Information Notice 2000-05, Recent Medical Misadministrations Resulting from Inattention to Detail
| ML003700710 | |
| Person / Time | |
|---|---|
| Issue date: | 03/06/2000 |
| From: | Cool D NRC/NMSS/IMNS |
| To: | |
| References | |
| IN-00-005 | |
| Download: ML003700710 (5) | |
UNITED STATES
NUCLEAR REGULATORY COMMISSION
OFFICE OF NUCLEAR MATERIAL SAFETY AND SAFEGUARDS
WASHINGTON, D.C. 20555 March 06, 2000
NRC INFORMATION NOTICE 2000-05: RECENT MEDICAL MISADMINISTRATIONS
RESULTING FROM INATTENTION TO DETAIL
Addressees
All medical licensees.
Purpose
The U.S. Nuclear Regulatory Commission (NRC) is issuing this information notice to remind
addressees of the importance of following written directives and procedures, and the need to
pay attention to detail, especially when verifying patient identity, programming treatment
devices and preparing treatment doses. It is expected that recipients will review the information
for applicability to their facilities and consider actions, as appropriate, to avoid similar problems.
However, suggestions contained in this information notice are not new NRC requirements;
therefore, no specific action nor written response is required.
Description of Circumstances
The NRC has become aware of a number of medical misadministrations over the past year, because of licensees not following written directives or procedures, and a lack of attention to
detail. The following are brief summaries of misadministrations, caused by inattention to detail, that have occurred since January 1999:
1. A patient received an underdose to an intended site and a dose to an unintended site
during a high dose rate afterloader (HDR) treatment. An error, made by a technologist
when programming the parameters into the HDR, was not detected by the physicist
required to verify the information keyed into the console. The technologist responsible
for setting up the HDR was unfamiliar with the skip process and did not program the
skip into the HDR, even though it was clearly marked on the written directive. The skip
process, in this particular remote afterloader, involves the sending of the source to the
end of the catheter as a starting point and then moving the source back to the
designated first radiation point. Because the skip was not programmed, the source
started the radiation treatment from the end of the catheter, resulting in a dose to an
unintended site. Ineffective training and inattention to detail were considered the root
causes of this misadministration.
2. A patient received a cobalt-60 teletherapy treatment instead of a linear accelerator
treatment, after being misidentified by the technologist, when the patient mistakenly
responded to the name announced by the technologist. The technologist had reviewed
the written directive and the photograph of the individual to be treated as per
procedures, but did not compare the photograph to the individual and did not ask for
additional identification.
ML 003700710
Template: NRR-052
IN 2000-05 March 6, 2000 3. A misadministration, resulting in an approximate 32 percent overdose, occurred when
the treatment dosage, ordered before the preparation of a written directive, was
greater than the dosage later prescribed in the written directive. The technologist
administering the dosage failed to compare it to the correctly prescribed dosage in the
written directive. The technologist also failed to obtain second party verification of the
dosage, before treatment, as required by procedure.
4. A patient received an underdose to the intended site and a dose to an unintended site
during an HDR treatment. After several unsuccessful attempts to electronically
transfer a patient's treatment plan to the HDR treatment system, the licensee manually
entered the treatment plan directly into the treatment system's control station. While
manually entering changes to the source dwell times, an unintended change to the
source step size occurred. The licensee did not notice this change and the patient was
treated using the incorrect step size resulting in the misadministration. The licensee
attributed this unintended and unnoticed change in step size to a software problem.
However, had the licensee properly reviewed the complete final treatment plan, which
clearly showed the changed step size, this misadministration could have been
prevented.
5. A patient received an overdose while participating in a new protocol that recommended
a lower dosage for a whole body scan using Iodine-131. The dosage administered to
the patient was the licensees standard dosage for a whole body scan and was not
verified against the written directive, resulting in a dosage 25 percent greater than that
prescribed in the written directive. The failure to check the written directive prior to
treatment resulted in this misadministration.
6. A licensee reported a teletherapy misadministration when a technician left a 30-degree
wedge out of the treatment site, which resulted in a weekly total dose 33 percent
greater than that prescribed for the teletherapy series. The misadministration occurred
during daily treatments for 5 consecutive days. The root cause of this
misadministration was inattention to detail and failure to follow the licensee's written
Quality Management Program procedures.
7. A medical misadministration was reported when a patient was administered a smaller
dosage instead of the intended therapeutic dosage, resulting in a 33 percent
underdose. The investigation determined that the dosage ordered from the
radiopharmacy was less than the dosage prescribed in the written directive. The root
causes of this incident were the failure to verify that the administered dosage was in
accordance with the written directive and the failure to order the correct dosage from
the radiopharmacy.
