[Federal Register Volume 67, Number 190 (Tuesday, October 1, 2002)]
[Notices]
[Pages 61671-61674]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-24942]
=======================================================================
-----------------------------------------------------------------------
NUCLEAR REGULATORY COMMISSION
[IA-02-017]
Perry M. Beale; Order Prohibiting Involvement in NRC-Licensed
Activities (Effective Immediately)
Perry M. Beale, a consultant in the field of health physics,
provided consulting services to City Hospital in Martinsburg, West
Virginia, Warren Memorial Hospital in Front Royal, Virginia, Culpeper
Memorial Hospital in Culpeper, Virginia, Fauquier Hospital in
Warrenton, Virginia, and Prince William Hospital in Manassas, Virginia
(Licensee or Licensees). City Hospital holds License No. 47-15501-01
issued by the Nuclear Regulatory Commission (NRC or Commission)
pursuant to 10 CFR part 35, last amended on June 25, 2001. Warren
Memorial Hospital holds License No. 45-19566-01 issued by the NRC
pursuant to 10 CFR part 35 on January 12, 1981, and last amended on
October 12, 2001. Culpeper Memorial Hospital holds License No. 45-
23040-01 issued by the NRC pursuant to 10 CFR part 35 on September 19,
1984, and last amended on June 12, 2002. Fauquier Hospital holds
License No. 45-19484-01 issued by the NRC pursuant to 10 CFR part 35 on
November 20, 1980 and last amended on August 2, 2001. Prince William
Hospital holds License No. 45-19485-01 issued by the NRC pursuant to 10
CFR part 35 on October 27, 1980, and last amended on October 12, 2001.
The licenses for each Licensee authorize the medical use of byproduct
material in accordance with the conditions specified therein.
In March 2001, NRC inspections of licensed activities were
conducted at City Hospital and Warren Memorial Hospital, and an in-
office review was conducted of the Culpeper Memorial Hospital license
file. Based on the results of the inspections and in-office review, the
NRC's Office of Investigations (OI) initiated an investigation in April
2001, to review the circumstances surrounding the potential
falsification of xenon gas clearance rate calculations, and dose
calibrator accuracy evaluations. Xenon gas clearance rate calculations,
required by 10 CFR 35.205(c), determine the amount of time that would
be needed to clear accidentally spilled radioactive xenon gas from
rooms where it was to be used. Dose calibrator accuracy tests, required
by 10 CFR 35.50(b)(2), compare a known radiation activity to that
measured by the calibrator. Mr. Beale had provided consulting services
to each of the licensed facilities with respect to the foregoing
calculations and evaluations. On March 27, 2002, OI completed its
review of the matter. A predecisional enforcement conference was held
between the NRC Staff and Mr. Beale on July 15, 2002, to discuss these
matters.
Mr. Beale admitted that he had knowingly prepared and submitted
inaccurate xenon gas clearance rate calculations to City Hospital,
Warren Memorial Hospital and Culpeper Memorial Hospital, and had
knowingly prepared and submitted inaccurate dose calibrator accuracy
evaluations to Culpeper Memorial Hospital. Specifically, Mr. Beale
submitted numerous reports to City Hospital,\1\ to Warren Memorial
Hospital,\2\ and to Culpeper Memorial Hospital,\3\ stating that he had
calculated xenon gas clearance rates according to the procedure
specified in Appendix O to NRC Regulatory Guide 10.8, ``Guide for the
Preparation of Applications for Medical Use Programs.'' The reports
stated that the rooms in question at the three hospitals all had the
same volume of 0.697 x 107 ml, although in fact they each had different
volumes. The reports further stated that all rooms at the three
hospitals had a total room air exhaust rate of 1.5 x 10\7\ ml per
minute, although Mr. Beale did not measure or calculate that value.
