EA-98-184 - José M. Colón Vaquer, M.D.

May 22, 1998

EA 98-184

José M. Colón Vaquer, M.D.
P.O. Box 76
Manatí, Puerto Rico 00674

SUBJECT:

NOTICE OF VIOLATION AND PROPOSED IMPOSITION OF CIVIL PENALTY – $4,400  (NRC INSPECTION REPORT NO. 52-25113-02/98-01)

Dear Dr. Colón:

This refers to the special inspection conducted on March 2 and 5, 1998, at your Manatí, Puerto Rico facility. The purpose of the special inspection was to determine whether activities authorized by the license were conducted safely and in accordance with regulatory requirements. The results of the inspection were discussed with you on March 5, 1998, and were formally transmitted to you by letter dated April 4, 1998. Based on the preliminary inspection results, you submitted a March 6, 1998, letter stating that you would suspend use of your Strontium-90 (Sr-90) eye applicator and place it in locked safe storage. On April 16, 1998, you agreed with the commitments described in the NRC's letter of April 15, 1998, regarding a Confirmatory Order Modifying License (Order) associated with discontinuance of use of your Sr-90 eye applicator. The NRC confirmed your commitment to do so with the issuance of the Order, effective immediately, on April 21, 1998. A closed and transcribed predecisional enforcement conference was conducted in the Region II office on May 4, 1998, to discuss the apparent violations, the root causes, and your corrective actions to preclude recurrence. A list of conference attendees, a copy of the Nuclear Regulatory Commission's (NRC) presentation material, and a copy of the information you provided at the conference are enclosed.

Based on the information developed during the inspection and the information you provided during the conference, the NRC has determined that ten violations of regulatory requirements occurred. The violations are cited in the enclosed Notice of Violation and Proposed Imposition of Civil Penalty (Notice), and the circumstances surrounding them are described in detail in the subject inspection report.

The violations, as enumerated in the enclosed Notice, involve: the failure to use written directives on multiple occasions as required by 10 CFR 35.32(a)(1); the failure to have a written procedure to ensure that final treatment plans and related calculations (exposure time) were in accordance with written directives as required by 10 CFR 35.32(a)(3); the failure to limit activities involving byproduct material to those related to decommissioning following the expiration of license No. 52-25113-01 as required by 10 CFR 30.36(c); the failure to secure from unauthorized removal or access to licensed material as required by 10 CFR 20.1801; the failure to perform annual reviews of the radiation protection program as required by 10 CFR 20.1101(c); the failure to test a brachytherapy source for leakage as required by 10 CFR 35.59(b)(2) (this is a repeat violation); the failure to perform brachytherapy surveys quarterly as required by 10 CFR 35.59(h); the failure to issue personnel dosimetry monitoring as required by condition 17 of license No. 52-25113-02; the failure to record brachytherapy source inventories as required by 10 CFR 35.59(g); and the failure to post copies of the current license and NRC regulations as required by 10 CFR 19.11(a) and (b). In addition, our inspection of March 2 and 5, 1998, identified that you did not take actions to correct an earlier violation identified during an inspection conducted on August 10, 1995, regarding the performance of an annual review of the Quality Management Program (QMP) as required by 10 CFR 35.32(b)(1). Thus, you continued to be in violation of this requirement from the time of identification on August 10, 1995, until the expiration of license No. 52-25113-01, on November 30, 1995. It should also be noted that you have not conducted a review of your QMP since issuance of License No. 52-25113-02 on March 28, 1997.

At the conference, you agreed that the violations occurred as documented in NRC Inspection Report No. 52-25113-02/98-01, and stated that the cause of the violations involved several factors, including personal hardship, the loss of key personnel at your office, and increased demands on your office associated with new health services reforms. Because of these factors, you did not apply the appropriate attention to ensure compliance with regulatory requirements.

Violations I.A and I.B of the enclosed Notice describe two misadminstrations. Although the misadministrations were not substantial and were within the normal treatment ranges the violations represent a substantial programmatic failure in the implementation of your QMP that resulted in at least these two misadminastrations. As a result, one individual was misadministered approximately 1500 centigrays instead of the intended dose of 1000 centigrays, while another individual was misadministered approximately 1000 centigrays instead of the intended dose of 1500 centigrays. In addition to the misadministrations, as a license holder, you are required to establish and maintain a written QMP to provide high confidence that byproduct material or radiation from byproduct material will be administered as directed by you, the authorized user. In this case, you routinely failed to prepare written directives to ensure proper administration of radiation dose and failed to provide for the verification of the calculations for exposure times. Therefore, Violations I.A and I.B are considered to be of very significant regulatory concern and 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 II problem.

