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0 2 !Sy MEMORANDUM FOR: Dr. Vincent Collins, Member, ACMUI Dr. Melvin Griem, Member, ACMUI Dr. Edward Webster, Member, ACMUI Dr. Peter Almond, Consultant FROM: Vandy L. Miller, Chief Material Licensing Brar.ch Division of Fuel Cycle and Material Safety
SUBJECT:
AMENDMENT TO 10 CFR PART 35 REGARDING MISADMINISTRATION
' Enclosed for your comments are a draft Advance Notice of Proposed Rulemaking (Enclosure 1) and a draft Final Rule (Enclosure 2) on misadministration.
The Commission recently notified us that due to recent misadministration an urgent priority must be placed on this issue. Therefore, we would appreciate it if you could provide comments on Enclosure 2 by telephone to Norman McElroy (301-427-4108) within the next few days. Please submit any written comments on both enclosures as soon as possible.
We expect the Commission to take action on the enclosed drafts on an expedited basis, perhaps as early as February 1987. Enclosure 2 is a final rule, but could be changcd to a proposed rule with a short public comment period. We will keep you informed of developments regarding misadministration. Thank you for your assistance.
Iginalsfped By-
""Y L. AnLtgg Vandy L. Miller, Chief Material Licensing Branch Divicion of Fuel Cylce and Material Safety
Enclosure:
- 1. Draft Advance Notice
- 2. Draft Final Rule DISTRIBUTION NMcEl roy;'- VLMiller JHickey RECunningham NMSS r/f FC Central File FCML r/f j l
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Subject:
MISADMINISTP.ATIONS Of RADIATION THERAPY l t
Purpose:
To submit foEtomission consideration (1) an advance notice of
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proposedtrulema' King, (2) a rule that can be issu'ed effective immediately or for public comment, and (3) the staff.rgsponse to issues raised by the Commission in its Decembpr, M,' 11%
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} y-Category: This) paper covers significant policy issues concerning the .
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regulation.of the medical use of byproduct material.
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This paper was developed in coordination with the Office of
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fssues: Quality assurance in radiation therapy arid penalties for ' 1>-
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negligence. a Summary: The Cons?ssio'n di Ncted,the staff to prepare a rulemaking to .
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" require independent veri.fication of therapeutic doses... .
and penal.ize lice;1 sees for their negligence. . ." The staff has tprepared an' $dvance rotice of proposed rulerraking to request early public commer.t on the scope of a rule that would; (1) req'uire radiation therapy licensees to implement quality assurance programs s
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7 y< 4/ ,3 t, f to Tidsen the chance of misadministration, and (2) provide for
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, , 7 'i radiation thera'py,. The staff has also prepared a rule that would require imp $dentation of a basic radiation therapy cuality assurance program. The Comission later raised a number of
) issues,concerning NRC's regulations that apply to medical use and requested#pff recommendations; this paper contains the response to th'at staff reouf rements memorandum, ground: ' #
diation I rapg ,
3 Teletherapy is the application of a beam of radiation emanating j, from a cobalt-60 source to a patient for a therapeutic purpose;
, , these clinical procedures are usually curative, prophylactic, or f
palliative cancer therapy. (High energy x-ray machines are also used for the same purposes.) A typical therapy may be
,, ,, comprisef of daily, treatments of 200 rads to the tumor volume for.ff g weeks, yielding a total tumor dose of 5000 rads.
,, 1 3 Bractytho;f spy is the insertion of small sealed sources of cesium-137,
[ , irfoium-192, or clodine-125 into the tumor volume for curative or
[neophylactic# cancer therapy. A typical therapy may require
('s 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
$ ,) . ga. tumor dose of 5000 rads.
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y, Radiopharmaceutical therapy is the administration of a radio-
? ,/ active drug for therapeutic purposes. The most common procedure
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i g is the oral' administration of liquid or encapsulated iodine-131
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as sodicrt'icdid,e. For hyperthyroidism, 5 to 30 millicuries is
' ' " administered; for thyroid cancer, 70 to 200 millicuries is administered. .
i r, hout400NRCand800AgreementStatelicenseesofferteletherapy indbrachytherapyservices,ardabout700NRCand1,400 Agreement C
State licensees offer radiopharmaceutical therapy services.
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The Commissioners 3' i
For a more complete description of the radiati6n therapy
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, process, see Enclosure 7.,
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Discussion: . ANPR on.0uality A,ssurance,and Penalties for Ne,qligence
/ s Following seieral therapy misadministration events over the years, ,
in Apr'l 1986 thdComission airected the staff to " develop a ,
1 rulemekirg to require independent verification of therapeutic
- ducieg...and penalize medical licensees for' their neg?igence or
'that of their employees, agents or practitioners." The staff has developed for public comment an Advance Notice of Proposed Rulemaking '(11NPR) that' contains both techtiical and policy '.
quest.f ons . The staff developed the ANPR rather than a-proposed yule because the staff needs infonAAtton, particular-ly from the medical community, before it cin develop a rule that is comprehensive yet will not inadvertently interfere with the delivery of medical care.
The staff has broadly constructed the term " independent verifica-tion" because, given the objective, it believes the better ap-
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proach would he to require each licensee to have a complete uuality assurance program that addresses each Stbp.in the radfatten therapy! '
precess. However, the personnel attequipment needed to implement a ccraprehensive quality assurance program may simply tot;he- i l
availab7e in the marketplace. The staff is seeking informa-tion on this matter through the ANPR. l l
The staff. believes there are many issues that should be 1 r. . 1 considered when developing an operating definition for
" negligence." (For example, NRC's medical policy statement, ,
NRC's handling of' " operator error," quality and availability ]
of medical care, state regulation of medical services, methods .
of reimbursement for medical care, tort law and insurarre 0
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07/24/86 10 CFR 75 THER MISAD Rul.E CP l
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't' 10e Commissioners 4 1;
rates, coor'dination with other federal acencies, and NRC resources. SeeEnclosuk$([]) Therefore, early public comment )/
- i. on this matter is essential.
The staff believes the better course would be to remove the
" Negligence" section from the Advance Notice of Proposed Rulemaking.
Use of the word " negligence" in a rulemaking' that applies to physicians and hospitals will not have a salutary effect on NRC's.' relationship with professional organizations that can assist NRC in its nission. The negligence section is likely to be controversial end may impede achieving the main objective of reducing misadministration. If the Commission wants to give clear notice that strong enforcement actions for non-compliance with NRC regulations are under consideration for medical licensees, the staff could replace the negligence section with a review
) and possible modification of NRC's enforcement policy as applied to the r:edicci use of byproduct material (see 10 CFR Part P.
Appendix C, particularly Supplement VI).
The staff expects 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 redece members' vulnerability to negligence torts. )
Immediately Effective or Proposed Rule 1 To avoid undue delays connected with the ANPR process while establishing basic quality assurance requirements, the staff has reviewed the technical and professional literature and drafted a rule (Enclosure 2) to require medical licensees to implement certain procedural cuality assurance steps that
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7 Th2 Commissioners 5 would reduce the chance of a misadministration. This rule would provide a basis for enforcement actions in many therapy misadministration cases.
This rule can be issued in final form. However, because many licensees would need to make new business arrangements to meet the requirements, and because the rule might not be clearly applicable to all medical programs, the staff believes the best course of action is to follow the normal rulemaking process by publishing it for public comment. This rule is contained in Enclosure 2. The staff believes a final rule could be submitted to the Commission by July 1987.
