EA-98-555 - Washington Hospital Center
March 31, 1999
EA 98-555
Joyce E. Jonson, D.Sc.
Senior Vice President, Nursing and Patient Care
Washington Hospital Center
110 Irving Street, N.W.
Washington, DC 20010-2975
SUBJECT: NOTICE OF VIOLATION AND PROPOSED IMPOSITION
OF CIVIL PENALTY
- $5,500
(NRC
Inspection Report Nos. 070-01500/98-001 and 030-01325/98-004)
Dear Dr. Johnson:
This refers to the NRC inspection conducted on December 2-3, 1998, at
your facility in Washington, D.C., to review the circumstances associated
with the loss of a nuclear pacemaker, which you reported to the NRC on
November 30, 1998. The inspection was continued in the Region I office
until December 22, 1998, to review additional information provided to
the NRC, subsequent to the onsite inspection. As described in the NRC
inspection report sent to you on January 6, 1999, several apparent violations
of NRC requirements were identified during the inspection. On February
8, 1999, a predecisional enforcement conference was conducted with you
and other members of the Washington Hospital Center (WHC) staff, including
your recently appointed Acting Director of Radiation Safety, to discuss
the apparent violations, their causes, and your corrective actions. A
copy of the enforcement conference report was provided to you on February
25, 1999.
Based on the information developed during the inspection, and the information
provided during the conference, two violations of NRC requirements are
being cited. The violations are described in the enclosed Notice of Violation
and Proposed Imposition of Civil Penalty (Notice) and the circumstances
surrounding them are described in detail in the subject inspection report.
The more significant violation involved the loss of control of a nuclear
pacemaker, which contained 2.8 curies (Ci) of plutonium-238 (Pu-238),
when it was being prepared for shipment on September 15, 1998,
to St. Jude Medical, a non-nuclear pacemaker company in Sylmar, California.
The other violation involved the failure to make a timely report (i.e.,
within 30 days) by telephone after your staff identified that the
pacemaker was lost or missing.
During the inspection, your staff informed the NRC inspector that the
pacemaker was likely shipped through the normal postal service, without
a return address on the package, and was intended to be sent to St. Jude
Medical. However, that entity was not authorized, either by the NRC or
an Agreement State, to receive it. At the predecisional enforcement conference,
your staff presented a chronology of events similar to that presented
to the inspector. Your staff also indicated that, due to the uncertainty
as to whether the pacemaker was actually given to the U.S. Postal Service
(USPS), your staff conducted an extensive search with radiation survey
instruments at your facilities in an effort to find the pacemaker. However,
these efforts did not locate the pacemaker.
The first violation is of particular concern to the NRC because: (1) the
failure to control radioactive material resulted in the loss of the pacemaker;
and (2) a breach of the nuclear pacemaker, within which the radioactive
material is encapsulated, could result in a potentially significant intake
of Pu-238. On March 26, 1999, you notified the NRC that the
pacemaker had been located at the facilities of a NRC licensee in Minnesota.
Although the pacemaker has apparently been found, the significance of
the concern is not lessened because the potential still existed for a
breach of the pacemaker and a significant intake of radioactive material.
Therefore, Violation A has been classified as a Severity Level III violation
in accordance with the "General Statement of Policy and Procedures for
NRC Enforcement Actions" (Enforcement Policy), NUREG-1600, Revision 1.
In the past two years, three predecisional enforcement conferences were
held with you for violations which occurred at your facility. The violations
discussed at the prior two conferences resulted in the NRC issuance of
$5,000 and $2,750 civil penalties on April 10, 1997, and April 28,
1998, respectively. In each of those cases, the failure to provide adequate
training and instruction to staff was a contributing factor, as it was
in a prior civil penalty issued to you on April 28, 1994, for other violations
at your facility. In this case, the failure to train hazardous materials
personnel in the applicable Department of Transportation (DOT) requirements
may have been a root cause of the loss of control of the pacemaker.
In accordance with the Enforcement Policy, a base civil penalty in the
amount of $2,750 is considered for a Severity Level III violation or problem.
Because your facility has been the subject of an escalated enforcement
action within the last two years, the NRC considered whether credit was
warranted for Identification and Corrective Action in accordance
with the civil penalty assessment process in Section VI.B.2 of the Enforcement
Policy. Credit for identification is warranted because the violation associated
with the loss of control of the nuclear pacemaker was identified by your
staff after they called St. Jude Medical to confirm whether the pacemaker
had been received, and learned that it had not. Credit for corrective
actions is warranted because your corrective actions, were considered
prompt and comprehensive. These corrective actions include, but were not
limited to: (1) placing a hold on all radioactive material shipments from
your facility, except for the return of empty radiopharmaceutical containers
to radiopharmacies, until a review of the shipping protocols could be
completed; (2) contracting with a consultant from the National Institute
of Health to review radioactive material shipping protocols; (3) providing
the necessary hazardous material training to personnel, including the
necessity to verify that the recipient has the appropriate license; (4) hiring
of an Acting Director of Radiation Safety to oversee the restructuring
of your Radiation Safety Department and the update of your Radiation Safety
Manual; (5) posting two additional health physics positions to increase
radiation safety staffing at the facility; and (6) conducting radiation
surveys at your facility in an effort to find the pacemaker.
