ML20235F945
Text
e -
m .
sn :. ..- \ . . .
,5 -
acGF/
ME
(%
v .,
Q '$
%...../
June 18,1987 RULEMAKING ISSUE "8""
(Notation Vote)
For: The Commissioners From: Victor Stello, Jr.
Executive Director for Operations ;
Subject:
SECY-87-29 MISADMINISTRATION
Purpose:
Obtain Commissions approval of two Federal Register Notices for public comment. ,
Background:
SECY-87-29, " Misadministration," dated February 5, 1987, centained: (1) an Advance Notice of Proposed Rulemaking, (2) a proposed rule for public comment, and (3) the staff response to issues raised by the Commission in a memorandum dated December 16, 1986. A staff Requirements Memorandum dated March 26, 1987 provided instructions to the staff concerning the matters contained in SECY-87-29. This Paper responds to the Staff Requirements Memorandum.
Discussion: The staff has revised the misadministration rulemakings in SECY-87-29, " Misadministration," in accordance with the Staff Requirements Memorandum dated March 26, 1987 (see Enclosures 1, 2, and 3; Enclosures 4 and 5 are marked up to show where changes were made; Enclosure 6 provides the requested analysis of resource needs). As directed, the Office of Nuclear Material Safety and Safeguards coordinated the revisions with the Office for Analysis and Evaluation of l Operational Data. The rulemaking notices will be sent to l the Agreement States by the Office of Governmental and l Public Affairs, with a specific request for comments, prior l to publication in the Federal Register. The Board of '
Directors of the Conference of Radiation Control Program Directors has been briefed on this project.
Both nuclear medicine and radiation therapy are dynamic l fields of medicine. Their future course over the next !
decade will be influenced by research breakthroughs that ;
are clearly on the horizon, competing technolo;;tes, and l
Contact:
Norman L. McElrcy, NMSS 427-4108 c
S% 7 L t 96 $vs i 3Byjm M
.~..
v.
,f
-5
^ *'
. s -
.[ E
^
s'
(j -b The Commissioners 2 medical economics. All of these factors will impact our regulatory program in this area.
Coordination:
~
The Offica of the General Counsel has reviewed the revised Notices and has no legal objection to them.
Recommendation: -The Commission:
- 1. Direct publication of the Advance Notice of Proposed Rulemaking (Enclosure 1) and the Notice cf Proposed Rulemaking (Enclosure 2).
- 2. Note:
- a. The Advance Notice of Proposed Rulemcking and the Notice of Proposed Rulemaking will be published in the Federal Register for public coment.
- b. The Director of the Office of Nuclear Material Safety and Safcguards 11as made a determination that these actions are categorically excluded, ,
under Sections 10 CFR 51.22(c)(3) and (c)(14), I from the requirement to perform an environmental impact assessment. This provides the basis in Enc 1csures 1 and 2 for the Comission's determi-nation not to prepare an environmental impact statement for the action:
- c. Regulatory analyses for these Notices have been revised in accordance with the Commission's instructions.
)
- d. A public announcement and congressional ' letter will be drafted and issued when the Notices are i filed with the Office of the Federal Register, j
- e. Copies of the Federal Register Notices will be distributed to all affected Comission specific licensees, all States, and other interestad organizations and individuals.
- f. Implementation of the requirements of the proposted rule and implementation of staff recommendations have the potential to essentially double the ,
rerources applied to this area by 1990. The number of inspections would increase from approximately 900 per ysar to 1700 per year. The source of these required resources has not yet been identified but will be considered during the current process of developing the FY89 NMSS budget request. 1 1
l l
l
__- _ __ _ - - - - - - - _-_ )
o The Commissioners 3
- g. The staff.is prepared to brief the Commission on nuclear medicine and radiation. therapy technology, should the Commission so desire. Staff is assuming, however, that the Commission desires that the briefing by interested parties should be held after comments on the prepared rule are received and analyzed by staff.
W e//r ctor Stel , .
Executive Director for Operations
Enclosures:
- 1. ~
Federal Register Advance Notice of Proposed Rulemaking
- 2. Federal Register Notice of Proposed Rulemaking
- 3. Annotated Staff Requirements Memorandum dated 3/26/87
- 4. Marked up Advance Notice of Proposed Rulemaking showing where changes were made
- 5. Marked up Proposed Rule showing where changes were made
- 6. Medical Use Program Resource Needs l
Commissioners' comments should be provided'directly to SECY by c.o.b. July 8, 1987, Commission staff office commcnts, if any, should be submitted to i the Commissioners NLT June 30, 1987, with an information copy to SECY. If the paper is of such a nature that it requires I additional time for analytical review and comment, the Commissioners and the Sc.cretariat should be apprised of when comments may be expected.
l DISTRIBUTION:
Conimissioneys ARM OGC (H ST) CENTRAL FILES OI AEOD OIA NMSS GPA NRR OCA RES
'SP OFF OF ENFORCEMENT OPA OGC (NMBB)
SECY SP REGIONS DMB EDO ACRS 4 DEDO ASLBP DEXEC DIR FOR REGIONAL OPS ASLAP l______--
O j' .
'b t
l ENCLOSURE 1 1
I i
1 L______._-._.____ ;
f
[7590-01]
NUCLEAR REGULATORY COMMISSION 10 CFR PART 35 Comprehensive Quality Assurance in Medical Usc 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 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 basie quality assurance program requirements set out in a proposed rule published elsewhere in this issue. l 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 on or before this date.
I 1
I
[7590-01]
ADDRESSES: Mail comments to: The Secretary of the Commission, U.S.
Nuclear Regulatory Commission, Washington, DC 20555, Attention: Docket-ing and Service Branch.
Deliver comments to: Room 1121, 1717 H Street NW., Washington, DC, between 8:15 am and 5:00 pm on Federal workdays.
Examine copies of comments received at: The NRC Public Document Room, 1717 H Street NW., Washington, DC.
FOR FURTHER INFORMATION CONTACT: Norman L. McElroy, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555, telephone (301) 427-4108.
SUPPLEMENTARY INFORMATION:
Therapy Use of Byproduct Material Teletherapy is the application of a beam of radiation emanating trom a cobalt-60 source to a patient for a therapeutic purpcse, usually cura-tive, prophylactic, or palliative cancer therapy. (High energy x-ray machines are also used for the same purposes.) As an example, a treatment might be comprised of daily treatments of 200 rads to the tumor volume for five weeks, yielding a total tumor dose of 5000 rads.
Brachytherapy is the insertion of small sealed sources such as cesium-137, iridium-192, pold-198, or iodine-125 into the tumor volume for curative 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 a tumor dose of 5000 rads.
2
e
[7590-01]
l Radiopharmaceutical therapy is the administration of a radioactive l drug for therapeutic purposes. The most common clinical procedure involves l the oral administration of liquid or gelatin-capsuled iodine-131 as sodium iodide. For hyperthyroidism, 5 to 30 r.:illicuries 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 i
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 diseas2, the thyroid dose would be several thousand rads.
l NRC'S Policy Regarding the Medical Use of Byproduct Material In a policy statement published February 9, 1979 (44 FR 8242), the j NRC stated:
) !
i I
1 "1. The NRC will continue to regulate the medical uses of radioisotopes I as necessary to provide for the radiation safety of workers and the general public.
"2. The NRC will regulate the radiation safety of patients where justi- )
fied by the risk to patients and where voluntary standards, or compliance with these standards, are inadequate. ;
"3. The NRC will minimize intrusion into medical judgments affecting i
patients and into other areas traditionally considered to be a part of the practice of medicine." j l
I 1
4 3
l l
_ - _ - - - _ - _ - - - - - - - - - - - - - . - - - - - - - -- - - -J
[7590-01]
l The NRC has the authority to regulate the medical use of byproduct 1 i
material to protect the health and safety of patients, but also recognizes that physicians have the primary responsibility for the protection of their patients. NRC regulations are predicated on the assumption that properly trained and adequately informed physicians will make decisions in the best interest of their patients.
NRC's Responsibilities in the Medical Use of Byproduct Material In developing this rulemaking the NRC has had to deal with the normal risk attendant to medical care and the risk associated with the careless l
use of byproduct material. l The NRC is aware of the public health benefits accrued in the medical use of byproduct material, and also is aware of the smail, but ,
real, risk attendant to the proper and responsible medical use of byproduct materials. However, the NRC draws a line between the unavoid-able risks attendant to purposefully prescribed and properly performed clinical procedures and the unacceptable risks of improper or careless use cf byproduct material in medicine. The NRC is obliged, as part of its public health and safety charge, to establish and enforce regulations that protect the public from the latter.
Reports of Misadministration in Radiation Therapy The NRC has published a study of the twenty-seven therapy misadministration that were reported over the period November 1980 through July 1984.2 The following NRC analysis of these events provides the basis for determining that a need exists for this rulemaking.
1For a copy this report, write to Kathleen H. Black, Office for Anai, is and Evaluation of Operational Data, Nuclear Regulatory Commission, Washington, DC 20555. Ask for report AE0D/C505.
4 4
_m_ _ _ _ _ _ _ _ . _- - - _ _ _ _ - - - - - . - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - " - ^ - - - - - - - - - - - - - - - - - " " - - - - - - -
^
i
[7590-01]
l The specific t.auses of the misadministration, detailed in Table 1, are, of course, related to the treatment medality. Nonetheless, three basic themes run through the reports: inadequate training, inattention to detail, and lack of redundancy, Inadequata training of workers has caused misadministration.
Although additional training may not reduce the chance of some kinds of mistakes, it should clearly impress on each individual involved in the medical use of byproduct caterial 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. Each bit of information that plays a role in 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 u expected step or if an expected step is missing. I l
Inattention to detail is often the t.edium in which a misadministra- l tica event germinates. This is not a problem specific to the medical use
! of byprodu.ct material. Any process or product that requires individual attention to a multitude of relatrd quantities that are similar in mag-nitude and used repeatedly will likely contein mistakes. Computerized radiation therapy treatment planning may redece the chance of mistakes in j l
sealed source treatment planning, and " record and verify" systems that '
l
! l i
I 5
1 l
3
[7590-01]
Table 1. Therapy misadministration reported to NRC from November 1980 to July 1984 Teletherapy Prescription j Total daily dose was delivered from each port (2)*
Oral and written prescriptions were different (1) i Boost dose of 500 rad /3 da was interpreted as 500 rad x 3 da (1)
Proper body side was not clear (1) ,
i Treatment planning Tumor depth was incorrectly measured (1)
Tumor depth was incorrectly recorded (1)
Dosimetrist used wrong computer program (1)
Dosimetry tables for wrong unit were used (1)
Arithmetic mistakes were made (3)
Records Arithmetic mistakes were made (1)
Poor handwriting of numerals caused misunderstanding (1)
Physical measurements Wedge factors were measured incorrectly (1-53 patier,ts affectea)
Application Field blocks were not used {1)
Brachytherapy Treatment planning Dose rate was much higher than first estimated (1)
Application Wrong sources were loaded ii. 2pplicator (2)
Source fell out of applicator (1)
Source was improperly seated in applicator (1)
Radiopharmaceutical Therapy Wrong radiopharmaceutical was administered (2)
Assay date un unit dosage was not read (3)
Patient was improperly identified (1)
- Numbers in parentheses indicate number of events of the type described, 6
[7590-01) check teletherapy unit orientations and settings may reduce the chance of mistakes in teletherapy administration. But even these systems. perform their functions on quantities. that are initially measured, recorded, and
)
entered into memory by individuals. '
Lack of redundancy nieans there is no mecnanism for checking for mis-takes. An independent check requires having a second individual examine each data entry, whether a physical measurement'or a number copied from a f table of values, and check each arithmetic operation for correctness.
Redundancy requires that two separate systems produce the same result. )
.q For rediation therapy treatment planning, the best method of early detec- l i
tion of mistakes raay be a simple independent check. Redundancy or inde- i pendent checks may airo be needed in each therapy facility's procedures ]
i for measuring radiation parameters, using those measurements for treatment j planning, and applying radiation to patients. In radiation therapy or i i
any other endeavor, an independent outside auditor can detect mistakes in i both process design and process application as well as citing areas where j a change in the process might reduce the chance for mistakes, i 1
This analysis leads the NRC to some general conclusions regarding quality assurance. i
'The radiation therapy process should be planned with the realization
)- that individuals are more likely to make mistakes in the absence of good s quality assurance. Some simple aids may include using tables and graphs 4 that are clearly titled and easy to read, and use of a uniform written prescription format. Based on inspection reports, the NRC believes that about ten percent of teletherapy unit calibrations and spot-cnecks are incomplete. Checklists could be used to assure completeness.
7
- - - - _ - - - - _ _ . - - - - . ~ - - - - - - - _ - - - . _ _ - - -
[7590-01]
A redundancy function must be integral to the design of the radiation therapy process. Independent double-check procedures and redundancy procedures should be considered. Each entry and calculation in a treat-ment plan should be checked by an individual who did not make the treat-ment plan. Each patient's chart should be reviewed weekly to check for I accumulated dose and implementation of prescription changes. A quality I assurance program for the teletherapy unit should include a periodic check of the teletherapy unit output and an occasional detailed examination of the complete teletherapy process, including physical measurements, by an I outside expert with an eye towards systematic errors and system improvements. j A program that requires a physical measurement of the dose or amount of radioactivity actually administered to the individual patient would 1
provide assurance that the given dose is the same as the prescribed dose. '
Such measurements are now done for radiopharmaceutica'l therapy and occa-sionally for some teletherapy cases, but because of expense or unavail-ability of equipment are not commonplace in sealed source therapy.
Reports of Diagnostic Misadministration That Result in Doses in the Therapy Range The NRC has also published a report on misadministration of 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 xFor a single copy, submit a request for report number AE00/N701 to the address in footnote 1.
8
]
t'
[7590-01]
I with a resulting thyroid dose of several thousand rads. Many of the events demonstrated that the physician authorized user is not reviewing the medical history of the referred natient to determine the suitability of a particular clinical procedure. It appears that the referring.
physician ~, who is not a nuclear medicine' expert, and the nuclear medicine technologist, who is not.a medical expert, frequently determine which radiopharmaceutical should be administered. In some events technologists were not familiar with the clinical procedure prescribed by the authorized user a1d mistakenly administered a dosage that was not requested. When radiopharmaceuticals that can give therapy doses are used, unclear nomenclature, lack of double-checks, and inadequate training cannot be i
tolerated, j
I Earlier NRC Efforts '
This is not the first time the NRC has examined the matter of quality {
assurance in the medical use'of byproduct material. In 1979 the NRC q j
i issued some basic quality assurance requirements-for teletherapy (see-10 CFR ,:4.632 and 10 CFR 35.634). This'rulemaking was precipitated by the it. action of a single licensee. The output of a teletherapy unit was incorrectly calculated and the licensee made no physical measurements to determine whether the calculation was correct. This inaction resulted in cobalt-60 teletherapy being misadministered to 400 patients. The 1979 rule addressed the circumstances surrounding that event but did not critically examine the entire radiation therapy process.
9
i
[7590-01]
Voluntary Initiatives The Commission is aware of voluntary initiatives to improve quality assurance. A notabla example is the Patterns of Care study managed by the .herican College of Radiology. In addition to comparing prescriptions, methods of applying radiation, and survival rates for certain diseases at various therapy facilities across the nation, methods of calculating and measuring applied dose rates are examined for accuracy. Such an examins-tion can detect whatever procedural flaws may be present as well as determine the precision and accuracy of day-to-day service.
Unfortunately these voluntary programs have not provided adequate assurance of public health and safety. Serious misadministration con-tinue to occur. The NRC would be remiss in its ; responsibilities were it to continue to rely on voluntary programs to reduce the chance of misadministration.
Summary The NRC believes many misadministration could reasonably be avoided if certain basic quality assurance steps were included in the radiation therapy process.
Effect on the Agreement States Program Many States, known as Agreement States, have assumed responsibility for regulating certain radioactive materials within their respective borders by agreement with the NRC. (This kind of agreement is authorized by the Atomic Energy Act.) They issue licenses for the use of byproduct material, and currently regulate about 5,000 medical licensees. Because 10
=,
l I
[7590-01]
the NRC will request'the Agreement States, as a matter of compatibility, to implement regulations equivalent to those that it implements on this matter, state regulatory agencies are asked to comment.
Request For Comments-The NRC has prepared the following questions to elicit comments on methods of preventing misadministration. Comments do not have to respond to these questions alone; other related topics or alternatives may be described if the commenter believes this will help to resolve issues j related to this rulemaking.
Quality Assurance General The following questions apply to the provision of all types of medical use:
- 1. How can the Commission most effectively implement requirements for comprehensive quality assurance? The Commission has the authority to
. adopt existing national standards. The Commission, in concert with medical experts, could identify and adopt by rulemaking the key elements I 1
in a quality assurance program. The Commission could impose a performance requirement under which licensees would be required to implement a quality assurance program that would provide absolute assurance that there would ,
1 be no misadministration. Phat other mechanistas should b.s considered?
i
- 2. Should the definition of misadministration in 10 CFR 35.2 be changed? Is it clear and complete?
l 11 l
L .
l
[7590-01]
Is the definition sufficiently broad to ir.clude all appropriate activities?
Is it so broad as to include inappropriate activities? Is the term i
" misadministration" appropriately descriptive of the activities? Should j i
some more descriptive term be used?
- 3. The NRC knows of o,.e instance in which radiation was administered b
to a patient without a request from the primary care physician. Should the NRC require that the authorized user actively consult with the primary care physician before prescribing radiation or deciding that radiation is not needed? How can the chance of miscommunication be reduced? What improve-ments can be made in terminology, prescription format, and orders?
- 4. What methods should be considered to provide assurance that the patient who is administered radiation is the patient for whom radiation was intended?
- 5. What current standards exist to ensure the adequacy and uniformity of training of all individuals who participate in the radiation therapy precess? Should NRC require certification or prescribe specific training criteria for technologists, dosimetrists, and others who participate in the application of radiation to patients, or should NRC have a performance requirement that requires licensees to provide each individual whatever training is necessary? In either case, how can NRC ensure the adequacy and consistency of this trcining throughout the radiation therapy community?
Should the NRC require licensees to administer written examinations to workers and evaluate them before allowing the workers to participate in radiction therapy? Should periodic retraining and re-examination be required?
12
~
[7590-01]
- 6. What other regulatory, certifying, accrediting, or inspecting organizations examine medical qunlity assurance programs? Deccribe 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 or given? What infor-
- nation 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 errar?
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 raitigate the consequences of all error?
- 2. To assure adequacy of continued experience, some organizations recommend that certain surgical or test-tube procedures only be performed if the practitioner has a sufficient case-load to assure that dexterity and familiarity with the procedure are not lost. Should NRC require that licensees have a certain minimum case-load to assure that their employees retain their expertise in performing radiation therapy clinical and quality assurance procedures?
- 3. What fraction of licensees already have a quality assurance program? What are its key elements?
13
4
[7590-01]
- 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, te:hnologists, and nurses, is currently budgeted for quality assurance work? If more staff b
were needed to meet quality assurance requirements, are the requisite individuals readily available or would a lengthy lead-in time be needed?
- 5. Are there complete model quality assurance programs already available that address every step of the radiation therapy process, or will model programs have to be developed? Should physical measurements, redundant calculations, or both be required to assure that the dose given is the same as the dose prescribed? What other areas are, or should be, covered in a complete quality assurance program?
- 6. Are the staff and equipment that are needed to implement a com-plete quality assurance program available in the 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 quality assurance of software accuracy and validity be improved? Should licensees be required to verify them? How can user skill snd knowledge of the inherent assumptions and limitations of a computer program be assured? Shoula additional quality assurance requirements be developed to ensure that users understand the algorithms on v:hich the programs are based?
