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EA-97-518 - Baxter Healthcare Corporation

October 9, 1998

EA 97-518

Baxter Healthcare Corporation of Puerto Rico
ATTN: Mr. Edwin A. Betancourt
General Manager
P. O. Box 1389
Aibonito, Puerto Rico 00705

SUBJECT:

AMENDED NOTICE OF VIOLATION AND PROPOSED IMPOSITION OF CIVIL PENALTIES - $10,500, AND DEMAND FOR INFORMATION (NRC INSPECTION REPORT NOS. 52-21175-01/96-01, 52-21175-01/97-01, 52-21175-01/98-02, AND OFFICE OF INVESTIGATIONS REPORT NO. 2-96-040)

Dear Mr. Betancourt:

This refers to a Nuclear Regulatory Commission (NRC) inspection conducted on August 19, 1998, at your facility in Aibonito, Puerto Rico. The purposes of the inspection were to determine whether activities were conducted safely and in accordance with regulatory requirements and to followup on a July 31, 1998, operational event at the facility involving a fatality. The results of the inspection were discussed with you on September 16, 1998. The enclosed report presents the results of the inspection.

Based on the results of this inspection, the NRC identified that a violation of regulatory requirements occurred. The violation involved a failure to adhere to the requirements of 10 CFR 36.31(a), which requires that the lock for the source control of a panoramic irradiator be designed so that the key may not be removed if the sources are in an unshielded position. The NRC inspection identified that between November 19 and 25, 1996, Baxter operated the irradiator with a lock for the source control that allowed the key to be removed with the sources in an unshielded position.

The inspection revealed that individuals at Baxter were apparently aware that the design of the replacement source control switch permitted the key to be removed while the sources were in the unshielded position. In addition, based on discussions with the inspector, these same individuals knew, or should have known, that NRC regulations at 10 CFR 36.31 specifically prohibit this condition because the individuals contacted the irradiator manufacturer and took measures to compensate for the lack of a properly functioning switch. Notwithstanding this knowledge, these individuals allowed the irradiator to be operated in noncompliance with 10 CFR 36.31. During this time, Baxter did institute compensatory measures recommended by the irradiator manufacturer; however, those measures were not a substitute for compliance with NRC requirements.

The NRC is citing the above violation and amending and reissuing the Notice of Violation and Proposed Imposition of Civil Penalties (Notice) originally issued to Baxter on May 14, 1998. As discussed in the enclosed inspection report, this violation is directly related to Violation I.B. of the May 14, 1998 Notice, which was associated with the unauthorized replacement of the lock for the irradiator source control on November 19 and 25, 1996. At the time that the original Notice was issued, the NRC was unaware that the replacement lock was a different design, and that this design allowed the key to be removed with the sources in an unshielded position, resulting in a violation of 10 CFR 36.31(a). This new violation is included in Section I.B. of the amended Notice as Violation I.B.(2). The civil penalty assessed for the violations cited in Section I.B. of the amended Notice remains the same as in the original Notice, $5,500.

In its letters dated July 8 and 15, 1998, Baxter provided responses to the May 14, 1998 Notice. Baxter is hereby required to respond to Violation I.B.(2) of the enclosed amended Notice. You may also supplement or amend any portion of your previous responses in order to take into account this new violation, or for any other reason. You should follow the instructions specified in the enclosed amended Notice when preparing your response. In your response, you should document the specific actions taken and any additional actions you plan to prevent recurrence of Violation I.B.(2).

In addition to the enclosed amended Notice of Violation and Proposed Imposition of Civil Penalties, the NRC is issuing a Demand for Information (Demand) because, as discussed above, Baxter employees were apparently aware that the design of the replacement source control switch permitted the key to be removed while the sources were in the unshielded position; and they apparently also knew, or should have known, that 10 CFR 36.31 specifically prohibits this condition. Therefore, in addition to the response required above, further information is needed to determine whether the Commission can have reasonable assurance that Baxter will, in the future, conduct NRC- licensed activities in compliance with NRC requirements.

