ENS 41220
ENS Event | |
|---|---|
05:00 Nov 23, 2004 | |
| Title | Report of Theft or Loss of Licensed Material |
| Event Description | {{#Wiki_filter:The following information is excerpted from an email submitted by the licensee describing in detail the circumstances and conclusions concerning the missing rad material:
. . II. DESCRIPTION OF LOSS OF LICENSED MATERIAL Radioisotope: Phosphorous-32 Chemical Form: Deoxycytidine 5'-Triphosphate [alpha-32P] Physical Form: Aqueous Solution Amount: Xenogen appears to be missing material from 2 separate vials as outlined below: 1. 150 �Ci (15 �l of material at 10 �Ci/�l) from a vial sent from GE HealthCare (formerly Amersham Biosciences) to Xenogen Biosciences on November 4, 2004. This vial was received at Xenogen Biosciences on Friday, November 5, 2004. The supplier's catalog number for the material is AA0005-1 mCi and the lot number for the material received is AC0445. The quantity requested was 1000 �Ci (37 MBq) under Purchase Order No. 36348. This vial was designated internally within Xenogen Biosciences as vial No. 491. 2. 100 �Ci (10 �l of material at 10 �Ci/�l) from a vial sent from GE HealthCare (formerly Amersham Biosciences) to Xenogen Biosciences on November 11, 2004. This vial was received at Xenogen Biosciences on Friday, November 12, 2004. The supplier's catalog number for the material is AA0005-1 mCi and the lot number for the material received is AC0446. The quantity requested was 1000 �Ci (37 MBq) under Purchase Order No. 36348. This vial was designated internally within Xenogen Biosciences as vial No. 492. Activity: 3000 Ci (111TBq)/mmole . . V. PROBABLE DISPOSITION OF THE LICENSED MATERIAL INVOLVED As of November 23, 2004, our current hypothesis is that the volume discrepancies (loss) of material in vials 491 and 492 were due to two conditions. First, the material appears to be evaporating in the vials. Second, any evaporated moisture that condensed on the lid of the vial is not being concentrated through centrifugation prior to removal of material by research associates. Evidence that supports this conclusion is listed below: 1. We have found that when this material is separated into 5 �l aliquots, placed in screw cap tubes with o-rings, and stored at 4�C for several days, the liquid evaporates and a dried and visible red pellet forms (concentrated dye). In addition, the volume of the pellet appears to be less than 1 �l (visual inspection). However, when the tube is centrifuged after storage, the full volume reappears in the bottom of the tube and can be confirmed by using a pipetting device. The experiment mentioned above was performed using one vial of 1000 �Ci of Redivue[TM] [alpha-32] deoxycytidine 5'-Triphosphate (dCTP) from GE Healthcare that was received at Xenogen Biosciences on Friday, November 19, 2004. This vial was designated internally as vial 493. Volume discrepancies were first noticed on Monday, November 22, 2004. 2. The occurrence of volume discrepancies in vial 491 and 492, along with a similar incident involving vial 486, which was reported to the U.S NRC on October 13, 2004, coincides with the recent switch (July 2004) by Xenogen from [alpha -32P] dCTP supplied by PE Life Sciences to material supplied by GE Healthcare. Unlike the material supplied by PE Life Sciences, the material from GE Healthcare is not kept frozen during transit and storage, but rather at 4 degrees Celsius. Hence, the material is subject to evaporation and condensation at the top of the vial. 3. Upon arrival, we have found that these vials need to be centrifuged in order to collect the material at the bottom of the vial. If the vials are not centrifuged, we are unable to verify that the volume sent is correct. Because it was determined that the volume of both vials was correct prior to any removal of material, we have eliminated the possibility that an incorrect volume was shipped to our facility by GE Healthcare. 4. During the November 18 meeting with the researchers, one employee notified [the RSO] with the EHS department, that he failed to make a log entry for which he removed 50 �Ci from vial 492. Other than this particular instance, there is no further evidence that a research associate or scientist removed material from vial 491 and 492 and failed to record this removal in the Isotope Inventory Log. Importantly, this discrepancy has been accounted for in the total amount of material missing from vial 492 as detailed in this report. 5. There appears to be no evidence that the volume discrepancies are due to inaccurate pipetting devices. Last month, all three P-20 pipetman that are used by users to remove radioactive material from P-32 vials were checked for accuracy by [the RSO]. Importantly, this evidence does not rule out the possibility a user had the pipettor accidentally set to a higher volume prior to removal or that the user did not use the pipetting device correctly. 