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l AliG 2 61987
- l. MEMORANDUM F0P: Kathleen M. Black, Chief Nonreactor Assessment Staff, AE0D FROM: Vandy L. Mille: , Chief l
Medical, Academic, and ;
Commercial Use Safety Branch, IMNS 1 1
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SUBJECT:
REQUEST FOR AE0D STUDY )
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J Reference the attached PN title " Teletherapy Misadministration," published by . i.
Region I. Please note that these Misadministration. involved several patients which were either overtreated or undertreated. .We would appreciate your. staff
'enr. ducting a special study on these Misadministration. ,
Please identify the relationship of these occurrences to our ANPR and NPR on l quality. assurance which we have forwarded to the Commission for approval, to j l determine if our quality assurance packages are sufficiently detailed to have 1
.-prevented most of the Misadministration,' j
. Norman McElroy of my staff. is being identified as the contact person to assist i your staff in the Study. You may reach him at Extension 74108.. l
" Original Signed for VANDY L MRIT Vandy L. Miller, Chief ;
Medical, Academic, and Commercial i Use Safety Branch, IMNS
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- 6835 IN 85-61 Supplement No. 1 UNITED STATES NUCLEAR REGULATORY COMMISSION H OFFICE OF INSPECTION AND ENFORCEMENT WASHINGTON, D.C. 20555 j April 15, 1987 IE INFORMATION NOTICE N0. 85-61, SUPPLEMENT 1: MISADMINISTRATION TO PATIENTS UNDERG0ING THYROID SCANS Addressees:
All licensees authorized to use byproduct material for human applications.
Purpose:
This notice supplements IE Information Notice 85-61 (attached). It is -
expected that licensees will review this supplemental information for applicability to their activities and consider actions, if appropriate, to preclude further iodine-131 misadministration. However, suggestions contained in this information notice do not constitute NRC requirements; therefore, no specific actions or written response is required.
Description of Circumstances:
Since the original notice was issutd on July 22, 1985, the NRC has reviewed 14 additional iodine-131 misadministration. The probable causes of these misadministration are as follows:
The cause of 8 of the 14 misadministration can be ascribed to the referring physician's order being misinterpreted or to a miscommunication to the technologists.
The cause of three other misadministration can be ascribed to the tech-nologists not being sufficiently familiar with the iodine-131 dosage requirements for thyroid scan procedures that involve scanning the chest area to ensure that the proper dosage was used.
The cause of the remaining three misadministration can be ascribed to miscellaneous factors: a patient's identity was not verified before administering the iodine-131 dosage; the technologist selected the wrong iodine-131 capsule from the isotope laboratory and did not assay it to ensure proper dosage before administering it to the patient; and the nuclear medicine physician or radiologist was not aware that part of the patient's thyroid was intact before prescribing the amount of lodine-131 for administration to the patient for a whole-body iodine-131 scan.
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IN 85-61 Supplement No. 1
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April 15, 1987 Page 2 of 3 Discursion:
Licensees that have experienced such misadministration,s have found that the following corrective actions have been effective in preventing iodine-131 misadministration.
- Provide periodic rafresher training for nuclear medicine personnel involved in the. performance of thyroid studies that emphasizes the effects on patients resulting from :alsadministrations involving iodine-131.
Maintain records of such training.
- For licensees conducting infrequent or nonroutine nuclear medicine procedures involving the administration of iodine-131, ensure that the authorized user, and any physicians under the supervision of the authorizcd user, as well as the technologists involved are sufficiently familiar with these procedures so that they will be properly conducted.
- Establish a manual that contains the proper procedures. for each of the nuclear. medicine studies (i.e., thyroid uptake, thyroid uptake and scan, thyroid neck and chest, thyroid whole-body scan, etc.).
