Information Notice 2007-25, Recommendations from the Advisory Committee on the Medical Use of Isotopes for Improved Compliance with 10 CFR 35.40 and 35.27
| ML062060013 | |
| Person / Time | |
|---|---|
| Issue date: | 07/19/2007 |
| From: | Schlueter J NRC/FSME/DMSSA |
| To: | |
| Howe D | |
| References | |
| IN-07-025 | |
| Download: ML062060013 (9) | |
UNITED STATES
NUCLEAR REGULATORY COMMISSION
OFFICE OF FEDERAL AND STATE MATERIAL AND
ENVIRONMENTAL MANAGEMENT PROGRAMS
WASHINGTON, D.C. 20555-0001 July 19, 2007 NRC INFORMATION NOTICE 2007-25: SUGGESTIONS FROM THE ADVISORY
COMMITTEE ON THE MEDICAL USE OF ISOTOPES
FOR CONSIDERATION TO IMPROVE COMPLIANCE
WITH SODIUM IODIDE I-131 WRITTEN DIRECTIVE
REQUIREMENTS IN 10 CFR 35.40 AND
SUPERVISION REQUIREMENTS IN 10 CFR 35.27
ADDRESSEES
All U.S. Nuclear Regulatory Commission (NRC) medical-use licensees and NRC Master
Materials Licensees. All Agreement State Radiation Control Program Directors and State
Liaison Officers.
PURPOSE
The U.S. Nuclear Regulatory Commission (NRC) is issuing this Information Notice (IN) to
underscore the requirement in 10 CFR 35.40 that the administration of sodium iodide
iodine-131 (I-131) in dosages greater than 1.11 megabecquerels (MBq) (30 microcuries (Ci))
requires a written directive signed and dated by an authorized user (AU). In this connection, this IN is being issued to emphasize the need for administering technologists to verify the
existence of written directive and/or the dosage with an AU prior to administration of sodium
Iodide I-131. Another purpose of the IN is to remind licensees of their responsibility under 10 CFR 35.27(a) to instruct the supervised individual in written directive procedures and to require
supervised individuals to follow the instruction of the supervising AU. This IN contains the
Advisory Committee on the Medical Use of Isotopes (ACMUIs) suggestions for ensuring
compliance in using written directives and improving communication between the AU and the
individual performing the administration. Recipients should review the information contained in
this IN for applicability to their facilities and consider actions, as appropriate. However, suggestions contained in this IN are not new NRC requirements; therefore, no specific action or
written response is required. NRC is providing this IN to the Agreement States for their
information and for distribution to their medical licensees as appropriate.
BACKGROUND
Between February, 2004, and May, 2005, NRC received eleven medical event reports involving
oral administrations of sodium iodide I-131 at activity levels that required written directives. The
NRC requested that the ACMUI examine these medical events identify root causes and ways of
reducing the occurrence of these types of medical events. In April, 2006, the ACMUI,
presented NRC with its conclusions and recommendations. The NRC incorporated the ACMUI
recommendations in this IN for distribution and consideration by the medical community. The dosage activity in seven of the eleven sodium iodide I-131 administrations exceeded the
minimum dosage activity that required a written directive (i.e., greater than 1.11 MBq (30 Ci)),
but a written directive had not been issued. Nine of the medical events resulted in over- dosages.
Although the details of the medical events varied, the primary cause for most of the events was
the licensees failure to verify all sodium iodide I-131 dosages greater than 30 Ci against a
written directive prior to administration.
The NRC notes that there is evidence that this failure continues to be a cause for medical
events. Specifically, since the ACMUI performed its review, there have been 8 additional
medical events involving sodium iodide I-131 (not included in the examples below) that also
involved the failure to verify that there was a written directive for sodium iodide I-131 dosages
greater than 30 Ci. These additional events underscore the continuing need to increase
awareness of the written directive requirements in 10 CFR 35.40 and corresponding supervision
requirements in 10 CFR 35.27(a).
DESCRIPTION OF CIRCUMSTANCES
There were no written directives for eight of the eleven administrations reviewed by the ACMUI,
because five prescribed dosages were for less than 30 Ci of sodium iodide I-131 (two of these
included verbal orders), one was for a different radionuclide (I-123), one had no prescribed
dosage, and one for greater than 30 Ci was only made verbally. The absence of written
directives for sodium iodide I-131 dosages greater than 30 Ci should have alerted the
administering technologist to seek a written directive and, if one was not found, to verify the
dosage with the AU prior to administration.