Need for Improved 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. I Effect on Agreement States l
The staff believes that the purpose of ouality 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.
Need for Resources
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The staff believes that e high level of Comission concern regarding j these matters, as indicated by the directive to begin rulemaking, is in stark contrast to NRC's limited visibility at licensees' l
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' The Commissioners 6 facilities; resource allocations only allow for hospital inspections once each three years. This is an objective that, in reality j is not fully achieved because of competing demands for resources.
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Because of the high turnover rate among technologists, many never see an NRC inspector. An increased NRC presence may improve licer: sees' attention to matters of quality and lead to a reduction in the misadministration rate. Additional resources will also be needed for both the licensing and inspection functions to properly address new regulations on quality assurance and negligence. The extent of resource requirements will depend on the nature of the final rules.
Public Pesponse 1
The staff cautions that these rulemakings, particularly the
" Negligence" section, will likely be very contentious, and might have far-reaching impacts on patient care and tort law. The 1 staff expects to receive requests for extensions of comment periods, and expects that mary individual users, professional associations, liability insurance carriers, and law firms will comment.
Recommendation: The Comnission: i
- 1. Direct publication of the rule (Enclosure 2) that requires licensees to implement certain basic quality assurance f steps after changing it to a proposed rule.
- 2. Direct publication of the Advance Notice of Proposed Rulemaking (Enclosure 1) regarding the scope of a quality assurance program rule after removing the section entitled " Negligence" and inserting a statement about enforcement policy.
- 3. Adopt the milestones and schedule proposed in Enclosure 6.
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The Commissioners 7
- 4. Agree to the staff initiatives (Enclosure 3) submitted in response to the Commission's December 16, 1986 memorandum on nedical regulations.
- 5. Note
- a. The Advance Notice of Proposed Rulemaking, with a 90-day public coment 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 to perform an environmental impact assessment. This provides the basis in Enclosure 1 for the Commission's determination under 6 51.32 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 I drafted and issued when the notices are filed with (
the Office of the Federal Register. The staff has I not included these in this Commission paper because their content will depend on Comission decisions on the final wording of the ANPR and the method of issuing the t'asic quality assurance rule.
- e. Copies of the Federal Register notices will be distributed to all affected Comission specific licensees and to other interested organizations and individuals, j O//24/86 10 CFR 35 THER MISAD RULE CP l
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Th2 Commissioners 8 !
Victor Stello, Jr.
Executive Director for Operations l
Enclosures:
.1. Federal Register Advance Notice of Proposed Rulemaking
- 2. Federal Register Notice of Final i
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 : FCML : FCML : D/FC : DD/NMSS : D/NMSS :
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l NUCLEAR REGULATORY COMMISSION 10 CFR PART 35 Radiation Therapy Quality Assurance and Penalties for Negligence AGENCY: Nuclear' Regulatory Commission.
ACTION: . Advance Notice of Proposed Rulemaking.
SUMMARY
- The Nuclear Regulatory Commission (NRC) is considering amendments to its regulations that apply tn the use of byproduct material for radiation therapy. In addition to the current requirements for quality assurance in radiation therapy, the contemplated amendments would reouire licensees
- that offer teletherapy or brachytherapy services to implement a complete quality assurance program to reduce the chance of misadministration, and would also provide penalties for negligence when using byproduct material q for radiation therapy. The NRC requests public comment as to whether additional radiophamaceutical therapy quality assurance requirements are needed, and invites advice and recommendations on several cuestions that will have to be addressed in the rulemaking process.
DATE: Submit comments by (90 days). Comments received after this date will be considered if it is practical to do so but assurance of considera-tion cannot be given except as to comments received before this date.
i ADDRESSES: Mail comments to: The Secretary of the-Commission, U.S.
Nuclear Regulatory Commission, Washington, DC 20555, Attention: Docket-ing and Service Branch.
l Enclosure 1 I 07/24/86 1
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Deliver comments to: Room 1121, 1717 H Street, NW., Washington, DC, between 8:15 am and 5:00 pm on Federal workdays.
Examine copies of comments received at: The NRC Public Document Room, 1717 H Street NW., Washington, DC.
FOR FURTHER INFORMATION CONTACT: Noman L. McElroy, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555, telephone (301) 427-4108.
SUPPLEMENTARY INFORMATION:
NRC'S Policy Regarding the Medical use of Byproduct Material In a policy statement published February 9, 1979 (44 FR 8242), the NRC noted.that it regulates the medical use of byproduct material as necessary to provide for the radiation safety of workers and the general public, regulates the radiation safety of patients where justified by the risk to patients, and minimizes its intrusion into medical 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 patients, but also recognizes that physicians have the primary responsi-bility for the protecticn 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.
07/24/86 2 Enclosure 1
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Therapy use of Byproduct Material I
Teletherapy is the application of a beam of radiation emanating from i 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.) A typical therapy may be i 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, or iodine-125 into the tumor volume for curative or prophylac-tic cancer therapy. A typical therapy may require insertion of 50 milli-curies for 48 to 72 hours8.333333e-4 days <br />0.02 hours <br />1.190476e-4 weeks <br />2.7396e-5 months <br />, resulting in a tumor dose of 5000 rads.
Radiopharnaceutical therapy is the administration of a radioactive drug for therapeutic purposes. The most common clinical procedure involves the oral administration of liquid or encapsulated fodine-131 as sodium iodide. For hyperthyroidism, 5 to 30 millicuries is administered; for thyroid cancer, 70 to 200 millicuries is administered.
l Therapy Misadministration The NRC recently mailed to all licensees a report about therapy misadministration (" Case Study Report on the Therapy Misadministration Reported to the FRC Pursuant to 10 CFR 35.32," NRC report AE0D/C505).
Althcugh the specific course o' each event was dif#erent, three basic then,es were apparent: inadequate trainino, inattention to detail, and lack of redundancy.
07/24/86 3 Enclosure 1
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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 authorized user prescribed a radiation dose for a patient that 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 radiction to a patient does not specifically constitute a violation of NRC regulations. The Commission's concern about radiation therapy )
misadministration was expressed in e memorandum to the staff dated April 14, 1986, which directed the staff to prepare a rulemaking that would provide the authority.to require independent verification of therapy doses and penalize medical licensees for'their negligence or that of their employees, acents, or practitioners.
The NRC believes it is important to begin rulemaking on this matter.
However, the NRC realizes that there vill be considerable public interest and would therefore like to take 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 i respective borders by agreement with the NRC. (This kind of agreement is l authorized by the Atomic Energy Act.) They issue licenses for the use of.
07/24/86 4 Enclosure 1
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. byproduct material, and currently regulate about 5,000. medical licensees.
I Because the NRC will request the Agreement States, as a matter of compatibility, to implement regulations equivalent to those that it i implements on this matter, state regulatory agencies will be asked to i
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comment.
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Request for comments i The NRC has prepared the following cuestions to elicit comments on methods of preventing misadministration. Comments do not have to respond .
to these questions; other related topics or alternatives may be described if the commenter believes this will help to resolve issues related to ,
i this-rulemaking.
Quality Assurance-i General The followino questions apply to the provision of all types of thera-
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peutic medical use.
- 1. 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? Should the NRC use a term other than " misadministration" to refer to these events?
- 2. If a patient has been referred for consideration of radiation therapy, should the NRC recuire that the authorized user actively consult with the referring physfcian before prescribing radiation or deciding that radiation is not needed?
