EA-02-160 - Bristol-Myers Squibb Radiopharmaceuticals, Inc.
August 22, 2002
NMED Item No. 020379
Bristol-Myers Squibb Radiopharmaceuticals, Inc.
ATTN: Joel Cordero, R.Ph.
Radiation Safety Officer
State Route #1, Marginal Bori 1500
Río Piedras, Puerto Rico 00926
|SUBJECT:||NOTICE OF VIOLATION (NRC SPECIAL INSPECTION REPORT NO. 52-25361-01MD/02-01)|
Dear Mr. Cordero:
This refers to the inspection conducted on April 22-23, 2002, at your Río Piedras, Puerto Rico facility, and our subsequent records reviews and telephone conversations with you through July 9, 2002. The purpose of the inspection was to follow up on the reported extremity overexposures at your facility during calendar year 2001. A preliminary exit briefing was held with you at the completion of the inspection. A final, telephonic exit briefing was held with Mr. Dennis Dumas, Director of Safety and Environmental Engineering, Bristol-Myers Squibb Medical Imaging, Inc. (BMS), on August 15, 2002. During the telephonic exit briefing, BMS was informed that the NRC was considering escalated enforcement action for an apparent violation involving extremity exposures to two operators during 2001, which were in excess of NRC limits. A second apparent violation associated with the extremity exposures involving the failure to perform adequate surveys was also discussed. During the exit of August 15, 2002, BMS was informed that the NRC believed it 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. BMS indicated during the telephonic exit that BMS did not believe that a predecisional enforcement conference or written response was necessary prior to taking enforcement action.
Therefore, based on the information developed during the inspection, the NRC has determined that violations of NRC requirements occurred. The violations are cited in the enclosed Notice of Violation (Notice), and the circumstances surrounding them are described in detail in the subject inspection report. Violation (A) involved extremity exposures during 2001 to two BMS operators of 129 rems and 151 rems, which exceeded the NRC's regulatory dose limit of 50 rems as specified by 10 CFR 20.1201(a)(2)(ii). Violation (B) involved BMS's failure to perform adequate surveys to evaluate the exposures to the fingertips of the two operators as required by 10 CFR 20.1501. Because the exposures were greater than two times the regulatory limit and because of the interrelationship of the violations, these two violations have been categorized collectively as a Severity Level II problem, in accordance with the "General Statement of Policy and Procedures for NRC Enforcement Actions", NUREG-1600.
BMS attributed the root cause of the exposures to the handling technique used by BMS operators during the preparation of unit dosages of Technetium-99m (Tc-99m) radiopharmaceuticals. In addition, based on the actual dose received, the NRC concluded that it is unlikely that the radiation dose received by the operators resulted in any significant health effects.
In accordance with the Enforcement Policy, a base civil penalty in the amount of $4,800 is considered for a Severity Level II violation. The NRC considered whether credit was warranted for the factors of Identification and Corrective Action in accordance with the civil penalty assessment process described in Section VI.C.2 of the Enforcement Policy.
Regarding the factor of identification, the NRC concluded that BMS identified this issue through substantial efforts to determine the cause of elevated extremity dosimetry reports, and in response to NRC Information Notice 2000-10, "Recent Events Resulting in Extremity Exposures Exceeding Regulatory Limits." Promptly after the purchase of two radiopharmacies in Puerto Rico in late 2001, BMS corporate management began reviewing operations in detail as a result of year-end dosimetry reports, which revealed recorded extremity exposures in excess of licensee administrative limits. During an initial two-day audit, BMS noted that the operators' routine recapping of syringes after preparation of Tc-99m unit dosages caused their finger tips to be in close proximity to the beam emitted from the base of the needles. BMS also noted that due to the location of the extremity dosimeters (ring badges) relative to an operator's finger tips, the dosimeters might not be recording the actual doses to the finger tips because the dosimeters were away from the beam. BMS corporate management subsequently conducted a four-day study using fingertip and ring dosimetry to determine the ratio between doses recorded at the fingertip versus doses recorded by the ring badge at the base of the finger. BMS determined that the exposure to the fingertips could be a factor of three to seven times greater than the recorded exposure on the ring badges. Based on the results of the study, BMS determined that the annual NRC radiation dose limit for two operators had been exceeded. The NRC concluded that on the basis of these efforts, credit was warranted for the factor of Identification.