Ensure that all thyroid studies Nferred te the nuclear medicine department involving the administration of iodine-131 will be in written form and the authorized user, or any physicians under the supervision of the authorized user, will prescribe an appropriate thyroid study for the particular patient conditions. for example, interview the patient, obtain additional information from the referring physician if needed, examine the patient, and sign the iodine-131 thyroid study prescription.
- Instruct all personnel involved in the performance of iodine-131 studies to request clarification from the prescribing physician if any element of a prescription or procedure is unclear, ambiguous, or apparently erroneous.
Before each administration to a patient (adult or child), always calculate the required dosago for the prescribe procedure, and then ensure the correct dosage is prepared by calibrating that dose in the dose calibrator.
Ensure compliance with 10 CFR 35.53, measurement of radiopharmaceutical dosages, 935.60, syringe shields and labels, and 935.61, vial shleids and labels prior to administ. ration of iodine-131, and maintain records of dosage disposition.
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7, IN 85-61 Supplament No. 1 , '..'
April 15, 1987 ' "
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l l No specific written response is required by this infortnation nctice. If you ,
have any questions regarding this matter, please contact the Regional .y ,
- Administrator of the appropriate NRC regional office or this office. - .
&DA $hk "'
James G. Partlow,1 0irectortdI -
D(vision of Inspection Programs Office of Inspection and Enforcement Technical
Contact:
H. Karagiar.nis, IE -
(301) 427-9030 W' Attachments:
- 1. IE inforniation Notice No. 85-61 -
- 2. List of Recently Issued IE Information Notices ,
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SSINS No.: 6835 IN 85-61
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UPITED STATES Attachment 1 NUCLEAR REGULATORY COMMISSION Ifi 85-61 Supplement 1 0FCICE OF INSPECTION AND ENFORCEMENT April 15,1987 WASHINGTON, D.C. 20555 July 22, 1985 IE INFORMATION NOTICE NO. 85-61: MISA0 MINISTRATIONS TO PATIENTS UNDERGOING THYROID SCANS Addressees:
Licensees authorized to use byproduct material for human applications.
Purpoy :
This information notice is intended to alert recipients of potentially significant problems pertaining to human applications of byproduct material. .
In four recent cases, because of errors, patients received significant, '
unnecessary radiation exposures. It is expected that licensees will review the information in this notice for applicability to their facilities cod consider actions, if appropriate, to preclude similar prob hms occurring at their facilities. However, suggestions contained in this information notice do not constitute NRC requirements; therefore, no specific action or written response is required.
Description of Circumstances:
In tne first case, a referring physician teiepnoned the hospital to request a
" radioactive iodine scan" for his patient. The written request was to be for-warded to the nuclear medicine department at a later date. When the patient arrived at the nuclear medicine department, the written request had not arrived.
The nuclear medicine physician did not review the patient's history.to evaluate ;
I the need for this scan or direct which isotope to use. The nucicar medicine technologist had interpreted the physician's telephone order as a total-body iodine-131 scan and administered a 5 millicurie dosage of iodine-131 to the patient. When the written request arrived at the hespital the next day, the request was for a " thyroid scan," which required a 5 millicurie dosage of technetium-99m. As a result of the misadministration, the patient received a dcse of from 6500 to 9000 rads to the thyroid instead of the 0.7 rads that would have resulted from the use of technetium-99m.
In the second case, a 5 millicurie dosage of iodine-131 was administered to the wrong patieAt. The patient's identification was not verified and the iodine-131 was administered to a patient that was supposed to receive a 5 milli-curie dosage of technetium-99m.
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, If4 85-61 July 22, 1985
-- Page 2 of 2 In the third case, because of incorrect patient scheduling, a 10 millicurie dosage of iodine-131 was administered to a patient instead of the intende'd 400 microcurie dosage of iodine-123. The nuclear medicine physician had not reviewed the patient's previous history and had not approved the nuclear medicine procedure and related dosage.
