EA-97-260 - St. Luke's Episcopal Hospital

January 30, 1998

EA 97-620

St. Luke's Episcopal Hospital/Caribbean
Nuclear Pharmaceuticals, Inc.
ATTN: Ms. Luz Rodriguez
Acting Director
St. Luke's Episcopal Hospital
P. O. Box 984
Ponce, Puerto Rico 00733-0984

(NRC INSPECTION REPORT NO. 52-16061-02MD/97-02)

Dear Ms. Rodriguez:

This refers to the inspection conducted on December 8 and 9, 1997 at the commercial nuclear pharmacy, operated by Caribbean Nuclear Pharmaceuticals, Inc. (CNP), under radiopharmacy license No. 52-16061-02MD, issued to St. Luke's Episcopal Hospital (St. Luke's)/CNP in Ponce, Puerto Rico. The purpose of the 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 formally transmitted to you by letter dated January 6, 1998. Based on the results of the inspection, a Confirmatory Action Letter (CAL) was issued on December 11, 1997, confirming that certain licensed activities would be discontinued until appropriate corrective actions were implemented and written confirmation of completion of the actions prescribed by the CAL was submitted to the NRC. In separate responses dated December 12, 1997, both St. Luke's and CNP confirmed that the actions prescribed by the CAL were complete. An open predecisional enforcement conference was conducted in Ponce, Puerto Rico on January 13, 1998, to discuss the apparent violations, the root causes, and your corrective actions to preclude recurrence. A list of conference attendees and copies of the Nuclear Regulatory Commission's (NRC) presentation materials are enclosed.

At the predecisional enforcement conference, the management of St. Luke's and CNP raised questions regarding who was intended to be the licensed entity and who was responsible for program oversight at the nuclear pharmacy. NRC License No. 52-16061-02MD designates the licensee as St. Luke's Episcopal Hospital/Caribbean Nuclear Pharmaceuticals, Inc. The management of CNP accepted full responsibility for the activities conducted under the license and clearly stated that CNP never intended for St. Luke's to have any responsibility under the radiopharmacy license. The current St. Luke's administration stated that they thought the arrangement between the two entities was strictly a landlord/tenant relationship and believed that they did not have oversight or other responsibility for radiopharmacy license No. 52-16061-02MD. The management of St. Luke's and CNP stated that the only reason St. Luke's was included on the license was because the NRC license reviewer indicated that separate licenses are not issued to groups located at the same medical institution. In this case, the pharmacy is located on the hospital grounds but in a building separate from the hospital. At the conference, both groups verbally requested a license amendment to change the licensee to only CNP. The NRC agreed to consider issuing a specific license to CNP upon receipt of a formal request.

After consideration of the licensing issues raised at the conference, the NRC has concluded that under the current license, both St. Luke's and CNP are responsible for proper implementation of licensed activities. As discussed at the conference, the NRC expects St. Luke's to provide appropriate oversight of the licensed activities conducted by CNP as long as St. Luke's is listed on the license as a responsible party.

Based on the information developed during the inspection and the information provided during the conference, the NRC has determined that violations of NRC 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 involved numerous examples of failures by CNP personnel to comply with regulatory requirements and the conditions of their NRC license. The violations included: (1) the failure to conduct surveys to demonstrate compliance with radiation dose limits for individual members of the public as a result of emissions of iodine-131 through a fume hood exhaust; (2) three separate examples of the failure to perform adequate surveys to demonstrate compliance with occupational radiation dose limits; (3) the failure to perform sealed source leak tests; (4) the failure to possess a required thyroid uptake probe; (5) the failure to calibrate radiation survey instruments; (6) the failure to perform a quarterly dose calibrator linearity test, a repeat finding from an inspection conducted on January 27, 1997; and (7) the failure to perform an adequate dose calibrator linearity test. The root causes of the violations were the lack of adequate CNP management oversight, particularly given the inexperience of the CNP Radiation Safety Officer (RSO).

Although the individual violations identified actually had only minor safety consequences, they represent a significant regulatory concern because they reflect a programmatic breakdown in your control of licensed activities. The lack of independent reviews of the RSO's activities and the lack of adequate oversight of licensed activities by the upper management of CNP are of particular concern to the NRC. The NRC is also concerned that the pharmacy's RSO did not effectively carry out his duties as RSO during a period of significant growth in the scope of licensed activities. In addition, Violation C.3 is a repeat of a violation identified in January 1997, indicating that your prior corrective actions were ineffective. Therefore, 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.

In accordance with the Enforcement Policy, a base civil penalty in the amount of $2750 is considered for a Severity Level III problem. Because your facility has not been the subject of escalated enforcement actions since original licensing of the facility, the NRC considered whether credit was warranted for Corrective Action in accordance with the civil penalty assessment process in Section VI.B.2 of the Enforcement Policy. Your corrective actions included: (1) implementation of effluent monitoring and associated procedures; (2) timely conduct of employee bioassays and establishment of long-term arrangements for services; (3) aquisition of calibrated instrumentation; (4) conduct of leak tests for sealed sources; (5) specific instruction for the RSO on regulatory requirements and procedures; (6) implementation of an audit program including quarterly and unannounced audits; (7) implementation of manual and computerized task tracking systems; and, (8) addition of new employees including a contract physicist. In addition, St. Luke's stated that they had included the pharmacy's RSO on the Radiation Safety Committee and would include the pharmacy in the hospital's audit plan until the licensing issues are resolved. Based on these facts, the NRC determined that credit was warranted for the factor of Corrective Action.

