[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]
[[Page Unknown]]
[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]
BILLING CODE 7590-01-M