[Federal Register Volume 63, Number 173 (Tuesday, September 8, 1998)]
[Notices]
[Pages 47534-47540]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-24011]
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NUCLEAR REGULATORY COMMISSION
[Docket Number: 030-14526; License Number: 37-00062-07]
Department of Veterans Administration Medical Center,
Philadelphia, PA; Issuance of Director's Decision Under 10 CFR
Sec. 2.206
Notice is hereby given that the Director, Office of Nuclear
Material Safety and Safeguards, U.S. Nuclear Regulatory Commission
(Commission or NRC), has taken action with regard to a
[[Page 47535]]
Petition dated January 28, 1998, submitted by Ann Lovell (Petitioner),
regarding the Department of Veterans Administration Medical Center,
Philadelphia, Pennsylvania (PVAMC). The Petitioner has requested that
NRC take immediate action to suspend or revoke the NRC license issued
to PVAMC. As grounds for her request, the Petitioner asserts that
executive management is operating in a manner that has the potential to
present a significant danger to medical center patients, staff, and the
general public. Specifically, the Petitioner asserts that: (1) there
has been a consistent pattern of NRC violations occurring within the
medical center for which PVAMC has failed to take corrective action;
(2) PVAMC has a history of supplying false information to NRC; (3)
individuals, including the Petitioner, became contaminated with
radioactive material in the nuclear medicine department as a result of
what the Petitioner believes was an intentional incident; and (4) PVAMC
employees are fearful of bringing safety concerns to the licensee for
fear of retaliation, and to NRC because of NRC's ``history of
inaction'' regarding the medical center. Additionally, the Petitioner
claims that NRC withdrew a civil penalty after a change in NRC Region I
management, which may have been withdrawn as it was not ``cost-
effective'' to pursue the issue.
The Director of the Office of Nuclear Material Safety and
Safeguards has denied the Petition. The reasons for this denial are
explained in the ``Director's Decision Under 10 CFR Sec. 2.206,'' (DD-
98-07) the complete text of which follows this notice. The Director's
Decision is available for public inspection at NRC's Public Document
Room, the Gelman Building, 2120 L Street, N.W., Washington, D.C.
A copy of this Decision will be filed with the Secretary of the
Commission, for the Commission's review, in accordance with 10 CFR
Sec. 2.206(c) of the Commission's regulations. As provided by this
regulation, the Decision will constitute the final action of the
Commission 25 days after the date of issuance of the Decision, unless
the Commission, on its own motion, institutes a review of the Decision
within that time.
Dated at Rockville, Maryland, this 28 day of August, 1998.
For the Nuclear Regulatory Commission.
Carl J. Paperiello,
Director, Office of Nuclear Material Safety and Safeguards.
Director's Decision Under 10 CFR Sec. 2.206
I. Introduction
By a Petition addressed to the Director, Division of Nuclear
Materials Safety, U.S. Nuclear Regulatory Commission (NRC), Region I,
dated January 28, 1998, Ann Lovell (Petitioner), requested that NRC
take immediate action to suspend or revoke the NRC license issued to
the Department of Veterans Administration Medical Center, Philadelphia,
Pennsylvania (PVAMC or licensee). As grounds for her request, the
Petitioner asserts that executive management is operating in a manner
that has the potential to present a significant danger to PVAMC
patients, staff, and the general public. Specifically, the Petitioner
asserts that: (1) there has been a consistent pattern of NRC violations
occurring within the medical center for which PVAMC has failed to take
corrective action; (2) PVAMC has a history of supplying false
information to NRC; (3) individuals, including the Petitioner, became
contaminated with radioactive material in the nuclear medicine
department as a result of what the Petitioner believes was an
intentional incident; and (4) PVAMC employees are fearful of bringing
safety concerns to the licensee, for fear of retaliation, and to NRC,
because of NRC's ``history of inaction'' regarding the PVAMC.
Additionally, the Petitioner claims that NRC withdrew a civil penalty
after a change in NRC Region I management, which may have been
withdrawn because it was not ``cost-effective'' to pursue the issue
against the Department of Veterans Affairs.
On February 27, 1998, the receipt of the Petition was acknowledged
and the Petitioner was informed that the Petition had been referred to
the Office of Nuclear Material Safety and Safeguards pursuant to 10 CFR
Sec. 2.206 of the Commission's regulations. The Petitioner was also
informed that her request that NRC immediately suspend or revoke the
PVAMC's license was denied, and that other action on her request would
be completed within a reasonable time, as provided by 10 CFR
Sec. 2.206.