In accordance with the Enforcement Policy, a base civil penalty in the amount of $4400 is normally considered for a Severity Level II problem. 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. These issues were identified as a result of an NRC inspection. Although you identified Violations I.A and I.B at the beginning of the inspection, you did so only after our announcement of an inspection at your facility which prompted you to review your QMP. The NRC has concluded that absent the announcement of our intent to conduct an inspection, these issues would not have been identified by you. As such, no credit is warranted for Identification. Your corrective actions, as indicated at the predecisional enforcement conference, included immediately suspending the use of your Sr-90 eye applicator source, and immediate placement of the Sr-90 source in locked safe storage. As stated earlier, you confirmed your commitment to take these actions by agreement to a Confirmatory Order Modifying License, effective immediately, issued by the NRC on April 21, 1998. You stated that you have reviewed the misadministrations and have concluded that no adverse consequences will result, as the total applied doses in both cases were below the maximum recommended dosage. You also have notified one of the patients involved and have attempted to notify the other one, and have offered medical followup. In addition, you stated at the conference that you are actively pursuing the transfer or disposal of your Sr-90 source. Thus, based on these facts, the NRC determined that credit is warranted for Corrective Action.

Violations I.A and I.B represent a substantial programmatic failure in your QMP which resulted in the misadministration of dose to two individuals. Therefore, to emphasize the importance of compliance with QMPs associated with the administration of brachytherapy doses to the eye, and after consultation with the Director, Office of Enforcement, I have been authorized to propose the enclosed Notice of Violation and Proposed Imposition of Civil Penalty in the amount of $4,400. Issuance of this Notice constitutes escalated enforcement action, that may subject you to increased inspection effort. In addition, you should be aware that future similar violations may result in a prohibition against conducting licensed activities in NRC jurisdiction.

Violation A in Part II of the Notice occurred as a result of your use of the Sr-90 eye applicator during a period when your license was expired, contrary to regulatory requirements and verbal instructions by the NRC. You stated at the conference that you unsuccessfully attempted to file a new application for an NRC license after expiration of your first license on December 1, 1995, and solicited the help of other individuals to assist in the preparation of the required application document. However, due to difficulties you encountered in acquiring assistance in completing and filing the new application, and the personal hardships you were experiencing at that time, you failed to do so. Nonetheless, your failure in assuring regulatory processes were adequately completed, which resulted in the unauthorized use of licensed radioactive material, represents a significant regulatory concern. Therefore, this violation is classified at Severity Level III in accordance with the "General Statement of Policy and Procedures for NRC Enforcement Actions" (Enforcement Policy), NUREG-1600.

Violations B through H of Part II of the Notice indicate a significant breakdown and lack of attention toward licensed responsibilities. The large number of non-compliances with regulatory requirements demonstrate your inability or unwillingness to develop and maintain the required oversight of the use of licensed radioactive material. Accordingly, these violations 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.

Regarding Violations A through H in Part II of the Notice, in accordance with the Enforcement Policy, a base civil penalty in the amount of $2750 is considered for each Severity Level III problem or violation. Because you have 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 discussed above for the Violations in Part I of the Notice, credit is warranted for Corrective Action.

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 for Violations A through H of Part II of the Notice. However, significant violations in the future could result in a civil penalty.

Since you have indicated your intent to transfer or dispose of your Sr-90 eye applicator in the future, the NRC will consider reducing the proposed civil penalty to $2200 if you properly dispose of or transfer the Sr-90 eye applicator in accordance with existing regulations within 90 days of the date of this enforcement action. If you decide to do so, you should specify your intentions in your response to the enclosed Notice. In addition, you should provide written confirmation to the NRC when you have properly disposed of or transferred the Sr-90 eye applicator.

