ML20207A430
| ML20207A430 | |
| Person / Time | |
|---|---|
| Issue date: | 05/05/1987 |
| From: | Zech L NRC COMMISSION (OCM) |
| To: | Udall M HOUSE OF REP., INTERIOR & INSULAR AFFAIRS |
| Shared Package | |
| ML20207A436 | List: |
| References | |
| NUDOCS 8705190503 | |
| Download: ML20207A430 (30) | |
Text
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9e o-UNITED STATES
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NUCLEAR REGULATORY COMMISSION
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.\\..r l CHAIRMAN May 5, 1987 The Honorable Morris K. Udall, Chairman Subcommittee on Energy-and the Environment Committee on Interior and Insular Affairs United States House of Representatives Washington, D. C. 20515-
Dear Mr. Chairman:
I am enclosing the Commission's responses to your questions of April 9, 1987, concerning federal indemnification of persons who produce or use radiopharmaceuticals.
We would note that the amendment under discussion would, if enacted, have a substantial impact on NRC. The amendment would require NRC to enter into and administer about 7,800 indemnity agreements. The amendment would also require unlimited Governmental indemnity for all liability, including liability for medical malpractice, for use of radioactive materials involved in the practice of nuclear medicine. The only limit on the Government's indemnity is that claims smaller than $500,000 would not be covered. We do not have the data to accurately assess the budgetary impact on the Federal Government for such a broad program of Federal indemnity.
Sincerely, N.
Lando W. Zech, r.
Enclosure:
As stated cc: The Honorable Manuel Lujan 8705190503 870511 PDR COMMS NRCC CORRESPONDENCE PDR w
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,g QUESTION 1.
a.
How many nuclear pharmacies or nuclear medicine departments of hospitals or clinics licensed by the Commission would the amendment require the Commission to indemnify?
ANSWER.
The number of affected licensees would depend on the scope of the amend-ment. Many different kinds of licensees use byproduct material in patient care services. The NRC has licensed 1800 medical institutions, 500 private practitioners, 20 mobile nuclear medicine services, 300 teletherapy services, 100 in vitro blood testing laboratories, 40 nuclear pharmacies,10 radiophar-maceutical manufacturers, and 10 sealed source manufacturers that possibly would be affected by adding an indemnification section.
4/9/87 UDALL Q1
, QUESTION 1 (Continued),
b.
In how many States are nuclear pharmacies and nuclear medicine departments licensed by the State rather than the NRC?
(Please provide a list of these States.)
ANSWER.
There are twenty-eight (28) Agreement States which license the possession and use of byproduct material by nuclear pharmacies and r.uclear medicine departments. A list of these states is enclosed.
Enclosure:
As stated 4/9/87 UDALL Q1
QUESTION 18. (continued) e e
AGREEMENT STATES Became an Agreement State On-10/1/66 Alabama 205-261-5313 Mr. Aubrey Godwin, Chief Bureau of Radiological Health Environmental Health Adminis.
Room 314, State Office Building l
Montgomery, Alabama 36130 5/15/67 Arizona 602-255-4845 Mr. Charles F. Tedford, Director Arizona Radiation Regulatory Agency 4814 South 40th Street Phoenix, Arizona 85040 7/1/63 Arkansas 501-661-2301 Ms. Greta Dicus, Director Div. of Radiation Control and l
Emergency Management Arkansas Dept. of Health 4815 West Markham Little Rock, Arkansas 72205-3867 l
l 9/1/62 California 916-445-0931 Licensing & Inspection i
Mr. Joe Ward, Chief - 916-322-2073 Radiologic Health Branch Department of Health 714 P Street, Room 498 Sacramento, California 95814 l
2/1/68 Colorado 303-331-8480 Amended Mr. Albert J. Hazle Director 4/20/82 Radiation Control Division Office of Health Protection l
Department of Public Health 4210 East lith Avenue Denver, Colorado 80220 i
Enclosure to Q1b
QUESTION 18 (continued) t t
7/1/64 Florida 904-487-1004 Lyle E. Jerrett, Ph.D., Of rector Office of Radiation Centrol Dept. of Health & Rehabilitative Service 1317 Winewood Blvd.
Tallahassee, Florida 32399-0700 12/15/69 Georgia 404-894-7610.
Thomas E. Hill, Acting Director Radiological Pealth Section Departrent of Human Resources Room 600 878 Peachtree Street Atlanta, Georgia 30309 10/1/68 Idaho 208-334-5879 Mr. Mark Torf, Manager Compliance Section Idaho Department of Health ard Welfare Statehouse Boise, Idaho 83720 1/1/86 Iowa 515-281-4928 Mr. John A. Eure, Director Environmental Health Section Iowa Department of Health Lucas State Office Building Des Moines, Iowa 50319 i
1/1/65 Kansas 913-862-9360 Ext. 284 Mr. David Ramono, Manager Bureau of Air Quality and Radiation Control Dept. of Health & Environment Forbes Field, Building 321 Topeka, Kansas 66620 1
3/26/62 Kentucky 502-564-3700 Mr. Donald Hughes, Manager Radiation Control Branch Cept. of Health Services Cabinet for Human Resources i
275 East Pain Street Frankfort, Kentucky 40621 W'
QUESTION 18.(continued) a 5/1/67 Lcuisiana 504-925-4518 FTS-687-0598 Mr. William H. Spell, Administrator Nuclear Energy Division-Office of Air Quality & Nuclear Energy P. O. Box 14690 Baton Rouge, Louisiana 70898 1/1/71 Maryland 301-333-3130 Mr. Roland G. Fletcher, Director Division of Radiation Control Dept. of Health and Mental Hygiene 201 W. Preston Street Baltimore, Maryland 21201 7/1/62 Mississippi 601-354-6657/6670 Mr. Eddie S. Fuente, Director Division of Radiological Health State Board of Health 3150 Lawson Street P. O. Box 1700 Jackson, Mississippi 39215-1700 10/1/66 Nebraska 402-471-2168 Mr. Harold Borchert Director Division of Radiological Health State Department of Health 301 Centennial Mall South P. O. Box 95007 Lincoln, Nebraska 68509 7/1/72 Nevada 702-885-5394 l
Mr. Stanley R. Marshall, Supervisor Radiological Health Section j
Health Division Department of Human Resources 505 East King Street, Room 202 Carson City, Nevada 89710 5/16/66 New Hampshire 603-271-4587 Ms. Diane Tefft, Program Manager Radiological Health Program Bureau of Environmental Health Division of Health Services Pealth & Welfare Bldg., Hazen Drive Concord, New Hampshire 03301
QUESTION 18. (continued) 5/1/74 New Mexico 505-827-2959 Mr. Michael Brown, Chief Radiation Protection Bureau Environmental Improvement Div.
