EA-02-227 - University of Puerto Rico

February 7, 2003

EA-02-227

University of Puerto Rico
Medical Sciences Campus
ATTN: Dr. José R. Carlo
Chancellor
G.P.O. Box 5067
San Juan, Puerto Rico 00936

SUBJECT:

NOTICE OF VIOLATION AND PROPOSED IMPOSITION OF CIVIL PENALTIES $9,000 (NRC INSPECTION REPORT NUMBERS 52-01946-07/02-01 AND 52-01946-07/02 AND OFFICE OF INVESTIGATION REPORT 2-2002-006)

Dear Dr. Carlo:

This refers to the inspections conducted on February 19-20, March 20, and June 4-5, 2002, at your Carolina and Rio Piedras, Puerto Rico facilities. The purpose of the inspections was to determine whether activities authorized by your materials license were conducted safely and in accordance with Nuclear Regulatory Commission (NRC) requirements. The preliminary results of these inspections were documented in the subject inspection reports and forwarded to you by letters dated May 5, 2002, and July 5, 2002. In addition to the subject inspections, the NRC's Office of Investigations (OI) conducted an investigation to determine if the University of Puerto Rico (UPR) deliberately violated certain NRC requirements. The results of the investigation and the identification of nine apparent violations of regulatory requirements associated with the inspections were forwarded to you by letter dated November 8, 2002. At the NRC's request, a closed and transcribed predecisional enforcement conference was conducted with you and members of your staff on December 13, 2002, at the UPR Medical Sciences Campus. The enclosures to this letter include the list of conference attendees and copies of the material presented by the NRC at the conference.

Based on the information developed during the inspection and investigation, and the information you provided during the conference, the NRC has determined that multiple violations of regulatory 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 report. Three violations are cited in Part I of the Notice, and involve: (A) the failure to perform daily radiation surveys of areas where radiopharmaceuticals are routinely administered to patients in accordance with 10 CFR 35.70(a); (B) the failure of the RSO to calibrate contamination survey instruments annually in accordance with 10 CFR 35.51(a); and (C) the failure to notify the RSO immediately after unexpectedly high radiation levels were found in accordance with License Condition No. 23. The NRC concluded that the violations in Part I of the Notice were willful, as discussed below.

At the conference, you indicated that the violations occurred, but disagreed with the NRC's characterization of the violations above as willful. Instead, you indicated that the violations occurred due to missed and unofficial communications between your staff, and the failure to follow the proper communication channels to ensure that responsible parties were notified or made aware such that corrective actions could be taken in a timely manner.

Based on the evidence from the OI report and information provided by UPR at the conference, we have concluded that violations I.A, I.B, and I.C were willful. The basis for this determination stems from the fact that the responsible UPR individuals involved were aware, at the time that the activities were conducted, that certain actions did not conform to regulatory requirements, yet failed to take appropriate measures to ensure conformance with these requirements. As such, the NRC concluded that these violations were willful.

In accordance with the "General Statement of Policy and Procedures for NRC Enforcement Actions," NUREG-1600 (Enforcement Policy), each violation referenced above would normally be categorized separately at Severity Level IV. However, independent of the technical significance of the above violations, the NRC considers willful violations to be of particular concern because our regulatory programs are based on licensees' and their employees' conformance to regulatory requirements. Therefore, in accordance with the Enforcement Policy, each violation cited in Part I of the Notice has been categorized separately as a Severity Level III violation.

In accordance with the Enforcement Policy, a base civil penalty in the amount of $3,000 is considered for each Severity Level III violation. 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. The violations were identified as a result of an NRC inspection and investigation, and as such, credit was not warranted for the factor of Identification. Your immediate and long-term corrective actions included: the hiring of a new Radiation Safety Officer (RSO); restructuring of the Radiation Safety Committee (RSC) and appointment of a new Chair person; a critique of and assistance to UPR's radiation safety program by an outside entity (Virginia Commonwealth University), who possesses a similar broad scope license; clarification regarding who is responsible for conducting surveys; substantial changes to the Radiation Safety Manual; the relocation of necessary equipment into the Nuclear Medicine laboratory such that the staff will have access to the equipment to conduct the required surveys in all areas where radiopharmaceuticals were administered; calibration of survey instruments at the proper frequency and the use of a computerized tracking system to serve as a reminder of when calibrations are due; providing phone numbers of the RSO and staff to users so that the RSO can be notified upon the discovery of unexpectedly high radiation levels; the periodic conduct of simulations and unannounced drills involving contaminated spills to verify proper lines of communication; the availability of several visitor film badges so that visitors will be assigned unique film badges (to prevent multiple visitors from using the same film badge); the ordering of syringe shields by the new RSO; and the establishment of a separate budget for the Office of Radiation Protection to purchase radiation safety equipment. In addition, the RSO has reminded all Nuclear Medicine Technologists to wear proper extremity monitoring devices, as appropriate. Based on this, the NRC concluded that credit was warranted for the factor of Corrective Action.

