EA-99-096 - Philadelphia Health and Education Corp.
May 11, 1999
Mr. Frank J. Bachich
Philadelphia Health and Education Corporation
c/o Drexel University
3141 Chestnut Street
Philadelphia, Pennsylvania 19104
SUBJECT: NOTICE OF VIOLATION
(NRC Inspection Report No. 030-12998/99-001)
Dear Mr. Bachich:
This refers to the NRC inspection conducted on April 7 and 9, 1999, at your facilities located at 3200 Henry Avenue; 3300 Henry Avenue; 2900 Queen Lane; and St. Christopher's Hospital for Children, Erie Avenue at Front Street, to determine whether activities authorized by your NRC license were conducted safely and in accordance with NRC requirements. The inspection consisted of observations by the inspector, interviews with personnel, and a selected examination of representative records. At the conclusion of the inspection, the findings were discussed with William Van Decker, M.D., Theodore Villafana, Ph.D., and other members of your organization.
During the inspection, the NRC reviewed the circumstances associated with an apparent violation involving the use of licensed material by an unauthorized individual in 1996. Based on our review of the inspection findings and your corrective actions described during the inspection, the NRC has concluded that we have sufficient information to make an enforcement decision without the need for a predecisional enforcement conference. During a telephone conversation on April 27, 1999, Dr. Mohamed Shanbaky of my staff informed you that the NRC was considering the apparent violation for escalated enforcement action in accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions" (Enforcement Policy), NUREG-1600 and offered you an opportunity to respond to the apparent violation either in writing or at a predecisional enforcement conference. In a telephone conversation on April 29, 1999, you informed Dr. Shanbaky that you did not believe that a written response or predecisional enforcement conference was necessary prior to the NRC making an enforcement decision.
Based on review of the information developed during the inspection, the NRC has determined that three violations of NRC requirements occurred. These violations are cited in the enclosed Notice of Violation (Notice). The significance of these violations and the need for lasting and effective corrective action were discussed with members of your staff at the inspection exit meeting on April 9, 1999.
The most significant of these violations involved the use of approximately 2 millicuries of iodine-125 (I-125) by an untrained, unsupervised, and unauthorized individual during a laboratory experiment on October 16, 1996. Your staff identified the violation the following day and performed bioassays for the Principal Investigator (PI), a trained researcher, and the untrained individual. The bioassays indicated no uptake of I-125. Although there were no actual safety consequences as a result of the unauthorized use of licensed material, there was a significant potential for contamination or inadvertent radiation exposure to the untrained individual or other individuals. Therefore, the violation, which is cited in Section A of the enclosed Notice, is classified at Severity Level III in accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions" (Enforcement Policy), NUREG-1600.
In accordance with the Enforcement Policy, a base civil penalty in the amount of $2,750 is considered for a Severity Level III violation. Because your facility has not been the subject of an escalated enforcement action within the last two years, the NRC considered whether credit was warranted for Corrective Action in accordance with the civil penalty assessment process in Section VI.B.2 of the Enforcement Policy. Credit for corrective actions is warranted because your corrective actions were considered prompt and comprehensive. These actions included, but were not limited to: (1) immediately shutting down the laboratory and investigating the incident; (2) prohibiting the authorized user [PI and/or researcher] from conducting experiments until the investigation was completed; (3) training of the laboratory staff to emphasize their responsibilities for safe use of radioactive material; and (4) review of the operations of other laboratories for similar problems.
Therefore, to encourage prompt and comprehensive correction of violations, I have been authorized to not propose a civil penalty in this case. However, similar violations in the future could result in further escalated enforcement action. In addition, issuance of this Severity Level III violation constitutes escalated enforcement action, that may subject you to increased inspection effort.
In addition to the violation set forth in Section A of the enclosed Notice, during a December 1998 audit, your staff identified that your PIs were not providing inventory reports of licensed materials to the Radiation Safety Office in a timely manner. Although you identified this problem, your corrective actions for this deficiency were apparently not effective because the NRC identified that inventory reports for the first quarter of 1999 were not submitted for all laboratories at the time of the inspection. Therefore, this violation, which is categorized at Severity Level IV in accordance of the Enforcement Policy, is cited in Section B of the enclosed Notice. Additionally, the inspector identified that you failed to obtain swipe tests of storage areas at least quarterly. This violation, which is also categorized at Severity Level IV, is also cited in Section B of the enclosed Notice.
With respect to the violation cited in Section A of the enclosed Notice, the NRC has concluded that the reason for the violation, the corrective actions taken and planned to correct the violation and prevent recurrence, and the date when full compliance was achieved are already adequately documented herein. Therefore, you are not required to respond to this violation unless our understanding does not accurately reflect your corrective actions or your position. In that case, or if you choose to provide additional information, you should follow the instructions specified in the enclosed Notice.
You are required to respond to the violations cited in Section B of the enclosed Notice and should follow the instructions specified in the enclosed Notice when preparing your response. The NRC will use your response, in part, to determine whether further enforcement action is necessary to ensure compliance with regulatory requirements.
