ML20035H807
| ML20035H807 | |
| Person / Time | |
|---|---|
| Issue date: | 02/02/1993 |
| From: | Parler W NRC OFFICE OF THE GENERAL COUNSEL (OGC) |
| To: | Selin I, The Chairman NRC COMMISSION (OCM) |
| Shared Package | |
| ML20035H800 | List: |
| References | |
| NUDOCS 9305070157 | |
| Download: ML20035H807 (35) | |
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WASHINGTON, D.C. 20ti55 February 2, 1993 MEMORANDUM FOR:
The Chairman Commissioner Rogers Commissioner Curtiss Commissioner Remick Commissioner de Planque FROM:
William C.
Parler General Counsel
SUBJECT:
NRC RESPONSIBILITIES TOWARD PATIENTS INVOLVED IN MEDICAL MISADMINISTRATIONS I.
INTRODUCTION At the Commission briefing of January 22, 1993, the Director of the Office of Nuclear Materials Safety and Safeguards indicated that the Commission's responsibilities toward patients involved in medical misadministrations were unclear and surrounded by complexities, on which further guidance from the Office of the General Counsel might be needed.'
While we are more than willing, now as in the past, to offer guidance as to the nature of the Commission's responsibilities toward patients who have received misadministrations, we do not share the view that the issue is murky; on the contrary, we believe that the agency's rule is relatively straightforward and unambiguous.
What is not
Contact:
William C.
Parler, GC 504-1743 Peter G.
Crane, OGC 504-1622 l
1 Cf. the letter from Dr. Eugene L.
Saenger, University of Cincinnati Hospital, to Chairman Selin, dated December 28, 1992.
Dr. Saenger is a former NRC consultant who investigated a number of misadministration incidents for the staff.
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' clear to us at this point,2 however, is the extent to which the rule has been implemented.
II.
HISTORICAL BACKGROUND The misadministration reporting rule, 10 CFR Section 35.33, was first adopted as one element of the Commission's three-part response to the Riverside Hospital incident, which came to light in 1976.
(The original final rule and its Statement of Considerations appear as Attachment B to this paper.)
In that event, some 400 persons were overdosed with radiation because a single individual miscalculated the rate of decay of a Cobalt-60 source in a teletherapy machine used to treat cancer patients.
At the time, the then General Counsel, Peter L.
Strauss, advised the Commission that patients and their physicians should be informed when they have been the victims of a misadministration.
(See Attachment C.)
In response to the Riverside event and the problems it revealed, the Commission:
(1) approved, in a Staff Requirements Memorandum dated March 7, 1977, a proposed rule requiring better checks on teletherapy devices such as the one involved at Riverside; (2) made a commitment, in a September 20, 1976, letter from then-Chairman Marcus A.
Rowden to then Representative Edward Koch of New York, that its consultant would follow up each of the patients affected at Riverside; and (3) directed, in the same March 7, 1977, Staff Requirements Memorandum, that a rule be drafted requiring.that misadministrations be reported to the NRC, to patients' referring physicians, and to the patients themselves.
The aftermath of the second and third of those decisions illustrates the problems that have occurred in translating Commission policy determinations in the medical area into practice.
With regard to the followup of the Riverside patients, the NRC's consultant (Dr. Eugene L. Saenger of the University of Cincinnati Medical Center) and officials of NRC Region III 2
It may be relevant that there are long-standing differences of opinion within NRC as to the desirability of misadministration reporting.
See, for example, the March 21, 1988, memorandum from the General Counsel to the Commission, "SECY-88-77, Medical Use Program," Attachment A to this paper.
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(The correspondence between them, as well as Chairman Rowden's letter to Rep. Koch, are attachments to the memorandum on " Patient Deaths Attributed to Medical Radiation Exposure, sent to the Commission by the staff on January 8, 1993.)
To the best of our knowledge, neither the then Chairman, who had made the commitment to the Congress regarding patient followup, nor any of the other Commissioners was advised of this decision.
The staff responded to the Commission's March 7, 1977 SRM with SECY-77-194, dated April 8, 1977, in which it asked the Commission, as a " minor policy question," to reconsider its decision to impose a misadministration reporting requirement.
The Commission rejected that request.. Though we have been unable to locate the document, we recall that the staff later submitted a "reclama" again asking for reconsideration of the rule.
It too was rejected.
The rule, approved in principle in March, 1977, was published in final form three years later.
At the April 2, 1980, affirmation session at which the final misadministration reporting rule was approved, the Commission requested "that the staff reexamine this rule after it has been in place for three years."
Less than seven months after the rule took effect, however, the staff submitted to the Commission SECY-81-333, " Reexamination of the Medical Misadministration Rule," proposing that the Commission announce that it was reconsidering the rule, which " continues to be controversial in the medical community and is perceived as an unwarranted intrusion of the federal government into the physician-patient relationship."
The staff stated that it believed that there were sufficient data to determine whether the rule was necessary, without waiting for the three-year period to elapse.
On June 30, 1981, the Commission rejected this request as well, although-it agreed that analysis of the first year's data on reported misadministrations was desirable.
Two of the four Commissioners then sitting stated that once the review and evaluation of the data were complete, they would be prepared to consider a public comment period on reexamination of the rule.
In September, 1982, the staff submitted SECY-82-388, " Withdrawal of the Medical Misadministration Reporting Requirements," in which it stated that the first year's data showed NRC regulation NOTE:
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-4 of medical uses to be adequate, and that the " incremental value j
of continuing the reporting requirements is far exceeded by the j
cost and administrative burden to licensees and to NRC and by the aggravation that the rule is causing within the medical community."
The Commission rejected the staff's recommendation in October, 1982.
J
)
In December, 1984, the staff sent the Commission SECY-84-485, proposing a rulemaking package to clarify and consolidate the j
requirements of Part 35.
The staff paper stated:
"The proposed Part 35 retains the misadministration definitions and reporting requirements of the current Part 35.
A discussion of these requirements appears at 35 FR 31701, published May'14, 1980."
3 (SECY-84-485, Enclosure 1, p. 30.)
There was no other discussion
]
of the misadministration rule in the paper.
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The Commission approved the proposed rewrite, and it directed the staff to add the following to the notice of proposed rulemaking:
j "Although the Commission has not revised its misadministration
'i reporting and recordkeeping requirements, it would like to take this opportunity to ask for.public comment on these requirements...."
The notice, with the Commission's insertion, 2
was duly published in the Federal Register on July 26, 1985, and the final rule was published on October 18, 1986.
t It was not until 1989 that OGC recognized, entirely by chance, that the proposed and final rule had in fact changed the reporting requirements.
Only this week, in preparing this memorandum, OGC recognized that the rule also changed the recordkeeping requirements.
The changes in the reporting and recordkeeping requirements are as follows.
~
With regard to reporting, the pre-1986 rule states that the patient (or responsible relative) must be notified of a misadministration unless the referring physician " personally informs" the licensee either that he will inform the patient or that, based on medical judgment, doing so would be harmful to the i
patient (or responsible relative);=under the 1986 rule, by contrast, such notification is to take place unless the referring physician " believes," based on medical judgment, that it would be-harmful to the patient or relative.
The requirement that this belief be personally communicated to the licensee had'been dropped.
Opinions differed within OGC as to whether this change, by omitting the need for " personal" communication between the referring physician and the licensee, would make it more NOTE:
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ATTORNEY WORK-PRODUCT MATERIAL -- LIMITED TO NRC UNLESS THE COMMISSION DETERMINES OTHERWISE 1 difficult for NRC ever to prove that a licensee had failed to inform a patient (or responsible relative) about a misadministration.
At OGC's insistence, this aspect of the rule was subsequently changed back to its pre-1986 form, as part of the QM rule, which became effective in January, 1992.
As to recordkeeping, records on misadministrations were, prior.to 1986, to be " preserved until the Commission authorizes their disposition."
The reasoning for this requirement was set forth in the Statement of Considerations accompanying the 1980 misadministration reporting rule.
It explained that the 1978 proposed rule had included a 5-year retention period for records of misadministrations, and that some commenters had criticized this, pointing to the long latency period of some cancers.
The "The Commi~sion agrees that there are compelling notice declared, s
reasons for insuring that the records of misadministrations should be maintained for a period of time longer than the five years as originally proposed."
Because it was not clear how long records should be retained, the final rule provided that they should be kept until the Commission authorized their disposition.
The 1986 revised rule, by contrast, required them to be retained only for 10 years.
As a legal matter, it is questionab?e whether either the change from indefinite retention to 10-year retention or the deletion of the " personally informs" language was valid, for not only was there no notice of the proposed change, the public was affirmatively led to believe that the text in question was being left undisturbed.
1 In 1990, the quality assurance (later renamed quality management) rule was issued in proposed form.
The proposed rule retained the 10-year period, and did not mention the retention requirement as an issue deserving comment.
Our brief review of the comments filed in the rulemaking has not found any member of the public who objected to, or even mentioned, the 10-year retention provision.
However, in the final rule, promulgated in 1991 with an effective date of January 29, 1992, the 10-year period was halved.
According to the Statement of Considerations, "the record retention period was reduced to 5 years from the proposed 10 years to reduce licensees' costs because a 5-year retention period is adequate for inspection purposes given that the current NOTE:
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- inspection frequency is less than 5 years." 3 Appendix D of this paper includes the rule in all three forms, as they appeared in the volumes of 10 CFR issued in 1986, 1987 (reflecting the change enacted in 1986), and 1992 (reflecting the change enacted in 1991).
Although the Paperwork Reduction Act makes the reduction of paperwork costs a general goal of government agencies, we believe that the reduction of licensees' costs in this instance is not, standing alone, an adequate or plausible rationale for dropping the record retention period to 5 years, in view of the discussion of record retention in the 1980 rulemaking.
It should be noted that the rule as written does not require that all records of a misadministration be retained; rather, it requires retention of "a record of each misadministration,"
identifying all individuals involved and including a "brief description of the event, the effect on the patient, and the action taken, if any, to prevent recurrence."
The difference in cost between retaining such a record for ten years and for five years would likely be negligible, even if misadministrations were f ar more common than they are.'
As a matter of policy, we believe that retention of records of a misadministration is desirable.
It has happened that misadministration events are not immediately uncovered, or that i
they must be reexamined after a period of years.
Thus the fact that inspections take place more frequently than every five years i
does not necessarily mean that recordkeeping beyond that period is pointless.
The Commission may wish to revisit the question of the record retention requirements for misadministrations.
III. THE MISADMINISTRATION REPORTING RULE AND ITS PURPOSES The misadministration rule and the Statement of Considerations that accompanied its issuance in 1980 appear as attachments to this paper.
Briefly, the rule requires that the licensee, within 3
OGC reviewed the entire rulemaking package and did not object to the change in record retention requirements.
We assume that such a record would be more like the contents of a folder than of a file drawer.
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ATTORNEY WORK-PRODUCT MATERIAL -- LIMITED TO NRC UNLESS THE COMMISSION DETERMINES OTHERWISE 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> of discovering a misadministration, report it to the NRC, the patient's referring physician, and, unless the referring physician personally informs the licensee that it would be harmful, the patient (or responsible relative).
A written followup is required within 15 days thereafter.
The rule originally made a distinction in the reporting requirements applicable to therapeutic misadministrations (reports to the NRC, the referring physician, and the patient or responsible relative, unless the referring physician personally informs the licensee that telling the patient or responsible relative would be harmful) and diaanostic misadministrations (reports to the referring physician and, quarterly, to the NRC).
The rule was revised in the course of Commission consideration of the quality management (QM) rule to take account of the fact that (a) most diagnostic misadministrations were medically of little significance, but (b) diagnostic misadministrations involving radiciodine had the potential to do serious harm.
(More than 25%
of misadministrations constituting abnormal occurrences have involved diagnostic administrations of Iodine-131 that resulted in organ doses in the therapy range.)
Thus in its present form, the term " misadministration" has been narrowed to include only the more serious events.
