[Federal Register Volume 60, Number 84 (Tuesday, May 2, 1995)]
[Notices]
[Pages 21570-21575]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-10730]



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NUCLEAR REGULATORY COMMISSION
[Docket No. 030-32493; License No. 29-28685-01; EA 93-072]


Radiation Oncology Center at Marlton, Marlton, New Jersey; Order 
Imposing a Civil Monetary Penalty

I

    Radiation Oncology Center at Marlton (Licensee) is the holder of 
Byproduct Materials License No. 29-28685-01 (License) issued by the 
Nuclear Regulatory Commission (NRC or Commission) on January 17, 1992. 
The License authorizes the Licensee to possess and use certain 
byproduct materials in accordance with the conditions specified 
therein. The License is due to expire on January 31, 1997. By a 
Confirmatory Action Letter dated February 5, 1993, the Licensee agreed 
to not obtain any sources of radioactive material authorized under the 
License until specifically authorized by NRC Region I. By a 
Confirmatory Order Modifying License (Effective Immediately) dated 
March 9, 1993, the Licensee was required to maintain any NRC-licensed 
material in a locked, stored, and shielded condition, and was 
prohibited from receiving any NRC-licensed material.

II

    An NRC inspection of the Licensee's activities was conducted on 
February 2 and 4, 1993. The results of this inspection indicated that 
the Licensee has 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 
May 31, 1994. The Notice states the nature of the violation, the 
provisions of the NRC requirements that the Licensee had violated, and 
the amount of the civil penalty proposed for the violation.
    The Licensee responded to the Notice in letters dated August 31, 
1994, October 4, 1994, and December 1, 1994. In its responses the 
Licensee denies Examples A.3, A.4, B.1, B.2, D., and G. of the 
violations, denies in part and admits in part Examples A.1, A.2, and C. 
of the violation, and admits Examples A.5, E., and F. of the violation. 
The Licensee also protests the amount of the civil penalty proposed and 
requests mitigation of the penalty as appropriate.

III

    After consideration of the Licensee's response and the statements 
of fact, explanation, and argument for mitigation contained therein, 
the NRC staff has determined, as set forth in the Appendix to this 
Order, that, with the [[Page 21571]] exceptions of Examples A.3 and G 
of the violation, the violation occurred as stated in the Notice; the 
Examples A.3 and G of the violation will be withdrawn; and the penalty 
proposed for the violation designated in the Notice 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 $80,000 within 
30 days of the date of this Order, by check, draft, money order, or 
electronic transfer, payable to the Treasurer of the United States 
and mailed to James Lieberman, Director, Office of Enforcement, U.S. 
Nuclear Regulatory Commission, One White Flint North, 11555 
Rockville Pike, Rockville, Maryland 20852-2738.

V

    The Licensee may request a hearing within 30 days of the date of 
this Order. A request for a hearing should be clearly marked as a 
``Request for an Enforcement Hearing'' and shall be addressed to the 
Director, Office of Enforcement, U.S. Nuclear Regulatory Commission, 
Washington, D.C. 20555, with a copy to the Commission's Document 
Control Desk, Washington, D.C. 20555. Copies also shall be sent to the 
Assistant General Counsel for Hearings and Enforcement at the same 
address and to the Regional Administrator, NRC Region I, 475 Allendale 
Road, King of Prussia, Pennsylvania 19406.
    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 the violation in the Notice referenced in 
Section II above, and the following specific examples given with the 
violation: Examples A.1, A.2, A.4, B.1, B.2, C., and D.; and
    (b) whether, on the basis of the violation set forth in the Notice 
of Violation, this Order should be sustained.

    Dated at Rockville, Maryland this 24th day of April 1995.

    For the Nuclear Regulatory Commission.
Hugh L. Thompson, Jr.,
Deputy Executive Director for Nuclear Materials Safety, Safeguards and 
Operations Support.