Department'of Health and Environment P. O. Box 968 Santa Fe, New Mexico - 87504-0968 10/15/62 New York 518-474-2190 Mr. Jay Dunkleberger, Director Bureau of Nuclear Operation New York State Energy Office' Agency Building 2 2 Rockefeller Plaza Albany, New York 12223 8/1/64 North Carolina 919-733-4283 Mr. Dayne H. Brown. Chief Radiation Protection Section Division of Facility Service 701 Barbour Drive Raleigh, North Carolina 27603 9/1/69 North Dakota 701-224-2348 Mr. Dana Mcunt, Director Div. of Environmental Engineering Radiological Health Program State Department of Health 1200 Missouri Avenue Bismarck, North Dakota 58502-5520 7/1/65 Oregon 503-229-5797 Mr. Ray Paris, Manager i
Radiation Control Section j
Dept. of Human Resources 1400 South West Fifth Avenue Portland, Oregon 97201 1/1/80 Rhode Island 401-277-2438 Mr. James E. Hickey, Chief Div. of Occupational Health and Radiation Control i
Rhode Island Dept. of Health Cannon Building 75 Davis Street Providence, Rhode Island 02908 I
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o QUESTION 1B.(contir.ued) 9/15/69 South Carolina 803-734-4700-Mr. Heyward Shealy, Chief Bureau of Radiological Health State Department of Fealth and Environmental Control J. Marion Sims Building 2600 Bull Street Columbia, South Carolina' 29201 9/1/65 Tennessee 615-741-7812 Mr. Michael H. Mobley, ' Director Division of Radiological Health Department of Public Health Cordell Hull State Office Building Nashville, Tennessee 37219 3/1/63 Texas 512-835-7000 Mr. David K. Lacker, Chief Bureau or Radiation Control Amended Texas Department of Health 3/24/82 1100 W. 49th Street (mail only)
Austin, Texas 78756 4/1/84 Utah 801-538-6734 Mr. Larry Anderson, Director Bureau of Radiation Control State Department of Health 298 North 1460 West P.0 Box 16700-0700 Salt Lake City, Utah 84116-0700 12/31/66 Washington 206-753-3459 Mr. Terry R. Strong, Head Office of Radiation Protection Xmended Department of Social and Health 2/19/82 Services Mail Stop LE-13 Airdustrial Park j
Olympia, Washington 98504 l
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) QUESTION 1-(Continutd) y.g+
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.How many nuclear. pharmac'ies'and nuclear medicine i
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departments that are. licensed by Agreement. States would l
the amenament requireLthe Commission to indemnify?-
ANSWER.
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'1 The amendment'would require the Commission:to indemnify.approximately L5,000 nuclear pharmacies and nuclear medicine departments.that are' licensed' by the 28 Agreenient' States.
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7 QUESTION 1 (Continued) 4-
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How many NRC employees (FTEs) would be required to administer the indemnification program mandated by the.
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' ANSWER.
i Although it is,too early to provide a firm estimate, it appears that since we wculd anticipate having to enter into over 7,800 indemnity agreements-with NRC l
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and Agreement State byproduct: material licentees, we estimate that eight (8)'
additional FTEs would be required to initiate the program and six (6) FTEs to administer these additional responsibilities on an orgoing basis.
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' QUESTION 2.
a..
What types of situations oces the Commission classify as a " misadministration"?
ANSWER.
The term " misadministration" is defined in 935.2 of 10 CFR Part 35. " Medical Use of Byprcduct Material " Misadministration means the administration of:
(1) A radiopharmaceutical or radiation from a sealed source other than the one intended; (2) A radiopharmaceutical or radiation to the wrong patient;.
(3) A radiopharmaceutical or radiation by route of administration other than that intended by the prescribing physician; (4) A diagnostic dosage of a radiopharmaceutical differing from the prescribed dosage by more than 50 percent; (5) A therapy dosage of a radiopharmaceutical differing from the prescribed dosage by more than 10 percent; or (6) A therapy radiation dose-from a sealed source such that errors in the source calibration, time of exposu'/e, and treatment geometry result in a calculated total treatment dose differing from the final prescribed total treatment dose by more than 10 percent.
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4/9/87 UDALL.Q2
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QUESTION 2.-(Continued).
b.
Would the. federal indemnity' under paragraph u.(1) of the amendment apply to "misadministrations" of nuclear-T medicine'(e.g., overdoses) or only to unintended releases of: radioactive materials?
ANSWER.
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An " administration" is an intentional release of radioactive material.
By definition, a " misadministration" may be an overdose due. to an unintsnded release of radioactive material. Notwithstanding._the fact that a single specific event characterized as an " unintended release of radioactive -
materials" also may constitute a " misadministration," both events would appear' to be covered by federal indemnity under subsection u.(1), provided, of course, that they occur in'the practice of nuclear medicine. Under the pro-
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visions of the proposed amendment, the agreements of indemnification would cover public liability "from nuclear incidents'or other events in which any>
radioactive materials are involved in the practice of nuclear medicine."
