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. UNITED STATES B ckjctd, RES
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- Taylor September 2,.1987 Rehm-m Jordan, AE0D OFFICE OF THE Murray, 0GC/B SECRETARY NMcElroy, NMSS Shelton,. ARM Meyer ARM MEMORANDUM FOR:
.VictorIStello, Jr.,-Executive Director
-for. Operations FROM:-
uel J. Chilk, Secretary.
SUBJECT:
SECY-87-29A - MISADMINISTRATION This is to advise you that the Commission (with Chairman Zech and Commissioners Roberts, Bernthal and Carr agreeing) has approved the proposed rule and the ANPR subject.to:-
1.
The Proposed Rule and the Advanced Notice'of Proposed Rulemaking should be revised to more thoroughly yet concisely state the need for two separate actions to immediately address basic quality assurance requirements in parallel with efforts to-examine the need for more comprehensive j
QA requirements; and (NMSS) 2.
The attached modifications.
The~ Commission requests that a draft final rule on basic QA
- be returned for Commission review by April 30, 1988 and a draft proposed rule on comprehensive OA by September 30,
- 1988, i
(EDO.) (SECY SUSPENSE:
As stated - high priority) j (RES) i Commissioner Rogers did not participate in this action.
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Attachments:
As Stated l
Copies:
Chairman Zech Commissioner Roberts i
. Commissioner Bernthal g gg*
Commissioner Carr Commissioner Rogers Dato _
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NUCLEAR REGULATORY COMMISSION 10 CFR PART 35 Comprehensive Quality Assurance in Medical Use and a Standard of Care AGENCY:
Nuclear Regulatory Commission.
O 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-g tion therapy and diagnostic uses involving large radiation dosages.
In f
addition to the current requirements for quality assurance, the contem-plated amendments would require licensees that offer teletherapy or brachy.
I 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 I
requirements are needed, and invites advice and recommendations on several questions that will have to be addressed in the rulemaking process.
The NRC is also requesting comments on some basic quality assurance program requirements set out in a proposed rule published elsewhere in this issue.
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-I tion cannot be given except as to comments received on or before this date.
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The NRC has the authority to regulate the medical use of byproduct material to protect the health and safety of patients, but also recognizes that physicians have the primary responsibility for the protection of their patients.
NRC regulations are predicated on the assumption that properly trained and adequately informed physicians will make decisions in the best interest of their patients.
I NRC's Responsibilities in the Medical Use of Byproduct Material
{4a develepit; this rul;;; king the NRC has had te deal with the-r,creal 4
ri t ettendant to ma & al ce"a and the *id ::seciated= Wit?Fthe careless--
-l 2 e of byprr e t u. w.-u; ~
The NRr _h aware nf tha n"blic het!th ben 0#4t; Z FJ d =ir, th y edical us: Of byproduct mat;ri:1, and 21so-iwaware-of=the-smabl,=but-Yeal, risk attendant to the preper and responsib4 wMit"atase-ef
- byprcduct materiel.w "..;ve TheNRCdrawsalinebetweentheunavoid-able risks attendant to purposefully prescribed and properly performed clinical procedures and the unacceptable risks of improper or careless use of byproduct material in medicine.
Th2 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 l
the basis for determining that a need exists for this rulemaking.
2For a copy this report, write to Kathleen M. Black, Office for Analysis and Evaluation of Operational Data, Nuclear Regulatory Commission, Washington, DC 20555.
Ask for report AE0D/C505.
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i, 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.
Inaaewate tra4R4mg Jf WerkerS haS eaWSed miSadmin49%ratien5v Althewgh additienal Improved training of the medical personnel who handle and administer byproduct material may net carl reduceggtWGMeh@te eM#W34@thepotentialforerror.theehaneeofsemekindsofmistakes, 46 Thorouph training should also clearly impress on each individual
' involved in the medical use of byproduct mrterial 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 All information that plays a role in integral to, the process, whether specific to the patient or to the clinic, should be carefully examined for clarity, applicability, and i
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 misadministration event germinates. NRC recognizes that this is net a problem i_s, not s
specific to the medical use of byproduct material. {Any-pMeees 67 pr:Aet J eeeedure: th:t r;;;;ir e in 'iVi A;1=6tt;atkrut4 Amit 2d: f.miet i q=r.titier the 6 are 2,mResh =ritudecand+=adwapgardly_ Cike;y
--a f W ir j M e esere=es i m ; r % *a-+ " :--- :rr:] Computerized radiation therapy treatment planning may reduce the chance of mistakes in sealed source tre6tment planning, and " record and verify" systems that 5
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check teletherapy unit orientations and settings may reduce the chance of mistakes in teletherapy administration. But even these systems perform I
must ultimately rely, their fune44 ens on quantities that are initially measured, recorded, and entered into memory by individuals.
Lack of redundancy means that there is exists no independent mechanism for eheek4mg for mistakes detecting errors. An independent eheek verification requires having examination by a second individual examine of each data entry, whether a physical measurement or a number f
copied from a tabl.e of values, and eheek eaeh as well'as a check of arithmetic operations for correctness.
Redundancy requires that two separate systems produce the same result.
For purposes of planning radiation' therapy, treatment planning the best method of early detection of mistakes may be a simple independent check. Redundaneyerinaependent eheeks. verification may also be needed in eaeh therapy fae414tyls need to be incorporated into 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 citinge areas where a change in the process might reduce'the chance for mistakes future error.
Th4sese analysis leads observations have led the NRC to some general conclusions regarding ouality assurance.
The radiation therapy process should be planned with the realization t
that individuals are more likely to make mistakes in the absence of good l
Quality assurance. Some simple aids may include using tables and graphs that are clearly titled and easy to read, and use of a uniform written prescription format. Based en inspeet4eR repePts, the NRG bel 4 eves NRC inspections have revealed that about ten percent of teletherapy unit cal.ibrations an spot-checks are incomplete.
Checklists could be used to assure completeness.
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4 M edundancy function must be integral to the design of the radiation
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therapy process.
Independent-douMe check-procedures-and-redundancy.
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S procedures chould ha concidered.
Eeeh-entry and calculation in a treat-1 cx&d ment plan should be checked by an individual who did not make the treat-j
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ment plan.
Each patient's chart should be reviewed weekly to check for j
l accumulated do;e 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 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-8 ability of equipment are not commonplace in sealed source therapy.
Reperts of Diagnostic Misadministration That Result in Doses in the Therapy Range The riRC has also published a report on misadministration cf 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 1
which patients were administered one to ten millicuries of iodine-131 ZFor a single copy, submit a request for report number AE00/N701 to the address in footnote 1.
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with a resulting thyroid dose of several thousand rads. Many of the events l
demonstrated that the physician authorized user failed,to review 4s not l
rev4ew4ng the medical history of the referred patient to determine the suitability of a particular clinical procedure.
In,many cases it espears that the referring physician, who is not a nuclear medicine expert, and the nuclear medicine technologist, who is not a medical expert, frequently determine wbich_radiopharmaceutical should be administered.
Furthermore, STFJ In same events chnologists were net unfamiliar with the clinical procedure prescribed by the authorized user and mistakenly administered therefore that When a dosage that was not reouested.
