EA-97-518 - Baxter Healthcare Corporation

May 14, 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:

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

Dear Mr. Betancourt:

This refers to the Nuclear Regulatory Commission (NRC) inspections conducted on October 29, 1996, and April 2, 1997, at your facility in Aibonito, Puerto Rico, and an NRC Office of Investigations (OI) investigation completed on November 19, 1997. The reports documenting the inspections were issued on November 27, 1996, and June 3, 1997, respectively. As a result of the initial inspection findings, the NRC issued a Confirmatory Action Letter (CAL) on October 31, 1996. Summaries of the apparent violations identified and the OI findings were formally transmitted to you by letter dated December 30, 1997, which also confirmed arrangements for a predecisional enforcement conference. A closed, transcribed, predecisional enforcement conference was conducted at your offices in Aibonito, Puerto Rico, on January 12, 1998, to discuss the apparent violations, the root causes, and your corrective actions to preclude recurrence. A summary of the conference was transmitted to you by letter dated January 27, 1998. After the conference, Baxter Healthcare Corporation of Puerto Rico (Baxter) requested that NRC also consider the results of an investigation of the event by its corporate office. By letter dated March 5, 1998, Mr. Raymond T. Murphy of Ross & Hardies, attorney for the Baxter corporate office, submitted the results of the corporate investigation to the NRC. A supplemental response to the March 5, 1998 letter was submitted to the NRC by Mr. Murphy on March 17, 1998. On May 11, 1998, Mr. Murphy informed the NRC that the Radiation Safety Officer (RSO) involved in this event had voluntarily resigned.

Based on the information developed during the inspections and the OI investigation, and the information you provided during the conference and by letters dated March 5 and March 17, 1998, the NRC has determined that violations of NRC requirements occurred. The violations are cited in the enclosed Notice of Violation and Proposed Imposition of Civil Penalties (Notice), and the circumstances surrounding them are described in detail in the subject inspection reports and our letter dated December 30, 1997.

Violation I.A involves willful actions, approximately in June 1996, that caused Baxter to be in violation of NRC requirements. Specifically, the roof plug interlock switch, a safety system which affected the irradiator "on/off" mechanism, was altered (i.e., bypassed) in violation of License Condition 14 and the RSO was aware that the switch had been altered, but authorized restart of the irradiator knowing that the switch was in an altered condition. Notwithstanding your view to the contrary in your March 5, 1998 response, the NRC concludes that the RSO's authorization to keep the roof interlock switch in an altered condition (after trouble-shooting of the system had been completed) was made with careless disregard. The conclusion is based on transcribed statements made by Baxter employees to an investigator from the NRC's Office of Investigations, which indicates that the RSO was initially aware of the bypassed switch and was reminded by the senior electrician of the inoperative switch one to two weeks later.

The NRC normally would issue a Severity Level IV violation for Violation I.A, because the actual and potential safety consequences of bypassing the roof plug interlock were low given the existence of a second interlock. However, the primary regulatory issue is the willful unauthorized alteration of a safety system. This issue is further exacerbated by the duration of the bypassed condition (i.e., the condition was not corrected until it was identified by the NRC on October 29, 1996), and the fact that the RSO was reminded of the inoperable inside roof plug interlock switch and failed to take action to correct the altered safety system. As noted in Section IV.C of the "General Statement of Policy and Procedures for NRC Enforcement Actions" (Enforcement Policy), NUREG-1600, the NRC attaches high regulatory significance to willful violations because the NRC must be able to rely on the integrity of licensee employees to implement and follow regulatory requirements. The willful, unauthorized bypassing of any safety system interlock is unacceptable and is of significant regulatory concern. Therefore, in accordance with the Enforcement Policy, the severity level of Violation I.A has been increased to Severity Level III.

Violation I.B involves three additional examples of a violation of License Condition 14 whereby Baxter conducted subsequent, unauthorized repairs to equipment affecting the irradiator control console's "on-off" mechanism. Notwithstanding your explanation in your March 5, 1998 letter that you believed your RSO and Assistant RSO were "specifically licensed" to perform these repairs, the NRC has concluded that Baxter should have known this was not the case, and that these examples constitute a willful violation of NRC requirements. This conclusion is based on Baxter's performance of these repairs after being advised by NRC inspectors, during the October 29, 1996 inspection, in a CAL dated October 31, 1996, in NRC Inspection Report No. 52-21175-01/96-02 dated November 27, 1996, and in the NRC's December 4, 1996 acknowledgment of your response to the CAL that repairs could only be conducted by the irradiator manufacturer or other persons specifically licensed by the Commission or an Agreement State to perform these services unless otherwise specified in writing by the Commission. Further, in a February 17, 1997 investigation memorandum to the operations manager, your facility's superintendent stated: "Until we have the approved License Amendment we will consult with MDS Nordion for any repair to the irradiator and request written authorization and instructions. We will also inform the NRC of these repairs and the instructions provided by MDS Nordion." Notwithstanding the above, you performed repairs to the irradiator on March 10 and 14, 1997, without obtaining NRC authorization. Consequently, Violation I.B is also of significant regulatory concern due to its willful nature and, thus, has been categorized, in accordance with the Enforcement Policy, at Severity Level III.

