Information Notice 1989-12, Dose Calibrator Quality Control
UNITED STATES
NUCLEAR REGULATORY COMMISSION
OFFICE OF NUCLEAR MATERIAL SAFETY AND SAFEGUARDS
WASHINGTON, D.C. 20555
February 9, 1989 NRC INFORMATION NOTICE NO. 89-12: DOSE CALIBRATOR QUALITY CONTROL
Addressees
All NRC medical licensees.
Purpose
This notice is provided to alert recipients to a frequent problem concerning
dose calibrator quality control tests, identified by NRC inspectors during
inspections of medical programs, and also to emphasize the importance of
quality control procedures for equipment used to assay patient doses. It
is expected that licensees will:
review this information for applicability
to their programs; distribute this notice to those responsible for radiation
safety and medical quality assurance, including technologists; and consider
actions to preclude similar situations from occurring at their facilities.
However, the suggestions contained in this notice do not constitute any new
NRC requirements, and no written response is required.
Description of Circumstances
During recent NRC inspections of medical facilities, inspectors have found
deficiencies and irregularities in the performance and recording of dose
calibrator quality control tests. The most common deficiency is a failure
to evaluate the recorded measurements against expected values, in order to
validate proper dose calibrator operation within the tolerances specified
in NRC regulations, licensee operating procedures, and license conditions.
Technologists often base their dose calibrator acceptance criteria solely
on the lack of any sudden or large changes in the recorded measurements, rather than using the approved, required NRC standards.
NRC inspectors
have documented several instances where measured readings have gradually
deviated from expected values; yet, licensees have failed to detect, and
therefore correct or repair, malfunctioning dose calibrators. In some
instances, a dose calibrator was later determined to be functioning properly, but the test itself had been performed improperly.
In all of these instances, prompt evaluation of recorded results would have assured proper performance
of tests and validation of measured patient doses.
A.
IN 89-12 February 9, 1989 Other types of problems related to the use of dose calibrators have also been
identified.
In some cases, licensees have identified a malfunctioning dose
calibrator, but then failed to take action to correct the problem.
In one
particular instance, the licensee's consultant made initial arrangements for
a replacement dose calibrator after a linearity test demonstrated non-linearity, but the licensee did not act on the consultant's recommendation and waited one
month before retesting the dose calibrator.
In other cases, technologists
failed to perform constancy checks when emergencies required the dose cali- brator to be used during periods such as weekends, when radiopharmaceuticals
are not normally administered to patients.
Of serious concern to the NRC is the finding, during several inspections, that
false information was recorded for dose calibrator tests.
In one case, a
consultant requested a technologist to repeat the linearity test.
Instead of
repeating the test, the technologist created a record using the results of a
linearity test performed 30 months before the recorded date.
In another case, an NRC inspection at a hospital revealed records indicating that a cobalt-57 check source (half life of 271 days) had not shown any decay in two months, resulting in a 15% decrepancy.
Discussion:
All medical licensees are reminded of the importance of making accurate
quaitycontrol checks of dose calibrators used to assay patient dosages.
NRC believes that the performance and evaluation of these dose calibrator
checks are necessary to ensure that the dosage administered is the same
as the dosage that was prescribed for the patient. These checks are es- sential steps for assuring safety and quality in the medical use of byproduct
material. Therefore, licensees should assure that technologists or other
individuals performing dose calibrator checks understand:
a) the applicable NRC regulations and specific license conditions;
by
the purpose, method, and importance of these tests; and
c when follow-up actions are necessary.
Licensees may wish to consider some type of audit or verification program to
detect performance errors, including:
failure to perform a test, inadequate
evaluation of a test, or falsification of test records. -Audits should include
interviews with and observations of personnel performing their duties, as well
as reviews of records to determine that the recorded results are correct.
Licensees are reminded that they are held responsible for the acts of their
employees and contractors.
Willful failure to perform required dose cali- brator tests and falsification of records have resulted in civil penalties
and orders modifying licenses to prohibit the involvement of individuals
responsible for licensed activities.
Willful violations can also result
in criminal prosecution against both the licensee and individual employees.
IN 89-12 February 9, 1989 No written response is required by this information notice. If you have any
questions about this matter, please contact the appropriate NRC regional
office or this office.
Richard E. Cunningham, Director
Division of Industrial and
Medical Nuclear Safety
Office of Nuclear Material
Safety and Safeguards
Technical Contact:
Sam Jones, NMSS
(301) 492-0571 Attachments:
1. List of Recently Issued
NtPSS Information Notices
2. List of All Recently Issued
NRC Information Notices
o
Attlchr t I
IN11
89-12
February 9. 19t9
Page I of I
LIST OF RECENilT
ISSUED
hl3S lNFORlA7101i
NOTICES
rrotrciarn
-
Date of
Itoti NO
S essuance
hIssou!d
te
N...-'Attachment
2 IN 89-1i
tebruary 9 19R9 Page I of l
LIS1 OF RECENTLV
ISSUED
NRC INFORMATION
NOTICES
Tn71rormtnl
D
Notice No.
