ML20236T728
| ML20236T728 | |
| Person / Time | |
|---|---|
| Issue date: | 03/26/1987 |
| From: | Hoyle J NRC OFFICE OF THE SECRETARY (SECY) |
| To: | Stello V NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO) |
| References | |
| FRN-52FR36942, REF-10CFR9.7, RULE-PR-35 AC65-1-023, AC65-1-23, NUDOCS 8712020057 | |
| Download: ML20236T728 (26) | |
Text
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j'[))Wj e ACTION-Thompson /leylor((8 UNITED STATES NUCLEAR REGULATORY COMMISSION gf g WASHINGTON.D.C 20555 Cyg. Stello
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March 26, 1987 Zerbe OFFICE OF THE Beckjord SECRETARY Heltemes Kerr, SP MEMORANDUM FOR:
Victor Stello, Jr.
Region 1 - V Executi D' rec r for Operations Murray
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'McElroy-
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FROM:
John C.
loyle, Acting Secretary
SUBJECT:
STAFF REQUIREMENTS - SECY-87 '
" MISADMINISTRATION" The Commission, with all Commissioners agreeing, requested the staff to revise the proposed NPR and ANPR of the subject paper as outlined below and to resubmit it for Commission approval.
PB904 (NMSS)
(SECY SUSPENSE: 5/29/87)
Both draft notices should be revised to include further support for the Commission's position.
A clear distinction should be drawn between the unacceptable risks of improper or careless use or 7s i""j byproduct material by medical licensees and the unavoidable risks attendant to prescribed and properly administered diagnostic and therapeutic procedures.
The NMSS staff should coordinate with AEOD the documentation of additional supportive information into the proposed rulemaking (see Commissioners Bernthal's and Carr's comments for more detail)
(attached)).
The regulatory analyses (Enclosures 4 and 5 to SECY-87-29) should be strengthened as discussed above.
Both the NPR and the AMPR should be appropriately f
modified to apply to misadministration of diagnostic procedures which fall in therapy dose ranges as well as to misadministration of radiation therapy.
(See j
Commissioners Bernthal's vote sheet )
Commissioner 4
Carr would have preferred that comprehensive quality assurance procedures for diagnostic procedures which fall in therapy dose ranges be addressed after thorough analysis of response to the ANPR.
The draft ANPR should solicit comments on the imposition of requirements regarding the use of 1
prepackaged computer software.
Should the licensees 7s
(
4 who use these packages be required to verify them?
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Are there additional QA requirements / procedures which could be developed to ensure that users understand the calculations embedded in these programs?
Refd off. ED)3 - A l-T) 8712020057 871201 Cfc-i PDR PR
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35 52FR36942 PDR h-20 7-~~
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O On page 21 of Enclosure 2 (Section 35.432 of the proposed rule), licensees are required to measure the strength of sources prior to use and annually thereafter.
Licensees are also directed that they may, when performing dose calculations, use the source strength as reported by the manufacturer.
Staff should specify licensee action in the event that the licensee's measurements differ significantly from those reported by the manufacturer.
Provide an analysis of the additional NRC resources necessary to implement the requirements of the proposed rule, as well as the resources needed to complete staff recommendations in Enclosure 3.
The estimates should include the overhead. (See Commission vote sheets)
Staff efforts in this area should be coordinated with the Agreement States and copies of the proposed rule and the ANPR should be sent to the Agreement States in advance of publication and specifically request their comments.
The proposed rule should be published for 60-day
(])
public comment period.
The staff should arrange for a public Commission briefing by the representatives of professional / medical industry organizations, Agreement States, and other interested parties to address the issues raised in the rulemakings.
The following comments address the staff's response to the Commission's 12/16/86 SRM:
Item 2:
The retitling of the term "misadmin-istration report" to " medical use event report" should be considered only if public comments on the proposed rule justify.
Item 4:
Tracking of wrongdoers.
Expedite the preparation of a response to the SRM for SECY-86-319.
(See Commissioner Bernthal's comments (attached).)
(IE)
(Wits 860227)
Item 5:
Solicit comments in the ANPR on whether NRC licensees should maintain and provide to patients, upcn request, a record of the radiation doses which result from all licensed procedures.
(]) '
Input from the Advisory Committee on the Medical Use of Radioisotopes should also be solicited on this item.
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1 Item 8:
Update Notice IN-85-61 as suggested in AEOD Report N701. (IE)
The staff should regularly advise the Commission of progress in followup activities which evolve in response to the December 16, 1986 SRM. (NMSS)
Commissioner Carr considered the statement in Part
- 35. 43 (d) of page 20, Enclosure 2, to be overly prescriptive.
He would prefer the staff to consider replacing other references to " ticking" throughout the proposed rule to allow the licensee flexibility in performing written verification.
The staff's revisions to the NPR and ANPR should consider the editorial changes in the attached sheets.
Attachments:
As stated cc:
Chairman Zech Commissioner Roberts Commissioner Asselstine
(~T Commissioner Bernthal
'd Commissioner Carr OGC, H Street 4
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Stello Roe NOTATION VOTE FYI: HThompson e
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SAMUEL J. CHILK, SECRETARY 05 THE COMMISSION FROM:
CHAIRMAN __ZE.CH l
SUBJECT:
SECY-87 MISADMINISTRATION l
APPROVED x as below DISAPPROVED ABSTAIN NOT PARTICIPATING REQUEST DISCUSSION COMMENTS:
I approve publication of an advanced notice of proposed rulemaki6g revised to reflect the Commission comments.
Request the staff to submit the revision
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g for Commission review within 60 days.
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SECRETARIAT NOTE:
PLEASE ALSO RESPOND TO AND/OR COMMENT ON OGC/0PE MEMORANDUM IF ONE HAS BEEN ISSUED ON THIS PAPER.
NRC-SECY FORM DEC. 80
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SAMUEL J. CHILK, SECRETARY OF THE COMMISSION FROM:
COMMISSIONER ROBERTS
SUBJECT:
SECY-87 MISADMINISTRATION APPROVED N DISAPPROVED ABSTAIN NOT PARTICIP. TING REQUEST DISCUSSION COMMENTS:
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O SECRETARIAT NOTE:
PLEASE ALSO RESPOND TO AND/OR. COMMENT ON OGC/0PE I
MEMORANDUM IF ONE HAS BEEN ISSUED ON THIS PAPER.
NRC-SECY FORM DEC. 80
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cc:
Stello Roe NOTATION V0TE FYI: Thompson (5
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RESPONSE SHEET TRehm T0:
SAMUEL J. CHILK, SECRETARY OF THE COMMISSION FROM:
COMMISSIONER ASSELSTINE
SUBJECT:
secY-87-29 MISADMINISTRATION l
l 1
APPROVEDx as nodified DISAPPROVED ABSTAIN l
NOT PARTICIPATING REQUEST DISCUSSION COMMENTS:
/1. The rationale and the regulatory analyses in both the PR and the ANPR should be strengthened to better support the Ca mission's proposals.
/ 2.
'Ihe proposed rule should apply to diagnostic uses as well as therapeutic.
I 3.
I am not convinced that the term "misadmi.nistration" should be deleted.
i
/ 4.
Specific cmment should be solicited in the ANPR on whether NRC licensees should be required to provide to patients, upon request, a record of tne radiation dose received during treatment.
/ 5.
Staff should continue to pursue the " tracking of wrongdoers" issue.
J
/ 6.
I agree with Commissioner Bernthal and Commissioner Carr's carnents on source strengths and ccruputer software.
/ 7.
I agree with Cm missioner Bernthal's modifications to the questions in Enclosure 1.
/ 8.
I agree to a 60-day cmment period and a public meeting with professional l
organizations, Agreement States and other interested parties.
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SECRETARIAT NOTE:
PLEASE ALSO RESPOND TO AND/OR COMMENT ON OGC/0PE MEMORANDUM IF ONE HAS BEEN ISSUED ON THIS PAPER.
NRC-SECY FORM DEC. 80
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SUBJECT:
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PLEASE ALSO RESPOND TO AND/OR COMMENT ON OGC/0PE MEMORANDUM IF ONE HAS BEEN ISSUED ON THIS PAPER.
NRC-SECY FORM DEC. 80
% sed 3}%/ff 7 C-Comments of Commissioner Bernthal on SECY 87-29; At the outset, I have to agree with the arguments of NMSS regarding the need All sml].1 materials licensees, taken for additional resources in this area.
m collectf vely, receive about 2.5% of NRC's licensina a3d inspection budget, l
Medical licensees in particular receive only 0.5%!
If the Commission is i
serious about greater attention not just to medical, but to all materials
)
licensees, I see no way to finesse the need for an infusion of significant additional resources.
I did not understand the use of the term " negligence" in the Commission's directive to imply that staff should venture into " uncharted" regulatory waters. Rather, Staff should merely apply the same enforcement criteria of "due care" as now apply to other classes of licenses.
