ML20127C120
| ML20127C120 | |
| Person / Time | |
|---|---|
| Issue date: | 09/20/1984 |
| From: | Cobb L NRC OFFICE OF INSPECTION & ENFORCEMENT (IE) |
| To: | Axelson W, Barr K, Joyner J NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION I), NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION II), NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION III) |
| Shared Package | |
| ML20127A504 | List: |
| References | |
| FOIA-85-69 NUDOCS 8410020202 | |
| Download: ML20127C120 (2) | |
Text
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.: s 4 % September 20, 1984 Dcs MEMORANDUM FOR: James H. Joyner, Chief Nuclear Materials and Safeguards Branch, RI ,
Kenneth P. Barr, Chief '
. Nuclear Materials Safety and Safeguards Branch, RII William L. Axelson, Chief Materials and Safeguards Branch, RIII Ramon E. Hall, Chief Vendor Programs Branch, RIV Matthew D. Schuster, Chief Safeguards and Emergency Preparedness Branch, RV FROM: Leonard I. Cobb, Chief Safeguards and Materials Programs Branch, IE
SUBJECT:
FREQUENCY OF VIOLATIONS OF NUCLEAR MEDICINE AND TELETHERAPY LICENSEES A study by IE of the results of about 400 inspections conducted over a six month period (January 1 - June 30,1984) showed that 61% of nuclear medicine and 65% of teletherapy' inspections were " clear" inspections. Below are listed the most frequently found serious violations.
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No. of NUCLEAR MEDICINE Inspections VIOLATIONS 88 Failure to conduct linearity checks (42), constancy checks (14),
and accuracy checks (22) 46 Failure to survey waste storage, preparation, and elution areas 30 Failure to follow procedures for surveying and opening inco.ning packages 30s 5 Failure of Isotopes Committees to meet quarterly
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Failure to leak test sealed sources 8 Failure of workers to wear gloves, protective clothing, or survey themselves Failure to secure licensed material in unrestricted areas 16 Failure to calibrate radiation survey instruments
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I O w Multiple Addressees 2 No. of . NUCLEAR MEDICINE Inspections VIOLATIONS 16 Failure to have any survey instruments or proper survey instruments 15 Workers not properly trained (10 CFR 19.12) 12 Failure to provide personnel extremity dosimetry 10 Radioactive materials used by unauthorized users 10 Improper disposal of radioactive materials 7 Failure to survey clean trash receptacles that were found to have radioactive materials in them 7 Failure to maintain records of personnel dosimetry 7 Failure to check for molybdenum-99 breakthrough TELETHERAPY 5 Failure to make spot checks or spot checks incomplete 4 Failure to leak least sealed sources 3 Failure to have spot checks reviewed by a qualified expert 3 Failure to calibrate dosimetry system There were many other violations equal to or greater in frequency than the above; however, the listed violations appear to be the most critical.
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Leonard I. Cobb, Chief Safeguards and Materials Programs Branch, IE cc: P. Vacca, NMSS Distribution DCS SMPB reading QASIP reading J. Metzger, IR L. Cobb, IE S y E C: J: IE JM6% str LCoM n 1 % __t M e e___ __ ___ _ __ __(1 Ih _1 OA
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E N C L 0 S_U R E .
E RADIOLOGICAL INCIDENTS AT MEDICAL FACILITIES .
FROM JANUARY 1982 TO DECEMBER 1984 t
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The incidents below have been reported by medical licensees for the PNs may or January 1982 to December 1984.due to a license condition or a 10 CFR regulation.
have, reported cay not have been issued for these incidents.
The incidents are categorized according to the frequency of occurrence.
A. Reports of Theft or Loss of Licensed Material i
B. Overexposures C. Radwaste D. Transportation E. Equipment Malfunction F. Effluent Release G. Leaking Sources .
H. Miscellaneous l
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i A. REFORTS OF THEFT OR LOSS OF LICENSED MATERIAL
- 1. A shipment consisting of a 6 millicurie (mci) I-131 caps delivery.
ment.
2.
Several mci of H-3 and C-14 were missing from the licensee's unlocked sto facility and thought to be stolen.
