[Federal Register Volume 59, Number 188 (Thursday, September 29, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-24075]
[[Page Unknown]]
[Federal Register: September 29, 1994]
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NUCLEAR REGULATORY COMMISSION
[Docket No. 030-11119, License No. 48-04193-03 EA 94-074]
John L. Doyne Hospital, Milwaukee, WI; Order Imposing Civil
Monetary Penalty
I
John L. Doyne Hospital, previously, Milwaukee County Medical
Complex (Licensee), is the holder of Byproduct Material License No. 48-
04193-03 issued by the Nuclear Regulatory Commission (NRC or
Commission) on May 5, 1975. The license was amended in its entirety on
January 8, 1993, was due to expire on November 30, 1993, and is
currently in timely renewal status pursuant to 10 CFR 2.109. The
license authorizes the Licensee to possess Cobalt-60 sealed teletherapy
sources for treatment of humans, human research, irradiation of
biological materials including animals and non-biological materials
(excluding flammable and explosive materials), and for Licensee
instrument calibrations.
II
An inspection of the Licensee's activities was conducted on March
21 through April 14, 1994. The results of this inspection indicated
that the Licensee had not conducted its activities in full compliance
with NRC requirements. A written Notice of Violation and Proposed
Imposition of Civil Penalty (Notice) was served upon the Licensee by
letter dated June 23, 1994. The Notice states the nature of the
violations, the provisions of the NRC's requirements that the Licensee
had violated, and the amount of the civil penalty proposed for the
violations. The Licensee responded to the Notice in two letters, both
dated July 20, 1994. In its response, the Licensee requested 100
percent mitigation of the civil penalty based on its view of the proper
application of the civil penalty adjustment factors in the areas of
identification, corrective action, and licensee performance.
III
After consideration of the Licensee's response and the statements
of fact, explanation, and argument for mitigation contained therein,
the NRC staff has determined, as set forth in Appendix A to this order,
that the violations occurred as stated and that the penalty 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 a civil penalty in the amount of $3,750 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 the Director, Office of Enforcement, U.S. Nuclear Regulatory
Commission, ATTN: Document Control Desk, Washington, DC 20555.
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, DC 20555, with a copy to the Commission's Document Control
Desk, Washington, DC 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 III, 801 Warrenville Road,
Lisle, Illinois 60532-4351.
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:
Whether on the basis of Violations I.A. and I.B., admitted by the
Licensee, this Order should be sustained.
Dated at Rockville, Maryland, this 20th day of September 1994.
For the Nuclear Regulatory Commission.
James Lieberman,
Director, Office of Enforcement.
Appendix A
Evaluation and Conclusion Regarding Violations Assessed a Civil Penalty
On June 23, 1994, a Notice of Violation and Proposed Imposition
of Civil Penalty (Notice) was issued for two violations identified
during an NRC inspection on March 21 through April 14, 1994. John L.
Doyne Hospital responded to the Notice in two letters, both dated
July 20, 1994. In its response, the Licensee requests 100 percent
mitigation of the civil penalty based on its disagreement with the
NRC Staff's application of the civil penalty adjustment factors in
the areas of identification, corrective action, and licensee
performance. The NRC's evaluation and conclusions regarding the
Licensee's request are as follows:
Restatement of the Violations
Violation I.A
10 CFR 20.101(a) limits the whole body radiation dose of an
individual in a restricted area to 1.25 rems per calendar quarter,
except as provided by 10 CFR 20.101(b). Paragraph (b) allows a whole
body radiation dose of 3.0 rems per calendar quarter provided
specified conditions are met.
Contrary to the above, an individual working in a restricted
area received a whole body radiation dose of 1.33 rem during the
first calendar quarter of 1993 and the conditions of paragraph (b)
were not met.
Violation I.B
10 CFR 20.201(b) requires that each licensee make such surveys
as (1) may be necessary for the licensee to comply with the
regulations in Part 20, and (2) 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 hazards associated with the presence of
radioactive materials under a specific set of conditions.