[Emphasisadded.]
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- QUESTf0N 2. (Ccntinued)
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c.
Would the bar to-recovery under paragraph u.(2) apply.
to "misadministrations" or onli to unintended. releases?
ANSWER.
Subsection u(2) of the amendment would lead to anomalous results because, while some misadministrations can be regarded as " emissions of radioactive
~
materials" within the meaning of subsection u(2), NRC has not prescribed any:
numerical levels for permitted releases to patients in the diagnosis or treatment of patients. See 10 CFR 20.107. Thus State courts,which would most likely be called upon to apply subsection u(2), may reasonably conclude that no release to the patient during the course of diagnosis or treatment, no matter how large, can be actionable.
-4/9/87 UDALL~Q2
, QUESTION 2 (Continued),
d.
Would the bar to recovery under paragraph u.(2) operate to prevent patients from recovering for injuries caused by medical malpractice?
ANSWER.
Yes. See response to Question 2.c.
4/9/87 ' DALL Q2 J
,OUESTION 2 (Continued),
Would the federal. indemnity under paragraph 0.(1) apply e.
to malpractice claims?
ANSWER.
Yes.
4/9/87 UDALL Q2
. QUESTION 3 a.
.Approximately how.many misadministrations and unintended releases occur at nuclear ' pharmacies' or nuclear medicine departments licensed by. the NRC per year?
ANSWER.
Diagnostic misadministration, as used in NRC regulations, refers to the misaaministration of radioisotopes in nuclear medicine studies such as brain 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.
Regarding the frequency of events, over a six year period ending December 1986, 42 therapy misadministrations were-reported or an approximate annual average of 7.
For diagnostic.
~
misadministrations there were 2396 reported or an approximate annual average of 400. A recent annual report on misadministrations is enclosed.
The NRC estimates that each year approximately 2. percent of its medical use licensees unintentionally release byproduct material. However, these releases almost always are composed of one-time, sub-microcurie: amounts of short half-life byproduct material that is in NRC's lowest hazard classification.
Therefore, the 'iRC does not expect =that any of these releases poses a hazard to the public health and safety.
Enclosure:
As stated q
l 4/9/87 UDALL Q3'
0UESTION 3 (Continued),
0 b.
Approximately how many misadministrations and unintended releases occur at nuclear pharmacies or nuclear medicine departments licensed by Agreement States per year?
ANSWER.
The Commission does not have data en this aspect, because not all Agreement States have misadministration reporting requirements.
It should be noted that the Commission has made misadministration reporting a matter of compatibility for Agreement States.
The Agreement States will have three years from April 1,1987, in which to adopt this requirement in order to remain compatible with NRC regulations.
There were approximately 450 medical misadministrations reported to the NRC during 1986 by its 2500 medical licensees. Since there are approximately 5,000 medical licensees in the Agreement States, one could infer a yearly medical misadministration rate of approximately 900 if one assumed that the number of incidents is directly proportional to the number of licensees.
The NRC does not have data regarding unintended releases from Agreement State nuclear medicine or nuclear pharmacy facilities except as they meet the criteria for Abnormal Occurrence Reporting.
The NRC receives reports of abn,rmal occurrences in Agreement States and combines them with similar NRC licensee data in a quarterly report to Congress. Not all unintended releases meet the abnormal occurrence report criteria and thus complete data on unintended releases of radicactivity from Agreement State licensees are not available. We have reviewed the last 2 years of Abnormal Occurrence Reports and have not fcund any unintended releases from Agreement State nuclear medicine facilities or nuclear pharmacies.
4/9/87 fbOALL Q3
, QUESTION 3 (Continued),
c.
Approximately how many such misadministrations and unintended releases, both at NRC licensees and at Agreement State licensees, could be expected to result in public liability in excess of $500,000 per year?
ANSWER.
We have no basis for answering this question.
4/9/87 UDALL_Q3
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QUESTION 4.
a.
Do any Agreement States impose emission standards for nuclear medicine that are more stringent than those of the NRC? If so, please identify the states.
ANSWER.
All Agreement States have adopted regulations which have equivalent standards to 10 CFR Part 20. There may be, however, individual cases in which an Agreement State could impose a more stringent emission requirement by license condition because of particular local circumstances. We do not have data on this aspect.
1 4/9/87 UDALL Q4 l
., QUESTION-4.(Continued)_
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b.
Would paragraph u.(2) of' the amendment bar victims from j
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suing a licensee if the licensee was within an
-inapplicable but more lenient NRC standard, even though the licensee violated an applicable.and more stringent state standard?-
ANSWER.
A' literal reading of proposed subsection u.(2) leads one to conclude that, in
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general, if a nuclear medicine licensee is in compliance with'NRC regulations, it is exempt from public liability resulting from emissions of radioactive material. As presently drafted, proposed subsectior. u.(2) does not appear to apply to Agreement State licensees. This drafting defect leads to an internal inconsistency within proposed.section u. regarding the section's.
applicability to Agreement State licensees.
4/9/87-UDALL Q4J
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- QUESTION 5.
Does paragraph u.(1) subject lthe federal government'to unlimited. liability'in view of the fact that the_ liability limit of section 6 of H.R. -1414 applies only'to. persons required to maintain financial protection and the amen' ment d
exempts nuclear medicine licensees from the financial-protection requirement?-
ANSWER.-
As presently drafted, subsection u.(1) read in connection the limitation of -
liability section of H.R.1414 would subject the federal government to the potential of unlimited liability. This interpretation stems from the fact that the-limitation of liability provisions of section 6 of ~ H.R.1414 only. apply to persons required to maintain financial protection. A similar situation would exist with respect to nonprofit educational institutions licensed under section 170 k., except for the fact that-the federal goverr. ment indemnity is limited
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to $500,000,000 by the provisions of section-170 k.
