EA-96-053 - Ashford Presbyterian Community Hospital

March 19, 1996

EA 96-053

Ashford Presbyterian Community Hospital
ATTN: Mr. Ivin Colin, Administrator
1451 Ashford Avenue
P. O. Box 32
San Juan, Puerto Rico 00902

SUBJECT:

NOTICE OF VIOLATION AND PROPOSED IMPOSITION OF CIVIL PENALTY – $2,500 (NRC Inspection Report No. 52-11810-02/96-01)

Dear Mr. Colin:

This letter refers to the inspection conducted at your medical facility in San Juan, Puerto Rico, on January 29-30, 1996. The inspection included a review of the implementation of your Quality Management Program (QMP) as required by 10 CFR Part 35. The results of the inspection were formally transmitted to you by letter dated February 21, 1996. A closed predecisional enforcement conference was conducted in the Region II office on March 6, 1996, to discuss the apparent violations, the root causes, and your corrective actions to preclude recurrence. A list of conference attendees, NRC slides, and a copy of the written materials which you presented to NRC are enclosed.

Based on the information developed during the inspection and the information you provided during the conference, the NRC has determined that violations of NRC requirements occurred. These 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. Violation A, in Part I of the Notice, involved a failure to implement the QMP as required by 10 CFR 35.32. Specifically, during 1994 and 1995, at least ten diagnostic administrations of iodine-131 (I-131) in quantities greater than 30 microcuries occurred without the required written directive or a review to identify and evaluate any unintended deviation from the written directives. Violation B, in Part I of the Notice, involved the failure to train key individuals, in particular the nuclear medicine technologists, on the QMP requirements applicable to diagnostic administrations of sodium iodide I-131 in quantities greater than 30 microcuries and the therapeutic administration of strontium-89 (Sr-89) radiopharmaceuticals. The root cause of Violations A and B, in Part I of the Notice, was the lack of management supervision and the Radiation Safety Officer's (RSO) lack of knowledge regarding the requirements of the QMP.

Based on our inspection findings and information provided during the predecisional enforcement conference and by your RSO during a telephone conversation on March 13, 1996, it is our understanding that you had implemented your QMP for the administrations of therapeutic radiopharmaceuticals. Specifically, your review of patient records determined that there were written directives for the two therapeutic administrations of Sr-89. However, the NRC is concerned that the violations in Part I of the Notice represent a substantial failure to implement the QMP which could have resulted in the administration of improper dosages of I-131 to patients. We recognize that the dosages administered were within the ranges that had been approved by authorized user physicians in the past. It is important to have a fully implemented QMP covering all aspects of significant radiopharmaceutical usage in order to provide high confidence that byproduct material will be administered as directed by the authorized user. Therefore, the violations in Part I of the Notice are classified in the aggregate in accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions" (Enforcement Policy), NUREG-1600, as a Severity Level III problem.

In accordance with the Enforcement Policy, a base civil penalty in the amount of $2,500 is considered for a Severity Level III problem. Because your facility has been the subject of escalated enforcement actions within the last two inspections, 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. In this case, the NRC has concluded that it would not be appropriate to give credit for Identification because the violation was identified by the NRC. In considering Corrective Action, we found that your corrective actions for this violation included a thorough review of pertinent administrations of radiopharmaceuticals and substantial training of personnel involved in licensed activities. In view of these actions, the NRC concluded that credit is warranted for Corrective Action.

Therefore, to emphasize the importance of full implementation of the QMP with respect to the administration of radiopharmaceuticals and the need for prompt identification of violations, I have been authorized, after consultation with the Office of Enforcement, to issue the enclosed Notice of Violation and Proposed Imposition of Civil Penalty in the base amount of $2,500 for the Severity Level III problem.

In addition, the violation described in Part II of the Notice involved your failure to review the implementation of the QMP within the required twelve-month interval as required by 10 CFR 35.32(b). Timely performance of the audit could have identified the administration of radiopharmaceuticals without written directives and the associated potential risk of administering improper doses. At the conference, you stated that to correct the violation you performed a complete review of the QMP on February 5, 1996.

