[Federal Register Volume 60, Number 84 (Tuesday, May 2, 1995)]
[Notices]
[Pages 21560-21569]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-10731]
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NUCLEAR REGULATORY COMMISSION
[Docket No. 030-31765, License No. 37-28540-01, EA 94-006]
Oncology Services Corp., Harrisburg, PA; Order Imposing Civil
Monetary Penalties
I
Oncology Services Corporation (Licensee) was the holder of
Byproduct Materials License No. 37-28540-01 (License) issued by the
Nuclear Regulatory Commission (NRC or Commission) on August 3, 1990.
The License authorized the Licensee to possess and use certain
byproduct materials in accordance with the conditions specified therein
at six facilities in Pennsylvania. The License was due to expire on
August 31, 1995. However, on December 13, 1993, the Licensee requested
termination of the License, with the License to be replaced by
individual licenses issued to the facilities named as locations of use
on the License. On August 24, 1994, License No. 37-28540-01 was
terminated, and the NRC subsequently issued separate licenses for the
following facilities previously named as locations of use under License
No. 37-28540-01: Greater Pittsburgh Cancer Center (License No. 37-
30163-01); Mahoning Valley Cancer Center (License No. 37-30086-01);
Stoneboro Oncology Associates, P.C. (License No. 37-30092-01); Greater
Harrisburg Cancer Center (License No. 37-30084-01); Indiana Regional
Cancer Center (License No. 37-28179-02); and Exton Cancer Center
(License No. 37-30087-01). In addition, a license was issued to
Jefferson Radiation Oncology Center (License No. 37-30085-01).
II
An inspection of the Licensee's activities at its facilities
located in Indiana, Pennsylvania and Pittsburgh, Pennsylvania was
conducted on December 3-18, 1992, by an NRC Incident Investigation
Team, following an event involving the Indiana, Pennsylvania facility
in which there was a significant misadministration to a patient who
died five days later, and significant radiological exposures to members
of the public. In addition, NRC Region I performed an inspection on
December 8, 1992, at the Licensee's Exton and Lehighton, Pennsylvania
facilities. The results of these inspections 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 Penalties (Notice) was served upon the Licensee by letter dated
May 31, 1994. The Notice states the nature of the violations, the
provisions of the NRC requirements that the Licensee had violated, and
the amount of the civil penalties proposed for the violations.
The Licensee responded to the Notice in letters dated August 31,
1994 and October 4, 1994. In its responses, the Licensee admits
Violations III.C.2, III.D.5, III.E. III.F, and III.I; denies Violations
I.A, I.B, II.A, II.B, III.A, III.B, III.C.1, III.D.1-4, III.D.6, III.G,
III.H, and III.J.1-3 protests the amount of civil penalties proposed;
and requests mitigation of the penalties, as appropriate.
III
After consideration of the Licensee's responses 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 the violations occurred as stated in the Notice, and that
the penalties proposed for the violations 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 civil penalties in the cumulative amount of
$280,000 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, PA 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 Violations I.A, I.B, II.A, II.B, III.A,
III.B, III.C.1, III.D.1-4, III.D.6, III.G, III.H, and III.J.1-3 of the
Notice referenced in Seciton II above, and
(b) Whether, on the basis of such violations and the additional
violations set forth in the Notice of Violation that the Licensee
admitted, 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 Penalties (Notice) was issued for violations identified during
NRC inspections (including an Incident Investigation Team (IIT)
inspection) at several Oncology Services Corporation (Licensee)
facilities. The Licensee responded to the Notice on August 31, 1994 and
October 4, 1994. The Licensee admitted Violations III.C.2, III.D.5,
III.E, III.F, and III.I; denied Violations I.A, I.B, II.A, II.B, III.A,
III.B, III.C.1, III.D.1-4, III.D.6, III.G, III.H, and III.J.1-3; and
requested remission of the civil penalties. The NRC's evaluation and
conclusion regarding the Licensee's requests are as follows:
Restatement of Violations in Section I of the Notice
I. A. 10 CFR 20.201(b) requires that each Licensee make such
surveys as may be necessary to comply with the requirements of 10 CFR
Part 20 and which are reasonable under the circumstances to evaluate
the extent of radiation hazards that may be present. As defined in 10
CFR 20.201(a), ``survey'' means an evaluation of the radiation hazards
incident to the [[Page 21561]] production, use, release, disposal, or
presence of radioactive materials or other sources of radiation under a
specific set of conditions.
Contrary to the above, on November 16, 1992, the Licensee did not
make a survey necessary to comply with the requirements of 10 CFR
20.101 which limits radiation exposure to individuals in restricted
areas, and 10 CFR 20.105(b) which limits radiation levels in
unrestricted areas. Specifically, although the room radiation monitor
in the treatment room (restricted area) at the Indiana Regional Cancer
Center (IRCC), flashed the red alarm signal even after the console of
the High Dose Rate (HDR) afterloader unit showed that a 4.2 Curie
iridium-192 source was safety retracted (because the source had broken
off inside the patient), a radiation survey was not performed to
confirm or discount the presence of a radiation hazard in the room or
the patient as indicated by the alarming room monitor.
B. Condition 17 of License No. 37-28540-01, Amendment No. 3 dated
August 19, 1992, requires, in part, that the Licensee conduct its
program in accordance with the statements, representations, and
procedures contained in the application dated June 1, 1990, and the
letter dated August 2, 1990.
Item 9.C.3 of the application dated June 1, 1990, requires, in
part, that a radiation monitor (PrimAlert or equivalent) be mounted on
the wall [in the HDR afterloader treatment room] and will remain in
place as a means of verifying a source ``safe'' or ``out'' condition.
Item 10.15.A.3 of the application dated June 1, 1990, requires, in
part, that all attending personnel must remain in the control area
during actual treatment and may not re-enter the treatment room until
the room radiation detector (PrimAlert) indicates a safe condition
prevails.
Item 6 of the letter dated August 2, 1990, states that failure of
the radiation monitor will result in termination of the treatment until
the monitor is replaced or repaired and, in the event of failure of the
room monitor, no personnel will enter the room without a portable
survey meter or audible dosimeter.
Contrary to the above, on November 16, 1992, during a patient
treatment utilizing an iridium-192 source in a HDR afterloader, at the
IRCC, when the wall-mounted radiation monitor flashed the red alarm
signal to indicate a source ``out'' condition, a physician authorized
user, who had been informed that the red alarm signal was flashing,
entered the treatment room without a portable survey meter or audible
dosimeter; and, at some point during the event, a Licensee technologist
entered the treatment room and unplugged and replugged the power supply
of the room radiation monitor to reset the alarm.
