Tfie seven misadministration (1,2,3,4,5,6,7) in this group involved cases where the patient was administered a dosage of iodine-131 for a nuclear medicine study that was not ordered by the referring physician. Of the seven misadministration, six (1,2,3,4,6,7) involved patients being admin-istered dosages of iodine-131 normally prescribed for an iodine-131 whole body scan whereas the patient's physician had ordered a thyroid scan. One misadministration (5) involved a patient being administered a dosage of iodine-131 normally prescribed for an iodine-131 whole body scan whereas the patient's physician had ordered a bone scan. i *These number (s) refer to case numbers in Table 4 and Appendix A. l l l l'
i d m i d d f m d t s o e e os e e cy i r i i i i l eb d y f f yd f b f i h i i ti t i t a fd o t c c i o f n c f n r s E ee r o e e l r oe e oe u t te y p p p iy m p m l s r h as rh y S S bh er S er a at o t mn et H at ei ei m en p l ie d o e e b o ra e ra
- i e Mu e e atc rp % n n op cp n gp A n n o n R esi oy 0 o o ry em o em / i o om o HEL BH 5 N N PH DI N DI N M N NA N n
o i d t i a ok s s s r rc s o o o t yo e o o o e o o e o e s hl Y N N N Y N N Y N N Y N N i TB n i m g g g g g g d a n n n n n n s i i i i i y i i y n n n n n n l n M r n a n n n n e n f e a c a a a a t a n ov c s c c c ; a c i o S S S S L i S ec r d s ms n e e
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- d b 8 1 e i 4 1 0 1 0 0 1 0 1 A 2 t r e . . 0 . . /
a c a) 0 0 0 0 2 0 0 0 0 0 N 0 6 m s ai i e sC t s P r om D( E P n D o derm M a b a m m m t ih 3 9 1 3 9 1 1 1 1 1 9 1 1 a rp 2 9 3 2 9 3 3 3 3 3 9 3 3 D co 1 - 1 1 - 1 1 1 1 1 c
- 1 1 c
. si - c - - - - - - - - - . y ed I T I I T I I I I 1 T I I r ra a PR m I _ m u e _ S s . _ ao 1 2 3 4 5 6 7 8 9 0 1 2 3 _ CN 1 1 1 1
10 TABLE 4 Primary Cause and Contributing Factors for Each Misadministration Study Radiopharmaceutical Case (dosage) No. Prescribed Administered Cause Contributing Factors 1 thyroid scan I-131 whole The term " iodine 1) The order was made l I-123 body scan scan" used by the by telephone. (0.4 mci) I-131 referring physician's 2) The technologist (10 mci) office in ordering administered the the thyroid scan in iodine without a ! the licensee's written prescrip- ; terminology meant tion.
" iodine-131 whole body scan" 2 thyroid scan I-131 whole The term " iodine 1) The order was Tc-99m body scan scan" used by the made by telephone.
(0.1 mC1) I-131 referring r)hysician's 2) The technologist (5.0 mci) office in ordering administered the the thyroid scan in iodine without a the licensee's written prescrip-terminology meant tion.
" iodine-131 whole body scan" 3 thyroid uptake / I-131 whole The nursing station None L scan body scan misinterpreted the {
I-131 1-131 physician's order for j (0.080 mci) (5.6 mci) an " iodine thyroid i uptake and scan" to j be an order for an i "I-131 whole body j scan" 1 4 thyroid uptake / I-131 whole The nuclear medicine The prescription j scan body se an physician mistakenly was transmitted to i 1-123 I-131 prescribed a dosage the radiopharmacy ) (0.15 mci) (5.0 mci) of 150 microcuries verbally, of I-131 instead of l of I-123 for a thyroid uptake and scan. 9 This prescription was transmitted verbally to the hospital s radiopharmacy where I it was apparently misinterpreted as a prescription for a I-131 whole body scan 1 i
11 i TABLE 4 (Continued) ! Primary Cause and Contributing Factors for Each Misadministration Study Radiopharmaceutical Case (dosage) No. Prescribed J Administered Cause Contributing Factors i 5 whole body I-131 whole The patient was 1) The patient was bone scan body scan mistakenly scheduled scheduled for the Tc-99m MD I-131 for an I-131 whole study by phone. (20 mci) (10 mci) body scan because 2) The technologist I the physician's order administered the ' was misinterpreted, iodine dose to the
" Total bone scan" was patient without a misinterpreted as written prescrip-iodine-131 total body tion.
