ML20206F826
| ML20206F826 | |
| Person / Time | |
|---|---|
| Site: | 07001500 |
| Issue date: | 04/12/1999 |
| From: | Burache C NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION I) |
| To: | |
| References | |
| MLER-RI-98-057, MLER-RI-98-57, NUDOCS 9905060248 | |
| Download: ML20206F826 (2) | |
Text
L nc.asun s r- r ( i NMSS LICENSEE EVENT REPORT
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Lic:nso No. SAy/) ///y(,
Docket No. c/ '/0 4 cas l
MLER-RI ff 5J l LICENSEE [A]Q c;h:n cfoi) Hospi lt j ('ci1 Fe v EVENT DESCRIPTION [oss a f Mucleo, Ow er e d Ad,'a c. / ermab EVENT DATE 9/n / 77 REPORT DATE n/ &>/99( )
I
- 1. REPORTING REQUIREMENT i
(
)
10 CFR 20.2201 Theft or loss 10 CFR 20.2203 30 Day Report
() 10 CFR 35.33 Misadministration
() License Condition
() 10 CFR 30.50 Report () 10 CFR 36.83 l
() Other
- 2. REGION I RESPONSE fuAM , hby i
( Immediate Site Inspection Inspector /Date 1 3 9 I -(
() Special Inspection Inspector /Date
() Telephone Inquiry Inspector /Date
(
( Preliminary Notification () Daily Report (d) Information Entered on the Region I Log x () Review at Next Routine Inspection
() Report Referred to
- 3. REPORT EVALUATION
' ), Description of Event ( \)[ Corrective Actions (LJ Levels of RAM Involved ( t)' Calculation Adequate
(/) Cause of Event () Letter to Licensee Requesting Additional Information
- 4. SPECIAL INSTRUCTIONS OR COMMENTS g iOf191 I Completed by [ N /[ Y at4 1 Date V//2[ff Reviewed by ._ M Date v /fa /99
, g:\las\mlerform Il57L Resp z~
,1 v (Revised 1/6/95)
R05060248 990412 l
' C ADOCK 07001500 PDR
4- 1 e December 1. 1998 PRELIMINARY NOTIFICATION OF EVENT OR UNUSUAL OCCURRENCE PNO-I-98-058 This preliminary notification constitutes EARLY notice of events of POSSIBLE safety or public interest significance. The information is as initially received without verification or evaluation, and is basically all that is known by Region I staff in King of Prussia, Pennsylvania on this date.
Facility Licensee Emeroency Classification Washington Hospital Center Notification of Unusual Event -
Washington Hospital Center Alert 110 Irving St., N.W. Site Area Emergency Washington. District Of Columbia 20010 General Emergency Dockets: 07001500 License No: SNM-1446 X Not Applicable
Subject:
LOSS OF A NUCLEAR-POWERED CARDIAC PACEMAKER At approximately 5:00 p.m. on November 30, 1998.-the Radiation Safety i Officer'(RS0) of Washington Hospital Center informed Region I that there
- was a potential loss of a nuclear-powered cardiac pacemaker, containing l 250 milligrams of plutonium-238, which equates to approximately 4.27 curies. The pacemaker had been explanted from an expired patient at a I
funeral home on August 26, 1998 and returned to a shington Hospital Center, the pacemaker licensee, for disposal by Washington Hospital Center.
The RSO stated that the pacemaker had been mailed to St. Jude Medical, Inc. of Sylmar, California on September 15, 1998 via U.S. Postal Service.
St. Jude Medical. Inc. was supposed to receive the pacemaker on behalf of the pacemaker vendor. On or about October 22, 1998, the licensee called St. Jude Medical for confirmation of receipt of the pacemaker. However, St. Jude Medical indicated that it had not received the pacemaker.
In its search for the missing pacemaker, surveys were conducted of various areas of the Washington Hospital Center facility, including the >
Postal Area. Washington Hospital Center has requested that St. Jude Medical. Inc. conduct an extensive search, including radiological surveys, of its various facilities in its continued attempts to locate .
the missing pacemaker. i Region I will continue to follow up on the incident and is planning an on-site' inspection. The District of Columbia has been informed. The i Region I Office of Public Affairs is prepared to respond to media i
$!'f2Cf f(A
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v inquiries.
The information is current as of 2:00 p.m.. December 1.1998.
Contact:
Neelam Bhalla Teresa Darden Mohamed Shanbaky (610)337-5188 (610)337-5245 (610)337-5209 l
l l ,
1 a
December 1, 1998
, PRELIMINARY NOTIFICATION OF EVENT OR UNUSUAL OCCURRENCE PNO-I-98-058 This preliminary notification constitutes EARLY notice of events of POSSIBLE sofoty or public interest significance. The information is as initially received without verification or evaluation, and is basically all that is known by Region I staff (King of Prussia, Pennsylvania) on this date.
Facility Licensee Emeraency Classification Wmchington Hospital Center Notification of Unusual Event Wcchington Hospital Center Alert 110 Irving St., N.W. Site Area Emergency Wnchington, District Of Columbia 20010 General Emergency Dockets: 07001500 License No: SNM-1446 X Not Applicable
Subject:
LOSS OF A NUCLEAR-POWERED CARDIAC PACEMAKER At cpproximately 5:00 p.m. on November 30, 1998, the Radiation Safety Officar (RSO) of Washington Hospital Center informed Region I that there was a potential loss of a nuclear-powered cardiac pacemaker, containing 250 milligrams of plutonium-238, which equates to approximately 4.27 curica. The pacemaker had been explanted from an expired patient at a funeral home on August 26, 1998 and returned to Washington Hospital C ntor, the pacemaker licensee, for disposal by Washington Hospital Center.
Th3 RSO stated that the pacemaker had been mailed to St. Jude Medical, Inc. of Sylmar, California on September 15, 1998 via U.S. Postal Service.
St. Jude Medical, Inc. was supposed to receive the pacemaker on behalf of tho pacemaker vendor. On or about October 22, 1998, the licensee called St. Jude Medical for confirmation of receipt of the pacemaker. However, St. Jude Medical indicated that it had not received the pacemaker.
In its search for the missing pacemaker, surveys were conducted of various areas of the Washington Hospital Center facility, including the Postel Area. Washington Hospital Center has requested that St. Jude Mndical, Inc. conduct an extensive search, including radiological curveys, of its various facilities in its continued attempts to locate tha missing pacemaker.
Region I will continue to follow up on the incident and is planning an on-site inspection. The District of Columbia has been informed. The Region I Office of Public Affairs is prepared to respond to media inquiries.
The information is current as of 2:00 p.m., December 1, 1998.
Contact:
Neelam Bhalla Teresa Darden Mohamed Shanbaky (610)337-5188 (610)337-5245 (610)337-5209
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HOSPITAL EVENT NUMBER: 35114 LICENSEE:' WASHINGTON HOSPITAL CENTER NOTIFICATION DATE: 12/04/98 CITY: Washington REGION: 1 NOTIFICATION TIME: 11:05 [ET] I COUNTY: STATE: DC EVENT DATE: 10/28/98 LICENSE #: SNM-1446 AGREEMENT: N EVENT TIME: [EST]
DOCKET: LAST UPDATE DATE: 12/04/98 NOTIFICATIONS GLENN MEYER R1 JOSEPHINE PICCONE/EO NMSS NRC NOTIFIED BY: DR. BILLY BASS STUART RUBIN, AEOD IRD HQ OPS OFFICER: LEIGH TROCINE EMERGENCY CLASS: NON EMERGENCY 10 CFR SECTION:
BAB1 LOST / STOLEN LNM>1000X NCAR CARDIAC PACEMAKER EVENT TEXT LOSS OF A COROTOMIC NUCLEAR-POWERED PACEMAKER CONTAINING 250 MILLIGRAMS (APPROXIMATELY 2.8 CURIES) OF PLUTONIUM-238 The following text is a portion of a facsimile addressed to NRC Region 1 ,
(received from the licensee on 11/30/98): I "Purcuant to a telephone conversation with Teresa Darden of [the NRC Region 1] office we are notifying you of the potential loss of a nuclear pacemaker containing [approximately] 250 milligrams of Pu-238. The pacemaker was chipped on September 15, 1998. A routine follow up phone call determined late in October that the manufacturer had no record of receiving the i pacemaker. A thorough survey of the Washington Hospital Center facility has turned up nothing. The manufacturer is currently in [the] process of performing a survey of their facility to track the pacer's whereabouts. A trace of electronic mail records has been started with the U.S. Postal Service. Results are expected within 2 weeks."
" Exposure levels at 1 meter from the pacemaker are about 20 microR/ [ hour]
prc=enting no risk to public individuals who may come in contact with the device." The licensee stated that dose rates at the surface of the source are approximately 300 microR/ hour.
Tho licensee intended to ship the model-OMNISTAMCOR pacemaker from Washington Hospital Center to Acufix Research Institute located in Florida; however, it was sent to St. Jude Medical, Inc., located in Filmar, California. Apparently, neither Acufix Research Institute nor St. Jude M dical, Inc., received the shipment.
(Continued on next page)
. A2&L._
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- e January 6,1999 Docket Nos. 070-01500 License Nos. SNM-1446 030-01325 08-03604-03 EA No.98-555 Joyce E. Johnson, D.Sc.
Senior Vice President, Nursing & Patient Care Washington Hospital Center 110 living Street, N.W.
Washington, DC 20010-2975
SUBJECT:
INSPECTION NOS. 070-01500/98-001 AND 030-01325/98-004
Dear Dr. Johnson:
On December 2 and 3,1998, Teresa Hall Darden and Richard McKinley of this office conducted a safety site inspection at the above address of activities authorized by the above listed NRC license. The inspection was limited to review of an incident involving a missing nuclear pacemaker. The inspection was an examination of your licensed activities as they relate to radiation safety and to compliance with the Commission's regulations and the license conditions. The inspection consisted of observations by the inspectors, interviews with personnel, and a selected examination of representative records. The findings of the inspection were discussed with you at the conclusion of the inspection and are documented in the enclosed report. The report includes additional information received from you through December 22,1998.
Based on the results of this inspection ten apparent violations, associated with the loss of control of a plutonium-238 nuclear pacemaker, were identified and are being considered for escalated enforcement in accordance with the " General Statement of Policy and Procedure for NRC Enforcement Actions"(Enforcement Policy), NUREG 1600. Accordingly, no Notice of Violation is presently being issued for these inspection findings. In addition, please be advised that the number and characterization of apparent violations described in the enclosed inspection report may change as a result of further NRC review.
A predecisional enforcement conference, open to the public, to discuss these apparent violations has been scheduled for January 14,1999, at 1:00 p.m. at the Region i Office in King of Prussia, PA. The NRC announces enforcement conferences to the public by issuing a press release. The decision to hold a predecisional enforcement conference does not mean that the i
NRC has determined that violations have occurred or that enforcement action will be taken.
l This conference is being held to obtain information to enable the NRC to make an enforcement decision, such as a common understanding of the facts, root causes, missed opportunities to identify the apparent violations sooner, corrective actions, significance of the issues, and the need for lasting and effective corrective action. In addition, this is an opportunity for you to point out any errors in our inspection report and for you to provide any information conceming your per==^= on 1) the severity of the violations,2) the application of the factors that the NRC
/
IE07 YWNTY b' -
J. Johnson 2 Washington Hospital Center considers when it determines the amount of a civil penalty that may be assessed in accordance with Section VI.B.2 of the Enforcement Policy, and 3) any other application of the Enforcement
. Policy to this case, including the exercise of discretion in accordance with Section Vll. In
' presenting your corrective action, you should be aware that the promptness and comprehensiveness of your action will be considered in assessing any civil penalty for the apparent violation. The guidance in the enclosed NRC Information Notice 96-28,
" SUGGESTED GUIDANCE RELATING TO DEVELOPMENT AND IMPLEMENTATION OF CORRECTIVE ACTION," may be helpful.
You will be advised by separate correspondence of the results of our deliberations on this matter. No response regarding these apparent violations is required at this time, in accordance with 10 CFR 2.790 of the NRC's " Rules of Practice," a copy of this letter and its enclosure will be placed in the NRC Public Document Room.
