IR 07100016/2011014
| ML20202C268 | |
| Person / Time | |
|---|---|
| Site: | 03001214, 07100016 |
| Issue date: | 11/26/1997 |
| From: | NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION IV) |
| To: | |
| Shared Package | |
| ML20202C209 | List: |
| References | |
| 30-01214-97-01, 30-1214-97-1, NUDOCS 9712030297 | |
| Download: ML20202C268 (18) | |
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I ENCLOSURE U.S. NUCLEAR REGULATORY COMMISSION
REGION IV
f NMED ltem No.:
970868
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Docket No.:
030-01214
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License No.:
04 00421-05 Report No.:
030 01214/97 01 Licensee:
Department of Veterans Affairs Facility:
Veterar..; Affairs Medical Center Location:
San Francisco, California
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Dates:
October 16 through November 14,1997 Inspector:
David D. Skov, Sr. Health Physicist Approved By:
D. Bialr Spitzberg, Ph.D., Chief, Nuclear Materials Inspection and Fuel Cycle and Decommissioning Branch Attachment:
Supplemental inspection Information 9712030297 971126 PDR ADOCK 03001214 L
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2-EXECUTIVE SUMM ARY Veterans Aff airs Medical Center NRC Inspection Report 030-01214/97-01 SUMMARY OF SITE STATUS This was a reactive, announced inspection of licensed activities involving the receipt and disposal of byproduct material received for use in a research laboratory. The reactive inspection was limited to a review of an event reported to NRC involving the accidentalloss of a package containing phosphorus 32 (P-32). The inspection was focused on the event, its direct, root, and contributing causes, notification, reports and records, consequences, and the licensee's program for receiving and disposing of radioactive packages. A different incident involving a minor spill and contamination of hydrogen 3 (H 3)in another reser,ch laboratory was also reviewed during the inspection.
_Backaround Reaardina Sotification of the Lost Source Event On September 2,1997, the licensee reported the ;nadvertent loss of a package
containing a 250 microcurie (uCl) vial of P 32 which was inadvertently left in a package received by a laboratory and later disposed to normal trash (Section 2).
Direct Causes The lost source event was directly caused by the f ailure of an authorized user to
properly check the radioactive contents of a package when it was opened in a research laboratory, and by the f ailure to survey the package to ensure it was empty of radioactive sources before it was disposed to normal trash (Section 4).
Root Causes A root cause of the event appeared to be a lack of attention to detail by the
laboratory authorized user while checking packing lists and other records to verify the contents of packages received. The researcher was also not knowledgeable about the requirement to survey packages before their disposal to normal trash, a second root cause of the event (Section 4).
Contributina Causes A contributing f actor in the event was the licensee's method for documenting the
amount of activity and the number of rr.dioisotope vials received in a shipping package (Section 4).
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3-Consecuences Any potential radiation exposures received by licensee personnel and members of
the public who handled the " empty" package af ter it was released to norrnal trash were likely small and well below NRC dose limits (Section 5).
Reaulatorv Issues A violation was identified involving the licensee's f ailures to verify that the package
contents agreed with the packing list for the shipment received, and the failure to survey the pac' age for contamination before disposal (Section 7).
A violation was identified involving the licensee's unauthorized disposal of licensed
material to normal, non-radioactive trash (Section 7).
Licensee Corrective Actions The licensee's corrective actions included a prompt and thorough search for the
missing material, issuing a violation notice to the responsible laboratory, implementing additional training, and making administrative changes to the licensee's program for receiving radioactive material. The licensee's response and corrective actions appeared adequate in addressing the causes of the incident (Section 8).
Soill Contamination incident A minor spillinvolved leakage of a small amount of radioactive material from a
freezer while it was removed from the Molecular Biology 1.aboratory. The licensee took appropriate action to mitigate the consequences of the event by isolating and decontaminating the areas involved, warning personnel, notifying the Radiation Safety Officer (RSO), and preventing or minimizing radiation exposure of laboratory workers and the public (Section 9).
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Reoort Details
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Program Overview (87100)
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1,1 Insoection Scone
The inspector reviewed the license application, supporting documents, and other
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records maintained by the licensee. Collectively, these documents describe the
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licensee's radiation saf aty program. Interviews were also held with licensee personnel.
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1.2 Observations and Findinos r
The Department of Veterans Aff airs Medical Center, San F ancisco, California (VASF) is authorized under its NRC license to use byproduct materief for diagnostic and therapeutic medical procedures as defined in 10 CFR 35.100 500, and for clinical and laboratory research activities conducted under the specific approval of
the radiation safety committee. At the time of the inspection, the research program
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had 53 principalInvestigators (Pis) and approximately 400 workers authorized to use i
radioactive material (Aus)in approximately 200 laboratories. The research
laboratories have received an averags of 15 packages per week containing such radioisotopes as carbon 14, hydrogen 3 (H 3), iodine 125, sulfur 35, and P 32 in
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microcurie to millicurie quantities.