It is apparentt whenever radiopharmaceuticals that son give capable of producing therapy.
doses are used, unclear nomenclature, lack of dewbie-sheeks independent verification, and inadequate training sann64 be telerated are essential.
l Earlier NRC E' forts 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 10 CFR 25.632 and 10 CFR 35.634).
This rulemaking was precipitated I
l by the inaction of a single licensee.
The output of a teletherapy unit was incorrectly calculated and the licensee made no physical measurements l
to determine whether the calculation was correct.
This in1ctica resulted in cobalt-60 teletherapy being misadministered to 400 patients.
The 1979 l
I rule addressed the circumstances surrounding that event but did not i
critically examine the entire radiation therapy process.
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s Voluntary Initiatives The Commission is aware of voluntary initiatives to improve quality assurance. A notable example is the Patterns of Care study managed by the American Cnllege 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 examination can detect whatever procedural flaws may be present as well as determine the precision and accuracy of day-to-day service.
Wafertunately these I_t, 3 NRC's position t_hn voluntary programs have alone gy.not provide adequate assurance of public health and safety.
f Serious misadministration continue to occur. The NRC would be remiss in its responsibilities were it to eent4mwe te rely en voluntary pregrams te redwee the ehamee of m4sadm4R4strat4 ens, fail _ g examine thoroughly all avenues available to reduce unnecessary exposure to licensed material.
Summary The NRC believes many misadministration could reascnably be avoided if certain basic quality assurance steps were included in the radiation therapy process.
1 Effect on the Agreement States Program Many States, known as Agreement States, have assumed responsibility.y for. regulating certain radioactive materials within their respective borders by agreement with the NRC.
(This kind of agreement is authorized l
by the Atomic Energy Act.) They issue licenses for the use of byproduct material, and currently regulate about 5,000 medical licensees.
Because l
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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.
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Request For Comments i
The NRC has prepared the following questions to' elicit comments on n u) no & b.t. & Q methods of preventing misadministration.
Comments do net have t.e cespond
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to these questions alone; other related topics or alternatives may be M M -dessib if the, commenter believes 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 standards.
The Commission, in concert with tr.edical experts, could identify and adopt by rulemaking the key elements 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 he no misadministration.
What other mechanisms should be considered?
2.
Should the definition of misadministration in 10 CFR 35.2 be l
changed?
Is it clear and complete?
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Is the definition sufficiently broad to include all appropriate activities?
Is it so broad as to include inappropriate activities?
Is the term
" misadministration" appropriately descriptive of the activities? Should some more descriptive term be used?
5.
The NRC knows of one instance in which radiation was administered j
to a patient withcut a request from the primary care physician.
Should the l
NRC require that the authorized user actively consult with the primary care I
physician before prescribing 'adiation 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 s administered is the patient for whom radiation I
was intended?
5.
What current standards exist to ensure the adequacy and uniformity 34 ~a o taw y of training of all individuals wno participate in the radiation thbeapy-A p W t '.
prec:::? 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 throughout the radiation therapy community?
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1 Should the NRC require licensees to administer written examinations to l
workers and evaluate them before allowing the workers to participate in 1
l radiation therapy? Should periodic retraining and re-examination be required?
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6.
What other regulatory, certifying, accrediting, or inspecting organizations examine medical quality assurance programs? Describe the purpose, objectives, and rigor of these examinations.
7.
Should the NRC require physicians to provide patients, upon
&/or g
request, a record of the radiation dose prescribed ec.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 and mini-mize human error?
Teletherapy and Brachytherapy The following questions apply to the provicion of teletherapy and bracilytherapy services.
1.
What performance criteria could be adopted to assure appropriate care', minimize the chance of human error, ano mitigate the consequences of (Nb Y
rror?
2.
To assure adequacy of continued experience, some organizations
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i recommend that certain surgical or test-tube procedures o^;ly be performed
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if the practitioner has a sufficient case-load to assure that dexterity
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and familiarity with the procedure are ast=lest.
Should NRC require that X licensees have a certain minimum case-load to assure that their employees i
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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?
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4.
The itegulatory Flexibility Act requires that regulatory agencies i
examine the cost of compliance with regulations.
How much does a quality cssurance program cost per patient or per year? What fraction of staff l
time, including physicians, physicists, dosimetrists, technologists, and j
nurses, is currently budgeted for quality assurance work? hb more staff-m =needed=to meet quality e5surance requirements, are the requisite
%div4dua4-PeadHy-oveHebh or woulo-a= lengthy-load-41Rimrtre needed?}
5.
Are there complete model quality assurance programs already available that address every step of the radiation therapy pr.;ess, or
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i will model programs have to be developed? Should physical measurements, redundant calculations, or both be required to assure that the dose given
{
l is the same as the dose prescribed? What other areas are, or shoula be, I
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 vould 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 and knowledge 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 algorithms on which the programs are based?
8.
What additional methods are available for reducing the frequency or impact of human error?
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Radiopharmaceutic.al Therapy The NRC requires that licensees use only certain radiopharmaceuticals for specified therapy clinical procedures, measure the radioactivity in radiopharmaceutical dosages before administration, and have a measurement quality assurance program for the dose calibrator used to make that
&>wp V455 measurement.
These requirements appear to cc;gru; clP the steps in a radiopharmaceutical therapy physical quality assurancs program.
- However, the NRC invites public comment on.this position.
There have been cases in which, due to procedural failure, a radio-pharmaceutical other than that intended has been ordered and administered.
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-ment,s nf prescription and verification before administration of any phar-maceutical.
The NRC would appreciate suggestions on methods to assure that the clinical procedure (including radiopharmaceutical, dosage, and route of administration) intended by the authorized user is prescribed, and that the prescribed clinical procedure is the clinical procedure that is performed.
The NRC has observed several cases of miscommunication of the referrir.g 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?
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Standards of Care a ^^^dh C, A rticularly m unc 7_:g7,gg :,3, : - 19 n o p u+
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Ser'- caLN!, ea eder=;;.at pel k.7 that ;t sen ;;;1y to S dical use
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The following questions apply to the medical use of byproduct material 2^d *^ ti. 0.....L y
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Is there a clear, generally accepted standard of care that the NRC can adopt?
If yes, please describe it.
If not, please describe a L standard that NRC could adopt.
Is a standard needed if NRC has
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comprehensive prescriptive requirements?
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 penaltips be imposed on employees?
s to cyQ. Pur 2 hppdk C.,
Should NRC's Enforcement Policy be changed, a,nd if so, how?
What effect would such a standard or comprehensive, prescriptive requirements have on provisions of radiation therapy care?
i 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:
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EtlCLOSURE 2 i
i Pages 5 and 7-11 of the NPR (Enclosure 2) are virtually identical to pp. 4-10 of the ANPR (Enclosure 1) and should be likewise modified I
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Unfortunately these voluntary programs have not provided adequate
-1 assurance of public health and safety.
Serious misadministration con-i l
l tinue to occur.
