ML20236L551
| ML20236L551 | |
| Person / Time | |
|---|---|
| Issue date: | 09/29/1987 |
| From: | Chilk S NRC OFFICE OF THE SECRETARY (SECY) |
| To: | |
| References | |
| FRN-52FR36942, RULE-PR-35 PR-870929, NUDOCS 8711100400 | |
| Download: ML20236L551 (34) | |
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NUCLEAR REGULATORY COMMISSION Q ui$$((Eh"'N-W ::
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-10 CFR Pan 35 Basic; Quality Assurance-in Radiation Therapy.
AGENCY:
Nuclear Regulatory Commission.
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1 ACTION:. Proposed Rule.
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SUMMARY
The Nuclear Regulatory Commission (NRC).is proposing to amend j
its regulations concerning the medical use of byproduct; material to.
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require its medical licensees to implement certain quality assurance. steps
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that will reduce the chance of therapy. misadministration.
This proposed R
action is necessary to provide better patient ~ safety and a basis for l
1 enforcement action in cases of. therapy misadministration.
The amendment 1
I is intended to reduce the chance and severity.of therapy' misadministra-tions.
The proposed regulations would primarily affect hospitals, clinics,
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.1 and individual physicians.
In an advance notice of proposed rulemaking
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published elsewhere in this issue of the Federal Register, the NRC is also requesting comments on the need for a comprehensive quality assurance program requirement.
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COMMENTS:
Comments must be received by 12/1/87.
Comments received after this date will be considered if it is practical to do so, but assurance of I
consideration cannot ce given except as to comments received on or before this date.
A g;; 16 8711100400 870929 f //J 7de, AN-#7 7
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Submit written comments an' suggestions.to the Secretary of.
d ADDRESSES:
the Commission, U.S. Nuclear Regulatory Commission, Washington, DC.20555, 1
Attention:
Docketing and Service Branch.
1 Copies of the regulatory analysis.and.the comments received on:thisfrule'
.may be examined at the Commission's Public Document Room at.1717 H Street NW., Washington, DC.
Single copies.of the regula' tory analysis are avail-j able from Norman L. McElroy, Office of Nuclear Material Safety and Safe '
d guards, U.S. Nuclear Regulatory Commission, Washington, DC 20555, j
1 Telephone:
(301) 427-4108.
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FOR'FURTHER INFORMATION CONTACT:
Norman L. McElroy, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear' Regulatory Commission, Washington, DC 20555, Telephone:
(301) 427-4108; SUPPLEMENTARY INFORMATION:
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I.
BYPRODUCT MATERIAL IN MEDICINE-l l
Use for Patient Care
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Radioactive materials are used in drugs in the field of nuclear medicine.
Drugs labeled with radioisotopes are known as radiopharmaceu-i ticals.
In diagnostic nuclear medicine, patients receive these materials' l
by injection, inhalation, or oral administration.
Physicians use radia-tion detection equipment to visualize the distribution of a radioactive i
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. drug within the patient.
Using this technology, it is possible to. locate tumors, assess organ function, or monitor the effectiveness of a treatment, i
I An estimated 10 million diagnostic nuclear medicine procedures are per-formed in this country annually.
In therapeutic' nuclear medicine, larger 09/09/87 2
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quantities lof radiopharmaceuticals1 areadministeredtoltreathyperactiveL
..thyroidconditionsand'certainforms;of; cancer,LAn'est.imatedl30,0'001 pro.
cedures are performed each. year.
1 Sealed radioactive sources...that produce.high radiation'f,ieldsiare
!1 used in radiation therapy primarily to treat cancer. 'Al radioactive; source
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in a teletherapy machine can~be adjusted' t6 direct a radiation: beam to:
q the part of the; patient's body to.beitreated. IAn estimated 100,000 patients-receive. cobalt-60 teletherapy, treatments!from NRC and Agreement State licensees each year.
Smaller sealed? sources with.less radioactivity __
l-are designed to be-implented.directly'.into a' tumor area'or appliedLon the' surface of an area to be treated.
This. procedure is.-known.as brachy-therapy.
Licensees perfctm approximately 50,000 brachytherapy treatments.
l annually.
Sealed radioactive-sources can.also be usedtin machines that are used for diagnostic purposes. - The source provides, a beam of radiation that 'is' projected through the patient.
A device ~on the other side of the; patient:
1 detects the amount or spatial distribution of-radiation that'goes through j
.y the patient.
This can provide information~about. tissues within'the patient.
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This is a relatively new development in-the field of medicine and the NRC j
has no estimate of the number of these diagnostic procedures perfor'med I
annually.
State and Federal. Regulation-a Many. states, known as Agreement-States, have.' assumed responsibility for regulating certain radioactive materials within their respective i.
borders by agreement with the NRC.
(This kind of agreement is authorized-L j
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by the Atomic Energy Act.). They issue licenses-for the medical'us'e.of-byproduct material, and currently regulate about 5,000' licensees. -In non-Agreement. States, the NRC has licensed 2-200 medical. institutions; (mostly hospitals and clinics) and 300 physicians in priv' ate. practice.
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These licenses authorize certain diagnostic and therapeutic uses~of-
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radioactive ~ materials.
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l II.
NRC'S. REGULATORY PROGRAM 3
l NRC's Policy Regarding the Medical.Use of Byproduct Material I
In a policy statement published February 9, 1979-(44 FR 8242), the NRC stated:
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"1.
The NRC' will continue to regulate th'e medical uses of l
radioisotopes as necessary;to provide for the radiation safety of workers and the general public.
l "2.