Appendix--Evaluations and Conclusion

    On May 31, 1994, a Notice of Violation and Proposed Imposition 
of Civil Penalty (Notice) was issued for a violation identified 
during an NRC inspection of Radiation Oncology Center at Marlton 
(ROCM) (Licensee). The licensee responded to the Notice on August 
31, 1994, October 4, 1994, and December 1, 1994. The Licensee denies 
Examples A.3, A.4, B.1, B.2, D., and G. of the violation, denies in 
part and admits in part Examples A.1, A.2, and C. of the violation, 
and admits Examples A.5, E., and F. of the violation. In addition, 
the Licensee protests the amount of the civil penalty proposed and 
requests mitigation of the civil penalty as appropriate. The NRC's 
evaluation and conclusion regarding the Licensee's requests are as 
follows:

Restatement of Violation

    10 CFR 35.21(a) requires, in part, that the licensee, through 
the Radiation Safety Officer (RSO), shall ensure that radiation 
safety activities are being performed in accordance with approved 
procedures and regulatory requirements in the daily operation of the 
licensee's byproduct material program.
    Contrary to the above, the Licensee, through the RSO, did not 
ensure that radiation safety activities were performed in accordance 
with approved procedures and regulatory requirements in the daily 
operation of the Licensee's byproduct material program. 
Specifically, the RSO named on the Radiation Oncology Center at 
Marlton (ROCM) license stated at the enforcement conference that, 
although she had signed the license submittal, she believed that her 
responsibilities and authorities were primarily a medical function 
and not a regulatory function. She said that she was aware that she 
was named as the RSO on the license and added, ``I was told that 
being--I was the fixed fixture there, that was the easiest thing to 
do, and that is all I was told. I had no concept of what that 
entailed.'' The following are specific examples of the failure of 
the Licensee, through the RSO, to ensure that radiation safety 
activities were performed in accordance with approved procedures and 
regulatory requirements in the daily operation of the Licensee's 
byproduct material program:
    A. Condition 14 of License No. 29-28685-01 requires that the 
Licensee conduct its program in accordance with the statements, 
representations, and procedures contained in the application dated 
July 11, 1991, letter received December 18, 1991, and letter dated 
January 15, 1992.
    1. Item 8.B of the Licensee's application, dated July 11, 1991, 
requires that all source exchanges be carried out by Omnitron 
Factory Personnel under the observation of the RSO.
    Contrary to this requirement, source exchanges carried out by 
Omnitron Factory Personnel were not always under the observation of 
the RSO. Specifically, the RSO stated that although she observed the 
first source exchange at the facility on March 5, 1992, she did not 
observe the three subsequent source exchanges on June 4, September 
16, and December 9, 1992.
    2. Item 10.12 of the Licensee's application, dated July 11, 
1991, requires that surveys of radiation levels in all adjacent 
areas and controlled areas be performed at initial installation and 
then quarterly thereafter at source exchanges and that results of 
the surveys be maintained.
    Contrary to this requirement, surveys of radiation levels in all 
adjacent areas and controlled areas were not performed during the 
source exchanges which occurred on March 5, June 4, and September 
16, 1992. In addition, the Licensee was unable to supply the 
inspectors with documentation demonstrating that surveys were 
performed in any adjacent areas following the December 9, 1992 
source change.
    3. Item 10.15.A.4 of the Licensee's application, dated July 11, 
1991, requires, in part, that a daily check of all interlocks, 
safety systems and alarms be performed and documented in log books, 
that daily operational system checks be recorded, and that source 
position indicators (visual and radiation detection) be checked 
before each use and recorded.
    Contrary to this requirement, as of February 4, 1993, daily 
checks of all interlocks, safety systems and alarms were not 
performed and documented in log books. Specifically, Licensee 
personnel believed that the performance of these checks was the 
responsibility of the physics consultant even though the physics 
consultant was only present for approximately one half of the total 
patient treatments, and the ROCM staff did not perform these daily 
checks when the physics consultant was not present. In addition, the 
Licensee was unable to provide any documentation indicating that 
daily checks of all the inter-locks, safety systems and alarms; 
daily operational system checks; and daily checks of source position 
indicators (visual and radiation detection) were performed on the 
occasions when the physicist was present.
    4. Item 8.E.5 of the Licensee's application, dated July 11, 
1991, requires, in part, that each operator/user of the HDR 
individually demonstrate competence in the emergency procedures 
during ``dry run'' emergencies using several failure modes for each 
operator.
    Contrary to this requirement, as of February 4, 1993, each 
operator/user of the HDR did not individually demonstrate competence 
in the emergency procedures during ``dry run'' emergencies using 
several failure modes for each operator.
    5. Item 9.1.C.4 of the Licensee's application, dated July 11, 
1991, requires, in part, that the radiation monitor (PrimAlert) have 
a battery backup.
    Contrary to this requirement, as of February 4, 1993, the 
Licensee did not have a battery back-up to operate the radiation 
monitor (PrimAlert).
    B. 10 CFR 19.12 requires, in part, that all individuals working 