4/9/87 UDALL Q5
OVESTION 6.
Are nuclear medicine licensees able to obtain any insurance against public liability either for misadministration or unintended releases?
ANSWER.
Although we do not address the issue directly in our regulatory program to ensure public health and safety, the NRC staff assumes that the malpractice insurance that most physicians and hospitals carry covers " misadministration" by a licensee. We are also uncertain as to whether nuclear medicine licensees purchase insurance for unintended releases. However, based on informal interviews with some licensees, the staff assumes that, if it is available at all, " environmental" insurance is very costly, that is to say in approximately the same premium range as malpractice insurance. This question would be better addressed to associations or trade groups representing hospital and other medical byproduct materials licensees.
4/9/87 UDALL Q6
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j-QUESTION 7.~
If insurance is not-available,~are~there other alternatives
-for these < licensees to utilize that'would provide liability coverage?
ANSWER.
Yes.
In a recently prepared report.for the Commission staff by Battelle Northwest on the related question of onsite clean up for' accidental releases of radioactive material, " Regulatory Analysis of Proposed Financial Assurance;
' Requirements for Materials. Licensees," April 1987, a -number of alternatives other than insurance' were discussed. These include the creation of_c'aptive insurance companies, the creation of trust funds, the: formation'of_ risk:
retsntion groups, or other financial mechanisms such as surety bonds or, standby letters of credit. None of these alternatives are presently being i
utilized so it is difficult to determine their advantages or disadvantages.
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QUESTION 8.
Has any nuclear medicine licensee ever been held lieble for any uninsured liability resulting from the practice of nuclear medicine?
ANSWER.
- The NRC staff responsible for medical use program oversight is not aware of any such case nor has any licensee ever brought such a situation to the staff's attention.
4/9/87 UDALL Q8
QUESTION 9.
Has any nuclear medicine licensee ceased practicing nuclear medicine because of the threat of uninsurable liability?
ANSWER.
The NRC staff responsible for medical use program oversight is not aware.of any such case.
4/9/87 UDALL Q9
QUESTION 10.
Has any nuclear medicine licensee ever, either formally or informally, requested NRC indemnification under the existing Price-Anderson Act?
ANSWER.
The NRC staff responsible for medical use program oversight is not aware of any case where a nuclear medicine licensee has requested, either formally or informally, such indemnification.
4/9/87 UDALL Q10
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' QUESTION 11.
What would be the impact onithe-NRC.if it were~ required to indemnify these types of licensees?
ANSWER.
The NRC staff has examined the following facets-of this question: 'the scope of coverage; the number of events expected each year; and the cost of managing the indemnification program.
The scope of coverage in the draft statutory language supplied does not clarify which portion of the medical use service industry-is to be indemnified. Many different kinds of licensees use byproduct material in patient care services as noted in response to question 1.a.
The impact on the NRC depends on the size of the: indemnification program but, irrespective of the exact size of the program, it appears that the impact would be substantial.
As a gauge of the number of incidents that may initiate indemnification action, the NRC notes that an average of 7 therapy misadministration events are reported each year.
It-is possible that indemnification action would be initiated for each reported event.
4/9/87.UDALL-Q11
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, UESTION 11.
(Continued) Q The cost of managing the indemnification program would depend on the scope of the statute. At present, the Commission has'in effect approximately 145 indemnity agreements.
If this amendment were retained, the Commission would be required to enter into more than 7,800 indemnity agreements, both with NRC byproduct materials licensees as well as with Agreement State licensees. As was stated in the answer to Question 1.d., the NRC would probably need six to eight additional FTEs to administer such a program.
It would also have to enter into claims adjudication contracts with outside companies. We would anticipate significant expenses involved in investigating, settling and defending claims.
Since H.R. 1414 presently precludes utilizing Price-Anderson funds to pay these expenses, separate appropriations would-be required.
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4/9/87 U0ALL Q11
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~' QUESTION 12.
To your knowledge,-do any hospitals with nuclear medicine Ldepartments self-insure for mal' practice or other types'of claims?
ANSWER.
-m The NRC staff has no information on.this matter because the NRC has-historically not examined-the business affairs of byproduct material. license.
j applicants unless those affairs are directly related to'the. applicant's
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ability.to assure the safe receipt,.use, tran'sfer, decommissioning, and disposal-of byproduct material..
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QUESTION 13.
Would the amendment-require Federal indemnity for activities not licensed by the NRC?
ANSWER.
The amendment would clearly require the federal government to indemnify those nuclear medicine licensees who are licensed by Agreement States.
4/9/87 UDALL Q13
AE0D/N702 MEDICAL MISADMINISTRATION REPORT MEDICAL MISADMINISTRATIONS REPORTED TO NRC FOR THE PERIOD JANUARY 1986 THROUGH OECEMBER 1986 by the Office for Analysis and Evaluation of Operational Data Nonreactor Assessment Staff March 1987 Prepared by:
Samuel L. Pettijohn This report characterizes the Medical Misadministration database maintained the Office 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 creas.
ENCLOSURE TO Q3A J 70%M WY
- O TABLE OF CONTENTS
'_ P_ age 1.
INTR 000CTION.........................................................
1 2.
THERAPY AND DIAGNOSTIC MISADMINISTRATIONS REPOR 3
2.1 General.........................................................
3 2.2 Therapy Misadministrations......................................
5 2.2.1 Teletherapy Misadministrations...........................
5 2.2.2 Brachytherapy and Radiopharmaceutical Misadministrations.
7 2.3 Diagnostic Misadministrations...................................
8 2.3.1 Iodine Misadministrations................................
10 PERSONNEL INVOLVED IN MISA0 MINISTRATIONS...............
3.
11 4.