The provision for misadministration reporting serves several purposes, which were set forth in the Statements of Considerations accompanying the 1980 misadministration rule and the 1992 Quality Management rule.
The 1980 Statement of Considerations declared that reporting misadministrations to NRC allowed the agency "to identify their causes in order to correct them and prevent their recurrence," either by providing guidance to other licensees or by changing its regulations to prevent specific errors.
The notice cited two rule changes resulting i
from misadministrations:
a rule requiring annual calibration of teletherapy units and one requiring radiation surveys of patients after the removal of implants.
As to patient notification, the 1980 Statement of Considerations declared, " Patients have a right to know when they have been involved in a serious misadministration, unless this information would be harmful to them."
The notice then pointed to parallel NRC requirements that workers be told of occupational exposures, and it noted "a trend in Federal legislation that recognizes the right of individuals to know information about NOTE:
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Among the examples cited was the message sent to the Congress by President Carter in April, 1979, in connection with the proposed
" Privacy of Medical Information Act."
The President spoke of individuals' right to see their own records; noted that provision had been made for cases in which direct access to information might harm the patient; and observed that one reason for a patient's needing accurate information about his or her medical condition is that " medical information is used to affect employment and collection of insurance and other social benefits."
(Emphasis added.)
In other words, the Commission's notice was giving explicit recognition to the fact that informing the patient about a misadministration might affect his or her ability to assert legal rights.
(The fact that the bill in question was not, to our knowledge, enacted into law does not alter the fact that its rationale was cited with approval by the Commission.)
Responding specifically to the' comment that the rule "would invite malpractice suits and thereby boost medical costs," the notice declared that "this may well be true."
The July 25, 1991 quality management rule, which became effective in 1992, elaborated on the rationale for' patient notification, stating:
" Patients need to be promptly informed when a nisadministration occurs so that they, in consultation with their personal physician, are allowed to make timely decisions regarding remedial and prospective medical care."
56 Federal Register 23360.
The patient's right to know about misadministrations implies an obligation on the part of the licensee to ascertain the full extent of the facts.
That obligation to know the facts extends to the Commission as well and is statutory, not discretionary.
Under Section 208 of the Energy Reorganization Act of 1974, the Commission's reports to the Congress on abnormal occurrences shall contain, among other things, "the nature and probable consequence of each occurrence."
It is difficult to see how one could reconcile the duty to report on the " probable consequence" of an occurrence with an inquiry that stopped after an initial NOTE:
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determination that'enough was known about the occurrence for
" roots cause" purposes To determine the extent of licensee compliance with the requirement of patient notification, one place to start _would be to review each of the misadministrations reported as abnormal occurrences since the misadministration reporting rule went into effect.
Also it should be possible, without great difficulty, to determine whether the patients involved received the written i
followup reports required under 10 CFR Section 35.33(a)(4).
Also on the issue of patient notification, we note that the most i
recent guidance from the staff to licensees on the investigation and reporting of misadministrations, NRC Information Notice No. 93-04 (January 7, 1993), says nothing of the licensees' obligation under the NRC's rules to inform patients and their referring physicians about misadministrations.
In describing the responsibilities of the Radiation Safety Officer to investigate and report misadministrations, the Information Notice discusses only the licensee's obligation to report the results of its investigation to the Commission.
The only reference in the Information Notice to discussion with the patient is presented in such a way as to make it seem elective and conditional:
"An investigation may include:
- 1) talking to all persons involved in the misadministration, to include the technologists, authorized user, and patient (if acceptable to the referring physician and l
necessary to the. investigation), in order to determine the correct details and sequence of events...."
The quoted language suggests that the patient is to be consulted if doing so will provide information to the licensee; the fact that the licensee has a duty under the rules to provide information to the patient is not mentioned.
I Licensees might well read the guidance of this notice as making it unnecessary to read the parallel provisions of the regulation.
j If so, the effect of this notice may actually be to diminish compliance with patient notification.
Further, the wording of this notice may be seen as signalling that the NRC regards 5
Section 208 may have led the Commission to comment (Chairman Rowden to Congressman Koch) that it would follow-up on each of the patients affected at Riverside Hospital, rather than merely ascertain the initial and preliminary number of patients known to have died from the occurrence.
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ATTORNEY WORK-PRODUCT MATERIAL -- LIMITED TO NRC UNLESS THE COMMISSION DETERMINES OTHERWISE patient notification as a low priority.
At the very time that NRC is being criticized in the press for allegedly failing to ensure that patients are notified of misadministrations, the notice should have highlighted the clear regulatory obligation of the licensee to notify patients,6 orally and then in writing, when they receive misadministrations.
In our view, consideration should be given to the need for issuance of a revised Information Notice.
In the January 22 briefing, the staff made the point that at the time of the Riverside incident, neither the misadministration reporting rule nor the quality management rule were in place.
OGC believes, however, that even at the time of Riverside, the Commission's obligations under Section 208 of the Energy Reorganization Act made it incumbent on the NRC to do more than it did to ascertain and report on the consequences of the event.
(In addition, as noted above, the staff had before it the memoranda from the General Counsel, and Chairman Rowden's commitment to Rep. Koch was also a matter of record.)
The statute does not state that the Commission shall report on the demonstrated consequences of abnormal occurrences, but on their probable consequences.
Thus OGC believes that the report called for by Section 208 cannot reasonably be limited to those known cases of acute, readily discernible injury.
A comparison to events at nuclear power plants is instructive.
Since the first nuclear power plant was licensed, it has been clear, we believe, that if an accident were to occur at a nuclear power plant, killing and injuring a number of members of the public, the NRC unquestionably would ascertain the injury sustained and the dose received by each one.
It does not seem plausible that the investigation would be terminated once the NRC ascertained the cause of the accident, the nature of the appropriate corrective action, and the fact that the accident was fatal.
Yet, as we understand, the background record indicates that this is what occurred in response to the Riverside event in the 1970's, and seemingly was suggested as recently as January 8, 1993, on the first page of the memorandum on " Patient Deaths Attributed to Medical Radiation Exposure" which states:
"The NRC practice has been to collect sufficient patient specific 6
OGC reviewed and did not object to the notice before the notice was distributed.
The sole purpose of this memorandum is to j
learn constructive lessons for the future.
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any regulatory changes to prevent similar future events."
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It is the view of the General Counsel that our obligation to 4
learn the full extent of the harm to individuals applies fully to accidents involving medical uses as it does to reactor accidents.
(See the memorandum from the General Counsel to the Commission,
" Regulation of Nuclear Medicine," dated April 15, 1992, in which we stated that the Atomic Energy Act "does not treat the medical use of byproduct material any differently in terms of scope or prescriptiveness of regulation than other uses of nuclear material.")7 We recognize that the EDO and Deputy EDO made clear, in the January 22 briefing, that if an event of the magnitude of Riverside were to take place today, the staff would approach it in the way in which it handled the recent fatal misadministration in Indiana, Pennsylvania:
with an Incident Investigation Team, ascertaining each person's exposure to contamination.
It is not clear to us, however, how medical misadministration events of lesser severity are to be handled:
for example, what criteria are used to determine whether the services of an NRC-consultant are called for, and how far the staff goes in ascertaining what actually happened to the patient.
In the January 19, 1993, staff paper to the Commission on
" Aspects of the National Medical Use Program Related to Prevention of Misadministrations" (SECY-93-007), the question of patient follow-up is discussed on pages 17 and 18.
The memorandum states:
...NRC's current practice is that following notification to the referring physician and 7 The point is sometimes raised that Section 104 of the Atomic Energy Act includes the requirement that NRC " impose the minimum amount of regulation consistent with its obligations under the Act" over uses of utilization facilities (reactors) in medical therapy.
There is, however, no comparable statutory provision applicable to byproduct material, which is the subject of 10 CFR Part 35.
See Memorandum, General Counsel to the Commission,
" Regulation of Nuclear Medicine," April 15, 1992.
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patient (as required), subsequent follow-up is a physician-patient matter.
The deviation in the dose given in some misadministrations is of such magnitude that the conclusion of radiation-induced injury or death is evident.
In other cases, more time may be required before effects are evident.
Further actual determination of cause of death or injury may be difficult or impossible to determine in some instances.
The memorandum goes on to discuss the pros and cons of long-term follow-up of patients.
OGC's opinion on patient follow-up is this.
Where a patient suffers acute, present injury, such as radiation sickness, burned tissue, or reddened skin, then NRC is obligated to see that further information concerning the subsequent consequences of the illness is obtained as long as there is a need and it is reasonably practicable to do so.
In addition, there are, as we understand it, some radiation-caused illnesses that will manifest themselves either promptly or not at all.
As we understand, radiation pneumonitis, an often fatal condition with a normal onset of 60-90 days after irradiation, falls in this category.
Where these conditions are the direct and immediate consequences of a misadministration, they must be followed by NRC, if for no other reason than our statutory duty to report on the consequences of events in its Abnormal Occurrence reports to the Congress.
We have not discharged our regulatory duties if we do no more than make sure that, 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> or 15 days after the event, the patient and the referring physician were notified.a 8 In SECY-93-007, at p. 16, the staff noted that the Office of the General Counsel believed that the following were " persuasive" reasons for determining the immediate and short-term consequences of misadministrations:
to know the magnitude of the consequences of errors associated with the activities that the Commission authorizes; to determine the appropriate level of enforcement sanctions; to determine the need for an Abnormal Occurrence report under Section 208 of the Energy Reorganization Act of 1974; to help determine the adequate level of regulatory oversight and the appropriate allocation of resources; and to facilitate informed health care decisions on the part of patients (or responsible relatives) in consultation with their referring physicians.
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ATTORNEY WORK-PRODUCT MATERIAL -- LIMITED TO NRC UNLESS THE COMMISSION DETERMINES OTHERWISE i It seems self-evident that in cases of acute injury, NRC must at least ask the obvious question whether the patient survived or succumbed.
If the patient has died, it is our obligation to try to ascertain whether the misadministration was the cause.
The staff may be correct in stating that " determination of cause of death or injury may be difficult or impossible to determine in some instances," but this is not an argument against even 3
attempting to determine causation.
The existence of pathologists, coroners, and death certificates is premised on the notion that cause of death normally can be ascertained.
Moreover, the view that death from radiation can be determined is not foreign to NRC's regulatory practice; such determinations are incorporated into our Enforcement Policy, where the definition of a Severity Level I violation includes, among examples, a failure to follow QM procedures "that results in a death or serious injury (e.g.,
substantial organ impairment) to a patient."
We would draw a distinction between these cases of direct and immediate consequences of misadministrations and situations in which a given dose of a particular form of radiation is known to create a statistically greater risk of developing cancer at some indefinite time in the future.
(Indeed, under the linear d
hypothesis, every exposure to excess radiation must be presumed to elevate, by however slight a degree, one's risk of later i
harm.)
We do not believe that the NRC's responsibility to assess
" consequences" extends to following patients through the several decades it may take for such an illness to develop, if it develops at all.'
' Whether a licensee has a duty to follow such patients over the long term is another matter, but that does not appear to turn on whether the increased risk was due to the use of NRC-licensed materials.
We have not researched the broader and much more complicated question of the responsibility of medical caregivers to follow up cases in which there is a potential for injury developing at some indefinite point in the future.
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! IV.
ARGUMENTS AGAINST NRC REGULATION i
It may be useful, finally, to address some of the arguments that are frequently raised in opposition to NRC regulation of medical uses, and to misadministration reporting in particular.
The argument has been made at various times that the NRC's requirements of misadministration reporting and patient notification constitute an improper " interference in the practice of medicine."
In OGC's view, this argument is fallacious and indeed frivolous."
The NRC does not dictate what treatment a patient should or should not get, it merely requires that a patient (or responsible relative) be informed if he or she is the subject of a misadministration of NRC-regulated material, just as l
he or she would be informed if unintentionally irradiated by any l
other NRC licensee.
The patient's referring physician is given the authority to withhold from the patient or the responsible relative any information that he or she thinks would be harmful to the patient (or relative).
Thus the NRC is in no sense making its regulatory judgments take precedence over the medical judgment of the patient's own physician.