- 8. What additional methods are available for reducing the frequency or impact of human error?
14 L_-_________________.
..- I
[7590-01]
Radiopharmaceutical Therapy The NRC requires that licensees use only certain radiopharmaceuticals 1
for specified therapy clinical procedures, measure the radioactivity in radiopharmaceutical desages before administration, and have a measurement j 1
quality assurance program for the dose calibrator used to make that
{
measurement. These requirements appear to comprise all the steps in a radiopharmaceutical therapy physi:al quality assurance program. However, '
the NRC invites public comment on this position.
There have been cases in which, due to procedural failure, a radio-pharmaceutical other than that intended nas been ordered and administered. l Many of these cases began with miscommunication between the referring e 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- 1 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.
the prescribed clinical procedure is the clinical procedure that is performed. The NRC has observed several cases of miscommunication of the referring physician's request. What improvements can be made to minimize '
such errors? Are there special needs regarding patient identification in radiopharmaceutical therapy that go beyond the information regarding patient identification that was requested in question 4. of the General subsection?
l 15
__.__.m. _ _ . _
\
J
[7590-01]
Standards of Care The NRC presently has, in 10 CFR Part 2, Appendix C, particularly i Supplement VI, an enforcement policy that it can apply to the medical use l
of byproduct material, i The following questions apply to the medical use of byproduct j material and to the Commission's Enforcement Policy, l
- 1. Is there a clear, generally accepted standard of care that the i
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 requirs:ments?
- 2. What kinds of penalties should be imposed on licensees, their employees, or both, if the standard or the comprehensive, prescriptive requirements are not met? Should penalties be imposed on employees?
Should NRC's Enforcement Policy be changed, and if so, how?
- 3. What effect would such a standard or comprehensive, prescriptive requirements have on provisions of radiation therapy care?
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.
The authority citation for this document is:
16
4
[7590-01]
, AUTH0r5ITY: Sec. 161, 68 Stat. 948, as amended (42 U.S.C. 2201); i l
i sec. 201, 88 Stat. 1242, as amended (42 U.S.C. 5841).
l Dated at Washington, DC, this day of , 1987.
For the Nuclear Regulatory Commission.
Samuel J. Chilk, Secretary of the Commission.
l l
J l
1 l
17 l
, I
. _ . - - . _ _ _ _ _ ________________________a
r---v-- - -- - - -- - - -- - - - - - - - - -- - - - - - - - - -
1 4
I 1
ErlCLOSURE 2-i d
i
)
i i
l i
l 1
1' l-l l
I l
I' l- _ _ - _ - _ _ .
~
. T a I Y
[7500-01] j i
i
)
)
1 NUCLEAR REGULATORY COMMISSION 10 CFR Part 35 d' Basic Quality Assurance in Radiation Therapy AGENCY: Nuclear Regulatory Commission.
ACTION: Proposed Rule.
SUMMARY
- The Nuclear Regulatory Commission (NRC) is proposing to amend )
I its regulations concerning the medical use of byproduct material to ^
require its medical licensees to implement certain quality assurance steps that will reduce the chance of therapy misadministration. This proposed action is necessary to provide better patient safety and a basis for l enforcement action in cases of therapy misadministration. The amendment is intended to reduce the chance and severity of therapy misadministra-tions. The proposed regulations would'primarily affect hospitals, clinics, and individual physicians. 'In an advance notice of proposed rulemaking published elsewhere in this issue of the Federal Register, the NRC is also 1
requesting comments on the need for a comprehensive quality assurance program requirement.
COMMENTS: Comments must be received by (60 days). Comments received after this date will be considered if it is practical to_do so, but assurance of consideration cannot be given except as to comments received on or before i
this date.
I l
05/13/87 1 I
l- -
[7590-C1]
ADDRESSES: Submit 3ritten comments and suggesticos to the Secretary of the Commission, U.S. Nuclear Regulatory Commission, Washington, DC 20555, Attention: Docketing and Service Branch.
Copies of the regulatory analysis and the comments received on this rule
) may be examined at the Commission's Public Document Room at 1717 H Street NW., Washington, DC. Single copies of the regulatory analysis are avail-able from Norman L. McElroy, Office of Nuclear Material Safety and Safe-guards, 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, DC 20555, Telephone: (301) 427-4108. ,
SUPPLEMENTARY INFORMATION:
I. BYPRODUCT MATERIAL IN MEDICINE Use for Patient Care Radioactive materials are used in drugs in the field of nuclear medicine. Drugs labeled with radioisotopes are known as radiopharmaceu-ticals. In diagnostic nuclear medicine, patients receive these materials by injection, inhalation, or oral administration. Physicians use radia-tion detection equipment to visualize the distribution of a radioactive drug within the patient. Using this technology, it is possible to locate tumors, assess organ function, or monitor the effectiveness of a treatment.
An estimated 10 million diagnostic nucrear medicine procedures are per-formed in this country annually. In therapeutic nuclear medicine, larger 05/13/87 2
i-
[7590-01]
quantities of radiopharmaceuticals are administered to treat hyperactive thyroid conditions and certain forms of cancer. An estimated.30,000 pro-cedures are parformed each year.
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 100,000 patients receive cobalt-60 teletherapy treatments from NRC and Agreement State licensees each year. Smaller sealed sources with less radioactivity are designed to be implanted directly into a tumor area or applied on the surface of an area to be treated. This procedure is known as brachy-therapy. Licensees perform approximately 50,000 brachytherapy treatments 1 i
annually.
Sealed radioactive sources can also be used in machines that are used !
for diagnostic purposes. The source provides a beam of radiation that is projected through the patient. A device on the other side of the patient detects the amount or spatial distribution of radiation that goes through the patient. This can provide information about tissues within the patient.
This is a relatively new development in the field of medicine and the NRC has no estimate of the number of these diagnostic procedures performed annually.
State and Federal Regulation Many states, known as Agreement States, have assumed responsibility for regulating certain radioactive materials within their respective borders by agreement with the NRC. (This kind of agreement is authorized 05/13/87 3 l l
[7590-01]
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 2,200 medical institutions.
(mostly hospitals and clinics) and 300 physicians in private practice. .;
These licenses authorize certain diagnostic and. therapeutic uses of radioactive materials.
II. NRC'S REGULATORY PROGRhM NRC's Policy Regarding the Medical Use of Byproduct Material In a policy statement published February 9, 1979 (44 FR 8242), the NRC stated:
"1 The NkC will continue to regulate the medical uses of radioisotopes as necessary to provide for the radiation l safety of workers and the general public.
1 "2. ' The NRC will regulate the radiation safety of patients where justified by the risk to patients and where volun-tary standards, or compliance with these standards, are inadequate.
"3. The NRC will mir.itnize intrusion into medical judgments affecting patients and into other areas traditionally considered to be a part of the practice of medicine."
'l The NRC has the authority to regulate the medical use of byproduct material to protect the health and ,afety of patients, but also recognizes that physicians have the primary responsibility for the protection of ;
l l 'their patients. NRC regulations are predicated on the assumption that 05/13/87 4 ,
4
[7590-01] 4 properly trained and adequately informed physicians will make decisions in the best interest of their patients.
NRC's Responsibilities in the Medical Use of Byproduct Material In developing this rulemaking the NRC has had to deal with the normal risk attendant to medical care and the risk associated with the careless use of byproduct material.
The NRC is aware of the public health benefits accrued in the medical use of byproduct material, and is also aware of the small, but real, risk atterdant to the proper and~ responsible medical use of byproduct materials.. i However, the NRC draws a line between the unavoidable risks attendant to purposefully prescribed and properly performed clinical proccdures and' the unacceptable risks 'of improper or careless use of byproduct inaterial in medicine. The NRC is obliged, as part of its public health and safety charge, to establish and enforce regulations that protect the public from i
the latter. !
l Reports of Misadministration in Radiation Therapy l
The NRC has published a study of the twenty seven therapy misadministration.3 that were reported over the period November 1980 'I through July 1984.1 The following NRC analysis of these events provides the basis for determining that a need exists for this rulemaking. l The specific causes of the niisadministrations, detailed in Table 1, are, of course, related to the treatment modality. Nonetheless, three i IFor a copy of this report, write to Kathleen M. Black, Office for Analysis !
and Evaluation of Operational Data, Nuclear Regulatory Commission, Washington, DC 20555. Ask for report AE00/C505.
05/13/87 5
Q
[7590-01]
I I
i Table 1. Therapy misadministration reported to NRC from November 1980 to July 1984 Teletherapy Prescription Total daily dose was delivered from each port (2)*
Oral and written prescriptions were different (1) i Boost dose of 500 rad /3 da was interpreted as 500 rad x 3 da (1)
Proper body side was not clear (1) f Treatment planning Tumor depth was incorrectly measured (1)
Tumor depth was incorrectly recorded (1)
Dosimetrist used wrcag computer program (1)
Dosimetry tables for wrong unit were used (1)
Arithmetic mistakes were made (3)
Records Arithmetic mistakes were made (1)
Poor handwriting of numerals caused misunderstanding (1)
Physical measurements Wedge factors were measured incorrectly (1-53 patients affected)
Application Field blocks were not used (1)
Brachytherapy Treatment planning Dose rate was much higher than first estimated (1)
Application Wrong sources were loaded in applicator (2)
Source fell out of applicator (1)
Source was improperly seated in applicator (1)
Radiopharmaceutical Therapy 1
Wrong radiopharmaceutical was administered (2)
Assay date on unit dosage was not read (3)
Patient was improperly identified (1)
- Numbers in parenthese; indicate number of events of the type described.
, 05/13/87 6
- ~ _ _ - .
l Q
[7590-01]
basic themes run through the reports: inadequate training, inattention
. to detail, and lack of redundancy.
Inadequate training of workers has caused misadministration.
Although additional training may not reduce the chance of some kinds of mistakos, it should 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 foe revealing mistakes early in the process are both essential for the delivery of quality care. Each bit of information that plays a role in 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 detaf is often the medium in which a misadministra-tion event germinates. This is not a problem specific to the medical use of byproduct material. Any process or product that requires individual attention to a meltitude of related quantities that. are similar in mag-nitude and used repeatedly will likely contain mistakes. Computerized )
)
radiation therapy treatment pisnning may reduce the chance of mistakes in sealed source treatment planning, and " record and verify" systems that check teletherapy unit orientations and settings may reduce the chance of inistakes in teletherapy ad. ministration. But even these systems perform )
their functions on quantities that are initielly measured, recorded, and entered into memory by individuals.
Lack of redundancy means there is no mechanism for checking for mis-takes. An independent check requires having a second individual examine each data entry, whether a physical measurement or a number copied from a 05/13/87 7 6
O
[7590-01]
table of values, and check each arithmetic operation for correctness.
Redundancy requires that two separate systems produce the same result.
For radiation therapy treatment plar.ning, the best method of early de'tec-tion of mistakes may be a simple independent check. Redundancy or inde-pendent checks may also be needed in each therapy facility's procedures for measuring radiation parameters, using those measurements for treatment planning, and applying radiation to patients. In radiation therapy or any other endeavor, an independent outside auditor can detect mistakes in '
both proc 1ss design and process application as well as citing areas where a change in the process might reduce the chance for mistakes.
i This analysis leads the NRC to some general conclusions regarding quality assurance.
The radiation therapy process should be planned with the realization that individuals are 'likely to make mistakes. Some cimpie aids may include using tables and graphs that are clearly titled and easy to read, and use of a uniform written prescription format. Based on inspection reports, the NRC believes that about ten percent of teletherapy unit calibrations and spot-checks are incomplete. Checklists could be used to assure completeness.
A redundcncy function must be integral to the design of the radia-tion therapy process. Independent double-check procedures and redundancy 'j procedures should be considered. Each entry and calculation in a treat, nent pl6n sho91d be checked by an individual who did not make the treat-ment plan. Each patient's chart should be reviewed weekly to check for accumulated dose and implementation of prescription changes. A quality assurance program for the teletherapy unit should include a periodic l
05/13/87 8
[7590~01]
check of the teletherapy unit output and an occasional detailed examina-tion of the complete teletherapy process, including physical measurements, by an outside expert with an eye towards systematic errors and system improvements.
A program that requires a physical measurement cf the dose or amount of radioactivity actually administered to the individual patient would l 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-ability of equipment are not commonplace in sealed source therapy.
Reports of Diagnostic Misadministration That Result in Doses in the Therapy Range The NRC has also published a report on misadministration of diag-nostic dosages of iodine-131 that lead to doses ln the therapy range.2 The report was a review of fourteen recent misadministration events in which patients were administered one to ten millicuries of iodine-131 with a resulting thyroid dose of several thousand rads. Many of the events demonstrated that the physician authorized user is not reviewing the medical history of the referred patient to determine the suitability of a particular clinical proceduie. . . appears that the referring physician, who is not a nuclear medicii 2 expert, and the nuclear medicine technologist, who is not a medical expert, frequently determine which radiopharmaceutical should be administered. In some events technolog .,ts were not familiar with the clinic 31 procedure prescribed by the authorized ZFor a single copy, submit a request for report number AE00/N701 to the address in footnott 1.
05/13/87 9
[7590-01]
user and mistakenly administered a dosage that was not requested. Use of unclear nomenclature, lack of double-checks, and inadequate training can-not be tolerated in programs in which radiopharmaceuticals that can give
. therapy doses are used.
Earlier NRC Efforts
.This is not the first time the NRC has examined the matter of quality assurance in the medical use of byproduct material. In 1979 the NRC issued some basic quality assurance requirements for teletherapy (see 44 FR 1722, published January 8, 1979). This rulemaking was precipitated by the inac-tion of a single licensee. The output of a teletherapy unit was incor-rectly calculated and the licensee made no physical measurements to deter-mine whether the calculation was correct. This inaction resulted in cobalt-60 teletherapy being misadministered to 400 patients. The 1979 rule addressed the circumstances surrounding that event but did not l l
critically examine the entire radiation therapy process.
Voluntary Initiatives The Commission is aware of voluntary initiatives to improve quality assurance. A notable example is the Patterns of Care study managed by j the American College of Radiology. In addition to comparing prescriptions, methods of applyir.g radiation, and survival rates for cer. ,n diseases at various therapy facilities across the nation, methods of calculating ;
and measuring applied dose rates are examined for accuracy. Such an q examination can detect whatever procedural flaws may be present as well as determine the precision and accuracy of day-to-day service.
05/13/87 10
_ __- _a
U ,
[7590-01]
L Unfortunately these voluntary programs have not provided adequate l
assurance of public health and safety. Serious misadministration con-tinue to occur. The NRC would be remiss in its responsibilities were it to continue to rely on voluntary programs to reduce the chance of misadministration.
Summary The NRC believes many misodministrations could reasonably be avoided if certain basic quality assurance step:; were included in the radiation therapy process.
The NRC staff has examined literature on the radiation therapy process and consulted with experts practicing in the field of radiation therapy to-discuss the need for these quality assurance steps. The NRC believes that the steps are basic to the radiation therapy process.
The regulations that would require implementation of these steps will provide guidanca for improved patient safety and will also provide a basis for NRC enforcement accion if not followed.
The NRC is also examining the need for a requircinent to implement a more complete quality assurance program. Comments on that matter are requested in an advance notice of propose.d rulemaking published elsewhere in this issue of the Fede*al Register.
III. DISCUSSION OF PROPOSED REGULATORY TEXT 6 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 alresdy in use in radiation therapy.
05/13/87 11
[7590-01]
\
1
, s 35.39 Ordering, prescribing, and administering certain j radiopharmaceuticals i
There have been a number of misadministration in which an unclear i
oral prescription by the authorized user resulted in the licensee ordering i the wrong radiopharmaceutical. Confusing colloidal and soluble 1
phosphorus-32 is a common mistake. The NRC is particularly' concerned
.zith the medical use of iodine-131 because of the high thyroid dose that results when a patient with a normal thyroid is misadministered'an.
iodine-131 dosage intended for a patient whose thyroid has been removed. j These misadministration appear to be precipitated by unclear instructions. This section would require close participation of the nuclear medicine physician in those cases involving the use of radio-
. pharmaceuticals that are clearly hazardous to the patient if misadministered.
In drafting this section the Commission considered applying these requirements to all licensees when using any diagnostic radiopharmaceu-tical. For the following reasons the scope of the section was limited to therapy radiopharmaceuticals and radiopharmaceuticals of iodine.
There is a clear history of misadministration of these two groups of radiopharmaceuticals, and medical experts generally agree that there is clear potential for harm to patients that receive these misadministra-tions. For the other radiopharmaceuticals identified in 35.100 and 35.200, the record shows that most misadministration involve either the conventional administration of a radiopharmaceutical to the wrong patient, or the conventional . administration of the wrong radiopharmaceu-tical to the patient (see "NRC Reports on Misadministration and Unannounced Safety Inspections," Journal of Nuclear Medicine, v27, n7, 05/19/87 12
l_ [7590-01),
i p1102, July 1986). Neither of these types.of misadministration pose a clear hazard to the patient. To misadminister a diagnostic radiopharmaceutical other than iodine in a manner that would pose a hazard to l
the patient would,-in the most likely circumstance, require administration of at least a full day's inventory of the radiopharmaceuti::al to the patient. This type of event is very' unlikely.
However, the absence of additional quality assurance requirements for diagnostic radiopharmaceuticals other than iodine should not be interpreted as Commission lack of inter' t in this matter.
S 35.43 Prescriptions and records of medical use for therapy The NRC has received one therapy misadministration report in which radiation was administered to a patient who had not been referred for .)
medical use of byproduct material. The NRC 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, I 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 exan.inations, a statement of diagnosis, and a prescription. Charts for teletherapy patients usually include: (1) photographs of the patient's face and the treatment area; (2) the treatment plan (which is comprised of: (a) dia-grams of physical measurements'of the patient, portal arrangements used 05/19/87 13 l
J
[7590-01]
to administer the radiation dose, and devices used to modify the radia-tion beam, (b) calculations made-to determine how long the beam must be applied each day to deliver the prescribed dose, and (c) the number of days radiation is to be administered); (3) a record of each daily appli-cation of radiation made at the time of application; and (4) records of
.any physical measurements of radiation or portal verification films made specifica11y'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.
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 usually contain the information needed to demonstrate that the licensee has implemented a quality assurance program. There would be no benefit gained by imposing additional recordkeeping requirements. However, the NRC would appreciate public comment on this matter.
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 legible handwritten or typed prescription on the patient's chart appears to be the most efficient way of ensuring clear communication between the prescribing physician and the dosimetrist who makes the calculations to determine how long radiation must be applied to deliver the prescribed dose.
The NRC believes that it is possible that some dosimetrists or tech-nologists may be disinclined to request clarification of instructions 6nd l 05/13/87 14
[7590-01) this may lead to misadministration. Therefore, the NRC would require licensees to specifically instruct workers to request clarification in cases where there may be ambiguity or error.
The NRC considered prescribing what documentation was needed to demonstrate that an independent check of data transferr and calculations had been made. The NRC has not included such a requirement in the proposed rule, but would appreciate comment on this matter. i S 35.65 Discrepancies in records and observations On occasion licensees have complied with required safety measures, such as performing surveys, yet not taken mitigating or corrective actions that the NRC believes were obviously necessary to assure public health and safety. The purpose of this section is to clearly require licensees to resolve discrepancies in records and observations.
The hRC foresees the possibility of many kinds of discrepancies.
The licensee's measurement of the source strength of a brachytherapy source may differ from the manufacturer's reported source strength. A thin patient may present a surface lesion, yet the patient's record may r
refer to a deep-seated lesion ;ith extensive overlying tissue. A post-mastectomy patient may be referred for a prophylactic treatment with no clear statement prescribing whether the tissue surrounding the site of surgery or the remaining breast tissue is to be treated. The prescrip-tion in the chart may not be in accord with the prescription agreed te by the physician, physicist, technologist, and dosimetrist during a treatment I planning meeting. Daily tailles of administered dose may not agree with project. ions made by multiplying the daily dose by the number of treatment days.