These violations represent a Severity Level I problem (Supplement
IV and VI) Civil Penalty--$100,000.
Summary of Licensee's Response to Violation I.A
The Licensee in its responses, denies Violation I.A and states that
the treatment room at the Indiana Regional Cancer Center was surveyed
with what the Licensee terms ``a wall mounted survey instrument
(`WMSI')'', the WMSI did not flash red in the presence of the
authorized user, and the WMSI stopped flashing when the electrical
connection was touched. The Licensee further asserts that the
authorized user was not aware, prior to entering the treatment room,
that the WMSI had flashed. The Licensee also asserts that all output on
the Omnitron unit and console indicated that the source was parked and
safe; no alarm went off on the Omnitron unit; and all personnel acted
in accordance with what the Licensee terms its ``NRC approved Omnitron
training.'' The Licensee states that the conduct of the authorized user
and the Licensee was reasonable at all times and in conformity with NRC
regulations.
The Licensee also states that the Omnitron machine failed; that
failure was neither expected nor intended; and that the Licensee could
not have prevented the failure. The Licensee also notes that it
believes the NRC was in a much better position to understand the need
for adequate surveys, yet the NRC license application reviewer did not
find it necessary to require, or even request, the Licensee modify its
license application or procedure to include a patient survey with a
hand held survey meter after each treatment. The Licensee states that
it believes that at all times it followed the applicable regulations,
and that it was the victim of a machine failure and inadequate and/or
outdated regulations. The Licensee further states that there was no
intent to violate any regulations and that personnel were not reckless.
The Licensee states that since the WMSI was not flashing when the
authorized user was in the treatment room, to expect the authorized
user to act other than as he did is not rational under the existing
circumstances. The Licensee believes that, in any event, this violation
would be classified at Severity Level IV.
NRC Evaluation of Licensee's Response to Violation I.A
The specific issue addressed in Violation I.A is whether the
Licensee performed a survey as required by 10 CFR 20.101 to confirm or
discount the presence of a radiation hazard in the room or the patient
as indicated by the alarming room monitor. The fact that the wall
mounted radiation monitor flashed the red alarm signal even though the
Omnitron console showed that the source was safety retracted is the
condition that triggered the requirement to conduct a survey pursuant
to Sec. 20.201. Thus, the Licensee cannot point to the same wall
mounted radiation monitor as fulfilling the requirement to conduct the
survey pursuant to Sec. 20.201. Rather, the Licensee was required under
those circumstances, pursuant to Sec. 20.201, to perform an independent
survey, such as by using a hand held radiation survey instrument, to
determine which indicator was correct--the wall mounted radiation
monitor, or the Omnitron console. The Licensee failed to do this and
chose instead to discount the alarm from the wall mounted radiation
monitor and to rely on the Omnitron console indicator.
As to the Licensee's statement that the regulations are inadequate
or outdated, the Licensee does not identify any particular regulation.
However, only 10 CFR 20.201 is cited in Violation I.A. An extensive
revision of 10 CFR Part 20 became effective January 1, 1994, and the
survey requirement of 10 CFR 20.201 is now codified at 10 CFR 20.1501.
The language of the specific requirement has been changed only
slightly. The survey requirement of 10 CFR 20.201 is not outdated or
inadequate. It would have been a simple matter for the Licensee to
comply with the requirement using the hand held survey instrument that
the Licensee had on hand, which is a basic radiation protection
practice.
Even before the authorized user (AU) arrived at the treatment room,
Licensee technologists noticed that the wall mounted radiation monitor
was flashing, knew that the Omnitron console indicated that the source
was retracted safely, and yet they were present in the treatment room
without having performed the survey required pursuant to Sec. 20.201.
At this point, such a survey was necessary to comply with the
requirements of 10 CFR 20.101, which limits exposure to individuals in
restricted areas. Thus, Violation I.A was occurring even before the AU
entered the room. [[Page 21562]]
Although knowledge on the part of the AU that the wall mounted
radiation monitor had been flashing is not necessary to prove the
violation, the fact that the AU was aware that the wall mounted
radiation monitor was flashing as he entered the treatment room is
corroborated by his testimony, as well as the testimony of others, in
transcribed interviews. Additionally, the transcribed interviews of the
AU consistently show that, while he was in the treatment room, he was
aware that: (1) The wall mounted radiation monitor had been flashing;
and (2) the Omnitron console showed that the source was safely
retracted.
NRC agrees that the Omnitron source broke off and was not
retracted, that this was neither expected nor intended by the Licensee,
and that the Licensee could not have prevented the break. However, that
does not change the fact that the survey required by 10 CFR 20.201 was
not performed, which is a matter that was within the Licensee's
control. Given the conflicting information from the flashing wall
mounted radiation monitor and the Omnitron control panel, such a survey
was reasonable under the circumstances to evaluate the extent of the
radiation hazards that were present. Since such a survey was not
performed, the NRC concludes that Violation I.A occurred as stated in
the Notice. The issue of the severity level of the violation is
addressed in the evaluation of the Licensee's Response to Violation
I.B, below.
Summary of Licensee's Response to Violation I.B
The Licensee denies Violation I.B; incorporates its response to
Violation I.A, summarized above; and asserts that Violation I.B would
be a Severity Level IV violation. The Licensee states that the wall
mounted radiation monitor should have continued to alarm, and that if
the monitor had done so, the technologist and authorized user would
have acted accordingly.
NRC Evaluation of Licensee's Response to Violation I.B
Licensee employees entered the treatment room while the wall
mounted radiation monitor was alarming, indicating a non-safe
condition, and they did so without a portable survey meter or audible
dosimeter. If the employees believed that the wall mounted radiation
monitor was functioning properly, they should not have entered the
treatment room while it was alarming, which is a violation of License
Condition 17. If the employees discounted the alarm because they
believed that the wall mounted radiation monitor was not functioning
properly (i.e., spuriously alarming), they should not have entered the
treatment room without a portable survey meter or audible dosimeter,
which is also a violation of License Condition 17.
Moreover, the requirements of License Condition 17 as cited in
Violation I.B were being violated even before the authorized user
entered the treatment room. The transcribed interviews clearly show
that the monitor was alarming when the technologists entered the
treatment room. The violation occurred upon entry. Thus, whether the
monitor should have continued to alarm after the technologist entered
the treatment room and manipulated its plug is not relevant to the
existence of the violation. Accordingly, the NRC concludes that
Violation I.B occurred as stated in the Notice.