II. Background
The circumstances surrounding the issues raised in the Petition can
be summarized as follows. From 1994 until Spring 1998, the Petitioner
was employed by PVAMC as the Radiation Safety Officer (RSO). In
November 1995, the Petitioner raised concerns to NRC regarding the
safety of the licensee's operations in connection with a potential
furlough of Federal government employees. As a result, NRC conducted a
special inspection of the licensee's facility on November 17, 1995
(Inspection Report No. 030-14526/95-002). During the inspection, the
inspector discovered that the licensee had replaced the RSO before NRC
approval and had held a Radiation Safety Committee (RSC) meeting
without a quorum, in that the RSO and half of the RSC membership were
not present. Based on these violations, a Notice of Violation (NOV) was
issued to PVAMC on January 4, 1996.
The licensee responded to the NOV by letter dated February 23,
1996. In its response, the licensee stated that it replaced the RSO
with a nuclear physician, to ensure continuous coverage of the
radiation safety program during a Federal government furlough, and that
the full complement of the RSC could not be assembled to formalize the
decision, because of the furlough of personnel, including the RSO.
On February 5, 1996, the Petitioner filed a discrimination
complaint with the United States Department of Labor (DOL), asserting
that she had been discriminated against for contacting NRC. In a
decision issued on March 6, 1996, the Acting District Director of the
DOL Wage and Hour Division determined that discrimination was a factor
in the actions that comprised the complaint, in violation of Section
211 of the Energy Reorganization Act of 1974, as amended, 42 U.S.C.
Sec. 5851 (1988 and Supp. V. 1993). The licensee did not appeal the
findings of the Acting District Director, so that the decision of the
Acting District Director became the final DOL decision.
NRC held an Enforcement Conference with PVAMC on August 26, 1996,
regarding this matter. On September 18, 1996, NRC issued a NOV and
Proposed Imposition of Civil Penalty to PVAMC based on the DOL Acting
District Director's decision and information provided by PVAMC during
the conference, for a violation of the Commission's Employee Protection
regulations, 10 CFR Sec. 30.7 (EA 96-182). Specifically, the licensee
was cited for discriminating against the Petitioner in that her
supervisor had chastised her for contacting NRC. The violation was
categorized, in accordance with the Commission's Enforcement Policy,
NUREG-1600, ``General Statement of Policy and Procedures for NRC
Enforcement Actions'' (hereafter,
[[Page 47536]]
Enforcement Policy), as a Severity Level II violation, and a civil
penalty of $8000 was proposed.
On November 15, 1996, PVAMC submitted a ``Response to Notice of
Violation and Proposed Imposition of Civil Penalty'' and ``Answer to a
Notice of Violation.'' In these documents, it admitted the violation,
but requested reconsideration of the determination that the violation
constituted a Severity Level II violation warranting a civil penalty of
$8000. In support of its request, PVAMC stated that the supervisor had
chastised the Petitioner not just for contacting NRC, but for failing
to notify him of certain information of which she was aware; that the
chastisement was an isolated occurrence; that other employees were not
``chilled'' from raising safety concerns as a result of this event; and
that a Severity Level II violation was for the most severe violations
involving actual or high potential impact on the public, which had not
been the case here. Following a review of the licensee's response and
the findings of an investigation conducted by NRC's Office of
Investigations (OI) that there had been no continued discrimination
against the Petitioner, NRC informed the licensee, by letter dated
September 25, 1997, that it had concluded that the violation would be
more appropriately classified as a Severity Level III violation and
that enforcement discretion should be exercised to not issue a civil
penalty, in accordance with Section VII.B.6. of the Enforcement
Policy.1 NRC conducted an inspection of the licensee's
facility from July 9 through October 20, 1997, (Inspection Report 030-
14526/97-001). On approximately July 24, 1997, a contamination incident
occurred in the licensee's Nuclear Medicine Department, in which the
hands of the RSO and the Chief Nuclear Medicine Technologist (CNMT)
became contaminated. The inspector determined that a radiation survey
instrument may have become contaminated during surveys of the Nuclear
Medicine Department, and that the two individuals' hands became
contaminated as a result of handling the instrument. The inspection
results indicated that the incident may have been caused by a weakness
in the licensee's contamination control techniques, including not using
contamination control precautions during the use of radioactive
material, and, in some cases, failing to wear gloves. In addition, NRC
determined that significant weaknesses existed in the licensee's
program in such areas as the functioning and effectiveness of the RSC,
training, teamwork, communications, leadership, and conflict
resolution. NRC issued a Confirmatory Action Letter (CAL) to PVAMC on
December 19, 1997, (with corrected copy issued December 31, 1997),
confirming the licensee's commitments to conduct a comprehensive review
and assessment of its radiation safety program; to provide training to
staff, including among other things, instruction regarding employees'
rights to raise safety concerns to management and NRC; and to develop a
formal program audit system to continuously identify and correct
program deficiencies.
