EA-00-071 - Spectrum Pharmacy, Inc.

September 21, 2000

EA-00-071

Gregory Hiatt
Radiation Safety Officer
Spectrum Pharmacy, Inc.
1301 Milburn Boulevard
Mishawaka, IN 46544

SUBJECT:

NOTICE OF VIOLATION AND PROPOSED IMPOSITION OF CIVIL PENALTY -$2750 (NRC INSPECTION REPORT NOS. 030-32564/99002(DNMS) AND 030-32564/2000-002(DNMS), AND INVESTIGATION REPORT NO. 3-1999-035)

Dear Mr. Hiatt:

This refers to the inspections conducted August 31 to November 19, 1999, and on March 1, 2000, at Spectrum Pharmacy, Inc., Mishawaka, Indiana, to the Office of Investigations (OI) report number 3-1999-035, and a follow-up investigation. The inspections were performed to review the circumstances surrounding an August 31, 1999, contamination event and your corrective actions. The event was reported to the NRC by telephone on August 31, 1999, and the reports documenting these inspections were sent to you by letters dated November 26, 1999, and March 8, 2000. The OI investigation was performed to determine whether radioactive material packages were deliberately shipped with removable surface contamination in excess of limits specified in your license and NRC regulations; whether individuals deliberately failed to follow emergency procedures; and whether individuals made false statements to the NRC regarding internal action levels for removable surface contamination on shipping packages. A predecisional enforcement conference (PEC) was held at the NRC Region III office on May 18, 2000, with you and members of your staff to discuss the apparent violations, their significance, their root causes and your corrective actions.

On August 31, 1999, a vial containing 950 millicuries of technetium-99m ruptured, spreading contamination throughout the Mishawaka facility. Subsequent to the rupture, licensee personnel failed to follow emergency procedures when the area of the spill was not evacuated and the room was not locked to prevent access. In addition, the licensee staff used a contaminated multi-channel analyzer to analyze wipes that were used to determine the extent of personnel and facility contamination and to determine the removable surface contamination on packages being offered for transportation. As a result, a total of nineteen packages were shipped with removable contamination in excess of the limits committed to in Spectrum's license. Fourteen of these packages exceeded the U.S. Department of Transportation (DOT) requirements, with seven of the packages in excess of ten times the DOT limit.

Based on the information developed during the inspections and investigation, the information that you provided during the conference, the information provided in a letter dated May 23, 2000, from Spectrum Pharmacy, and additional OI interviews of several current and former Spectrum employees after the PEC, the NRC has determined that violations of NRC requirements occurred. However, the NRC has determined that the violations were not willful. 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 inspection report 030-32564/99002(DNMS). The violations in Section I of the Notice involved: (1) offering for transportation packages with removable surface contamination that exceeded the regulatory requirements; (2) failure to follow your emergency procedures; and (3) failure to perform surveys that may be necessary to ensure compliance with the requirements in 10 CFR Part 20.

In accordance with Supplement V to the "General Statement of Policy and Procedure for NRC Enforcement Actions - November 9, 1999," (Enforcement Policy), NUREG-1600, offering packages for shipment with removable surface contamination greater than 10 times the regulatory limit would normally result in a Severity Level II violation. However, based on the safety significance of the event, i.e., short half life and the low energy gamma radiation emitted by technetium-99m, these violations are categorized in the aggregate in accordance with the Enforcement Policy as a Severity Level III problem.

In accordance with the Enforcement Policy, a base civil penalty in the amount of $2750 is considered for a Severity Level III problem. Because your facility has not been the subject of escalated enforcement actions within last two inspections, the NRC considered whether credit was warranted for Corrective Action in accordance with the civil penalty assessment process in Section VI.C.2 of the Enforcement Policy. Your corrective actions, which were discussed during the conference and documented in Inspection Report 030-32564/2000-002(DNMS), included: (1) revising the emergency procedures to include procedures to be followed in the event of a ruptured vial; (2) amending the license to raise the internal threshold for removable surface contamination to the regulatory limit; (3) obtaining a single channel analyzer to be used as a backup to the multi-channel analyzer; (4) preparing radiopharmaceuticals that require heating in a fume hood; and (5) incorporating the revised emergency procedures into your routine training program. The NRC recognizes that credit is warranted for your corrective actions and that application of the civil penalty assessment process would not normally have resulted in a civil penalty. However, the NRC is exercising discretion in accordance with Section VII.A.1 of the Enforcement Policy, because of your particularly poor performance during the vial rupture and subsequent evaluation of facility, staff and package contamination. This resulted in widespread contamination of your facility and the shipment of packages with removable surface contamination in excess of regulatory limits. In particular, without NRC input during the event, the ventilation system would have remained operational, continuing to spread contamination throughout the facility.

Therefore, to emphasize the importance of prompt and thorough evaluation of incidents to ensure that the magnitude of the event is understood and appropriate immediate corrective actions are implemented, I have been authorized, after consultation with the Director, Office of Enforcement, to issue the enclosed Notice of Violation and Proposed Imposition of Civil Penalty (Notice) in the base amount of $2750 for the Severity Level III problem. In addition, issuance of this Notice constitutes escalated enforcement action, that may subject you to increased inspection effort.

The violation described in Section II of the Notice addressed shipping packages with removable surface contamination in excess of the limit specified in License Condition No. 28. This violation was categorized in accordance with the Enforcement Policy as a Severity Level IV violation.