Among other things, Violations I.A and I.B were classified in the
aggregate as a Severity Level I problem in accordance with Supplements
IV and VI of the NRC Enforcement Policy because: (1) Conducting the
survey and complying with the requirements of License Condition 17
regarding the wall mounted radiation monitor, and the use of a portable
survey meter or audible dosimeter in the event of a failure of the wall
mounted radiation monitor, constitute a system designed to prevent or
mitigate a serious safety event, and in this case, the system was not
operable when actually required to perform; and (2) the violations
resulted in acute radiation exposure and subsequent death of a patient.
See Enforcement Policy (1993), Supplement IV, Example A.2; and
Supplement VI, Examples A.2 and A.4.
Restatement of Violations in Section II of the Notice
II.A. 10 CFR 20.207(a) requires that licensed materials stored in
an unrestricted area be secured against unauthorized removal from the
place of storage. 10 CFR 20.207(b) requires that licensed materials in
an unrestricted area and not in storage be tended under constant
surveillance and immediate control of the Licensee. As defined in 10
CFR 20.3(a)(17), an unrestricted area is any area access to which is
not controlled by the Licensee for purposes of protection of
individuals from exposure to radiation and radioactive materials.
Contrary to the above, from November 16, 1992 to December 1, 1992,
licensed material consisting of Curie quantities of iridium-192 was
located at a nursing home, a waste disposal facility, and several
vehicles, which are unrestricted areas, and the licensed material was
not secured against unauthorized removal nor was it under the constant
surveillance and immediate control of the Licensee.
B. 10 CFR 20.105(b) requires that, except as authorized by the
Commission in 10 CFR 20.105(a), no Licensee shall possess, use, or
transfer licensed material in such a manner as to create radiation
levels in unrestricted areas which, if an individual were continuously
present in the area, could result in his receiving a dose in excess of
2 millirems in any one hour or 100 millirems in any seven consecutive
days.
Contrary to the above, from November 16, 1992 to December 1, 1992,
the Licensee allowed the creation of radiation levels in unrestricted
areas, such that if an individual were continuously present in the
area, he could have received a dose in excess of 2 millirems in any one
hour or 100 millirems in any seven consecutive days. Specifically, the
Licensee allowed the creation of radiation levels of approximately 2000
millirem per hour at a distance of one meter in unrestricted areas,
specifically a nursing home, a waste disposal facility, and several
vehicles.
These violations represent a Severity Level I problem (Supplement
IV) Civil Penalty--$100,000.
Summary of Licensee Response to Violations II.A and II.B
The Licensee denies Violations II.A and II.B and incorporates by
reference its response to the violations in Section I. The Licensee
contends that the source was lost, not possessed, used, transferred or
stored. According to the Licensee, loss is an accidental act, while, as
used in NRC regulations, possession, use, transfer and storage are
deliberate acts. The Licensee asserts that the cited violations would
have required knowledge of attending personnel that the source was
still in the patient, but since they did not know the source was still
inside the patient, the Licensee did not possess, use, transfer or
store material in violation of any regulations.
NRC Evaluation of Licensee's Response to Violations II.A and II.B
The Notice does not assert, expressly or otherwise, that the
violations were knowing or deliberate. Neither 10 CFR Sec. 20.207 nor
Sec. 20.105 require a knowing failure to maintain control of licensed
material, or knowing exposure of individuals to radiation, in order to
establish a violation. Under the regulations in 10 CFR part 20,
licensees are strictly held accountable for loss of
[[Page 21563]] radioactive material and for radiation levels in
unrestricted areas caused by such loss. As a result of the Licensee's
use of the source on November 16, 1992, the source escaped the
Licensee's control and was transferred to the nursing home and,
subsequently, to other unrestricted areas, where it created radiation
levels far in excess of the allowable limits. Therefore, the NRC
concludes that Violations II.A and II.B occurred as stated in the
Notice.
Restatement of Violations in Section III of the Notice
III.A. 10 CFR 19.12 requires, in part, that all individuals working
in a restricted area be instructed in the precautions and procedures to
minimize exposure to radioactive materials, in the purpose and
functions of protective devices employed, and in the applicable
provisions of the Commission's regulations and licenses.
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.
Condition 17 of License No. 37-28540-01, Amendment No. 3 dated
August 19, 1992, requires, in part, that the Licensee conduct its
program in accordance with the statements, representations, and
procedures contained in the application dated June 1, 1990.
Item 8 of the application dated June 1, 1990, requires, in part,
that training for HDR device operators will include emergency training
where the device operator will demonstrate emergency routine competence
during a ``dry run'' emergency of the source not retracting.
Contrary to the above, individuals who were working in the HDR
afterloader treatment room, a restricted area, at three of the
Licensee's six facilities in Pennsylvania, had not been adequately
instructed in the precautions and procedures to minimize exposure to
radioactive materials, in the purpose and functions of protective
devices employed, and in the applicable provisions of the Commission's
regulations and the conditions of the license, as evidenced by the
following examples:
1. As of December 18, 1992, technologists working in a restricted
area at the Indiana facility were not adequately instructed in how to
use a survey meter, the meaning of a high radiation area, the methods
of performing HDR afterloader door interlock checks, the significance
of the alarm setpoint (the preset value) of the wall-mounted radiation
monitor, the meaning of HDR afterloader error messages, the activity of
the sources contained in the HDR unit and their potential radioactive
hazard, or the corporate policy that requires the staff to survey each
patient treated with the HDR afterloader unit with a portable survey
meter before the patient's release, and in addition, individuals who
operated the HDR device had not performed a ``dry run'' emergency; and
2. As of December 8, 1992, Licensee personnel working in restricted
areas at the Exton and Lehighton facilities had not been instructed in
the applicable provisions of the Commission's regulations and the NRC
license, and individuals who operated the HDR device had not performed
a ``dry run'' emergency of the source not retracting.
B. 10 CFR 35.25(a)(1) requires, in part, that a Licensee that
permits the use of byproduct material by an individual under the
supervision of an authorized user shall instruct the supervised
individual in the Licensee's written quality management program.
Contrary to the above, as of December 8, 1992, the Licensee did not
instruct personnel who used iridium-192 under the supervision of an
authorized user at the Exton facility in the Licensee's written quality
management program.