in or frequenting any [[Page 21572]] portion of a restricted area be 
instructed in the purposes and functions of protective devices 
employed, and in the appropriate response to warning made in the 
event of any unusual occurrence or malfunction that may involve 
exposure to radiation or radioactive material.
    10 CFR 35.25(a)(1) requires, in part, that a Licensee that 
permits the use of byproduct material under the supervision of an 
authorized user shall instruct the supervised individual in the 
principles of radiation safety appropriate to that individual's use 
of byproduct material.
    Contrary to these requirements,
    1. As of February 4, 1993, individuals working in or frequenting 
portions of a restricted area were not instructed in the purposes 
and functions of protective devices employed. Specifically, the 
Licensee failed to instruct the dosimetrist in the proper use of the 
radiation survey meter. The dosimetrist, when questioned by the 
inspector on the operation and use of the survey meter, stated that 
the X1000 setting was the instrument's ``lowest strength'' scale. 
The X1000 setting is actually the highest scale setting on the 
instrument.
    2. As of February 4, 1993, individuals working in or frequenting 
portions of a restricted area were not instructed in the appropriate 
response to a warning made in the event of any unusual occurrence or 
malfunction that may involve exposure to radiation or radioactive 
material. Specifically, the Licensee failed to adequately train the 
dosimetrist to identify and respond to HDR error messages.
    When questioned by the inspector on February 4, 1993, the 
dosimetrist did not know the meaning of the error messages from a 
random printout of a treatment execution record, dated May 7, 1992, 
which contained several error messages.
    C. 10 CFR 35.31(b) requires that a licensee that makes minor 
changes in radiation safety procedures, as permitted under 10 CFR 
35.31(a), retain a record of each change until the license has been 
renewed or terminated. The record shall include the effective date 
of the change, a copy of the old and new radiation safety 
procedures, the reason for the change, a summary of radiation safety 
matters that were considered before making the change, the signature 
of the RSO, and the signatures of the affected authorized users, and 
of management or, in a medical institution, the Radiation Safety 
Committee's chairman and the management representative.
    Contrary to this requirement, prior to February 2, 1993:
    1. The Licensee made a minor change in its radiation safety 
procedures, as permitted under 10 CFR 35.31(a), by posting emergency 
procedures that differed from those procedures submitted to the NRC 
in support of the license application, and the Licensee did not 
retain a record of the change that included the effective date of 
the change, the reasons for the change, a summary of the radiation 
matters that were considered before making the change, the signature 
of the RSO, and the signatures of the affected authorized users, and 
of management.
    2. The Licensee made a minor change in its radiation safety 
procedures, as permitted under 10 CFR 35.31(a), by using HDR 
calibration procedures that differed from those procedures submitted 
to the NRC in support of the license application, and the Licensee 
did not retain a record of the change that included the effective 
date of the change, the reason for the change, a summary of the 
radiation matters that were considered before making the change, the 
signature of the RSO, and the signatures of the affected authorized 
users, and of management.
    D. 10 CFR 35.32 requires, in part, that each licensee, as 
applicable, establish and maintain a written quality management 
program to provide high confidence that byproduct material or 
radiation from byproduct material will be administered as directed 
by the authorized user.
    Contrary to this requirement, from March through December 1992, 
the Licensee engaged in licensed activities (namely, the 
administration of brachytherapy radiation doses using an iridium-192 
source in an HDR unit) which required the establishment of a quality 
management program, and as of February 5, 1993, the Licensee had not 
established a written quality management program.
    E. 10 CFR 35.51(a)(3) requires that the apparent exposure rate 
from a dedicated check source as determined at the time of 
calibration, be conspicuously noted on the instrument with the date 
of calibration.
    Contrary to this requirement, as of February 4, 1993, the 
apparent exposure rate from a dedicated check source as determined 
at the time of calibration, was not conspicuously noted on the 
instrument with the date of calibration.
    F. 10 CFR 19.11 (a) and (b) require, in part, that the Licensee 
post current copies of Part 19 and 20, and the license, or post a 
notice describing these documents and where they may be examined. 10 
CFR 19.11(c) also requires that the licensee post a Form NRC-3, 
``Notice to Employees.''
    Contary to this requirement, as of February 4, 1993, the 
Licensee did not post current copies of Parts 19 and 20, and the 
license, or a notice describing the documents and where they could 
be examined, and did not post a Form NRC-3.
    G. 10 CFR 30.51(a) requires each licensee to keep records 
showing the receipt, transfer, and disposal of byproduct material.
    Contrary to this requirement, as of February 4, 1993, the 
Licensee did not keep records showing the receipt, transfer, and 
disposal of byproduct material. Specifically, the Licensee did not 
maintain records of the source receipt and transfer for disposal.
    This is a Severity Level II violation (Supplement VI).