07/24/86 5 Enclosure 1
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- 3. Is there a method to provide absolute assurance that the patient h who is administered radiation is the patient for whom radiation was intended?. l l
Teletherapy and Brachytherapy j 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 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 - l 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? !
- 2. Should smaller licensees with fewer staff and equipment resources use a different quality assurance program than larger licensees? ?
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- 3. Will current reimbursement methods hinder the implementation of a quality assurance program? What fraction of licensees already have- !
a quality assurance program? How much does it cost per patient or per year?
- 4. Are there complete model quality assurance programs already !
available that address every step of the radiation therapy process, or will model programs have to be developed? Should physical measurements, redundant calculations, or both be required? What other areas are, or should be, covered in a complete quality assurante progran?
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- 5. Are the staff and equipment that are needed to implement a com-plete quality assurance program available in the marketplace, or would j new training programs and equipment development be needed?
- 6. What methods are available for reducing the frequency or impact {
l of human error?
'Radiopharmaceutical Therapy i
The NRC requires that licensees use only certain radiopharmaceuticals for specified therapy clinical procedures, measure the radioactivity in radio- )
pharmaceutical dosages prior to administration, and have a measurement 1
quality assurance program for the dose calibrator used to make that ,
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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. !
1 There have been cases in which a radiopharmaceutical other than that intended has been ordered and administered. The NRC expects that all '
licensees 'have policy ' requirements for clear statements of prescription and verf #ication prior to administration of any pharmaceutical. The NRC would appreciate suggestions on methods to assure that the clinical !
procedure (including radiopharmaceutical, dosage, and route of administration intended by the authorized user) is the clirical procedure that is performed.
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07/24/86 7 Enclosure 1 !
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Negligence The following questions apply to the provision of teletherapy, brachytherapy, and radiopharmaceutical therapy services.
- 1. Is there a clear, universally accepted definition of negligence that the NRC can use? What level of regligence should trigger a penalty--
l the licensee's willful action, the licensee's reckless disregard for gener-ally accepted patient care procedures, or the 1%ensee's simple. inadvertent i
error? Should there be actual clinically discernible harm to a patient or simply radiation dose abova a certain level, or should presence or absence of actual patient harm not be a consideration in making a finding of negligence?
- 2. Should negligence-penalties te imposed on licensees, or on their i employees? What kinds of negligence penalties should be impnsed? Should the negligence penalty, or the test for negligence, be related to the amount or kind of byproduct material that was misused? Should NRC institute a system to assure that an individual who precipitates a misadministration or commits a violation does not simply leave and go to another licensee, either an NRC or Agreement State licensee, and continue to engage in similar activities.
- 3. What effect wnuld a negligence penalty rule have on liability insurance rates and availability of insurance? ,
4 Would issuance of a negligence penalty prejudice a licensee's ability to defeno against a regligence lawsuit?
- 5. Wnuld the professional risk of government-imposed penalties reduce the willingness of licensees to provide radiation therapy l
services? l 07/24/86 8 Enclosure 1 i
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List of Subjects in 10 CFR Part~ 35 Byproduct Material, Drugs, Health facilities, Health professions, Incorporation by reference, Medical devices, Nuclear materials, Occupa-tional safety and health, Penalty, Radiation protection, Reporting and recordkeeping requirements.
The authority citation for this document is AUTHORITY: Sec. 161, 68 Stat. 948, as amended (42 U.S.C. 2201); sec. 201, 88 Stat. 1242, as
..aended (42 U.S.C. 5841).
Dated at Washington, DC, this day of , 1987.
For the' Nuclear Regulatory Commission.
i Samuel J. Chilk, Secretary of the Commission 1
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07/24/86 9 Enclosure 1
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1 NUCLEAR REGULATORY COMMISSION 10 CFR Part 35
{
Basic Quality Assurance in Radiation Therapy- 1 AGENCY: Nuclear Regulatory Commission.
I ACTION: Final Rule'. .
SUMMARY
- The-Nuclear Regulatory Commission (NRC) is revising its regulations
, to 'requirt. its medical licensees to implement certain quality assurance steps 'I that will reduce the chance of therapy misadministration. The regulations will primarily affect hospitals, clinics, and individual physicians.
)
EFFECTIVE DATE: (30 days) l J COMMENTS: Although'this rule is being issued in final form, the'NRC i
would appreciate comments. The NRC will consider modifying it or ;
i publishing notes of clarification. The comment period expires (90-days). .l 1
Comments received after this date will be considered if it is practical l to do so, but assurance, of consideration cannot be given except as to comments filed on or before this date.
. ADDRESSES: Submit written comments and suggestions to the Secretary of i
the Commission,' U.S. Nuclear Regulatory Commission, Washington, DC, ]
i 20555, Attention: Docketing and Service Branch.
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Copies of the regulatory analysis and the comments received on this rule may be examined at the Commission's Public Document Room at 1717 H Street NW., Washington, DC. Single Copies of the regulatory analysis are available from Norman L. McElroy, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555, Telephone: (301) 427-4108.
FOR FURTHER INFORMATION CONTACT: Norman L. McElroy, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, Dr 20555, Telephone (301) 427-4108.
SUPPLEMENTARY INFORMATION:
- 1. BYPRODUCT MATERIAL IN MEDICINE Use for Patient Care Radioactive materials are used in drugs in the field of nuclear medicine. Drugs labeled with radioisotopes are know as radiopharmaceu-ticals. In diagnostic nuclear medicine, patients receive these materials by injection, inhalation, or oral administration. Physicians use radiation detection equipment to visualize the distribution of a radioactive drug within the patient. Using this technology, it is possible to locate tumors, assess organ function, or monitor the effectiveness of a treatment. An estimated 10 million diagnostic nuclear medicine procedures are performed in this country annually. In therapeutic nuclear medicine, larger quantities of radiopharmaceuticals are administered to treat hyperactive thyroid and certain forms of cancer. An estimated 30,000 procedures d each year.
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i Sealed radioactive sources that produce high radiation fields are used in radiation therapy primarily to treat cancer. A radioactive source'-
in a teletherapy machine can be adjusted to direct a radiation beam to {
the part of the patient's body to be treated. An estimated 300,000 patients receive cobalt-60 teletherapy treatments from NRC and Agreement State licensees each year. Smaller sealed sources wit'h'less radioactivity are' designed to be implanted directly into a tumor area or applied on the surface of an area to be treated. This procedure is.know as brachytherapy.
Licensees perform approximately) 30,000 brachytherapy treatments annually. i Sealed radioactive sources can also be used in machines that are !
l used for diagnostic purposes. The source provides a beam of radiation j that is projected _through the patient. A device on the other side of the patient detects the amount or spatial distribution of radiation that goes through the patient. This can provide information about tissues within the patient. This is a relatively new development in the field of medicine i
and the NRC has no estimate of the number of these diagnostic procedures j performed annually.
1 State'and Federal Regulation I Twenty-eight states, know as Agreement States, have assumed ;
I responsibility for regulating certain radioactive materials within their l respective borders by agreement with the NRC. (This kind of agreement is authorized by the Atomic Energy Act.) They issue licenses for the medical use of byproduct material, and currently regulate about 5,000 licensees.
In non-Agreement States, the NRC has licensed 2200 medical institutions (mostly hospitals and clinics) and 300 physicians in private practive.
j' These licenses authorize certain diagnostic and therapeutic uses of radioactive materials.
