ML20248E250
| ML20248E250 | |
| Person / Time | |
|---|---|
| Issue date: | 07/30/1996 |
| From: | Martin T NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION I) |
| To: | Thompson H NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO) |
| Shared Package | |
| ML20248E220 | List: |
| References | |
| NUDOCS 9806030242 | |
| Download: ML20248E250 (18) | |
Text
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Rio 0,, UNITED STATES 8 o NUCLEAR REGULATORY COMMISSION
$ $ REGIGN I o, 475 ALLENDALE ROAD KING OF PRUSSIA, PENNSYLVANIA 19406-1415 July 30, 1996 MEMORANDUM T0: Hugh L. T1ompson, Jr.
Deputy Ex4cutive Director for Nuclear Meterials Safety, Safeguards and Ope /ations Support eg na A strator Region I
SUBJECT:
FINAL INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM (IMPEP) REPORT ON REGION I MATERIALS PROGRAM Your memorandum dated June 27, 1996, forwarded the subject report and requested a plan for addressing the regional action items. . Attached to this memorandum is a summary of our actions to address the findings of the IMPEP team. I am very pleased with the results of the review, and welcome the constructive recommendations for improvement. I also am pleased to note that corrective actions were implemented either during or shortly after the review for each of the recommendations, based on information provided during the team's exit meeting with my staff and me on March 22, 1996.
I also want to add my thanks for the professional way in which the review was performed. While the regional resources required to prepare for and carry out the IMPEP review were substantial, I believe the IMPEP to be a worthwhile enterprise. I also believe that the interaction between the team members and our staff improved the team's understanding of the scope and complexity of the i Region I materials program, and the management controls implemented by Bill Hehl and his staff to assure the program is kept on track with Operating Plan commitments. In addition, the interactions enhanced our understanding of the expectations of the HMSS staff regarding implementation of the programs under NMSS auspices. Ms. Cathy Haney and her team did an excellent job preparing for ard carrying out the review.
Attachment:
As stated cc w/ attachment:
J. Taylor J. Milhoan
, .C. Haney 9806030242 980513 PDR ORG NE E
e REGION I RESPONSE TO 1996 IMPEP RECOMMENDATIONS l
Recommendation 1. The team recommends that Region I continue efforts to improve its timeliness in conducting initial inspection in accordance with IMC 2800 guidelines.
Status: The inspection planning and scheduling system used by Region I was modified to flag to the Branch Chiefs initial inspections (which are treated as core activities) that are not completed by four months after the license is issued, rather than six months as had previously been the case. This modification was completed by March 27, 1996, and should prevent recurrence of the deficiency. The status of core inspections is checked as part of the monthly DNMS management review.
Recommendation 2. It is recommended that the Region verify that the inspection field notes available in the docket room and on the LAN are current.
Status: Region I has verified that these documents now are current and consistent. Current versions of the field notes (hard copies in the docket.
room and electronic versions on the LAN) were made available before the conclusion of the IMPEP review. In addition, we will check the electronic version of the IMC quarterly to assure that we are using the current version of the field notes. That was last done on July 23, 1996, and no discrepancies were noted.
Recommendation 3. It is recommended that staff assure documentation of the reciprocity inspections be maintained in the Region.
Status: A Division procedure has been developed that requires generation of inspection folders by the Licensing Assistance Team (LAT) for all reciprocity inspections, assures copies of the resulting inspection documentation (field notes or reports) are properly distributed, and assures a copy is maintained in the Region I reciprocity inspectica file.
Additional item: In addition to addressing the above recommendations, Region l
I took action on a concern of the IMPEP team related to updating the Incident j Report tog maintained by Region I. Effective October 1, 1995, the DNMS Senior Project Manager (SPM) was assigned responsibility for: performing a timely review of LERs, making sure information from the LERs is made available to the staff, and keeping the Incident Report Log up-to-date. To address the team's concern, the SPM reviewed all LERs received since October 1,1995, and queried the AE0D database for PNs and event reports involving Region I materials licensees, to assure that all LERs required had been submitted. Several LERs were determined to have been required, but not submitted, and were obtained from the licensees involved. The SPM then assured that the log was made Attachment l
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current for each of the pre-October 1,1995, LERs identified as not logged by the IMPEP team, corrected the other incident file deficiencies identified, and assured that the other actions specified above had been completed for each of the LERs received since the beginning of the fiscal year. The SPM now receives a copy of each PN issued involving Region I materials licensees, periodically reviews the AE00 event report database, and tracks receipt of required LERs. 3 of the IMPEP teamWe hasbelieve these actions are sufficient to assure the concern been addressed.
