ML20203H781

Discusses,For Docket 7003092,insp Rept 70-3092/97-01 for Crozer-Chester Medical Ctr on 971119.Noncited Violation Re Failure to Continue Patient follow-up Procedures for Nuclear Pacemaker Was Identified

ML20203H781
Person / Time
Site:	070*****, 07003092
Issue date:	02/24/1998
From:	Shanbaky M NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION I)
To:	Saunders J CROZER-CHESTER MEDICAL CENTER, CHESTER, PA
References
70-3092-97-01, 70-3092-97-1, NUDOCS 9803030325
Download: ML20203H781 (3)

Text

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February 24,1998 ,

b Docket No. 070-03092 License No.- SNM-2003

! I i Joseph SaundersL 1 Vice President, Support Services Crozer-Chester Medical Center

. One Medical Center Boulevard -

Upland, PA 19013-3995

SUBJECT:

INSPECTION NO. 070-03092/97-001 L

Dear Mr. Saundersi i 1

! On November '19,1997, Louis Manning of this office conducted a safety inspection at the above

location of activites authorized by the above listed NRC license. The inspection was an examination of your licensed activities as they relate to radiation safety and to compliance with i

. the Commission's regulations and the license conditions. The inspection consisted of- l observations by the inspector, Interviews with personnel, and a selected examination of -

representative records, Additional information provided in your facsimile dated January 6,- 1998 was also examined as part of the inspection. The findings of the inspection were discussed with : .

Ms. Diana Stockdale, Radiation Safety Officer and Mr. Frank Kline, Administrative Director of u g Radiology of your organization at the conclusion of the inspection.

F Based upon information obtained during the inspection, the inspector lommed that you received a letter from Bio-Control Technology, Inc. in July 1996. This letter requested information.-

concoming a patent who leceived a nuclear pacemaker at your facility, it is our understanding - l that you were not aware that this patent existed prior to receiving the letter from Bio-Control =!

, - Technology, Inc. As a result, you initiated a search to venfy whether or not the patient actually l

received a nuclear pacemaker at your facility. Once the patent was identified, you also l l confirmed that no additional patients were implanted with nuclear pacemakers, and applied for a - -  !

L new license in January 1997." This license replaced the special nuclear materials license, which 0 L you had previously terminated in October 1981 based on your understanding, at that time, that L

l no patients received a nuclear pacemaker implant at your facility. The patient in question, was b

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_ originally admitted to Hahneman Hospital in Philadelphia, PA., and later transferred, along with

the pacemaker, to Crozer-Chester Medical Center. The pacemaker was received and -

implanted under Crozer-Chester Medical Center's license in February 1977. We also j

; understand, that because this~ patient was transferred to Crozer-Chester Medical Center, that ..

!- the patient would not be admitted through normal channels. - As a result, your records did not -l L indicate that any patient received a nuclear pacemaker. - You leamed, from the patient, that she was transferred from Hahneman Hospital to Crozer-Chester Medical Center, because there

~were no available beds in Hahneman's Cardiology Unit. You are presently following this patient  !

as required. if our understanding differs from yours, please notify this office in writing.

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J. Saunders 2 Crozer-Chester Medical Center Condition 14 of NRC License No. SNM 2003 states, in part, that the licensee shall continue patient follow-up procedures for the nuclear pacemrker dunng the life of the patient. Failure to contir,ue patient follow-up procedures for the nuclear pacemaker, is a violation of Condition 14 of NRC License No. SNM-2003. However, because the violation was self identified, and corrected, the violation will not be cited in eccordance with Section Vll.B.1. of NRC Enforcement Policy (NOREG 1600). This policy was implemented to encourage licensees to identify and correct problems in their program. You are reminded to continue to follow the patient at intervals not to exceed six months. You must also ensure the proper disposal of the nuclear

. pacemaker once it is removed from the pabent. Please notify this office in writing, once the pacemaker has been explanted and retumed to the manufacturer. No response to this letter is -

required.

In accordance with Section 2.790 of the NRC's ' Rules and Practices," Pert 2, Title 10, Code of Federal Regulations, a copy of this letter will be placed in the Public Document Room. No reply to this letteris required.

Your cooperation with us is appreciated.

l Sincerely, Original signett by Mohamed M. Shanbeky .

Mohamed M. Shanbaky, Chief Nuclear Materials Safety Branch 1 cc: .

Diana Stockdale, M.S., Radiation Safety Officer i Commonwealth of Pennsylvania

i J Saunders 3 Crozer Chester Medical Center Distribution:

PUBLIC Nuclear Safety Information Center (NSIC)

Region i Docket Room (w/ concurrences) i l

i I

DOC.UMENT,NAME:

T. . . y . en e G:\DNMSOOCWORK\lNSPLTR\LSNM2003 nt. me m in. no : c c.,y wi. .it.caz.nci 9767585 e c.,y wi .it. chi.nci u - no . y OFFICE DNMS/RI_ y lN DNMS/RI l l l NAME LManning F MShanbakyM ~

DATE 02/24/98 ~~ 020/98 ' 02/ /98 02/-/98 OFFICIAL RECORD COPY

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