EA-01-145 El Señorial PSI

September 28, 2001

EA-01-145

El Señorial PSI,
   Nuclear Medicine Laboratory
ATTN: Joel Ramos, M.D.
            Radiation Safety Officer
Calle Paraná #1716, Urb. El Cerezal
Río Piedras, PR 00926

SUBJECT:

NOTICE OF VIOLATION AND PROPOSED IMPOSITION OF CIVIL PENALTY - $2,750 (NRC OFFICE OF INVESTIGATIONS REPORT NO. 2-2000-033 AND NRC INSPECTION REPORT NO. 52-25493-01/00-01)

Dear Dr. Ramos:

This refers to the investigation completed on April 30, 2001, at El Senorial PSI Nuclear Medical Laboratory (EPSI), Río Piedras, Puerto Rico. The NRC's Office of Investigations (OI) conducted the investigation to determine whether EPSI operated without required dose monitoring devices. The investigation substantiated that the authorized user and Radiation Safety Officer (RSO) deliberately permitted the conduct of operations at the facility for approximately six weeks without proper dose monitoring devices as required by your license. The investigation was conducted as a followup to NRC Inspection Report No. 52-25493-01/00-01, issued on December 29, 2000, which documented the identification of seven apparent violations.

The results of the OI investigation, including one apparent violation, were discussed with you and formally transmitted to you by letter dated July 6, 2001. As clarification, the one apparent violation was also documented as apparent violation (7) in NRC Inspection Report No. 52-25493-01/00-01. The NRC's letter of July 6, 2001, also provided you the opportunity to either respond to the apparent violation in writing or request a predecisional enforcement conference. In letter dated August 23, 2001, you provided EPSI's response to the apparent violation and addressed the causes. We have reviewed your response and conclude that sufficient information is available to determine the appropriate enforcement action in this matter.

Based on the information developed during the inspection and the information you provided in your response, the NRC has determined that a violation of NRC requirements occurred. The violation is cited in the enclosed Notice of Violation, and the circumstances surrounding it are described in detail in the subject inspection report. Specifically, License Condition 14, Item 9.4 of the license application, and Item 2 in Appendix D to Regulatory Guide 10.8, Revision 2, require all individuals who are occupationally exposed to ionizing photon radiation on a regular basis to be issued a film or thermoluminescent dosimeter (TLD) whole body monitor that will be processed by a contract service on a monthly basis. The NRC determined that the RSO permitted the use of licensed materials from August 17 to October 10, 2000; however, the first batch of film or TLD whole body monitors was not received until October 10, 2000. Based on the low dose rates the workers were exposed to during the period they were unmonitored as well as the low number of patients that were treated during the period, it is unlikely that workers received any significant exposures. The NRC concluded that the RSO's failure to issue film or TLD whole body monitors to all individuals who were occupationally exposed to ionizing photon radiation on a regular basis was deliberate. Therefore, this violation has been categorized in accordance with the "General Statement of Policy and Procedures for NRC Enforcement Actions" (Enforcement Policy), NUREG-1600, May 1, 2000, as a Severity Level III violation.

In accordance with the Enforcement Policy, a base civil penalty in the amount of $2,750 is considered for each Severity Level III violation. The NRC considered whether credit was warranted for Identification and Corrective Action in accordance with the civil penalty assessment process in Section VI.B.2 of the Enforcement Policy. Credit was determined not to be warranted for Identification in that the NRC identified the violation, resulting in no mitigation of the base civil penalty. Based on EPSI's corrective actions as verified during an NRC inspection conducted at the EPSI facility on May 14, 2001, credit was warranted for the factor of Corrective Action.

Therefore, to emphasize the need for all individuals who are occupationally exposed to radiation on a regular basis to be issued a film or TLD whole body monitor, and in recognition of the significance of a willful violation of regulatory requirements, 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 $2,750 for the Severity Level III violation. In addition, issuance of this Notice constitutes escalated enforcement action that may subject you to increased inspection effort.