scan 6 thyroid scan not specified The technologist None I-131 I-131 misread the physi-(0.050 mci) (3.09 mci) cians's consult order for the thy-roid scan). The licensee's report did not specify what was misread. 7 thyroid uptake not specified Technologist error. None I .'.31 1-131 The type of error (0.015mC1) (4.9 mci) (i.e., misreading of order, selecting the wrong capsule, etc.) was not given. 8 thyroid scan thyroid scan Unfamiliar with None I (chestscan) (chest scan) dosage requirements, I-131 1-131 the technologist (0.100 mci) (4.9 mC1) thought that the higher dosage was required since this type of thyroid scan I involved scanning the chest area. thyroid scan thyroid scan 4 9 Unfamiliar with Technologist was l (chestscan) (chest scan) dosage requirements, new to nuclear I I-131 1-131 the technologist medicine service. 1 (0.030 mC1) (2.0 mci) thought that the j higher dosage was ) required since this type of thyroid scan involved scanning the ; chest area.
a 12. 4 TABLE 4 (Continued) Primary Cause and Contributing Factors for Each Misadministration Study Radiopharmaceutical Case (dosage) No. Prescribed Administered Cause Contributing Factors _ 10 thyroid scan thyroid scan Unfamiliar with Thyroid scan procedure (chestscan) (chestscan) dosage requirements, was performed 1-131 1-131 the technologist infrequently at the (.1 mci) (1 mci) thought that the hospital, higher dosage was-required since this type of thyroid scan involved scanning the chest area, 11 thyroid scan 1-131 whole The technologist did None Tc-99m body scan not verify the (N/A)* I-131 patient's identity (5 mci) and consequently administered the I iodine to the wrong i patient, i 12 thyroid scan thyroid scan The technologist did None I-131 I-131 not assay the iodine-( 2 mC1) (1 mci) 131 dose immediately prior to administer-ing the dose to the patient. The tech-i nologist selected the wrong capsule. 13 1-131 whole I-131 whole The nuclear medicine None body scan body scan physician was not I-131 I-131 aware that the left (6mC1) (6 mci) lobe of the patient's thyroid was intact. Had this been known, the prescribed dose for the whole body I scan would have been l 2 mci instead of 6 mci. ( 14 thyroid scan not specified The licensee's report None I-131 I-131 did not specify the l (0.030 mci) (5.6mC1) factors that contributed to the misadministration
- Information not available. The normal dosage is 5-10 millicuries.
< I l 13 l
Referring to Table 4, we see that for four of the seven misadministration (1,2,3,5) that involved the. misinterpretation /miscommunication of the
. physician's orders, the physician's order may have contained terminology that led to the orders being misinterpreted /miscommunicated. For exemple, in each of three cases (1,2,3)' either the term " iodine scan" or the term
" iodine thyroid scan and uptake" was used by the referring physician or personnel. representing the referring physician to order a thyroid scan.
In the language of the-licensees involved, " iodine scan" and " iodine thyroid scan and uptake".apparently meant an " iodine-131 whole body scan," a procedure that requires the administration of millicuries amounts of iodine to'a patient. Based on our review of' literature on the relative use of iodine-131 and other radiopharmaceuticals (iodina-123 and technetium-99m) for performing thyroid scans, the term " iodine scan" is used in some instances to denote that a requested thyroid uptake and scan is to be done with iodine-131 versus iodine-123 or technetium-99m. Data from a survey on the in vivo use of radioisotopes for the third quarter of 1984 that was published by Medical Marketing, Inc., showed that 47% of thyroid scans are performed using technetium-99m, 40% are performed using iodine-123 and only 13% are performed using iodine-131. In case 5, the physician's order for a bone scan contained the term
" total body bone scan:" this was interpreted by the licensee as an
" iodine-131 whole body scan."