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II. NRC'S REGULATORY PROGRAM l
Policy Regarding the Medical Use of Byproduct Material In a policy statement published February 9, 1979 (44 FR 8242), the NRC noted that it regulates the medical use of byproduct material as i necessary to provide for the radiation safety of workers and the general public, regulates the radiation safety of patients where justified by the risk to patients, and minimizes its intrusion into medical judgments affecting patients and into other areas traditionally considered to be i
the practice of medicine. The NRC does have the authority to regulate the i medical use of byproduct material to protect the health and safety of patients, but also recognizes that physicians have the primary responsibility for the protection of their patients. NRC regulations have been predicated ;
on the assumption that properly trained and adequately informed physicians will make decisions in the best interest of their patients. ;
i Reports of Therapy Misadministration ;
The NRC continues to receive reports of therapy misadministration. In a recently published st.udy, the NRC noted that one half of reported therapy misadministration resulted in doses that were 20 percent to as much as 200 percent greater than prescribed. In one event, 53 patients did not receive i as much radiation as prescribed because the effect of certain beam modifying devices on the dose rate from a teletherapy unit had been improperly measured.
(See Case Study Report on the Therapy Misadministration Reported to the NRC l
Pursuant to 10 CFR 35.42, NRC Report Number AE00/C505.) The NRC believes !
l these misadministration of radiation pose a clear risk to patients because, as noted in a recent report, "The dose response curve in radiation therapy is quite steep in certain cases, and there is evidence that a 7-10 percent 4
i
C- .1 I
[7590-01]
change in the' dose to the target volume may result in a significant change in tumor control probability. Similarly, such a dose change may i
also result in a sharp change in the incidence and severity of radiation l
l induced morbidity." (See Physical Aspects of Quality Assurance in l Radiation Therapy, American Association of Physicists in Medicine Report
! Number 13, published 1984.) Thus, administration of less radiation than prescribed may be of little therapeutic value; administration of more radiation than prescribed may prove unnecessarily harmful to the patient's i healthy tissue. The NRC believes many misadministration could reasonably be avoided if certain basic quality assurance steps were included in the f l
radiation therapy process.
The NRC staff has examined literature on the radiation therapy i
process and consulted with experts in the field to discuss the need for these quality assurance steps. The NRC believes that they are basic to-the radiation therapy process, and that for a licensee to provide radiation therapy without performing these steps would present an unjustified risk to the patient. The regulations that require implementation of these steps will provide guidance for improved patient safety and will also provide a basis for enforcement action if not followed.
III. DISCUSSION OF REGULATORY TEXT S 35.2 Definitions.
The NRC has added several definitions to the regulations to ensure that the regulatory requirements are clear. The definitions are intended to be similar to those already in use in radiation therapy. ,
l 5
l
[7590-01)
(. ,
L 'Section 35.43 Prescriptions and records of medical use for therapy.
The NRC has received one therapy misadministration report in which l radiation was administered to a patient who had not been referred for medical use of byproduct material. The NRC believes that a physician with special training and experience is needed to consult with the primary care physician in cases of referral, and make a determination that a clinical procedure that requires radiation dose to the patient is indicated.
When a decision has been made.to treat a patient for any malady, whether with radiation, surgery, or drugs, a physician makes a patient chart that includes information about the care provided for the patient. The. chart is made for medical and legal reasons. All charts contain the patient's name, the results of laboratory tests and physical
. examinations, a statement of diagnosis, and a prescription. Charts for teletherapy patients usually include photographs of the patient's face and the treatment area, the treatment plan (which is comprised of diagrams of physical measurements of the patient, portal arrangements used to administer the radiation dose, and devices used to modify the radiation beam, calculations made to determine how long the beam must be applied each day to deliver the prescribed dose, and the number of days radiation is to be administered), a record of each daily application of radiation made at the time of application, and records of any physical measurements of radiation or portal verification films made specifically for the patient. Charts for brachytherapy patients include the same type of information, but the diagrams and calculations refer to implanted radiation sources rather than externally applied radiation beams. Each entry in a chart is dated and signed or initialed.
6 i
[7590-01]
The NRC considered preparing prescriptive recordkeeping requirements-for the application of therapeutic amounts of radiation, but believes that the patient charts and calibration records that licensees make and retain for medical and legal purposes usually contain the information needed to demonstrate that the licensee has implemented a quality assurance program.
There would be no benefit gained by imposing recordkeeping requirements.
However, the NRC'would appreciate public comment on this matter.
l Several therapy misadministration have been precipitated by unclear prescriptions. In radiation therapy, a different dose is prescribed for each' patient, depending on the type and extent of the malady. Therefore, requiring a written prescription on the patient's chart appears to be the most efficient way of ensuring clear communication between the prescribing physician and the dosimetrist who makes the calculations to determine how long radiation must be applied to deliver the prescribed dose.
The NRC believes that it is possible that some dosimetrists or technologists may be disinclined to request clarification of instructions and this may lead to misadministration. Therefore, the NRC is requiring licensees to specifically instruct workers to request clarification in cases where there may be ambiguity or error.
S 35.432 Source strength measurements, j The radiation dose rate from a sealed source, which is known as source strength, depends on the amount of radioactivity in the source and the material used to encapsulate it. (See National Council on Radiation l-l 7
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p.
[7590-01]
Protection and Measurements Report Number 41, " Specification of Gamma-Ray Brachytherapy Sources," Chapter 4.)1 Manufacturers usually provide source strength information with sources, but the NRC believes that an independent measurement is needed to ensure that the information relates specifically to the source under consideration.
However, the NRC will not require licensees to use these measurements in dose calculations. In some cases manufacturers are able to provide more accurate measurements of source strength than licensees; the licensee must be free to use the source strength that it believes is.the most accurate.
S 35.452 and 35.652 Physical measurements of patients. '
The NRC knows that dose rates depend to some extent on the tissua volume to be treated and_its depth within'the patient. -These parameters may be determined by physical examination or examination of images such as radiographs, or images from computerized tomography, ultrasound, ,
nuclear'oedicine, or nuclear magnetic resonance. The NRC considered requiring that two individuals independently make the physical measure-ments of the patient that are needed for dosimetry purposes, and believes that such a requirement may reduce the chance of misadministration. i However, such a requirement would be an expensive use of limited medical l resources that may negatively impact the delivery of medical care.
.Therefore, no requirement has been placed. However, the NRC will continue to examine this matter.
1 Copies of reports may be purchased by contacting NRCP Publications, P.O. Box 30175, Washington, DC 20014.
8 x
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I S 35.454 Check of calculations, and S 35.654 Checks and measurements of dose.
Dose calculations are made for each teletherapy and brachytherapy patient _before radiation is administered to determine how long the source must be used to deliver the prescribed radiation dose to the treatment volume. Several therapy misadministration have been precipitated by arithmetic mistakes or incorrect assumptions in dose calculations. An independent check will likely uncover many of these mistakes.
Ideally, teletherapy dose calculations should be checked before radiation is administered, and the NRC expects most licensees already do this. However, a second person may not always be available to check the dose calculations before therapy begins. The NRC believes that requiring the check to be made before 20 percent of the dose has been administered provides a proper balance between patient safety and administrative flexibility for the licensee.
For most brachytherapy cases, final dose calculations cannot be performed until the sources are implanted in the patient because the exact location of the sources with respect to certain tissues cannot be predetermined. Brachytherapy sources are typically left in place for two to three days. Thus, a 20 percent criterion may be difficult to meet in many cases, because the check would have to be made within hours after the sources are implanted. Thus, the NRC has selected a dose calculation check criterion of 50 percent.
