ML20058P814
| ML20058P814 | |
| Person / Time | |
|---|---|
| Issue date: | 12/09/1993 |
| From: | Siegel B NRC ADVISORY COMMITTEE ON MEDICAL USES OF ISOTOPES (ACMUI) |
| To: | Paperiello C NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| References | |
| NACMUI, NUDOCS 9312270286 | |
| Download: ML20058P814 (1) | |
Text
%
-g MEMORANDUM FOR: Carl J. Paperiello, Director Division of Industrial and Medical Nuclear Safety, NMSS FROM:
Barry A. Siegel, M.D., Chairman Advisory Committee on the Medical Uses of Isotopes
SUBJECT:
CERTIFICATION OF THE MINUTES OF THE NOVEMBER I AND 2, 1993, MEETING 0F THE ADVISORY COMMITTEE ON THE MEDICAL USES OF IS0 TOPES I hereby certify that to the best of my knowledge and belief, the enclosed minutes for the November 1 and 2,1993, meeting are an accurate record of the proceedings for that meeting.
Barry A. Siegel, M.D., Chairman (Date)
I
Enclosure:
As stated Distribution:
EWBrach IMNS Central Files NRC File Center IMAB r/f NMSS r/f WMorris, RES JEGlenn-NMSS Dir r/f LWCamper i
DCool=
STreby, 0GC PDR JTelford ACMUI members (list attached) i 0FC IMAB U
ACHUI NAME SMeNfdt BSieh DATE 11/h93 12/ 9 /93 1
C = COVER E - COVER & ENCLOSURE N = NO COPY 9312270286 931209 0FFICIAL RECORD COPY g 4 g fy,f J
PDR ACRS G: Nov.93 CENERAL PDR d 5 ? M b[ N_
]
b' 7
C ;,:
' {jry
i
',y f* "%,
/
5 UNITED STATES j
j.( ) ^ 'j NUCLEAR REGULATORY COMMISSION '
l
-W
- fr 1 WASHINGTON, D C. 20555-0001 1
/
N.w.-
DEC 131333 i
~
1 MEMORANDUM FOR:
Carl J. Paperiello, Director Division of Industrial and i
Medical Nuclear Safety, NHSS FROM:
Barry A. Siegel, M.D., Chairman l
Advisory Committee on the Medical Uses of Isotopes i
SUBJECT:
SUMMARY
REPORT - MEETING 0F THE ADVISORY COMMITTEE.0N l
THE MEDICAL USES OF ISOTOPES, NOVEMBER 1 AND 2, 1993 H
The Advisory Committee on the Medical Uses of Isotopes (ACMUI) held its semiannual meeting on November 1 and 2, 1993, at the Sheraton Reston Hotel, I
11810 Sunrise Valley Drive, Reston, Virginia.
)
Committee members present at the meeting were:
j Barry A. Siegel, M.D., Chairman Peter R. Almond, Ph.D.
Judith Brown i
Daniel F. Flynn, M.D.
Melvin L. Griem, M.D.
Carol S. Marcus, Ph.D.,M.D.
Wil B. Nelp, M.D.
Robert M. Quillin, M.S.P.H., M.S.
Judith Anne Stitt, M.D.
David Woodbury. M.D., FDA Also present: John E. Glenn, Ph.D, Nuclear Regulatory Commission (NRC),
(Designated Federal Official for the panel); Carl J. Paperiello, Ph.D, Director, Division of Industrial and Medical Nuclear Safety, NRC; Larry W.
Camper, Section Leader, Medical and Academic Section, NRC; Florence Koltovich, FDA; and Daniel S. Berman, M.D. and Dennis P. Swanson, M.S., both of whom were appointed to the ACMUI, but had not as yet completed their personnel processing.
Before the official opening of the meeting, John Szabo, of NRC's Office of the General Counsel, discussed the Committee members' responsibilities regarding conflicts of interest and other related ethical issues.. Sally Merchant', of the NRC staff, discussed travel procedures and the processing of vouchers for professional services.
John E. Glenn, Ph.D., NRC, opened the meeting officially and announced that a closed session of the Committee would be held 'on November 1,1993, to discuss the credentials of a physician seeking to be approved as an authorized user for a strontium-90 eye applicator.
$/ yTM
Carl J. Paperiello 2
Dr. Glenn introduced the new members of ACMUI: Robert Quillin, Wil Nelp, M.D.,
Judith Stitt, M.D., Daniel Berman, M.D., and Dennis Swanson, MS.
He announced that Drs. Berman and Swanson had not completed their personnel processing, and, therefore, could not participate as full committee members in consensus development.
The Chairman, Barry A. Siegel, M.D., announced that during the discussions of prcnosed rulemakings on patient-release criteria and radiopharmacy, Carol Marcus, M.D. would not participate as a committee member, but could be recognized, at the chairman's discretion, as a member of the general public.
Additionally, Dr. Siegel instructed the Committee regarding the need for it to arrive at a consensus on each issue discussed. He further indicated that members with dissenting opinions should so indicate clearly for the record.
The ACMUI discussed the issues and made the recommendations indicated below.
1.