6. There is no evidence that an employee or visitor intentionally stole licensed material from vial 491 and 492. Because of the number of employees (approximately 65) at the facility, employees, in general, know one another and work in an environment where they are likely to observe any unusual behavior. In addition, there are relatively few visitors come to the facility. Furthermore, the refrigerator that is used to store the vials of P-32 material is locked with a combination lock. Only users of radioactive material have access to this combination. Moreover, the room (Radioisotope Laboratory) is locked by a punch combination lock. Only users of radioactive material have access to this combination. All employees, whether they are a user or nonuser of radioactive material, receive training that explicitly informs them that it is a crime to remove radioactive material from the facility. 7. There is no evidence that a research associate or scientist recorded an inaccurate amount of material withdrawn from vial 491 or 492 because all employees who used vial 491 and 492 verified, through interviews conducted by [the RSO], that the amount of material indicated on the Isotope Inventory Log is the amount that was intended to be used. 8. There is no evidence that the loss was due to spillage because: a. There were no reports of a spillage by anyone who worked with the material; b. The amount of material presumed missing would have easily been detected through our weekly monitoring program by swipe analysis using a Liquid Scintillation Counter. Furthermore, 100 �Ci would have easily been detected from monitoring conducted with a GM survey meter by other employees who used the Radioisotope Laboratory over the time in question. VI. EXPOSURE OF INDIVIDUALS TO RADIATION Following an intensive survey of the laboratory area and other sections of the building, there is no indication of radiation exposure to individuals due to the unaccounted material. VII. ACTIONS TAKEN TO RECOVER MATERIAL At this time, our current hypothesis is that the volume discrepancies with vials 491 and 492 are due to two conditions: 1) evaporation of material within the vial and 2) lack of centrifugation of vials prior to removal of material. Hence, it is not anticipated that the material will be found. More importantly, if it is true that the lost volume was due to evaporation, then radioactivity may not be actually missing. Again, the Radiation Safety Officer does not believe that any employee, or non-employee, unlawfully removed licensed material from vial 491 and 492. . . . . VIII. PROCEDURES OR MEASURES THAT WILL BE ADOPTED TO ENSURE AGAINST A RECURRENCE OF THE LOSS OR THEFT OF LICENSED MATERIAL. The company has implemented the following Standard Operating Procedures immediately to insure that 1) the material is not being removed by a user without correct documentation; 2) the material is not being taken or removed for purposes other than those purposes outlined in Materials License 29-30350-01; and 3) the proper amount of material is being used in each experiment. 1. Every commercial vial of P-32 entering the facility and which will be used for DNA/RNA labeling experiments will be separated into 5 �l aliquots (or the volume typically used for one reaction) at the time the package is surveyed and its contents verified. The aliquots will be consecutively numbered for tracking purposes. Aliquots will be stored in Eppendorf tubes and these tubes will be stored in shielded centrifuge test tube racks. The rack will be made of acrylic and will be a solid-block design with drilled wells. One rack will hold aliquots from only one source vial (e.g. Shielded rack reads "vial no. 500" . Eppendorf tubes within read 1-20). 2. A user should use the lowest consecutive numbered aliquot when removing an aliquot from the rack for use. 3. [The RSO] (or his designee) will check daily the supply of P-32 aliquots and determine if there are any inconsistencies with the number of aliquots versus the number used by researchers based on the Isotope Inventory Log (or equivalent). In addition, all pipetting devices used during the handling or dispensing of P-32 will be calibrated immediately by a commercial vendor, unless recently calibrated in the last 2 months. As mentioned earlier, [the RSO and another individual] met with all users of P-32 at the Cranbury Facility on November 18, 2004 to make them aware of the problem, to review pipetting techniques, and to train them on the new SOPs. HOO Note: See similar Event Report #41126. }}[[Event description::Description::{{#Regex_clear:The following information is excerpted from an email submitted by the licensee describing in detail the circumstances and conclusions concerning the missing rad material: . . II. DESCRIPTION OF LOSS OF LICENSED MATERIAL Radioisotope: Phosphorous-32 Chemical Form: Deoxycytidine 5'-Triphosphate [alpha-32P] Physical Form: Aqueous Solution Amount: Xenogen appears to be missing material from 2 separate vials as outlined below: 1. 