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APPENDIX D INSPECTION FILE REVIEWS File No.: 1 Licensee: Geodax Technology Location: Meadville, PA License No.: 37-30192-01MD Inspection Type: Routine, unannounced License Type: Nuclear Pharmacy Inspection Date: 11/19/97- 11/20/97 Priority: '.
Inspector. C.O.
File No.: 2 Licensee: Westinghouse Location: Cheswick, PA License No.: 37-05809-02 inspection Type: Routirle, unannounced License Type: Industrial Radiography Inspection Date: 04/23/96 Priority: 1 inspector: R.L.
File No.: 3 Licensee: Mobile Dynarnic Irnaging Location: Englewood, NJ License No.: 29-30322-01 Inspection Type: Routine, unannounced Ucense Type: Mobile Nuclear Medicine Service inspection Date: 10/16/97 Priority: 2 inspector L.M.
File No.: 4 Licensee: University of Pennsylvania Location: Philadelphia, PA License No.: 37-00118-07 Inspection Type: Routine, unannounced License Type: MedicalInstitution Broad Inspection Date: 07/15/97- 07/21/97 Pnonty: 1 Inspector: J.D.
File No.: 5 Licensee: City of Philadelphia Location: Philadelphia, PA License No.: 37-07983-07 Inspection Type: Routine, unannounced License Type: Portable Gauge Inspection Date: 10/09/97 Priority: 5 Inspector J.J.
File No.: 6 Licensee: Novartis Pharmaceuticals Corporation Location: East Hanover, NJ License No.: 29-08978-02 Inspection Type: Routine, unannounced License Type: Res. & Dev. Type A Broad Inspection Date: 08/28/96 Priority: 2 Inspector: P.L.
File No.: 7 Licensee: West Penn Hospital Location: Pittsburgh, PA License No.: 37-02136-01 Inspection Type: Routine, unannounced License Type: Medical Institution, Broad Inspection Date: 03/24/97 - 03/25/97 Priority: 1 Inspector I.C.
Region i Final Report '
inspection File Reviews Page D.2 File No.: 8 Licensee: Milton S. Hershey Medical Center Location: Hershey, PA License No.: 37-13831-04 Inspection Type: Routine, unannounced License Type: Self-shielded irradiator Inspection Date: 10/03/97-'10/05/97 Priority: 5 Inspector: N.B., T.T.
File No.: 9 Licensee: AlfacellCorporation Location: Bloomfield, NJ License No.: 29-30360-01' Inspection Type: Telephone Call License Type: Research and Development- Other Priority: 3 inspection Date: 06/26/97 (phone call)
, inspector: J.B.
File No.: 10 Licensee: R. E. Wright Environmental,Inc.
Location: Middletown, PA License No.: 37-28362-01 Inspection Type: Routine, unannounced License Type: Portable Gauge Inspection Date: 07/18/96 Priority: 5 l inspector: E.R.
File No.: 11 Licensee: Arawak Paving Company, Inc.
Location: Hammonton, NJ License No.: 29-27824-02 Inspection Type: Routine, unannounced License Type: Portable Gauge Inspection Date: 04/18/97 Priority: 5 Inspector: C.A.
File No.: 12 Licensee: Safety Light Corporation Location: Bloomsburg, PA License No.: 37-00030-02 inspection Type: Routine, unannounced License Type: Mnfr and Distribution, Type A Broad Inspection Date: 09/18/97 - 09/19/97 Priority: 1 Inspector: J.K. ;
.I L File No.: 13 i
! Licensee: American Geotech, Inc.
Location: Wyomissing, PA License No.: 37-30399-01 Inspection Type: Routine, unannounced License Type: . Portable Gauge Inspection Date: 11/06/97 Priority: 5 inspector: J.J.
File No.: 14 Licensee: Atlantic Richfield Company License No.: SNM-1933
- Location: Los Angeles (West Chester, PA) Inspection Type: Routine, unannounced 1
License Type: Pacemaker Mnfr and/or Disir i inspection Date: 12/11/97 Priority: 1 i Inspector: P.H. i l
.o y Region i Final Report Inspection File Reviews Page D.3 -
File No.: 15
! Licensee: Branch' Radiographic Laboratories, Inc.
L Location: Cranford, NJ License No.: 29-03405-02 Inspection Type: Routine, unannounced
' License Type: Indust. Radiography, Temp Job Sites Priority: 1 Inspection Date: 06/16/97 & 06/18/97 Inspector. J.M.
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. File No.: 16 Licensee: StoriGenics Intemational Location: Salem, NJ License No.: 29-20900-01 Inspection Type: Routine, unannounced License Type: Irradiator - Other, Greater Than 370 TBq Priority: 1 Inspection Date: 08/07/97, & 08/13/97- 08/14/97 Inspector. AJ., R.L., (R.B,)
in addition, a review team member made the following inspection accompaniments as par 1 of the on-site IMPEP teview:
Accompaniment No.: 1 .