The three remaining medical events involved written directives which were not followed. These
three events were primarily due to human errors (i.e., lack of attention to detail and failure to
follow procedures) compounded by the staffs failure to follow a written directive. Reviewing the
written directive or contacting the AUs prior to administering the dosages could have prevented
these errors.
Cases in which No Written Directive was issued - Eight Cases:
Pharmacy Errors
P A contaminated pipette in the radiopharmacy raised the desired dosage of 20 Ci, to 0.9 millicurie (mCi). The dosage was correctly labeled as 0.9 mCi. The activity displayed
on the radiopharmacy dose calibrator of 0.915 mCi was misinterpreted by the
radiopharmacy technologist as 9.15 Ci. The nuclear medicine technologist misread
the 0.9 mCi on the label as 9 Ci and administered the dosage. This resulted in an
administered dosage of 915 Ci rather than the requested dosage of 5 to 20 Ci.
P The radiopharmacy prepared a dosage of 980 Ci instead of the prescribed dosage of
15 Ci. The dosage of 980 Ci was administered to a patient by a technologist at the
medical facility without verification of the dosage. This mistake could have been prevented by verifying the dosage and recognizing that a written directive is required for
all sodium iodide I-131 administrations exceeding 30 Ci.
Pharmacy Error Compounded by a Verbal Order
P The AU gave a verbal order for 2.0 mCi without providing the required written directive.
The nuclear pharmacy inadvertently prepared and sent a 2.8 mCi dosage, which was
then administered by the technologist at the medical facility.
Verbal Order
P The technologist misunderstood the verbal orders of the AU and ordered 500 Ci of
sodium iodide I-131 instead of 5 Ci. The patient was administered 535 Ci instead of
the intended 5 Ci. The technologist did not verify the existence of a written directive, which is required for all sodium iodide I-131 administrations exceeding 30 Ci.
Misunderstood request/written order
P The technologist misunderstood the referring physicians request (the report does not
specify the form of the request) and administered 3 mCi of sodium iodide I-131 rather
than the intended 25 Ci. Approval of the dosage was not obtained from the AU prior to
administration.
P The AU intended to prescribe 12 mCi but instead wrote 12 Ci by mistake on the
prescription. The technologist did not realize that the AU had written 12uCi and ordered
and administered a dose of 12mCi which the technologist thought was what the AU had
intended; however, this administration did not comply with the written directive, and
therefore constituted a medical event. This event was caused by the failure to compare
a dosage greater than 30 Ci with the AUs written instruction and lack of
communication between the technologist and the AU.
Wrong Patient
P The individual received a 2 mCi I-131 dosage instead of the intended 200 Ci I-123 dosage because the patient incorrectly responded affirmatively to being the patient that
was supposed to receive the I-131 dosage.
No Order
P The technologist administered a 4 mCi dosage that was left over from a previous no
show patient without a written directive under the assumption that the prescribing
physician would complete the written directive at a later time. After administering the 4 mCi dosage, the technologist discovered that the AU had intended to prescribe
150 mCi. As there had been no written directive, the technologist could not verify the
prescribed dosage against the dosage about to be administered.
Failure to Follow a Written Directive - Three Cases:
P Two different medical events resulted in administered dosages of 5.2 mCi and 15 mCi
instead of the prescribed 2 mCi dosages. One was attributed to lack of attention to detail and the other to failure to follow procedures.
P The technologist confused the dosages of three patients who were scheduled to receive
I-131 treatments on the same day and administered 100 mCi to a patient who was
scheduled to receive 17.3 mCi.
DISCUSSION
As outlined in the
DESCRIPTION OF CIRCUMSTANCES
, most of the medical events were
caused primarily by failure to recognize that dosages greater than 30 Ci of sodium iodide I-131 require a written directive and should have been verified against a prescribed dosage in a
written directive. With the exception of the patient misidentification, these events could have
been preventable if procedures had been established and followed for checking dosages about
to be administered against a prescribed dosage contained in a written directive. The ACMUI
developed four suggestions that the medical community may consider to improve compliance
with the regulations.
1) Licensees are required to have a written directive before the administration of greater than
30 Ci of sodium iodide I-131 (10 CFR 35.40) and to provide instructions in written directive
procedures to supervised individuals (10 CFR 35.27). The ACMUI suggests that licensees
reemphasize these requirements to their staff so that the staff is aware that a written
directive is required for dosages of sodium iodide I-131 greater than 30 Ci and verifies that
there is a written directive before administering these dosages. Licensees also should
remind staff that verbal orders are only acceptable under specific situations and, even then, must be followed up with a written directive (10 CFR 35.40(a)(1) and 35.40(c)(1)).