150 �Ci (15 �l of material at 10 �Ci/�l) from a vial sent from GE HealthCare (formerly Amersham Biosciences) to Xenogen Biosciences on November 4, 2004. This vial was received at Xenogen Biosciences on Friday, November 5, 2004. The supplier's catalog number for the material is AA0005-1 mCi and the lot number for the material received is AC0445. The quantity requested was 1000 �Ci (37 MBq) under Purchase Order No. 36348. This vial was designated internally within Xenogen Biosciences as vial No. 491. 2. 100 �Ci (10 �l of material at 10 �Ci/�l) from a vial sent from GE HealthCare (formerly Amersham Biosciences) to Xenogen Biosciences on November 11, 2004. This vial was received at Xenogen Biosciences on Friday, November 12, 2004. The supplier's catalog number for the material is AA0005-1 mCi and the lot number for the material received is AC0446. The quantity requested was 1000 �Ci (37 MBq) under Purchase Order No. 36348. This vial was designated internally within Xenogen Biosciences as vial No. 492. Activity: 3000 Ci (111TBq)/mmole . . V. PROBABLE DISPOSITION OF THE LICENSED MATERIAL INVOLVED As of November 23, 2004, our current hypothesis is that the volume discrepancies (loss) of material in vials 491 and 492 were due to two conditions. First, the material appears to be evaporating in the vials. Second, any evaporated moisture that condensed on the lid of the vial is not being concentrated through centrifugation prior to removal of material by research associates. Evidence that supports this conclusion is listed below: 1. We have found that when this material is separated into 5 �l aliquots, placed in screw cap tubes with o-rings, and stored at 4�C for several days, the liquid evaporates and a dried and visible red pellet forms (concentrated dye). In addition, the volume of the pellet appears to be less than 1 �l (visual inspection). However, when the tube is centrifuged after storage, the full volume reappears in the bottom of the tube and can be confirmed by using a pipetting device. The experiment mentioned above was performed using one vial of 1000 �Ci of Redivue[TM] [alpha-32] deoxycytidine 5'-Triphosphate (dCTP) from GE Healthcare that was received at Xenogen Biosciences on Friday, November 19, 2004. This vial was designated internally as vial 493. Volume discrepancies were first noticed on Monday, November 22, 2004. 2. The occurrence of volume discrepancies in vial 491 and 492, along with a similar incident involving vial 486, which was reported to the U.S NRC on October 13, 2004, coincides with the recent switch (July 2004) by Xenogen from [alpha -32P] dCTP supplied by PE Life Sciences to material supplied by GE Healthcare. Unlike the material supplied by PE Life Sciences, the material from GE Healthcare is not kept frozen during transit and storage, but rather at 4 degrees Celsius. Hence, the material is subject to evaporation and condensation at the top of the vial. 3. Upon arrival, we have found that these vials need to be centrifuged in order to collect the material at the bottom of the vial. If the vials are not centrifuged, we are unable to verify that the volume sent is correct. Because it was determined that the volume of both vials was correct prior to any removal of material, we have eliminated the possibility that an incorrect volume was shipped to our facility by GE Healthcare. 4. During the November 18 meeting with the researchers, one employee notified [the RSO] with the EHS department, that he failed to make a log entry for which he removed 50 �Ci from vial 492. Other than this particular instance, there is no further evidence that a research associate or scientist removed material from vial 491 and 492 and failed to record this removal in the Isotope Inventory Log. Importantly, this discrepancy has been accounted for in the total amount of material missing from vial 492 as detailed in this report. 5. There appears to be no evidence that the volume discrepancies are due to inaccurate pipetting devices. Last month, all three P-20 pipetman that are used by users to remove radioactive material from P-32 vials were checked for accuracy by [the RSO]. Importantly, this evidence does not rule out the possibility a user had the pipettor accidentally set to a higher volume prior to removal or that the user did not use the pipetting device correctly. 