Contrary to the above, on February 3, 1993, the licensee did not
make a survey (evaluation) of a radiation hazard to assure
compliance with 10 CFR 20.101(a) in that two individuals entered a
teletherapy room, while the cobalt-60 source was in an exposed
position and did not evaluate the radiation hazard by surveying the
radiation field or by observing the warning light on the control
panel.
Summary of Licensee's Request for Mitigation
1. Identification
The Licensee contends that the incident surrounding the alleged
violations was self identified and self evident. The Licensee also
notes that the NRC described the incident as a self-disclosing event
in the cover letter of the Notice of Violation.
2. Corrective Action
The Licensee quotes the NRC's statement from the June 23, 1994
letter that, ``The staff recognizes that immediate corrective action
was taken.'' According to the Licensee, the corrective action
included an improved console light, an additional light at the entry
door at eye level, an indicator light in the entry way, a radiation
monitor with two visual and one audio alarms, and a policy and
procedure that requires a person to be stationed near the door to
prevent inadvertent entry to the room when the door interlock has
been defeated and the source is in the exposed position. The
Licensee notes that the incident was discussed at the February and
May 1993 Radiation Safety Committee meetings demonstrating the
involvement of the management of the Licensee. The Licensee
disagrees with the NRC statement in the June 23, 1994 letter that
the Licensee was not aggressive in publicizing the event to other
staff members to help prevent similar events from recurring. The
Licensee states that within hours of the incident, individuals
directly involved with both cobalt-60 teletherapy units and most of
the persons who work in the department knew of the incident.
According to the Licensee, the incident was a unique situation that
happened during initial acceptance testing and final stages of
installation of the teletherapy unit with the room entrance door
interlock defeated. The Licensee further claims that this is a very
unique set of circumstances and given this situation it is not
likely that a similar event could occur.
The Licensee also notes that its internal information notice,
the ``Surveyor'' is used to disseminate information to authorized
users and handlers of unsealed sources of radioactive materials in
research applications on an individual basis. According to the
Licensee, the ``Surveyor'' was not intended, nor ever expressed in
the enforcement conference, to be exclusively devoted to this event,
and the scope of the ``Surveyor'' was to be the results of the NRC
inspection as it related to unsealed radioactive materials use in
research applications. The Licensee states that the ``Surveyor'' was
not published at the time of the enforcement conference because the
Licensee did not receive the apparent violations letter until May
17, 1994, only four working days prior to the enforcement
conference.
3. Licensee Performance
The Licensee believes that the violations assessed a civil
penalty represent an isolated failure and suggests that mitigation
of the civil penalty is appropriate to recognize and encourage good
or improving Licensee performance.
NRC Evaluation of Licensee's Request for Mitigation
1. Identification
The NRC Enforcement Policy, Section VI.B.2(a), states that the
base civil penalty may be escalated up to 50 percent if the NRC
identifies a violation. Although the Licensee was aware of the self-
disclosing event in February 1993, it did not conclude that a
violation had occurred. The NRC identified the violations during the
inspection conducted in March 1994. Specifically, the NRC identified
to the Licensee that it violated 10 CFR 20.101 when an individual
received a whole body dose of 1.33 rem in the first calendar quarter
of 1993, an amount in excess of the 1.25 rem quarterly dose limit.
The quarterly dose limit was 1.25 rem instead of 3 rem because the
Licensee did not have a Form NRC-4 on file for the individual prior
to the event. After the NRC identified the violation, the Licensee
reported it to NRC in a written report dated April 15, 1994. That
report should have been submitted to NRC in March of 1993 as
required by 10 CFR 20.405. The NRC also identified, during the
inspection in March 1994, that the Licensee had violated 10 CFR
20.201(b) when the two individuals entered a teletherapy room in
February 1993, while the cobalt-60 source was in an exposed
position, and did not evaluate the radiation hazard by surveying the
radiation field or by observing the warning light on the control
panel.
Based on the above, the NRC concludes that 50 percent escalation
of the base civil penalty is warranted for NRC identification.