The NRC will regulate the radiation safety of patients where justified by the risk"to patients and where volun-l tary standards,. or compliance with these standards, are l
inadequate.
"3.
The NRC will minimize intrusion into medical judgments affecting patients and into other areas traditionally considered to be a part of the practice of n.adicine."
The NRC has the authority to regulate the medical use of byproduct material to protect the health and safety of patients, but also recognizes l
that physicians have the primary responsibility for the protection of l
their patients.
NRC regulations are predicated on the assumption that' 09/09/87
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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 The NRC dr&ws a-line between the unavoidable risks attendant t'o purposefully prescribed and properly performed clinical procedures and i
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.
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.
Improved training of medical personnel who handle-and administer l
byproduct material can reduce the potential for error.
Thorough training should also clearly impress on each individual involved in the medical use of byproduct material that a clear communication of concepts 1For a copy of this report, write to Kathleen M. Black,' Office for Analysis and Evaluation of Operational Data, Nuclear Regulatory Commission, Washington, DC 20555.
Ask for report AE0D/C505.
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Table 1.
Therapy misadministration reported to NRC from November 1980 to July 1984 l
1 Teletherapy:
Prescription j
' Total daily dose was delivered from each port (2)*
Oral and written prescriptions were different (1)
Boost dose of 500 rad /3 da was interpreted as 500 rad x 3 da (1) i Proper body side was not clear.(1) 1
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Treatment planning.
Tumor depth was incorrectly measured (1) p Tumor depth was incorrectly recorded (1)
Dosimetrist used wrong computer program (1)_
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Dosimetry tables for wrong unit were used (1)
Arithmetic mistakes were made (3)
Records Arithmetic mistakes were made (1)
Poor handwriting of numerals' caused misunderstanding (1) i Physical measurements j
l Wedge factors were measured incorrectly (1-53 patients affected)
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1 Application J
Field blocks were not used (1)
Treatment planning l
l Dose rate was much higher than first estimated (1)
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1 Application
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Wrong sources were loaded in applicator (2)
Source fell out of applicator (1)
Source was improperly seated in applicator (1) j I
Radiopharmaceutical Therapy j
l Wrong radiopharmaceutical was administered (2) i Assay date on unit dosage was not read (3)
Patient was improperly identified (1)
- Numbers in parentheses indicate number of events of the type described.
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j and quantities; as well as systematic checksLfor revealing mistake's earls l
4 in' the process are both essential for the delivery.of quality care.
All l
d information integral to-the process, whether specific to the: patient.or:
to the clinic, should be carefully examined for clarity, applicability, and correctness. -Each individual' involved in.th'e process should be 1
d strongly encouraged to ask for clarification if there is any; unclear or unexpected step or if anl expected step.is miss_ing.
Inattention to d'etail is often the medium in which a misadministra-
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tion event germinates..NRC recognizes that this problem is not specific j
to the medical use of byproduct m?terial.
Computerized. radiation therapy.
I treatment planning may reduce the chance of mistakes'in' sealed' source j
treatment planning, and." record and verify" cystems. that check teletherapy i
i unit orientations and settings may reduce the chance.of mistakes.in j
teletherapy administration.
But even these systems must ultimately rely on quantities that are initially measured, recorded, and entered into memory by individuals.
Lack of redundancy means that there exist no independent mechanism for detecting errors.
An independent verification requires examination by a second individual of each data entry, whether a physical measure-ment or a number copied from a table of values, as well as'a check of I
arithmetic operations for correctness.
Redundancy requires that two l
separate systems produce the same result.
For purposes of planning radiation therapy, the best method of early detection of mistakes may be a simple independent check.
Independent verification may also 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 09/11/87-7
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- outside auditor can detect mistakes in both process.desir,n and process
. application as well as cite.' areas where.a. change.in the' process might!
reduce the chance for' future error.
These observations have led the NRCLto some' general conclusion _s q
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regarding quality assurance.
H The radiation therapy process'should be planned with the realization that individuals are likely.to make mistakes. 1Some simple aids may include using tables and' graphs that'are. clearly titled.and eas./ to' read, and use'of a uniform written prescription format.
NRC. inspections 1have j
revealed that about ten' percent of teletherapy. unit' calibrations and.
spot-checks are incomplete.
Checklists could be used to assure completeness.
Independent verification must;be made integral to the design -of the radiation therapy process.
A111 entries and calculations in' a; treatment:
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plan should be checked by.an individual who did not construct:the treat-ment plan.
Each patient's chart should be reviewed weekly totcheck.for t
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accumulated dose and implementation.of prescription changes.
'A quality 1
assurance program for the teletherapy unit should include a periodic check of the teletherapy unit output-and an occa'sional detailed examina-tion of the complete teletherapy process, including. physical measurements, by an outside expert with an eye towards systematic errors an'd 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.
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Such measurements are now done.for radiopharmaceutical therapy and~oce -:
sionally. for.some teletherapy. cases,- b'ut because lof expense. or..unavali-ability of. equipment are not commonplace inl sealed source l therapy; j
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{l Reports of Diagnostic Misadministration That-Result in' Doses in the Therapy Range The NRC has-also published a report on misadministration:s of' diag-
-l nostic dosages of iodine-131 that lead to doses in.the' therapy range.2 j
t The report was a review.of; fourteen 1recent misadministration events in which patients were administered one'to ten millicuries of iodine-131 with a resulting th~yroid dose of several thousand rads.
Many of.the.
.i events demonstrated.that the physician authorized user, failed to review the medical history of the referred patient.to determine'the suitability i
of a particular clinical. procedure.