6. There is no evidence that an employee or visitor intentionally stole licensed material from vial 491 and 492. Because of the number of employees (approximately 65) at the facility, employees, in general, know one another and work in an environment where they are likely to observe any unusual behavior. In addition, there are relatively few visitors come to the facility. Furthermore, the refrigerator that is used to store the vials of P-32 material is locked with a combination lock. Only users of radioactive material have access to this combination. Moreover, the room (Radioisotope Laboratory) is locked by a punch combination lock. Only users of radioactive material have access to this combination. All employees, whether they are a user or nonuser of radioactive material, receive training that explicitly informs them that it is a crime to remove radioactive material from the facility. 7. There is no evidence that a research associate or scientist recorded an inaccurate amount of material withdrawn from vial 491 or 492 because all employees who used vial 491 and 492 verified, through interviews conducted by [the RSO], that the amount of material indicated on the Isotope Inventory Log is the amount that was intended to be used. 8. There is no evidence that the loss was due to spillage because: a. There were no reports of a spillage by anyone who worked with the material; b. The amount of material presumed missing would have easily been detected through our weekly monitoring program by swipe analysis using a Liquid Scintillation Counter. Furthermore, 100 �Ci would have easily been detected from monitoring conducted with a GM survey meter by other employees who used the Radioisotope Laboratory over the time in question. VI. EXPOSURE OF INDIVIDUALS TO RADIATION Following an intensive survey of the laboratory area and other sections of the building, there is no indication of radiation exposure to individuals due to the unaccounted material. VII. ACTIONS TAKEN TO RECOVER MATERIAL At this time, our current hypothesis is that the volume discrepancies with vials 491 and 492 are due to two conditions: 1) evaporation of material within the vial and 2) lack of centrifugation of vials prior to removal of material. Hence, it is not anticipated that the material will be found. More importantly, if it is true that the lost volume was due to evaporation, then radioactivity may not be actually missing. Again, the Radiation Safety Officer does not believe that any employee, or non-employee, unlawfully removed licensed material from vial 491 and 492. . . . . VIII. PROCEDURES OR MEASURES THAT WILL BE ADOPTED TO ENSURE AGAINST A RECURRENCE OF THE LOSS OR THEFT OF LICENSED MATERIAL. The company has implemented the following Standard Operating Procedures immediately to insure that 1) the material is not being removed by a user without correct documentation; 2) the material is not being taken or removed for purposes other than those purposes outlined in Materials License 29-30350-01; and 3) the proper amount of material is being used in each experiment. 1. Every commercial vial of P-32 entering the facility and which will be used for DNA/RNA labeling experiments will be separated into 5 �l aliquots (or the volume typically used for one reaction) at the time the package is surveyed and its contents verified. The aliquots will be consecutively numbered for tracking purposes. Aliquots will be stored in Eppendorf tubes and these tubes will be stored in shielded centrifuge test tube racks. The rack will be made of acrylic and will be a solid-block design with drilled wells. One rack will hold aliquots from only one source vial (e.g. Shielded rack reads "vial no. 500" . Eppendorf tubes within read 1-20). 2. A user should use the lowest consecutive numbered aliquot when removing an aliquot from the rack for use. 3. [The RSO] (or his designee) will check daily the supply of P-32 aliquots and determine if there are any inconsistencies with the number of aliquots versus the number used by researchers based on the Isotope Inventory Log (or equivalent). In addition, all pipetting devices used during the handling or dispensing of P-32 will be calibrated immediately by a commercial vendor, unless recently calibrated in the last 2 months. As mentioned earlier, [the RSO and another individual] met with all users of P-32 at the Cranbury Facility on November 18, 2004 to make them aware of the problem, to review pipetting techniques, and to train them on the new SOPs. HOO Note: See similar Event Report #41126. }}| ]] |
| Where | |
|---|---|
| Xenogen Biosciences Cranbury, New Jersey (NRC Region 1) | |
| License number: | 29-30350-01 |
| Organization: | Xenogen Biosciences |
| Reporting | |
| 10 CFR 20.2201(a)(1)(ii) | |
| Time - Person (Reporting Time:+10.93 h0.455 days <br />0.0651 weeks <br />0.015 months <br />) | |
| Opened: | Joseph D'Ippolito (Rso) 15:56 Nov 23, 2004 |
| NRC Officer: | Steve Sandin |
| Last Updated: | Nov 23, 2004 |
| 41220 - NRC Website | |
Xenogen Biosciences with 10 CFR 20.2201(a)(1)(ii) | |
WEEKMONTHYEARENS 412202004-11-23T05:00:00023 November 2004 05:00:00
[Table view]10 CFR 20.2201(a)(1)(ii) Report of Theft or Loss of Licensed Material ENS 411262004-10-05T04:00:0005 October 2004 04:00:00 10 CFR 20.2201(a)(1)(ii) Missing Licensed Material 2004-11-23T05:00:00 | |