2. Corrective Action
The Enforcement Policy, Section VI.B.2(b), states that the
purpose of the corrective action factor is to encourage licensees to
(1) take the immediate actions necessary upon discovery of a
violation that will restore safety and compliance with the license,
regulation(s), or other requirements, and (2) develop and implement
(in a timely manner) the lasting actions that will not only prevent
recurrence of the violation at issue, but will be appropriately
comprehensive, given the significance and complexity of the
violation to prevent occurrence of similar violations. The
Licensee's corrective actions to be considered under this factor
generally begin after the Licensee clearly understands the scope of
the violation.
NRC acknowledges the corrective actions described by the
Licensee in its letters, both dated July 20, 1994. However,
according to the Enforcement Policy, some corrective actions are
always expected; therefore, corrective action that is considered
average but acceptable will normally result in no adjustment to the
base civil penalty. Additionally, the corrective actions described
by the Licensee were narrowly focused on preventing an entry into
the teletherapy room when the source is exposed and do not
comprehensively address the larger issues of preventing personnel
exposures that occur as a result of the failure to make surveys
during actual or suspected off-normal conditions.
The NRC acknowledges the Licensee's clarification that the
``Surveyor'' is an information notice for matters concerning
unsealed radioactive materials use in research applications and is
not applicable to the teletherapy units. Nevertheless, the NRC is
concerned with the Licensee's lack of certain corrective actions
following the identification of the violations in March 1994. First,
relative to Violation I.A, the Licensee had not, as late as its July
20, 1994 response, recognized that the Form NRC-4 was required by
regulation to be completed and on file prior to allowing an
individual to exceed the 1.25 rem quarterly dose limit. Second,
relative to Violation I.B, the Licensee's July 20, 1994 response
fails to propose any corrective actions for preventing inadequate
surveys in the future. The NRC's June 23, 1994 letter highlighted
significant NRC concerns about the event in that it involved two of
the Licensee's experienced personnel, the physicist and the
Radiation Safety Officer. Both individuals entered the teletherapy
room with the source exposed. The physicist had no radiation
detection survey instruments, and the Radiation Safety Officer had a
survey meter with the audible alarm turned off; he also did not
immediately look at the meter itself and only recognized that the
sources was exposed after they were inside the room. This concern
was not addressed by the Licensee in its corrective actions.
Based on the above, the NRC concludes that no mitigation is
warranted for the corrective action factor.
3. Licensee Performance
The NRC Enforcement Policy, Section VI.B.2(c), states that the
licensee performance factor should not be applied for those cases
where the licensee has not been in existence long enough to
establish a prior performance or inspection history. Similarly,
mitigation based on this factor is not normally appropriate where
the area of concern has not been previously inspected, unless
overall performance is good. The NRC had not inspected the
teletherapy license since 1986 because of its inactive status for
medical use, and therefore, the NRC had no recent history upon which
to judge the Licensee's performance. Moreover, there has been a
decline in overall performance, as evidenced by the 14 violations in
Section II of the Notice of Violation that were not assessed a civil
penalty.
Based on the above, the NRC concludes that no mitigation is
warranted for the licensee performance factor.
NRC Conclusion
Based on its evaluation of the Licensee's response, the NRC
staff concludes that an adequate basis for mitigation of the civil
penalty has not been provided by the Licensee. Accordingly, NRC
concludes that a civil monetary penalty of $3,750 should be imposed
by order.
Appendix B
Evaluation and Conclusion Regarding Violations Not Assessed a Civil
Penalty
Of the violations not assessed a civil penalty, the Licensee
admitted Violations II.A, II.B, and II.D through II.M, and denied
Violations II.C and II.N.
Restatement of Violation II.C
Condition 16B of License 48-04193-03 requires that licensed
material be possessed and used in accordance with statements,
representations, and procedures contained in a letter dated December
11, 1992.
The section entitled ``Safety Device Checks'' of that letter
states, in part, that the electrical stops will be tested for proper
operation before each patient or monthly, whichever is greater.
Contrary to the above, the electrical stops were not tested for
proper operation monthly or before a patient was treated in November
1993.
Summary of the Licensee's Response to Violation II.C
The Licensee indicates that the electrical stops were tested
after completing the installation of the unit in April 1993.
Documentation of this testing was submitted to the NRC in a letter
dated May 5, 1993. The Licensee, therefore, concludes that Condition
16B of License No. 48-04193 was met because the electrical stops
were tested prior to the patient being treated in November 1993.
