EA-02-018 - Spectrum Pharmacy, Inc.

February 23, 2002

EA-02-018

Mr. Gregory Hiatt, R.Ph., Owner
Spectrum Pharmacy, Inc.
1301 Milburn Boulevard
Suite 100
Mishawaka, IN 46544

SUBJECT:

NOTICE OF VIOLATION NRC INSPECTION REPORT NO. 03032564/2002-001(DNMS)

Dear Mr. Hiatt:

This refers to the special inspection conducted on January 14 and 25, 2002, at Spectrum Pharmacy, Inc., Mishawaka, Indiana. This was a special inspection conducted to review the circumstances surrounding the reported misadministrations of samarium-153 that occurred at nine of your client hospitals during the period July 23, 1997, to December 12, 2001. On December 14, 2001, Mr. Scott Van Heesbeke, manager/radiation safety officer, notified the NRC of the possible misadministrations due to an error in the pharmacy's dose calibrator calibration for samarium-153. As a result of the inspection, one apparent violation of NRC requirements was identified. The apparent violation involved the failure to adequately measure the radioactivity of samarium-153 before commercial distribution. At the conclusion of the inspection, the findings were discussed with you and Mr. Van Heesbeke.

In a telephone conversation on February 7, 2002, Gary Shear of my staff informed you that the NRC was considering escalated enforcement for the apparent violation. Mr. Shear also informed you that we had sufficient information regarding the apparent violation and your corrective actions to make an enforcement decision without the need for a predecisional enforcement conference or a written response from you. You indicated that you did not believe that a predecisional enforcement conference or written response was needed.

Based on the information developed during the inspection, the NRC has determined that a violation of NRC requirements occurred involving the failure to adequately measure the radioactivity of samarium-153 before commercial distribution. The violation is cited in the enclosed Notice of Violation (Notice) and the circumstances surrounding it are described below and in detail in the enclosed inspection report. You began distribution of unit dosages of samarium-153 in plastic syringes in July 1997. Following the pharmaceutical manufacturer's recommended procedures, you determined that the dose calibrator calibration factor (potentiometer setting) for this radiopharmaceutical should be 170. However, you failed to realize that the calibration factor would only apply to this radiopharmaceutical if it were measured in a 10 cubic centimeter glass vial. As a result, on December 14, 2001, you determined that dosages previously distributed to your client hospitals contained an actual activity that was between 21 and 28 percent less than the activity listed on the labeling.

This violation is significant because your client hospitals are not required to measure the activity of each dosage of an alpha- or beta-emitting radiopharmaceutical when obtaining unit dosages from a licensed nuclear pharmacy and, therefore, they relied solely on you to provide dosages that were properly measured and labeled with the correct activity. In addition, the violation is significant due to its duration, and that the incorrect indication of the actual activity contained in the unit dosages resulted in 61 misadministrations. Therefore, this violation has been categorized in accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions" (Enforcement Policy), NUREG-1600 at Severity Level III.

In accordance with the Enforcement Policy, a base civil penalty in the amount of $3000 is considered for a Severity Level III violation. Because your facility has not been the subject of an escalated enforcement action within the 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. Credit for corrective action is warranted and included: (1) discussions with the manufacturer regarding this issue (attenuation of beta radiation in plastic and glass containers); (2) ordering a new NIST traceable standard and recalibrating the dose calibrator to account for attenuation and geometry characteristics of samarium-153 in plastic syringes; (3) implementing new procedures for determining the attenuation and geometry correction factor for plastic syringes; (4) requiring dual verification on all samarium-153 dosages before distribution; (5) notifying customers of the revised correction factor; and (6) requiring cross-training of all authorized nuclear pharmacists at both of the licensee's facilities (Fort Wayne and Mishawaka, Indiana).

Therefore, to encourage prompt and comprehensive correction of violations, and in recognition of the absence of recent escalated enforcement action, I have been authorized, after consultation with the Director, Office of Enforcement, not to propose a civil penalty in this case. However, significant violations in the future could result in a civil penalty. In addition, issuance of this Severity Level III violation constitutes escalated enforcement action that may subject you to increased inspection effort.

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 and the date when full compliance was achieved is already adequately addressed on the docket in the enclosed report. 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 enclosures, and your response, if any, will be made 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. 13-26367-01MD

Enclosure: Notice of Violation

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NOTICE OF VIOLATION

Spectrum Pharmacy, Inc. Mishawaka, Indiana

Docket No. 030-32564 License No. 13-26367-01MD EA-02-018

During an NRC inspection conducted on January 14 and 25, 2002, a violation of NRC requirements was identified. In accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions," NUREG-1600, the violation is listed below:

10 CFR 32.72(c) requires, in part, that the licensee possess and use instrumentation to measure the radioactivity of radioactive drugs. The licensee shall measure, by direct measurement or by combination of measurements and calculations, the amount of radioactivity in dosages of alpha-, beta-, or photon-emitting radioactive drugs prior to transfer for commercial distribution. In addition, the licensee shall perform tests before initial use, periodically, and following repair on each instrument for accuracy, linearity, and geometry dependence, as appropriate for the instrument, and make adjustments when necessary.

Contrary to the above, during the period July 23, 1997, to December 12, 2001, the licensee failed to measure correctly, by direct measurement or by combination of measurements and calculations, the radioactivity in beta-emitting radioactive drugs (samarium-153) prior to transfer for commercial distribution. Specifically, the licensee failed to use the appropriate correction factor (potentiometer setting), as determined by a geometry dependence test for the instrument used to measure the radioactivity of radioactive drugs, for determining the radioactivity of samarium-153 dosages in plastic syringes. The actual activity contained in the dosages was 21 to 28 percent less than the amount measured by the dose calibrator and listed on the label.

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

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, and the date when full compliance was achieved, is already adequately addressed on the docket in Inspection Report No. 03032564/2002-001(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, 801 Warrenville Road, Lisle, IL 60532, 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 made 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 23^rd day of February 2002.