Staff protests a bit too much (cf. bottom of p. 3 and following).
In any case, Staff's decision to reference NRC enforcement policy for use in medical enforcement actions is appropriate.
The broad rationale staff supplies for Commission action in this entire area strikes me as inadequate, and it is not for want of strong, clearly evident arguments that could be constructed, based on recent events and the AE0D report. Therefore, both draft notices should be revised to include further support for the Commission's position. A clear distinction should be drawn between the unacceptable risks of improper or careless use of byproduct material by medical licensees and the unavoidable risks attendant to g
prescribed and properly administered diagnostic and therapeutic procedures.
o The NRC is obligated to establish and enforce regulations that protect the public from the former.
No one argues that the enormous benefits of nuclear medicine fail to outweigh the small (but real) risk attendant to its proper and responsible use.
I would suggest that much important anecdotal information supportive of these rulemakings may be found in three AE0D reports produced in the past 18 months.
In rewriting these sectinns, NMSS staff should be instructed specifically to work with the authors of these reports.
]
i The regulatory analyses (Enclosures 4 and 5) are likewise weak. They should j
not be published in their present form. While there may be no compelling i
reason to publish them at all, if they are to be made available to the public they should be strengthened as discussed above.
Staff has crafted the proposed rule such that it applies only to
)
misadministration of radiation therapy (which is in strict compliance with the wording of the SRM) -- this despite the fact that certain diagnostic procedures involving I-131 can, if carried out improperly, result in therapeutic doses. Staff argues that the Commission specified therapy.
j According to Staff, rewording the proposed rule to address the different I
training, work practices and license requirements of diagnostic as opposed to therapeutic uses of radioisotopes would take much longer.
I am unconvinced. The Commission surely does not intend to ignore serious misadministration simply because they occur as the result of a diagnostic (q) procedure rather than a therapeutic one.
In fact, because recipients of diagnostic misadministration are far healthier as a group (i.e. have longer life expectancies) than recipients of therapeutic misadministration, the j
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Datential for long term harm is greater.
AE0D's most recent report, L
(attached) makes an excellent case for additional regulatory measures to i
l orevent just such misadministration. The NPR and ANPR should be j
appropriately modified to apply to these cases as well.
In the draft ANPR, comment should be solicited en the imposition of I
requirements regarding the use of prepackaged computer software. Should the j
licensees who use these packages be required to verify them? Are there additional 0A requirements / procedures which could be developed to ensure that users understand the calculations embedded in these programs.
(Recall that in the Cleveland Clinic incident, the overexposure resulted from the radiation physicist's failure to realize that the distance from source to the exterior of the instrument was already accounted for in the computer software).
On page 21 of Enclosure 2 (section 35.432 of the proposed rule), licensees are required to measure the strength of sources prior to use and annually -
thereafter. Licensees are also directed that they may, when performing dose Calculations, use the source strength as reported by the manufacturer.
Staff should specify licensee action in the event that the licensees measurements differ significantly from those reported by the manufacturer.
I also have the following further comments on Staff's response to the Commission's 12/16/86 SRM:
0lV Item #2:
Staff suggests that licensees view the term " misadministration report" quite negatively, and propose instead that thought be given to retitling it as a " medical use event report." This would be similar I suppose, to a licensee event report (LER) for power plants.
I don't necessarily object to this, but I would consider making such a change only if comments on the proposed rule justify it.
Item #4:
Tracking of wrongdoers. Staff says that this was addressed in SECY-86-319. That paper was rejected by the Commission (5-0) and sent back to staff to be redrafted.
It has yet to return to the Commission. Staff also cites a recent law (to be implemented by HHS) for tracking physicians who have been disciplined or defeated in malpractice cases. No details of this law are provided.
Even if such a law proves to be applicable to NRC violations, it fails to address the problem of radiation physicists, technicians, HPs etc. who may be violating NRC regulations.
I believe that staff preparation of a response to the SRM for SECY-86-319 should be expedited so that the Commission may address this problem in a manner consistent with its treatment of all licensees.
Item #5 All physicians do not, upon request, provide such information.
Many do not even know the dose of a given procedure. Specific comment should be solicited in the ANPR on whether NPC licensees should maintain and provide to patients, upon request, e record of the radiation doses which result from all licensed procedures.
I would welcome the opinion of the O
Advisory Committee on the Medical Use of Radioisotopes on this matter, as O
staff has suggested, but would still seek public comment as well.
___-__._,___s
I()
Item #8 Staff has indeed made a laudable effort to provide to licensees information on the causes and frequency of misadministration. The list of II.E notices and other publications is commendable. Staff should be encouraged to continue these efforts. Staff should be directed to update Notice IN-85-61 as suggested in AEOD Report N701, " Diagnostic Misadministration Involving the Administration of Mil 11 curie Amounts of I-131".
Item #10: During the public con: ment period for the NPR and the ANPR, the Commission should hold a public meeting on the sub.iect. Representatives of professional / medical / industry organizations should be specifically invited to address the issues raised by the Commission for rulemaking consideration I approve SECY-87-29 subject to the above comments and minor edits on the attached sheets.
O O
[7590-01]
O NUCLEAR REGULATORY COMMISSION 10 CFR PART 35 Comprehensive Quality Assurance in Medical Use and a Standard of Care AGENCY: Nuclear Regulatory Commission.
1 e
ACTION: Advance Notice of Proposed Rulemaking.
SUMMARY
- 'The Nuclear Regulatory Comission (NRC) is considering amendmente to its regulations that apply to the use of byproduct material for rad'1ation therapy and diagnostic uses involving large radiation dosages.
In addition to the current requirements for quality assurance, the contemplated amendments-would require ifcensees that offer teletherapy or brachytherapy services to O
implement a comprehensive qual 4ty assurance pro 9 ram to reduce the chance of en ne. extent to w hi c.h misadministration. The NRC requests public comment = 2 t". additional g
radiopharmaceutical quality assurance requirements are needed, and invites advice and recommendations on several questions that wf11 have to be addressed in the rulemaking process.
[ Note: a cross-reference to the proposed rule will be inserted.]
l DATE:
Submit coments by (90 days).
Coments received after this date will be considered if it is practical to do so but assurance of considera-
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tion cannot be given except as to comments received before this date.
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[759,0-01]
Effect on the Agreement Sta'te Program
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O Twenty-eight States, known as Agreement States, have assumed responsibility for regulating certain radioactive materials within their respective borders by agreement with the NRC.
(This kind of agreement is authorized by the Atomic Energy Act.) They issue licenses for the use of byproduct material, and currently regulate about 5,000 medical licensees.
Because the NRC will request the Agreement States, as a matter of compatibility, to implement regulations equivalent to those that it implements on this' matter, state regulatory agencies are asked to comntent.
Request For Comments The NRC has prepared the following questions to elicit comments on AU methods of preventing misadministration.
Connents do not have to respond to these questions alone; other related topics or alternatives may be described if the commenter believes this will help to resolve issues related to this rulemaking.
Quality Assurance 1
General The following questions apply to the provision of all types of thera-peutic medical use, and large diagnostic dosages.
- ",i"[*"""..'.?.E. _mest effe<f. gel.is,,ed.. e=ief,re3yemegs for a
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aus:(A) Adept Arewsk rule== kin,9 andedr3 c.as ensus standurJs, (s) Parkcipate w comprehensive quality assurancr. programpith t :p :1fying it: centent, Or to idenbf u *Le.meMs.f r,acA s p rogram, (c) Comisseea estal. lash
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wJudrg 'd the "C 'f:t ::rt:f cc: lit; :::;r:n : :tep: th:t :::t i: p;rf:. n t?
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[7590-01]
1
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2.
Should the definition of misadministration in 10 CFR 35.41 oV (the same definition that appears in 10 CFR 35.2 that was published on I
October 20, 1986 at 51 FR 36932) be changed?
Is it clear and complete?
Is the definition sufficiently broad to include all appropriate activities?
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Is it so broad as to include inappropriate activities? Is the term i
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" misadministration" appropriately descriptive of the activities? Should J
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p 3.
The NRC knows of one instance in which radiation was administered E' h to a patient without a request from the primary care physician.
Should the ts, 44 NRC require that the authorized user actively consult with the primaryi care tu~
physician before prescribing radiation or deciding that radiation is not wkd..pe. vents can be adopted +. mmmise pet nt.hl.,se. u cation and
'? [g h 4 ambsu ws te ~not ss ?shoutcl be con $ide.re.J OsY wo aJ needed?
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4.
Whatmethodsg: Oui?:5?: 1:,o provide aiid ic assurance that the I
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patient who is administered radiation is the patient for whom radiation was
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intended?
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Should NRC require certification or specific training criteria 4n g
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for technologists, dosimetrists, and others who participate in the applica-On s
$3' tion of radiation to patients, or assume that licensees will provide each q4hw rg i.<.e ns,. s p"v,J e uhdever train.ng is necess a rs, L,u.i ca.
