ML20155G913

Lists Actions Agreed to Accomplish Resulting from Quarterly Review of Reactor Safeguards Licensing & Insp,Fuel Facilities Insps & TLD Program.Actions Include Assessment of Long & short-term Options for Clerical Staff

ML20155G913
Person / Time
Issue date:	07/21/1988
From:	Sjoblom G NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION I)
To:	Russell W NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION I)
Shared Package
ML20155G876	List: IA-88-424, Advises of Decision to Standardize Incident Response Training Program,Per Federal Field Exercise.Objective Is to Provide Level of Training on 1 to 2 Yr Basis.W/O Encls ML20155G873 ML20155G879 ML20155G887 ML20155G892 ML20155G901 ML20155G913 ML20155G925 ML20155G929 ML20195B327
References
FOIA-88-424 NUDOCS 8810180092
Download: ML20155G913 (2)

Text

{{#Wiki_filter:. _ _ _ _ _ _ _ _ _ _ _ _ _ _ JUL 11 1999 I MEMORANDUM FOR: William T. Russell, Regional Administrator FROM: Glen L. Sjoblom. Acting Director, DRSS

SUBJECT:

ACTIONS RESULTING FROM QUARTERLY REVIEW 0F REACTOR SAFEGUARDS LICENSING AND INSPECTION, FUEL FACILITIES INSPECTIONS, TLD PROGR#i - JUNE 22, 1988 During the subject briefing, DRSS agreed to take the actions described below: 1. The DRSS recomendation to obtain assistance in reducing backlog of Reactor Safeguards plan revisions and inspections was approved. , in a conversation with Region I on June 23, 1988, Sjoblom Subsequently (NRR), agreed that NRR would review reactor safeguards plans and Grimes and Region 11 (Stohr) agreed that Region 11 would conduct some inspections. Details are to be worked out and documented by DRSS (Keimig). 2. DRSS agreed to assess short and long tenn options for clerical staff FTE and support of reactor safeguard plan revisions and to report back, a. Support from DRS b. Support from DRSS Materials Section 3. In the Fuel Facilities area, DRSS agreed to amend the Fuel Facilities inspection matrix to include expected FTE by inspection category and FTE budgeted, so that this matrix would be the basic matrix for reviewing future efforts in this area. 4. In the TLD program, DRSS will consider the need for a new TLD reader and make a detennination of need. Approval will be obtained, as appropriate. Also, an audit of the TLD program will be conducted and reported to Mr. Russell. 5. For future Quarterly Reviews of any reactor related subject area, resources will be covered by SALP category, showing how SALP results have been used to decide upon inspection coverage. This will be done by a ~ matrix showing budgeted and allocated resources in each category and reactor plant. Coordinate this with DRP Branch 1. A!!\\ 01 2 800915 FELTON88-424 PDR

~ William T. Russell 2 JUL 21 Jggg 6. Future Quarterly Reviews in t y subject area should review the status of qualification of personnel, covering initiation of individual development plans, establishment of qualification journal and discussion of training being provided. For materials, see new MC 1245 required courses, urisinal 81sned sy a 4 Glen L. Sjoblom, Acting Director Division of Radiation Safety and Safeguards CC: S. Ebneter R. Bellamy J. Joyner M. Shanbaky W. Pasciak R. Keimig W. Lazarus J. Ainneman J. Glenn J. White I l f i hy c? t X3LO: A A1 /p/80 7/g//88 i 0FFICIAL REC 0E0 COPY i

/ UNITED STATES NUCLEAR REGULATGRY COMMISSION .j j REGION 1 476 ALLENDALE ROAD / KING oF PRUE81 A. PENNSYLVANIA 1H06 2 8 JUL 1988 Docket No. 030-17020 License No. 31-00636-07 EA No. 84-98 V. A. Medical Center ATTN: James Dooley Director 130 Kingsbridge Road Bronx, New York 10468 Gentlemen:

Subject:

Coepletion of Requirements of Order Modifying License On March 5,1985, an Order Modifying License was issued to the V. A. Medical Center, Bronx, New York. The Order resulted from the circumstances associated with an exposure to a licensee researcher in excess of NRC limits for iodine-125. This Order required four unannounced audits of licensed activities by an inde-pendent organization. The requirements of that Order were relaxed by letter dated November 29, 1986 and signed by James M, Taylor, then Director, NRC Office of Intpection and Enforcen.ent, to require two audits to be performed by Dr. Walter Shreeve and Mr. Terry Johnson of the V. A. Medical Center, Northport, New York. We have reviewed the reports of the two audits Conducted on December 4, 1985 and December 3,1986. A copy of the most recent audit report was forwarded to Dr. John Glenn of this office by your correspondence dated April 21, 1988. Accordingly, we have concluded that all terms of the Order have been satisfactorily completed. No reply to this letter is required. Your cooperation with us is appreciated. Sincerely, WA William T. Russell Regional Administrator /V auw-n -v 2PP'