Although the values purportedly used to make the calculations were the
same, reported calculated xenon gas clearance rates varied. Mr. Beale
told OI investigators and NRC Staff, that in fact he had measured
airflows into and out of the rooms at each of the three hospitals to
determine that the rooms were under negative pressure, performed no
calculations, and then ``guessed'' the clearance rates. In addition,
Mr. Beale admitted that on a day after May 6, 1999, he had generated
three dose calibrator accuracy evaluation reports for Culpeper Memorial
Hospital dated May 16, 1998, December 10, 1998, and May 6, 1999. Mr.
Beale stated that he had used published decay tables to determine the
remaining activity in a calibration source, but the values he reported
were markedly inconsistent with the values which would have been
determined using published decay tables.\4\ Mr. Beale submitted a
report to Culpeper Memorial Hospital of a dose calibrator accuracy
evaluation, which he purportedly performed on April 25, 1997, for a
Cobalt-57 source, Serial No. 559186-9, which was certified as having
been initially calibrated by the manufacturer on November 1, 1997. Mr.
Beale could not explain these inaccuracies. Records of xenon clearance
rate calculations and dose calibrator evaluations are required to be
maintained by 10 CFR 35.205(d) and 10 CFR 35.50(e), respectively. These
records are material to the NRC in that they are relied upon to
demonstrate the Licensees' compliance with 10 CFR
[[Page 61672]]
35.205(c) and 10 CFR 35.50(b)(2), which require the performance of
xenon clearance rate calculations and dose calibrator evaluations,
respectively.
---------------------------------------------------------------------------
\1\ Dated February 6, 1998, August 7, 1998, February 5, 1999,
August 2, 1999, February 4, 2000, August 24, 2000, and February 21,
2002.
\2\ Dated January 8, 1999, July 14, 1999, January 7, 2000,
January 11, 2000, July 7, 2000, and July 12, 2000.
\3\ Dated May 14, 1998, November 12, 1998, May 3, 1999, November
19, 1999, and April 22, 2000.
\4\ For May 6, 1999, 1.58 millicuries versus 1.37 millicuries.
For December 10, 1998, 2.65 millicuries versus 1.99 millicuries. For
May 16, 1998, 1.1 millicuries versus 3.34 millicuries.
---------------------------------------------------------------------------
In addition, Mr. Beale admitted at the predecisional enforcement
conference that inaccurate information regarding his educational
background and professional qualifications had been provided to
Culpeper Memorial Hospital. Specifically, Mr. Beale's resume indicated
that he had received a Master of Science Degree in Radiologic
Technology, Nuclear Medicine, Radiological Physics from the University
of Virginia and that he had been certified by the American Board of
Radiology (ABR) in Radiological Physics. Mr. Beale also acknowledged
that a certificate purportedly issued by the ABR indicated that he was
certified in Radiological Physics. Mr. Beale stated at the
predecisional enforcement conference that, in fact, he does not possess
a Master Degree from the University of Virginia and has not received
ABR certification. Based on a written request from Culpeper Memorial
Hospital dated December 19, 1995, the NRC amended Culpeper Memorial
Hospital's license to name Mr. Beale as alternate RSO by Amendment No.
10, dated December 22, 1995. The request from Culpeper Memorial
Hospital included Mr. Beale's inaccurate resume. In addition, based on
a written request from Culpeper Memorial Hospital dated July 23, 1996,
the NRC amended the license to name Mr. Beale as RSO by Amendment No.
11, dated August 7, 1996. The request included Mr. Beale's inaccurate
resume and a copy of the purported ABR certificate. The inaccurate
resume information and purported ABR certificate were material to the
NRC because they were relevant to Mr. Beale's qualifications to be
named an alternate RSO and an RSO on the Culpeper Hospital Memorial
license.
