[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