28 JUL B88 V.,A, Medical Center 2 4 1 cc: Public Document Room (PDR) Nuclear Safety Information Center (NSIC) State of New York 4 Dr. James W. Fletcher Director; AdministrationNuclear Medicine Service (115) Veterans 3 810 Vermont Avenue, N.W. Washington, D.C. 20420 bec: Region 1 Docket Room (w/ concurrences) Dan Holody, R1 J. Lieberman, OE J. Joyner, R1 R. Cunningham, NMSS J. Goldberg. OGC f J i I i 2 v 1 i l

[%\\ tallTIO STA788 t" NUCLEAR REOULATORY COMMl8B40N I m eio i SPe ALLWESALe A048 use or pavessa.peawevivama mass JLR 211984 Docket No. 030 09226 030-13634 License No. 29-02957-13 EA-88-163 29 02957-14 University of Medicine and Dentistry of New Jersey ATTN: Erich Hirshberg, M.D. Associate Dean of Research 100 Sergen Street Newark, New Jersey 07103 Gentlemen: On May 26 - 27 and June 1 - 2, 1988, Mr. John M. Petchat of this office conducte i a routine safety inspection at the University of Medicine and Dentistry of the j activities authortred by the above NRC Licenses. The findings of the inspection Gove11tz at the conclusion of the inspection.were discussed with your The results of the inspection were also the subject cf telephone conversations between yourself and Dr. John Glenn on June 20, 1988 and Dr. Elizabeth Alger and Dr. Glenn on June 21, 1988. Areas exa'nined during this inspection are described in the NRC Region ! Inspec tion Report which is enclosed with this letter. Within these areas, the inspec-tion consisted of selective examinations of procedures and representative records interviews with personnel, and observations by the inspector. As discussed during the telephone conversation between Dr. Alger and Dr. Glenn an enforcement conference has been scheduled for 10:30 on June 29, 1988, at our of fice in King of Prussia, Pennsylvania. 4 this meeting with eeebers of your staff. We understand that you will attend to discuss the causes cf the violations and your proposed corrective action The NRC Enforcement Policy is described in M CFR Part 2. which is enclosed for your inforsation. C, a copy of Region I office. Also enclosed are directions to the In accordance with Section 20,790 of the NRC's "Rules of Practice',10 CFR Part 2, a copy of this leuer and the enclosures will be placed in the NRC Public Document Room, laf;tmtion in this re:Ord w3s dt!!ted in a:cerm:e w.th the Freenra of Inf; mation Act, eum;t,ans 8 F0i A.

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a 21 C3 , University of Medicine and 2 Dentistry of New Jersey No reply to this letter is required. Your cooperation with us in this satter is appreciated. Stace 1 Gr L. Sjob os, Acting Director Di' ision of Radiation $afety l nd Safeguards

Enclosures:

1. NRC Region ! Combined Inspection Report Nos. 030-09926/88-01, 2 030-13634/84 01 2, 10 CFR Part 2 3. Directions to the NRC Region I office cc w/ encls: Pubi te Docurent Room Nuclear $4fety Infors(POR) ation Center (NSIC) St4te of New Jersey I i i i I l i l l l l l l

8 U. S. NUCLEAR REGULATORY COPNIS$10N REGION I 030 09926/88 001 Report Nos. 030 13634/88 001 030 09926 Docket Nos. 030 13634 29 02957 13 2 G1 2110 License Nos. 29 02957 14 Priority 3 Category E_ Program Code 3510 Licensee: University of Medicine and Dentistry of New Jersey 100 Bergen 5treet Ilewark, New Jersey 07103 Facility Name: University of Medicine and Dentistry of New Jersey (UMONJ): Center for Molecular and Medical lununology (CMI) Inspection at: 100 Bergen Street, Newark, New Jersey Inspection Conducted: May 26 27 and June 1 2, 1988 e Inspector; ,fp // V John M. Felchat, Health Physicist ae Approved by: $ A/ ['f _ _r Ohn L. Glenn, Ph.D., Chief date Inspection Sum y: Routine Safety inspection Conducted on Ja 26 27 and June 1 - 2, 1988, M lCombined Inspection Report Mos 030 09no758 Dol and c3013634/ss co11 Areas Inspected: Corrective Actiont for Previously Identified Violations and Open Items; Licensee Organization' Radioisotopes Committee' Radiation Safety and Instruction; Security of Radioactive Material; Uses of Radioactive Material. Instruments, and Procedures Personnel Protection - External; Personnel Protection Internal; Receipt and Olsposal of Radioactive Material; Notifications and Reports; Radioactive Material Handling Practices; Special lasts and Inventories; Misadministrations; Posting and other Requirements. Results: Within the st. ope of the inspection, a total of 17 examples of six apparent violations: f ailure to conduct appropriate surveys (7 examples l paragraphs 7, 8, and 9); failure to maintain survey results in the same. units z;S'0 707mQ 3 PP

2 used in 10 CFR 20 (2 examples, paragraphs 7 and 9); failure to provide radiation safety training to individuals prior to entering areas to which the licensee limits access for the purpose of radiation protection (2 examples, paragraph 5); failure to possess and use radioactive material in accordance with the statements representations and procedures in the licensee's application (4 examples, p,aragraphs 5, 9,d ra,dioactiv)e material in accordance w 12 and 13 ; failure to perfors leak tests of sealed sources containing license conditions of the license (paragraph 13); failure to perfore leak tests of irradiator sealed sources containt licensed radioactive material in accordance with the conditions of the license paragraph 13). r t I

DETAli.S 1. Persons Contacted

• George Govelitz, Radiation Safety Officer (RS0) h
• Erich Hirshberg, M.D., Associate Dean of Researc
• Bonita Bachl, R.D., Acting Chairman / representative, Radioisotope Committee Geraldine Wilson Radiation Safety Technician tanka Venkta, Ralliation Safety Technician
• Robert Sharkey. M.D., Head of Research, Center for Molecular and Medical Imunology Roberta Cola (CMMI) Acting Chief Nuclear Medicine Technolog nert Medicine and Denlistry (UMONJ)ine Technologist, UMDO Abraham Matthew Nuclear Medic Robert Lee, Chlef Nuclear Medicine Technologist, Cm!