C. 10 CFR 20.202(a) (1) and (3) requires, in part, that: Each
Licensee supply appropriate personnel monitoring equipment to, and
require the use of such equipment by, each individual who enters a
restricted area under such circumstances that he receives, or is likely
to receive, a dose in any calendar quarter in excess of 25 percent of
the applicable value specified in 10 CFR 20.101(a); and each Licensee
supply appropriate personnel monitoring equipment to, and require the
use of, such equipment by each individual who enters a high radiation
area.
Contrary to the above,
1. On November 16, 1992, during a treatment of a patient with
iridium-192 in a HDR afterloader unit, the physician authorized user at
the Indiana facility entered the treatment room, a restricted area,
and, although the wall-mounted radiation monitor had flashed the red
alarm signal to indicate the presence of a radiation field, the
authorized user did not wear his personal monitoring equipment; and,
2. On December 1, 1992, the authorized user at the Indiana
facility, in efforts to retrieve the iridium-192 radioactive source,
entered a high radiation area at the Browning-Ferris Industries waste
facility in Carnegie, Pennsylvania, and did not wear his personnel
monitoring equipment.
D. Condition 17 of License No. 37-28540-01 requires, in part, that
licensed material be possessed and used in accordance with statements,
representations, and procedures contained in an application dated June
1, 1990, and a letter dated August 16, 1991.
1. Item 10.2 of the application dated June 1, 1990, states that the
Licensee will establish and implement the ALARA program that was
published in Appendix G to Regulatory Guide 10.8, Revision 2.
Appendix G to Regulatory Guide 10.8, Revision 2, requires, in part,
that the RSO [Radiation Safety Officer] be in close contact with all
users and workers in order to develop ALARA procedures for working with
radioactive materials.
Contrary to the above, as of December 3, 1992, the RSO did not
maintain close contact with all users and workers. For example, Medical
Director/Authorized Users at the Indiana and Lehighton facilities were
not aware of who the RSO was. Additionally, the RSO had not visited the
Lehighton facility in the past 6-9 months.
2. Item No. 10.15.A.1 of the June 1, 1990, application requires
that emergency procedures be conspicuously posted near the control
console.
Contrary to the above, on December 8, 1992, the emergency
procedures were not posted at the Exton facility.
3. Item No. 10.15.B.1 of the June 1, 1990, application requires
that the calibration of the HDR afterloader source and device include a
check of source travel time error and accuracy of the timing device.
Contrary to the above, as of December 8, 1992, the calibration of
the HDR afterloader source and device at the Exton facility did not
include a check of source travel time error and accuracy of the timing
device.
4. Item No. 10.12 of the June 1, 1990, application requires that
surveys of radiation levels in adjacent and control areas be performed
at each source exchange and logged.
Contrary to the above, as of December 8, 1992, surveys of radiation
levels in adjacent and control areas were not performed at each source
exchange at the Exton facility.
5. The Licensee's letter dated August 16, 1991, requires, in part,
that the key for the linear accelerator and the key for the HDR
afterloader unit be on the same ring to prohibit the simultaneous
activation of these units.
Contrary to the above, on December 8, 1992, the key for the linear
accelerator and the key for the HDR afterloader unit
[[Page 21564]] were not on the same ring at the Exton facility and the
Lehighton facility. At each facility, the inspector noted that the
linear accelerator key was in the linear accelerator console and the
HDR key was in the HDR console.
6. Item 4 of the letter dated August 2, 1990, requires, in part,
that ancillary personnel will receive an orientation program and an
annual review of the basic principles related to identifying, and
proper procedures in working in, areas controlled under this license.
Instructions for individuals will include the subjects listed on page
A-1 of NRC Regulatory Guide 10.8, Rev. 2.
Regulatory Guide 10.8, Rev. 2, page A-1, requires instruction in
potential hazards associated with radioactive material in each area
where the employee will work.
Contrary to the above, as of December 4, 1992, ancillary personnel
at the IRCC facility were not informed about radiation hazards
associated with a 3.7 Curie iridium-192 source in a source container
located in the HDR afterloader treatment room. Specifically,
housekeeping personnel had access to the keys to the treatment room and
offered to move the source container which measured approximately 80
millirem per hour at the surface.
E. 10 CFR 20.203(c)(1) requires that each high radiation area be
conspicuously posted with a sign or signs bearing the radiation caution
symbol and the words: ``Caution High Radiation Area.''
Contrary to the above, on December 8, 1992, the high radiation area
in the HDR afterloader treatment room at the Exton facility was not
posted as required with the required sign bearing the radiation caution
symbol and the words: ``Caution High Radiation Area.''
F. 10 CFR 35.51(c) requires, in part, that a Licensee check each
survey instrument for proper operation with the dedicated check source
each day of use.
Contrary to the above, as of December 8, 1992, the Licensee at the
Exton facility routinely did not check its survey meter with a
dedicated check source on days when the instrument was used.
G. 10 CFR 35.25(a)(3) requires, in part, that a Licensee that
permits the use of byproduct material by an individual under the
supervision of an authorized user shall periodically review the
supervised individual's use of byproduct material and the records kept
to reflect this use.
Condition 17 of License No. 37-28540-01 requires, in part, that
licensed material be possessed and used in accordance with statements,
representations, and procedures contained in an application dated June
1, 1990, and a letter dated August 16, 1991.
Item 10.15.A.4 of the application dated June 1, 1990, requires, in
part, that daily checks of interlocks, safety systems, and alarms be
performed and logged.
Contrary to the above, as of December 3, 1992, supervised
individuals at the IRCC facility routinely did not perform daily
interlock checks as required in conjunction with operating the HDR
afterloader containing iridium-192, and the Licensee did not review
their performance of this procedure.
H. 10 CFR 35.21(b)(2) requires, in part, that the RSO establish,
collect in one binder or file, and implement written policy and
procedures for:
(v) Using byproduct material safely,
(vi) Taking emergency action if control of byproduct material is
lost,
(viii) Performing checks of survey instruments and other safety
equipment, and
(x) Training personnel who work in or frequent areas where
byproduct material is used or stored.
Contrary to the above, as of November 16, 1992:
1. The RSO did not establish and implement written policy and
procedures for using byproduct material safely. Specifically, although
iridium-192 was in use in HDR afterloader units at the Indiana, Exton,
and Lehighton facilities, written procedures entitled, ``Oncology
Services Corporation, Department of Physics, HDR Treatment Manual'',
existed only in draft form and the RSO had not distributed them to the
staff.
2. The RSO did not establish and implement procedures for taking
emergency action if control of byproduct material was lost.
Specifically, the RSO had not established or implemented such
procedures as of December 1, 1992, when the Licensee retrieved a 3.7
Curie iridium-192 source from a waste disposal facility and transported
it back to the Licensee's facility.
