EA-03-134 - Caribe Medical Plaza

October 9, 2003

EA-03-134

Caribe Medical Plaza
Department of Oncology
ATTN: Jaime Cervera
Administrator
Carretera #2, Marginal Santa Rita #1
Vega Alta, Puerto Rico 00692

SUBJECT:

NOTICE OF VIOLATION (NRC INSPECTION REPORT NO. 52-25591-01/02-01 AND NRC OFFICE OF INVESTIGATIONS REPORT NO. 2-2002-036)

Dear Mr. Cervera:

This refers to the inspection conducted on October 22, 2002, at your Vega Alta, Puerto Rico facility and subsequent communications with your Radiation Safety Officer through November 14, 2002. The purpose of the inspection was to determine whether activities authorized by the license were conducted safely and in accordance with Nuclear Regulatory Commission (NRC) requirements. At the conclusion of the onsite inspection, the findings were discussed with Ms. Jacqueline Rosa, Acting Administrator, and the subject inspection report was forwarded to you by letter dated February 6, 2003. The NRC's Office of Investigations (OI) also conducted an investigation into matters related to the inspection findings. The results of the investigation and additional information regarding the identification of five apparent violations were forwarded to Caribe representatives by NRC letter dated July 18, 2003.

On September 4, 2003, a closed predecisional enforcement conference was conducted in Dorado, Puerto Rico, with you and members of your staff to discuss the apparent violations, their significance, root causes, and your corrective actions. A listing of conference attendees and the materials presented by the NRC at the conference are included as Enclosures 2 and 3, respectively. At the conference, you committed to providing supplemental information related to the apparent violations. This information was forwarded to the NRC on September 12, 2003, and is included as Enclosure 4.

Based on the information developed during the inspection and investigation, the information that you presented at the conference, and your supplemental information of September 12, 2003, the NRC has determined that four 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. The violations include: (A) the failure of Caribe, through its Radiation Safety Officer (RSO), to ensure that radiation safety activities were being performed in accordance with approved procedures and regulatory requirements in the daily implementation of the licensee's radiation safety program; (B) the failure to provide radiation safety training to Operating Room personnel and those individuals who worked with or were in the vicinity of radioactive materials; (C) the failure to issue film or TLD finger monitors to all individuals who handled radioactive material that emits ionizing photons on a regular basis, and (D) the failure of a Caribe representative to provide information to the Commission that was complete and accurate in all material respects. With respect to the apparent violation the NRC presented at the predecisional enforcement conference regarding the failure to control and maintain constant surveillance of licensed material (Apparent Violation #2), the NRC has concluded that this issue does not represent a violation of regulatory requirements. This conclusion was based on the additional information you provided at the conference regarding Caribe's control of licensed material. As you indicated at the conference, a root cause of the above violations was the lack of communication or miscommunication between the Caribe representatives responsible for the radiation safety program.

Although no actual safety consequences occurred as a result of the violations, the potential consequences are of concern to the NRC. In particular, Caribe used licensed material prior to a review by the RSO of its radiation safety activities. This review is an essential element in ensuring that activities will be conducted safely and in accordance with approved procedures and regulatory requirements. The NRC also concluded that Caribe representatives were aware, or should have been aware, that the RSO had not taken the necessary actions to ensure that radiation safety activities would be performed in accordance with approved procedures and regulatory requirements in the daily implementation of the radiation safety program. As such, the NRC concluded that this violation was willful. The NRC also concluded that Violations B and C were, at least in part, the result of the decision by Caribe representatives to commence licensed activities prior to the RSO's review of the radiation safety program. Furthermore, during the NRC's inspection and investigation into the facts of this matter, the Caribe RSO verbally provided contradictory information. Although the RSO later recognized during discussions with the NRC the contradictory nature of some of this information, the incomplete and inaccurate information affected the focus and scope of the NRC's review of the technical details of the non-compliances. Given their low safety significance, the violations would normally be characterized at Severity Level IV in accordance with the "General Statement of Policy and Procedures for NRC Enforcement Actions" (Enforcement Policy), NUREG-1600. However, the NRC concluded that the violations were due to the willful actions of the Caribe RSO and/or other Caribe personnel. The NRC's regulatory program is based on licensees and their employees acting with integrity and candor in adhering to regulatory requirements, and in taking the necessary steps to comply with these requirements. Based on this and in accordance with the Enforcement Policy, the NRC has concluded that these violations should be characterized at Severity Level III. Because of the interrelationship of the violations cited in the Notice, the NRC also has concluded that these violations should be cited as one Severity Level III problem.