Sincerely, OriginalsignedbyJohn D.Kinneman George Pangburn, Director Division of Nuclear Materials Safety
Enclosures:
- 1. Inspection Report Nos. 070-01500/98-001 and 030-01325/98-004 l
- 3. NRC Information Notice 96-28 i
l cc:
Billy Bass, D.Sc., Radiation Safety Officer District of Columbia l
i
t J. Johnson 3
. Washington Hospital Center Distribution: w/ enclosure 1 PUBLIC Nuclear Safety information Center (NSIC)
Region i Docket Room (w/ concurrences)
F. Miraglia, DEDR J. Wiggins, Rl D. Cool, NMSS J. Lieberman, OE A. Nicosia, OGC L Davis, OGC J. Fewell, RI D. Holody, RI T. Walker, RI
- G. Pdhgburn, RI D. White, Rl R. Bores, RI M. Campion, RI L Manning, RI DOCUMENT NAME: G:\DNMS\DOCWORK\lNSPLTR\LSNM1446.A 39988527 To vocalve e copy of tNs docuenent,Indcate h the boa: "C' - Copy w/o attach /enci *E' = Copy w/ attach /ancy 'M" = No copy OFFICE DNMS/RI lN DNMS/Rl , ,, 3 l DNMS/RI l ChMP;pRf NAME TDarden O//h i R#cKinley #" MShanbaky , , @@um lDATE 01//p99 6 01//,/99 01/6/99 /N ../ OT/ti/99 OFFICIAL RECORD COPY L
1 t
- REV.1 January 14,1999 REV 1
! EA No.98-555 l MN No. 99-02 I
! U.S. NUCLEAR REGULATORY COMMISSION REGION I NOTICE OF LICENSEE MEETING Name of Licensee: Washington Hospital Center Washington, D. C.
Name of Facility: Washington Hospital Center Docket No.: 070-01500/030-01325 i
License No.: SNM-1446/08-03604-03 l Time and Date of Meeting: 10:00 a.m. or, February 8,1999 Location of Meeting: U.S. Nuclear Regulatory Commission Public Meeting Room 475 Allendale Road King of Prussia, PA 19406 Purpose of Meeting: Predecisional Enforcement Conference to discuss ten apparent violations, involving the apparent loss of control of a nuclear pacemaker, reported by the licensee on November 30,1998.
NRC Attendees: George Pangbum, Director, Division of Nuclear Materials Safety Daniel J. Holody, Manager, ORA Technical Program Staff !
Tracy Walker, Sr. Enforcement Specialist J. Bradley Fewell, Regional Counsel Mohamed Shanbaky, Chief, Nuclear Materials Safety Branch 1 Teresa Hall Darden, Senior Health Physicist Richard McKinley, Health Physicist Licensee Attendees: Dr. Joyce Johnson, Sr. Vice President, Nursing and Patient Care Services 1 Dr. Billy Bass, Radiation Safety Officer Dr. Michael Porrazzo, Chairman, Radiation Safety Committee !
Dennis Dionne, Administrative Director, Radiology and Nuclear Medicine Dr. John Glenn, Consultant l
l N
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Distribution: (Hard copy)
PUBLIC Commonwealth of Pennsylvania Rl Receptionist DRM Secretary DRS Div Secretary DRP Div Secretary DNMS Div Secretary RA Secretary
' DRA Secretary PAO D. Holody, RI D. White, RI R. Bores, RI M. Campion, RI I
1 l
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January 7,1999
)
l EA No.98-555 MN No. 99-02 U.S. NUCLEAR REGULATORY COMMISSION REGION I l i
NOTICE OF LICENSEE MEETING 1
Name of Licensee: Washington Hospital Center Washington, D. C.
Name of Facility: Washington Hospital Conter Dociet No.: 070-01500/030-01325 -
License No.: SNM-1446/08-03604-03 Time and Date of Meeting: 1:00 p.m. on January 14,1999 4 Location of Meeting: U.S. Nuclear Regulatory Commission i Public Meeting Room I 475 Allendale Road l
King of Prussia, PA 19406 Purpose of Meeting: Predecisional Enforcement Conference to discuss ten apparent l
violations, involving the apparent loss of control of a nuclear pacemaker, reported by the licensee on November 30,1998.
! NRC Attendees: George Pangbum, Director, Division of Nuclear Materials Safety Daniel J. Holody, Manager, ORA Technical Program Staff Tracy Walker, Sr. Enforcement Specialist J. Bradley Fewell, Regional Counsel Mohamed Shanbaky, Chief, Nuclear Materials Safety Branch 1 Teresa Hall Darden, Senior Health Physicist Richard McKinley, Health Physicist Licensee Attendees: Dr. Joyce Johnson, Sr. Vice President, Nursing and Patient Care Services Dr. Billy Bass, Radiation Safety Officer Dr. Mark Seliksen, Radiation Safety Dr. John Glenn, Consultant *
-Q 'rC i ? k 9ff.
i' i
5 4
3 Distribution; (Hard copy)'
PUBLIC Commonwealth of Pennsylvania
- RI Receptionist DRM Secretary DRS Div Secretary DRP Div Secretary DNMS Div Secretary RA Secretary DRA Secretary PAO D. Holody, RI D. White, RI R. Bores, RI M. Clampi'o n, RI .
i
, o U.S. NUCLEAR REGULATORY COMMISSION REGION I INSPECTION REPORT Report No. 070-01500/98-001 030-01325/98-004 Docket No. 070-01500 030-01325 License No. SNM-1446 08-03604-03 Licegsee: , Washington Hospital Center Location: 110 frving Street, N.W.
Washington, D. C. 20010-2975 Inspection Dates: December 2 and 3,1998 Date Follow up Information Received: December 4,7,8,9,10, & 22,1998 inspectors: JA/JA Mchard McKinley Jb Am x m u./9y date /
() Health Physicist [
\/ a[8 dl ~
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Teresa Hall Darden date /
Senior Health Physicist Approved By: W- ,S-! / 799 Mohamed191. Shanbalf Chief date Nuclear Materials Safety Branch 1 Division of Nuclear Materials Safety Document Name: G:ONMSDOCWoRKVNSPRPTVtSNM1446 i i
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4 EXECUTIVE
SUMMARY
Washington Hospital Center NRC inspection Report Nos. 070-01500/98-001 and 030-01325/98-004 On November 30,1998, Washington Hospital Center (WHC) reported to NRC Region I that a 4.27 Curie (Ci), approximately 250 milligrams (mg) plutonium-238 (Pu-238) nuclear pacemaker was missing. During the site inspection conducted on December 2 and 3,1998, the inspectors learned that the nuclear pacemaker had been mailed on September 15,1998, through the normal U. S. Postal Service (USPS), without a WHC retum address, to St. Jude Medical, a non-nuclear pacemaker company in Sylmar, CA. WHC learned that the nuclear pacemaker was missing on or about October 22,1998. On October 27,1998, WHC discovered that the company to whom they had sent the nuclear pacemaker was not authorized to receive it and did not possess an NRC or Agreement State license to receive Pu-238. WHC made several attempts to recover the nuclear pacemaker through in house surveys, and attempted to get St. Jude Medical staff to perform surveys within their facility. The loss of the nuclear pacemaker and aslociated issues were discussed at the licensee's Radiation Safety Committee (RSC)
Meeting on October 28,1998. Since St. Jude Medical did not handle nuclear pacemakers and had no survey instruments, WHC express mailed a survey instrument to them so that a survey could be performed within their facility. Although, WHC has retained assistance and has expanded the search for the nuclear pacemaker to Post Offices in Califomia and Atlanta, Gecrgia, and other areas as deemed necessary, these efforts occurred after their November
- 30,1998 report to the NRC. As of the date of this report, the pacemaker has not been recovered. On December 8,1998, WHC revised the estimate of the Pu-238 activity and weight of the nuclear pacemaker to 2.8 Ci and 175 mg.
The loss of the nuclear pacemaker is of significant concern, particularly if it is in the public arena, because if breached, a significant uptake of nuclear material may occur that could significantly exceed the Annual Limit on intake (ALI).
. The inspection focused on the licensee's implementation of regulations and procedures for radioactive materials (RAM) packaging, receipt, transfer, transportation, and other areas surrounding the loss of the Pu-238 pacemaker.
Ten apparent violations were identified as a result of this inspection: 1) failure to follow the NRC requirements in 10 CFR 71.0 that requires the licensee to follow USPS regulations for shipping RAM through the USPS in that a) WHC mailad a package through the USPS that was required to be labeled " White l' in violation of USPS regulation; and b) the amount of RAM l shipped exceeded the USPS allowable limits, (Section lll B); 2) failure to provide Hazardous !
Material (HAZMAT) training to the WHC Shipper (Section 111 B); 3) failure to provide a Shipper's Certification (Section ill B); 4) unauthorized transfer of RAM (Section 111 B); 5) failure to verify the license of the recipient of the nuclear pacemaker (Section 111 B); 6) failure to notify the NRC of the loss of RAM in a timely manner (Section lil B) ; 7) loss of control of RAM (Section lli B);
- 8) failure to label package with a White i Label (Section ill B); 9) failure to verify that an authorized package was used for shipping a nuclear pacemaker (Section lil B); and 10) failure
_ to ship a package with the appropriate shipping papers (Section 111 B).
1 ii inspection Report No. 070-01500/98-001 G:ONMScoCWoRKVNSPRPTWtSNM1446
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1 REPORT DETAILS
- l. INCIDENT l
j A. Insoection Scooe The inspection focused on the chronology of events leading to the loss of control of the Pu-238 nuclear pacemaker and notification to the NRC of the loss.
B. Observations and Findinas On November 30,1998, NRC Region I was notified by WHC of a missing nuclear-powered cardiac pacemaker containing approximately 250 mg of Pu-238 with activity of approximately 4.27 Cl. This was later revised to 175 mg Pu-238 with an approximate activity of 2.8 Cl. The pacemaker had been explanted from an expired patient at a funeral home on August 26,1998, and retumed to Washington Hospital Center for
" disposal. On September 15,1998, the licensee mailed the pacemaker to St. Jude Medical, of Sylmar, Califomia through the USPS. . WHC staff believed, at that time, that St. Jude Medical was to receive the pacemaker on behalf of the pacemaker vendor, to whom it would be forwarded. On or about October 22,1998, the licensee called St. Jude Medical to confirm receipt of the pacemaker, and was informed that it had not arrived. The licensee initiated surveys of its facility, and requested that St. Jude Medical survey its facilities for the missing pacemaker. St. Jude Medical staff was unable to perform a survey for Pu-238 with a survey instrument since they do not handle nuclear ;
pacemakers and had no instrument to perform such a survey. On or about December 1, I l
1998, WHC sent a survey instrument to St. Jude Medical so that they could perform a survey in an attempt to locate the nuclear pacemaker in their facility.
C. Conclusion
! As of the date of this report the pacemaker has not been recovered. l
. II. < CHRONOLOGY OF EVENTS
! A. Insoection Scooe I The chronology lists the events that led to the shipping of the Pu-238 nuclear pacemaker to an unauthorized recipient. The chronology also lists the WHC actions that may have l
t contributed to the loss of the nuclear pacemaker.
B. Qbservations and Findinas The pacemaker is a Cordis Omni Stanicor Model, later owned by Coratomic. Prior to 1996 Coratomic was bought by Teletronics, Inc., of Hialeah, Florida.
1 Inspection Report No. 070-01500/98-001 G:DNMSOoCWoRKMNSPRPTESNM1446
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- 1. Events Prior to Auaust 26.1998 1996/1997 Teletronics was purchased by an Australian firm called Pacific Dunlap.
2/98 Pacific Dunlap sold Teletronics to St. Jude Medical of Sylmar, California.
St. Jude Medical abolished Teletronics and divided its functions. The nuclear pacemakers were to be received by a new company called Accufix Research, headquartered in Englewood, Colorado, but with storage facilities for nuclear pacemakers in Hialeah, Florida. The latter facility is licensed by the State of Florida. Non-nuclear pacemakers were to be processed at St. Jude Medical of Sylmar, California. When pacemaker functions were divided, the toll-free phone number previously used by Teletronics, Inc., was retained for use by St. Jude Medical. A new toll-free number was assigned to Accufix Research in Hialeah, Florida.