The NRC would be remiss in its responsibilities were it
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to continue to rely on voluntary programs to reduce the chance of misadministration, i
j Summary
'I J
The NRC believes many misadministration could reasonably be avoided if certain basic quality assurance steps were included in the radiation l
l therapy process.*
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The NRC staff has examined literature on the radiation therapy i
process and consulted with. experts practicing in the field of radiation therapy to discuss the need for these quality assurance steps.
The NRC believes that the steps are basic to the radiation therapy process.
The regulations that would require implementation of these steps will provide guidance for improved patient safety and_will also provide a LS A % S w s 3 basis for NRC enforcement action /jF not followed.
The NRC is also examining the need for a r9quirement 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 j
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S 35.2 Definitions The NRC has added several definitions to the regulations to ensure that the regulatory requirements are clear. The definitions are intended to be similar to those already in use in radiation therapy.
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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 of at least a full day's inventory of the radiophannaceutical to the patient fhi:. typ; 4 ever,t is-very ur.likely 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.
The Commission would appreciate public comment on how 11 might address future diagnostic q
applications of, radioisotopes which, H misadministered, could produce f
doses jn the therapy range.
5 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 rec.uires radiation dose to the patient I
is indicated.
When a decision has been made tc treat a patient for any malady, whether with radiation, surgery, or drugs, a physician makes a patient I
chart that incluocs iriformation about the care provided for :he patient.
The chart is made for medica' and legal reasons.
All charts contain the i
patient's r,ame, the rescits 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 b
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I to administer the radiation dose, and device; 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 l
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 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.
heraesidho4ene fit Mained ty=impos4ng addittana12scordkeeping=.requtrenwmts 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 and 05/13/87 14
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this may lead to misadministration.
Therefore, the NRC would require i
licensees to specifically instruct workers to request clarification in l
l cases where there may be ambiguity or error.
PL p.s The NRC consider d escribing 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.
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 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 to by the physician, physicist, technologist, and dosimetrist during a treatment planning meeting.
Daily tallies of administered dose may not agree with projections made by multiplying the daily dose by the number of treatment d6ys.
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.as radiographs, or images from computerized tomography, ultrasound, nuclear medicine, or nuclear magnetic resonance.
The NRC considered requiring that two individuals independently make the physical measure-ments of.the patient that are needed for dosimetry purposes, and believes that such a requirement may reduce the chance of misadministration.
However, because hereareafinitenumberofindividualstrainedtodo\\
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uch a requirement could'(egatively impact 4he delivery of' these' tasks medic care.
Therefore, a r frement of this e has not be included u However, the NRC will cont ue to examine this matter. f 1
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S 35.454 Check of dose calculations, and S 35.654 Checks and measurements of dose Dose calculations are made for each teletherapy and brachytherapy patient before adiatio'n is administered to determine how long the source must be used to deliver the prescribed radiation dose to the treatment volume.
Several therapy misadministration have been precipitated by arithmetic mistakes or incorrect assumptions in dose calculations.
An independent check will likely uncover many of these mistakes.
Ioss11y, 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 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 N eause the 05/13/87 17
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FYI: Thompson, NMSS y, NMss-RESPONSE SHEET i
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SAMUEL J. CHILK, SECRETARY OF THE COMMISSION FROM:
COMMISSIONER BERNTHAL
SUBJECT:
SECY-87-294 - MISADMINISTRATION APPROVED _
DISAPPROVED ABSTAIN NOT PARTICIPATING REQUEST DISCUSSION b
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PLEASE ALSO RESPOND TO AND/OR COMMENT ON OGC/0PE i
MEMORANDUM IF ONE HAS BEEN ISSUED ON THIS PAPER.
NRC-SECY FORM DEC 80
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The NRC has the authority to regulate the medical use of byproduct material to protect the health and safety of patients, but also recognizes that physicians have the primary responsibility for the protection of their patients.
NRC 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 j
In develop n s rulemaking the NRC has had to deakwithInorm2 risk attendant to medical care het with the careless j use of byprodudt ma-1 The NRC is aware of the public 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 paocedures and the unacceptable risks of improper or careless 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.
2For a copy 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.
4
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.
Inadewate train 4mg ef werkers has eaused misadministration, A4thewsk additient.4 Improved training of the medical p_ersonnel who handle and administer byproduct material may net can reduce 2 g not completely eliminate the potential for error. the ehanee of seme kinds of mistakes, 46 Thorouoh training should also clearly impress on each individual involved in the medical use of byproduct material that a clear communication of concepts and quantities as well as systematic checks for revealing mistakes early in the process are both essential for the delivery of quality care.
Eaeh bit of All information that plays a rele in integral tpo 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 misadministration event' germinates.
NRC recognizes that this 4s met a problem is not specific to the medical use of byproduct material. Any preeess er predwet Procedures that requires individual attention to a multitude of related quartities that are similar in magnitude and used repeatedly w&44 likely eenta4H mistakes are especially vulnerable to human error. Computerized o
radiation therapy treatment planning may reduce the chance of mistakes in sealed source treatment planning, and " record and ved fy" systems that 5
check teletherapy unit orientations and settings may reduce the chance of mistakes in teletherapy administration. But even these systems perfem must ultimately rely their fune44 ens on quantities that are initially measured, recorded, and entered into memory by individuals.
Lack of redundancy means that there 4s exists no independent mechanism for eheeking fer mistakes detecting errors. An independent eheek verification requires having examination h a second individual examine of each data entti, whether a physical measurement or a number l
copied -from a-table of values, and eheek eaeh as well as a check of i
arithmetic operation,s_ for correctness. Redundancy requires that two separate systems produce the same result.
For purposes of planning radiation therapy, treatment planning the best method of early detection of mistakes may be a simple independent check.
RedundaneyerJ_ndependent eheeks, verification may also be needed 4n eaeh therapy fae414tyls need to h incorporated into precedures 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 citinge areas where a change in the process might reduce the chance for m4 stakes future error.
Th4sese analysis leads observations have led the NRC to some general conclusions regarding ouality assurance.
The radiation therapy process should be planned with the realization that individuals are more likely to make mistakes in the absence of good quality assurance. Some simple aids may include using tables and graphs that are clearly titled and easy to read, and use of a uniform written i
prescription format. Based en inspeet4en reperts, the NRG believes NRC inspections have revealed that about ten percent of teletherapy unit calibrations an spot-checks are incomplete. Checklists could be used to assure completeness.
7
[7590-01) e9n&& v#{1W p1 h
/rredundancy functM must be integral to the design of the radiation A
therapy process.
bdependen-t-dvubie check procedures aiid redundency treced"ran should ha rendd0re!
entr and calculatio in a treat-can&ved-ment plan should be checked by an individual who did not make the treat-Each patient's chart should be reviewed Lech'y &
V to check for ment plan.
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 radioactivity actually administered to the individual patient would provide assurance 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 report was a review of fourteen recent misadministration events in I
which patients were administered one to ten millicuries of iodine-131 l
i ZFor a single copy, submit a request for report number AE00/N701 to the address in footnote 1.
8 l
l
with a resulting thyroid dose of several thousand rads. Many of the events demonstrated that tb physician authorized user failed to review 4s net i
iav4ew4mg the medical history of the referred patient to determine the suitability of a particular clinical procedure.