Summary of Licensee's Response to Example A.1 of the Violation

    The Licensee admits this example in part and denies it in part, 
but does not state specifically what it admits or denies. The 
Licensee states that, although the RSO was not present in the room 
during the source exchange, the RSO or the physicist was physically 
present at the facility during the source exchanges, or readily 
available in case of an emergency, and thus the RSO was overseeing 
the source exchanges. The Licensee believes that this was all that 
was intended by its license application, that the RSO may delegate 
duties, and that the physical presence of the RSO during a source 
exchange would violate ALARA principles. The Licensee believes that, 
in any event, this example would constitute a Severity Level IV 
violation.

NRC Evaluation of Licensee's Response to Example A.1 of the 
Violation

    The Licensee's application is clear in requiring that all source 
exchanges be carried out by Omnitron Factory Personnel under the 
observation of the RSO. With proper planning and the application of 
common radiation protection methods, the RSO could observe source 
exchanges without violating ALARA principles. At the transcribed 
enforcement conference, the RSO confirmed that she observed the 
first source exchange but did not observe the three subsequent 
source exchanges. Since source exchanges occurred that were not 
under the observation of the RSO, the NRC concludes that this 
example of the violation occurred as stated in the Notice. The issue 
of severity level is addressed below under ``NRC Evaluation of 
Licensee's Request for Mitigation.''

Summary of Licensee Response to Example A.2 of the Violation

    The Licensee admits this example in part and denies it in part, 
but does not state specifically what it admits or denies. The 
Licensee states its belief that surveys of radiation levels in 
adjacent areas and/or controlled areas were performed during the 
source exchanges which occurred on March 5, June 4, and September 
16, 1992, by Omnitron for the Licensee's benefit. The Licensee, in 
its letter dated December 1, 1994, provided Omnitron's record of 
surveys conducted during the source exchange on December 9, 1992, as 
well as other records of surveys conducted on March 5, June 4, and 
September 16, 1992. The Licensee believes that, in any event, this 
would constitute a Severity Level IV violation.

NRC Evaluation of Licensee's Response to Example A.2 of the 
Violation

    Omnitron's record of surveys conducted on December 9, 1992 does 
not show that all adjacent areas were surveyed as required by 
License Condition 14. Regarding the records of other surveys that 
the Licensee submitted, the NRC inspection report indicates that the 
inspectors did see documentation of partial surveys for March 5, 
1992, June 4, 1992, and September 16, 1992. With the exception of 
the survey record for December 17, 1992, the survey records that the 
Licensee submitted show that the surveys did not include all 
adjacent areas as required by the license condition. As noted in the 
inspection report, examples of adjacent areas that were not surveyed 
include a staff restroom, a utility room, the patient examination 
room, and the patient dressing room. Therefore, the NRC concludes 
that this example of the violation occurred as stated in the Notice. 
The issue of severity level is addressed below under ``NRC 
Evaluation of Licensee's Request for Mitigation.'' [[Page 21573]] 

Summary of Licensee Response to Example A.3 of the Violation

    The Licensee states that it denies this example. The Licensee 
states that, contrary to the NRC findings, checks were performed and 
an entire log indicating that certain checks were performed does 
exist. In its letter dated December 1, 1994, the Licensee provided 
numerous log entries to show that checks were performed.

