[Federal Register Volume 68, Number 41 (Monday, March 3, 2003)]
[Notices]
[Pages 10049-10051]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-4891]


-----------------------------------------------------------------------

NUCLEAR REGULATORY COMMISSION

[Docket No. 030-35594, License No. 37-30603-01, EA No. 02-072]


In the Matter of Advance Medical Imaging and Nuclear Services, 
Easton, PA; Order Imposing a Civil Monetary Penalty

I

    Advanced Medical Imaging and Nuclear Services (Licensee) is the 
holder of Byproduct Materials License No. 37-30603-01 (License) issued 
by the Nuclear Regulatory Commission (NRC or Commission) pursuant to 10 
CFR parts 30 and 35. The License authorizes the Licensee to possess and 
use certain byproduct materials (identified in 10 CFR 35.100 and 
35.200) at its Easton, Pennsylvania facility for any uptake, excretion, 
imaging, and localization procedures approved in those parts. The 
license was issued on February 16, 2001, and is due to expire on 
February 28, 2011.

II

    An inspection of the Licensee's activities was conducted on 
November 30, 2001, at the Licensee's facility located in Easton, 
Pennsylvania. Further, an investigation was also conducted by the NRC 
Office of Investigations. The results of this inspection and 
investigation indicated that the Licensee had not conducted its 
activities in full compliance with NRC requirements. A written notice 
of violation and proposed imposition of civil penalty (notice) was 
served upon the Licensee by letter dated October 22, 2002. The notice 
stated the nature of the violations, the provisions of the NRC's 
requirements that the Licensee had violated, and the amount of the 
civil penalty proposed for the violations.
    The Licensee responded to the notice, in a letter, dated November 
21, 2002. In its response, the Licensee: (1) Admits the first of three 
violations that were classified as a Severity Level II problem; (2) 
denies the other two violations that were part of the Severity Level II 
problem; (3) contests the Severity Level II classification for the 
three violations; (4) contests the amount of the civil penalty for the 
Severity Level II problem; and (5) admits two other violations that 
were classified at Severity Level IV.

III

    After consideration of the Licensee's response and the statements 
of fact, explanation, and argument contained therein, the NRC staff has 
determined, as set forth in the Appendix to this Order, that an 
adequate basis was not provided for withdrawal of any violations, for 
reduction of the Severity Level II classification, or for reduction or 
withdrawal of the penalty. Therefore, the NRC staff has determined that 
a penalty of $43,200 should be imposed.

IV

    In view of the foregoing and pursuant to section 234 of the Atomic 
Energy Act of 1954, as amended (Act), 42 U.S.C. 2282, and 10 CFR 2.205, 
it is hereby ordered that:
    The Licensee pay a civil penalty in the amount of $43,200 within 30 
days of the date of this Order, in accordance with NUREG/BR-0254. In 
addition, at the time of making the payment, the licensee shall submit 
a statement indicating when and by what method payment was made, to the 
Director, Office of Enforcement, U.S. Nuclear Regulatory Commission, 
One White Flint North, 11555 Rockville Pike, Rockville, MD 20852-2738.

V

    The Licensee may request a hearing within 30 days of the date of 
this Order. Where good cause is shown, consideration will be given to 
extending the time to request a hearing. A request for extension of 
time must be made in writing to the Director, Office of Enforcement, 
U.S. Nuclear Regulatory Commission, Washington, DC 20555, and include a 
statement of good cause for the extension. A request for a hearing 
should be clearly marked as a ``Request for an Enforcement Hearing'' 
and shall be addressed to the Secretary, U.S. Nuclear Regulatory 
Commission, ATTN: Rulemakings and Adjudications Staff, Washington, DC 
20555. Copies also shall be sent to the Director, Office of 
Enforcement, U.S. Nuclear Regulatory Commission, Washington, DC 20555, 
to the Assistant General Counsel for Materials Litigation and 
Enforcement at the same address, and to the Regional Administrator, NRC 
Region I, 475 Allendale Road, King of Prussia, PA 19406. Because of 
continuing disruptions in delivery of mail to United States Government 
offices, it is requested that requests for hearing be transmitted to 
the Secretary of the Commission either by means of facsimile 
transmission to 301-415-1101 or by e-mail to [email protected] and 
also to the Office of the General Counsel either by means of facsimile 
transmission to 301-415-3725 or by e-mail to [email protected].
    If a hearing is requested, the Commission will issue an Order 
designating the time and place of the hearing. If the Licensee fails to 
request a hearing within 30 days of the date of this Order, the 
provisions of this Order shall be effective without further 
proceedings. If payment has not been made by that time, the matter may 
be referred to the Attorney General for collection.
    In the event the Licensee requests a hearing as provided above, the 
issues to be considered at such hearing shall be:
    (a) Whether the Licensee was in violation of the Commission's 
requirements as set forth in Violations B and C of the notice 
referenced in section II above, and
    (b) Whether, on the basis of such violations, and the additional 
violations

[[Page 10050]]

set forth in the notice of violation that the Licensee admitted, this 
Order should be sustained.