In accordance with the Enforcement Policy, for a Severity Level III violation occurring before November 12, 1996, a base civil penalty of $2,500 is considered. For a Severity Level III violation occurring after November 12, 1996, a base civil penalty in the amount of $2,750 is considered. Because the violations described in the enclosed Notice are willful violations of NRC requirements, the NRC considered whether credit was warranted for Identification and Corrective Action in accordance with the civil penalty assessment process in Section VI.B.2 of the Enforcement Policy.

The NRC identified Violation I.A, thus, credit for the factor of Identification was not warranted. Your corrective actions for Violation I.A included repair of the roof plug interlock, a performance check on irradiator safety systems, a review by a representative of the irradiator's manufacturer of the actual as-built configuration of the irradiator safety systems and functional inspections of safety system response, and re-training of irradiator operators and support personnel including training on specific License limitations on repairs and alterations and additional controls on maintenance of safety systems. However, Baxter's corrective action was not comprehensive in that it did not preclude recurrence of the violation, as evidenced by the subsequent unauthorized repairs described in Violation I.B. As a result, the NRC determined that credit was not warranted for the factor of Corrective Action and, therefore, twice the base civil penalty is proposed for Violation I.A ($5,000).

With regard to Violation I.B, credit for the Identification factor is not warranted because the NRC identified the violation. Your corrective actions included obtaining written approval of all repairs from the irradiator manufacturer and the NRC, and submission of a license amendment to clarify the requirements of License Condition 14. Based on these facts and in light of the training you have provided on specific license limitations on repairs and alterations, the NRC determined that credit was warranted for the factor of Corrective Action. Therefore, a base civil penalty would normally be proposed. However, in this case, additional violations similar to Violation I.A occurred between October 29, 1996 and April 2, 1997, due to Baxter's failure to comply with License Condition 14. In addition, the NRC considers Violation I.B to be particularly egregious due to the verbal and written notice of the requirements of License Condition 14 that were given to Baxter by the NRC. Therefore, the NRC is exercising discretion in accordance with Section VII.A.1 of the Enforcement Policy and proposing a civil penalty at twice the base amount ($5,500).

Therefore, to emphasize the seriousness of willful violations and the need for prompt identification and comprehensive correction of violations, I have been authorized, after consultation with the Director, Office of Enforcement, and the Deputy Executive Director for Regulatory Effectiveness to issue the enclosed Notice in the total amount of $10,500 for the two Severity Level III violations. In addition, issuance of this Notice constitutes escalated enforcement action that may subject you to increased inspection effort.

The other apparent violations described in the NRC's letter of December 30, 1997, with regard to inadequate radiation safety training and electrical interlock of the source hoist mechanism (identified as issue numbers 4 and 5 in your March 5, 1998 letter), are being withdrawn, based on review of Baxter's corporate office response dated March 5, 1998. However, the four remaining violations, which are described in Part II of the Notice and have each been categorized at Severity Level IV based on their low safety significance, are being cited for the following reasons:

• Violation II.A: In the March 5, 1998 letter, Baxter disagreed with this violation stating that all operators are and have been given an annual written examination covering irradiator operations, safety, and emergency procedures as required by 10 CFR 36.51(e). A copy of the exam was provided as an attachment to the March 5, 1998 letter.

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. The purpose of this requirement is to ensure that the operator's performance is observed while the operator is operating the irradiator to determine if the operator complies with the regulations, license conditions, and operating and emergency procedures when he actually performs his job. The regulations distinguish between the safety review described in 10 CFR 36.51(d), which includes a written test, and the evaluation of safety performance required by 10 CFR 36.51(e). 10 CFR 36.51(d) contains requirements to ensure that, on an annual basis, the operator is knowledgeable of changes affecting the operation of the irradiator, recent events, and results of the performance review required in 10 CFR 36.51(e). During the April 2, 1997 inspection, the inspectors asked the RSO if the licensee conducted performance evaluations of each irradiator operator at least annually and the RSO responded that the licensee did not do an annual performance evaluation of each irradiator operator.

• Violation II.B: In the March 5, 1998 letter, Baxter disagreed with this violation stating that the Nordion irradiator plans did not provide for removal of the conductivity meters and, thus, there was no way to calibrate them. Further, Baxter argued that grab samples were taken of the pool water using a bench model conductivity meter.