NRC Evaluation of Licensee's Response to Example A.3 of the 
Violation

    The NRC staff has reviewed the log entries provided by the 
Licensee on December 1, 1994. Based on those records, which were not 
provided during the inspection or the transcribed enforcement 
conference, the NRC staff is withdrawing this example of the 
violation. The withdrawal of this example of the violation does not 
change the fact that the violation occurred, nor does it affect the 
appropriateness of the amount of the civil penalty assessed for the 
violation in this case, given the nature of the violation and the 
numerous other examples of the violation that are not being 
retracted.

Summary of Licensee Response to Example A.4 of the Violation

    The Licensee denies the example and asserts that relevant 
personnel attended Omnitron training where dry runs were performed 
and emergency situations and procedures were taught and discussed. 
The Licensee believes that, in any event, this could constitute a 
Severity Level IV violation.

NRC Evaluation of Licensee's Response to Example A.4 of the 
Violation

    While Omnitron training may have covered emergency situations, 
License Condition 14 specifically requires that each operator/user 
of the HDR individually demonstrate emergency routine competence 
during ``dry run'' emergencies using several failure modes for each 
operator. At the transcribed enforcement conference, the Medical 
Director, recalling the portion of the Omnitron training that 
pertained to emergency situations, stated, ``[t]o the best of my 
recollection, I believe they went through some of the descriptive 
terms on how to recrank the machine manually, and I believe they 
showed us the knob. But I cannot say with any degree of recollection 
that we actually went through it.'' As noted in the inspection 
report, the dosimetrist stated to inspectors that she had not 
performed ``dry run'' emergencies using several failure modes. 
Therefore, the NRC concludes that this example of the violation 
occurred as stated in the Notice. The issue of severity level is 
addressed below under ``NRC Evaluation of Licensee's Request for 
Mitigation.''

Summary of Licensee Response to Example A.5 of the Violation

    The Licensee admits this example of the violation, but states 
its belief that this would constitute a Severity Level IV violation.

NRC Evaluation of Licensee's Response to Example A.5 of the 
Violation

    The issue of severity level is addressed below under ``NRC 
Evaluation of Licensee's Request for Mitigation.''

Summary of Licensee Response to Example B of the Violation

    The Licensee denies this example. The Licensee states that 
failure to answer all questions posed by the inspector does not 
necessarily constitute evidence that employees were not adequately 
trained in accordance with the commitments in the application or in 
the regulations. The Licensee believes that at all times personnel 
were trained as required under the license and under the applicable 
regulations. The Licensee states that 10 CFR 19.12 only requires 
that personnel be trained ``commensurate with potential radiological 
health protection problems in the restricted area.'' The Licensee 
also states that ``the NRC did not allege that the dosimetrist did 
not know how to operate a hand held survey meter or that she was not 
trained in its operation.'' The Licensee asserts that the 
dosimetrist was trained pursuant to license requirements. The 
Licensee believes that, in any event, this would constitute a 
Severity Level IV violation.