GEOGRAPHIC DISTRIBUTION OF LICENSEES REPORTING 12 5.
LICENSEE PROPOSED CORRECTIVE ACTIONS......................
14 6.
PROPOSED AND PENDING REGULATORY CHANGES INVOLVI 15 7.
FINDINGS AND CONCLUSIONS.............................................
16 APPENDIX A Summary of Therap to NRC...........y Misadministrations Reported 17 APPENDIX B Summary Description of Diagnostic Misadministrationt Reported to NRC Involving the Administration of Millicurie Amounts of 'odine-131...............
19 APPENDIX C List of Previous AE00 Reports en Medical Misadministrations.....
21
MEDICAL MISADMINIS7 RATIONS REPORTED TO NRC-FOR THE PERIOD JANUARY 1986 THROUGH OECEMBER 1986 1.
INTRODUCTION This is the sixth annual report documenting AE00/NAS' review of medical mis '
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.
Medical misadministrations are reported to NRC pursuant to the requirements contained in 10 CFR 35.41 through 10 CFR 35.43.
The regulations which became effective on November 10, 1980, define a misadministration to mean the administration of:
(a) a radiopharmaceutical or radiation from a sealed source other than the one intended; 4
(b) a radiopharmaceutical or radiation to the wrong patient; i
(c) a radiopharmaceutical or radiation by a route of administration other than that intended by the prescribing phpsician; (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
,rescribed dose by more than 10%; or p
(f) a therapeutic radiation dose from a sealed source such that errors in the source calibration, time of exposure, and treatment geometry 4
result in a calculated total treatment dose differing from the final prescribed total treatment dose by more than 10%.
- The Atomic Energy Act of 1954, as amended in 1974, limits the NRC's regulation of radioactive materials to reactor produced isotopes.
2 Diagnostic misadministration, as used in NRC regulations, refers to the misadministration of radioisotopes in nuclear medicine studies such as brain 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.
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 t.he event.
.AE00 has used the data collected on misadministrations 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 " Patterns of Care" study of the American College of Radiol-ogy, the error rate per patient is estimated to be about 0.015L For diagnos-tic misadministrations, there were about 2400 reported to NRC over this 6 yea period.
A recent study by the Technologist Section of the Society of Nuclear 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. 01L Regarding the magnitude of the potential or actual impact of the event, therap misadministrations are associated with procedures in which large doses of radiation are administered to patients to achieve a therapeutic effect.
Diagnostic misadministrations are associated with procedures designed to permit 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.
Therapy misadministrations have larger pctential impacts on the health of the patient than diagnostic misadministrations.
Diagnostic misadministrations that result in the erroneous 3 einistration of an iodine-131 whole body scan
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can result in thyroid doses that are_near the therapy range.
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Since both teletherapy misadministrations and diagnostic misadministrations have about same estimated error rate, the therapy misadministrations and some iodine-131 misadministrations as a class appear to be individually.and collectively more significant than diagnostic misadministrations. hE00, therefo're, reviews 'in detail therapy misadministration reports ~and diagnostic misadministration reports that involve the administration of-therapy amounts of radioisotopes (e.g., 1-5 mci of iodine-131 administered for a whole body iodine scan).
Most diagnostic misadministration reports are reviewed from a collective or statis-tical viewpoint.
.This. report is a compilation of data on misadministrations reported to NRC the period January 1986 through December 1986 and is divided into the sections:
General; Therapy and Diagnostic Misadministrations Reported to NRC; Personnel Involved in Diagnostic Misadministrations; Geographic Distribution of Licensees Reporting Misadministrations; Licensee Proposed Corrective A i
and Proposed and Pending Regulatory Changes-Invalving'Misadministrations.
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Appendix A contains a summary of therapy misadministrations reported to Appendix B contair.s a summary of diagnostic misadministrations reported to l
that involved therapy doses of iodine-131, and Appendix C contains a list of previous AE0D reports on misadministrations.
2.0 THERAPY AND DIAGNOSTIC MISADMINISTRATIONS REPO 2.1 General J
For the period January 1986 through December 1986, NRC licensees involv nuclear medicine and radiation therapy reported 8 therapy misadministrations and 438 diagnostic misadministrations.
1 Table 1 summarizes the statistics for the medical misadministrations repor to the NRC for 1986.
For this period, 369 of the approximately 2600 NRC 1
licensees authorized to perform nuclear medicine studies or radiation reported one or more misadministrations, a total of 446 reports involving 495 patients.
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Of the 446 reports of misadministrations for 1986, 438 (98*.)'
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4 reported diagnostic misadministrations, and 8 (2%) reported therapy mis-administrations.
Table 1 Medical Misadministrations Reported to NRC in 1986 Misadministration Diagnostic Therapy
_ Total Number of Reports 436 8
446 Number of Patients Involved 487 8
495 Number of Licensees Repcrting 361 8
'369 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 licensees reporting misadministrations are given.
From the table we see that about the same number of diagnostic misadministrations were reported for 1986 as were reported annually for the previous five years.
The number of therapy misadministrations reported in 1986 was about the average number reported annually in 1981-1985 (7 reports).
Table 2 Misadministration Reports for 1981-1986 1981. 1982 1983 1984 1985 1986 Therapy Misadministrations Reported 10 4
4
'12 4
8 Diagnostic Misadministrations Reported 430 417 334 397 380 438 Number of Patients 517 451 437 442 410 495 Number of Licensees Reporting 351-355 293~
318.293 369 r-e
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Eight therapy misadministrations were reported in 1986.
q Four of the' o^-
misadministratie,r,s involved teletharapy, two involved brachytherapy and two 4
s involved radiopharmaceutical ther&py. Table 3 presents data or the type and b
probablecauseof.themisadminisIrations.
Appendix A contains a summary description of-eac(h(of the misadmipistrations.