3. The RSO did not implement procedures at the IRCC for performing
checks of survey instruments and other safety equipment. Specifically,
the RSO did not implement procedures for checking survey instruments
for proper operation with a dedicated check source on days when the
instrument was used, as required by 10 CFR 35.51(c); and for checking
the treatment room door interlock in conjunction with operating the HDR
afterloader, as required by License Condition 17, application dated
June 1, 1990, Item 10.15.A.4.
4. The RSO did not establish and implement written policy and
procedures for training personnel who work in or frequent areas where
byproduct material is used or stored. For example, the RSO believed
that it was the responsibility of the physicist at the Indiana, PA,
facility to provide such training to the individuals there; however,
the medical physicist stated that his contract did not indicate that he
should provide training.
I. 10 CFR 35.13(e) requires that a Licensee apply for and must
receive a license amendment before it adds to or changes the areas of
use or address or addresses of use identified in the application or on
the license.
Contrary to the above, on or about April 23, 1991, the Licensee's
RSO changed the area of use of iridium-192 in a HDR afterloader for a
shielding experiment from the shielded therapy room at the Greater
Harrisburg Cancer Center, the area of use identified in the
application, to an area outside of the building and, as of that date,
the Licensee had not applied for or received a license amendment
authorizing the change.
J. 10 CFR 71.5(a) requires that a Licensee who transports licensed
material outside the confines of its plant or other place of use, or
who delivers licensed material to a carrier for transport, shall comply
with the applicable requirements of the regulations appropriate to the
mode of transport of the Department of Transportation (DOT) in 49 CFR
Parts 170 through 189.
1. 49 CFR 173.24(f)(ii) requires, in part, that closures on
packagings shall be so designed and closed that under conditions
normally incident to transportation, the closure is secure.
49 CFR 173.475(c) requires, in part, that before each shipment of
any radioactive materials package, the shipper shall ensure by
examination or appropriate tests that each closure device of the
packaging is properly installed, secured, and free of defects.
Contrary to the above, on December 1, 1992, the Licensee
transported a radioactive materials package containing 3.7 Curies of
iridium-192 and there was no closure device on the packaging.
2. 49 CFR 177.817(a) requires that a carrier not transport a
hazardous material unless it is accompanied by a shipping paper
prepared in accordance with 49 CFR 172.200-203. Pursuant to 49 CFR
172.101, radioactive material is classified as hazardous material.
Contrary to the above, on December 1, 1992, the Licensee
transported 3.7 [[Page 21565]] Curies of iridium-192, a radioactive
material, without a shipping paper.
3. 49 CFR 172.504 prescribes requirements for placarding vehicles
used to transport hazardous materials. Specifically, Table 1 requires
that the transport vehicle be placarded on each side and each end with
a ``RADIOACTIVE'' placard when transporting packages bearing a
``RADIOACTIVE YELLOW-III'' label (footnote 4).
Contrary to the above, on December 1, 1992, the Licensee
transported 3.7 Curies of iridium-192 outside the confines of its plant
in a package with the required YELLOW-III label, and the transport
vehicle was not placarded with a ``RADIOACTIVE'' placard.
These violations represent a Security Level II problem (Supplement
IV, V and VI) Civil Penalty--$80,000.
Summary of Licensee's Response to Violations III.A and III.B
The Licensee denies Violations III.A and III.B and states that at
all times it adequately instructed all personnel in relevant areas
consistent with 10 CFR 19.12, 10 CFR 35.25(a)(1), and the license, and
that it would be incorrect for NRC to take the position that each and
every individual must be knowledgeable about each and every regulation
and/or license condition. The Licensee believes that, in any event,
these violations would be classified at Severity Level III.
NRC Evaluation of Licensee Response to Violations III.A and III.B
The Licensee was not cited for failure to instruct each and every
individual in every NRC requirement. 10 CFR 19.12 requires that
training for workers be commensurate with potential radiological health
protection problems in restricted areas. Additionally, training must
fulfill specific regulations such as 10 CFR 35.25(a)(1), as well as
specific commitments made by the Licensee and incorporated into the
license by condition. Violations III.A and III.B were identified as a
result of discussions between OSC personnel and NRC inspectors or
investigators. NRC does not dispute that some training did occur.
However, as documented in the inspection report, the Incident
Investigation Team (IIT) report, and the investigation by NRC's Office
of Investigations (OI), the training that was given was not adequate to
meet the requirements. The Licensee's general assertion that it
complied with all requirements does not refute the fact that the
specific subjects described in Violations III.A and III.B were not
covered adequately in the training that the Licensee gave to the
personnel described in Violations III.A and III.B. Thus, the NRC
concludes that the violations occurred as stated in the Notice.
The NRC did not categorize the individual violations and examples
of violations in Section III of the Notice by severity level. Rather,
the NRC considered the violations in the aggregate as a single problem
categorized at Severity Level II. The Enforcement Policy defines a
Severity Level II violation or problem as one of very significant
concern. Clearly, this severity level is appropriate here because the
number and nature of the violations represent a very significant
corporate management breakdown in the control of licensed activities;
and the lack of attention to, and understanding of, regulatory
requirements on the part of Licensee management and its RSO contributed
to the November 1992 event. The purpose of aggregating violations is to
focus the Licensee's attention on the fundamental underlying causes for
which enforcement action is warranted, and to reflect the fact that
several violations with a common cause are more significant
collectively than individually, and therefore, warrant a more
substantial enforcement action. See Enforcement Policy, Section IV.A.
In this case it was necessary to focus the Licensee's attention on the
importance of meticulous oversight of the corporate radiation safety
program, the lack of which was a common causative factor in the
violations.
Summary of Licensee's Response to Violation III.C
The Licensee denies Example III.C.1 and states that it supplied and
required the use of personnel monitoring equipment; however, the
authorized user had no reason to believe that it was necessary to wear
a film badge. The Licensee further incorporates by reference its
response to Violations A and B in Section I of the Notice. The Licensee
believes that, in any event, Example III.C.1 would constitute a
Severity Level V violation. The Licensee admits Example III.C.2 but
believes that it constitutes a Severity Level V violation.
