ML20086F546
| ML20086F546 | |
| Person / Time | |
|---|---|
| Site: | University of Missouri-Columbia |
| Issue date: | 09/04/1991 |
| From: | Mckibben J, Reilly W MISSOURI, UNIV. OF, ROLLA, MO |
| To: | Office of Nuclear Reactor Regulation |
| Shared Package | |
| ML20086F494 | List: |
| References | |
| NUDOCS 9112030273 | |
| Download: ML20086F546 (4) | |
Text
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3 September 4,1991 Director of Nuclear Reactor Regulation US Nuclear Regulatory Commission Mail Station Pl.137 Washington, DC 20555 REFERENCT:
Docket 50186 University of Missouri Research Reactor License R 103
SUBJECT:
Report of Deviation from 10 CFR 71.5 Incorrect Radionuclide listed on a Type A Package
Dear Sir:
On August 5,1991 the University of Missouri Research Reactor (MURR) made two shipments with the incorrect radionuclides and activities listed in the shipping papers and on the package.
10 CFR 71.5 requires licensees to follow the Department of Transportation regulations, Chapter 49 of the Code of Federal Regulations,in shipping radioactive materials. These two shipments did not meet the requirements of 49 CFR 172.203 and 17M03. The error resulted from the two samples being inadvertently switched in the MURR hoi -
Chapters 10 (NRC) and 49 (DOT) of the Code of Federal Regulations do not require a fermal r.
n this situatim, but we are providing a description and'our corrective actions for your information. We c.:lled Mr. Alexander Adams, NRC. Washington D.C., on August 7 and Mr. Andrew Dunlop, NRC Region III, on August 9 to describe this discrepancy and volunteered to file this uport within 30 dsys.
As a result of the report to Mr. Dunlop, Mr. Mark Mitchell and Mr. Paul F elke, Region III, visited MURR on August 21 to investigate the discrepancy and the MURR shippint; program.
l DISCREPANCY Activated rock samples intended for NASA-Johnson Space Center were misakenly sent to Mallinckrodt Medical labeled as Re.156,11 Ci. The Re 166 shipment inter ded for Mallinckrodt Medical was sent to NASA-Johnson Space Center labeled as Na.24,16 mCf Jprimary activity in the aluminum foil around the rock samples). Both were Type A shipments and tacy were both properly labeled with dose rates and transpart indices (TI). The rocks (shipped as Re456) were properly labelled as a Yellow 111 shipment and the Re IS6 (shipped as rocks Na.24) was properly labelkJ as a Yellow Il shipment. MURR verified that both Mallinckrodt and NASA licenses were authorized to receive the intended isotopes prior to shipment. The Mallinckrodt NRC license also authorized them to receive the isotope and activity in the mistaken shipment to them, but the NASA license did not authorize NASA to receive the Re IS6 shipment.
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hptemhrt 4,1991 Page 2 NASA discovered their rock samples were not in the package shipped to them when it was opened on August 6. Personnel at NASA momentarily removed the plastic bag containing a sealed quartz vial (Re.iB6) from its shipping pig and recognized the sample was not their expectd ramples in ses. led quarts vials wrapped in aluminum foil. They immediately reinserted the bag into th-shipping pig. NASA informed MURR of the discrepancy at approximately 11:00 a.m. and refused receipt of the insterial which they secured under NASA health physics control. The NASA and Mallinckrodt shipping pigs had been in the hot cell with Ove other containers for MURR in house resectc).ers, and those five samples had been properly received by the researchers on August 5. It was concluded ths.t the NASA and Mallinckrodt samples had been switened. We immediately called Mallin krodt Medical to inform them of the discrepancy and found that they had opened the averpack but had not epened t% sealed shipping can ;ontained in the MURR Type A packa :e.
s The d'screpancy was caused ty an error in loading shipping pigs in the h.. cell. During later steps in processing for shipment, surface and Tl raoiation readings were made. The magnitudes of the readings were not sufUclently discrepant to suggest that the contents were the wrong radionuclides, and, based on those readings, the shipping label designatiens were correct for the actual material in each pf chage.
HECOVERY The MURR Health Physics Menager remained in close contact with the NASA Radiation Safety Ofncer e.Rer we were informe : > the discrepancy. Based on MURR measurements of another Re.
186 sample tha' had a similar arradiation history and was sealed in a quart.: vid as was the Re 166 at NASA, t)
URR llealth Physles Manager estimated the dose for a 30 second exposure at 4 inches from e.166 vial at 8:00 a.m. on August 6 to be approximately 970 mrem, about 95% due to beta radiatto Jsing this dose Information, NASA's RSO made an assessment of extremity dose to their own pe. onnel NASA obtained immediate processing of the whole body film badges of the p,rson who opened the package and another person in the vicinity. The readings on both whole body badges were minimal (below 10 mrem).