NRC Evaluation of the Licensee's Response to Violation II.C
Licensee Condition 16 specifically states that the NRC
regulations shall govern unless the statements, representations, and
procedures in the licensee's application and correspondence are more
restrictive than the regulations. 10 CFR 35.634(d)(3) requires that
a licensee authorized to use a teletherapy unit for medical use
shall perform safety spot-checks of each teletherapy facility once
in each calendar month that assure proper operation of the
electrical stops. The Licensee's commitment as referenced in License
Condition 16B cannot be less restrictive than the regulation unless
an exemption is obtained. The test of the electrical stops following
installation of the unit in April 1993 does not meet the minimum
regulatory requirement to test once per month. Therefore, the NRC
concludes that Violation II.C did occur as stated.
Restatement of Violation II.N
10 CFR 35.32(a)(1) requires, in part, that the licensee
establish and maintain a written quality management program which
must include written policies and procedures to meet the objectives
that, prior to the administration, a written directive is prepared
for any brachytherapy radiation dose.
Item 3 of the licensee's quality management program states, in
part, that a written directive will be used for every brachytherapy
patient and will include specific information, including the
isotope, total number of sources, and the total time or dose to be
delivered.
10 CFR 35.2 defines a written directive as an order in writing
for a specific patient, dated and signed by an authorized user prior
to the administration of a radiopharmaceutical or radiation and
containing certain other specific information. As described in Item
(6) of the QMP all other brachytherapy shall include the following
specific information:
(i) Prior to implantation: the radioisotope, number of sources,
and source strength and;
(ii) After implantation, but prior to completion of the
procedure: the radioisotope, treatment site, and total source
strength and exposure time (or equivalently, the total dose).
Contrary to the above, the written directive for a brachytherapy
patient did not contain all the required information. For example,
the written directive for the iridium-192 implant on January 19,
1993 specified the number of ribbons rather than the number of
seeds.
Summary of the Licensee's Response to Violation II.N
The Licensee references 10 CFR 35.400 which states, in part,
that ``a licensee shall use the following sources * * * iridium-192
as seeds encased in nylon ribbon,'' and concludes that a ribbon is a
source. The licensee asserts that sources of iridium-192 as seeds
encased in nylon ribbon cannot be directly compared to sources such
as cesium-137 because cesium-137 sources as needles or applicator
cells are readily identifiable and only a few are used at one time
for patient treatment, in comparison to the potential use of
hundreds of seeds per treatment utilizing iridium-192 seeds encased
in nylon ribbon. According to the Licensee, counting the number of
cesium-137 sources takes only a relatively short time since few are
used and they are large enough to be seen from a distance; whereas
counting the number of seeds encased in a nylon ribbon would take
significantly longer due to the small size and the handling
necessary to be able to accurately determine several hundred seeds
contained in 10, 20 or more ribbons. According to the Licensee, this
would add to hand exposure, and some whole body exposure, with no
benefit to the source preparer or the patient, and would be contrary
to ALARA principles.
NRC Evaluation of the Licensee's Response to Violation II.N
10 CFR 35.2, ``Definitions,'' states that brachytherapy source
means an individual sealed source or a manufacturer-assembled source
train that is not designed to be disassembled by the user. A nylon
ribbon containing iridium-192 seeds is not a brachytherapy source
because it can be cut by the user to contain any given number of
iridium seeds. An iridium-192 seed is an individual sealed source
because it is not designed to be disassembled by the user.
Therefore, the NRC concludes that Violation II.N occurred as stated.
Appendix B
NRC acknowledges that the requirement involves some exposure,
which should be minimized through training and the use of proper
equipment. The requirement benefits the patient because it helps to
assure that the radiation dose delivered is the dose intended by the
prescribing physician.
NRC Conclusion
The Licensee has not provided an adequate basis for withdrawal
of Violations II.C and II.N. Therefore, the NRC concludes that
Violations II.C and II.N occurred as stated in the Notice.
[FR Doc. 94-24075 Filed 9-28-94; 8:45 am]
BILLING CODE 7590-01-M