NRC Evaluation of Licensee Response to Violation III.C
10 CFR 20.202(a)(1) requires that the Licensee require the use of
appropriate personnel monitoring equipment by each individual who
enters a restricted area (the HDR treatment room) under such
circumstances that he receives, or is likely to receive, a dose in any
calendar quarter in excess of 25 percent of the occupations dose limits
specified in 10 CFR 20.101(a). The treatment room constituted a
restricted area because access to this area was controlled by the
Licensee for purposes of protection of individuals from exposure to
radiation and radioactive materials. See 10 CFR 20.3(a)(14). With a 4.2
Curie iridium-192 source in the unshielded configuration, an individual
entering the treatment room would be likely to receive a dose in excess
of 25% of the occupational dose limits specified in 10 CFR 20.101(a).
Moreover, 10 CFR 20.202(a)(3) requires that the Licensee require
the use of personnel monitoring equipment by each individual who enters
a high radiation area. The treatment room constituted a high radiation
area because, when the source is in an unshielded configuration,
radiation levels in the treatment room are such that a major portion of
the body could receive in any one hour a dose in excess of 100
millirem. See 10 CFR 20.202(b)(3). The Licensee was well aware of this
fact, because it had posted the room as a high radiation area at the
time of the November 16, 1992 event.
The requirement that the Licensee supply and require the use of
appropriate personnel monitoring equipment does not depend on the
individual's perception of a radiation hazard, but rather on the fact
of a radiation hazard that may result in an exposure in excess of the
limit in Sec. 20.202(a)(1), or that requires posting as a high
radiation area as per Sec. 20.202(a)(3). Any time that the authorized
user (AU) supervised the use of the HDR unit, he could be called upon
to make an emergency entry into the treatment room with the source in
an unshielded configuration. The Licensee should have been well aware
of this fact, because the license application specifies training for
its employees in emergency procedures involving entry into the
treatment room with the source in an unshielded configuration. See
License Condition 17, Application dated June 1, 1990, Item 10.15.C.
Thus, the Licensee should have assured that the AU wore his personnel
monitoring equipment whenever he supervised the use of the HDR unit.
The AU did enter the treatment room with the source in an unshielded
configuration and he was not wearing his personnel monitoring
equipment. Therefore, the NRC concludes that Example III.C.1 occurred
as stated in the Notice. Moreover, even if the Licensee had provided an
adequate reason to withdraw Example III.C.1, Violation III.C still
occurred as evidenced by the [[Page 21566]] Licensee's admission of
Example III.C.2. The issue of the Severity Level of the violation is
addressed in the evaluation of the Licensee's response to Violations
III.A and III.B, above.
Summary of Licensee's Response to Violation III.D.1
The Licensee denies Violation III.D.1, states that the RSO did not
fail to discharge his duties, states that the RSO did not violate any
regulation relating thereto, and notes that the NRC has not cited any
such specific regulation and that the RSO had an ALARA program in
place. The Licensee states that there is no requirement that the
Licensee have any physical presence at any facility. In addition, the
Licensee states that the RSO and a physicist were in communication with
the Lehighton facility by telephone and fax.
NRC Evaluation of the Licensee Response to Violation III.D.1
The Licensee was required, pursuant to License Condition 17, to
follow the commitments it made in the June 1, 1990, application to the
NRC. Item 10.2 of the application required that Appendix G of
Regulatory Guide 10.8 be followed which in turn required the RSO to be
in ``close contact'' with all users and workers in order to develop
ALARA procedures for working with radioactive materials. The Licensee
specifically committed in its license application that the RSO would do
this. The development of ALARA procedures is a continuing and evolving
process and requires firsthand observations and audits of employee
knowledge, work, and work conditions. The fact that some ALARA
procedures may have been in place does not relieve the Licensee of full
compliance with this requirement.
The mere fact that the RSO may have been in communication by
telephone or facsimile does not disprove the violation. In order for
that fact to be relevant at all, the Licensee would have to show that
such communications were with all users and workers and were for the
purpose of developing ALARA procedures, which the Licensee has not
done. Clearly, communications concerning, for example, patient
treatment parameters, would have no bearing at all.
The NRC determined, via interviews, that the Medical Director and
authorized user at the Indiana, Pennsylvania and Lehighton,
Pennsylvania facilities were not aware, at the time of the IIT and the
NRC inspection in December 1992, who the RSO was. Additionally, the RSO
had not visited the Lehighton facility in the past 6-9 months. Also, as
determined during the inspection of the Exton facility, the
technologist and the medical physicist at the Exton facility both
believed that the medical physicist was the RSO. Accordingly, it is
appropriate to conclude that the RSO did not maintain close contact
with all users and workers as required by License Condition 17.
Therefore, the NRC concludes that Violation III.D.1 occurred as stated
in the Notice.
Summary of Licensee's Response to Violation III.D.2
The Licensee denies Violation III.D.2 and states that emergency
procedures were available but not vertically posted because they kept
falling down, and that it immediately posted the procedures following
the inspection. The Licensee believes that, in any event, this
constitutes a Severity Level V violation.
NRC Evaluation of Licensee Response to Violation III.D.2
The Licensee stated that the emergency procedures kept falling
down. The inspection report states that the procedures were available
but not posted at the time of the inspection, and that this was
corrected before the inspectors left the facility. During the
inspection, the medical physicist obtained a copy of a set of emergency
procedures which was incomplete (contained blanks), and the Licensee
had to fill in the blanks with Licensee specific information, and post
the procedures conspicuously near the control console so that
appropriate staff would have access to the procedures. The Licensee
specific information had not been entered on the emergency procedures
prior to the inspection. Therefore, even the emergency procedures that
were available, but not posted, were incomplete.
At the time that the Licensee established its HDR brachytherapy
program, the blanks in the emergency procedures should have been filled
in with Licensee specific information and the procedures should have
been conspicuously and durably posted near the control console so that
appropriate staff would have immediate access to it. This was not done.
There, the NRC concludes that Violation III.D.2 occurred as stated in
the Notice. The issue of the Severity Level of the violation is
addressed in the evaluation of the Licensee's response to Violations
III.A and III.B, above.
Summary of Licensee's Response to Violation III.D.3
The Licensee denies Violation III.D.3 and states that Exton
personnel always did hand calculations and always checked the source
travel time error and accuracy of the timing device by using the clock
on the wall and their wrist watches. The Licensee believes that, in any
event, Violation III.D.3 would constitute a Severity Level V violation.
NRC Evaluation of Licensee Response to Violation III.D.3
The Licensee's unsupported general assertion that the calculations
and checks for timing device accuracy and travel time error were in
fact performed does not demonstrate that the violation did not occur.