In many cases the' referring physi-cian, who is not a nuclear medicine expert, and the nuclear medicine i
technologist, who is not a medical expert, determine.which radiophar-maceutical should be administered.
Furthermore, in some events tech-'
nologists unfamiliar with'the clinical procedure prescribed by.the authorized user mistakenly' administered a dosage that was not requested.
It is apparent, therefore, that whenever radiopharmaceuticals capable of producing therapy doses are used, clear nomenclature, independent' verification, and adequate training are essential.
Earlier NRC Efforts This is not the first time the NRC has examined the matter of quality 1
assurance in the medical use of byproduct material.
In 1979 the NRC issued some basic quality assurance requirements for teletherapy (see 44 FR 1722,.
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published January 8, 1979).
This rulemaking was precipitated by the j
d inaction of a single licensee.
The output of a teletherapy unit was
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J incorrectly calculated and.the licensee made no physical measurements to l
determine whether the calculation was correct.
This inaction resulted'in
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cobalt-60 teletherapy being misadministered t,o 400 patients.
The 1979 l
rule addressed the circumstances surrounding that event but did not l
critically examine the entire radiation therapy process.
l Voluntary Initiatives The Commission is aware of voluntary initiatives to improve quality assurance.
A notable example is the Patterns of Care study managed by l
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 1
as determii.a the precision and accuracy of day-to-day service.
It is NRC's position that voluntary programs alone may not provide adequate assurance of public health and safety.
Serious misadministration continue to occur.
The NRC would be remiss in its respo'nsibilities were it to fail to examine thoroughly all avenues available available to reduce unnecessary exrosure from licensed material.
Summary The NRC believes many misadministration could reasonably'be avoided if certain basic quality assurance steps were included in the radiation therapy process.
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Other Actions The NRC recognizes that the medical use of byproduct material is a complex field, and that preparing _ regulations to reduce the likelihood of misadministration must be done carefully.
However, the NRC cannot allow the complexity of medical use to prevent it from taking regulatory action when patients are harmed by the incorrect _ application of byproduct material.
The NRC has balanced these competing desiderata by preparing two rulemaking actions for contemporary publication, This Notice of Propose Rulemaking (NPR) will provide the foundation for a basic quality assurance program that addresses some simple sources of error that have come to light under NRC's misadministration reporting program.
Elsewhere in this issue of the Federal Register, the NRC has published an Advance Notice of Proposed Rulemaking (ANPR) that provides the foundation for a comprehensive quality assurance program requirement
..i that addresses broad areas where error can lead to a misadministration.
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The NRC believes this two pronged approach to the problem of l
misadministration provides the best balance between the need to assure 1
public health and safety without inadvertently interfering in the delivery of quality medical care.
l III.
DISCUSSION OF PROPOSED REGULATORY TEXT The NRC staff has examined literature on the radiation therapy process and consulted with experts practicing in the field of radiation therapy to discuss these quality assurance steps.
The NRC believes that the following steps are basic to the radiation therapy process.
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l regulations that.would require!implementat' ion:of.these' steps will?provi.de j
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- guidance for. improved patientLsafety and will' also provideia t,asisL forj j
.1 NRC enforcement action 'should these steps: not be fol. lowed.
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.S 35.2 Definitions.
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'The'NRC has'added several definitions to the regulations'to_ ensure' that 'the regulatory requirements <are clear.
The. definitions are intended a
t'o be similar'to those already in use in radiation. therapy.-
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& 35.39. Ordering,' prescribing, and-administering certain radiopharmaceuticals
~ There have been a number of misadministration in which an unclear oral prescription by the authorized user resulted in the licensee o'rdering i
the wrong radiopharmaceutical.
Confusing colloidal and. soluble phosphorus-32 is a common mistake.
The NRC is particularly concerned.
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with the medical use of iodine-131 because of the high, thyroid l dose.that results when a patient with a' normal thyroid is thisadministered an iodine-131 dosage intended for a patient.whose thyroid'has been removed.
These misadministration appear to be precipitated by. unclear instructions.
This section would require close participation of.'the.
nuclear medicine physician in those cases-involving the use of radio-pharmaceuticals that are clearly hazardous to the patient if misadministered.
In drafting this section the Commission. considered applying'these.
requirements to all licensees when using any diagnostic radiopharmaceu-tical.
For the following reasons the scope of the section was limited to.
therapy radiopharmacauticals and radiopharmaceuticals of7 iodine.
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There is a cle v 3'iory of misadministration of'these two'. groups.of /
i radiopharmaceuticals, and medical expertsigenerally' agree-that there is j
clear potential. fort harm 'to patients' that receive' these misadministra-1 tions.
For the'.other radiopharmaceuticals identified in 35.100.
and 35.200, the record shows that taost misadministration involve eithe'r the conventional-administration of a'radiopharmaceutical to the wrong L
patient, or the conventional administration of the wrong.radiopharmaceu-4 1
.tical.to the patient (see "NRC Reports on Misadministration and
-Unannounced Safety Inspections," Journal of Nuclear Medicine,'v27, n7, p1102, July 1986). 'Neither of.these types of misadministration, pose'a clear hazard to the patient.
To-misadminister'a diagnos. tic' radiopharmaceutical other than iodine in a manner that'would pose a: hazard to.
j the patient would, in the most'likely circumstance,: require administration of at least a full day's inventory of the radiopharmaceutical to1the l
patient.
L However, the absence of additional quality assurance requirements'.
i for diagnostic radiopharmaceuticals other than iodine should not be interpreted as Commission lack of interest in this matter.