Subject
Issued to
89-11 Failure of DC Motor-Operated
212/89
All holders of OXs
valves to Develop Rated
or Cps for nuclear
-
Torque Because of leproper
power reactors.
Cable
Sizing
89-03
Potential Electrical
Equipment Problems
89-02 e-ionn
88-90
88-66
58-62 ee-33
Criminal prosecution of
licensee s former president
for
Intent
ional safety
violations
Memorandum
of understanding
between NRC
and 0SA3 relating
to ORC-licensed
facilities
(53 FR 43950, October 31 1 9M
Teletherapy Events
Unauthorized removel of
industrial nuclear gauges
Industrial radiography
inspection and enforcement
Recent findings concerning
Irplemeatatisn
of quality
assurance programs by suppliers
of transport packages
Recent problems involving the
model Spec 2-T radiographic
exposure device
01/l/Ag
All Fuel Cycle
and
maJor nuclear materials
licensees
01/09/88
All holders of hRC
specific license
12/23/Be
All major
nuclear
materials
licensees
and utilities holding
CPs and Ots.
12/88
All NRC sedical
licensees
11/22/88 All NRC
licensees
authorized to
pss$ns. use, manufacture, or
distribute Industrial
nuoIear gauges
08/22/88
All NIR Industrial
radiography
licensees
09/1/288
All holders of NRC
quality assurance
progrom approvals for
rdioactive materiel
packages
05/27/8N
All Agreement States
and NRC licensees
authorized to
manufacture, distribute
or operate
radiographic etposure
devices and source
changers
89-10
Undetected Installation
Errors ta Maim
Stem Line
Pipe Tunnel Differential
Teomorature-Sensing Elements
at Boiling
Water
Reactors.
89-09
Credit for Control Rods
Without Scra Capability
in the
alcellstion of the
Shutdown Margie
89-08
PusP Deage Caused by
Low-Flow peration
89-07
89-06
89-05 failures
of Sall-Diameter
Tubing Ia Control Air, Peal
Oil, and Lube Oil Systems
Which Render Emargency Diesel
Genarators Inoperable
Beat Anchor 8.1ts In
8oiling tater Reactor
Tors Supports
Use of Deadly Force b
Suards Protecting Rluear
Power Reactors Against
Radiological Subotage
1/27189
All holders of Os
or CPs for BORs.
1/26/89
All holders of OLs
or CPs for test and
research reactors.
1/26/89
All holders of OLs
or CPs for nuclear
power reactors.
1/25S89
All holders of tLs
or CPs for nuclear
power reactors.
1/24/89
All holders of OLs
or CPs for MiRS with
llark I steal torus
shells.
1l/9/89
All holders of OLs
for nuclear power
reactors.
X
- Operating License
tP
- Construction Permit
- Operating
License
- Construction Permit
UNITED STATES
NUCLEAR REGULATORY COMMISSION
WASHINGTON, D.C. 20555
OFFICIAL BUSINESS
PENALTY FOR PRIVATE USE, $300
FIRST CLASS MAIL
POSTAGE At FEES PAID
PERMIT No. G7
IN 89-12 February 9, 1989 No written response is required by this information notice.
If you have any
questions about this matter, please contact the appropriate NRC regional
office or this office.
Richard E. Cunningham, Director
Division of Industrial and
Medical Nuclear Safety
Office of Nuclear Material
Safety and Safeguards
Technical Contact:
Sam Jones, NMSS
(301) 492-0571 Attachments:
1. List of Recently Issued
NMSS Information Notices
2. List of All Recently Issued
NRC Information Notices
- See Previous Concurrences*
Editor*
EKraus
1/30/89 IMAB*
SJones
2/1/89 IMAB*
NMcElroy
2/2/89 RI*
JJoyner
2/2/89 OE*
JLieberman
1/30/89 OFC: IMOB*
- IMOB
- IMAB
- IMOB
- IMNS
- IMNS
NAME:SMoore/sm :DCool
- JAustin :JHickey
- GSjoblom :RECunn
gham
DATE:1/26/89
- 2/02/89
- 2/02/89
- 2/02/89
- 2/ /89
- 2/03/89
IN 89-
February 1989
No written response is required by this Information Notice.
If you have any
questions about this matter, please contact the appropriate NRC Regional
Office or this office.