There are two usual methods for performing dosimetry checks. Two individuals may independently calculate treatment times and compare results.
Alternatively, one individual may make the calculation and then a second individual can tick each entry and arithmetic operation after verifying its accuracy.
9
[7590-01)
In teletherapy, the arithmetic associated with records of the daily administration of radiation must also be checked. Radiation is usually administered in daily doses over several' days or weeks and each dose is recorded in the patient's chart. A weekly check is required to assure the daily doses have been summed correctly. In contrast, brachytherapy is administered continuously until the prescribed dose has been given; thus, there is no need for a comparable requirement.
One recent teletherapy misadministration occurred in a case in which an unusual treatment configuration of the teletherapy unit, the beam collimators, and the patient was required. Whereas an ar'thmetic mistake would likely be obvious in a commonly used configuration because certain calculated values for patients usually fall within small ranges, an unexpected treatment time in an uncommon configuration would likely be attributed to the uncommonness of the configuration rather than triggering an examination of calculations for a dosimetry mistake. Therefore, the NRC believes that a physical measurement of the dose rate should be made in such cases.
The NRC considered requiring physical measurements for brachytherapy but believes the methodology (comprised of a comparison of calculated and measured dose rates) that is needed to make such measurements has not been fully developed.
The NRC knows that some treatments must be administered within hours after a decision has been made to administer radiation therapy. These i
cases usually involve compression of the spinal cord or superior vena cava, respiratory distress, brain metastases, or severe vaginal bleeding. In such cases it may not be possible for the licensee to perform an independent check of calculations.
10
[7590-01]
The NRC believes the prescribing physician is best situated to determine 4
whether the time needed to make normal quality' assurance checks might
-jeopardize the patient's health. This provision is not designed to provide licensees a basis for administrative convenience or economy of operation.
-S 35.632 Full calibration measurements.
In one misadministration eve'nt, 53 patients received doses of radiation--
different than prescribed because a mistake was made when measuring the j effect of certain beam modifying devices on the teletherapy unit output.
The NRC believes the re-validation of these data are just as'important as the annual full calibration itself.'
S 35.633 Independent check of full calibration measurements.
Teletherapy dose calculations are all based on the output of the teletherapy unit, which is measured each year es part of the full calibration. If a mistake were made in.that measurement, all dose calculations would be incorrect. Therefore, the NRC believes there should be an independent check of the output.
The check must be made by a teletherapy physicist because that _
individual has special training and experience in the measurement of therapeutic radiation. l l
The check should be made using a measuring system other than the [
system used in the full calibration. This will better assure that any mistake made in the methodology or the calibration of dosimetry equipment I
will not go unnoticed. (The term " measuring system" is used in a broad sense here to mean not just the dosimetry equipment, but the personnel, i
11 x
. ___________________________U
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, [7590-01]
1 9
t 40
rc , r-records," site-specific'inthodology! 'and even origin of dosimetry equipment f ,
calibration when possiblu. However, the NRC is not certain that this i
/
95 eld be available to,all licensees ap.d requests comment on this matter.)
y , u Thedeviceusedhamak,etheoutputmeasurementmaybeonedescribedi,n e
(
in , '
f
- 1 S35.630Dolimetryegoipment. It may also he made using a specialized' '
i i i dosimetry servit;'q ahailable by mail. Some organizations supply licensees jt , ,
with precisely calibiatjed thermolumirascent dosimeters within a device made of " tissue-equivalent" material. The licensee irradiates the device,
. A calculates the given dose, and returns the dosiceters to the organization by mail. By processing the thermoluminescent, dosimeters, the organization canfaasuEd the gben dose and compare that measure'to the calculat'ed
.i u-gj ve/u;., ose.
Ti{is p9 ides c.ap.rance that the detput has been correctly measured. 3 a
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IV. ADMINISTRATIVE' STATEMENTS :
o, '
, 'c )3 f Environmental Impact: ' Categorical Exo% tion 6-The NRC has determined that, ois regulation.is the type of action
- u. 6 ,
described fn rategor/a1 exclusion 10 CFR 51.22(c)(3). Therefore, neither o \ w , ,
an environmental im, pact 4tatement nor an environmental assessment fas been
, f '
si $
preparery for this oropsed regulation. ;
/
6 n '
Myry,oLiReductionActStateunt Th proposeh rule would' anynd ahrmation collection requirements U N
' that are subject,to ttu Pap 4mork /
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fle,,wt; tier Act of 1980 (44 U.S.C. 3501 et' seq.).- ThisrdTenasbeeIliubmittedto'.theOfficeofManagementand
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e
'BudgetI?ar review and ap,n p V of the paperwork requirements.
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., x h Regulatory Flcribility Certification I Basedontheinformation'failableatthisstageoftherulemaking 3
proceeding, in accordance with section 605(b) of the Regulatory
' 'Flekheility Act of 1980, the Commission certifies that this rule will
\(p \,i /'r'p noy have a1 economic impact on a substantial number of small significant I entities. The NRC has issued approximately 2500 medical licenses under e
10 CFR Part 35. Of these, approximately 2200 are held by institutions, and,hppro'ximatthy300physiciansinprivatepractice. Most of the
.insututiona Jicenseesarecommunityhospitals. The Small Business y' /
Administration size standards,13 CFR Part 171, (49 FR 5037; February 9, 1984) classify a hospital or physician's office as a small entity if its average gross annual receipts do not exceed $3.5 million. Under these size standards, some NRC medical licensees could be considered "small entities" for purposes of the Regulatory Flexibility Act.
The Number of mcdical licensees that would fall into the small entity category does not constitute a substantial number for purposes of the Regulatory Flexibility Act.
The primary objective of the rule is to require licensees that provide radiation therapy service to implement certain cuality assurance
,a steps that will reduce the chance of therapy misadministration. The.NRC believes that most licensees already performs these steps in order to Es7ure the provision of quality medical care. Therefore, there should
> \'
e .,
,/1 .not be a significant economic impact on these small entities.
4 13 Y _ -__.___-______-____-__-_ _ _ -
, +
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The Commission has prepared a preliminary regulatory analysis for this regulation which contains information concerning the anticipated
- economic effect of.this regulation on licensees and presents the basis ,
/'
for the Commission's belief that the regulation will not result in significant addftional costs to any licensees. .Th is avhilable for public inspection the NRC Public Document Room at 1717 H Street NW. ,
Washington, DC. Single copies are available from Mr. McElroy.
Because of the widely differing conditio'ns under which licensees covered by this propused regulation cperate, the Commission specifically )
seeks public comment from small entities. Any small entity subject to thisregulationwhichdeterminesthat,becauseofitsside,itislhely to bear a disproportionate adverse economic impact should notify the Commission of this in a comment that indicates: (1) The licensee's size insterms of annual income or revenue, number of employees and, if the licensee is a treatment center, the number of beds and patients treated annually; (2) How the regulation woald result in a significant economic Durden on the licensee as compared to that on a large licensee; (3) How the regulations could be modified to take into account the licensee's differing needs or capabilities; (4) The benefits that would be gained or the detrimut1Ihat would be avoided to the licensee, if the regulations were modified as suggested by the Commenter; and (5) how the regulation, as modified, would still adequately protect public health and safety.
I c
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i 14
._a._ . . _ . - _ _ - - . - - . - - - - - - - - . - - - - - - - . - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - ' - - - - - ^ ^ - - - - ^ - ' - ^'--' ' ' ^ ^ " ' - - - '
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Basis for issuance of a rule without public comment, l'
The Commist ion knows of many events in which radiation has been .l
. improperly' administered to patients. The Commission has determined that notice of rulemaking and public procedures theron are impracticable and i
contrary to the public interest.