NRC Inspection Report No. 52-25493-01/00-01 also documented six additional apparent violations, and indicated that these apparent violations remained under NRC review. The NRC has completed its review of these issues, and has concluded that six violations occurred. The violations are cited in the enclosed Notice, and involved the failures to: (1) secure from unauthorized removal or access, or maintain under constant surveillance licensed material that was in an unrestricted area; (2) use syringe shields; (3) label syringes with the necessary information; (4) perform surveys for removable contamination once each week in all areas where radiopharmaceuticals were routinely prepared for use, administered, or stored; (5) monitor the external surfaces of incoming packages labeled with a Radioactive White I, Yellow II, or Yellow III label for radioactive contamination; and (6) perform surveys with a radiation detection survey instrument at the end of each day of use in all areas where radiopharmaceuticals were routinely prepared for use or administered. The NRC has concluded that, because your licensed activities only involved unit doses of diagnostic radiopharmaceuticals and the low safety significance of the violations, these violations should be characterized at Severity Level IV in accordance with the NRC Enforcement Policy.

The NRC has concluded that adequate 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 documented on the docket in your August 23, 2001, letter and in NRC Inspection Report 52-25493-01/00-01. In addition, the issues were reviewed during an NRC inspection conducted at the EPSI facility on May 14, 2001, as documented in NRC Inspection Report 52-25493-01/01-01, dated July 19, 2001. Therefore, you are not required to respond to this letter unless the description herein 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 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 (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,
		LOREN R. PLISCO FOR
		Bruce S. Mallett Regional Administrator