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Type and Probabje Cause of Therapy Misa(a',ninistrations
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Reported for 1986 s
ij
,, s N
l Dose differen (from,orescribed by >10T t
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(Teletherapy) j
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, /[
Error ik dd5i calculations / 3.
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4 g
Wrong p5tienIt identiffs foY,'hrrapy r
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A telether,apy treatmenh(order f'tr a' linear accelerator was m.litaken as a teletherapy
. treatment order f4r a cobalt '60 machine The source head rotation switch was 1-inadvertently left in the rotation icode
[
position N
l 1
s Dosedifferentfrompres'cribed'dyfjfk0%
(Brachytherapy) g Error in dose calculations l\\
The wrong activity brachytherapy sources i
were loaded into the source applicator
(
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1 Wrong radiopharmaceutical (Radiopharmaceutical Therapy)
Y, '
i Misunderstandingof(verbalorder e
i y'x,.g, 1
r i
Dose differen; from the prescribed dose by >10%
,3 (Radiopharmaceutical Therapy) l
' Failure to properly screen patient for pregnailcy )
1
~~
t c' g 2.2.1 Teletherapy Misadmi,nistrations The teletherapy misadministration caused by a dose calcula i'on erro' involved i
r an error in the treatment tirne.
The correct treatment was'5.~31 mibq ydes but the calculation error resulted in a treatment time of 8.72 minutes, f
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6 The teletherapy misadministration involving the wrong patient involved an order.
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for teletherapy treatment that was issued for the wrong patient.
The patient 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 factors may have contributed to the cause of the misadministration.
There was a procedure in the radiotherapy facility requiring that all kidney transplant patients receive a 150 rad treatment.
The patient involved 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 patient's physician 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 written order for the cobalt-60 treatment.
The technologist apparently performed the treatment on the cobalt-60 machine because this type'of treatment was normally performed on the cobalt-60 machine.
The fourth teletherapy misadministration resulted from.the source head rotation switch inadvertently being left in the rotation made position after a previous patient was 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 misadministrations.
AE00 case study report, AE00/C505, " Therapy j
Misadministrations Reported to the NRC Pursuant to 10 CFR 35.42," shows that 12 of 16 teletherapy misadministrations reported to NRC for the period November:
1980 through July 1984 involved errors associated with the dose calculation phase of treatment.~
The errors involving the wrong patient; a patient being treated with the wrong teletherapy machine (cobalt-60 machine versus a linear accelerator); and the source heid rotation switch being left in the wrong
d t
7 position are types of errors that have not previously been identified as causes of_ teletherapy misadministrations.
Although these causes are different from previously identified causes, the general-conclusion drawn in the AE00 case' study report, that is, the occurrence'of therapy misadministrations can be reduced by improvements in licensee quality assurance procedures, appears to apply equally to preventing misadministrations from the three newly identified-causes.
2.2.2 Brachytherapy and Radiopharmaceutical Misadministratio'ns The brachytherapy misadministrations 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 36.85 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 primary cause was human error.
There were two radiopharmaceutical misadministrations:
one involved the admireistration of 15 millicuries of phosphorus-32 into the peritoneal cavity below the breastbone in a soluble rather than colloidal form.
c The cause of this misadministration was identified as " misunderstanding of verbal prescription."
The other radiopharmaceutical mistdministration involved the'administrationiof 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 i
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 the only therapy misadministration of this type that we are aware of that has
- been reported to NRC.
1 1
Except for the cause of the radiopharmaceutical. misadministration involving the administration of iodine-131 to a pregnant patient, the causes of the other brachytherapy and radiopharmaceutical misadministrations were the same as the t
\\
l l
1
S types of causes identified in a previous AE00 report on therapy misadminis-trations (AE00 Report AE00/C505,'" Therapy Misadministrations Peported to the NRC Pursuant to 10 CFP 35.42"). The general conclusion -drawn from the eralysis of previous therapy nisadministration reports, i.e...the occurrence of therapy misadministrations can be reduced by improvements in licensee.auality assurance procedure, appears to'apoly equally to preventing all of the brachytherapy and radiopharmaceutical misadministrations reported in 1986.
2.3 Diagnostic Misadministrations Of the 438 reports of diagnostic'misadministrations received in 1986, 337
~
involved the administration of the wrong radiopharmaceutical to.a patient and 80 involved the administration of a radiopharmaceutical to.the wrong patient-(95% of the repcrted misadministratians were of these two types). The remainino diaonostic misadministrations 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) to 438 (1986), with an average of 400. Without detailed data on the number of diagnostic procedures that were perfomed using radioisotopes no conclusion can be drawn about whether the higher number of repnrted misadministrations 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 19A6 number from the average was small. The types and causes of the diagnostic misadminis-trations were about the same as reported in prior years.
Effectively, all of the diagnostic misadministrations involving the wrong radiophazmaceutical or the we'.g patient stem from human error. With regard to administration of the wrong radiopharmaceutical, the data shcw that 34_ of the 337 events (10i'.) resulted from receipt of mislabeled doses from a radiopharmacy.
In the remainder of the events, 30 (9%) resulted from misinterpretation of the physiciar's ' order, ar.d errors in the preparation or delivery-of doses acccunted for 175 (52%). Arother 98. reports. (about 29%),.
g 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 3
the nuclear medicine department,18 events (23%); a failure to correlate the 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 the patient's medical history; asking the patient to state his name) might reduce the frequency of these events.
The remaining twc types of diagnostic misadministrations, excess dose and wrong route of administrations, which represent about 5% of the misadministrations had diverse causes.
Table 4 presents data for 1986 on the number of diagnostic misadministrations by the type and cause of misadministration for misadministrations involving the wrong radiopharmaceuticals and misadministrations involving the wrong patient.
2.3.1 lodine Misadministrations Although most of the diagnostic misadministrations 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 misadministrations 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 where this large amount of iodine-131 is used.