05/13/87 15
_a .
[7590-01]
1 If, when faced with an obvious discrepancy, a licensee, physician, 4
)
physicist, technoloc.,ist, dosimetrist or other individual fails to take i reasonable clarifying, mitigating, or corrective action and the dis-i crepancy results in a misadministration, than a citation will issue under this section.
S 35.432 Source strength measurements 1
The radiation dose rate from a sealed source, which is known es source etrength, depends uh the' amount of radioactivity in the source and j the material used to encapsulate it. l (See National Council on Radiation j l
Protection and Measurements Report Number 41, " Specification of Gamma-Ray >
Brachytherapy / Sources," Chapter 4.)3 Manufacturers usually provide source
]
strength information with sources, but the NRC believes that as independent measurement is needed to ensure that the information relates sp0cifically to the source under consideration.
H0 wever, the NRC would r.ot require licensees to use these measurements in Gesc calculations. In some cases, manufacturers are able to provide more accurate measurements of source strength than licensees; the licensee must be free to use the source strength that it believes is the most accurate.
SS 35.452 and 35.652 Physical measurements of patients The NRC knows that dose rates depend to some extent on the tissue volume to be treated and its depth within the patient. These parameters may be determined by physical examination or examination of imoges such t l.
l 3 Copies of this tcport may be purchased by contacting NCRP Publications, l P.O. Box 30175, Washington, DC 20014. j l
l i
05/13/87 16 4 l 1 i
f
. - - _ 1
[7590-01]
as radiographs, or images from computerized tomography, ultrasound, nuclear medicine, or nuclear magnetic resonance. The NRC considered requiring that two individuals independently make the physical measure-ments of the patient that are needed for dosimetry purposes, and believes that such a requirement rtay reduce the chance of misadministration.
However, because there are a finite number of individuals trained to do these tasks, such a requirement cauld negatively impact the delivery of medical care. Therefore, a requirement of this type has not been included.
However, the NRC will continue to examine this matter.
1 S 35.454 Check or dose calculations, and S 35.654 Checks and measurements of dose Dose calculations are made for each teletherapy and brachytherapy patient before r&diation is administered to determine how long the source must be used to deliver the prescribed radiation dose to the treatment volume, Several thertpy misadministration have been precipitated by arithmetic mistakes or incorrect assumptions in dose calculations. An independent che" will likely uncover many of these mistakes.
Idealiy, teletherapy dose calculations should be checked before radiation is administered, and the NRC expects that most licensees already do this. However, a second person may not always be available to check the dose calculat' ions before therapy begins. The NRC believes that requiring the check to be made before 20 percent of the dose has Deen administered provides a proper balance between patient safety and administrative flexibility for the licenst.e.
For most brachytherapy cases, final dose calculations cannot be performed until the sources are implanted in the patient because the 05/13/87 17
[7590-01]
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.
' Public' comments are invited on the workability of these 20 percent and 50 percent criteria.
.There are two usual methods for performing checks of manual dose calculation. Two individuals may independently calculate treatment times and compare results. Alternatively, one individual may make the calcula-tion and then a second individual can examine each entry and arithmetic.
operation to verify its accuracy.
The NRC considered requiring that licensees perform a manual check of the dose to a single point in the treatment volume' predicted by computer generated dose calculations. However, checks of computer-1 generated dose calculations pose difficult problems. It is not clear whether r,omograms or manual algorithms are available that can be used to )
check the accuracy of computer generated dose calculations. Many computer programs that are used contain steps for calculating the effect on the dose caused by tissue density differences, organ and tissue contours, and radiation field contours. The NRC believes that a manual check of a computer calculation with that many physical correction factors may be beyond the reasonably expected means of :.any licensees, and may adversely affect the delivery of medical care. Therefore, the NRC has only drafted I
a requirement that a second individual assure that the correct parameters, ;
such as radionuclides, dose, and physical measurements of patients, were a
05/13/87 18
[7590-01]
used in the computer generated dose calculation printout to information in the patient's chart, and examining each relevant piece of information on the calculation printout. ;
The NRC would appreciate comments on the best method for documenting that these checks have been made.
Regarding the concept cf "1ndependent check," the NRC would parti-cularly appreciate comments on whether a second individual should begin with only the prescription, independently calculate the dosimetry and.
treatment plan, and then compare those results with those of the first t individual.
In teletherapy, the arithmetic that sums the daily administration of radiation must also be checked. Radiation is usually administered i in daily doses over several days or weeks and each dose is recorded in the patient's chart. A weekly check will assure the daily doses have been summed correctly. In contrast, brachytherapy is administered continuously until the prescribed dose has been given; thus, there !
1 is no need for a comparable requirement.
One recent teleth rapy misadministration occurred in a case in which an unusual treatment configuration of the. teletherapy unit, the beam )
collimators, and the patient was required. Whereas an arithmetic mistake would likely be obvious in a commonly used configuration because certain calculated values for patients usually fall within small ranges, an unexpected treatment time in an uncommon configuration would likely be attributed to the uncommonness of the configuration rather than triggering an examination of calculations for a d9simetry mistake. Therefore, the j NRC believes that a physical measurement of the dose rate should be made i
if the teletherapy unit settings or beam modifying devices used for a I 05/13/87 19 1
l
_ _ _ _ _ _ - - - 1
6
[7590-01]
patient fall outside the ranges examined during the last set of full i calibration measurements.
The NRC considered requiring physical measurements for brachytherapy but believes the methodology (comprised of a comparison of calculated and measured dose rates) that is needed to make such measurements has not been fully developed. The NRC also considered requiring that two indi-viduald verify that the correct sources were being implanted. This would clearly add to workers' radiation dose, but it is not clear that this would reduce the number of brachytherapy misadministration.
The hRC knows that some treatments must be administered within hours after a decision has been made to administer radiation therapy. These cases usually involve compression of the spinal cord or superior vena cava, respiratory distress, brain metastases, or severe vaginal bleeding. In such cases, it may not be possible for the licensee to perform an inde - )
pendent check of calculations.
The NRC believes the prescribing physician is best situated to deter-mine whether the time needed to make normal quality assurance checks might jeopardize the patient's health. This provision is not intended to give licensees a basis for not providing the required quality assurance steps in a timely fashion.
S 35.632 Full calibration measurements In one misadministration event, 53 patients received doses of radia-tion different from the doses that were prescribed because a mistake was made when measuring the effect of certain beam modifying devices on the teletherapy unit output. The NRC believes the revalidation of the effect 05/13/87 20 f
[7590-01]
of these devices on the output is just as important as the annual full calibration itself.
S 35.633 Independent check of full calibration measurements All teletherapy dose calculations are based on the output of the teletherapy unit, which is measured each year as part of the full calibra-tion. If a mistake were made in that measurement, all dose calculations would be incorrect. Therefore, the NRC believes there should be an inde-pendent check of the output that was determined during the full calibra-tion. The check should be made by a teletherapy physicist because that individual has special training and experience in the measurement of therapeutic radiation.
The check should be made using a measuring system other than the system used in the full calibration. This will better assure that any mistake made in the methodology or the calibration of dosimetry equipment will not go unnoticed. (The term " measuring system" is used in a broad sense here to mean not just the dosimetry equipment, but the personnel, records, site-specific methodology, and even origin of dosimetry equipment calibration when possible. However, the NRC is not certain that this would be available to all licensees and requests comment on this matter.)
The device used to make the output measurement could be one described in S 35.630 " Dosimetry equipment." Alternatively, it could be made using a specialized dosimetry service available by mail. Some organizations supply licensees with precisely calibrated thermoluminescent dosimeters within a device made of " tissue-equivalent" material. The licensee irradiates the device, calculates the given dose, and returns the dosimeters to the organization by mail. By processing the thermoluminescent dosimeters, the 05/13/87 21
[7590-01]-
organization can measure the given dose and compare that measure to'the calculated given dose. This provides assurance that the output.has been correctly measured.
IV. ADMINISTRATIVE STATEMENTS Environniental Impact: Categorical Exclusion The NRC has determined that this regulation is the type of action described in categorical exclusion 10 CFR 51.22(c)(3) and (c)(14).
Therefore, neither an environmental impact statement nor an environmental assessment has been prepared for this proposed regulation.
Paperwork Reduction Act Statement This proposed rule does not contain a new or amended information collection requirement subject to the Paperwork Reduction Act of-1980 (44 U.S.C. 3501, et seq.). Existing requirements were approved by the Office.of Management and Budget under. approval number 3150-0010. j Regulatory Analysis The Commission has prepared a regulatory analysis on this regulation.
The analysis examines the costs and benefits of the alternatives considered by the Commission. The analysis is available for inspection in the NRC
.Public Document Room, 1717 H Street N.W., Washington, DC. Single copies may be obtained from Mr. McElroy (see "FOR FURTHER INFORMATION CONTACT" heading).
l
-05/13/87 22 !
[7590-01]
Regulatory Flexibility Certification 4
Based on the information available to date, in accordance with the Regulatory Flexibility Act of 1980 (5 U.S.C. 605(b)), the Commission certifies that this rule, if promulgated, will not have a significant economic impact on a substantial number of small entities. The NRC has issued approximately 2,500 medical licenses under 10 CFR Part 35. Of these, approximately 2,200 are held by institutions, and'approximately 300 physicians in private practice. Most of the institutional licensees are community hospitals. The size standards adopted by the NRC (50 FR 50241, December 9,1985) classify a hospital as a small entity if its average gross annual receipts do not exceed $3.5 million, and a private practice physician as a small entity if the physician's annual gross receipts do not exceed $1 million. Under these size standards, some NRC medical licensees could be considered "small entities" for purposes of the Regulatory Flexibility Act.
The number of medical licensees that would fall into the small entity category does not constitute a substantial number for purposes of the Regulatory Flexibility Act.
The primary objective of the rule is to require licensees that provide radiation therapy service to implement certain quality assurance steps that will reduce the chance of therapy misadministration. The NRC believes that most licensees already perform these steps in order to !
assure the provision of quality' medical care. Therefore, there should not be a significant economic impact on these small entities.
The Commission has prepared a preliminary regulatory analysis for this regulation which contains information concerning the anticipated 05/13/87 23
[7590-01]
economic effect of this regulation on licensees and presents the basis for the Commission's belief that the regulation will not result in significant additional costs to any licensees. It is available for public inspection in the NRC Public Document Room, 1717 H Street N.W.,
Washington, DC. Single copies are available from Mr. McElroy.
Because of the widely differing conditions urv' y which licensees covered by this proposed regulation operate, the Commission specifically seeks public comment from small entities. Any small entity subject to this regulation which determines that, because of its size, it is likely to bear a disproportionate adverse economic' impact should notify the Commission of this in a comment that indicates: (1) The licensee's size in terms of annual income or revenue, number of employees and, if the licensee is a treatment center, the number of beds and patients treated annually; (2) how the regulation would result in a significant economic burden on the licensee as compared to that on a large licensee; (3) how the regulations could be modified to take into account the licensee's differing needs or capabilities; (4) the benefits that would be gained or the detriments that would be avoided to the licensee, if the regulations were modified as suggested by the Commenter; and (5) how the regulation, as modified, would still adequately protect public health and safety.
The Commission is particularly interested in comments on whether individ-uals with special training and experience (such as treatment technologists, dosimetrists, and radiation therapy physicists) are readily available in the. marketplace, either as full-time employees or as a contract service.
05/13/87 24 ;
I
[7590-01]
Backfit Analy,is The staff has determined that a backfit analysis is not required for this rule because these amendments do not apply to 10 CFR Part 50 licensees.
V. . LIST OF SUBJECTS IN 10 CFR PART 35 Byproduct material, Drugs, Health devices, Health professions, Incorporation by reference, Medical devices, Nuclear materials, Occupa-tional safety and health, Penalty, Radiation protection, Reporting and recordkaeping requirements.
VI. TEXT OF PROPOSED REGULATIONS 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 proposing to adopt the following amendments to 10 CFR Part 35.
Part 35 - Medical Use of Byproduct Material
(
- 1. The authority citation for Part 35 is revised to read as follows- i 1
Authority: Secs. 81, 161, 182, 183, 68 Stat. 935, 948, 953, 954, as i amended (42 U.S.C. 2111, 2201, 2232, 2233); sec. 201, 88 Stat. 1242, as amended (42 U.S.C. 5841). j For the purposes of sec. 223, 68 Stat. 958, as amended (42 U.S.C. I 2273): SS 35.11, 35.13, 35.20(a) and (b), 35.21(a) and (b), 35.22, 35.23,
- 35.25, 35.27(a), (c) and (d), 35.31(a), 35.39, 35.43, 35.49, 35.50(a)-(d),
05/13/87 25
[7590-01] !
35.51(a)-(c), 35.53(a) and (b), 35.59(a)-(c), (e)(1), (g) and (h), 35.60, 35.61, 35.70(a)-(f), 35.75, 35.80(a)-(e), 35.90, 35.92(a), 35.120, 35.200(b), 35.204(a) and (b), 35.205, 35.220, 35.302, 35.310(a), 35.315, l
35.320, 35.400, 35.404(a), 33.406(a) and (c), 35.410(a), 35.415, 35.420, 35.432, 35.454, 35.500, 35.520, 35.605, 35.606, 35.610(a) and (b),
35.615, 35.620, 35.630(a) and (b), 35.632(a)-(f), 35.633, 35.634(a)-(i),
35.636(a) and (b), 35.641(a) and (b), 35.643(a) and (b), 35.645(a) and (b), 35.654, 35.900, 35.910, 35.920, 35.930, 35.932, 35.934, 35.940, 35.941, 35.95r, 35.960, 35.961, 35.970, and 35.971 are issued under sec.
161b., 68 Stat. 948 as amended (42 U.S.C. 2201(b)); and SS 35.14, ;
30.21(b), 35.22(b), 35.23(b), 35.27(a) and (c), 35.29(b), 35.33(a)-(d),
35.36(b), 35.39, 35.43(b) and (d), 35.50(e), 35.51(d), 35.53(c), 35.59(d) and (e)(2), 35.59(g) and (i), 35.70(g), 35.80(f), 35.92(b), 35.204(c),
35.310sb), 35.315(b), 35.404(b), 35.406(b) and (d), 35.410(b), 35.415(b),
35.610(c),35.615(d)(4),35.630(c),35.632(g),35.634(j),35.636(c),
35.641(c), 35.643(c), 35.645, and 35.647(c) are issued under sec. 161o.,
68 Stat. 950, as amended (42 U.S.C. 2201(o)).
- 2. In Subpart A--General Information, 6 35.2, the following terms are added in alphabetical order:
S 35.2 Definitions.
" Beam modifying devices" means items such as trays, wedges, compensators, boluses, and blocks that are used to change the radiation dose profile within the patient.
05/13/87 26
[7590-01]
" Computer generated dose calculation" means a dose calculation that has been made by a computer program with no human action necessary other than the input of patient data,' selection of a certain computer program, and the instruction to the computer to begin calculation.
a a a a *
" Manual dose calculation" means a calculation made by an individual using patient data, tabulated data or graphs, nomograms, and a calculator that was not specifically designed or programmed for raaiation therapy calculations.
a a a a a
" Patient chart" means a record of the diagnosis and radiation treatment applied to a patient. It may be part of the hospital admission chart prepared for each patient and kept with the patient, or a chart prepared primarily as a result of radiation treatment and kept in the clinic.
" Prescription" means the written instruction to make medical use of byproduct material for the benefit of a specific patient.
n s a s s
" 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).
a a a *
- 05/13/87 27
l
[7590-01] !
l
- 3. In Subpart B--General Administrative Requirements, 6 35.39 is added to read as follows:
S 35.39 Ordering, prescribing, and administering certain radiopharmaceuticals.
(a) A licensee may not order any radiopharmaceutical of iodine for diagnosis or therapy or any radiopharmaceutical for therapy without the approval of the authorized user.
(b) A physician may not prescribe administration of a radio-pharmaceutical of iodine for diagnosis or therapy or any radiopharmaceut-ical for therapy without personally examining the patient and the patient's chart, and consulting with the referring physician if reasonably available.
Prescriptions for these byproduct materials must be in writing, and must include the patient's name, the radiopharmaceutical, dosage, and route of administration.
(c) A licensee may not administer a radiopharmaceutical of iodine for diagnosis or therapy or any radiopharmaceutical for therapy without comparing the radiopharmaceutical label and desage on hand with the physician's prescription.
- 4. In Subpart B--General Administrative Requirements, S 35.43 is added to read as follows:
S 35.43 Prescriptions, records, and checks 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, the patient has been referred for a therapeutic clinical procedure that requires the medical use of byproduct material.
05/27/87 28
[7590-01]
(b) Before beginning a patient's treatment, the licensee shall verify that the authorized user or a physician working under supervision of the authorized. user has personally made, dated, and signed a written prescrip-tion in the patient's chart that identifies the body part to be treated.
Any change in the prescription must also be made in writing in the patient's chart,'ar.d must be dated and signed.
(1) For radiopharmaceutical therapy, the prescription must also identify the radiopharmaceutical, the amount of activity to be administered, and the route of administration.
i (2) For brachytherapy, the prescription must also identify the sources of radiation and the total tumor dose.
(3) For teletherapy, the prescription must also identify the teletherapy unit to be used, the prescribed dose, and the treatment plan.
(c) Prescriptions and other records made regarding the medical use of byproduct material must be legible and unambiguous.
(d) The licensee shall instruct all workers involved in the radiation ]
1 therapy process orally and in writing to request clarification from the prescribing physician if any element of a prescription or other record is unclear, ambiguous, or apparently erroneous.
- 5. In Subpart C--General Technical Requirements, S 35.65 is added to read as follows:
S 35.65 Discrepancies in records and observations.
A licensee may not use byproduct material for medical use on a patiert if there is a discrepancy in records, observations, or physical 05/27/87 29
f
[7590-01]
measurements that may result in a misadministration. A licensee may resume use after resolving the discrepancy.
- 6. In Subpart F--Radiopharmaceuticals for Therapy, 6 35.302 is added to read as follows:
S 35.302 Administration of radiopharmaceutical dosages.
A licensee shall verify that the prescribed radiopharmaceutical is being administered by comparing the written prescription and the container label. '
- 7. In Subpart G--Sources for. Brachytherapy, S 35.432 is added to read as follows:
6 35.432 Source strength measurements.
(a) A licensee shall measure the source strength of sources before first use and annually thereafter. Sources that are in storage and not being used do not have to be measured; they must be measured before they are placed in service again. For sources manufactured and supplied in lots of nominally identical sources, a sample from each lot may be selected rather than measuring each source.
i (b) When performing dose calculations, a licensee may use the source strength reported by the manufacturer rather than using the source strength measured by the licensee.
- 8. In Subpart G--Sources for Brachytherapy, S 35.452 is added to read as follows:
S 35.452 Physical measurements of patient.
[ Reserved]
05/27/87 30
[7590-01]
- 9. In Subpart G--Sources for Brachytherapy, 6 35.454 is added to read as follows:
6 35.454 Check of dose calculations.
.A licensee shall check dose calculations for accuracy befo.re 50 percent of the prescribed dose has been administered. The check must provide assurance that the final treatment plan will provide the dose prescribed in the patient's chart.
(a) Manual dose calculations must be checked for accuracy by an individual who did not make the calculations.
(b) Computer generated dose calculations must be checked by examining the calculation printout to assure that the correct parameters and parameter values were used in the calculation. The check must be made by an individual who did not enter the patient data or prescription into the computer.
(c) If the prescribing physician makes a determination to delay treatment in order to perform the checks of dose calculations required 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, and the licensee shall perform the checks as soon as practicable.