The NRC has concluded that information regarding the reason for the violation, the corrective actions taken and planned to correct the violation and prevent recurrence is already adequately addressed on the docket in Inspection Report No. 030-32564/2000-002(DNMS). Therefore, you are not required to respond to the provisions of 10 CFR 2.201 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 your response, if any, will be available electronically for public inspection in the NRC Public Document Room or from the Publicly Available Records (PARS) component of NRC's document system (ADAMS). ADAMS is accessible from the NRC Web site at the Public NRC Library.

		Sincerely,
		/RA/
		J. E. Dyer Regional Administrator

Docket No. 030-32564
License No. 13-26367MD

Enclosure: Notice of Violation and Proposed Imposition of Civil Penalty

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NOTICE OF VIOLATION
AND
PROPOSED IMPOSITION OF CIVIL PENALTY

Spectrum Pharmacy, Inc. Mishawaka, Indiana		Docket No. 030-32564 License No. 13-26367-01MD EA-00-071

During an NRC inspection conducted between August 31 and November 19, 1999, violations of NRC requirements were identified. In accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions - November 9, 1999," 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:

I.	Violations Assessed a Civil Penalty
	A.	10 CFR 71.87(i) requires, in part, that the licensee shall determine that the level of non-fixed (removable) radioactive contamination on the external surfaces of each package offered for shipment is as low as reasonably achievable, and within the limits specified in DOT regulations in 49 CFR 173.443. 49 CFR 173.443(a)(1) requires, in part, with exceptions not applicable here, that for beta and gamma emitting contaminants, the level of non-fixed (removable) radioactive contamination on the external surfaces of each package offered for transport must not exceed 22 disintegrations per minute per square centimeter (dpm/cm2). Contrary to the above, on August 31, 1999, the licensee offered for transport packages with the level of non-fixed (removable) radioactive contamination on the external package surface in excess of 22 dpm/cm2. Specifically, the licensee shipped 14 packages containing radiopharmaceuticals with the external package surface removable contamination levels between 23 and 482 dpm/cm2. (01013)
	B.	License Condition No. 28 states, in part, that the licensee shall conduct its program in accordance with its application dated November 4, 1991. Item 4 of Appendix I of the November 4 application states, in part, that in the event of a major spill: the area will be cleared and all persons not involved in the spill will vacate the room; the room will be closed; and the room and doors locked to prevent entry. Contrary to the above, subsequent to a major spill that occurred on August 31, 1999, the licensee failed to vacate all persons not involved in the spill from the room, to close the room, and lock the doors to prevent entry. Specifically, persons not involved in the spill were not vacated from the room, and the room and doors were not locked to prevent entry because individuals were allowed access to the contaminated area. (01023)
	C.	10 CFR 20.1501(a)(2) requires, in part, that licensees 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 adiological 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 materials or other sources of radiation. Contrary to the above, on August 31, 1999, subsequent to a major spill, the licensee failed to make or cause to be made, reasonable surveys to evaluate the potential radiological hazards that could be present. Specifically, the licensee utilized a contaminated multi-channel analyzer to evaluate the presence and extent of personnel and facility contamination. (01033)
	This is a Severity Level III problem (Supplement VI). Civil Penalty - $2750.
II.	Violation Not Assessed a Civil Penalty
	A.	License Condition No. 28 requires, in part, that the licensee conduct its program in accordance with statements made in letter dated November 25, 1992. Item G. of the November 25, 1992, letter, states, in part, that packages containing radioactive material will not be dispensed from the pharmacy if removable contamination is greater than 220 dpm/100 cm2. Contrary to the above, on August 31, 1999, the licensee dispensed 19 packages from the pharmacy with removable contamination greater than 220 dpm/100 cm2. Specifically, 14 packages exceeded the DOT limit of 22 dpm/cm2 and are addressed in violation I.A. The remaining 5 packages exceeded the license condition limit of 220 dpm/100 cm2. (02014)
	This is a Severity Level IV violation (Supplement VI).

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 will be achieved is already adequately addressed on the docket in Inspection Report No. 030-32564/2000-002(DNMS). 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 III, within 30 days of the date of the letter transmitting this Notice of Violation (Notice).

The Licensee may pay the civil penalty proposed above in accordance with NUREG/BR-0254 and by submitting to the Director, Office of Enforcement, U.S. Nuclear Regulatory Commission, Washington, DC 20555, a statement indicating when and by what method payment was made, 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 violation(s) 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, you should address the factors in Section VII.A.1 of the Enforcement Policy and specifically address your performance in response to the event. 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 234(c) of the Act, 42 U.S.C. 2282c.

The response noted above (Reply to Notice of Violation, statement as to payment of civil penalty, and Answer to a Notice of Violation) should be addressed to: R. W. Borchardt, 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 III.

If you choose to respond, your response will be available electronically for public inspection in the NRC Public Document Room or from the Publicly Available Records (PARS) component of NRC's document system (ADAMS). ADAMS is accessible from the NRC Web site at the Public NRC Library. Therefore, to the extent possible, the response should not include any personal privacy, proprietary, or safeguards information so that it can be made available to the public without redaction.

In accordance with 10 CFR 19.11, you may be required to post this Notice within two working days.

Dated this 21^st day of September 2000.