It is also asserted that the NRC's regulations in this area should be withdrawn because the regulated medical community is opposed to them.
Even if the regulated medical community were universally opposed to an NRC regulation, the NRC does not give veto power over its regulations to medical licensees, any more than to nuclear utilities.
Anyone adversely affected by a commission rule has the opportunity to challenge that rule in court, as in fact happened in the case of the medical quality management rule.
It_should also be noted that when the 1
misadministration reporting rule was proposed, some commenters outside the regulated community, including the Department of Radiological Health of one state (Arkansas), strongly endorsed the concept of patient notification.
"'Similar arguments were made by the American College of Nuclear Physicians and the Society of Nuclear Medicine in their legal challenge to the quality management rule. Their petition for review was turned down by the U.S.
Court of Appeals for the D.C.
Circuit without opinion, a strong indication that the court viewed their arguments as meritless.
ACNP & SNM v.
NRC, 976 F.2d 45 (1992).
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ATTORNEY WORK-PRODUCT MATERIAL -- LIMITED TO NRC UNLESS THE COMMISSION DETERMINES OTHERWISE The argument is also sometimes heard that the obligation to report misadministrations is somehow diminished because the victims of these events are frequently very sick already.
In our legal judgment, this argument is wholly invalid.
One does not lose one's rights by becoming ill.
NRC's duty to protect public health and safety does not vary according to the pre-existing state of health of the particular member of the public."
In addition, it has been suggested that NRC should not be regulating medical misadministrations because the risk of harm from such procedures is less than that from other kinds of nedical procedures not regulated by NRC.
Assuming for purposes of argument that the factual premise is correct, it would be inconsistent with our approach to all our other responsibilities to allow comparison with non-nuclear risks to be dispositive.
In the same way, our judgment on " adequate protection" in the nuclear power plant context is not dictated by the health risks posed by coal-fired plants.
Congress has given the NRC the duty of protecting the public with regard to civilian nuclear uses; whether other comparable risks are adequately or inadequately regulated is not our concern.
Lastly, the principal argument made against patient notification is that it may provide a factual basis for malpractice suits against licensees.
This argument is not relevant to NRC's regulatory authority and responsibility.
Whether medical malpractice lawsuits are desirable or undesirable is not a matter within NRC's jurisdiction.
It is not the business of the NRC to encourage patients to sue licensees, but neither is it NRC's business to stand in the way of their doing so.
Our responsibility is to see that patients and referring physicians know the facts about misadministrations so that they can use that information to make appropriate medical decisions and whatever other decisions they choose to make.
Whether a patient decides to use that information.to seek redress is not a matter of NRC As OGC has previously pointed out in guidance to the Commission, the Supreme Court has made clear, in the context of the dispute over the " drug" Laetrile, that the Federal Governnent owes the same legal protection to the terminally ill that it owes to all others.
See Memorandum, General Counsel to the Commission,
" Response to SRM Dated June 23, 1992, Re:
Practice of Medicine,"
Sept. 10, 1992, at 14, citing U. S.
v.
Rutherford, 442 U.S.
544 (1979).
NOTE:
ATTORNEY WORK-PRODUCT MATERIAL -- LIMITED TO NRC UNLESS THE COMMISSION DETERMINES OTHERWISE
NOTE:
ATTORNEY WORK-PRODUCT MATERIAL -- LIMITED TO NRC UNLESS THE COMMISSION DETERMINES OTHERWISE i responsibility or authority.
(of course, not every misadministration causes serious harm, and the fact that an event has been identified as a misadministration by the NRC does not mean that a patient will have grounds for a successful lawsuit.)
V.
CONCLUSION Our bottom line regarding the obligation to patients may be summarized as follows.
NRC has a statutory obligation to inform itself about the harm that is suffered by patients as a result of serious misadministrations of NRC-licensed materials.
(This obligation extends to other persons who may be irradiated as the result of a misadministration.)
What the NRC learns about harm to a patient, the patient also, by NRC rule, has a right to know, unless that knowledge, in the declared medical judgment of his or her physician, would be harmful.
What use the patient chooses to make of that information is his or her business.
The patient's right to know is a consideration entirely separate from the NRC's interest in determining the root cause of the event in order to assure that other patients, at the same facility or elsewhere, are protected from experiencing similar harm.
Based on what we have heard and read in carrying out our official duties, it is our view that the agency has, for many years, given great weight to the NRC's important interest in determining and correcting the root causes of events, but has apparently not given similar attention and weight to the companion requirement in the rule, the patient's right to be informed.
The foregoing has been couched in terms of NRC regulation of its own licensees.
We have no reason to believe, however, that at least some of the problems identified with regard to medical uses regulated by NRC are not also present in Agreement States.
If the statements of the State officials at the January 29, 1993, i
i l
1 NOTE:
ATTORNEY WORK-PRODUCT MATERIAL -- LIMITED TO NRC UNLESS THE COMMISSION DETERMINES OTHERWISE i
1
1 i
NOTE:
ATTCRNEY WORK-PRODUCT MATERIAL -. LIMITED TO NRC UNLESS THE COMMISSION DETERMINES OTHERWISE !'
s l
]
}
public briefing are representative, they provide further support for our belief in that regard.
l i
William C.'Parler General Counsel Attachments:
A -- Memorandum, General Counsel-to the Commission, "SECY-88-77:
Medical Use Program," March 21, 1988 B -
" Misadministration Reporting Requirements," Final Rule and Statement of Considerations, 45 Federal Register 31701 (May 14, 1980)
C -- Three memoranda on medical issues from General Counsel Peter L.
Strauss to the Commission (December 16, 1976; August 5, t
1976; April 22, 1977)
D -- Misadministration reporting rule.as it appeared in the 1986, 1987, and 1992 editions of 10 CFR cc:
w/ attachments SECY EDO OCA OPA t
NOTE:
ATTORNEY WORK-PRODUCT MATERIAL -- LIMITED.TO NRC UNLESS THE COMMISSION DETERMINES.OTHERWISE j
i
1,0 )
- ,pSasuq'e.
UNITED ST ATES NUCLEAR REGULATORY COfe.
.ilON i
1,,
e waswinctow. o. c. 20ssa
{g7
)
(7..e1/
March 21, 1988 MEMORANDUM FOR:
Chairman Zech Commissioner Roberts Commissioner Bernthal Commirsioner Carr Commissioner Roger i
William C. Parler.
FROM:
General Counsel
/
SUBJECT:
SECY-88-77, " MEDICAL USE PROGRAM"
)
While OGC ordinarily would have no comment on a paper of this kind, which deals primarily with issues of internal allocation of resources within ancther Commission Office, we would note that SECY-BB-77 revives a policy issue -- the apprepriateness of NRC regulation of diagnostic medical misadministrations -- which the Commission addressed only last year when it voted to issue a proposed rule on the subject.
Because statements in SECY-88-77 are inconsistent with the position taken in the Commission's notice of proposed rulemaking, and might be used to undercut the l
NRC's litigative position in any lawsuit arising out of the rulemaking, OGC feels obliged to bring the issue to the Commission's attention.
The NRC's proposed rule, which appeared in the Federal Register on October 2, 1987, involved quality assurance procedures designed to prevent medical misadministrations.
The rule included both therapeutic misadministrations and diagnostic j
misadministrations involving large radiation dosages.
As the Federal Register notice explained, the NRC was aware of a series of 14 diagnostic misadministrations (all involving radiciodine) that resulted in doses to the thyroid of up to "several thousand rads.'
The notice therefore declared that "whenever radio-pharmaceuticals capable of producing therapy doses are used, clear nomenclature, independent verification, and adequate training are essential."
The Federal Register notice which the Commission approved was l
presented in draft form in SECY-87-29A.
That paper in turn responded to a March 26, 1987 Staff Requirements Memorandum on SECY-87-29 which included the directive that "the NPR and the
Contact:
Peter G. Crane, OGC, 41465 ATTACHMENT A
. ~.
i a
1.
d ANPR should be appropriately modified to apply to misadministra-tion of diagnostic procedures which fall in-therapy dose ranges as well as to misadministration of radiation. therapy.'
j 1
(Enclosure 3 of SECY-87-;9A.)
I In SECY-88-77, the staff suggests.that regulation of 1
I misadministrations other than therapeutic misadministrations I
'could negatively impact.public health and safety" by diverting
]
resources from other problems, including problems that are beyond i
j the scope of NRC. regulation.
(Enclosure 1, p. 7.)
The point j
seems to be picked up again at p. 18 of enclosure 1, where the i
staff states its intention to. examine, among other things, 'the extent'to which NRC regulatory activities detract from quality of care:in conventional medical programs," with its examination to be " conducted under the premise that.a rational Federal program on controlling risks should seek to address the worst and most controllable risks first without undue uttention to lesser risks."
Leaving aside the issue of whether NRC has any basis for making comparisons between problems that are within NRC's jurisdiction and those that are beyond
.t, the cited' statements in SECY-88-77 i
go directly to a central issue in:the pending rulemaking:
the need for regulation of diagnostic misadministrations.
If the-i Commission approves the staff plan as'now proposed, and if the current rulemaking concludes with a Commission decision to continue regulating diagnostic misadministrations, the statements l
cited above.could be of immense value to any petitioner seeking to persuade a reviewing court.that the NRC was over-regulating i
nuclear medicine.
A reviewing court.might well ask why, if the.
l Commission thought that closer-regulation _of diagnostic.misadmin-istrations.was necessary in October 1987, it approved, only half a year later, a staff plan which asserted that regulation of non-therapeutic administrations could actually detract from j
public~ health and safety.
-l We therefore recommend that if the Commission: continues to believe that the approach taken'in-the proposed rule is sound, it should direct the staff'to conform the statements-on misadminis-trations in SECY-88-77 with,the policy-expressed in the proposed rule.
I cc:
SECY-H. Thompson, NMSS 1
r t
1
/ Vet 45. Ns. 93 / Wadnisday. Ms-1930 / Rults and Rigulatians 31701 '
Federal Rer*
authorise a cooperative applying for including full p[yment of the reqmrod NRC, the refming physician, and the 4
initial approval to acquire or receive for membership asock or fees, either in cash patient or a responsible relatfwe (unless
}
[,._ N marketing from its members a smaller or earned eqalty credita,is accepted by the refwring physician stated that the j
i 4
Quantity of such oop that 80 percent, if the coopwative and is entitled to all information would harm them):and j
that quantity has a value greater than membership rtshts including voting and.
(3) FoDow the prompt report with a i
the value of the quantity acquired or holding ofRoe.
written report to NRC and the patient or received from nonmembers for (c) Active member. * *
- responsible relative within is days.
marketing and if the cooperative (sees. 4 and s et stat. tare, as amended its la the propowd mle a ntablishes to the satisfaction of the UAC rieb and cl: sas.101. scs. scsA.1cPA. misadministration was defined as the
- l i
Executive Vice President. CCC, that act. aos, act,401. as stat. icst, m== a.a gr administretion of:
j such authorization is necessary for the USC,1441.14ee(f).14eec.144sh.144ed.1447, (1) A radiopharmaceutfest or.
j radiation from a source other than the t
efficient operation of the cooperative 14:1lal)!
and is in the best laterest of the signed at Waabiostoa.D.C.en May F.
one intended:
i I
members of the cooperative. Purchase of 1ses.