The a
Commission would appreciate public comment on how it might: address future diagnostic applications of radioisotopes which, if misadministered, could produce doses in the therapy range.
I S 35.43 Prescriptions and records of medical use for therapy.
The NRC has received one therapy misadministration report in which' l
radiation was administered to 3 patient who had not been referred for_
medical use of. byproduct material.
The NRC believes that a physician-l -
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L 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 dru'gs, 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 prescr.iption.
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-i grams of physical measurements of the patient, portal arrangements used to administer the radiation dose, and devices used to modify the radia-tion beam, (b) calculations made to determine how long the beam must be-applied each day to deliver the prescribed dose, and (c) the number of days radiation is to be administered); (3) a. record of each daily appli-cation of radiation made at the time of application; and (4) records of any physical measurements of radiation or portal verification films made 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 09/09/87 14
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has implemented a quality' assurance' program.
However, the NRC would appreciate public comment on.this matter.
Several therapy misadministration have been precipitated by-unclearL prescriptions.
In radiation therapy, a.different dose'is prescribed'for' each patient, depending on the type and extent 'of the malady.
Therefore,
. j requiring a legible handwritten or typed prescription'on the patient's chart appears to be the most efficient way.of: ensuring clear communication.
l between the prescribing physician.and the dosimetrist who makes the calculations to determine how long radiation must be applied to. deliver I
the prescribed dose.
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The NRC believes that it is possible that some dosimetrists.or tech-
!l Hologists may be disinclined to request clarification of instructions _and this may lead to misadministration.
Therefore, the NRC would require licensees to specifically instruct workers to. request clarification in.
j cases where there may be ambiguity or error.
The NRC is considering prescribing what documentation'is needed.to 1
demonstrate that an independent check of. data transfers and calculations had been made.
The NRC has~ not included.such a requirement'in the l
proposed rule, but would appreciate comment on this matter.
l 655.65 Discrepancies in records and observations.
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On occasion licensees have complied with required safety measures, f
such as performing surveys, yet not taken mitigating or corrective' actions
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that the NRC believes were obviously necessary to assure public health g) and safety.
The purpose of this section is to cleaply ' require licensees to resolve discrepancies in records and obser><ations.
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The NRC foresees the possibility of many kinds of. discrepancies.
The licensee's measurement of the source strength of a brachytherapy -
1 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 days.
l If, when faced with an obvious discrepancy, a licensee, physician, physicist, technologist, dosimetrist or other individual-fails to take reasonable clarifying, mitigating, or corrective action and the dis-crepancy results in a misadministration, then a citation will issue under this section.
S 35.432 Source strength measurements.
The radiation dose rate from a sealed source, which is known as source strength, depends on the amount of radioactivity in the source and the material used to encapsulate it.
(See National Council on Radiation Protection and Measurements Report Number 41, " Specification of Gamma-Ray Brachytherapy Sourcee." Chapter 4.)3 Manufacturers usually provide source 3 Copies or this report may be purchased by contacting NCRP Publications, P.O. Box 30175, Washington, DC 20014.
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l strength information:with sources,1but'the NRC' believes'thatlan-independent 1
,j measurement is'needed.to ensure > that the information relates specifically j
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to the. source under consideration.
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- q Howevei, the NRC would not require licensees to uselth'ese' mea'surements i
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in dose calculations' In some cases,-manufacturers are able to provide:more
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s accurate measurements of. source strangth than licensees'; the-licensee;must:
be free to use the source strength that it believes is the most accurate' 3
I SS 35.452 and 35.6'52. Physical measurements _of' patients.
1 The NRC knows that dose' rates depend to some eitent on the' tissue b
volume to be treated and its depth within the patiente These paramaters F
may-be determined by physical. examination or~ examination of images lsuch-1 as radiographs, or images from' computerized tomography; ultrasound,.
nuclear medicine, or nuclear magnetic resonan'ce.
The.NRC considered i
l requiring that two individuals independeritly 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.
The NRC would like comment on this matter, q
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 radiation is administered to determine how long'the source must be used to deliver the prescribed radiation dose to the treatment 1
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.
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Ideally, 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 I
dose calculations before therapy begins.
The NRC believes that requiring the check to be made before 20 percent of the dose has.been administered provides a proper balance between patient safety and-administrative flexibility for the licensee.
For most brachytherapy cases, final dose calculations cannot be performed until the sources are implanted in the patient because the j
exact location of the sources with respect to certain tissues cannot be predetermined.
Brachytherapy sources are typically left in place'for l
l two to three days.
Thus, a 20 percent criterion may be difficult to meet j
in many cases, because the check would have to be made within hours after 1
l the sources are implanted.
Thus, the NRC has selected a dose calculation i
check criterion of 50 percent.
Public comments are invited on the workability of these 20 percent and 50 percent criteria.
There are two usual methods for performing checks of manual dose calculation.
Two individuals may independently calculate treatment times l-and compare results.
Alternatively, one individual may make the calcula-tion and then a second individual can examine each entry and arithmetic operation to verify its accuracy.
The NRC considered requiring that licensees perform a manual check of the dose to a single point in the treatment volume predicted by computer generated dose calculations.
However, checks of computer-generated dose calculations pose difficult problems.
It is not clear-whether nomograms or manual algorithms are available that can be used to-09/09/87 18
[7590-01) check the accuracy of computer generated dose calculations.
Many computer programs that are used contain steps for calculating the effect on the j
dose caused by tissue density differences, organ and tissue contours, and radiation field contours.
