EA-97-309 - Grand View Hospital
EA No. 97-309
Mr. Robert C. Vitto, Vice President, Clinical
and Support Services
Grand View Hospital
700 Lawn Avenue
Sellersville, Pennsylvania 18960
SUBJECT: NOTICE OF VIOLATION AND PROPOSED IMPOSITION OF CIVIL PENALTY - $4,400 (NRC Inspection Report No. 030-12571/97-002)
Dear Mr. Vitto:
This refers to the NRC inspection conducted on June 4-5, and June 10, 1997, to review the circumstances associated with an event which occurred at your facility on June 3, 1997, involving the shipment of a package from your facility to Syncor Corporation in Allentown, Pennsylvania. The package was found to have external contamination levels above the regulatory limit. As described in the NRC inspection report which was sent to you on June 30, 1997, four apparent violations of NRC requirements were identified during the inspection. On July 17, 1997, a Predecisional Enforcement Conference was conducted with you and members of your staff to discuss the violations, their causes, and your corrective actions. A copy of the enforcement conference report was sent to you by separate correspondence on August 6, 1997.
Based on the information developed during the inspection, and the information that you provided during the conference, the NRC has determined that three violations of NRC requirements occurred. These violations are cited in the enclosed Notice of Violation and Proposed Imposition of Civil Penalty (Notice) and the circumstances surrounding them are described in detail in the subject inspection report. These violations involve: (1) failure to ensure, by examination or special tests (surveys), that the external contamination levels of a Class 7 (radioactive) materials package (containing small quantities of technetium-99m from spent or unused doses) were within regulatory limits prior to shipment, and delivery to a carrier for shipment back to Syncor Corporation in Allentown, Pennsylvania, a Class 7 (radioactive) materials package with non-fixed (removable) contamination measuring as high as 6,000 dpm/cm 2 , which is approximately 273 times the regulatory limit; (2) failure to conduct daily radiation level surveys and weekly removable contamination level surveys of the Nuclear Medicine hot lab floor from where the package was apparently contaminated; and (3) failure of the Radiation Safety Officer (RSO) to ensure that radiation safety activities were being performed in accordance with approved procedures and regulatory requirements in the daily operation of the licensee's byproduct material program.
These violations are of very significant concern to the NRC because they resulted in the shipment of material in the public domain with contamination levels in excess of the regulatory limits. The lack of adequate oversight by the RSO appears to have been a significant contributor to these violations. During the inspection, the RSO was unable to clearly define his responsibilities with respect to program oversight, and during the enforcement conference, admitted that he did not routinely observe activities. The lack of adequate program oversight was evident by the inconsistent techniques exhibited by the nuclear medicine technologists (NMTs) in surveying and wiping package surfaces prior to shipment. During the inspection, the NRC also learned that: (1) the RSO was not observing the NMTs' techniques to minimize contamination; (2) the RSO was unaware of the discrepancies in technique among the NMTs in performing the required package surveys; and (3) the reporting between the NMTs and the RSO was inadequate. With respect to the latter issue, the RSO was not even aware that the contaminated package had been sent to Syncor until he was contacted by the NRC on June 4, 1997.
The failure of your staff to ensure that an adequate survey was performed prior to transporting the package to Syncor, as well as the failure of the RSO to adequately oversee the radiation safety program, represents a very significant regulatory concern because such failures have the potential to cause unnecessary exposure to members of your staff, the staff at the receiving facility, and members of the public while the package is in transport. Normally, given the regulatory significance of these violations and the fact that these violations involved surface contamination levels in excess of 50 times the NRC limit, these violations would be classified in the aggregate as a Severity Level I problem in accordance with Supplement V, "Transportation," of the "General Statement of Policy and Procedure for NRC Enforcement Actions" (Enforcement Policy), NUREG-1600. However, after considering the facts in this case and the actual safety consequences that resulted from these violations, the NRC has determined that these violations are best classified in the aggregate as a Severity Level II problem in accordance with Section IV, "Severity of Violations," of the Enforcement Policy.
