ML20217N118
| ML20217N118 | |
| Person / Time | |
|---|---|
| Site: | 03019679 |
| Issue date: | 04/28/1998 |
| From: | Reyes L NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION II) |
| To: | Pena S RYDER MEMORIAL HOSP., HUMACAO, PR |
| Shared Package | |
| ML20217N121 | List: |
| References | |
| 30-19679-97-01, 30-19679-97-1, EA-97-626, NUDOCS 9805050224 | |
| Download: ML20217N118 (6) | |
See also: IR 07100117/2012011
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. - , . g , = - S E b - $ April 28, 1998 E8 EA 97-626 " 9 - Ryder Memorial Hospital. Inc. d ATTN: Mr. Saturnino Pena Flores - a Executive Director @ c Call Box 859 - Humacao PR 00661 1 = - SUBJECT: EXERCISE OF ENFORCEMENT DISCRETION AND NOTICE OF VIOLATION I (NRC INSPECTION REPORT NO. 52-21026-01/97-01) i
q j Dear Mr. Pena: } This refers to the inspection conducted on November 17 and December 11. 1997, i at your facility in Humacao Puerto Rico, and a medical consultant's review
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completed on February 20. 1998. The pur)ose of the inspection was to 3 - determine whether activities authorized )y the license were conducted safely ( [ and in accordance with regulatory requirements. The results of the onsite a k inspection were discussed with you on November 17 and December 11. 1997 and q formally transmitted to you by letter dated January 30, 1998. The results of g the review by our medical consultant were transmitted to you on February 24.- 3 1998. g - An open and transcribed predecisional enforcement conference was conducted in J Isla Verde. Puerto Rico on March 2. 1998, with you and members of your staff j _ to discuss the apparent violations, the root causes, and corrective actions to -a 3reclude recurrence. A list of conference attendees, copies of the Nuclear E Regulatory CommissicCs (NRC's) slides, and materials provided by Ryder 4 ' Memorial Hospital at the conference are enclosed. The predecisional g enforcement conference was held to discuss two apparent violations: (1) the failure to establish and implement a Quality Management Program (OMP) for use _ of Strontium-90 (Sr-90) in ophthalmic brachytherapy between July 1994 and 8 February 1996, and (2) the failure to include an authorized Sr-90 user on the I Radiation Safety Committee. As you stated at the predecisional enforcement conference. Ryder Memorial ' " Hospital documented in its Radiation Safety Committee minutes of March 1996 the discovery of unauthorized uses of Sr-90 at the hospital. The Sr-90 uses I involved approximately 46 ophthalmic brachytherapy administrations conducted d at Ryder Memorial Hospital Jy Dr. Jos6 N. De Le6n. of which 14 treatments were -- subsequently determined to be misadministrations. Specifically, the administered dose was approximately two times the intended dose of
2000 centigrays. At the conference you stated that the NRC had erroneously - associated the misadministrations with Ryder Memorial Hospital's failure to - establish and implement a OMP, and you contended that the misadministrations were outside the oversight of the Ryder Memorial Hospital Radiation Safety L Program. The bases for your statement were:
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- _- -- --_-_ , . . . . . Ryder Memorial Hospital. Inc. 2 -- The NRC was provided the necessary information by Dr. De Le6n. in June 1994 and April 1995. to determine the obvious changes in exposure time which led to the misadministrations, yet failed to realize and act on this information. Ryder Memorial Hospital took appro)riate steps to inform the NRC by - letter dated June 28, 1994, that tie hospital was canceling the authorization given to Dr. De Le6n under the hospital's License No. 52-21026-01 to use his Sr-90 eye applicator. In your June 28 letter, you stated that this action was taken because the NRC holds Ryder Memorial Hospital ultimately responsible for the im)lementation of the OMP that ophthalmologists are required to submit to tie NRC. and that it is impossible for Ryder Memorial Hospital to accept such a responsibility over the use of a source it does not own or store. and does not even know when the source has been brought onto hospital premises. - After receipt of your June 28, 1994 letter. the NRC notified Ryder Memorial Hospital by letter dated July 22. 1994 that the NRC would remove Dr. De Le6n's authorization for Sr-90 use from the hospital's license during the next licensing action. However, the NRC has not removed Dr. De Le6n as an authorized user of Sr-90 from the hospital's license. Ryder Memorial Hospital informed Dr. De Le6n via a copy of the - June 28, 1994. letter that he was no longer authorized to use the hospital facilities while performing Sr-90 treatments. At the predecisional enforcement conference. Dr. De Le6n acknowledged receipt of the June 28. 