[Federal Register Volume 59, Number 188 (Thursday, September 29, 1994)]
[Unknown Section]
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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