11/26/98 A Pu-238 nuclear pacemaker was explanted from an expired patient and retumed to WHC.
- 2. Events after Auaust 26.1998 8/28/98 The WHC Radiation Safety Officer (RSO) was notified by the hospital cardiology department that a nuclear pacemaker had been returned for disposal. ;
I 1
8/30/98 Verbal notification of the explanted nuclear pacemaker was made to NRC, Region i by the WHC RSO.
8/30/98 The licensee called St. Jude Medical, using the old toll-free number, for shipping instructions and packaging for retum of the nuclear pacemaker.
9/1/98 A written report was sent to NRC with information identifying the pacemaker and describing its retum to WHC.
9/14/98 WHC RSO received, from St. Jude Medical, the packaging for retum shipping of the pacemaker which consisted of an eight-inch by ten-inch cardboard box with a Styrofoam holder inside. Also included were a biohazard bag and shipping papers, which requested information identifying the patient and the explanting physician, technical evaluations of the device, reasons for removal, and the name and address of the person and institution returning the pacemaker to St. Jude Medical.
9/15/98 The Pu-238 nuclear pacemaker was shipped in the above described box to St. Jude Medical to their address in Sylmar, CA without a return address on the package and without verification of the recipient's license.
2 inspection Report No. 070-01500/98-001 G:ONMSOoCWoRKMNSPRPTRSNM1446
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10/22/98 The licensee called the old toll-free number that had been retained by St. Jude Medical to confirm receipt of the pacemaker and leamed that the nuclear pacemaker had not been received. WHC learned that St. Jude Medical received only non-nuclear pacemakers and also of the sale and division of Teletronics. WHC also leamed that the toll free number for retum of nuclear pacemakers was different than the one that they had used initially.
10/28/98 The loss of the Pu-238 nuclear pacemaker was discussed at an RSC meeting.
11/30/98 WHC notified NRC of the loss of the Pu-238 nuclear pacemaker.
C. Conclusions The inspector concluded that the various changen and transactions in the company, including the diversification of the pacemaker companies into a non-nuclear pacemaker campany and a nuclear pacemaker company may have contributed to this event. Also, the retention of the original toll free number by the non-nuclear pacemaker company may have been a contributing factor to the confusion that led to the failure to contact correct company. Additionally, the failure of the companies (Teletronics and St. Jude Medical) to notify WHC of the changes, were potential contributing factors to the failure of WHC to notify the correct company to receive instructions for retum of the Pu-238 nuclear pacemaker. The inspector also determined that WHC's failure to verify the recipient's license prior to attempting to retum the nuclear pacemaker may have contributed to the loss of licensed material.
111. MATERIAL TRANSFER, CONTROL AND TRANSPORTATION A. Insoection Scope The inspection focused on the transfer and control of licensed material and the licensee's implementation of regulations, license conditions and procedures to safely package, ship and transfer licensed material.
B. Observations and Findinos RAM shippers are required to abide by the regulations of the NRC, the Department of Transportation (DOT) and other agencies in the transportation of licensed material. 10 CFR 71.0 (b), in part, requires that in addition to the NRC requirements for packaging !
and transportatio'1 of licensed material; packaging and transportation of licensed material are also subject to the regulations of other agencies, such as the USPS. Postal Service Manual (Domestic Mail Manual), Section 124.3 is incorporated by reference in i 39 CFR 111.1 and provides regulatory requirements for mailing RAM through the USPS.
Postal Bulletins contain amendments to the Domestic Mail Manual and contain the full l text of all published interim and final regulations. Postal Regulations for Transport of l Radioactive Matter are also in USPS Publications #6,M and 52, in the U.S. Postal Manual and 39 CFR.
3 Inspection Report No. 070-01500/98-001 G:ONMSOoCWoRKilNSPRPTVisNM1446 l
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- 1. Packsoe Limits
- a. Postal Bulletin 21969 dated April 9,1998 prohibits radioactive materials in domestic mail if, among other things, the packages are required to bear the DOT Radioactive White-1 Label as described in 49 CFR 172.436. A White I Label is required if the maximum radiation level on the surface at any point is less than or equal to 0.5 millirem per hour (mrem /hr) in accordance with 49 CFR 172.403 for Class 7 (radioactive material). The Pu-238 nuclear pacemaker package was mailed without bearing a White l Label, as required. The inspector determined, that had the package containing the Pu-238 pacemaker bore the White 1 Label, it may have alerted USPS workers of the prohibition on receiving such packages and transportation through the USPS may have been prevented.
Mailing a package through the USPS that requires a White i Label is an apparent violation of USPS Postal Bulletin 21969 dated April 9,1998, and therefore, a violation of 10 CFR 71.0.
- b. The USPS rules for " allowable radioactive matter" provides an additional restriction that the amount of radioactwity in a mailable package be limited to one tenth of the values listed in USPS Table 8 Activity Limits for Excepted Packages and 49 CFR 173.425 Table 7 Activity Limits for Limited Quantities, instruments, and Articles. Table 7 limits Special form instruments or articles to 108 of A, quantity as specified in 10 CFR 71 Table A-1. The A, quantity is 54 Cl, therefore 10% of 2 X 10 Ai value is l 0.054 Cl. In addition to the requirement for a White i Label, the activity of
!- the Pu-238 pacemaker was 2.8 Cl, which exceeded the limit for a
( mailable package through the USPS.
Failure to meet the limitations of USPS Table 8 or 49 CFR 173.425 -
Table 7 made the Pu-238 package containing the nuclear pacemaker unacceptable for mail through the USPS and is an apparent violation of USPS Regulations, and, therefore constitutes a violation of 10 CFR 71.0 l requirements.
WHC's failure to comply with the USPS Regulations are apparent violations of 10 CFR 71.0.
- 2. HAZMAT Trainina Shippers of HAZMAT are required to receive HAZMAT training. The RSO and the health physics technician who acted as the shipper said that HAZMAT training was not provided as required in accordance with 49 CFR 172.702. The inspector determined that the failure to provide HAZMAT training to the shipper was probably a significant contributing factor to the loss of control of RAM.
49 CFR 172.702 (a) requires that a HAZMAT employer ensure that each of its HAZMAT employees is trained in accordance with the requirements. On September 15,1998, the 4 Inspection Report No. 070-01500/98-001 G:ONMSOoCWoRKVNCPRP1VtSNM1446
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licensee had not ensured that a HAZMAT employee was trained in accordance with the requirements prescribed for Pu-238 packaging and shipping.
Failure to provide HAZMAT training as required is an apparent violation of 49 CFR 172.702.
3, Shioner's Ceitificetion (Declaration)
Review of the licensee's actions related to the training deficiency indicated that the failure to provide HAZMAT training also contributed to, among other things, the -
licensee's failure to provide a Shipper's Certification in accordance with 172.204.
172.204 requires, in part, that each person who offers a hazardous material for transportation shall certify that the material is offered for transportation by printing on the shipping paper containing the required shipping description a certification (declaration) with the following language; "This is to certify that the above named materials are property classified, described, packaged, marked and labeled, and are in propier condition for transportation according to the applicable regulations of the DOT".
The shipper was not aware of the requirement. Therefore, A Shipper's Certification was not provided by the WHC Shipper.
Failure to provide a Shipper's Certificabon is an apparent violation of 49 CFR 172.204.
- 4. Transfer of Special Nuclear Material
- Even though the WHC shipper stated that he specifically requested shipping materials and instructions for the retum of a " nuclear pacemaker " when speaking to St. Jude
. Medical personnel, apparently the words " nuclear pacemaker" did not alert St. Jude Medical staff that they were not licensed to handle nuclear pacemakers. It was unclear to the inspector that the quality of communication was clear between WHC and St. Jude Medical staff. This apparent lack of clarity may have led to St. Jude Medical staff sending instructions and packaging for the retum of a non-nuclear pacemaker which was used by the WHC shipper. Also, the WHC procedure for Shipping of Radioactive Material, in part, mquires that "All shipments must comply with the current Federal regulations goveming the transfer of RAM, as required by titles 8 (District of Columbia),
10 CFR (NRC),49 CFR (DOT), and 39 CFR (U.S. Postal Service). The procedure also requires that the recipient of any RAM from WHC fumish evidence or a copy of his NRC or Agreement State license to the RSO before shipment can be made to verify l authorization of the recipient. These are also the requirements of 10 CFR 70.42 (a) and (c). The licensee told the inspectors that they had received a copy of the license in October and provided a faxed copy of the appropriate recipient's (Accufix) license dated October 27,1998. Since St. Jude Medical does not handle RAM, they had no -
Agreement State license. Prior to mailing the Pu-238 nuclear pacemaker, WHC neither followed their procedures nor the regulatory requirements to verify the recipient's license. This failure to verify the license prior to shipment caused WHC to mail the nuclear pacemaker to an unauthorized recipient.
10 CFR 70.42 (a) requires that no licensee transfer special nuclear material except as authorized. 10 CFR 70.42 (b)(5) requires, in part, that special nuclear material be 5 Inspection Report No. 070-01500/98-001 ;
G:ONMSOoCWORKMNSPRPTVtSNM1446 l
transferred to any person authorized to receive such special nuclear material under terms of a specific license issued by the Commission or an Agreement State. On September 15, 1998, the licensee transferred special nuclear material to St. Jude Medical, a non licensee, and the transfer was not authorized by 10 CFR 70.42.
Failure to transfer special nuclear material as authorized by 10 CFR 70.42 (a) and M9 is an apparent violation.
- 5. Recipient License Verification 10 CFR 70.42 (c) requires that before transferring special nuclear material to a specific l licensee of the Commission or an Agreement State or to a general licensee who is required l to register with the Commission or with an Agreement State, prior to receipt of the special nuclear material, the licensee transferring the material shall verify that the transferee's i license authorizes receipt of the type, form, and quantity of special nuclear material to be l
transferred. Specifically, on September 15,1998, the licensee transferred 2.8 Ci of P-238 to
%t. Jude Medical without venfying that St. Jude Medical had a license that authorized receipt l of Pu-238.
l l Failure to venfy the license of the recipient is an apparent violation of 10 CFR 70.42 (c).
l 6. Notification of NRC The licensee's procedure for verifying the receipt of pacemakers is described in Appendix U, " Nuclear Pacemaker Patient Tracking ," of their Radiation Safety Manual.
The licensee's RSO stated that this is supposed to be done within 10 working days, which would have been on or about September 29,1998. This procedure was not followed. On October 22,1998, the WHC RSO ca' icd St. Jude Medical to verify their receipt of the Pu-238 pacemaker and was told that the pacemaker had not arrived. . At that time, WHC was also informed by St. Jude personnel of the establishment of Accufix Research and the rn toll-free number of Accufix in Hialeah, Florida.' WHC staff said that they had not pulously been informed of the new toll free number or of the establishment of Accufix Research. Accufix Research was then contacted and provided to WHC a copy of their ;
license from the State of Florida, as well as samples of the appropriate shipping documents j for nuclear pacemakers. The sample shipping documents included a Declaration for i Dangerous Goods, which contained the proper shipping name, and a description of the packaging and its contents. Other documents included were a Removal and Recovery Form, a Shipping Certification, mode of transportation, and packaging instructions to meet the DOT requirements The receipt of the sample of correct package and shipping .
materials caused WHC staff to launch an expanded search for the missing Pu-238 nuclear !
pacemaker at its facility, including the mail room, and requested that surveys be done by St. Jude Medical in Sylmar, CA, at their facility. !
On October 22,1998, WHC was aware that the nuclear pacemaker had not been received by St. Jude Medical. The pacemaker was missing, and the possibility that they had lost control !
of the nuclear pacemaker was apparent on that date. Also, the loss of control of the Pu 238 '
nuclear pacemaker was discussed at the October 28,1998, RSC meeting, at which the RSO and Management were present. However, it was not reported to the NRC until November 30, l
6 Inspection Report No. 070-01500/98-001 ,
GdDNMScoCWoRKilNSPRPTVtSNM1446 l
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1998, a period of more than 30 days. Notification to NRC is required to be made within 30 days of discovery of the loss of licensed materialif the quantity exceeds 10 times the quantity specified in 10 CFR 20, Appendix C, which is 0.001 Ci. The missing pacemaker contains 2.8 Ci of Pu-238.
