EA-97-189 - DMS Imaging, Inc.
February 24, 1999
EA 97-189
Mr. Dennis Clemenson, President
and Radiation Safety Officer
DMS Imaging, Inc.
P.O. Box 1010
Bemidji, MN 56601
| SUBJECT: | NOTICE OF VIOLATION AND PROPOSED IMPOSITION OF CIVIL
PENALTY - $2,500 (NRC Inspection Report 030-10809/96001(DMNS), NRC
Office of Inspector General (OIG) Investigation Report 97-79G, and
NRC Office of Investigations (OI) Reports 3-96-045 & 3-96-45S) |
Dear Mr. Clemenson:
This refers to the August 23, 1996, NRC inspection and the OI and OIG
investigations conducted between November 13, 1996, and November 4, 1998.
The purpose of the inspection was to review DMS Imaging, Inc. (DMS), licensed
activities. The investigations were conducted to follow up on statements
made by your staff during the inspection and the May 13, 1997, predecisional
enforcement conference (conference) held in the NRC Region III office.
The inspection and investigations findings were sent to you by letters
dated April 29, 1997, and November 20, 1998. Because of the new information
DMS was offered the opportunity to attend a second predecisional enforcement
conference, which you declined.
Based on the information developed during the inspection, the OI and OIG
investigations, the information provided during the 1997 conference, and
the information provided in your letter dated December 2, 1998, the NRC
has determined that violations of NRC requirements occurred. The violations
are cited in the enclosed Notice of Violation and Proposed Imposition
of Civil Penalty, and the circumstances surrounding them are described
in detail in the subject inspection report.
During the May 13, 1997, conference, violations involving the failure
of staff to wear lab coats and proper dosimetry when handling radioactive
materials were discussed. DMS provided its corrective actions during the
conference and those actions appeared appropriate. A subsequent inspection
was conducted on December 15 and 16, 1997, and confirmed the adequacy
of the corrective actions implemented. However, based on the findings
of the OIG report, the NRC staff concludes that the violation involving
failure to wear dosimetry occurred because a DMS supervisor deliberately
allowed the technologist to perform routine nuclear medicine duties, knowing
that the technologist had not yet obtained the required dosimetry.
A second violation identified during the investigations involves the failure
of DMS employees, on October 1, 1996, to provide complete and accurate
information to an NRC investigator about performing licensed activities
without wearing dosimetry. This violation is of significant concern to
the NRC. DMS employees claimed that a newly-hired technologist did not
handle radioactive material prior to receiving dosimetry when, in fact,
the technologist had eluted a generator, prepared doses and injected patients
prior to receiving dosimetry. Based on the findings of the OIG report,
the NRC staff concludes that the same DMS supervisor deliberately instructed
the DMS employees to provide the inaccurate information to the NRC investigator.
The explanation given by the DMS supervisor is that he was concerned about
the
consistency
of the answers that the DMS employees would provide
to the NRC investigator,
i.e.
, that they should be the same as
those given to the NRC inspector by the employees during the August 23,
1996, inspection. However, the standard is not consistency, but rather
accuracy
and
truthfulness
. The importance of promptly
identifying and correcting inaccurate or incomplete information provided
to the NRC is emphasized in Section IX of the NRC's "General Statement
of Policy and Procedures for NRC Enforcement Actions" (Enforcement Policy),
NUREG-1600, Rev 1. Moreover, the DMS employees were, in fact, truthful
with the NRC inspector during the August 23, 1996, inspection. Thus,
a concern for consistency would dictate that they be truthful with the
NRC investigator as well.
It is essential that the NRC be able to maintain the highest trust that
individuals supervising or working with radioactive materials will comply
with regulatory requirements. The NRC's regulatory programs are based
on licensees and their employees acting with integrity and conducting
their programs in an open and honest manner, and DMS, as an entity licensed
to possess and use radioactive material, is responsible for the acts of
its employees. Therefore, because of the willful nature of these violations,
they have been categorized as a Severity Level III problem in accordance
with the Enforcement Policy.
The NRC is corresponding directly with the DMS supervisor and the nuclear
medicine technologists concerning these issues. You will receive a copies
of that correspondence under separate cover.
In accordance with the Enforcement Policy, a base civil penalty in the
amount of $2,500 is considered for a Severity Level III violation. Because
the violations involve willfulness, 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. NRC staff identified the violations; consequently,
credit for identification is not warranted. Credit for corrective action
is warranted based on the following actions taken by DMS: (1) adding a
written notice to the new hire orientation which informs nuclear medicine
personnel that it is imperative that they abide by all DMS policies and
procedures, and that they ensure that all NRC policies are carried out
to maintain strict compliance with NRC licensing; (2) establishing that
failure to abide by all policies and procedures will result in immediate
employment termination; and (3) requiring all new hires and existing nuclear
medicine technologists to acknowledge by signature that they have received
and understand the notice. The initial issue of providing dosimetry and
lab coats was discussed during the May 13, 1997, conference. DMS instituted
a policy that, prior to beginning the orientation, a new hire technologist
will be issued lab coats and other protective clothing and proper personnel
monitoring devices.