The radiation safety office was organized under the licensee's Environmental Health and Safety Service (EH&S), and is staffed by the RSO, two assistant RSOs, a health physics technologist, and clerical support which report to the Associate Medical
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Center Director. Research activities involving licensed material have been organized under 35 separate laboratory programs which report to the Chief of Staff. Licensed activities in each laboratory program have been supervised under each individual Pl i
but are routinely administered and implemented by a radiation safety person (RSP)
designated by the Pl and approved by the RSO.
1.3 Conclusions The licensee has a large laboratory research program involving the receipt of approximately 800 radioactive packages per gear. Program activities were consistent with approved usages authorized ut. der the license.
Background (87103)
At 2:57 p.m. (Eastern Time) on September 2,1997, the licensee notified the NRC Operations Center of an incident involving the inadvertent disposal of a vial containing 250 uCi of P 32 to normal trash. VASF reported that a package
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containing three vials of P 32 had been delivered to a researcher on August 18, i
1997. The researcher removed two of the three vials he had ordered but disposed 1-H
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5-of the package containing the remaining vial without '...owing the shipping records or surveying the package. The licensee traced the. rash to a local landfill but was unable to locate the P 32 vial. A written report < i the lost source event was issued by the licensee on September 12,1997, and ret ived by NRC on September 26,1997.
Based ca the information discussed above, the inspector was dispatched to VASF on October 16,1997, to begin a reactive inspection of certain licensed activities, with primary emphasis on the circumstances surrounding the reported incident.
Sequence of Events (87103)
3.1 Insoection Scoon The inspector interviewed VASF personnel and examined licensee records to reconstruct the circurnstances surrounding the reported event.
3.2 Observations and Findings The following is a chronological sequence of key events that occurred prior to, during, and following the incident.
15,1997, an " Approval Form for Radioactive isotope Order," from a On August
molecular research laboratory Pl, was prepared and signed by the laboratory's AU (Researcher A) who was also the laboratory's designated RSP. The form was sent to and approved by the licensee's radiation safety office which authorized the laboratory to order the material. The form specified an order for Arnersham Corporation, Arlington Heights, illinois, to ship the following radioisotopes with an expected arrival date of August 18, ? 997: "P 32 alpha DCTP [ deoxy cytosine triphosphate],0.250 mci and P 32 alpha UTP luracil triphosphate),0.250 mci x 2."
This organic material had been ordered for use in labeling experiments routinely conducted according to an existing research protocol application previously approved by the hospital's radiation safety ccmmittee.
Between 10:30 a.m. and 11 a.m., August 18,1997, a single carton with
Department of Transportation White-I labels, was delivered to and initially received by the VASF warehouse. A warehouseman delivered the package a few minutes later to the nospital's radiation safety office for processing.
At approximately 11 a.m., August 18, assistant radiation safety officer A (ARSO A)
transferred the package to the radiation safety laboratory (Room 10A, Building 21 for a log in and receipt survey, in accordance with a written procedure for receiving radioactivo packages. Af ter placing the package in the fume hood and noting no visible physical damage, ARSO A measured maximum radiation levels of 0.4 mR/hr and 0.05 mR/hr at its surf ace and a distance of 1 meter, respectively. The package outside surf ace was wiped for removable contamination and none was detected.
The survey results were recorded on a receipt log (" Radioactive Materials Package
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6-I Survey") form. ARSO A opened the package and checked the enclosed packing list for the investigator's name and radioisotope type, form, and quantity. The packing list specified a total (shipping) activity of 1.030 mci and the fo!!owing contents:
Product Descriotion. Radionuclide. Chemical and Quantity i
Shioned Unit Size Physical Form
260 Ci (Alpha 32P) UTP, Approx 800 Ci/mmol,20 mCl/mi Dry ice labeled compound liquid
250 Ci (Alpha 32P) DCTP, Approx 3 Ci/mmol,10 mCl/mi Dry ice labeled compound liquid" Between 11 a.m. and 11:30 a.m., August 18, ARSO A removed the three vials from
the package and, af ter checking the labeled radioactive contents against the laboratory's inventory record, determined that the amount received was below the quantity authorized under the permit issued to the Pl. When viewed from the
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outside of the package inward, the radioactive contents were packaged as follows:
the outer cardbeard carton contained a styrofoam liner with an inside cavity of approximate dimensions,4 to 6 inches per side. This inner package enclosed dry ice and thres 2 inch diameter by 4 inch high screw top, (yellow) plastic vial containers which were labeled with its radioactive contents (e.g., P 32, UTP, 250 Cl, August 22,1997). Sealed inside each plastic container was a smaller vial containing P 32 -
liquid in a small volume of either 12.5 or 25 microliters.