Given that credit is warranted for identification and corrective actions,
the NRC would not normally propose a civil penalty in this case. However,
I have decided, after consultation with the Director, Office of Enforcement,
and the Deputy Executive Director for Regulatory Effectiveness, to exercise
enforcement discretion pursuant to Section VII.A.1 of the Enforcement
Policy, and issue a Notice of Violation and Proposed Imposition of a Civil
Penalty in the amount of $5,500 (twice the base amount for Violation A).
Such discretion is warranted because: (1) this case involves the
loss of radioactive material, which was intended to be shipped to an entity
without verifying that the entity possessed an NRC license for receipt
of such material; (2) your performance in this case was poor; and (3)
your prior enforcement history has been particularly poor.
Based on the presumption that the pacemaker was shipped through the USPS,
the NRC's January 6, 1999 inspection report identified eight additional
apparent violations involving DOT requirements. While these apparent violations
are not being cited in the Notice, they will be referred to the USPS for
its review and action, as appropriate. Nevertheless, compliance with DOT
requirements is intended to serve as safety barriers designed to prevent
losses of radioactive material and to protect members of the public from
inadvertent and potentially significant radiation exposures. DOT requirements
include, but are not limited to, training, providing shipping papers,
labeling of packages, and verifying (before shipping) that the transferee
is authorized to receive radioactive material.
You are required to respond to this letter and should follow the instructions
specified in the enclosed Notice when preparing your response. As part
of your response, you should address any actions taken, or planned to
be taken, to ensure that future offsite shipments of radioactive material
meet applicable DOT requirements. The NRC will use your response, in part,
to determine whether further enforcement action is necessary to ensure
compliance with regulatory requirements.
In accordance with 10 CFR 2.790 of the NRC's "Rules of Practice," a copy
of this letter and its enclosure, will be placed in the NRC Public Document
Room (PDR).
| Sincerely, |
||
| ORIGINAL SIGNED BY JAMES T. WIGGINS |
||
| FOR | Hubert J. Miller Regional Administrator |
Docket Nos. 070-01500 and 030-01325
License Nos. SNM-1446 and 08-03604-03
Enclosure: Notice of Violation and Proposed Imposition of Civil Penalty
cc w/encl:
District of Columbia
ENCLOSURE
NOTICE OF VIOLATION
AND
PROPOSED IMPOSITION OF CIVIL PENALTY
| Washington Hospital Center (WHC) Washington, D.C. |
License Nos. SNM-1446 ;08-03604-03 Docket Nos. 070-01500; 030-01325 EA 98-555 |
During an NRC inspection conducted at WHC on December 2-3, 1998, and
continued in the Region I office until December 22, 1998, violations of
NRC requirements were identified. In accordance with the "General Statement
of Policy and Procedure for NRC Enforcement Actions," (Enforcement Policy),
NUREG-1600, the NRC proposes a civil penalty pursuant to Section 234 of
the Atomic Energy Act of 1954, as amended (Act), 42 U.S.C. 2282 and 10
CFR 2.205. The violations and associated civil penalty are set forth below:
| A. | 10 CFR 20.1802 states that the licensee shall control
and maintain constant surveillance of licensed material that is in
a controlled or unrestricted area and that is not in storage. As defined
in 10 CFR 20.1003, controlled area means an area, outside of a restricted
area but inside the site boundary, access to which can be limited
by the licensee for any reason; and unrestricted area means
an area, access to which is neither limited nor controlled by the
licensee. Contrary to the above, between September 15, 1998, and March 25, 1999, the licensee failed to control and maintain constant surveillance of licensed material, a pacemaker containing 2.8 Ci of plutonium-238 (Pu-238), that was in an unrestricted area and that was not in storage in that the licensee could not account for the pacemaker. (01013) The is a Severity Level III violation (Supplement IV). Civil Penalty - $5,500. |
| B. | 10 CFR 20.2201(a)(1)(ii) states that each licensee shall report
by telephone within 30 days after the occurrence of any lost, stolen,
or missing licensed material becomes known to the licensee, all licensed
material in a quantity greater than 10 times the quantity specified
in Appendix C to Part 20 that is still missing at the time. Contrary to the above, the licensee did not report by telephone within 30 days after the occurrence of lost, or missing licensed material became known to the licensee, all licensed material in a quantity greater than 10 times the quantity specified in Appendix C to Part 20 that was still missing at that time. Specifically, the licensee knew of the missing nuclear pacemaker containing 2.8 Ci of Pu-238 on October 22, 1998, when the designated recipient of the material informed the licensee that the material had not been received. However, notification was not made to NRC until November 30, 1998, a period in excess of 30 days. (02014) The is a Severity Level IV violation (Supplement IV). |
Pursuant to the provisions of 10 CFR 2.201, Washington Hospital Center
is required to submit a written statement or explanation to the Director,
Office of Enforcement, U.S. Nuclear Regulatory Commission, within 30 days
of the date of this Notice of Violation and Proposed Imposition of Civil
Penalty (Notice). This reply should be clearly marked as a "Reply to a
Notice of Violation" and should include for each alleged violation: (1) admission
or denial of the alleged violation, (2) the reasons for the violation
if admitted, and if denied, the reasons why, (3) the corrective steps
that have been taken and the results achieved, (4) the corrective steps
that will be taken to avoid further violations, and (5) the date when
full compliance will be achieved. If an adequate reply is not received
within the time specified in this Notice, an Order or a Demand for Information
may be issued as why the license should not be modified, suspended, or
revoked or why such other action as may be proper should not be taken.