10 CFR 36.63(b) requires that the pool water conductivity be measured with a conductivity meter that has been calibrated annually. This measurement is required to be obtained weekly. During the April 2, 1997 inspection, the inspectors determined that the licensee monitored the pool water conductivity on a weekly basis with a conductivity meter system that was installed next to the water recirculation system and which had its detection probe mounted inside one of the recirculation system pipes. The inspectors asked the licensee if this meter was calibrated annually and the licensee responded that it was not. The inspector reviewed the records of these grab samples taken by the licensee and determined that these samples were obtained and monitored not weekly, but about once every two months.

• Violation II.C: In the March 5, 1998 letter, Baxter stated that they disagreed with the violation and maintained that the cited regulation did not require recording of all repairs and maintenance but rather only major malfunctions, significant defects, operating difficulties or irregularities and major operating problems.

An irradiator condition resulting from the malfunction of a safety system that causes the source rack to automatically return to the pool and/or prevent the continued operation of the irradiator is an operating difficulty or irregularity that is recordable pursuant to 10 CFR 36.81(j), and if not properly corrected, is a major operating problem. In this case, the licensee did not maintain a record of the operating difficulty associated with the malfunction of the inside roof plug interlock switch which apparently occurred on June 21, 1996, that, if not properly corrected, is clearly a major operating problem. Had such a record been maintained, difficulties associated with determining the date the malfunction occurred would have been avoided, and a record may have served as a reminder to the licensee's staff that the switch had not been replaced.

• Violation II.D: In the March 5, 1998 letter, Baxter disagreed with this violation stating that neither License Condition 17 nor Baxter's letter of September 12, 1994 require wiring inspections every six months.

In a response dated April 12, 1994, to a previously cited violation in Inspection Report No. 52-21175-01/94-01, dated March 15, 1994, Baxter stated in Item F that procedures were in place for electrical wiring inspection for radiation damage. The electrical wiring inspection procedure, submitted to the NRC in a separate April 12, 1994 letter, states that this inspection will be performed by an authorized irradiator operator every six months and requires that the irradiator operator perform specific activities and inspect specific elements of the irradiator wiring system. As documented in NRC Inspection Report No. 52-21175-01/96-02, this specific procedure was shown to the RSO and the alternate RSO who is also the Maintenance Engineer during the October 29, 1996, inspection. The RSO and the alternate RSO (ARSO) both responded that they were not familiar with this procedure and that the activities required by the procedure had not been performed. At no time during the inspection, subsequent to the inspection, or in the March 5 or March 17, 1998 letters, has the licensee provided any evidence that this procedure was implemented as described in its March 17, 1998 letter. In evaluating Baxter's response to the enclosed Notice, the NRC will consider an affirmative evidence such as affidavits from the individuals that you believe implemented the procedure. In any such response, please describe why the RSO and ARSO were not familiar with this procedure.

Our letter dated December 30, 1997, also identified an apparent violation for providing inaccurate information to the NRC. After review of the available information, the NRC has decided not to take enforcement action for this matter. However, we remain concerned that information provided to the NRC at the time of the inspections, during interviews with OI, during the predecisional enforcement conference, and in letters dated March 5 and March 17, 1998, contained inconsistencies which raise questions with regard to the quality of the information provided by Baxter to the NRC and Baxter's overall ability to ensure that information provided to the NRC is complete and accurate. Notwithstanding our decision, you should note that licensees are required to ensure that such information provided to the NRC is in accordance with 10 CFR 30.9. The NRC must be able to rely on complete and accurate information, both written and verbal, to ensure that regulatory requirements are met. Failure to provide complete and accurate information in the future may result in escalated enforcement action.

You are required to respond to this letter and should follow the instructions specified in the enclosed Notice and described above when preparing your response. In your response, you should document the specific actions taken and any additional actions you plan to prevent recurrence. After reviewing your response to this Notice, including your proposed corrective actions and the results of future inspections, the NRC will determine whether further NRC enforcement action is necessary to ensure compliance with NRC regulatory requirements.

In accordance with 10 CFR 2.790 of the NRC's "Rules of Practice," a copy of this letter, its enclosure, and any response will be placed in the 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 L.A. Reyes L.A. Reyes Regional Administrator

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

Enclosure: Notice of Violation and Proposed Imposition of Civil Penalties

cc w/encl:

Commonwealth of Puerto Rico

Mr. Raymond T. Murphy
Ross & Hardies
150 North Michigan Avenue
Chicago, Illinois 60601-7567

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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 and April 2, 1997, 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.	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)
	This is a Severity Level III violation (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.
		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 Notice of Violation and Proposed Imposition of Civil Penalties (Notice). This reply should be clearly marked as a "Reply to a Notice of Violation" and should include for each alleged violation: (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.

Within the same time as provided for the response required above under 10 CFR 2.201, the Licensee may pay the civil penalties 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 penalty proposed above, or the cumulative amount of the civil penalties if more than one civil penalty is proposed, or may protest 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, an order imposing the civil penalties will be issued. 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 response 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 14th day of May 1998