2 n a. o individual whatever training is necessary?g Should the NRC require licensees W
to administer written examinations to workers and evaluate them before allowing the workers to participate in radiation therapy? Should periodic retraining e
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r and re-examination be required?
7/.
What other regulatory, certifying, accrediting, or inspecting pi 1
L 4,e organizations examine medical quality assurance programs? Ar: th:::
- = in: tion: : n:i'cr:d pcrfun:tery or exh:u:tive?
D e s e r d e d e.
Y oyethve.s und rid o r of de.se e.x a nn a n ah o n s.
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Teletherapy and Brachytherapy The following questions apply to the provision of teletherapy and
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brachytherapy services.
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.To sure quality of patient c e, some org izations rec end
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[. WLd per(psac.e. *Lj ut4ves could les
- and famil-o i prac appropetate.
d,pted to ensure f ari-
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and mammate hu ms.n havA reta error 7 ei ial y
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em oyee to ssure t t licensee ployees are ot rushed i their wor hould N requir licensees t) specialize treating c tain kind or
[ stage of disea e rather th allowing t m to treat 1 kinds o direase?
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Should s Ier licens s with fewe staff and equipment esources
'be.r quired to t differen quality ass ance requ ements t n those f
larger 11 nsees?
,1 t.
What fraction of licensees already have a quality assurance progran?
i 3 /.
The Regulatory Flexibility Act requires that regulatory agencies j
J' examine the cost of compliance with regulations. How much does a quality i
assurance program cost per patient or per year? What fraction of staff time, j
including physicians, physicists, dosimetrists, technologists, and nurses,
)
1 is currently budgeted for cuality assurance work? If more staff were needed
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to meet quality assurance requirements, are the requisite individuals readily available or would a lengthy lead-in time be needed?
7
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[7590-01]
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Are there complete model quality assurance programs already O
available that address every step of the radiation therapy process, or will model programs have to be developed? Should physical measurements, redundant calculations, or both be required to assure that the dose l
given is the same as the dose prescribed? What other areas are, or should be, covered in a complete quality assurance program?
SWE Are the staff and equipment that are needed to implement a complete quality assurance program available in the marketplace, or would new training programs and equipment development be needed?
a Mit,,,*l (s X What methods are available for reducing the frequency or impact 4
of human error?
Radiopharmaceutical Therapy The NRC requires that licensees use only certain radiopharmaceuticals for specified therapy clinical procedures, measure the radioactivity in
~
radiepharmaceutical dosages before administration, and have a measurement quality assurance program for the dose calibrator used to make that measurement. These requirements appear to comprise all the steps in a j
radiopharmaceutical therapy physical quality assurance program.
- However, the NRC invites public coment on this position.
There have been cases in which, due to procedural failure, a radio-pharmaceutical other than that intended has been ordered and administered.
)
l The NRC expects that all licensees have policy requirements for clear q
l statements of prescription and verification before administration of any pharmaceutical. The NRC would appreciate suggestions on methods to assure j
O that the clinical procedure (including radiopharmaceutical, dosage, and i
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)
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obse6 ved sever ol c os 25 of f7590-01]
g( The. NR.c has i
..-munico+..e o s +Le. req. r.es r%.cians reto,w.
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j*sokd imprwe. men 4s
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route of administration) intended by the authorized user is prescribed, e
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and that the prescribed clinical procedure is the clinical procedure that L
isperformed]Aretheref,pecialneedsregardingpatientidentification in radiopharmaceutical therapy that go beyond the information regarding patient identific& tion that was requested in question 4. of the Generai subsection?
Standards of Care The NRC presently has, in 10 CFR Part 2, Appendix C, particularly Supplement VI, an enforcement policy that it can apply to the medical zuse i
l of byproduct material.
The following questions apply to the provision of teletherapy, j
brachytherapy, and radiopharmaceutical services, and to the Conunission's Enforcement Folicy.
f g
1.
Is there a clear, generally accepted standard of care that the NRC can adopt? If yes, please describe it.
If not, please describe a standard that NRC could adopt.
Is a standard needed if NRC has comprehensive prescriptive requirements?
2.
What kinds of penalties should be imposed on licensees, their employees, or both, if the standard or the comprehensive, prescriptive requirements are not net? Should penalties be imposed on employees?
Should NRC's Enforcement Policy be changed, and if so, how?
3.
What effect would such a standard or comprehensive, prescriptive requirements have on provisions of radiation therapy care?
9 9
cc:
Stello Roe N 0 T A T_I O N V0TE FYI: HThompson NMcElroy
]
RESP 0BSE SHEET TRehm TO:
SAMUEL J. CHILK, SECRETARY OF THE COMMISSION FROM:
COMMISSIONER CARR
SUBJECT:
SecY-87 MISADMINISTRATION W-u h DISAPPROVED ABSTAIN APPROVED NOT PARTICIPATING REQUEST DISCUSSION COMMENTS:
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A.AJ: W.
SlbMAl uRt.
YES NO 3.1. I)
Entered on AS"
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PLEASE ALSO RESPOND TO AND/OR COMMENT ON SECRETARIAT NOTE:
MEMORAND'Ji>' IF ONE HAS BEEN ISSUED ON THIS PAPE i
NRC-SECY FORM DEC. 80
--___ ___ __._-____.________-- - _____ A
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y0 Commissioner Carr's comments on SECY 87-29 I. commend the staff for'its timely response and efforts to respond to the Commission's concerns about the need for greater NRC attention to the oversight of medical licensees.
I have the following comments on the L
' staff's proposed actions:
Proposed Rule - Basic Ouality Assurance in Radiation Therapy (1) The NRC staff, including NMSS~, AE0D,'and the Regions, have invested significant effort over the past 5 years in evaluating reported medical misadministration, analyzing the underlying causes and recommending corrective action to prevent recurrence. The proposed rule should be revised to reflect this experience and more thoroughly explain the need to revise the Commission's regulations.
(2) 35.43(d) as stated is overly prescriptive. Regulatory guidance should afford the licensee flexibility in the'means of written-verification of independent checks of data transfer and calculation. The staff should consider replacing other references to " ticking" throughout the proposed rule to allow the licensee flexibility in performing written verification.
p (3) Proposed revisions to 35.432 address source. strength measurements.
t)
Licensees will be required to measure source strength initially and a
on an annual basis. However,.when performing dose calculations, tl licensees will be permitted to use the source strength reported by 1
the manufacturer without any required comparison between reported and' measured values. Licensees'should be required to establish.
procedures if source strength measurements differ from that reported-by the manufacturer.
ANPR - Comprehensive Quality Assurance in Medical Use and a Standard of Care (1) See Comment l'above. The paper should be revised to more thoroughly explain the Comission's position, based on NRC experience and analysis (including AE0D case studies and reports and reported incidents), that some licensees do not have adequate quality assurance programs to minimize human error and avoid medical misadministration.
(2) Revise according to specific modifications on pages 1,5,6,7,8,9 of Enclosure 1.
(3) The staff should address comprehensive quality assurance requirements for therapy procedures and diacnostic procedures which fall in therapy dose ranges in a proposed rule if warranted after thorough analysis of responses to the ANPR and progress on staff actions proposed in
' Enclosure 3, Response to Questions in December 16, 1986 Staff th Requirements Memorandum.
Ir, any case, the staff should regularly advise the Commission of progress in follow-up activities described in SECY-87-29. Enclosure 3.
1
)
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l l
Resources I noted with interest that only approximately 0.5% of NRC's total r: sources l
are applied to.itcensing and inspection of 2500 NRC medical licensees.
I 69ree with the staff'c observation that an increased NRC presence coupled With requirements of the proposed rule may enhance licensee attention to quality assurance, training, and management controls. However, the discussion of resources on page 6 of the staff paper does not provide sufficient information to ascertain what resources are necessary for the proposed rule separate from future actions that may be recommended. The staff should be asked.to provide an analysis of additional NRC resources nece:sary to implement requirements of the. proposed rule. Also, the staff is asked to provide a separate analysis of NRC ' resources needed to complete staff recommendations'i.n Enclosure 3.
Please include overhead in these estimates.
In preparing these resources analyses staff should consider creative solutions to maximize results from resource investments.
Coordination with Agreement States I believe that interactions and coordination with the Agreement States are essential on these important issues.
Because the staff notes that these interactions have not occurred due to timing constraints, I suggest that
()
the Agreement States be sent advanced copies of the proposed rule prior to publication requesting their comments.
I woulu have preferred that these customary interactions had occurred prior to submittal of the proposed i
regulation to the Commission because of the valuable experience the Agreement States bring to the development of our regulations.
Public Comment Period I agree with the staff recommendation that the proposed rule be published for 60-day public comment period.
Commission Meetino with Professional Organizations The staff should arrange for representatives of key professional organizations to brief the Commission after the close of public comment on the ANPR on initiatives planned and underway which could be effective in preventing medical misadministration.
w 31M O.