In many cases it appears that the referring physician, who is not a nuclear medicine expert, and the i
nuclear medicine technologist, who is not a medical expert, frequently determine which radiopharmaceutical should be administered.
Furthermore, in seme events technologists were net unfamiliar with the clinical procedure prescribed by the authorized user and may mistakenly administered a dosage that was not requested.
It is apparent, therefore that When l
whenever radiopharmaceuticals that can give capable of producing therapy doses are used, unclear nomenclature, laek ef dewbie-eheeks independent verification, and inadequate training sannet be telerated are essential.
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 sc.ne basic quality assurance requirements for teletherapy (see 10 CFR 35.632 and 10 CFR 35.634).
This rulemaking was precipitated by the inaction 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 inisadministered to 400 patients.
The 1979 1
rule addressed the circumstances surrounding that event but did not critically examine the entire radiation therapy process.
]
1 a
[
Voluntary initiatives The Commission is aware of voluntary initiatives to improve quality assurance. A notable example is the Patterns 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 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 may be present as well as' i
determine the precision and accuracy of day-to-day service.
Unfortunately these It is NRC's position that voluntary programs have alone m_ay not provide adeouate assurance of public health and safety.
Serious misadministration continue'to occur. The NRC would be remiss in its responsibilities were it to eentinue te rely en veluntary pregrams te redwee the ehanee of misadministrat4 ens, fail to, examine thoroughly all avenues available to, reduce unnecessary exposure _t_o, licensed material.
o Summary The NRC believes many misadministration could reasonably be avoided if certain basic quality assurance steps were included in the radiation 4
therapy process.
I
-Effect on the Agreement States Program J
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 l
material, and currently regulate about 5,000 medical licensees.
Because 10 L
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[7590-01) j.
i the NRC will request the Agreement States, as a matter of compatibility, to impleraent 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 Au<) no 4-b ccabQ methods of preventing misadministration.
Comments de cet have to respond >--es t3 these questions alone; other related topics or alternatives may be C'aa_(,
MW -describc!if the commenter believes N will help to resolve isaas 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 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 j
be no 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?
I i
11 l
[7590-01]
+
Is the definition sufficiently broad to include all appropriate activities?
t l
Is it so broad as to include inappropriate activities?
Is the term
" misadministration" appropriately descriptive of the activities?
Should some more descriptive term be used?
3.
The NRC knows of one instance in which radiation was' administered to a patient without a reouest frem the primary care physician.
Should the NRC require that the authorized user actively consult with the primary care l
I physician before pr2 scribing 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 I
patient ho s administered 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.
p'rocess? 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 tiaining is necessary?
In either case, how can HRC ensure the adequacy and consistency of this training 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 I
radiation therapy?
Should periodic retraining and re-examination be required?
12
[7590-01) f What other regulatory, certifying, accrediting, or inspecting l
6.
Describe the organizations examine medical quality assurance programs?
purpose, objectives, and rigor of these examinations.
Should the NRC require physicians to provide patients, upon
- (
md/or 7.
What infor-request, a record of the radiation dose prescribed oe given?
mation should or should not be provided?
Apart from increased NRC oversight, what changes in industry 8.
practice or standards could improve the quality of performance and m mize human error?
Teletherapy and Brar,j,her m The following qu w /;ons apply to the provision of teletherapy and brachytherapy services.
What performance criteria could be adopted to assure appropriate 1.
care, minimize the chance of human error, anc' mitigate the consequ Y
rror?
To assure adequacy of centinued experience, some organizations 2.
recommend that certain surgical or test-tube procedures only be perfor if the practitioner has a sufficient case-load to assure that dexterity M. Should NRC require that X and familiarity with tht: procedure are rat-4mt.
licensees have a certain minimum case-load to assure that their employe retain their expertise in performing radiation therapy clinical and ouality assurance procedures?
What fraction of licensees already have a quality assurance 3.
program? What are its key elements?
[7590-01]
9 t
l.
Radiopharmaceutical Therapy The NRC requires that licensees use only certain radiopharmaceuticals l
L for specified therapy clinical procedures, measure the radioactivity in i
radiopharmaceutical dosages before administration, and have a measurement quality assurance program for the dose calibrator used to make that
&>tc.cavfe55 measurement.
These requirements appear to compri3; Ff'the steps in a i
radiopharmaceutical therapy physical quality assurance program.
- However, l
the NRC invites public comment on this position.
There have been cases in which, due to procedural failure, a radio-pharmaceutical other than that intended has been ordered and administered.
Many of these cases began with miscommunication between the referring physician and the licensee.
Some began with miscommunication between the l
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-l 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?
15
r- -
i.
i 1
ENCLOSURE 2 Pages 5 and 7-11 of the NPR (Enclosure 2) are virtually identical to pp. 4-10 of the ANPR (Enc?nsure 1) and should be likewise modified
k cl e[7590 Q- ]
I 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 tne chance of misadministration.
Summary I
The NRC believes many misadministration could reasonably be avo',ded 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 assurance steps.
The NRC believes that the steps are basic to the radiation therapy process.
The regulations that would require implementation of these steps will provide guidance for improved patie t safety and will also provide a
'1 SL~id % S M basis for NRC enforcement action 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 propnsed rulemaking published elsewhere l
in this issue of the Federal Register.
l III.
DISCUSSION OF PROPOSED REGULATORY TEXT l
l S 35.2 Definitions The NRC has added several definitions to the regulations to ensure that the regulatory requirements are clear.
The definitions are intended to be similar to those already in use in radiation tnerapy.
i 05/13/87 11 i
c p1102, July 1986). Neither of these types of misadministration pose a clear hazard'to the patient. To niisadminister 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 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. The Comission would appreciate public comment on how it might address future diagnostic applications of radioisotopes which, if misadministered, could produce doses in,the therapy rance.
n M 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, 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 1
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FYI: Thompson, NMSS N0TATI0N
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TRehm 3ESPONSE SHEET LTO:
SA5UEl. J CHitx, SECRETARY OF THE COMMI.SSION FROM:
consISSzousa losERTS
SUBJECT:
SECY-87-294-MISADMINISTRATION APPROVED xd DISAPPROVED ABSTAIN NOT PARTICIPATING
' REQUEST DISCUSSION _
COMMENTS:
Please make the' attached modifications to maintain appropriate regulatoryobjectivity.g; J'%
4
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51aNAIURL YEs N_o Entered on "AS"
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ggjg SECRETARIAT NOTE:
PLEASE ALSO RESPOND TO AND/OR COMMENT ON MEMORANDUM IF ONE HAS BEEN ISSUED ON THIS PAPE NRC-SECY FORM DEc, 80
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[7590-01)
The NRC has the authority to regulate the medical use of byproduct trial to protect the health ano safety of patients, but also recognizes that physicians have the primary responsibility for the protection of their patients.
RC 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 t risk attendant to medical care and the risk associate ess use of byproduct material.