The NRC believes that a manual check of a i
l computer calculation with that many physical correction factors may be beyond the reasonably expected means of many licensees, and may adversely 3
affect the delivery of medical care. Therefore, the NRC has only drafted a requirement that a sec6nd individual assure that the correct parameters, j
j such as radionuclides, dose, and physical measurements of patients, were used in the computer generated dose calculation printout to information
!l in the patient's ch' art, and examining each relevant piece of information j
l cn the calculation printout.
The NRC wouid appreciate comments on the best method for documenting
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that these checks have been made.
Regarding the concept of " independent check," the NRC would parti-l t
cularly appreciate comments on whether a second individual should begin I
i with only the prescription, independently calculate the dosimetry and j
i treatment plan, and then compare those results with those of the first l
i individual.
l In teletherapy, the arithmetic that sums the daily administration i
i of radiation must also be checked.
Radiation is usually administered
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in daily doses over several days or weeks and each dose is recorded 1
in the patient's chart.
A weekly check will assure the daily doses have been summed correctly.
In contrast, brachytherapy is administered l
continuously until the prescribed' dose has been given; thus, there is no need for a comparable requirement.
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One recent-teletherapy. misadministration occurred in:a' case in..which:
an unusualitreatment. configuration'of the: teletherapy l unit, th'e' beam "collimators, and tho' patient was required.. Whereas:an' arithmetic mistake would.likely be obvious:in ~a commonly used configuration because certain
q calculated values for. patients usually fall within small. ranges, an' unexpected. treatment time in an' uncommon configuration'w'ould likely be-attributed to the uncommonness of the configuration.rather than triggering an examination of calculations. for a dosimetry mistake; Therefore, the NRC believes that a physical measurement of'the. dose-rate should'be'made-if the teletherapy unit settings or beam. modifying device's u' sed for a.
patient-fall outside the ranges e'xamined during the'1ast. set of full' calibration measurements.
t The NRC considered requiring physical measurements for. brachytherapy?
f but believes the methodo_ logy (comprised'of'a comparison.of calculated and q
measured dose rates) that is needed to make such measurements bas not' 1
been fully developed.
TheNRCalso^consideredrequiring{thattwoindi-1 1
viduals verify that the correct sources _were being' implanted. LThis would clearly add to workers' radiation dose, b'ut it is not clear that this would reduce the number of brachytherapy misadministration.
The NRC knows that some tre.,tments must be. administered within.hou'rs-after a decision has been made to administer radiation therapy. 'These L
cases usually involve compression of the spinal cord or' superior vena:cava, respiratory distress, brain metastases, or severe l vaginal bleeding.
In; such cases, it may not be possible for the licensee.to perfm~i an'inde-pendent check of calculations.
The NRC believes the prescribing physician is best =s'ituated to deter-l-
'mine whether the time needed to make normal quality' assurance checks might.
f.
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jeopardize the patient's. health.' ;This provision is_not intended toigive licensees a' basis.for not providing,the required' quality assurance steps.
in a timely' fashion.
. S 35J632 : Full calibration measurements
~
In one misadministration event, 53 patients received doses of radia-t on different from the doses that were prescribed:because~a-mistake was i
made when measuring the'effect of certain beam modifying devices on the
. teletherapy unit output.
The NRC-believes the revalidation of the'effect of these devices on the output is just as important as the annual full calibration itself.
l S 35.633 Independent check of full calibration measurements All teletherapy dose calculations are based nn the output of the-teletherapy unit, which is measured each year as part o'f the full calibra-tion.
Ifamistakeweremadeinthatmeasurement,alidosecalculations would be incorrect.
Therefore, the NRC believes there'should be an inde-pendent check of the output that was ' determined during the full 'calibra-
- tion, The check should be made by a teletherapy physicist.because.that' individual has special training and experience in the measurement-of therapeutic radiation.
L The check should be made using a measuring system other than the l
system used in the full calibration.
This will better assure that'.any mistake made in the methodology or the calibration of dosimetry equipment will not go unnoticed.
(The term " measuring system" is used in a broad sense here to mean not just the dosimetry equipment', but the personnel, 09/09/87 21
_ _ _ _ = _ _ _ _ = _ _.
1.-
'[7590-01) records, site-specific methodology, and' even origin of, dosimetry equipment calibration when possible.
However, the'NRC is ~not certain that :this would be availab~ie to all licensees and. requests comment on'this matteri)'
The device used to make the output-measurement could be one described in
~
S'35.630 " Dosimetry equipment." Alternatively, it could be made using a specialized dosimetry service available by mail Some organizations supply 1
]
licensees with precisely calibrated thermoluminescent dosimeters within'ai j
H device made of " tissue-equivalent". material. The licensee irradiates the 1
device, calculates the given dose, and returns the dosimetersLto the I
organization by mail.
By processing the thermoluminescent dosimeters, the l
organization can measure the given dose and compare that measure:to the
]
calculated given dose.
This provides assurance that the' output ha's=been l
correctly measured.
o
'l IV.
ADMINISTRATIVE-STATEMENTS' Environmental Impact:
Categorical Exclusion i
The NRC has determined that this regulation ~is the type of action
'j described in categorical exclusion 10 CFR 51.22(c)(3) and'(c)(14).
Therefore, neither an environmental impact statement nor an. environmental l assessment has been prepared for this proposed regulation, Paperwork Reduction Act Statement This proposed rule does not contain a-new or amended information collection requirement subject to the Paperwork Reduction Act of'1980 09/09/87 22
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-(44 U.S.C. 3501, et~ seq.-). -Existing requirements were approved by the.