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______.s
[7590-0 0 O
NUCLEAR REGULATORY COMMISSION 10 CFR PART 35 Comprehensive Quality Assurance in Medical Use and a Standard of Care AGENCY: Nuclear Regulatory Comission.
ACTION: Advance Notice *of Proposed Rulemaking.
SUMMARY
- The Nuclear Regulatory Comission (NRC) is considering amendments to its reguTation's that apply to the use of byproduct matertaf Wr radiatMon therapy and diagnostic uses invciving large radiation dosa@s.
In addition to the current requirements for quality assurance,the contemplated amendments would require licensees that offer teletherapy or brachytherapy, servicerto I
O implement a comprehensive quality assurance program to reduce the chance of w
l Ao w u r.<t -, *
- misadministration: The NRC requests public comment a'
" ';.;6r additional I
radiophannaceutical quality assurance requirements ^are needed, and invites
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I advice and recommendations on several questions that will have to be addressed in the rulemaking process.
[ Note: a cross-reference to the proposed rule will be inserted.]
DATE: Submit coments by (90 days).
Coments received after this date will be considered if it is practical to do so but assurance of considera-l tion cannot be given except as to coments received before this date.
i W"
%MS-4FWsp Am i g 1
[7590-01)
Effect on the Agreement State Program oO 6 s, known as Agreement States, have assumed respontitriitty for regulating certwirt radioactive materials within their respective borders by agreement with the NRC.
(This kind of agreemnt is authorized by the Atomic Energy Act.) They issue licenses for the use of byproduct material, and currently regulate about 5,000 medical licensees.
Because the NRC will request the Agreement States, as a matter of compatiffflity, to implement regulations equivalent to those that it fnp1Winents on this matter, state regulatory agencies are asked to comments Request For Comments The NRC has prepared the following questions to elicit comments on methods of preventing misadministration.
Coments do not have to respond to these questions alone; other related topics or alternatives may be described if the commenter believes this will help to resolve issues related to this rulemaking.
Quality Assurance General The following questions apply to the provision of all types of thera-peutic medical use, and large diagnostic dosages.
%u w m (2nuc,w won e :2 e ~ u=u mw,%v v m y,m - mn 1.
Should the Oc-mi sis cqu ire e mrw@Q(na w.hicmcr&a i.h a' -*et cgog w
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comprehensive quality assurance p'togram withou_t scecifying-it; ccntent a r j
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shtfuld the NRL, iisNtain cualf J :ssurance step'ethdt inust bchmed?
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3y - gg Should the _ definition of misadministration in 10 CFR 35.41 h*
2.
(the same definition'that appears in 10 CFR 35.2 that was published on 20,.1986 at 51 FR 36932) be changed?.Is it clear and complete?
October Is the definition sufficiently broad to include all appropriate activities?
Is it so broad as to include inappropriate activities? Is the term
" misadministration" appropriately descriptive of the activities? Should some more descriptive term be used?
The NRC knows of one instance in which radiation was administered 3.
to a patient without a request from the primary care physician. Should the NRC require that the authorized user actively consult with the primary care-physician before prescribing radiation or deciding that radiation is not
/ needed? * *" '# " " ' '""'7"'***"'""'"
-,wr %,,e.m. tcae.mwt What methods are available that provide reliable assurance that the 4.
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patient who is administered radiation is the,atient for whom radiation was intended?
Should NRC require certification or specific training criteria
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for technologists, dosimetrists, ano others w1o participate in the applica-
,44 tion of radiation to patients, or assume that licensees will provide eac.h.3
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- p:'(,,, r individual whatever training is necessary') Should the NRC require license S.w" v"
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d evaluate them before allowing-p, p ras,t,,o administer written examinations to war ers an os o
? Should periodic retraining
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the workers to participate in radiation therapy an'd re-examination be required?
What other regulatory, certifying, accrediting, or inspecting q f.
organizations examine medical quality assurarce programs? 4re these I
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[examtrauonscons1ceredperTunctoryorexhaustive?
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March'4, 1987 Note to:
Norman McElroy j
1 l
From:
Connie Schum
SUBJECT:
SECY-87 MARGARET FEDERLINE'S COMMENTS ON PAGE 6 0F THE ANPR f'
A.
No change to item 2.
l L.
L B.
At the end of-item 3. add the following question.
"What improvements can be adopted to minimize potential miscommunication and ambiguous terminology?"
C.
No change to item 4.
D.
Insert-new item 5.
"What standards exist in the industry to ensure the adequacy and i
uniformity of training for those personnel who participate in the nV administration of radiation to patients?"
l E.
Old item 5 should be renumbered as item 6.
Also on line 4 after
... training is necessary?, insert the following question.
i "If licensees provide whatever training is necessary, how can NRC ensure the adequacy and consistency of this training throughout i
the industry?"
l l
F.
Old item 6 should be renumbered as item 7.
Also delete the last question which begins on line 2 and replace with the following sentence.
" Describe the objectives and rigor of these examinations."
G.
Add item 8.
" Apart from increased NRC oversight, are there any changes in industry practice or standards that could substantially improve the quality of performance and minimize human error?"
.O
f7590-01]
Teletherapy and Brachytherapy g
The following questions apply to the provision of teletherapy-and
/
brachytherapy serwices.
- 1. 'T assure quality of patient care, some organizations recommend y
that certain sur (qal or test-tube procedures only be perfomed if the f,1cientcasedoadtoassurethatdexterityandfamil-practitioner has a iarity with the procedure are n'ot lost. Should Nhc requitt that licensees 0
how a mort l tin afhimum cass'-lohd to assm that thef.c employees retain their'expertist iW1MW1draing radtation therapy clinicat and qualityj
/
essem nce procedueps Should NRC link the permissible-ret:fo ofecases per that licensee employeeg are not rushed in their work?
employee to as ShouldNRCytquirelicenseestospecializeiAtreatingcertainkindsor disease rather than allowing them to iireet a!1 kinds of disea' sir?
/
stages differing training or certification requirements be imposed based h
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be regtrtha tu mi. difie.nc wiii ty assurance mqui
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en those fe, terger lic;n;;;;? '
What fPsetion of licensees already have a quality assurance progran?
3.
The Regulatory Flexibility Act requires that regulatory agencies 4.
Few much does a quality examine the cest of compliance with regulations.
What fraction of staff time, assurance program cost per patient or per year?
including physicians, physicists, dosimetrists, technologists, and nurses, If more staff were needed is currently budgeted for quality assurance work?
to meet quality assurance reovirements, a e the requisite individuals readily available or would a lengthy lead-in time be needed?
7
[7590-01]
5.
Are there complete model quality assurance programs already 0'
available that address every step of the radiation therapy process, or will model programs have to be developed? Should physical measurements, redundant calculations, or both be required to assure that the dose given is the same as the dose prescribed? What other areas are, or
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should be, covered in a complete quality assurance program?
U / +,, # d Are the staff and equipment that are needed to implement a
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Q complete quality assurance program available in the marketplace, or
, %.SdT# would new training programs and equipment development be
+*
,., %, r* $m c.v*y '
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What' methods are available for reducing the frequency or impact
&.f of human error?
i Radiopharmaceutical Therapy O.
fleelMt requires that licensees use only certain radiophamaceuticals
's specMM therapy clinical procedures, measure. the radioactivity in radiophennaceutical dosages before administration, and have a measurement quality assurance program for the dose calibrator used to make that measurement. These requirements appear to comprise all the sters in a
- However, redfopharmacautiee M herapy physical quality assurance program.
the NRC invites public coment e this position.
IbsetMtive Beeft cases in which, due to procedural failure, a radio-pharmemet$eetMher than that-intended has been ordered and administered.
The NRC expects that all licensees have policy requirements for clear statements of prescription and verification before administration of any i
phannace9tical. The NRC would appreciate suggestions on methods to assure O
that the clinical procedure (including radiopharnaceutical, dosage, and 8
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j route of administration) intended by the authorized user is prescribed,-
and that the prescribed clinical procedure is the clinical procedure that for1ned.kAre there special needs regarding patient identification
~
in radiopharmaceutical therapy that go beyond the information regarding patient identification that was requested in question 4. of the General subsection?
Standards of Care
~
The NRC presently has, in 10 CFR Part 2, Appendix C, particularly Supplement VI, an enforcement policy that it can apply to the medical use of byproduct material.
The following questions apply to the provision of teletherapy, brachytherapy, and radiopharmaceutical services, and to the Commission's O
caforcemeat Poi <cy.
1.
Is there a clear, generally accepted standard of care that the NRC cea adopt? If yes, please describe it.
If not, please describe a standard that NRC could adopt.
Is a standard needed if NRC has comprehensive prescriptive requirements?
2.
What kinds of penalties should be imposed on licensees, their employees, or both, if the standard or the comprehensive, prescriptive requirements are not met? Should penalties be imposed on employees?
Should NRC's Enforcement Policy be changed, and if so, how' 3r-What effect would such a =LandorJ vr cump,ebensiver-preteN etive requ ir ements-trave on prvv is ions vi radiation ttrerapy-care?