Donald Varga, Research Technician CMI i Francis Chinard, M.b. Medical Physleist,icine, UMONJ (Aut Christopher Hawkins Radiation Oncology, UMONJ , Professor of Med Vivian Bowers, Research Technician, UMONJ Marilyn Wysocki, M.D., visiting physician - denotes individual present at the exit interview 2. Corrective Actions for Previously Identified Violations and Open items (0 pen) Inspection 86 001: 10 CFR 20.20)(b) Failure to make surveys to assure compliance with the provisions of 10 CFR 20.101 which limit radiation exposure to the extremities of individuals. The licensee comitted to correct this violation by warning the individual involved that continued failure to wear extremity dosimetry would result in a suspension of that individual's privilege to possess and use radioactive material. 4 Interview of the involved individual and observation by the inspector confirmed that the individual was wearing appropriate dosimetry.

However, this violation has recurred.

A research tecinician was observed not wearing extremity dosimetry while obtaining an aliquot of technettua 99m from the Nuclear Medicine Department. l (0 pen) Inspection 86 001: License No. 29 02957-13 Conditten 21 - Failure of individuals handling allitcurie quantities of lodine 131 to have routine thyroid bloassays performed in accordance with the guidance in Regulatory Guide 8.20. The licensee coanitted to correct this violation by estab-lishing a systen to track the specific dates thyroid bicassays were re-quired based on the date of receipt of radiciodine shipments. The RSO 4 1 muld then be required to contact the Nuclear Medicine Department where thyroid bioassays are performed and confirm that individuals scheduled to handle millicurie quantities of radioactive lodine had reported for a bicassay. If the R50 had found that such an individual had not reported i for a bloassay, he would cause that individual to report or take imediate i {

t 3 actions to prevent the individual from handling radioactive materials. However, this violation has recurred. Review of records revealed that numerous individuals perforsing radiciodinations with quantities of I 125 and 1131 ranging from 1 to 350 millicuries did not receive thyroid bloassays. The RSO stated that he was not aware of radiolodinations before they perfonned. The R$0 also siated that no mechantse was in place to assure that persons handling millicurie reported for bloassay on a timely basis. quantities of radioactive todtne (closed License No. 29 0257-14 the cess? Inspection 86 001:ual37 trradiator by individuals not designa C Un of ted by the Radioisotope Coenittee as authorized users. The licensee coanitted to correct this violation by establishing a mechanism to register and approve all users of the irradiator >rtor to their initial use of the device. In addition possession of t te key to operate the irradiator would be limited to the RSO and to authorized irradiator users. Review of records and interviews with i authorized irradiator users and the RSO revealed that all users of the irradiator were now approved by the Radioisotope Committee before initial use c? the device. (Closedj Inspection 86 001: License No. 29 0257 13 Condition 8 - possesston of 1131 in quantitles greater than the authorized possession limit. The licensee amended the license to increase the 1131 pos:ession limit to 1500 millicuries (amendment no.12 dated November 4,1986). The licensee also established a computerized possession tracking system. to assure that authorized users do not exceed individual possession. A review of radioactive material receipt, possession and inventory records revealed that the licensee possesses quantities of licensed radioactive material ) less than the quantities specified in Condition 8 of the license. I LClosed) Inspections 86 001 and 87 001: License No. 29 02957 13 Condition L6 Failure to review and approve all uses of Itcensed radioactive I material prior to procurement and use. The licensee counttted to correct this violation by the establishment of a licensing subcospittee to ensure i that requests for new uses of radioactive material are reviewed in a timely sanner. Record review and interviews with persons working in radioactive I i material use areas revealed that all uses of licensed radioactive satertal had been approved by the Radioisotope Committee. The individual who had obtained and used radioactive saterial without the approval of the Radioisotope Countttee was suspended from using radioactive saterial for 90 days and was required to reapply in entirety for persission to use material at the end of the suspension. 3. Licensee Organization I 'he University of Medicine and Dentistry of New Jerseyzed by their broa radioactive material for diagnostic and therapeutic nuclear medicine and research, lhe 1 UMDNJ 1s also specifically licensed to possess and use a 400 Curie (Cl) I. 1 I