710 Table 4-Type and Cause of Diagnostic Misadministrations Reported to NRC for 1986-Wrong Radiopharmaceutical 337 Radiopharmaceutical received from radiopharmacy was m.islabeled 34 Physician's-order misinterpreted
'30 Errors in_ preparation or 1elivery of dose:
' Mix-up of radiopharmaceutical doses stored in lead pigs 91 Wrong reagent kit used to prepare dose 38 Lead pigs or syringes were mislabeled 21 Mix up of syringes conte.ining radiopharmaceuticals 25 Other causes:
Nuclear medicine requisition.was not checked Insufficient information 8
Miscellaneous 57 33 Wrong Patient 80 Patient answered to wrong name 13 Wrong patient's name on requisition 17 Patient's ID was not correlated with type of study 11 Wrong patient delivered to nuclear medicine department Insufficient information 18 Other-8 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.
l During 1986, AEOD undertook an engineering evaluation study of diagnostic misadministrations that involved administering near therapy amounts of q
iodine-131 to patients.
j l
-11 Preliminary findings of the sttidy were:
1)
The direct causes~of 10 of the 14 reported iodine misadministrations (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 for thyroid scan procedures that involved scanning the chest area (3 cases).
2)
Causal factors' associate'd with the misadministrations 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 misadministrations appears to have been a lack of licensee control over the adminis-tration of millicurie amounts of iodine-131 to patients.
These 11 misadministrations could likely have been prevented, despite the errors that led to the misadministrations, 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 MISADMINISTRATIONS Table 5 shows the distribution of reported diagnostic misadministrations for the various personnel involved in the misadministrations.
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 misadministrations (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
+-
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12-2 pharmacies, 34_ events.(8%); and. physicians, 2 events (<1%).
The personnel involved with 6 events (about'1%) was not determined.
i Based on the'causes identified for most of the misadministrations (e.g., simple errors associated with the preparation and delivery of radiopharmaceutical doses account-for about 52% of the misadministrations), it follows that the technologist would be the person a~ sociated with most of the misadministrations.
s Nurses and other' personnel generally contribute to wrong patient events.
i.
Table 5 Personnel Involved in' Diagnostic ~Misadministrations Personnel Misadministrations Percent Technologist
~312 71%-
Student Technologist.
9 Nursing Staff 2%
18 4%
Radiopharmacy 34 Other Personnel
- 8%
57 Physicians
~13%
2 Not Specified'
< 1%.
6 1%
~* Clerical personnel / transporters / aides.
t 4.
GEOGRAPHIC DISTRIBUTION OF LICENSEES REPORTING M t
Figures 1 and 1A show the distribution of misadministrations reports by stat and the distribution of radioisotope facilities, generally hospitals (though some are private practice clinics), by state for the 22 states regulated'by the NRC and the District of Columbia.
From the graphs,.it can be'seen-that generally states having a higher number of radioisotope facilities (indicatin a higher number of administrations ~ of radiopharmaceuticals) are generally )
ones that have reported a higher number. of misadministrations, although the relation between.the number of radioisotope facilities and the number of misadministrations' reported is not linear.
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DISTRIBLITION OF REPORTS BY STATE.
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14 5.
LICENSEE PROPOSED CORRECTIVE ACTIONS Table 6 shows the corrective actions proposed by-licensees.
The dominant corrective actions involve' 1) the retraining of personnel,197 events (45%);
- 2) implementing new radiopharmaceutical labeling and handling procedures, 75 events (17%); 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 misadministrations.
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.
Table 6 Corrective Actions Proposed by Licensees in 1986 Diagnostic Misadministration Reports Type of Corrective Action Number of Reports Implement new procedures requiring technologist to check patient's chart for physician order 18 Implement new radiopharmaceutical labeling and i
handling procedures, e.g., color coding, i
segregation of radiopharmaceuticals, etc.
75 Implement new procedures for patient identification, 1.e., ask patient to state or write name, check
)
patfent SSAN, use of secondary identification, as well as patient 10 bracelet
]
22 Reinstruct personnel 197 Reprimand technologist or other personnel 27 Improve supervision of personnel 2
Not Specified 18 Other 79 i
Total 438
~~~
o
-15 6.
PROPOSED AND PENDING REGULATORY CHANGES INVOLVING HISADMINISTPATIO The Commission's purpose in requiring the submittal of misadministration reports to the NRC is to verify that 'their caus~es 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 need for additional actions, e.g., changes in regulai! ions to reduce the occurrence of similar and perhaps more. serious events.
In this regard as a result of the findings in AE00 case study report, AE00/C505, " Therapy Misadministrations Reported to the NRC Fursuant to 10 CFR 35.42," and the findings from the investigation (by Regional Offices) of several recent misadministrations, the Commission directed NMSS to undertake ruletraking 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 f
j In addition, the reporting requirements for diagnostic misadministrations have
}
been changed to incorporate a threshold for reporting. The new reporting i
requirements are contained in section 10'CFR 35.33 of the final rule on
" Medical Use of Byproduct Material" (10 CFR Parts 30,31,32,35,and'40),
j 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-i tions are only to be reported if:
the misadministration involved the use of radioactive material
- not intended for medical use; i
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 brdy radiatior, dose is likely to exceea
[
500 millirem.
k 1
- Radicactive materials rer': lated by PRC pursuant to the Atnmic Engery Act of 1954, as amended in 197t.
16 Under the previous reporting requirements for diagnostic nisadministrations (contained in 10 CFR 35.43, January 1, 1986 edition), all diaanostic mis-administrations are required to be reported. The basis for charging the reporting requirements to incorporate a threshold for reporting is that-the review of diagnostic misadministrations for 1984-1985 has shown that esseqtially no additionel information on the type and causes of diagnostic misadministrations is contained in the data on most (over 90%) of the diagnostic misadministrations being reported. That is, most (over 90%) of the diagnostic misadministrations either involve 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 misadministrations have been documented in AEOD reports on. medical misadministrations.