{ A 2C !; ;
.e vi une puviiu neaica venciaus ocurueu in stie med' :1
- .f % ;r; L t u,ouerial, and also is aware of the smali, o'uT.
emm1 whk nH
^--..w une gruper ano responsione mecica use 'f o
by ~c t;t u.a m iais.-i:; ~ c he NRC draws a line between the unavoid-ab,1e risks attendant to purposefully prescribed and properly p clinical procedures and the unacceptable risks of improper or r ormed e 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.
I
\\
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 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 report, write to Kathl and Evaluation of Operational Data, Nuclear Regulatory Commissio Washington, DC 20555.
Ask for report AE00/C505.
4
i a
D590-01]
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.
Inadequate trair.ing of workers has cauced 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 cf 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 of byproduct material. Inv ne - ee l
r ri:t th:t c;v4~e indiv4 M 1 a-2" ^.t i,,, w a muiu ww. J 7:!:t:d ;' :"t't# : '"?+
c 4 # ' r '
=
.-it.J on...,, J. g.. w w l,y
- 1 : a'l; :
-*'4m m4=+2ka<
Computerized radiation therapy treatment planning may reduce the chance of mistakes in i
sealed source treatment planning, and " record and verify" systems that 5
~
[7590-01]
l l
A' edundancy function must be integral to the design of the radiation ther k procsss.
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 v
assurance program for the teletherapy unit should include a periodic check j
of the teletherapy unit output and an occasior.a1 detailed examination of
/
the complete teletherapy process, including physical measurements, by an V
R4 n
y
')outside expert with an eye towards systematic errors and system improvements.
Y A program that requires a physical measurement of the dose or amount j
4 of radioactivity actually administered to the individual patient would k
provide assurance 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-abilityof equipment are not commonplace in sealed source therapy.
Reports of Diagnostic Misadministration That Result in Doses I
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 l
ZFor a singl<e copy, submit a request for report number AE00/N701 to the address in footnote 1.
8
j
[7590-01]
4 The Regulatory Flexibility Act requires that regulato exan6=d the cost of compliance with regulations.
ry agencies assurance program cost per patient or per year?
How much does a quality What frat, tion of staff time, including physicians, physicists, dosimetrists
, technologists, and
. h u=~ nurses, is currently budgeted for quality assurance work?
F ~~ -t:S naadad t:
x J. woiiuy a==uroove requis==iwo, ind fid :
ai e voc e' b "M'" D := i l ab l e
.,,ae l4 A id. l= ;t'e ' :d S
- L; x:t d?
v.
5.
f Are there complete model quality assurance progr L
). available that address every step of the radiation thera ams already A
will model programs have to be developed?
Should physical measurements,
/j.
redundant calculations, or both be required to assure that th I
h A
is the same as the dose prescribed?
e dose given What other areas are, or should be, covered in a complete quality assurance program?
6.
Are the staff and equipment that are needed to implem plete quality assurance program available in the marketpl ent a com-ace, or would new' training programs and equipment development be needed?
7.
Computers are used in radiation therapy to calculate d distributions and to control the operation of equipme t ose i
n.
How could quality assurance of software accuracy and validity be i licensees be required to verify them?
mproved? Should How can user skill and knowledge of the inherent assumptions and limitations of a computer program be assured?
Should additional quality assurance requirements be d to ensure that users understand the algorithms eveloped based?
on which the programs are 8.
What additional methods are available for reducing th or impact of human error?
e frequency 14
4 g
[7590-01) properly trained and adequately informed physici ns lwill make decisi in the best interest of their patients.
ons NRC's Responsibilities in the Medical Use of Byproduct Mat i
erial In developing this rulemaking the NRC has had to deal with th risk attendant to medical care and the risk associated normal careless use of byproduct material.
{AeNRCisawarenf+honom i e h= = 1 + "
M : fit.,
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,, u,,,,,,,,,,;_
'Ec ;f L7rivuucT,ma6eries
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, ;;1, -f 2 u w..
A INO..
ww wns ya vpur duu a sapund lD ic muu e wol.;. Of bj,ivdw w
";-- wr,Ihe NRC draws a line between the unavoidable risks p
ma wwa su attendant to purposefully prescribed and properly performed clinical procedu res and a
the unacceptable risks of improper or careless use of byp roduct material in medicine.
The NRC is obliged, as part of its public health and safe charge, to establish and enforce regulations that protect the pu c from the latter.
Reports of Misadministration in Radiation Therapy The NRC has published a study of the twenty seven therapy 1
misadministration that were reported over the period November 1 through July 1984.1 The following NRC analysis of these events provides the basis for determining that a need exists for this rul emaking.
i The' specific causes of the misadministration, detciled in T bl i
a e 1, are, of course, related to the treatment modality.Nonetheless, three i
l 1For a copy of this report and Evaluation of Operational Data, Nuclear Regulatory Comm Washington, DC 20555.
Ask for report AE00/C505.
05/13/87 l
5
a
,t
)
[7590-01]
t basic themes run through the reports:
inac equate training, inattention to detail, and lJck cf redundancy.
Y 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 material that a clear communication of c and quantities as well as systematic checks for revealing mista 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 t o
the patient or to the clinic, should be carefully examined for cl
- arity, applicability, and correctness.
Each individual involved in the process should be strongly encouraged to ask for clarification if there is a unclear or unexpected step or if an expected step is missing Inattention to detail is often the medium in which a m tion event germinates.
This is not a problem specific to the medical use of byproduct material.
y wo"
~
r vauct T.nac,eywo ; '-df"id ul a+tu tivo o -se2+ 4"de :' rit;.J m,,ti t 4 ~
ou
+Mt : e c 4-4 hr ir, n;p n4+"da
=d "ud unnatedly will 1 % b ;;r,t:f, -i:t:
Computerized radiation therapy treatment planning may reduce the chance of mista sealed source treatment planning, and "recora and verify" systems that check teletherapy unit orientations and settings may reduce the chanc mistakes in teletherapy administration.
But even these systems perform
. their functions on quantities that are initially measured, recoraed, 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 fro 05/13/87 7
[7590-01) o i
s 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 of at least a full day's inventory of the radicpharmaceutical to the patient. (HS t M;.= i;.m mi. A b - ]
m 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 4
that a clinical procedure that requires radiation dose to the patient is indicated.
When a decision has been made to tre s a patient for any malady, whether with radiation, riurgery, 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. Dortal arrangements used 05/19/87 13 l
- - - - - - - ~-
[7590-01) to administer the radiation dose, and devices used to modif y the radia-tion beam, (b) calculations made to determine how long the b 3
eam must be applied each day to deliver the prescribed dose, and (c) the num days radiation is to be administered); (3) a record of ea h d i of c
a ly appli-cation of radiation made at she time of application; and (4) reco d r s of any physical measurements of radiation or portal verification fil specifically for the patient.
ms made Charts for brachytherapy patients include the same type of information, but the diagrams and calcul ti a
ons refer to implanted radiation sources rather than externally appli d radiation beams.
e 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 licens ees make and retain usually contain the information needed to demonstrate that the li has implemented a quality assurance program.
censee c:L vy e 4m4a nc. benaff t
\\
, imposing owm t ':r ' *a~Jjgtepino ramd- :] However, the NRC would appreciate public comment on this matter Several therapy misadministration have been precipitated b y unclear prescriptions.
