ML20236L843
| ML20236L843 | |
| Person / Time | |
|---|---|
| Issue date: | 09/19/1987 |
| From: | Chilk S NRC OFFICE OF THE SECRETARY (SECY) |
| To: | |
| References | |
| FRN-52FR36949, RULE-PR-35 PR-870929-01, NUDOCS 8711110082 | |
| Download: ML20236L843 (17) | |
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NUCLEAR REGULATORY COMMISSION
'87 OCT -2 Ni':33 10 CFR PART 35 '
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i . Comprehensive' Quality Assurance in Medical Use and a Standard of' Care AGENCY: Nuclear Regulatory Commission.
ACTION: Advance Notice of Proposed Rulemaking.
SUMMARY
- The Nuclear Regulatory Commission'(NRC) is considering amendments to its regulations that apply to the use of byproduct material for radia-tion therapy and diagnostic uses involving large radiation dosages. In addition to the current requirements for quality assurance, the contem-plated amendments would require licensees that offer teletherapy or brachy-therapy services to implement a comprehensive quality assurance program to L
reduce the chance of misadministration. The NRC requests public comment on the extent to which additional radiopharmaceutical quality assurance requirements are needed, and invites advice and recommendations on several questions that will have to be addressed in the rulemaking process. The NRC is also requesting comments on some basic quality assurance program requirements set out in a proposed rule published elsewhere in this issue.
l DATE. Submit comments by 12/31/87. 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 on or before this date.
8711110082 870919 PDR PR 1 /}
35 52FR36949 PDR s.
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- , ' ADDRESSES
- ; Mail comments'to: The-Secretary of the Ccamission, U.S.
h ;,s Nuclear Regulatory Commission, Washington, DC 20555, Attention: Docket-L hyg.
ing and, Service Branch.'
L, Deliver comments _to: Room 1121, 1717 H Street NW.., Washington', DC,
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between 7:30 am and 4:15 pm on Federal workdays.
- Examine copies of comments - received at: The NRC Public Document Room, 1717 H Street NW. , Washington, DC; m
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.
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i SUPPLEMENTARY INFORMATION:
l Therapy Use of Byproduct Material l
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Teletherapy is the application of a beam of radiation emanating from a cobalt-60. source to a patient for a therapeutic purpoce, usually cura-tive, prophylactic, or palliative cancer therapy. (:High energy x-ray I.
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machines are also used for the same purposes.) As en example, a treatment might be comprised of daily treatments of 100 rads to the tumor volume for five weeks, yielding a total t eor dose of 5000 rads.
Brachytherapy is the inse,rtion of small sealed sources such as )
t cesium-137, tridium-192, gold-198, or iodine-125 into the tumor volume fcr curCive or prophylactic cancer therapy. As an example, a treatment might 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 is >
tumor dose of 5000 rads.
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Radiopharmaceutical therapy is the administration of a radioactive drug for therapeutic purposes. The most common clinical proceuure involves the oral administration of liquid or gelatin-capsuled iodine-131 as sodium iodide. For hyperthyroidism, 5 to 30 millicuries might be administered; for thyroid cancer, 70 to 200 millicuries might be administered.
Most diagnostic uses result in whole body doses of about 0.1 rem and
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target organ doses of about 2.0 rem. Occasionally, however, as much as 5 millicuries of iodine-131 is administered as a diagnostic dosage for patients who have been treated for thyroid cancer. If this dosage were mistakenly administered to a patient who has no thyroid disease, the __
thyroid dose would be several thousand rads.
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NRC'S Policy Regarding the Medical Use of Byproduct Material L In a policy statement published February 9, 1979 (44 FR 8242), the -
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l NRC stated:
The NRC will continue to regulate the medical uses of radioisotopes
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as necessary to provide for the radiation safety of workers and the general public.
"2. The NRC will regulate the radiation safety of patients where justi-
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fled by the risk to patients and where voluntary standards, or compliance with these standards, are inadequate.
i "3. The NRC will minimize intrusion into medical judgments affecting patients and into other areas traditionally considered to be a part of the practice of medicine."