Licensee: SteriGenics Intemational Location: Rockaway, NJ License No.: 29-30308-01 Inspection Type: Routine, unannounced License Type: Poolirradiator Inspection Date: 01/13/98 - 01/14/98 Priority: 1 Inspector: R.L.
Accompaniment No.: 2 Licensee: Phoenixville Hospital of the University of Penn. Ucense No.: 37-10237-01
- Location: Phoenixville, PA Inspection Type: Routine, unannounced License Type: Limited Medical Inspection Date: 01/13/98 Priority: 2 Inspector, M.B.
Accompaniment No.: 3 Licensee: Rohm and Haas Company Location: Springhouse, PA License No.: 37-01665-01 Inspection Type: Routine, unannounced License Type: Res. and Development, Type A Broad Priority: 2 Inspection Date: 01/15/98 Inspector. R.G.
Accompaniment No.: 4 Licensee: Voith Hydro, Inc.
Location: York, PA License No.: 37-16280-03 inspection Type: Routine, unannounced License Type: Radiography -
Inspection Date: 01/16/98 Priority: 1 inspector. S.C.
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s APPENDIX E LICENSE FILE REVIEWS File No.: 1 Licensee: Naugatuck Valley Radiological Association License No.: 06-30265-01 Location: Waterbury, CT Ucense Type: 02200 - Medical Private Practice Type of Action: New Date issued: 03/27/96 License Reviewer: M.B.(J1)
File No.: 2 Licensee: Gor,d Samaritan Med Ctr.,
Location:' Johnstown, PA License No.: 37-05272-02 License Type: 02120 - Medical Institution Type of Action: Notification Date issued: 01/15/97 Comment: License Reviewer: T.W.(J9)
On 1/15/97, the licensee was told that adding a qualified medical authorized user required only a notification to NRC; that no fee was required. The fee was retumed on 5/1/97.
File No.: 3 Ucensee: Powell-Harpstead, Inc.,
License No.: 37-30384-01 Location: West Chester, PA Ucense Type: 03121 - Portable Gauge Type of Action: New Date issued: 04/05/97 License Reviewer: J.J.(P8)
File No.: 4 Licensee: DuPont Merck Pharmaceutical, Location: Wilmington, DE Ucense No.: 37-28764-02 License Type: 03800 - Possession Only Type of Action: Termination Date issued: 11/19/97 License Reviewer S.L.(Q2)
File No.: 5 Licensee: Aquatec., Inc.
License No.: 44-18128-01 Location: Colchester, VT License Type: 03123 - Gas Chromatograph Type of Action: Termination Date Amendment issued: 03/97 Comment: License Reviewer: P.H.(K7)
The action was completed within 1-day of receiving faxed request. l File No.: 6 Licensee: Harris Semiconductor License No.: 37-24841-01 Location: Mountaintop, PA Amendment No: 1 )
License Type: 03520 - Self-shielded Irradiator Type of Action: Renewal and Amendment Date issued: 07/03/96 and 05/01/97 j License Reviewers: S.C.(K4) and J.M.(QO) i r l l
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Region i Final Report Page E.2 Ucense File Reviews i File No.: 7 Licensee: Lucius Pitkin, Inc License No.: 29-27816-01 Location: Patterson, NJ Amendment No.: 5 License Type: 03320 - Radiography Type of Action: Amendment Date issued: 05/02/97 License Reviewer: D.W.(Q4)
File No.: 8 Ucensee: St. Bamabas Ambulatory Care License No.: 29-01608-05 Location: Uvingston, NJ Ucense Type: 02201 - Medical Private Practice Type of Action: New Date issued: 06/09/97 License Reviewer: M.B.(J1)
File No.: 9 Licensee: Radiation Science,Inc.
License No.: 29-30310-01 Location: Cranbury, NJ Ucense Type: 03225 - Service Provider Type of Action: New Date issued: 09/21/96 License Reviewer: E.R.(L3)
File No.: 10 Licensee: Celgene Corporation License No.: 29-28056-01 Location: Warren, NJ Ucense Type: 03620- R&D Amendment No.: 6 Type of Action: Amendment Date issued: 04/30/96 License Reviewer P.L.(P6)
File No.: 11 Licensee: Catholic University License No.: SNM-164 Location: Washington, DC Amendment No.: 15 License Type: 22110- SNM, Less Than Critical Mass Type of Action: Amendment Date issued: 10/15/97 Comment: License Reviewer P.H.(K7)
Action completed within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> of being received.