In three (1,2,5) of the four above cases the physician's order for the nuclear medicine study was transmitted to the nuclear medicine service verbally and the technologist administered the iodine dosage without a written prescription.* In a fourth case (4), the prescription for the iodine dosage to be administered to a patient for a thyroid scan was transmitted verbally to the hospital radiopharmacy. From Table 4, we see for each of the remaining two misadministration (6,7) involving the misinterpretation /miscommunication of the referring physician's orders, no contributing factors were identified.
- 2. The Technologist was Not Familiar With The Dosage Requirements for Thyroid Scans. Each of the three misadministration in this group (8,9,10) involved a technologist administering a higher dosage of iodine to a patient for a thyroid scan than is nonnally prescribed. The type of thyroid scan involved in each case involved scanning the chest area and the technologist apparently thought that a higher dosage of i i
iodine-131 was needed in order to scan the chest area. Referring to Table 4, we see that for misadministration cases 9 and 10, the factor identified as contributing to the cause of the misadministration was respectively, the technologist was new to the nuclear medicine service, and thyroid scan procedures were performed infrequently at the hospital where the misadministration occurred. ; i
*In two of these cases (1,5) the licensees had procedures requiring that nuclear medicine studies not be done without a written prescription.
l.
, i 14
- 3. Miscellaneous Causes. Two of the misadministration in this group (11,12) involved simple errors associated with the identification of patients and the preparation of radiopharmaceuticals: the technologist administered a 10 millicurie dosage of iodine-131 to a patient without verifying that the patient was the patient for whom the dosage was prescribed; and the technologist picked up the wrong iodine capsule and administered it to a patient without verifying the activity of i the capsule. These types of errors have been identified in previous AE0D reports on medical misadministration.
The other misadministration in this group resulted from a unique error: the nuclear medicine physician or radiologist did not know that part of the patient's thyroid was intact when a 6 millicurie dosage of iodine-131 was prescribed for the patient for a "whole body iodine-131 scan." From the above analysis, five causal factors associated with the occurrence of the micadmini:trations can be identified. They are: use of verbal orders for nuclear medicine studies use of similar terms by referring physicians and licensees to refer to different procedures lack of technologist trainina lack of procedures failure of technologist to follow procedures. These causal factors represent the direct causes of the misadministration. However, a review of the general circumstances involved with most of the misadministration reveals a single underlying cause common to 11 of the 14 mi administrations. That is, licensee personnel did not appear to exercise adequate control over the administration of millicurie amounts of iodine-131 to patients. For example, in these 11 cases the misadministration could likely have been prevented despite the causal factors discussed above if the prescription for the iodine-131 dosage had been verified before the iodine-131 was administered to the patient. In most of the misadministration cases, the technologist administered a dosage of iodine that is normally only prescribed (for diagr,ostic purposes) for a patient with known thyroid cancer to locate metastatic deposits of the cancer throughout the body. It appears that a review of the patient's medical history would have revealed that the specific study had erroneously been scheduled for the patient. A general problem highlighted by the occurrence of these diagnostic mis-administrations involving millicurie amounts of iodine-131 is that licensees may be exercising less control over the administration of millicurie amounts of iodine-131 if the iodine-131 is being administered for a diagnostic study (e.g., iodine-131 total body scan) than if the iodine-131 is being administered for a therapeutic purpose (e.g., treatment of hyperthyroidism). For example, a patient to be administered a millicurie or greater dosage of iodine for a therapy procedure, such as for the treatment of hyperthyroidism, is likely to be interviewed by the nuclear medicine physician, radiologist, etc., to ensure the correctness of the dosage, the correctness of the identification of the i patient, etc. While there are no regulatory requirements that this be done, the clinical requirements associated with assessing the effectiveness of the therapy will generally require this physician interaction with the patient. Or the other hand, because the technologist uses a dosage schedule to