V. LIST OF SUBJECTS IN 10 CFR PART 35 g Part 35 - Byproduct material, Drugs, Health devices, Health professions, Incorporation by reference, Medical devices, Nuclear materials, Occupational N safety and health, Penalty, Radiation protection, Reporting and recordkeeping requirements.
Under the-authority of the Atomic Energy Act of 1954, as amended, the '
Energy Reorganization Act of 1954, as amended, and 5 U.S.C. 553 the NRC is adopting the following revision of 10 CFR Part 35.
VI .- TEXT OF FINAL REGUL TIONS The revision of 10 CFR Part 35 that was published on October 16, 1986, 7 (51 FR 36932) is revised to read as follows: )
,1. The following terms are added in alphabetical order to S 35.2 Definitions:
?
" Beam modifying devices" means items such as trays, wedges, compensators, boluses, and blocks that are used to change the radiation dose profile within the patient.
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[7590-01]
" Computer generated calculation" means a calculation that has-been' made by a computer program with no human action necessary other~ :)
than the input of patient data, selection of a certair, computer program, and the instruction to the computer to begin calculation.-
" Manual . calculation" means a calculation made by an individual using l patient data, tabulated data or graphs, nomograms, and a calculator that was not specifically designed or programmed for radiation therapy calculations.
" Patient chart" means a record of the diagnosis and radiation treatment applied to a patient.
" Prescription" means the instruction to make medical use of byproduct material for the benefit of a specific patient.
" Source strength" means the exposure rate at a specified distance from a source (usually expressed as Roentgens per hour at one meter), the amount of radioactivity in a source (usually expressed as millicuries), or the amount of a different radionuclides that produces the same dose rate (usually expressed as milligrams of radium equivalent).
- 2. Section 35.43 is added to read as follows:
S 35.43 Prescriptions and records of medical use for therapy.
(a) The authorized user or a physician under supervision of the authorized user shall ensure that, if there is a primary care physician, I
16
[7590-01] l T
the pstient has been referred for a therapeutic clinical procedure that-requires the medical use of byproduct material.
(b) The authorized user or a physician working under supervision of the authorized user shall personally make, date, and sign a written prescription on the patient's chart that identifies the body part to be treated. Changes in the prescription must also be made by being written
. in the patient's chart, dated, and signed.
(1) For radiopharmaceutical therapy, the prescription must also 1 j
identity the radiopharmaceutical, the amount of activity to be administered, and the route of administration.
(2) For brachytherapy, the prescription must also identify the sources of radiation and the total tumor dose.
(3) For teletherapy, the prescription must also identify the I teletherapy unit to be used, the prescribed dose, and the treatment plan.
(c) Prescriptions and other records made regarding the medical use of byproduct material must be legible and unambiguous.
(d) The licensee shall instruct workers orally and in writing to request clarification from the prescribing physician if any element of a prescription or other record is unclear, ambiguous, or apparer,ily cirroneous.
- 3. Section 35.302 is added to read as follows:
$ 35.302 Administration of radiopharmaceutical dosages.
A licensee shall verify that the prescribed radiopharmaceutical l
is being administered by comparing the written prescription and the container label. j L I l
t 17 '
. _ _ _ - - _ - _ _ _ _ _ _ _ _ _ - _ - _ = _ - -
[7590-01]
- 4. Section 35.432 is ed'ed to read as follows:
6 35.432 Source strength measurements.
A licensee shall measure the source strength of sources before first.
use and annually thereafter. Sources that are in storage and not being used do not have to be measured until they are placed in service again.
For sources manufactured by lots, a sample may be selected rather than measuring each source. When performing dose calculations, a licensee may use the source strength reported by the manufacturer rather than using the source strength measured by the licensee.
- 5. Section 35.452 is added to read as follows:
6 35.452 Physical measurements of patient.
[ Reserved]
- 6. Section 35.454 is added to read as follows:
6 35.454 Check of calculatio~.>.
A licensee shall check calculations for accuracy before 50 percent of the prescribed dose has been administered.
(a) Manual calculations must be checked for accuracy by an individual who did not make the calculations.
(b) Computer generated calculations must be checked manually for accuracy by calculating the dose given to a single point in the treatment field. The check must be made by an individual who did not enter the patient data or prescription into the computer.
1 18
L [7590-01]-
L V
(c) .If the prescribing physician makes a determination that to delay treatment in order to perform the checks of calculations required by this section would jeopardize the patient's health because of the emergent nature of.the patient's condition, the licensee may provide the.
prescribed treatment without performing the checks. 'The prescribing-
~
physician shall make a notation of this determination on the patient's chart. The licensee shall perform the checks as soon as practicable.
I
- 7. Section 35.632 is revised to read as follows:
1 S 35.632 Full calibration measurements. :
l .- (a) ***
[ -(b) To satisfy the requirement of paragraph (a) of this section, full calibration measurements must include determination of:
(1) The output within 3 percent for the range of field sizes, f
range of distances, and selection of beam modifying devices (for example:
trays, wedges, and the stock material that is used for making compensators and boluses) used for medical use; I * * * * *
- 8. Section 35.633 is added to read as follows:
6 35.633 Independent check of full calibration measurements.
)
(a) A licensee shall have an independent check of the output determined within one month after completion of the full calibration required by S 35.632 of this Part.
(b) The independent check must be performed by a teletherapy l physicist using a dosimetry system other than the one used to measure the output during the full calibration.
I 19 1
[7590-01).
i
'9. Section 35.652 is added to' read as followsi S 35.652 Physical measurements of patient.
[ Reserved]
- 10. Section 35.654 is added to read as follows:
6 35.654 Checks of dose calculations and measuremen. of dose.
A licensee shall check dose calculations for accuracy before 20 percent of the prescribed dose has been administered. l (a) Manual calculations must be checked for accuracy by an individual who did not make the calculations.
(b) ' Computer generated calculations must be checked manually for accuracy by calculating the dose given to a single point in the treatment field. The check must be made by an individual'who did not enter the patient data or prescription into the computer.
(c) A licensee shall make a weekly accuracy check of daily ar.ithmetic operations in patient's charts.
(d) If the field size, or source-to-skin distance fall outside the range of those normally used by the licensee, the licensee shall make a-physical measurement of the dose rate to be administered.to the patient.
This measurement must be made before 20 percent of the prescribed dose has been administered.
(e) If the prescribing physician makes a determination that.to
~
delay treatment in order to perform the checks of calculations or physical measurements required by this section would jeopardize the patient's health because of the emergent nature of the patient's L condition, the licensee may provide the prescribed treatment without 1
l 20 i l
_ _ _ _ _ _ _ _ _ . _ _ _ _ _ _ _ _ _ _ l
I l [7590-01] i I !
performing the checks of calculations or physical measurements. The .
prescribing physician shall make a notation of this determination on the patient's chart. The licensee shall perform the checks of calculations or physical measurements as soon as practicable.
l l
Dated at Washington, DC, this day of , 1987.
l FOR THE NUCLEAR REGULATORY COMMISSION Samuel J. Chilk Secretary of the Commission I
.21
g
(
)
i RESPONSE T0. QUESTIONS IN DECEMBER 16, 1986 l
STAFF REQUIREMENTS MEMORANDUM l
Introduction
, In a followup memorandum on medical misadministration dated December 16, 1986 the Commission directed the staff to give priority attention to the development of a proposed rule that would strengthen NRC oversight of medical j/
licensees. The staff has provided-regu-latory-textwf- an Advanced Notice of f\
Proposed Rulemaking in Enclosure I as well as a proposed rule in Enclosure 2.
