EA-99-093 - Medi-Physics, Inc.

June 17, 1999

EA 99-093


John C. Carr, R.Ph.
Facility Manager
Medi-Physics, Inc.
d.b.a. Nycomed Amersham Imaging
One Naylon Place, Suite 3
Livingston, New Jersey 07039


SUBJECT:   NOTICE OF VIOLATION (NRC Inspection Report No. 030-31972/99-001)

Dear Mr. Carr:

This refers to the NRC inspection conducted on April 6, 8, and 22, 1999, at your facility in Livingston, New Jersey, to determine whether activities authorized by your license were conducted safely and in accordance with NRC requirements. The inspection was conducted after the NRC was notified by Brick Hospital, Brick, New Jersey, that it had received a package of radioactive material from your facility on April 5, 1999, with removable radioactive contamination on the outside of the package, dose rates as high as 960 millirem per hour on the surface of the package, and dose rates as high as approximately 19 millirem per hour at one meter from the surface. On May 14, 1999, the NRC sent you the inspection report which described four apparent violations. The letter transmitting that report also indicated that it may not be necessary to conduct a predecisional enforcement conference on this matter. In the alternative, you were provided an opportunity to provide a written response which you sent to us in a letter, dated June 4, 1999.

Based on the information developed during the inspection and the information provided in your letter, three violations of NRC requirements are being cited. The violations are described in the enclosed Notice of Violation (Notice) and the circumstances surrounding them are described in detail in the subject inspection report. The first violation involves your failure to ensure that the package offered for shipment to Brick Hospital was proper for the contents to be shipped. The package was not properly prepared in that a gasket and absorbent pad were missing in the primary shielding container. The individual responsible for preparing the package did not recognize that the gasket and pad were missing. As a result, when a vial (containing radioactive technetium-99m) cracked sometime after initial packaging and final survey, the contents leaked beyond the initial container. The other violations involve the failure to properly label the package, and the failure to ensure radiation and contamination levels at the package surface were within the regulatory limits.

Although subsequent follow-up indicates that there does not appear to have been any exposures to individuals as result of these violations, the violations are significant because the package, contained approximately one curie of technetium-99m in a vial and a syringe, as well as a vial of iodine-123 regulated by the State of New Jersey. The failure to properly package these radioactive materials created the potential for unnecessary exposure to any individual handling, or in close proximity to the package between the time it left your facility at 4:50 a.m. on April 5, 1999, and the time it arrived at Brick Hospital, approximately two hours later. Therefore, the violations collectively represent a Severity Level III problem in accordance with the "General Statement of Policy and Procedures 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 or problem. 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, which were described in your June 4, 1999, letter to the NRC, include, but are not limited to:  (1) use of additional packaging to minimize the potential for damage to glass containers during transport; (2) a full inspection of the existing inventory of all such glass containers, with plans to eventually discontinue use of such containers; (3) additional training of all pharmacy staff members responsible for transportation of radioactive material; and (4) a review of this event with all staff, as well as with management of all of your other facilities.

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.

The NRC has concluded that information regarding the reason for the violations, and the corrective actions taken and planned to correct the violations and prevent recurrence, is already adequately addressed on the docket in your June 4, 1999 letter. 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 and its enclosures, will be placed in the NRC Public Document Room (PDR).

		Sincerely,
		ORIGINAL SIGNED BY
		Hubert J. Miller Regional Administrator

Docket No. 030-31972
License No. 29-28341-02MD

Enclosure: Notice of Violation

cc w/encl:

State of Connecticut

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ENCLOSURE NOTICE OF VIOLATION
Medi-Physics, Inc., d.b.a.    Nycomed Amersham Imaging Livingston, New Jersey		Docket No. 030-31972 License No. 29-28341-02MD EA 99-093

During an NRC inspection conducted on April 6, 8, and 22, 1999, 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:

 

10 CFR 71.5 requires, in part, that each licensee who transports licensed material outside the site of usage, as specified in the NRC license, comply with the applicable requirements of the DOT regulations in 49 CFR Parts 170 through 189 appropriate to the mode of transport.
	A.	49 CFR 173.475(a) requires, in part, that before each shipment of any Class 7 (radioactive) materials package, the offerer must ensure the packaging is proper for the content to be shipped. 49 CFR 173.475(c) requires, in part, that before each shipment of any Class 7 (radioactive) materials package, the offerer must ensure that each closure device of the packaging, including any required gasket, is properly installed, secured, and free of defects. Contrary to the above, on April 5, 1999, the licensee shipped a Type A package to Brick Hospital, in Brick, New Jersey, and prior to the shipment, the licensee did not ensure the packaging was proper for the content to be shipped. Specifically, the package, which contained a glass vial holding in excess of one curie of technetium-99m in solution, included neither the required gasket nor the required absorbent pad. (01013)
	B.	49 CFR 172.403(a) states, in part, that each package of radioactive material must be labeled as provided in 49 CFR 172.403(c). 49 CFR 172.403(c) specifies radiation levels at any point on the surface of a Yellow II labeled package must be less than or equal to 50 mrem/hr. Contrary to the above, on April 5, 1999, the licensee did not label a package of radioactive material as provided in 49 CFR 172.403(c). Specifically, the package was labeled as Yellow II, and the radiation levels at the surface of the package were as high as 960 mrem/hr upon its arrival at Brick Hospital, in Brick, New Jersey. (01023)
	C.	49 CFR 173.443 (b) states, in part, that in case of packages transported as exclusive use shipments by public highway only, the removable (non-fixed) radioactive contamination on any package at any time during transport may not exceed ten times the levels prescribed in Table 11 of 49 CFR 173.443(a). Contrary to the above, on April 5, 1999, the licensee transported a package of radioactive material as an exclusive use shipment by public highway to Brick Hospital, Brick, New Jersey, and the removable (non-fixed) contamination on the package during the transport exceeded ten times the levels prescribed in Table 11 of 49 CFR 173.443(a). Specifically, the licensee transported a package containing the gamma emitter technetium-99m as an exclusive use shipment and the removable contamination on the external surface of the package was 269 dpm/cm2, which is in excess of 220 dpm/cm2 (ten times the level prescribed in Table 11). (01033)

These violations are categorized in the aggregate as a Severity Level III problem (Supplements IV and VI).

The NRC has concluded that information regarding the reason for the violations, and the corrective actions taken and planned to correct the violation and prevent recurrence is already adequately addressed on the docket in your letter, dated June 4, 1999. 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, 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).

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.

If you choose to respond, your response will be placed in the NRC Public Document Room (PDR). Therefore, to the extent possible, the response should not include any personal privacy or proprietary information so that it can be placed in the PDR without redaction.

Dated this 17^th day of June 1999