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\1\ Section VII.B.6 of the Enforcement Policy (63 FR 26630, May
13, 1998) provides that NRC may refrain from issuing a civil penalty
if the outcome of the normal process described in the Enforcement
Policy does not result in a sanction consistent with an appropriate
regulatory message. The Enforcement Policy further provides that NRC
may reduce, or refrain from issuing, a civil penalty, for a Severity
Level II, III, or IV violation based on the merits of the case.
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III. Discussion
As stated above, the Petitioner has raised numerous issues in
support of her assertion that executive management of PVAMC is
operating in a manner that has the potential to present a significant
danger to medical center patients, staff, and the general public. These
issues, and NRC's evaluation of these issues, are set forth below.
A. Petitioner's Assertion of Consistent Pattern of Violations for Which
PVAMC Failed to Take Corrective Action
Among other things, the Petitioner maintains that there has been a
consistent pattern of NRC violations occurring within the medical
center for which PVAMC has failed to take corrective action. In support
of this assertion, the Petitioner has submitted an attachment to her
Petition, entitled ``Chronology of PVAMC/NRC Interaction Since Whistle
Blower Incident of November 17, 1995,'' that she purports ``attests''
to such a consistent pattern of violations within the facility.
NRC inspections conducted at PVAMC's facilities from 1995 through
1997 identified several violations. However, none of these violations
was of high safety significance, and, with the exception of the
enforcement action discussed above, involving discrimination against
the Petitioner for raising safety concerns (EA 96-182), all the
violations were categorized as Severity Level IV violations in
accordance with the Commission's Enforcement Policy.2 The
Severity Level IV violations are described in Inspection Reports 030-
14526/96-002 and 030-14526/97-001, issued on September 11, 1997, and
December 10, 1997, respectively. The licensee responded to the
violations identified in Inspection Report 030-14526/96-002 by letter
dated November 4, 1997, and to the violations identified in Inspection
Report 030-14526-001, by letter dated January 9, 1998. In its
responses, the licensee described its corrective actions for the
violations.
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\2\ As described in the Enforcement Policy, Severity Level IV
violations are less serious violations, but of more than minor
safety concerns, in that, if left uncorrected, they could lead to a
more serious concern.
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In addition, as noted above, during these inspections, certain
programmatic weaknesses were identified by NRC, including conflicts
between management, the RSO, the RSC, and the licensee's staff. NRC
determined that weaknesses existed in such areas as the functioning and
effectiveness of the RSC, training, teamwork, communications,
leadership, and conflict resolution. NRC also was concerned that PVAMC
employees may have been reluctant to raise safety concerns because of
these communication problems. As a result of these findings, NRC
management toured the facilities on December 15, 1997, and met with
representatives of the licensee on December 18, 1997, to discuss these
program weaknesses. Subsequently, on December 19, 1997 (with corrected
copy issued December 31, 1997), a CAL was issued to PVAMC, documenting
the licensee's commitment to: (1) have the RSO and the RSC Chairman
conduct a comprehensive review and assessment of the radiation safety
program; (2) provide training, conducted by the RSO and the RSC
Chairman, to all nuclear medicine staff, researchers using radioactive
material, RSC members, and the facility management, on all applicable
NRC regulatory requirements, on management expectations, and on the
policy on bringing forth identified program deficiencies; and (3)
establish a formal program audit system to identify, report, and
correct program deficiencies. The licensee completed these actions by
May 30, 1998. Additionally, the CAL provided that the licensee was to
notify NRC, after completing all items in the CAL, so as to arrange for
a meeting between NRC and PVAMC senior management, to discuss the
program status and achievements. This meeting was held as part of the
exit meeting on June 3, 1998, at the conclusion of the
[[Page 47537]]
inspection conducted by NRC at the licensee's facilities from June 1-3,
1998 (Inspection Report 030-14526/98-001, issued July 23,
1998).3
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\3\ This inspection is discussed later in Section D of this
Decision.