Office of Management and Budget under approval. number 3150-0010._
. Regulatory Analysis l i
(31
?
The' Commission has prepared a regulatory; analysis,on.this regulation.
The analys'is examines the costs and benefits of the. alternatives considered '
b by the Commission' :The analysis is available for ins'pection-in: the NRC
. Public Document Room, 1717 H Street NW., Washington,-.DC. l Single-copie's may be. obtained from Mr. McElroyL (see:"FOR FURTHER INFORMATION _ CONTACT"'
v heading).
I Regulatory. Flexibility Certification Based on the information available to date,-in accordance with'the
]i Regulatory Flexibility Act of 1980 (5 U.S.C. 605(b)), the Commission certifies that this rule, if promulgated, will not have.'a1significant economic impact on a substantial number of small entities.- The NRC has issued approximately 2,500 medical licenses under'10'CFR Part 35. Of these, approximately 2,200 are_ held by institutions, and approximately 300 physicians in private practice.
Most of the institutional-licensees are community hospitals.
The size standards adopted by the NRC (50 FR-50241, December 9, 1985) classify a hospital'as a small. entity if its I
l i
average gross annual receipts do not exceed $3.5 million, and a private 1
l practice physician as a small entity if.the physician's annual _ gross l '
receipts do not exceed $1 million.
Under these size standards, some-NRC.
j l
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[7590-01]
d medical licensees could be considered "small entities"- for purposes of -
the Regulatory Flexibility Act.
The number of medical licensees that' would fall into the small i
entity category does not constitute a substantial number for purposes of.
the Regulatory Flexibility. Acts The primary objective'of the rule isLto require licensees-that l
provide radiation therapy service to! implement ~certainl quality assurance-l.
l steps that will reduce trie chance of therapy. misadministration.
The NRC l
.l 1
believes that most' licensees already perform these steps in order to assure the provision of quality medical care.
Therefore, there should.
[
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not be a significant economic impact on these small entities.
.j
)
i The Commission has prepared a preliminary regulatory analysis for
(
this regulation which contains information'concerning the anticipated economic'effect of this regulation on licensees and presents.the basis:
for the Commission's belief that the regulation will not result'in' q
l l
significant additional costs to any licensees.-
It is available for t
public inspection in the NRC Public Document Room, 1717 H Street.N.W.,
Washington, DC.
Single copies are available from Mr. McElroy.
l Because of the widely differing conditions under which licensees covered by this proposed regulation operate,' the Commission specifically l
seeks public comment from small entities.
Any small-entity subject to this regulation which determines that, because of its size, it isLlikely i
to bear a disproportionate adverse economic impact should notify the ti Commission of this in a comment that indicates:
(1) The licensee's size in terms of annual income or revenue, number of employees and,.if the licensee is a treatment center,'the number of beds and patients treated annually; (2) how the regulation would result in'a significant economic l
09/09/87
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I
. burden on the licensee as compared to that on a large licensee;:(3).how the regulations could be modified to take into account the licensee's' y
differing needs or capabilities;-(4) the benefits that'would be' gained'or the detriments that would be.' avoided to'the licensee, if'the regulations.
were modified as suggested by the Commenter; and (5).how the' regulation, asmodified,wouldstilladequatelyprotectpublic'healthand) safety.
The Commission is particularly interested in comments on' whether individ-N
~
l uals with special training and experience (such as treatment technologists, q
dosimetrists, and radiation therapy phys'icists) are readily available in l
the marketplace, either as full-time employees or as.a contract service'.'
Backfit Analysis j
The staff has determined that a backfit analysis is not' required for l
this rule because these amendments do not apply to 10 CFR Part 50 licensees.
i V.
LIST OF SUBJECTS IN 10 CFR PART 35 Byproduct material, Drugs, Health devices, Health professions, Incorporation by reference, Medical' devices,- Nuclear materials, Occupa-tional safety and health,. Penalty, Radiation protection,. Reporting and recordkeeping requirements.
VI.
TEXT OF PROPOSED REGULATIONS Under the authority of the Atomic Energy Act of 1954, as amended the Energy Reorganization Act of 1954, as amended, and 5 U.S.C. 553 the NRC i
is proposing to adopt the following amendments to 10 CFR Part 35.
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[7590-01h Part 35 - Medical Use of Byproduct Material 1.
The authority citation for'Part 35 is revised to read as"thllows:
Authority:
Secs. 81, 161, 182, 183, 68 Stat. 935, 948, 953, 954, as amended (42 U.S.C. 2111, 2201, 2232, 2233); sec. 201,.88 Stat. 1242, as amended (42 U.S.C. 5841).
For the purposes of sec. 223, 68 Stat. 958, as amended (42 U.S.C.
2273):
SS 35.11, 35.13, 35.20(a) and (b), 35.21(a) and (b), 35.22, 35.23, 35.25, 35.27(a), (c) and (d), 35.31(a), 35.39, 35.43, 35.49, 35.50(a)-(d),
35.51(a)-(c), 35.53(a) and (b), 35.59(a)-(c), (e)(1), (g) ana'(h), 35.60, 35.61, 35.70(a)-(f), 35.75, 35.80(a)-(e), 35.90, 35.92(a), 35.120, 35.200(b), 35.204(a) and (b), 35.205, 35.220, 35.302, 35.310(a), 35.315, 35.320, 35.400, 35.404(a), 35.406(a) and (c), 35.410(a), 35.415, 35.420, 35.432, 35.454, 35.500, 35.520, 35,605, 35.606, 35.610(a) and (b),
35.615, 35.620, 35.630(a) and (b), 35.'632(a)-(f), 35.633, 35.634(a)-(i),
35.636(a) and (b), 35.641(a) and (b), 35.643(a) and (b), 35.645(a) and
~
(b), 35.654, 35.900, 35.910, 35.920, 35.930, 35.932, 35.934, 35.94b, 35.941, 35.950, 35.960, 35.961, 35.970, and 35.971 are issued under sec.
