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EA-97-498 - Hospital San Pablo

EA 97-498

Hospital San Pablo
ATTN: Mr. Jorge Matta
Administrator
P. O. Box 236
Bayamon, Puerto Rico 00960-6036

SUBJECT:  NOTICE OF VIOLATION 
          (NRC INSPECTION REPORT 52-21325-01/97-01)

Dear Mr. Matta:

This refers to the special, unannounced inspection conducted by this office on October 1, 1997, at your facility in Bayamón, Puerto Rico. The purpose of the inspection was to review the circumstances surrounding the loss of control and subsequent inadvertent incineration of licensed materials. The incident was verbally reported to the Nuclear Regulatory Commission (NRC) on May 14, 1997, and a written report was submitted to the NRC on May 23, 1997. The results of the inspection were discussed with you on October 1, 1997, and were formally transmitted to you by letter dated October 28, 1997. That letter also provided you the opportunity to respond to the apparent violations in writing or request a predecisional enforcement conference. Subsequently, you declined a conference, and by letter dated November 24, 1997, you admitted the apparent violations and stated that the inspection report appropriately described the apparent violations, the root causes, and your corrective actions to preclude recurrence. No additional information was provided in your submittal. We have reviewed the inspection results and your May 23 and November 24, 1997, letters and have concluded that sufficient information is available to determine the appropriate enforcement action in this matter.

Based on the information developed during the inspection and subsequent reviews, the NRC has determined that violations of regulatory 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 are associated with work performed on April 15, 1997, at your facility which involved the demolition and relocation of the room used to store radioactive waste held for decay-in-storage. Three violations occurred: (1) the failure to secure licensed materials from unauthorized removal; (2) unauthorized disposal of the licensed materials; and (3) the failure to monitor, with a radiation survey meter, radioactive waste held for decay-in-storage prior to disposing of it.

Specifically, on April 15, 1997, unqualified engineering personnel obtained a key to the decay room to remove material prior to demolition of the room. Based on perceived instructions from a nuclear medicine technologist, material dated 1996 and earlier was removed and transferred to the Environmental Services Department to be discarded as biomedical waste, and included six reference sources. Accounting for decay, the reference sources consisted of two non-NRC regulated cobalt-57 sources containing 0.03 and 0.47 microcuries (µCi) each, two cobalt-60 (Co-60) sources containing 18 and 28 µCi each, and two cesium-137 (Cs-137) sources containing 77 and 86 µCi each. The waste, was transferred the same day to an incineration contractor and was subsequently incinerated. The missing sources were identified by a nuclear medicine technologist on May 13, 1997, upon accessing the new decay room. The root causes of the violations were inadequate supervision of unqualified licensee employees performing the demolition and source removal activities and miscommunications between personnel regarding which materials could be discarded.

In this case, the actual safety consequences of the violations were low in that some precaution was exercised in handling the reference sources because they were believed to be hazardous biochemical waste, and the determination that, due to the incineration parameters, 10 CFR Part 20, Appendix B limits for release of licensed materials to unrestricted areas were not exceeded. However, the violations are of significant regulatory concern because they indicated a lack of attention to licensed activities and involved the conduct of activities by technically unqualified personnel. Individuals handling the reference sources were unaware of the potential radiation hazard and consequently, took no action to monitor their radiation exposure or control the material. It was fortuitous that the lack of controls and awareness did not result in unnecessary radiation exposures to the workers or the public or, contamination or incinerator effluent which exceeded regulatory limits. Therefore, in accordance with the "General Statement of Policy and Procedures for NRC Enforcement Actions" (Enforcement Policy), NUREG-1600, the three violations are classified, in the aggregate, as a Severity Level III problem.

In accordance with the Enforcement Policy, a base civil penalty in the amount of $2,750 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. As documented in detail in the inspection report and your May 23, 1997, report to the NRC, your corrective actions included: (1) conduct of a prompt and thorough investigation of the missing sources including a response to the contract incinerator facility; (2) segregation of toxic materials from radioactive materials in storage areas; (3) initiation of key control to the decay room; (4) cessation of the storage of reference sources in the decay room; (5) implementation of a policy which provides that items stored in the decay facility can only be removed under the supervision of the Nuclear Medicine Laboratory Supervisor or the Radiation Safety Officer; (6) prompt reporting of the incident to the NRC; (7) implementation of disciplinary actions against certain employees; and (8) plans to begin utilizing radiopharmacy services resulting in the reduced build-up of radioactive waste. Based on these facts, the NRC concluded that credit was warranted for the factor of Corrective Action.