i File No.: 12 Ucensee: Teledyne Environmental License No.: 29-00055-17 I Location: Westwood, NJ License Type: 03219- Decontamination Services Type of Action: New Date issued: 6/28/96 License Reviewer: D.W.(Q4)
File No.: 13 Ucensee: Allegheny Univ. of the Health Sciences License No.: 37-00467-34 Location: Center City Campus, Philadelphia, PA Amendment No.: 33 License Type: 01100- Academic, Type A Broad Type of Action: Amendment Date issued: 04/97 (Financial Assurance)
License Reviewer. K.B.(Q7)
o y Region i Final Report Page E.3 License File Reviews l
File No.: 14 Licensee: Army, Department of Location: Waterstown, MA License No.: SUB-238 Ucense rype: 11300 - Source Material Amendment No.: 14 Type of Action: Amendment Date issued: 07/97 License Reviewen R.B.(J8) l File No.: 15 Licensee: E.I. DuPont DeNemours License No.: 07-13441-02 Location: Newark, DE Ucense Type: 03610 - R&D Amendment (s) No.: 9 and 10 Type of Action: Amendments Date Isr.ued: 08/97 and 10/07/97 License Reviewen K.B.(Q7) and D.E.(K2)
File No.: 16 Licensee: Newark Medical Associates License No.: 29-30282-01 Location: Newark, NJ Amendment No.: 1 Ucense Type: 02201 - Medical Private Practice Type of Action: New and Amendment Date issued: 09/25/96 and 02/07/97 License Reviewen M.B.(J1) and R.G.(J2)
File No.: 17 Licensee: Mid Atlantic Equine Location: Ringoes, NJ license No.: 29-30392-01 License Type: 02400 - Veterinary Type of Action: New Date issued. 06/20/97 License Reviewen R.G.(J2)
File No.: 18 Licensee: Ronson Metals Corp Location: Somerset, NJ License No.: STB-1451 Amendment No.: 4 License Type: 11200 - Source Material-Shielding Type of Action: Amendment Date issued: 4/25/97 License Reviewer: S.S.(J5)
File No.: 19 Licensee: MPM Technologies, Inc Location: Lemont, PA License No.: 37-30408-01 License Type: 03620- R&D Type of Action: New Date Renewalissued: 09/05/97 License Reviewen J.B.(Q6)
File No.: 20 Licensee: AlfacellCorporation License No.: 29-30360-01 Location: Bloomfield, NJ Ucense Type: 03214 - Manufacturing and Distribution Type of Action: New Date Amendment issued: 3/18/97 License Reviewen R.G.(J2)
s APPENDIX F INCIDENT FILES REVIEWED File No.: 1 Licensee: Packard Bioscience Co., dba: Canberra Industries License No.: 06-15099-01 incident ID No: PNO-l-97-076 1.ocation: Meriden, CT Date of Event: 12/11/97 Type of Event: Equipment Failure / Lost RAM Investigation Date: 12/15/97 investigation Type: Onsite inspection Summary of incident and Final Disposition: A Type A package shipped by the lic9nsee failed, and a sealed source from the package was found in the back of a Federal Express truck. U.S.
DOE retrieved the source and stored it. An onsite inspection was conducted. No violations were identified.
File No.: 2 Licensee: St. Elizabeth Hospital License No.: 29-04333-01 Incident ID No: PNO-l-97-034 Location: Elizabeth, NJ Date of Event: 04/18/97 Type of Event: Leaking Source / Loss of Control investigation Date: 06/06/97 and 06/10/97 investigation Type: Onsite inspection Summary of incident and Final Disposition: A leaking 1-131 capsule was found in a bag of medical waste and retumed to the licensee by a medical waste shipper. The Region conducted inspections of St. Elizabeth Hospital and St. Michael's Medical Center, and determined that a patient who was administered an 1131 dose at St. Michael's did not swallow the capsule.
Instead, the patient carried the 1-131 capsule and disposed of it at St. Elizabeth Hospital, where the patient provides volunteer service. Bioassay confirmed that the patient did not swallow the capsule. Riissued a CAL to St. Michael's Medical Center.
File No.: 3 Licensee: Larchmont Imaging Associates License No.: 29-23540-01 Incident ID No: PNO-l-97-030 Location: Mount Laurel, NJ Date of Event: 05/14/97 Type of Event: Release of RAM Investigation Date: 07/03/97 investigation Type: Next inspection Summary of incident and Final Disposition: Licensee received a package containing TI-201, that was contaminated with Tc-99m. Two technologists were contaminated on their finger tips. An inspection was conducted and no violations were noted.
' a Region i Final Report Incident File Reviews Page F.2 File No.: 4 Licensee: Overlook Hospital License No.: 29-03308-01 Incident ID No: PNO-l-97-027 Location: Summit, tJJ Date of Event: 05/05/97 Type of Event: Misadministration investigation Date: 05/07/97 investigation Type: Onsite inspection Summary of incident and Final Disposition: Patient was administered the wrong dose of I-131 for a whole body scan (7 mci vs. 2 mci intended). RI conducted an inspection and identified two violations: failure to prepare written directives prior to administration and failure tp provide adequate supervision. RI held an enforcement conference and issued an NOV and civil penalty.