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 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 LAR
	Luis A. Reyes Regional Administrator

Docket No. 030-34060
License No. 52-25113-02

Enclosures:	1.  Notice of Violation and Imposition of Civil Penalty
	2.  List of Attendees
	3.  NRC Slides
	4.  Licensee Material

NOTICE OF VIOLATION
AND
PROPOSED IMPOSITION OF CIVIL PENALTY

---

José M. Colón Vaquer, M.D. Manatí, Puerto Rico

Docket No. 030-034060 License Nos. 52-25113-01 (expired) and 52-25113-02 EA 98-184

During an NRC inspection conducted on March 2 and 5, 1998, violations of NRC requirements were identified. In accordance with the "General Statement of Policy and Procedures 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 35.32(d) requires, for each administration of a radiopharmaceutical or radiation for which a written directive is required under 10 CFR 35.32(a)(1), that the licensee retain, for three years after the date of the administration, the written directive and a record of the radiation dose or radiopharmaceutical dosage administered.
		10 CFR 35.2 defines a written directive as an order in writing for a specific patient, dated and signed by an authorized user prior to the administration of a radiopharmaceutical or radiation and containing certain specified information.
		10 CFR 35.32(a)(1)(iii) requires, with exemptions not applicable here, that a written directive be prepared for any brachytherapy radiation dose.
		Contrary to the above, between June 24, 1994, and March 5, 1998, the licensee used a 91 millicurie (mCi) Strontium-90 eye applicator for the administration of brachytherapy radiation doses on approximately 131 occasions, and did not prepare written directives for the administrations. Consequently, no written directives or radiation dose records were retained for the required retention period. (01012)
	B.	10 CFR 35.32(a) requires, in part, that the licensee establish and maintain a written quality management program to provide high confidence that byproduct material or radiation from byproduct material will be administered as directed by the authorized user.
		Pursuant to 10 CFR 35.32(a)(3), the quality management program must include written policies and procedures to meet the specific objective that final plans of treatment and related calculations for brachytherapy, teletherapy, and gamma stereotactic radiosurgery are in accordance with a written directive, which is defined in 10 CFR 35.2.
		10 CFR 35.2 defines a written directive as an order in writing for a specific patient, dated and signed by an authorized user prior to the administration of a radiopharmaceutical or radiation and containing, for brachytherapy, (1) prior to implantation: the radioisotope, number of sources, and source strengths; and (2) after implantation but prior to completion of the procedure: the radioisotope, treatment site, and total source strength and exposure time (or, equivalently, the total dose).
		Contrary to the above, as of March 5, 1998, the licensee's quality management program did not include a dosimetry calculation/verification procedure to ensure that final treatment plans and related calculations for brachytherapy were in accordance with written directives. As a result, two misadministrations occurred on August 23, and September 27, 1994, respectively. (01022)
	This is a Severity Level II Problem (Supplement VI). Civil Penalty - $4,400.
II.	Violations Not Assessed a Civil Penalty
	A.	10 CFR 30.36(c) states that each specific license continues in effect, beyond the expiration date if necessary, with respect to possession of byproduct material until the Commission notifies the licensee in writing that the license is terminated. During this time, the licensee shall limit its actions involving byproduct material to those related to decommissioning.
		Contrary to the above, on November 30, 1995, the licensee's byproduct material license No. 52-25113-01 expired, and between December 1, 1995 and March 27, 1997, the licensee failed to limit actions involving byproduct material to those related to decommissioning. Specifically, the licensee used byproduct material (91 mCi of Strontium-90) for medical purposes on approximately 52 occasions after expiration of the license. (02013)
	This is a Severity Level III Violation (Supplement VI).
	B.	10 CFR 20.1801 requires that the licensee shall secure from unauthorized removal or access licensed materials that are stored in controlled or unrestricted areas. 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 5, 1998, the licensee did not secure from unauthorized removal or limit access to an eye applicator brachytherapy source containing approximately 91 mCi of Sr-90. Specifically, the Sr-90 source was in an unlocked file cabinet, and the licensee did not control and maintain constant surveillance of the area. (03013)
	C.	10 CFR 20.1101(c) requires, in part, that licensees review periodically (at least annually) the radiation protection program content and implementation.
		Contrary to the above, as of March 5, 1998, the licensee failed to review periodically (at least annually) the radiation protection program content and implementation for the years 1995 and 1997. (03023)
	D.	10 CFR 35.59(b)(2) requires, in part, that a licensee in possession of a sealed source test the source for leakage at intervals not to exceed six months or at other intervals approved by the Commission or an Agreement State.
		Contrary to the above, between March 28, 1997, and March 5, 1998, an interval in excess of six months, the licensee did not test a sealed source containing approximately 91 mCi of Sr-90 for leakage. No other interval was approved by the Commission or an Agreement State. (03033)
	E.	10 CFR 35.59(h) requires, in part, that a licensee in possession of a sealed source or brachytherapy source measure the ambient dose rates quarterly in all areas where such sources are stored.
		Contrary to the above, from March 28, 1997, until March 5, 1998, a period in excess of a calendar quarter, the licensee did not measure the ambient dose rates in exam room 1, the area where the brachytherapy source was stored. (03043)
	F.	Condition 17 of NRC License No. 52-25113-02, requires, in part, that the licensee conduct its program in accordance with the statements, representations, and procedures contained in the documents listed therein, including any of their enclosures. Included therein are the application dated January 31, 1996, and a letter dated May 16, 1996.
		Item C of the application, states, in part, that the licensee "will establish and implement the model personnel external radiation exposure monitoring program published in Appendix D - Regulatory Guide 10.8 Revision 2, August 1987."
		The model personnel external radiation exposure monitoring program published in Appendix D to Regulatory Guide 10.8, Revision 2, August 1987, states that "all individuals who, on a regular basis, handle radioactive materials that emit ionizing photons will be issued a film or TLD finger monitor that will be processed by a contract service on a monthly basis."
		Contrary to the above, from September 1995 until March 5, 1998, the licensee did not issue a film or TLD finger monitor to an authorized user who, on a regular basis, handled radioactive materials that emit ionizing photons. Specifically, the licensee's personnel dosimetry contract service was canceled by the supplier in September 1995 and the licensee did not obtain the services of another provider. (03053)
	G.	10 CFR 35.59(g) requires, in part, that a licensee retain for five years records of quarterly physical inventories of sealed sources and brachytherapy sources in its possession, and that the records contain the model number of each source, and serial number if one has been assigned, the identity of each source radionuclide and its nominal activity, the location of each source, and the signature of the Radiation Safety Officer.
		Contrary to the above, as of March 5, 1998, the licensee did not retain records of quarterly physical inventories of the brachytherapy sources in its possession between March 28, 1997, and March 5, 1998. Specifically the licensee did not create physical inventory records. Consequently, no records were retained for the required retention period. (03063)
	H.	10 CFR 19.11(a) and (b) require, in part, that the licensee post current copies of Part 19, Part 20, the license, license conditions, documents incorporated into the license, license amendments and operating procedures; or that the licensee post a notice describing these documents and where they may be examined. 10 CFR 19.11(c) requires that a licensee post Form NRC-3, "Notice to Employees."
		Contrary to the above, as of March 5, 1998, the licensee had not posted current copies of Part 19, Part 20, Form NRC-3, the license, license conditions, documents incorporated into the license, license amendments and operating procedures; nor had the licensee posted a notice describing these documents and where they may be examined. (03073)
	This is a Severity Level III Problem (Supplement VI).