In radiation therapy, a different dose is prescribed for each patient, depending on the type and extent of the malady There fore,
requiring a legible handwritten or typed prescription on the patient's chart appears to be the most efficient way of ensuring clear com between the prescribing physician and the dosimetrist who munication makes the calculations to determine how long radiation must be applied to d the prescribed dose.
e ver The NRC believes that it is possible that some dosimetrist nologists may be disinclined to request clarification of inst s or tech-ructions and
w n
y l
[7590-01) i h
this may lead to misadministration.
Therafire,pithe NRC would require licensees to specifically instruct workers to uest clarification in cases where there may be ambiguity or error, n < *n s.%;
The NRC cci... h d prescribing what documentation was needed to demonstrate that an independent check of data transfers and calculations j
had been made.
The NRC has not included such a requirement in the
, proposed rule, but would appreciate comment on this matter.
6 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 statement prescribing whether the tissue surrounding the site of surgery or the remaining breast tissue is to be treated.
The prescri;:-
tion in the chart may not be in accord with the prescription agreed to by i
the physician, physicist, technologist, and dosimetrist during a treatment l
planning meeting.
Daily tallies of administered dose may not agree with projections made by multiplying the daily dose by the number of treatment days.
05/13/87 15
7 o
v o
{
[7590-01]
as radiographs, or images from computerized k
,omography, ultrasound, nuclear medicine, or nuclear magnetic resNee
\\
I The NRC considered requiring that two individuals independently m k ments of the patient that are needed for do i a e the physical mea
' b[o that such a requirement may reduce th s metry purposes, and believes
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- ...... a...
e chance of misadministration.
g.3 i,,n o, h
n u,,,,,, m
+' r M:E:, r-' :
,,,,, n uvai s trainea w co r: W.,_....,
.',,..y ou.vely impace the deli
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ve D
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S 35.454 Check of dose calculations, and S 35 654 Check s and measurements of dose Dose calculations are made for each telether
\\
patient before radiation is administered to d t apy and brachytherapy must be used to deliver the prescribed radiatie ermine how long the on dose to the treatment volunte.
Several therapy misadministration have bee arithmetic mistakes or incorrect assumptions in do n precipitated by independent check will likely uncover man se calculations. An y of these mistakes.
Ideally, teletherapy dose calculations should b radiation is administered, and the NRC expects th e checked before do this. However, a second person may not always be av ilat dose calculations before therapy begins able to check the a
the check to be made before 20 percent of thThe NRC believes p,rovides a proper balance between patient safete dose has been flexibility for the licensee.
y and administrative For most brachytherapy cases. final dose cal culations cannot be performed until the sources are implanted in th e patient because the 05/13/87 17
cc:
Stello N 0 T'N T I O N V0TE Toylor FYI: Thompson, NMSS RESPONSE SHEET qNcEltoygNMS$ g g 3
TRehm d~.
T0:
SAMUEL J. CHILK, SECRETARY OF THE COMMISSION FROM:
CHAIRMAN ZECH
SUBJECT:
sEcy-87-294-ursaanzarsraxerous APPROVED DISAPPROVED ABSTAIN' NOT PARTICIPATING REQUEST DISCUSSION COMMENTS:
i
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i J
f
& N. Y p
SibNAIUR(
(
j 7 - fr d '
l "2
)
Entered on "As"
/
/
ljAlt
)
SECRETARIAT NOTE:
PLEASE ALSO RESPOND TO AND/OR. COMMENT ON OGC/0PE MEMORANDUM IF ONE HAS BEE!! ISSUED ON THIS PAPER.
NRC-SECY FORM DEC. 80
.-_-..___._____________________j
ffpu,IN ACTION - Thompson, NMSS/
g UNITED STATES Beckjord, RES
., f f
NUCLEAR REGULATORY COMMISSION
, *i s
W ASHIN GTON, '! C. 20555 CyS: StellO
~%
Taylor Septeder 2, 1987 Rehm Jordan, AE00 OFFICE OF THE Murray,0GC/B SECRETARY
'NMcEl roy," NMSS '
Shelton, ARM Meye, ARM MEMORANDUM FOR:
Victor Stello, Jr., Executive Director for Operations
[l uel J. Chilk, Secretary FROM:
k
SUBJECT:
SECY-87-29A - MISADMINIS'rDATIONS This is to advise you that the Commission (with Chairman Zech and Commissioners Roberts, Bernthal and carr e.greeing) has approved the proposed rule and the ANPR subject to:
1.
The Proposed Rule and the Advanced Notice of.
[et
/j Proposed Rulemaking should be revised.to more thoroughly yet' concisely state the need for two
/V((p //.
separate actions to immediately address basic
' /
quality assurance requirements in parallel with efforts to examine the need for more comprehensive QA requirements; and (NMSS) 2.
The' attached modific'.tions.
Sdd nd!h5 dd The Commission requests that a draft final rule on basic QA gM be returned for Commission review by April 30, 1988 and a draft proposed rule on comprehensive QA by September 30, 1988..
(EDO.) (SECY SUSPENSE:
As stated - high priority)
(RES)
Commissioner Rogers did not participate in this action.
Attac?.aents:
As Stated i
Copies:
Chairman Zech Commissioner Roberts Commissioner Bernthal g.g g 7 g0
-Commissioner Carr Commissioner Rogers Ot.fo
? f7 Opg l
lime
[7590-01]
t Ckanfe (YWtb nS hrec/c/
EI-&&ama #dLdefP&f>oredSAmslmy p
E 2-A4C& a 2g>s.redAlwtaby NUCLEAR REGULATORY COMMISSION 10 CFR PART 35 Comprehent,ive 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-i 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 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 consid9 red 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
u.-
m The NRC has the authority to regulate the medical use of byproduct material to protect the health and safety of patients, but also recognizes that physicians have the primary responsibility for the protection of their patients.
NRC regulations are predicated on the assumption that i
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
{Meveloping -this-rulemeMng the NRO-has-had-4o-deal n ith-
-ALQ_ attendant to ~ * "1 ma and the *ick-- 33ccietedNit7Ft11e care 4ess a ce cf byprM ue+- =+ = 'M -
The NRQ is_.itware nf tho n u h 10- health benefit -accrued 4Me=-
medicci use of byproduct-meteri:1, 2nd ho=i.s=awar*-nfMhe-smaMAut-
.rs:1, risk ettendant to the proper end responsihharTdtt"4hsewf
--bypeeduct matertait.==HowevekIhe NRC draws a line between the unavoid-a able risks attandant to purposefully prescribed and properly performed clinical procedures and the unacceptable risks of improper or careless 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 report, write to Kathleen M. Black, Office for Analysis and Evaluation of Operational Data, Nuclear Regulatory Commission, l
Washington, DC 20555.
Ask for report AEOD/C505.
l 4
l
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.