In accordance with the Enforcement Policy, a base civil penalty in the amount of $3,000 is considered for a Severity Level III problem. Because the violations were willful, 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 Violations A, B, and C were identified by Caribe. Violation D was identified by the NRC during our subsequent review of the inspection and investigation results. However, our review of the RSO's statements indicate that the statements were due, at least in part, to carelessness and the impulsive nature of his responses to NRC inquiry. The RSO also recognized during the inspection and investigation process that certain information may have been incomplete or inaccurate, and in part, attempted to clarify the matter. Based on this, the NRC concluded that, on balance, credit was warranted for the factor of Identification for the Severity Level III problem. Regarding the factor of Corrective Action, your actions included improving communications between the RSO, the Caribe medical staff, and the Caribe Medical Plaza Administrator. In particular, as indicated in your supplemental response of September 12, 2003, communications regarding activities affecting the license, license amendments, and training, will involve the RSO, radio-oncologists, the Caribe medical staff, and the Caribe Medical Plaza Administrator. In addition, prior to the NRC's inspection of October 22, 2002, the RSO conducted a complete review of the radiation safety program and procedures, which resulted in correction of all violations prior to the inspection. Additional confirmation was provided at the conference and in your letter of September 12, 2003, regarding the training of individuals and issuance of film or TLD finger monitors to appropriate personnel. Based on this, the NRC concluded that credit was warranted for the factor of Corrective Action.

Therefore, to emphasize the importance of self-identification and correction of regulatory non-compliances, I have been authorized, after consultation with the Director, Office of Enforcement, to propose that a civil penalty not be assessed in this case. In addition, issuance of this Notice constitutes escalated enforcement action, that may subject you to increased inspection effort.

You are required to respond to this letter and should follow the instructions specified in the enclosed Notice when preparing your response. The NRC will use your response, in part, to determine whether further enforcement action is necessary to ensure compliance with regulatory requirements.

In accordance with 10 CFR 2.790 of the NRC's "Rules of Practice," a copy of this letter and its enclosures will be 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/ L. Plisco for
		Luis A. Reyes Regional Administrator

Docket No. 030-36003
License No. 52-25591-01

Enclosures:1. Notice of Violation
2. List of Attendees
3. Information Presented by NRC
4. Supplemental Information Presented by Caribe

cc:
Braquiterapia.com, Inc.
ATTN: Mr. Mariano De Socarraz
President
7171 SW Coral Way
Miami, Florida 33155

CRMI
ATTN: David M. Rhoe
Radiation Safety Officer
Paseo de la Fuente
Calle Tivoli D-4
San Juan, Puerto Rico 00926-6459

Commonwealth of Puerto Rico

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NOTICE OF VIOLATION

Caribe Medical Plaza Vega Alta, Puerto Rico

Docket No. 030-36003 License No. 52-25591-01 EA-03-134

During an NRC inspection conducted on October 22, 2002, subsequent communications through November 14, 2002, and an investigation completed by the NRC's Office of Investigations (OI) on April 29, 2003, 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:

A.	10 CFR 35.21(a) required, in part, that a licensee, through the Radiation Safety Officer (RSO), ensure that radiation safety activities are being performed in accordance with approved procedures and regulatory requirements in the daily operation of the licensee's radiation safety program. Contrary to the above, between August 16 and 30, 2002, the licensee, through the RSO, did not ensure that radiation safety activities were being performed in accordance with approved procedures and regulatory requirements in the daily implementation of the licensee's radiation safety program. Specifically, the licensee initiated brachytherapy procedures without assuring, through the RSO, that individuals who would be involved in this activity received appropriate training or proper dosimetry.
B.	License Condition 16 of NRC License No. 52-25591-01 requires, in part, that the licensee conduct its program in accordance with the statements, representations, and procedures contained in the license application dated April 11, 2002. Item 8.1 of the license application states that the licensee will establish and implement the model training program published in Appendix A to Regulatory Guide 10.8, Revision 2. Appendix A to Regulatory Guide 10.8, Revision 2, specifies that the licensee will provide training to personnel before assuming duties with, or in the vicinity of, radioactive materials. Contrary to the above, between August 17 and 30, 2002, the licensee did not provide radiation safety training to personnel from the Operating Room (OR) and those individuals who worked with, or in the vicinity of, radioactive materials.
C.	Item 9.4 of the license application dated April 11, 2002, states that the licensee will follow the personnel monitoring program published in Appendix D to Regulatory Guide 10.8, Revision 2. Item 3 of Appendix D to Regulatory Guide 10.8, Revision 2, states that all individuals who, on a regular basis, handle radioactive material that emits ionizing photons will be issued a film or TLD finger monitor that will be processed by a contract service on a monthly basis. Contrary to the above, between August 17 and 30, 2002, the licensee failed to issue film or TLD finger monitors to all individuals who handled radioactive material that emits ionizing photons on a regular basis. Specifically, the licensee commenced use of licensed materials on August 17, 2002, and as of August 30, 2002 the licensee had not issued film or TLD finger monitors to personnel from the OR.
D.	10 CFR 30.9 requires, in part, that information provided to the Commission by a licensee be complete and accurate in all material respects. Contrary to the above, during an on-site inspection on October 22, 2002, and during subsequent investigations by the NRC Office of Investigations, the licensee's RSO provided information that was not complete and accurate in all material respects. Specifically, during the inspection the RSO stated he did not know he was the RSO until August 30, 2002, and, as a result, several violations of NRC requirements occurred when the licensee began licensed activities on August 17, 2002. The investigations revealed that, in fact, the RSO knew or should have known he was the RSO well before August 16, 2002. This is material in that, had the RSO provided complete and accurate information during the inspection, the NRC would have had sufficient information to correctly characterize the apparent violations identified during the initial inspection.

This is a Severity Level III Problem (Supplements VI and VII).

Pursuant to the provisions of 10 CFR 2.201, Caribe Medical Plaza, Inc., is hereby required to submit a written statement or explanation to the U. S. Nuclear Regulatory Commission, ATTN: Document Control Desk, Washington, D.C. 20555, with a copy to the Regional Administrator, Region II, within 30 days of the date of the letter transmitting this Notice of Violation (Notice). This reply should be clearly marked as a "Reply to a Notice of Violation" and should include for each violation: (1) the reason for the violation, or, if contested, the basis for disputing the violation or severity level, (2) the corrective steps that have been taken and the results achieved, (3) the corrective steps that will be taken to avoid further violations, and (4) the date when full compliance will be achieved. Your response may reference or include previously docketed correspondence, if the correspondence adequately addresses the required response. 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 to why the license should not be modified, suspended, or revoked, or why such other action as may be proper should not be taken. Where good cause is shown, consideration will be given to extending the response time.

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.

Because your response will be made available electronically for public inspection in the NRC Public Document Room or from the NRC's document system (ADAMS), accessible from the NRC Web site at the Public NRC Library, to the extent possible, it should not include any personal privacy, proprietary, or safeguards information so that it can be made available to the public 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.

In accordance with 10 CFR 19.11, you may be required to post this Notice within two working days.

Dated this 9th day of October 2003