In discussions with the licensee about the lag in reporting the lost nuclear pacemaker, they explained that due to the very low dose rates emanating from the pacemaker and the fact that
' the Pu-238 is encapsulated in a strong metal as a sealed source, it did not appear that an exposure could result to persons in an unrestricted area. The inspector stated that loss of the nuclear pacemaker is of significant concem, particularly if it is in the public arena, because if breached, a significant uptake of nuclear material may occur that could significantly exceed the All. The licensee said that they had not considered the likelihood of a breach of the nuclear pacemaker in their initial evaluation. The inspector stated that the loss of a
' pacemaker containing 2.8 Ci of Pu-238 is of significant concem because the All for Pu-238 is 2 X 10-8 Cl, and 1 microgram ( g) of Pu-238 taken intomally into the human body is equivalent to 8.5 X 10: All. The nuclear pacemaker contains 175 mg of Pu-238; which is
- equivalent to 1.5 X 10' All. WHC did not report to NRC upon discovery of the loss of the nuclear pacemaker or within 30 days after discovery of lost licensed material in a quantity greater than 10 times the quantity specified in Appendix C to Part 20. Specifically, the licensee was aware of the loss of the pacemaker on October 22,1998, and discussed the missing material during the October 28,1998, RSC meeting, but did not notify the NRC of the loss until November 30,1998, a period of time that was greater than 30 days.
10 CFR 20.2201 (a)(1)(ii) in part, requires, that each licensee shall report within 30 days after the occurrence of any lost, stolen, or missing licensed material becomes known to the licensee, all licensed material in a quantity greater than 10 times the quantity specifM in Appendix C to Part 20.
Failure to notify the NRC within 30 days is an apparent violation of 10 CFR 20.2201 (a)(1)(ii).
- 7. Control of Radionetive Materials in addition to the previously discussed issues, further discussions with WHC staff indicated that they did not control and maintain constant surveillance of licensed material that was in an unrestricted area. The WHC shipper mailed the Pu-238 nuclear pacemaker, uncertifM (any method that required a signature by the recipient), through the USPS without a retum address, making it almost impossible for retum should the package be undeliverable or lost in the mail.
On September 15,1998, the licensee mailed licensed material through the normal USPS, an unauthorized mode of shipping. The inspector determined that WHC, by mailing the Pu-238 nuclear pacemaker through the normal USPS bulk mail, without any other controls, failed to use appropriate procedures to ensure that licensed material that was not in storage was under control and constant surveillance until it was either received by the addressee or retumed to 99 sender,
- > protect against unantkrized removal or loss of materials,10 CFR 20.1802 states that the licensee shall control and maintain constant surveillance of licensed material that is in a controlled or unrestricted area and that is not in storage.
7 Inspection Report No. 070-01500/98-001 G:ONMSOoCWORKVNSPRPT\RSNM1446
Failure to control and maintain constant curveillance of licensed material that is in a controlled or unrestricted area and that is not in storage is an apparent violation of 10 CFR 20.1802.
- 8. Labelina of Packaaes Class 7 (radioactive) material packages are required to bear the appropriate label when offered for transportation. 49 CFR 172.403 requires, in part, that the proper label be affixed to a package of Class 7 material and is based on the radiation level at the surface of the package and the transport index (TI). The Tl is approximately 0.2 for this package and a maximum radiation level at any point on the external surface that is less than or equal to 0.5 mrem /hr is required to have a White 1 Label. On September 15,1998, the package containing the Pu-238 nuclear pacemaker that WHC mailed through the USPS was not labeled with a White 1 Label.
Failure to have the package bear the required DOT White I Label is an apparent violation of 49 CFR 172.403.
- 9. Packaaina of Material Appropriate packaging that meets Type 7A specifications is required to be used for transportation of Pu-238 nuclear pacemakers. 49 CFR 173.22 (a)(2), in part, requires that the shipper determine that the packaging or container is authorized and meets all applicable requirements in accordance with Part 173, and that it has been manufactured, assembled, and marked in accordance with Section 173.7 (a) and Parts 173,178, or 179. On September 15,1998, the licensee did not determine before shipping that the package was an authorized package, including Part 173 requirements, or that it had been manufactured, assembled, and marked in accordance with Section 173.7 (a) and Parts 173,178, or 179.
Failure to verify that a package or container meets the requirements for authorized packaging is an apparent violation of 49 CFR 173.22 (a)(2).
10 Materials Description Hazardous materials are required to be described on the shipping papers that accompany them during transportation. 49 CFR Subpart C - Shipping Papers,172.200 requires, in part, that each person who offers a hazardous material for transportation shall describe the hazardous material on the shipping paper in the manner required by Section 172.202.
172.202, in part, requires that the shipping description of a hazardous material on the shipping paper must include the proper shipping name, the hazard class, the identification number and the packing group. 179.203 has additional requirements for RAM that includes the word RADIOACTIVE MATERIAL", the name of the radionuclide, description of the physical and chemical form, the activity contained in the package in appropriate units, the I
category of label and the Ti. On September 15,1998, the licensee offered a hazardous material for transportation, but did not describe the hazardous material on the shipping paper in the manner required by Subpart C, Sections 172.202 and 172. 203.
Failure to properly describe the hazardous material on the shipping papers is an apparent violation of 49 CFR Subpart C,172.200 and 172.203.
8 inspection Report No. 070-01500/98-001 G:\DNMs\DoCWoRK\lNsPRPTVtsNM1446
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C. Conclusions The inspector concluded that the lack of training, non-verification of the recipient's license, lack of proper marking and labeling of the package, lack of timely action including verification of package receipt, may have contributed to the loss of control of radioactive material.
IV. EXIT MEETING On December 3,1998, an exit meeting was held with licensee management. The inspectors reviewed the inspection findings, discussed apparent violations of NRC requirements, and obtained a commitment from licensee management to continue efforts to recover the missing pacemaker.
.After the conclusion of the exit meeting, WHC staff continued to apprise Region I of its progress in the material recovery attempts. On December 10,1998, the licensee reported that they had secured assistance to er. hance recovery efforts for the nuclear pacemaker. Also, they said that they had coordinated an effort that on or about December 17,1098, the Agreement State of California and an individual whom they retained and has experience in performing plutonium surveys would meet at St. Jude Medical, Sylmar CA and the Sylmar Post Office. Dependent upon outcome of these surveys, they would determine further action. On December 22,1998, the licensee provided an update of their actions, they reported that they had not been successful in their Sylmar, CA efforts, and would proceed to coordinate efforts to perform surveys in the Washington, DC Post Office where the nuclear pacemaker should have gone l
after it left their facility. Also, their survey efforts will include the Atlanta, Georgia Post Office which has the " dead letter" section for the Washington, DC area.
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9 Inspection Report No. 070-01500/98-001 GENMSOoCWoRKUNSPRPTRSNM1446 j r
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, PARTIAL LIST OF PERSONS CONTACTED Licensee Joyce Johnson, Ph.D., Senior Vice President, Nursing and Patient Care Services Billy G. Bass, Ph.D., Radiation Safety Officer Mark Seliksen, Ph.D., Radiation Safety Officer designate
. Terry Lane, Radiation Safety Assistant Dennis Dionne, Administrative Director, Radiology and Nuclear Medicine and other WHC staff members i
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DRAFT DRAFT NOTICE OF VIOLATION Washington Hospital Center Docket No. 070-01500 Washington, DC License No. SNM-1446 During an NRC inspection conducted on December 2 and 3,1998, ten violations of NRC requirements were identified. In accordance with the " General Statement of Policy and Procedure for NRC Enforcement Actions,"(Enforcement Policy), NUREG-1600, the violations are listed below:
A. 10 CFR 71.0, requires, in part, that in addition to the NRC requirements for packaging "and fransportation of licensed material; packaging and transportation of licensed material are also subject to the regulations of other agencies, such as the U.S. Postal Service (USPS). Postal Service Manual (Domestic Mail Manual), Section 124.3 which is incorporated by reference in 39 CFR 111.1, and Postal Bulletins contain amendments to ,
the Domestic Mail Manual. These documents provide some of the regulatory requirements for mailing radioactive material (RAM) through the USPS. 3
(
Postal Bulletin 21969 dated April 9,1998, prohibits radioactive materials in domestic mail if the package is required to bear the White 1 Label (described in 172.436). A White 1
)
Label is required if the maximum radiation level on the surface at any point is less than or equal to 0.5 millirem per hour in accordance with 49 CFR 172.403 for Class 7 (radioactive material).
The USPS rules for " allowable radioactive matter" requires, in part, that the amount of radioactivity in a mailable package be limited to one tenth of the values listed in USPS Table 8 or DOT Regulation 49 CFR 173.425 Table 7 Activity Limits for Limited Quantities, instruments, and Articles. Table 7 limits Special form articles to 10-2 of the A, quantity as specified in 10 CFR 71 Table A-1. The A, quantity is 54 Curies (Cl),10% of the value is 0.054 Cl. The Pu-238 nuclear pacemaker activity was 2.8 Cf.
Contrary to the above, on September 15,1998, the license failed to comply with the requirements of 10 CFR 71.0 by not following the USPS Regulations as directed by Postal Service Manual (Domestic Mail Manual), and Section 124.3 incorporated by reference in 39 CFR 111.1. Specifically,1) a prohibited package containing Class 7 material and required to bear the DOT Radioactive White-1 Label was sent through the domestic mail; and 2) the package was mailed through the USPS that contained a plutonium-238 (Pu-238) nuclear pacemaker that exceeded the Table 7 Limited Quantities activity limits for mail through the USPS.
B. 49 CFR 172.702 (a) requires that a Hazardous Material (HAZMAT) employer shall ensure that each of its HAZMAT employees is trained in accordance with the prescribed requirements.
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Notice of Violation 2 Washington Hospital Center Contrary to the above, as of September 15,1998, the licensee did not ensure that a HAZMAT employee was trained in accordance with the prescribed requirements.
Specifically, on September 15,1998, the licensee's shipper mailed a Pu-238 nuclear pacemaker through the USPS and had not been trained, as required.
C. 49 CFR 172.204 Shipper's Certification requires, in part, that each person who offers a hazardous material for transportation shall certify that the material is offered for transportation by printing on the shipping paper containing the required shipping description, a certification (declaration) with the following language; "This is to certify that the above named materials are properly classified, described, packaged, marked and labeled, and are in proper condition for transportation to the applicable regulations of the DOT."
Contrary to the above, on September 15,1998, the licensee offered a HAZMAT for transportation and did not provide the Shipper's Certification. Specifically, no shipping papers accompanied the Pu-238 nuclear pacemaker. Therefore, no description of the Pu-238 nuclear pacemaker was offered.
D. 10 CFR 70.42 (a) states that no licensee shall transfer special nuclear material except as authorized. 10 CFR 70.42 (b)(5) requires, in part, that special nuclear material be transferred to any person authorized to receive such special nuclear material under terms of a specific license issued by the Commission or an Agreement State.
Contrary to the above, special nuclear material was transferred to a company that did not have an NRC or Agreement State license, and therefore was not authorized to receive it.
Specifically, on September 15,1998, the licensee transferred special nuclear material (a Pu-238 nuclear pacamaker) to St. Jude Medical, Inc., and the transfer was not authorized by 10 CFR 70.42.
E. 10 CFR 70.42 (c) requires that before transferring special nuclear material to a specific licensee of the Commission or an Agreement State or to a general licensee who is required to register with the Commission or with an Agreement State prior to receipt of the special nuclear material, the licensee transferring the material shall verify that the transferee's license authorizes receipt of the type, form, and quantity of special nuclear material to be !
transferred.