2) Licensees are required to determine and record the activity of each dosage before medical
use (10 CFR 35.63). The ACMUI recognizes that licensees are not required to perform a
direct measurement of a unit dosage in a dose calibrator prior to administration, if it is
received from a drug manufacturer or commercial nuclear pharmacy. However, the ACMUI
believes that it is a good standard of practice to make direct measurements of therapeutic
dosages in dose calibrators. The ACMUI also suggests that licensees have the written
directive readily available while determining the dosage prior to administration to verify and
ensure that the dosage to be administered conforms with the written directive.
3) The licensee is required to have written procedures to provide high confidence that the
patients identity is verified before each administration (10 CFR 35.41(a)(1)). The ACMUI
suggests that licensees evaluate their identity verification procedures to prevent patient
misidentification. Although not required by the regulations, the ACMUI suggests that
licensees consider confirming positive patient identification by two separate methods prior to
dosage administration. The ACMUI suggests following a patient identification procedure
similar to that required for a blood administration.
4) The ACMUI suggests that licensees seek to improve communication between AUs and the
individuals performing the administration. The AUs should consider reviewing plans for the
treatment with the administering technologists. In addition, licensee management should
foster a culture at the licensees facility that encourages technologists to freely ask
questions of the AUs regarding written directives. NRC licensees must ensure that their staff fully understand and adhere to the requirements
contained in the regulations. NRC, in coordination with the ACMUI, has developed this IN to
convey the above suggestions drawn from a study of medical events involving the oral
administration of sodium iodide I-131. Unless specifically addressed in 10 CFR Part 35, these
suggestions are not NRC requirements. The ACMUI believes consideration of these
suggestions will improve compliance with the regulations and minimize the likelihood of medical
events.
CONTACT
This IN requires no specific action or written response. If you have any questions about the
information in this notice, please notify the technical contact listed below or the appropriate
regional office.
/RA/
Janet R. Schlueter, Director
Division of Materials
and State Agreements
Office of Federal and State Materials
and Environmental Management Programs
Technical Contact:
Donna-Beth Howe, PhD, FSME
(301) 415-7848 dbh@nrc.gov
Enclosure:
List of Recently Issued FSME/NMSS
Generic Communications convey the above suggestions drawn from a study of medical events involving the oral
administration of sodium iodide I-131. Unless specifically addressed in 10 CFR Part 35, these
suggestions are not NRC requirements. The ACMUI believes consideration of these
suggestions will improve compliance with the regulations and minimize the likelihood of medical
events.
CONTACT
This IN requires no specific action or written response. If you have any questions about the
information in this notice, please notify the technical contact listed below or the appropriate
regional office.
/RA/
Janet R. Schlueter, Director
Division of Materials Safety
and State Agreements
Office of Federal and State Materials
and Environmental Management Programs
Technical Contact:
Donna-Beth Howe, PhD, FSME
(301) 415-7848 dbh@nrc.gov
Enclosure:
List of Recently Issued FSME/NMSS
Generic Communications
DISTRIBUTION:
FSME/ r/f Regional Administrators DBHowe
ML062060013 OFFICE MSEA MSEA MSEA OGC TechEd MSEA MSA/FSME
NAME DBHowe CFlannery SWastler FCameron CPoland AMcIntosh JSchlueter
5/ 18 /07 5/ 18 /07 5/ 22 /07 7/ 5 /07 / /07 6 / 07 /07 7 / 6 /07 OFFICIAL RECORD COPY Recently Issued FSME/NMSS Generic Communications
Date GC No. Subject
Addressees
12/7/06 RIS-06-26 TRAINING AND EXPERIENCE All NRC medical licensees and Radiation
AND GRANDFATHER Control Program Directors.
PROVISIONS FOR AUTHORIZED
MEDICAL PHYSICISTS UNDER
10 CFR PART 35
12/7/06 RIS-06-25 Requirements For The Distribution All U.S. Nuclear Regulatory Commission
And Possession Of Tritium Exit (NRC) licensees distributing tritium exit
Signs And The Requirements In 10 signs and those possessing a tritium exit
CFR 31.5 AND 32.51a sign under a general license.
11/15/06 RIS-06-22 Lessons Learned From Recent 10 All Title 10 Code of Federal Regulations
CFR PART 72 Dry Cask Storage (10 CFR) Part 72 specific licensees and
Campaign certificate holders and holders of
operating licenses for nuclear power
reactors (including those who have
permanently ceased operations and have
certified that fuel has been permanently
removed from the reactor vessel) that are
not 10 CFR Part 72 specific licensees.