I We dispatched a certified shipper and a QA inspector (who is also a Certi0ed Health Physicist) to NASA on August 8 to retrieve the Re.186 under a MURR Radiation Work Permit. Since the required equipment to prepare MURR hpe A shipments is not portable, we had sent a Type B container to NASA to use in the retrieval. Mallinckrodt Medical needed to have the Re 166 by August 9 for treatment of a patient, so the Re 166 was sent by MURR from NASA to Mallinckrodt 4
Medical as a'Me A s'hlpment made in a Type B container Repackaging of the Re 166 vial by MURR personnel required that the vial was out ofits shieloing (handled with forceps and behind a leaded glars shield) for approximately 35 seconds. During this repackaging, MURR personnel wore whole body film badges, and TLD wrist and ring badges. All dosimetry badges registered minimal.
MURR also sent a shipper to Mallinckrodt Medical on August 8, and he brought the activated roch back to MURR.
ANALYSIR Samples to be irradiat a. MURR and shipped go through the following process. Irradiation targets are placed in aluminum cans or apsules which are welded shut and leak tested. Small I
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targets thgt are loaded in espsules r.re then placed into " host
- cans which are welded shut and leak tested. Next the cans are placed in irradiation positions for speciGed periods and then removed to reactor pool storage posillons when irradiations are complete. They au rernoved frorn the pool, i
under health physics supervision, and transported in transfer casks to the hot laboratory or hot cell for opening, processing, and prepniellen for shipment.
1 In keeping with the principles of ALARA, samples to be processed in the hot cell are transferred la groups to reduce the number of transfers and openings of the hc t cell. Prior to moving the trantfor cask into the hot cell, the required shipping pigs are marked and placed in the hot cell.
The transfer cask is then placed inside the hot cell, opened, and the. cans are removed. As far as possible, decanning, processing, and leading for shiprner,t are completed on the contents of an irradiation can before another enn is opened, liost cans contain multiple irradiation capsules, Some of which are shipped and some cf which are loaded into another host can for further irradiation, Special care is exercised to identify the empsules and ensure that they reach their proper destinatlen.
A double veri 0 cation of each irradiation capsule prior to opening in the hot cell had been instituted in September 1990 as a result c,f a shipment of Pd.103 which wn destined for Theragtnics Corporation but was shipped to htallinckrodt hiedical. In that instance, the discrepancy was discovered by htORR and the package was returned prict to opening. The Mallinckrodt Medical NRC license did authorire receipt of the Pd.103 material.
Processing may include a determination of the activity using a shielded Caplatee inside the hot cell. The sample is then loaded into a plast!c bag preplaced inside the shipping pig. Tops are rnanually placed on the pigs aller the het cellis opened under health physics supervision, and surface dose rates and enternal contamination assetiments are made.
t The shipping pigs or Type A shipments are then transported to a shipping preparation area where i
each is placed in a can and sealed. Contact and one foot dose rate readings are taken and recorded on each can for information for the receiver, The sealed can is placed in an identiDed expanded polystyrene overpack which is strapped, and the overpack is placed in an identified shipping container (box) which is strapped and sealed. Contact dose rates are read and recorded at the top, bottom, and all sides of the shipping container and the TIis measured to determine the proper shipping label (i.e. White 1, Yellow !!, Yellow 111).
Procedures were followed on August 5, but human error in not properly identifying each shipping pig resulted in switching the placement of the samples between the contalners.
Due to the number of shipments being handled at MURR, the staffing for this area was reviewed during June and July 1991. The decision was made to increase the number and qualification level of the staff. The group is being.'ncreased from four personnel (one Reactor Services Supervisor, one Laboratory Technician, and tuo Laboratory Assistants) to five personnel (one Reactor Services Supervisor and four Labora'ory Technicians)mThe steps to complete this change were in progress when the August 5 shipping esent occurred. Currently, the shipping group consists of the Reactor Services Supervisor and three Laboratory Technicians, and we are interviewing candidates to fill the open position.
Septemler 4,1991 Page 4 CQHRECTIVE ACT1DRS i
The irmnediate corrective action consisted of notification of hiallinckrodt hiedical and retrieval of the shipments described above, review and revision of processing and shipping procedures, and personnel actions.
l The initial procedure review was performed August 7, and interim revised procedures were used for proces:Ing and shipping after that date. The main thrust of the procedure review was to identify pctential steps where samples could be accidentally switched. The revised procedures included requiring recorded double checks (two person verification) for these sample handling steps that had a potential for rnisidentifying the shipment, and improving the identifying marks on the shipping pigs.