- 10. In Subpart I--Teletherapy, S 35.632, the introductory text cf paragraph (b) and paragraph (b)(1) are revised to read as follows:
6 35.632 Full calibration measurements.
f 05/27/87 31
[7590-01]
(b) To satisfy the requirement of paragraph (a) of this section, full calibration, measurements must include determination of:
(1) The output within 13 percent for the range of field sizes, range of distances, and selection of beam modifyin0 devices (for example:
trays, wedges, and the stock material that is used for making compensators ano boluses) used for medical use';
I 11. In Subpart I--Teletherapy, 6 35.633 is added to read as follows:
S 35.633 Independent check of full calibration measurements.
(a) A licensea shall have an independent check of the output determined within one month after completion of the full calibration required by S 35.632, (b) The independent check must be performed by a teletherapy physicist who did not perform the full calibration and made using a dosimetry system other than the one used to measure the output during the full calibration. The teletherapy physicist does not have to be" ;
listed as a teletherapy physicist on an NRC or Agreement State license.
The dosimetry system may be one described in S 35.630, or it may be ,
another system that provides a similar level of accuracy and precision.
- 12. In Subpart I--Teletherapy, S 35.652 is added to read as follows:
S 35.652 Physical measurements of patient.
[ Reserved]
- 13. In Subpart I--Teletherapy, 9 35.654 is added to read as follows:
I l
'l 1
i 05/27/87 32
,. a
, [7590-01]
l' L 6 35.654 Checks of dose calculations and measurements of dose.
A licensee shall check oose calculations for accuracy before 20 percent of the prescribed dose.has been administered. The check must provide assurahce that the final treatment plan will provide the dose
'l prescribed in the patient's chart. .
't (a) Manual dose calculations must be checked for accuracy by an individual who did not make the calculations.
(b) Computer generated dose calculations must be checked by examining the calculation printout to assure that the correct parameters and parameter values were used in the calculation. The check must be made by an iidividual who did not enter the patient data or prescription l l
into the computer.
(c) A licensee shall make a weekly accuracy check of daily arithmetic.
calculations that have been made in patient's charts.
(d) If the patient's dose calculations include parameters or parameter values that fall outside the range of those measured in calibrating the teletherapy unit, the licensee shall make a physical measurement of the dose rate to be administered to the patient. This measurement must be made before 20 percent of the prescribed dose has been administered.
(e) If the prescribing physician makes a determination that to delay treatment in order to perform the checks of dose calculations or physical measurements required by this section would jeopardize the patient's health because of the emergent nature of the patient's condition, the licensee may provide the prescribed treatment without performing the checks of dose calculations or physical measurements; the 05/27/87 33
[7590-01]
proscribing physician shall make a notation of this determination on the patient's chart, and the licensee shall perform the checks of calculations or physical measurements as soon as practicable.
Dated at Washington, DC, this day of , 1987.
For the Nuclear Regulatory Coma.ission, 3amuel J. Chilk, Secretary of the Commission.
05/27/87 34 1
- - - - - ~ - . - - - - - , - - - - - - , - -- - - , - - - - - - - . .
k',
=
(,.
j l
ENCLOSURE 3 1
1 I
'li s
4
'I l
['%,s . ,
j NUCLEAR REGULAYOR E COfimS3th j f)q,fp/glVj WASHINGTON, O C. 20$55 .4* *. 4
[ '1 v p/ E00 Rehm
) ..... March 26, 1987 -
OFFICE OF THE drbe j SECRETARY Beckjord )
Heltemes l Kerr, SP l MEMORANDUM FOR: Victor Stello, Jr. Region I - V I Executi .D recypr for Operations Murray '
/foy A McElroy FROM John C, oyle, Acting Secretary l'l
SUBJECT:
STAFF REQUIREMENTS - SECY-87 " MISADMINISTRATION" Tne conmission, with all Commissioners agreeing, requested the staff to revise the proposed NPR and ANPR of the subject paper as outlined below and to resubmit it for !
Commission approval.
(EBD) (MSS) (SECY SUSPENSE: 5/29/87)
Both draft notices should be revised to include . ree nud M i further suoport for the Commission's cosition. J /////?ff 0f, cTear distinction should be drawn between the ' V/fjj e/-//, j unacceptable risks of improper or careless use or gggg/g Typroduct material by medical licensees and the g /jf f unavoietsbie r 4 eik e attendant to prescribed and properly f 7 administered diagnostic and therapeutic procedures.
The NMSS staff should coordinate with AEOD the documentation of additional supportive information ,
into the proposed rulemaking (see Commissioners Bernthal's and Carr's comments for more detail)
(attached)).
The reaulatorv analvses (Enclosures 4 and 5 to /#M W"W I"IM#I/#"/,
SECY-87-29) should be strengthened as discussed above.h,y/ Indtl11hdA .
a p1e
- Both '.he NPR and the ANPR should be appropriately M# *'6 modified to apply to misadministration of diaanostic-procedures which f all in theraov dose rances as well
, g'/ 7,g#
as to misadministration of radiation therapy. (See / "O* /A) M/M Commissioners Bernthal's vote sheet.) Commissioner g 9 - / d , / 2.*/ Ij Carr would have preferred that comprehensive quality g pg' assurance procedures for diagnostic procedures which fall in therapy dose ranges be addressed after j thorough analysis of response to the ANPR.
The draft ANPR should solicit comments on the imposition of requirements regarding the use of fy /)g/Mf/3, '
prepackaged computer software. Should the licensees who use these packages be required to verify them?
Are there additional QA requirements / procedures which could be developed to ensure that users understand the calculations embedded in these programs? Red Off. ED3 m_ 3'A1-r . ., - 2j,_'._f--
e
- On page 21 of Enclosure 2 (Section 35.432 of the proposed rule), licensees are required to measure the strength of sources prior to use and annuelly thereafter. Licensees are also directed that they may, when performing dose calculations, use the source strength as reported by the manufacturer. Staff should specify licensee action in the event that the gee A//hf licensee's measurements dif fer significantly from ///5-/6 1[.
those reported by the manufacturer.
I
' Provide an analysis of the additional NRC resources necessary to implement the requirements of the proposed rule, as well as the resources needed to complete staff recommendations in Enclosure 3. The estimates should include the overhead. (See Commission fee Int / d vote sheets) -
- Staff efforts in this area should he coordinated with w/// a/,,
the Agreement States and cepies of the proposed rule gpg /egaf and the ANPR should be sent to the Agreement States in advance of publication and specifically request their comments.
The proposed rule should be published for 60-day fe e A//Mp /.
public comment period.
' The staff should arrange for a public Commission 3x briefing by the representatives of *'II I8' professional / medical industry organizations, Agreement Ms#f.I /6LI States, and other interested parties to address the issues raised in the rulemakings.
The foll.owing comments address the staff's response to the Commission's 12/16/86 SRM:
Item 2: The retitling of the term "misadmin- see AM8N/
istration report" to " medical use event report" g. 2.
should be considered only if public comments on a the proposed rule justify.
Item 4: Tracking of wrongdoers. Expedite the preparation of a response to the SRM for SECY-86-319. (See Commissioner Bernthal's comments (attached).) (IE) (Wits 860227)
Item 5: Solicit comments in the ANPR on whether fe(M$.
NRC licensees should maintain and provide to r
patients, upon request, a record of the radiationy G,g I W.g7 doses which result from all licensed procedures.
Input from the Advisorv Committee on the Medical- p////o/. 4 Use of Radioisotopes should also be solicited onI ggff /gapf this item.
3
, i i
- ltem 8: Update Notice IN-85-61 as suggested in IJf W 4 AEOD Report N701. (IE) /hdeM j
- Thestaffshouldregularlyadvise-theCommission$*N!$f i of progress in followup activities which evolve g/j/ f, in response to the December 16, 19 56 SRM. ' (NMSS) - fjy Commissioner Carr considered the statement in Part 35.43 (d)' of page 20, Enclosure 2, to be ovsrly prescriptive. He would prefer the staff to consider 888 M replacing other references to " ticking" throughouttheg/6,jf.
proposed rule to allow the licens,ee flexibility in performing written verification.
The staff'sthe consider revisions to the editorial NPR and chances ANPR in the should sheets. f g , gg attached i
I r htWk of Attachments:
As stated cc: -Chairman "ech Contnissioner- Roberts Commissioner Asselstine
. Commissioner Bernthal Commissioner Carr OGC ,H Street
- .(
I
.. [7590-01)
I KUCLEAR REGULATORY COMMISSION 10 CFR PART 35 Comprehensive Quality Assurance in Medical Use and a Standard of Care AGENCY: Nuclear Regulatory Commission.
ACTION: Advance Notice of Proposed Rulemaking.
SUMMARf: The Nuclear Regulatory Con?.ission (NRC) is considering amendments to i $ regulations that apply to the use of byproduct material for radiation :
therapy and diagnostic uses involving large radiation dosages. In addition to ,
the current requirements for quality assurance, the-contemplated amendments would require licensees that offer teletherapy or brachytherapy services to implement a comprehensive quality assurance program to reduce the chance of
) on ne. estent to w hi ch misadministration. The NRC requests public comment g :: t: *:th;r additional radiopharmaceutical quality assurance requirements are needed, and invites advice and recommendations on several questions that will have to be addressed in the rulemaking process. [ Note: a cross-reference to the proposed rule willbeinserted.]
I 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.
l l-L l
1 Enclosure 1 1
[hh-Uw .
Effect on the Agreement Sta'te Program i 1
l I
Twenty-eight States, known as Agreement States, have assumed responsibility for regulating certain radioactive materials within their re:pective borders by agreement with the NRC. (This kind of agreement is authorized by the Atomic Energy Act.) They issue licenses for the use of 1
. byproduct material, and currently regulate about 5,000 medical licensees.
Because the NRC will request the Agreement States, as a matter of compatibility, to implement regulations equivalent to those that it implements on this matter, state regulatory agencies are asked to coment. i
! l l
Request For Cocrnents l
The NRC has prepared the following questions to elicit comments on !
l methods of preventing misadministration. Comente do not have to respond to these questions alone; other related topics or alternatives may be described !
if the commenter belicyes this will help to resolve issues related to this rulemaking.
Qurlity Assurance General The following questions apply to the provision of all types of thera-peutic medical use, and large diagnostic dosages, a
th.t C ;hsmpfensent H~ <an %e Co mm e ss s e n o ost e54ea.+oue13 IICCC CC I. rey;erements 10 Cnt Qr .
- 1. A Ch lid thi Coo. 533 f an EW T
.yo A4.pt Arevsk r le=. kin.9 ..Jntr$ ceas casus standarJs , (s) P rte Paic wid comprehensive quality assurance programpithe t 3;;Cifjii.; it: ::nt:nt, Or mL5t to idente(s etwcwts of 5ueb s erosram . (c) Co-isssea ettal.ledi 8 .u M the "C 'f:t : -::f cua1#ty :::gr:rt: Otti: that =:t h ;; r f .-- d ?
r**(.e m ee obj ec. hse s to te a c.Lievel L 3 im plem ent at,,o ,( sue.L a l*S .r3 m > C D) Q tl,e r.
5 Enclosure I
m
- 2. Should the definition of misadministration in 10 CFR 35.41 (the same ' definition that appears in 10 CFR 35.2 that was published on October 20, 1986 at 51 FR 36932) be changed? Is it clear and complete?
v Ts the definition sufficiently broad to include all appropriate activities?
.x i
- 8[
oep Is it so broad as to include inappropriate activities? Is the term i
)if " misadministration" appropriately descriptive of the activities? Should l
i e +
j {$ some more descriptive term be used? -
l w-
) -
- 3. The NRC knows of one instance in which radiation was administered P!g to a patient without a request from the primary care physician. Should the 1 E *s NRC require that the authorized user actively consult with the primary care l
44*k 1
w physician before prescribing radiation or deciding that radiation f; not
- b takaf . prevents can be adopted f. ,m. mise p.te nWat msco m.o t Aen and / l needed?4 ad w.u s ter~a. lass 7 l J.r
,- M U"N.#a ** houtel be c.ons'idered OE WodIN -
-ij- 4. What methods p ;.,; :c:i':F': L ; provide ;'i;i'; assurance that the
% y{o L q
[ c- patient who is administered radiation is the patient for whom radiation was s .
e o Ig rsl i +{ =) intended?
1 -
g f. Should NRC require certification or specific training criteria dem5 :! +" c for technologists, dosimetrists, and others who participate in the applica-
- s o#
3 g* p ' tion of radiation to patients, or assume that licensees will provide each
.e -e ., w rg raens,.s er.ede .katever tea n.ns .4 nec es s a r,5 L,w cy /
2DAo individual whatever training is necessary?g Should the NRC require licensees x W $,
to administer written examinations to workers and evaluate them before allowing ,,
a the workers to participate in radiation therapy? Should periodic retraining nE' EE and re-examination be required? +f f
e it a a -
7g. What other regulatory, certifying, accrediting, or inspecting 4s organizations examine tredical quality assurance programs? Arc th:::
- a t.
-+ ,j >
- =incti:n: :;n:i>^r:f perfunct:ry cr exh:u: tic ? T>e s c ed e. d e. i- k c loj*ce,Y'av e.S 2nd Fag o F c( Ne.Se c.X3sman d tens, [, k
- r
/ B. Aped from increasect N R.C oversthd, are -here any cLuges m end as4r_s p en de c e or sta nd z eils O n+ cou ld h+
%5 sdstantiall 3 improv e +ke. p ulif3 of Performance and
"'a' m t e kuan cerer 7*
d{
6 Er. closure 1
-_ _ - - - - b
1 \
Teletherapy and Brachyther6py J The following questiens apply to the provision of teletherapy and
~
brachytherapy services. f
- 1. To pssure quality of/ patient cpe, some orgpoizatiens rec .. er.d t3,,....d......I,....../....../. . . / .
,. 13, )
i, m a g q.- m e. q u.h es coata be ,
- y and famil ,
i
. prac /
d ,gted to e.nsure appropmaYe. t licens s gi i fari eyger.fisc. and raimm 4e humu.n I hav>! reta l f e rro r .[ 'alf y
]
ei !
as s t.. casespe[
em~ oyee to ssure t t licensee oployees are ot rushed i their wor ?
hould N requir licersees t specialize . treating c tain kind or
/ stegeg of disea,e rather th, allowing t, m to treat 1 kinds e disease? m 2;uld differb- tr:12" Or ~^rMkattr r^;'_'f r0~0"t? M *?"ad h*d c,, .. '. ~". _
-v ,
1
- 2. . Should srr ler licens _s with fewe staff and equipment escurces
/ '\
be r quired to m et differen quality ass' ance requ' ements t n those f larger li .nsees? /
2 g. What fraction of licensees already have a quality assurance prograni ,
3 /. The Regulatory Flexibility Act requires that regulatory agencies examine the cost of compliance with regulations. Few much does a quality assurance program cost per patient or per year? What fraction of staff time, including physicians, physicists, dosimetrists, technologists, and nurses, !
I is currently budceted for quality assurance work? If more staff wera needed ) 1 to meet quality assurance reoufrements, are the requisite individuals readily I available or would a lengthy lead-in time be needed? !
i l
7 Enclosure 1
w..p.
- g'. Are there complete raodel quality assurance programs already available tht 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 tc assure that the dose given is the same as the dosa orescribed? khat other arets are, or should be, covered in a complete quality assurance procram?
I 5 f f. Are the staff and equipment that are needed to implement a complete quality assurance program available in the marketplace, or would new training programs and equipment development be needed?
d$ thor 13l (K X Whatg methods are available for reducing the frequency or impact of human error?
Radiopharmaceutical Therapy ,
The NRC requires that 11,:ensees use only certain radiopharmaceuticals for specified therapy clinical precedures, measure the radioactivity in radiopharmaceutical dosages before adminisi; ration, and have a measurement !
quality assurance program for the dose calibrator used te make that measurement. These requirements appear to comprise 411 the steps in a radiopharmaceutical therapy physical quality assurance program. However, the NRC invites public coment on this position. j There have been cases in which, due to procedural failure, a radio-1 pharmaceutical other than that intended has been ordered and administered, l l
The NRC expects that all licensees have policy requirements for clear 1
)'
statements of prescription and verification before administration of any pharm ceutical. The NRC would appreciate suggestions on methods to assure tnat the clinical procedure (including radiopharmaceutical, desage, ar.d i
8 Enclosure 1 )
I l
. /. . .u m erve.$ seve.u :e.ws Q
- ..::-: .c.g ,:'f7590-01)
, i .
j
- .7 _ ~, g.,A rs e a s ca r, bc sn z.s.:. - . m.u ., m e s d ey'67, 7
, )
s v. i f route of_ administration) intended by tne authorized user is prescribed, l and that the prescribed clinical procedure is the cifnical procedure that is perfome Are there special needs regarding patient identification in radiophamaceutical therapy that go beyond the infomation regarding -
patient identification that was requested in question 4. of the General -
subsection? j l
Standards of Care The NRC presently has, in 10 CFR Part 2, Appendix C, particularly I
Supplement VI, an enforcement policy that it can apply to the medical 3use of byproduct material. ]
The following questions apply to the provision of teletherapy, brachytherapy, and radiopharmaceutical services, and to the Commission's Enforcement Policy.
- 1. Is there a clear, generally accepted standard of care that the NRC can adopt? If yes, please describe it. If not, please describe a standard thc' NRC could adopt. Is a standard needed if NRC has comprehensive prescriptive requirements?
- 2. What kinds of penalties should be imposed on licensees, their 4 I
employees, or both, if the standard or the comprehensive, prescriptive requirements are not met? Should penalties be imposed on employees?
I Should NRC's Enforcement Policy be changed, and if so, how?
- 3. What effect would such a standard cr comprehensive, prescriptive requirements have on provisions of radiation therapy care?
i i
l 9 Enclosure I
___. _________-_-_____a
L ,. . d vu -
Comments of Commissioner Bernthal on SECY 87-29:
1 At the outset, I have to agree with the arguments of NMSS reoarding the need for additional resources in this area. All small materials licensees, taken collectively, receive about 2.5% of NRC's licemina ,a_ndn inspection budget.
Medical licensees in particular receive only 0.5%1 If the Commission is serious about greater attention not just to medical, but to all materials licensees, I see no way to finesse the need for an infusion of significant additional resources.
I did not understand the use of the term " negligence" in the Commissinn's oirective to imply that staff should venture into " uncharted" regulatory waters. Rather, Staff should merely apply the same enforcement criteria of "due care" as now apply to other classes of licenses. Staff protests a bit
, too much (cf. bottom of p. 3 and following). In any case, Staff's decision to reference NRC enforcement policy for usa in medical enforcement actions iS appropriate. i The broad rationale staff supplies for Commission action in this entire area strikes me as inadequate, and it is not for want of strong, clearly evident arguments that could be constructed, based on recent events and the AE00 report. Therefore, both draft notices should be revised to include further support for the Commission's position. A clear distinction should be drawn between the unacceptable risks of improper or careless use of byproduct material by medical licensees and the unavoidable risks attendant to prescribed and properly administered diagnostic and therapeutic procedures.
The NRC is obligated to establish and enforce regulations that protect the public f rom the former. No one argues that the enormous benefits of nuclear medicine fail .to outweigh the small (but real) risk attendant to its proper and responsible use. I would suggest that much important anecdotal information supportive of these rulemakings may be found in three AE00 reports produced in the past 18 months. In rewriting these sections, NMSS staff should be instructed specifically to work with the authors of these reports.
The regulatory analyses (Enclosures 4 and 5) are likewise weak. They should not be published in their present form. While there may be no compelling reason to publish them at all, if they are to be made available to the public they should be strengthened as discussed above.
