ML20114C461
| ML20114C461 | |
| Person / Time | |
|---|---|
| Site: | University of Missouri-Columbia |
| Issue date: | 08/27/1992 |
| From: | Mckibben J MISSOURI, UNIV. OF, COLUMBIA, MO |
| To: | Office of Nuclear Reactor Regulation |
| References | |
| NUDOCS 9209020194 | |
| Download: ML20114C461 (6) | |
Text
m____ _ . _ _ _ __ _ _ _
t Research Reactor Facihty I rch Fwk MM cosumtna tw o 05211 UNIVERSITY OF MISSOURI COLUMBIA W Q 33f [ M t
August 27,1992 Director of Nuclear Reactor Regulation l US Nuclear Regulatory Coramission Mail Station Pb137 Washington, DC 20555
REFERENCE:
Docket 50-180 University of Missouri Research Reactor License R 103
SUBJECT:
Report of Deviation from 10 CFR 71.5 incorrect Activities listed on a Type A l'ackage
Dear Sir:
On Monday July 27,1992, the University of Missouri Research Reactor (MURIO mistakenly switched two aliquots of a 110-100 sample from the Rare Earth Radiochemicals research project that produces lanthanide radionuclides for medical research. The aliquot containing 18.3 millicuries of110100 intended for the Dow Chemical Company in Freeport, TX (Dow FreeporO was sent to the University of Texas M.D. Anderson Cancer Center in llouston, TX (M.D. Anderson) externally labeled as 482 millicuries of 110100. On the same day, the aliquot containing 482 millicuries of 110-100 intended for M.D. Anderson was sent to Dow.Frneport externally labeled as 18.3 millicuries of 110-100. Both were Type A shipments with correct isotope and transport indices (TI) properly labeled on the package and shipping papers, The labels on the internal lead sample containers listed the correct amount of activity. Both Dow Freeport arJ M.D. Anderson licenses l authorize receipt of more than the 482 millicuries of110100. The destinations were switched when
! the MURR Radiopharmaceutical (HP) Research Groupl made corrections to the radioactive materiallabels for the two internal lead sample containers. The changes were being made to correct an error found when double verifying the labels.
Chapter 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(d)(4) and 172 403(gX2),
because the activity contained was in error on the package and the associated shipping papers.
Chapters 10 (NRC) and 49 (DOT) of the Code of Federa) Regulations do not require a formal report
, in this bituation, but we are providing this report describing our corrective actions for your-l information. We called Mr. Marvin Mendonca, NRC Washington, D.C., August 20,1992 to inform the NRC of this discrepancy and let them know we were filing this report. Mr. Charles Cox, NRC - Region 111, was also informed on August 27,1992 Washington, D.C, I
Formerly called the Radioiwtope Applications (RIA) Croup.
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Page 2 DISCREPANCY hl.D. Anderson opened their package Tuesday, July 28 at approximately 10:30 a.m. They transferred the sample into a dose calibrator for activity measurement and discovered that it contained only 11 millicuries in less than 0.5 milliliters when approximately 250 millieuries in 6.0 milliliters were expected based on decay of the amount recorded on the shipping documents.
Since no evidence of leakage or contamination was found, our principal contact at hi.D. Anderson called the RP Group's Senior Research Specialist to report the discrepancy. The specialist realized that bl.D. Anderson had probably received the sample intended for Dow Freeport, explained the assumed error to the caller, and called our principal contact at Dow Freeport to alert him of the situation. Dow Freeport had not yet received the other shipment in their laboratory, so the higher activity sample had not been opened. Dow Freeport was instructed not to open the package until further notice.
Packaging documentation for both samples was reviewed. A comparison of the measured ,
dose rate and labeled activities was supportive of the switched sample hypothesis. Our principal contact at bl.D. Anderson was called again and was asked to read the label from the internal lead .
sample container. It listed the destination as A1.D. Anderson, the activity as 18.3 millicuries, the volume as 0.2 milbliters, the date and time as 7/27/92 at 12:25 CDT, and the sample as lot hon 23, ,
vial 1. All this information was consistent with the sample received. INwever, the destination ;
differed from the intended destination of the sample and from the Shipping Requent that the RP Group gave to the h1URR Service Applications (SA) Group 2 . This information confirmed the sample switch and pinpointed the error as originating in the RP Group (who had generated the >
label on the lead sample containerL RECOVERY-Dow Freeport was authorized and equipped to ship the unopened package to hi.D. Anderson.