(2) Aradio harmaceuticalor j
commodities from CCC and processed Rey Fltagamid.
rs&stion to a wrong patient: '
i products from other processors or hoevche vice president. Coeunedty Dodt (3) A radiopharmaceutical or i
merchandisers shall not be considered Carparecen, radiation by a route of administration in determining the volume of membw ps on. =-usa read wwm em==l other than that intended by the bg e ci business.
same ones semes.e P
- 4. Section 1425.13(d) of the regulations radiopharmaceutical differing from the le amended to read as follows:
NUCt. EAR REGUt.ATORy prescribed dose by more than 20 j
g 142s.13 gugees osmmoety and pooans. COstMISSION percent; or (5) A therapeutic dose of a
]
(d) Commodityrequirements.De 10 CFR Part 35 radiopharmaceutical or exposure from a commodity offered for price support radiation source such that the total dose 1
Min R
w expmum diffes imm b pmcrbd i
j Requiroments dose or exposure by more than to g
j
- 5. Section 1425.17(b) of the regulations asaucy: U.S. Nuclear Regulatory "n
blic was invited to submit
[1 7
is amended to read as follows:
Commission (NRC).
written comments and suggestions on actiose Final rule.
the proposed rule.De pro sed rule i
g 34 g,,7 g
,g,,,,,,,,,,g, was maued to aH medical censen.
summany:ne NRCis amendingits aboo m e
and internt (b) dispositions. De cooperative shall regulations to require its licensen to:(1)
(
date sold, the date shipped and the price maintain a record which shows each keep records of all misadministrations 8"P
an
'I I
^"
quantity of commodity disposed of, the of radioactive material: (2) promptly i
report therapy misedministrations to the Comments an ProposedRule -
received in the following manner:
NRC, the referring physician, and the
. De Commission received 150 letters (1) Commodities which are processed. patient or the patient's responsible commenting on the proposed rule.
1 The inventory of an eligible pool or relative (or guardian); and (3) report Copies of these letters, a summary and j
ineligible pool or both eligible and diagnostic misadministrations quarterly analysis of the comments, and the ineligible pools shall be adjusted when to NRC.
value/ impact analysis supporting the j
the commodity is withdrawn from upscTive cate: November 10.19eo.
finalrule are svallable for public inventory and is processed.
Nota.- NRC has submitted this rule to the inspection at the Commission's Public (2) Commodities notprocessed. ne Comptroller General for review under the Document Room at 1717 H Street. NW.,
commodity shallbe allocated to en Federal Reports Act. as amended. 44 UAc Washington, D.C. Single copies of the eligible pool, an ineligible pool, or both sst23e date so which the rule becomes summary and analysis of the comments i
eligible and ineligible pools and the pool esective reDects teclusion of the es. day or value/ impact analysis may be t
inventories shall be adjusted period that the statute allows for this review obtained from Edward Podolak at the 1
accordingly when the commodity is (44 UAC sataicMa)).
above address.
shipped.
pon pusmosa esponesafices costracT: -
Ninetypercent of the comments were ne commodity shallbe allocated to Edward Podolak.OfBoe of Standards opposed to the rule, most citing it as an eligible orineligible pools or a Development. U.S. Nuclear RT 1i unprecedented intrusion into medical combination of eligible and ineligible Commission. Washington. D.C. 30555 practice. Sasically, the commenters pools in the above manner until the (Telephone: 301443-4000).
were opposed to misedministration entire inventory in a particular pool is supptassastrany esponesattest On July ^ reporting to NRC where reports would depleted.
7.1978. NRC published in the Federal be open to public scrutiny, and
- 8. Section 1425.211s amended by Register (43 FR asas7) a proposed rule misadministration reporting to patients redesignating paragraph (b) to read on the miesdministration of radioactive - which they felt would cause " undue paragraph (c) and adding a new
. material to patients ne proposed alarm" and " unwarranted malpractice paragraph (b) which reeds as follows:
I 35.33 would have required medical '
eults." Many commentere offered helpful licensees to do three things:
- suggestions which were incorporated
.I14a5.21 Deansnena-(1) Keep recorda of all into the final rule as explained below 1
Y*
misadministrations for 8 years; under ' Summary ofMofor Chartges in 4 me(b) Afember.De term" member"shall (2) promptly report all therapy
' AheFinalAule "
4 an a person who has met all of the misadministrations and those diagnostic Many commenters questioned the requirements as specified in the articles misadministrations that could cause a need for a misadministration reporting ofincorporation and/or bylaws, clinically detectable adverse effect to:
rule.ney cited the low number of -
.M ATTACHMENT B
~
m w-y w
+aw--y-w-+tm w-w----=+-
w
---w,-
e w e st w-
+iw---
- w w-e was w~s-*-w-eeew-w
- --wes'-mi-*ve-*---*+=-s'-ww
- - +
- e
'31702 Federal Register / Vol. 45. No. 95 / Wednesday May 14, 1980 / Rules and Regulations reported misadminstraticos. Wy stated Commission believes that the should expand NRC's authority, the that misadministrations of radioactive misadnunistration recordkeeping and NRC must operste under the material were less frequent than reporting requirement is necessary to presumption that Congress intended that-1 misadministrations of other drugs or protect patients, a disproportionate degree of Federal types of therapy. And they noted that Many commenters were concemed regulatory control be exeroned over
./
th:re are no similar reporting about the privacy of patients' records nuclear matenals as coposed to these requirements in medical prectice.
when misadministrations an reported to other sources of radiat2on.
The Commission's purpose in a third party such as NRC.
In many respects the adverse requiring misadministration reports to N final rule states that the patient's comments track those received by the NRC is to idennfy their causes in order nema should not be reported to NRC.
Food and Drug Mmmistration (EA)in to correct them and prevent their The reports of misadminhtrations would response to a request for comments to recunence.ne Commission can do this be available for public review but help FDA formulate a policy on labeling by notifying other licensees if there is a without infonnation that would lead to of prescription drug products to promote i
possibility that they could make the identification of the patient.
patient understandmg of the nature and i
same errors.De commission can also s The vast majority of the commenters effects of the drugs prescnbed for them.
change its regrJations to prevent specific consider the proposed rule as a senous in a notica of proposed rulemaking (44 errors.The rigmficance of a diagnostic intrusion into the phyalef an patient FR 40016, July 6.1979), the FDA rejected misadministration goes beyond the selationship.They contend that the the assertion that mandatory patient unnecessary radiation exposure if it proposed rule is an intrusion of a labeling would constitute an results in misdiagnosis. Apparently regulatory agency into the care of a unwarranted interference in the isolated incidents at Individual medical patient without assuming responsibility physician patient relationahlp. pointing institutions could reveal a generic for that care. Many commenters pointed out among other things that a patient problem when compared nationa!!y.
out that the misedministration reporting has a right to know about a drug's Examples of rule changes resulting requirement was unique in medical benefita, risks, and directions for use.
from misadministrations are: a rule practice and noted that NRC regulations Also, in a January 1979 report (EMD-requiring annual calibration of did not apply to X-rays, accelerator or 79-16) the General Accounting Office s teletherapy uruts (44 FR 1722). and a rule radium therapy, and accelerator.
(CAO) stated:
pequiring radiation surveys of patients produced radiopharmaceuticala.
g, g
,g g,,,
yfollowmg removal ofimplants (43 FR The Commission recognizes the report miss&ninistratms to NRC is not an
':55345),
intrusion into the physician-patient intrusion mio me6 cal practica. This is clearly
) The Commission does not know the relationship in the sense that the rule consistent with NRC regulatory
- entire extent of misadministrations of does affect. to a limited degree, the responsibihties and a necesesry part of an radioactive material. In 1976 NRC nature of the physician's obligation to effective nuclear medicine regulatory investigated an incident where 400 his or her patient-it imposes in certain program. Without this kind of feedback on therapy patients had received radiation circumstances an obligation on the incidents affectmg the public health and 5<
doses exceeding the prescribed doses by physician to report information to the safety. NRC cannot be sure it is adequately es much as 41 percent. In 1977 NRC patient and the NRC. For many in the
[aYn m a Ye&
/
pracnos received seven reports of health professions. this limited mi administrations ranging from minor involvement may be understood. rightly Many commenters were concerned misadminirtrations to a senous or wrongly, as fcrashadowing some that the proposed rule, particularly the teletherapy overexposure. In 1978 NRC greater degree of Governmental patient reporting requirement, would r:ceived eleven reports nf involvement or as symbolizing some invite unwarranted malpractice suits misadministrations. one of them a general movement toward more and thereby boost medical costa. Some serious misadministration of four tr-192 regulation of the profession.
of these commenters suggested that the sesds that were left in a patient. !n 1979 ne Commission does not believe, rule would lead to covenng up NRC has received a smgle report of a however, that this limited intrusion misadministrations to avoid liability.
misadministration: colloidal N2 was warrants abandoning the rule. Some The Commission believes that the administered instead of soluble N2.
physiciana do support the rule--the requirement in the final rule to report The Commission does not know what medical profession is not unanimous therapy misadministrations to patients fraction of the actualincidence of that the rule would constitute an or a responsible relative is important.
misadministrations these reports unwarranted intrusion 1nto the Patients have a right to know when they represent. However, whenever there has physician-patient relationship. ne have been involved in a serious been a serioco misadministration, the "physief an-patient" relationship is a misadministration, unless this Commission has been able to act to help concept'that was developed to advance information would be harmful to them.
prevent recurrence by issuing notices or the needs of the patient.ne NRC has parallel requiremeets for orders to licensees or through relationship involves duties of licensee reports to workers on rulemaking.
reasonable care and skill.
occupational overexposures. Also, there The Commission recognizes that its confidentiality, and good faith owed by is a trend in Federallegislation that misadministration reportmg requirement the physician to the patient Nothing in recognizes the right of individuals to may be unique to medical practica.no the rule would detreet from these duties, know information about themselves Commission also recognizes that the nua. in a strict sensa, the rule would which is contained in the records of misadministration of not interfere with the relationship.
Institutions both inside and outside of radiopharmawuticals and radiation It is true that no similar repornns the Federal sector. Examples are: the frnm sealed sources may be less requirements are attached to use of X-Privacy Act of 1974. which set rules for frequent than the nusadministrution of rays, accelerator or radium therapy, or Federal Agencies'recordkeeping: the cther drugs or forms of therapy, because accelerator-produced isotopea.
Fair Credit Reporting Act and related s
the radiopharmaceutical dosas and However, this is the direct result of acts, which gave consumees the right to radiation doses can be measured before limitations in NRC's regulatory know information about themselves cdmimstration to patients. However, the authority. At present, unless Congress contained in the records of credit-
Federal Register,
- 45. No. 95 / Wednesday. May 14, i
/ Rules and Regulations 31703 nporting bassas; and the Family give a smauer radiatian dose to the Several commenters questioned Education Rights and Privacy AaL patient.
whether extravasation is considered a
'"~
.which gave students the nght to see ne proposed rule had a threshold for misadministration.
personal records held by educational nporting diagnostic misadministrations.
Extravaastion is the innitration of institutions. Also. in April 1979, the The threshold was not clear.no injected fluid into the tissue surrounding President sent the proposed " Privacy of proposed rule required reporting of all a vein or artery. Extravasation Medical lnformation Act" to Congress.
therapy misadministrations and those inquently occurs m otherwiu normal and President said:
diagnostic misadministrations that could intravenous or intrearterial injections. It The " Privacy of Medicallafamation Act" cause a " clinically detectable" advarse is virtuaUy impossible to avoid.
is being subrnattad to you todar. it establishes effect on the patient Denfom. b Conmunion does not pnvecy protecnons for infarseban The sta5 ayees that the dennition of mem a n by alm m
nette a diagnoetic misedministration as a 20 Iars questioned whether km m& cal mwds. Nerus acases percent enoris too low.%st level was may bane the petient, the Ass provide that chosen originally because it was within they would have to measure the activity in a syringe before and after the access may be primded thnmsk at the state-of-the-art for injection in order to determine if a intersnediary. This leyelsean aDeus the radiopharmaceutical measurement and misadmmistration has occurred.
