ML20127J996

Responds to NRC Ltr Re Violations Noted in Insp Rept. Corrective Actions:Notified Dow-Freeport to Request That They Not Open Mislabeled Package & Procedures Have Been Modified

ML20127J996
Person / Time
Site:	University of Missouri-Columbia
Issue date:	01/14/1993
From:	Mckibben J MISSOURI, UNIV. OF, COLUMBIA, MO
To:	NRC OFFICE OF ENFORCEMENT (OE), NRC OFFICE OF INFORMATION RESOURCES MANAGEMENT (IRM)
References
NUDOCS 9301260016
Download: ML20127J996 (4)

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Research Reactor Facihty II -

Cet>a Muam 65211 UNIVERSITY OF MISSOURI COLUMBIA T N # M 3141882421 FAX {314) 882 = 3443 January 14,1993 Director, Omce of Enforcement US Nuclear Itegulatory Commission ATTN: Document Control Desk Washington, DC 20555 11EFEllENOE: Docket 50-186 University of Missouri llesearch iteactor

. License 11103

SUBJECT:

lleply to a Notice of Violation in Accordance with 10 CFil 2.201

Dear Sir:

This is the written statement required by the provisions of 10 CFR 2.201 in response to the December 2,1992 US NitC llegion 111 Notice of Violation and Proposed imposition of Civil Pennity-$625 and Demand for Information (N!!C Inspection Report No. 5018&92002 (DitSS)] concerning events at the University of Missouri itesearch Reactor (MultIO. On December 17,1992, NRC Itegion 111 approved an extension of the required reporting date to January 15,1993, The two violations are groui,ed together because the reply for both is the same.

Violations

1. On July 27,1992, the licensee delivered a package containing 0.482 curies of holmium 106 to a carrier for transport to Dow Chemical Company in Freeport, Texas, with the description on the shipping papers and the radioactive label stating that the shipment contained 0.0183 curies of holmium 166, and the package was not excepted from labeling.

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2. On July 27,1992, the licensee delivered a package containing 0.0183 curies of holmium 106 to a carrier for transport to the University of Texas, M.D. Anderson Cancer Center, llouston, Texas, with the description on the shipping papers and the radioactive label stating that the shipment contained 0.482 curies of holmium 160, and the package was not excepted from labeling.

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January 15,1993 Page 2 Iteply

1. Admission or Denial of the Alleged Violations i

! These violations are admitted. MURR voluntarily reported them to the NRC Omce of ,

Nuclear Reactor Regulation by telephone on August 20,1992, and to Mr. Charles Cox, 4

NRC Region III, by telephone August 27,1992. A written report was submitted to the

! NRC by letter dated August 27,1992, in preparing this reply two errors were found in l this August 27 letter where the word " activity" should have been " isotope." Both errors l are in the last paragraph of page 5. The second sentence should have started as:"The

! destination, isotope, and MURR ID W. . ." The fourth sentence should have d

similarly ended as: ". . . by destination, isotope, and MURR ID #." I apologize for i

any confusion this may have caused the NRC staff in reviewing this incident.

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2. The reasons for the violation if admitted, and if denied, the reasons why.

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! The caut.e of both violations was human error in correcting errors on sample container labels. New errors were introduced which were not detected, thereby revealing weaknesses in certain policies and procedures used by the I

Radiopharmaceuticals Research (RP) Group. Specific shortcomings included

incomplete reverification of replacement labels and a missed opportunity to detect j inconsistencies between the associated Shipping Requcst and sample container label, A

l After a previous similar shipping error, the circumstances of the incident, lessons learned and their associated corrective actions had been communicated to MURR etaff and the MURR Reactor Advisory Committee and subcomrrittees. Discussions 5

i had included how corrective actions taken would impact the process of other groups requesting and providing information for the Service Applications (SA) Group to j make shipments. The application of similar corrective actions to procedures conducted by these groups prior to sample transfer to the SA Group for shipment had not been emphasized. The HP Group had begun instituting changes in their

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procedures, such as double verification. Ilowever, the need for standardizing the

! designation of critical information in the transfer of sample containers and i Shipping Requests to the SA Group had not been thoroughly examined. The following paragraphs explain each of the identified weakneases in more detail. ,

j Doubl'e verification of the July 27 sample container labels was performed by the RP j 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-4 checked for accuracy.

Although the infomation on the sample container labels was in error, the Shipping Requests were correct for the intended shipments and each had been checked and signed by the same two individuals. The sample container labels and Shipping-Requests were generated at different times, then given to different members of the SA Group. They were never compared with one another, so an opportunity to catch the discrepancy between them was lost.