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UNITED STATES 4
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g NUCLEAR REGULATORY COMMISSION M Es
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9 E WASHINGTON, D. C. 20555
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tiarch 23., 1987 f
- ss AE0D/N702 INFORMATION ROUTING ONLY THOMPSON MEMORANDUM FOR:
Eric S. Beckjord, Director, RES BERNER0
,r Hugh L. Thompson, Director, NMSS
@f cc:
James M. Taylor, Director, IE 32 Regional Administrators WL.
FROM:
C. J. Heltemes, Jr., Director DTHER: Srw W Office for Analysis and Evaluation Uc d cy of Operational Data
/j,,., -
U
SUBJECT:
MEDICAL MISADMINISTRATION REPORT - MEDICAL MISADMINISTRATION REPORTED TO NRC FOR THE PERIOD JANUARY 1986 THROUGH DECEMBER 1986 The enclosed AE0D report, provided for your information, is a compilation of
-data derived from a review of therapy and diaonostic medical misadministration reported to NRC for the period January 1986 through December 1986.
Should you have any comments or other feedback concerning the subject report, you may contact Sam Petti;tohn of this office on X28348.
N
[itemesMr., Director Fe ~
C.
Of e for Analysis ano Evaluation of Operational Data
Enclosure:
As Stated cc w/ enclosure:
V. Stello, EDO T. Rehm, A0/EDO J. Sniezek, DEDROGR T. Guynn, OCM G. Wayne Kerr, SP M. Beaumont, Westinghouse Electric Corporation C. Brinkman, Combustion Engineering Company
,l-R. Borsum, Babcock & Wilcox L. Gifford, Geneul Electric Company
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AE0D/N702 MEDICAL MISADMINISTRATION REPORT MEDICAL MISADMINISTRATION REPORTED TO NRC FOR.THE PERIOD JANUARY 1986 THROUGH DECEMBER 1986 by the 0ffice for Analysis and Evaluation of Operational Data Nonreactor Assessment Staff March 1987
~!
l Prepared by:
Samuel L. Pettijohn This report characterizes the Medical Misadministration database maintained by the.0ffice for Analysis and Evaluation of Operational Data.
This report does
-)
not contain detailed analyses of individual events, but focuses on an attempt to identify. potential and actual problem areas, and address the status of NRC activities in those areas.
]
nm a,e 1,
ao n,-
virtuovaho 33 PP-J
TABLE OF C'ONTENTS Page 1.
INTRODUCTION........................................................
1 2.
THERAPY AND DIAGNOSTIC MISADMINISTRATION REPORTED TO NRC IN 1986....
3 2.1 General.........................................................
3 2.2 Therapy Misadministration.....................................
5 2.2.1 Teletherapy Misadministration...........................
5 2.2.2 Brachytherapy and Radiopharmaceutical Misadministration.
7 2.3 Diagnostic Misadministration...................................
8 2.3.1 Iodine. Misadministration................................
10 3.
PERSONNEL INVOLVED IN MISADMINISTRATION............................
11 4.
GE0 GRAPHIC DISTRIBUTION OF LICENSECS REPORTING MISADMINISTRATION....
12 i
5.
LICENSEE PROPOSED CORRECTIVE ACTIONS.................................
14 6.
PROPOSED AND PENDING REGULATORY CHANGES INVOLVING MISADMINISTRATION.
15 t
7.
FINDINGS AND CONCLUSIONS............................................
16 APPENDIX A Summary of Therapy Misadministration Re to NRC................................ ported 17 i
APPENDIX B Summary Description of Diagnostic Misadministration l
Reported to NRC Involving the Administration of
)
Millicurie Amounts of Iodine-131......................
19 APPENDIX C List of Previous AE00 Reports on Medical Misadministration.
21 l
i L __
h
)
l MEDICAL MISADMINISTRATIdNS REPORTED TO NRC i
FOR THE PERIOD JANUARY 1986 THROUGH DECEMBER 1986
.)
I i
1.
INTRODUCTION l
This is the sixth annual report documenting AE0D/NAS' review of medical mis-j administrations involving radiopharmaceuticals or radiation from radioisotopes regulated by NRC* that were reported to NRC.
A list of previous AE00 reports is contained in Appendix C.
I Medical misadministration are reported to NRC pursuant to the requirements contained in 10 CFR 35.41 through 10'CFR 35.43.
I The regulations which became effective on November 10, 1980, define a l
misadministration to mean the administration of:
(a) a radiopharmaceutical or radiation from a sealed source other than.
the one intended; (b) a radiopharmaceutical or radiation to the wrong patient; (c) a radiopharmaceutical or radiation by a route of administration other than that intended by the prescribing physician; o
(d) a diagnostic dose of a radiopharmaceutical differing from the pre-scribed dose by more than 50%;
(e) A therapeutic dose of a radiopharmaceutical differing from the prescribed dose by more than 10%; or (f) a therapeutic radiation dose from a sealed source such that errors in the source calibration, time of exposure, and treatment geometry result in a calculated total treatment dose differing from the final prescribed total treatment dose by more than 10%.
i
- The Atomic Energy Act of 1954, as amended in 1974, limits the NRC's regulation of radioactive materials to reactor produced isotopes.
l i
r r ' *
)
E Diagnosticmisadministration,asusedin)JRCregulations,referstothe
_ misadministration of radioisotopes in nuclear medicine studies such as brain _
j scans and bone scans.
Therapy misadministration, as used in NRC regulations, refers to the misadministration of radiation from cobalt-60 teletherapy or radioisotopes in radiation therapy.
i The significance of any event stems from the potential impact of the event on-public health and safety.
One dimension or event risk is the frequency of the event; a second is the magnitude of the potential impact of the event.
AE00 has used the data collected on misadministration for 6 years (1981-1986) to estimate error rates for certain of these misadministration events.
Regarding the frequency of events over the 6 year period, there were 25 therapy misadministration reports that involved teletherapy machines.
In these 25
. events, a total of 77 patients were overtreated or undertreated.
Using patient
~
statistics from the "Fatterns of Care" study of the American College of Radiol-l ogy, the error rate per patient is estimated to be about 0.015%.
For diagnos-l tic misadministration, there were about 2400 reported to NRC over this 6 year period.
A recent study by the Technologist Section of the Society of Nuclear l
Medicine estimated that about 10 million diagnostic procedures are performed annually in the United States.
Since NRC regulates only 22 of the 50 states, it is estimated that about 4 million procedures are performed annually by NRC licensees.
The diagnostic error rate per procedure is estimated to be about 0.01%.
Regarding the magnitude of the potential or actual impact of the event, therapy misadministration are associated with procedures in which large doses of
{
radiation are administered to patients to achieve a therapeutic effect, l
i Diagnostic misadministration are associated with procedures designed to permit I
a diagnosis to be made with little exposure to the patient.
An exception is a diagnostic procedure known as an iodine-131 whole body scan which is discussed in detail below.
i l
I Therapy misadministration have larger potential impacts on the health of the patient than diagnostic misadministration.
Diagnostic misadministration I
that result in the erroneous administration of an iodine-131 whole body scan l
1
3 can result in thyroid doses that are near the therapy range.
Since both teletherapy misadministration and diagnostic misadministration have about the same estimated error rate, the therapy misadministration and some iodine-131 misadministration as a class appear to be individually and collectively more significant than diagnostic misadministration.
AE00, therefore, reviews in detail therapy misadministration reports and diagnostic misadministration reports that involve the administration of therapy amounts of radioisotopes j
(e.g., 1-5 mci of iodine-131 administered for a whole body iodine scan).
Most l
diagnostic misadministration reports are reviewed from a collective or statis-tical viewpoint.
1 This report is a compilation of data on misadministration reported to NRC for the period January 1986 through December 1986 and is divided into the following sections:
General; Therapy and Diagnostic Misadministration Reported to NRC; Personnel Involved in Diagnostic Misadministration; Geographic Distribution of Licensees Reporting Misadministration; Licensee Proposed Corrective Actions; and Proposed and Pending Regulatory Changes Involving Misadministration.
Appendix A contains a summary of therapy misadministration reported to NRC; Appendix B contains a summary of diagnostic misadministration reported to NRC that involved therapy doses of iodine-131, and Appendix C contains a list of.
previous AE0D reports on misadministration.
2.0 THERAPY AND DIAGNDSTIC MISADMINISTRATION REPORTED TO NRC IN 1986 2.1 General For the period January 1986 through December 1986, NRC licensees involved in nuclear medicine and radiation therapy reported 8 therapy misadministration and 438 diagnostic misedministrations.
Table 1 summarizes the statistics for the medical misadministration reported to the NRC for 1986.
For this period, 369 of the approximately 2600 NRC licensees authorized to perform nuclear medicine studies or radiation therapy reported one or more misadministration, a total of 446 reports involving 495 patients.