Staff has crafted the proposed rule such that it applies only to misadministration of radiation therapy (which is in strict compliance with the wording of the SRM) -- this despite the fact that certain diagnostic procedures involvino '.-131 can, if carried out improperly, result in therapeutic doses. Staff 3rcaes that the Commission specified therr?y.
According to Staff, rewoning the proposed rule to address the different treining, work practices and license requirements of diagnostic as opposed to therapeutic uses of radioisotopes would take much longer. I am unconvinced. The Commission surely does not intend to ignore serious misadministration simply because they occur as the result of a diagnostic procedure rather than a therapeutic one. In fact, because recipients of diagnostic misadministration are far healthier as a group (i.e. have longer life expectancies) than recipients of therapeutic misadministration, the
I -
4 Datential for long term harm is greater. AEOD's most recent report, fattached) makes an excellent case for additional regulatory measures to prevent just such misadministration. The NPR and ANPR should be ,
appropriately mcdified to apply to these cases as well.
In the draft ANPR, coment should be solicited on the imposition of requirements regarding the use of prepackaged computer software. Should the ;
I licensees who use.these packages be required to verify them? Are there additional QA requirements / procedures which could be developed to ensure I that users understand the calculations embedded in these programs. (Recall i that in the Cleveland Clinic incident, the overexposure resulted from the !
radiatien physicist's failure to realize that the distance from source to the exterior of the instrument was alrehdy accounted for in the computer software).
On page 21 of Enclosure 2 (section 35.432 of the proposed rule), licensees ,
are required to measure the strength of sources prior to use and annually e thereafter. Licensees are also directed that they may, when performing dose calculations, use the source strength as reported by the manufacturer. u Staff should specify licensee action in the event that the licensees measurements differ significantly from those reported by the manufacturer.
I also have the following further coan.ents on Steff's response to the Commission's 12/16/86 SRM:
Item #2: Staff suggests that licensees view the term " misadministration report" quite negatively, and propose instead that thought be given to l retitling it as a " medical use event report." This would be similar, I suppose, to a licensee event report (LER) for power plants. I don't necessarily object to this, but I would consider making such a change only if comments on the proposed rule justify it.
Item #4: Tracking of wrongdoers. Staff savs that this was addressed in SECY-86-319. That paper was rejected by the Conuission (5-0) and sent back to staff to be redrafted. It has yet to return to the Commission. Staff '
also cites a recent law (to be implemented by HHS) for tracking physicians who have been disciplined or defeated in malpractice cases. No details of j this law are provided. E'ven if such a law proves to be applicable to NRC violations, it fails to address the prob 1cm of radiation physicists, j technicians, HPs etc. who may be violating NRC regulations. I believe that l staff preparation of a response to the SRM for SECY-86-319 should be expedited so that the Commission may address this problem in a manner consistent with j its treatment of all licensees.
Item #5 All physicians do not, upon request, provide such information. !
Many do not even know the dose of a given procedure. Specific comment I '
should be solicited in the ANPR on whether NPC licensees should maintain and provide to patients, upon request, a record of the radiation doses which result from all licensed procedures. I would welcome the opinion of the l Advisory Committee on the Medical Use of Radioisotopes on this matter, as !
o staff has suggested, but would still seek public comment as well. l l
i
1
/. i i 3 (7) Item (3 Staff has indeed made a laudable effort to provide to licensees infonnation en the causes and frequency of misadministration. The list of I AE notices and other publications is commendable. Staff should be encouraged
[
- to continue these efforts. Staff should be directed to update Notice IN-85-61 as suggested in AEOD Report N701, " Diagnostic Misadministration Involving the Administration of Mil 11 curie Amounts of I-131".
Item #10: During the public ccmment period for the NPR and the ANPR, the Comission should hold a public meeting on the subiect. Representatives of professional / medical / industry organizations should be specifically invited ;
to address the issues raised by the Commission for rulemaking consideration I approve SECY-87-29 subject to the above comments and minor edits on the attached sheets. l 1
i I
I i
t^
l-2 1
i 6
4 p6 - k[,
' 4
l Commissioner Carr's comments on SECY 87-29 I commend the staff for its timely response and efforts to respond to the Commission's concerns about the need for greater NRC attention to the oversight of medical licensees. I have the following comments on the staff's proposed actions:
Proposed Rule - Basic Ouality Assurance in Radiation Therapy (1) The NRC staff, including NMSS, AEOD, and the Regions, have invested significant effort over the past 5 years in evaluating reported medical misadministration, analyzing the underlying causes and recommending corrective action to prevent recurrence. The proposed rule should be revised to reflec_ this experience and more thoroughly explain the need to revise the Commission's regulations. ,
I (2) 35.43(d) as stated is overly prescriptive. Regulatory guidance should afford the licensee flexibility in the means of written verification of independent checks of data transfer and i calculation. The staff should consider replacing other '
references to " ticking" throughout the proposed rule to allow the. licensee flexibility in performing written verification.
~
(3) Proposed revisions to 35.432 address source strength measurements.
- Licensees will be required to measure source strength initially and on an annual basis. However, when performing dose calculations, licensees will be permitted to use the source strength reported by the manufacturer without any required comparison between reported and measured values. Licensees should be required to establish procedures if source strength measurements differ from that reported by the manufacturer.
ANPR - Comprehensive Ouality Assurance in Medical Use and a Standard of Care (1) See Coment 1 above. The paper should be revised to more thoroughly explain the Commission's position, based on NRC experience and analysis (including AE00 case studies and reports and reported incidents), that some licensees do not have adecuate quality assurance programs to minimize human error and avoid medical misadministration.
(2) Revise according to specific modifications on pages 1,5,6,7,8,9 of Enclosure 1.
(3) The staff should address comprehensive quality assurance requirements for therapy procedures and diagnostic procedures which fall in therapy dose rar.ges in a proposed rule if warranted after thorough analysis of responses to the ANPR and progress on staff actions proposed in Enclosure 3, Response to Questions in December 16, 1986 Staff Requirements Memorandum. In any case, the staff should regularly advise the Commission of progress in follow-up activities described in SECY-87-29, Enclosure 3.
1 c q _2 Resources I noted with interest that only approximate 1.v 0.5% of NRC's total resources are applied to licensing and inspection of 2500 NRC medical licensees. I agree with the staff's observation that ar increased NRC presence coupled with requirements of the proposed rule may enhance licensee attention to quality assurance, training, and management controls. However, the discussion of resources on page 6 of the staff psper does not provide sufficient information to ascertain what resources are necessary for the proposed rule separate from future actions that may be recommended. The staff should be asked to provide an analysis of additional NRC resources necessary to implement requirements of the proposed rule. Also, the staff is asked to provide a separate analysis of NRC resources needed to complete staff recommendations in Enclosure 3. Please include overhead in.these 3 estimates. In preparing these resources analyses staff should consider creative solutions to maximize results from resource investments.
Coordination with Acreement States I. believe that interactions and coordination with the Agreement States are essential on these important issues. Because the staff notes that these interactions have not occurred due to timing constraints I sugoest that the Agreement States be sent advanced copies of the. proposed rule prior to publication requesting their comments, I would have preferred that these customary interactions had occurred prior to submittal of the proposed i regulation to the Commission because of the valuable experience the '
Agreement States bring to the development of our regulations.
Public Comment Period I agree with the staff recommendation that the proposed rule be published for 60-day public comment period.
Commission Meetino with Professional Organizations j i
The staff should arrange for representatives of key professional l organizations to brief the Commission after the close of public comment i on the ANPR on initiatives planned and underway which could be effective J in preventing medical misadministration.
Dn_ . .- .,
~3 *T = M i
- _ - _ _ _ _ _ _ _ _ _ . _ _ . l
f7550-Cli 4
NUCLEAR REGULATORY COMtilSSION 10 CFR PART 35 Comprehensive Quality Assurance in Medical Use and a Standard of Care AGENCY:. Nuclear Regulatory Comissicn. ,
4 ACTION: Advance Not;ce of Proposed Rulemaking.
SUMMARY
- The Nuclear Regulatory Comissicn (NRC) is considering amendments to its regulations that apply tc the use of byproduct materf a1 for radiation ~
therapy and diagnostic uses involving large radiation dosages. In addition to the current requirements for quality assurance, the contemplated amendments would require licensees that offer teletherapy or brachytherapy services to I implement a comprehensive quality assurance program to redece the chance of i en ne extent to w hi c.h misadministration. The NRC requests public coment 4 r r t: i r additional l radiopharmaceutical quality assurance requirements are needed, and invites advice and recommendations on several questions that will have to be addressed
- in the rulcmaking process. [ Note: a cross-reference to the proposed rule willbeinserted.]
DATE: submit coments by (90 days). Coments received after this date will be considered if it is practical to do so but assurance of considera-tion c6nnot be given except as to consnents received before this date. f l
l 1 Enclosure 1
I7{00 QI,1 Effect on the Agreement Sta'te Program Twenty-eight States, known as Agreement States, have assumed responsibility for regulating certain radioactive materials within their ;
respective borders by agreement with the NRC. (This kind of agreement is authorizedbytheAtomicEnergyAct.) They issue licenses for the use of a
byproduct material, and currently regulate about 5,000 medical licensees.
Because the NRC will request the Agreement States, as a matter of compatibility, to implement regulations equivalent to those that it impler/*.nts on this' matter, state regulatory agencies are asked to connent.
Request For Coments l l
l The NRC hes prepared the following questions to elicit coments on j methods of preventing misadministration. Coments do not have to respond ;
to these questions alone; other related topics or alternatives may be described .
if the commenter believes this will help to resolve issues related to i this rulemaking.
l 1
Quality Assurance 4
i General ]
The following questions apply to the provision of all types of thera-1
- peutic medical use, and 16rge diagnostic dosages.
"** ",i' C**"'.55 M?. most ef. fecfgely,,#,
air, lead.myguge7ents fo a
i
..m,. - . . .~ . , . . . . . . , . .
- 1. A -w w m ..m - . . . . ..m
- (4 A4.pt Areusl. r le== kin,9 ,,ide,tes c... ensas s%d a rj s , ce) p.,t.ci pate w i+1 l comprehensive quality assurance programpf thout :pccifying it: :ent:nt, r l I
t iden+.f s ele.me.nts of s uch 3. p rogra m . (c) Co. -issena estal.lish mLsteg
- . u ld the "9C 'f:t ::rt:f :::lity :::ur:n:: :tp: th:t :t h ;;rf:r:d? 1 Pa-4.rmance objec.tve s to be ac.lieeved f.3 im ple men t atwn ,( s uci a i
PPSSram, C.D) d t ke r, 1 l
5 Enclosure 1
_ _ _ _ _ _ - _ _ _ _ _ _ _ _ - . l
~
w- .
(
t
- 2. 'Should the definition of misadministration in 10 CFR 35.41'
(.
(the same. definition that appears in 10 CFR 35.2 that-was published on-October 20, 1986 at 51 FR 36932) be changed?~ Is it clear and complete?
v- Is the definition sufficiently broa'd to include all appropriate activities?.
s
- j$ Is it so broad as to include inappropriate activities? Is the term i
U e p:
.+) -?+* " misadministration" appropriately descriptive of the activities? .Should !
j k.Y some more descriptive term be used?
w-p 3. The NRC knows of one instance in which radiation was administered tI'_h;,g to a patient without t. request from the. primary care physician. Should the NRC require that the authorized user actively. consult with the primaryi care 4,4 ]
~ ~
4 physician before prescribing radiation or deciding that radiation is not W *gb. tak.f . pe, vents can be adopted +. wa mote p.te aWat ,se.. w .t:6. and
+=~ a.t4sT
- p [ .'s @ :needed?4 ambis u u Sbe conside.re,2 OaY would shoutcl b y. s* ,
., 4. What methodsg ; ;;;f';i'; L provide c.ii d ic assurance that the t . 1. e
.g y L o- patient who is' administered radiation is the patient for whom radiation was a o4 intended?
7 4n"I 's .j ) g g. - Should NRC require certification or specific training criteria
.c --
4made7+f for technologists, dosimetrists, and others who participate in the applica-Sa 0 0 tion of radiation to patients, or assume that ifcensees will provide each 9
.I 4}# If I.censees P reved e uh.tever trainias .s necess arg, L,w caf i 8 D "- o individual whatever training is necessary?g Should the NRC require licensees ;
\n, to administer written examinations to workers and evaluate them befnre allowing the workers to participate in radiation therapy? Should periodic retraining and re-examination be required? r!l I i!
7/. What other regulatory, certifying, accrediting, or inspecting 4:i
=u organizations examine medical quality assurance programs? 'r; th;;; A,
- =.in;ti;n; ;;n;i'cr:d p;rfun;t;ry ;r c2;;tiv;7 'Descede. Ne f ol.jectiv es and ri$ o e of Nese e.x a n. i n aYe o i 5 . '?.
.+ ,
- 8. Aped fro.a increasect NE eversiM,.ae Sere an3 cksages m ind ustr3 p ra ch c e or sfandveds Oat could b(2 54st,nfia ll3 improv e +ke. p ulity o( performa nce and djl
'4d '
- v m ea e ha an cerer ~f 6 Enclosure 1 i
e
______.____._.._._._-.-______O
~ ~ : C - U. ,7
_, Teletherapy and Brachytherapy -
The following questions apply to the provision of teletherapy and brachytherapy services.
- 1. To ssure quality of/ patient c e, some org 12ations rec tend that ~~~ ' ' "' ~ ' I' * * * ' ' ' I ' " ' ' ' ' ' ' ' ' ' * ' '
I the
[. WLd per(orm3nce. *L*3 u YWes cou!d be
. prac iyandfamil 4 i*d F Y* *'"5""' " P P " P " * "'
fari t licens s ex per-i t s e. 8nd mtntmi*e hum 2n ha v,e reta
/
e1 error 7 'al y asst. /casespe em oyee to ssure t t licensee .ployees are at rushed i their wor hould NP. requir licensees t specialize ' treating c tain kind or stegee /of disea e rather th allowing t m to treat 1 kinds e disease?
- Should differing-training rweeti#f eatf er req"iments be 17 ead hae=d
- c ", . .' " '. m^ ^ ^.
y
- 2. Should sr 1er licens s with fewe staff and equipment escurces be r quired to m et differen quality ass ance requ' ements t. n those f larger 11 nsees?
A 7. What fraction of licensees already have a quality assurance progran? ,
3 /. The Regulatory Flexibility Act requires that regulatory agencies l
examine the cost of compliance with regulations. How much does a quality k
assurance program cost per patient or per year? What fraction of staff time, including physicians, physicists, dosimetrists, technologists, and nurses, j is currently budoeted for quality assurance work? If more staff were needed ,
to meet quality assurance requirements, are the requisite individuals readily available or would a lengthy lead-in time be needed?
t..
7 Enclosure 1
[7EFO-01) 4 f. Are there complete model quality assurance programs already l
available that address every step of the radiation therapy process, or will model programs have to be developed? Should physical measurements, redundant calculations, or both be required to assure that the dose given is the same as the dose prescribed? What other areas are, or -
should be, covered in a complete quality assurance program?
5 3f f. Are the staff and equipment that are needed to implement a complete quality assurance program available in the marketplace, or I
would new training programs and equipment development be needed?
- cichhon 1 (s X What metho"ds are available for reducing the frequency or impact g
of human error? .
Radiopharmaceutical Therapy
)
i The NRC requires that licensees use only certain radiopharmaceuticals for specified therapy clinical procedures, measure the radioactivity in radiopharmaceutical dosages before administration, and have a measurement ;
quality assurance program for the dose calibrator used to make that measurement. These requirements appear to comprise all the steps in a. ,
radiopharmaceutical therapy physical quality assurance program. However, the NRC invites pu'olic comment on this position.
There have been cases in which, due to procedural failure, a radio- l pharmaceutical other than that intended has been ordered and administered.
The NRC expects that all licensees have policy requirements for clear j statements of prescription and verification before administration of any pharmaceutical. The NRC would appreciate suggestions on methods to assure j that the clinical procedure (including radiopharmaceutical, dosage, and
(
8 Enclosure 1 ,
l
r'
( De 14Rc he;, okserved several coss5 of i f7590-01]
vf I Lc. r:- br r. r.5 E7' 5 2 8 5 r*g~ r t .
\
g (l c'usammu uwt smeroveme nica4dsenenn lo s m u Ae. % m m s .s ia s u k are ,es ,' ,
route of administration) intended by the authorized user is prescribed, and that the prescribed clinical procedure is the clinical procedure that is perfonne Are there special needs regarding patient identification in radiopharmaceutical therapy that go beyond the iriformt. tion regarding patient identification that was requested in question 4. of the General subsection?
Standards of Care The NRC presently has, in 10 CFR Part 2, Appendix C, particularly Supplement VI, an enforcement policy that it can apply to the medicai ruse of byproduct material. .
The following questions apply to the provision of teletherapy, brachytherapy, and radiopharmaceutical services, and to the Commission's y
- 1. Is there a clear, generally accepted standard of care that the j NRC can adopt? If yes, please describa it. If not, please describe a standard that NRC could adopt. Is a ' standard needed if NRC has comprehensive prescriptive requirements?
- 2. What kinds of penalties should be imposed on licensees, their employees, or both, if the standard or the comprehensive, prescriptive l- requirements are not met? Should penalties be imposed on employees?
Should NRC's Enforcement Policy be changed, and if so, how?
- 3. What effect would such a standard or comprehensive, prescriptive requirements have on provisions of radiation therapy care?
h I
9 Enclosure 1 5
,5 s:
l l
ENCLOSURE 4
'hehE lb>'b4bEtjyt & Yd4lEY 0 (yg99 933
&kd/Ca k />t/A/ $U fW b s'Ut dtd 3 24 ff i
NUCLEAR REGULATORY COMMISSION l
10 CFR PART 35 Comprehensive Quality Assurance in Medical Use and a Standard of Care AGENCY: Nuclear Regulatory Commission. ,
ACTION: Advance Notice of Proposed Rulemaking.
SUMMARY
- The Nuclear Regulatory Commission (NRC) is considering amendments to its regulations that apply to the use of byproduct material for 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 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. g NRC is also requesting comments on some basic quality assurance program requirements set out in a proposed rule published elsewhere in this issue.
DATE: Submit comments by (90 days). Comments 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.
1
l
[7590-01]
ADDRESSES: Mail comments to: The Secretary of the Commission, U.S.
Nuclear Regulatory Commission, Washington, DC 20555, Attention: Docket-ing and Service Branch. '
Deliver comments to: Room 1121, 1717 H Street NW., Washington, DC, between 8:15 am and 5:00 pm on Federal workdays.
Examine copies of comments received at: The NRC Public Document Room, 1717 H Street NW., Washington, DC.
FOR FURTHER INFORMATION CONTACT: Norman L. McElroy, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555, telephone (301) 427-4108.
SUPPLEMENTARY INFORMATION:
Therapy Use of Byproduct Material Teletherapy is the application of a beam of radiation emanating from a cobalt-60 source to a patient for a therapeutic purpose, usually cura-l tive, prophylactic, or palliative cancer therapy. (High energy x-ray machines are also used for the same purposes.) As an example, a treatment might be comprised of daily treatments of 200 rads to the tumor volume for five weeks, yielding a total tumor dose of 5000 rads.
Brachytherapy is the insertion of small sealed sources such as ,
cesium-137, iridium-192, gold-198, or iodine-125 into the tumor volume for curative or prophylactic cancer therapy. As an example, a treatment might require insertion of 50 millicuries for 48 to 72 hours8.333333e-4 days <br />0.02 hours <br />1.190476e-4 weeks <br />2.7396e-5 months <br />, resulting in a tumor dose of 5000 rads.