After the predecisional enforcement conference, NRC staff conducted
inspections from July 31 through August 2, 2002, at Fauquier Hospital,
Culpeper Memorial Hospital and Prince William Hospital, hospitals which
used the consulting services of Perry M. Beale. Mr. Beale contracted
with the hospital to provide reviews of their radiation safety programs
and to participate in Radiation Safety Committee activities. Mr. Beale
also performed xenon clearance rate calculations, leak tests, dose
calibrator tests (including decay correction calculations) for the
hospitals, and undertook to have the licensees' survey instruments
calibrated by a calibration vendor at the appropriate frequency. The
inspections revealed that xenon clearance rate calculations prepared by
Mr. Beale for the three hospitals were similar to those he had prepared
for City Hospital and Warren Memorial Hospital and which had been
examined during the OI investigation. Specifically, the input values
for the calculations were the same, and the forms Mr. Beale provided to
the three hospitals stated that his xenon gas clearance rate
calculations were performed according to the procedure specified in
Appendix O to NRC Regulatory Guide 10.8, ``Guide for the Preparation of
Applications for Medical Use Programs.'' The clearance rates calculated
by Mr. Beale, however, were different from those that would have been
calculated if the formula specified by Regulatory Guide 10.8 had been
used. Records of xenon clearance rate calculations are required to be
maintained by 10 CFR 35.205(d), and are material to the NRC in that
they are relied upon to demonstrate the Licensee's compliance with 10
CFR 35.205(c), which requires the performance of xenon clearance rate
calculations.
Also, during the inspection at Prince William Hospital, a survey
instrument that was used to perform activities required by regulation
was observed to have an overdue calibration sticker. When questioned
about this, the licensee representative presented a current calibration
certificate which showed that the instrument had been calibrated within
the past several months. As part of his consultant activities for the
hospitals, Mr. Beale was to pick up their instruments prior to the
calibration due date and send them to RSO, Inc. for calibration. After
calibration, Mr. Beale was to return the instruments to the licensees
with a current calibration certificate and calibration sticker. The
calibration certificate which Prince William Hospital provided stated
that RSO, Inc. had calibrated the instrument on May 7, 2002. The RSO,
Inc. representative, whose name appeared on the certificate as the
individual who had performed the calibration, advised NRC inspection
staff that according to RSO, Inc. records, no instrument bearing the
serial number referenced on the calibration certificate for Prince
William Hospital (119312) had been calibrated by RSO, Inc. for
several years. The RSO, Inc. representative further advised that the
RSO, Inc. order number referenced on the calibration certificate
supplied by Prince William Hospital (2118) was in fact for
Culpeper Memorial Hospital. Comparison of the Prince William Hospital
calibration certificate to the calibration certificates obtained from
Culpeper Memorial Hospital and Fauquier Hospital demonstrates that the
calibration data, order/tracking numbers, and probe serial numbers were
identical for all three hospitals. Based on the above, the NRC
concludes that Mr. Beale did not calibrate a radiation survey
instrument for Prince William Hospital at the required frequency, and
that Mr. Beale deliberately provided inaccurate information to Prince
William Hospital to conceal his failure to calibrate the instrument.
Licensees are required to note on the survey instrument the date of
calibration and the apparent exposure rate from a dedicated check
source, and to retain calibration records by 10 CFR 35.51(a)(3) and
(d). These records are material to the NRC in that they are relied upon
to demonstrate the Licensee's compliance with 10 CFR 35.51(a), which
requires calibration of survey instruments. Moreover, the calibration
certificate which Mr. Beale supplied to Prince William Hospital
certifies that the instrument had been calibrated on May 7, 2002,
approximately one year after Mr. Beale's interview with NRC's OI.
During that interview, the Commission's regulation requiring complete
and accurate information and the deliberately inaccurate xenon
clearance rate calculations and dose calibrator evaluations which Mr.
Beale had submitted to City Hospital, Warren Memorial Hospital and
Culpeper Memorial Hospital were discussed at length.
Based on the above, it appears that Perry M. Beale has engaged in
deliberate misconduct in violation of 10 CFR 30.10(a)(1) in that he
caused City Hospital, Warren Memorial Hospital, Culpeper Memorial
Hospital, Fauquier Hospital, and Prince William Hospital to be in
violation of 10 CFR 35.205 and 10 CFR 30.9. It also appears that Mr.
