EA-99-211 - Howard University

September 17, 1999

EA 99-211

Celia J. Maxwell, M.D.
Assistant Vice President for Health Affairs
Howard University
2041 Georgia Avenue, NW
Washington, DC 20060

SUBJECT:  NOTICE OF VIOLATION   (NRC Inspection Report Nos. 030-11063/99-01 and 030-01321/99-01)

Dear Dr. Maxwell:

This refers to the NRC inspection conducted on July 27 and 28, 1999, at your facility in Washington, DC. The inspection was performed, in part, to review the circumstances associated with the loss of a package containing radioactive material (2.0 millicuries of iodine-125) that was reported to the NRC by your Radiation Safety Officer on July 13, 1999. The inspection also included a review of another incident involving the apparent loss of control of 1.3 millicuries of iodine-131 in August 1998.

In our letter to you, dated August 19, 1999, we informed you that three apparent violations associated with the loss of control of licensed material were being considered for escalated enforcement in accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions" (Enforcement Policy), NUREG-1600. The apparent violations related to the loss of radioactive material on two occasions, inadequate training of certain members of the shipping and receiving and mail room staff which may have contributed to one of the occurrences, and the failure to report one of the losses in a timely manner. In a letter dated September 10, 1999, Howard University Hospital provided its understanding of the facts, the corrective actions taken and planned, and your assessment of the safety significance of the issues. In addition, a predecisional enforcement conference was held in our Region I office in King of Prussia, Pennsylvania, on September 13, 1999, with you and other members of your staff to discuss the apparent root cause(s) and corrective actions implemented by your staff. A copy of the predecisional enforcement conference summary report is enclosed.

Based on the information developed during the inspection and the information that you provided during the conference and in your September 10, 1999 letter, the NRC has determined that three violations of NRC requirements occurred. These violations are cited and described in the enclosed Notice of Violation (Notice). The violations involve: (1) failure to control and maintain constant surveillance of licensed radioactive material on two occasions; (2) failure to provide required radiological safety training to certain members of your shipping and receiving and mail room staff; and (3) failure to make immediate notifications to the NRC once the material was determined to be lost on one of the occasions.

In the first instance, a package containing radioactive material (1.3 millicuries of iodine-131) was delivered to the wrong place in your hospital on August 25, 1998, and was inadvertently discarded in the regular hospital waste. Although the radiation detector in the hospital's shipping and receiving area alarmed, an employee thought it was a false alarm and sent the waste to a waste hauling facility. The package was retrieved from the commercial waste hauler (about 24 hours later) after the radiation detectors alarmed at the waste hauling facility. In the second instance, a package of radioactive material (2.0 millicuries of iodine-125) was received in your shipping and receiving area on June 7, 1999, and was signed for by one of your employees. However, after receipt, the package was not appropriately controlled. Further, the employee who received the package did not follow your procedures for receipt of radioactive materials in that no inventory entry was made in the logbooks. Although your staff searched for the package, the material has not been found.

The loss of the radioactive material on these occasions is significant because the iodine was in liquid form which could readily be absorbed through the skin during inadvertent leakage or inappropriate handling of the package, causing unnecessary radiation exposure. The violation is of additional concern because the corrective actions for the first occurrence of the lost material in August 1998 did not preclude the subsequent occurrence in June 1999. Therefore, the three violations described in the attached Notice represent a Severity Level III problem 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 or problem. Because your facility has not been the subject of an escalated enforcement action within the last two years or two inspections, 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, as described in your letter and at the conference, were considered prompt and comprehensive. These actions include, but are not limited to, (1) instruction of personnel in the shipping/receiving area and the mail room, (2) posting of instructional signs, (3) implementing uniform delivery procedures for all radioactive materials, (4) implementing a policy that requires all radioactive material deliveries to be recorded in a logbook, (5) installing a video camera and recorder on the radioactive material receiving vault, and (6) installing additional alarming radiation monitoring equipment.

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 Notice constitutes escalated enforcement action that may increase the NRC inspection effort at your facility.

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, were already described adequately during the inspection, in your September 10, 1999 letter, and in the predecisional enforcement conference. 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 enclosure, and your response (if any) will be placed in the NRC Public Document Room (PDR).

		Sincerely,
		ORIGINAL SIGNED BY: JAMES T. WIGGINS
		Hubert J. Miller Regional Administrator

Docket Nos. 030-11063, 030-01321
License Nos. 08-00386-19, 08-03075-07

Enclosure: Notice of Violation

cc w/encl:
Gregory Talley, Radiation Safety Officer
District of Columbia

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ENCLOSURE

NOTICE OF VIOLATION

Howard University/ Howard University Hospital Washington, DC

Docket Nos 030-11063, 030-01321 License Nos. 08-00386-19, 08-03075-07 EA 99-211

During an NRC inspection conducted on July 27-28, 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:

A.	10 CFR 20.1802 requires the licensee to control and maintain constant surveillance of licensed material that is in a controlled or unrestricted area and that is not in storage. As defined in 10 CFR 20.1003, controlled area means an area, outside of a restricted area but inside the site boundary, access to which can be limited by the licensee for any reason; and unrestricted area means an area, access to which is neither limited nor controlled by the licensee. Contrary to the above, the licensee did not maintain constant surveillance of licensed material that was in a controlled or unrestricted area and that was not in storage on two occasions. Specifically,
	1.	On June 7, 1999, the licensee received a package of licensed material (containing 2.0 millicuries of iodine-125) and the licensee did not control and maintain constant surveillance of the package and the material was lost; and
	2.	On August 25, 1998, the licensee did not maintain constant surveillance and lost control of a package of licensed material (containing 1.3 millicuries of iodine-131) and the package was inadvertently discarded in the trash. The material was later discovered and retrieved from a commercial waste hauling facility on August 26, 1998. (01013)
B.	10 CFR 19.12 requires, in part, that all individuals who in the course of employment are likely to receive in a year an occupational dose in excess of 100 mrem (1 mSv) shall be instructed in the health protection problems associated with exposure to radiation and/or radioactive material, in precautions or procedures to minimize exposure, and in the purposes and functions of protective devices employed. Contrary to the above, prior to July 1999, the licensee did not provide instruction to the shipping and receiving and mail room personnel who in the course of their employment duties are likely to receive in a year an occupational dose in excess of 100 mrem. Specifically, the shipping and receiving and mail room personnel routinely handled packages containing radioactive material and are likely to be exposed to an occupational dose of radiation in excess of 100 mrem through contaminated or damaged packages or improper handling of the packages. (01023)
C.	10 CFR 20.2201(a)(1) requires, in part, that each licensee shall report to the NRC by telephone immediately after its occurrence becomes known to the licensee, any lost, stolen, or missing licensed material in an aggregate quantity equal to or greater than 1,000 times the quantity specified in Appendix C to Part 20 under such circumstances that it appears to the licensee that an exposure could result to persons in unrestricted areas. Contrary to the above, on June 7, 1999, the licensee did not immediately report to the NRC after it became aware of the loss of two millicuries of iodine-125 which is an amount greater than 1,000 times the quantity in Appendix C to Part 20 (which amounts to one microcurie). (01033)

These violations are categorized as a Severity Level III problem (Supplement 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 were adequately described during inspection, and are already adequately addressed on the docket in the NRC inspection report and in previous correspondence. 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 17th day of September 1999