EA-96-189 - Geisinger Medical Center

July 3, 1996

EA 96-189

Mr. Tim Nebel
Senior Vice President, Operations
Geisinger Medical Center
100 North Academy Avenue
Danville, Pennsylvania 17822-2408

SUBJECT:

NOTICE OF VIOLATION (NRC INSPECTION REPORT NO. 030-02984/96-001)

Dear Mr. Nebel:

This letter refers to the NRC inspection conducted April 17 - May 22, 1996, at your facilities in Danville, Pennsylvania, of activities authorized by NRC License No. 37-01421-01. During the inspection, apparent violations of NRC requirements were identified. A copy of the NRC inspection report was sent to you on June 17, 1996. On June 26, 1996, a transcribed predecisional enforcement conference was conducted with you and other members of your staff to discuss the apparent violations, their causes, and your corrective actions. A copy of the Enforcement Conference Report is enclosed.

Based on the information developed during the inspection, information provided in a facsimile, dated May 3, 1996, from your Radiation Safety Officer, and information provided during the conference, three violations of NRC requirements are being cited, as described in the enclosed Notice of Violation. The violations involve: (1) two examples of failure to maintain complete and accurate information concerning the amount of radioactive material in a particular container, as well as whether a survey had been done prior to disposal of certain waste; (2) two examples of failure to perform required radiological surveys at the facility; and (3) failure to follow required procedures for ordering iodine-131 (I-131). The fourth apparent violation described in the inspection report is being withdrawn for the reasons described in the enforcement conference report.

The NRC recognizes that all of the violations were identified by your staff, and were documented at your facility. The NRC also recognizes that appropriate disciplinary action was taken. Nonetheless, the NRC is particularly concerned with the failure to maintain accurate records of certain activities at the facility, since the NRC must be able to rely on its licensees and their employees to maintain records that are complete and accurate in all material respects. The NRC also is concerned that conditions existed that warranted the performance of radiological surveys, yet the responsible nuclear medicine technologists did not perform the required surveys.

Your facility was issued a $1,250 civil penalty on June 20, 1994 for other violations of NRC requirements. Given that past history, as well as the significance of maintaining records that were inaccurate, and not performing required surveys, these two recent violations demonstrate a breakdown in the control of licensed activities at your facility which collectively represent a potentially significant lack of attention or carelessness toward licensed responsibilities. Therefore, the two violations have been categorized in the aggregate at Severity Level III in accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions" (Enforcement Policy), NUREG-1600. The two violations are described in Section I of the enclosed Notice. The third violation being cited is classified at Severity Level IV and is described in Section II of the enclosed Notice.

In accordance with the Enforcement Policy, a base civil penalty in the amount of $2,500 is considered for the Severity Level III violation. Because your facility has been the subject of escalated enforcement in the past two inspections, the NRC considered whether credit was warranted for identification and corrective action in accordance with the civil penalty assessment process in Section VI.B.2 of the Enforcement Policy. Credit was warranted for identification because you identified the violations. Credit also is warranted for corrective action because your actions were both prompt and comprehensive. Your corrective actions, which were described in your presentation during the conference, included, but were not limited to: (1) immediate removal from the nuclear medicine department of those individuals responsible for the inaccurate records, once the inaccuracies were identified; (2) establishment of a new disciplinary program which includes investigation of incidents to determine culpability of the individual(s) involved, referral to the Employee Assistance Program of any individual found culpable, and certain actions for negligence and failure to follow procedures, including suspension and/or termination; (3) revision of the decay-in-storage form to minimize chances of misreviewing data; (4) retention of a new Chairman of Radiology; and (5) establishment of a multi-disciplinary investigation team to review incidents at the facility.

Therefore, to encourage continued identification and prompt and comprehensive correction of violations, I have been authorized not to propose a civil penalty in this case. However, any similar violations in the future could result in more significant escalated enforcement action, including issuance of a civil penalty.

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 document the specific actions taken and any additional actions you plan to prevent recurrence. In addition, you should further emphasize to your staff the importance of ensuring that all records of activities at your facilities are complete and accurate in all material respects. After reviewing your response to this Notice, including your proposed corrective actions and the results of future inspections, the NRC will determine whether further NRC enforcement action is necessary to ensure compliance with NRC regulatory requirements.

In accordance with 10 CFR 2.790 of the NRC's "Rules of Practice," a copy of this letter, its enclosures, and your response will be placed in the NRC Public Document Room (PDR). To the extent possible, your response should not include any personal privacy, proprietary, or safeguards information, so that it can be placed in the PDR without redaction.

The responses directed by this letter and the enclosed Notice are not subject to the clearance procedures of the Office of Management and Budget as required by the Paperwork Reduction Act of 1980, Pub. L. No. 96-511.