The new reporting requirements will ensure that diagnostic misadministrations 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 diagnostic misadministrations for 1986 involved either the administration of the wrong radiopharmaceutical or the administration of a radiopharmaceutical to the wrong patient. The number, type, and cause of diagnostic misadministrations are about the same as reported for 1985. The causes reported by licensees are generally the same as have been reported in the past; that is, simple errors associated with 1) preparation of radio-pharmaceuticals, 2) processing nuclear medicine requisitions, and 3) patient identification.
In addition, for misadministrations involving the adminis-tration of millicurie amounts of iodine to patients, the primarv cause was the failure of licensees to exercise adecuate control over the administration of millicurie arounts of iodire-131 to patients.
1
+
17 APPENDIX A
+
Summary of Therapy Misadministrations Reported to NRC I
l MISAD #1 l
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 i
to be a factor in the occurrence of the misadministration. At the time of the i
misadministration the patient had been admitted-to the hospital for treatment-of hypertension, however an order for radiation therapy for the patient was i
-entered into the department's computer erroneously.
The 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 i
therapy.
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.
i MISAD d2 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 (excess 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 4
therapeutic treatment of throat cancer resulted in an underdose of 700 rads.
A total. of 103 iridium-192 seeds with an activity of 36.85 milligrams radium i
equivalent was used in the implant.
MISAD #4.
A patient undergoing radiation treatment to the upper torso with a prescribed i
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 t
resulted in an exposure time of 8.72 minutes.
The long exposure resulted in a dosage of 328 rads or approximately 1968 rads-over the six treatments instead of the 1200 rads.
The patient died about a month after the therapy was per-t
[The cause of death was not determined at the time of the writino of formed.
l this report.]
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'MISA0 a5 A patient scheduled for treatment on a 15 MV linear accelerator was given two i
treatments on a cobalt-60 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.
4 MISAD #6 A' patient who was between 4 and 6 weeks pregnant was treated with 12.4 mci of f
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 i
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.
)
MISAO #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-3 i
therapy treatment that was more than 10% of the prescribed dose.
One area'was i
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 beino loaded into the source applicator instead of 10.67 mg radium equivalent sources as prescribed. The person who loaded the sources indicated that the error resulted from a failure to follow established quality assurance procedures for verifying the accuracy of the source loading. The error was l
discovered when the sources were unloaded, j
MISA0 #8 A patient undergoing teletherapy radiation treatment was administered a dose i
with the treatment' geometry different than the-prescribed geometry. The j
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 geometry, being treated with a rotating head The administered dose durino the rotation was 42 rads (12 seconds geometry.
4 elapsed before the treatment was terminated).
-l I
j
19 APPENDIX B Summary Description of Diagnostic Misadministrations Reported to NRC Involving the Administration of Millicurie Amounts of Iodine-131 MISAD 81 Prescribed Radiopharmaceutical Tc-99m MDP Prescribed Dosage 20.0 mci Administered Radiopharnaceutical I-131 Administered Dosage 10.0 mci
==
Description:==
The patient was-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 tine'of scheduling, a verbal confirmation for an iodine-131 "whole body scan" was received from the doctor's office.
The technologist administered the fodine-131 dose without written orders which was contrary to licensee policy.
HISAD #,2 Prescribed Radiopharmaceutical I-131 Prescribed Dosage 0.05 uCi Administered Radiopharnaceuti:al I-131 Administered Dosage 3.09 mci
==
Description:==
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 50 microcurie dosece of iodine-131 for a thyroid scan.
did not sp,ecify exactly what was misread to cause the technologist toThe licen administer the high dosage of iodine-131.
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-4
20 MISAO #3 Prescribed Radiophamaceutical I-131 Prescribed Dosage-0.1 - 0.2 uCi Administered Radiophamaceutical I-131 Administered Dosage I mC.i
==
Description:==
A patient was administered a'l millicur;ie 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 lookin0 for the residual thyrofd-tissue and i
administered one millicurie of iodine to a patient.
MISAD #4-Prescribed Radiopharmaceutical I-131-Prescribed Dosage 0.03-0.05 uCi 4
Administered Radiophamaceutical I-131 i
Administered Dosage 1.53 mci l
==
Description:==
4 A patient was administered a 1.53 millicurie dosage of iodine-131-instead of f
1 the prescribed dosage of 30 to 50 microcuries of iodine-131. The thyroid scan was to diagnose possible substernal thyroid tissue and the technologist thought that a whole body scan was ordered to look for metastatic disease and adminis-tered 1.53 millicu*ies of iodine-131 to the patient.
J-MISAO #5 Prescribed Radiopharmaceutical Tc-99m MOP Prescribed Dosage 20 mci Administered Radiopharmaceutical I-131 t
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.
j
21 APPENDIX C List of Previous AE00 Reports on Medical Misadministrations Report on Medical Misadministrations for the Period November 10, 1980 - September 30, 1981, dated January 1982.
AE00/N204A, Report on Medical Misadministrations' for-1981, dated March 1982.
AE0D/N2048, Report on Medical Misadministrations-for January 1981 - June 1982, dated November 1982.
AE00/N204C, Report on Medical Misadministraticas for January 1981 - December 1982, dated July 1983.
AF00/N2040, Report on Medical Misadministrations for January 1983 - June 1983, dated May 1984 AEOD/N403, Report on Medical Misadministrations for July 1983 - December 1983, dated June 1984 AEOD/N503, Report on Medical Misadministrations for January 1984 - December 1984, dated July 1985.
AEOD/N602, Aedical Misadministration Report -
Medical Misadministrations Reported for 1985 and Five-Year Assessment of 1981-1985 Reports, dated June 1986.
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