The Commission also directed the staff te prepare a comprehensive analysis of NRC's regulations and other initiatives that may reduce the frequency of misadministration, and specifically raised ten elements to be considered.
Analysis Impact on the Delivery of Medical Care In considering changes to the regulatory program governing the medical use of byproduct material that would improve public health and safety, the staff is faced with several dilemmas. We know that diagnostic and therapeutic procedures save lives and reduce human suffering.
For example, one diagnostic procedure alone, the detection and localization of pulmonary embolisms, has reduced this as a cause of death in hospitals from about 200 to 300 per week to essentially zero. There are other potentially life saving diagnostic procedures such as those for gastro-intestinal bleeding and .
hepato-biliary dysfunction.
In the case of therapy, which involves large radiation doses, there is often a fine line drawn between providing sufficient radiation to destroy a lethal tumor while attempting to avoid damage to vital healthy tissues. Such therapy often involves a risk which'must be balanced.
In efforts to improve the regulatory regime covering nuclear medicine, care must be taken to avoid unintentionally impeding the delivery of medical care by <
imposing unworkable regulatory requirements or making regulatory control so onerous, and the professional risk so great, that the availability of nuclear medicire for those in need is curtailed.
DRAFT 12/22/86 1 Enclosure 3
l l In a similar vane, regulations must be developed in a way which does not influence physicians' decisions on taking such actions as they believe to be in
.the best interest of their patients. Regulations should not unduly influence medical decisions. There is often not time for a physician to seek clarific0 tion of rules or seek exceptions as applied to a particular case before he or she must make decisions about treatment.
Continuing Evolution of the Medical Use of Byproduct Material In diagnostic nuclear medicine we have witnessed in the last few years the development of dev1ces that contain radioactivity and that can be used by physicians and paramedic personnel who have never before been under NRC licensure. in conventional nuclear medicine, in which radiopharmaceuticals are administered to patients for diagnostic or therapeutic purpose, the development of new radiopharmaceuticals and clinical procedures has raised new technical problems for staff analysis as well as attracting new practitioners who were never before NRC licensees. The nost dramatic example of this is the development of diagnostic nuclear cardiology. As little as ten years ago, this speciality was only briefly mentioned in the closing chapters of nuclear medicine science textbooks. Now, nuclear cardiology clinical procedures are employed in many cardiology departments as well as nuclear medicine tiepartments.
The staff will also likely have to deal with the development of the clinical use of radio-labelled monoclonal antibodies for diagnostic and therapeutic use.
If research with alpha-emitter labels is successful, the staff will have to address a whole new plethora of worker and public radiation safety issues and technical issues associated with alpha-emitting radioisotopes, which are new to nuclear medicine. The use of teletherapy, although not evolutionary in and .
I of itself, will be complicated by its application with hyperthermic and -!
chemotherapy. Thus, the scope of NRC's medical use regulations will likely have to be kept open for revision as new treatment regimens are developed.
i Need for Resources Staff resources are an important issue in increasing the effectiveness of the NRC's medical use regulatory programs. The staff presently has essentially no budgeted resources to keep its regulatory practices abreast of evolving technology and to work with the medical community on development of safe practices and procedures. The staff believes more effort in this area is essential for maintaining a viable and effective regulatory program.
DRAFT 12/?2/86 2 Enclosure 3
& N Given competing demands for NRC resources,ystaff resources that are devoted to medical use, and the materials program as e whole, have been reduced to a bare minimum. [ provide budget data on the materials programs as a whole.'
In the case of misadministration, we are attempting to further reduce a reported overall' incidence rate of approximately of 10-4 per patient and a death rate which is probably less than 10-6 To accomplish this objective, additional resources will be needed to review cuality assurance programs in the licensing process and to inspect for compliance. Also, more frequent inspections than are provided for in the current budget (each three years, but rarely fully achieved in reality) are needed if our goal is prevention of misadministration rather than reactions to them.
Given these constraints, however, the staff does believe there is opportunity for improvement in the regulatory program for medical use.
Response to Elements Initiatives are discussed in the staff response to each of the elements raised by the Commission in its December 16, 1986 memorandum as follows:
Question 1. Whether the rulemaking under development in response to the April 14, 1986 SRM goes far erough in strengthening NPC regulations?
Response 1. There are two parts to the April 14, 1986 SRM: quality assurance for radiation therapy and penalties for negligence. The sta#f believes that the April 14, 1986 SRM provides the staff ampla opportunity to strengthen NRC regulations in these two areas. Compliance with the basic ouality assurance rule in Enclosure 2 would have eliminated about three-fourths of the misadministration reported in AE00/C505. The staff believes more can be done but is not certain of how much cuality assurance is in place now and how much can be realistically required without negatively impacting the delivery of medical care. Therefore, the staff developed the advance notice in Enclosure 1, which poses certain policy and technical questions for public I comment.
Recommendation: The staff should address this matter in the context of the proposed rule that evolves from the ANPP cn this subject.
DRAFT 12/22/86 3 Enclosure 3
}
l Question 2. What additional measures are needed, including improvement in the regulations or inspection program? Shou 1c there be changes to the 'l content or an increased frequency of NRC inspections of Part 35 licensees?
i Response 2. In addition to rules that might be needed to address the l elements raised by.the Commission, there are other matters that need to be i
considered. For example, the Office of the Analysis ar.d Evaluation of Operational Data (AE0D) is currently conducting a study on diagnostic misadmi-nistrations that lead to doses in the therapy range. Depending on the outcome of that study, further rulemaking might be indicated for diagnostic quality assurance. l The new 10 CFR Part 35 was recently issued. As experience.is gained with the new rule, further adjustments or additional guidance related to implementa-tion might be indicated.
The staff also believes the application of the tenn " misadministration report" to a rule that was designed to collect information has had a detrimental effect on NRC's ability to participate in voluntary industry improvement programs that are under way and tends tc undermine cooperation with the medical community which the staff seeks. The staff notes that at the Food and Drug Administration, which regulates manufacturers but not end esers, the programs to collect information about potentially faulty products and devices are entitled,
" Problem Reporting Programs." The two programs are endorsed by over 80 regional and national organizations. Each year about 7,000 reports a re submitted by l individuals that result in about 200 recalls or corrective actions. The staff recommends that NRC's reporting requirement be retitled, " Medical Use Event Report." ;
With the reorganization, the staff anticipates a closer coupling of licensing and inspection policy and procedures. Changes in the rules neces-sarily result in changes in licensing and inspection content. These will be re-examined. The staff anticipates that licensing standard review plans and inspection modules will need to be ecdified.
Imposition of quality assurance regulations would require training of NRC >
staff because medical quality assurance is a technology that is different from radiation safety. There is little overlap. Inspec;f ons of ouality assurance programs would be time consuming--at least an entire day.
The amount of resources devoted to medical licensing and inspection is a critical issue. As regulations become more comprehensive, additional DRAFT 12/22/86 4 Enclosure 3 L __-____
resources will be required for both. Presently approximately percent of NRC resources are devoted to medical licensing and inspection. Inspection resources is a key issue. Of the 2,500 NRC medical licenses, 749 were inspected in 1985. NRC " presence" is not very great in nuclear medicine.