15 determine the radiopharmaceutical and dosage to administer for a prescribed diagnostic nuclear medicine study (see above), and because diagnostic nuclear medicine studies are more routine procedures (i.e., similar to routine X-ray examinations) than are therapy procedures, a patient may not be interviewed by the nuclear medicine physician, radiologist, etc., before being administered a radiopharmaceutical for a diagnostic study. Based on the licensee reports, it appears that in each of the 14 misadminis-trations, one to ten millicuries of iodine-131 was administered to a patient without the patient being interviewed by the nuclear medicine physician, radiologist, etc., or otherwise screened to ensure that the dosage of iodine-131 was correct for the patient involved. This problem seems to be unique to the administration of iodine-131 because the same dosage range of iodine-131 is used fcr both diagnostic and therapy procedures. The protocols for administering iodine-131 appear to be determined by the purpose (diagnosis or therapy) for which the iodine-131 is administered instead of the amount of iodine-131 administered, an oversight that results from the generally separate protocols that govern the use of radioisotopes for diagnostic and therapeutic purposes., Licensee Proposed Corrective Action Thirteen of the 14 licensees reporting a misadministration described one or more corrective actions to prevent the recurrence of the misadministration. Table 5 summarizes the proposed corrective actions. TABLE 5 Summary of Licensee Proposed Corrective Actions Number of Licensees Proposed Corrective Action Recommending Action Reauire physician (nuclear medicine, radiologist, etc.) 5 to attend the administration of iodine-131 dosages (all dosages or dosages above a specified dosage) Retrain personnel 6 Other 2 None 1 I From the table, we see that five of the 14 licensees' (35%) proposed corrective action would recuire that the nuclear medicine physician attend the adminis-tration.of iodine dosages (either all dosages or dosages above a specified dosage). I i
16 FINDINGS AND CONCLUSIONS The significance of diagnostic misadministration involving the administration of millicurie amounts of iodine-131 to a patient is that similar to therapy ! ri3 administrations, each misadministration had the potential to result in severe health effects on the patient involved. The direct causes of ten of the 14 reported iodine misadministration (71%) were ascribed to either the physician's order being misinterpreted by or miscomunicated to the technologist (7 cases), or the technologist not knowing , the correct dosage to administer for thyroid scan procedures that invo'"ed scanning the chest area (3 cases). Causal factors associated with the occurrences of the misadministration were: l use of verbal orders for nuclear medicine studies i ! use of similar terms by referring physicians and licensees to refer to different procedures ) l l lack of technologist training ! lack of procedures l failure of technologist to follow procedures. The underlying cause of 11 of 14 (79%) of the misadministration appears to have been a' lack of licensee control over the administration of millicurie amounts of iodine-131 to patients. These 11 misadministration could likely have been prevented, despite the errors that led to the misadministration, if - l the prescription for the iodine-131 dosage had been verified for each patient , before the iodine-131 was administered to the patient. l 1 I The precautions that are taken to ensure the accuracy of therapy doses to i patients (e.g., interviewing of patients by the nuclear medicine physician, j ! radiologist, etc.), should be taken for the administration of all millicurie ; amounts of iodine-131, whether the purpose of.the administration is diagnostic l or therapeutic. However, it appears that licensees may exercise less control over the administration of millicurie amounts of iodine-131 if the iodine-131 l is being administered for a diagnostic study (e.g., an iodine-131 total body i scan) than if the iodine-131 is being administered for a therapeutic purpose (e.g.,treatmentofhyperthyroidism). i Based on this engineering evaluation, AEOD suaaests that: ! (1) The Office of Inspection and Enforcement send an update to Information Notice IN-85-61 (Misadministration to Patients Undergoing Thyroid l Scans) J the affected licensees informing them of the more recent l misadministration events involving iodine-131. (2) NMSS assess the proposed regulatory changes to 10 CFR 35 to determine whether the requirements for quality assurance procedures for radiotherapy facilities should be expanded to include a requirement for quality assurance procedures for the administration of radio- j pharmaceuticals for therapy or for diagnosis in which the dosage of ! the radiopharmaceutical administered is in the therapy dosage range i for the radiopharmaceutical. i
' o 17 APPENDIX A Descriptions of the Misadministration MISAD #1 Prescribed Radiopharmaceutical 1-123 Prescribed Dosage 0.400 mci Administered Radiopharmaceutical I-131 Administered Dosage 10.0 mci
Description:
The referring physician's secretary telephoned an order for an "icdine scan"
.to the hospital nuclear medicine department. The nuclear medicine technologist took the term " iodine scan" to mean an I-131'whole body scan; the technologist administered a 10 millicurie I-131 capsule to the patient without a written prescription.