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By letters dated February 20, April 6 (with revisions to audit
report dated April 10), April 13, and May 28, 1998, PVAMC responded to
the CAL, and submitted the results of its audit. In its responses, it
stated that it had made numerous improvements to its program. Among
these were the implementation of an ``Open-Door Policy'' of encouraging
staff to identify and report program deficiencies. A notice from
executive management, the RSC, and the RSO was sent to employees and
posted in numerous, visible locations. The notice encouraged all staff
to report apparent radiation safety problems, violations, and potential
misadministrations. It explained that management, the RSC, and the RSO
encouraged all staff to report problems without fear of reprisal,
indicating that it was management's responsibility to assure a safe
working environment. The notice stated that the goal was to create a
secure, friendly environment that fosters self-identification of
problems. A list of whom to contact, including the RSO, executive
management, and the members of the RSC, and their phone numbers, was
included in the notice. PVAMC staff has received training in this
policy. PVAMC hired an Interim RSO while the previous RSO (the
Petitioner) was out on medical leave,4 and also informed NRC
of the new Interim Director of the PVAMC. The Interim RSO was mandated
to evaluate the radiation safety program and to recommend any needed
changes. PVAMC provided NRC with a copy of its assessment and audit of
the radiation safety program, in which it evaluated its program,
identified certain program deficiencies, and specified its corrective
actions. PVAMC also indicated that training would be provided, by March
15, 1998, to staff who use radioactive material. The training would
include, as a minimum, instruction regarding all applicable NRC
regulatory requirements, management expectations, and the policy on
bringing forth identified program deficiencies. PVAMC also submitted
its formal radiation safety audit program.
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\4\ The Petitioner has subsequently resigned from PVAMC.
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NRC has verified that the licensee has taken the actions required
by the CAL. NRC has reviewed PVAMC's audit report and found that the
licensee's audit demonstrated that PVAMC had taken corrective actions
and implemented its commitments in the CAL to improve its oversight of
the radiation safety program and to improve its problems related to
communication, teamwork, and conflict resolution. PVAMC has conducted a
comprehensive review and assessment of the radiation safety program.
NRC has determined that PVAMC's audit was thorough in its assessment of
the problems with communication, teamwork, and conflict resolution, as
well as its evaluation of program deficiencies. In the audit report,
PVAMC recognized the problems, and indicated that it had made progress
in those areas. PVAMC noted that it had been concentrating on re-
focusing attention on issues rather than past interpersonal conflicts,
and is working on re-establishing trust and team work. PVAMC also
stated that staff was beginning to feel more comfortable with admitting
mistakes and initiating corrective actions. To clarify
responsibilities, and to prevent the RSO from auditing its own
activity, the Interim RSO recommended that the authorized users and
their staff perform their own routine monitoring duties, with radiation
safety staff auditing these duties. Staff has received training on all
applicable NRC regulatory requirements, on management expectations, and
on the policy on bringing forth identified program deficiencies.
Additionally, PVAMC has established a formal system for conducting
radiation safety program audits.
NRC conducted an inspection from June 1-3, 1998, at the licensee's
facility (Inspection Report 030-14526/98-001, issued July 23, 1998).
The inspection focused on the licensee's responses, dated November 4,
1997, and January 8, 1998, to the violations identified in Inspection
Reports 030-14526/96-002 and 030-14526/97-001, respectively; licensee
actions to assess and improve the radiation safety program; and
implementation of management commitments addressed in the CAL. Within
the scope of this inspection, no violations were identified. The
inspectors verified that PVAMC's submitted corrective actions, as
described previously, had been implemented for the violations
identified in Inspection Reports 030-14526/96-002 and 030-14526/97-001.