Since they were participating in a collaborative project with the researchers at h!.D. Anderson and had planned to be present for the tests, they offered to relt. bel the package appropriately and transport it to h1.D. Anderson on the following day. The lass of activity due to the delay was not considered a sede problem for the testh to be performe<l. The SA Group supplied Dow Freeport with certification information for the Type A package so that the sample would not require opening and repackaging.
DESCRIPTION OF EVENT '
l Plans for production of Ho 100 originated in the RP Group in response to a request from Dow.
EarPer in July, the Senior Research Specialist in the HP Group received a phone call from our i principal contact at Dow Freeport requesting the production of Ho 100 for themselves and ht.D.
Anderson. Dow Freeport is planning a new clinical trial in collaboration with hl.DJAnderson to investigate the use of Ho 100 in the treatment ofleukemia. Our principal contact at h!.D.
Anderson submitted a written request by facsimile on July 20,1992 for approximately 500 -
millicuries to be shipped to h1.D. Anderson on hionday, July 27i1992. The upper acceptable activity
, limit for Ho.166 at bl.D.' Anderson is 3.0 Curies. The principal contact at Dow Freeport requested L the remaining activity from the Ho 106 process to be shipped to Dow Freeport. The license at Dow.
Freeport permits them to receive a maximum of 1.0 Curie of Ho 160. Therefore both Dow Freeport and h!.D. Anderson licenses authorize receipt of more than the 482 mdlicuries of Ho 166.
A quartz vial containing 2.0 mg of holmium (as holmium nitrate) was prepared by the RP Group and delivered to the SA Group on July 17,1992. The target was identified with the unique 2
Formerly caUed Reactor Services Group.
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' designation lloN 23, assigned by the EP Group, and ent; raved on the quartz vial. An In house Irradiation Request was completed and submitted to the SA Group with the target. This request form identified the target by its Sample ID OloN 23), material, weight, and other pertinent information.
Each in poolirradiation is assigned a unique irradiation number (MURR ID #) and a can number. kradiation number 90458 and can number 10 were assigned by the Sn Group for the lloN 23 sample irradiation. The sample was irradiated following standard procedures.
Following irradiation, the irradiation can was opened in the hot cell and the dal placed in a lead sample container labeled with the can number, companies, isotope, and MURR ID #. The critical steps were double verified. The properly labeled lead sample container was delivered to RP Group personnel with the completed Irradiation Request.
RP Group personnel washed the exterior of the q'iartz vial in the vial cleaning station according to approved procedure. An empty clean lead sample container was h beled with the date, isotope, expected activity, and Sample ID OloN-23). After cleaning, the quartz vial was transferred to a prelabeled lead sample container for transfer to the processing laboratory.
An SOP for processing 110100 in a remote processing facility was in draft form, so the llealth Physics Group had approved a Radiation Work Permit (RWP) utilizing this draft procedure. The process was performed by a Senior Research Laboratory Technician and supervised / witnessed by a Senior Research Specialist. Critical steps of the process, initialed by technician and witness, included dissolution of the target in hydrochloric acid solution, transfer of the solution via syringe pump into three empty serum vials, and measurement of11010G activity using a dose calibrator inside the remote processing facility. The scrum vials were not labeled or marked in any way. They were identified on the process check sheet as Vial 1,2, and 3.
Prior to the activity measurement step, empty lead sample containers marked with the designations 1,2, and 3 were placed in the processing facility pass.through area. The vials were removed from the filling area in sequence. Each vial was lowered into the dose alibrator, the activity reading was recorded as vial 1,2, or 3 by the technician and verified by the witness, and the vial was moved into the lead sample container marked with the number corresponding to its designation (1,2, or 3) on the process paperwork _ The transfer of each vial into the correct lead sample container was also verined by the witness. The three lead sample containers were removed from the processing facility pass through and taken to another area of the laboratory.
Vial 1 is typically retained for Quality Assurance testing in this type of process, llowever, Vial 3 contained a slightly higher acuvity (21.0 millicuries compared to 18.3 millicuries in Vial 1). Since the retained sample would be analyzed for long lived radioactive impurities, the Senior Research Specialist decided to retain Vial 3 and ship Vial 1 to Dow Freeport. Vial 2, containing '
482 millicuries, was intended for shipment to M.D. Anderson. These shipment destinations were communicated to the technician and recorded on the process paperwork. The lines where the vial numbers and destinations were recorded in the procesa paperwork had "2/M.D. Anderson"listect above *1/Dow-Texas " The information recorded in this order on the process form could have
. contributed to the technician's error described below.