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.. o The' NRC has the authority to regulate' the medical use of byproduct '
material:to protect:the health and safety of patients,-but'also recognizesi ';
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-that physicians have the primary responsibility for the protection of' their= patients. NRC regulations are predicated? on the assumption that' ,
, properly trained and adequately informed physicians will make' decisions' 1 ,
in the best interest of their-patients,
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.NRC's Responsibilities in the Medical Use of. Byproduct Material !
l The NRC draws a line between the unavoidable risks attendant to .
j purposefully prescribed and properly performed clinical procedures and the unacceptable risks of improper or careless 'use of byproduct material {
q in medicine. The NRC is obliged, as part of..its public health and safety I charge, to establish and enforce regulations that protect the public from j theLlatter, s w ,
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' Reports of Misadministration in Radiation Therapy The NRC has published a study of the twenty seven therapy misadministration that were reported over the period November 1980 through July 1984.1 The following NRC analysis of these events provides the basis for. determining that a need exists for this rulemaking.
The specific causes of the misadministration, detailed in Table 1, are, of course, related to the treatment modality. Nonetheless, three basic themes run through the reports: inadequate training, inattention
'to detail, and lack of redundancy.
1 IFor a cpy of this report, write to Kathleen M. Black, Of fice for Analysis and Evaluation of Operational Data, Nuclear Regulatory Commission, Washington, DC 20555. Ask for report AE00/C505.
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l Table 1. Therapy misadministration reported to NRC l
from November 1980 to July 1984 Teletherapy Prescription Total daily dose was delivered from each port (2)*
Oral ar.d written prescriptions were different (1)
Boost dose of 500 rad /3 da was interpreted as 500 rad x 3 da (1)
Proper body side was not clear (1)
Treatment planning l Tumor depth was incorrectly measured (1)
Tumor depth was incorrectly recorded (1) 3 Dosimetrist used wrong computer program (1) '
Dosimetry tables for wrong unit were used (1)
Arithmetic mistakes were made (3)
. Records Arithmetic mistakes were made (1) ,
Poor handwriting of numerals caused misunderstanding (1) l Physical' measurements ;
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Wedge factors were measured incorrectly (1-53 patients affected) {
q Application Field blocks were not used (1)- ]
Treatment planning Dose rate was much higher than first estimated (1)
Application 4 Wrong sources were loaded in applicator (2) l Source fell out of applicator (1) !
Source was improperly seated in applicator (1) l Radiopharmaceutical Therapy Wrong radiopharmaceutical was administered (2) l Assay date on unit dosage was not read (3) '
Patient was improperly identified (1)
% umbers in parentheses indicate number of events of the type described.
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- Improved training of' medical personnel who handle and administer byproduct material can reduce the potential for error. Thorough training should also clearly impress on each individual involved in the medical use of byproduct material that a clear communication of concepts and quantities as well as systematic checks for revealing mistakes early in the process are both essential for the delivery of quality care. All information integral to the process, whether specific to the patient or to the clinic, should be carefully examined for clarity, applicability, and correctness. Each individual involved in the process should be strongly encouraged to ask for clarification if there is any unclear or unexpected step or if an expected step is missing.
Inattention to detail is often the medium in which a misadministra-tion event gerrrinates. NRC recognizes that this problem is not specific to the medical use of byproduct material. Computerized radiation therapy treatment planning may reduce the chance of mistakes in sealed source treatment planning, and " record and verify" systems that check teletherapy i unit orientations and settings may reduce the chance of mistakes in teletherapy administration. But even these systems must ultimately rely i
on quantities that are initially measured, recorded, and entered into !
memory by individuals.
Iack of redundancy means that there exists no independent mechanism ;
l for detecting errors. An independent verification requires examination j by a second individual of each data entry, whether a physical measurement or a number copied from a table of values, as well as a check of arithmetic l l
operations for correctness. Redundancy requires that two separate systems produce the same result. For purposes of planning radiation therapy, the best method of early detection of mistakes may be a simple independent l
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b check.' ' Independent 1 verification:may also need to be incorporated into'-
procedui'es for. measuring' radiation parameters,. using those measurements - {')
.for treatment planning, and' applying. radiation to patients. .In radiation
., therapy or any other endeavor, an independent outside. auditor can detect mistakes.in both process design and process application.as well'as cite-areas where a change in the' process might reduce the chance for' future '
error.