2
[7590-01]
Radiopharmaceutical therapy is the administration of a radioactive drug for therapeutic purposes. The most common clinical procedure involves the oral administration of liquid or gelatin-capsuled iodine-131 as sodium iodide. For hyperthyroidism, 5 to 30 millicuries might be administered; for thyroid cancer, 70 to 200 millicuries might be administered.
Most diagnostic uses result in whole body doses of about 0.1 rem and ,
target organ doses of about 2.0 rem. Occasionally however, as much as 5 millicuries of iodine-131 is administered as a diagnostic dosage for patients who have been treated for thyroid cancer. If this dosags were mistakenly administered to a patient who has no tnyroio disease, the thyroid dose would be several thousand rads.
NRC'S Policy Regarding the Medical Use of Byproduct Material In a policy statement published February 9, 1979 (44 cR 8242), the NRC stated:
" 1. The NRC will continue to regulate the medical uses of radioisotopes as necessary to provide for the iadiation safety of workers and the general public.
"2. The NRC will regulate the radiation safety of patients where justi-fied by the risk to patients and where voluntary standards, or compliance with these standards, are inadequate.
"3. The NRC will minimize intrusion into medical judgments affecting l patients and into other areas traditionally considered to be a part j of the practice of medicine."
l 3 l
u _ _ - _ )
l
[7590-01]
l The NRC has the authority to regulate the medical use of byproduct material to. protect the health and safety of patients, but also recognizes that physicians have the primary responsibility for the protection of l J '
their patients. NRC regulations are predicated on the assumption that properly trained and adequately informed physicians will make decisions in the best ir.terest of their patients. !
NRC's Responsibilities in the Medical Use of. Byproduct Matcrial In developing this rulemaking the NRC has had to deal with the normal :
risk attendant to medical care and the risk associated with the careless i
use of byproduct material. l The NRC is aware of the pubite health benefits accrued in the medical use of byproduct material, and also is aware of the small, but real, risk attendant to the proper and responsible medical use of ]
byproduct materials. However, the NRC draws a line between the unavoid-able risks attendant to purposefully prescribed and properly performed clinical proc >edures and the unacceptable risks of improper or careless j use of byproduct material in medicine. The NRC is obliged, as part of its public health and safety charge, to establish and enforce regulations that protect the public from the latter.
Reports of Misadministration in Radiation Therapy The NRC has published a study of the twenty-seven therapy misadministration that were reported over the period November 1980 through July 1984.1 The following NRC analysis of these events provides the basis for determining that a need exists for this rulemaking.
1For a copy this repcrt, write to Kathleen M. Black, Office for Analysis ar.d Evaluation of Operational Data, Nuclear Regulatory Commission, Washington, DC 20555. Ask for report AE0D/C505. !
4
[7590-01]
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.
Inadequat,e training of workers has caused misadministration.
Although additional training'may not reduce the chance of some kinds of mistakes, it should clearly impress on eacn individual involved in the medical use of byproduct material that a clear communication of concepts and quantitics as well as systematic checks for revealing mistakes early in the process are both essential for the delivery of quality care. Each
' bit of informatica that plays a role in the process, whether specific to the patient or to the clinic, should be carefully examined for clarity, applicability, and correctness. Each individual involved in the process should be strongly encouraged to ask for clarification if there is any unclear or unexpected step or if an expected step is missing.'
Inattention to detail is often the medium in which a misadministra-tion event germinates. This is not a problem specific to the medical use of byproduct material. Any process or product that requiros individual attention to a multitude of related quantities that are similar in mag-nitude and used repeatedly will likely contain mistakes. Computerized radiation therapy treatment planning may reduce the chance of mistakes in sealed source treatment planning, and " record and verify" systems that l
5
{
l 1
- m. .
.j
, [7590-01]
Tabl e - '1. Therapy misadministration reported to NRC from November 1980 to July 1984 Teletherapy Prescription
- Total daily dose was delivered from each port (2)*
' Oral and written prescriptions were different (1)
Boost dose of 500 rad /3 da was interpreted as 500 rad x 3 da' (1)
Proper body side was not clear (1)
+
Treatment planning Tumor depth was incorrectly measured (1)
Tumor depth was incorrectly recorded (1)
Dosimetrist used wrong computer program (1)
Dosimetry tables for wrong unit were used (1)
Arithmetic mistakes were made (3)
Records Arithmetic mistakes were made (1)
Poor handwriting of numerals caused misunderstanding (1)
Physical measurements Wedge factors were measured incorrectly (1-53 patients affected)
Application' Field blocks were not used (1)
Brachytherapy Treatment planning i
Dose rate was much higher than first estimated (1)
Application Wrong sources were loaded in applicator (2)
Source fell out of applicator (1)
Source was improperly seated in applicator (1) j Radiopharmaceutical Therapy Wrong radiopharmaceutical was administered (2)
Assay date on unit desage was not read (3)
Patient was improperly identified (1)
- Numbers in parentheses indicate number of events of the type described.
6
[7590-01]
check teletherapy unit orientations and settings may reduce the chance of mistakes in teletherapy administration. But even these systems perform their functions on quantities that are initially measured, recorded, and entered into memory by individuals.
Lack of redundancy means there is no mechanism for checking for mis-takes. An independent check requires having a second individual examine each data entry, whether a physical measurement or a number copied from a table of values, and check each arithmetic operation for correctness.
Redundancy requires that two separate systems produce the same result.
For radiation therapy treatment planning, the best method of early detec-tion of mistakes may be a simple independent check. Redundancy or inde-pendent checks may also be needed in each therapy facility's procedures for measuring radiation parameters, using those measurements for treatment planning, and applying raJiation 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 citing areas where a change in the process might reduce the chance for mistakes.
1 This analysis leads the NRC to some general conclusions regarding {
quality assurance.
The radiation therapy process should be planned with the realization that individuals are more likely to make mistakes in the absence of good 1
quality assurance. Some simple aids may include using tables and graphs j i
that are clearly titled and easy to read, and use of a uniform written l l
prescription format. Based on inspection reports, the NRC believes that i about ten percent of teletherapy unit calibrations and spot-checks are incomplete. Checklists could be used to assure completeness.
1 1
1 7
j c .
[7590-01]
A redundancy function must be integral to the design of the radiation therapy process. Independent double-check procedures and redundancy procedures should be considered. Each entry and calculation in a treat-ment plan should be checked by an individual who did not make.the treat-ment plan. Each patient's chart should be reviewed weekly to check for accumulated dose and implementation of prescription changes. A quality assurance program for the teletherapy unit should include a periodic check of the teletherapy unit output and an occasional detailed examination of the complete teletherapy process, including physical measurements, by an outside expert with an eye towards systematic errors and system improvements.
A program that requires a physical measurement of the dose or amount of radioac'.ivity.actually administered to the individual patient would provide assuran.ce that the given-dose is the same as the prescribed dose.
Such measurements are now done for radiopharmaceutical therapy and occa-sionally for some teletherapy cases, but because of expense or unavail-ability of equipment are not commonplace in sealed source therapy.
Reports of Diagnostic Misadministration That Result in Doses in the Therapy Range The NRC has also published a report on misadministration of diagnostic dosages of iodine-131 that lead to doses in the therapy range.2 The repcrt was a review.of fourteen recent misadministration events in whichpy,tientswereadministeredonetotenmillicuriesofiodine-131 "For T single copy', submit a request for report number AE00/N701 to the address in footnote 1.
8 j
o
[7590-01]
with a resulting thyroid dose of several thousand rads. Many of the events demonstrated that the physician authorized user is not reviewing f the medical history'of the referred patient to determine the suitability of a particular clinical procedure. It appears that the referring l physician, who is not a nuclear medicine expert, and the nuclear medicine technologist, who.is not a medical expert, frequently determine which radiopharmaceutical should be administered. In some events technologists l were not familiar with the clinical procedure prescribed by the authorized user and mistakenly administered a dosage that was not requested. When-radiopharmaceuticals that can.give therapy doses are used, unclear +
nomenclature, lack of double-checks, and inadequate training cannot ~be tolerated.
Earlier NRC Efforts This is not the first time the NRC has examined the matter of quality assurance in the medical use of byproduct material. In 1979 the NRC issued some basic quality assurance requirements f6r teletherapy (see 1
10 CFR 35.632 and 10 CFR 35.634). This rulemaking wa precipitate ~d by the inaction of a single licensee. The output of a teletherapy unit was incorrectly calculated and the licensee made no physleal measurements to determine whether the calculation was correct. This inaction resulted in cobalt-60 teletherapy being misadministered to 400 patients. The 1979 i
rule addressed the circumstances surrounding that event but did not critically examine the entire radiation therapy procsss.
9 l
[7590-01]
Voluntary Initiatives l The Commission is aware of voluntary initiatives to improve quality
- assurances .A notable example is the Patterns of Care study managed by the American College of Radiology. In addition to comparing presc'riptions, .
meth'ods of applying radiation, and survival rates for certain diseases at various therapy facilities across the nat' ion, methods of calculating'and measuring applied dose rates are examined for accuracy. Such an examina-
' tion can detect whatever procedural flaws may be present as well as determine the precision and accuracy of day-to-day service.
Unfortunately these voluntary programs-have not provided adequate assurance of public health and safety. Serious misadministration con-tinue to occur. The NRC would be remiss in its responsibilities were it }
to continue to rely on voluntary programs +o reduce the chance of l misadministration.
Summary The NRC believes many misadministration could reasonably be avoided if certain basic quality assurance steps wers included in the radiation therapy process.
Effect on the Agreement States Program Many States, known as Agreeme'nt States, have assumed responsibility for regulating certain radioactive materials within their respective borders by agreement with the NRC. (This kind of agreement is authorized by the Atomic Energy Act.) They issue licenses for the use of byproduct material, and currently regulate about 5,000 medical licensees. Because 10
e i
[7590-01) the NRC will request the Agreement States, as a matter of compati'ility, u
to implement regulations equivalent to those that it implements on this matter, state regulatory agencies are asked to comment.
Request For l'omments The NRC has prepared the following questions to elicit comments on methods of preventing misadministration. Comments do not have to resoond to these questions alone; other related topics or alternatives may be described if the commenter believes this will help to resolve issues related to this rulemaking.
Quality Assurance General The following questions apply to the provision of all types of medical use:
- 1. How can the Commission most effectively implement requirements for comprehensive quality assurance? The Commission has the authority to adopt existing national standardc. The Commission, in concert with medical experts, could identify and adopt by ruiecaking the key elemeats in a quality assurance program. The Commission could impose a performance requirement under which licensees would be required to implement a quality assurance program that would provide absolute assurance that there would be nn misadministration. What other mechanisms should be considered?
- 2. Should the definition of misadministration in 10 CFR 35.2 be changed? Is it clear and complete?
l 11 l
l
[7590-01]
Is the definition sufficiently broad to include all appropriate activities?
Is it so broad as to include inappropriate activities? Is the term
" misadministration" appropriately descriptive of the activities? Shoula some more descriptive term be used?
- 3. The NRC knows of one instance in which radiation was administered to a patient without a request from the primary care physician. Should the NRC require that the authorized user actively consult with the primary care physician before prescribing radiation or deciding that radiation is not needed? How can the chance of miscommunication be reduced? What improve-
_ments can be made in termincloqy, prescription format, and orders?
- 4. What-methods should be considered to provide assurance that the patient who is administered radiation is the patient for whom radiation was intended?
- 5. What current standards exist to ensure the adequacy and uniformity of trainino of all individuals who participate in the radiatior, ther g orocess? Should NRC require certification or prescribe specific training criteria for technologists, dosimetrists, and others who participate in the application of radiation to patients, or should NRC have a performance requirement that requires' licensees to provide each individual whatever training is necessary? In either case, how can NRC ensure the adequacy and consistency of this training through.out the radiation therapy community?
Should tne NRC require licensees to administer written examinations to workers and evaluate them before allowing the workers to participate in radiation therapy? Should periodic retraining and re-examination be required?
l 12 u E __ _ - __ _ _ -. _ _ _ _ _ _ _ _ _ _ _ _ _ _ . _ _ _ _ _
[7590-01]
1
.6. What other regulatory, certifying, accrediting,-or inspecting organizations examine medical quality assurance programs? Describe'the 1
purpose, objectives.'and ricor of these examinations. y
- 7. Should the NRC require physicians to provide patients, upon request, a record of the radiation dose prescribad or given? What infor-mation 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 cnd mini-L 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 l care. minimize the chance of human error, and mitigate the consequences of
!# #W/
all error? #
Y#/ #' ##
2.
l q l // a m e l b A t N >1 / V 6 @ $kA.
To asstfre adequacy of continued experience, some organizations recommend that certain surgical or test-tube procedures only be performed if the practitioner has a' sufficient case-load to assure that dexterity and familiarity with the procedure are not lost. Should NRC require that licensees have a certain minimum case-load to assure that their employees retain it5cir expertise in performing radiation therapy clinical and quality assurance p ocedures?
- 3. What fraction of licensees already have a quality assurance program? What are its key elements?
I 13
I
[7590-01]
- 4. The Regulatory Flexibility Act rcquires that regulatory: agencies examine.the cost of compliance with regulations. How much does a quality assurance program cost per patient or per year? What fract. ion of staff time, including physicians, physicists, dosimetrists,' technologists, and nurses, is currently budgeteti for quality atsurance work? If more staff. '
were needed to meet quality assurance requirements, are the requisite individuals readily available or would a lengthy lead-in. time be needed?
- 5. Are there complete model quality assurance programs already available that address every step of the radiation therapy process, or will model programs have to be developed? Should physical measurements, redundant calculat .1s, or both be required to assure that the dose given is tha same as the dose prescribed? What other areas are, or should ce, covered in a complete quality assurance program?
- 6. Are the staff and equipment that are needed to implement a com-plete quality assurance program available in the marketplace, or would new training programs and equipment development be ceeded?
- 7. Computers are used in radiation therapy to calculate dose distributions and to control the operation of equipment. How could quality assurance of software accurscy and validity be improved? Should licensees be required to verify them? How can user skill and knowleoge of the inherent assumptions and limitations of' a computer program be assured? Should additional quality assurance requirements be developed to ensure that users understand the algorithnis on which the programs ar:
based?
- 8. What additional methods are available for reducing the frequency or impact of human error?
14
, .o
[7590-01]
Radiopharmaceutical Therapy I The NRC requires that licensees use only certain radiopharmaceuticals for specified therapy clinical' procedures, measure the radioactivity ir, radiopharmaceutical dosages before administration, and have a measurement
' quality assurance program for the dose calibrator used ta make that measurement. These requirements appear to comprise all the steps in a radiopharmaceutical therapy physical quality assurance program. However, the NRC invites public comment on this position.
There have been cases in which, due to procedural failure, a radio-pharmaceutical other than that intended hns 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-macautical. 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 the prescribed clinical procedure is the clinical procedure that is performed. The NRC has observed several cases of miscommunication of the referring physician's request. What improvements can be made to minimize '
_such errors? Are there special needs regarding patient identification in {
radiopharmaceutical therapy that go beyond the information regarding patient identification that was requested in question 4. of the General cubsection?
l l
15 r
a
[7590-01]
.i Standards of Care The NRC presently has, in 10 CFR Part 2, Appendix C,'particularly Supplement VI, an enforcement policy that it can apply to the medical.use i of byproduct material.
The following questions apply to the medical use'of byproduct !
material and to the Commission's Enforcement Policy.
- 1. Is there a clear, generally accepted: standard of care that the !
NRC can adopt? If yes, please describe it. If not, please describe a standard that NRC could adopt. Is a standard needed if NRC has comprehensive prescriptive requirements?
- 2. What kinds of penalties sh'ould be imposed on licensees, their
. employees, or both, if the standard or the comprehensive, prescriptive ;
requirements are not met? Should penalties be imposed on employees? ,
Should NRC's Enforcement Policy be changed, and if so, how?
- 3. What effect would such a standard or comprehensive, prescriptive requirements have on provisions of radiation therapy care?
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.
The autherity citation for this document is:
16
. f
[7590-01)
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).
Dated at Washington, DC, this day of , 1987.
For the Nuclear Regulatory Commission.
Samuel J. Chilk, Secretary of the Commission.
4 l
l l
f i
l 17 l
l L-_________________.
't ,
l l
1 i
i l
l l
8 l
ENCLOSURE 5 i 1
i i
I i
1 l
l f
i I
l
(
)
k h h W /s '
$9*4 WA$4b /Mck Nu ' ~0 3 4w M mai tw1 axaw ~ sarm A I
cf.M gam 3 % /-
NUCLEAR REGULATORY COMMISSION 10 CFR Part 35 Basic Quality Assurance in Radiation Therapy AGENCY: Nuclear Regulatory Commission.
ACTION: Proposed Rule.
SUMMARY
- The Nuclear Regulatory Commission (NRC) is proposing to amend its regulations concerning the medical use of byproduct material to require its medical licensees to implement certain quality as:urance steps that will reduce the chance of therapy misadministration. This proposed action is necessary to provide better patient safety and a basis for enforcement action in cases of therapy misadministration. The amendment is intended to reduce the chance and severity of therapy misadministra-tions. The proposed regulations would primarily affect hospitals, clinics, and individual physicians. In an advance notice of proposed rulemaking published elsewhere in this. issue of the Federal Register, the NRC is also requesting commente on the need for a comprehensive quality assurance J
~
I program requirement. f COMMENTS: Comments must be received by (60 day:,). Comments received after this date will be considered if it is practical to do so, but assurance of consideration cannot be given except as to comments received on or before this date.
i 05/13/87 1 l l
i e
[7590-01]
ADDRESSES: Submit written comments and suggestions to the Secretary of the Commission, U.S. Nuclear Regulatory Commission, Washington, DC 20555, Attention: Docketing and Service Branch.
Copies of the regulatory analysis and the comments received on this rule may be examined at the Commission's Public Dncument Room at 1717 H Street !
NW., Washington, DC. Single copies of the regulatory analysis are avail-able from Norman L. McElroy, Office of Nuclear Material Safety and Safe-guards, U.S. Nuclear Regulatory Commission, Washington, DC 20555, Telep'ione: (301) 427-4108.
FOR FURTHER INFORMATION CONTACT: Norman L. McElroy, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20$55, Telephone: (301) 427-4108.
SUPPLEMENTARY INFORMATION:
- 1. BYPRODUCT MATERIAL IN MEDICINE Use for Patient Care j l
Radioactive materials are used in drugs in the field of nuclear i 1
medicine. Drugs labeled with radioisotopes are known as radiopharmaceu- j ticals. In diagnostic nuclear medicine, patients receive these materials by injection, inhalation, or oral administration. Physicians use radia- l
(
tion detection equipment to visualize the distribution of a radioactive l 1
drug within the patient. Using this technology, it is possible to locate l tumors, assess organ function, or monitor the effectiveness of a treatment.
An estimated 10 million diagnostic nuclear medicine procedures are per-formed in this country annually. In therapeutic nuclear medicine, larger j i
05/13/87 2 l I
i
[7590-01]
quantities of radiopharmaceuticals are administered to treat hyperactive thyroid conditions and certain forms of cancer. An estimated 30,000 pro-cedures are performed each year.
Sealed radioactive sources that produce high radiation fields are.
used in radiation therapy primarily to treat cancer. A radioactiv? source in a teletherapy machine can be adjusted to direct a radiation beam to the part of the patient's body to be treated. An estimated 100,000 patients receive cobalt-60 teletherapy treatments from NRC and Agreement State licensees each year. Smaller sealed sources with less radioactivity I
are designed to be implanted directly into a tumor area or applied on the surface of an area to be treated. This procedure is knowr, as brachy-therapy. Licensees perform approximately 50,000 brachytherapy treatments annually.