Pursuant to the provisions of 10 CFR 2.201, José M. Colón Vaquer, M.D. (Licensee) is hereby required to submit a written statement or explanation to the Director, Office of Enforcement, U.S. Nuclear Regulatory Commission, within 30 days of the date of this Notice of Violation and Proposed Imposition of Civil Penalty (Notice). This reply should be clearly marked as a "Reply to a Notice of Violation" and should include for each alleged violation: (1) admission or denial of the alleged violation, (2) the reasons for the violation if admitted, and if denied, the reasons why, (3) the corrective steps that have been taken and the results achieved, (4) the corrective steps that will be taken to avoid further violations, and (5) the date when full compliance will be achieved. 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. Consideration may be given to extending the response time for good cause shown. Under the authority of Section 182 of the Act, 42 U.S.C. 2232, this response shall be submitted under oath or affirmation.

Within the same time as provided for the response required above under 10 CFR 2.201, the Licensee may pay the civil penalty by letter addressed to the Director, Office of Enforcement, U.S. Nuclear Regulatory Commission, with a check, draft, money order, or electronic transfer payable to the Treasurer of the United States in the amount of the civil penalty proposed above, or the cumulative amount of the civil penalties if more than one civil penalty is proposed, 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 the time specified, 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.B.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, letter with payment of civil penalty, and Answer to a Notice of Violation) should be addressed to: James Lieberman, 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.

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 22nd day of May 1998