EA-97-513 - Hospital Metropolitano

January 16, 1998

EA 97-513

Hospital Metropolitano
ATTN: Lcda. Racheline A. Gonzalez, MHSA, MBA
Administrator
P. O. Box EH
Caparra Heights Station
San Juan, PR 00922

SUBJECT:

NOTICE OF VIOLATION (NRC INSPECTION REPORT NO. 52-16033-01/97-01)

Dear Ms. Gonzalez:

This refers to the inspection conducted on September 24 and October 21, 1997, at your facility in San Juan, Puerto Rico. 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. The results of the inspection were formally transmitted to you by letter dated November 19, 1997. An open, predecisional enforcement conference was conducted at your facility on January 13, 1998, to discuss the apparent violations, the root causes, and your corrective actions to preclude recurrence. A list of conference attendees and copies of the NRC's presentation materials are enclosed.

Based on the information developed during the inspection and the information you provided during the conference, 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 involves the failure to control and maintain constant surveillance of licensed materials, as required by 10 CFR 20.1802. Specifically, on May 18, 1996, a 7.6 millicurie cesium-137 brachytherapy source was inadvertently left in a patient's room, uncontrolled, following an oncology procedure until discovery on May 20, 1996. Violation B includes five examples of the failure to return brachytherapy sources to the storage area and promptly count the number returned as required by 10 CFR 35.406(a). The root causes of the violations were (1) the failure to ensure that a member of the hospital staff was adequately trained in the use of a new brachytherapy device and survey instrumentation use and (2) the lack of understanding by the staff of the need to promptly account for sources after removal from patients. At the conference, you stated that confusion did exist regarding how "prompt" the inventory of sources had to be performed. The NRC clarified that although a specific time for source inventory was not specified by 10 CFR 35.406(a), "prompt" was analogous to inventory conducted at the time the sources are returned to storage.

Although the actual safety consequences of the violations were low, these violations are of significant concern due to the potential for exposure to members of your staff, patients, and members of the public due to uncontrolled radioactive material. The NRC expects licensees to exercise control over licensed activities, and that licensed material is properly inventoried and secured, and personnel receive appropriate training in the use of these materials. In these instances, you didn't exercise adequate control. As indicated in our Inspection Report, part of the problem is associated with the inadequate oversight of licensed activities conducted by your contract oncology department. NRC recognizes that you identified the violation and followed-up with your staff; however, these instances of inadequate oversight are of significant regulatory concern. Therefore, Violations A and B have been classified in the aggregate in accordance with the "General Statement of Policy and Procedures 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 $2750 is considered for a Severity Level III problem. Because your facility has not been the subject of escalated enforcement action within the last two years or two inspections, the NRC considered whether credit was warranted for Corrective Action in accordance with the civil penalty assessment process described in Section VI.B.2 of the Enforcement Policy. Although you did not fully understand the issues associated with the promptness of source inventories, NRC determined that credit was warranted for this factor because your corrective actions were prompt and appropriately addressed the root causes you identified. Your corrective actions, which were discussed in your presentation during the predecisional enforcement conference, included conducting a review of the incident, assessing the process for removal and inventory of sources, and training of personnel on the event and the use of the new brachytherapy device and survey instrumentation. Also, you advised the NRC that restart of oncology operations was anticipated this year, and you planned to place contractual requirements on the contract oncology group to ensure that they adhere to the hospital's Radiation Safety Program.

Therefore, to encourage prompt and comprehensive correction of violations and in recognition of the absence of previous escalated enforcement, I have been authorized 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 Notice constitutes escalated enforcement action that may subject you to increased inspection effort.

Although the NRC concluded that the corrective actions taken should be effective in precluding recurrence of the issues, given your near term plans to restart oncology services, the NRC requests that you reiterate in your response to the Notice how you will ensure adequate oversight of contractors who perform radiation oncology services at your facility in the future. Additionally, we request that you inform this office when oncology services are reinitiated.

You are required to respond to this letter and should follow the instructions specified in the enclosed Notice and 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.

At the predecisional enforcement conference, you provided two clarifications regarding NRC Inspection Report No. 52-16033-01/97-01. You clarified paragraph O4.(b) of the Inspection Report to note that the authorized user of the HENCHKE oncology device was in fact aware that the device was new, although he had not been trained on the device. You also clarified a statement in the same paragraph that the Radiation Safety Officer was indeed aware of the requirements of 10 CFR 35.406(a); it was merely the specific definition of "prompt" inventory which was ambiguous and not fully understood. We concur with these clarifications, and this letter serves to document these changes.

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 NRC 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 Bruce S. Mallett Luis A. Reyes Regional Administrator

Docket No. 030-11155
License No. 52-16033-01

Enclosures:
1. Notice of Violation
2. List of Attendees
3. NRC Presentation Materials

cc w/encls:
Commonwealth of Puerto Rico

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NOTICE OF VIOLATION

Hospital Metropolitano San Juan, Puerto Rico

Docket No. 030-11155 License No. 52-16033-01 EA 97-513

During an NRC inspection conducted on September 24 and October 21, 1997, violations of NRC requirements were identified. In accordance with the "General Statement of Policy and Procedures for NRC Enforcement Actions," NUREG-1600, the violations are listed below:

A. 10 CFR 20.1802 requires that the licensee control and maintain constant surveillance of licensed material that is in a controlled or unrestricted area and that is not in storage. As defined in 10 CFR 20.1003, controlled area means an area, outside of a restricted area but inside the site boundary, access to which can be limited by the licensee for any reason; and unrestricted area means an area, access to which is neither limited nor controlled by the licensee.

Contrary to the above, on May 18, 1996, the licensee did not control and maintain constant surveillance of a 7.6 millicurie source of cesium-137 left in a patient's room, which is an unrestricted area (01013).

B. 10 CFR 35.406(a) requires that promptly after removing them from a patient, a licensee return brachytherapy sources to the storage area and count the number returned to ensure that all sources taken from the storage area have been returned.

Contrary to the above, after removing cesium-137 brachytherapy sources from a patient at 12:45 a.m. on May 18, 1996, the licensee did not promptly return the sources to the storage area and count the number returned until approximately 7:45 a.m. on May 20, 1996, a period of approximately 55 hours. In addition, on August 25, 1995, March 1, 1996, October 14, 1996, and November 2, 1996, after removing cesium-137 sources from patients and returning them to the storage area, the licensee did not promptly count the number of sources returned to ensure that all sources taken from the storage area had been returned (01023).

These violations represent a Severity Level III problem (Supplement VI).

Pursuant to the provisions of 10 CFR 2.201, Hospital Metropolitano 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 to the Director, Office of Enforcement, United States Nuclear Regulatory Commission, Washington, DC 20555-0001.

Under the authority of Section 182 of the Act, 42 U.S.C. 2232, this response shall be submitted under oath or affirmation.

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 16th day of January 1998