Inspection and enforcement is a necessary adjunct to rules intended to reduce I the misadministration rate. If our objective is to prevent misadmin-istrations rather than investigate after an incident occurs, the staff needs to assess compliance with quality assurance rules and identify licensee program-matic weaknesses before failures lead to a misadministration rather than later.
The staff also believes more frequent inspections are an important facet to the Commission goal of reducing misadministration, although the staff does not have benchmarks by which it can correlate frequency of inspection to reduction of the misadministration rate.
Recommendation: The staff should consider in the next budget cycle adding resources to cover new rule development, increased licensing and inspection effort to evaluate licensee QA programs and a modest increase in inspection ,
frequency to provide a greater NRC " presence" at medical licensees.
Question 3. Whether the training, guidance, and supervision of technologists is adequate?
Response 3. The staff believes there is room for improvement. However, the issues are complex and improvements may prove difficult. The staff estimates there are about 12,00 diagnostic nuclear medicine technologists and 2,400 radiation therapy technologists working under NRC and Agreement State licenses. The licensees' training criteria vary widely depending on the patient load and the responsibilities assigned by the supervising physician.
There is a chronic, nationwide shortage of therapy technologists and dosimetrists (specially trained technologists that calculate treatment plans based on the physician's prescription). The departure of incumbents from these occupations is higher than for other occupations because of tht difficult physical and emotional work environment. Experienced workers are not readily available in the marketplace. When these concerns are applied to the entire field of medical use of byproduct material, the dimensions of the issues expand considerably.
DRAFT 12/22/86 5 Enclosure 3 t____--__--
Recommendation: Include, in the FY88 budget, funds for a contract study that would (a) provide information about patterns of technologists' duties and responsibilities, (b) assess the adequacy of training, guidance and supervision of technologists (c) identify weaknesses in training, supervision, and the workplace, and (d) make recommendations for improvement either through the regulatory process or compliance with voluntary standards prepared by the medical community.
Question 4 Development of a mechanism to track practitioners known to ,
have willfully violated NRC regulations so that such information is ennsidered in any subsequent licensing; also an assessment of the adequacy of the feedback of information on individuals who repeatedly violate NRC regulations.
Response 4. The staff addressed this issue for all licensees in SECY-86-319. However, the staff notes that the President recently signed Public Law 99-660, which, among other things, establishes a tracking system on physicians that 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 meet with HPS to explore methods for NRC access to the tracking system to obtain and supply information.
Question 5. A requirement that all licensees maintain, and provide to patients upon reouest, 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 a requirement to disclose information in patient charts may run counter to the high degree of privacy accorded to medical records as well as some state laws on this matter. The staff believes that physicians already provide information on the amount of radiation used and the method of treatment, and does not believe this is e significant issue.
l Specific, detailed medical or technical information is easily subject to misunderstanding, and the staff belia"es this question should not be handled I '
DRAFT 12/22/86 6 Enclosure 3
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as a radiation matter but as a physician-patient matter. A rule governing availability of dose information would not explain the basis of the physician's prescription for the condition being treated, or the expected results. (See, for example, Enclosure 7, which discusses the problem of compromise in radiation dose to eradicate 'a tumor while minimizing structural or functional injury.)
Such matters often extend beyond NRC's jurisdiction on to the referring physician who is.not a licensee. To require full disclosure or 011 information in the patient's chart is likely to chill or influence the deliberative process between various. professionals who are key to providing quality patient care. l 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 subject to reported misadministration.
Response 6. Some type of followup requirement could be provided as part of the complete quality assurance rule. However, the staff believes that this question should also be handled not as a radiation matter but as a physician-patient matter. The need for any kind of patient followup varies widely depending on the nature of the misadministration.
Recommendation: The staff should explore follow-up requirements for patients who have received therapy misadministration as part of the rule that evolves from the ANPR on quality assurance in radiation therapy.
Question 7. A procedure to verify that referring physicians and patients are indeed notified of misadministration, as currently recuired 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 b been notified. Also, inspectors can check during routine inspections that notification was accomplished. l I
DRAFT 12/22/86 7 Enclosure 3 J E________ 3
l Recommendation: The staff should undertake appropriate modifications of j the misadministration reporting requirement.
Question 8. The need for additional feedback mechanisms such as addf-l l
tional NRC information notices on reported medical misadministration to l
ensure that all licensees can benefit from lessens learned.
Response 8. The staff is already doing this. See:
"One Year's Experience With Misadministration Reporting," L. Roche, Society of Nuclear. Medicine Newsline, v7, ni, pp 4-5, March 1982.
"NRC Reports on Missdministrations and Unannounced Safety Inspections," '
I N.L. McElroy, and " Physician Removed from NRC License for Failure to Report Misadministration," J. E. Frohman,. Journal of Nuclear Medicine, Vol. 27, l pp 1102-1107, July 1986. i "NRC Reports on Therapy fiisadministrations," N.L. McElroy, accepted for January 1987 publication in newsletters of the Americar College of Radiology and American Association of Physicists in Medicine.
" Case Study Report on the Therapy Misadministration Reported to the NRC Pursuant to 10 CFR 35.42," S. Pettijohn, was distributed to all medical licensees.
The staff notes that medical organizations have been very willing to publish NRC-authored articles in their jcurnals and newsletters.
l Recommendation: The staff should continue to inform the medical community of misadministration events and enforcement actions through NRC !
notices and publications in professional jcurnals.
Question 9. Whether, apart from increased NRC oversight, there are any j changes in industry practice or standards that could substantially i improve the cuality of performance and minimize human error.
DRAFT 12/27/86 8 Enclosure 3 :
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Response 9. The staff believes respenses to the advance notice of proposed rulemaking in Enclosure I may provide insights on this matter. !
i Recommendation: During the course of developing rules that evolve from the ANPR, the staff should identify and consider other changes in industry practice that could substantially improve the cuality of performance and l minimize human error.
Question 10. What interactions do we have with industry organizations and what initiatives do they have in progress which could help?
Response 10. The American College of Radiology (ACR) and the American Association of Physicists in Medicine (AAPM) are the two key organizations.
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The ACR has developed, quality assurance programs for delivery of radiation l therapy, and has also operated the Patterns of Care study, which is apparently the first medical study in any medical specialty to provide long-term follow-up of patients to develop a prospective data base that will allow the determination oftheoptimumtreatmentforpatientswithcertaindiseases.((
The AAPM has been active in assisting in the development of quality assurance programs, and instrumental in the development and management of a i certification program for dosinetry equipment calibration laboratories. Tbc following task groups are working on quality assurance projects that apply to sealed source therapy: Regional Calibration Laboratory, Computer Applications, Radiotherapy Port Film Ouality, Total and Palf-Body Irradiation, Radiotherapy Quality Assurance in Clinical Trials: Treatment Specification 8 Review, Specification and Calibration of Brachytherapy Sources, Lung Corrections, and Evaluation of Models for Dose Response in Radiation Oncology. This is in addition to twenty-one other committees working on quality assurance programs for medical use of radiation that is not under NRC jurisdiction.
The staff has already had informal meetings with the ACR and the AAPM and intends to fully utilize the resources of all these organizations once the public is given formal notice of NRC's intent to initiate rulemaking on these matters.
DRAFT 12/22/86 9 Enclosure 3
i Recommendation: The staff should continue communicating with affected professional organizations to inform them of NRC plans regarding safety in nuclear medicine and radiation therapy, and work with these organizations to 1
establish industry solutions to the extent practicable.
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