File No.: 5 Licensee: Merck and Company, Inc.
License No.: 29-00117-06 Incident ID No: PNO-l-97-023 Location: Rahway,NJ Date of Event: 04/10/97 Type of Event: Loss of control / Release of RAM Investigation Date: 04/08/97 - 04/11/97 and 4/24/97 Investigation Type: Onsite inspection Summary of incident and Final Disposition: The licensee disposed of two vials containing 1-125 in the normal trash. The licensee attempted to reclaim the material before incineration, but was unsuccessful. Calculations of the release indicate that no member of the public received a dose in excess of 1 mrem. RI conducted an inspection and cited two violations. An enforcement conference was held, and NOV issued. The licensee made corrective actions.
File No.: 6 Licensee: None - Incident involving a private home Ucense No.: Not Applicable incident ID No: PNO-l-97-028 Location: Union, NJ Date of Event: 05/10/97 Type of Event: Overexposure / Release of RAM / Stolen material Investigation Date: 05/10/97; 05/12/97; and 05/23/97 investigation Type: Telephone Followup and Onsite 8nspection Summary of Incident and Final Disposition: An individual obtained three exit signs at a building demolition site, dismantled one sign inside his home, and broke several tubes containing tritium gas during the process. The NJ Department of Environmental Protection and DOE Brookhaven National Laboratory responded, performed extensive bioassays, and surveyed the house, finding moderate to trace amounts of contamination. RI conducted inspections to review the circumstances associated with the event, and issued an NOV.
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. Region i Final Report Page F.3 -
Incident File Reviews File No.: 7'
! ' Licensee: Stroh Brewery 'l l License No.: General Licensee !
Incident ID No: PNO-l-97-056 Location: Lehigh, PA
- Date of Event
- 08/27/97 Type of Event: Lost RAM investigation Date: 09/02/97 and 09/03/97 Investigation Type: Onsite inspection Summary of incident and Final Disposition: A load of shredded non-ferrous automotive parts from a metal recycler in Temple, PA, (Royal Green Metal Recyclers) that alarmed a radiation monitor at a Michigan recycling center was retumed to the PA recycler. RI dispatt.hed an inspector to the PA facility, analyzed inspection samples at the RI laboratory, and confirmed _ the presence of Am-241. RI coordinated with PADEP, EPA, DOE, and other NRC offices on the ,
event response. The RAM was traced back to the Stroh Brewery Company in Lehigh, PA. RI 'I conducted an inspection of Stroh Brewery and identified two violations. RI held an enforcement conference and issued a NOV.
File No.: 8 Licensee: Medical College of PA/Hahnemann University I License No.: 37-00467-34.
Incident ID No: PNO-l-96-032 Location: Philadelphia, PA Date of Event: 05/08/96 Type of Event: Lost RAM Investigation Date: None Investigation Type: None [Next inspection)
Summary of incident and Final Disposition: The licensee lost a 76 MBq (2.0 mci) sealed source used on the surface of an eye plaque. The licensee searched for the source, then submitted corrective actions (with root cause). RI licensing file indicated that this incident will be reviewed at the next inspection.
File No.:' 9 Licensee: Mallinkrodt Medical, Inc., and Wilkes-Barre General Hospital License No.: 24-04206-10MD and 37-16170-01 incident ID No: PNO-l-96-019 -
Location: Wilkes-Barre, PA
.Date of Event: 03/26/96 Type of Event: Overexposure
' investigation Date: 03/27/96 investigation Type: Onsite Inspection Summary of incident and Final Disposition: A nuclear medicine technology student at the hospital became contaminated, and alarmed a radiation monitor before leaving a restricted area.
A RI supervisor and two inspectors interviewed the student and performed follow-up inspections at the hospital and pharmacy. Bioassay showed an uptake of approximately 15-30 mci of Tc-99m. Investigations and interviews revealed that the uptake resulted from a dropped syringe,
. and subsequent personnel contamination. RI concluded that this was an accident, and not negligence or malice. RI identified no violations. j i
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Region i Final Report Page F.4 incident File Reviews File No.: 10 Licensee: MQS Inspection, Inc.