ARSO A performed a wipe survey of each vial but detecteu no removable contamination. He next prepared a separate " Radioisotope Disposition and Disposal
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Record Sheet" (receipt /use) form for each radiochemicalin the shipment which identified, among other information, the laboratory and principalinvestigator, date received, radioisotope, chemical form, and radioactivity. Specifically, one record form specified an activity of 0.250 mci of --DCTP for one vial, while the other form denoted a (total) activity of 0.500 mci of - UTP for the remaining two vials. (These
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forms were to be issued to the laboratory for tracking its use, disposa!. and inventory of each radiochemical.) ARSO A then called the laboratory to notify Researcher A that the package was ready for pick-up, but he received no response.
(Researcher A was on a lunch break and not availabls to take the phone call.)
ARSO A placed the disposition form and packing list on top of the styrofoam container, closed the top of the outside carton with masking tape, and wrote "P 32"
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and the laboratory's name on the carton.
- At approximately 12 p.m., August 18, a second assistant radiation safety
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officer B (ARSO B) delivered the package to the laboratory in Building 12 rather than
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wait for Researcher A to return from lunch to accept the package at the radiation safety laboratory. An individual (Researcher B) in the research laboratory signed a radiation safety receipt log to accept delivery, and without looking inside or opening the package, he placed it on Researcher A's desk.
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Between approximately 12:30 p.m. and 1:30 p.m., August 18, Researcher A
returned from lunch. He opened the package in Laboratory Room 224, and removed the packing list and two receipt /use forms. Researcher A did not look at the packing lie,t and placed it away in a file folder. The AU then opened the styrofoam liner and re. moved two yellow, plastic vial containers, one of which held P 32 labelea UTP and the other, P 32 DCTP, Researcher A read the chemical form on the labeling attached to both yellow containers and checked them against the two radioisotope disposition sheets. The AU marked both yellow containers with the receipt date and placed them in a freezer for later use. Confirming receipt of the two radiochemicals ordered and assuming that the styrofoam package contents were empty, Researcher A replaced the styrofoam lid and closed the outer carton of the " empty" package. (The third vial, containing 250 Cl of P 32 UTP, was left in the inner istyrofoaml package.)
At approximately 1:30 p.m., August 18, Researcher A def aced all outside
radioactive markings and placed the " empty package" in the hallway directly outside the laboratory (Room 224) for later removal and disposal as normal, non radioactive trash. He did not perform any survey of the packaging before it was disposed.
On either August 18 or 19, a VASF housekeeper apparently picked up and carried
tha "empt/" package containing the third P 32 vial along with other normal trash to a garbage dumpster outside adjacent Building 2. The employee said he did not remember the " empty" package and did not open any packaging material he collected for disposal either day. (This housekeeper was the only person assigned to remove trash f rom the laboratories in Building 12.)
On the morning of either August 19 or 20, the Building 2 dumpster was
mechanically emptied into a garbage truck operated by Sunset Scavenger Company.
Trash from other dumpsters were also emptied into the garbage truck, and the entire load was transported to the company's landfill receiving station in San Francisco, where it was dumped in a large pit together with waste from other trucks. The waste was bulldozed into a shredder / compactor, comoressed, and transported by truck and buried in a general waste landfillin Alviso, California.
Late morning, August 20, the (third) P-32 UTP vial was initially discovered to be
missing from the Building 12 laboratory when another researcher attempted to use the materialin a P-32 labeling experiment. Believing that Amersham had not shipped all of the P 32 material ordered, Researcher A contacted the radiation safety office but was told that all three vials were in the package delivered to his laboratory two days earlier by radiation safety staff. Researcher A believed that someone in his laboratory may have tak':n the vial from the package before he opened it but did not tell him.
At approximately 12 p.m., August 20, Researcher A told the radiation safety office
that he did not find anyone who might have taken the vials from the package, and the licensee initiated an investigation and search for the missing package. These activities included interviewing molecular laboratory personnel, performing a detailed
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inventory check of all radioisotopes in the laboratory, and conducting extenUe radiation surveys in severallaboratcry rooms. Radiation safety staff also questioned the housekeeper who removed trash from Building 12 and learned the location of the dumpster whe:e the " empty" package may have been discarded. This and another dumpster for Building 12 were searched and surveyed, but the licensee was
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unabh to locatc the package containing the missing P-32 rnaterial or package.
On August 28, the RSO contacted Sunset Scavenger Company to inform them
about the missing iadioactive material. A company representative replied that
radiation detectors installed at the Sunset receiving station and Alviso landfill had not alarmed, and that waste collected from the hospital had a' ready been buried in the landfill.