09/22/06 RIS-06-14 Enforcement Discretion for Facility All fuel cycle licensees regulated under
Changes Under 10 CFR Title 10 of the Code of Federal
70.72(c)(2) Regulations (10 CFR) Part 70, Subpart H.
09/14/06 RIS-06-20 All community water systems (CWSs), in
Guidance for Receiving
U.S. Nuclear Regulatory Commission
(NRC) non-Agreement States, that during
Concentrating Uranium at
the treatment of drinking water, may
Community Water Systems
accumulate and concentrate naturally- occurring uranium in media, effluents, and other residuals, above 0.05 percent
by weight.
09/14/06 RIS-06-19 Availability of Guidance on All NRC medical licensees.
Radioactive Seed Localization
08/31/06 RIS-06-18 Requesting Exemption from the All NRC medical licensees.
Public Dose Limits for Certain
Caregivers of Hospital Patients
08/15/06 RIS-06-16 Transfer of the Management All NRC materials licensees.
Oversight Of Certain NRC Region I
Licensees in Mississippi
To the NRC Region IV Office
07/20/06 RIS-06-11 Requesting Quality Assurance All 10 CFR Part 71 quality assurance
Program Approval Renewals program and certificate holders.
Online by Electronic Information
Exchange
04/23/06 RIS-06-10 Use of Concentration Control for All licensees authorized to possess a
Criticality Safety critical mass of special nuclear material. Date GC No. Subject
Addressees
01/26/06 RIS-02-15, NRC Approval of Commercial Data All authorized recipients and holders of
Rev. 1 Encryption Products For the sensitive unclassified safeguards
Electronic Transmission Of information (SGI).
Safeguards Information
01/24/06 RIS-06-01 Expiration Date for NRC-Approved The U.S. Nuclear Regulatory Commission
Spent Fuel Transportation Routes (NRC) licensees who transport, or deliver
to a carrier for transport, irradiated
reactor fuel (spent nuclear fuel (SNF)).
01/13/06 RIS-05-27, NRC Timeliness Goals, All 10 CFR Parts 71 and 72 licensees
Rev. 1 Prioritization of Incoming License and certificate holders.
Applications and Voluntary
Submittal of Schedule for Future
Actions for NRC Review
11/14/06 IN-06-25 Lessons Learned From NRC All power reactors, category I fuel cycle
Inspection Of Control And facilities, independent spent fuel storage
Accounting Of Special Nuclear installations, conversion facility, and
Material At Commercial Nuclear gaseous diffusion plants. Note that the
Power Reactors information notice contains physical
security information and is, therefore, being withheld from public disclosure in
accordance with 10 CFR 2.390
11/7/06 IN-06-23 Events Involving Potential All power reactors, category I fuel cycle
Tampering Or Malfeasance By facilities, independent spent fuel storage
Persons Granted Unescorted installations, conversion facility, and
Access gaseous diffusion plants. Note that the
information notice contains physical
security information and is, therefore, being withheld from public disclosure in
accordance with 10 CFR 2.390
07/10/06 IN-06-13 Ground-Water Contamination All holders of operating licenses for
Due to Undetected Leakage of nuclear power and research and test
Radioactive Water reactors including those who have
permanently ceased operations and
have certified that fuel has been
permanently removed from the
reactor and those authorized by Title
10 of the Code of Federal Regulations
(10 CFR) Part 72 licenses to store
spent fuel in water-filled structures.
07/06/06 IN-06-12 All materials licensees.
Exercising Due Diligence When
Transferring Radioactive
Materials
06/12/06 IN-06-11 Applicability of Patient Intervention All medical licensees.
in Determining Medical Events for
Gamma Stereotactic Radiosurgery
and Other Therapy Procedures
03/31/06 IN-06-07 Inappropriate Use of a Single- All licensees authorized to possess a
parameter Limit as a Nuclear critical mass of special nuclear material.
Criticality Safety Limit Date GC No. Subject
Addressees
03/21/06 IN-02-23, Unauthorized Administration of All medical licensees.
Supl. 1 Byproduct Material for Medical Use
01/19/06 IN-06-02 Use of Galvanized Supports and All holders of operating licenses for
Cable Trays with Meggitt Si 2400 nuclear reactors except those who have
Stainless- Steel-jacketed Electrical permanently ceased operations and have
Cables certified that fuel has been permanently
removed from the reactor vessel; and fuel
cycle licensees and certificate holders.
Note: NRC generic communications may be found on the NRC public website at http://www.nrc.gov, under Electronic