4 cesium 137 self shielded irradiator. The Center for Molecular and Medical Imunology is a branch of the UMONJ and is involved in the research and developm(CMI)f monoclonal antibodies tagged with radioactive t ent o technetium for use in diagnostic and therapeutic procedures. The activt-ties of the CMI involve the administration of these tagged monoclonal antibodies to human beings as part of the research and development effort. The use of all radioactive materials on the UMDNJ campus is administered by the Radioisotope Comittee. The Radioisotope Coenittee has delegated responsibility for the day to day oversight of the use of radioactive material to the Radiation Safety Officer (R50?. The Radiation Safety i Office it staffed by 2 radiation safety techn'etans and a secretary in addition to the RSO. There are approximately 40 active authorized research perstts employing 200 - 300 people administered under the broad scope Itcense program. ~he following table sumartzes the sonthly patient caseload for each of the 04partments involved in the administration of radioactive saterial to human beings: Department Cases / Month 4 (MONJ Nuclear Medicine 215 Radiation Oncology (brachytherapy) 34 C ml Nuclear Medicine 12 No violations of NRC rules, regulations o: license conditions were identified. 4. Radioisotopes Comittee The Radioisotopes Comittee has oversight responsibility for the uses of all ionizing radiation used at the UMDNJ. The Radioisotope Comittee is composed of 15 members and includes representation from each department using radioactive material, as well as representatives from the admints-tratten and the nursing staff. l As noted above, a licensing subcomittee has been established to review all requests for new and amended radioactive naturtal use approvals. Ihts subconsittee meets independent of the Radioisotope Comittee and makes recommendations to the full cosnittee concerning approvals to use radioactive saterial. The licensing subcosnittee is authorized to grant i provisional approvals pending the next meeting of the full Radioisotope Comittee. Tae Radioisotopes Cosnittee has recently estabitshed a training subcosmittee to review and propose revisions to the t#0NJ radiation safety training program, i A review of the Radioisotope Comittee meeting minutes indicated that the { comittee meets a minisium of once per calendar quarter. The minutes of t

~ 5 J these meetings indicate that the Radioisotope Cosmittee discusses items such as the following at each of its meetings: The recommendations of the licensing subcoenittee. This review include the approval or disa amendment, or suspension of gproval of the granting,f license,d renewal Itcenses' for the use o radioactive material. The committee also discusses the criteria the licensing subcoenittee to follow when considering appitcations. The R50's quarterly report of personnel radiation monitoring results. These reports appeared to be based on the results of reports received from the LM*J's coamercial dosimetry ver. dor eni. The reports also include the results of investigations by the RSO s staff into dosimetry results that exceeded the licensee's ALARA I investigation limits. These investigations appeared to be complete were frequently unsuccessful in establishing the cause, of a hichalthough they dosimetry result. The R50's quarterly reports generally failed t discuss the results or evaluation of thyroid or urine bionssays. oThe R$0's report to the comittee on October 29, 1987 did include the results of an investigation into a high breathin zone eensurement result and subsequent thyroid bioassay indicati that an individual had exceeded the licensee's administrative uptak limit for 1 131. The R50's investigation concluded that the uptake was less than regulatory limits. Other subjects discussed by the comittee have included: Results of the investigation into the causes of a diagnostic i misadministrations (also see paregraph 14). Discussion of an NRC allegation investigation after an employee first coeplained about the presance of radioactive saterial in a non radiation laboratory and subsequent concerns about possible termination. The results of investigations by the NRC and the Radioisotope Comittee established that radioactive saterial had been i stored in an unauthorized location. The individual resposible for the unauthorized storage of radioactive saterial and subsequent remarks about the alleger's employment resulted in the responsible individual's radioactive mater \\al use authorization being suspended for 90 days. The individual was also cited by the Committee for not being cooperative with the NRC inspector investienting the allegation. i At the end of the ninety day suspension, the individual was required i l to reapply in entirety for permission to use radioactive materini, I The Radioisotope Cosnittee reaffirmed that it was Comittee Policy not to take any action against persons teho contacted state or federal regulatory agencies with any safety concern, i j No violations of NRC rules, regulations or license conditions were i identified. 1 ) i

6 5. Radiation Safety Training and Instruction All persons working with radioactive material at the UMONJ are required to attend a 4 hour radiation safety training class upon emplo nt by the UPONJ. The course is offered on an approximately quarter) basis. Supervisors are required by UPONJ Radiation Safe 3y policy a provide additional on theNob training to assure that new employees are capable of handling radioactive materials safely. New employees who work witi radioactive material before attending the radiation safety class are first required to receive additional training and supervision. The R50 stated that the UMONJ radiation safety manual was currently under revision and that the training curriculum and handouts were also being revised to reflect the changes in the new manual. The RSO also stated that the text of the ranual would be submitted to the NRC for review as part of the upcoming broad scope license renewal. No additional formal training is offered to those persons who will be handling millicurie quantitles of i radioactive iodine. Several radiation workers who were working in research areas were interviewed during the course of the inspection. It was found that all of these individuals had attended the Radiation Safety Office's training clast. Interviews of the two nuclear medicine department technologists indicated that both individuals had received the required initial training and quarterly received refresher training in radiation safety or other aspects of nuclear medicine during meetings w'th the department's censulting health physicist. An individual was observed caring for a patient who had.iust received a experimental diagnostic administration of 10.24 millicurles (mC1)l was n of I 131 i i tagged monoclonal antibodies, it was observed that the individua wearing srotective clothing gloves or dosimetry as required in the col esta>11shed in the 'CPed Radiotherapy Program' dated November 5,proto-1987 The R$0 was not able to identify the individual. During an interview of the individual, it was found that the individual was a physician with a speciality in ophthalmology and was the patient's daughter. The individual stated that she was not named as an authorized user er radioactive material on a USNRC or Agreement State license and was not an employee of the UPONJ. i The individual stated that her radiation safety training was lialted to training received during a rotation through diagnostic nuclear medicine as part of her medical training. The individual stated that the licensee had 1 not provided her with any radiation safety training. The 150 confirmed that he had not provided this individual any radiation safety training nor had the R50 been notified that the individual would be enterlag a restricted area. During the inspection of the nuclear medicine department, the department recep,ionist was interviewed, it was found that she was a temporary replacement for the staff receptionist who was absent on leave. The receptionist was asked what instructions she had received when coming to t l