On September 2,1997, the licensee eported the event to the NRC Operations
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investigation'and Causes of the Event
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4.1 jnsoection Dmne i
Through interviews of licensee personnel and a review of records and procedures
asr.ociated with the receipt and disposal of licensed material, the inspector evaluaL_
the event to determino direct, root, and contributing causes.
4.2 Qbservations and Findinas 4.2.1 Direct Causes One direct caua ot *.ne event was the f=illure of Researcher A to adequately check the contents of the package to ensure that allindioactive material ordered from the supplier was included in the shipment. The AU/RSP stated that he neither examined the packing list ru the order form he prepared which was RSO-approved prior to ordering the shipment. The supplier's packing list for the shipment fully described the number of vials (" quantity") ar.d utivitf or each ra:Hochemical which exectly f
matched the number and unit ac;ivity ardered fl.e., P-32 --DCTP,0.250 mci and P-32 - UTP,0.250 mci x 2). A% hough he reviewed the receipt /use fctms issuej by the radiatior safety office for the August 18 shipment, the AU said he only looked at the chemical name (i.e., DCTP and UTP) and not the activity that was recorded on each sheet (i.e.,0.250 mci, - DCTP on one sheet and 0.500 mci, --UTP on a second sheet fcr the remaining two vials). The AU said he assumed the activity recorded on the second receipt /use form for the two UTP vials was only 250 yCi because all vials Se had previously ordered and receiv.rd contained no more than 250 yCi. After removing two vial containers from the styrofoam box, the AU read
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the activity (250 Ci) on the Amersham label attached to each vial and matched the chemical name recorded on the receipt /use forms agair st those on the Amersham labels. However, 'he activity identified o. the vial labei was not cross-checked saainst the activity recorded on the receipt /use forms. The AU therefore assumed
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that only two P 32 vials were in the shipment and he f ailed to search the package for any remaining vials in the sty ofoam container. A careful check of the Amersham packing list and the reccipt/use forms provided with the shipment, and a thorough search of the packsgo contents likely would have prevented subsequent disposal and loss of the remaining P 32 vial to normal trasn.
A second direct cause identified during the inspection was the researcher's f ailure to
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conduct a radiation survey of tSe package and packagi9g material before it was
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disposed to regular trash. A calibrated Eberline Model PRM 6 survey meter connected to a Model HP 260 pancake GM detector, was located about 1 foot from the package wl.ile it was opened by Researcher A. However, he f ailed to turn on the instrument and it was not used to survey the " empty" package before it was placed in the hallway outside the laboratory for disposal. The AU said the survey
instrument is normally "on" when he opens radioactive packages, but he did not do so in this case because the day the package was received Rugust 18) was a very hectic day and he was in a hurry. He further stated that the instrument had typically read only background radiation lavels while opening radioactive packages previously received. (The usual distance between the package and the survey meter was approximately 1 foot.) The inspector cvaluated whether the laboratory's survey meter was sufficiently sensitive to detect radiation emitted by a single P 32 vial with
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an approximate activity of 250 pCl. Another P 32 vial received by the laboratory on J
October 22,1997, was used for the test survey. The Model PRM 6 survey meter measured count rates approximately equal to twice background radiation and 25 times background levcis (2500 3000 counts pcr min"te) with the instrument probe placed 612 inches from, and in near surfoce contact with, the vial container, respectively. Consequently, the licensee 4 survey meter, if appropriately used, would have detected the P 32 vial in the " empty" package prior to its distsosal.
4.2.2 Root Causes The f ailure to properly verify the radioactive contents of the package apparently resulted from a routine lack of attention to detail by the AU when opening such packages, a root cause of the disposalincident. Although radiation safety office inspections of packages and records appear to have been careful and thorough, package checks by the AU were very cuisory and limited. For example, Researcher A admitted that he had not routinely examined packing lists for shipments received previously, and had considered the package receipt process to be a " trivial matter." Ucensee receipt logs showed the laboratory had received a total of 71 radioactive packages in 1996, snd another 30 packages as of
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October 22,1997. Researcher A said he normall*/ had ordered and received shipping packages, each containing only a single vial of P-32, occasionally two P 32 vials per package, but almost never three vials in a package (of 26 shipments of P 32 vials received since Jar":ary 1,1997, only the package received on August 18 contained three vials). The AU indicated that he, therefore, did not expect to
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receive or did not remember omring more then two P 32 vials in the package which appeared to him as a normal shipment not requiring any further check. To evaluate whether this problem was programmatic in nature, the inspector intarviewed RSPs in
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-10-eight other research laboratories chosen at random which had routinely received radioactive packages. All RSPs indicated that they had always checked packing lists and receipt /use forms in detail to ensure that all radioactive materials ordered were received. Consequently, Researcher A's failure to carefully check the packing list and other paperwork to verify package contents appeared to be an isolated problem limited to only one research laboratory.