Accordingly, pursuant to sections 81, 161c, 161o, 182 and 186 of the Atomic Energy Act of 1954, as amended, and the Commission's regulations in 10 CFR 2.204 and 10 CFR 30.32(b), in order to determine whether your license should be modified, suspended or revoked, or other enforcement action taken to ensure compliance with NRC requirements, Baxter is hereby required to submit to the Director, Office of Enforcement, U.S. Nuclear Regulatory Commission, One White Flint North, 11555 Rockville Pike, Rockville, Maryland 20852-2738, within 30 days of the date of this Demand, with a copy to the Regional Administrator, U.S. Nuclear Regulatory Commission, Region II, the following information, in writing and under oath or affirmation:

An explanation as to why the NRC should not conclude that Violation I.B.(2) of the Amended Notice of Violation and Proposed Imposition of Civil Penalties is a willful violation as defined in Section IV.C of the NRC Enforcement Policy⁽¹⁾. If your employees were not aware of the relevant NRC requirements, you should address the reasons for the lack of awareness and why the Commission should have reasonable assurance that Baxter employees will, in the future, have sufficient knowledge and understanding of NRC requirements.

An explanation as to why the NRC should have confidence that, in the future, Baxter employees will conduct NRC-licensed activities in accordance with NRC requirements. In developing your response, you should address whether Baxter has considered acquiring the services of an outside contractor familiar with NRC regulatory requirements to serve as a consultant and to train and audit your staff to ensure that they understand and comply with NRC requirements.

You may provide any other information you deem appropriate, including an assessment of whether the facts related to this issue as documented in Inspection Report 52-21175-01/98-02 are correct.

The NRC's evaluation of your responses of July 8 and 15, 1998, is ongoing. After we review the responses required by the enclosed amended Notice and the Demand, the NRC will inform you of our decision as to whether additional Agency action will be taken with regard to these violations.

In accordance with 10 CFR 2.790 of the NRC's "Rules of Practice," a copy of this letter, its enclosures, and any response will be placed in the Public Document Room (PDR). To the extent possible, your response should not include any personal privacy, proprietary, or safeguards information so that it can be placed in the PDR without redaction.

If you have any questions regarding this letter, please contact Douglas M. Collins, Director, Division of Nuclear Materials Safety at (404) 562-4700.

		Sincerely,
		original signed by LAR
		Luis A. Reyes Regional Administrator

Docket Nos: 030-19882
License Nos: 52-21175-01

Enclosures: 1. Amended Notice of Violation and Proposed Imposition of Civil Penalties
2. Inspection Report 52-21175-01/98-02

cc w/ encls:
Commonwealth of Puerto Rico
Mr. Raymond T. Murphy
Ross & Hardies
150 North Michigan Avenue
Chicago, Illinois 60601-7567

AMENDED NOTICE OF VIOLATION
AND
PROPOSED IMPOSITION OF CIVIL PENALTIES


Baxter Healthcare Corporation of Puerto Rico Aibonito, Puerto Rico		Docket No.030-19882 License No.52-21175-01 EA 97-518

During NRC inspections conducted on October 29, 1996, April 2, 1997, and August 19, 1998, and an investigation completed on November 19, 1997, violations of NRC requirements were identified. In accordance with the "General Statement of Policy and Procedures for NRC Enforcement Actions," NUREG-1600, the NRC proposes to impose civil penalties 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 penalties are set forth below:

I.	Violations Assessed a Civil Penalty
	A.	Condition 14 to License No. 52-21175-01, Amendment No. 10, requires, in part, that the licensee not perform repairs and/or alterations on the irradiator, its control console and safety systems, its shielding or any other mechanism that might affect the irradiator "on-off" mechanism. Unless otherwise specified in writing by the Commission, these services shall be performed only by the irradiator manufacturer or other persons specifically licensed by the Commission to perform these services. Contrary to the above, in approximately June 1996, the licensee performed an unauthorized alteration to its irradiator consisting of disabling the lower roof plug safety interlock switch and bypassing its associated circuitry, which affected the irradiator "on-off" mechanism, and such alteration had been neither performed by persons specifically licensed by the Commission to perform these services nor otherwise specified in writing by the Commission. (01013)
	This is a Severity Level III violation (Supplement VI). Civil Penalty - $5,000
	B.	(1)	Condition 14 to License No. 52-21175-01, Amendment No. 10, requires, in part, that the licensee not perform repairs and/or alterations on the irradiator, its control console and safety systems, its shielding or any other mechanism that might affect the irradiator "on-off" mechanism. Unless otherwise specified in writing by the Commission, these services shall be performed only by the irradiator manufacturer or other persons specifically licensed by the Commission to perform these services. Contrary to the above, the licensee performed repairs and/or alterations on the irradiator, its control console and safety systems, which affected the irradiator "on-off" mechanism, and such alteration had been neither performed by persons specifically licensed by the Commission to perform these services nor otherwise specified in writing by the Commission. Specifically:
			1.	On November 19 and 25, 1996, the licensee replaced the control console start switch, which might have affected the "on-off" mechanism.
			2.	On March 10, 1997, the licensee replaced wiring from the DL-2 #5 radiation monitor, a safety system, to the control console, which operates the irradiator "on-off" mechanism.
			3.	On March 14, 1997, the licensee replaced a floor mat (safety system) located in the product entrance area, which operated the irradiator "on-off" mechanism. (02013)
	B.	(2)	10 CFR 36.31(a) requires that the lock for the source control of a panoramic irradiator be designed so that the key may not be removed if the sources are in an unshielded position. Contrary to the above, between November 19 and 25, 1996, the licensee operated the irradiator with a lock for the source control having a design that allowed the key to be removed with the sources in an unshielded position. (02023)
	These violations represent a Severity Level III problem (Supplement VI). Civil Penalty - $5,500
II.	Violations Not Assessed a Civil Penalty
	A.		10 CFR 36.51(e) requires, in part, that the licensee evaluate the safety performance of each irradiator operator at least annually to ensure that regulations, license conditions, and operating and emergency procedures are followed. Contrary to the above, during the year 1996, the licensee failed to evaluate the safety performance of any irradiator operator, to ensure that regulations, license conditions, and operating and emergency procedures were followed. (03014)
	This is a Severity Level IV violation (Supplement VI).
	B.		10 CFR 36.63(b) requires, in part, that conductivity meters (used to measure pool water conductivity) be calibrated at least annually. Contrary to the above, from July 1, 1993, until April 2, 1997, the licensee failed to calibrate the conductivity meter used to measure the pool water conductivity. (04014)
	This is a Severity Level IV violation (Supplement VI).
	C.		10 CFR 36.81(j) requires that the licensee maintain records of major malfunctions, significant defects, operating difficulties or irregularities, and major operating problems that involve required radiation safety equipment for three years after repairs are completed. Contrary to the above, as of October 29, 1996, the licensee failed to maintain records of major malfunctions, significant defects, operating difficulties or irregularities, and major operating problems that involve required radiation safety equipment for three years after repairs are completed. Specifically, the licensee failed to maintain records of a roof plug switch failure which occurred in approximately June 1996. (05014)
	This is a Severity Level IV violation (Supplement VI).
	D.		Condition 17 to License No. 52-21175-01, Amendment No. 10, requires, in part, that the licensee conduct its program in accordance with the statements, representations, and procedures contained in the license application dated July 22, 1993, and in letters dated September 12, 1994, and February 5, 1995. Item 4.7 in Addendum 7 to the letter dated September 12, 1994, describes the electrical wiring inspection procedure which will be performed by an authorized operator every six months. Contrary to the above, between February 23, 1995 and March 2, 1997, the licensee failed to perform the electrical wiring inspection procedure. (06014)
	This is a Severity Level IV violation (Supplement VI).