Your corrective actions included the conduct of additional audits of the program, and comprehensive improvements in the handling techniques used by BMS operators. Some of these improved techniques included the practice of recapping syringes with pliers to avoid contact with the cap, remotely recapping syringes using a shield to hold the cap, thereby shielding the fingers from the direct path of the radiation coming from the syringe, modifications to the physical configuration of hardware to allow the use of longer tongs when handling vials containing radioactive material, changes in dose drawing techniques for the assay kits so that the top of the vial is better shielded and the hand is out of the direct path of the radiation beam, and changes in the syringe size when preparing the radioactive material kits so that the radioactive material is further away from the hand. Operators have also been placed on a weekly dosimeter readout frequency to better track dose control success and provide an earlier warning of problems. BMS will implement a program of monthly investigational levels as part of a formal ALARA program, with the establishment of a monthly dose extremity action level. In addition, based upon our review of your extremity dosimeter results for February 10 through April 9, 2002, these corrective actions resulted in a significant decrease in the extremity doses received by your staff. Based on the above, the NRC concluded that credit was warranted for the factor of Corrective Action.
As discussed in Section VII.A.1 of the Enforcement Policy, the NRC normally considers the exercise of discretion to propose a civil penalty for violations resulting in overexposures. After consultation with the Director, Office of Enforcement, and the Deputy Executive Director for Materials, Research, and State Programs, I have been authorized to propose that no civil penalty be assessed in this case. In reaching this determination, the NRC considered the proactive and aggressive efforts taken that led to the identification of the overexposures, BMS's determination of the root cause as discussed above, the fact that the root cause of the overexposures could not be attributed to handling techniques that were inconsistent with industry practices, and the prompt and comprehensive corrective actions taken by BMS. In addition, the NRC acknowledges that the root cause of the exposures likely would not have been identified through routine licensee efforts, is generic in nature, and could serve to alert other licensees of the necessity of reviewing handling techniques to reduce radiation exposures.
Please be advised that you are on notice that significant violations in the future could result in a civil penalty. In addition, issuance of this Severity Level II problem 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 adequately addressed on the docket in this letter, NRC Inspection Report No. 52-25361-01MD/02-01, and your correspondence dated April 16 and June 5, 2002. Therefore, you are not required to respond to this violation unless the description herein 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 (should 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 http://www.nrc.gov/reading-rm/adams.html (the Public NRC Library).
If you have any questions regarding this matter, please contact Douglas M. Collins, Director, Division of Nuclear Materials Safety, at 404-562-4700.
Docket No. 030-34187
License No. 52-25361-01MD
Enclosure: Notice of Violation
Commonwealth of Puerto Rico
Bristol-Myers Squibb Medical Imaging, Inc.
ATTN: Mr. Dennis Dumas, Director
Safety & Environmental Engineering
331 Treble Cove Road
North Billerica, MA 01862
NOTICE OF VIOLATION
|Bristol-Myers Squibb Radiopharmaceuticals,
Río Piedras, Puerto Rico
|Docket No. 030-34187
License No. 52-25361-01MD
NMED Item No. 020379
During an NRC inspection conducted on April 22-23, 2002, and subsequent records reviews and telephone conversations through July 9, 2002, violations of NRC requirements were identified. In accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions," NUREG-1600 (Enforcement Policy), the violations are listed below:
|A.||10 CFR 20.1201(a)(2)(ii)
requires, with exceptions not applicable here, that the licensee control
the occupational dose to individual adults to an annual limit of 50
rems shallow-dose equivalent to the skin or to any extremity.
Contrary to the above, during the calendar year 2001, the licensee did not limit the annual dose to the extremities of two adult operators to 50 rems shallow-dose equivalent. Specifically, one operator received 129 rems and another operator received 151 rems shallow-dose equivalent to the fingertips.
|B.||10 CFR 20.1501 requires that each licensee
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
radiological 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 material or other sources of
Contrary to the above, during the calendar year 2001, the licensee did not make surveys adequate to assure compliance with 10 CFR 20.1201(a)(2)(ii), which limits radiation exposure to the extremities. Specifically, the licensee did not adequately evaluate radiation levels at the fingers, which were extremity areas, of two individuals. The licensee relied on ring badges at the base of the fingers to monitor extremity exposures for the individuals. However, the highest radiation levels were at the fingertips, which received exposures in excess of the limits in 10 CFR 20.1201(a)(2)(ii).
This is a Severity Level II problem (Supplement IV).
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 the letter transmitting this Notice of Violation (Notice), and in NRC Inspection Report No. 52-25361-01MD/02-01, and your correspondence dated April 16 and June 5, 2002. 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 II within 30 days of the date of the letter transmitting this 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 http://www.nrc.gov/reading-rm/adams.html (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 22nd day of August 2002