7 the department concerning areas and materials she should avoid. The receptionist responded that she had not received any such instructions and that she had entered areas in the department %ere radioactive materials are used. The RSO confirmed that the individual had not received any radiation safety training and discussed the difficulty of providing such training to persons who have been temporarily assigned to work in areas where they eteht have need to enter restricted areas. The cited reaso;is for these difficulties included the large size of the (Mpu staff and the high turnover rates in some of the hosp' tal's positions. The failure to provide training to oersons who work in or frequent any portion of areas the licensee restrlets access to for the purpose of radiation protection is an apparent violation of 10 CFR 19.12. During a visit of the hospital floor where a brachytherapy case was in progress, the nurse working as the floor shift supervisor was interviewed. The individual stated that although she had not cared for the patient involved in the current brachytherapy treatment, she had routinely cared for brachytherapy patients. When asked if she had attended any of the in services the RSO had conducted for nurses carin patients, she stated that she had attended one in g for brachytherapy service approximately four years ago. She also stated that she had recently returned from maternity leave and had not received any instruction in the care of brachytherapy patients since her return. When advised by the inspector and the R50 that she avoid caring for brachytherapy patients until she had attended the next in service, she stated that decisions concerning which staff would care for each patient were made solely by her supervisor. The supervisor was not available for interview. The R50 and the Radiation Oncology Medical Physicist stated that they would take action to ensure that only those nurses with current radiation safety training would be involved in the care of brachytherapy patients. Item 12, page 24 Section D of the application dated April 20, 1983 sintes that the kSO will mee,t with nursing staff assigned to tne care, of brachytherapy patients before the beginning of each therapy procedure and instruct the nursing staff as to the spectric hazards associated with that particular case and discuss what dostmetry will be required. The failure of the licensee to possess and use radioactive material in accordance with the statements specifically, presentations, and procedures in thefailure re Itcense application,for brach staff before carin Condition No. 21 ( icense No.ytherag713) patients, is an apparent violation of 29 02 r i

8 6. Security of Radioactive Material The inspector arrived on site prior to the opening of the Radiation Safety Office and Nuclear Medicine Department. It was four.d that these areas were securely locked to prevent unauthorized entry. Interview of the acting chief nuclear medicine technologist indicated that only the two technol-ogists, the chief nuclear medicine physician and security had keys to the Nuclear Medicine Department. During a tour of research facilities using radioactive material it was of radioactive material.quate security was being maintained for,the storage found that generally ade The inspector was regularly challenged by laboratory staff when entering an area where radioactive material was used or stored. In all but a single case unoccupied laboratories which contained radioactive raterial were found to be locked. In that instance, microcurie quantities of tritium (H 3) and carbon 14 LC 14) were found in an unlocked refrigerator located 9n an unoccupied, un' ocked laboratory. Both the door to {he laboratory and the refrigerator were yellow ano ragenta ' Caution. Radioactive Materials

• signs. posted withThe inspecto noted the laboratory was not in an area to which the general public had routine access and the relatively small quantities of radioactive material present.

No violations of NRC rules, regulations or license conditions were identified. 7. Use of Radioactive Material. Instruments, and Procedures it was observed that all areas in which radioactive saterial was used or stored were properly posted. The tagging of various biological compounds with radioactive iodine is carried out in three locations on the UMONJ campus. Researchers working in the University Medical School use a recirculating hood located in a dedt-cated room in the Radiation Safety Office, lodinations using u millicuries (mC1) of 1125 or 1 131 are performed in this hood.p to ten Researchers and medical staff working at the CMI use two dedicated hoods located in the Cm!'s single story building located adjacent to the UMDNJ Medical School / Hospital building. One hood is used for ledinations using up to ten act of 1-125 or i 131. The second hood is used exclusively for the todination of monoclonal antibodies. These iodination procedures can involve anywhere 10 to 700 sci of I 131. At Cml. hood effluent is released at the roof of the single story structure, an area to which the licensee does not restrict access for the purpose of radiation protwetion (i.e., an unrestricted area). Both the Cal iodination hood exhaust stacks a re equipped with charcoal filters. 10 CFR 20.201 assure complia(b) requires that a licensee aske appropriate surveys to nce with all the requirements of 10 CFR 20. 10 CFR 20.201(a) defines ' survey