Patient Release Criteria: Rulemaking Status Report Donald Cool, of NRC, provided a status report on the proposed rulemaking regarding patient-release criteria and the conflicts between 10 CFR Part 20 to be effective on January 1, 1994, and existing 10 CFR Part 35 (35.75). Since the May 1993 staff presentation to the ACMUI, there has been substantial work on how the proposed rule will be presented and supported, but there has been only one change to the actual proposed text of the rule.. That change, the NRC staff's current views on the rulemaking, and other developments since May 1993 are as follows.
l Chance to the Proposed Rule: The record retention period for documents relating to patient release has been reduced from 5 years to 3 years.
The consensus among the technical and legal staff is that the status quo should be maintained for patient release, i.e.,10 CFR 35.75 i
should remain the overriding rule with respect to patient release.
l An Information Notice is planned for publication before i
l January 1, 1994, that will explain NRC's interim policy with respect l
to the patient release criteria until a final rule is published.
Staff plans to publish the regulatory analysis as NUREG-1492,
" Regulatory Analysis on Criteria for the Release of Patients Administered Radioactive Material."
L The draft Regulatory Guide has been completed and contains a table l
that relates both retained activity and dose rates for specific L
radionuclides to the release limits in the proposed revision of l
1
w 9
Carl J. Paperiello 3
Members of the Committee discussed the changes and re-asserted that the provisions of 10 CFR Part 35 should prevail and, therefore, that the 100-mrem limit should not apply to exposures to members of the general public resulting from patients containing byproduct material.
Additionally, the Committee questioned the need for the record-keeping requirement when doses were expected to range between 100 and 500 mrem.
Dr. Cool described one purpose for this record-keeping requirement: namely, in those cases where a patient receives multiple treatments or fractionated doses, the records will allow both the licensee and the NRC to determine the cumalative radiation doses to affected members of the general public.
2.
Discussion of 10 CFR 20.1301: Patients as Members.of the Public Cynthia Jones, of NRC, provided a review of 10 CFR 20.1301 and the issues that have recently been raised concerning the applicability of 10 CFR 20.1301 to patients as members of the general public and to radiation exposures to members of the public resulting from patients containing byproduct material.
10 CFR 20.1301 addresses the dose limits for individual members of the public.
Specifically 20.1301(a) states that:
"Each licensee shall conduct operations so that -
(1) The total effective dose equivalent to individual members of the public from the licensed operation does not exceed 0.1 rem (1 mSv) in a year, exclusive of the dose contribution from the licensee's disposal of radioactive material into sanitary sewerage in accordance with 20.2003; and (2) The dose in any unrestricted area from external sources does not exceed 0.002 rem (0.02 mSv) in any one hour."
20.1301(c) states that:
"A licensee or license applicant may apply for prior NRC authorization to operate up to an annual dose limit for an individual member of the public of-0.5 rem (5 mSv). The licensee or license applicant shall include the following information in the application:
(1) Demonstration of the need for and the expected duration of operations in excess of the limit in paragraph (a) of this section; (2) The licensee's program to assess and control dose within the 0.5 rem (5 mSv) annual limit; and (3) The procedures to be followed to maintain the dose as low as is reasonably achievable.
Dr. Siegel commented that the ACMUI-had never been asked to review the new Part 20 during the proposed rule stage. The Committee would have liked to
7 t
e Carl J. Paperiello 4
have had input during the development of this rule, especially since some parts of the rule are impractical and cannot be achieved in medical facilities. Ms. Jones responded that the proposed rulemaking wasLopen for comment for an extended period of time, and ACMUI members thus should have had ample opportunity to comment. Dr. Marcus mentioned that.the ACMul met very infrequently during this comment period.
Dr. Almond noted that requiring licensees to add additional ~ shielding in order to be in compliance would cause a significant hardship for older facilities designed and shielded to comply with the prior 500-mrem limit. The cost of installing the additional shielding would be tremendous.
NRC Staff's Ouestions:
What,is the expected impact of meeting the 100 mrem in a year and 2 mrem in any one hour dose limits, to members of the general public, around radiation treatment rooms? In areas adjacent to rooms of patients confined pursuant to 10 CFR 35.75?
What would be the impact of meeting the 100 mrem in a year and 2. mrem in an hour dose limits, to individuals exposed to diagnostic patients administered byproduct material and still within the confines of the medical facility? In particular, comment on waiting rooms and patient rooms.
- A 2 mrem /h limit is likely to be a very serious problem for the practice of nuclear medicine since licensees cannot easily comply with.this limit in waiting rooms or patient rooms.
- For therapy, if additional shielding is required, the cost would also be prohibitive.
If segregation of patients having diagnostic studies were to be required, it would have an adverse psychological impact on patients, since many patients are accompanied by family members or friends for support during diagnostic procedures. Also, the cost of segregation would be prohibitive because many nuclear medicine facilities would have to be redesigned.
What are the implications of assuming that 10 CFR 35.75 applies even when the patient has not been confined, i.e., diagnostic patients treated on an outpatient basis?
10 CFR 35.75 criteria should hold more generally, in that any patient who does not specifically need to be confined pursuant to 10 CFR 35.75 should be considered to be no longer under the licensee's control. This should apply to
~both outpatients and inpatients.