    Dated in Rockville, Maryland, this 19th day of February, 2003.

    For the Nuclear Regulatory Commission.
Carl J. Paperiello,
Deputy Executive Director for Materials, Research and State Programs.

Appendix

Evaluations and Conclusion

    On October 22, 2002, a notice of violation and proposed 
imposition of civil penalty (notice) was issued for violations 
identified during an NRC inspection conducted at the Licensee's 
facility located in Easton, Pennsylvania. The penalty was issued for 
three violations that were classified as a Severity Level II 
problem. The Licensee responded to the notice in a letter, dated 
November 21, 2002. In its response, the Licensee: (1) Admits the 
first of the three violations that were classified as a Severity 
Level II problem; (2) denies the other two violations that were part 
of the Severity Level II problem; (3) contests the Severity Level II 
classification for the three violations; (4) contests the amount of 
the civil penalty for the Severity Level II problem; and, (5) admits 
two other violations that were classified at Severity Level IV. The 
NRC's evaluation and conclusion regarding the Licensee's request is 
as follows:

1. Restatement of the Three Violations Classified at Severity Level 
II and Assessed a Civil Penalty

    A. 10 CFR 35.11 requires, in part, that a person shall not use 
byproduct material for medical use except in accordance with a 
specific license or under the supervision of an authorized user as 
provided in 10 CFR 35.25.
    Contrary to the above, from June 2001 to November 30, 2001, a 
Nuclear Medicine Technologist (NMT) used byproduct material for 
patient diagnosis on approximately 590 occasions, and the use by the 
NMT was not in accordance with a specific license. In addition, the 
NMT was not under the supervision of an authorized user.
    B. 10 CFR 35.21(a) requires that a licensee shall appoint a 
Radiation Safety Officer responsible for implementing the radiation 
safety program. The licensee, through the Radiation Safety Officer, 
shall ensure that radiation safety activities are being performed in 
accordance with approved procedures and regulatory requirements in 
daily operation of the licensee's byproduct material program.
    Contrary to the above, from about March 2001 to November 30, 
2001, the licensee conducted licensed activities, including ordering 
and administering radiopharmaceuticals on approximately 590 
occasions, and during that time, the licensee had not appointed a 
Radiation Safety Officer responsible for implementing the radiation 
safety program, to ensure that activities were being performed in 
accordance with approved procedures and regulatory requirements in 
daily operations of the licensee's program.
    C. 10 CFR 30.9(a) requires, in part, that information required 
by license conditions to be maintained by the licensee, shall be 
complete and accurate in all material respects.
    License condition 15.A of the NRC license for AMINS requires 
that the licensee conduct its program in accordance with the 
statements, representations, and procedures contained in various 
documents, including the license application dated October 20, 2000.
    Item 10, Attachment 10.6 of the NRC license application for 
AMINS dated October 20, 2000, requires that written records will be 
made that identify the Authorized User when ordering radioactive 
materials.
    Contrary to the above, on November 30, 2001, information 
required to be maintained by the licensee was not complete and 
accurate in all material respects. Specifically, all records of 
radioactive materials ordered between March 2001 and November 2001 
indicated that the Authorized User who ordered the 
radiopharmaceuticals was Dr. Brij Mohan Gupta (Dr. Mohan). These 
records were not accurate in that Dr. Mohan was not employed by the 
licensee as an Authorized User, nor did he function in that 
capacity. This statement was material because an Authorized User was 
required by the license and by NRC regulations for supervision of 
the administration of radiopharmaceuticals to patients.
    These violations represent a Severity Level II problem 
(Supplement IV). Civil Penalty--$43,200

2. Summary of Licensee's Response Denying Violation 1.B

    The licensee denies Violation 1.B, involving the licensee not 
appointing an RSO responsible for implementing the program when the 
radiopharmaceuticals were ordered and administered on the 
approximately 590 occasions. The licensee contends that with the 
assistance of its consultant, it was able to assure regulatory 
requirements were met during daily operations of the facility.