• as an evaluation of the radiation hazards incident to the

9 production, use release, disposal or presence of radioactive saterials or other sources of radiation under a, specific set of circumstences. When appropriate, such an evaluation includes a physical survey of the location of satorials and equipment and measurennts of levels of radiation or concentrations of radioactive saterial present. 10 CFR 2c106 estabitshes the maximus concentrations of radioactive saterial that a licensee is persitted to release in effluents to an unrestricted area. The licensee's protocols for iodinations require that the person perforsing the iodination collect hood effluent air samples continuously durlng he radiolodination l procedure. The inspector asked what measurements were made to assure that releases from the CJm! hood exhausts did not exceed the lialts established in 10 CFR 20.106. The Radiation Safety Officer stated that no monitoring was made of stack releases after the effluent had passed through the charcoal filter. The licensee's failure to monitor and evaluate radiolodination hood effluent to assure that releases of radioactive iodine did not exceed the maximum permissible concentrations specified in 10 CFR 20.106 is an apparent violation of 10 rFR 20.201(b). 10 CFR 20.103 establishes the maximum concentrations of radioactive material in air to which a licensee is permitted to expose a radiation worker in a restricted area. The licensee's protocols for iodinations require that the person performing the iodination collect breathing zone air samples continuously during the radiciodination procedure. A review of breathing zone air sampling records revealed that no breathing zone air sample was collected during an todination procedure conducted at the CMI on April ll, 1988. The licensee's failure to monitor and evaluate breathing zone air in a restricted area during an todination procedure to assure that concentrations of airborne radioactive lodine did not exceed the raximum permissible concentrations specified in 10 CFR 20.103 is an apparent violation of 10 CFR 20.201(b). A review of the following survey records for the period October 1986 through May 1988 was made: Package Receipt Surveys for LMDNJ, Nuclear Medicine, and C*l. Area Radiat ?on Surveys of l#0NJ trradiator area,18000 nuclear medicine department, CMI nuclear medicine area, brachytt.erapy patient roces, monoclonal antibody patient rooms, and brachytherapy source storage room by authortred users and the radiation safety office staff. Area Contamination Surveys of LMDNJ Nuclear Medicine, CMI Nuclear Medicine, tMDNJ research areas, and CMI research areas by authorized users and the radiation safety office staff. Surveys of radioactive waste.

10 Review of these records indicated that frequent and regular surveys were made of all areas where radioactive saterial was .ad or stored. Review of area contamination surveys records revealed tht' asults of these surveys 1 were re:orded in units of counts per unit time, rather than disintegrations perunittime,andthatinsomecases,contaminationsurye not expressed in activity per 100 square centimeters (ca )y reJults were or some other standard unit of area. During various interviews of personnel involved with the collection and analysis of these wipe samples, they were asked what criteria was to determine that a sample result indicated the need to decontaminate a particular area. In all cases, these individuals responded that they would decontaminate an area if the sample results, in counts per minute, were in excess of twice the measured background. No evaluation of these counting results was made to determine the actual quantity of removable radioactivity in the surveyed areas or to deternike the sensitivity of the counting systems used in the measurement of these samples. The failure of 1teensee personnel to evaluate the results of area contamination surveys is an apparent violation of 10 CFR 20.201(b). performed in a(b) requires that the records of results of all surveys 10 CFR 20.401 ccordance with 10 CFR 20.201(b) be recorded in the same units as the units used in 10 CFR 20. The failure to record the results of area contamination surveys in the same units used in 10 CFR 20.5 is an apparent violationof10CFR20.401(b). During a review of the UMDNJ nuclear medicine department area contamination i survey results, it was noted that when the wipe sample analysis was done by I l the two different technologists, it was found that there were significant differences in the measured background}ysis. depending on which of the technologists performed the sample ana Each of the technologistr was isked to demonstrate the method the contamination survey wipe samples. y used for the anal sis of area l Each technologist laced the samples in disposable gloves and counted the samples using the su ti channel analyzer l located in the Nuclear Medicine Department. The multi-channel anal detector installed in a lead s gleid. probe and a sodium iodide (Nal)y equipped with both a thyroid u stake The first tet.hnologist turned the thyroid uptake probe upward and collected a one minute background count. The technologist then placed a glove into the open end of the thyroid probe and counted the sample for one minute. It was noted during this demonstration that the thyroid probe was very sensitive to variations in ambient background, such as those that would occur when a patient who had received a radiopharmaceutical would > ass by. The second technologist used the same counting, method except the sackground and samples were counted with the shielded Nai detector. The RSO stated that he had instructed the nuclear medicine technologists to use the shielded Na! detector when counting area contamination survey samples. The failure of the the nuclear medicine technologist to properly count tho area contamination survey samples is an appaient violation of 10 CFR 20.201(b). t l