In accordance with the Enforcement Policy, a base civil penalty in the amount of $4,400 is considered for a Severity Level II violation or problem. Consistent with the enforcement policy, the NRC considered whether credit was warranted for both Identification and Corrective Action . Credit for identification is not warranted since Syncor reported the contaminated package to the NRC after identifying that the package had external contamination in excess of the regulatory limit. The remaining violations were subsequently identified by the NRC. Credit for corrective action is warranted because your actions, at the time of the enforcement conference, were both prompt and comprehensive. These actions, which were noted in the inspection report and/or at the conference, included: (1) review, evaluation, and revision to procedures by the RSO and the Lead Nuclear Medicine Technologist; (2) retraining of all technologists; (3) commitment by management to assure increased RSO involvement in the Radiation Safety Program; (4) plans to perform surveys and wipe tests of all surfaces of the transport cases; (5) plans to utilize a package identification system to identify incoming and outgoing transport cases; and (6) plans to wipe test Hot Lab floors weekly, and survey them daily.
Therefore, to emphasize the importance of appropriate management and RSO oversight of the radiation safety program and the importance of ensuring that shipments containing radioactive material comply with regulatory requirements, I have been authorized, after consultation with the Director, Office of Enforcement, to issue the enclosed Notice in the base amount of $4,400. In addition, issuance of this Notice constitutes escalated enforcement action, that may subject you to increased inspection effort.
You are required to respond to this letter and should follow the instructions specified in the enclosed Notice when preparing your response. In your response, you should also confirm the commitments you made at the conference, and during the inspection. 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).
Sincerely, Hubert J. Miller Regional Administrator
Docket No. 030-12571
License No. 37-13187-02
Enclosure: Notice of Violation and Proposed Imposition of Civil Penalty
Commonwealth of Pennsylvania
PROPOSED IMPOSITION OF CIVIL PENALTY
Grand View Hospital Docket No. 030-12571 Sellersville, Pennsylvania License No. 37-13187-02 EA 97-309
During an NRC inspection conducted on June 4 - 5, and June 10, 1997, violations of NRC requirements were identified. In accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions," NUREG 1600, the NRC proposes to impose a civil penalty pursuant to Section 234 of the Atomic Energy Act of 1954, as amended (Act), 42 U.S.C. 2282, and 10 CFR 2.205. The particular violations and associated civil penalty are set forth below:
A. 10 CFR 71.5(a) requires that a licensee who transports licensed material outside of the site of usage, as specified in the NRC license, or where transport is on public highways, or who delivers licensed material to a carrier for transport, comply with the applicable requirements of the regulations appropriate to the mode of transport of the Department of Transportation (DOT) in 49 CFR Parts 170 through 189.
49 CFR 173.475 requires, in part, that before each shipment of any Class 7 (radioactive) materials package, the offeror must insure by examination or appropriate tests, that the external radiation and contamination levels are within the allowable limits in 49 CFR Parts 171-178. 49 CFR 173.443(a) requires, in part, with exceptions not applicable here, that for beta and gamma emitting contaminants, the level of non-fixed (removable) radioactive contaminants on the external surfaces of each package offered for transport, at the beginning of transport, not exceed 0.4 Becquerel per square centimeter (22 disintegrations per minute per square centimeter) on any single wiping material, determined by wiping an area 300 square centimeters of the surface concerned with an absorbent material, using moderate pressure, and averaging over the surfaced wiped. Sufficient measurements must be taken in the most appropriate location to yield a representative assessment of the non-fixed contamination levels.
Contrary to the above, on June 3, 1997, before shipment of a Class 7 (radioactive) materials package, the offeror (licensee) did not ensure by examination or appropriate tests, that the external contamination levels were within the allowable limits; and the licensee delivered to a carrier for transport a Class 7 (radioactive) materials package which was determined to have non-fixed contamination caused by technetium-99m, a beta/gamma emitting radionuclide, of up to approximately 6,000 disintegrations per minute per square centimeter over the surface wiped. (01012)
B. 10 CFR 35.70(a) and (e) requires, in part, that a licensee shall: (1) survey with a radiation detection survey instrument at the end of each day of use all areas where radiopharmaceuticals are routinely prepared for use, and (2) survey for removable contamination once each week all areas where radiopharmaceuticals are routinely prepared for use.
Contrary to the above, as of June 4, 1997, the licensee: (1) did not survey with a radiation detection survey instrument at the end of each day of use all areas where radiopharmaceuticals are routinely prepared for use, and (2) did not survey for removable contamination once each week all areas where radiopharmaceuticals are routinely prepared for use. Specifically: (01022)1. Since April, 1994, the licensee did not survey the Nuclear Medicine hot lab floor with a radiation detection survey instrument at the end of each day of use. The hot lab is an area where radiopharmaceuticals were routinely prepared for use; and
2. Since April, 1994, the licensee did not survey each week, the Nuclear Medicine hot lab floor for removable contamination. The hot lab is an area where radiopharmaceuticals were routinely prepared for use.