-These observations have led'the NRC to some general conclusions' regarding. quality assurance.
The radiation th'erapy proce'ss should be' planned with-the realization -
that individuals.are'likely to make mistakes._ Some simple aids may include using tables and graphs that are clearly titled and easy. to read,.
and use of a uniform written prescription formet. NRC' inspections have-
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' revealed that about ten percent of teletherapy unit calibrations and .m spot-checks are incomplete. Checklists could be used to~ assure completeness.
Independent verif.ication must be made integral to the design of i i
the radiation therapy process. All entries and calculations.in'a treat-ment plan should be checked by an individual who did not construct the treatment plan. Ech patient's chart should be reviewed weekly to check for accumulated dose and implementation of prescription changes. A p quality assurance program for the teletherapy unit should include a I periodic check of the teletherapy unit output and an occasional detailed
- .i L examination of the complete teletherapy process, including physical L
measurements, by an outside expert with an eye towards systematic errors .
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A program that requir.es a physical measurement of the dose _or, amount I 2 j of radioactivity actually administered to the individual patient would I provide assurance that the given dose is the same as the prescribed dose. ' i Such measurements are now'done for radiopharmaceutical therapy and'occa-sionally for some teletherapy cases, but.because of expense or unavail -
4 ability of equipment are-_not commonplace in sealed source therapy. .i-a; ,
Reports of Diagnostic Misadministration That Result in Doses
'in the Therapy Range The NRC has.also published a report on misadministration of v diagnostic dosages of iodine-131 that lead to doses in the therapy' range.2 The report was>a review of fourteen recent misadministration events in which patients were administered one to ten millicuries of iodine-131' with a'resulting thyroid dose of several thousand rads. Many of the-
+ Levents demonstrated that the physician authorized user failed to review
.the medical history of the referred patient to determine the suitability of a particular clinical procedure. In many cases the referring physician, who is not a nuclear medicine expert, and the nuclear medicine technologist, i L who is not a medical expert, determine which radiopharmaceutical should be administered. Furthermore, in some events technologists unfamiliar with i
the clinical procedure prescribed by the authorized user mistakenly administered a dosage that was not requested. It is apparent, therefore, 4 that whenever radiopharmaceuticals capable.of producing therapy doses are used, clear nomenclature, independent verification, and adequate training are essential.
I "For a single copy, submit a request for report number AE0D/N701 to the address in footnote 1.
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! Earlier NRC. Efforts
~This.i's not the first time ~the NRC has examined the matter of quality-
' assurance in the medical'use of' byproduct material. .In'1979 the NRC.
issued.some basic quality assurance requirements for. teletherapy l(see.
j 10 CFR 35.632 and.10 CFR 35.634). This'rulemaking was precipitated by the inhetion of a single licensee. The' output'of.a teletherapy unit was incorrectly calculated and the. licensee.made no phys.ical measurements q
. to determine'whether the calculation was correct. This inaction resulted j in cobalt-60 teletherapy being misadministered to 400 patients. The 1979
. rule addressed ~the circumstances surrounding that event.but did not-critically examine the entire radiation therapy process. <j Voluntary Initiatives h l
Th'e Commission is aware of voluntary. initiatives to improve quality assurance. A notable example is the Patterns of Care study managed by i the American College of Radiology. In addition to comparing prescriptions, l
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methods of applying radiation, and survival rates for certain diseases at
. vari ous.' therapy facilities across the nation, methods of calculating and h measuring applied dose rates are examined for accuracy. Such an examina- !
tion can detect whatever procedural flaws may be present as well as determine the precision and accuracy of day-to-day service, l l
It is NPC's position that voluntary programs alone may not provide adequate assurance of public health and safety. Serious misadministration j i
continue to occur. The NRC would be remiss in its responsibilities were it to fail to thoroughly examine all avenues available to reduce unnecessary exposure from licensed material. I l
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Summary The NRC believes many misadministration could reasonably be avoided i if certain quality assurance steps were included in the radiation therapy process.
