EA-02-001 - I. González Martínez Oncologic Hospital

March 12, 2002

EA-02-001
EA-02-002

I. González Martínez Oncologic Hospital
ATTN: Lcda. Milagros Vargas
Administrator
P.O. Box 1811
Hato Rey, Puerto Rico 00919

SUBJECT:

NOTICE OF VIOLATION AND PROPOSED IMPOSITION OF CIVIL PENALTY – $7500 (NRC INSPECTION REPORT NO. 52-13471-01/01-01 AND NRC OFFICE OF INVESTIGATIONS REPORT NO. 2-2001-006)

Dear Lcda. Vargas:

This refers to the Nuclear Regulatory Commission (NRC) inspection conducted on March 21, 22, and 27, 2001, at I. González Martínez Oncologic Hospital, Hato Rey, PR. The purpose of the inspection was to review the circumstances surrounding a reported missing and subsequently recovered radioactive implant containing approximately 97 millicuries of Cesium-137 on March 14-15, 2001. The circumstances surrounding the event, your response to the missing implant, and preliminary corrective actions were discussed with you on March 27, 2001, and documented in NRC Inspection Report No. 52-13471-01/01-01, issued to you on April 26, 2001. The NRC's Office of Investigations (OI) initiated an investigation on April 20, 2001, to determine whether the licensed material was intentionally disposed of by placing it in a trash compactor outside the hospital building. OI concluded that the evidence developed during the investigation did not substantiate a finding that the licensed material was intentionally placed in the trash compactor. The results of the OI investigation, including additional review of the circumstances surrounding this event, were discussed and forwarded to you in a letter dated January 16, 2002.

On February 6, 2002, an open predecisional enforcement conference was conducted at the I. González Martínez Oncologic Hospital located in Hato Rey, Puerto Rico, with you and members of your staff to discuss the apparent violations, their significance, their 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 revising the hospital's dose assessment for individuals who may have received unintended radiation doses as a result of this event. This dose assessment was forwarded to the NRC on February 12, 2002, and is included as Enclosure 4.

Based on the information developed during the inspection and the information that you presented at the conference, the NRC has determined that eight 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. Part I of the Notice consists of five violations associated with the failure to secure licensed material. These violations include; (A) the failure to control or secure from unauthorized removal or limit access to approximately 97 millicuries of unshielded Cesium-137 as required by 10 CFR 20.1801 and 10 CFR 20.1802 once the material entered an unrestricted area; (B) the failure to return the brachytherapy sources to the storage area and count the number returned to ensure that all sources taken from the storage area have been returned as required by 10 CFR 35.406(a); (C) the failure to label a bag that contained an implant with approximately 97 millicuries of unshielded Cesium-137 as required by 10 CFR 20.1904(a); (D) the failure to limit the dose in an unrestricted area to less than 2 millirems in any one hour as required by 10 CFR 20.1301(a)(2); and (E) the failure to conduct surveys to evaluate the radiation levels created in areas adjacent to the brachytherapy preparation room, and ensure a member of the public did not receive a dose in excess of the limits in 10 CFR 20.1301(a)(1), when leaving an implant unshielded in the brachytherapy preparation room and allowing a member of the public access to the room, as required by 10 CFR 20.1501.

Part II of the Notice involves three violations, which include: (A) the failure to report the missing 97 millicuries of unshielded Cesium-137 immediately as required by 10 CFR 20.2201(a)(i); (B) the failure to ensure that housekeeping personnel receive radiation safety instruction at a frequency of once per year as required by the license; and (C) the failure to make a radiation survey of a patient with a radiation detection survey instrument to confirm that all sources have been removed as required by 10 CFR 35.404(a).

As discussed at the conference, the root and contributing causes of the event included the failure of hospital personnel to follow hospital policy and procedures, and inadequate communication between the hospital staff. This event highlighted the failure of multiple barriers which are specifically required by NRC regulations, the purpose of which are to preclude an event such as the one that occurred in March 2001. In addition to this concern, the event resulted in unintended radiation doses to non-medical workers and a member of the public at the hospital who entered the brachytherapy preparation room to conduct non-medical tasks. Although it is unlikely that a member of the public received a dose in excess of the limits in 10 CFR 20.1301(a)(1) from this event (the actual estimated radiation dose to a member of the public was approximately 90 mrem) a significant potential existed for a member of the public to receive a dose in excess of the 0.1 rem per year limit (employees who are not radiation workers are considered members of the public). Our conclusion about the realistic potential for an overexposure is based on the fact that I. González Martínez Oncologic Hospital was not controlling the dose rate or exposure time for the member of the public. The dose rate could realistically have been greater, resulting in an overexposure, and the exposure time could have been longer, also resulting in an overexposure. The NRC views any unintended dose as significant because of the substantial potential for much higher doses under different circumstances. A substantial potential for unintended radiation doses to members of the public also existed while the unshielded Cesium-137 sources were in the trash compactor behind the hospital.