Contrary to the above, the licensee did not verify that the transferee's license authorized receipt of the type, form, and quantity of special nuclear material that was to be transferred. ;
Specifically, on September 15,1998, the licensee transferred 2.8 Ci of Pu-238 to St. Jude Medical without verifying that St. Jude Medical possessed a license that authorized receipt of Pu-238. i F. 10 CFR 20.2201 (a)(1)(ii) states that each licensee shall report by telephone within 30 days after the occurrence of any lost, stolen, or missing licensed material becomes known to the licensee, all licensed material in a quantity greater than 10 times the quantity specified in :
Appendix C to Part 20 that is still missing at this time.
_=
, I Notice of Violation 3
- Washington Hospital Center i Contrary to the above, the licensee did not report by telephone within 30 days after the occurrence of lost, or missing licensed material became known to the licensee, all licensed material in a quantity greater than 10 times the quantity specified in Appendix C to Part 20 that was still missing at that time. Specifically, the licensee knew of the missing nuclear pacemaker containing 2.8 Ci of Pu-238 on October 22,1998, when the designated recipient of the material informed the licensee that the material had not been received.
G. 10 CFR 20.1802 states that the licensee shall control and maintain constant surveillance of licensed material that is in a controlled or unrestricted area and that is not in storage.
Contrary to the above, the licensee did not control or maintain constant surveillance of l licensed material that was in an unrestricted area. Specifically, on September 15,1998, a pacernaker containing 2.8 Ci of Pu-238 was shipped by an unauthorized mode, to an unauthorized recipient and the package did not bear any label or information such as retum l address or White DOT Label. Also, on or about October 22,1998, the licensee teamed that i licensed material which had been mailed to St. Jude Medical, had not arrived, and due to l the lack of marking, labeling and return address, the material was not controlled or under surveillance.
H. 49 CFR 172.403 requires, in part, that the proper label be affixed to a package of Class 7 (radioactive) material. The label type is based on the radiation level at the surface of the package and the transport index (TI). The Tl is 02 for a maximum radiation level at any point
)
on the external surface that is less than or equal to 0.5 millirem per hour is required to bear l a Radioactive White 1 Label. j Contrary to the above, on September 15,1998, the licensee mailed a Class 7 package that !
contained a 2.8 Ci Pu-238 nuclear pacemaker, with a 02 TI, without affixing a Radioactive White 1 Label.
- l. 49 CFR 173.22 (a) requires that the shipper shall determine that the packaging or container is an authorized package, including part 173 requirements, and has been manufactured, assembled, and marked in accordance with Section 173.7 (a) and parts 173,178, or 179.
Contrary to the above, on September 15,1998, the licensee did not determine, prior to shipping a Pu-238 nuclear pacemaker, that the packaging or container was authorized packaging, or that it had been manufactured, assembled, and marked in accordance with Section 173.7 (a) and Parts 173,178, or 179. Specifically, the packaging was designed for non-radioactive pacemakers and the licensee did not determine if it met the package specification requirements for a Pu-238 nuclear pacemaker.
J. 49 CFR 172.200 requires, in part, that each person who offers a HAZMAT for transportation shall describe the HAZMAT on the shipping paper in the manner required by this subpart, specifically Section 172.203.
Contrary to the above, on September 15,1998, the licensee offered a HAZMAT for transportation, but did not describe the HAZMAT on the shipping paper in the required
4 Notice of Violation 4 Washington Hospital Center manner. Specifically, no shipping papers accompanied the package containing the Pu-238 nuclear pacemaker. Therefore the HAZMAT was not described.
The NRC has concluded that information regarding the reason for the violations, the corrective actions taken and planned to correct the violation and prevent recurrence and the date when full compliance will be achieved is already adequately addressed on the docket. However, you are required to submit a written statement or explanation pursuant to 10 CFR 2.201 if the description therein does not accurately reflect your corrective actions or your position. In that case, or if you choose to respond, clearly mark your response as a " Reply to a Notice of Violation," and send it to ths U.S. Nuclear Regulatory Commission, ATTN: Document Control Desk, Washington, D.C.
20555 with a copy to the Regional Administrator, Region I, within 30 days of the date of the letter transmitting this Notice of Violation (Notice). ,
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 Cection 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. 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 1 the public. j i
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4 INSPECTION HISTORY 98-001(SNM-1446)
Failure to follow the NRC requirements in 10 CFR 71.0 that requires the iicensee to follow USPS regulations for shipping RAM through the U.S. Postal Service a) WHC mailed a package through the USPS that was required to be labeled
" White 1". Materials required to bear a DOT label class are prohibited in the Mail.
b) the amount of RAM shipped exceeded the USPS allowable limits, Failure to provide Hazardous Material (HAZMAT) training to the WHC Shipper Failure to provide a Shipper's Certification Unauthorized transfer of RAM i Failure to verify the license of the recipient of the nuclear pacemaker Failure to notify the NRC of the loss of RAM in a timely manner Loss of control of RAM
. Failure to label package with a White I Label Failure to verify that an authorized package was used for shipping a nuclear pacemaker Failure to ship a package with the appropriate shipping papers98-003 Failure to establish a quorum at RSC meetings.
Failure to survey rooms used by radiopharmaceutical therapy patients before reassigning the rooms Confirmatory Action Letter closed 98-001 Failure to obtain authorization before incinerating radioactive waste.
Failure to survey radioactive waste.
Failure to train radioactive waste handlers.
Failure to control or maintain constant surveillance over radioactive waste not in storage. >
Failure to secure radioactive material stored in controlled or unrestricted areas.
Confirmatory Action Letterissued.
Civil Penalty of 5 2750.96-001 Repeated failure to perform bioassays.
Failure to train.
Failure to notify NRC of loss of 280 microcuries of I-125.
Civil Penalty of $ 5000.95-002 Clear.95-001 Failure to train in requirements of QMP Program.
Failure to develop procedures to conduct QMP review.
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,94-001 Failure to limit whole ; -y d<v o : s 1.25 rems per quarter.
Failure to provide appropi;.u n: sonal monitoring equipment.
Failure to train in radia+irsa m%s l Failure to ensure that ra6cN, procedures were performed in accordance with the l license.
Failure to survey.
Failure to maintain records of package receipts and dose rate measurements.
Civil Penalty of $ 2500.
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! February 25,1999 1 Docket Nos. 070-01500 / Ucense Nos. SNM-1446 030-01325 08-03604-03 Joyce E Johnson, D.Sc.
Senior Vice President, Nursing & Patient Care Washington Hospital Center 110 frying Street, N. W.
Washington, DC 20010-2975
SUBJECT:
PREDECISIONAL ENFORCEMENT CONFERENCE CONDUCTED FEBRUARY 8,1999
Dear Dr. Johnson:
This letter refers to the Predecisional Enforcement Conference held with you and other members of your staff on February 8,1999. This meeting enabled us to gain a better understanding of your position and your completed and planned actions to correct the apparent violations identified at your facility. A report summarizing the meeting is enclosed.
Enforcement action will be transmitted to you under separate cover.
In accordance with Section 2.790 of the NRC's " Rules and Practices," Part 2, Title 10, Code of Federal Regulations, a copy of this letter and the enclosure will be placed in the Public Docurnent Room. No reply to this letter is required. f;f
/
Your cooperation with us is appreciated.
Sincerely, ,
Mohamed M. Shanbaky, Chief Nuclear Materials Safety Branch 1 Division of Nuclear Materials Safety
Enclosure:
NRC Region i Enforcement Conference Report Nos. 070-01500/98-001 and 030-01325/98-004 l cc w/ enclosure:
l Billy Bass, D.Sc., Radiation Safety Officer l District of Columbia I
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J. Johnson 2 Washington Hospital Center Distribution:
PUBLIC Nuclear Safety information Center (NSIC)
Region I Docket Room (w/ concurrences)
F. Miraglia, DEDR J..Wiggins, RI D. Cool, NMSS J. Ueberman, OE A. Nicosia, OGC L. Davis, OGC J. Fewell, RI D. Holody, RI T. Walker, RI G. Pangburn, RI D. White, RI R. Bores, RI M. Campion, RI L Manning, RI DOCUMENT NAME: B:\DNMS Documents \lnsp LetteALSNM-1446.JJ.wpd To receive a copy of this document, Indicate in the bar:"C" = Copy w/o attach /end "E" = Copy w/ sttadi/end "N" = No copy OFFICE DNMS/RI / DNMS/RI , DNMS/RI DNMS/RI/ l NAME RMcKinley /f/i ///( Tdarden 3M'D MShanbakyAS GPanob6m DATE 02/24/99 02/lff99 02W//99 02///99
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OFFICIAL RECORD COPY
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9 COhrenENCE SUManagy Washington Hospital Center NRC Enforcement Conference Report No. 07001500/98-001 A predecisional enforcement conference was held at NRC Region i in King February 8,1999, to discuss the apparent violations associated with the los plutonium-238 pacemaker identified during inspection No.98-001 conducte 2-3,1998, and the corrective actions to prevent recurrence.
I LIST OF PERSONS ATTENDING
& Licensee {
I Joyce E. Johnson, Ph.D., Senior Vice President, Nursing and Patient Care Sj\
John E. Glenn, Ph.D., Acting Director, Radiation Safety Billy G. Bass, Sc.D., Radiation Safety Officer {
Michael Porrazzo, M.D., Chairman, Radiation Safety Committee l Denis Dionne, Administrative Director, Radiology Don Silverman, Attomey; Morgan, Lewis, and Bockius 9
Alex Polonsky, Attomey; Morgan, Lewis, and Bockius lb fiBQ George Pangbum, Director, DMsion Nuclear Materials Safety (DNMS)
J. Bradley Fewell, Regional Counsel Louis Manning, Enforcement Specialist Mohamed M. Shanbaky, Chief, Branch 1, DNMS Teresa Hall Darden, Senior Health Physicist, Branch 1, DNMS Richard W. McKinley, Health Physicist, Branch 1, DNMS 11 Summary Details
- On February 8,1999, a predecisional enforcement conference was held at NR Office, King of Prussia, Pennsylvania. The conference was open for public In the attendanc opening statement, the Director of the Division of Nuclear Materials Safety (DNMS) the enforcement conference process. He stated that it provided Washington Hospi inspection that was conducted December 2-3,1998, ;
provide corrections to the inspection report. Management oversight and other progr issues were also discussed.
Minor corrections or clarifications to the inspection report were presented. The license i acknce.tdged that the violations had occurred. The Administrative Director of R presented a chronology of events which was very similar to that in the inspection report.
2 Enforcement Conference Report No. 070-01500/98-001 sADNMS Documents \ cont Report \RSNM-1446.98 001.wpd
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' U.S. NUCLEAR REGULATORY COMMISSION ,
' REGION I '
ENFORCEMENT CONFERENCE
SUMMARY
' Report No. ;
070-01500/99-001 030-01325/99-001 i
Docket No. 070-01500 030-01325 ,
1 License No. SNM-1446 08-03604-03 Licensee: Washington Hospital Center 110 Irving Street, N.W.
Washington, D.C. 20010-2975 Facility Name: Washington Hospital Center Conference Date and Time: February 8,199910:00 a.m.
Conference Location: NRC Region I, King of Prussia, Pennsylvania inspectors: < d A 4~ 2r 99 TeTesa Hall Darden Senior Health Physicist /dat/
YYbY hL YY hichard McKinley /
07/9/
' date' Health Physicist ,
. Approved By: M. --
A 2' /2A/99 Mohamed IG. Shanbak' hief date Nuclear Materials Saf Branch 1 Division of Nuclear Materials Safety i
Document Name: B:\DNMs Documentc\ Cont Report \RsNM-1446.98 001.wpd
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then listed root causes of the event which were: 1) failure of WHC personnel to confirm the transferee's radioactive material license; 2) fack of clear communication between WHC i personnel and St. Jude Medical personnel; 3) failure to confirm the appropriateness of packaging sent by St. Jude Medical; 4) incomplete shipping procedures in the Ra Manual; and 5) failure to provide Department of Transportation (DOT) Hazardous Materials
! (HAZMAT) training to WHC personnel. The licensee concluded that contributing factors w
! 1) the failure of Teletronics to notify them of corporate changes, and 2) St. Jude's retentio l
the toll free number formerly held by Teletronics. The Administrative Director concluded wl description of WHC's attempts to recover the pacemaker.