The following personnel acticns were taken:
All processing / shipping personnel were informed of the misshipnents, reminded of the importance of correct processing and shipping, and trained in the revised procedures The person responsible (c.r the discrepancy was counseled by the person's supervisor and seme restrictions were imposed on the persen's work duties Long term corrective actions will consist of follow.up on immediate actions on procedures and personnel. Procedures, to include procedures for target preparation and irradiation, will be r
reviewed, revised if necessary, and finalized.
i Evaluation of the person responsible for the August 5 shipping discrepancy will continue to deterrnine further action to be taken,if any. Hiring actions will be completed, and new personnel will be Indoctrinated and trained.
Sincerely, hfhN William F. Reilly Assistant Director, FiscaVReacter Services Reviewed and Approved:
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m J. Charles hicKibben Associate Director xc: NRC Region 111 Reactor Advisory Comm!ttee p onsin n m Reactor Safety Subecmmittee NWAr rws: sTAn u rus'tn 1sotope Use Subcommittee
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........m,64 ouueuw..ui.....m SEP 101991 University of Missourt
_ Columbia 1,1 cense No, R-103 ATTNr Dr. James J., Rhyne Docket No. 50-186 Director EA 91-113 Rosaarch Reactor Facility Research Park Columbia, MO 65201
Dear Dr. Rhyne:
SUBJECT:
NRC INSPECTION REPORT No. 50-186/91004(DRSS)
This refers to the in,pection conducted by Messrs. P. R. Pelke and M. Mitchell of this office on-August 21.-1991. The inspection included a review of activities authorized for your Hissouri University Research Reactor facility.
The inspection was conducted to review the circumstances surrounding the August 5, 1991, inadvertent switching of samples in the hot cell, which resulted in the incorrect shipment of 11 curies of rhen1ur-186-to the NASA / Johnson Space Center and 16 millicuries of sodium-24 (activated cosmic dust) to Hallinckrodt Medical. Although not reportable, you reported this event to NRC Region !!! on August 9, 1991. At the conclusion of the inspection, the findings were discussed with those members of your staff identified in the enclosed report.
Areas examined during the inspection are identified in the report. Within these areas, the inspection consisted of selective oxaminations of procedures and representative records, interviews with personnel, and observation of activities in progress.
Based on the results of this inspection, five apparent violations were identified, four of which are being considered for escalated enforcemert i
action in accordance with the " General Statement of Policy and Procedure for NRC Enforcement Actions" (Enforcement Policy),10 CFR Part,2, Appendix C
-(1991). 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.
.An enforcement conference to discuss these apparent violations has been scheduled for September 18. 1991. The purposes of this conference are to discuss the a > parent violations, their causes and. safety significance; to p'rovide you_ tie opportunity to point out any errors in our inspection report; to provide an opportunity for you to present your proposed corrective actions;-
and to discuss any other information that will help us determine the appropriate enforcement action in accordance with the Enforcement policy.
You will be advised by separate correspondence of the results of our deliberations on this matter.
No response regarding the apparent violations-is required at this time.
09/11<91 07:43 709 7ec " 45 CG3 J
A University of Missouri - Columbia 2
SEP 101991 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, l
/
/
Cha les
. Nor tus, Direct r Division of Ra lation Safety and Safeguards Enclosuret Inspection Report No. 50-186/91004(ORSS) cc w/ enclosure:
DCD/DCB (RIOS)
OC/LFDCB Dr. William Vernetson, Director of Nuclear Facilities J. Lieberman OE J. Partlow, NRR J. Goldberg, OGC R. Burnett, NHSS A. Beach, RIV A, Adams, NRR B. Berson, Regional Counsel i
09/1a48 07125 700 '790 BC69 004 NUCLEAR REGULATORY COMMIS$10N REGION !!!
Report No. 50-186/91004(DR$5)
Docket No. 50-186 License No. R-103 Licensee University of Missouri - Columbia Facility Names Missouri Un'1versity Research Reactor (MURR)
Inspection At:
Research Reactor Facility Columbia, Missourt Inspection Conducted: August 21, 1991
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Inspectors:
M. W. Mitchell Date W Pk
- hi P. R. Pelke Date Approved By:
(6.C., L Mf j/j/,p) ^
W. G. $nell, Ctiief Date Nuclear Materials Safety Section 2 Inspection Summary inspection on August 21. 1991 (Report No. 50-186/91004(DRSS)),
Areas inspected: Announced, special inspection of the circumstances surrounding the August 5, 1991 inadvertent shipment of 11 curies of rhenium-186 intended for Hallinckrodt Medical, St. Louis, Mo., to NASA / Johnson Space Center, Houston, Tx., and 16 mt111 curies of sodium-24 intended for the Johnson Space Center to Hallinckrodt; and Type A peckage design and testing documentation (86740).
