EA-01-283 - Central Pharmacy Services, Inc.

December 18, 2001

EA-01-283

Jeffery Dillon, R.Ph.
Pharmacy Manager/
Radiation Safety Officer
Central Pharmacy Services, Inc.
d/b/a Premier Pharmacy Services, P.C.
7026 Georgetown Road
Indianapolis, IN 46278

SUBJECT:

NOTICE OF VIOLATION (NRC INSPECTION REPORT NO. 03033503/2001-001(DNMS); NRC SPECIAL INSPECTION REPORT NO. 03033503/2001-002(DNMS); AND INVESTIGATION REPORT NO. 3-2001-018)

Dear Mr. Dillon:

This refers to the routine inspection conducted on April 30 and May 2, 2001, with continued review through June 5, 2001, at Central Pharmacy Services, Inc., Indianapolis, Indiana. The inspection included a review of two unresolved items involving a pharmacy technician who did not always use vial shields and wear a thermoluminescent (TLD) finger badge when preparing, assaying, or dispensing radioactive material. The inspection report was issued July 3, 2001. In addition, this refers to the special inspection conducted on September 6, 2001, with continued in-office review through September 7, 2001. This inspection included a review of your corrective actions for the two unresolved items, and the report was issued September 21, 2001. Finally, this refers to Office of Investigations (OI) Report 3-2001-018. The purpose of the investigation was to determine if the unresolved items involved deliberate actions by the pharmacy technician.

In a telephone conversation on November 15, 2001, Mr. Gary Shear of my staff informed you that the NRC was considering escalated enforcement action for apparent violations involving the deliberate failure of a pharmacy technician to always use vial shields and always wear a TLD finger badge when preparing, assaying, or dispensing radioactive material. Mr. Shear also informed you that we had sufficient information regarding the apparent violations and your corrective actions to make an enforcement decision without the need for a predecisional enforcement conference or a written response from you. On November 16, 2001, you indicated that Central Pharmacy Services, Inc., did not believe that a predecisional enforcement conference or written response was needed.

Based on the information developed during the inspections and investigation, the NRC has determined that deliberate violations of NRC requirements occurred. A summary of the OI report is enclosed. These violations are cited in the enclosed Notice of Violation (Notice) and the circumstances surrounding them are described in detail in Inspection Report No. 03033503/2001-001(DNMS). Between December 20, 1999, and March 15, 2000, a pharmacy technician, while preparing and dispensing radioactive material, deliberately removed multi-dose vials from their shields several times each day to view the technetium-99m remaining in the vial. This practice resulted in elevated exposure to the individual's extremities as documented by TLD finger badge results. The technician was counseled regarding the elevated exposure and the proper handling of syringes and vials containing radioactive materials. Because of the counseling, between March 15 and May 29, 2000, the technician deliberately failed to wear the TLD finger badge in an attempt to keep exposure results low.

The failures to always use vial shields and always wear a TLD finger badge when preparing or dispensing radioactive material would be categorized as Severity Level IV violations, since the technician's extremity exposure was below the regulatory limit of 50 rem per year to any extremity. However, the NRC is concerned that the pharmacy technician deliberately removed vials containing radioactive materials from their shields and deliberately failed to wear appropriate dosimetry when handling radioactive material. It is essential that the NRC be able to maintain the highest confidence that licensees and their employees will abide by regulatory requirements designed to protect employees from unnecessary exposure to radiation and radioactive materials. Therefore, based on deliberateness, the NRC has increased the severity level and has categorized the violations in accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions" (Enforcement Policy), NUREG-1600 as a Severity Level III problem.

In accordance with the Enforcement Policy, a base civil penalty in the amount of $3000 is considered for a Severity Level III problem. Because the violations are willful, the NRC considered whether credit was warranted for Identification and Corrective Action in accordance with the civil penalty assessment process in Section VI.C.2 of the Enforcement Policy. Credit is warranted for identification. The radiation safety officer (RSO) investigated the elevated exposure to the technician and identified the cause as the technician's practice of removing the vials from the vial shields. The RSO also investigated the low exposure results of the technician's dosimetry and identified that the individual was not always wearing the TLD ring badge when handling radioactive material. Credit for corrective action was warranted and included: (1) training the individual regarding efforts to reduce future extremity exposures; (2) observing the individual's dose drawing technique and use of vial and syringe shields; (3) counseling the individual about wearing dosimetry at all times during the work shift; and (4) informing the individual of employment termination if dosimetry was not worn as required.

Therefore, to encourage prompt identification and comprehensive correction of violations, 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 problem constitutes escalated enforcement action, that may subject you to increased inspection effort.

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 Inspection Report No. 03033503/20001-001(DNMS). 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 you choose to provide one, 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. 030-33503
License No. 13-26472-01

Enclosure: Notice of Violation

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NOTICE OF VIOLATION

Central Pharmacy, Inc. Indianapolis, Indiana

Docket No. 030-33503 License No. 13-26472-01 EA-01-283

During an NRC inspection conducted between April 30 and June 5, 2001, and investigation completed on October 15, 2001, violations of NRC requirements were identified. In accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions," NUREG-1600, the violations are listed below:

Condition 19.A of License No. 13-26472-01MD, requires, in part, that licensed material be possessed and used in accordance with statements, representations and procedures contained in an application dated January 24, 1993.

	A.	Item 11 of Appendix H to this application entitled "General Rules for Safe Use of Radioactive Material," requires, that individuals always wear TLD [thermoluminescent] finger badges when eluting the generator and preparing, assaying, or dispensing millicurie quantities of radioactive material. Contrary to the above between March 15, 2000, and May 29, 2000, an individual did not always wear a TLD finger badge when preparing, assaying, or dispensing millicurie quantities of radioactive material.
	B.	Item 4 of Appendix H to this application entitled "General Rules for Safe Use of Radioactive Material," requires that individuals always use syringe shields and vial shields for preparing and dispensing radiopharmaceuticals. Contrary to the above, between approximately December 20, 1999, and March 15, 2000, an individual did not always use vial shields for preparing and dispensing radiopharmaceuticals. Specifically, the individual removed multi-dose vials from the vial shield several times per day to view the technetium-99m remaining in the vials while preparing and dispensing radiopharmaceuticals.

This is a Severity Level III problem (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 was achieved, is already adequately addressed on the docket in Inspection Report No. 03033503/2001-001(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 20555-0001 with a copy to the Regional Administrator, Region III, 801 Warrenville Road, Lisle, Illinois 60532-4351 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 18^th day of December 2001.