Beale engaged in deliberate misconduct in that he caused Culpeper
Hospital to be in violation of 10 CFR 35.50 and 10 CFR 30.9, and caused
Prince William Hospital to be in violation of 10 CFR 35.51 and 30.9. It
further appears that Perry M. Beale has engaged in deliberate
misconduct in violation of 10 CFR 30.10(a)(2) by providing to Culpeper
Memorial Hospital information regarding his educational and
professional qualifications that he knew to be incomplete or inaccurate
in some respect material to the NRC. The NRC must be able to rely on
its Licensees and their employees, including consultants, to comply
with NRC requirements, including the requirement to provide complete
and accurate information in
[[Page 61673]]
all material respects. Mr. Beale's deliberate misconduct, including
falsification of records related to his qualifications to be named a
Radiation Safety Officer (RSO) and to licensees' compliance with
regulatory requirements, especially continued falsification of records
after being interviewed by OI concerning his falsification of records,
raises serious concerns regarding his trustworthiness and reliability,
and call into question his willingness to comply with NRC requirements,
including the requirement to provide complete and accurate information
to the NRC and to entities who perform NRC-licensed activities.
Consequently, I lack the requisite reasonable assurance that
licensed activities can be conducted in compliance with the
Commission's requirements and that the health and safety of the public
would be protected if Perry M. Beale were permitted at this time to be
involved in NRC-licensed activities. Therefore, the public health,
safety and interest require that Perry M. Beale be prohibited from any
involvement in NRC-licensed activities for a period of three years from
the date of this Order. Additionally, Mr. Beale is required to notify
the NRC of his first employment in NRC-licensed activities following
the prohibition period, and provide documentation of his qualifications
to fill that position. Furthermore, pursuant to 10 CFR 2.202, I find
that the significance of Mr. Beale's conduct described above is such
that the public health, safety and interest require that this Order be
immediately effective.
Accordingly, pursuant to sections 81, 161b, 161i, 161o, 182 and 186
of the Atomic Energy Act of 1954, as amended, and the Commission's
regulations in 10 CFR 2.202, 10 CFR 30.10, and 10 CFR 150.20, it is
hereby ordered, effective immediately, that:
1. Perry M. Beale is prohibited for three years from the date of
this Order from engaging in NRC-licensed activities. NRC-licensed
activities are those activities that are conducted pursuant to a
specific or general license issued by the NRC, including, but not
limited to, those activities of Agreement State licensees conducted
pursuant to the authority granted by 10 CFR 150.20.
2. If Perry M. Beale is currently involved with another licensee in
NRC-licensed activities, he must immediately cease those activities,
and inform the NRC of the name, address and telephone number of the
employer, and provide a copy of this Order to the employer.
3. After completion of the term specified in Paragraph IV.1 above,
Perry M. Beale shall, at least 20 days before resuming participation in
NRC-licensed activities (as a Consultant to, Radiation Safety Officer
for, or employee of, an NRC licensee, or in any other capacity),
provide notice to the Director, Office of Enforcement, U.S. Nuclear
Regulatory Commission, Washington, DC 20555, of the names, addresses,
and telephone numbers of the employers or entities for whom he is, or
will be, involved in NRC-licensed activities. In the notification,
Perry M. Beale shall include his qualifications to participate in NRC
licensed activities (as appropriate), a statement of his commitment to
compliance with regulatory requirements, and provide a basis for why
the Commission should have confidence that he will now comply with
applicable NRC requirements.
The Director, OE, may, in writing, relax or rescind any of the
above commitments upon demonstration by Perry M. Beale of good cause.