11 During the review of the UPOLI Nuclear Medicine Department area contamination survey results, detector varied less than + ground counting it was noted that the back results for the shielded Wa! the value of one theoretical standard deviation of the mean from the bacEground count. Statistically, it is expected that about 66% of repeated measurements would fall within the range of + one standard deviation of the mean and that about 33% of the measurements would fall out of that range. theRSOand the inspector collected ten, one minute background counts using the proper system configuration. It was found that seven of the measurements fell within the range of + one standard deviation of the mean and that three fell out of that range. It was strongly suogested to the RSO that he closely monitor the analysis of area contamination wipe samples in the UMDNJ Nuclear Medicine Department to determine the cause of the unexpected ccunting results. The RSO did state that a printer would be added to preserve all the counting data for review. The inspector examined several radiation survey instruments throughout the licensee's facilities. All survey instruments had current calibration data and appeared to be in good working order. 8. personnel Protection - External The Radiation Safety Office issues about 1400 whole body and extremity dosimeters on about the 15th of each month. Review of monthly personnel dosimetry records noted the following whole body dosimetry results: Date of Dosimeter Recorded Exposure issue millires per month Worker A May 18, 1987 2,250 December 15, 1986 7,140 November 15, 1986 2,020 Worker 8 May 18, 1987 19,210 December 15, 1986 3,110 The review of the records revealed that the two involved workers were promptly notified of the results and were instructed to immediately halt all activities with all sources of ionizing radiation. The licensee's ( investigation in early 1987 revealed that the two individuals routinely hung their labcoats on the inside of the door to their small of fice/ laboratory with their dosimetry stored in their labcoats. The l workto use both radioactive material and X ray equi nt in their i laboratory activities. The apparent cause of the hl h dosimeter readings was that the labcoats (hich involved e)xtended operation of the X raywere in the 1 and dosimeters series of experiments w equipment. The individuals were not in the room during this portion of their work. The Radiation Safety staff subsequently determined that the dosimetry results were not valid and assigned administrative exposures for i \\ - _ - -

12 i the two individuals. The Radiation Safety staff instructed the two individuals about the proper fashion to store personnel dosimeters. The licensee's investigation appeared to be complete and the inspector had no further questions concerning this matter. The review noted no other exposures in excess of NRC limits during the review period October 1986 through March 1988. Film badge records were founo to be complete and listed all required personnel information. A research technologist was observed entering the nuclear medicine hot lab to pick up an aliquot of stock Technetium 99m. It was noted that the individual was not wearing any extremity radiation exposure monitoring devices. When asked if he was assigned a extremity dosimeter, the individual indicated that he was assigned a ring badge, but that he had forgotten it back in his work area. The individual complied when directed by the inspector to retrieve his ring badge before handling radioactive material. The failure to monitor extrer ity radiation exposures to assur'e that they do not exceed the limits established in 10 CFR 20.iOl(a) is an apparent violation of 10 CFR 20.201(b). The inspector observed no other instances of radiation workers failing to wear required personnel dosimetry. A brachytherapy procedure was in progress during the inspection. The inspector observed that the patient was assigned to a single room and that the adjacent room was not occupied. The rooms were properly posted. A document listing the results of radiation surveys and instructions to the nursing staff were also posted on the patient's door. Upon completion of the treatment, the survey form is updated with the results of the post treatment survey and source inventory. The survey form is maintained in the patient's permanent medical record. A number of these records were examined in the medical records department and results of all required surveys.rere found to be ademjate. Interviews with nurses assigned to the floor where the brachytherapy procedure was being performed revealed that the nursing floor supervisor had not been trained in a> proximately four years in precautions to be followed when caring for )rachytherapy patients (see paragraph 5). Other brachytherapy records reviewed revealed that physical inventories of sealed sources were conducted at the required frequency and that results of l sealed source leak tests indicated less than 0.005 microcurie of removable l activity detected. 9. Personnel Protection - Interr.41 Bioassay records were reviewed for the period October 1984 through June 1988. l

13 A review of thyroid bioassay results revealed that these records listed only the results of individual bioassays in units of alcrocuries (uct). The records indicated, and interview of the RSO confinned, that the itcensee did not perform any evaluation of these results to assure that individuals handling radioactive iodine were not exposed to concentrations of radioactive iodine in excess of the limits established in 10 CFR 20.103. The licensee's failure to evaluate thyroid bioassay results to assure that concentrations of radioactive iodine as a result of inhalation ingestion, or injection did not exceed the maximum permissible concentrations specified in 10 CFR 20.103 is an apparent violation of 10 CFR 20.201(b). A review of urine bionssay results revealed that results of assaying urine by liquid scintillation counting were recorded in units of counts per minute (cpm)he number of microcuries taken up by the worker or to evaluat and that no additional evaluation was made to relate these results to t the uptake with regard to the maximum concentrations established in 10 CFR 20.103. Review of the records also showed that results of background counting consistently ran higher than the results of urine counting. Interview of the RSO and a radiation safety technician indicated that, during calibration of the liquid scintillation counting system no correction for color quenching was made in counting urine samples. Failure to correct for color quench will result in systematic errors evidenced in higher background counts This could result in a statistically valid >ositive result not beind evaluated since it could be less than the biased sackground counting result. A review of the records also revealed the following urine bioassay results: Date of Sample Gross Beta Activity

• Background
• June 17, 1987 457 212 February 17, 1988 413 236 February 17, 1988 323 236 Results were recorded in cpm; no units of volume were available.

