View source for Information Notice 1989-12, Dose Calibrator Quality Control

{{Adams
| number = ML031180519
| issue date = 02/09/1989
| title = Dose Calibrator Quality Control
| author name = Cunningham R
| author affiliation = NRC/NMSS/IMNS
| addressee name = 
| addressee affiliation = 
| docket = 05000000, 05000003, 05000010, 05000029, 05000133, 05000155, 05000171, 05000206, 05000213, 05000219, 05000220, 05000237, 05000244, 05000245, 05000247, 05000249, 05000250, 05000251, 05000254, 05000255, 05000259, 05000260, 05000261, 05000263, 05000265, 05000266, 05000267, 05000269, 05000270, 05000271, 05000272, 05000275, 05000277, 05000278, 05000280, 05000281, 05000282, 05000285, 05000286, 05000287, 05000289, 05000293, 05000295, 05000296, 05000298, 05000301, 05000302, 05000304, 05000305, 05000306, 05000309, 05000311, 05000312, 05000313, 05000315, 05000316, 05000317, 05000318, 05000320, 05000321, 05000322, 05000323, 05000324, 05000325, 05000327, 05000328, 05000329, 05000330, 05000331, 05000333, 05000334, 05000335, 05000336, 05000338, 05000339, 05000341, 05000344, 05000346, 05000348, 05000352, 05000353, 05000354, 05000358, 05000361, 05000362, 05000364, 05000366, 05000368, 05000369, 05000370, 05000373, 05000374, 05000382, 05000387, 05000388, 05000389, 05000390, 05000391, 05000395, 05000397, 05000400, 05000409, 05000410, 05000412, 05000413, 05000414, 05000416, 05000417, 05000423, 05000424, 05000425, 05000437, 05000438, 05000439, 05000440, 05000441, 05000443, 05000444, 05000445, 05000446, 05000454, 05000455, 05000456, 05000457, 05000458, 05000461, 05000482, 05000483, 05000498, 05000499, 05000508, 05000528, 05000529, 05000530
| license number = 
| contact person = 
| document report number = IN-89-012, NUDOCS 8902060122
| document type = NRC Information Notice
| page count = 10
}}
{{#Wiki_filter: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 have any

No written response is required by this information notice. If you

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

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89-12 IN11                                                      N...-'Attachment

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89-03              Potential Electrical            01/l/Ag       All Fuel Cycleand         89-11 Equipment Problems                                                                      Failure of DCMotor-Operated   212/89         All holders of OXs

maJor nuclear materials                   valves to Develop Rated                       or Cpsfor nuclear

licensees                       -         Torque Because of leproper                    power reactors.

89-02             Criminal prosecution of         01/09/88       All holders of hRC                        CableSizing

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Teletherapy Events                                                                       in the alcellstion of the                    research reactors.

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88-90            Unauthorized removel of                                                   89-08          PusPDeage Causedby            1/26/89
                                                    11/22/88      All NRC   licensees                       Low-Flow peration                            All holders of OLs

industrial nuclear gauges                     authorized to                                                                           or CPsfor nuclear

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manufacture, or            89-07          failures  of Sall-Diameter     1/25S89       All holders of tLs

distribute Industrial                     Tubing Ia Control Air, Peal                  or CPsfor nuclear

nuoIear gauges                            Oil, andLube Oil Systems                     power reactors.

88-66             Industrial radiography                                                                   Which Render Emargency Diesel

08/22/88       AllNIRIndustrial                          Genarators Inoperable

inspection andenforcement                      radiography     licensees

58-62            Recent findings concerning                                                89-06           Beat Anchor 8.1ts In          1/24/89        All holders of OLs

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UNITED STATES

NUCLEAR REGULATORY COMMISSION                                                                                                                  FIRST CLASS MAIL

WASHINGTON, D.C. 20555                                                                                                         POSTAGE AtFEES PAID

USNRC

PERMIT No. G7 OFFICIAL BUSINESS

PENALTY FOR PRIVATE USE, $300

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*      IMAB*         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 :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*       IMAB*         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   :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*
Edi tor*     IMAB*          IMAB*        RI*            OE*
EKraus       SJones         NMcElroy     JJoyner        JLieberma

1/30/89      2/1/89         2/2/89       2/2/89         1/30/89     \
OFC:  IMOB*     :IMOB,     *IMAW     :I         :AMNS       :IMNS

NAME:SMoore/sm             :JA  tin 'cJ

:OH   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:    List of Rc-cntly Issued NRC Iffoion.             Notices

awa4 #4 4 ,P       V)MS$524r                 0
L. CZ       AM' gertj,;        w      A10C l40-    1           ?41 See Previous Concurrences*
Editor*        IMABA1 fr' IMAB                RI     i        OE

EKraus        SJones         NMcE roy         JJoyner

1/30/89       21/ /89       A/00 /9          ;/1/ /89         1/;.AI89&deg;
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:   List of Recently Issued NRC Information Notices

Ar       IMAB           IMAB         RI             OE

SJones         NMcElroy     JJoyner

rr    9s    1/ /89         1/ /89       1/ /89         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}}

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