NRC Evaluation of Licensee's Response to Example B of the Violation

    As documented in the inspection report, the dosimetrist was 
asked to demonstrate the operation and use of the radiation survey 
meter. The dosimetrist incorrectly set the instrument response dial 
to the X1000 scale, stating that this was the instrument's lowest 
strength scale. The inspectors asked the dosimetrist to repeat this 
demonstration and explanation a second time and the dosimetrist 
produced the same result. The dosimetrist is the individual who 
operated the HDR unit at Marlton. When the inspectors asked the 
dosimetrist to explain the meaning of the ``error code'' and ``error 
class'' messages on a printout of a treatment record, the 
dosimetrist stated that she did not know the meaning of the error 
messages.
    The NRC staff finds that the dosimetrist's lack of understanding 
of the differences between the highest setting on the meter and the 
lowest setting on the meter, as well as the lack of understanding 
concerning response to HDR error messages are clear evidence that 
adequate training was not provided.
    10 CFR 19.12 also requires that all individuals working in or 
frequenting any portion of a restricted area shall be instructed in 
precautions or procedures to minimize exposure, and in the purposes 
and function of protective devices employed. The extent of these 
instructions shall be commensurate with potential radiological 
health protection problems in the restricted area. The dosimetrist 
operated the HDR. In an emergency situation, the dosimetrist's 
duties could involve use of a survey meter to determine the status 
and location of the source in the restricted area as a means of 
protecting herself as well as other employees and patients. The 
Licensee clearly recognized that emergency situations could arise 
because it discussed ``dry run'' emergency procedures in its license 
application. In addition, since the dosimetrist's duties included 
operation of the HDR, this individual should have been knowledgeable 
on the meaning of error messages and how to respond to error 
messages generated by the HDR unit. Error messages could indicate 
hazardous conditions in the restricted area. Therefore, this 
individual was required by 10 CFR 19.12 to be trained by the 
Licensee on the meaning of the error messages, how to respond to 
error messages, and the use of a hand-held survey meter. Based on 
the above, the NRC concludes that this example of the violation 
occurred as stated in the Notice. The issue of severity level is 
addressed below under ``NRC Evaluation of Licensee's Request for 
Mitigation.''

Summary of Licensee Response to Example C of the Violation

    The Licensee states in its response that it admits in part and 
denies in part this example. The Licensee asserts that it did record 
certain changes and may not have recorded others. The Licensee 
further asserts that, in this case, there was no potential or actual 
impact on health and safety. The Licensee believes that, in any 
event, this would constitute a Severity Level V violation.

NRC Evaluation of Licensee's Response to Example C of the Violation

    10 CFR 35.31 authorizes medical use licensees to make minor 
changes in radiation safety procedures that are not potentially 
important to safety. 10 CFR 35.31(b) requires that if these changes 
(ministerial changes) are made, the licensee must maintain a record 
as specified in the regulation. There is no exception granted to the 
Licensee to only record certain changes. Since the Licensee did not 
maintain a record of some changes, the NRC concludes that this 
example of the violation occurred as stated in the Notice. The issue 
of severity level is addressed below under ``NRC Evaluation of 
Licensee's Request for Mitigation.''

Summary of Licensee Response to Example D of the Violation

    The Licensee states in its response that it denies this example. 
The Licensee asserts that it had a written quality management 
program (QMP) which was in effect at the relevant times. In 
addition, the Licensee states that it has modified its quality 
management plan pursuant to completion of a review of its HDR 
program, and that the modified plan has been submitted to the NRC.

NRC Evaluation of Licensee's Response to Example D of the Violation

    The requirement is that the Licensee establish and maintain a 
written quality management program to provide high confidence that 
byproduct material or radiation from byproduct material will be 
administered as directed by the authorized user. The inspection 
report indicates that inspectors did find a copy of ``Quality 
Management of Brachytherapy Patients High Dose Rate Techniques'' 
authorized by David Cunningham of Oncology Services Corporation and 
dated January 16, 1992. This [[Page 21574]] document was in a 
notebook containing other HDR records. According to the inspection 
report, the facility Medical Director/RSO had no knowledge of the 
document. In addition, the Medical Director/RSO stated at the time 
of the inspection that no one at the facility had received training 
on the document. Further, at the time of the inspection, the 
Licensee had not submitted its quality management program (QMP) to 
NRC as required by 10 CFR 35.32(f)(2). Since the Medical Director/
RSO had no knowledge of the QMP, had not trained the staff on the 
QMP, and had not submitted the QMP to NRC, it is clear that the QMP 
was neither established nor maintained so as to provide high 
confidence that radiation from byproduct material would be 
administered as directed by the authorized user. Therefore, the NRC 
concludes that this example of the violation did occur.

Summary of Licensee Response to Example E of the Violation

    The Licensee admits this example, but states its belief that 
this would constitute a Severity Level V violation.

NRC Evaluation of Licensee's Response to Example E of the Violation

    The issue of severity level is addressed below under ``NRC 
Evaluation of Licensee's Request for Mitigation.''