Therefore, to encourage prompt and comprehensive correction of violations and in recognition of the absence of previous escalated enforcement action at your facility, 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.

The NRC has concluded that the reasons for the violations, the corrective actions taken and planned to correct the violations and prevent recurrence, and the date when full compliance will be achieved are adequately addressed on the docket in NRC Inspection Report No. 52-21325-01/97-01, dated October 28, 1997, and your May 23 and November 24, 1997, letters. Therefore, no response to this letter is required unless the description therein or described above 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. With issuance of the Notice of Violation, Escalated Enforcement Items (EEI) 52-21325-01/97-01-01, EEI 51-21325-01/97-01-02, and 51-21325-01/97-01-03 are closed.

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 NRC Public Document Room (PDR). To the extent possible, a 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 Charles M. Hosey, Acting Deputy Director, Division of Nuclear Materials Safety at (404) 562-4701.

                              Sincerely,



                              Luis A. Reyes
                              Regional Administrator

Docket No. 030-20510
General License No. 52-21325-01

Enclosure: Notice of Violation

cc w/encl:
Commonwealth of Puerto Rico
Hospital San Pablo
ATTN: Mr. Jorge De Jesús
Executive Director
P. O. Box 236
Bayamón, PR 00960-6036

Hospital San Pablo                                        Docket No. 030-20510
Bayamón, Puerto Rico                                      License No. 52-21325-01 
                                                          EA 97-498

During a Nuclear Regulatory Commission (NRC) inspection conducted on October 1, 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 20.1801 requires that the licensee secure from unauthorized removal or access, licensed materials that are stored in controlled areas.

Contrary to the above, on April 15, 1997, the licensee did not secure from authorized removal licensed materials consisting of cobalt-60 (Co-60) and cesium-137 (Cs-137) dose calibrator reference sources that were stored in the licensee's radioactive waste decay room, a controlled area. Specifically, the licensee permitted unqualified personnel from the licensee's engineering staff to remove four reference sources containing 86 and 77 microcuries (µCi) of Cs-137 and 28 and 18 µCi of Co-60, respectively, for transfer to a disposal facility. (01013)

B. 10 CFR 20.2001(a) requires that the licensee dispose of licensed material only by certain specified procedures. These procedures include: (1) by transfer to an authorized recipient; (2) by decay in storage; (3) by release in effluents within the limits of 10 CFR 20.1301; or (4) as authorized under 10 CFR 20.2002 through 10 CFR 20.2005.

Contrary to the above, on April 15, 1997, the licensee disposed of four reference sources containing 86 and 77 microcuries (µCi) of Cs-137 and 28 and 18 µCi of Co-60, respectively, by a method prohibited by 10 CFR 20.2001(a). Specifically, the reference sources were disposed of by release to a commercial incinerator which was not authorized to receive the material. (01023)

C. 10 CFR 35.92(a)(2) requires that, before disposing of radioactive waste held for decay-in-storage, the licensee monitor the byproduct material at the container surface to determine that its radioactivity cannot be distinguished from the background radiation level with a radiation detection survey meter set on its most sensitive scale and with no interposed shielding.

Contrary to the above, on April 15, 1997, the licensee failed to monitor, with a radiation survey meter, radioactive waste held for decay-in-storage prior to disposing of it. (01033)

These violations constitute a Severity Level III problem (Supplements IV and 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 will be achieved are already adequately addressed on the docket in NRC Inspection Report No. 52-213250-01/97-01 dated October 28, 1997, and in your May 23 and November 24, 1997, letters. However, Hospital San Pablo is 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 Notice of Violation," and send it 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).

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 20555-001.

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

Because your response, if you choose to provide one, 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 23rd day of December 1997