Of the 446 reports of misadministration for 1986, 438 (98%)
l-l 4
(
reported diagnostic misadministration, and 8 (2%)' reported therapy mis-1 i
administrations, i
s Table 1
.)
1 1
i Medical Misadministration Reported to NRC in 1986 l
I Misadministration Diagnostic Therapy Total l
Humber of Reports 438 8
446 Number of Patients Involved 487 8
495 Number of Licensees Reporting 361 8
369 l
j
-Table 2 compares the 1986 misadministration reports with those of prior years, The number of.. reports', the number of patients involved, and the number of-l' licensees reporting. misadministration are given.
From the table we see that about the same number of diagnostic misadministration were reported for 1986
~
as were reported annually for the previous five years.
The number of therapy j
j.
misadministration-reported in 1986 was about the average number reported annually in'1981-1985 (7 reports).
Table 2 Misadministration Reports for 1981-1986 1
1981 1982 '1983 1984 1985 1986 Therapy Misadministration Reported 10 4
4 12 4
8 Diagnostic Misadministration Reported 430 417 334 397 380 438 Number of Patients 517 451 437 442 410 495 Number of Licensees Reporting 351 355 295 318 293 369
b 2.2 -Therapy Misadministration Eight.th5rapy misadministration were reported in 1986.
Four of.the misadministration involved teletherapy, two. involved brachytherapy and two involved radiopharmaceutical therapy.
Table 3 presents data on the type and probable cause of the misadministration.
Appendix A contains a summary description of each of the misadministration.
Tabic 3 Type and Probable Cause of Therapy Misadministration Reported for 1986 Dose different from prescribed by 110%
(Teletherapy) i Error in dose calculation.
1
)
Wrong patient identified for therapy-1 A teletherapy treatment order for a linear accelerator was mistaken as a teletherapy treatment. order.for a cobalt-60 machine 1
The source head' rotation switch was inadvertently left in the rotation. mode pocition 1
i I
Dose different from prescribed by >10%
(Brachytherapy) l Error in dose calculations 1
The wrong activity brachytherapy sources-were loaded into the source applicator 1
l Wrong radiopharmaceutical (Radiopharmaceutical Therapy) l 3
Misunderstanding of verbal order 1
)
{
Dose different from the prescribed dose by 110%
{
(Radiopharmaceutical Therapy)
Failure to properly screen patient for pregnancy 1
i
}
2.2.1 Teletherapy Misadministration The teletherapy misadministration caused by a dose calculation error involved an error in the treatment time.
The correct treatment was 5.31 minutes but the calculation error resulted in a treatment time of 8.72 minutes.
l 4
L__ ___ __ - _ _
6 The ' teletherapy misadministration involving the wrong patient involved an order for teletherapy treatment that was issued for the wrong patient.
The patient l
l received one treatment of 150 rads. A review of the licensee's and the medical consultant's reports for this misadministration revealed that the following I
factors may have contributed to the cause of the misadministration.
i There was a procedure in the radiotherapy facility requiring that all kidney transplant patients receive a 150 rad treatment.
l The patient invohed in the misadministration had had a recent kidney transplant (albeit during a previous stay at the hospital).
The treatment was performed without a prescription for the treatment from the p'atient's physicien indicating a quality assurance problem (either adequate quality procedures did not exist or the procedures were not followed).
A third teletherapy misadministration resulted from a radiation therapy order for a linear accelerator being mistaken as an order for treatment on a cobalt-60 machine.
A review of the licensee's report on this misadminis-tration indicated a quality assurance problem in that there was not a writter:
order for the cobalt-60 treatment.
The technologist apparently performed the treatment on the cobalt-60 machine because this type of treatment was normally I
i performed on the cobalt-60 machine.
i l
The fourth teletherapy misadministration resulted from the source head rotation switch inadvertently being left in the rotation mode position after a previous patient u s treated.
The next patient whose prescribed treatment called for a fixed head geometry was treated with a rotating head geometry.
Errors in dose calculations have previously been identified as a cause of teletherapy misadministration.
AE00 case study report, AEOD/C505, " Therapy Misadministration Reported to the NRC Pursuant to 10 CFR 35.42," shows that 12 of 16 teletherapy misadministration reported to NRC for the period November 1980 through July 1984 involved errors associated with the dose calculation j
phase of treatment.
The errors involving the wrong patient; a patient being 1
treated with the wrong teletherapy machine (cobalt-60 machine versus a linear accelerator); and the source head rotation switch being left in the wrong 1
7 position are types of errors that have not, previously been identified as causes of teletherapy' misadministration.
Altliough these causes are different from previously identified causes, the general conclusion drawn in the AE00 case study report, that is, the occurrence of therapy misadministration can be reduced by improvements in licensee quality assurance procedures, appears to apply equally to preventing misadministration from the three newly identified causes.
2.2.2 Brachytherapy and Radiopharmaceutical Misadministration The brachytherapy misadministration were caused by 1) an error in dose calculations; and 2) the wrong activity sources being loaded into the source applicator.
In the former case the patient received an underdose of radiation while being treated with 36.8E mg radium equivalent iridium-192 brachytherapy seeds.
In the latter case four 20.63 mg. radium equivalent brachytherapy seeds were loaded into the source applicator instead of four 10.67 mg radium equivalent seeds as prescribed.
In both misadministration cases the primery cause was human error.
There were two radiopharmaceutical misadministration:
one involved the administration of 15 millicuries of phosphorus-32 into the peritoneal cavity below the breastbone in a soluble rather than colloidal form.
The cause of this misadministration was identified as " misunderstanding of verbal prescription."
The other radiopharmaceutical misadministration involved the administration of 12.4 millicuries of iodine-131 (for treatment of hyperthyroidism) to a patient who was between 4 and 6 weeks pregnant, resulting in an estimated 9-12 rad dose to the embryo.
The cause of this misadministration was ascribed to a failure of the licensee to properly screen the patient for pregnancy.
This is l
the only therapy misadministration of this type that we are aware of that has been reported to NRC.
l Except for the cause of the radiopharmaceutical misadministration involving the administration of iodine-131 to a pregnant patient, the causes of the other I
brachytherapy and radiopharmaceutical misadministration were the same as the l
l l
1 1
8 types of causes identified in a previous AE00 report on therapy misadminis-trations (AE0D Report AE0D/C505, " Therapy Misadministration Peported to the NRC Pursuant to 10 CFR 35.42").
The general conclusion drawn from the eralysis of previous therapy misadministration reports, i.e., the occurrence of therapy misadministration can be reduced by improvements in licensee quality assurance procedure, appears to apply equally to preventina all of the brachyther n f and radiopharmaceutical misadministration reported in 1986.
2.3 Diagnostic Misadministration Of the 438 reports of diagnostic misadministration received in 1986, 337 involved the administration of the wrong radiopharmaceutical to a patient and 80 involved the administration of a radiopharmaceuticci to the wrong patfent (95% of the reported misaaministrations were of these two types). The remainino diagnostic misadministration involved eight reports of the wrong route of administration, and 13 reports in which the diagnostic dose of a radiopharmaceutical differed from the prescribed dose by greater then 50%.
The number of reports for.1986 was about 10% higher than the average rate for the six-year period 1981-1986. The annual number of reports ranged from 334 (1983)to438(1986), with an average of 400. Without detailed data on the number of diagnostic procedures that were performed using radioisotopes no conclusion can be drawn about whether the higher number of reported misadministration in 1986 represents a higher rate of misadministration, e constant rate of misadministration from a growing number of procedures or a statistical fluctuation.
In any case, the deviation of the 19R6 number from i
the average was small. The types and causes of the diagnostic nisadminis-l trations were about the same as reported in prior years.
)
i l
Effectively, all of the diagnostic misadministration involving the wrong radiopharmaceutical or the wrong patient stem from human error. With regard to administration of the wrong radiopharmaceutical, the data show that 34 of the 337 events (10%) resulted from receipt of mislabeled doses from a radiopharmacy.
In the remainder of the events, 30 (9%) resulted from misinterpretation of the physicier's order, and errors in the preparation or delivery of doses acccunted for 175 (52%). Arother 98 reports (about P9%),
A
i 9
I had other causes or contained. inadequate information from which to assign a cause.
The dominant'causes for the' wrong patient events were:
the wrong patient's name on the requisition, 17 events (21%); the wrong patient.was delivered to the nuclear medicine department, 13 events (23%); a failure to correlate the l
patient's identification with the study,11 events (14%); and the patient answering to the wrong name, 13 events (16%).
Relatively simple. quality assur-ance procedures (checking the patient's identification against the study and I
l the patient's medical history; asking the patient to state his name) might l
red'uce the frequency of these events.
The remaining two types of diagnostic misadministration, excess dose and wrong l
route of administrations, which represent about 5% of the misadministration had diverse causes.
Table 4 presents data for 1986 on the~ number of diagnostic misadministration by the type and cause of misadministration for misadministration involving l
the wrong radiopharmaceuticals and misadministration involving the wrong patient.