License No.: 12-00622-07 incident ID No: PNO-l-97-075 & 075A Location: Tosco Refinery, Marcus Hook, PA Date of Event: 12/08/97 Type of Event: Equipment Failure investigation Date: 12/08/97 investigation Type: Onsite inspection Summary of incident and Final Disposition: The Region received a request from Amersham Corp.
to perform an emergency source retrieval of a 62 Ci Ir-192 radiography source at a temporary jobsite at the Tosco Refineryin Marcus Hook, PA. RI staff conducted an inspection of the incident and of Amersham's retrieval operations, and determined that the source disconnect resulted in minimal exposure to workers and members of the general public. The RI inspector noted that the connector had detached from the wire, and the end of the wire was frayed and rusty.
File No.: 11 Licensee: NationalInstitutes of Health License No.: 19-00296-10 incident ID No: PNO-l-97-007 & 007A
' Location: Bethesda, MD Date of Event: 01/22/97 Type of Event: Lost Material investigation Date: None Investigation Type: None Summary of incident and Final Disposition: On January 22,1997, the licensee reported that a package containing 1 mci of1-125 could not be found. The licensee conducted a search for the package. The Region scheduled an investigation for 1/27/97; however, on 1/24/97 the licensee informed the Region that the package had been found. RI canceled the inspection.
File No.: 12 Licensee: R. A. Laboratories License No.: 06-30007-01 incident ID No: PNO-1-97-044
. Location: Hebron, CT Date of Event: 07/22/97 Type of Event: Loss of Control investigation Date: 07/23/97 and 07/30/97 -
Investigation Type: Telephone Followup and Onsite inspection Summary of incident and Final Disposition: The licensee reported that they had received Sr-90 sealed sources and a radium sealed source which had been found at Shelton High School in Shelton, CT. The licensee performed a survey of the high school and found contamination limited to a box where the sources had been stored. RI conducted a survey and took wipe r
l samples at the school, analyzed the survey information and samples, and detected no activity.
3 2 Region i Final' Report incident File Reviews Page F.5 File No.: 13 Licensee: Altoona Hospital License No.: 37-11826-01 Incident ID No: PNO-i-97-002 Location: Altoona, PA Date of Event: 09/19/93 (Reported 01/09/97) .
Type of Event: Misadministration investigation Date: 01/16/97, 01/17/97 & 01/24/97 investigation Type: Onsite Inspection Summary of incident and Final Disposition: The licensee identified on an annual QMP audit that three patients were administered dosages of approximately 2.3 mci of I-131 for whole body scans, instead of 3 mci as prescribed. The physicians did not issue written direcJives to change the prescriptions. In addition, the licensee determined that all 24 patients who received whole body scans in 1996 were administered these doses without written directives. RI conducted inspections and identified two violations: failGre to instruct the supervised individuals in the licensee's QMP and failure to include written procedures in QMP to meet the objective that written directives be prepared. ,
File No.: 14 Licensee: Cen'.rs Community Hospital License No.: 37c13681-01
. Incident ID No: PNO-l-97-005 Location: State College, PA Date of Event: 12/20/97 Type of Event: Misadministration
. Investigation Date: 01/23/97 investigation Type: Onsite Inspection Summary of incident and Final Disposition: During an HDR treatment of a patient's nasal cavity, a catheter containing the Ir-192 source was dislodged from the treatment site, and may not have been in its proper location during treatment. The medical physicist and the physicians subsequently concluded that a misadministration had occurred. NRC contacted a Medical Consultant to assist with the investigation and conducted an inspection. The misadministration may have resulted in an unintended dose to the skin of the patient's cheek of up to 3000 centigray.- RI issued a CAL and an NOV.
File No.: 15 Licensee: Geomechanics,Inc.
License No.: PNO-l-97-003 incident ID No: 37-17332-01 Location: Elizabeth, PA (Event: Pittsburgh, PA)
Date of Event: 01/01/97 Type of Event: Damaged Equipment investigation Date: 01/21/97 investigation Type: Onsite inspection Summary of incident and Final Disposition: At a temporary jobsite in Pittsburgh, PA, a construction vehicle ran over a portable density gauge. A licensee-contracted health physics service performed surveys, took swipes of the damaged gauge, and detected no removable contamination. RI conducted an inspection, identified violations, and issued an NOV.