A second root cause of the disposal incident was also identified curing the inspection. Researcher A said he f ailed to survey the " empty" package prior to its disposal on August 18 because he was unaware of any requirement to conduct such surveys. The researcher explained that other radioactive packages he received and opened since he was employed and designated as an RSP in approximately July 1994, had also not been surveyd %% their disposal to normal trash. The RSP indicated that disposal surveys were not needed since packages emptied of their radioactive contents were unlikely to be contaminated.
Section XV, "Badioactive Waste Manaoement," of the licensee's Radiation Safety Manual, sent to all research labora+ories in October 1995, states that, " Prior to disposa: of packagings of radioactive material, the packaging will be surveyed to insure it is free of radioactive material and any radioactive markings will be removed or obliterated." lTnis manual has not been directly incorporated into the license and is used only as an internal document in the licensee's radiation safety program.) An
" Authorized User Record" attached to the safety manual on file in the molecular research laboratory, and an " Annual Euucation 1995" acknowledgement form signed by Researcher A and dated December 6,1995, signified thu the AU bad read the manual. In addition, the RSO indicated that his training of radiation safety persons in 1994, ettendea by Researcher A, had repeatedly emphacized the requirement for authorized users to survey packages before disposal to normal trash. The RSO added that training of authorized users on other occasions had also errphasized the same requirement. Although Researcher A acknowledged receiving previous radiation safety training and reviewing the radiation safety manual, ha said he could not remember being told er reading about the disposal requiremen* In an effort to determine whether this problem was isolated or widespreaa, "Se inspector randomly interviewed RSPs in nine other research laboratories. All riine RSPs iridicated that they were aware of the disposal survey requirement and had routinely surveyed and def aced radioactive markings from packages to ensure tha. they were fren of any radioactive material or contamination.
4.2.1 f.ontributino Cause The inspection discosed that the procedure used by the radiation safety office for documenting the amount of activity and the number of radioisotope vials received in packages may have contributed to the event. Nearly all P-32 packages previotc.1 delivered to Researcher A had each contained only a single vial of each chemical compound (e.g., UTP) and a unit activity of 0.250 Ci per vial. The radiation safety of fice had prepared and issued a single receipt /use form for each separate vial and chemical compound. However, on a few occasions, including the shipment received
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-11 on August 18,1997, packages delivered to Researcher A contained two vials containing the same chemical compound. In these cases, the total activity for both vials (i.e. 500 Ci) was recorded on a single form without also indicating the total number of vials containing the same radiochemical. Issuing a separate receipt /use form to document the contents of each vial received on August 18 might have alerted Researcher A that three instead of two vials were in the package.
4.3 Conclusions The loss of licensed material was directly caused by the researcher's f ailure to properly check the contents of the package upon receipt, and the f ailure to survey the package to ensure it was empty of radioactive sources before it was disposed to normal trash. One root cause of the event appeared to ue the researcher's routine lack of attention to detail while checking packing lists and other records to verify package contents. The rer Acher was also unaware or forgot about the licensee's lnternal requirement to survey packages before tneir disposal to normal trash, which was identified as a second root cause of the event, The licensee's everall program for training laboratory personnelin the proper procedures for receipt and disposal of licensed material appeared adequate and the problems related to the improper receipt and disposal of the P 32 package appeared to be isolated to one individual.
A contributing f actor in the event was the licensee's practice of documenting the amount of activity and the number of radioisotope vials received in a shipping package containing multiple vials of the same radiochemical.
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Consequences (87103)
5.1 Insoection Scong The inspector interviewed licensee personnel and reviewed radiation monitoring and other records to determine the consequences of the incident.
5.2 Observations and Findinas The potential for internal and external radiation exposure to licensee personnel and the public during handling of the P-32 package was evaluated durir.g the inspection.
The housekeeper who apparently picked up the " empty" package said he did not open any packaging material he had collected for disposal to the dumpster on August 18 19,1997. As noted earlier, the P-32 liquid was in a small vial that was sealed in a plastic vial container and enclosed within a dry ice styrofoam liner and outer cardboaro carton. Consequently, the overall package had several barriers to prevent leakage of its radioactive contents and the potential for internal exposure to licensee personnel and the public appeared remote. No evidence was obtained during the inspection that indicated the " empty" package containing the third vial had been opened after it was disposed to normal trash. As a precaution, the licensee performed urine bioassays of all 11 workers in the Building 12 molecular resetrch laboratery. Tbc negative bioassay iesults indicated the absence of any ingested P-32 mat 0V.
