[Federal Register Volume 59, Number 62 (Thursday, March 31, 1994)]
[Unknown Section]
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From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-7639]


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[Federal Register: March 31, 1994]


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NUCLEAR REGULATORY COMMISSION

[Docket No. 030-01807; License No. 20-00275-08; EA 93-256]

 

Boston City Hospital; Boston, MA; Order Imposing Civil Monetary 
Penalty

I

    Boston City Hospital (Licensee), Boston, Massachusetts, is the 
holder of Byproduct/Source Material License No. 20-00275-08 (License), 
issued by the U.S. Nuclear Regulatory Commission (NRC or Commission) 
pursuant to 10 CFR parts 30 and 35. The License authorizes the Licensee 
to use byproduct material for medical diagnosis and therapy; in 
prepackaged kits for in-vitro studies; as specifically identified 
radionuclides for research and development and animal studies; as a 
strontium-90 sealed source for instrument calibration; and as a 
strontium-90 sealed source for the treatment of superficial eye 
conditions. The license most recently was renewed on September 17, 
1992, and is due to expire on August 31, 1997.

II

    An NRC inspection of the Licensee's activities was conducted on 
October 6, 1993. During the inspection, seven violations of NRC 
requirements were identified, one of which involved the failure to 
maintain control of access to licensed material. A written Notice of 
Violation and Proposed Imposition of Civil Penalty (Notice) was served 
upon the Licensee by letter dated December 2, 1993. 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 on 
December 28, 1993. In its response, the Licensee admitted all of the 
violations, but requested remission or mitigation of the proposed civil 
penalty.

III

    After consideration of the Licensee's response and the statements 
of fact, explanation, and argument for mitigation or remission 
contained therein, the NRC staff has determined, as set forth in the 
appendix to this Order, that the violations occurred as stated and that 
the penalty proposed for the violation designated in Section I of the 
Notice should be mitigated by 50 percent for the Licensee's good prior 
performance consistent with the NRC Enforcement Policy.

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 $1,250 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.

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, 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 I, 475 Allendale Road, King of 
Prussia, Pennsylvania 19406.
    If a hearing is requested, the Commission will issue an Order 
designating the time and place of the hearing. If the Licensee fails to 
request a hearing within 30 days of the date of this Order, the 
provisions of this Order shall be effective without further 
proceedings. If payment has not been made by that time, the matter may 
be referred to the Attorney General for collection.
    In the event the Licensee requests a hearing as provided above, the 
issue to be considered at such hearing shall be whether, on the basis 
of the violation set forth in Section I of the Notice that the Licensee 
admitted, this Order should be sustained.

    Dated at Rockville, Maryland this 24th day of March 1994.

    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 December 2, 1993, a Notice of Violation and Proposed Imposition 
of Civil Penalty (Notice) was issued for violations identified during 
an NRC inspection conducted on October 6, 1993. A proposed civil 
penalty was issued for the violation in Section I of the Notice. Boston 
City Hospital (Licensee) responded to the Notice by a letter dated 
December 28, 1993. In its response, the Licensee admits all of the 
violations, but requests remission or mitigation of the proposed civil 
penalty. The NRC's evaluation and conclusion regarding the Licensee's 
requests are as follows:

Restatement of Violations

I. Violation of the Security Requirement
    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 the 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, on October 6, 1993, licensed material 
consisting of at least 200 millicuries of technetium-99m and 40 
microcuries of iodine-131 located in the hot lab of the nuclear 
medicine department, an unrestricted area, was not secured against 
unauthorized removal, and was not under the constant surveillance and 
immediate control of the licensee.
    This is a Severity Level III violation (Supplements IV and VI). 
Civil Penalty--$2,500.
II. Violations of the Quality Management Program Requirements
    A. 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, the licensee established a written quality 
management program, and as of October 6, 1993, had not instructed the 
supervised individuals in the licensee's written quality management 
program. Specifically, the nuclear medicine technologists, who also 
administer I-131 dosages, were not trained in the licensee's written 
quality management program requirement regarding the authorized users' 
review of the written directive and the signature requirement.
    This is a Severity Level IV violation (Supplement VI).
    B. 10 CFR 35.32(a)(1)(iv) and (4) requires, in part, that: the 
licensee establish and maintain a written quality management program to 
provide high confidence that byproduct material or radiation from 
byproduct material will be administered as directed by the authorized 
user; and the quality management program must include written policies 
and procedures to meet the objectives that, prior to administration, a 
written directive is prepared for any administration of quantities 
greater than 30 microcuries of either sodium iodide I-125 or I-131, and 
that each administration is in accordance with the written directive.
    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 quantities greater than 30 microcuries of sodium 
iodide I-125 or I-131, and containing the dosage.
    Contrary to the above, the licensee's written policies and 
procedures for the quality management program did not ensure the 
objective that a written directive be prepared prior to administering 
greater than 30 microcuries of sodium iodide I-131, and that each 
administration is in accordance with the written directive. On multiple 
occasions, prior to administration of a radiopharmaceutical containing 
I-131, the licensee did not prepare a written directive containing the 
required information. Specifically, on at least four different 
occasions between April 9, 1993, and September 3, 1993, the licensee 
administered dosages of iodine-131 in quantities greater than 30 
microcuries to patients, without the written directives for these 
administrations, in that the instructions specifying the dosage to be 
administered on these occasions were not signed by an authorized user.
    This is a Severity Level IV violation (Supplement VI).
    C. 10 CFR 35.32(b) requires, in part, that the licensee develop 
procedures for and conduct a review to verify compliance with all 
aspects of the quality management program at intervals no greater than 
12 months, and evaluate each of these reviews to determine the 
effectiveness of the quality management program and, if required, make 
modifications to meet the objectives of 10 CFR 35.32(a).
    Contrary to the above, as of October 6, 1993, the licensee had not 
developed procedures for conducting a review to verify compliance with 
all aspects of the licensee's quality management program. Specifically, 
the RSO stated that there were no written policies or procedures to 
conduct the required review; that a review of the nuclear medicine 
program was conducted in July 1993; and the July 1993 review has not 
yet been evaluated to determine the effectiveness of the quality 
management program or the needed changes.
    This is a Severity Level IV violation (Supplement VI).
III. Other Violations of NRC Requirements
    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 the protective devices employed, and to the extent within 
the worker's control, in the applicable provisions of the Commission's 
regulations and licenses.
    Contrary to the above, as of October 6, 1993, individuals who were 
working in the nuclear medicine department, a restricted area, had not 
been instructed in the applicable provisions of the regulations and the 
conditions of the license. Specifically, at least two nuclear medicine 
technologists stated that they were not instructed in the procedure to 
check the survey meter for proper operation, a matter within their 
control.
    This is a Severity Level IV violation (Supplement VI).
    B. 10 CFR 35.14 requires, in part, that a licensee notify the NRC 
by letter within 30 days when an authorized user permanently 
discontinues performance of duties under the license.
    Contrary to the above, in July 1993, at least two authorized users 
permanently discontinued performance of duties under the license, and 
the licensee did not notify the NRC as of October 6, 1993, a period in 
excess of 30 days.
    This is a Severity Level IV violation (Supplement VI).
    C. 10 CFR 35.50(b)(3) requires, in part, that a licensee test each 
does calibrator at least quarterly for linearity over the range of its 
use between the highest dosage that will be administered to a patient 
and 10 microcuries.
    Contrary to the above, the licensee's dose calibrator linearity 
tests performed on February 9, 1993, and April 21, 1993, did not 
include activities below 18 microcuries. Similarly, the linearity test 
performed on July 27, 1993, did not include activities below 17.8 
microcuries, and there are no other linearity tests during the quarters 
when the identified tests were performed.
    This is a Severity Level IV violation (Supplement VI).