Under what circumstances should a patient be considered a member of the general public?
The recent interpretation of new Part 20 (that administration of a radioactive drug to the wrong patient, not meeting the criteria of a misadministration, i
3-Carl J..Paperiello 5
could be considered an overexposure of a member of the. general public) has the potential to undermine the principles that form the basir of the Quality Management. rule.
Specifically, this would divert attention of licensees away from error minimization for procedures where there is real potential for harm.
In addition, Dr. Marcus noted that this interpretation is not consistent with the intent of the ICRP or NCRP; the 100-mrem limit was intended as a maximium population-exposure limit without implication that such a dose would be dangerous to any one individual.
Because of these types of concerns, Dr. Marcus suggested that ACMUI should petition NRC to stop Part 20 from going into effect in January 1994..The committee chose to put this in the form of a recommendation from the ACMUI, and after a lengthy discussion, the ACMUI approved the following Statement (7-2, with one abstention).
The ACMUI recommends that implementation of 10 CFR Part 20 be delayed until the conflicts with the practice of medicine are resolved because the new Part 20 will adversely affect the oractice of medicine.
Revisions should specifically include a consideration of cost / benefit.
Revisions should specifically address: the "wrona patient". the oatient as a "walkina restricted area" (> 2 mR/h). and shieldino of theraov rooms.
The ACMUI concluded this discussion by reiterating that, under no circumstances, should patients be considered members of the general public.
3.
Discussion of Pulsed-dose-rate Remote Afterloading Brachytherapy John E. Glenn, Ph.D., of NRC, provided an overview of NRC staff's actions and concerns regarding the safe use of pulsed-dose-rate (PDR) remote afterloaders for brachytherapy.
PDR brachytherapy is a new (investigational) technique for providing the equivalent of low-dose-rate (LDR) brachytherapy treatments with use of a single source of Ir-192 of 1 Curie or less. The PDR remote afterloader is essentially identical in design and function to the manufacturer's high-dose-rate (HDR) device, except for'the smaller' source and system software changes to provide for the pulsed mode of operation.
The principal advantage of PDR therapy is that it allows.for more access of nursing staff and visitors to the patient than does conventional LDR brachytherapy because the source is only out of the safe for a fraction of each hourly cycle. PDR brachytherapy also allows for a more uniform dose-distribution in the tumor because of the ability to vary the stepping of the i
source in accordance with a specific dose prescription..
l Dr. Glenn noted that, with PDR Ir-192 source strengths typically varying
'l between 0.3 to 1.0 Curies and corresponding exposure rates typically varying i
between 1400 and 4600 R/hr at I cm, these devices are treated by the NRC as I
HDR devices in terms of the controls necessary to protect the public health and safety. These restrictions severely impact the potential usefulness of' these devices.
In particular, the present NRC requirement for the continuous presence of both the authorized user physician and either a physicist or the RSO during patient treatment makes PDR brachytherapy virtually impractical.
i
./.
Carl-J. Paperiello 6
Dr. Glenn further noted that ttere is also some tendency for users to view this device as a LDR device and disregard important safety measures required for use of the high activity source.
Jeffrey Williamson, Ph.D., representing the American Association of Physicists in Medicine (AAPM), provided a presentation of PDR brachytherapy as a safe alternative to LDR brachytherapy that could be accomplished in less time, with less chance of catheter moversent (and therefore more precise treatment), and less exposure to hospital personnel and visitors.
In response to NRC's concern that the authorized user or medical physicist might not be available to respond promptly in case of emergency (e.g., if the source did not retract for any reason), Dr. Williamson suggested, on behalf of AAPM, that nurses could be extensively trained to intervene in such cases. The suggested training would consist of didactic instruction and hands-on experience, and would be validated by. examination.
^
Dr. Griem responded that, although he was in general agreement with the recommendations of the AAPM, a physician and physicist should be present for treatments of certain more sensitive sites. Therefore, the safety.
requirements for use of PDR brachytherapy may need to be organ specific.
Dr. Flynn supported the concept that a two-phase approach to a rare PDR accident would be a workable solution to safety concerns. A specially trained nurse on duty at all times during treatment.would be the fir.st responder.
In cardiac units, nurses have received the two-day ACLS (Advanced Cardiac Life Support) course which includes hands-on training to respond to a number of emergency conditions on which they are tested during the two-day course.
The cardiologist does not sleep in the cardiac unit. The same-is true for' ventilator patients in the hospital.
If the ventilator supporting a patient's breathing fails, the problem is handled immediately by non-physician personnel.
For PDR, the nursing staff would receive hands-on training to address the several types of problems in a timely fashion to prevent an NRC misadministration (in terms of dose) as a result of the incident. However, the responsible radiation oncologist and physicist would be required to be on-site within 30 minutes of the event to. investigate and to assure the misadministration was properly addressed. Since the PDR strength.is 10%
that of an HDR source, a 3-minute HDR accident resolution is equivalent to a 30-minute PDR response in terms of dose.