Individual se ensure shat she infeemation the Commission was concerned that the Misadnumstrations of a maintained as part ofles medical care limit for a diagnostic misadministration radiopharmaceuticalis defined as a relauonship is accurate timely and relevant would be constmed as good practica.
percentage error from the prescribed db ov"e"su'on ts The Coramission secognizes that there dose.it is necessary to measure the 8
u used to effect employment and collec
. am facton, such as pahent schedulag.
activity prior to injection and then inject insurance and other sosial humeats..tio.n.of which are not erron but could cause the the contents of the syringe. it is not patient to receive a dose di5aring from necessary to measure the residual Regarding the comment that the rula the prescribed done by more than 20 activity in the syringe.
i would invite malpractice suits and percent without affectmg the One commenter suggested that thereby boost medical costs, this may effectiveness of the test. The Baal rule licensees be required to keep records of well be true.ne amount of this increase defines a diagnostic misadministration, misadministrations for 50 years. Instead is not known. In response to NRC quary, in part, as that differing from the of the proposed 8 years, because of the the Nanonal Association ofInsurance prescn' bed dose by more than 50 long latency period for radiation-Brokers replied:
percent. At this limit of 50 percent:(1) an induced cancers. For the same reason, it is simply beyond oar compelmace to error has obviously occurred and (2) 50 another commenter suggested that the quant fy the eNect as medacal malprecame percent over or under the prescribed records be maintained for 30 years, rates of your proposed rule. * * ' that the dose can clearly compromise the The Commission agrees that there are proposed chanse would have an adverse effect ao retes seems indisputable. since the effectiveness of the diagnostic compelling reasons forinsuring that the doctors would be required. ta a ornee. to procedure, records of misedministrations should be prepare testimony against themaetwee. W, Some commenters objected to the maintained for a period of time longer frankly doubt that anyane can gauge the absence of a definition for a " clinically than the Bye years as originally likely e5ect at such a rule * *
- detectable adverse e5ect"in the ptoposed. At the same time it is not yet
)
8 w 1d le to co a
istra ans ersq tioned Ce ou uim oe m sadministratio avoid liability. thf who would make that determination.
"*in eli g,
Cornmission does not believe that Others objected to the physicien having physicians would willfully disregard the too much laway in making b Ilcensees to maintain misedministration rule. Moreover, there is nothing in the determination. Still others complained records for any speca$c length of time, rule that would in any way modify the that, without guidelines, they would the final rule requuse that licensees legal rules governing malpractice suits have difficulty in making the shall preserve misedministration.
arising out of reported determination.
records until the Commission authorizes disposition. Dis approach is consistent misadministrations.
At the proposed rule stage, the with Part 20.401 of NRC's regulations A majority of the commenters who Commission believed that "c!InicaDF which requires that NRC licensees opposed the rule were opposed to the detectable" was a term well understood maintain and preserve radiation requirement for reporting diagnostic in medicine. According to some exposure records for monitored misadministrations to petlanta. ney commenters. this is not the case. D*
personnel untd the Coaunission stated that most misedministrations of Commission recognizes that the authorises disposition.
diagnostic radiopharmaceuticals would diagnosis of an " adverse effect" may in.
Under the provisions of section 20s of not harm the patient.ney also stated
, one case be based on a single dramatic the Energy Reorganisation Act of1974, that the definition of a diagnostic symptom, while in another case it may the Conunission reports each quartar to misadministration as an error greater be based os a number ofindividustly the Congress on any abnormal than 20 percent would unduly alarm the minor deviations from the normal for occurrences involving facilities and patient becanes it was too low. They that patient. Because of this and activities regulated by the NRC. An stated that the w==ded dosage because adverse effects may be delayed abnormal occurrence is defined in ranges in the drog labeling spanned in time, the term "clinicaDy detectable section aos as an unscheduled incident factors of two and grsator. ney further adverse effect"is a moving target, or event which the Conunission :
stated that the standard dosages very,
Therefore, the Commission is detersuces is sigruficant from the between institutions by as much as too abandoning this term and the threshold, standpoint of public health or safety.
percent. ney also stated that this The final rule will requus reporting of The t%==i== ion published a policy.
definition discriminated against short all dispostie misadaurustratJons to staternent on abnormal occurrence half-life radiopharmaceuticals which NRC.
reporting in the Federal Register (42 FR s
~.;
.._,-.1
-, _ ~ _ _ _ _ _
~
31704 Federal Register.
.t. 45. No. 95 / Wednesday. May 14.
/ Rules and Regulations 10950).Those misadministrations which In The final rule, the definition of a calculated total treatment dose differing l
' the Commission determines meet the therapy misadministration in i 35.41 (e) from the final prescribed total treatment criteria for abnormal occurrence and (f) distinguishes between dose by more than to percent.
i reporting willbe published in the radiopharmaceutical therapy and sealed quarterly " Report to Congress on source therapy. For sealed source Abnormal Occurrences."in the past, therapy, the new definition (a)Immdiots telephone report. When teletherapy overexposures have been that the therapist often adjusts e dose e
ad*Wehe my reported to Congress in this manner.
during treatment. Also, the new -
therapy procedure, the licensee shall n
that '
j Summary of MaJoe Changesla the Final j',
,,y
) repy notify, by telephone only, the appropriate NRC Regional Ofnce listed Rule calculated as a function of doserate, ne finalrule was organized into time, and treatment geometry, and is not in A pendix D of Part 20 of this chapter.
separate sections, specificaDy ll 35.41 usually measured directly.These ne censu s,hau also nonly the nferring physician of the affected through 35.45. to make the requirementa changes resulted from several coniments patient and the patient or a responsible easier to understand.
from radiation therapists.
relative (or guardian), unless the Several commenter's suggestions were inco rated into the final rule. As Final Rule referring physician ersonallyinforms note above, the term "could cause a Under the Atomic Energy Act of1954 the licensu either at he willinform c!!nically detectable adverse effect"in as amended, the Energy Reorganization the patient or that. in his medical the threshold for reporting diagnostic Act of1974, as amended, and Sections judgment. telling the atient or the misadministrations has been abandoned 552 and 553 of Title 5 of the United patient's responsible lative (or in the final rule. Instead. all diagnostic States Code, the following amendments guardian) would be harmful to one or misadministrations will be reported to Title 10. Chapter L Code of Federal the other, respectively. Dese quarterly to NRC only. These reports of Regulations. Part 35, are publis5ed as a notifications shall be made within 24 diagnostic misadministrations are to be document subject to codiScation.
hours after the licensee discovers the in letter format and postmarked not misadministration.(If the referring physician or the patient's responsible later than to days following the PART 35-HUMAN USES OF calendar quarters ending in March. June. BYPRODUCT MATERIAL relative or guardian cannot be reached within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />, the licensee shall notify September, and December.
New 1135.41 through 35.45 are edded them as soon as practicable.The The Commission encourages licensees to to CFR Part 35 to read as follows:
licenne shall not delay medical care for to report diagnostic misadministrations to patients but does not believe that the the patient because of this.)
g 35.41 Definition of a misadmintatretion.
(b) Written report. Within 15 days
)
risk of a diagnostic misadministration warrants Federal intervention in this 35.42 Re rts of therapy after the initial therapy i
decision. Therefore, the Commission
' misa strations.
misedmintstration report to NRC, the will not require licensees to report 35.43 Reports of diagnostic licensee shall report, in writing, to the diagnostic misadministrations to the misedministrations.
NRC Regional Office initially i
patient or relative (or guardian).
35.44 Records of all misadministrations.
telephoned and to the refering in the final rule, only therapy 35.45 Rights and duties of licensees.
physician, and furnish a copy of the misadministrations are required to be
. Authority: Sections 81. tes b. and o Pub. L report to the patient or the patient's reported to the referring physician and 83-703, sa Stat. 335. 948 b. and o. 42 U.SC responsible relative (or guardian) if 4
the patient or responsible relative.There 2111.12o1 b. and o.:Section 201. Pub. L B3-either was previously notified by the are two changes regarding notification ass, se Stat 2242,42 U.Sc 5841.
Licensee under paragraph (a) of this of the patient or responsible relative in Mindminf atration Reports and Recaeds section. The written report shall include i 35.42(a). First, a renthetical"(or the licensee's name: the referring guardian)" was a ed to " responsible 1 35.41 DefWoon of a misadminletremon.
physician's name; a brief description of relative" to cover persons who do not For this part. misadministration the event the effect on the patient the have relatives. Second. now the means the administration of:
setion taken to prevent recurrence:
referring physiciana,if they wish, may (a) A radiopharmaceutical or whether the licensee informed the inform the patient of the radiation from a sealed source other patient or the patient's responsible misadministration.
than the one 104. & **
relative (or guardian), and if not, why in the final rule. the limit for a (b) A redir ase stedorradiation not.The report shall not include the diagnostic misadministration in i 35.41 to the wron patient's name, or other information has been raised to errors greater than 50 (c) A radiumusaceutical or which could lead to identification of the percent. Many commenters pointed out radiation by a route of administration patient.
that the recommended dosages in other than that intended by the ra diopharmaceutical labeling cover prescribing physician:
I 38.43 Meports of diagnosec ranges of up to a factor of to and that.
(d) A diagnostic dose of a misadministretena, comparing nuclear medicine radiopharmaceutical differing from the When a misadministration involves a departments. there is often a 100% or prescribed dose by more than 50 diagnostic procedure, the licensee shall greater difference in the standard percent mottfy,in writing, the referring physician dosages for the same procedure.The (e) A therapeutic dose of a and the appropriate NRC Regional Commission did not raise the limit of radiopharmaceutical differing from the Office listed in Appendix D of Part 20 of error for a diagnostic misadministration presenbed dose by more than10 this chapter. Licensee reports of above the 50% level because this level percent or diagnostic misadministrations are due begins to affect the quality of the (f) A therapeutic radiation dose from a within 10 days after the end of the diagnostic procedures. A poor quality sealed source such that errors in the calendar quarters (defined by March, diagnostic procedure could require a re-source calibration, time of exposure, and June. September, and December)in take or could result in a misdiagnosis.
treatment geometry result in a which they occur. These written reports
i, l
j I
Fed ral Re-
/ Vol. 45. No. 95 / Wsdnesday. Me 1980 / Rulze and Regulations 317DS i
l shall indede the 11oensse's name. the
' Smith Section Chief, or John C. Wood, effect is that the requirement to identify r
1 i-referring physician's name, e description Attorney (202-454-3412). Division of on theidrminalreceipt en type of i
. of the ennt the effect on the petimmt Consumer and Community Affairs.
- accoat a===ad welmet apply in POS and the action taken to provost Board of Governors of the Federal transfers where the soness device used
, \\
meurrence.De report should not Reserve System. Washington D.C.
can access only one soooupt. If the l
Include the patient's name or other 20551.Regarding the -kimpact access' device can acomesmore than ene i
+
information which couldleed to analysia: Frederick J.Schroeder, aconent when need at eAiffarent type of identification of the patient.
Economist (303-453-2584). Diviales of.
facility (for example. yautomated teller Research and Statistics. Board of-machinas), the eaa
- will 1
j 135.44 Aueresof asm Covernors of the Federal Reserve. ~
nevertheless be av ble at point of.
3 Eachlicensee shallmaintain for System. Washington. D.C.205st.
. ' sale.On the otbaceand the exemption Commission inspection, records of all misadministrations of suppi.assawrany Neponsaanon:(1) willapply only POS transfers.it will radiopharmaceuticals or radiation from Explonotion of omendmeirt. Regdaden not be avails for example.in E requires that at the time an electronic automahd,
machine transfera, j
teletherapy or brachytherapy sources.
fund transfer is initiated at an electronic mnif egocess device can accus i
nese acords shallcontain the names
$ote Woo est so wad aWa one unt in eose transim.
terminal, the Anancialinstitution make of allindividuals involvedin the event (including the physician, allied health available to the consumer a receipt containing certain information about the md io'ee amadment afers only M personnel, the patient. and the patient's transfer. Section 205.9(a)(3) requires that accoynts as defined in Regulation E. i.e.,
t 1
1 refering physician), the patient's social the receipt identify the type of account M consume amt accounts.Dus.if a =
J
. security number, a brief description of accessed (for example, checidag or egnaumer can use a card at a M the event, the effect on the patient, and savings).It has come to the Board's reinal either to debit an asset account j
l the ection taken to prevent recurrence.
attention that compliance with this w k obtain cmdit m an open ud cast nese records sball be preserved until re utrementisimpracticablein the
. *ccant. 6e mapdon muld i
i the Commission authonses their j
disposhn.
of debit cards used ininterchange omrtheless appl of-sale (POS) systems. Cards need in y, d*g g dak n w i
g 35.45 Alghts and duties of Boonsess.
such systems contain no indication Aside from the notification the type of account est wM be i 205.9(a)(3) goes into effect. his action i
requirement, nothing in this section shall accmed. -
is taken in order to avoid unnecessary harm to Bnancialinstitutions that would affect any rights or duties oflicensees The options for disflosing type of a[nd physicians in relation to each other, scennt,if es mquimmen%sined in be subject to risk of civilliability if they atient or responsible relatives (or place. appear impracticable /First, store continue to provide this service. and to p
j guadians).
clerks could ask customerW what type of censumers who might be deprived of a beneficial service il financial institutions Deted i Washinston, D.C., this 7th day of
, Mand 7e e n u ne e inf ti n on the i
F receipt. The difficulty here is that the For the Nuclear Regula tory f==issisu.
clerk may fail to perform the procedure notice public procedure, and deferralof Samuell.chlik.
or that the customer for privacy reasons effectiw date provisions of 5 U.S.C.