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l I Groups submitting samples to the SA Group for shipment have been marking the i destination, isotope, activity and h1URR ID # on each sample container to be shipped.

{ The destination,isetope, and h1URR ID # were used by the SA Group on the preprinted j package identification labels to track identity on each successive layer of packaging l j and to match the completed shipping package to the appropriate shipping paperwork.

In this instance, the two Ho-166 shipments were taken from a single processed target and sent to different rece

vers, so the two sample containers were labeled with the l

hame 51URR ID #. The paperwork given to the shippers for packaging each samplo

! for shipment identified the sample by destination, isotope and h1URR ID #. In this j case the h10RR ID # and the isotope were identical for the two samples in question.

] This left the one item in error on the sample container labels, the destination, as the only unique identifier when the shippers matched the packaging packet to the lead sample container to be packaged and later to the shipping documentation.

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! 3. The corrective steps that have been taken and the resulta achieved.

i The immediate corrective action consisted of notifying Dow Preeport to request that l

j they not open the mislabeled package, which contained higher activity than indicated j on the package label and shipping papers. Arrangements were made for Dow.

< Freeport to ship the sample to hl.D. Anderson in accordance with Federal I Regulations. The RP Group stopped processing samples for shipment until their procedures were revised and reviewed. Revised procedures specifically state that all

items must be reverified when corrections are made after finding an error. Other

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groups that routinely request shipments by the SA Group were made aware of the

incident and also began double verifying the appropriate information on the l Shipping Request and verifying the Shipping Request against the sample container label. A review was immediately started to determine root cause(s).

Procedures have been modified to insure that the information on all the items auociated with the shipment (sample container label, packaging packet, and l

, shipping documentation) agrees and is accurate. 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 h1URR ID #). The SA Group now requires other groups to assign a sufrix letter at the end of the h1URR ID #

l j for multiple shipments made from a single irradiation target. In addition, the preprinted packago identification labels for their shipments now include the activity, l which, combined with the destination and isotope, provides additional opportunitlei to detect errors before shipments are released. The SA Group management is required to routingly review the daily shipping summary log for discrepancies and inconsistencies.

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blURR staff visited DuPont NEN, Best Industries and hiallinckrodt to review f

procedures, check sheets, equipment and training related to preparation and shipment of radioactive materials in an effort to identify ways to improve the hlURR system.

- h1URH has hired a consultant to assist in improving our procedures and related training. lie has worked for Union Electric Company at the Callaway Nuclear y Power Plant for the past 12 years writing procedures and corresponding training l

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outlines to meet INPO certification. Previously, he had been in charge of the h!URR

electronics shop for 14 years, so he is familiar with the facility.

j Dr. Marcus Voth, Director of the Penn State Radiation Science and Engineering

Center and past manager of Nuclear Operations for the Union Carbide Corporation-Medical Products Division (later named Cintichem), conducted a peer review of the J

l MURR shipping program October 15 and 16,1992.

The staff visits, engagement of a consultant and peer review are steps that have been taken but no additional concerns were identified requiring immediate changes, j Steps discussed under 4 below will further consider the stafivisits and peer review for ,

j enhancement to the shipping program, and the work of the consultant is in progress. ,

As a result of these steps, MURR has an improved system for shipping radioactive l

matericts which should not permit a repeat of past incidents and which we continue to j seek to improve, i

j 4. The corrective steps that will be taken to avoid further viciations.

} A task force with diverse experience was established to develop the corrective actions l listed in 3. above. Formalization of procedures and development of an associated

[ training and retraining plan are under way to co.mplete those actions, t The task force is continuing to perform a global review of the MURR shipping

program to determine the best was to perform radioactive shipments involving the broad diversity ofisotopes that MURR ships with a heavy emphasis on short half. life

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isotopes. The main objectives of the task force are physical control and ALARA. As

required by the December 2,1992 Region lit letter and subsequent communication with Region 111, the results of the global review to date and a milestone schedule for

completing the review will be reported separately by January 15,1993.

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5. The date when full compliance is achieved.

There have been no mistakes in switching shipments of radioactive materials since j July 27,1992.

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Sincere  ; ,

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l J. Charles McKibben Associate Director xc: NRC Region Ill

S. Weiss, NRC/NRR r Reactor Advisory Committee ,, .

Reactor Safety Subcommittee isotope Use Subcommittee P~~

</t5$, h'htyg / /qf3 OWSDNE H. EMANT!

J. Sheridan, Vice Provost WW PmuC STATE OF MISSOU J. Rhyne .,

BoME COUNTY m coMrtssicr4 tXP. APA. 14.1995 i

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