Docket No. 030-35256
License No. 52-25493-01

Enclosure:  Notice of Violation and Proposed Imposition of Civil Penalty

cc w/encl:  Commonwealth of Puerto Rico

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NOTICE OF VIOLATION
AND
PROPOSED IMPOSITION OF CIVIL PENALTY

El Señorial PSI Río Piedras, Puerto Rico

Docket No.: 030-35256 License No.: 52-25493-01 EA-01-145

During an NRC Office of Investigations investigation completed on April 30, 2001, and an NRC inspection completed on December 29, 2000, violations of NRC requirements were identified. In accordance with the "General Statement of Policy and Procedures for NRC Enforcement Actions," NUREG-1600, May 1, 2000, 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.	Violation Assessed a Civil Penalty
	License Condition 14 of NRC License No. 52-25493-01 requires, in part, that the licensee conduct its program in accordance with the statements, representations, and procedures contained in the license application dated July 19, 1999. Item 9.4 of the licensee's license application dated July 19, 1999, states, "[El Señorial PSI] will establish and implement the model personnel external exposure monitoring program published in Appendix D to Regulatory Guide 10.8, Revision 2." Item 2 of Appendix D to Regulatory Guide 10.8, Revision 2, states: "All individuals who are occupationally exposed to ionizing photon radiation on a regular basis will be issued a film or TLD whole body monitor that will be processed by a contract service on a monthly basis." Contrary to the above, from August 17, 2000 to October 10, 2000, the licensee failed to issue film or TLD whole body monitors to all individuals who were occupationally exposed to ionizing photon radiation on a regular basis. Specifically, the licensee commenced use of licensed materials on August 17, 2000, and obtained the first batch of film or TLD whole body monitors on October 10, 2000.
This is a Severity Level III violation (Supplement IV). Civil penalty – $2,750.
II.	Violations Not 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, as of November 14, 2000, the licensee did not secure from unauthorized removal or limit access to millicurie quantities of Technetium-99m, located in the imaging room, which is an unrestricted area, nor did the licensee control and maintain constant surveillance of this licensed material. Specifically, on several occasions when the nuclear medicine personnel were not available, licensed materials delivered by the nuclear pharmacy were unattended in the imaging room in front of the door to the hot laboratory until nuclear medicine personnel became available and secured the material.
This is a Severity Level IV violation (Supplement IV).
B.	License Condition 14 of NRC License No. 52-25493-01 requires in part that the licensee conduct its program in accordance with the statements, representations, and procedures contained in the license application dated July 19, 1999. Item 10.4 of the license application states that the licensee will establish and implement the model safety rules published in Appendix I to Regulatory Guide 10.8, Revision 2. Item 4 of Appendix I to Regulatory Guide 10.8, Revision 2, specifies that the licensee will use syringe shields for routine administration of radiopharmaceuticals to patients. Contrary to the above, on November 14, 2000, the licensee failed to use a syringe shield for a routine administration of a radiopharmaceutical to a patient. Specifically, the licensee placed the syringe in an upright shield until the time of administration and then administered the dose and handled the syringe without a shield during the administration, and a syringe shield was available.
This is a Severity Level IV violation (Supplement IV).
C.	License Condition 14 of NRC License No. 52-25493-01 requires in part that the licensee conduct its program in accordance with the statements, representations, and procedures contained in the license application dated July 19, 1999. Item 13 of Appendix I to Regulatory Guide 10.8, Revision 2, specifies that syringes and unit dosages should be labeled with the radiopharmaceutical name or abbreviation, type of study, or the patient's name. Contrary to the above, on November 14, 2000, the licensee failed to label syringes used for the administration of radiopharmaceutical doses with the radiopharmaceutical name or abbreviation, the type of study, or the patient's name. Specifically, the unlabeled syringes were removed from the labeled shielded container supplied by the nuclear pharmacy, and were placed in an unlabeled upright shielded container until the time of administration.
This is a Severity Level IV violation (Supplement VI).
D.	10 CFR 35.70(e) states that a licensee shall survey for removable contamination once each week all areas where radiopharmaceuticals are routinely prepared for use, administered, or stored. Contrary to the above, during the weeks of August 17 to November 13, 2000, the licensee did not survey for removable contamination in all areas where radiopharmaceuticals are routinely prepared for use, administered, or stored. Specifically, the licensee did not perform removable contamination surveys (wipes) on some occasions, and on other occasions obtained wipes that were not properly analyzed in that the licensee used an uncalibrated survey instrument.
This is a Severity Level IV violation (Supplement VI).
E.	10 CFR 20.1906(b) and (c) require that each licensee monitor the external surfaces of a package labeled with a Radioactive White I, Yellow II, or Yellow III label for: (1) radioactive contamination, unless the package contains only radioactive material in the form of a gas or in special form as defined in 10 CFR 71.4; and (2) radiation levels, unless the package contains quantities of radioactive material that are less than or equal to the Type A quantity, as defined in 10 CFR 71.4 and Appendix A to Part 71. This monitoring shall be performed as soon as practicable, but not later than 3 hours after receipt of the package during the licensee's normal working hours, or not later than 3 hours from the beginning of the next working day if it is received after working hours. Contrary to the above, from August 17 to November 13, 2000, the licensee received packages labeled with a Radioactive White I/Yellow II label during working hours, the packages were not exempt from the monitoring requirement for radioactive contamination and radiation levels, and the licensee did not perform the required monitoring. Specifically, the inspector determined that the licensee obtained and counted samples of removable contamination (wipes), but did not properly analyze them in that the licensee used an uncalibrated survey instrument.
This is a Severity Level IV violation (Supplement IV).
F.	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, from September 1, 2000 until September 18, 2000, the licensee did not survey with a radiation detection instrument at the end of the day areas where radiopharmaceuticals were routinely prepared for use and administered.

This is a Severity Level IV violation (Supplement VI).

The NRC has concluded that adequate information regarding the reasons for the violation, the corrective actions taken and planned to correct the violations and prevent recurrence and the date when full compliance was achieved is already documented on the docket in EPSI's letter dated August 23, 2001, and in NRC Inspection Report No. 52-25493-01/00-01. In addition, these issues were reviewed during an NRC inspection conducted at the EPSI facility on May 14, 2001. Therefore, you are not required to respond to this Notice. 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 II within 30 days of the date of the letter transmitting this 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.

The response noted above (Reply to Notice of Violation, statement as to payment of civil penalty, and Answer to a Notice of Violation) should be addressed to: Mr. Frank J. 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.

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 (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 28^th day of September 2001