Pursuant to the provisions of 10 CFR 2.201, Baxter Healthcare Corporation of Puerto Rico (Licensee) is hereby required to submit a written statement or explanation to the Director, Office of Enforcement, U.S. Nuclear Regulatory Commission, within 30 days of the date of this Amended Notice of Violation and Proposed Imposition of Civil Penalties (Notice) for Violation I.B.(2) only. The Licensee has already responded to the remaining violations in its letters dated July 8 and 15, 1998. However, the Licensee may amend its responses or provide any additional information at this time, and may address the aggregation of Violations I.B.(1) and I.B.(2) if it chooses to do so. This reply should be clearly marked as a "Reply to a Notice of Violation" and should include, for Violation I.B.(2): (1) admission or denial of the alleged violation, (2) the reasons for the violation if admitted, and if denied, the reasons why, (3) the corrective steps that have been taken and the results achieved, (4) the corrective steps that will be taken to avoid further violations, and (5) the date when full compliance will be achieved. If an adequate reply is not received within the time specified in this Notice, an order or a Demand for Information may be issued as why the license should not be modified, suspended, or revoked or why such other action as may be proper should not be taken. Consideration may be given to extending the response time for good cause shown. Under the authority of Section 182 of the Act, 42 U.S.C. 2232, this response shall be submitted under oath or affirmation.

Although the licensee's responses of July 8 and 15, 1998, protested the civil penalties proposed in the NRC's May 14, 1998 Notice, the Licensee may pay the civil penalties at this time if it chooses to do so; or the Licensee may await NRC's determination concerning this matter, including the Licensee's response to Violation I.B.(2) and any other information that the Licensee chooses to submit. If the Licensee chooses to pay the civil penalties at this time, payment should be made within 30 days by letter addressed to the Director, Office of Enforcement, U.S. Nuclear Regulatory Commission, with a check, draft, money order, or electronic transfer payable to the Treasurer of the United States in the amount of the civil penalties proposed above. The Licensee may, if it chooses, submit a further response protesting the imposition of the civil penalties 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, the NRC will proceed with its review on the basis of the information available to date. Should the Licensee elect to file an answer in accordance with 10 CFR 2.205 protesting the civil penalties, 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 penalties should not be imposed. In addition to protesting the civil penalties in whole or in part, such answer may request remission or mitigation of the penalties.

In requesting mitigation of the proposed penalties, the factors addressed in Section VI.B.2 of the Enforcement Policy should be addressed. 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 penalties.

Upon failure to pay any civil penalties due which subsequently have been determined in accordance with the applicable provisions of 10 CFR 2.205, this matter may be referred to the Attorney General, and the penalties, unless compromised, remitted, or mitigated, may be collected by civil action pursuant to Section 234c of the Act, 42 U.S.C. 2282c.

The responses noted above (Reply to Notice of Violation, letter with payment of civil penalties, and Answer to a Notice of Violation) should be addressed to: Mr. James Lieberman, 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 II.

Because your response will be placed in the NRC Public Document Room (PDR), to the extent possible, it should not include any personal privacy, proprietary, or safeguards information so that it can be placed in the PDR without redaction. If personal privacy or proprietary information is necessary to provide an acceptable response, then please provide a bracketed copy of your response that identifies the information that should be protected and a redacted copy of your response that deletes such information. If you request withholding of such material, you must specifically identify the portions of your response that you seek to have withheld and provide in detail the bases for your claim of withholding (e.g., explain why the disclosure of information will create an unwarranted invasion of personal privacy or provide the information required by 10 CFR 2.790(b) to support a request for withholding confidential commercial or financial information). If safeguards information is necessary to provide an acceptable response, please provide the level of protection described in 10 CFR 73.21.

Dated at Atlanta, Georgia
this 9th day of October 1998

1. "General Statement of Policy and Procedures for NRC Enforcement Actions," NUREG-1600.