In accordance with 10 CFR 2.202, Perry M. Beale must, and any other
person adversely affected by this Order may, submit an answer to this
Order, and may request a hearing on this Order, within 20 days of the
date of this Order. Where good cause is shown, consideration will be
given to extending the time to request a hearing. A request for
extension of time in which to request a hearing must be made in writing
to the Director, Office of Enforcement, U.S. Nuclear Regulatory
Commission, Washington, DC 20555, and include a statement of good cause
for the extension. Unless the answer consents to this Order, the answer
shall, in writing and under oath or affirmation, specifically admit or
deny each allegation or charge made in this Order and shall set forth
the matters of fact and law on which Perry M. Beale or other person
adversely affected relies and the reasons as to why the Order should
not have been issued. Any answer or request for a hearing shall be
submitted to the Secretary, U.S. Nuclear Regulatory Commission, ATTN:
Rulemakings and Adjudications Staff, Washington, DC 20555. Copies also
shall be sent to the Director, Office of Enforcement, U.S. Nuclear
Regulatory Commission, Washington, DC 20555, to the Deputy Assistant
General Counsel for Enforcement, and to the Director, Office of Nuclear
Materials Safety and Safeguards, at the same address, to the Regional
Administrator, NRC Region II, 61 Forsyth Street, SW., Suite 23T85,
Atlanta, Georgia, 30303-8931, and to Perry M. Beale if the hearing
request is by a person other than Mr. Beale. Because of continuing
disruptions in delivery of mail to United States Government offices, it
is requested that any request for hearing be transmitted to the
Secretary for the Commission either by means of facsimile transmission
to 301-415-1101 or by e-mail to [email protected] and also to the
Office of the General Counsel either by means of facsimile transmission
to 301-415-3725 or by e-mail to [email protected]. If a person
other than Perry M. Beale requests a hearing, that person shall set
forth with particularity the manner in which his or her interest is
adversely affected by this Order and shall address the criteria set
forth in 10 CFR 2.714(d).\5\
---------------------------------------------------------------------------
\5\ The most recent version of Title 10 of the Code of Federal
Regulations, published in January 2002, inadvertently omitted the
last sentence of 10 CFR 2.714(d) and subparagraphs (d)(1) and
(d)(2), regarding the criteria for intervention and contentions.
Those provisions are extant and still applicable to petitions to
intervene. Those provisions are as follows: ``* * *such ruling body
or officer shall, in ruling on-- (1) A petition for leave to
intervene or a request for hearing, consider the following factors,
among other things: (i) The nature of the petitioner's right under
the Act to be made a party to the proceeding. (ii) The nature and
extent of the petitioner's property, financial, or other interest in
the proceeding. (iii) The possible effect of any order that may be
entered in the proceeding on the petitioner's interest. (2) The
admissibility of a contention, refuse to admit a contention if: (i)
The contention and supporting material fail to satisfy the
requirements of paragraph (b)(2) of this section; or (ii) The
contention, if proven, would be of no consequence in the proceeding
because it would not entitle petitioner to relief.''
---------------------------------------------------------------------------
If a hearing is requested by Perry M. Beale or a person whose
interest is adversely affected, the Commission will issue an Order
designating the time and place of any hearing. If a hearing is held,
the issue to be considered at such hearing shall be whether this Order
should be sustained.
Pursuant to 10 CFR 2.202(c)(2)(i), Perry M. Beale may, in addition
to demanding a hearing, at the time the answer is filed or sooner, move
the presiding officer to set aside the immediate effectiveness of the
Order on the ground that the Order, Including the need for immediate
effectiveness, is not based on adequate evidence but on mere suspicion,
unfounded allegations, or error.
In the absence of any request for hearing, or written approval of
an extension of time in which to request a hearing, the provisions
specified in Section IV above shall be final 20 days from the date of
this Order without further order or proceedings. If an extension of
time for requesting a hearing has been approved, the provisions
specified in Section IV shall be final when the extension expires if a
hearing request has not been received. A Request for hearing shall not
stay the immediate effectiveness of this order.
[[Page 61674]]
Dated this 23rd day of September 2002.
For the Nuclear Regulatory Commission.
Carl J. Paperiello,
Deputy Executive Director for Materials, Research and State Programs.
[FR Doc. 02-24942 Filed 9-30-02; 8:45 am]
BILLING CODE 7590-01-P