Information Notice 1989-12, Dose Calibrator Quality Control

Dose Calibrator Quality Control

ML031180519
Person / Time
Site:	Beaver Valley, Millstone, Hatch, Monticello, Calvert Cliffs, Dresden, Davis Besse, Peach Bottom, Browns Ferry, Salem, Oconee, Mcguire, Nine Mile Point, Palisades, Palo Verde, Perry, Indian Point, Fermi, Kewaunee, Catawba, Harris, Wolf Creek, Saint Lucie, Point Beach, Oyster Creek, Watts Bar, Hope Creek, Grand Gulf, Cooper, Sequoyah, Byron, Pilgrim, Arkansas Nuclear, Three Mile Island, Braidwood, Susquehanna, Summer, Prairie Island, Columbia, Seabrook, Brunswick, Surry, Limerick, North Anna, Turkey Point, River Bend, Vermont Yankee, Crystal River, Haddam Neck, Ginna, Diablo Canyon, Callaway, Vogtle, Waterford, Duane Arnold, Farley, Robinson, Clinton, South Texas, San Onofre, Cook, Comanche Peak, Yankee Rowe, Maine Yankee, Quad Cities, Humboldt Bay, La Crosse, Big Rock Point, Rancho Seco, Zion, Midland, Bellefonte, Fort Calhoun, FitzPatrick, McGuire, LaSalle, 05000000, Zimmer, Fort Saint Vrain, Shoreham, Satsop, Trojan, Atlantic Nuclear Power Plant
Issue date:	02/09/1989
From:	Cunningham R NRC/NMSS/IMNS
To:
References
IN-89-012, NUDOCS 8902060122
Download: ML031180519 (10)

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

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

89-12 IN11 N...-'Attachment

February 9. 19t9 IN 89-1i 2 Page I of I tebruary 9 19R9 Page I of l

LIST OF RECENilT

ISSUED

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NOTICES LIS1OFRECENTLV ISSUED

NRCINFORMATION NOTICES

rrotrciarn - Date of

Itoti NO hIssou!dS essuance Tn71rormtnl D

te Notice No. Subject Issued to

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

licensee s former president specific license 89-10 Undetected Installation

for

Intent

ional safety 1/27189 All holders of Os

violations Errors taMaimStem Line or CPsfor BORs.

Pipe Tunnel Differential

e-ionn Memorandum of understanding Teomorature-Sensing Elements

12/23/Be All majornuclear at Boiling WaterReactors.

between NRC and0SA3relating materials licensees

to ORC-licensed facilities and utilities holding 89-09 Credit for Control Rods

(53 FR43950, October 31 19M 1/26/89 All holders of OLs

CPsandOts. Without Scra Capability or CPsfor test and

Teletherapy Events in the alcellstion of the research reactors.

12/88 All NRC sedical Shutdown Margie

licensees

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

pss$ns. use, power reactors.

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

09/1/288 All holders of NRC 8oiling tater Reactor or CPsfor MiRSwith

Irplemeatatisn of quality quality assurance Tors Supports

assurance programs by suppliers llark I steal torus

of transport packages progrom approvals for shells.

rdioactive materiel

packages 89-05 Useof Deadly Force b 1l/9/89 All holders of OLs

ee-33 Recent problems involving the Suards Protecting Rluear for nuclear power

05/27/8N All Agreement States Power Reactors Against

model Spec 2-T radiographic and NRClicensees Radiological Subotage

reactors.

exposure device authorized to

manufacture, distribute

or operate

radiographic etposure X

• Operating License

devices and source tP

• Construction Permit

changers

OL* Operating License

CP* Construction Permit

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

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

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

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

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

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°

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

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