Richard E. Cunningham, Director
Division of Industrial and
Medical Nuclear Safety
Office of Nuclear Material
Safety and Safeguards
Technical Contact:
Sam Jones, NMSS
(301) 492-0571 Attachments:
1. List of Recently Issued
NMSS Information Notices
2. List of All Recently Issued
NRC Information Notices
See Previous Concurrences*
Editor*
EKraus
1/30/89 IMAB*
SJones
2/1/89 IMAB*
NMcElroy
2/2/89 RI*
JJoyner
2/2/89 OE*
JLieberman
1/30/89 OFC: IMOB*
- IMOB
- IMAB
- IMOB
- IMNS
- IMNS
NAME:SMoore/sm :DCool
- JAustin
- JIH
key
- GSjoblom :KECunningham
DATE:1/26/89
- 2/02/89
- 2/02/89
- 2/02/89
- 2/ /89 :2/03/89
IN 89- February
, 1989 No written response is required by this Information Notice. If you have any
questions about this matter, please contact the appropriate NRC Regional
Office or this office.
Richard E. Cunningham, rector
Division of Industri
and
Medical Nuclear S fety
Office of Nuclear aterial
Safety and Sa guards
Technical Contact:
Sam Jones, NMSS
(301) 492-0571 Attachments:
1. List of Recently Issued
NMSS Information Notices
2. List of All Recently Issued
NRC Information Notices
See Previous Concurr nces*
Editor*
MAB*
IMAB*
RI*
OE*
EKraus
SJones
NMcElroy
JJoyner
JLieberman
1/30/89
2/1/89
2/2/89
2/2/89
1/30/89 OFC: IMOB*
- IMOB
- IMAB
- IMOB
- IMNS
- IMNS
NAME:SMoore/sm :DCool
- JAustin :JHickey
- GSjoblom : ECunn7ngham
DATE:1/26/89
- 2/ /89
- 2/ /89
- 2/ /89
- 2/ /89
- 2/S /89
IN 89- February
, 1989 No written response is required by this Information Notice. If you have any
questions about this matter, please contact the appropriate NRC Regional
Office or this office.
Richard E. Cunningham, Director
Division of Industrial and
Medical Nuclear Safety
Office of Nuclear Material
Safety and Safeguards
Technical Contact:
S. Jones, NMSS
(301) 492-0571 Attachments:
1. List of Recently Issued NMSS Information Notices
2. List of All Recently Issued NRC Information Notices
See Previous Concurrences*
OE*
JLieberma
1/30/89
\\
Edi tor*
EKraus
1/30/89 IMAB*
SJones
2/1/89 IMAB*
NMcElroy
2/2/89 RI*
JJoyner
2/2/89 OFC: IMOB*
- IMOB,
- IMAW
- I
- AMNS
- IMNS
NAME:SMoore/sm
JA tin
- OH
'cJ
ey
- GS
lom :RECunningham
DATE:1/26/89
- 2/i /89
- 2/ V/89
- 2/ ) 89
- 2/ /1
,
- 2/ /89
IN 89- February
, 1989 No written response is required by this Information Notice. If you have any
questions about this matter, please contact the appropriate NRC Regional
Office or this office.
Richard E. Cunningham, Director
Division of Industrial and
Medical Nuclear Safety
Office of Nuclear Material
Safety and Safeguards
Technical Contact:
S. Jones, NMSS
(301) 492-0571 Attachment:
L.
C Z
List of Rc-cntly Issued NRC Iffoion. Notices
awa4 #4 4,P
V)MS$ 524r
0
AM' gertj, ;
w
A10C l40-
1
?41 See Previous Concurrences*
Editor*
EKraus
1/30/89 IMABA 1 fr'
SJones
21/ /89 IMAB
NMcE roy
A/00 /9 RI
i
JJoyner
- /1/ /89 OE
1/;.AI89°
OFC: IMOB*
- IMOB
- IMAB
- IMOB
- IMNS
- IMNS
NAME:SMoore/sm :DCool
- JAustin
- JHickey
- GSjoblom :RECunningham
DATE:1/26/89
- 1/
/89
- 1/ /89
- 1/ /89
- 1/ /89
- 1/ /89
IN 89- February
, 1989 No written response is required by this information notice.
If you have any
questions about this matter, please contact the appropriate NRC regional
office or this office.
Richard E. Cunningham, Director
Division of Industrial and
Medical Nuclear Safety
Office of Nuclear Material
Safety and Safeguards
Technical Contact:
S. Jones, NMSS
(301) 492-0571 Attachment:
Ar
rr
9s
List of Recently Issued NRC Information Notices
IMAB
SJones
1/ /89 IMAB
NMcElroy
1/ /89 RI
JJoyner
1/ /89 OE
1/ /89 OFC: IMOB
- IMOB
- IMAB
- IMOB
- IMNS
- IMNS
NAME:SToo're/sm :DCool
- JAustin
- JHickey
- GSjoblom :RECunningham
DATE:1/96/89
- 1/ /89
- 1/ /89
- 1/ /89
- 1/ /89
- 1/ /89