The NRC inspectors, through a review of records, discussions with
the licensee's staff, and observation of onsite activities, noted that
major staff changes have occurred in areas that affect radiation safety
and communication of management's message to staff concerning the
significance of bringing forth any safety concerns. A new chairman of
the RSC was appointed in September 1997, and a new RSO was appointed in
December 1997. The Chief Operating Officer currently has direct
oversight of the radiation safety program, and the RSO is reporting to
this individual. When the new Chief of Staff (COS) is appointed, the
RSO will report directly to the COS. The inspectors noted that these
staff changes, and their initiatives, significantly improved
personnel's understanding of the importance of radiation safety and the
importance of a work environment in which staff is encouraged to bring
forth issues relating to radiation safety without fear of retaliation.
The licensee's Interim Director (appointed March 1998), the new RSC
chairman, and the new RSO, in cooperation with the facility staff, have
initiated and implemented specific actions that enhanced and improved
management oversight of the radiation safety program. These actions
included establishing a formal audit program and providing training to
staff on all applicable NRC regulatory requirements and the importance
of reporting any program deficiencies. Additionally, management has
worked to build teamwork and improve communication, and has made a
commitment to increase program oversight. In summary, although the
Petitioner is correct that certain violations and programmatic
weaknesses have been identified in the past at PVAMC, as discussed
above, the violations were not of major safety significance, and the
licensee has undertaken extensive corrective actions for such
deficiencies. In addition, NRC will continue to inspect the licensee's
radiation safety program on an accelerated inspection schedule, in
accordance with NRC's Inspection Manual Chapter 2800, so as to closely
monitor the licensee's progress in improving its radiation safety
program and communication among its RSO, RSC, management, and staff. In
sum, the NRC has not substantiated the Petitioner's assertion that
there has been a consistent pattern of violations occurring at the
licensee's facilities for which the licensee has failed to take
corrective action, and has found no basis for taking the action
requested by the Petitioner.
B. Petitioner's Assertions of Altered Records and Licensee's
``History'' of Providing Inaccurate Information
The Petitioner also asserts that the inspector to whom she had
provided information concerning problems at PVAMC had ``copies of
records which
[[Page 47538]]
appeared to have been deliberately altered by medical center
personnel.'' In addition, she asserts that PVAMC has a ``history of
supplying information inconsistent with reality to the NRC.'' Finally,
in her attachment to the Petition, the Petitioner refers to a letter
from PVAMC to NRC, dated February 23, 1996, which she asserts contained
inaccurate information.
The Petitioner has not specified the records that were allegedly
altered by PVAMC personnel, and NRC has not identified any alterations
of records required to be provided or maintained by NRC requirements.
Therefore, this portion of the Petitioner's assertion has not been
substantiated.
The Petitioner also asserts that her attached ``chronological
summary'' of correspondence between PVAMC and NRC will ``attest'' to
the fact that there had been a ``consistent pattern of NRC violations
occurring within the medical center'' and that the licensee has a
``history of supplying information inconsistent with reality to the
NRC, and taking minimal, if any effort to correct cited violations.''
The attachment to the Petition references, among other documents: (a)
an NOV issued to the licensee dated January 4, 1996; (b) a letter from
PVAMC responding to the NOV, dated February 23, 1996, in which PVAMC
allegedly supplied NRC with inaccurate information; (c) a letter from
NRC to the licensee dated April 19, 1996, which noted
``inconsistencies'' in the licensee's letter, dated February 23, 1996;
(d) a letter from the licensee dated May 6, 1996, in which the licensee
acknowledged that there were inconsistencies in its letter dated
February 23, 1996; and (e) a letter from NRC, dated June 27, 1996,
accepting the licensee's statements in its letter, dated May 6, 1996,
and approving the licensee's corrective actions to the violations cited
in the NOV dated January 4, 1996.
The licensee's letter, dated February 23, 1996, responded to the
NOV issued on January 4, 1996, citing it, among other things, for
violating 10 CFR 35.13(c) by replacing the RSO without receiving a
license amendment, and for violating 10 CFR 35.21(a) and 35.22(a)(3) by
conducting a meeting of the RSC without half of the RSC membership or
the RSO being present. In its response to the violations, by letter
dated February 23, 1996, the licensee stated that an amendment request
had been filed during the government-wide furlough, as the RSO was
furloughed but, in order to ensure uninterrupted coverage of the
radiation safety program, a nuclear physician was assigned as RSO until
the shutdown terminated. The licensee also stated that the full RSC
could not be assembled because its members, including the RSO, had been
furloughed.