In the fourth case, a patient, who was scheduled for a thyroid uptake and scan, received a do:e of 1000 microcuries of iodine-131 instead of the intended 100 microcuries of iodi.Me-131. The hospital staff reported that this misadminis-tration occurred because the involved personnel were unfamiliar with this clinical procedure, which was not frequently performed.
Discussion:
Checking the patient's identification and previous history before approving nuclear medicine procedures is very important, especially where a high dose to the patient will result from the procedure. It also is important for licensees to establish written procedures for dosage preparation and administration and .
to check the referring physician's wr.tten request before administering the .
dosage.
No specific action or written response is reouired by this information notice.
If you have any questions regarding this matter, please contact the Regional Administrator of the appropriate NRC regional office or this office.
Jamqs G. Partlow, Director Div1Nion of Inspection Programs Office of Inspection and Enforcement
Contact:
Harriet Karagiannis, IE (301) 492-9655
Attachment:
List of Recently Issued IE Information Notices
~
e, Attachment IN 85-61
- July 22, 1985 LIST OF RECENTLY ISSUED IE INFORMATION NOTICES Information Date of Notice No. Subject Issue Issued to 85-60 Defective Negative Pressure 7/17/85 All power reactor Air-Purifying, Fuel Facepiece facilities holding Respirators an OL or CP 85-59 Valve Stem Corrosion Failures 7/17/85 All power. reactor facil. Ties holding an OL oi CP 85-58 Failure Of A General Electric 7/17/85 All power reactor '
Type AK-2-25 Reactor Trip facilities designed Breaker by B&W and CE holding an OL or CP ,
85-57 Lost Iridium-192 Source 7/16/85 All power reactor Resulting In The Death Of facilities holding Eight Persons In Morocco an OL or CP; fuel facilities; and ,
material licensees j l
85-55 Inadequate Environment 7/15/85 All power reactur i Control For Components And facilities holding Systems In Extended Storage an OL or CP -
Cr Layup ,
l 85-55 Revised Emergency Exercise 7/15/85 All power reactor l Frequency Rule facilities holding j en OL or CP 85-54 Teletherapy Unit Malfunction 7/15/85 All NRC licensees authorized to use teletherapy units 85-53 Performance Of NRC-Licensed 7/12/85 All power reactor Individuals While On Duty facilities holding an OL or CP 85-52 Errors In Dose Assessment 7/10/85 All power reactor l
Computer Codes And Reporting facilities holding i Requirements Under 10 CFR an OL or CP Part 21 l OL = Operating License CP = Construction Permit i
d Attachment 2 IN 85-61 Supplement No. 1
- - - April 15, 1987 LIST OF RECENTLY ISSUED IE INFORMATION NOTICES
. 'i Information Date of Issued to Notice No. Subject Issue Perforation and Cracking 4/9/87 All Westinghouse 87-19 of Rod Cluster Control power PWR facilities Assemblies holding an OL or CP l 87-18 Unauthorized Service on 4/8/87 All NRC licensees Teletherapy Units by authorized to use l Nonlicensed Maintenance radioactive material 1 Personnel- in teletherapy units 87-17 Response Time of Scram 4/7/87 All GE BWR facilities Instrument Volume Level holding an OP or CP-Detectors ,
87-16 Degradation of Static "0" 4/2/87 All LWR facilitie.s f holding an OL or CP
! Ring Pressure Switches 1
87-15 Complaince with the Posting 3/25/87 All power reactor l facilities holding l
Requirements'of Subsection 2233 of the Atomic Energy a CP and all firms Act of 1954, as Amended supplying components or services to such facilities 87-14 Actuation of Fire Sup- 3/23/87 All power reactor facilities holding pression System Causing Inoperability of Safety- an OL or CP Related Ventilation Equipment 86-106 Sup. 2 Feedwater Line Break 3/18/87 All power reactor facilities holding an OL or CP 87-13 Potential for High Radiation 2/24/87 All power reactor Fields Following loss of facilities holding Water from Fuel Pool an OL or CP except l
Fort St. Vrain.86-106 Sup. 1 Feedwater Line Break 2/13/87 All power reactor facilities holding an OL or CP Potential Problems With 2/13/87 All power reactor 87-12 facilities holding a
Metal Clad Circuit Breakers, General Electric Type AKF-2-25 an OL or CP OL = Operating License ,
CP = Construction Permit !