Sincerely,

ORIGINAL SIGNED BY WILLIAM F. KANE FOR Thomas T. Martin Regional Administrator

Docket No. 030-02984
License No. 37-01421-01

Enclosures:
Notice of Violation
Enforcement Conference Report

cc w/encls:
Ms. C. Anderko, Radiation Protection Officer
Commonwealth of Pennsylvania

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NOTICE OF VIOLATION

Geisinger Medical Center Danville, Pennsylvania

Docket No. 030-02984 License No. 37-01421-01 EA 96-189

During an NRC inspection conducted April 17 - May 22, 1996, violations of NRC requirements were identified. In accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions," NUREG-1600, the violations are listed below:

I. VIOLATIONS FOR INACCURATE RECORDS AND LACK OF ADEQUATE SURVEYS

A. 10 CFR 30.9(a) requires, in part, that information required by the Commission's regulations to be maintained by the licensee shall be complete and accurate in all material respects.

Contrary to the above, certain information required by the Commission's regulations to be maintained by the licensee was not complete and accurate in all material respects. Specifically,

1. On January 28, 1993, a container label required to be maintained in accordance with 10 CFR 20.1904 was not accurate in that the label, which was completed by a nuclear medicine technologist, indicated that the container held 350 millicuries (mCi) of technetium-99m (Tc-99m) when, in fact, the container actually held less than 50 mCi of Tc-99m. This was material because it was required to be maintained.
2. On January 18, 1996, a waste disposal log required to be maintained in accordance with 10 CFR 35.92(b) [as a record of a disposal made pursuant to 10 CFR 30.92(a)] was not accurate in that the log indicated that a radiation survey of iodine-131 (I-131) and Tc-99m waste had been performed prior to disposal, and radiation measurements were recorded at background; however, the licensee concluded that this survey was never performed because the waste contained millicurie quantities of I-131 and Tc-99m, including a straw used in the administration of an I-131 therapy dose, and it was not possible for radiation levels of this waste to be at background. This was material because it was required to be maintained. (01013)

B. 10 CFR 20.1501 requires that each licensee make or cause to be made surveys that may be necessary for the licensee to comply with the regulations in Part 20 and that are reasonable under the circumstances to evaluate the extent of radiation levels, concentrations or quantities of radioactive materials, and the potential radiological hazards that could be present.

Pursuant to 10 CFR 20.1003, survey means an evaluation of the radiological conditions and potential hazards incident to the production, use, transfer, release, disposal, or presence of radioactive material or other sources of radiation.

Contrary to the above, the licensee did not make surveys to assure compliance with 10 CFR 20.1201, which limits radiation exposure to occupational workers. Specifically:

1. On January 28, 1993, although a nuclear medicine technologist observed that a vial (known to contain 350 mCi of Tc-99m) that had been placed in a water bath was found in a dry pot on direct heat, a survey was not conducted to determine whether the integrity of the vial had been compromised and radioactive material released.
2. On March 8, 1996, although a nuclear medicine technologist suspected that a spill of radioactive material had occurred in the Cardiac Stress Laboratory, a survey was not conducted by the technologist before leaving the work area to verify his suspicion that a spill of greater than 20 microcuries had occurred and that the licensee's emergency procedures needed to be implemented. (01023)

These violations represent a Severity Level III problem (Supplement IV and VII).

II. OTHER VIOLATION OF NRC REQUIREMENTS

Condition 28 of License No. 37-01421-01 requires, in part, that the licensee conduct its program in accordance with statements, representations, and procedures contained in a letter, including enclosures, dated September 10, 1993.

Item No. 1 of Attachment No. 5 of the September 10, 1993 letter, Control of Procurement and Use, requires that for medical use, only authorized personnel listed on the NRC License, or authorized persons working under the direct supervision of an authorized user listed on the license, may prescribe and have radioisotopes ordered for diagnosis and therapy.

Contrary to the above, on September 28, 1995, 7 millicuries of I-131 was ordered for therapy by an individual who was neither an authorized user listed on the NRC license, nor an authorized person working under the direct supervision of an authorized user listed on the license. (02014)

This is a Severity Level IV violation (Supplement VI).

Pursuant to the provisions of 10 CFR 2.201, Geisinger Medical Center is hereby required to submit a written statement or explanation to the U.S. Nuclear Regulatory Commission, ATTN: Document Control Desk, Washington, D.C. 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 each violation: (1) the reason for the violation, or, if contested, the basis for disputing the violation, (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.

Under the authority of Section 182 of the Act, 42 U.S.C. 2232, this response shall be submitted under oath or affirmation.

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. However, if you find it necessary to include such information, you should clearly indicate the specific information that you desire not to be placed in the PDR, and provide the legal basis to support your request for withholding the information from the public.

Dated at King of Prussia, Pennsylvania
this 3rd day of July 1996