MISAD #2 Prescribed Radiopharmaceutical Tc-99m Prescribed Dosage 0.100 mci Administered Radiopharmaceutical I-131 Administered Dosage 5.0 mci
Description:
Personnel in the referring physician's office telephor,ed an order to the hospital nuclear medicine department for a " radioactive iodine scan". In the licensee's normal terminology radioactive " iodine scan" is a iodine-131 whole body scan. The referring physician intended the order to be for a thyroid scan using iodine-131. HISAD #3 Prescribed Radiopharmaceutical I-131 Prescribed Dosage 0.080 mci Administered Radiopharmaceutical I-131 Administered Dosage 5.6 mci
Description:
A nursing station submitted an order for an iodine-131 whole body scan to be performed on a patient. The order should have been for an iodine-131 thyroid uptake and scan. The nursing staff misinterpreted the order from the referring physician for an " iodine thyroid uptake and scan" for an " iodine-131 whole body , scan."
7 18 l l l MI5AD #4 l Prescribed Radiopharmaceutical I-123 Prescribed Dosage 0.15 mci Administered Radiopharmaceutical I-131 Administered Dosage 5.0 mci
Description:
The attending physician mistakenly prescribed a dosage of 150 microcuries of iodine-131 instead of iodine-123 for a thyrcid uptake study and scan. This order was apparently orally transmitted to the licensee's radiopharmacy where it was interpreted as a reouest for a 5 millicurie dosage of iodine-131, the iodine-131 dosage normally prescribed for an " iodine-131 whole body scan". i MISAD #5 Prescribed Radiopharmaceutical Tc-99m MDP Prescribed Dosage 20.0 mci Administered Radiopharmaceutical 1 '131 Administered Dosage 10.0 mci
Description:
The patient was mistakenly scheduled for an iodine-131 "whole body scan". The prescribed study for the patient was ".vhole body bone scan". The patient was scheduled for the study by telephone. At the time of scheduling, a verbal confirmation for an iodine-131 "whole body scan" was received from the doctor's l office. The technologist administered the iodine-131 dose without a written prescription. 1 MISAD #6 l Prescribed Radiopharmaceutical I-131 i Prescribed Dosage 0.050 mci ! I Administered Radiopharmaceutical 1-131 Administered Dosage 3.090 mci
Description:
1 1 The technologist misread the physician consult (order for the study) and l administered a patient a 3.09 millicurie dosage of iodine-131 instead of a 50 i microcurie dosage of iodine-131 for a thyroid scan. The licensee's report did l not specify exactly what was misread to cause the technologist to administer l the higher dosage of iodine-131. l l l l
m .i; . . 19 MISAD #7 Prescribed Radiopharmaceutical I-131 Prescribed Dosage 0.015 mci Administered Radiopharmaceutical. 1-131 Administered Dosage 4.9 mci
Description:
L' The technologist administered a 4.9 millicurie dosage of iodine-131 instead of l a 10 to 15 nicrocurie dosage of iodine-131 as normally prescribed. The reason j-for.the technologist's error was not given in the licensee's report. MISAD #8 Prescribed Radiopharmaceutical 1-131 Prescribed Dosage 0.100 mci Administered Radiopharmaceutical I-131 Administered Dosage 4.9 mci
Description:
The chief technologist ordered a 4.9 millicurie dosage of iodine-131 for a patient undergoing a thyroid scan for diagnosis of substernal extension of an enlarged thyroid (aoiter). Since this procedure involves scanning the chest area the technologist thought the higher dosage was required. The technologist apparently related this study to the iodine-131 whole body scan where the chest ard other body areas are scanned in searching for " metastatic deposits of functional thyroid carcinomas". MISAD #9 Prescribed Radiopharmaceutical I-131 Prescribed Dosage 0.030 mci Administered Radiopharmaceutical 1-131 Administered Dosage 2.0 mci
Description:
J The technologist administered a 2 millicurie dosage of iodine-131 to a patient ) for a thyroid scan (chest scan) instead of the 30 microcurie dosage of ; iodine-131 that was indicated in the physician's notes. The technologist who - was new to the nuclear medicine service apparently thought the higher dosage , was required because of the need to scan the chost area. ! l 1 l 4 L________________.u___._.. _ _ _ _ _ _ _ _
20 MISAD #10 Prescribed Radiopharmaceutical I-131
- j. Prescribed Dosage 0.100 microcurie Administered Radiopharmaceutical I-131 Administered Dosage 1.0 mci
Description:
The technologist administered a 1 millicurie dosage of iodine-131 to a patient for a thyroid scan instead of a dosage of 100 microcuries of iodine-131 which is the dosage normally prescribed at the licensee's: facility for thyroid scans. The patient had a history of possible substernal thyroid (extension of thyroid tissue into the chest area). The technologist appeared to be relatively unfamiliar with the dosage requirements for the thyroid scans which the
. licensee stated were not performed frequently at the hospital.