During the inspection, the NRC found evidence that the checks of the
source travel time error and accuracy of the timing device were not
done. Specifically, as noted in Section 7 of NRC Inspection Report 30-
31765/92-001, issued on December 23, 1992, the record of the HDR
calibration performed at Exton indicated that the source output was
checked but that the source travel time error and accuracy of the
timing device were not checked. Therefore, the NRC concludes that the
violation occurred as stated in the Notice. The issue of the Severity
Level of the violation is addressed in the evaluation of the Licensee's
response to Violations III.A and III.B, above.
Summary of Licensee's Response to Violation III.D.4
The Licensee denies Violation III.D.4 and states its belief that
Omnitron personnel performed surveys for the benefit of the Licensee.
The Licensee believes that, in any event, Violation III.D.4 would
constitute a Severity Level IV violation.
NRC Evaluation of Licensee Response to Violation III.D.4
The Licensee's response provides no facts or records to support the
Licensee's assertion that the surveys in question were ever performed
by Omnitron. While Omnitron personnel may have performed some surveys
in connection with their work during source exchanges, the Licensee
provides no evidence that any such surveys included all adjacent areas
as well as control areas. Therefore, the NRC concludes that Violation
III.D.4 occurred as stated in the Notice. The issue of the Severity
Level of the violation is addressed in the evaluation of the Licensee's
response to Violations III.A and III.B, above.
Summary of Licensee's Response to Violation III.D.5
The Licensee admits the violation but believes that it would
constitute a Severity Level IV violation. [[Page 21567]]
NRC Evaluation of Licensee Response to Violation III.D.5
The issue of the Severity Level of the violation is addressed in
the evaluation of the Licensee's response to Violations III.A and III.B
above.
Summary of Licensee's Response to Violation III.D.6
The Licensee states that since it does not have sufficient
knowledge as to the specific truth regarding whether ancillary
personnel (specifically, housekeeping personnel) were informed about
radiation hazards associated with a 3.7 curie iridium-192 source in a
source container located in the High Dose Rate (HDR) afterloader
treatment room, it must deny this violation. The Licensee believes
that, in any event, Violation III.D.6 would constitute a Severity Level
IV violation.
NRC Evaluation of Licensee Response to Violation III.D.6
Housekeeping personnel interviewed by the NRC staff were not aware
of the radiation hazards associated with a 3.7 curie iridium-192
source. Specifically, on December 4, 1992, OSC housekeeping personnel
unlocked the area where the iridium source was being stored following
the source retrieval operation and accompanied NRC inspectors into the
area, and the housekeeping personnel had not been informed about the
radiation hazards associated with the source. Therefore, the NRC
concludes that Violation III.D.6 occurred as stated in the Notice. The
issue of the Severity Level of the violation is addressed in the
evaluation of the Licensee's response to Violations III.A and III.B,
above.
Summary of Licensee's Responses to Violations III.E-F
The Licensee admits the violations but believes that Violation
III.E would constitute a Severity Level V violation and that Violation
III.F would constitute a Severity Level IV violation.
NRC Evaluation of Licensee Response to Violation III.E-F
The issue of the Severity Level of the violations is addressed in
the evaluation of the Licensee's response to Violations III.A and
III.B, above.
Summary of Licensee's Response to Violation III.G
The Licensee states that daily interlock checks were consistently
done by individuals at IRCC, and that there was no requirement for the
Licensee to review such completed checks as of December 1992. In
addition, the Licensee notes that such checks would have been reviewed
at an annual audit. The Licensee believes that, in any event, Violation
III.G would constitute a Severity Level IV violation.
NRC Evaluation of Licensee's Response to Violation III.G
Licensee technologists interviewed by the Incident Investigation
Team (IIT) indicated that daily HDR interlock checks routinely were not
performed as required. This is corroborated by the fact that there is
not a log record for every check required. The Statements of
Consideration for 10 CFR 35.25, ``Supervision'', state: ``The purpose
of supervision is to provide assurance that technologists and
physicians do not use byproduct materials in a manner that is contrary
to the requirements of the license, the regulations, or that is
hazardous to the public health and safety [emphasis added].'' See 51
Fed. Reg. 36940. While the Licensee was not required to review each and
every check on a daily basis, it was required, pursuant to 10 CFR
Secs. 35.11, 35.25(a)(2), and 35.25(a)(3), to perform periodic reviews
at a frequency sufficient to provide reasonable assurance that
individuals working under the supervision of an authorized user were
complying with, among other things, License Condition 17 with respect
to the performance of daily interlock checks. It is clear from the fact
that the noncompliance was occurring, undetected to the Licensee, that
a single audit at the end of the year would not suffice. The NRC
concludes that Violation III.G occurred as stated in the Notice. The
issue of the Severity Level of the violation is addressed in the
evaluation of the Licensee's response to Violations III.A and III.B,
above.
Summary of Licensee's Response to Violation III.H
The Licensee denies the violation and states that at all times the
RSO fully complied with relevant regulatory requirements, including
implementing and distributing policies and procedures, and gathering
materials. The Licensee also states that the RSO was immediately
notified about the November 16, 1992 incident and instructed personnel
how to respond appropriately.
NRC Evaluation of Licensee Response to Violation III.H
The Licensee provides no information to support its general
assertion that it complied with all regulatory requirements or to
refute the facts documented in the Incident Investigation Team (IIT)
report, and the investigation by NRC's Office of Investigations (OI),
upon which the violations are based. Accordingly, the NRC concludes
that the violation occurred as stated in the Notice.
Summary of Licensee's Response to Violation III.I
The Licensee admits that the RSO conducted the experiment, but
states that the RSO took all measures to assure that such experiment
was done safely and without risk, and this was not a willful violation
but was done for the purpose, in part, of radiation safety. The
Licensee believes that, in any event, Violation III.I would constitute
a Severity Level IV violation.
NRC Evaluation of Licensee Response to Violation III.I
The Licensee admits that the RSO conducted the experiment and does
not deny that the RSO changed the area of use of iridium-192 from the
shielded therapy room to an area outside the building without first
applying for or receiving a license amendment authorizing the change.
The Licensee and its RSO may not pick and choose which regulatory
requirements they will follow, even if they believe that noncompliance
would somehow further radiation safety. 10 CFR 35.13(e) requires that
the Licensee apply for and receive a license amendment before changing
the area of use specified in the license. Moreover, willfulness is not
a necessary element of a violation of 10 CFR 35.13(e). Accordingly, the
NRC concludes that Violation III.I occurred as stated in the Notice.
The issue of the Severity Level of the violation is addressed in the
evaluation of the Licensee's response to Violations III.A and III.B,
above.