In terms of patient dose, in the unlikely event that the nurse responder was not able to resolve a PDR event, the patient would receive a maximum dose of 2200 centigray at I cm but less '
than 1000 centigray at 2 cm from a 1 Ci (maximum strength) source. Neither dose would likely result in irreparable tissue damage or death. However, since the nurse responder would be trained to handle the incident, the exposure-rate to.the nursing staff would be only 7 mrem per minute. The nurse would be one meter (100 cm) on average from the souru: for a 1 Ci (maximum strength) source, 4500 centigray / hour at I cm is equivalent to only 7 millirem i
per minute at 100 cm. This exposure rate is certainly ecceptable and would not result in harm to the emergency responders.
i
y Carl J. Paperiello 7
Dr. Stitt stated that, although the proposal is. sound, she believes it will be difficult to find nursing staff willing to accept these responsibilities.
The consensus of ACHUI was that the AAPM-proposed use of trained nurses to fulfill the requirements for adequate emergency responsiveness is a well reasoned proposal that should be considered feasible. - The Committee recommended that NRC evaluate license amendments from facilities proposing this approach on a case-by-case basis in order to ensure that continued assessment of PDR brachytherapy will occur.
4.
Impact of Fees on Medical. Programs John E. Glenn, Ph.D. led a discussion of the impact of NRC fees on medical users of byproduct material. Dr. Glenn began by describing the basis for the NRC's direct fees and annual fees, followed by data showing terminations of medical licensees over the last several years (with evidence of a definite increase in terminations for certain types of licenses after institution of fees). Dr. Swanson asked whether there was a limit as to how much fees could' rise and whether fees were tied to cost-of-living? Dr. Glenn responded.that the fees are developed through a budget process that is constrained by Congress.
Dr. Glenn directed the Committee to the following questions that were provided in the briefing book:
1.
Any personal knowledge of programs canceled or decreased as a direct result of NRC fees? If so, what types of medical programs?
Dr. Marcus said that she had spoken to two licensees with very small practices who were considering dropping their licenses because the fees charged were large.
Dr. Siegel asked whether there were provisions in the fee structure for small-entity licensees. Dr. Glenn responded that there are adjustments in the fees made for small entities and very small entities. A very small licensee (< $250,000 in gross receipts) may be charged an annual fee of as little as $400.
To qualify as a small entity. an institution may gross up to $3.3 million a year and a private practice up to
$1 million per year.
2.
Are the costs of regulations for byproduct material creating a ' demand for alternative technologies? Please provide specific' examples.
1 Dr. Flynn commented that he believes that the cost of NRC licensure is one of several factors that have caused teletherapy licensees to abandon use of Co-60. teletherapy in favor of use of linear accelerators.
7 Do NRC fees represent a major or minor additional cost for a nuclear medicine department? A radiation oncology department?
e Carl J. Paperiello 8
Dr. Siegel commented that, for large and moderately sized nuclear medicine departments, the fees do not have a large impact.
But he agreed with Dr. Marcus that a small specialty practice (e'.g., an endocrinologist performing thyroid studies or therapy in a rural community) may be hurt.
Dr. Nelp asked if there is a process in place for the user to appeal the fee.
Dr. Glenn responded that, if applicable, a licensee ~ could apply for small-entity status.
Mr. Quillin commented that the State of Colorado had fees-comparable to those charged by the NRC, except that Colorado's annual fee is 37% of the NRC fee.
He knew of only one licensee in Colorado who had dropped his license due to the cost of the fee.
Dr. Siegel pointed out that licensees may be frustrated because there is no explicit allowance for increasing NRC fees in the reimbursement structure of the Health Care Financing Administration (HCFA).
5.
Calibration of Strontium-90 Eye Applicators Larry Camper led the discussion of the use of Sr-90 eye applicators in brachytherapy, and problems associated with calibration of these devices.
Mr. Camper stated that discussions between NRC staff member Bob Ayres and researchers at the National Institute of Standards and Technology (NIST) have revealed that a number of potentially serious calibration errors exist for Sr-90 eye applicators. NIST has documented calibration errors as large as 100% for devices from some vendors.
They have :,1so found problems with non-1 homogeneous distributions.of activity across the surface of these devices.
This would be expected to produce variations in dose rate when masks are used on the device to reduce the treatment to a specific (shaped) area of the eye.
Many of these devices are over 20 years old and the manufacturers are no longer in business. Additionally, an allegation recently made to NRC reports that some Sr-90 eye applicators in use have been out of calibration for some time.
Further, the NRC Office of the General Counsel has determined that the Quality Management rule is applicable to Sr-90 eye applicators.
Dr. Marcus asked about the frequency of use of this procedure. Mr. Camper responded that NRC's Region II had about 30 to 40 licensees- (many~ in Puerto Rico) and there were fewer scattered through the other regions. Mr. :amper continued that, although there are not many licensees, NRC once NRC becomes aware of a problem such as this, it cannot ignore it.
Dr. Paperiello asked the ACMUI how accurately the Committee members believed-
.,T the dose was delivered by Sr-90 applicators. Dr. Siegel. responded that the-dose delivery was unlikely to be accurate. Dr. Marcus noted that the medically required tolerance was being met 'ith present devices and NRC did not have data showing harm as a result of this calibration discrepancy. She
' indicated that this was an example where the Quality Management' rule and the
T Carl J. Paperiello 9
definition of a misadministration did not make sense. Dr. Paperiello voiced the additional-concern that, if these devices have been incorrectly calibrated for years and all practice was based on this incorrect calibration, then fixing the error may result in problems because there will be no data base for determining safe and effective use with properly calibrated sources.