I Other Actions j The NRC recognizes that the medical use of byproduct material is a j l
complex field, and that preparing regulations to reduce the likelihood "
of misadministration must be done carefully. However, the NRC cannot !
allow the complexity of medical use to prevent it from taking regulatory .)
i action when patients are harmed by the incorrect application of byproduct material. The NRC has balanced these competing desiderata by preparing l
two rulemaking actions for contemporary publication. ]
2 Th'is Advance Notice of Proposed Rulemaking (ANPR) will provide the foundation for a comprehensive quality assurance program requirement that will address each source of error that can lead to a misadministration.
The NRC elected to prepare the ANPR because of the complexity of medical use. Elsewhere in this issue of the Federal Register, the NRC has 1
published a Notice of Proposed Rulemaking (NPR) that provides the I l
foundation for a basic quality assurance program that addresses some j simple sources of error that have come to light under NRC's misadministra-tion reporting program.
The NRC believes this two pronged approach to the problem of
< s misadministration provides the best balance between the need to assure public health and safety without inadvertently interfering in the delivery of quality medical care.
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Effect on.the Agreement-States Program- {
j .Many' States,.known as-Agreement _ States,.have assured responsibility !
for regulating 'certain ra'dioactive materials within their respective j borders by ' agreement dith the NRC'.' (This kind lcf agreement is authorized. -
by the Atomic Energy Act.) They issue 1icenses for:the use of byproduct'
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o material, and currently regulate about: 5,000 medical licensees. .Because.
l the NRC will request th'e. Agreement States, as a matter of compatibility, t6 implement regulations equivalent to those that it implements on this I
matter, state regulatory agencies are asked to comment, j I;
Request For Comments The NRC has prepared the following questions to elicit comments on b
- methods of preventing. misadministration. Comments need not be confined to.these questions alone; discussion of.other related topics or alter-natives'is welcome if the commenter believes this will help to resolve !
issues related to this rulemaking. L!
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Quality Assurance j General-The following questions apply to the provis!on of all types of medical use:
- 1. How can the Commission most effectively imploment requirements j for-comprehensive quality assurance? The Commission has the authority to !
adopt existing national standards. The Commission, in concert with j i
medical experts, could identify and adopt by rulemaking the key elements i i
, in a quality assurance program. The Commission could impose a performance j requirement under which licensees would be required to implement ; quality j j
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assurance program that would pro' vide absolute assurance that there would.
I be 'ne misadministration. What other nechanisms should be considered? ]
- 2. Should the definition of misadministration in 10 CFR 35.2 be !
changeG Is it clear and complete? .Is the definition sufficiently broad i
to include all appropriate activities? Is it so broad as to include ]
l inappropria" . civities? Is the term " misadministration" appropriately i descriptive of the activities? Should some more descriptive term be used? !
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- 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 l NRC require that the authorized user actively consult with the primary care 1
physician before prescribing radiation or deciding that radiation is not j 1
needed? How can the chance of rain; communication be reduced? What improve- !
l ments can be made in terminology, prescription format, and crders?
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- 4. What methods shou'ld be considered to provide assurance that the j patient to whom radiation is administered is the patient for whom radiation
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was intended?
- 5. What current standards exist to ensure the adequacy and uniformity of training of all-individuals who participate in the administration of i radiation to patients? Should NRC require certification or prescribe ;
specific training criteria for technologists, dosimetrists, and others I
who participate in the application of radiation to patients, or should ;
I NRC have a performance requirement that requires licensees to provide j each individual whatever training is necessory? In either case, how can i NRC ensure the adequacy and consistency of this training throughout the radiation therapy community? Should the NRC require licensees to 1 i
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.,i administer written examinations to workers and evaluate them before
'l allowing the workers to participate in radiation therapy? Should periodic retraining and re-examination be required?
' 6. What other regulatory, certifying, accrediting, or inspecting organizations examine medical quality assurance programs? Describe the purpose, objectives, and rigor of these examinations.
- 7. Should the NRC require physicians to provide patients, upon request, a record of the radiation dose prescribed and/or given?' What information should or should not be provided?
- 8. Apart from increased NRC oversight, what changes in industry practice or standards could improve the quality of performance and mini-mize human error?-
Teletherapy and Brachytherapy The following questions apply to the provision of teletherapy and brachytherapy services.
- 1. What performance criteria could be adopted to assure appropriate care, minimize the chance of human error, and mitigate the consequences of poteatiel error?