Therefore, to emphasize the importance of providing accurate and complete
information to the NRC, procedural compliance, and prompt identification
of violations, I have been authorized, after consultation with the Director,
Office of Enforcement, to issue the enclosed Notice of Violation and Proposed
Imposition of Civil Penalty (Notice) in the base amount of $2,500 for
the Severity Level III problem. In addition, issuance of this Notice constitutes
escalated enforcement action, that may subject you to increased inspection
effort.
You are required to respond to this letter and should follow the instructions
specified in the enclosed Notice when preparing your response. Your response
should include your basis for concluding that the DMS supervisor will
not, in the future, commit willful violations of NRC requirements and
that he is committed to assuring that all NRC requirements are followed
and that information provided to the NRC is complete and accurate in all
material respects. The NRC will use your response, in part, to determine
whether further enforcement action is necessary to ensure compliance with
regulatory requirements.
All final NRC documents, including the final OIG investigation report,
are official agency records and may be made available to the public under
the Freedom of Information Act (FOIA), subject to redaction of information
in accordance with the FOIA.
In accordance with 10 CFR 2.790 of the NRC's "Rules of Practice," a copy
of this letter, its enclosures, and your response will be placed in the
NRC Public Document Room.
| Sincerely, |
||
| Original Signed By |
||
| James E. Dyer Regional Administrator |
Docket No. 030-10809
License No. 22-16328-01
Enclosure:
Notice of Violation and Proposed Imposition of Civil Penalty
NOTICE OF VIOLATION
AND
PROPOSED IMPOSITION OF CIVIL PENALTY
| DMS Imaging, Inc. Bemidji, MN |
Docket No. 030-10809 License No. 22-16328-01 EA 97-189 |
|
During an NRC inspection and investigations conducted between August
23, 1996, and November 4, 1998, violations of NRC requirements were identified.
In accordance with the "General Statement of Policy and Procedures for
NRC Enforcement Actions," NUREG-1600, the NRC proposes to impose 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 particular violations and
associated civil penalty are set forth below:
| I. | Condition 16 of License No. 22-16328-01 requires, in
part, that the licensee conduct its program in accordance with the
statements, representations, and procedures contained in the application
dated June 27, 1991, which includes implementation of Appendix I to
Regulatory Guide 10.8, Revision 2., Item 7 of Appendix I, "Model
Rules for Safe Use of Radiopharmaceuticals," requires individuals
to wear personnel monitoring devices at all times while in areas where
radioactive materials are used or stored. Item 8 of Appendix I requires
individuals to wear a finger exposure monitor during the elution of
generators; during the preparation, assay and injection of radiopharmaceuticals;
and when holding patients during procedures. Contrary to the above, on August 21 and 23, 1996, a newly-hired technologist eluted a generator, injected patients, and performed patient scans without the appropriate personal monitoring devices. |
| II. | 10 CFR 30.9(a) requires, in part, that information provided to the
Commission by a licensee, or information required by the Commission's
regulations to be maintained by the licensee, shall be complete and
accurate in all material respects. Contrary to the above, on October 1, 1996, information provided by licensee employees to an NRC investigator was inaccurate. Specifically, two of the licensee's nuclear medicine technologists, in response to questions regarding the use of licensed material, told the NRC investigator that one of them, a newly-hired technologist, did not elute generators or inject patients during the period of August 19 through 23, 1996. These statements were inaccurate in that on August 21 and 23, 1996, the newly-hired technologist eluted a generator, injected patients, and performed patient scans without the appropriate personal monitoring devices. This information is material because it could have influenced the NRC as to whether a violation existed, and if so, the scope of that violation. |
These violations represent a Severity Level III problem (Supplements
VI and VII).
Civil Penalty - $2,500
Pursuant to the provisions of 10 CFR 2.201, DMS Imaging, Inc. (Licensee),
is hereby 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.
Within the same time as provided for the response required above under
10 CFR 2.201, the Licensee may pay the civil penalty proposed
above or the cumulative amount of the civil penalties if more than one
civil penalty is proposed, in accordance with NUREG/BR-0254 and by submitting
to the Director, Office of Enforcement, U.S. Nuclear Regulatory Commission,
Washington, DC 20555, a statement indicating when and by what method payment
was made, 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 violations 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, statement as to
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 III, 801 Warrenville Road,
Lisle, IL 60532-4351.
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).
In accordance with 10 CFR 19.11, you may be required to post this Notice
within two working days.
Dated this 24th day of February 1999