s APPENDIX G SDMP AND DECOMMISSIONING FILES REVIEWED FILES REVIEWED FOR SDMP SITES File No.1 Licensee: Dept of the Army, U.S. Army Research Laboratory Location: Watertown, MA License No.: 20-01010-04 (Terminated)
License Type: R & D Type A Broad Scope File No. 2 Licensee: Dept of the Army, U.S. Army Research Laboratory Location: Watertown, MA License No.: SNM-244 (Terminated)
License Type: Special Nuclear Materials (Storage Only)
File No. 3 Licensee: Dept. of the Army, U.S. Army Research Laboratory Location: Watertown, MA License No.: SUB-238 (Active)
License Type: Part 40, Possession Only for Characterization and Decommissioning File No. 4 Licensee: Safety Light Corporation Location: Bloomsburg, PA License No.: 37-00030-08 (Active)
License Type: Manufacturing & Distribution File No. 5 Licensee: Heritage Minerals, incorporated Location: Tinton Falls, NJ License No.: SMB-1541 (Expired, but Licensee in Decommissioning)
License Type: Source Material File No. 6 Licensee: The Pesses Company (METCOA)
Location: Pulaski, PA License No.: STB-1254 (Expired)
License Type: Metal Reclaiming File No. 7 Licensee: Whittaker Corporation Location: Simi Valley, CA License No.: SMA-1018 (Active)
License Type: Ore Processing
s APPENDIX G SDMP AND DECOMMISSIONING FILES REVIEWED FILES REVIEWED FOR SDMP SITES File No.1 Licensee: Dept of the Army, U.S. Army Research Laboratory Location: Watertown, MA License No.: 20-01010-04 (Terminated) '
License Type: R & D Type A Broad Scope File No. 2 Licensee: Dept of the Army, U.S. Army Research Laboratory Location: Watertown, MA License No.: SNM-244 (Terminated)
License Type: Special Nuclear Materials (Storage Only)
File No. 3 Licensee: Dept. of the Army, U.S. Army Research Laboratory Location- Watertown, MA License No.: SUB-238 (Active)
Ucense Type: Part 40, Possession Only for Characterization and Decommissioning File No. 4 Licensee: Safety Light Corporation Location: Bloomsburg, PA License No.: 37-00030-08 (Active)
License Type: Manufacturing & Distribution File No. 5 Licensee: Heritage Minerals, incorporated Location: Tinton Falls, NJ License No.: SMB-1541 (Expired, but Licensee in Decommissioning)
License Type: Source Material File No. 6 Licensee: The Pesses Company (METCOA)
Location: Pulaski, PA License No.: STB-1254 (Expired)
License Type: Metal Reciaiming i
File No. 7 Licensee: Whittaker Corporation Location: Simi Valley, CA '
License No.: SMA-1018 (Active)
Ucense Type: Ore Processing l
-s ,
Region i Final Report Page G.2 SDMP and Decommissioning File Reviews FILES REVIEWED FOR NON-SDMP SITES UNDERGOING DECOMMISSIONING File No.1 Ucensee: Prometcor, Inc.
Location: Somerset, NJ License No.: STB-1451 (Active)
License Type: Source Material File No. 2 Ucensee: Norton Company Location: Worcester, MA License No.: STS-00770 (Formerly Licensed Site)
Ucense Type: Refractory Processing File No. 3 Licensee: IEA, Inc.
Location: Monroe, CT License No.: 06-30139-01 License Type: Analytical Laboratory FILES REVIEWED FOR NON-SDMP TERMINATED SITES
{
File No.1 Licensee: Non-Destructive Testing Corporation Location: Manville, NJ l License No.:
29-19742-01 License Type: Industrial Radiography File No. 2 Ucensee: Ledoux & Company Location: Teaneck,NJ License No.: SMC-1181 License Type: Industrial; Source Material l File No. 3 '
Licensee: The DuPont Merck Pharmaceutical Company Location: Glenolden, PA License No.: 37-28764-02 Ucense Type: Pharmaceutical Manufacturer File No. 4 Ucensee: Duquesne Light Company Location: Pittsburgh, PA License No.: 37-06424-05 License Type: Gas Chromatography I l
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y 1
Region i Final Report Page G.3 SDMP and Decommissioning File Reviews File No. 5 Licensee: Industrial Cc rrosion Management, Inc.
Location: Randolph, NJ License No.: 29-19571-01 License Type: Gas Chromatography File No. 6 Licensee: Harvard University Location: Cambridge, MA License No.: SNM-71 License Type: Medical R & D File No. 7 .
Licensee: Sharp Electronics Corporation Location: Mahwah,NJ License No.: 29-23702-02 License Type: Manufacturing & Distribution File No. B -
Licensee: The Osteoporosis Testing Center, Inc.
Location: Englewood, NJ License No.: 29-20940-01 License Type: Medical Private Practice
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k UNITED STATES
[ g NUCLEAR REGULATORY COMMISSION o,
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[- 475 ALLENoALE ROAo KING OF PRuS$1A, PENNSYLVANIA 19406 1415 March 16, 1998
, MEMORANDUM TO: Carl J. Paperiello, Director Office of Nuclear Material Safety i
and Safeguards FROM: Hubert J. Miller Regional Administrator
SUBJECT:
COMMENTS ON DRAFT 1998 REGION 1 INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM (IMPEP) REPORT
~
This is in response to your memorandum of February 27,1998 which requested our review and comments on the draft 1998 IMPEP report for Region 1. As you know, Region I was the first Region to be evaluated under the pilot indicators in 1994 and this represents our third review under IMPEP. We have seen considerable change and refinement in the program over time.