3.
Two seeds of I-125 expelled with the patient's urine were set aside for the RSO.
When the RSO arrived shortly thereafter, only one of the two seeds A thorough search did not reveal the missing seed.
remained.
4.
One strip of three Ir-192 seeds 1.6 mci removed from a patient was lost.
Surveys of the area and the patient showed no radioactivity.
5.
A nuclear medicine technologist used a 6.3 microcurie (pCi)thesource for However, instrument calibration and returned the source to storage.
source could not be located afterwards.
- 6. A dose consisted of capsules of cyanocobalamin 0 I
truck.
Probably thrown out mci of H-3 were missing from the licensee's lab.
- 7. Two with trash.
8.
A 6.7 pCi CS-137 source reported lost was found undamaged in the of a lead container used to store reference sources.The ribbon containing Seven Ir-192 seeds around 4.4 mci were found missing.
- 9. the seeds had come out of the tongue implant in spite of having been in place.
10.
A Mo-99/Tc-99m generator, 880 mci, delivered by a Nuclear Pharmacy to a licensee could not be found.
Seeds totaling 57 mci were discovered to be missing after being remo 11.
a patient.
Loss discovered approximately five weeks after sources had been removed from a patient.
- 12. A 50 mci Cs-137 seed was discovered to be lost.
The seeds were lost during a therapy procedure,
- 13. Seven Ir-192 seeds were lost. It is theorized that the patient swallowed '
a total of 16 Ir-192 ribbons.
the ribbon and subsequently passed it in a bowel movement.
- 14. An Ir-192 seed containing 0.77 mci was lost.
Licensees found to have a poor accounta-
- 15. A 100 mci Cs-137 source was lost.
bility process.
16.
A 50 mci Cs-137 brachytherapy source was lost after removal from p I a
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4 Page 2 Reports of Theft or loss of Licensed Material -
I Survey failed
- 17. One Ir-192 seed .77 mci after removal from patient was lost.
to turn up seed.
18.
A source used with an anatomical marker was lost sometime during the last four years.
The source discovered missing when wipe test was to be con-ducted.
They had been sent to
- 19. Fifty I-125 seeds totaling about 25 mci were lost.the facilities ste
- 21. Three Ir-192 seeds were unaccounted for and presumed lost, most probab ,
disposed of to sanitary landfill with trash.
total.
- 22. Four I-125 seeds implanted in patient were lost.
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- l B. OVEREXPOSURES 1.
An individual working in a restricted area received a 1.279 rcm whole body dose.
2.
A medical technologist received a whole body dose of 9.710 rems while attemp i
ing to correct a malfunction of a Co-60 teletherapy machine.
Two 3.
A thyroid bioassay ir.dicated an employee uptake of I-131 of 400 MPC-HRS.
other individuals showed uptakes of 156 and 56.3 MPC hours.
- 4. A film badge showed 5.1 rem to a therapy physicist.
Therapist removed
- 5. A radiation therapist received a dose of 2.15 rads.
applicators from two patients believing sources had already been removed The brachytherapy sources were still present in one applicator.
6.
An individual working in a restricted area in a nuclear medicine department received 1.330 rem.
7.
An individual working in a restricted area received a whole body exposure of 1.270 rem.
- 8. An individual received a whole body exposure of 1.79 rem.
- 9. An exposure of 1.34 rem was received in the 4th quarter of 1983.
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- 10. A radiation therapy employee indicated a 1.45 rem whole b month of January.
- such an exposure.
Lab coat with film badge attached had been thrown into linen bag in a Co-60 room.
11.
An individual working in a medical facility received a total absorbed dose to the thyroid of approximately 2000 rad.
12.
About 50 hospital employees received radiation exposures as a result of nine iridium-192 seeds found in a strand of nylon ribbon in one of the <
a needles. Hospital personnel thought there were no ribbons or see remaining in the needles. ;
member of the public and not a radiation worker, received a whole body
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l dose estimated to be between 750 and 800 millirems and, in addition, received dose of between 15 and 18 rems to the hands.
13.