MISAD #11 Prescribed Radiopharmaceutical Tc-99m Prescribed Dosage N/A* Administered Radiopharmaceutical I-131 Administered Dosage 5.00 mci
Description:
The technologist administered a 5 millicurie dosage of iodine-131 to the patient without verifying the patient's identity. The patient was scheduled for a thyroid scan using technetium-99m. MISAD #12 Prescribed Radiopharmaceutical I-131 Prescribed Dosage 0.200 microcurie Administered Radiopharmaceutical I-131 Administered Dosage 1.0 mci
Description:
The technologist initially assayed the 200 microcurie capsule but was-distracted before administering it to the patient. The technologist then picked up a 1 millicurie capsule. did not assay it, and gave it to the patient.. !
*Informatha not available. The normal dosage range is 5-10 millicuries.
- _ _ _ _ _ _ _ - _ _ _ _ - _ _ - - - - t
l l- , . i . 21 MISAD #13 Prescribed Radiopharmaceutical I-131 ' Prescribed Dosage 6.0 mci Administered Radiopharmaceutical I-131 Administered Dosage 6.0 mci
Description:
In prescribing the dosage for an " iodine-131 whole body scan" for a patient the nuclear medicine physician was not aware that one lobe (left) of the patient's thyroid was intact and thus prescribed a dosage of 6 millicuries of iodine-131 instead of 2 millicuries. MISAD #14 p Prescribed Radiopharmaceutical I-131 Prescribed Dosage 0.030 mci Administered Radiopharmaceutical I-131 Administered Dosage 5.6 mci
Description:
The cause of the misadministration was not given in the licensee's report. 1 i i I
r _ _ . _ _ _ .- - - _ - _ _ i Attachment 2 Summary of Diagnostic Misadministration Reports Received by AE00 Since the Engineering Evaluation was Undertaken MISAD #1 Prescribed Radiopharmaceutical I-131 Prescribed Dosage 0.1 - 0.2 mci ' . Administered Radiopharmaceutical I-131
- Administered Dosage 1 mci
Description:
A patient was administered a 1 millicurie dosage of iodine-131 instead of the usual 100-200 microcurie dosage of iodine-131 administered for a thyroid scan. Based on the doctor's office request and the notation in the schedule book, 3 the technologist thought the doctor was looking for the residual thyroid tissue I and ordered a one millicurie dosage of iodine to be administered to a patient. MISAD #2 Prescribed Radiopharmaceutical Tc-99m MDP Prescribed' Dosage 20 mci Administered Radiopharmaceutical 1-131 Administered Dosage 20 mci t
Description:
A patient for whom a bone scan was prescribed was administered 20 millicuries I of iodine-131 instead of 20 millicuries of technetium-99m methylenediphos-phonate as prescribed. The bone scan had been prescribed verbally and was j not clearly described on the nuclear medicine department's calendar. The 1 technologist interpreted the ambiguous test description as a request for a i thyroid scan. I MISAD #3 Prescribed Radiopharmaceutical I-131 Prescribed Dosage 0.030-0.050 mci Administered Radiopharmaceutical I-131 Administered Dosage 1.53 mci
Description:
A patient was administered a 1.53 millicurie dosage of iodine-131 instead l of the prescribed dosage of 30 to 50 microcuries of iodine-131. The thyroid scan was to diagnose possible substernal thyroid tissue and the technologist thought that a whole body scan was ordered to look for metastatic disease. J
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