Dr. Almond described the use of the applicator and commented that, even with the best technique, the uncertainty in calibration is 12 %.
Additionally,- the physical application procedure, the way the applicator is held, and the timing of the procedure may add another 10 to 20% uncertainty. Dr. Flynn added that other factors that affected the delivery of the prescribed dose were the amount of tearing in the patient's eye and the amount of topical anesthetic used.
Dr. Marcus suggested that NRC send the licensees an Information Notice explaining the variations in the calibration of these devices and alerting them that if they use an applicator other than the one currently in their possession or buy a new one, their current technique may not be applicable to another device.
The ACMUI agreed with this proposal.
Dr. Paperiello commented, based on the ACMUI discussion, that knowledge by the treating physician of the strength of the source and the time of application (based on the medical judgement of that physician), meets the requirements of the Quality Management rule.
Even though there may be a problem n measuring i
actual delivered doses (in rems) for any given source or between sources of different vendors, medical practice is not based on this and the Quality Management rule does not require that brachytherapy prescriptions be in rems.
6.
Memorandum of Understanding between NRC and FDA Regarding Medical Use Program.
Larry Camper provided a status report on the recently signed (August 26,1993)
Memorandum of Understanding (M00) between the U.S. Nuclear Regulatory Commission and the U.S. Department of Health and Human Services, Food and Drug Administration (FDA). The purpose of the MOU is to coordinate existing NRC-and FDA regulatory programs for medical devices, drugs, and biological products utilizing byproduct, source, and special nuclear material. Under the terms of the MOV, the two agencies agree to establish day-to-day contacts for exchange of information; to assist each other in the investigations of~
incidents or complaints involving products of mutual regulatory concern; to provide expert technical assistance to the other agency with' respect to investigations; to share information concerning new technology and methods i
under development or review; to offer each other the opportunity to comment on regulations, policies, and communications to manufacturers, operators, l
licensees, or patients; and to allow participation by the other agency in l
advisory committees that advise on issues related to the MOU.
I i
1
~
3 s -;
t Carl J. Paperiello
'IO 9
Dr. Marcus' expressed concern about the sharing of proprietary information about~ drugs and biologics.
In a Federal Reaister notice published in 1975,
- FDA explained why proprietary information would not be shared with NRC. Does t
NRC anticipate the sharing of such information as a result of this M007 Larry l
Camper responded that,.during the. discussion's of this M00 with FDA, they.were very sensitive to the issue of proprietary information.
If it is necessary to' share proprietary information, the M00 indicates that there are sub-agreements l
- in place to assure that sharing will be done under strict guidelines.
l Dr. Woodbury added that FDA'would assure that guidelines would be followed.
r Dr. Siegel asked about the process that would assure the flow of information t
- between NRC and FDA. Mr. Camper responded that NRC had procedures in place,.
as did FDA, indicating when the other agency was-to be notified, but there j
would.still be occasions when the staffs of the agencies would call, on an ad -
hoc basis to talk with one another.
Dr. Siegel asked whether it is the intention for FDA to seek approval from NRC i
on new drug applications, or vice versa? Larry Camper responded that it was
.j not.
}
'l Mr. Camper finished by stating that, there is nothing in this MOV.that changes ~
the authority of either agency.
It is an attempt to enhance communication-between the agencies.
1 7.
Overview of the Management Plan for the Medical Use Regul'atory' Program.
I Carl J. Paperiello, the Director of the Division of Industrial and _ Medical Nuclear Safety, provided a review of the management plan developed by the staff for the regulation and inspection _ of medical users of byproduct j
material.
_.l The management plan identifies major regulatory program areas and reflects the i
~'
current management direction for the medical use program.
It-incorporates 90 action items that were either previously identified by the staff, resulted from the findings of the Indiana, Pennsylvania Incident. Investigation Team,'or 4
were identified in the senior management review of the regulatory program j
conducted in June 1993 by Dr. Paperiello.
Dr. Siegel asked the following question: since' the National Academy of Science study would last two years,L and since one potential conclusion af that study could be that the NRC medical use program should be disbanded'and transferred:
in some modified form to another Federal agency, couldn't a substantial amount
- 1
- of the effort' proposed in'the Management Plan prove to be a waste'of time and money? Dr. Paperiello responded that.there was that possibility, but until _
such time as that happened, the NRC has a responsibility to continue its work.-
1 In response to the portion of Dr.-Paperiello's presentatie. regarding:the QM
- rule and misadministrations, Dr. Siegel said that the signal coming to him -
i from other licensees regarding misadministrations is that the inspectors
]
1 r
1 l
^
-Carl J. Paperiello 11 investigating these incidents often try to "criminalize" the activities surrounding the misadministration (or to search for enough other violations to guarantee a civil penalty), and this was contrary to the underlying principles of quality improvement.
Dr.Griem commented, during the discussion of patient follow-up, that some deterministic biological effects in humans do not show up for 6-12 months.
