EA-97-427 - York Hospital

March 4, 1998

EA 97-427

Mr. Bruce M. Bartels, President
York Hospital
1001 South George Street
York, Pennsylvania 17405-7198

SUBJECT:

NOTICE OF VIOLATION (NRC Inspection Report No. 030-03085/97-001; NRC Office of Investigation Report Synopsis No. 1-97-003)

Dear Mr. Bartels:

This letter refers to the NRC inspection conducted on January 14, 15, and 22, 1997, at your facility in York, Pennsylvania, to determine whether activities authorized by the license were conducted safely and in accordance with NRC requirements. This also refers to the subsequent investigation conducted by the NRC Office of Investigation to determine whether a former Chief Nuclear Medicine Technologist (CNMT) at the facility, deliberately disregarded regulations concerning the transportation of radioactive material between the hospital and the Apple Hill Medical Center in York, Pennsylvania; directed personnel to transport the material without following certain regulations; and provided an NRC inspector with false information. Based on its investigation, OI concluded that the former CNMT deliberately disregarded regulations regarding the transportation of material (technetium-99m) between the facilities; directed personnel to transport the material in violation of regulations; and purposely tried to mislead the inspector by providing false information when he told the inspector that transportation of material between the facilities occurred only once.

During the investigation and inspection, four apparent violations of NRC requirements were identified, as described in the inspection report and OI synopsis forwarded to you with the NRC letter dated January 6, 1998. In that letter, the NRC provided you an opportunity to either respond in writing to the apparent violations addressed in the inspection report and OI synopsis, or request a predecisional enforcement conference. You responded to the apparent violations in a February 4, 1998 letter to the NRC and admitted the apparent violations and provided corrective action.

Based on the information developed during the inspection and investigation, and the information you provided in your February 4, 1998 letter, the NRC has determined that four violations of NRC requirements occurred. The violations are cited in the enclosed Notice of Violation (Notice) and the circumstances surrounding them are described in detail in the subject inspection report. The first three violations, set forth in Section I of the enclosed Notice, involve the transport of radioactive material (technetium-99m) between your facility and the Apple Hill Medical Center on numerous occasions between 1988 and 1995 without shipping papers accompanying the shipment; without examination or testing of the shipment to ensure radiation and contamination levels were within limits; and without properly securing the material to prevent shifting during transport. The fourth violation, which is set forth in Section II of the enclosed Notice, involves your former CNMT providing inaccurate information to an NRC inspector during the inspection.

The NRC is corresponding separately with the CNMT regarding these issues. You will receive a copy of this correspondence under separate cover.

The three violations in Section I of the Notice are of significant concern because the failure to adhere to transportation requirements could result in material being inadequately controlled while in transit in the public domain. This, in turn, could result in the potential for members of the public to be exposed to radioactive material. Further, the three violations take on additional significance in this case because the violations were based on the deliberate actions of the CNMT. The NRC recognizes that these three violations were identified by your Radiation Safety Officer prior to the inspection, and you took aggressive corrective actions at that time to preclude recurrence.

With respect to the violation in Section II of the Notice, the former CNMT, in response to the inspector's questions regarding the transportation of NRC licensed radioactive materials, told the inspector during the inspection that there was one only instance of radioactive material being transported between the facility and the Apple Hill Medical Center, and that it was done properly. This statement was inaccurate in that the radioactive material was transported between the two facilities on a monthly to quarterly basis, and was done so without following NRC/DOT regulations. This violation is also of significant regulatory concern since it was deliberate, i.e., the individual knew the information was inaccurate at the time he provided it to the inspector.

Given the deliberate nature of these violations, the violations in Section I are classified 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. Similarly, the violation in Section II is also classified at Severity Level III.

In accordance with the Enforcement Policy, a base civil penalty in the amount of $2,500 is considered for a Severity Level III violation or problem. Since the violations were willful, 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. With respect to the violations in Section I, credit for identification is warranted in each case because your RSO did identify the violations prior to the inspection. Credit for corrective actions is also warranted since the actions were considered prompt and comprehensive. These actions, which were described during the inspection and in your February 4, 1998 response, included, but were not limited to (1) discontinuance, in November 1995, of transport of material between the two facilities until such time as personnel were trained; (2) development, in November 1995, of a procedure for transfers of the material between the two facilities; and (3) discussion of this finding at a subsequent Radiation Safety Committee meeting.

Therefore, to emphasize the importance of prompt identification and correction of problems at the facility, I have been authorized, after consultation with the Director, Office of Enforcement, not to propose a civil penalty for the violations in Section I.