Summary of Licensee's Request for Mitigation

    In its December 28, 1993 written response to the Notice, the 
Licensee admits the violations but requests remission or mitigation of 
the civil penalty. In support of its request, the Licensee vigorously 
contests the NRC's conclusion that the results of the October 6, 1993 
inspection constitute a decline in performance. Rather than indicating 
a decline in performance, the Licensee maintains that the brief lack of 
constant surveillance of the hot lab represents a unique and temporary 
situation. The Licensee adds that it had identified a potential 
security problem with the existing hot lab (i.e., deterioration of the 
floor made opening and closing the door very difficult) and that it 
took steps to correct the problem, including the building of a 
completely new hot lab with new floors and a self-closing, combination 
locked, door.
    The Licensee indicates that it took actions to maintain security of 
the existing hot lab during the construction of the new lab, such as 
instructing the construction supervisors to keep their personnel away 
from the hot lab and locating a secretary near the door to the hot lab. 
However, the Licensee acknowledges that the secretary had stepped away 
from her desk without informing anyone prior to the NRC inspector's 
arrival.
    The Licensee further contends that the lack of security of the hot 
lab is not indicative of the Licensee's deteriorating compliance; 
rather, this security violation was the result of a mistake made during 
a unique and time-limited situation. The Licensee acknowledges that 
having the door open without the direct line of sight of the Licensee's 
personnel is certainly a violation that should not have occurred, and 
would not have occurred but for construction. However, the Licensee 
maintains that this violation should be viewed in the larger context of 
the Licensee identifying a potential permanent problem, and taking 
lasting and comprehensive action to prevent a breach of hot lab 
security. The Licensee states that this anticipatory correction of 
potential problems is more consistent with its prior good performance, 
and the door being open is an isolated failure that is inconsistent 
with the Licensee's prior performance.
    Additionally, in supporting its request for mitigation, the 
Licensee addressed circumstances for the violations relating to its 
Quality Management Program (QMP) and its dose calibrator. The Licensee 
states that learning an entirely new regulatory scheme such as the QMP 
is rarely accomplished immediately, and that Licensee personnel's 
failure in one specific area to completely follow the QMP does not 
indicate a failure to implement the QMP. With regard to the dose 
calibrator, the Licensee states that while 10 CFR 35.50(b)(3) mandates 
calibration of dose calibrators down to 10 microcuries, the Licensee 
was informed by various personnel of the NRC that this level is being 
evaluated for change because measurement of technetium-99m in the dose 
calibrator at this quantity leads to a greater margin of error. The 
Licensee maintains that its failure to test the dose calibrator down to 
this level was based on its desire to reduce the margin of error.

NRC Evaluation of Licensee's Request for Mitigation

    The NRC determined that the failure to secure licensed material 
against unauthorized removal was a significant violation which was 
classified at Severity Level III in accordance with Supplement VI.C.1 
of the Enforcement Policy (10 CFR part 2, appendix C). In determining 
the amount of the civil penalty, the NRC considered the escalation and 
mitigation factors set forth in the NRC Enforcement Policy.
    The NRC recognizes that the Licensee had identified, even prior to 
the NRC inspection, a potential problem concerning the security of the 
hot lab and initiated long term action to correct it. Although the 
Licensee did not assure that appropriate security was maintained during 
the interim period, the NRC agrees that the Licensee's initiative in 
making the long-term changes to the hot lab is indicative of extensive 
corrective actions. However, the failure to secure licensed material 
against unauthorized removal from the hot lab is a significant 
regulatory concern.
    With regard to the Licensee's understanding and implementation of 
its QMP and circumstances related to its dose calibrator, the NRC views 
the Licensee's failure to prepare a written directive, as defined in 10 
CFR 35.2, prior to administering greater than 30 microcuries of sodium 
iodide, as a failure to implement the QMP in accordance with 10 CFR 
35.32(a) (1)(iv) and (4). Concerning the dose calibrator, the staff 
expects licensees to fully comply with NRC regulations. Licensees are 
not excused from compliance with NRC requirements because revisions to 
those requirements may be under consideration.
    With respect to the Licensee's prior performance, Section VI.B(c) 
of the Enforcement Policy states, in part, that ``the base civil 
penalty may be mitigated by as much as 100% if the current violation is 
an isolated failure that is inconsistent with the licensee's 
outstandingly good prior performance. The base civil penalty may also 
be escalated by as much as 100% if the current violation is reflective 
of the licensee's poor or declining prior performance.''
    The NRC acknowledges that the Licensee had generally good 
performance during the last two NRC inspections. However, the staff 
notes that in addition to the four violations identified during the 
last two NRC inspections conducted in 1992 and 1989, six violations 
occurred over a period of nine months since the 1992 NRC inspection. 
These violations, in addition to the security violation, are not 
reflective of outstandingly good performance. Therefore, on balance, 
after reconsidering the matter, the staff has concluded that while full 
mitigation (i.e., 100 percent) is not appropriate, 50 percent 
mitigation of the base civil penalty based on the Licensee prior 
performance is warranted.

NRC Conclusion

    The NRC concludes that the violations occurred as stated, and that 
the Licensee has not provided an adequate basis for full remission of 
the proposed civil penalty; however, mitigation of 50 percent is 
warranted based on the Licensee's prior performance. Accordingly, the 
NRC has determined that a civil penalty in the amount of $1,250 should 
be imposed.

[FR Doc. 94-7639 Filed 3-30-94; 8:45 am]
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