Seciviaryof the commission.
may prefer not to divulge the 853(b) and (d) would be impracticable tm om aman nme aos==l informstion. Second, debit cards could and contrary to the public interest. For the same reasons. the expanded pg sone,,, m,
be encoded ylth a symbolindicating the rulemaking procedures set forth in the type of account to which they relate.
This option, however, would necessitate Boards policy statement of January 15 FEDERA1. RESERVE SYSTEM the reissaance of all debit cards now in -
1979 (44 FR 3957). will not be followed in circulation and the replacement of connecdon wie this procudhg.
(2) Economic /mpoet analysis. Section 12 CFR part 20g" existing stocks of sale slips (so as to add 305.9(e)(3)is amended to provide that.
g gg,,g an explanation of the code).FinallF.
when only one of a consumer's accounts '
informstion of account type might be at a Anancialinstitution can be Electronic Fund Transfera; ettained for each POS transfer via the accessed by an ecosas device at point of 1
Documentation of Transfers authorization network, but this again sale, the POS documentation need not would require ma}or mprogramming and ina5cate the type of account accessed.-
i assisev: Board of Goversees of 6e place an unnecessary new burden on
%e Act requires that the documentation Federal Reserve System.
h network.
Identify the account to or from which acnose Final rule.
it also appears that a disclosure of *
' funds are transferred.De regulation type of account would be oflittle sales spednes that the account has to be -
suumaan ne Boardis amending
. to the cardholder in these identified by type: thle provision is I 205.e(aX3) of Regulation E, whicit Implements the Electronic Fund Tlrunsfer circumstances.%e cards in question -
designed to analds osasamers to can access only one account of the determine that the correct account was Act, to exempt int.of-sale fpOS) consumer when used at POS termhela-
' n foot debited.
i transfem from aquiressent to -
identify,en the terminal 6ceipt, the type The consumer aheadyknows which Bank caniassociatinas have pointed f
account est is. A consumw signks up out estlatwchange networks am not of account accessed. ne examptiesis.
for the service indicates to the Saancial capable of providinginformation on e
limited to POS transfersin which the accese device involved can soness only. Institution the particular deposit account account type at the time of the tranafar.
to be accessed when the card is asedin Furthemore, the majorinterchange one particular account at point of sale.
a POS transaction.
networks allow access devices to access -
EPPacyrvt cava:May 10.1980..
. Board is amending i 205.9(a)(3)by '
type is not useful infonnation. Costs of For the reasons stated above. the.
only one account,se that the account PoR PUNTHER tedPOResaMOII c0NTact Regarding the regulation: Dolores S.
adding a sentence to footnote 3.no redesigning interchange network
-).
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S NUCLEAR REGULATORY Ct.
.S$10N d} E WASHINGTON, D. C. MBE W
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December 16, 1976
') O HEMORANDUM FOR:
Chairman Rowden Commissioner Mason i
Commissioner Gilinsky Commissioner Kennedy j
Peter L. Strauss, General Counsel s#
FROM:
f
SUBJECT:
SECY-76-574 (AMENDMENT TO 10 CFR PART 35: " HUMAN USES OF BYPRODUCT MATERIAL")
l I
I have no objections, legal or otherwise, to the proposed amendment, as far as it goes, but this is not far enough.
For example, I would feel more confident that miscalibra-tions would be brought promptly to the Commission's atten-tion if the proposed rule required licensees to make reports when a miscalibration exceeding a certain amount is detected, rather than simply " maintain records", which may or may not come promptly to the attention of the Commission, depending on the frequency of inspections.
Further, the rule is in no way responsive to the follow-up concerns expressed in the attached OGC memo of August 5 and noted by Commissioner Gilinsky.
For example, there is no provision to guide (or compel) licensees in steps to remedy the consequences of past errors in dosages which calibration checks pursuant to the new rule may bring to light.
Accord-ing to an earlier staff document (SECY-76-529, "The Issues Concerning NRC Involvement in the Regulation of Nuclear Medicine" page 14) the staff is still considering amendments to 10 CFR Part 35, proposed by the AEC and published Septem-ber 9, 1973 (38 Fed. Reg. 6399), that would require reports to the Comnission and to the patient of any "misadministra-tiens of byproduct material," defined to include administra-tion of radiation "outside of the intended dose range prescribed by the physician."
This proposed rulemaking was based on a GAO recommendation "that was in turn based on GAO's review of the AEC's investigations of twelve instances of misadministrations of radioactive material (involving 20 patients) between 1961 and 1972."
The subsequent Riverside
Contact:
E. Leo Slaggie 49-28155 ATTACHMFNT C
~
The Commission 2
1 incident appears to point up strongly the need for something like what the GAO recommends.
I continue to regard Commission action in this direction as I
an immediate need and would hope to see a staff recommenda-tion shortly on the proposed AEC rule for dealing ~with the general problem of misadministration of byproduct materials.
With regard to the specific problem of misadministration in the teletherapy case and as a response to the concerns raised in this memorandum, I suggest replacing paragraph.
(b) (6) 'of the rule proposed in SECY-76-574 by _ the following two paragraphs:
Sec. 35.13 (b)
(6)
When measurements made pursuant to paragraphs (b) (1) and (b) (4 ) of this section indicate that patients treated by teletherapy units may have received.a radiation dose differing from the prescribed dose-by more than 10 per cent, the licensee shall notify the appropriate Regional Office of Inspection and Enforcement listed.in Appendix D cf.10 CFR Part 20, and, where practicable, the authorized physicians of affected patients.
This notificction shall be made within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> after the licensee's discovery that such misadministration is likely to have occurred.
(7)
The licensee shall maintain for inspection by the I
Commission records of the meas.remar.'..*. made pursuant to paragraphs (b) (1) and (b) (d) sf T.il.s section and of reports made to authorized physicians pursuant ~to paragraph (b) (6) of this section.
Attachment:
i As stated' cc/with attachment V. Gossick EDO Mt K. Chapman, NMSS B. Huberman, OPE SECY (2) i
UNITED STATES p atc0 4,*.,
~
NUCLEAR REGULATORY.
' MISSION g
WASHINGTON, D. C. '.
2 1
OFFICE OF THE com,issiONEn August 26, 1976 d
MEMORANDUM FOR:
Chairman Rowden Commissioner Mason commissioner Kennedy FROM:
Commissioner Gilinsky
SUBJECT:
Calibration Errors in Teletherapy (Riversile Hospital Incident)
I believe that the General Counsel'c mamerandum of August 5,1976 (attached) should-be carefully considered.
I suggest that the GC's proposal for an organized follow-up effort be discussed at an early sesnion.
i cc:
S. Chilk, SECY 4
~v re
s y
^
UNITED STATE 1 NUCLEAR REGULATORY CoMMISSloN g
j WASHINGTON, D. C.20SM j
=L e
i j
...../
i August 5, 1976 3
)
3
. MEMORANDUM FOR:
Chairman Rowd'en Con =11ssioner Mason j
Co==issioner Gilinsky g - g Commissioner Kennedy g
i FROM:
Peter L. Strauss, General Counsel
SUBJECT:
AUGUST 2,1976 BRIEFING ON RIVERSIDE HOSPITAL j
INCIDENT 4
In my view the' results of this meeting repi ese'n't an appropriate first step to deal with the most pressing im=ediate problem 1
disclosed by the incident, namely the fact that because of calibration errors many teletherapy patients throughout the country are probably receiving doses significantly different i
from those prescribed.
The concluding emph' asis of the meet-j ing rightly focused on t,he need to be.sure that these machines 4
are calibrated correctly now and henceforth.
2 l
While the Co m4ssion obviously has a paramount concern that future da= age be avoided, it also seems clear that action should 4
be taken to identify and remedy where possible the human con-l sequences of past errors in dosages.
More attention to this j
, subject appears to be needed than the August 2 briefing 1
provided.
It is my impre'ssion from the briefing and from the documentation of this incident that physicians of Riverside 4
Hospital patients who received a-dose substantially different 4
i from the one prescribed are being notified of this fact.
It l-was not clear from the briefing, however, that an organized effort is-bein~g planned to identify patients elsewhere and pro-
?
vide notification and follow.-up,. where the NBS study or futdre NRC evaluations indicate a likelihood that doses in error have been delivered.
I recognize that there is a major resource 1
problem in. accomplishing this task'in view of the. fact that d
25,000 or more patients may b'e involved.
As was recognized there are also sensitive questions concern-
~
at the briefing,bility of the hospitals. -Nevertheless, the ing possible lia l
("potentially explosive" nature of the affair makes it prudent
'as well as humane for the NRC.in its position of radiation safety leadership to.make a substantial effort to assist those who may have been injured.
j contact:-
E.L. Slaggie 492-8155
~
a vt a r UptkIT f
1 y.:l x..
(.
(
2 HRC consultant Dr. Saenger, in his letter of May 26, 1976, indicates that many months of study are needed, once an erroneously dosed patient is identified, to consider fully the needs of the patient.
Thus a program for identifying patients affected by these errors and notifying their
' physicians is needed prompt y knd probably should commence l
during the NRC ?rogram for correcting existing calibration Once t ae latter program is effectively underway, the errors.
question of how best to proceed with identification and notifica-tion might be the subject.of a future Commission ' briefing.
~
cc:
Ben Huberman SECY (2)
Lee Gossick
~,
R. J. Voe'geli e
e e
t e
,e O
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i 4
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1
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V f-e
'p'#'%g UNITES STATE' t
NUCLEAR REGULATORY s
.AISSION I
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[ (Y'.
WASHINGTON, D. C. 20565
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%,.....*e#
April 22, 1977 MEMORANDUM FOR:
The Commissioners FROM:
Peter L. Strauss, General Counsel p>C-47~
j
SUBJECT:
SECY-77-194, REQUESTING RECONSIDERATION OF THE MISADMINISTRATION REQUIREMENT SPECIFIED BY THE COMMISSION AS PART OF THEIR APPROVAL OF SECY-76-574 Although this paper directly concerns a comment arising in my office, OGC was not made aware of staff's concerns or pro-posed course of action prior to publication of the paper.
The course suggested by EDO (alternative 1 with a special request for comment) should be followed.
The staff's grounds for the requested reconsideration and fur-ther delay in promulgating the amendments appear to me unper-suasive at best.
I do not see how even the narrowest conception of NRC's regulatory mission can justify the repeatedly expressed concern for the " sensitivity" of the medical community without any expression of concern for the patients who have by hypothesis received doses seriously at variance from the prescribed dose.
The adverse comments to the 1973 pr'oposed rule change (Enclosure 2 of SECY-77-194) are simply not applicable to our present pro-posed Part 35 reporting requirement, which does not call for reports to the patient.
Further, the notion that the reporting requirement could be "self-incrimination"'in the constitutional sense verges on legal nonsense.
The comments by the ACMUI (Enclosure 3 of SECY-77-194) have some relevance.
If " referring physicians" is the correct phrase, rather than " authorized physicians," then I cer-tainly concur. in making this change before publishing the proposed rule.