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-12-The housekeeper said he hand carried the " empty' P 32 carton while collecting other normal trash from B silding 12, and he estimated that 3 minutes had elapsed while carrying the carton to t dumpster. Radiation levels measured by the licensee at the outside surf at af several packages contair ;ng 0.250 mci of P 32 previously received in 1997, were between 0.1 mR/hr and 0.5 mR/ht, a range that was likely due to a vial's position within a packege at the time of measurement.
Assuming a maximum carton surf ace radiation level of 0.5 mR/hr and a 3 minute sixposure time, the highest potential TEDE to the housekeeper was estimated as approximately 0.03 millirem. This possible exposure is insignificant when compared to the annual dose limit for an individual member of the public (100 millirem, TEDE),
and smai! when compared to the dose limit in any unrestricted area from extemal sources (2 millitem in any one hour), as allowed under 10 CFR 20.1301(a).
After the " empty" P 12 carton was apparently disposed to the dumpster, Sunset Scavenger Company personnel mechanically emptied the Building 4 dumpster into a garbage truck. The refuse from other dumpsters were also emptied into the truck, and the load was taken to the landfill receiving station where it was dumped into a large pit along with waste from other trucks. The waste was then bulldozed into a shredder / compactor, pressed into a truck, and taken te a landfill where it was buried with other normal waste. Consequently, the method of waste handling by Sunset Scavenger would have precluded any close contact with the " empty" P 32 package and likely prevented any significant radiation exposure to members of the public.
5.3 Conclusions The only person known to have handled the " empty" P-32 package after it was released to normal trash may have received a very small external radiation exposure which was well below NRC dose limits for an individual member of the public. The form of packaging, the low external radiation leve'
i the method of waste handling by Sunset Scavenger personnelindicate th.t no other members of the public had received any radiation exposure as a result of the disposalincident.
O Notification and Reports (87103)
6.1 Insoection Scone The inspector interviewed VASF personnel and reviewed the licensee's records relative to the event and itt, notification of the NRC.
6.2 Observations,and Findinas After laboratory pert.nnelinitially discovered the P 32 vial was missing on August 20,1997, Researcher A immediately and correctly reported its possible loss to the RSO. During the following several days, the licensee searched for, but did not succeed,in locating the missing material. The RSO reported the loss of the meterial by telephone to Region IV at 12 p.m. (PST) and about 1 hour1.157407e-5 days <br />2.777778e-4 hours <br />1.653439e-6 weeks <br />3.805e-7 months <br /> later to the NRC Operations Center on September 2,1997. The licensee reported the event to l
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the NRC within 30 days af ter loss of the material became known, as required by
10 CFR 20.2201(a)(ii). A written repoit of the lost source event was issued by VASF on September 12,1997, and received by NRC on September 26,1997. The licensee's description of the incident and its follow-up actions appeared accurate, and the written report included all of the information required by 10 CFR 20.2201to).
6.3 Conclusions The licensee properly identified and repo ted the lost source incident in compliance with NRC requirements.
Regulatory issues (87100)
7.1 Insoection Scone The inspector's review of the disposal incident included interviews with licensee personnel and a review of the license docket file, departmental policies, procedures, and records, and the licenses's investigation report of the incident.
7.2 Observations and Findinas During the inspection, two apparent violations were identified and subsequently discussed with the licensee during exit briefings conducted at VASF on October 27,1997, and by telephone on November 14,1997.10 CFR 20.2001(a)
requires that the li:ersee dispose of licensed material only jy certain piocedures, as specified in 520.2001. The licenne disposed of the P-32 material by release to normal, non-radioactive trash, a method not authorized by 620,2001. Although the licensee's report referred to the loss of 250 pCi of P-32, the RSO considered this a
" nominal" activity only, and was less than the activity actually disposed to normal trash. Based on Amersham's assay date (" reference date") of August 22,1997, dnd a P-32 activity of 250 pCi recorded on the vir.1 container, the inspector calculated a larger decay-corrected activity of approximately 305 pCi for the date (August 18,1997) the researcher disposed the vial to normal tiash. The licensee's unauthorized disposal was identified as an apparent violation of 10 CFR 20.2001(a)
(030-01214/9Ki-01).
License Condition 24.A requires the licensee to conduct its program in accordance with the statements, representations, and procedures, including any enclosures, contained in the application dated October 11,1990. Item 10.7, " Opening Procedures." of the application requires the licensee to establish and implement the model procedure published in Appendix L to NRC Regulatory Guide 10.8, Revision 2, for the receipt of radioactive materials other than those used by nuclear medicine for administr.ition to patients. Model procedure 2.d.(3) requires the licensee to open the inner package and verify that the contents agree with the packing slip.
Procedure 2.g. in Appendix L further requires the licensee to monitor the packing material and the empty packages for contamination w'th a low-range GM survey meter before discarding.