Sealed radioactive sources can also be used in machines that are ured for diagnostic purposes. The source provides a beam of radiation that is projected thruugh the patient. A device on the other side of the patient detects the amount or spatial distribution of rediation that goes through the patient. This can provide information about tissues within the patient. j This is a relatively new development in the field of medicine and the NRC has no estimate of the number of these diagnostic procedures performed annually. l l
i State and rederal Regulation Many states, known as Agreement States, have assumed responsibility :
l l for regulating certain radioactive materials within their respective bo'rders by agreement with the NRC. (Thic kind of agreement is authorized 05/13/87 3 L________-_---_---
4
[7590-01]
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 2,200 medical institutions (mostly hospitals and clinics) and 300 physicians in private practice.
These licenses authorize cortain diagnostic and therapeutic uses of radioactive materials.
II. NRC'S REGULATORY PROGRAM NRC's Policy Regarding the Medical Use of Byproduct Material In a po~licy statement published February 9, 1979 (44 FR 8242), the NRC stated:
4 l
"1. The NRC will continue to regulate the medical uses of radioisotopes as necessary to provide for the radiation safety of workers and the general public.
"2. The NRC will regulate the radiation safety of patients where justified by the risk to patients and where volun-tary standards, or compliance with these standards, are inadequate.
"3. The NRC will minimize intrusion into medical judgments affecting patients and into other areas traditionally considered to be a part of the practice of medicine."
The NRC has the authority to reguiate the medical use of byproduct material to protect the health and safety of patients, but also recognizes that physicians have the primary responsibility for the protection of their patients. NRC regulations are predicated on the assumption that 04/28/87 4 j l
l l
(7590-01] {
i
. properly trained and. adequately informed physicians will make decisions l in the best interest of their patients.
NRC's' Responsibilities in the Medical Use of Byproduct Material In developing this 'rulemaking the NRC has had to deal with the normal risk attendant to medical care and the risk associated with the careless use of byproduct material.
The NRC draws a clear line between the unavoidable risks attendant' to purposefully prese.ribed and properly performed clinical procedures and
, the unacceptable risks of improper'or carel.ess use of byproduct material in medicine. The NRC is obliged, as part of.its public health and safety charge, to establish and enforce regulations that protect the public from the'latter. It is clear that the enormous public health benefits accrued j in the medical use of byproduct material cannot begin to be outweighed by the smail, but real, risk attendant to the proper and responsible medical use of byproduct materials.
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 tnis rulemaking.
The specific causes of the misadministration, detailed in Table 1, are, of. course, related to the treatment modality. Nonetheless, three 1For a copy of reports, write to Kathleen M. Black, Office for Analysis and Evaluation of Operational Data, Nuclear Regulatory Commission, j Washington, DC 20555. Ask for report AE00/C505. :
04/27/87 5 I l
[7590-01]
Table 1. Therapy misadministration reported to NRC.
from November 1980 to July 1984 Teletherapy Prescription Total daily dose was delivered from each port (2)*
Oral and written prescriptions were different (1)
Boost dose of 500 rad /3 da was interpreted as 500 rad x 3 da (1)
Proper body side was not clear (1)
Treatment planning Tumor depth was incorrectly measured (1)
Tumor depth was-incorrectly recorded (1)
Dosimetrist used wrong computer program (1)
Dosimetry tables for wrong unit were used (1)
Arithmetic mistakes were made (3)
Records Arithmetic mistakes were made (1)
Poer handwriting of numerals caused misunderstanding (1)
Physical measurements Wedge factors were measured incorrectly (1-53 patients affected)
Application Field blocks were not used (1)
Brachytherapy Treatment planning Dose rate was much higher than first estimated (1)
Application Wrong sources were loaded in applicator (2)
Source fell out of applicator (1)
Source was improperly seated in applicator (1)
Radiopharmaceutical Therapy Wrong radiopharmaceutical was administered (2)
Assay date on unit dosage was not read (3) .
Patient was improperly identified (1) '
- Numbers in parentheses indicate number of events of the type described.
l 04/27/87 6 l
__-_--_____a
t
[7590-01]
basic themes run through the reports: inadequate training, inattention to detail, and lack of redundancy.
Inadequate training of workers has caused misadministration.
Although additional training may not reduce the chance of some kinds of mistakes, it should 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. Each bit of information that plays a role in the process, whether specific to the patient or to the clinic, should be carefully examined for clarity, applicability, and correctness. Each individual involved in the process should be strongly encouraged to ask for clarification if there is any unclear or unexpected step or if an expected step is missing. !
Inattention to detail is often the medium in which a misadministra-tion event germinates. This is not a problem specific to the medical use l of byproduct material. Any process or product that requires individual i i attention to a multitude of related quantities that are similar in mag- l nitude and used repeatedly will likely contain mistakes. Computerized radiation therapy treatment planning may reduce the chance of mistakes in !
sealed source treatment planning, and " record and verify" systems that check teletherapy unit orientations and settings may reduce the chance of mistakes in teletherapy administration. But even these systems perform their functions on quantities that are-initially measured, recorded, and entered into memory by individuals.
)
l Lack of redundancy means there is no mechanism for checking for mis-
]
takes. An independent check requires having a second individual examine each data entry, whether a physical measurement or a number copied from a 04/27/87 7
J
[7590-01) table of values, and check each arithmetic operation for correctness.
Redundancy requires that two separate systems produce the same result.
For radiation therapy treatment planning, the best method of early detec- I l
tion of mistakes may be a simple independent check. Redundancy or inde- i pendent checks may also be needed in each therapy facility's procedures for measuring radiation parameters, using those measurements for treatment planning, and applying radiation to patients. In radiation therapy or any other endeavor, an independent outside auditor can detect mistakes in both process design and process application as well as citing areas where a change in the process mignt reduce the chance for mistakes.
This analysis leads the NRC to some general conclusions regarding quality assurance.
The radiation therapy process should be planned with the realization that individuals are likely to make mistakes. Some simple aids may include using tables and graphs that are clearly titled and easy to reed, and use of a uniform written prescription format. Based or inspection reports, the NRC believes that about ten percent of teletherapy unit ,
l calibrations and spot checks are incomplete. Checklists could be used to l 1
assure completeness.
]
A redundancy function must be integral to the design of the radia-I tion therapy process. Independent double-checx procedures and redundancy procedures should be considered. Each entry and calculation in a treat-ment plan should be checked by an individual who did not make the treat-ment plan. Each oatient's chart should be reviewed weekly to check for accumulated dose and implementation of prescription changes. A quality assurance program for the teletherapy unit should include a periodic 04/27/87 8
[7590-01]
check of the teletherapy unit output and an occasional detailed examina-tion of the complete teletherapy process, including physical meast.rements, by anloutside expert with an eye towards systematic errors and system improvements. !
1' A program that' requires a physical measurement of the dose or amount 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-ability of. equipment are not commonpicce in sealed source therapy.
Reports of Diagnostic Misadministration That Result in Doses '
in the Therapy Range The NRC has also published a report on misadministration of diag-
- nostic dosages of iodine-131 that lead to doses in the therapy range.2 The report was a review of fourteen recent misadministration events in which patients were administered one to ten millicuries of iodine-131 with a'resulting thyroid dose of several thousand rads. Many of the events demonstrated that the physician authorized user is not reviewing the medical history of the referred patient to determine the suitability of a particular clinical procedure. It appears that the referring physician, who is not a nuclear medicine expert, and the nuclear medicine technologist, who b not a medical expert, frequently determine which radiophar.maceutical should be administered. In some events technologists were not familiar with the clinical procedure prescribed by the authorized ZFor a single copy, submit a request for report number AEOD/N701 to the address in footnote 1.
04/27/87 9
__mm_.-_-_____ _ _ _ _ - - - - - - - - - - - - - - - - - - - - - - - - - -
4 g [7590-01]
user and mistakenly administered a dosage that was not requestod. Use of I unclear nomenclature, lack of double-checks, and inadequate training can-not be tolerated in programs in which radiopharmaceuticals that.can give therapy doses are used.
I Earlier NRC Efforts This is not the first time the NRC has examined the matter of. quality assurance in the medical use of byproduct material. In 1979 the NRC issued !
1 some basic quality assurance requirements for teletherapy'(see'44 FR 1722, published January 8, 1979). This rulemaking was precipitated by the inac- .
g s .. L tion of a single licensee. The output of a teletherapy unit was incor- i rectly calculated and the licenset made ne physical measurements to deter-li '
mine whether the calculation was correct. This inaction resulted in !
cobalt-60 teletherapy being misadministered to 400 patients. The 1979 rule addressed the circumstances surrounding that event but'did not critically examine the entire radiation therapy process.
Voluntary Initiatives j
.The Commission is aware of voluntary initiatives to improve quality l assurance. A notable-example is the Pattarn. of Care study managed by the American College of Radiology. In addition to comparing' prescriptions, methods of applying radiation, and survival rates for certain diseases s
at.various therapy facilities across the nation, methods of calculating and measuring applied dose rates are examined for accuracy. Such an examination can detect whatever procedural flaws niay be present as well as determine the precision and accuracy of day-to-day service.
1 04/27/87 10
[7590-01]
Unfortunately these voluntary programs have not provided adequate assurance of public health ar.d safety. Serious misadministration con-tinue to occur. The NRC would be remiss in its responsibilities were it to continue to rely on voluntary programs to reduce the chance of misadministration.
Summary The HRC believes many misadministration could reasonably be avoided if certain basic quality assurance steps were included in the radiation therapy process.
The NRC staff has examined literature on the radiation therapy process and consulted with experts practicing in the field of radiation therapy to discuss the need for these quality essurance steps. The NRC believes that th steps are basic to the radiation therapy process.
The regulations that would require implementation of these steps will provide guidance for improved patient safety and will also provide a basis for NRC enforcement action if not followed.
The NRC is also examining the need for a requirement to implement a more complete quality assurance program. Comments on that matter are requested in an advance notice of proposed rulemaking published elsewhere in this issue of the Federal Register.
III. DISCUSSION OF PROPOSED REGULATORY TEXT S 35.2 Definitions i
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.
05/13/87 11 i
. _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ . . . _ l
[7590-01] 1 l
l S 35.39 Ordering, prescribing, and administering certain radiopharmaceuticals There have been a number of misadministration in which an unclear oral prescription by the authorized user resulted in the licensee ordering '
the wrong radiopharmaceutical. Confusing colloidal and soluble phosphorus-32 is a common mistake. The NRC is particularly concerned with the medical use of iodine-131 because of the high thyroid dose that results when a patient with a normal thyroid is misadministered an iodine-131 dosage intended for a patient whose thyroid has been removed.
These misadministration appear to be precipitated by unclear instructions. This section would require close participation of the nuclear medicine physician in those cases involving the use of radio-pharmaceuticals that are clearly hazardous to the patient if misadministered.
In drafting this section the Commission considered applying these requirements to all licensees when using any diagnostic radiopharmaceu-tical. For the following reasons the scope of the section was limited to therapy radiopharmaceuticals and radiopharmaceuticals of iodine There is a clear history of misadministration of these two groups of radiopharmaceuticals, and medical experts generally agree that there is clear potential for harm to patients that receive these misadministra-tions. For the other radiopharmaceuticals identified in 35.100 and 35.200, the record shows that most misadministration involve either the conventional administration of a radiopharmaceutical to the wron2 patient, or the conventional administration of the wrong radiopharmaceu-tical to the patient (see "NRC Reports on Misadministration and Unannounced Safety Inspections," Journal of Nuclear Medicine, v27,"n7, 05/19/87 12
.k
[7590-01]
p1102, July 1986). Neither of these types of misadministration pose a clear hazard to the patient. To misadminister a diagnostic radiopharmaceutical other than iodine in a manner that would pose a hazard to the patient would,. in the most likely circumstance, require administration 1
of at least a full day's inventory of the radiopharmaceutical to the patient. This type of event is very unlikely.
However, the absence of additional quality assurance requirements for diagnostic radiopharmaceuticals other than iodine should not be interpreted as Commission lack of interest in this matter.
S 35.43 Prescriptions and records of medical use for therapy The NRC has received one therapy misadministration report in which radiation was administered to a patient who had not been referred for medical use of byproduct material. The NRC 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 c?inical procedure that requires radiation dose to the patient is indicated. _,
When a decision has been made to treat a patient for any malady, whether with radiation, surgery, or drugs, a physician makes a patient chart that includes information about the care provided for the patient.
The chart is made for medical and legal reasons. All charts contain the patient's name, the results of laboratory tests and physical examinations, a statement of diagnosis, and a prescription. Charts for teletherapy patients usually include: (1) photographs of the patient's face and the treatment area; (2) the treatment plan (which is comprised of: (a) dia-grams of physical measurements of the patient, portal arrangements used 05/19/87 13
m . ;; ;:;;;;; :: .-.. - : - . .L . . 7
. l
[7590-01]
to administer the radiation dose, and devices used to modify the radia- ;
tion beam, (b) calculations made-to determine how lon0 the beam must be applied each day to deliver the prescribed dose, and (c) the number of days radiation is to be administered); (3) a record of each daily appli- I cation of radiation made at the time of application; and (4) records of any physical measurements of radiation or portal verification films made specifically for the patient. Charts for brachytherapy patients include the same type of information, but the diagrams and calculations refer to implanted radiation sources rather than externally applied radiation beams.
Each entry in a chart is dated and signed or initialed.
The NRC considered preparing prescriptive recordkeeping requirements for the application of therapeutic amounts of radiation, but believes that the patient charts and calibration records that licensees make and retain usually contain the information needed to demonstrate that the licensee has implemented a quality assurance program. There would be no benefit gained by imposing additional recordkeeping requirements. However, the NRC would appreciate public comment on this matter.
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 legible handwritten or typed prescription on the patient's chart appears to be the most efficient way cf 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 tech-nologists may be disinclined to request clarification of instructions and 4
1 05/13/87 14
^
- ~------ - - _ -
l
[7590-01]
l this may lead to misadministration. Therefore, the NRC would require licensees to specifically instruct workers to request clarification in cases where there may be ambiguity or error.
The NRC considered prescribing what documentation was needed to demonstrate that an independent check of data transfers and calculations had been made. The NRC has not included such a requirement in the proposed rule, but would appreciate comment on this matter.
Ak:%d;g *.unured S 35.65 Discrepancies in records and observations On occasion licensees have complied with required safety measures, such as performing surveys, yet not taken mitigating or corrective actions that the NRC believes were obviously necessary to assure public health and safety. The purpose of this section is to clearly require licensees to resolve discrepancies in records and observations.
The NRC foresees the possibility of many kinds of discrepancies.
The licensee's measurement of the source strength of a brachytherapy source may differ from the manufacturer's reported source strength. A thin patient may present a surface lesion, yet the patient's record may refer to a deep-seated lesion with extensive overlying tissue. A post-mastectomy patient may be referred for a prophylactic treatment with no clear stcternent prescribing whether the tissue surrounding the site of surgery or the remaining breast tissue is to be treated. The prescrip-tion in the chart may not be in accord with the prescription agreed to by the physician, physicist, technologist, and dosimetrist during a treatment planning meeting. Daily tailies of administered dose may not agree with projections made by multiplying the daily dose by the number of treatment days.
05/13/87 15
. . - _ - - - . - - - ----__--w
[7590-01]
If, when faced with an obvious discrepancy, a licensee, physician,
) physicist, technologist, dosimetrist or other individual fails to take I
reasonable clarifying, mitigat.ing, or corrective action and the dis-crepancy result.s in a misadministration, then a citation will issue under this section.
\
S 35.432 Source strength measurements The radiation dose rate from a sealed source, which is known as source strength, depends on the amount of radioactivity in the source and the material used to encapsulate it. (See National Council on Radiation Proi,ection and Measurements Report Number 41, " Specification of Gamma-Ray
, Brachytherapy Sources," Chapter 4.)3 Manufacturers usually provide source
\siiMath information with sources, but the NRC believes that an independa.t measu e 5%t is needed to ensure that the information relates specifically tothesou%gderconsideration.
rce However, t C would not require licensees to use these measurements indosecalculationfii n some cases, manufacturers are able to provide more accuratemeasurementsol' rce strength than licensees; the licensee must be free to use the source sf ,i th that it believes is the most accurate.
4hg ,
c ,
SS 35.452 and 35.652 Physi'. asurements of patients The NRC knows that dose ratcs depen' ome extent on the tissue volumetobetreatedanditsdepthwithinthh4$pnt. These parameters maybedeterminedbyphysicalexaminationorexami% of images such
+
3 Copies of this report may be purchased by contacting NCRP Pu ions, P.O. Box 30175, Washington, DC 20014. w,g 5
{
05/13/87 16 gN.,
~ ~- ~ -~ ~
"~...._, 2._ __
7
.s.
[7590-01]
as radiographs, or images from computerized tomography, ultrasound, nuclear medicine, or nuclear magnetic resonance. The NRC considered requiring that two individuals independently make the physical measure-ments of the patient that are needed for dosimetry purposes, and believes l that such a requirement may reduce the chance of misadministration. .
However, because there are a finite number of individuals trained to do these tasks, such a requirement could negatively impact the delivery of medical care. Therefore, a requirement of this type has not been irs;1uded. j However, the NRC will continue to examine this matter. !
S 35.454 Check of dose calculations, and S 35.654 Checks and
! measurements of dose i Dose calculations are made for 4h 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 l volume. Several therapy misadministration have been precipitated by I arithmetic mistakes or incorrect assuciptions in dose calculations. An .!
independent check will likely uncover many of these mistakes.
Ideally, teletherapy dose calculations should be checked before radiation is adrainistered, and the NRC expects that most licensees already j 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 05/13/87 17 i l
[7590-01] I exact lotstion 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.
Public conyants are invited on the workability of these 20 percent i
and 50 percent criteria.
There are two usual methods for performing checks of manual dose calculation. Two individuals may independently calculate treatment times and compare results. Alternatively, one individual may make the calcula-tion and then a second individual can examine each entry SM urithmetic.
operation to verify its accuracy, The NRC considered requiring that licensees perform a manual check of the dose to a single point in the treatment volume predicted by computer generated dose calculations. However, checks of computer-generated dose calculations pose difficult problems. It is not clear whether nomograms or manual algorithms are available that can be used to i
check the accuracy of computer generated dose calculations. Many computer programs that are used contain steps for calculating the effect on tne dose caused by tissue density differences, organ and tissue contours, and radiation field contours. The NRC believes that a manual check of a computer calculation with that many physical correction factors may be beyond the reasonably expected mecns of many licensees, and may adversely affect the delivery of medical care. Therefore, the NRC has only drafted a requirement that a second individual assure that the correct parameters, L- such as radionuclides, dose, and physical measurements of patients, were 05/13/8/ 18 l
m _.. . . . _ . . . ~ . . . . - - . _ .
i :
[7590-01]
used in the computer generated dose calculation printout to information in the patient's chart, and examining each relevant piece of information
/[/h[d' "[d[//p wM
' ~
on the calculation printout.
The NRC would appreciate comments on the vest method for documenting that these checks have been made.
Regarding the concept of " independent check," the NRC would parti-cularly appreciate comments on whether a second individual should begin with only the prescription, independently calculate the dosimetry and treatment plan, and then compare those results with those of the first individual.
In teletherapy, the arithmetic that sums the daily administration of radiation must also be checked. Radiation is usually administered in daily doses over several days or weeks and each dose is recorded in the patient's chart. A weekly check will assure the daily doses have been summed correctly. In contrast, brachytherapy is administered I
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 arithmetic mistake would likely be obvious in a commonly used configuration because certain calculated values for patients usually fall within small ranges, an unexpected treatment time in an uncommon configuration would likely be i
attributed to the uncommonness of the configuration rather than triggering an examination of calculations for a siosimetry mistake. Therefore, the NRC believes that a physical measurement of the dose rate should be made if the teletherapy unit settings or beam modifying devices used for a 05/13/87 19
[7590-01]
1 1 patient fall outside the ranges examined during the last set of full calibration measurements.