8. A patient received a 12.3 percent therapeutic underdose during a treatment involving
gamma sterotactic radiosurgery. While inputting the treatment data into the planning
computer, an incorrect date, 1/6/1998, was entered rather than the actual date,
1/6/1999, resulting in a difference in the decay calculation for the source. Contributing
factors to the event included: 1) a failure to recognize a treatment planning computer
warning that the entered treatment date differed from the system date; 2) a decision
not to repeat the daily treatment planning computer test after the computer had gone
down; and, 3) a failure to ensure that the treatment date was accurate before dose
administration.
IN 2000-05 March 6, 2000 Discussion:
The guidance in 10 CFR 35.32(a)(1) requires that written directives be prepared before
administration for brachytherapy, teletherapy, gamma sterotactic radiosurgery, quantities
greater than 30 microcuries of either sodium iodide I-125 or I-131, and any therapeutic
administration of a radiopharmaceutical other than sodium iodide I-125 or I-131. 10 CFR
35.32(a)(3)& (4) require that final treatment plans and related calculations and administration
are in accordance with the respective written directives. It is important that written directives
and procedures are kept up to date and provide adequate information. It is also important that
management place a high premium on staff following all procedures and directives, that all staff
are trained, and that training programs are effective in relaying necessary information. In all of
the cases noted above, written directives and procedures were in place. However, failure to
adhere to the procedures and directives, a lack of attention to detail, or a failure to perform
adequate, independent verification of treatment plans, patient identities, and treatment doses
contributed to all of these misadministrations.
Licensees should ensure that personnel are aware of and understand the requirements for
written directives, procedures and policies; and that personnel review written directives (during
pre-planning and prior to administration); confirm patient identity; review parameters entered for
treatment planning computers; and verify patient doses. Additional time and effort spent in
verifying calculations, patient identities, and treatment parameters, before a procedure or an
administration, will help to ensure that the physicians written directive is carried out.
Related Generic Communications:
NRC IN 95-39: Brachytherapy Incidents Involving Treatment Planning Errors; and NRC
IN 88-93: Teletherapy Events.
This IN requires no specific action nor written response. If you have any questions about the
information in this notice, please contact the technical contacts listed below or the appropriate
regional office.
/RA/
Donald A. Cool, Director
Division of Industrial and
Medical Nuclear Safety
Office of Nuclear Material Safety
and Safeguards
Contact(s): Susan L. Greene, NMSS
(301) 415-7843 E-mail: slg@nrc.gov
John D. Jones, RIII/DNMS
(630) 829-9832 E-mail: jdj@nrc.gov
Attachments:
1. List of Recently Issued NMSS Information Notices
2. List of Recently Issued NRC Information Notices
IN 2000-05 March 6, 2000 Discussion:
The guidance in 10 CFR 35.32(a)(1) requires that written directives be prepared before
administration for brachytherapy, teletherapy, gamma sterotactic radiosurgery, quantities
greater than 30 microcuries of either sodium iodide I-125 or I-131, and any therapeutic
administration of a radiopharmaceutical other than sodium iodide I-125 or I-131. 10 CFR
35.32(a)(3)& (4) require that final treatment plans and related calculations and administration
are in accordance with the respective written directives. It is important that written directives
and procedures are kept up to date and provide adequate information. It is also important that
management place a high premium on staff following all procedures and directives, and that all
staff are trained in training programs that are effective in relaying necessary information. In all
of the cases noted above, written directives and procedures were in place. However, failure to
adhere to the procedures and directives, a lack of attention to detail, and a failure to perform
adequate, independent verification of treatment plans, patient identities, and treatment doses
contributed to causing all of these misadministrations.
All licensees should remind personnel that written directives, procedures and policies are
required; and that personnel must review written directives (during pre-planning and prior to
administration); confirm patient identity; review parameters entered for treatment planning
computers; and verify patient doses. Extra time and effort spent in verifying calculations, identities, etc., before a procedure/administration can save a lot of time and effort in dealing
with misadministrations; and more importantly, reduce the potential for patient injury.
Related Generic Communications:
NRC IN 95-39: Brachytherapy Incidents Involving Treatment Planning Errors; and NRC
IN 88-93: Teletherapy Events.
This IN requires no specific action nor written response. If you have any questions about the
information in this notice, please contact the technical contacts listed below or the appropriate
regional office.
/RA/
Donald A. Cool, Director
Division of Industrial and
Medical Nuclear Safety
Office of Nuclear Material Safety
and Safeguards
Contact(s): Susan L. Greene, NMSS
(301) 415-7843 E-mail: slg@nrc.gov
John D. Jones, RIII/DNMS
(630) 829-9832 E-mail: jdj@nrc.gov
Attachments:
1. List of Recently Issued NMSS Information Notices
2. List of Recently Issued NRC Information Notices
G:ADAMS/ML 003700710
- SEE PREVIOUS CONCURRENCE
OFC MSIB EDITOR MSIB DCOOL
NAME SGreene EKraus* JHickey* DCool
DATE 2/17/00 12/17/99 1/24/00 2/23/00
OFFICIAL RECORD COPY