2.3.1 Iodine ~ Misadministration Although most of the diagnostic misadministration involved the administration of the wrong technetium-99m compound to a patient or the administration of a technetium-99m compound to the wrong patient, five diagnostic misadministra-tions involved the administration of near therapy doses of iodine-131 to patients.
These misadministration typically involved events in which the
' technologist performed a whole body iodine scan on the patient, when the referring physician had ordered a thyroid uptake or scan.
The dose for whole body' iodine. scans is typically 1 to 5 millicuries; the typical dose for thyroid uptake study or' scan is 30 microcuries of iodine-131, or 5 to 10 millicuries of technetium-99m.
The " iodine-131 whole body scan" is the only diagnostic study L
where this large amount of iodine-131 is used.
3
.10 Table'4 Type'and Cause of Diagnostic Misadministration Reported to NRC for 1986 Wrong Radiopharmaceutical.
337 Radiopharmaceutical received from radiopharmacy was mislabeled
'34
. Physician's order misinterpreted 30 Errcrs in preparation or delivery of dose:
Mix-up of radiopharmaceutical doses stored in lead pigs 91 Wrong reagent kit usedEto prepare dose 38
' Lead pigs or syringes were mislabeled 21-Mix-up of syringes containing radiopharmaceuticals 25 Other causes:
Nuclear medicine requisition was not checked 8
' Insufficient information 57 Miscellaneous-33 Wrong Patient 80 Patient answered to wrong name 13 Wrong patient's name en requisition 17 Patient's'ID was'not correlated with type of study 11 Wrong patient-delivered to nuclear medicine department 18 Insufficient information 8
Other 13 Total Number Reported 417 The radiation dose to a patient is significantly higher if he is administered a near therapy dose of iodine-131 -instead of a prescribed diagnostic dose of a radiopharmaceutical.
For example, a patient prescribed a 5 millicurie dose of technetium-99m for a " thyroid scan" would receive 0.7 rads to the thyroid; a five millicurie dose of iodine-131 can produce a dose of 4000-9000 rads to the thyroid.
4 During 1986, AE0D undertook an engineering evaluation study of diagnostic misadministration that invcived administering near therapy amounts of iodine-131 to patients.
______m________
11 Preliminary findings of the study were:
1)
The direct causes of 10 of the 14 reported iodine misadministration I
(71%) were ascribed to either the physician's order being misinterpreted by or miscommunicated to the technologist (7 cases),
or the technologist not knowing the correct dosage to administer fcr thyroid scan procedures that involved scanning the chest area i
(3 cases).
2)
Causal factors associated with the misadministration appeared to include:
use of verbal orders for nuclear medicine studies
- use of similar terms by referring physicians and licensees to refer to different procedures lack of technologist training lack of procedures failure of technologist to follow procedure.
3)
The underlying cause of 11 of 14 (79%) of the misadministration appears to have been a lack of licensee control over the adminis-tration of millicurie amounts of iodine-131 to patients.
These 11 misadministration could likely have been prevented, despite the errors that led to the misadministration, if the prescription for the iodine-131 dosage had been verified for each patient before the iodine-131 was administered to the patient.
3.
PERSONNEL INVOLVED IN DIAGNOSTIC MISADMINISTRATION Table 5 shows the distribution of reported diagnostic misadministration for the various personnel involved in the misadministration.
By " involved in the misadministration," we mean the primary personnel associated with the identified cause of the misadministration.
From the table, we see that 312 of the 438 misadministration (71%) involved the technologist.
Other personnel involved were nursing staff, 18 events (4%); clerical personnel / transporters /
aids, etc., 57 events (13%); student technologist, 9 events (2%); nuclear
12 pharmacies, 34 events (8%); and physicians, 2 events (<1%).
The personnel involved with 6 events (about 1%) was not determined.
Ba' sed on the causes identified for most of the misadministration (e.g., simple errors associated with the~ preparation and delivery of radiopharmaceutical doses account for about 52% of the misadministration), it follows that the technologist would be the person associated with most of the misadministration.
Nurses and other personnel. generally contribute to wrong patient events.
f.
Table 5 Personnel Involved in Diagnostic Misadministration Personnel Misadministration Percent Technologist 312 71%
Student Technologist 9
2%
Nursing Staff 18 4%
Radiopharmacy 34 8%
Other Personnel
- 57 33%
Physicians 2
<1%
Not Specified 6
1%
- Clerical personnel / transporters / aides.
4.
GE0 GRAPHIC DISTRIBUTION OF LICENSEES REPORTING MISADMINISTRATION Figures 1 and 1A show the distribution of misadministration reports by states
{
and the distribution of radioisotope facilities, generally hospitals (though-
]
some are private practice clinics), by state for the 22 states regulated by the l
NRC and the District of Columbia.
From the graphs, it can be seen that j
generally states having a higher number of radioisotope-facilities (indicating a higher number of administrations of radiopharmaceuticals) are generally the ones that have reported a higher number of misadministration, although the relation between the number of radioisotope facilities and the number of misadministration reported is not linear.
i q
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DISTRIBUTION OF REPORTS BY STATE 1
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14 5.
LICENSEE PROPOSED CORRECTIVE ACTIONS Table 6 shows the corrective actions proposed by licensees.
The dominant corrective actions involved 1) the retraining of personnel, 197 events (45%);
- 2) implementing new radiopharmaceutical labeling and handling procedures, 75 events (37%); 3) implementing new procedures for patient identification, 22 events (5%); 4) implementing new procedures requiring the technologist to check the patient's chart for the physician's orders, 18 events (4%); and
- 5) reprimand of technologist or other personnel, 27 events (6%).
Since the corrective actions and their effectiveness are licensee specific, a meaningful determination of whether corrective actions were effective would have to focus on the trend in misadministration rates at specific licensees that reported several misadministration.
Because the highest misadministra-tion rate estimated for a sample of licensees was 0.1%, no detailed evaluation of these rates and the associated corrective-actions has been made.
1 Table 6 Corrective Actions Proposed by Licer.sess in 1986 Diagnostic I
Misadministration Reports Type of Corrective Action Number of Reports 1
Implement new procedures requiring technologist to check' patient's chart for physician order 18 Implement new radiopharmaceutical labeling and handling procedures, e.g., color coding, segregation of radiopharmaceuticals, etc.
75 Implement new procedures for patient identification, i.e., ask patient to state or write name, check patient SSAN, use of secondary identification, as well as patient ID bracelet 22 Reinstruct personnel 197 Reprimand technologist or other personnel 27 Improve supervision of personnel 2
1 Not Specified 18
)
Other 79 1
Total 438
l.
15 6.
PROPOSED AND PENDING REGULATORY CHANGES INVOLVING MISADMINISTRATION The Commission's purpose in requiring the submittai of misadministration reports to the NRC is to verify that their causes are properly identified and that licensees implement appropriate corrective actions to prevent recurrence.
If potential generic problems are identified, the Comission notifies other licensees of the generic problem or concerns and assesses the l
need for additional actions, e.g., changes in regulations to reduce the l
occurrence of similar and perhaps more serious events.
l In this regard as a result of the findings in AE0D case study report, AEOD/C505, " Therapy Misadministration Reported to the NRC Pursuant to 10 CFR 35.42," and the findings from the investigation (by Regional Offices) of several recent misadministration, the Commission directed NMSS to undertake rulerraking to require radiotherapy facilities to have quality assurance programs to, among other things, ensure the accuracy of patient deses. An ANPRV for this rulemaking is expected to be published in early 1987.
In addition, the reporting requirements for diagnostic misadministration have been chanced to incorporate a threshold for reporting.
The new reporting requirements are contained in section 10 CFR 35.33 cf the final rule on
" Medical Use of Byproduct Material" (10 CFP Part.s 30, 31, 32, 35, and 40),
issued October 16, 1986 (FR/Vol. 51, Fe. 202). The effective date of the rule is April 1, 1987.
In accordance with the requirements of 10 CFR 35.33 diagnostic misadministra-tions are only to be reported if:
the misadministration involved the use of radioactive material
- not intended for nedical use; the administered dosage was five-fold different from the prescribed dosage; or the critical organ radiation dose is likely to exceed 2 rem or the whole body radiatior, dose is likely to exceed 500 milliren.
- Radioactive materials regulated by PRC pursuant to the Atomic Engery Act of 1954, as amended in 197t..
16 Under the previous reporting requirements for diagnostic misadministration (contained in 10 CFR 35.43, January 1,1986 edition), all diaanostic mis-administrations are required to be reported. The basis for changing the reporting requirements to incorporate a threshold for reporting is that the review of diagnostic misadministration for 1984-1985 has shown that essentially no additionel information on the type and causes of diagnostic misadministration is contained in the date on most (over 90';) of the diagnostic misadministration being reported. That is, most (over 90%) of the e
diagnostic misadministration either irvolve the administration of the wrong radiopharmaceutical to a patient or the administration of a radiopharmaceutical to the wrong patient, and the causes of these types of misadministration have been documented in AEOD reports on medical misadministration.