Results: Of the two areas inspected, five apparent violations were identified, f*
OETAILS 1.
Persons Contacted University of Missouri - Columbia
'J. Rhyne, Director "C. McKibben Associate Director
- B. Reilly, Assistant Director, Fiscal / Reactor Services
'S. Langhorst, Manager, ' Reactor Health Physics
- S. Gunn, Reactor Service Engineer "M. Carter-Tritschler, Supervisor, Reactor Services-Shipping
- J. Ernst Assistant Manager, Reactor Health Physics
- Denotes those attending the exit meeting on August 21, 1991.
NASA / Johnson Soace Center - Houston D. Waggart, Radiation Safety Officer (Telcons on August 22, and September 5,1991)
MallinckrodtMedical R. Brown, Radiation Safety Of ficer (Telcon on September 5,1991) 2.
frproper Shipping and Transfer of Type A Material On August 5,1991, a number of samples were removed from the reactor pool to the hot cell including seven cans which had been located in the flux traps. Can #46 was a 2-inch can which contained 2 vials wrapped in aluminum foil.
The vials contained cosmic dust (quartz grains) which had been irradiated for 124.18 hours2.083333e-4 days <br />0.005 hours <br />2.97619e-5 weeks <br />6.849e-6 months <br /> in a 4.00E+14 n/cm*-sec flux.
The primary sample activity was due to sodium-24.
The cosmic dust Was irradiated for HASA.
Can #79 was a host can containing five capsules, one of which was
, designated Can #$48 which contained Re-186 produced for Hallinckrodt Medical.
Enriched rhenium had been used to minimize the production of rhenium-188.
This sample had been irradiated in the same flux for the same time as the cosmic dust.
In the hot cell, each sample was to be placed into its respective lead pig (identified with the respective can number and customer name) after being placed in the Capintec ton chamber to determine its gross activity.
The rhenium-186 read at 11 curies and the cosmic dust (sodium-24) at 16 milli-curies. The shipping technician then inadvertently placed the Mallinckrodt sample in the NASA lead pig and vice versa.
The licensee indicated that the technician was somewhat confused due to the number of samples being
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processed at the sane time in the hot cell.
However, the technician did not verify that a mistake had not been made.
The lids were placed on the 2
5 & 85 4 s 07:46 70si~999 M C N
pigs, they were swiped and verified clean, taped, and moved to the packaging / shipping area.
Each lead pig was placed in a shipping can, which was placed in the middle of a polystyrene cube, which was placed in a fiber box.
Dose rate readings on contact, were taken at all six sicos of each package and an appropriate transport index was assigned for each package.
The package bound for NASA was given a Yellow 11 label and marked as containing 16 m1111 curies of sodium-24.
The package bound for Hallinckrodt was given a Yellow III label and marked as containing 11 curies of rhenium-186. Additionally, the shipping papers for each package had the wrong isotope and activity specified.
The packages were then shipped with overnight c'ouriers.
On August 6, 1991, a rpsearcher at NA$A opened the package containing 11 curies of rhenium-186 and immediately recognized that it was the wrong material.
NASA was only authorized to receive 100 m1111 curies of rhenium (l.icense No. 42-09388-01). University of Missouri estimated that the researcher received 700 millirem to the hand based en handling the sample with tongs at arm's length for 30 seconds no closer than 4 inches to the hand.
The researcher's whole body dosimeter showed no measurable exposure.
NASA independently estimated that the researcher received 750 millirem to the hand and 50 millirem to the face and eyes.
Discussions by the inspectors with the Mallinckrodt Radiation saf ety Officer confirmed that if Hallinckrodt had opened the same petkage, no exposure would have been received by their technician in that the contents of the lead pig would have been removed in a lead window glove box with mechanical manipulators.
NA$A notified the University of Missouri, who notified Mallinckrodt of the error. Mallinckrodt had not yet opened its package.
On August 8,1991, the University sent two employees to NASA to package the rhenium-106 and ship it to dallinckrodt. Additionally, University of Hissouri sent an employee to Mallinckrodt to retrieve the sodium-24 package.
Although not reportable, the licensee reported this event to Region III on August 9, 1991.