The technician generated radioactive materials labels for each of the three lead sample containers. The sample retained for quality assurance (3) was not destined for shipment;its -
radioactive label identined the isotepe, lot number (identical to the Sample ID, lion 23), activity, date and time of measurement.- The remaining two samples were intended for shipment. Their labels identified the destination, isotope, activity, volume, date and time of measurement, lot lloN 23, and vial number (Vial 1 or Vini 2).
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'J To verify the sample container labeh, the RP Group technician showed the labels to another RP technician before placing them on-th leno sample contmess. The :,econd techmeian noticed that the ec ay on each label identifying the sample as Vial 1 or Vial 2 was incorrect. The sample for M.D. Anderra n containing 482 millicuries was marked as Vial 1 rather than Vial 2. cs it was listed on the paperwork. The 18.3 millicuries sample for Dow Freeport war similarly mislabeled as Vial 2. Two new labels were generated and shown to the otlnr technician This time the identifu - Dn of 482 millicuries for Vid 2 and 18.3 millicuries for Vial 1 was correct, so the labels ,
were p t ud on the sample containers. Neither technician noticed that the new labels identified the destinations incorrectly-the new ' .aels still had Vial 11abel destination M.D Anderson and m- 4 2 destination Dow-Texas. sach label was placed on the hmd sample container corresponding n %'
s to its ccirect vial number and activity, but intended destinations were switched. The MURR ID #
h "( from the irradiation request (90458) was written en the te f both sample contain ,. which were p J. then delivert d to the SA Group's hot lab to be packaged . 31.pment. 9 Me P.P technician then generated a Shipping Rei,aest for each shipm nt. Both techt..:ians
% item on then request forms rlminst tY process paperwork, O. signed and dated the forms correctly requested the 4 32 millicuries of 110400 to be s pped to M.F
'<% 18.3 millicuries to be shipped te Dow-Freeport. The forms were taken to the SA jk un o- where the informatW was used to generate . hipping documents.
N4 SA Group's packagi.ig of the lead sample containers was initiated one at tin 2 after the i Te given a packaging packet for the desired shipment. Each packet was generated by a sk t < haician using information supplied on the Irradiath.i Request and san"' + ig sr ect. A geket included: a 7A Containa Control Check Sher . a shipping c- "' .nted pack ige Wicativn labels, cud two package certificatiot. isbels. Each C u 4et.
. hipping d and package identification label contain(d the followint . tat chipment: .ination, isotope, and MURR ID #. The package identifica 5 ..a e uouble-checked age..it the label and markings on the lead sample container. Tl u package identification label was placed on the outside each layer of the packaging material-can, expanded polystyrene, and box-to insure that the identity of the shipment wr ; m tained as each successive layer of the package was assembled.
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Upone J ets of assembling each package, the package do 3 -ati mersurements were recorded. These dose -ate Ang with the Snipping Request supplieu ny the RP Group, were used to complete the requi. ip. .., docs;aentation: the address label, shipper's declaration, and primaa . id subsido risk labels. This documentation was reviewed and placed on each pacha c .orresponding to the set ofinfcrmation identifying the shipment: destination, isotope and MURR iD #. Both st <ns wen independent yl verified before the package was released by the SA Group to Federal Exprew for shipment.
AN \ LYSIS A meeting was held at 2:30 p.m. Jul3 28, shortly arter being called by M.D. Anderson. It was attended by all full-time isotope prodaction staff of the RP Group and by the Health Physice Manager and Assistant Manager, Service Applications Manager and Supervisos, the Reactor Manager, Assistant Director, and Associate Director. Tho purpose was to analyze the emise(s) of this error and to plan procedure modifications to avoid reoccurrence. Personnel at this session and follow up sessions during the past month focused not only on the specific error that caused thic situation, but on any potential weaknesses in recording or communicating that might allov misidentifications to occur, and root cause(s) why an error of this nature could occur after pwous correctise actions ccncerning shioping ecors had been implemented.
Due to the previous errors, manngement had implemented a Une-item double verification for a'l critical items in the proussing and shipping of samples in the SA Group. They handle most of
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- tha rbdioactive sample processing and all of the shipping. This incident showed that there were o weaknesses in how corrective actions were identified and implemented in other groups that do processing of samples and request shipments of radioactive material by the SA Group. The HP Group personnel were asked to revise procedures and Shipping Requests to be used for their next processes that were scheduled the following week, A follow-up meeting was held at 1:30 p.m.