Consideration may be given to extending the response time for good cause
shown. Under the authority of Section 182 of the Act, 42 U.S.C. 2232,
this response shall be submitted under oath or affirmation.
Within the same time as provided for the response required above under
10 CFR 2.201, the Licensee may pay the civil penalty by letter
addressed to the Director, Office of Enforcement, U.S. Nuclear Regulatory
Commission, with a check, draft, money order, or electronic transfer payable
to the Treasurer of the United States in the amount of the civil penalty
proposed above, or the cumulative amount of the civil penalties if more
than one civil penalty is proposed, or may protest imposition of the civil
penalty in whole or in part, by a written answer addressed to the Director,
Office of Enforcement, U.S. Nuclear Regulatory Commission. Should the
Licensee fail to answer within the time specified, an order imposing the
civil penalty will be issued. Should the Licensee elect to file an answer
in accordance with 10 CFR 2.205 protesting the civil penalty, in whole
or in part, such answer should be clearly marked as an "Answer to a Notice
of Violation" and may: (1) deny the violation listed in this Notice,
in whole or in part, (2) demonstrate extenuating circumstances, (3) show
error in this Notice, or (4) show other reasons why the penalty should
not be imposed. In addition to protesting the civil penalty in whole or
in part, such answer may request remission or mitigation of the penalty.
In requesting mitigation of the proposed penalty, the factors addressed
in Section VI.B.2 of the Enforcement Policy should be addressed. Any written
answer in accordance with 10 CFR 2.205 should be set forth separately
from the statement or explanation in reply pursuant to 10 CFR 2.201, but
may incorporate parts of the 10 CFR 2.201 reply by specific reference
(e.g., citing page and paragraph numbers) to avoid repetition. The attention
of the Licensee is directed to the other provisions of 10 CFR 2.205, regarding
the procedure for imposing a civil penalty.
Upon failure to pay any civil penalty due which subsequently has been
determined in accordance with the applicable provisions of 10 CFR 2.205,
this matter may be referred to the Attorney General, and the penalty,
unless compromised, remitted, or mitigated, may be collected by civil
action pursuant to Section 234c of the Act, 42 U.S.C. 2282c.
The response noted above (Reply to Notice of Violation, letter with payment
of civil penalty, and Answer to a Notice of Violation) should be addressed
to: James Lieberman, Director, Office of Enforcement, U.S. Nuclear Regulatory
Commission, One White Flint North, 11555 Rockville Pike, Rockville, MD
20852-2738, with a copy to the Regional Administrator, U.S. Nuclear Regulatory
Commission, Region I.
Because your response will be placed in the NRC Public Document Room (PDR),
to the extent possible, it should not include any personal privacy, proprietary,
or safeguards information so that it can be placed in the PDR without
redaction. If personal privacy or proprietary information is necessary
to provide an acceptable response, then please provide a bracketed copy
of your response that identifies the information that should be protected
and a redacted copy of your response that deletes such information. If
you request withholding of such material, you must specifically identify
the portions of your response that you seek to have withheld and provide
in detail the bases for your claim of withholding (e.g., explain why the
disclosure of information will create an unwarranted invasion of personal
privacy or provide the information required by 10 CFR 2.790(b) to
support a request for withholding confidential commercial or financial
information). If safeguards information is necessary to provide an acceptable
response, please provide the level of protection described in 10 CFR 73.21.
Dated at King of Prussia, Pennsylvania
this 31st day of March 1999