Summary of Licensee Response to Example G of the Violation

    The Licensee states in its response that it denies this 
violation. The Licensee states that it believes that certain records 
were maintained and that Omnitron also kept records for the benefit 
of the Licensee. The Licensee, in its letter dated December 1, 1994, 
provided copies of shipping papers showing the transfer of sources 
back to Omnitron, and copies of leak test results performed on 
sources by Omnitron. The Licensee believes that, in any event, this 
would constitute a Severity Level V violation.

NRC Evaluation of Licensee's Response to Example G of the Violation

    The NRC staff has reviewed the records submitted by the Licensee 
on December 1, 1994. The particular shipping records that the 
Licensee submitted, which include the transferee, isotope, activity, 
and date, meet the requirement for records of the transfer of 
byproduct material. The leak test records that the Licensee 
submitted meet in part the requirement for records of receipt of 
licensed material. The leak test records did identify the 
transferor, isotope, and activity; but not the date of receipt. 
However, because the Licensee has other records, such as source 
exchange records, that identify the date of receipt, the NRC is 
withdrawing this example of the violation. The withdrawal of this 
example of the violation does not change the fact that the violation 
occurred, nor does it affect the appropriateness of the amount of 
the civil penalty assessed for the violation in this case, given the 
nature of the violation and the numerous other examples of the 
violation that are not being retracted.

Summary of Licensee's Request for Mitigation

    The Licensee states in its response that it has taken numerous 
corrective actions to strengthen and improve all aspects of its 
radiation safety program. The licensee also states that over the 
past eighteen months, it has attempted to continually review and 
update its HDR program and staff, and emphasize the importance of 
radiation safety and applicable regulations. In addition, the 
Licensee indicates that management has attended courses regarding 
RSO duties and responsibilities. The Licensee also notes that five 
patients were treated with the HDR unit between March 1992 and 
December 1992 and there were no misadministrations or incidents.
    The Licensee states that it: (1) Immediately and voluntarily 
suspended all HDR treatments in order to review the entire HDR 
program; (2) fully and timely complied with any and all CALs; and 
(3) replaced its contract physicist with a full-time physicist who, 
as RSO under the license, would provide necessary onsite RSO 
continuity needed to assure Licensee management and the NRC that the 
HDR program could run safely and in accordance with all regulations 
at all times. The Licensee also states its belief that the 
replacement of the RSO constitutes required and necessary corrective 
action regarding the identified issues, noting that the new 
physicist has held quarterly meetings where radiation safety, and 
regulatory issues have been reviewed with the staff. According to 
the Licensee, staff members have attended additional outside 
training and the authorized users have attended a six hour Radiation 
Safety Officers Review Course. In addition, the Licensee states that 
it has hired a Certified Health Physicist to assist in the 
coordination and oversight of all aspects of the Licensee's 
radiation safety program.
    The Licensee states its belief that by hiring a full-time 
physicist to serve as RSO and obtaining the assistance of the 
Certified Health Physicist, it has clearly demonstrated that it has 
committed the resources necessary to develop and implement an 
appropriate, comprehensive and long lasting commitment to address 
the root cause of the violations. The Licensee believes that its new 
program, which permits only the physicist and physician to be 
involved with actual HDR patient treatments, will assure the NRC 
that none of the examples of the violation will be repeated.
    The Licensee contends that a fine of $80,000 for what the 
Licensee terms ``a number of Level IV and V violations'' is 
arbitrary, capricious and unsupported by any of the NRC rules, 
regulations and/or legislative history. In support of this argument, 
the Licensee claims that similar enforcement actions involving 
similar violations by Part 35 licensees resulted in substantially 
smaller penalties. The Licensee further states that these citations 
collectively do not constitute a Severity Level II program and, in 
any case, the maximum penalty should be $8,000 before any 
mitigation. The Licensee asserts that it has an exemplary record 
having had no previous violations or misadministration. The Licensee 
cites a number of NRC Enforcement sanctions which the Licensee 
believes supports its claim that the sanction imposed on the License 
is inappropriate.