NRC Evaluation of Licensee's Response Denying Violation 1.B

    Although the licensee denies this violation, the licensee, in 
its response, admits that it was unable to finalize arrangements 
with the individual who was listed on its license as the RSO. 
Therefore, since such arrangements were never finalized, and since 
the individual listed as the RSO never served as the licensee's RSO, 
the licensee did not appoint an RSO, consistent with requirements, 
responsible for implementing the radiation safety program. Rather, 
the license identified an individual as the RSO who was not employed 
by the licensee either directly, or as a contractor or consultant, 
and who did not implement the radiation safety program at any time, 
including between March 2001 and November 30, 2001, when the 
radiopharmaceuticals were ordered and administered on the 
approximately 590 occasions. Therefore, even though the licensee 
indicates that it was able to assure, as evidenced by a subsequent 
review by its consultant, that other regulatory requirements had 
been met during daily operations of the facility, the licensee did 
not provide an adequate basis for the NRC to withdraw Violation 1.B 
in the notice. Accordingly, the violation remains as stated in the 
notice.

3. Summary of Licensee's Response Denying Violation 1.C

    The licensee denies Violation 1.C involving the creation of 
inaccurate records of the radioactive materials ordered on the 590 
occasions. The records were considered inaccurate in that the 
licensee listed as the authorized user an individual physician who 
was not employed by the licensee and was not performing the duties 
of the authorized user. The licensee denies this violation because 
the physician was identified on the license as the AU, and the 
records were completed in a manner consistent with the license. The 
licensee states that it was not aware of any regulatory requirement 
that the authorized user be employed by the licensee.

NRC Evaluation of Licensee's Response Denying Violation 1.C

    The NRC had determined that Violation 1.C occurred because 
information required to be maintained by the licensee was not 
complete and accurate in all material respects. Specifically, all 
records of radioactive materials ordered between March 2001 and 
November 2001 indicated that the Authorized User who ordered the 
radiopharmaceuticals was Dr. Brij Mohan Gupta (Dr. Mohan). These 
records were not accurate in that Dr. Mohan was not employed by the 
licensee, nor acting in any capacity, as an Authorized User.
    In denying this violation, the licensee states that the crux of 
this regulatory requirement is that the licensee's records be 
accurate, and that the performance by the AU of his/her obligations 
is not the focus of this regulation but is covered under other 
regulations. The NRC maintains that these records were not accurate 
because the individual listed in the records as the AU was never 
employed by the licensee, nor did that individual otherwise serve or 
act as the AU (such as via a contractor or consultant arrangement). 
Therefore, the licensee did not provide an adequate basis for the 
NRC to withdraw Violation 1.C in the notice. Accordingly, the 
violation remains as stated in the notice.

4. Summary of Licensee's Response Contesting Classification of the 
Three Violations at Severity Level II

    The licensee contests the Severity Level II problem 
classification for the three violations set forth in section I of 
the notice. The licensee contends that the violations were not 
willful; the VP and COO have been penalized; even if the VP and 
COO's actions were willful, the action taken against them obviates 
the need for substantial penalties to the licensee; there were no 
actual or realistic potential safety consequences as a result of the 
violations; and classification of the violations at a Level II is 
inconsistent with NRC policy and prior determinations. With respect 
to the last point, the licensee indicates that the seven examples of 
Severity Level II described in the HP supplement of the enforcement 
policy, relate to overexposures or unauthorized releases.

[[Page 10051]]

Further, the licensee provided a list of 16 other Severity Level III 
enforcement actions that the licensee maintains are similar to its 
case.

NRC Evaluation of Licensee's Response Contesting Classification of the 
Three Violations at Severity Level II

    In assessing the significance of violations, and assigning an 
appropriate Severity Level, the NRC considers the actual and 
potential consequences of the violations, their impact on the 
regulatory process, and any willful aspects of the violations, as 
noted in section IV.A of the NRC enforcement policy (NUREG-1600). 
The supplements to the enforcement policy provide examples of 
different Severity Levels and serve as guidance in determining the 
appropriate Severity Level for the violations, as noted in section 
IV.B of the enforcement policy. In this case, since the violations 
included the failure to have an AU and RSO, the violations would 
normally have been classified at Severity Level III in accordance 
with section C.8 of Supplement VI of the enforcement policy. 
However, section IV.A.4 of the enforcement policy specifies that 
violations may be considered more significant if they include 
indications of willfulness. In deciding whether to increase the 
significance of the violations, the NRC considers the positions and 
responsibilities of the persons involved, the significance of the 
underlying violations, the intent of the violators, and the economic 
advantage gained.
    In this case, the NRC maintains that the violations were 
deliberate, notwithstanding the licensee's denial. As noted in the 
NRC October 22, 2002, letter transmitting the notice of violation 
and proposed imposition of civil penalty, the NRC considered the 
following facts in concluding that the violations were deliberate: 
(1) The VP prepared the NRC license application in October 2000, 
with the aid of a consulting physicist, and he listed an individual 
(a physician) as the AU and RSO on the application; however, the 
named individual was never employed by AMINS and never performed the 
duties of the AU or RSO at AMINS; (2) from June 2001 through 
November 2001, AMINS staff listed that individual as the AU of 
record when it ordered and administered radiopharmaceuticals on 
approximately 590 occasions; (3) in October 2001, a consulting 
physicist conducted an audit that revealed that the duties of the 
AU/RSO had not been performed, and he briefed the licensee regarding 
the problem at the end of the audit, yet NRC licensed activities 
continued until the NRC inspection on November 30, 2001; (4) the VP, 
when interviewed by an OI investigator, admitted that he knew the 
facility was required to have an AU and RSO and knew as early as 
June 2001 that not having an AU and RSO was a problem, but he did 
not take action to correct the situation; and (5) both the VP and 
COO admitted to the OI investigator that there were financial 
considerations associated with keeping the facility open.
    Furthermore, the violations were the result of the actions by 
senior individuals in the organization (namely a Vice President and 
the Chief Operating Officer), and there was an economic advantage to 
the licensee when it performed 590 administrations of radioactive 
materials at a time when it did not have an RSO and AU. Accordingly, 
even though there were no safety consequences identified from these 
violations, and actions were taken against both the Vice President 
and Chief Operating Officer, by both the licensee and the NRC, the 
NRC maintains that it was appropriate to increase the Severity Level 
classification from a Severity Level III to a Severity Level II in 
this case, and that such an increase is consistent with NRC policy 
and past determinations. In addition, contrary to the licensee's 
assertion, the 16 enforcement actions listed in the licensee's 
response are not similar to the circumstances of the AMINS 
enforcement action. Only six involved medical or human uses, and 
each of those six only involved one or two incidents of regulatory 
violations.