You are required to respond to this letter and should follow the instructions specified in the enclosed Notice when preparing your response. In your response, you should document the specific actions taken and any additional actions you plan to prevent recurrence. After reviewing your response to this Notice, including your proposed corrective actions and the results of future inspections, the NRC will determine whether further NRC enforcement action is necessary to ensure compliance with NRC 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 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.

Should you have any questions concerning this letter, please contact us.

Sincerely,

Stewart D. Ebneter Regional Administrator

Docket No. 030-09858br> License No. 52-11810-02

Enclosures:
1. Notice of Violation and Proposed Imposition of Civil Penalty
2. List of Conference Attendees
3. NRC Slides
4. Licensee Handout at Predecisional Enforcement Conference

cc w/encls: Commonwealth of Puerto Rico

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NOTICE OF VIOLATION
AND
PROPOSED IMPOSITION OF CIVIL PENALTY

Ashford Presbyterian Community Hospital San Juan, Puerto Rico

Docket No. 030-09858 License No. 52-11810-02 EA 96-053

During an NRC inspection conducted on January 29-30, 1996, violations of NRC requirements were identified. In accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions," NUREG-1600, the Nuclear Regulatory Commission 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(a) provides, 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.

10 CFR 35.32(a)(1) provides, in part, that the Quality Management Program must include written policies and procedures to meet the specific objective that, prior to administration, a written directive is prepared for any administration of quantities greater than 30 microcuries of sodium iodide I-131, or any therapeutic administration of a radiopharmaceutical, other than sodium iodide I-125 or I-131.

10 CFR 35.32(a)(5) states, in part, that the Quality Management Program must include written policies and procedures to meet the specific objective that any unintended deviation from the written directive is identified and evaluated, and appropriate action is taken.

Item I.A.1 of the licensee's Quality Management Program requires that prior to the administration of quantities greater than 30 microcuries of I-131, any administration dose be dated and signed by an NRC authorized user.

Item I.B.2 of the licensee's Quality Management Program requires that after administration of quantities greater than 30 microcuries of I-131, the chief nuclear medicine technologist check the patient's treatment chart in order to detect mistakes in connection with the dose administered.

Contrary to the above, on at least ten occasions during 1994 and 1995, the licensee failed to fully implement its Quality Management Program with regard to diagnostic administrations of sodium iodide I-131 as evidenced by the following:

1. The authorized users failed to prepare, sign, and date written directives for diagnostic administrations of sodium iodide I-131 in quantities greater than 30 microcuries.

2. The chief technologist did not check the patients' treatment charts in order to detect mistakes in connection with the dose administered. (01013)

B. 10 CFR 35.25(a)(1) requires, in part, that a licensee that permits the use of byproduct material under the supervision of an authorized user instruct the supervised individual in the licensee's written quality management program.

Contrary to the above, as of January 29, 1996, the licensee had not adequately instructed its nuclear medicine technologists in the licensee's written quality management program regarding diagnostic uses of sodium iodide I-131 in quantities greater than 30 microcuries or therapeutic uses of Strontium-89. (01023)

This is a Severity Level III problem (Supplement VI).
Civil Penalty – $2,500

II. Violation Not Assessed a Civil Penalty

10 CFR 35.32(b) requires, in part, that the licensee develop procedures for and conduct a review to verify compliance with all aspects of the quality management program at intervals no greater than 12 months.

Contrary to the above, as of January 30, 1996, the licensee had not conducted a review to verify compliance with the quality management program since approximately June 1994, an interval greater than 12 months. (02014)

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

Pursuant to the provisions of 10 CFR 2.201, Ashford Presbyterian Community Hospital, (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 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 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 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. However, if you find it necessary to include such information, you should clearly indicate the specific information that you desire not to be placed in the PDR, and provide the legal basis to support your request for withholding the information from the public.

Dated at Atlanta, Georgia this 19th day of March 1996