Iodine-125 seed containing approximately 38-40 mil 11 curies of iodine-1 used for brachytherapy The wasrupture foundofinadvertently crushed during manipula the seed caused contamination in the brachytherapy room.
problems.
The highest dose in the exposed individuals was approximately
' O.77 rad.
- 14. Occurrence of badge overexposure of 18.7 rem.
- 15. Occurrence of hand exposure of 18.8 rem.
- 16. Deliberate badge overexposure of 1,850 mrem.
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I C. RADWASTE 1.
Radioactive gloves us.ed in the nuclear medicine department were dispos in the normal waste.
I- 2.
A contaminated disposable surgical glove was found in a laboratory receptacle for nonradioactive waste.
3.
A 2 mci tritiated waste disposed of with normal trash.
- 4. A vial containing 97 microcuries of radioactive solutio found in a receptacle for non-radioactive materials. ,
containing H-3 and C-14 were disposed
- 5. Seven plastic bags of dry solid waste of as ordinary trash.
6.
A box of radioactive waste was shredded in error and placed in a dumpster Fifty microcuries of iodine-125 was released as nonradioactive trash 7.
hospital incinerator. This material was incinerated with the normal trash.
The event resulted from a failure of the licensee to conduct proper surveys of potentially radioactive material prior to disposal. i f
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D. TRANSPORTATION d
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10 spent Tc-99m generators were lost during transportation and r from a field. it f cover.
- 2. because tape securing it did not cover both sides j A delivery agent from a radiopharmaceutical distributor t without removed se
- 3. decaying Mo-99/Tc-99m generators from a nuclear medicine depar authorization of shipping paper. lost Shipment of a 6100 mci iodine-131 capsules shipped to a hospi
- 4. r during transportation.
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a E. EQUIPMENT MALFUNCTION An installed radiation monitor, located in the teletherapy NRC treatmen
- 1. failed to' operate in the battery backup mode when tested by the inspector.
7 2.
Teletherapy room radiation monitoring device was not equipped wi battery backup. ff 3.
A malfunction in an AECL Theratron resulted from a loop being thro the cord reel.
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F. EFFLUENT RELEASE
- 1. A release of iodine-131 occurred during iodination.
- 2. Xenon 133 was released in a stack effluent.
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.G. LEAKING SOURCES Patients were not treated with
- 1. A Cs-137 needle was found to be leaking.
suspect needle.
2.
.A 430 microcurie Fe-55 source was found to be leaking.
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H. MISCELLANE0US
- 1. Unauthorized nuclear medicine procedures were performed in medical-facilities.
- 2. Two radiopharmacies received faulty Mo-99m/Tc-99m generators. Molybdenum breakthrough was not performed. As a result, a few hospitals received contaminated doses.
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CONCLUSION This report includes a review of incidents in medical facilities from January 1982 - December 1984. The enclosed chart illustrates the various categories of incidents versus the frequency of each category. Most of the incidents have occurred due to the theft or loss of licensed material and overexposures. The highest activity of the lost source was an 800 mci Mo-99/Tc-99m generator. The highest overexposure was a total absorbed dose of 2,000 rad to an employee's thyroid. Two overexposures included nonradiation workers. Such incidents may be a result of inadequate management direction. This is demonstrated by examples of insufficient supervision, limited or nonexistent instruction to radiation workers, improper surveillance techniques, and the inadequate implementation of procedures and licensed requirements.
Also these incidents indicate that licensees (1) Fail to read and understand the conditions of the license.
(2) Fail to train employees in the conditions of the license including the radiation safety procedures that are incorporated into the license.
(3) Fail to control operations including failure of licensee employees to follow approved radiation safety procedures.
I CHART I INCIDENTS AT MEDICAL FACILITIEIS 1982-1984 23-I ***
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D 6-I *** *** ***
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A B C D E F G H TYPE OF INCIDENTS A. Lost or Stolen Material E. Equipment Malfunction B. Overexposures F. Effluent Release C. Radioactive Waste G. Leaking Sources-D. Transportation H. Miscellaneous
i ENCL 0SURE 4 IE Staff Opinion:
MOST EFFECTIVE MEDICAL LICENSEE INSPECTION METHODS
.