ML20202C205
| ML20202C205 | |
| Person / Time | |
|---|---|
| Site: | 03001214 |
| Issue date: | 11/26/1997 |
| From: | Scarano R NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION IV) |
| To: | Cullen S VETERANS ADMIN. MEDICAL CENTER, SAN FRANCISCO, CA |
| Shared Package | |
| ML20202C209 | List: |
| References | |
| 30-01214-97-01, 30-1214-97-1, EA-97-529, NUDOCS 9712030283 | |
| Download: ML20202C205 (5) | |
See also: IR 07100016/2011014
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EA 97 529
Sheila Cullen
Actin 3 Medical Center Director
Department of Veterans Affairs
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Medical Center
4150 Clement Street
San Francisco, California 94121
SUBJECT: NRC INSPECTION REPORT 030-01214/97 01
Dear Ms. Cullen:
On October 27,1997, the NRC completed a special, anaounced inspection of licentad
activities at your f acility in San Francisco, California. The inspection was conducted in
response to an event involving the loss of a phosphorus 32 (P 32) source from your facility
that was reported to NRC on September 2,1997. The findings of the inspection were
discussed with you and other members of your staff on October 27,1997. Additionally, a
telephonic exit briefing was subsequently conducted with the Associate Medical Center
Director and Radiation Safety Officer on November 14,1997.
Based on the results of this inspection, two apparent violations were identified and are
being considered for escalated enforcement action in accordance with the ' General
Statement of Policy and Procedure for NRC Enforcement Actions" (Enforcement Policy),
NUREG 1600. These apparent violations involved: (1) the failure to verify that the
contents of a package containing three P 32 vials agreed with the packing list for the
shipment received and to survey the package for contamination before it was disposed to
normal trash; end (2) the unauthorized disposal of a single P 32 vial to normal,
non-radioactive trash. The apparent violations identified above are described in detail in the
onclosed report.
The inspection disclosed that on August 18,1997, a shipping package enclosing three
vials. each containing approximately 30S microcuries of P-32, was initially received,
opened, suiveyed, logged in, and the contents checked by radiation safety office staff.
The package was closed and a short timo lates transferred to a research laboratory where it
was re-opened by an authorized user. However, the authorized user failed to adequately
4
check the shippinD records and contents of the package when it was opened and only two
of the three vials were removed. The package containing the third vial was then disposed
to normal trash whhout a radiation survey to determine that it was empty and free of
contamination. The package was apparently collected by a housekeeper and ultimately
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buried in a waste landfill. The third vial was. discovered missing on August 20,1997, and
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has not been recovered.
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November 26,1997
Department of Veterans Affairs
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Root causes of the event appeared to be a lack of attention to detail by the laboratory's
authorized user when checking the contents of packages received, and his lack of
knowledge about the requirement to survey packages before their disposal to normal trash.
Although these problems appear to have been limited to only one laboratory and authorized
user, the lack of control of licensed material in your facility is a radiation safety and
regulatory concern.
The circumstances surrounding the apparent violations, the significance of the issues, and
.
the need for lasting and effective corrective action werc discussed with you during the exit
briefing on October 17,1997, and with the Associate Director on November 14,1997.
Your immediatc actions to promptly and properly respond to the event were noteworthy.
Follow up corrective actions included issuing a vloiation notice to the responsible
laboratory, conducting additional training of authorized users that emphasized the
importance of carefully checking the contents of packages when received and surveying
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packages before their disposal to normal trash, and making administrative changes to the
licensed program involving the receipt of radioactive material, it also appears that any
radiation exposeres received by licensee personnel and members of the public who handled
the " empty" package af ter it was released to normal trash were small and well below NRC
dose limits.
As a result, it may not be necessary to conduct a predecblonal enforcement conference in
order to enable the NRC to make an enforcement decision. However, a Notice of Violation
is not presently being issued for these inspection findings. Before the NRC makes its
enforcement decision, we are providing you an opportunity, within 30 days of the date of
this letter, to either (1) respond to the apparent violations addressed in this inspection
report or (2) request, within 7 days of the date of this letter, a predecisionel enforcement
conference.
Your response should be clearly marked as a " Response to Apparent Violations in
inspection Report No. 030-012143/97 01 and should include for each apparent violation:
(1) the reason for the apparent violation, or, if contested, the basis for disputing the
apparent violation, (2) the corrective steps that have been taken and the results achieved,
(3) the corrective steps that will be taken to avoid further violations, and (4) the date when
tull compliance wi1 be achieved. Your response should be submitted under oath or
affirmation and may reference or include previous docketed correspondence, if the
correspondence adequately addresses the required response, if an adequate response is
not received within the time specified or an extension of tirne has not been granted by the
NRC, the NRC will proceed with its enforcement decision or schedule a predecisional
enforcement conf erence.
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in presenting your corrective action, you should be aware that the promptness and
comprehensiveness of your actions w!;l be considered in assessing any civil penalty for the
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November 26,1997
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apparent violations. The guldance in the enclosed NRC Information Notice 96 28,
" SUGGESTED GUIDANCE REl.ATING TO DEVELOPMENT AND IMPLEMENTATION OF
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CORRECTIVE ACTION" may be helpful.
If you choose not to provide a response and would prefer participating in a predecisional
enforcement conference, please contact Dr. D. Blair Spitzberg at (81*i) 860 8191 within
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7 days of the date of this letter.
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In addition, please be advised that the number and characterization of apparent violations
described in the cnclosed inspection report may change as a result of further NRC review.
You will be advised by separate correspondence of the results of our deliberations on this
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matter.
In accordance with 10 CFR 2.700 of the NRC's " Rules of Practice," a copy of this letter,its
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enclosures, and your response (if you choose to provide one) will be placed in the NRC
Public Document Room (PDR). To the extent possible, your response should not include
any personal privacy, proprietary, or safeguards information so that it can be placed in the
POR without redaction.
Should you have any questions concerning this inspection or the enclosed report, please
contact Dr. Spit-berg at the telephone number noted above.
Sincerely,
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Ross A. Scarano, Director
Division of Nuclear Materials Safety
Docket No.: 030-01214
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License No.: 0^-00421 -05
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Enclosures:
1. NRC Inspectinn Report 030-01214/97-01
2. NRC Enforcement Policy, NUREG 1600
3. NRC Information Non.e 96 28
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cc w/ enclosure 1:
California Radiation Control Program Director
Department of Veterans Affairs-
National Health Physics Program (115HP)
915 North Grand Boulevard
St. Louis, MO 63106
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November 26,1997
Edwin M. Leidholdt, Jr., Ph.D.
Radiation Safety Program Manager (134 RAD)
Department of Veterans Affairs
Western Region
301 Howard Street, Suits 700
San Francisco, CA 94105 2241
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