- The Acting Director of Radiation Safety then explained WHC's actions to prevent recurre the event. The licensee's actions were to
- 1) provide training for radiation safety, ma other personnel as appropriate, that includes DOT HAZMAT training and other procedures f
! shipping radioactive material; 2) place a hold on radioactive material shipments from WHC l pending a review of shipping protocols, the exception being the return of empty radiopharmaceutical containers; 3) contract with a consultant from NIH to review all shi protocols; 4) determine the correct recipients for all nuclear pacemakers currently under their license; 5) update phone numbers and addresses for nuclear pacemaker vendors; 6) ge protocol checklists for each type of radioactive material that WHC ships; and 7) take d
! actions against certain personnel. The Acting Director also presented actions which include future plans: 1) initial HAZMAT training for new hires, with refresher training every thre l
- 2) retention of the Acting Director of Radiation Safety; 3) the posting of openings for two ,
additional health physicists, with interviews currently underway; 4) formal upgrading of the i Radiation Safety Manualapproved b
- implementation currently in process;y RSC with the upgraded Radiation Safety progra and 5) restructuring of Radiation Safety Department assignments / responsibilities to provide routine assurances to executive management and the RSC that responsibilities have been appropriately assigned, performance is adequate, and t prompt corrective actions are being taken when exceptions are noted.
Enforcement options available to the NRC were discussed by the Enforcement Specialist.
Since the NRC does not enforce the U.S. Postal Service (USPS) regulations, the violations against USPS regulations will be referred to the USPS for action as they deem appropriate.
The enforcement conference was closed by the DNMS Director.
\
l l
I I
3 Enforcement Conference Report No. 070-01500/98-001 emNMs Documents \ conf ReporNISNM-1446.98-001.wpd
F 'd 9 o
l l January 6,1999 Docket Nos. 070-01500 # License Nos. SNM-1446 030-01325 08-03604-03 EA No.98-555
- Joyce E. Johnson, D.Sc.
i ;
Senior Vice President, Nursing & Patient Care '
Washington HospitalCenter 110 Irving Street, N.W.
Washington, DC 20010-2975 1
SUBJECT:
INSPECTION NOS. 070-01500/98-001 AND 030-01325/98-004 1
i
Dear Dr. Johnson:
l Gn Dewmber 2 and 3,1998, Teresa Hall Darden and Richard McKinley of this office conducted !
a safety site inspection at the above address of activities authonzed by the above listed NRC license. The inspection was limited to review of an incident involving a missing nuclear pacemaker. The inspection was an examination of your licensed activities as they relate to radiation safety and to compliance with the Commission's regulations and the license conditions. The inspection consisted of observations by the inspectors, interviews with personnel, and a selected examination of representative records. The findings of the inspection were discussed with you at the conclusion of the inspection and are documented in the enclosed report. The report includes additional information received from you through December 22,1998. i Based on the results of this inspection ten apparent violations, associated with the loss of control of a plutonium-238 nuclear pacemaker, were identified and are being considered for escalated enforcement in accordance with the " General Statement of Policy and Procedure for NRC Enforcement Actions"(Enforcement Policy), NUREG 1600. Accordingly, no Notice of Violation is presently being issued for these inspection findings. In addition, please be advised that the number and characterization of apparent violations described in the enclosed inspection report may change as a result of further NRC review.
A predecisional enforcement conference, open to the public, to discuss these apparent i violations has been scheduled for January 14,1999, at 1:00 p.m. at the Region i Office in King of Prussia, PA. The NRC announces enforcement conferences to the public by issuing a press
. release. The decision to hold a predecisional enforcement conference does nct mean that the NRC has determined that violations have occurred or that enforcement action will be taken.
This conference is being held to obtain information to enable the NRC to make an enforcement decision, such as a common understanding of the facts, root causes, missed opportunities to identify the apparent violations sooner, corrective actions, significance of the issues, and the need for lasting and effective corrective action. In addition, this is an opportunity for you to point out any errors in our inspection report and for you to provide any information conceming your perspechvos on 1) the seventy of the violations, 2) the application of the factors that the NRC
--^1100!?0 770106 PDR ADOCK 07001500 C- . , _
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Distribution: w/ enclosure 1 i
PUBLIC
, Nuclear Safety Information Center (NSIC) t Region i Docket Room (w/ concurrences)
F. Miraglia, DEDR ;
i J. Wiggins, RI D. Cool, NMSS
! J. Ueberman, OE A. Nicosia, OGC L Davis, OGC J. Fewell, RI D. Holody, RI T. Walker, RI G. Pangburn, Rl D. White, RI R. Bores, RI M. Campion. RI L Manning, RI i
DOCUMENT NAME: G:\DNMS\DOCWORK\lNSPLTR\LSNM1446.A To receive a copy of this document. Indicate in the boa: 'C' = Copy w/o attach /enct 39988527
- E' = Copy w/ attach /ency *N" = No, copy OFFICE DNMS/RI N DNMS/RI . ,, 3 l DNMS/RI QIRMSLRT NAME TDarden O//h i BMcKinley @W MShanbaky , , AW urn g
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1 01/l//99 f 01//,/99 01/6/99 /N ../ OV/J/99 ,
OFFICIAL RECORD COPY
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January 6,1999 Docket Nos. 070-01500 V Ucense Nos. SNM-1446 030-01325 08-03604-03 EA No.98-555 Joyce E. Johnson, D.Sc.
i Senior Vice President, Nursing & Patient Care Washington Hospital Center 110 frying Street, N.W.
Washington, DC 20010-2975 i
SUBJECT:
l INSPECTION NOS. 070-01500/98-001 AND 030-01325/98-004 i
Dear Dr. Johnson:
On December 2 and 3,1998, Teresa Hall Darden and Richard McKinley of this office conducted a safety site inspection at the above address of activities authorized by the above listed NRC '
license. The inspection was limited to review of an incident involving a missing nuclear pacemaker. The inspection was an examination of your licensed activities as they relate to radiation safety and to compliance with the Commission's regulations and the license conditions. The inspection consisted of observations by the inspectors, interviews with I personnel, and a selected examination of representative records. The findings of the inspection were discussed with you at the conclusion of the inspection and are documented in the enclosed report. The report includes additional information received from you through December 22,1998.
Based on the results of this inspection ten apparent violations, associated with the loss of control of a plutonium-238 nuclear pacemaker, were identified and are being considered for escalated enforcement in accordance with the " General Statement of Policy and Procedure for NRC Enforcement Actions"(Enforcement Policy), NUREG 1600. Accordingly, no Notice of Violation is presently being issued for these inspection findings. In addition, please be advised that the number and characterization of apparent violations described in the enclosed inspection report may change as a result of further NRC review.
i A predecisional enforcement conference, open to the public, to discuss these apparent violations has been scheduled for January 14,1999, at 1:00 p.m. at the Region i Office in King of Prussia, PA. The NRC announces enforcement conferences to the public by issuing a press release. The decision to hold a predecisional enforcement conference does not mean that the NRC has determined that violations have occurred or that enforcement action will be taken. i This conference is being held to obtain information to enable the NRC to make an enforcement decision, such as a common understanding of the facts, root causes, missed opportunities to identify the apparent violations sooner, corrective actions, significance of the issues, and the need for lasting and effective corrective action. In addition, this is an opportunity for you to point out any errors in our inspection report and for you to provide any information concerning your perspectives on 1) the seventy of the violations,2) the application of the factors that the NRC l
NPDRM ?iU106 ADOCK 07001500 l c .
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J. Johnson 2 Washington Hospital Center
, considers when it determines the amount of a civil penalty that may be assessed in accordance l with Section VI.B.2 of the Enforcement Policy, and 3) any other application of the Enforcement Policy to this case, including the exercise of discretion in accordance with Section Vll. In
.. presenting your corrective action, you should be aware that the promptness and -
comprehensiveness of your action will be considered in assessing any civil penalty for the apparent violation. The guidance in the enclosed NRC Information Notice 96-28,
" SUGGESTED GUIDANCE RELATING TO DEVELOPMENT AND IMPLEMENTATION OF CORRECTIVE ACTION," may be helpful.
l You will be advised by separate correspondence of the results of our deliberations on this matter. No response regarding these apparent violations is required at this time.
l in accordance with 10 CFR 2.790 of the NRC's " Rules of Practice," a copy of this letter and its enclosure will be placed in the NRC Public Document Room.
Sincerely, OriginalsignedbyJohn D.Kinneman George Pangbum, Director i Division of Nuclear Materials Safety
Enclosures:
- 1. Inspection Report Nos. 070-01500/98-001 and 030-01325/98-004
- 3. NRC Information Notice 96-28 m ,
tsilly Bass, D.Sc., Radiation Safety Officer District of Columbia 1 .
i
4
'J. Johnson 3 I
Washington Hospital Center Distribution: w/ enclosure 1 PUBLIC Nuclear Safety information Center (NSIC)
Region i Docket Room (w/ concurrences) -
l F. Miraglia, DEDR
! J. Wiggins, RI D. Cool, NMSS J. Lieberman, OE A. Nicosia, OGC L. Davis, OGC J. Fewell, RI l D. Holody, RI
! T. Walker, RI G. Pangburn, RI D. White, RI R. Bores, RI M. Campion, RI L. Manning, RI l
l l
l DOCUMENT T. w . .
NAME: G:\DNMS\DOCWORK\lNSPLTR\LSNM1446.A 39988527 !
,v s a e.cu, ni. 6 ac h> vi. e.m c - copy wro . .cni.aci s copy wi .ii.cht.ncy m - no. copy ;
l OFFICE DNMS/RI lN DNMS/RI . ,, 3 l DNMS/RI l ShMsyRf l l l lNAME TDarden O#h 6 RMcKinley #W MShanbaky , , A@ um lDATE 01////99 6 01/4/99 01/6/99 /N _./ Of/ti/99 !
t OFFICIAL RECORD COPY
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U.S. NUCLEAR REGULATORY COMMISSION REGION I INSPECTION REPORT l
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l Report No. 070-01500/98-001 030-01325/98-004 Docket No. 070-01500 030-01325:
l License No. SNM-1446 08 4 3604-03 Licensee: Washington Hospital Center Location: 110 Irving Street, N.W.
Washington, D. C. 20010-2975 i
Inspection Dates: December 2 and 3,1998 Date Follow up Information Received: December 4,7, 8,9,10, & 22,1998 Inspectors:
1AExaJhp. Am xm u./9y Mchard McKinley j date /
O Health Physicist d afv ~
- date V 799/
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Teresa Hall Darden Senior Health Physicist Approved By: 8- / /999 Mohamed kl. Shanba(Chief date Nuclear Materials Safety Branch 1 Division of Nuclear Materials Safety P K 0 00 500 g Document Name: G:ONMSOoCWORKVNSPRPTVtSNM1446 pg f
4 .
,e .
EXECUTIVE
SUMMARY
Washington Hospital Center NRC Inspection Report Nos. 070-01500/98-001 and 030-01325/98-004 On November 30,1998, Washington Hospital Center (WHC) reported to NRC Region I that a 4.27 Curie (Cl), approximately 250 milligrams (mg) plutonium-238 (Pu-238) nuclear pacemaker was missing. During the site inspection conducted on December 2 and 3,1998, the inspectors leamed that the nuclear pacemaker had been mailed on September 15,1998, through the normal U. S. Postal Service (USPS), without a WHC retum address, to St. Jude Medical, a non-nuclear pacemaker company in Sylmar, CA. WHC leamed that the nuclear pacemaker was missing on or about October 22,1998. On October 27,1998, WHC discovered that the company to wnom they had sent the nuclear pacemaker was not authonzed to receive it and did not possess an NRC or Agreement State license to receive Pu-238. WHC made several atterapts to recover the nuclear pacemaker through in house surveys, and attempted to get St. Jude Medical staff to perform surveys within their facility. The loss of the nuclear pacemaker and associated issues were discussed at the licensee's Radiation Safety Committee (RSC)
Meeting on October 28,1998. Since St. Jude Medical did not handle nuclear pacemakers and had no survey instruments, WHC express mailed a survey instrument to them so that a survey could be performed within their facility. Although, WHC has retained assistance and has expanded the search for the nuclear pacemaker to Post Offices in Califomia and Atlanta, Georgia, and other areas as deemed necessary, these efforts occurred after their November 30,1998 report to the NRC. As of the date of this report, the pacemaker has not been recovered. On December 8,1998, WHC revised the estimate of the Pu-238 activity and weight of the nuclear pacemaker to 2.8 Cl and 175 mg.