This should not require another 45 days.
Also, the 10 per cent error criterion and the 24-hour time limit are clearly open to some amount of change _without compromising the principle of the reporting requirement.
However, these matters can be adjusted during aad following
Contact:
E. Leo Slaggie 492-8155 w
ATTAINMFNT r
o s.
o 2
i the 45-day public comment period in response to suggestions from the public rather than delaying the publication of the proposed rule as the staff now suggests.
The present recom-mendation for further delay is hard to reconcile with the staff's earlier recommendation in SECY-76-574 that because of urgent need for a teletherapy rule the normal public comment period prior to effectiveness should be omitted.
I would agree with EDO's comment that the rule be published as it now stands with a modified statement of consideration soliciting comments on the specific reporting requirement issues which trouble the staff ~and the ACMUI.
The supposed ambiguity and lack of clarity which apparently bothered the'ACMUI would not in practice be of significance in carrying out the purpose of the rule.
For example, if measurements indicate that dosage errors of more than 10 per cent have occurred, I see no reason why reporting of this fact should depend on whether a single treatment or a course of 20 or 30 is involved.
The point is that the medical significance of this misadministration should be determined by the referring physician.
The reporting requirement will at least alert the physician to the need for making a deter-mination and for possibly compensating by adjusting the remaining treatments.
The ACMUI seems to suggest that the teletherapy operator could on his own adjust the remaining treatments to compensate for his earlier errors without consultation with the referring physician.
This is somewhat akin to letting the pharmacist, without telling you or your doctor, adjust the dose in your next prescription to make up for the fact that he previously failed to give you the medicine as prescribed.
Whether or not the proposed reporting requirement will in the end survive the searching examination of the Commission's involvement with nuclear medicine that the staff is going to conduct some day or other should not be a factor in a deci-sion to impose it now.
Unless misadministrations actually occur, the rule will simply never come into practice.
If mis-administrations do happen, it is unconscionable that they not be reported to the person who is primarily concerned with the patient's welfare -- the referring physician.
The 1
very documents to which this memo responds indicate that this report should be required by regulation rather than left to the discretion of those whose primary concern is with mal-practice suits against the hospital.
Unless and until a better rule is proposed or another agency takes over the G
l
i
(
3 l
i
~
responsibility of insuring that some regard will be paid to the patient's welfare, I think that the considerations favoring our proposed part 35 amendments override the' staff's reasons for still more delay.
No one so far has suggerted that the reporting requirement as we have drafted-it could cause injury to the patient, while it appears' obvious that the continued lack of a reporting requirement may have the effect that serious injuries will go without remedy.
i cc:
Lee V. Gossick, EDO Ben Huberman, OPE Howard K. Shapar, ELD l
Clifford V. Smith, NMSS SECY'(2) t P
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e 1
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l e
i M 43 10 CFR Cit.1 (1-1-M Edsilon)
Nucloor Regulology Commisolon 4MN (b) WrHies report. Within 16 days tient's social security number, a brief (2) lodine-125 as sodium lodide or it.
(sith Succimer; citer the initial therapy misadmints-descripuon of the event, the effect on brinogen; (Elv) Albumin colloid; and tratlon report to NRC, the licensee the patient and the action taken to (38 Chromium-51 as human serum (5) Any generator or reagent kit for chall report. In writing to the NRC prevent recurrence. These records albumin; preparation and diagnostic use of a ra-Regional Office Inlllally telephoned shall be preserved until the Commis-(4) Gold-198 in colloidal form; diopharmaceutical containing byprod-y and to the referring physician, and alon authorises their disposition.
(5) Mercury.197 as chlormerodrin; uct material for which generator or re-1
]
furnish a copy of the report to the pa-(S) Mercury-293 as chlormerodrin; agent kit a " Notice of Claimed Investi-l tient or the paHent's responsible rela. O R45 Rights and deales of Itceneses.
(7) Selenium *l5 as selenomethlonine; sational Eseseption of a New Drug" tl72 (or guardian) If either was previ-Aside from the notificallon require.
(S) Strontium-85 as nitrate; (IND) has been accepted by the Pood ously notified by the lleensee umler ment. nothing in this section shall (9) Technetium-99m as pertechne-and Drug Adsninistration (PDA).
paragraph (a) of this section. The affect any rights or duties of licensees tale, sulfur colloid or macroasgregated (d) Group JF. Use of prepared radio-written report shall include the lleens-and physicians in relation to each human serum albumin; pharmaceuticals for certain therapeu-ee's name; the referring phymaca-t's other, patient or responsible relatives (10) Ytterbium ts9 as pentatate tic uses that do not normally require i
name; a brief description of the event; (or guardians).
sodium; hospitalisation for purT= F N88-
]
the effect on the patient; the action (Il) Indium-!!3m as chlorlde; ation safety; taken to prevent recurrence; whether Scussous (12) Any byproduct material in a ra-(1) Iodine-131 as lodide to AL-the licensee informed the paHent or diopharmaceutical prepared frosa a re-ment of hyperthyroidism and cardiac the patient's rest onsible relaHve (or SElee Schedule A-groupe of need6cel agent kit listed in paragraph (cM4) of dysfunction; guardian), and if not, why not. The uses of byW emoseriet.
this section; and (2) Phosphorus-32 as soluble phos-report shall not include the patient's (a) Ovomp J. Use of prepared radio-(13) Any byproduct material in a ra-phate for treatment of polycythesnia name, or other information which pharnanceuticals for certain diagnosuc diopharmaceutical and for a diagnos-vera, leukemia and bone me nne-a.
a could lead to identification of the pa-studies involving measurements of tic use involving imaging or locallsing (3) Phosphorus-ND32 as colloidal I
LA'#L-uptake, dilution and escretion. This for which a " Notice of Claimed Inv3 chromic phosphate for intracavitary I
les yR 31194. 38ay 14. Iges; 48 FR assas, group does not include imaging or 10-Ligational Exemption for a New Dms treatment of malignant effusions;
)
June l3. !ssel calisallon studies.
(IND) has been accepted by the Fbod (4) Any byproduct material in a ra-t
' (1) Iodine-131 as sodium lodide, lo-and Drug Administration (PDA).
diopharmaceutical and for a therapeu-3 35.43 Reporte of diesseetle ""
dinated human serum albumin, la-(c) Group lif. Use of generators and tic use not normally requiring hospi-8883*"*-
' beled rose bengal, triolein, or sodium reagent kits for the preparation and talizadon for purposes of rediadon When a misedministration involves a todohippurate; use of radiopharmaceuticals contain-safety for which a " Notice of Claimed diagnostic procedure, the Ilcensee (2) Iodine-125 as sodium lodide, lo-Ing byproduct material for certain di-Investigational Exemption for a New shLll notify. In writing. the referring dinated human serum albumin, oleic agnostic studies
- Drug" (IND) has been accepted by the l
physician and the appropriate NRC acid or sodium lethalamate; (1) Molybdenum-99/Lechnetium-99m Pood and Drug Adeninistration (FDA).
[
Regional Office listed in Appendia D (3) Cobalt 54 as labeled cyanocobala.
sencrators for the elution of technett-(e) Group F. Use of prepared radio-cf Part 39 of this chapter. IJeensee re. ' atin; um-99m as pertechnetste; pharmaceuticals for certain therapeu-ports of diagnostic salmaduninistrations (4) Cobalt-89 as labeled cyanocobala.
(2) Technetium-99m as pertechne-Lic uses that normally require hospi-are due within 19 days after the end of. min; tate for use with ressent hits for prep-non for pu" of lon the calendar quarters (defined by (5) Chromium-51 as sodium chro-aration and use of radiopharm-
,,g,gy.
l March. June. September, and Decem-mate or labeled human serum albu-aceuticals containing technetium-99m
,g3 Oold-198 as colloid for in cavi-t ber) In which they occur. These writ-min; as provided in parnsraphs (c) (4) and I"'II'**I"'"""I **III"*" * " " * " "
- ten reports shall include the licensee *s (G) Iron-59 as citrate; (5) of this section; (2) Iodine-131 as lodide for treet-i.
name; the referring physician's nasne.
('f) Techneuum-99m 'as pertechne-(3) Tin-113/ indium-ll3m generators a description of the event; the effect late; and for the elution of the Indium-113m as ment of thyroid carcinoma.
(3) Any byproduct material in a re-on the patient and the action taken to (9) Any byproduct material in a ra.
chloride; prevent recurrence. The report should diopharmaceutical and for a diagnos-(4) Itengent kits for preparation of diopharmaceutical and for a therapeu-not include the patient's nasne or tac use involving measurements of technetium-99m labeled:
tic use normally requiring hospitaliza-tion for radiation safety reasons for other informadon which could lead to uptake, dilution or escretion for which (D Sulfur colloid; which a "NoHee of Claimed Investisa-identification of the paHent, a " Notice of Claimed Investigational all) Pentatate sodium;
- 'O**'**
~'""
I by spt es and Drug Administradon (FDA).
i
-Each licensee shall: maintain for Administration (FDA).
(lv) Polyphosphates;
. Commission inspection, records of all (b) Group 11 Use of prepared radio.
(v) Macroaggregated human serum (f) Group FI. Use of sources and de-vices containing bypmduct matedal misadministrations of redlopharma-pharmaceuticals for diagnostic imag-albumin; ceuHeals or radiation from teletherapy Ing and localization studies (vD Etidronate sodium; for certain medical uss t
or brachytherapy sources. These (1) Iodine-131 as sodium lodide.10 (vlO Stannous pyrophosphate; (1) Americium-241 as a sealed source records shall contain the names of all dinated human serum albumin, macro-(viin lluman serum albumin; in a device for bone mineral analysis; individuals involved in the event (in-aggregated lodinated human serum al.
(1x) Medronate sodium; (2) Cesium-13T encased in needles ciuding the physician, allied health bumin, colloidal (micromsgregated) 10-(x) Ghsceptate sodium; and applicator cells for topical, inter-personnel. the patient, and the pa-dinated human serum albumin, rose (xD Oxidronate sodium; stltial, and intracavitary treatment of Llent's referring physician), the pa-benegal or sodlum ledohippurate; (mil) Disolenin; cancer;
.,v.m mrnv n
~ _ _ -.,- -,
rm ms, u-
_m l 35.29 10 OR Ch, I (1-1-87 Edlelse) ll"I E
-D "I'"
N permit medical use, that identifies the license renewal, or amendment except air relative or guardian cannot be to determine whether a report is se-
,,eched within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />, the licensee quired.
i visiting suthorised user by name ns an for those changes in ll 35.13 and inall notify thern as soon as practica-Ed) Each licensee shall retain a cuthorized user for medical use; and -
35.ges of this part. Examples of sisch
,.ite beensee is not required to record of each misadministration for (3) Only those procedures for which ministerial changes include: editing of the patient os the pat 6ent's re-ten years The record must contain the visiting authorised user is specift-procedures for clarity or conferinance spensabh reint.ve os guarihar. without the names of all Individuals involved celly authorized by the license or with local drafting policy or updating ant consu: ting the referring physa in the event tincsuding the physician, i
permit are perforneed by that Individ-names, telephone numbers, and ad-can. however the licenset shal. not aiheo hea'th personnel, the pellent.
ual.
dresses; adoption of model radiation snedica care for the patient be-and the patients relerring physician).
Ib) A licensee need not apply for a 11-safety procedures published in NRC cause of this the patient's social security number or cense amendment in order to permit a Regulatory Guides; replacennent et ibt within It days aften an Imtlal identalication number la one has been visiting authorised user to use licensed equipment; reassignment of tasks
.hnapy misadministration report to assigneo, a - brief description of the material an described in paragraph ta) amons employees; or assignment el 91tC.the licensee shat! report in writ-event, the effect on the patient, and at this section.
service contracts for services such as as to the NHC Regional Oltice Ini the action taken, if any, to prevent re-(c) A licensee shall retaan the personnel dosimetry, radiation safety untly telephoned and to the referring currence.
records specified in this section for equipment repair or calibration, waste physaclan, and furnish a copy of the te) Aside from the notification two years after the visiting authorised an.pa.ma, and safety surveys. A licensee woort to the patient or the patient's quirement, nothing in this section m.
user's last use ol licensed material. but is responsible for assuring that any wapensible relative for guardian) 12 fecta any rights or duties of licensees may discard the records if the visiting change snade is its compilance with the edher was previously notified by the and physicians in relation to each authorised user has been listed as an requirements of the regulations and neensee under paragraph ist of this other, patients, or responsible relatives cuthorised user on the licensee a 10-the license.
wetten. The written report must in-tor guardians).
cense.