1994 letter. Ryder. Memorial Hospital has a OMP established since January 1992 which - governs any therapeutic dosage of a radiopharmaceutical or any dosage of quantities greater than 30 microcuries of either sodium I-125 or I-131. - After your discovery of the unauthorized use of Sr-90 at Ryder Memorial Hospital in February 1996. you took immediate action to stop the use of ' the Sr-90 eye applicator by Dr. De Le6n on hospital premises. Based on the information developed during the inspection and the information that was provided during the predecisional enforcement conference the NRC has determined that two violations of NRC requirements occurred. The first violation involves the failure to maintain a written OMP as required by 10 CFR 35.32 that specifically addresses use of the Sr-90 eye applicator. -The NRC concluded that a violation occurred because, at the time of the administrations in question. Ryder Memorial Hospital continued to be authorized for Sr-90 use with Dr. De Le6n as an authorized user. and the hospital is ultimately responsible for ensuring the proper use of licensed byproduct material on its premises. In our July 22. 1994 response to your June 28,1994-letter of negative declaration for the use of Sr-90. we indicated that during the next licensing action, we would remove Dr. De Leon's authorization to use Sr-90 at the hospital. However, no licensing action has
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- . Ryder Memorial Hospital . Inc. 3 been taken. You had the option of removing Dr. De Leon through the formal licensing amendment process, but chose not to do so. (As of the date of this letter, you have not requested an amendment to your license to remove Dr. De Leon as an authorized use? of Sr-90.) Normally, a violation of regulatory requirements associated with a programmatic failure related to the OMP that results in a misadministration woulo be considered for escalated enforcement in accordance with the " General Statement of Policy and Procedures for NRC Enforcement Actions" (Enforcement Policy). NUREG-1600. However. as discussed in Section VII.B.6 of the Enforcement Policy, the NRC may refrain from issuing a Notice of Violation for
cases involving special circumstances. Although the NRC usually considers a l failure to have a QMP to be a matter of significant regulatory concern, the special circumstancer associated with this issue make it clear that Ryder Memorial Hospital toos reasonable and appropriate steps to 3reclude the use of the Sr-90 eye applicator on hospital premises. Therefore. ]ased on the facts of this case, and after consultation with the Director. Office of Enforcement. the NRC is exercising enforcement discretion in accordance with Section VII.B.6 of the Enforcement Policy and is refraining from issuance of a Notice of Violation for this violation. The NRC considers this issue closed, and no response is necessary from Ryder Memorial Hospital for this issue. I The second violation involves failure to include an authorized user of strontium-90 on the membershi) of your Radiation Safety Committee (RSC) since January 1. 1987, as required )y 10 CFR 35.22(a)(1). This violation has been categorized at Severity Level IV. and is described in the enclosed Notice of Violation (Notice). You will continue to be in violation of this requirement l until such time as you include an authorized user on the RSC or you amend your license to remove authorization for possession and use of the strontium-90 eye applicator. You are required to respond to the Notice and should follow the instructions s)ecified in therein when preparing your response. In your response, you s1ould document the specific actions taken and any additional actions you plan to prevent recurrence. After reviewing your response to the 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, l 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 1 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. i
_, ' , . l < . ! Ryder' Memorial Hospital. Inc. 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. 030-19679 License No. 52-21026-01 Enclosures: 1. Notice of Violation 2. NRC Presentation Material 3. Ryder Memorial Hospital Material 4. List of Attendees cc w/ encls: . Commonwealth of Puerto Rico l l l 1 l l , 1 l i i
FROM ,NRCe5FPO 03.10 3900 18:50 0.10 . Ryder Memorial Hospital. Inc. Distribtition w/ enc 1: LJCallan. EDO HThompson. DEDR ' ~ ~" - th. C M" i JGoldberg. 0GC i i an CY BKeeling. CA Enforcement Coordinators Rt. Rill. RIV JLiebernan. OE WBeecher. OPA GCaputo. 01 TMartin. ALOD ' HBell. OlG SCreene. NHSS CEvans. RII KClark. Ril RTrojarowski RIl DMCollins. RII MLesser. Ril Mlschiltz. OE00 ABoland. R11 CHosey Ril DE:l A file (BSunmers. OE)(2 letterhead) PUBLIC
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- . . 1 Ryder Memorial Hospital. Inc 5 , Distribution w/ encl: LJCallan. EDO HThompson. DEDR AThadani. DEDE LChandler, OGC JGoldberg. OGC ' DCool. NMSS EJulian. SECY BKeeling CA Enforcement Coordinators RI. RIII RIV JLieberman. OE l l WBeecher. OPA ! GCaputo. 01 TMartin. AEOD l HBell OIG SGreene. NMSS l CEvans. RII l KClark. RII RTrojanowski, RII DMCollins. RII j MLesser. RII l MTschiltz. OEDO . l ABoland. RII l CHosey. RII OE:EA File (BSummers. OE)(2 letterhead) PUBLIC }}