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-14 The radiation safety office properly checked the contents of the P-32 shipment against the packing list before the psckage was re-sealed and transferred to the molecular research laboratory. However, after re-opening the package, the researcher f ailed to verify that the package contents agreed with the packing list, as required. The researcher also f ailed to monitor the packing material and the " empty" package for radioactive contamination or the presence of a radioactive source with a low range GM survey meter before it was discarded to normal trash. The failures to properly verify the package contents and to survey the package before disposal was identified as an apparent violation of License Condition 24.A. (030-01214/9701-02).
~3 Conclusions The inspection dise!osed two apparent violations of NRC requirements, including: (1)
the licensee's f ailure to verify that the inner package contents agreed with the packing list for the shipment and to survey the package for contamination before disposal; and (2) the licensee's unauthorized disposal of licensed material to normal, non-radioactive trash.
Licensee Corrective Actions (87100,8T 03)
8.1 Insoection Scoce The inspector's evaluation of this area included interviews with VASF personnel, and a review of the licensee's incident reports, package receipt and disposal procedures, and related records.
8.2 Observations and Findinas As noted earlier, the licensee promptly conducted a search for the missing material whita included source inventory checks, laboratory and dumpster rafation surveys, and telephone contacts with the waste contractor. The same day the material was discovered as missing (August 20,1997), the RSO issued a written violation notice to the molecular research labors"ry PI or failure to conduct a radiation survey of the " empty" packaging before its disposal, and required a written response from the Pi addressing corrective actions needed relative to ensuring that his staff was knowledgeable about disposal survey and other radiation safety manual requirements. In a letter to the RSO dated August 21,1997, the Pl stated that he had reviewed the survey requirement with Researcher A, and he committed to informing other laboratory personnel about the requirement. On August 22,1997, the RSO sent a memo to all medical center Pls which described the disposal incident, reminded laboratory users of the disposal survey requirement, and requested each Pl to brief their laboratory personnel on the incident and respond to the RSO in writing to acknowledge that all personnel were briefed. As of October 17,1997, acknowledgement forms returned to the RSO indicated that nearly all Pts had briefed tMir laboratory staff on the licensee's survey requirements, I
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-15-which the inspector confirmed through interviews with the molecular laboratory Pi and other laboratory RSPs.
Procedures for EH&S receipt e.nd transfer of packages to laboratories were also revised by the RSO to more readily identify all vials contained in shipments. These administrative actions ;ncluded: (1) preparing a separate line item on the health physics receipt iog form for esch separate radioisotope vial when logged in by a hehlth physicist; (2) preparing and issuing a " Radioisotope Disposition and Disposal" form for each radioisotope vial upon receipt and transfer; (3) requiring laboratory personnel who receive radioactive packages to acknowledge the presence of multiple vials as specified in packing lists and receipt /use forms; and (4) requesting that only authorized personnel (i.e., RSPs) receive and sign for radioactive packages.
The RSO stated that on September 16,1097, the licensee's radiatior' safety committee reviewed the incident, the violation notice issued to and response from the molecular laboratory Pl, and the PI's prior record of compliance. The RSC determined that based on the RSP's cooperation and honesty, the PI'; prompt response and corrective actions, and the PI's good overall compliance history, no other disciplinary action was warranted.
B.3 Conclusions The licensee promptly conducted a search for the missing material which included source inventory checks, laboratory and dumpster radiation surveys, and telephone contacts with the waste contractor. A violation notice was issued to the responsible laboratory Pi and additional training of laboratory personnelin receipt and disposal proccdures was implemented. Administrative changes were also made to the licensee's program for receiving radioactive material. The licensee's response and corrective actions appeared to be adequate in addressing the causes of the incident.
Spill Contamination incident (87100)
9.1 Insoection Scooe The inspector interviewed licensee personnel and reviewed radiation monitoring and other records related to another incident involving the spill cf contaminated liquid
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from a research laboratory freezer.
9.2 Observations and Findinas in mid August 1997, the molecular biology laboratory contacted the radiation safety office to arrange a decommissioning survey of a large, upright freezer prior to its removal from the laboratory and subsequent disposal. The freezer had been used for storage of H 3 and carbon-14 in Laboratory Room 215, Building 12. After removal of allitei.is and defrosting, the health physics technologist conducted a radiation level and a wipe survey inside the dry freezer and detected no radioactive l
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contamination. On September 26,1997, three workers moved the freezer from the laboratory and down an elevator to the building ground floor. During this period, a PI noticed a liquid spill of approximately 250 mi to 500 ml on the floor in Room 215
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that apparently resulted when the freezer was initially tilted and placed on a hand truck for removal.