The loss of the nuclear pacemaker is of significant concem, particularly if it is in the public arena, because if breached, a significant uptake of nuclear material may occur that could significantly exceed the Annual l_imit on intake (All).
The inspection focused on the licensee's implementation of regulations and procedures for radioactive materials (RAM) packaging, receipt, transfer, transportation, and other areas surrounding the loss of the Pu-238 pacemaker.
Ten apparent violations were identified as a result of this inspection: 1) failure to follow the NRC requirements in 10 CFR 71.0 that requires the licensee to follow USPS regulations for shipping RAM through the USPS in that a) WHC mailed a package through the USPS that was required to be labeled White 1" in violation of USPS regulation; and b) the amount of RAM shipped exceeded the USPS allowable limits, (Section lli B); 2) failure to provide Hazardous Material (HAZMAT) training to the WHC Shipper (Section lli B); 3) failure to provide a Shipper's Certification (Section til B); 4) unauthonzed transfer of RAM (Section 111 B); 5) failure to verify the license of the recipient of the nuclear pacemaker (Section lil B); 6) failure to notify the NRC I
of the loss of RAM in a timely manner (Section lil B) ; 7) loss of control of RAM (Section ill B);
- 8) failure to label package with a White i Label (Section lil B); 9) failure to verify that an authonzed package was used for shipping a nuclear pacemaker (Section 111 B); and 10) failure to ship a package with the appropriate shipping papers (Section ill B).
il Inspection Report No. 070-01500/98-001 G:ONMSOoCWoRKMNSPRPTESNM1446 l
i
4 Eg_P. ORT DETAILS
- 1. INCIDENT A. Insoechon Scooe
' The inspechon focused on the chronology of events leading to the loss of control of the Pu-238 nuclear pacemaker and notification to the NRC of the loss.
- B. Observations and Findinos On November 30,1998, NRC Region I was nobfied by WHC of a missing nuclear-pcu.ed cardiac pacemaker containing approximately 250 mg of Pu-238 with actmty of approximately 4.27 Cl. This was later revised to 175 mg Pu-238 with an approximate activity of 2.8 Cl. The pacemaker had been explanted from an expired patient at a funeral home on August 26,1998, and retumed to Washington Hospdal Center for disposal. On September 15,1998, the licensee mailed the pacemaker to St. Jude Medical, of Sylmar, Califomia through the USPS. WHC staff believed, at that time, that St. Jude Medical was to receive the pacemaker on behalf of the pacemaker vendor, to whom it would be forwarded. On or about October 22,1998, the licensee called St. Jude Medical to confirm receipt of the pacemaker, and was informed that it had not arrived. The licensee initiated surveys of its facility, and requested that St. Jude Medical survey its facilities for the missing pacemaker. St. Jude Medical staff was unable to perform a survey for Pu-238 with a survey instrument since they do not handle nuclear pacemakers and had no instrument to perform such a survey. On or about December 1, 1998, WHC sent a survey instrument to St. Jude Medical so that they could perform a survey in an attempt to locate the nuclear pacemaker in their facility.
C. Conclusion As of the date of this report the pacemaker has not been recovered.
- 11. CHRONOLOGY OF EVENTS A. Insoection Scope
~ The chronology lists the events that led to the shipping of the Pu-238 nuclear pacemaker
- to an unauthorized recipient. The chronology also lists the WHC actions that may have
- contributed to the loss of the nuclear pacemaker.
B. Observations and Findinos The pacemaker is a Cordis Omni Stanicor Model, later owned by Coratomic. Prior to 1996 Coratomic was bought by Teletronics, Inc., of Hialeah, Florida.
1 Inspection Report No. 070-01500/98-001 G:ONMScoCWoRKNNSPRPTVISNM1446
' \
j
- 1. Events Prior to Auaust 26.1998 1996/1997 Teletronics was purchased by an Australian firm called Pacific Dunlap. l 2/98 Pacific Dunlap sold Teletronics to St. Jude Medical of Sylmar, Califomia.
St. Jude Medical abolished Teletronics and divided its functions. The nuclear pacemakers were to be received by a new company called Accufix Research, headquartered in Englewood, Colorado, but with storage facilities for nuclear pacemakers in Hialeah, Florida. The latter facility is licensed by the State of Florida. Non-nuclear pacemakers were to be processed at St. Jude Medical of Sylmar, Califomia. When pacemaker functions were divided, the toll-free phone number previously used by Teletronics, Inc., was retained for use by St. Jude Medical. A new toll-free number was assigned to Accufix Research in Hialeah, Florida.
8/26/98 A Pu-238 nuclear pacemaker was explanted from an expired patient and retumed to WHC.
- 2. Events after Auaust 26.1998
{
8/28/98 The WHC Radiation Safety Officer (RSO) was notified by the hospital cardiology department that a nuclear pacemaker had been retumed for disposal.
8/30/98 Verbal notification of the explanted nuclear pacemaker was made to NRC, Region i by the WHC RSO.
8/30/98 The licensee called St. Jude Medical, using the old toll-free number, for shipping instructions and packaging for return of the nuclear pacemaker.
9/1/98 A written report was sent to NRC with information identifying the pacemaker and describing its retum to WHC.
9/14/98 WHC RSO received, from St. Jude Medical, the packaging for retum shipping of the pacemaksr which consisted of an eight-inch by ten inch cardboard box with a Styrofoam holder inside. Also included were a biohazard bag and shipping papers, which requested information identifying the patient and the explanting physician, technical evaluations of the device, reasons for removal, and the name and address of the person and institution retuming the pacemaker to St. Jude Medical.
9/15/98 The Pu-238 nuclear pacemaker was shipped in the above described box to St. Jude Medical to their address in Sylmar, CA without a retum address on the package and without verification of the recipient's license.
l 2 Inspection Report No. 070-01500/98-001 ;
G:ONMSDOCWoRKVNSPRPTRSNM1446
10/22/98 The licensee called the old toll-free number that had been retained by St. Jude Medical to confirm receipt of the pacemaker and leamed that the nuclear pacemaker had not been received. WHC leamed that St. Jude Medical received only non-nuclear pacemakers and also of the sale and division of Teletronics. WHC also leamed that the toll free number for retum of nuclear pacemakers was different than the one that they had used initially.
10/28/98 The loss of the Pu-238 nuclear pacemaker was discussed at an RSC meeting, 11/30/98 WHC notified NRC of the loss of the Pu-238 nuclear pacemaker.
C. Conclusions i
- The inspector concluded that the various changes and transactions in the company, including the diversificabon of the pacemaker companies into a non-nuclear pacemaker company and a nuclear pacemaker company may have contributed to this event. Also, the retention of the original toll free number by the non-nuclear pacemaker company
, may have been a contributing factor to the confusion that led to the failure to contact correct company. Additionally, the failure of the companies (Teletronics and St. Jude Medical) to notify WHC of the changes, were potential contributing factors to the failure of WHC to nobfy the correct company to receive instruebons for retum of the Pu-238 nuclear pacemaker. The inspector also determined that WHC's failure to verify the recipient's license prior to attempting to retum the nuclear pacemaker may have contributed to the loss of licensed material.
111. MATERIAL TRANSFER, CONTROL AND TRANSPORTATION A. Inspection Scope The inspection focused on the transfer and control of licensed material and the licensee's implementation of regulations, license conditions and procedures to safely package, ship and transfer licensed material.
B. Observations and Findinos
' RAM shippers are required to abide by the regulations of the NRC, the Department of Transportation (DOT) and other agencies in the transportation of licensed material. 10 CFR 71.0 (b), in part, requires that in addition to the NRC requirements for packaging and transportation of licensed material; packaging and transportation of licensed material are also subject to the regulations of other agencies, such as the USPS. Postal Service Manual (Domestic Mail Manual), Section 124.3 is incorporated by reference in 39 CFR 111.1 and provides regulatory requirements for mailing RAM through the USPS.
Postal Bulletins contain amendments to the Domestic Mail Manual and contain the full text of all published interim and final regulations. Postal Regulations for Transport of Radioactive Matter are also in USPS Publications #6,* and 52, in the U.S. Postal Manual and 3g CFR.
3 Inspection Report No. 070-01500/98-001 G:ONMSOOCWORK\lNSPRPTVtSNM1446 i
- 1. Packaos Limits
- a. Postal Bulletin 21969 dated April 9,1998 prohibits radioactive materials in domestic mail if, among other things, the packages are required to bear the DOT Radioactive White-1 Label as described in 49 CFR 172.436. A White 1 Labelis required if the maximum radiation level on the surface at any point is less than or equal to 0.5 millirem per hour (mrem /hr) in accordance with 49 CFR 172.403 for Class 7 (radioactive material). The Pu-238 nuclear pacemaker package was mailed without bearing a White I Label, as required. The inspector determined, that had the package containing the Pu-238 pacemaker bore the White 1 Label, it may have alerted USPS workers of the prohibition on receiving such packages and transportation through the USPS may have been prevented.
Mailing a package through the USPS that requires a White i Label is an apparent violation of USPS Postal Bulletin 21969 dated April 9,1998, and therefore, a violation of 10 CFR 71.0.
- b. The USPS rules for " allowable radioactive matter" provides an additional restncbon that the amount of radioactnnty in a mailable package be limited to one tenth of the values listed in USPS Table 8 Activity Limits for Excepted Packages and 49 CFR 173.425 Table 7 Activity Limits for Limited Quantities, instruments, and Articles. Table 7 limits Special form instruments or articles to 104 of A, quantity as specified in 10 CFR 71 Table A-1. The A, quantity is 54 Cl, therefore 10% of 2 X 104 A, value is 0.054 Cl. In addition to the requirement for a White i Label, the activity of the Pu-238 pacemaker was 2.8 Cl, which exceeded the limit for a mailable package through the USPS.
Failure to meet the limitations of USPS Table 8 or 49 CFR 173.425 -
Table 7 made the Pu-238 package containing the nuclear pacemaker unacceptable for mail through the USPS and is an apparent violation of USPS Regulations, and, therefore constitutes a violation of 10 CFR 71.0 requirements.
WHC's failure to comply with the USPS Regulations are apparent.
violations of 10 CFR 71.0.
- 2. HAZMAT Trainino
' Shippers of HAZMAT are required to receive HAZMAT training. The RSO and the health physics technician who acted as the shipper said that HAZMAT training was not provided as required in accordance with 49 CFR 172.702. The inspector determined that the failure to provide HAZMAT training to the shipper was probably a significant contributing factor to the loss of control of RAM.
49 CFR 172.702 (a) requires that a HAZMAT employer ensure that each of its HAZMAT employees is trained in accordance with the requirements. On September 15,1998, the 4 Inspection Report No. 070-01500/98-001 G:ONMSOoCWoRK\lNSPRPTRSNM1446
W. .
- b *n licensee had not ensured that a HAZMAT employee was trained in accordance with the requirements prescribed for Pu-238 packaging and shipping.
Failure to provide HAZMAT training as required is an apparent violation of 49 CFR 172.702.
o 3. Shipper's Calificetion (Declaration)
Review of the licensee's actions related to the training deficiency indicated that the failure to provide HAZMAT training also contributed to, among other things, the licensee's failure to provide a Shipper's Certificabon in accordance with 172.204.
172.204 requires, in part, that each person who offers a hazardous material for transportabon shall certify that the matenal is offered for transportabon by printing on the shipping paper containing the required shipping description a certification 1 (declaration) with the following language; "This is to certify that the above named l materials are properly classified, described, packaged, marked and labeled, and are in
- proper condition for transportation according to the applicable regulabons of the DOT".