Summary of Licensee's Response to Violations III/J.1-3
The Licensee states that its intent was not to become a shipper or
a carrier of licensed material but under the extenuating circumstances,
the Licensee contacted the NRC and was told what to do to retrieve the
source. In addition, the Licensee states that at no time did the NRC
attempt to alert the Licensee about the regulations cited in the
Notice. The Licensee states that at the time of the incident, it did
not transport sources, and as such was not generally knowledgeable
about such. The Licensee further states that the Licensee took extreme
precautions and brought the source back in a safe, secured container.
Finally, the Licensee states that since it quickly retrieved the source
after the NRC specifically told the Licensee to get the source, it
would be unfair to cite the Licensee for these
[[Page 21568]] violations. The Licensee believes that, in any event,
Violations III.J.1-3 would constitute Severity Level V violations.
NRC Evaluation of Licensee Response to Violations III.J.1-3
Prior to the incident, the Licensee requested a license amendment
to permit it to transport licensed material as part of its licensed
activities. License Condition No. 15 of Amendment No. 03, dated August
19, 1992, authorized the Licensee to transport licensed material in
accordance with the provisions of 10 CFR Part 71, ``Packaging and
Transportation of Radioactive Material''. Therefore, the Licensee
should have been familiar with the provisions of 10 CFR Part 71. In any
case, the Licensee transported the radioactive source on December 1,
1992, and therefore was bound by the requirements in 10 CFR 71.5(a).
The fact that the NRC advised the Licensee to retrieve the Licensee's
source does not excuse the Licensee from the requirements of Part 71,
nor does it excuse the Licensee from its ignorance of the requirements
of Part 71. At no time did NRC suggest that applicable regulations
should not be followed. Since these requirements were not met, the NRC
concludes that Violations III.J.1-3 occurred as stated in the Notice.
The issue of the Severity Level of the violations is addressed in the
evaluation of the Licensee's response to Violations III.A and III.B,
above.
Summary of Licensee's Request for Mitigation
The Licensee states that subsequent to the Indiana event, Licensee
management took corrective action by: immediately and voluntarily
suspending HDR treatments at the Licensee's facilities that did not
have full-time physicists for HDR treatments in order to review its
entire HDR program; fully and timely complying with any and all
Confirmatory Action Letters (CALs); replacing its RSO with a
brachytherapy specialist; replacing multiple contract physicists; and
hiring additional, qualified full-time physicists. The Licensee states
that its proposed replacement of the RSO constitutes corrective action
regarding all issues raised by the NRC, and notes that its new RSO has
regularly been physically present at the Greater Pittsburgh and Greater
Harrisburg facilities to review the entire HDR program.
The Licensee also notes that it has completely modified its HDR
program, that the revised program has been approved by the NRC, and
that Licensee management has been highly involved with the HDR program
and has met on a regular basis with the new RSO. In addition, the
Licensee notes that it has restructured its physics program, which has
resulted in at least quarterly training/refresher courses in radiation
safety and regulatory compliance at all facilities for all staff.
Further, the Licensee notes that is authorized users have attended an
intensive training session with the new RSO regarding HDR usage, safety
and emergency responses. The Licensee also notes that it hired a
Certified Health Physicist (CHP) as Vice President of Regulatory
Affairs and gave the CHP broad management authority, and that the CHP
is responsible for the day-to-day radiation safety program company-
wide.
The Licensee also states that it believes that the fines imposed
are inappropriate and unsupported by the facts and applicable law. The
Licensee states that to apply the $100,000 per violation discretionary
fine on the Licensee is now warranted and is unfair. In addition, the
Licensee states that the NRC has attempted to impose the $100,000 fine
twice for one alleged failure, that being the alleged failure by the
authorized user to do a survey with a hand held survey meter; and
asserts that the loss of the source was not a separate action and
cannot be separated from the alleged survey failure. With respect to
the $80,000 fine for the violations in Section III, the Licensee
submits that the alleged violations, even if true, do not constitute a
Severity Level II problem. The Licensee claims that it appears that NRC
has not taken the past exemplary conduct of the Licensee into
consideration and the Licensee requests that this conduct be reviewed
again.
The Licensee cites a number of enforcement sanctions taken by the
NRC against other licensees, which the Licensee believes supports its
claim that the sanction imposed on the Licensee is not only unfair and
inappropriate, but unlawful. The Licensee requests that the fines be
reduced to $14,000.
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 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. In view of the particularly serious
violations, which resulted in the death of a patient and exposure of
numerous members of the public to radiation in excess of regulatory
limits, and in view of the necessity of emphasizing to the Licensee the
importance of meticulous management oversight of the radiation safety
program, a very significant civil penalty was warranted. The NRC
appropriately exercised its statutory authority when it proposed a
$100,000 civil penalty each for the violations in Section I and II of
the NOV, and an $80,000 civil penalty for the violations in Section
III. The NRC also expects that these penalties will give all other
similar licensees, including the successor licensees to OSC, an
incentive to closely scrutinize their operations to avoid similar
violations.
The Licensee's assertion that Problems I and II constitute a single
violation is mistaken. Problems I and II involve violations of separate
and distinct NRC requirements, with separate and distinct facts and
consequences. Problem I involves a failure to perform surveys and to
use radiation safety devices in violation of 10 CFR 20.201(b) and
License Condition 17, which led to a misadministration resulting in
acute radiation exposure and subsequent death of the patient. Problem
II involves a loss of control of a radioactive source and the creation
of radiation levels in unrestricted areas in violation of 10 CFR 20.206
and 10 CFR 20.105, which led to exposures of numerous members of the
public to radiation in excess of regulatory limits. Therefore, separate
violations are clearly justified. Atlantic Research Corporation, ALJ-
78-2, 7 NRC 701 (1978).
The issue of the severity level of the violations in Section III of
the NOV was addressed under ``NRC Evaluation of Licensee's Response to
Violations III.A and III.B.''
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, [[Page 21569]] 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.
Contrary to the Licensee's statements, the civil penalties proposed
in this case are within the authority of the NRC. The Licensee's
comparison of the civil penalties in this case with civil penalties in
other cases does not bring the 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 not
required in enforcement decisions, which inherently involve the
exercise of informed judgment 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 the violations occurred as stated in the
Notice and an adequate basis for mitigation of the civil penalties was
not provided by the Licensee. Consequently, the proposed civil
penalties in the amount of $280,000 should be imposed.
[FR Doc. 95-10731 Filed 5-1-95; 8:45 am]
BILLING CODE 7590-01-M