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 airo considered requiring that two indi-viduals verify that the correct sources were being implanted. This would clearly add to workers' radiation dose, but it is not clear that this would reduce the number of brachytherapy misadministration.
The NRC knows that some treatments must be administered within hours after a decision has been made to administer radiation therapy. These cases usually involve compression of the spinal cord or superior vena cava, respiratory distress, brain metastases, or severe vaginal bleeding. In such car,es, it may not be possible for the licensee to perform an inde--
pendent check of calculations.
The NRC believes the prescribing physician is best situated to deter-mine whether the time needed to make normal quality assurance checks might jeopardize the patient's health. This provision is not intended to give licensees a basis for not providing the required quality assurance steps in a timely fashion.
S 35.632 Full calibration measurements In one misadministration event, 53 patients received doses of radia-tion different from the doses that were prescribed because a mistake was made when measuring the effect of certain beam modifying devices on the teletherapy unit output. The NRC believes the revalidation of the effect 8
05/13/8/ 20
_--------__j
a[-
[7590-01]
of these devices on the output is just as important as-the annual full calibration itself.
S 35.633 Independent check of full calibration measurements All teletherapy dose calculations are based on the output of the teletherapy unit, which is measured each year as part of the full calibra-tion. If a mistake were made in that measurement, all dose calculations would be incorrect. Therefore, the NRC believes there should be an inde-pendent' check of the output that was determined during the full calibra-tion. The check should be made by a teletherapy physicist because that individual has special training and experience in the measurement of therapeutic radiation.
a The check should be made using a measuring system other than the system used in the full calibration. This will better assure that any mistake made in the methodology or the calibration of dosimetry equipment will not go unnoticed. (The term " measuring system" is used in a broad sense here to mean not just the dosimetry equipment, but the personnel,,
records, site-specific methodology, and even origin of dosimetry equipment calibration when possible. However, the NRC is not certain that this would be available to all licensees and requests comment on this matter.)
The device used to make the output measurement could be one described in S 35.630 " Dosimetry equipment." Alternatively, it could be made using a specialized dosimetry service available by mail. Some organizations supply licensees with precisely calibrated thermoluminescent dosimeters within a ,
device made of " tissue-equivalent" material. The licensee irradiates the device, calculates the given dose, and returns the dosimeters to the l
organization by mail. By processing the thermoluminescent dosimeters, the l W.
05/13/87 21 q 1
~q c .:
[7590-01]
i organization can measure'the given dose and compare that measure to the j
calculated given dose. .This provides assurance that the output has been correctly measured.
l IV. ADMINISTRATIVE STATEMENTS l I
' Environmental Impact: Categorical Exclusion The NRC has determined that this regulation is the type of action .)
described in categorical exclusion 10 CFR 51.22(c)(3) and (c)(14).
.Therefore, neither an environmental impact statement nor an environmental assessment has been prepared for this proposed regulation.
l Paperwork Reduction Act Statement' This proposed rule does not contain a new or amended information collection requirement subject to the Paperwork Reduction Act of 1980 (44 U.S.C,~3501, et seq.). Existing requirements were approved by the Office of Management and Budget under approval number 3150-0010.
Regulatory Analysis The Commission has prepared a regulatory analysis on this regulation.
The analysis examines the costs and benefits of the alternatives' considered by the Commission. The analysis is available for inspection in the NRC Public Document Room, 1717 H Street N.W., Washington, DC. Single copies may be obtained from Mr. McElroy (see "FOR FURTHER INFORMATION CONTACT" heading).
l 05/13/87 22
[7590-01]
I Regulatory Flexibility Certification Based on the information available to date, in accordance with the Regulatory Flexibility Act of 1980 (5 U.S.C. 605(b)), the Commission certifies that this rule, if promulgated, will not leave a significant economic impact on a substantial number of small entities. The NW has issued approximately 2,500 medical licensos under 10 CFR Part 35. Of these, approximately 2,200 are held by' institutions. and approximately 300 physicians in private practice. Most of the institutional licensees are community hospitals. The size standards adopted by the NR': (50 FR 50241, December 9,1985) classify a hospital as a small entity if its average gross annual receipts do not exceed $3.5 million, and a private pra::tice physician as a small entity if the physician's (annual gross receipts do not exceed $1 million. Under these size standards, some NRC medical licensees could be considered "small entities" for purposes of the Regulatory Flexibility Act. .
The number of medical licensees that would fall into the small entity category does not constitute a substantial number for purposes of _
the Regulatory Flexibility Act.
The primary objective of the rule is to require licensees that provide radiation therapy service to implement certain quality assurance steps that will reduce the chance of therapy misadministration. The NRC believes that most licensees already perform these steps in order to
! assure the provision of quality medical care. Therefore, there should not be a significant economic impact on these small entities.
1 The Commission has prepared a preliminary regulatory analysis for '
this regulation which contains information concerning the anticipated 1 05/13/87 23 l
=.. :...; ::...- ::::.: ....
~ - -
[
\
[7590-01]
i economic effect of this regulation on licensees 6nd presents the basis for the Commission's belief.that the regulation will not result in significant additional costs to any liceitsees. It is available for public inspection in the NRC Public Document Room, 1717 H Street N.W.,
Washington, DC. Single copies are available frcm Mr. McElroy.
Because of the widely differing conditions under which licensees
-ccvered by this proposed regulation operate, the Commission specifically seeks public cooment from small entities. Any small entity-subject to I this regulation which determines that, because of its size, it is likely to bear a disproportionate adverse economic impact should notify the Commission of this in a comment that indicates: (1) The licensee's size-in terms of annual income or revenue, number of employees and,.if the licensee is a treatment center, the number of beds and patients treated annually; (2) how the regulation would result in a significant economic burden on the licensee as compared to that on a large licensee; (3) how the regulations could be modified to take into account the licensee's differing needs or capabilities; (4) the benefits that would be gained or l the detriments that would be avoided to the licensee, if the regulations were modified as suggested by the Commenter; and (5) how the regulation, as modified, would still adequately protect public health and safety.
The Commission is particularly interested in comments on whether individ-uals with special. training and experience (such as treatment technologists, dosimetrists, and radiation therapy physicists) are readily available in the marketplace, either as full-time employees or as a contract service.
05/13/87 24
{
[7590-01]
i 8tikfit Analysis The staff has determined itat a backfit analysis is not required for this rule because these amendment. do not cpply to 10 CFR Part 50 licensees.
V. LIST OF SUBJECTS IN 10 CFR PART 35 i Byproduct material, Drugs, Health devices,, Health professions, Incorporation by reference, Medical devices, Nuclear materials, Occupa-tional safety and health, Penalty, Radiation protection, Reporting and recordkeeping requirements.
VI. TEXT OF PROPOSED REGULATIONS Under the authority of the Atomic Energy Act of 1954, as amended, the Energv Reorganization Act of 1954, as amended, and 5 U.S.C. 553 the NRC is proposing to adopt the following amendments to 10 CFR Part 35.
Part 35 - Medical Use of Byproduct Material
- 1. The authority citation for Part 35 is revised to read as follows:
Authority: Secs. 81, 161, 182, 183, 68 Stat. 935, 948, 953, 954, as amended (42 U.S.C. 2111, 2201, 2232, 2233); sec. 201, 88 Stat. 1242, as amended (42 U.S.C. 5841).
For the purposes of sec. 223, 68 Stat. 958, as amended (42 U.S.C.
2273): SS 35.11, 35.13, 35.20(a) and (b), 35.21(a) and (b), 35.22, 35.23, 35.25, 35.27(a), (c) and (d), 35.31(a), 35.39, 35.43, 35.49, 35.50(a)-(d),
05/13/87 25
1 (7590-01]
35.51(a)-(c), 35.53(a) and (b), 35.59(a)-(c), (e)(1), (g) and (h), 35.60, 35.61, 35.70(a)-(f), 35.75, 35.80(a)-(e), 35.90, 35.92(a), 35.120, 35.200(b), 35.204(a) and (b), 35.205, 35.220, 35.302, 35.310(a),'35.315, 35.320, 35.400, 35.404(a), 35.406(a) and (c), 35.410(a), 35.415, 35.420, 35.432, 35.454, 35.500, 35.520, 35.605, 35.606~, 35.610(a) and (b),
35.615, 35.620, 35.630(a) and (b), 35.632(a)-(f), 35.633,.35.634(a)-(i), ;
35.636(a) and (b), 35.641(a) and (b), 35.643(a) and (b), 35.645(a) and (b),35.654,35.900,35.910,35.920,35.930,35.932,35.934,35.940, 35.941, 35.950, 35.960, 35.961, 35.970, and 35.971 are issued under sec.
161b.,'68 Stat. 948 as amended (42 U.S.C. 2201(b)); and SS 35.14, 35.21(b), 35.22(b), 35.23(b),.35.27(a) and (c), 35.29(b), 35.33(a)-(d),
35.36(b), 35.39, 35.43(b) and (d), 35.50(e), 35.51(d), 35.53(c), 35.59(d) and (e)(2), 35.59(g).and (i), 35.70(g), 35.80(f), 35.92(b), 35.204(c),
35.310(b), 35.315(b), 35.404(b), 35.406(b) and (d), 35.410(b), 35.415(b),
35.610(c),35.615(d)(4),35.630(c),35.632(g),.35.63itj),35.636(c),
35.641(c), 35.643(c), 35.645, and 35.647(c) are issued under sec. 161o.,
68 Stat. 950, as amended (42 U.S.C. 2201(o)).
- 2. In Subpart A--General Information, 6 35.2, the following terms are added in alphabetical order:
S 35.2 Definitions.
a * * * *
" 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.
x a * *
- 05/13/87 26
m
[7590-01]
" Computer generated dose calculation" means a dose calculation that
- has been made by a computer program with no human action necessary other than the input' of patient data, selection of a certain computer program, and the instruction to the computer to begin calculation.
- A A A A
" Manual dose. calculation" means a calculation made by an individual using patient data, tabulated' data or graphs, nomograms, and a calculator that was not specifically designed or programmed for
-radiation therapy calculations. i a a
- x a
" Patient chart" means a record of the diagnosis and radiation.
treatment applied to a patient. .It may be part of the hospital admission chart prepared for each' patient and kept with the patient, or a chart prepared primarily as a result of radiation treatment and kept in-the clinic.
l a' x x a x-
" Prescription" means the written 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 1
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).
- n
- x
- 05/13/87 27 i
g
. 1
[7590-01)
I
'3. In Subpart' 8--General Administrative Requiren,ents, S 35.39 is !
-added to read as follows:
S 35.39 Ordering, prescribing, and administering certain
]
radiopharmaceuticals. I i
(a)1 A' licensee may not order any radiopharmaceutical of iodine for. 1
~ diagnosis or therapy or any radiopharmaceutical for therapy without.the approval of the authorized user.
(b). A physician may not prescribe administration of a radio-pharmaceutical of' iodine for diagnosis or' therapy or any radiopharmaceut-ical. for therapy without personally examining the patient and the patient's chart, and consulting with the referring physician if reasonably available.
Prescriptions for these byproduct materials must be in writing, and must '
include the ' patient's name, the radiopharmaceutical, dosage, and route of administration.
.(c) A licensee may not administer a radiopharmaceutical of iodine
'for diagnosis or therapy or any radiopharmaceutical for therapy without comparing the radiopharmaceutical label and dosage:on hand with the physician's prescription.
- 4. In Subpart B--General Administrative Requirements, S 35.43 is added to read as follows:
S 35.43 ' ascriptions, records, and checks of medical use for therapy.
(a) The uethorized user or a physician under supervision of the l L authorized user shall ensure that, if there is a primary care physician, the patient has been referred for a therapeutic clinical procedure that requires the medical use of byproduct material.
i 05/19/87 28
[7590-01]
(b) 82 fore beginning a patient's treatment, the licensee shall verify that the authorized user or a physician working under supervision of the authorized user has personally made, dated, and signed a written prescrip-tion in the patient's chart that identifies the body part to be treated.
Any change in the prescription must also be made in writing in the patient's chart, and must be dated and signed.
(1) For radiopharmaceutical therapy, the prescription must also identify the radiopharmaceutical, the amount of activity to be administered, and the route of administration.
(2) For bra;;hytherapy, the prescription must also identify the sources of radiation and the total tumor dose.
(3) For teletherapy, the prescription must also identify the-teletherapy unit to be used, the prescribed dose, and the treatment j P *** klt ' YEkir1g ' 4 4Y k (c) Prescriptions and other records made regarding the medical use of byproduct material must be legible and unambiguous.
(d) The licensee shall instruct all workers involved in the radiation therapy process or, ally and in writing to request clarification from the prescribing physician if any element of a prescription or other record is unclear, ambiguous, or apparently erroneous.
(
- 5. In Subpart C--General Technical Requirements, S 35.65 is added to read as follows:
1 1
9 35.65 Discrepancies in records and observations.
A licensee may not use byproduct material for medical use on a l
patient if there is a discrepancy in records, observations, or physical :
05/19/87 29 l
l
, \
[7590-01] l 1
measurements that may resu't in a misadministration. A licensee may resume use after resoh ng u:e discrepancy.
- 6. .In Subpart F--Radiopharmaceuticals for Therapy, 6 35.302 is added to read as follows:
S 35.302 Administration of radiopharmaceutical dosages.
A licensee shall verify that the prescribed radiopharmaceutical is being administered by comparing the written prescription and the container label.
- 7. D Subpart G--Sources for Brachytherapy, 6 35.432 is added to read as follows:
S 35.432 Source strength measurements.
(a) A licensee shall measure the source strength of sources before first use and annually thereafter. Sources that are in storage and not being used do not have to be measured; they must be measured before they are placed in service again. For sources manufactured and supplied in lots of nominally identical sources, a sample from each lot may be selected rather than measuring each source.
(b) When performing dose calculations, a licensee may use the source strength reported by the manufacturer rather than using the source strength measured by the licensee.
- 8. In Subpart G--Sources for Brachytherapy, 6 35.452 is added to read as follows:
S 35.452 Physical measurements of patient.
[ Reserved]
05/27/87 30
O
[7590-01]
- 9. In Subpart G--Sources for Brachytherapy, 6 35.454 is added to read as follows:
6 35.454 Check of dose calculations.
A licensee shall check dose calculations for accuracy before 50 percent of the prescribed dose has been administered. The check must provide assurance that the final treatment plan will provide the dose prescribed in the patient's chart.
(a) Manual dose calculations must be checked for accuracy by an individual who did not make the calculations.
(b) Computer generated dose calculations must be checked by examining the-calculation printout to assure that the correct parameters
~
and parameter values were used in the calculation. The check must be made by an individual who did not enter the patient data or prescription into the computer.
(c) If the prescribing physician makes a determination to delay treatment in order'to perform the checks of dose calculations required 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 rirescribing physician shall make a notation of this determination on the patient's chart, and the licensee shall perform the checks as soon as practicable.
- 10. In Subpart I--Teletherapy, 6 35.632, the introductory text of paragraph (b) and paragraph (b)(1) are revised to read as follows:
6 35.632 Full calibration measurements.
x * * *
- P I
05/19/87 31 !
l
_ __ - -- - - - - - 1
(7590-01]
(b) To satisfy the requirement of paragraph (a) of this section, full calibration measurements must include determination of:
(1) The output within 13 percent for the range of field sizes, range of distances, and selection of beam modify'ing devices (for example:
trays, wedges, and the stock material that is used for making compensators and boluses) used for medical use;
- 11. In Subpart I--Teletherapy, S 35.633 is added to read as follows:
S 35.633 Independent check of full calibration measurements.
(a) A licensee shall have an independent check of the output determined within one month after completion of the full calibration required by S 35.632.
(b) The independent check must be performed by a teletherapy l physicist who did not perform the full calibration and made using e dosimetry system other than the o'ne used to measure the output during the full calibration. The teletherapy physicist does not have to be listed as a teletherapy physicist on an NRC or Agreement State license.
The dosimetry system may be one described in S 35.630, or it may. be ,
another system that provides a similar level of accuracy and precision.
i
- 12. In Subpart I--Teletherapy, 6 35.652 is added to read as follows:
6 35.652 Physical measurements of patient.
l [ Reserved]
l l
f 13. In Subpart I--Teletherapy, S 35.654 is added to read as follows:
l i
a 05/19/87 32 i 1
[7590-01] j I
i i'
f 35.654 Checks of dose calculaticas and measurements of dose.
A licensee shall check dose calculations for accuracy before 20 percent of the prescribed dose has been administered. The check must provide assurance that the final treatment plan will provide the dose '
prescribed in the patient's chart.
(a) Manual dose calculations must be checked for accuracy by an individual who did not make the calculations.
(b) Computer generated dose calculations must be checked by examining the calculation printout to assure that the correct parameters and parameter values were used in the calculation. The check must be made by an individual who did not enter the patient data or prescription into the computer.
(c) A licensee shall make a weekly accuracy check of daily arithmetic calculations that have been made in patient's charts.
(d) If the patient's dose calculations include parameters or parameter values that fall outside the range of those measured in calibrating the teletherapy unit, the licensee shall make a physical measurement of the, dose rate to be administered to the patient. This measurement must be made before 20 percent of the prescribed dose has i
been administered.
(e) If the prescribing physician makes a determination that to delay treatment in order to perform the checks of dose calculations or physical measurements required by this section would jeopardize the patient's health because of the emergent nature of the patient's '
condition, the licensee may provide the prescribed treatment without 1
performing the checks of dose calculations or physical measurements; the 05/19/87 33 l
P L_______________._
[7590-01]
prescribing physician shall make a notation.of this. determination on the patient's chart, and the licensee shall perform the checks of calculations or physical measurements as soon as practicable.
Dated at Washington,'DC, this day of , 1987.
For the Nuclear Regulatory Commission, Samuel J. Chilk, Secretary of the Commission.
t c
i i
05/27/87 34
'l
g ', c . :' -
ENCLOSURE 6
MEDICAL USE PROGRAM RESOURCE NEEDS In the Staff Requirements Memorandum dated March 26, 1037, the staff was instructed to provide an analysis of the additional NRC resources necessary to implement the requirements of the proposed rule and to address recommen-dations in Enclosure 3, " Response to Questions..." of SECY-87-29. Staff resources are summarized below. The numbers in parentheses include overhead.
Total Resources Current Proposed Increase l
Program Development 1 ( 1.1) 4 ( 4.6) 3 ( 3.4)
Licensing 7(8.0) 10 (11.4) 3 ( 3.4)
Inspection 13 (14.9) 28 (32.0) 15 (17.2) l Allocation of Proposed Total Resources Program Development Revise and update regulatory guides 1.0 ( 1.1) H0*
1 Provide technical support for rulemaking .5 ( 0.6) HQ Manage studies related to training of physicians, technologists, and dosimetrists, and quality assurance programs .5 ( 0.6) H0 [+$200k]
l Analyze events and provide feedback; analyze new technology and medical use developments affecting regula-tions; participate with industry and other organizations to develop initiatives to improve quality; and develop programmatic initiatives, e.g., performance indicators 2.0 ( 2.3) HQ
- HQ-Headquarters
~ ~
, . A' 2
i Licensing Review projected license casework 7.0(8.0)R*
Increased load due to basic quality assurance rule .5 ( 0.6)'R' Increased load due to comprehensive quality assurance rule 1.0(1.1)R Monitor licensing cases for quality.
and completeness, provide refresher training for staff 1.5(1.7)HQ*'
Inspection Needed for 3-year inspection cycle 13 (14.9) R Needed to increase to 1.5-year inspection cycle 12 (13.7)R Increased load'due to basic quality assurance rule 1 ( 1.1) R Increased load due to comprehensive quality assurance rule 2 ( 2.3).R
- R-Regional; HQ-Headquarters ,
.J