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,'I IN 85-61 4
+4 UNITED STATES J NUCLEAR REGULATORY COMMISSION ;l>i 0FFICE OF INSPECTION AND ENFORCEMENT LO#
WASHINGTON, D.C. 20555 '2jj July 22, 1985 i{4,
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};(g IE INFORMATION NOTICE NO 85-61 MISADMINISTRATION TO PATIENTS UNDERG0ING THYROID SCANS Addressees-Ltcensees 3uthorized to use byproduct material for human applications.
I Purpose.
This information notice is intended to alert recipients of potentially significant problems pertaining to human applications of byproduct material.
In 'our recent cases, because of errors, patients received significant, unnecessary radiation esposures. It is expected that licensees will review the information in this notice for applicability to their facilities and cens' der actions, if appropriate, to preclude similar problems occurring at their #acilities. However, suggestions contained in this information notice do not constitute NRC requirements; therefore, no specific action or written response is requiret Description of Circumstances:
In the first case, a referring physician telephoned the hospital to request a
' radioactive iodine scan" for his patient. The written request was to be for-warded to the nuclear medicine department at a later date. When the patient arrived at the nuclear medicine department, the written request had not arrived.
The nuclear medicine physician did not review the patient's history to evaluate the need for this scar or direct which isotope to use. The nuclear medicine technologist had interpreted the physician's telephone order as a total-body iodine-131 scan and administered a 5 millicurie dosage of iodine-131 to the patient.
When the written request arrived at the hospital the next day, the request was for a " thyroid scan," which required a 5 millicurie dosage of technetium-99m. As a result of the misadministration, the patient received a dose of from 6500 to 9000 rads to the thyroid instead of the 0.7 rads that would have resulted frota the use of technetium-99m.
In the second case, a 5 millicurie dosage of iodine-131 was administered to 1the wrong patient. The patient's identification, was not verified and the i J >
, iodine 131>was administered to a patient that was supposed to receive a 5 mittf4J '
. curie dosage of tecnnetium-99m. O ~,
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IN 85-61 July 22, 1985 Page 2 of 2 In the third case, because of incorrect patient scheduling, a 10 millicurie dosage of iodine-131 was administered to a patient instead of t he intended 400 microcurie dosage of iodioc-123. The nuclear redicine physician had not reviewed the patient's previous history and had not approved the nuclear medicine l
procedure and related dosage.
In the fourth case, a patient, who tuas scheduled for a thyroid uptake and scan, received a dose of 1000 microcuries of iodine-131 instead of the intended 100 microcuries of f odir.e-131. The hospital staff reported that this misadminis-tration occurred because the involved personnel were unfamiliar with this clinical procedure, which was not frequently performed.
Discussion:
{
Checking the patient's identification and previous history before approving nuclear medicine procedures is very important, especially where a high dose to the patient wl!1 result from the procedure. It also is important for Itcensees to establish written procedures for dosage preparation and administration and to check the referring physician's written request before administering the dosage.
No specific action or written response is required by this information notice.
- If you have any questions regarding this matter, please contact the Regional W
Admini,trator of the appropriate NRC regional office or this offico.
Orislami ensand 4 s M Jones & W - ph y ;z
, a James G. Partlow, Otra: tor Division of Inspection Programs + :!d ?'
if Office of Inspection and Enforcement gg
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Contact:
Harriet Karagiannis, IE T -
(301) 492-965!s ;} .
Attachment:
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List of Recently Issued IE Information Notices 6
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