However, NRC asks the consultant to make a report within 30 days.
Dr. Flynn reiterated the need to follow some more serious incidents for longer than 30 days Dr Siegel reminded the members that a consultant can write a preliminary report indicating that final conclusions and recommendations are pending additional follow-up of the patient. Dr. Paperiello agreed.
Dr. Flynn questioned the availability of information regarding misadministrations and other incidents. Dr. Paperiello responded that AE0D tracks that information and it was available. He continued that he had recently appointed a staff member to coordinate and track misadministration reports.
The Committee complained of poor communication between the professional organizations and NRC.
Dr. Paperiello responded that he plans to improve communication since he wants feedback from the community.
On the topic of enforcement, Dr. Siegel reminded the NRC, that at a previous meeting, the Committee counseled NRC to put less attention on civil penalties, and more attention on' enforcement actions that have potential to affect the economic viability of bad licensees (e.g., probation and license termirjation).
8.
Discussion of the Term " Referring Physician" as Used in 10 CFR Part 35.
Dr. Paperiello led the discussion.
Recently,' questions regarding which physician represents the referring physician were raised by NRC staff.
Licensees are required by 10 CFR 35.33 to notify the referring physicia'n within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> of discovery of a misadministration. The referring physician also is the one responsible for determining whether informing the patient of a misadministration would be harmful to the patient. When submitting documentation of notification, licensees often use various titles to refer to certain physicians involved in the patient's care. These include refer'ing, r
attending, and prescribing physician. As a result, in some cases, there has been a question regarding who is the referring physician., There is no !
definition of " referring physician" in 10 CFR Part 35, and the Statements of Consideration do not provide further clarification.
The:1973 version of the proposed rule for revisions to Part 35 required that the' licensee inform the patient in the event of a misadministration. Many commentors to the 1973 proposed rule believed that having the licensee inform the patient directly is an intrusion into the physician-patient relationship. Hence, this responsibility was delegated to the referring physiciar..
Currently, the HCFA defines referring physician as a physician who requests j
services for a patient by referring the patient for consultation, treatment,
]
l
r Carl J. Paperiello 12 or diagnostic tests. The majority of diagnostic tests and therapy procedures involving byproduct material are performed on a referral basis.
Thus, in most cases, the referring physician will not be the authorized user physician, i.e., a radiation oncologist, nuclear medicine physician, or other category of authorized-user physician (including physicians under the supervision of an authorized-user physician).
Dr. Nelp commented that he had discussed this issue with others, including Dr. Pollycove of NRC, and believes that the HCFA definition of the term
" referring physician" is appropriate for NRC's needs.
Dr. Siegel commented that the authorized user may also be the referring physician.
Examples include cardiologists who perform diagnostic studies on their own patients, endocrinologists who perform thyroid uptake and imaging studies and 1-131 therapy on their own patients, and nuclear medicine physicians who also have internal medicine practices. This dual role does not create any special conflict of interest for those physicians. Dr Siegel reminded that ACMUI is on record as saying that informing patients in the event of an error.is in the best interest of.both the patient and the physician.
Truth-telling in medical practice is the standard of care.
In response to a discussion about the significance of the problem, Larry Camper noted that of 72 misadministrations reported to NRC between 1990 and 1992, referring physicians were notified approximately 90% of the time, and patients received oral notification 75% of the time.
The reasons given for the referring physician not telling the patient were inconsistent with the wording of the rule. ACMUI members suggested that this most likely reflects failure of licensees to understand the provisions of the rule and reiterated that medical consultants, in their discussions of misadministrations with licensee physicians, could often reverse this situation quickly in a manner.
that licensees found non-threatening.
The Committee discussed the definition of a " responsible relative" and whether a responsible relative needs to be informed about a misadministration if the decision is made not to inform the patient. The discussion involved Marjorie Rothschild of NRC's Office of the General Counsel and there was clear agreement between her and members of the ACMUI that one either informs the patient E the responsible relative, defined as the. person who would.normally.
make decisions for an individual when that individual is not capable of doing so by themselves for various reasons (i.e., not legally competent).
Ordinarily, the patient would be considered legally competent if he or she-had given the consent for the diagnostic procedure or therapy.
Dr. Siegel said that.the issue, as he saw it, was whether the licensee must
' find and notify a patient's nearest relative when, in the physician's l
judgement, it would be unwise to notify a legally competent patient.. The -
l Committee agreed that the issue of " telling the patient" must be decided on a I
case-by-case basis. Additionally, when the patient is " legally competent", it would be.a violation of the patient-physician contract to discuss the case with the " responsible relative" without the patient's permission.
l L
l 1
=
t A
Carl J. Paperiello 13 A discussion followed regarding notification in the event that the patient died or was incapacitated by the treatment (i.e., became legally incompetent).
The Committee agreed that the "next of kin" should be notified under these circumstances.
The Committee specifically addressed the staff's questions as follows:
1.
Which physician is in the best position to determine follow-up care after a misadministration?
With the patient's agreement, the authorized user (because of his expertise in radiation injury) in concert with all of the other physicians responsible for the patient's care.
2.
Under what circumstances could referring physicians have the appearance of a conflict of interest between the patient and the institution?