The failure to control and maintain constant surveillance of licensed material could be characterized as a Severity Level III violation, in accordance with the "General Statement of Policy and Procedures for NRC Enforcement Actions" (Enforcement Policy), NUREG-1600. We have concluded, however, that based on the interrelationship of the Part I violations in contributing to the event, these five violations (I.A-E) should be categorized collectively as a Severity Level III problem. The violation in Part II.A has been categorized separately as a Severity Level III violation in accordance with the Enforcement Policy, because the NRC places high importance on reporting requirements to ensure that prompt actions and timely communications with stakeholders have or will take place. In this case, you did not contact the NRC until approximately 42 hours after identifying that the source was missing. The two violations listed in Part II.B and C involve less significant non-compliances of regulatory requirements and are characterized at Severity Level IV.

In accordance with the Enforcement Policy, a base civil penalty is considered for each Severity Level III violation or problem. Because the hospital has not been the subject of escalated enforcement action within the last two inspections, the NRC considered whether credit was warranted for Corrective Action in accordance with the civil penalty assessment process described in Section VI.C.2 of the Enforcement Policy. Your corrective actions were detailed at the conference and included, in part: a search that resulted in the eventual location and retrieval of the radioactive sources; a complete review of hospital policies and procedures to ensure consistency with regulatory requirements; procedural changes to ensure adequate communication among the hospital staff; additional training of the medical staff in the use of brachytherapy devices and regulatory requirements; the hiring and retention of an outside consultant to advise the hospital in the use of radioactive medical devices; a complete review of this event and corrective actions by the Radiation Safety Committee; the installation of a portable radiation monitor in a location to alert the hospital staff should an incident with similar circumstances occur; and radiation safety training of new employees. In addition, your event report of March 16, 2001, included an Action Plan that identified several additional corrective actions to prevent recurrence of the event. Based on the above, NRC concluded that your actions were prompt and comprehensive, and credit was warranted for the factor of Corrective Action.

Application of the normal civil penalty assessment process would not result in a civil penalty in this case. However, the revised Enforcement Policy published on December 18, 2000, (effective February 16, 2001), provides that, notwithstanding normal application of the civil penalty assessment process, a civil penalty of at least the base amount should normally be proposed in this type of case to reflect the significance of the violation and to emphasize the importance of maintaining control of licensed material (see Section VII.A.1(g) of the Enforcement Policy). The base civil penalty values were developed to correspond to approximately three times the average cost of disposal. Normal application of the civil penalty assessment process, as reflected in Tables 1A.f.2 and 1B of the Enforcement Policy, would result in a civil penalty of $7500 in this case. Therefore, I have been authorized, after consultation with the Director, Office of Enforcement, to issue the enclosed Notice of Violation and Proposed Imposition of Civil Penalty (Notice) in the amount of $7500 for the Severity Level III Problem. You may pay the civil penalty proposed above in accordance with NUREG/BR-0254 (Enclosure 5). In addition, issuance of this Notice constitutes escalated enforcement action that may subject you to increased inspection effort.

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 is already adequately addressed on the docket in this letter and in a letter from the I. González Martínez Oncologic Hospital dated March 16, 2001. Therefore, you are not required to respond to the provisions of 10 CFR 2.201 unless the description therein 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 enclosure, and your response, if any, 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 Website at 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.

	Sincerely,
	/RA/
	Luis A. Reyes Regional Administrator

Docket No. 030-03532
License No. 52-13471-01

Enclosures:
1.Notice of Violation and Proposed Imposition of Civil Penalty
2. List of Attendees
3. Material Presented by NRC
4. Dose Assessment
5. NUREG/BR-0254cc w/ encls.: Commonwealth of Puerto Rico

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NOTICE OF VIOLATION
AND
PROPOSED IMPOSITION OF CIVIL PENALTY

I. González Martínez Oncologic Hospital Hato Rey, Puerto Rico

Docket No. 030-03532 License No. 52-13471-01 EA-02-01, EA-02-02

During an Nuclear Regulatory Commission (NRC) inspection conducted on March 21, 22, and 27, 2001, and an NRC Office of Investigations (OI) investigation initiated on April 20, 2001, violations of NRC requirements were identified. In accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions," NUREG-1600, the NRC proposes to impose a civil penalty 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 penalty are set forth below:

I.	Violations Assessed a Civil Penalty
	A.	10 CFR 20.1801 requires that the licensee secure from unauthorized removal or access licensed materials that are stored in controlled or unrestricted areas. 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 March 14, 2001, the licensee did not secure from unauthorized removal or limit access to approximately 97 millicuries of unshielded Cesium-137 located in a trash compactor outside the hospital and next to a public parking area, which is an unrestricted area, nor did the licensee control and maintain constant surveillance of this licensed material. Specifically, the licensee left unattended a radioactive implant in the brachytherapy preparation room, and the implant was subsequently removed from this area and placed in a trash compactor located outside the hospital, an unrestricted area per 10 CFR 20.1003. The source remained out of the licensee's control for approximately 19 hours.
	B.	10 CFR 35.406(a) requires that, promptly after removing brachytherapy sources from a patient, the licensee return the 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, on March 14, 2001, the licensee failed to promptly return brachytherapy sources to the storage area and count the sources to ensure that all taken from the storage area had been returned, after removing the sources from a patient. Specifically, the licensee removed an implant that contained approximately 97 millicuries of Cesium-137 from a patient at approximately 11:30 a.m. and it was not until approximately 8:00 p.m. that the licensee noted that the implant was missing.
	C.	10 CFR 20.1904(a) requires that the licensee ensure that each container of licensed material bear a durable, clearly visible label bearing the radiation caution symbol and the words "CAUTION-RADIOACTIVE MATERIAL." The label must provide sufficient information to permit individuals handling or using the container, or working in the vicinity of the container, to take precautions to avoid or minimize exposures. Contrary to the above, on March 14, 2001, the licensee failed to label a bag that contained an implant with approximately 97 millicuries of unshielded Cesium-137.
	D.	10 CFR 20.1301(a)(2) requires that the dose in any unrestricted area from external sources does not exceed 2 millirems in any one hour. Contrary to the above, on March 14-15, 2001, the licensee created radiation levels of up to approximately 50 millirems in one hour in the vicinity of the trash compactor and a public parking lot.
	E.	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 radiation. Contrary to the above, on March 14, 2001, the licensee did not make surveys to assure compliance with 10 CFR 20.1301(a)(1), which limits the total effective dose equivalent from licensed operation to individual members of the public to 0.1 rem in a year, and with 10 CFR 20.1301(a)(2), which limits radiation levels in unrestricted areas. Specifically, the licensee allowed a member of the public access to the brachytherapy preparation room, a restricted area, but did not perform adequate surveys to ensure the member of the public did not receive a dose in excess of 0.1 rem. Dose rates in the area occupied by the member of the public realistically could have resulted in doses in excess of the limits in 10 CFR 20.1301(a)(1). Additionally, an Authorized User failed to evaluate the radiation levels he created in areas adjacent to the brachytherapy preparation room when leaving an unshielded brachytherapy implant in the brachytherapy preparation room. Areas adjacent to the brachytherapy preparation room were unrestricted areas as defined in 10 CFR 20.1003.
This is a Severity Level III problem (Supplements IV and VI). Civil Penalty – $7500.
II.	Violations Not Assessed a Civil Penalty
	A.	10 CFR 20.2201(a)(i) requires that the licensee report by telephone, immediately after its occurrence becomes known, any missing licensed material in an aggregate quantity equal to or greater than 1,000 times the quantity specified in Appendix C to Part 20 under such circumstances that it appears to the licensee that an exposure could result to persons in unrestricted areas. Contrary to the above, on March 14, 2001, the licensee failed to immediately report the missing 97 millicuries of unshielded Cesium-137, a quantity 9,700 times that specified in Appendix C to Part 20, which was subsequently found in an unrestricted area. The licensee did not contact the NRC until approximately 42 hours after identifying the missing source.
This is a Severity Level III violation (Supplement IV).
	B.	Condition 14.A.1 of License No. 52-13471-01 requires, in part, that the licensee conduct its program in accordance with the procedures contained in the license application dated December 28, 1990. Item 8 of the application dated December 28, 1990 requires, in part, that housekeeping personnel receive radiation safety instruction at a frequency of once per year. Contrary to the above, as of March 22, 2001, at least one member of the licensee's housekeeping staff had not received radiation safety instruction in two years.
This is a Severity Level IV violation (Supplement VI).
	C.	10 CFR 35.404(a) requires, in part, that, immediately after removing the last temporary implant source from a patient, the licensee make a radiation survey of the patient with a radiation detection survey instrument to confirm that all sources have been removed. Contrary to the above, on March 14, 2001, a patient was surveyed approximately two hours after the removal of the implant by an Authorized User.
This is a Severity Level IV violation (Supplement VI).

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 this letter and in a letter from the I. González Martínez Oncologic Hospital dated March 16, 2001. 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 RII, within 30 days of the date of the letter transmitting this Notice of Violation (Notice).

The Licensee may pay the civil penalty proposed above in accordance with NUREG/BR-0254 and by submitting to the Director, Office of Enforcement, U.S. Nuclear Regulatory Commission, a statement indicating when and by what method payment was made, or may protest imposition of the civil penalty 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 30 days of the date of this Notice of Violation and Proposed Imposition of Civil Penalty, an order imposing the civil penalty will be issued. Should the Licensee elect to file an answer in accordance with 10 CFR 2.205 protesting the civil penalty, in whole or in part, such answer should be clearly marked as an "Answer to a Notice of Violation" and may: (1) deny the violations 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 penalty should not be imposed. In addition to protesting the civil penalty in whole or in part, such answer may request remission or mitigation of the penalty.

In requesting mitigation of the proposed penalty, the factors addressed in Section VI.C.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 penalty.

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

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 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 12^th day of March 2002