This information initially appeared to the NRC staff to be
inconsistent with its understanding of the events surrounding the
furlough. Among other things, the NRC determined that, contrary to the
licensee's statement, the RSO had never been furloughed. By letter
dated April 19, 1996, the licensee was requested to provide
clarification of the facts surrounding its understanding of these
events. By letter dated May 6, 1996, the licensee submitted its
response to this letter. In its response, it apologized for any
inconsistency. The licensee stated that the RSO had been scheduled to
be furloughed and the redesignation request filed with the NRC was to
ensure radiation safety compliance in preparation for the contingency
of the furlough. The licensee admitted, however, that the RSO was never
officially furloughed and had not been contacted to attend the meeting.
NRC evaluated the information submitted by the licensee and
determined that the information it had submitted in its letter dated
February 23, 1996, was inaccurate. Nonetheless, the NRC concluded that
the inaccuracy was not a deliberate attempt by the licensee to deceive
the NRC, and that the licensee admitted to, and clarified, its error.
The Petitioner's ``chronological summary'' that she submits as an
attachment to her Petition does not provide any additional examples of
the licensee's failure to submit accurate information. Therefore, this
single incident of supplying inaccurate information does not support
the Petitioner's assertion that PVAMC has a ``history of supplying
information inconsistent with reality to the NRC and taking minimal, if
any, effort to correct cited violations.'' In addition, as described
above, the licensee has taken considerable corrective action with
regard to other identified violations and problems. Therefore, this
matter does not provide a sufficient basis for taking the action the
Petitioner has requested.
C. Petitioner's Assertion Regarding Contamination Incident
The Petitioner also asserts that individuals at PVAMC have become
contaminated in what the Petitioner believes was an intentional
incident. As noted above, NRC conducted an inspection of PVAMC during
the period of July 9 through October 20, 1997, during which the
inspectors examined the circumstances surrounding a contamination
incident that occurred in the Nuclear Medicine Department around July
24, 1997 (Inspection Report 030-14526/97-001, dated December 5, 1997).
The incident involved the contamination of the hands of the RSO and the
CNMT and contamination of a survey instrument.
The cause of the contamination was not definitively identified;
however, NRC staff believes that the instrument may have been
contaminated during routine surveys of the Nuclear Medicine Department.
The licensee later determined that the survey instrument was
contaminated with indium-111, a radionuclide that is not regulated by
NRC. However, during the course of NRC's investigation of the
contamination incident, NRC found violations of procedures related to
the use of byproduct material. The inspector noted that the incident
may have been caused by a weakness in the licensee's contamination
control techniques, including not using contamination control
precautions during the use of radioactive material, and, in some cases,
failing to wear gloves. The inspector determined that the RSO and CNMT
hand contamination was most likely caused by handling the contaminated
instrument. The PVAMC was cited for four violations, three of which
were related to NRC program deficiencies found as a result of NRC's
review of the contamination incident, in an NOV dated December 10, 1997
(Inspection Report 030-14526/97-001): (1) failure to provide training
to personnel who work in or frequent an area where radioactive
materials are used or stored; (2) performing inadequate surveys in an
area where radiopharmaceuticals were prepared for use and administered,
in that an instrument with a faulty cable that rendered the instrument
inoperable was used; and (3) failure to use an extremity monitor by a
nuclear medicine technologist.5
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\5\ The licensee committed, in its response to the NOV by letter
dated January 9, 1998, to providing training to staff, to ensure
that appropriate techniques will be used by its personnel so as to
minimize contamination and avoid such incidents in the future. It
also committed to provide training in the requirement to use
personnel monitors and proper survey techniques.
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Notwithstanding the above, the results of urinalyses performed on
the licensee personnel involved in the incident indicated that there
had been no intake of radioactive material by any of these individuals,
including the Petitioner. In addition, the results of thyroid counts
taken of these individuals indicated that the Petitioner did not
exhibit any counts above
[[Page 47539]]
background in any of the radioactive iodine channels.6
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\6\ The CNMT did have an uptake of 1.5 x 10=3 Bq (40
nanocuries) of iodine-123, which is indicative of a minor intake of
iodine-123 (a radionuclide not regulated by NRC, but regulated by
the State of Pennsylvania). The licensee indicated that training
will be given to this individual to ensure that appropriate
techniques are used to minimize contamination in the future.