Under no circumstance could there be such an appearance.
The referring physician's responsibility is first and foremost to his or her patients.
9.
Status reports a.
High-Dose-Rate Afterloader Programs Robert Ay.es, Ph.D., of NRC, provided the following status report on staff actions regarding the regulation of high-dose-rate (HDR) afterloader programs. On September 23, 1993, NRC issued Temporary Instruction (TI) 2800-024 that defines a pilot inspection program for inspecting remote afterloading brachytherapy devices and verifying licensee compliance with NRC Bulletin 93-01 " Release of Patients after Brachytherapy Treatment with Remote Afterloading Devices", and on September 28, 1993, NRC issued Revision 1 to Policy and Guidance t
Directive (P&GD) FC 86-4, "Information Required for Licensing Remote Afterloading Devices," both for immediate use by the Regions. This P&GD provides licensing guidance to the Regions for low, medium, high, and pulsed-dose-rate remote afterloading brachytherapy devices, replacing the 1986 P&GD, which covered only HDR devices.
Additionally, efforts are presently-ongoing to resolve a number of issues raised about appropriate licensing and use criteria for PDR devices. This is initially being addressed through efforts to resolve differences and issues raised in the response to NRC Bulletin 93-01 of one NRC licensee presently licensed for PDR brachytherapy.
Mr. Quillin asked why comments from Agreement States were not incorporated in the P&GD. Mr. Ayres responded that no comments were received from Agreement States. He continued by stating that NRC considered the comment period still open, and any significant comments received would be incorporated.
i
e.
r-u p-.-n w
4
,n p
4 n
f i
ye
>,.7 Carl J. Paperiello -
14
.* y 1
Dr. Grium asked if' licensing guidance had been provided.to the Regional Offices regarding special situations? Dr Ayres responded that the cover-j letter accompanying the P&GD -instructed the license reviewers to refer i
unusual applications to Headquarters.
b.
Implementation of the Quality Management Rule y
Sally Merchant, NRC's Project Manager for QM implementation provided a summary of staff actions since January 27 1992, when the QM rule became effective. This included initiation of a contract for review of all l
tubmitted QM programs by the Lawrence Livermore National Laboratory.
Ms. Merchant provided a summary of some early findings resulting from the reviews of the first 200 programs.
'j Dr. Griem described some of the s'
- a quality assurance requirements j
of the JCAHO. Ms. Merchant comme...,.J ! _t she had found some overlap in the requirements of the two progras, and had observed that some licensees keep the data for both programs together.
i Dr. Swanson commented that NRC should remember that quality assurance or l
quality management programs are in place to help prevent errors.
NRC should ensure that -systems are in place rather than be concerned with-.
I minutiae (e.g., whether an authorized user initialed rather.than signed
]
a written directive). NRC should focus on problems with the systems t
rather than individual omissions within the system. -
c.
NUREG on Management of Radioactive Materia 1LSafety Programs-at. Medical.
i Facilities
.l Janet Schlueter, NRC's Project Manager for this NUREG, prov'ided the following summary. The NMSS. staff initiated a Task Force-to develop a NUREG addressing effective management-of radioactive material safety
-i programs at medical facilities..The NUREG will serve as a practical
~
guide for NRC staff and NRC/ Agreement State license.es to clarify'the role of each member of the management triangle, i.e., licensee executive'.
management, the radiation safety officer.(RS0) and radiation safety i
committee (RSC). The NUREG is primarily focused on the perspective of i
management rather than that of users, by discussing'such topics-as identifying and securing adequate resources, ~ selecting-the best-qualified individual to be RSO, the interrelationship of responsible parties, the audit and feedback elements of an effective program, the use of consultants, and enforcement-related issues.
As part of the discussion Ms. Schlueter described the affiliations of i
Task Force members, the groups.that have been contacted.for input from the affected community, and the responses received from these groups.
j Dr. Marcus commented that the list of groups contacted for' input appears 7
to have selectively neglected physician groups, in favor of physicist-o w.'
l' A
. ~-
e i
w t
Carl J. Paperiello 15 groups, and thus the NRC-has not-included an appropriate,: unbiased sample of commentors. Secondly, Dr. Marcus evinced a belief that-NRC
-has not' clearly discriminated those regulations necessary to protect
.l heal.th and safety, from those just-resulting in " paperwork." Ms.
Schlueter responded that the groups to whom presentations were provided were not chosen with a mind to exclude any particular group or groups.
Future presentations'will.be to physician groups. As _ an example, -in-j November 1993, NRC plans to provide a presentation at the annual' meeting J'
of_ the Radiological Society of North America. : Second, this NUREG'is-intended to be a guidance document based on the current requirements to help licensees maintain regulatory compliance.
Dr. Flynn, commenting on RSCs, said that ordinarily, the RSO should ~ not.
chair the RSC. Ms. Schlueter commented that a reason the RSO should not-be chairman is that it would be difficult-for the RSO to perform the required audit on-the RSO since he would be auditing himself.
3 Dr. Siegel questioned when the ACMUI would be brought into the "NUREG l
loop." Mr. Camper responded that the NUREG would be an agenda item for i
the May 1994 meeting, and the Task Force would provide Committee l members with a draft of the NUREG in the first quarter of 1994.-
d.