July 30 to review the procedure modifications.
This incident resulted from human error in labelling the lead sample containers that were delivered to the SA Group. The fact that the new error was nct detected revealed weaknesses in certain policies and procedures used by the RP Group. Specific shortcomings included incomplete rever.fication of replacement labels and a missed opportunity i.o detect inconsistencies between the associated Shipping Request and sample container label.
The circumstances of previous sMoping incidents, lessons learned and their associated curective actions had been communicated to MURR staff and the MURR Reactor Advisory Committee and subcommittees. Discussions had included how corrective actions taken _would impact the process of other groups requesting and providing information for the SA Group to make shipments. The application of similar corrective actions to procedures cc ..ed by these groups prior to sample transfer to the SA Group for shipment had not been emphas' red. The RP Group had begun instituting changes in their procedures, such as double verincation. However, the need for standarnizing the designation of critical information in the transfer of sample contamers and Shipping Roquests to the SA Group had not been thoroughly examined. The following paragraphs i will explain each of the identified weakm sses in more detail.
Double verification of the sample container labels was performed by the RP Group technicians, but when an error was detected and replacement labels were generated, they should have been verified as new labels, with each entry double. checked for accuracy.~ This i much more obvious in retrospect than it was to the technicians at the time. Their new procedures specifically state allitems must be reverified when corrections are made when finding an error.
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' Although the information on the Shipping Requests wa. correct for the intended shipments and had been checked ar.d signed by two individuals, the sample container labels rnd Shipping
}
Requests were generated at different times, then given to different members of the PA Group. They were never compared with one another, so an opportunity to catch the discrepancy between them was lost. Procedures have been revised to require comparing Shipping Requests egainst the sampi e container labels before packaging for shipment is started.- Groups that rou*inely request -
shipments by the SA Group were made aware of the incident and also began double veiifying the appropriate information on the Shippmg Request and verifying the Shipping Request against the sample container label.
'Lps submitting samples to the SA Group for shipment have been markirg the destina an,-
isotope, activity, and MURR ID # on each' sample container to be shipped. The destinaten,
- activity, and MURP. ID # were used by the SA Group on the preprinted package identification labels to track identity on each successive layer of packaging and used to match the complete shipping packaga to the apprcpriate shipping paperwork. In this instance, the two 110-106 shipments were kea from a single processed target and sent to different receivers, so the two sample containers vcere labeled with the same MURR ID #. The paperwork given to the shippers for packaging each sample for shipment identified the sample by destination, activity, and MURR ID #. In this core the MURR ID # and the isotope were identical for the ! -, samples in question.
- This len the one item in error on the sample container 16els, the destinauon, as the unique identifier when the shippers matched the packaging packet tc the lead sample container to be packaged and later to the shipping documentation. The preprinted package identification labels
, . for all shipments coming ( mi other groups now include the activity.
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' CORRECTIVE ACTIONS i
i The immediate corrective action consisted of notifying Dow-Freeport to request them to not . ,
! open the mislabeled package, which contained higher activity than indicated on the pcckage label l
! and shipping papers. Arrangements were made for Dow-Freeport to ship the sample to M.D. '
- j. Anderson in accordance with Federal Regulations as described above. The HP Group stopped
! processing samples for shipment until their procedures were revised and reviewed. Other groups that routinely request shipments by the SA Group were made aware of the incident and also began double verifying the c.ppropriate information on the Shipping Request and verifying the Shipping
- Request against the sample contt.iner label. A review was immediately started to determine root j cause(s).
I Procedures have been modified to insure that the information on all the items associated with the shipment (sample container label, packaging packet, and shipping documentation) agre- and is ao: urate. Any group submitting radioactive materials to the SA Group for shipment must now double verify critical information on the Shipping Request (destination, isotope, activity, and i MURR ID #). The SA Group now requires other ge ups to add a letter
- signation to the end of the '
j MURR ID # fur multiple shipments made from a s!ncle 4 radiation t( '. and the preprinted j package identification labels for their shipments now include the activny which, combined with i the destination and isotope, provides additional opportunities to detect errors before shipments are -
! released.
Sincerep i
d
/ J. Charles McKibben Associate Director th .
xc: NRC Region III Reactor Advisory Committee
! - Reactor Safety Subcommittee -
l Isotope Use Subcommittee
. J. Sheridan, Vice Provost ;
! J. Rhyne l Dow. Freeport I- M.D. Anderson l
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