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The Petitioner also asserted in her Petition that she was fearful
for her personal safety as well as that of her then unborn child, that
certain NRC staff shared these concerns, and that she believed that the
contamination was intentional. In support of her claim, she stated that
``two senior NRC physicists telephoned, and cautioned me to remove all
consumable items from my office and not to eat or drink anything over
which I did not have positive control.'' Although the NRC inspector did
caution the Petitioner as she stated, this was advice given following
the contamination incident as a reasonable precautionary health physics
recommendation, based on the circumstances of the individual situation
and the Petitioner's expressed concern for her personal safety.
Additionally, the Petitioner stated that ``I received a visit in my
office by two NRC inspectors, one of whom came to caution me that he
believed my physical safety was in jeopardy due to the allegations I
had made regarding violations involving human uses of radioactive
materials.'' The Petitioner has not provided specific information as to
who the inspector was who made this statement, and NRC has been unable
to identify any individual as having made this statement. Nonetheless,
NRC is aware that the Petitioner had raised a concern about her
personal safety during 1997 following her raising allegations to NRC.
However, NRC also was aware that the PVAMC security force was contacted
by the parties involved. Therefore, the Petitioner has not raised any
new information of which the NRC was not aware. As discussed above, NRC
investigated the contamination incident, and did not find any evidence
that the contamination incident was intentional and that the Petitioner
was in any physical danger as a result of this incident.
Furthermore, as explained above, the licensee has since made
numerous changes to its program and organizational structure, and has
developed a program to encourage employees to raise nuclear safety
concerns without fear of retaliation. In addition, as is also explained
above, NRC will continue to closely monitor the licensee's program on
an accelerated inspection schedule to assure that PVAMC's corrective
actions for past problems continue to be effective. Therefore,
notwithstanding the seriousness of the situation that occurred during
1997, the Petitioner has not provided any information that would
provide a basis for the NRC to take additional action such as she
requested at this time.
D. Petitioner's Assertion of Employees' Fear of Raising Safety Concerns
The Petitioner also asserts that PVAMC employees are fearful of
bringing safety concerns to the licensee for fear of retaliation, and
to NRC due to NRC's ``history of inaction'' regarding the medical
center.7 With regard to the Petitioner's assertion that
PVAMC employees are fearful of bringing forth safety concerns, as
described above, during NRC inspections conducted at the licensee's
facility from 1995 through 1997, certain programmatic weaknesses were
identified, including communication problems among PVAMC staff,
management, the prior RSO, and the previous RSC chairman. Furthermore,
NRC became aware that, as a result of these problems, some PVAMC
employees may have been reluctant to inform management or NRC about
safety concerns. However, as described above, NRC Region I and
Headquarters management met with the licensee on December 18, 1997, to
discuss these program deficiencies, and subsequently issued a CAL, in
which the licensee made several commitments to improve its oversight of
the radiation safety program and to provide training to all nuclear
medicine staff, researchers using radioactive material, RSC members and
the facility management, on all applicable NRC regulatory requirements,
on management expectations, and on the policy on encouraging employees
to bring identified program deficiencies to management's attention. The
licensee committed to complete these items by May 30, 1998. As
discussed above, NRC inspected the facility June 1-3, 1998, and
confirmed that the licensee completed these items. Additionally, the
licensee is on an accelerated inspection schedule so that NRC can
closely monitor PVAMC's progress in improving communication among the
facility staff and program performance.
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\7\ The Petitioner's assertion of NRC's history of inaction
regarding the PVAMC was referred to the Office of the Inspector
General on February 12, 1998.
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The licensee has conducted a comprehensive review and assessment of
its radiation safety program and provided a copy of the report to NRC
by letters dated April 6 (with revised copy of report dated April 10)
and April 13, 1998. NRC has determined that the assessment was of an
adequate depth and breadth and covered not only technical radiation
safety program issues but was expanded to include interpersonal
communications, cooperation, and conflict resolution among the facility
staff, as well. An audit was also performed by the Department of
Veteran's Affairs' National Health Physics office manager.
NRC has found, through a review of the audit report and during its
inspection performed June 1-3, 1998, that PVAMC has provided
comprehensive training to all nuclear medicine staff, researchers using
radioactive materials, RSC members, and facility management. The
training focused on, among other things, the right and duty of
employees to raise any nuclear safety concerns to management, or
directly to NRC.