Inadewate training of weekers has eaused misadministratiense Althewgh additional Improved training of the medical personnel who handle and administer byproduct material may net can reduceQtg%eTAlteAhv
@Mitad the potential for error. the ehanee of seme kinds of m4stakesy
~
44 Thorouph training should also clearly impress on each individual involved in the medical use of hyproduct naterial 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. Eaeh b44 ef All information that plays a role j
in integral to the process, whether specific to the patient or to the o
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 misadministration event genninates. NRC recognizes that this is net a problem h not-specific to the medical use of byproduct material. hey-peseess-eMeedwet Jr-^chres-4 hat rcquirca ir.dividuel=Tttelttden 1p_Asiul ti!W: c'.elet;?
';er.ti ticrte i. ai e a nuiier-ir, =gW"da-ud-nod -raputFdly.*:m t hely
- eBtMr udes_are=EFe Libebrabi
---] Computerized radiation. therapy treatment planning may reduce the chance of mistakes in sealed source treatment planning, and " record and verify" systems that
/ E/p &
E2p1 I
L 5
l
t check teletherapy unit orientations and settings may reduce the chance of mistakes in teletherapy administration.
But even these systems perform must ultimately rely their fwnet4 ens on quantities that are initially measured, recorded, and entered into memory by individuals.
Lack of redundancy means that there 4s exists no independent
/ E/p/e mechanism for eheeking (er mistakes detecting errors. An independent 62p[
eheek verification requires.having examination bl a second individual examine of each data entry, whether a physical measurement or a number copied from a table of values, and eheek eaeh as well as a check of arithmetic operations _ for correctness.
Rcdundancy requires that two i
separate systems produce the same result.
For purposes g planning radiation therapy, treatment planning the best method of early detection of mistakes may be a simple independent check. Redundaney er,I_ndependent eheeks. verification may also be needed in eaeh therapy faellityls need g be incorporated into 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 cutside auditor can detect mistakes in both process design and process I
application as well as citinge areas where a change in the process might reduce' the chance for mistakes future error.
Th4sese analysis leads observations have led 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 Quality assurance. Some simple aids may include using tables and graphs that are clearly titled and easy to read, and use of a uniform written prescription format. Based en inspeet4en reperts, the NRG believes NRC inspections have revealed that about ten percent of teletherapy unit
, cal.ibrations an spot-checks are incomplete. Checklists could be used to I
assure completeness, f
7 w-__
L/bsu-Ulj
$,~ Ltp.sd,5-lv-<E<~-
3
-Aeedundaney-function must be integral to the design of the radiation *
^
therapy process.
Ind epen d e n t-d o u b l e-c hec k-p ro c e du re s-a nd-re d u nda ncy.
17 Alf 0
pr medures cha"1d be considered.
Eaeh-entry and calculation'in a treat-f0
\\
m m -h.. d 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 radioactivity actually administered to the individual patient would provide assurance that the given dose is the same as the prescribed dose.
Such measurements are now done for radiopharmaceutical therapy and occa-siona11y 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 ZFor a single copy, submit a request for report number AE00/N701 to the address in footnote 1.
8
I with a resulting thyroid dose of several thousand rads. Many of the events /
5/[e demonstrated that the physician authorized user failed,to review 4s net o
rev4 ewing the medical history of the referred patient to determine the suitability of a particular clinical procedure.
In many cases 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 d
mine x ich radiopharmaceutical should be administered.
Furthermore,
,S T ET' in seme events chnologists were net unfamiliar with the clinical procedure prescribed by the authorized user and mistakenly administered a dosage tha*. was not reouested.
H j_s, apparent, therefore that When s
whenever radiopharmaceuticals that can give capable of producing therapy doses are used, unclear nomenclature, lack of desble-sheeks independent verification, and inadequate training sannet be tolerated are essential.
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 i
10 CFR 35.632 and 10 CFR 35.634).
This rulemaking was precipitated I
by the inaction of a single licensee.
The output of a teletherapy unit j
l was incorrectly calculated and the licensee made no physical measurements to determine whether the calculation was correct.
This inaction resulted in cobalt-60 tel? therapy being misadministered to 400 patients.
The 1979 rule addressed the circumstances surrounding that event but did not critically examine the entire radiation therapy process.
l
Voluntary Initiatives The Comission is aware of voluntary initiatives to improve quality assurance. A notable example is the Patterns of Care study managed by the American College of Radiology.
In addition to comparing p9scriptions, 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 examination can detect whatever procedural flaws may be present as well as determine the precision and accuracy of day-to-day service.
Wafertunately these I_t is, NRC's position that voluntary programs have
[f t
alone may not provide adequate assurance of public health and safety.
Serious misadministration continue to occur. The NRC would be remiss in its responsibilities were it to eent4mwe te rely en voluntary pregrams te reduce _ the sharise of misadmin4strat4ensi fail to, examine thoroughly all avenues available to reduce unnecessary exposure g licensed material.
Sumary 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 i
10
(7590-01]
I the NRC will request the Agreement States, as a matter of compatibility, j
i to implement regulations equivalent to those that it implements on this matter, state regulatory agencies are asked to comment.
Request For Comments E/[//
i The NRC has prepared the following questions to elicit comments on l
rue <) no 4-kt ccwN l
metnods of preventing misadministration.
Comments de e t have to respond to these questions alone; other related topics or alternatives mayM%
tiescr bc!if thq commenter believes will help to resolve issues
]
W l
related to this rulemaking.
j l
Quality Assurance General The following questions apply to the provision of all types of 1
medical use:
1.
How can the Commission most effectively implement requirements l
l fnr comprehensive quality assurance? The Commission has the authority to adopt existing national standards.
The Commission, in concert with j
medical experts, could identify and adopt oy rulemaking the key elements 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 no misadministration.
What other mechanisms should be considered?
l 2.
Should the definition of misadministration in 10 CFR 35.2 be i
i changed?
Is it clear and complete?
l t
i l
l 11 i
[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? Should some more descriptive term be used?
3.
The NRC knows of one instance in which radiation was administered to a patient wit! rt a request from the primary care physician.
Should the NRC require that the authorized user actively consult with the primary care S
physician before prescribing radiation or deciding that radiation is not needed? How can the chance of miscommunication t>e reduced? What improve-ments caa be made in terminology, prescription format, and orders?
4.
What methods should be considered to provide assurance that the o
I administered (a$1,og is the patient for whom radiation patient ho
!p[
was intended?
5.
What current standards exist to ensure the adequacy and uniformity sie %%s ey.
of training'of all individuals who participate in the raclija jon thbeapy-ya-We.
A /tfj)/Z porread 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 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 radiation therapy?
Should periodic retraining and re-examination be l
required?
I 12 i
t
[7590-01).
l 6.
What other regulatory, certifying, accrediting, or inspecting organizations examine medical quality assurance programs? Describe the purpose, _ objectives, and rigor of these examinations.
7.
Should the NRC require physicians to provide patients,'upon-1
&lW
)(
i l
request, a record of the radiation dose prescribed se given? What infor-
{
mation should or should not be provided?
[ b /3
/
8.
Apart from increased NRC oversight, what changes in industry practice or standards could improve the quality of performance and mini-mize human error?
p' Teletherapy and Brachytherapy The following questions apply to the provision of teletherapy and.
brachytherapy services.