In accordance with 10 CFR 2.790 of the NRC's "Rules of Practice," a copy of this letter, its enclosure, and your response will be placed in the NRC Public Document Room (PDR).
|ORIGINAL SIGNED BY||JAMES T. WIGGINS
|FOR||Hubert J. Miller
Docket No. 030-12998
License No. 37-07438-15
Enclosure: Notice of Violation
Theodore Villafana, Ph.D., Radiation Safety Officer
William Van Decker, M.D., Chairman, RSC
Eric Cottington, Associate VP - Research Operations
Commonwealth of Pennsylvania
|NOTICE OF VIOLATION
|Philadelphia Health & Education Corporation Philadelphia, PA||Docket No. 030-12998
License No. 37-07438-15
During an NRC inspection conducted on April 7 and 9, 1999, three violations
of NRC requirements were identified. In accordance with the "General Statement
of Policy and Procedure for NRC Enforcement Actions," (Enforcement Policy),
NUREG-1600, the violations are listed below:
|A.||Condition 11.A of License No. 37-07438-15
requires that licensed material be used by, or under the supervision
of, individuals designated in writing by the Radiation Safety Committee.
Condition 23 of License No. 37-07438-15 requires, in part, that the
licensee conduct its program in accordance with the statements, representations
and procedures contained in a letter dated September 23, 1994. Item
1 of Supplement B of the letter dated September 23, 1994, requires
that a designated supervisor assure that any new worker receives orientation.
Specifically, the supervisor is to introduce the new worker to radiation
safety practices as well as necessary documentation procedures.
Contrary to the above, on October 16, 1996, licensed material was used by an individual who was neither designated in writing by the Radiation Safety Committee, nor under the supervision of an individual designated in writing by the Radiation Safety Committee, and the supervisor of the individual did not assure that the new worker received orientation. Specifically, an individual used about 2 millicuries of iodine-125 in a laboratory experiment without proper authorization or supervision, and the individual had not received initial radiation safety training from a licensed user or the Radiation Safety staff. (01013)
This is a Severity Level III violation (Supplement VI).
|B.||Condition 23 of License No. 37-07438-15 requires, in
part, that the licensee conduct its program in accordance with the
statements, representations and procedures contained in the application
received on August 4, 1993.
|1.||Item IV.B. of the Radiation Safety Manual attached to
the application received on August 4, 1993, requires, in part, that
the licensed users provide the Radiation Safety Office with monthly
updates of the receipt, use and disposal of radioactive materials.
Contrary to the above, as of April 9, 1999, licensed users did not provide the Radiation Safety Office (RS Office) with monthly updates of the receipt, use and disposal of radioactive materials. Specifically, as of April 9, 1999, inventory reports for the months of January, February, and March 1999 had not been submitted for all laboratories. (02014)
This is a Severity Level IV violation (Supplement VI).
|2.||Item B.8 of Supplement G of the Radiation Safety Manual enclosed
with the application received on August 4, 1993, requires, in part,
that waste storage areas are to have a swipe test obtained no less
Contrary to the above, as of April 9, 1999, the licensee had not obtained swipe tests of the storage areas no less than quarterly. Specifically, as of April 9, 1999, the swipe tests had not been obtained since July 1998, an interval greater than quarterly. (03014)
This is a Severity Level IV violation (Supplement VI).
The NRC has concluded that information regarding the reason for Violation
A, the corrective actions taken and planned to correct the violation and
prevent recurrence and the date when full compliance was achieved is already
adequately addressed in the letter transmitting this NOV. Therefore, you
are not required to provide a response for Violation A. However, you are
required to submit a written statement or explanation pursuant to 10 CFR 2.201
if the description therein does not accurately reflect your corrective
actions or your position regarding Violation A. In that case, or if you
choose to respond, clearly mark your response as a "Reply to a Notice
of Violation," and send it to the U.S. Nuclear Regulatory Commission,
ATTN: Document Control Desk, Washington, DC 20555 with a copy
to the Regional Administrator, Region I, within 30 days of the date of
the letter transmitting this Notice of Violation (Notice).
With regard to the violations in Section B, pursuant to the provisions of 10 CFR 2.201, Philadelphia Health and Education Corporation is hereby required to submit a written statement or explanation to the U.S. Nuclear Regulatory Commission, ATTN: Document Control Desk, Washington, DC 20555, with a copy to the Regional Administrator, Region I, within 30 days of the date of the letter transmitting this Notice of Violation (Notice). This reply should be clearly marked as a "Reply to a Notice of Violation" and should include for Violations B.1 and B.2: (1) the reason for the violation, or, if contested, the basis for disputing the violation or severity level, (2) the corrective steps that have been taken and the results achieved, (3) the corrective steps that will be taken to avoid further violations, and (4) the date when full compliance will be achieved. Your response may reference or include previous docketed correspondence, if the correspondence adequately addresses the required response. If an adequate reply is not received within the time specified in this Notice, an order or a Demand for Information may be issued as to why the license should not be modified, suspended, or revoked, or why such other action as may be proper should not be taken. Where good cause is shown, consideration will be given to extending the response time.
If you contest this enforcement action, you should also provide a copy of your response, with the basis for your denial, to the Director, Office of Enforcement, United States Nuclear Regulatory Commission, Washington, DC 20555-0001.
Your response will be placed in the NRC Public Document Room (PDR); therefore, to the extent possible, it should not include any personal privacy or proprietary information so that it can be placed in the PDR without redaction. If personal privacy or proprietary information is necessary to provide an acceptable response, then please provide a bracketed copy of your response that identifies the information that should be protected and a redacted copy of your response that deletes such information. If you request withholding of such material, you must specifically identify the portions of your response that you seek to have withheld and provide in detail the bases for your claim of withholding (e.g., explain why the disclosure of information will create an unwarranted invasion of personal privacy or provide the information required by 10 CFR 2.790(b) to support a request for withholding confidential commercial or financial information).
In accordance with 10 CFR 19.11, you may be required to post this Notice within two working days.
Dated at King of Prussia, PA
this 11th day of May 1999