161b., 68 Stat, 948 as amended (42 U.S.C. 2201(b)); and SS 35.14, 35.21(b), 35.22(b), 35.23(b), 35.27(a) and (c), 35.29(b), 35.33(a)-(d),
35.36(b), 35.39, 35.43(b) and (d), 35.50(e), 35.51(d), 35.53(c), 35.59(d) and (e)(2), 35.59(g) and (i), 35.70(g), 35.80(f), 35.92(b), 35.204(c),
35.310(b), 35.315(b), 35.404(b), 35.406(b) and (d), 35.410(b), 35.415(b),
35.610(c), 35.615(d)(4), 35.630(c), 35.632(g), 35.634(j), 35.636(c),
35.641(c), 35.643(c), 35.645, and 35.647(c) are issued under sec. 151e.,
68 Stat. 950, as amended (42 U.S.C. 2201(o)).
09/09/87 26
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I 2.
In Subpart A--General Information, 6 35 2, the'following terms
.]
are added in alphabetical order:
t S 35.2 Definitions.
I i
" Beam modifying devices" means items such as trays, wedges, l
compensators, boluses, and blocks that are used to change the l
radiation dose profile within the patient.
)
n
" Computer generated dose calculation" means a dose calculation that has been made by a computer program with no human action necessary other than the input of patient data, selection of a certain computer i
program, and the instruction to the computer to begin calculation.
g l
" Manual dose calculation" means a calculation made by an individual i
using patient data, tabulated data or graphs, nomograms, and a d
calculator that was not specifically designed or programmed for radiation therapy calculations.
" Patient chart" means a record of the diagnosis and radiation treatment applied to a patient.
It may be part of the hospital admission chart prepared for each patient and kept with the patient, or a chart prepared primarily as a result of radiation treatment and kept in the clinic.
" Prescription" means the written instruction to make medical use of byproduct material for the benefit of a specific patient.
09/09/87 27
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'I t "55urce strength" means the exposu e rate at a specified distance from a s'ource (usually expressed s roentgens per hour at one l
J 5
meter)/ the arMat.'of radioactivity in a source (usually expressed as millicuries), or the amount of a different radionuclides that h'
produces the same dose rats'(usually expressed as milligrams of radium equivalent).
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1 3.
In Subpart B--General Administrative Requirements, S 35.39 is si j
3
- 'ded to reaa 'as follo):s:
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.ilS 35.39 Ordering, prescribing, and administering certain s
a
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's,
s
/
radiopharmacNticals' l
s I
5 s
/a) A licensea may not order any radiopharmaceutical of iodine for h
N 1
i }) 'pliagnosis oq therapy or sny radiopharmaceutical for therapy without the 3
s i
e approval of the autSo ized user.
(b(' A ' phys'ilSoilmay not prescribe administration of a radio-l i
i s
r f pharmaYnutical of, odine for diagnosis or therapy or any radiopharmaceut-s s
7 '
ical for thdapf without personally examining the patient and the patient's
]
s 3.,';
chart,,and consultina,witt'sthe referring physician if reasonably available.
i f
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s 'Preaceiptions for these byproduct materials must be in writing, and must j
)
){.
incitdit'e patient's name, the radiopharmaceutical, dosage, and route
,l, of adminis'tr,ation, j fi.)
/
(c) A Flicensee may not administer a radiopharmaceutical of iodine j
'1 fordiagncIisorT.narapyoranyradiopharmaceuticalfortherapywithout l
i comparing the radiopharmaceutical label and dosage on band with the
)
i phyj,1cian's prescription.
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4.
In_ Subpart.B--General Administrative Requirements','S 35.43.is added to read as follows:
-6 35.43 ' Prescriptions, records, and ch'ecks of medical'use for therapy..
(a) The authorized user. or. a physician under supervision of f he
~
t authorized user shall ensure that', if.there is a primary careiphysician,
'the patient has been referred for a therapeutic clinical' procedure thatl
. requires the medical use of. byproduct material.
(b) ' Before beginning a' patient's treatment, the licensee shall verify.
that the authorized user or a physician working under supervision"of the
' authorized user has personally made, dated, Land signed a written prescrip-
~
tion in the patient's chart that identifies the. body part to.beitreated.
Any change in the prescription must also be made in writing in the patient's chart, and must'be dated and signed.
(1) For radiopharmaceutical therapy, the prescription must also identify the radiopharmaceutical, the amount of activity to be administered, l
and the route of administration.
L l
(2) For brachytherapy, the prescription'must also~ identify the sources of radiation and the total tumor dose.
(3) For teletherapy, the prescription must alse' identify the teletherapy unit to be used, the prescribed dose, and the treatment' plan.
l (c) Prescriptions and other records made regarding the medical use of byproduct material must be legible and unambiguous.
(d) The licensee shall instruct all workers involved in the radiation therapy process orally and in writing to requ'est clarification from the-prescribing physician if any element of a prescription or other record. is unclear, ambiguous, or apparently erroneous.
09/09/87 29
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5.
In Subpart C--General Technical Requirements, S 35.65 is added
)
i to read as follows:
]
.q S 35.65 Discrepancies in records and observations.
j A licensee may not use byproduct material for medical use on a patient if there is a discrepancy in records, observations, or physical 1
measurements that may result in a misadministration.