During the inspection, the inspectors asked the licensee if there had been any similar problems in the past.
The licensee described a similar event which occurred in Septembur 1990.
The licensee inadvertently shipped 35 curies of pa11adium-103, -109 to Mallinckrodt Medical instead of 6.19 curies of rhenium-186.
However, the licensee discovered the error internally and notified Mallinckrodt before they opened the package.
Mallinckrodt was authorized to receive the palladium isotopes.
Both the September 1990 and the August 1991 incidents were caused by the same shipping technician.
Failure to include the correct name of each radionuclide and activity contained in each package in the shipping paper description for the August 5, 1991 shipment of rhenium-106 to NASA, the August 5, 1991 shipment of sodium-24 to Hallinckrodt, and the September 4, 1990 shipment of pa11adium-103, -109 to Mallinckrodt are considered to be three apparent violations of 10 CFR 71.5(a), 49 CFR 172.203(oti,- and 49 CF6L 172.203(d) tit-(50-186/91004-01a, -Olb, and -01cy.
Transfer of a source containing 11 curies of rhenium-186 to NASA / Johnson Space Center, a person who was not 3
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L@TIEM t#RD Wa5 % $ YB W autherized to receive such byproduct material is an apparent violation of 10 CTR 30.41(a) and (b)(S These viu1ations were caused by personnel error) w(50-186/91004-02).
hen the shipping technician incorrectly read s
markings ulch resulted in placing byproduct materials in the wrong transport shielding device (lead pig) while working in tho hot cell.
Following the September 1990 incident," Material Transfer Sheets" at the the licensee's corrective action included posting a copy of each day's hot cell work stations.
The Isotopes Division also included the capsulo bottom symbol on the sheets.
Two thipping technicians were required to verify and initial the identity of the capsule (s) on the Material Transfer Sheets. A memorandum was issued on the incident and daily meetings wera established to discuss the processing and shipping activities for the next day.
It is important (o note that the September 1990 incident involved a
- , mall aluminum can (capsule), therefore, the licensee concluded that the root cause was a problem with identifying the small cans while working in the hot cell. Therefore, the above corrective action (double verification of the bottom symbol) was limited to small cans.
Following the August 5, 1991 incident, the licensee instituted a double verification system involving a second individual every time there is the potential to switch a sample during the packaging process.
There is a signature requirement for each performer and: observer in the cross check.
The performer and obserYer Cannot be the same individuals.
The 11censeo y
has created an additional position in the shipping department and has b7-increased the basic education and experience requirements for the applicants.
In the long term, the licensee plans to build more hot cells and to streamline the hot cell process.
Samples would go through the het cells in a linear rather than parallel process, thus eliminating the potential for switching samples. The licensee is procuring a system which will use a sodium iodide detector to provide a final survey of all material shiaments as a final quality assurance check.
Additionally,thelicensee@""
The system is expected to >e in place by September 30, 1991.
is daveloping a requalification training program for shipping technicians.
Currontly, only initial training is given.
3.
_ Review of Type A Package Design and Testing Oscumentation The inspectors reviewed the Itcensee's use of Type A shipping containers.
In response to the request to see the required testing documentation, the licensee provided a video tape of the testing process that took place in May of 1988.
This video was a visual documentation of the testing ?rocess but not a documentation of the packaging quality that would allow tie licensee to replicate the prototype. The video took into account the tests required in 49-CFR 373'.465 and 466-but did not make reference te the requirements of construction and package design found in 49 CFR 173.411 and 412 or the preparation of specimens found in 49 CFR 173.462(a)(1).
Empirical data and conclusions were not provided in the video.
4
i 4g CTR 173.415(47 states that each shipper of a $pecification 7A package must maintain on file for at least one year af ter the latest shipment, and shall provide to DOT on request, complete documentation of tests and an engineering evaluation or comparative data showing that the construction methods, packaging design, and materials of construction comply with that specification.
$pecification 7A, general packaging, Type A, requires, in part, that each packaging must be so designed and constructed that it meets the standards for Type A packaging (49 CFR 179.350-2(a)).
- Failure to maintain on file complett documentation of tests and engineering evaluation for the contaAners used for Type A shipments is an apparent violation of 49 CFR 173/415(s$ (50-186/91004-03).
4.
Exit Interview The inspectors met with licensee representatives denoted in Paragraph I during and at the conclusion of the inspection on August 21, 1991.
The inspectors summarized the scope and results of the inspection and discussed the likely content of the inspection report.
The licensee acknowledged the information and did not indicate tha't any of the information disclosed during the inspection could be considered proprietary in nature.
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