NRC Evaluation of Licensee's Request for Mitigation

    Pursuant to Section 234 of the Atomic Energy Act, as amended, 
the NRC is authorized to impose civil penalties of up to $100,000 
per violation per day for each day that a violation continues. 
Normally, proposed civil penalties are determined after application 
to the base civil penalty of the mitigating and escalating factors 
in Section VI of the Enforcement Policy, including corrective action 
and past licensee performance. Section VII.A of the Enforcement 
Policy provides, however, that notwithstanding the outcome of the 
normal civil penalty adjustment process, the NRC may exercise its 
full enforcement authority to ensure that the resulting enforcement 
action appropriately reflects the level of NRC concern regarding the 
violations at issue and conveys the appropriate message to the 
licensee, in order to provide an appropriate sanction when 
particularly serious violations or serious breakdowns in management 
controls have occurred. Given the seriousness of the violation in 
that the RSO failed to devote time or attention to the radiation 
safety program and that corporate management created the environment 
in which this was allowed to occur, a large civil penalty is 
warranted to emphasize the unacceptable performance of the Licensee, 
its RSO, and its corporate owner; and to emphasize the need for the 
Licensee and its corporate owner, as well as other licensees engaged 
in similar activities, to assure that controls are in place to avoid 
similar violations. THe NRC appropriately exercised its statutory 
authority when it proposed an $80,000 civil penalty for the 
violation.
    As the Licensee's arguments that some of the examples are 
appropriately classified at Severity Level IV or V, the NRC did not 
categorize the individual examples of the violation in the Notice by 
severity level. Rather, the NRC categorized the single violation, 
including all of the listed examples, at Severity Level II. The 
violation is appropriately categorized at Severity Level II because 
it is of very significant regulatory concern and involved high 
potential impact on the public. Enforcement Policy Section IV. The 
guidance given by the examples in Supplements I-VII of the 
Enforcement Policy is neither exhaustive nor controlling in 
classifying the severity level of violations. The NRC reviews each 
enforcement action on its own merits to ensure that the severity 
level of a violation is characterized at the level best suited to 
the significance of the violation, which may warrant an adjustment 
to the severity level categorization. Enforcement Policy, Section 
IV. In this case, the violation represents a near total failure of 
the RSO to address her regulatory responsibilities and an equally 
serious failure of licensee management to exercise oversight over 
the radiation safety program in order to ensure that regulatory 
requirements were met, all of which created a high potential impact 
on the public for an incident similar to the November 1992 
misadministration and [[Page 21575]] radiological event at the 
owner's facility in Indiana, Pennsylvania.
    The NRC acknowledges that the Licensee has taken corrective 
actions and is aware of the Licensee's past performance. However, in 
this case, the NRC exercised discretion to escalate the civil 
penalties, which supersedes the normal application of the adjustment 
factors, as explained above. In addition, civil penalties are 
imposed, in part, to deter future violations by not only the 
involved licensee, but other licensees conducting similar 
activities. See Enforcement Policy, Section VI.B.
    The civil penalties proposed in this case are within the 
authority of the NRC. The Licensee's comparison of the civil penalty 
in this case with civil penalties in other cases does not bring 
NRC's exercise of its lawful authority into question. Of decisive 
importance is the NRC's clear authority to exercise discretion in 
the choice of enforcement sanctions and the ordering of enforcement 
priorities. Advanced Medical Systems, Inc., (CLI-94-6), 39 NRC 285, 
320 (1994). A sanction is not rendered invalid because it is more 
severe than that issued in other cases. Id. As explained above, the 
NRC acted within its statutory authority and the bounds of the 
Enforcement Policy when NRC exercised its discretion to escalate the 
civil penalties in this case. A rigid uniformity is neither required 
nor possible in enforcement decisions, which inherently involve the 
exercise of informed judgement on a case-by-case basis. Id. See 
also, Radiation Technology, Inc., (ALAB-567), 10 NRC 533, 541 
(1979).

NRC Conclusion

    The NRC has concluded that: (1) With the exceptions of Examples 
A.3 and G., the violation occurred as stated in the Notice; (2) 
Examples A.3 and G are being withdrawn; (3) the withdrawal of these 
two examples of the violation does not change the fact that the 
violation occurred nor does it affect the appropriateness of the 
amount of the civil penalty assessed for the violation; and (4) an 
adequate basis for mitigation of the civil penalty was not provided 
by the Licensee. Consequently, the proposed civil penalty in the 
amount of $80,000 is being imposed.

[FR Doc. 95-10730 Filed 5-1-95; 8:45 am]
BILLING CODE 7590-01-M