(b) A licensee shall retain a record of ciude the Itcensee's name; the refer-IM each change until the license has been nas physician's name; a briel descrip-3 3E49 Besppliers.
g Q-~
renewed or terminated. The record use of the event; the effect on the pa*
A licensee may use for medical use f
apply pew must include the effective date of the urnt; the action taken to prevent re-only[-
"edlelm seh change, a copy of the old and new re-currence; whether the licensee in-g, Byproduct materlat manufac-ta) The Cosnmission will license distion safety procedures, the reases Inneed the patient or the patient's re-tured, labeled, packaged, and distribut-j snobile nuclear snedicine service only for the change, a summary of radi-gossible relative (or guardian), and if ed in accordance with a license issued in accordance with Subparts D, E and - allon safety matters that were cond not, why not. The report must not in-pursuant to the regulations in Part 30 J
H of this part and I 31.11 of this chap-ered before making the change, the clude the patient's name or other in-and il 32.'t2. 32.'f3, or 32/I4 of this ter.
signature of the Radiation Safety Of lensation that could lead to identifi-chapter or the equivalent regulations (b) Idobile nuclear medicine service ficer and the signatures of the affett-cation of the patient, I
of an Agreement State
- hist I
licensees shall obtain a letter misreed ed authorized users and of niansee act When a misedministration in.
i (b) Reagent hits t have been by the management of each client for snent or, in a medical institution, the solves a diagnostic procedure, the Ra*
manufactured. Isbeled, packaged. and j
which services are rendered a
Radiation Safety Committee's chair-nation Safety Officer shall prosnotly distributed in accordance with an ap-thorises use of bn,. -
=
i the client s address of use. The snobile. man and the management represente Jeestigste its cause, make a record tw proval by the Commission pursuant 8" tive-4RC review and retain the record as 4
l nuclear medicine service licensee shall stenett in i 35.33(d) ~ The licensee -
I retain the letter for two years after a3E33 Itecords med reporte of mM ihail also notify the referring physi-I or top u a f i
the last prownston of service.
letrealens.
ran and the appropriate NRC Office eg i
Ides serv s hat is.
(a) When a misadministration is.
led 30 o this in wrl (c
e herapy sources manufac-r3so authortaed to provide, the client is volves any therapy procedm. tM E daysif the misadministration iavoIved responsible for assuring that services censee shall notify by telephone the i
with a license lasued pursuant to Part i
are conducted in accordance with the appropriate NRC ltestonal Office. the me of byproduct material not in-30 of this chapter or the equivalent or kal n
regulations in this chapter while the. listed in Appendix D of Part 20 of a,t regulations of an Agreennent State.
mobile nuclear medicine service is chapter. The licensee shall also not under the ellent's direction.
the referring physician of the a
$wippert C.-G.eneral hchnical (d) A mobile nuclear medicine serv-patient and the patient or a g_
ice may not order byproduct saaterial ble relative (or guardianA. un l
Lo be delivered directly from the man-referring physician agrees to 03E54 Posseestesh m celebrauen, and ufacturer or distributor to the ellent's the patient or believes, based on check of dose eenbreeere.
t e pa L'*s espo ib c re at ocser
- ksge inserts, corrected only for (a) A medical use 16censee authorized l'
s 35.31 Itadention safety progrese changes-guardiani would be harmful to one or tasunt of radioacttvity administered, to administer radiopharmaceuticals (a) A licensee may make minor the other, respectively. These noufics.
shall have in its passenion a dose cali-changes in radiation safety procedures Lions must be made within 24 houn
'The staff is develop 6ng this foran and will brator and use it to measure the that are not potentially important to after the licensee discovers the spised tak it avaHable before the effective date amount of activity administered to safety, i.e ministerial changes. that ministratiert. If the referring phys Jihis regulation. A notice of its availabliity each patient.
were described in the application for clan, patient, or the patient's respopst Se he pubushed in the Passent. Msonersa.
lb) A licensee shall;
.w
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a
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l
$ 35.33 10 CFR Cia. I O-1-92 Ediolon)
Nudoor R:;iy Commission 5 35.33 tactic radiosurgery are in accordance appropriate NRC Regional Office (3) The licensee shall notify the re.
a ss.22 lier ed. and reparu me " ^
^en with the respective written directives; within 30 days after the modification ferring physician and also notify the tw (4) That each administration is in has been made.
patient of the misadministration no sat when a m6sedmt.datretton involves accordance with the written directive; (fx1) Each applicant for a new li-later than 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> after its discovery, any therapy procedure, the licenseg shall 4
and cense, as applicable, shall submit to unless the referring physician person. notify by telephone the appropriate NRC (5) That any unintended deviation the appropriate NRC Regional Office ally informs the licensee either that
"'88*"*8 ""
"*"'d I" ^8*d D
from the written directive is identitled in accordance with 10 CPR 30.s a qual-he will inform the patient or that, g[, g"er I
p chn l
and evaluated, and appropriate action ity management program as part of based on med6 cal judgment, telling the tected patient and the patient or a respones l
is taken.
the applicallon for a license and im-patient would be harmful. The licens-ble relative (or svardians, inniess the refer l
(b) The licensee shall:
piement the program upon lasuance of ee is not required to notify the patient eine physician aerees le Inform the patient '
(1) Develop procedures for and con-the license by the NRC.
without first consulting the referring or hel6 eves. based on medical Judsment, that duct a review of the quality unanage.
(2) Each existing licensee, as applica-physician. If the referring physician tellens the patient er the patient's response ment prograan including, since the last ble, shall submit to the appropriate or pallent cannot be reached within 24 ble relative for suardiant would be harmfut review, an evaluation of:
NRC Regional Office in accordance hours. the licensee shall notify the pa-18 *"' 8' th' *th" "*pMilvely. Thee nett i
(1) A representative sample of pa-with le CPR 30.8 by January 27,1992 tient as soon as possible thereafter, sications maast he smede wither heure tient administrations, a written certification that the quality The licensee may not delay any appro-
["hy
ree.a6,e es i gg p
(11) All recordable events, and nianagement program has been imple-priate medical care for the pellent, in' or the patteners (ilD All misadministrations niented along with a copy of the pro-ciuding any necessary resnedial care as suardian cannot he ' reached w6 thin 24 [
to verify compilance with all aspects gram.
a result of the misadministration, be-hours. the licensee shall notify these as seos<
x sf the quality management program; cause of any delay in notification.
as pract6 cable. The 16censee is not reenaaree-i II8 PR 3*III* #"IF 38 I"II these revim sMll be ceducW at im (4) If the patient was notified, the 11-to notify the pat 6ent or the pat 6ent's respon i tervals no greater than 12 nmnths-E'vectnes Daws Nors: At ts FR 34121*
censee shall also furnish, within 15 sable relatew or suardsen w6thout prat een (2) Evaluate each of these reviews to July 25. IMt. $ 36.32 was added, eHectiw
- ""*'F days after discovery of the misadmin. sultins the referrens physician; howeves I
Estration, a written report to the pa-
"',',',*h* "*" ('*
determine the effeettveness of the g h l
Cuality sannagement progrant and, if g 33,33 Igetincat6 ens. reports, and records tient by sending either:.
(bl Within 16 days after an inttial therap>
{
required. make modifications to uneet et minedsmialstressema.
(1) A copy of the report that was sub.
m6sadenanistretton report to NRC. the It the objectives of paragraph (a) of this mitted to the NRC; or censee shalt report. In writons. to the NH4 i
l section and (al Por a misedministration:
(lin A brief description of both the Restones office nnit6 ally telephoned end to (3) Retain records of each review. in-(1) The licensee shall notify by tele-event and the consequences as they the referring physician, and furnish a ceps ciuding the evaluations and findings phone the NRC Operations Center
- may affect the patient, provided a of the report to the pat 6ent or the patient's af the review in an auditable forms for no later than the nest calendar day statement is included that the report responstbee relative for suardsent if eithes three years.
after discovery of the snimadministra-submitted to the NRC can be obtained was previously notif6cd by the lacense.
(c) The licensee shall evaluate and Lion-from the licensee.
undu parasreph tol M this ton respond within 30 days after dameavery (2) The licensee shall siebmit a writ-th) Each licensee shall retain a
",'." g[#*',I,y","'I 8%'
see q
sf the recordable event, to each re-ten report to the appropriate NRC Re-record of each misadministration for brief description of the event-the etfeet es.
cordable event by:
gional Office listed in 10 CFR 30.s
. five years. The record maast contain the pat 6ent; the aceton taken to
-nt se (1) Assembling the relevant facts in-within 15 days after discovery of the L the names of all Individuals involved currence; whether the licensee I dthe ciuding the cause; misadministration. The written report (including the prescribing physician, patient or the patient's respons
' lative (2) Identifying what, if any, correc. must include the licensee *s name; the allied health personnel, the patient, for suard6 ant and if not. why ut. The Live action is required to prevent re.
prescribing physician's name; a brief and the patient's referring physician), report must not tncluese the patient's name 4
I currence; and description of. the event; why the the patient's social security number or or other informatten that could lead te I
(3) Retaining a record. in an audita. ' event occurred; the effect on the pa-identification number if one has been 6de 1 6an ad i t
bla form, for three years, of the rete, tient; what isnprovements are needed assigned a br6ef description of the m,
diasnostac procedure the Radiation assiety vant facts and what corrective action, to prevent recurrence; actions taken to misadministration. why it occurred, offecer shaat preenpaly inventasmae its cause l
If E.ny, was Latten.
prevent recurrence; whether the 11-the effect on the patient, what im*
make a record for NRC review. and retaan (d) The licensee shall retain.
censee notified the patient. or the pa-provements are needed to prevent re-the record as d6rected in 3 3S.334dt The li (1) Each written directive; and tient's responsible relative or guardian currence and the actions taken to pre-censee shall also notify the referrens physe (2) A record of each administered ra.
(this person will be subsequently re-vent recurrence.
clan and the appropriate NRC Off6ce spect dlAtton dose or radiopharmaceutical ferred to as "the patient ** in this sec-(c) Aside from the notification re-fled 6n a 3e e of th6s part en writans on Perm da==ne where a written directive is re.
tion), and if not why not, and if the quirement. nothing in this section af.
NRC 413 within 15 days if the m6sadments P_'**"*
quired in paragraph (aN 1) above, in an patient was notified, what information fects any rights or duties of licensees
- cuditable form. for three years after was provided to the patient. The and physicians in relation to each 4
trat6on of a desase five fond different from the date of administration.
report must not include the patient's other, patients. or the patient's re-the lntended dosase. or admanistration et (e) The licensee may make modifica, name or other information that could sponsible relatives or guardians.
byproduct spaterlat such that the patient in tions to the quality managesnent pro.
lead to identification of the patient.
I 16kely to receive en orsan dose seester than I
gram to increase the program's effl.
ISS PR 34122. July 25.19981 2 rem er a whole body dose arcater than See ciency provided the program's effec-eTh Errscrivs Dats Nors At 54 FR 34122. - millarem. LJcensees may me desemetry -
July 25.1998. I 35 33 was revised. effective tables in packese inserts, corrected only fee Liveness is not decreased. The licesuee the NRC e te is (3 1 I5I th ll furnish the modification to the a550' Jassuary 27. 1992. Pur the conven6ence of smount of radtonctivity administered, to de.
the user. the superseded tent follows:
term 6ne wtwther a report la resguared-n
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