The shipper was not aware of the requirement. Therefore, A Shipper's Certification was not provided bythe WHC Shipper.
l Failure to provide a Shipper's Cerbfication is on apparent violation of 49 CFR 172.204.
! 4. Transfer of Special Nuclear Material Even though the WHC shipper stated that he specifically requested shipping materials and instructions for the retum of a " nuclear pacemaker " when speaking to St. Jude Medical personnel, apparently the words " nuclear pacemaker" did not alert St. Jude l Medical staff that they were not licensed to handle nuclear pacemakers. It was unclear to the inspector that the quality of communication was clear between WHC and St. Jude Medical staff. This apparent lack of clarity may have led to St. Jude Medical staff sending instructions and packaging for the retum of a non-nuclear pacemaker which was used by the WHC shipper. Also, the WHC procedure for Shipping of Radioactive L
Material, in part, requires that "All shipments must comply with the current Federal regulations goveming the transfer of RAM, as required by titles 8 (District of Columbia),
10 CFR (NRC),49 CFR (DOT), and 39 CFR (U.S. Posta' Service). The procedure also l
requires that the recipient of any RAM from WHC fumish evidence or a copy of his NRC
- l. - or Agreement State license to the RSO before shipment can be made to verify
- authorization of the recipient. These are also the requirements of 10 CFR 70.4L ;) and ,
( - (c). The licensee told the inspectors that they had received a copy of the license in (
October and provided a faxed copy of the appropriate recipient's (Accufix) license dated l
October 27,1998. Since St. Jude Medical does not handle RAM, they had no ;
l Agreement State license. Prior to mailing the Pu-238 nuclear pacemaker, WHC neither J followed their procedures nor the regulatory requirements to verify the recipient's 1 license. This failure to verify the license prior to shipment caused WHC to mail the L nuclear pacemaker to an unauthorized recipient.
i 10 CFR 70.42 (a) requires that no licensee transfer special nuclear material except as l authorized. 10 CFR 70.42 (b)(5) requires, in part, that special nuclear material be 5 Inspection Report No. 070-01500/98-001 G:ONMSOoCWoRKVNSPRPTVtSNM1446 i
E_________ .. .. .. .
4
,. < a transferred to any person authorized to receive such special nuclear material under terms of a specific license issued by the Commission or an Agreement State. On September 15, 1998, the licensee transferred special nuclear material to St. Jude Medical, a non licensee, and the traasfer was not authorized by 10 CFR 70.42.
Failure to transfer special nuclear material as authorized by 10 CFR 70.42 (a) and (b)(5) is an apparent violation.
- 5. Recioient License Wrircenen 10 CFR 70.42 (c) requires that before transferring special nuclear material to a specific licensee of the Commission or an Agreement State or to a general licensee who is required to register with the Commission or with an Agreement State, prior to receipt of the special nuclear material, the licensee transferring the material shall verify that the transferee's license authonzes receipt of the type, form, and quantity of special nuclear material to be transferred. Specifically, on September 15,1998, the licensee transferred 2.8 Ci of P-238 to St. Jude Medical without verifying that St. Jude Medical had a license that authorized receipt of Pu-238.
Failure to venfy the license of the recipient is an apparent violation of 10 CFR 70.42 (c).
- 6. Nuui,caton of NRC The licensee's procedure for venfying the receipt of pacemakers is described in Appendix U, " Nuclear Pacemaker Patient Tracking ," of their Radiation Safety Manual.
The licensee's RSO stated that this is supposed to be done within 10 working days, which would have been on or about September 29,1998. This procedure was not followed On October 22,1998, the WHC RSO called St. Jude Medical to verify their receipt of the Pu-238 pacemaker and was told that the pacemaker had not arrived. At that time, WHC was also informed by St. Jude personnel of the establishment of Accufix Research and the new toll-free number of Accufix in Hialeah, Florida. WHC staff said that they had not previously been informed of the new toll free number or of the establishment of Accurix Resea ch. Accufix Research was then contacted and provided to WHC a copy of their licenso from the State of Florida, as well as samples of the appropriate shipping documents for nuclear pacemakers. The sample shipping documents included a Declaration for Danges ous Goods, which contained the proper shipping name, and a description of the packaging and its contents. Other documents included were a Removal and Recovery Form, a Shipping Certification, mode of transportation, and packaging instructions to meet the DOT requirements. The receipt of the sample of correct package and shipping materials caused WHC staff to launch an expanded search for the missing Pu-238 nuclear pacemaker at its facility, including the mail room, and requested that surveys be done by St. Jude Medical in Sylmar, CA, at their facility.
On October 22,1998, WHC was aware that the nuclear pacemaker had not been received by St. Jude Medical. The pacemaker was missing, and the possibility that they had lost control of the nuclear pacemaker was apparent on that date. Also, the loss of control of the Pu-238 nuclear pacemaker was discussed at the October 28,1998, RSC meeting, at which the RSO and Management were present. However, it was not reported to the NRC until November 30, 6 Inspection Report No. 070-01500/98-001 GONMSOoCWoRKVNSPRPTVtSNM1446
1998, a period of more than 30 days. Notification to NRC is required to be made within 30 days of discovery of the loss of licensed material if the quantity exceeds 10 times the quantity specified in 10 CFR 20, Appendix C, which is 0.001 Cl. The missing pacemaker contains 2.8 Ci of Pu-238.
In discussions with the licensee about the lag in reporting the lost nuclear pacemaker, they explained that due to the very low dose rates emanating from the pacemaker and the fact that the Pu-238 is encapsulated in a strong metal as a sealed source, it did not appear that an I
exposure could result to persons in an unrestricted area. The inspec+or stated that loss of the nuclear pacemaker is of significant concem, particularly if it is in the public arena, because if breached, a significant uptake of nuclear material may occur that could significantly exceed the ALI. The licensee said that they had not considered the likelihood of a breach of the nuclear pacemaker in their initial evaluation. The inspector stated that the loss of a pacemaker containing 2.8 Ci of Pu-238 is of significant concem because the ALI for Pu-238 is 2 X 10- Cl, and 1 microgram (pg) of Pu-238 taken intamally into the human body is equivalent to 8.5 X 10: All. The nuclear pacemaker contains 175 mg of Pu-238; which is equivalent to 1.5 X 10' All. WHC did rot report to NRC upon discovery of the loss of the I nuclear pacemaker or within 30 days after discovery of lost licensed material in a quantity greater than 10 times the quantity specified in Appendix C to Part 20. Specifically, the licensee was aware of the loss of the pacemaker on October 22,1998, and discussed the missing material during the October 28,1998, RSC meeting, but did not notify the NRC of the loss until November 30,1998, a period of time that was greater than 30 days.
10 CFR 20.2201 (a)(1)(ii) in part, requires, that each licensee shall report within 30 days after the occurrence of any lost, stolen, or missing licensed material becomes known to the licensee, all licensed material in a quantity greater than 10 times the quantity specified in .
Appendix C to Part 20. j Failure to notify the NRC within 30 days is an apparent violation of 10 CFR 20.2201 (a)(1)(ii).
- 7. Control of Radioactive Materiglg in addition to the previously discussed issues. further discussions with WHC staff indicated that they did not control and maintain constant surveillance of licensed material that was in an unrestricted area. The WHC shipper mailed the Pu-238 nuclear pacemaker, uncertified (any method that required a signature by the recipient), through the USPS without a retum address,
~ making it almost impossible for retum should the package be undeliverable or lost in the mail.
On September 15,1998, the licensee mailed licensed material through the normal USPS, an unauthorized mode of shipping. The inspector determined that WHC, by mailing the Pu-238 nuclear pacemaker through the normal USPS bulk mail, without any other controls, failed to use appropriate procedures to ensure that licensed material that was not in storage was under control and constant surveillanco until it was either received by the addressee or retumed to the sender.
To protect against unauthorized removal or loss of materials,10 CFR 20.1802 states that the licensee shall control and maintain constant surveillance of licensed material that is in a controlled or unrestricted area and that is not in storage.
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, .* O Failure to control and maintain constant surveillance of licensed material that is in a co or unrestncted area and that is not in storage is an apparent violation of 10 CFR 20.1802.
- 8. Labelina of Packaaes Class 7 (radioactive) material packages are required to bear the appropriate label when offered for transportation. 49 CFR 172.403 requires, in part, that the proper label be affixed to a package of Class 7 material and is based on the radiation level at the surface of the package and the transport index (TI). The Tl is approximately 0.2 for this package and a maximum radiabon level at any point on the extemal surface that is less than or equal to 0.5 mrem /hr is required to have a White 1 Label. On September 15,1998, the package containing the Pu-238 nuclear pacemaker that WHC mailed through the USPS was not labeled with a White 1 Label.
Failure to have the package bear the required DOT White i Label is an apparent violation of 49 CFR 172.403.
- 9. Packmaina of Material .
l Appropriate packaging that meets Type 7A specifications is required to be used for transportation of Pu-238 nuclear pacemakers. 49 CFR 173.22 (a)(2), in part, requires that the shipper determine that the packaging or container is authorized and meets all applicable requirements in accordance with Part 173, and that it has been manufactured, assembled, and marked in accordance with Section 173.7 (a) and Parts 173,178, or 179. On September 15,1998, the licensee did not determine before shipping that the package was an authorized package, including Part 173 requirements, or that it had been manufactured, assembled, and marked in accordance with Section 173.7 (a) and Parts 173,178, or 179.
Failure to verify that a package or container meets the requirements for authorized packaging is an apparent violation of 49 CFR 173.22 (a)(2).
10 Materials Description "
Hazardous materials are required to be described on the shipping papers that accompany ,
them during transportation. 49 CFR Subpart C - Shipping Papers,172.200 requires, in part, l that each person who offers a hazardous material for transportation shall describe the
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hazardous material on the shipping paper in the manner required by Section 172.202. l 172.202, in part, requires that the shipping description of a hazardous material on the '
shipping paper must include the proper shipping name, the hazard class, the identification l number and the packing group. 179.203 has additional requirements for RAM that includes the word " RADIOACTIVE MATERIAL", the name of the radionuclide, description of the physical and chemical form, the activity contained in the package in appropriate units, the i category of label and the Tl. On September 15,1998, the licensee offered a hazardous '
l material for transportation, but did not describe the hazardous material on the shipping paper in the manner required by Subpart C, Sections 172.202 and 172. 203.
1 Failure to properly describe the hazardous material on the shipping papers is an apparent ,
violation of 49 CFR Subpart C,172.200 and 172.203. !
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C. Conclusions The inspector concluded that the lack of training, non-verification of the recipient's license, lack of proper marking and labeling of the package, lack of timely action including verification of package receipt, may have contributed to the loss of control of radioactive material.
IV. EXIT MEETING On December 3,1998, an exit meeting was held with licensee management. The inspectors reviewed the inspection findings, discussed apparent violations of NRC requirements, and obtained a commitment from licensee management to continue efforts to recover the missing pacemaker.
After the conclusion of the exit meeting, WHC staff continued to apprise Region I of its progress in the material recovery attempts. On December 10,1998, the licensee reported that they had secured assistance to enhance recovery efforts for the nuclear pacemaker. Also, they said that they had coordinated an effort that on or about December 17,1998, the Agreement State of Califomia and an individual whom they retained and has experience in performing plutonium surveys would meet at St. Jude Medical, Sylmar CA and the Sylmar Post Office. Dependent upon outcome of these surveys, they would determine further action. On December 22,1998, the licensee prov6ded an update of their actions, they reported that they had not been successful in their Sylmar, CA efforts, and would proceed to coordinate efforts to perform surveys in the Washington, DC Post Office where the nuclear pacemaker should have gone after it left their facility. Also, their survey efforts will include the Atlanta, Georgia Post Office which has the " dead letter" section for the Washington, DC area.
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- PARTIAL LIST OF PERSONS CONTACTED Licensee I Joyce Johnson, Ph.D., Senior Vice President, Nursing and Patient Care Services Billy G. Bass, Ph.D., Radiation Safety Officer Mark Seliksen, Ph.D., Radiation Safety Officer designate Terry Lane, Radiation Safety Assistant Dennis Dionne, Administrative Director, Radiology and Nuclear Medicine and other WHC staff members l
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