Therefore, to emphasize the importance of proper oversight of licensed activities, I have been authorized, after consultation with the Director, Office of Enforcement, to issue the enclosed Notice of Violation and Proposed Imposition of Civil Penalties (Notice) in the base amount of $3,000 for each Severity Level III violation, resulting in a cumulative civil penalty of $9,000. In addition, issuance of this Notice constitutes escalated enforcement action, that may subject you to increased inspection effort.

Six additional violations (Violations II.A-F) were identified and are cited in Part II of the enclosed Notice. These violations include; (A) the failure to maintain complete records of the results of dosimetry issued to visitors in accordance with License Condition No. 23; (B) the failure of the RSO to implement actions to correct radiation safety issues in accordance with 10 CFR 35.21(a); (C) the failure to issue dosimetry to all personnel handling radioactive materials in accordance with License Condition No. 23; (D) the failure to adequately monitor extremity exposures in accordance with10 CFR 20.1501; (E) the failure to apply for and receive a license amendment before changing RSO in accordance with10 CFR 35.13(c); and, (F) the failure of the RSC to review the training and experience of a prospective RSO before the submission of an amendment request to the NRC in accordance with10 CFR 35.22(b). Based on their low safety significance, these violations have been characterized separately at Severity Level IV in accordance with the Enforcement Policy.

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, its enclosures, and 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.

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. 030-13584
License No. 52-01946-07