- 2. To assure adequacy of continued experience, some organizations recommend that certain surgical or test-tube procedures only be performed if the practitioner has a suf ficient case-load to assure that dexterity and familiarity with the procedure are retained. Should NRC require that I licensees have a certain minimum case-load to assure that their employees 1
retain their expertise in pe forming radiation therapy clinical and quality assurance procedures?
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program?':What are its'_ key elements?-
- 4. :The. Regulatory Flexibility Act requires.that. regulatory agencies examine the. cost of compliance:with regulations. How much does a quality 1
- assurance ' program cost'per patient'or per year? What fraction of staff' time, including physicians, physicists, dosimetrists, technologists, ano
'I nurses, is currently budgeted for quality assurance work?
- 5. Are there~ complete model quality assurance programs already- 1 t available that address every step of the radiation therapy process, or l will model programs have to be developed? Should physical measurements, j redundant calculations, or both be required to assure that the dose given is the'same as the dose prescribed? What other areas are, or should be, 3 covered in a complete quality assurance program? j
- 6. .Are the staff and equipment that are needed to implement a com-plete quality assurance program available in the marketplace, or would new training programs and equipment development be needed?
- 7. Computers are used in radiation therapy to calculate dose distributions and to control the operation of equipment. How could i
quality assurance of software' accuracy and validity be improved? Should i licensees be required to verify them? How can user skill and knowledge of the inherent assumptions and limitations of a computer program be l 1
assured? Should additional quality assurance requirements be developed to ensure that users understand the algorithms on which the programs are based?
- 8. What additional methods ar? available for reducing the frequency or impact of human error? !
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.Radiopharmaceutical Therapy The.NRC requires that licensees use only certain radiopharmaceuticals l for specified therapy clinical procedures, measure the radioactivity in radiopharmaceutical dosages before administration, and have a measurement quality assurance program for the dose calibrator used to make that measurement. These requirements appear to encompass the steps in a !
radiopharmaceutical therapy physical quality assurance program. However, the NRC invites public comment on this position.
There have been cases in which, due to procedural failure, a radio-i pharmaceutical other than that intended has been ordered and administered. '
Many of these cases began with miscommunication between the referring physician and the licensee. Some began with miscommunication between the physician's authorized user and the nuclear medicine technologist. The NRC expects that all licensees have procedural requirements for clear state-ments of prescription and verification before administration of any phar-maceutical. 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 prescribed, and that l the prescribed clinical procedure is the clinical procedure that is l
l performed. The NRC has observed several cases of miscommunication of the '
referring physiciar's request. What improvements can he made to minimize 1
such errors? Are there special needs regarding patient identification in !
radiopharmaceutical therapy that go beyond the information regarding patient identification that was requested in question 4 of the General subsection?
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i Standards of Care.
The following questions apply.to the medical use of byproduct-
-material.
- 1. Is there a clear, generally accepted standard of care that the NRC can adopt? If yes, please describe it. If,not, please describe a standard that NRC could adopt. Is a standard needed if NRC has comprehensive prescriptive requirements? '
- 2. What effect would such a standard or comprehensive, prescriptive requirements have on provisions of radiation therapy care?
- 3. What kinds of penalties should be imposed on licensees, their employees, or both, if the standard or the comprehensive, prescriptive requirements are not met? Should penaltie be imposed on employees?
Should NRC's Enforcement Policy (see 10 CFR Part 2, Appendix C) be changed, and if so, how? q List of Subjects in 10 CFR Part 35 Byproduct material, Drugs, Health facilities, Health professions, Incorporation by reference, Medical devices, Nuclear materials, Occupational safety and health, Penalty, Radiation protection, Reporting and recordkeeping requirements.
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- The: authokty citation. for. this'. document .f s:
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! AUTHORITf: ,Sec; 161, 68 Stat.-948, as amended-(42 U.S.C.' 2201);
-sec.;201, 88, Stat. 1242, as' amended (42 U.S.C 5841).L' .
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'da9 o'f3M Dated at:Was '
N ington, DC, this , 1987.
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.For the Nuclear Regulatory Commission.
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Samue1 J. h%
o- Secretary. f the Commission.
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