The Pi questioned whether the spill might be radioactive and telephoned a second PI on the ground floor to halt the movers from leaving the area. A 1 mi sample of the W!I, assayed in a liquid scirtillation counter, measured approximately 1000 disintegrations per minute (dpm) of H-3. A second small spill of about 30 ml was also noted near the elevator on the ground floor. Both Pls stated that they and the Program Assistant, Associate Chief of Staff, Research Office,immediately warned laboratory personnel on both floors about the spill and they isolated the areas to prevent personnel from spreading the contamination. Laboratory personnel notified the radiation safety office, and the spill areas were decontaminated.
Pust-decontamination surveys of the floor spill areas and wipe surveys of the hand truck and shoes worn by movers and laboratory personnelinvolved showed no residual radioactive contamination. The freezer was later moved to a radiation
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safety office controlled area for storage and decontamination.
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The licensee was unable to explain the source of the radioactive contamination and no information was available to indicate the presence of any prior radioactive spills inside the freezer. However, the appearance of rusted soms at the bottom of the freezer suggested that radioactive material may have leaked down from the inside freezer compartment above. Based on the activity of the sample collected and the volume of the spill, the total activity released apperently did not exceed approximately 10 dpm (= 0.5 Ci), and it therefore constituted a minor spill event.
Records were maintained on file for the area and personnel surveys conducted. The licensee appeared to have followed license required procedures for recovery of the spill event by isolating and decontaminating the areas involved, warning personnel, notifying the RSO, and preventing or minimizing radiation exposure to laboratory workers and members of the public. According to the licensee, these problems will be prevented in the future by placing absorbent paper undernecth freezers and refrigera*?rs when they are tilted and movement will be stopped and the RSO notified immediately if water is discovered inside or leaking from the equipment.
9.3 Conclusions A minor spill event occurred that involved leakage of a small amount of radioactive material from a freezer while it was removed from the Molecular Biology Laboratory.
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Appropriate action was taken by licensee personnel to mitigate the consequences of the event by isolating and decontaminating the areas involved, warning personnel, notifying the RSO, and preventing or miriimizing radiation exposure of laboratory workers and the public.
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l ATTACHMENT EARTIAL LIST OF PERSONS CONTACTED Ucensee J. Ahlering, Associate Medical Center Director C. Anderson, Chief, Magnetic Resonance Imaging and Chairman, Radiation Safety Committee K. Baner, Radiation Safety Person, Neurology Laboratory G. Cecchinl, Principal Investigator, Molecular Biology Laboratory S. Cullen, Acting Medical Center Director S. Fcng, Radiation Safety Person, Molecular Howatopolesis Laboratory V. Gilbertson, ;;adiation Safety Person, Cell Growth Laboratory A. Herm9s, Assistant Radiation Safety Officer D. Horowitz, Radiation Safety Person, Membrane Bioc.emistry Laboratory D. Izon, Post Doctoral Felltw, Molecular Hematopoieses Laboratory G. Jensen, Radiation Safety Person, Molecular Pathology Laboratory C. Jones, Radiation Safety Person, Respiratory / Pulmonary Laboratory M. Kim, Radia:lon Safety Person, Liver Studies Laboratory C. Largman, Principal Investigator, Molecular Hematopoieses Laboratory W. McIntire, Principal Investigator A. Moser, Radiation Safety Person, Metabolism #1 Laboratory P. Muldoon, Assistant Radiation Safety Officer A. Ow, Radiation Safety Person, Endocrine Surgery Laboratory L. Phillips, Radiation Safety Officer H. Shigenari, Radiation Safety Person, Immunology Laboratory I. Tokuda, Housekeeper, Environmental Management Service D. Vessey, Principal investigator, Hepatic Studies Laboratory T. Ward, Health Physics Technologist Non Licensee:
Edwin M. Leidholdt, Jr., Radiation Safety Program Manager, We stern Region, Department of Veterans Affairs INSPECTION PROCEDURES USED 83822 Radiation Protection 87100 Licensed Materials Programs 87103 Inspection of incidents at Nuclear Materials Facilities
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ITEMS OPENED. CLOSED. AND DISCUSSED Ooened 030-01214/9701-01 APV Disposal of licensed material by release to normal, non-radioactive trash, a method not authorized by 10 CFR 20.2001(a).
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030-01214/9701-02 AFV Failure to properly verify the package contents and the failure to survey the package before its disposal, as required by a model procedure incorporated into License Condition 24.A.
Closed none Discussed none LIST OF ACRDNYMS USED APV Apparent violation ARSO Assista.'t Radiation Safety Officer AU authorized users CFR Code of Federal Regulations EH&S Environmental Health & Safety Ge:vice DCTP deoxy cytosine triphosphate H3 hydrogen-3 (tritium)
IP inspection procedure P 32 phosphorus-32 P!
principal investigators RSO Radiation Safety Officer RSP Radiation Safety Person UTP uracil triphosphate VASF Veterans Aff airs Medical Center, San Francisco
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