The inspectors also reviewed the implementation of PVAMC's actions
documented in its responses to the CAL. The inspectors, through a
review of records, discussions with the licensee's staff, and
observation of onsite activities, noted that major staff changes have
occurred in areas that affect communication of management's message to
staff concerning the improved communications at all levels and the
significance of bringing forth any safety concerns. The inspectors
noted that these staff changes, as well as the implementations of their
directives, significantly improved personnel's understanding of the
importance of radiation safety and the importance of a work environment
in which staff is encouraged to bring forth issues relating to
radiation safety without fear of retaliation. The licensee's new senior
management, the new RSC chairman, and the new RSO, in cooperation with
the facility staff, have initiated and implemented specific actions,
including providing training to staff on the importance of reporting
any program deficiencies and safety concerns. Additionally, management
has worked to build teamwork and improve communication, and has made a
commitment to increase program oversight. During the June 1998
inspection, the inspectors found that the licensee's corrective actions
to date have been effective. The new RSO and management team are making
a concerted effort to create a favorable work environment which fosters
an open flow of communication. The inspectors interviewed staff and
found
[[Page 47540]]
that individuals appear to be ``more comfortable'' raising safety
concerns without fear of retaliation.
In sum, although, as a result of a general weakness in
communications at the licensee's facility, there may have been, in the
past, a reluctance among employees to raise safety concerns, NRC has
found that the licensee has taken numerous effective corrective actions
to ensure that employees are encouraged to raise nuclear safety
concerns. Additionally, as stated earlier, PVAMC is on an accelerated
inspection schedule, and this issue will be reviewed during future
inspections. Therefore, the Petitioner's assertions regarding this
issue do not provide a basis that would warrant the action she has
requested.
The Petitioner also asserts that NRC withdrew a civil penalty after
a change in NRC Region I management, possibly because it was not
``cost-effective'' to pursue the issue. She states that NRC's
withdrawal of a civil penalty involving a violation of protected
activities sent a ``chilling'' effect to individuals both within and
external to the PVAMC who may have thought of raising a safety concern.
NRC staff assumes that the Petitioner is referring to the NOV dated
September 18, 1996 (EA 96-182). As discussed earlier, NRC issued a NOV
and Proposed Imposition of Civil Penalty of $8000 to PVAMC as a result
of concluding that PVAMC had discriminated against the Petitioner for
raising safety concerns in November 1995, related to then-impending
Federal government furloughs. NRC had identified this violation based
on the determination of the DOL Acting District Director of the Wage
and Hour Division that the Petitioner had been chastised by her
immediate supervisor, the Chief of Engineering, for raising safety
concerns. However, as explained previously, after its review of all of
the available information, including the results of the OI
investigation and PVAMC's responses to the NOV, NRC concluded, in a
letter dated September 27, 1997, that the violation would be more
appropriately classified as a Severity Level III violation and that
enforcement discretion would be exercised to withdraw the civil
penalty, pursuant to Section VII.B.6 of the Enforcement Policy. In this
case, the determination to withdraw the civil penalty was made based on
the fact that the chastisement of the Petitioner did not substantially
affect the conditions of her employment; an apology was issued; she
remained the RSO; DOL had concluded that it found that PVAMC had met
the terms and conditions of remedies it had outlined concerning the
violation; and investigations conducted by DOL and OI failed to
substantiate that there had been any continued discrimination against
the Petitioner. Nonetheless, while NRC believes that there is no merit
to the Petitioner's assertion that the decision to withdraw the civil
penalty resulted from the fact that it was not ``cost-effective'' to
pursue the issue against PVAMC, the Petition was forwarded to the
Office of the Inspector General for its review on February 12, 1998.
IV. Conclusion
NRC has determined that, for the reasons discussed above, the
Petitioner has not provided a sufficient basis for taking any action to
suspend or revoke PVAMC's license, as requested in the Petition.
Accordingly, the Petition is denied.
As provided by 10 CFR Sec. 2.206(c), a copy of this Decision will
be filed with the Secretary of the Commission, for the Commission's
review. The Decision will become the final action of the Commission 25
days after issuance unless the Commission, on its own motion,
institutes review of the Decision within that time.
Dated at Rockville, Maryland, this 28th day of August, 1998.
For the Nuclear Regulatory Commission.
Carl J. Paperiello,
Director, Office of Nuclear Material Safety and Safeguards.
[FR Doc. 98-24011 Filed 9-4-98; 8:45 am]
BILLING CODE 7590-01-P