C. 10 CFR 35.21(a) requires, in part, that the licensee, through the Radiation Safety Officer, ensure that radiation safety activities are being performed in accordance with approved procedures and regulatory requirements in the daily operation of the licensee's byproduct material program.
Contrary to the above, since December 8, 1995, the licensee, through its Radiation Safety Officer, failed to ensure that radiation safety activities were being performed in accordance with approved procedures and regulatory requirements in the daily operation of the licensee's byproduct material program. Specifically, the Radiation Safety Officer was (1) not observing the technologists techniques to minimize contamination, (2) unaware of the discrepancies in technique among the technologists in performing the required package surveys (radiation level surveys and removable contamination level surveys), and (3) not aware of the failure to perform the required dose rate and removable contamination surveys. (01032)
These violations represent a Seventy Level II problem. (Supplement V).
Civil Penalty - $4,400.
Pursuant to the provisions of 10 CFR 2.201, Grand View Hospital (Licensee) is hereby required to submit a written statement or explanation to the Director, Office of Enforcement, U.S. Nuclear Regulatory Commission, within 30 days of the date of this Notice of Violation and Proposed Imposition of Civil Penalty (Notice). This reply should be clearly marked as a "Reply to a Notice of Violation" and should include for each alleged violation: (1) admission or denial of the alleged violation, (2) the reasons for the violation if admitted, and if denied, the reasons why, (3) the corrective steps that have been taken and the results achieved, (4) the corrective steps that will be taken to avoid further violations, and (5) the date when full compliance will be achieved. 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 why the license should not be modified, suspended, or revoked or why such other action as may be proper should not be taken. Consideration may be given to extending the response time for good cause shown. Under the authority of Section 182 of the Act, 42 U.S.C. 2232, this response shall be submitted under oath or affirmation.
Within the same time as provided for the response required above under 10 CFR 2.201, the Licensee may pay the civil penalty by letter addressed to the Director, Office of Enforcement, U.S. Nuclear Regulatory Commission, with a check, draft, money order, or electronic transfer payable to the Treasurer of the United States in the amount of the civil penalty proposed above, or the cumulative amount of the civil penalties if more than one civil penalty is proposed, or may protest imposition of the civil penalty in whole or in part, by a written answer addressed to the Director, Office of Enforcement, U.S. Nuclear Regulatory Commission. Should the Licensee fail to answer within the time specified, an order imposing the civil penalty will be issued. Should the Licensee elect to file an answer in accordance with 10 CFR 2.205 protesting the civil penalty, in whole or in part, such answer should be clearly marked as an "Answer to a Notice of Violation" and may: (1) deny the violations listed in this Notice, in whole or in part, (2) demonstrate extenuating circumstances, (3) show error in this Notice, or (4) show other reasons why the penalty should not be imposed. In addition to protesting the civil penalty in whole or in part, such answer may request remission or mitigation of the penalty.
In requesting mitigation of the proposed penalty, the factors addressed in Section VI.B.2 of the Enforcement Policy should be addressed. Any written answer in accordance with 10 CFR 2.205 should be set forth separately from the statement or explanation in reply pursuant to 10 CFR 2.201, but may incorporate parts of the 10 CFR 2.201 reply by specific reference (e.g., citing page and paragraph numbers) to avoid repetition. The attention of the Licensee is directed to the other provisions of 10 CFR 2.205, regarding the procedure for imposing a civil penalty.
Upon failure to pay any civil penalty due which subsequently has been determined in accordance with the applicable provisions of 10 CFR 2.205, this matter may be referred to the Attorney General, and the penalty, unless compromised, remitted, or mitigated, may be collected by civil action pursuant to Section 234c of the Act, 42 U.S.C. 2282c.
The response noted above (Reply to Notice of Violation, letter with payment of civil penalty, and Answer to a Notice of Violation) should be addressed to: James Lieberman, Director, Office of Enforcement, U.S. Nuclear Regulatory Commission, One White Flint North, 11555 Rockville Pike, Rockville, MD 20852-2738, with a copy to the Regional Administrator, U.S. Nuclear Regulatory Commission, Region I.
Because your response will be placed in the NRC Public Document Room (PDR), to the extent possible, it should not include any personal privacy, proprietary, or safeguards 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). If safeguards information is necessary to provide an acceptable response, please provide the level of protection described in 10 CFR 73.21.
Dated at King of Prussia, Pennsylvania
this 13th day of August 1997