5. Summary of Licensee's Response Contesting the Amount of the 
Civil Penalty and Requesting Withdrawal or Reduction of the Civil 
Penalty

    The licensee contests the amount of the civil penalty, 
contending that the NRC has abused its discretion by proposing a 
civil penalty of $43,200. In support of that contention, the 
licensee reiterates that it denies two of the three violations that 
were classified as the Severity Level II problem. In addition, the 
licensee maintains that it should be given credit for notification, 
asserting that the COO and VP voluntarily informed the inspector of 
the violations. Also, the licensee stated that even if it is not 
entitled to credit for identification, the violations should be 
classified at Severity Level III and the penalty should not exceed 
the base amount of $3000 for a Severity Level III. Finally, the 
licensee states that the use of weekly civil penalties was not 
warranted and was inconsistent with prior NRC cases, and cited 
examples of prior enforcement actions that the licensee believes to 
be inconsistent with the action taken against the licensee.

NRC Evaluation of Licensee's Response Contesting the Amount of the 
Civil Penalty and Requesting Withdrawal or Reduction of the Civil 
Penalty

    The NRC disagrees that it has abused its discretion in 
determining the amount of the civil penalty in this case. For the 
reasons set forth in sections 3 and 4 above, the NRC maintains that 
all three violations occurred as stated in the notice, and were 
appropriately classified as a Severity Level II problem.
    In addition, the NRC also maintains that the licensee is not 
entitled to credit for identification because the violations were 
identified by the NRC when the inspector arrived at the site on 
November 30, 2001. The NRC was not informed of such violations prior 
to that inspection, nor were there any indications in licensee's 
records identifying the violations. During that inspection, the NRC 
learned that the licensee's consulting physicist had identified the 
failure to have an AU during an audit, and briefed the licensee 
regarding the problem on October 3, 2001.
    Finally, as noted in the October 22, 2002, letter transmitting 
the notice of violation and proposed imposition of civil penalty, 
the NRC decided that consideration of daily civil penalties was 
appropriate in this case, due to the multiple instances of 
deliberately ordering and administering byproduct material to human 
patients without the benefit of a physician authorized user and a 
radiation safety officer, the level of management involved, the 
economic benefit associated with continuing to operate without an AU 
and RSO, and the failure to correct the problem even after the 
findings of the licensee's consultant on October 3, 2001. The NRC 
has also reviewed the enforcement cases referenced by the licensee, 
and finds that the circumstances in this case are not similar to any 
of the cases cited. Accordingly, the NRC maintains that it is 
appropriate to issue: (1) A base civil penalty amount of $4,800 for 
the occurrence of the violations between March 2001 and October 3, 
2001; and (2) additional civil penalty in the base amount of $4,800 
for each of the eight weeks that the violations continued even after 
the consultant identified the problem to the licensee on October 3, 
2001. Therefore, the licensee has not provided an adequate basis to 
withdraw or reduce that civil penalty.

6. NRC Conclusion

    The NRC has concluded that the Licensee did not provide an 
adequate basis for withdrawal of any of the violations, or for 
withdrawal or reduction of the civil penalty amount. Accordingly, 
the proposed civil penalty in the amount of $43,200 should be 
imposed.
[FR Doc. 03-4891 Filed 2-28-03; 8:45 am]
BILLING CODE 7590-01-P