Therefore, to encourage prompt and comprehensive correction of violations and in consideration of the absence of previous escalated enforcement, I have been authorized not to propose a civil penalty in this case. However, you should be aware that the NRC staff gave serious consideration to exercising enforcement discretion to propose a civil penalty, notwithstanding the credit given for your corrective actions. The violations in the attached Notice, and the insufficient involvement in ensuring implementation of program requirements on the part of CNP management and the RSO, reflect particularly poor licensee performance. The NRC expects and requires that your licensed program be conducted in accordance with NRC requirements. Failure to do so in the future may result in more significant enforcement action, including the assessment of civil penalties and modification, suspension, or revocation of your NRC license. In addition, issuance of this Notice constitutes escalated enforcement action that may subject you to increased inspection effort.

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.

If you have any questions regarding this letter, please contact Douglas M. Collins, Director, Division of Nuclear Materials Safety at (404) 562-4700.


Luis A. Reyes
Regional Administrator

Docket No. 030-34161
License No. 52-16061-02MD

1. Notice of Violation
2. List of Attendees
3. NRC Slides

cc w/encls:
Commonwealth of Puerto Rico

W. Cox, President
Carribbean Nuclear Pharmaceuticals, Inc.
25 Midtown Park West
Mobile, Alabama 36606


St. Luke's Episcopal Hospital/
Caribbean Nuclear Pharmaceuticals, Inc.
Ponce, Puerto Rico
Docket No. 030-34161
License No. 52-16061-02MD
EA 97-620

During an NRC inspection conducted on December 8-9, 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 20.1501(a) requires that the licensee make or cause to be made, as appropriate, surveys that may be necessary for the licensee to comply with the regulations in 10 CFR 20, and are reasonable under the circumstances to evaluate: (1) the extent of radiation levels, (2) concentrations or quantities of radioactive material, and (3) the potential radiological hazards that could be present.

10 CFR 20.1003 defines "survey" as an evaluation of the radiological conditions and potential hazards incident to the production, use, transfer, release, disposal or presence of radioactive materials or other sources of radiation.

1. Contrary to the above, as of December 9, 1997, the licensee was not performing surveys to ensure compliance with the dose limits in 10 CFR 20.1301 for individual members of the public. Specifically, the licensee was not surveying iodine-131 effluents released from its hood to ensure that members of the public were not being exposed to levels exceeding the limits specified in 10 CFR 20.1301. (01013)

2. Contrary to the above, as of December 9, 1997, the licensee's surveys used to demonstrate compliance with the occupational dose limits in 10 CFR 20.1201 were inadequate in that:

a. The licensee was using the incorrect efficiency of its well counter to assess thyroid intakes of iodine-131. Specifically, the licensee calibrated the well counter with a source rod placed inside the well and licensee personnel performed thyroid bioassays by placing each side of their thyroids at the surface of the well, thus significantly underestimating the results of the bioassay.

b. The Radiation Safety Officer's extremity monitoring was inadequate in that he placed his ring film badge facing away from the palm of his hands, thus significantly underestimating the exposure received by the palms of his hands.

c. As of December 9, 1997, the licensee's surveys of the breathing zone work sp ace air around the iodine-131 handling hood were inadequate in that they were not representative. Specifically, the filter used to collect volatilized iodine-131 for analysis was located near the pharmacist's waist, and there was no evaluation performed to demonstrate that the air sampled was representative of the pharmacist's breathing zone. (01023)

B. Condition No. 12.A of License No. 52-16061-02MD requires, in part, that the licensee test its sealed sources for leakage at intervals not to exceed six months.

Contrary to the above, as of December 9, 1997, the licensee had not tested its sealed sources for leakage since their receipt in October 1996, an interval in excess of six months. (01033)

C. Condition No.21 of License No. 52-16061-02MD requires, in part, that the licensee conduct its program in accordance with the statements, representations and procedures contained in the license application dated June 5, 1996.

1. Item 9 of the application dated June 5, 1996, specifies that the licensee will possess a thyroid uptake probe.

Contrary to the above, as of December 9, 1997, the licensee did not possess a thyroid uptake probe. (01043)

2. Item 10.3 of the application dated June 5, 1996, states that a survey meter will not be used beyond the anniversary of its last successful calibration.

Contrary to the above, as of December 9, 1997, three survey meters were in use at the CNP pharmacy beyond the anniversary of their last successful calibration. The meters included: (1) a Ludlum Model 177 contamination monitor (serial number 123636), last calibrated on August 23, 1995; (2) a Ludlum Model 2200 survey meter (serial number 130501), last calibrated on September 17, 1996; and (3) a Ludlum Model 14C survey meter (serial number 129741), last calibrated on September 19, 1996. (01053)

3. Item 10.4.3.c of the application dated June 5, 1996, requires, in part, that the dose calibrator be tested for linearity at quarterly intervals.

Contrary to the above, the licensee's dose calibrator was not tested for linearity between March 1997 and July 1997, an interval in excess of one quarter. This is a repeat violation. (01063)

4. Item 10.4.3.c of the application dated June 5, 1996, further specifies that, as an alternate dose calibrator linearity test procedure, the linearity test can be performed with the Calicheck kit, and that its manufacturer's instructions for use will be followed.

The manufacturer's instructions for use of the Calicheck kit specify that, once initially determined, sleeve calibration factors may not be changed unless the dose calibrator has been serviced or if the sleeves are used in another dose calibrator.

Contrary to the above, the licensee did not follow the manufacturer's instructions for the use of the Calicheck kit during the linearity test conducted during the fourth quarter of 1997. Specifically, the licensee changed the calibration factors, and the dose calibrator had not been serviced and no other dose calibrator was in use, thus rendering inaccurate linearity test results. (01073)

These violations represent a Severity Level III problem (Supplement VI).

Pursuant to the provisions of 10 CFR 2.201, St. Luke's Episcopal Hospital/ Caribbean Nuclear Pharmaceuticals, Inc. 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.

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 20555-0001.

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

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 30th day of January 1998

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