National Academy of Science Study b
Patricia Rathbun, NRC's Project Manager for this. project, provided the following summary. The Commission requested,.and the ACMUI recommended,_
that the staff obtain the services of an outside group to conduct:an in-depth review of NRC's, policies, practices and procedures in' orderito o
assess whether the NRC'.s current-regulatory framework-for medical use of; byproduct material is appropriate to fulfil'NRC's statutory '
responsibilities for public health and safety. The staff considered : _ _
d various outside groups to perform this wod, and concluded that the best-1 approach was to contract with the National Academy of Sciences (NAS) to.
perform the review.
Dr. Siegel questioned the approach planned by_ NAS to do the work...
Dr. Rathbun responded that a group of. pro bono experts, supported by NAS>
staff, will conduct workshops, site visits,.etc. They will meet, come to some consensus, and-issue a report. The duration of the contract is two years. Dr. Siegel asked if members of.the group had as yet been identified. Dr. Rathbun responded that they had not.
j b.
Abnormal Occurrence Criteria This topir. was not discussed since a Commission Paper regarding the topic-is currently with the Commissioners.
-[
f.
Rulemaking Efforts i
Dr. Marcus was again reminded that she was recused from takinglpart in-discussions of the Radiopharmacy rule.
t o.
s, Carl J. Paperiello 16 Bill Morris, Director of the Division of Regulatory Applications, provided status reports on the proposed rulemakings regarding Pregnancy and Breastfeeding and Radiopharmacy.
1.
Pregnancy and Breast Feeding Dr. Morris described the staff's efforts to obtain additional guidance from several professional organizations and the staff's current thinking on this proposed rriemaking regarding unintended radiation exposures to an embryo or fetus or a breast-feeding infant. He indicated that the general concept was to develop a performance-oriented rule supported by a regulatory guide and then to have reporting requirements. He further indicated that current thinking favored no threshold for reporting of such unintended exposures, in part, because no good scientific basis for setting a threshold had been identified.
Dr. Marcus made documents from the U.S. Pharmacopeia regarding lactation-related concerns for several hundred drugs available to Dr. Morris.
Dr. Siegel commented that he and most other ACMUI members believed that having no threshold for reporting such incidents did not make sense.
He reminded Dr. Morris that ACMUI had previously suggested that reporting requirements be similar to those for reporting of diagnostic misadministrations, with division by a constant for reasons of conservativeness because the exposed subjects are infants and children.
Dr. Siegel asked Judy Brown if she wanted to comment.
She responded not at this time.
Dr. Siegel asked whether the purpose of the reporting requirement was similar to that of misadministration reporting or whether other purposes were intended. Mr. Morris responded that he could envision two kinds of requirements for reports: one, in the event of a significant exposure that would require an immediate report; and another at a lower level, that would require a report describing the breakdown of the system put in place by a facility to prevent these types of incidents.
Dr. Siegel commented that if the goal of no-threshold reporting was to gather statistics regarding the frequency of low-exposure events, the NRC should fund a study, rather than impose a rule. Mr. Morris responded that the objective is to find out whether systematic breakdowns are occurring.
Dr. Siegel suggested that, if NRC felt compelled to impose this burden, then the rule should contain a 2-3 year " sunset" provision and a requirement that the findings be reported to the Commissinn.
If the frequency of events is found to be exceedingly low, the rule should not be renewed.
Dr. Siegel, speaking for the committee, said that since the last time
y b,
I
. Carl J. Paperiello' 17 I
Dr. Siegel, speaking for the; committee, said that since the last time
[
t the Counittee had received information.regarding this rulemaking,'there.
has been a significant change in NRC's philosophical direction, and what -
l was provided at this meeting.was more than a status report.
He-i requested that,.at the May 1994 meetinp ACMUI should have the opportunity to see the full language ot the rule' to discuss it in depth.-
l
~
The review by ACMUI also should include provisional. text of the-
' Statements of Consideration and the regulatory impact analysis.
- 2. -Radiopharmacy Rule Mr. Morris provided a status-report on the recently published proposed:
Radiopharmacy rule. He indicated that there has been a lot:ofipublic:
comment on this rule, most of it favorable. The' staff is still
}
reviewing the public comments to determine if any modifications are needed. The final rulemaking package is scheduled to go.to the Commission in June of 1994 Dr. Siegel asked the members of the ACMUI for-any comments on the proposed Radiopharmacy rule, and received none.
Dr. Siegel concluded with a discussion of administrative matters. He said that a list of dates will be circulated by FAX (during the next week) to choose dates-for-the meeting with the Commissioners in January or. February 1994, and the regularly scheduled meetings of the ACMUI in April /May and October / November 1994. Judy Brown requested'that the next regular _ meeting not.
be held in Reston, Virginia. Dr. Siegel responded it was likely that the new White Flint building would be completed by then.
' Dr. Siegel asked for any final comments, and since there were none, Dr. Glenn declared that the meeting was closed at 1:38 p.m. on November 2, ~1993.
.f A
ge Barry A. tfegel,-M.D., Chairman 9 Deceurbep-Ifts (Date)'
- j I
.i