A licensee may
.]
resume use after resolving the discrepancy.
i i
6.
In Subpart F--Radiopharmaceuticals-for Therapy, S 35.302 is added to read as follows:
S 35.302 Administration of radiopharmaceutical dosages.
A licensee shall verify that the prescribed radiopharmaceutical is being administered by. comparing the written prescription and the container label.
7.
In Subpart G--Sources for Brachytherapy, S 35.432 is added to read as follows:
S 35.432 Source strength measurements.
(a) A licensee shall measure the source strength of sources before first use and annually thereafter.
Sources that are in storage and not being used do not have to be. measured; they must be measured before they are placed in service again.
For sources manufactured and supplied in lots of nominally identical sources, a sample from each lot may.be selected rather than measuring each source.
(b) When performing dose calculations, a licensee may use the source strength reported by the manufacturer rather than using the source strength measured by the licensee.
09/09/87 30
'[7590-01]
8.
In Subpart G--Sources for Brachytherapy, S 35.452 is added.to-read as follows:
$ 35.452 Physical measurements of patient.
[ Reserved]
,3 l
9.
In Subpart G--Sources for Brachytherapy, 6 35.454 is added to-read as follows:
i l
S 35.454 Check of dose calculations.
A licensee shall check dose calculations for accuracy before.50 percent.
of the prescribed dose has been administered.
The check must provide l
assurance that the final treatment plan will provide the dose prescribed il in the patient's chart.
(a) Manual dose calculations must'be. checked for accuracy by an individual w'ho did not make the calculations.
(b) Computer generated dose calculations must be checked by examining the calculation printout to assure that the' correct parameters 3
{
l and parameter values were used in the calculation.
The check must be made by an individual who did not enter the. patient data or prescription into the computer.
(c) If the prescribing physician makes a determination to delay 1
treatment in order to perform the checks of dose calculations required I
by this section would jeopardize the patient's health because of the
~
emergent nature of the patient's condition, the licensee may provide the prescribed treatment without performing the checks;-the' prescribing i
l physician shall make a notation of this determination on the patient's chart, and the licensee shall perform the checks as soon as practicable.
l 09/09/87 31-1
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.10.
In.Subpart I--Teletherapy,t8~35!632, the: introductory textiof:
paragraph (b)'.andl paragraph (b)(1)'are revised to; read.as?follows:
$ 35.632-Full' calibration measurements' (b) ' To satisfy.the requirement: of L. paragraph'(a).: of this, se'ction,:
full calibration: measurements mu'st includeldetermination' of:
(1) The output within i3. percent for the range of/ field sizes,;
range of distances, and selection of' beam modifying devices (for example:i trays,' wedges, and the. stock material that is..used for. making compensators' and boluses) used for~me' dical use;
- 11. 'In Subpart I--Teletherapy, S 35.633 istadded to ' read as:follows:-
S 35.633 Independent check-of full calibration' measurements.
(a) A licensee shall have an independent check of.the output determined within one month after completion of the-full calibration.
required by S 35.632.
(b) The independent check must be' performed by'a teletherapy-physicist who did not perform the; full calibration'and made using a.
dosimetry system other than the one used to measure the output during_-
the full calibration.
The teletherapy physicist'does not have to be.
listed as a teletherapy physicist on an NRC or. Agreement State license.
The dosimetry system may be one described in S 35.630,- cr--it may-be another system that provides a-similar level of accuracy and precision.
09/09/87 -
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- 12. 'In'Subpart I--Teletherapy,.S.35.652'is added to. read as follows:
$ 35.652 Physical measurements of patient.
[ Reserved]
.q l
13.
In Subpart?I--Teletherapy, 6 35.654'is added to read-as:followsi 6 35.654 Checks of dose calculations and measurements of dose.
A licensee shall check dose calculations'for accuracy'before 20' percent of the prescribed dose has'been' administered.
The check must provide assurance that the final ~ treatment plan will' provide the dose prescribed in the patient's chart.
1 1
(a) Manual dose calculations'must be checked for accuracy by an
)
individual who did not.make the calculations.
(b) Computer generated dose calculations must be checked by 1
examining the calculation printout to assure that the correct parameters.
and parameter values were used in-the calculation.
The check must be f
made by an individual who did not enter the patient data or prescription into the computer.
)
l (c) A licensee shall make a weekly accuracy check of daily arithmetic calculations that have been made in patient's charts.
(d) If the patient's dose ' calculations include parameters or parameter values that fall outside the range of those measured in l
calibrating the teletherapy unit, the licensee shall make a physical measurement of the dose rate to be. administered to the patient.
This measurement must be made before 20 percent of the prescribed dose has-been administered.
(e)
If the prescribing physician makes a determination that to-delay treatment in order to perform the checks of dose calculations or 09/09/87 33
[7590-01]
physica1' measurements required'by this section would jeopardize the:
3-j patient's. health because of the emergent. nature of the patient's condition, the 1.icensee may provide the prescribed treatment without i
performing the checks of dose calculations.or. physical measurements;' the :
.j prescribing physician shall make a notation of this determination'onithe-patient's' chart, and the licensee shall perform the checks'of calculations or physical measurements.as soon as practicable.
1 b
3,;, 1987.
Dated at Washington, DC,. this 7-
' day of ~ T-For the Nuclear Regulatory Commission,-
s
(
Gb loa R 1
' Samuel J. Chi k 1
Secretary of the Commission.
4 09/09/87 34
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