1.
What performance criteria could be adopted to assure appropriate care', minimize the chance of human error, and mitigate the consequences of p d ] lr7or?
,g,p,3x 2.
To assure ' adequacy of continued emperience, 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,3 Should NRC req / Eln 1 m.
uire that X and familiarity with the procedure are no h t.
i licensees have a certain minimum case-load to assure that their employees retain their expertise in performing radiation therapy clinical and l
quality assurance procedures?
3.
What fraction of licensees already have a quality assurance program? What are its key elements?
(13)
,.... m 4.
The Regulatory Flexibility Act requires that regulatory agencies examine the cost of compliance with regulations.
How much does a quality assurance program cost per patient or per year? What fraction of staff time, including physicians, physicists, dosimetrists, technologists, and nurses, is currently budgeted for quality assurance work? hf more 3taff;
/
/El.o M,
-wer4=needed=to-meet quelitj 633uranee-requirementure-the-requitite indiv4duahHwdily-avai4eble or trould ea= lengthy-lead <iti-Tihie7e neededi 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 marketp' lace, 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 and knowledge 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 algorithms on which the programs are I
based?
1 8.
What additional methods are availabic for reducing the frequency l
or impact of human error?
j l
I l
14 i
[7590-01]
Radiopharmaceutical Therapy The NRC requires that licensees use only certain radiopharmaceuticals for specified therapy clinical procedures, measure the radioactivity in radiopharmaceutical dosages before administration, and have a measurement quality assurance program for the dose calibrator used te make that uww B
These requirements appear to eempms; Mf'the steps in a measurement.
]
radiopharmaceutical therapy physical quality assurance program.
- However, the NRC invites public comment on this position.
There have been cases in which, due to procedural failure, a radio-pharmaceutical other than that intended has been ordered and administered.
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-ment,s of prescription and verification before administration of any phar-maceutical.
The NRC would appreciate suggestions on methods to assure that the clinical procedure (including radiopharmaceutical, dosage, and route of administration) intended by the authorized user is prescribed, and that l
the prescribed clinical procedure is the clinical procedure that is 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 I
l
i
[7590-01)
-l 1
l Standards of Care
]
rrendF W rticularly-f 9
a uoc pr = tg u,
- 29 cro p u+
he Styr'^~^^t 9, aa e N ce ncit policy that it ser, c;;!y t: th umdical use p4-byg wvuu m m r!M.-
/
The following questions apply to the medical use of byproduct material M ' tt C....L J g., :,A,_....ct on14 cy
&F 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 l
I L standard that NRC could adopt.
Is a standard needed if NRC has
'f comprehensive prescriptive requirements?
What kinds of penalties should be imposed on licensees, their o
employees, or both, if the standard or the comprehensive, prescriptive requirements are not met? Should penaltips be imposed on employ 6es?
\\
ShouldNRC'sEnforcementPolicybechanged,a,nd@ifso, hob?(
s \\D CFQ. ikT % hp h C.
hat effect would such a standard or comprehensive, prescriptive requirements have un 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:
l l
16
i i
ENCLOSURE 2 i
Pages 5 and 7-11 of the NPR (Enclosure 2) are virtually y identical to pp. 4-10 of the ANPR (Enclosure 1) and v
should be likewise modified Seeapf)df4 FY/S 011/) W #
}
pages of /44 T2fl l
k l.
kcl % 90 I
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 I
to continue to rely on voluntary programs to reduce.the chance of misadministration.
Summary The NRC believes many misadministration could reasonably be avoided l
if certain basic quality assurance steps were included in the radiation therapy process..l[nc/p /0 0/her 0cNOH " on f ll
.ll[,
OOcUSH0N & h@pcSw hCMUlTdY 7NT The NRC staff has examined literature on the radiation tnerapy 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 prosside guidance for improved patie t safety and_ will also provide a SLnM % 5@ / Np / b basis for NRC enf'tcement action not followed.
The NRC 1. also examining the ne
_for a requirement to implement a more comple'4 quality assurance p gram.
Comments on that matter are i
requeste in an advance noti of proposed rulemaking published elsewhere in tV ; issue of the Fed al Register. d /d b l see 'C/Str OcINS "
m O p //.
III.
DISCUSSION OF PROPOSED REGULATORY TEXT S 35.2 Definitions The NRC has added several definitions to the regulations to ensure that the regulatory requirements are clear.
The definitions are intended to be similar to those already in use in radiation therapy.
05/13/87 11
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 of at least a full day's inventory of the radiopharmaceutical to the patient his, type 4 event is-very unlikely However, the absence of additional quality assurance requirements for diagnostic radiopharmaceuticals other than iodine should not be interpreted as Comission lack of interest in this matter. The Conmission would appreciate public comment on how 3 might address future diagnostic /
E2[ /3 applications of radioisotopes which, if misadministered, could produce
~
doses,irl the therapy ranoe.
5 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, 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
L7590-01]
to administer the radiation dose, and devices used to modify the radia-I tion beam, (b) calculations made to determine how long the beam must be 7
l 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 specifically for the patient.
Charts for brachytherapy patients includt 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. hhcraavid@smo= benefit EP 'I 7
mained by=imposrkg additindmcordkeeping= requirements However, the NRC would appreciate public comment on this matter.
Several therapy micadministrations 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 rsdiation must be applied to deliver j
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 05/13/87 14
1
..e 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.
nsidered pNscribing what documentation was needed to /E2p 6 The NRC 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.
S 35.65 Discrepancies in records and observations On occasion licensees have compliad 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 I
refer to a deep-seated lesion with extensive overlying tissue.
A post-mast. ectomy patient may be referred for a prophylactic treatment with no I
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 to by the physician, physicist, technologist, and dosimetrist during a treatment
\\
planning meeting.
Daily tallies of administered dose may not agree with projections made by multiplying the daily dose by the number of treatment l
days.
I 05/13/87 15 f
1 i
_j
t/ovu-uij 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-i ments of the patient that are needed for dosimetry purposes, and believes that such a requirement may reduce the chance of misadministration.
liowever, because there are a finite number of individuals t ified to do \\
1 these tasks
.,uch a requirement cou d' negatively impac he delivery f'
medic care.
Therefore, a r irement of this e has not be
, included Howevar
, the NRC will continue to examine thi matte L e
.~._._.
Th nu
.a M u
.,3. ~ 2Wfr e24 6 35.454 Check of dose calculations, and S 35.654 Checks and measurements of dose Dose calculations are made for each teletherapy and brachytherapy patient before radiatio'n is administered to determine how long the source must be used to deliver the prescribed radiation dose to the treatment i
volume.
Several therapy misadministration have been precipitated by i
arithmetic mistakes or incorrect assumptions in dose calculations.
An independent check will likely uncover many of these mistakes.
Ideally, teletherapy dose calculations should be checked before i
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 calculations before therapy begins.
The NRC believes that requiring the check t) be made before 20 percent of the dose has been administered provides a proper balance between patient safety and administrative i
flexibility for the licensee.
For most brachytherapy cases, final dose calculations cannot be performed until the sources are implanted in the patient because the I
i 05/13/87 17 l
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