As a result these reviews represent a significant opportunity to improve our performance in implementation of NMSS programs. The 1998 team was thorough and professionalin da approach to and execution of the review, resulting in relatively little impact on the staff's ability to continue its ongoing work.
Our specific comments on facts contained in the report are relatively limited and are contained in the Attachment. We would like to comment here on actions taken and planned to address the two recommendations for Region I action resulting from the review.
With respect to the first recommendation, that Region i "... continue efforts to improve its timeliness in conducting initial inspections in accordance with IMC 2800 guidelines..."
we have taken several steps since the team's visit was completed on January 30,1998. First, we have inspected all initial licensees that were identified as overdue by the team as well as several others that were beyond the scope of the team's inquiry, We have also made modifications to the staff's entry of data into the Ucensing Tracking System (LTS) to assure that initial inspections take place within the 12 months identified in IMC 2800. In addition, DNMS management has conducted root cause analysis in an effort to better understand the circumstances that led to this finding not being closed out during the review. Further, we intend to ensure that all DNMS self-audits will evaluate our effectiveness and conformance relative to overall program guidance, as delin Hited in the inspection Manual, Management Directives and other documents. The combination of these activities along with a planned audit every six months of all new licenses issued by the Division to assure that inspections have been conducted as required give us confidence that we will be in compliance with the requirements of IMC 2800.
CONTACT: George Pangburn, DNMS (610) 337-5283 Attachment 2 fdfQ~
V CarlJ. Paperiello 2 With respect to the second recommendation, that Region l"... implement a process to ensure that each NOV receives a licensee response in a timely manner...", we are conducting a thorough review of our inspection report records and are implementing appropriate followup actions. We believe that the existing administrative processes are sufficient to prevent recurrence, but that we need to provide greater management attention in this area. Specifically, we plan to provide the Branch Chiefs with a report from the inspection Planning System each week that identifies each inspection where a licensee response has not yet been received. Those inspections which are approaching the 30 day response will be discussed as part of our weekly planning meeting.
In addition, we plan to have the Licensing Assistance Team review the suspense copies of inspection reports at the end of each month to identify and provide to the Branch Chiefs any reports for which licensee responses to NOV's are due or overdue.
We look forward to discussing these recommendations as well as other aspects of our materials and decommissioning program with you at the Management Review Board meeting.
Attachment:
Specific Comments on Factual Statements in the Draft R1IMPEP Report cc w/ attachment:
S. Moore, NMSS D. Cool, , NMSS F. Combs, NMSS J. Piccone, NMSS G. Deegan, NMSS I
l
o SPECIFIC COMMENTS ON FACTUAL STATEMENTS IN THE DRAFT RI IMPEP REPORT Pace /Paracraph/Line Comment Page 7, Paragraph 3, Line 3 The report states that "RI grants reciprocity for a single calendar year, and closes the files at the end of each calendar year." This statement may give the impression that RIis unique in this regard, when in fact, all Regions and the regulations themselves are geared toward dealing with reciprocity on a calendar year basis. We suggest that the statement be modified by adding the introductory phrase, " Consistent with the regulations contained in 10 CFR Part 150,..."
Page 8, Paragraph 5, Line 9 This line mentions that the overhire situation in RI may grow, in part, " ..because of the reduced number of inspections needed with Massachusetts as an Agreement State.. ." There is, indeed, potential for growth in our overhire situation, but not for the reason stated. The FY98 Budget and Operating Plan have already accounted for the loss of these former R1 licensees to the Commonwealth of Massachusetts in its capacity as an Agreement State and therefore, this factor will have no additional effect on the overhire situation. We suggest that this phrase be deleted.
Page 9, Paragraph 3, Line 1 The referenced training on the Decommissioning Handbook took place in February,1998, as scheduled.
Page 14, Paragraph 2, Line 5 The biweekly ARB meetings are not intended "...to review any existing allegation files for closure.. ." These meetings focus on review and action plan / assignment of new allegations received in the previous two weeks as well as specific allegations for which newly-received information warrants a "repaneling." Review of existing allegations for closure is accomplished as part of a monthly review which is discussed in paragraph 3 of page S.
Page 14, Paragraph 3, Line 2 This line indicates that the "... Senior Allegations Coordinator generates statisticalinformation on allegations on a monthly basis.. " and that this information is the basis for a meeting between DNMS management and the allegations staff, in fact, reports developed by the SAC include statisticalinformation (i.e., allegation performance indicators) and detailed status of all open allegations. Our monthly meeting uses the detailed status report to focus on management actions necessary to assure prompt and procedurally correct followup of those allegations.
Attachment
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