Enclosure: Notice of Violation and Proposed Imposition of Civil Penalties

cc w/encl: Commonwealth of Puerto Rico

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NOTICE OF VIOLATION
AND
PROPOSED IMPOSITION OF CIVIL PENALTIES

University of Puerto Rico San Juan, Puerto Rico

Docket No. 030-13584 License No.52-01946-07 EA-02-227

During an NRC inspection conducted on February 19-20, March 20, and June 4-5, 2002, at your Carolina and Rio Piedras, Puerto Rico facilities, and an investigation completed by the NRC's Office of Investigations (OI) on August 27, 2002, 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 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. 10 CFR 35.70(a) requires that a licensee survey, with a radiation detection survey instrument at the end of each day of use, all areas where radiopharmaceuticals are routinely prepared for use or administered. Contrary to the above, between August 2001 and April 2002, the licensee failed to survey all areas where radiopharmaceuticals were administered at the end of each day of use. Specifically, the Radiation Safety Officer and the Chairman of the Radiation Safety Committee deliberately allowed individuals to use and administer radiopharmaceuticals without conducting the daily area radiation surveys required in 10 CFR 35.70(a). This is a Severity Level III violation (Supplement VI) Civil Penalty - $3,000   B. 10 CFR 35.51(a) requires, in part, that a licensee calibrate the survey instruments used to show compliance with 10 CFR Part 35 before first use, annually, and following repair. Contrary to the above, as of February 20, 2002, the licensee willfully failed to calibrate contamination survey instruments annually. This is a Severity Level III violation (Supplement VI) Civil Penalty - $3,000   C. License Condition No. 23 requires that, except as specifically provided otherwise in the license, the licensee shall conduct its program in accordance with the statements, representations, and procedures contained in the documents, including any enclosures, and including, in part, the license application dated January 27, 1994. Item 10.12 of the license application dated January 27, 1994 states that the licensee will establish and implement the model procedure for area surveys that was published in Appendix N to Regulatory Guide 10.8, Revision 2. Item 2 of the section entitled "Ambient Dose Rate Surveys" of Appendix N requires that the Radiation Safety Officer (RSO) be immediately notified if unexpectedly high or low radiation levels are found. Contrary to the above, on March 23, 2000, a nuclear medicine technologist employed by the licensee willfully failed to notify the RSO of the discovery of unexpectedly high radiation levels on the floor of the hallway adjacent to the nuclear medicine hot lab, an unrestricted area. This is a Severity Level III violation (Supplement VI). Civil Penalty - $3,000 II. Violations Not Assessed a Civil Penalty License Condition No. 23 requires that, except as specifically provided otherwise in the license, the licensee shall conduct its program in accordance with the statements, representations, and procedures contained in the documents, including any enclosures, and including, in part, the license application dated January 27, 1994 and the letter dated August 24, 1995.   Item 10.1.2(8) of the license application dated January 27, 1994 states, in part, that the Radiation Safety Officer is responsible for keeping records of personnel exposures. Contrary to the above, as of February 20, 2002, the Radiation Safety Officer did not keep complete records of personnel exposures. Specifically, a nuclear medicine technologist responsible for issuing dosimetry at the Carolina Regional Hospital, a licensee facility, willfully failed to make a record of the persons to whom temporary employee dosimetry was issued. This is a Severity Level IV violation (Supplement VI).   10 CFR 35.21(a) requires, in part, that a licensee, through the Radiation Safety Officer (RSO), shall ensure that radiation safety activities are being performed in accordance with approved procedures and regulatory requirements in the daily operation of the licensee's byproduct material program. 10 CFR 35.21(b)(1) requires that the RSO investigate overexposures, accidents, spills, losses, thefts, unauthorized receipts, uses, transfers, disposals, misadministrations, and other deviations from approved radiation safety practices and implement corrective actions as necessary.   Contrary to the above, between March 2001 and February 2002, the Radiation Safety Officer failed to ensure that radiation safety activities were being performed in accordance with approved procedures and regulatory requirements in the daily operation of the licensee's byproduct material program. Specifically, the Radiation Safety Officer failed to implement corrective actions reviewed and approved by the licensee's Radiation Safety Committee, in that, the Radiation Safety Officer failed to procure syringe shields for use in the nuclear medicine department. This is a Severity Level IV violation (Supplement VI)   License Condition No. 23 requires that except as specifically provided otherwise in the license, the licensee will conduct its program in accordance with the statements, representations, and procedures contained in the documents, including any enclosures, and including, in part, the license application dated January 27, 1994 and the letter dated August 24, 1995.   Item 9.a of the letter dated August 24, 1995 states that the licensee will issue personnel dosimetry, with certain exceptions, to all individuals handling radioactive materials. Item 9.4(a)(5) of the application dated January 27, 1994, states that dosimeters will be exchanged monthly. Item 10.4(b)(4) of the application dated January 27, 1994, requires the wearing of an extremity ring dosimeter when handling radiopharmaceuticals. Contrary to the above, between April and July 2001, the licensee did not exchange or issue personnel dosimetry monthly. Specifically, the licensee did not exchange dosimeters used in April 2001 until July 2001, and did not issue extremity dosimetry to a temporary nuclear medicine technologist providing vacation coverage at Carolina Regional Hospital. This is a Severity Level IV violation (Supplement VI).   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. 10 CFR 20.1201(a)(2)(ii) requires, in part, that licensees control the occupational dose to individual adults to a shallow-dose equivalent of 50 rem (0.5 Sv) to the skin of the whole body or to the skin of any extremity. 10 CFR 20.1201(c) permits that the shallow-dose equivalent to be assessed from surveys or other radiation measurements for the purpose of demonstrating compliance with the occupational dose limits, if the individual monitoring device was not in the region of highest potential exposure, or the results of individual monitoring are unavailable. Contrary to the above, as of February 20, 2002, the licensee did not make adequate surveys to assure compliance with 10 CFR 20.1201(a)(2)(ii), which limits radiation exposure to the skin of any extremity. Specifically, on February 20, 2002, a nuclear medicine technologist wore her finger ring TLD with the TLD portion on the distal portion of the finger opposite the maximally exposed portion of the hand or fingers. Wearing the ring TLD in such a manner may under-measure the individual's extremity dose between 20 and 67%. The licensee made no assessment to demonstrate compliance with the applicable occupational dose limit. This is a Severity Level IV violation (Supplement IV).   10 CFR 35.13(c) requires that a licensee apply for and receive a license amendment before it changes Radiation Safety Officer (RSO).   Contrary to the above, as of February 20, 2002, the licensee did not apply for or receive a license amendment before it changed RSO. This is a Severity Level IV violation (Supplement IV).   10 CFR 35.22(b)(2) requires, in part, that the Radiation Safety Committee review, on the basis of safety and with regard to the training and experience standards in Subpart J of Part 30, and approve or disapprove any individual who is to be listed as the RSO before submitting a license application or request for amendment or renewal.   Contrary to the above, as of February 20, 2002, the Radiation Safety Committee had not reviewed the training and qualifications of an individual, yet approved this individual, and requested, in a license amendment request of January 28, 2002, that the individual be listed as RSO. This is a Severity Level IV violation (Supplement IV).

Pursuant to the provisions of 10 CFR 2.201, the University of Puerto Rico 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.

Within 30 days of the date of this Notice, the Licensee may pay the civil penalties 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 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 30 days of the date of this Notice of Violation and Proposed Imposition of Civil Penalties, 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 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 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.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 civil penalties.

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.

The payment of civil penalties should be addressed to Frank Congel, 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.

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). 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. ADAMS is accessible from the NRC Web site at the Public NRC Library. 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).

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

Dated this 7th day of February 2003