The new reporting requirements will ensure that diagnostic misadministration that are not in the category described above continue to be reported.
7.
FINDINGS AND CONCLUSIONS Eight therapy misadministration were reported in 1986, a rate not too different from prior years. Both the teletherapy and the brachytherapy nisadministrations that occurred in 1986 might have been prevented by quality
]
assurance procedures directed to verifying dose calculations, type of treatment, and patient identification.
Essentially all of the diagnost3 misadministration for 1986 involved either the administration c' the wrong ndiopharmaceutical or the administration of a radiopharmaceutical to the wrong stient. The number, type, and cause of diagnostic misadministration are about the same as reported for 1985.
The causes reporteC by licensees are generally the same as hav been reported in the past; that it., sir'pb errors associated with 1) preparation of radio-J pharmaceuticals, 2) process ng nuclear medicine requisitions, and 3) patient identification.
In addition, for misadministration involving the adminis-tration of millicerie amounu n' iodine to patients, the primary cause was the failure of licensees to exercise adecuate control over the administration of millicurie amounts of iodire-131 to patients.
4
17
\\
APPENDIX A Summary of Therapy Misadministration Reported to NRC MISAD #1 The wrong patient was administered a 150 rad dose of radiation. The patient had' received a kidney transplant six months prior to the event which appeared to be a factor in the occurrence of the misadministration. At the time of the misadministration the patient had been admitted to the hospital for treatment-of hypertension, however, an order for radiation therapy for the patient was entered into the department's computer erroneously. Tne patient was examined by a radiation therapy physician, who consulted the patient's chart and noted that there was no order in the chart from the attending physician for radiation thera py. The physician decided to proceed with the treatment anyway. The
. protocol for kidney transplant patients at the licensee's facility included radiation therapy for all patients receiving a transplant.
MISAD #2 A 15 millicurie dosage of phosphorus-32 was administered' peritoneally (inte the peritoneal cavity below the breastbone), in soluble rather than colloidal form, to a patient with carcinoma of the kidney with ascites (exces: fluid in the cavity similar to edema).
The misadministration occurred as a result of misunderstanding of verbal prescription. The red blood marrow dose may rance from 350 to 550 rads.
MISAD #3 An error in calculations of a dose to a patient implanted with iridium-192 for therapeutic treatment of threat cancer resulted in an underdose of 700 rads.
A total of 103 iridium-192 seeds with an activity of 36.85 milligrams radium equivalent was used in the implant.
MISAD #4 A patient undergoing radiation treatment to the upper torso with a prescribed dose of 1200 rads was administered a radiation dose of 1968 rads.
The treat-ment plan called for six treatments of 200 rads to the upper torso. The correct exposure time would have been 5.31 minutes, but the calculational error resulted in an exposure time of 8.72 minutes. The long exposure resulted in a l
dosage of 328 rads or approximately 1968 rads over the six treatments instead l
of the 1200 rads. The patient died about a month after the therapy was per-formed.
[The cause of death was not determined at the time of the writino of this report.]
18 I
t MISAD #5 A patient scheduled for treatment on a 15 MV linear accelerator we,s given two treatments on a cobalt 40 teletherapy unit.
The error in treatment apparently resulted from the technologist confusing simulation information for the patient for the linear accelerator with the cobalt unit since similar treatments were frequently done on the cobalt unit.
HISAD #6 l
l A patient who was between 4 and 6 weeks pregnant was treated with 12.4 mci of iodine-131 for Graves disease.
This resulted in an estimated 9-12 rad dose to the embryo. The unintentional radiation dose to the embryo was considered by the licensee to be a possible misadministration. As a result of this event the licensee indicated that better procedures for screening potentially pregnant patients are being implemented.
MISAD #7 A patient undergoing brachytherapy treatment for carcinoma of the uterine cervix as part of a radiation therapy protocol that involved both brachytherapy and teletherapy treatment received an amount of radiation from the brachy-therapy treatment that was more than 10% of ~~the prescribed dose. One area was overtreated by 16% (13,015 rads instead of 11,285 rads) for brachytherapy and teletherapy treatment; and one area was overtreated by 6% (7387 rads instead of 6947 rads) for brachytherapy and teletherapy treatment.
The overtreatment occurred as a result of 20.63 mg radium equivalent sources beina loaded into the source applicator instead of 10.67 mg radium equivalent sources as prescribed. The person who loaded the sources indicated that the l
error resulted from a failure to follow established quality assurance procedures for verifying the accuracy of the source loadirg.
The error was discovered when the sources were unloaded.
MISAD #8 A patient undergoing teletherapy radiation treatment was administered a dose with the treatment geometry different than the prescribed geometry. The patient was being treated with an AECL Theratron-80 and the source head rotation switch was inadvertently left in the rotation mode after a previous patient's treatment. This resulted in the subsequent patient, whose prescribed treatment was for a fixed head geonetry, boing treated with a rotating head geometry.
The administered dose durino the rotation was 42 rads (12 seconds elapsed before the treatment was terrninated).
L
19 APPENDIX B i
Summary Description of Diagnostic Misadministration Reported to NRC Involving the Administration of Millicurie Amounts of Iodine-131-1 MISAD #1 1
Prescribed Radiopharmaceutical Tc-99m MDP Prescribed Dosage 20.0 mci Administered Radiopharnaceutical I-131 Administered Dosage 10.0 mci
==
Description:==
The patient vas mistakenly scheduled for an iodine-131 "whole body scan."
The prescribed study for the patient was "whole body bone scan." The patient was scheduled for the study by telephone. At the time of scheduling, a verbal confirmation for an iodine-131 "whole body scan" was received from the doctor's office. The technologist administered the iodine-131 dose without written orders which was contrary to licensee policy.
MISAD #2 Prescribed Radiopharmaceutical I-1?1 Prescribed Dosage 0.05 uCi Administered Radiopharnaceutical I-131 Administered Dosage 3.09 mci
==
Description:==
1 The technologist misread the physician's consult (order for the study) and administered a patient a 3.09 millicurie dosage of iodine-131 instead of a i
50 microcurie dosece of iodine-131 for a thyroid scan.
The licensee's report did not specify exactly what was misread to cause the technologist to i
administer the high dosage of iodine-131.
I J
l L.
1 20 MISAD #3 Prescribed Radiopharmaceutical I-131 Prescribed Dosage 0.1 - 0.2 uCi Administered Radiopharmaceutical I-131 Administered Dosage 1 mci
==
Description:==
A patient was administered a 1 millicurie dosage of iodine-131 instead of the usual 100-200 microcurie dosage of iodine-131 administered for a thyroid scan.
Based on the doctor's office request and the notation in the schedule book, the technologist thought the doctor was looking for the residual thyroid tissue and administered one millicurie of iodine to a patient.
i MISAD #4 Prescribed Radiopharmaceutical I-131 Prescribed Dosage 0.03-0.05 uCi Administered Radiopharmaceutical I-131 Administered Dosage 1.53 mci
==
Description:==
A patient was administered a 1.53 millicurie dosage of iodine-131 instead of the prescribed dosage of 30 to 50 microcuries of iodine-131. The thyroid scan was to diagnose possible substernal thyroid tissue and the technologist thoucht that a whole body scan was ordered to look for metastatic disease and adminis-tered 1.53 millicuries of iodine-131 to the patient.
MISAD #5 Prescribed Radiopharmaceutical Tc-99m MDP Prescribed Dosage 20 mci Administered Radiopharmaceutical I-131 Administered Dosage 20 mci
==
Description:==
A patient for whom a bone scan was prescribed was administered 20 millicuries of iodine-131 instead of 20 millicuries of technetium-99m methylene-disphos-phonate as prescribed. The bone scan had been prescribed verbally and was not clearly described on the nuclear medicine department's calendar. The technologist interpreted the ambiguous test description as a request for a thyroid scan.
._-_..__-_mm.___m
4 2.
21 APPENDIX C List.of Previous AE0D Reports on Medical Misadministration:
l L
Report on Medical Misadministration for the Period l
November 10, 1980
, September 30, 1981, dated January 1982.
AE0D/N204A, Report on Medical Misadministration for 1981, dated March 1982.
AE00/N2048, Report on Medical Misadministration for January 1981 - June 1982, dated November 1982.
. AE0D/N204C, Report on Medical Misadministration for January 1981 - December 1982, dated July 1983.
AE00/N2049,' Report on Medical Misadministration for January 1983 - June 1983, dated May 1984.
AEOD/N403, Report on Medical Misadministration for July 1983 - December 1983, dated June 1984 AE00/N503, Report on Medical Misadministration for January 1984 - December 1984, dated July 1985.
AE0D/t.602, Medical Misadministration Report -
Medical Misadministration Reported for 1985 and Five ' fear Assessment of 1981-1985 Reports, dated June 1986.
___