With respect to the violation in Section II, credit for identification is not warranted since the violation was identified by the NRC. Credit for corrective action is warranted based on the following: (1) after the CNMT provided the inaccurate information on January 15,1997, your radiation safety officer informed the NRC in writing on February 3, 1997, that her investigation indicated recurrent occasions on which licensed material had been transported in violation of NRC requirements, thus correcting the CNMT's inaccurate statement; (2) your Senior Vice President, Operations, also corresponded with the NRC on February 20, 1997, concerning the CNMT's failure to forthrightly disclose the transportation issues; and (3) you issued a written counseling memorandum to the CNMT, who is no longer employed in licensed activities. Considering both the identification and corrective action adjustment factors, a civil penalty in the amount of $2,500 normally would be proposed to emphasize the importance of assuring that all employees involved in licensed activities act in a forthright manner and provide accurate information to the NRC. However, in light of the seriousness with which you viewed the inaccurate information; your aggressive investigation of the underlying transportation violations, including documenting them in the records of the Radiation Safety Committee which are available for NRC inspection; and your frank and open communication with the NRC throughout, the NRC has decided, after consultation with the Director, Office of Enforcement, to exercise discretion, pursuant to Section VII.B.6 of the enforcement policy, and not propose a civil penalty in this case. Any similar violations in the future could result in more significant enforcement action.

The NRC has concluded that information regarding the reason for the violations, the corrective actions taken and planned to correct the violations and prevent recurrence, is already adequately addressed on the docket in your February 4, 1998 letter to the NRC. Therefore, you are not required to respond to this letter unless the description therein 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.

In accordance with 10 CFR 2.790 of the NRC's "Rules of Practice," a copy of this letter, its enclosure, and any response will be placed in the NRC Public Document Room (PDR).

Sincerely, ORIGINAL SIGNED BY WILLIAM L. AXELSON FOR Hubert J. Miller Regional Administrator

Docket No. 030-03085
License No. 37-07161-01

Enclosure: Notice of Violation

cc w/encl:
Commonwealth of Pennsylvania

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NOTICE OF VIOLATION

York Hospital York, PA

Docket No. 030-03085 License No. 37-07161-01 EA 96-455

During an NRC inspection conducted on January 14 and 15 and 22, 1997, as well as a subsequent investigation by the NRC Office of Investigation, 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 particular violations are set forth below:

I. VIOLATIONS OF TRANSPORTATION REQUIREMENTS

10 CFR 71.5(a) requires that a licensee who transports licensed material outside of the confines of its plant or other place of use, 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.

1. 49 CFR 172.200(a) requires, with exceptions not applicable here, that each person who offers a hazardous material for transportation describe the hazardous material on the shipping paper in the manner required by subpart C of 49 CFR Part 172.

Pursuant to 49 CFR 172.101, radioactive material is classified as hazardous material.

Contrary to the above, on and before November 7, 1995, the licensee offered radioactive material (technetium-99m) for transport (from its facility to the Apple Hill Medical Center, York, Pennsylvania), and did not include with the shipment a shipping paper describing the material. (01013)

2. 49 CFR 173.475 requires, in part, that before each shipment of any radioactive materials package, the shipper ensure by examination or appropriate test that the external radiation and contamination levels are within the allowable limits specified in 49 CFR Parts 171-177.

Contrary to the above, on and before November 7, 1995, the licensee transported outside the confines of its plant (from its facility to the Apple Hill Medical Center, York, Pennsylvania), packages of radioactive materials without ensuring by examination or appropriate test that either external radiation or removable surface contamination levels were within allowable limits. (01023)

3. 49 CFR 173.448(a) requires that each shipment of radioactive materials be secured in order to prevent shifting during normal transportation conditions.

Contrary to the above, on and before November 7, 1995, the licensee transported outside the confines of its plant (from its facility to the Apple Hill Medical Center, York, Pennsylvania), a package containing radioactive material (technetium-99m) which was not properly secured to prevent shifting during transport. Specifically, the licensee stated that they placed the licensed material inside a syringe shield on the seat of the vehicle next to the driver and did not in any way secure the material from shifting during normal transportation conditions. (01033)

These violations are classified in the aggregate at Severity Level III (Supplement VII).

II. VIOLATION INVOLVING INACCURATE INFORMATION

10 CFR 30.9(a) requires, in part, that information provided to the Commission by a licensee, or 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, on January 15, 1997, information provided by the licensee's former Chief Nuclear Medicine Technologist (CNMT) to an NRC inspector was inaccurate. Specifically, the former CNMT, in response to the inspector's questions regarding the transportation of NRC licensed radioactive materials, told the inspector that there was one instance of radioactive material being transported between the facility and the Apple Hill Medical Center, and that it was done properly. This statement was inaccurate in that the radioactive material was transported between the two facilities on a monthly to quarterly basis, and was done so without following NRC/DOT regulations. This statement was material because it could have influenced the NRC as to the whether a violation existed at the facility, and if so, the scope of that violation. (02013)

This is a Severity Level III violation (Supplement VII).

The NRC has concluded that information regarding the reason for the violations, the corrective actions taken and planned to correct the violations and prevent recurrence, and the date when full compliance was achieved is already adequately addressed on the docket in the licensee's letter, dated February 4, 1998, to the NRC. 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. 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, 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).

Dated at King of Prussia, Pennsylvania
this 4th day of March 1998