The RSO was tsked for evaluations of these bioassay results. The RSO showed the inspector his evaluations of these results, but the evaluations failed to relate the individuals' uptake to the regulatory limits established in 10 CFR 20.103. The RSO stated that his calculations based on the urine counting results indicated that the individuals had taken up more activity than the workers handled at any ce time during an experiment. The RSO stated that he was not n b to reselve this discrepancy. The RSO stated that the involved individuals all worked in the same laboratory using primarily C-14 labeled alcohols in animal research. The RSO was asked to prepare evaluations of these uptakes to assure that the limits established in 10 CFR 20.103 had not been exceeded, independent calculations by the RSO and the NRC indicate that the individuals' uptakes were not in excess of reguistory limits. The failure to evaluate the results of urine bioassays at the time of the uptakes to

14 ensure individuals working with C-14 labeled materials did not exceed the maximum permissible concentrations specified in 10 CFR 20.103 is an apparent violation of 10 CFR 20.201(b). A specific concern in reviewing the RSO's evaluation was the assumqttions used in the calculations. For example the RSO assised that 50% of the C-14 tagged alcohols would be excreted,in the urine. Interview of the i researcher revealed that the fraction present in urine would likely be less than 10%. While this did not result in a difference in the deteralnation of whether an overexposure had occurred in this case, such an error could easily affect body burden and exposure calculations. performed in a(cc)ordance with 10 CFR 20.201(b)to 10 CFR 20.401 b requires that the records of results of all surveys be recorded in the same units as the units used in lu CFR 20. The failure results in the same units used in 10 CFR 20.103 is an apparent violation of 10 CFR 20.401(b). A review of bioassay results also revealed that a research worker's urine indicated that the worker had possibly been subject to a suspected shophorus-32 (P 32) uptake within the few days prior to beginning of this WRC inspection. Review of the R50's evaluation indicated that the worker was not exposed to concentrations of radioactive material in excess of the limits established in 10 CFR 20.103. While reviewing the evaluation of this uptake the RSO stated that the results were collected with the liquid scintillation counting system's counting window wide open and that no attempt had been had to recount the urine samples with the counting system's window set for counting only the P-32 high energy beta. Readjustment of the counting system's window would have allowed for lower background counts. The RSO stated that all bio-assays for H 3, C-14, and P 32 were counted in this fashion and that the Radiation Safety Office's li uid scintillation counting system was not capable of simultaneous anal sis of identification of all three radionuc-lides. The failure to proper y perform radioanalysis of urine bioassay samples capable of identif tion of 10 CFR 20,201(b). ying radioisotopes present is an apparent viola-Condition 21 of License No. 29 02597-13 requires that the licensee possess and use radioactive material in accordance with the statements, representations, and procedures contained in the radioactive material application dated April 20 states that bioassays for I 1983.125 and I-13) will be Item 23 on page 53 of the application vith the requirements specified in Regulatory Guide 8.20, ' Applications of lioassay for 1 125 and 1-131". Regulatory Guide 8.20 states that a licensee will perform bioassays when an individual handles a quantity of radioactive lodine in excess of 105 of the values in Table 1 on page 8.20 4. The licensee, however, would not be required to perform bloassays if the licensee has prepared and recorded a written justification for not

15 L 1 a performing such measurements and maintained this justification for NRC review. A review of thyroid bloassay records and radiolodination logs for the period between January 1,1988 and March 31,fter 32 of the 71 1988 revealed that individuals failed to perform thyroid bioassay a todinations performed during this period. The activity of radioactive iodine handled during these iodinations where bioassays were not performed ranged from I to 580 sci. The Radiation Safety Officer stated that the licensee had established a written policy that required all individuals urforming radiotodinations to have their thyroid bioassayed 24 hours after iandling radioactive iodine. The failure of individuals handling radioactive todine to License Condition 21. perform thyroid bioassay is an apparent violation of The inspector found a number of factors which may have contributed to the failure of licensee personnel to perform the required thyroid bionsseys after handling radioactive iodine. First there was only one thyroid bioassay probe available on the UMDNJ camp,us. This counting sys",em is located in the hospital's Nuclear Medicine Department for diagnostic procedures and is only available when this department is open. This would prevent persons performing radioiodination procedures on a Friday from having a thyroid bloassay performed within the licensee's required 24 hour limit without making special arrangements. This was evidenced when the the inspector observed preparations to perform a radiolodination at approx. imately 4:15 on a Friday afternoon. The inspector asked the RSO when the persons handling the radioactive iodine would be bioassayed. The licensee staff then realized that it would necessary to bioassay the individuals on Saturday. After an extended discussion between the sersons planning to i perform the radiotodination and the RSO concerning tie need to perform a timely bioassay and making arrangements to obtain access to the Nuclear Medicine Department, it was decided to postpone the iodination until the following Tuesday, when more convenient arrangements could be made. Second, it was found that there was no mechanism in place for the RSO or other responsible individuals to identify when radiotodination procedures were performed and assure that persons involved with these procedures would report on a timely basis for thyroid bioassay. The licensee committed in a letter dated December 2 1986 to establish a system to track the specific dates thyroid bionssays,were required, based on the date of receipt of radiolodine shipments. The RSO would then be required to contact the Nuclear Medicine Department where thyroid bioassays are performed and

enfirm that individuals scheduled to handle millicurie quantities of radioactive lodine had reported for a bioassay.

If the RSO had found that tuch an individual had not reported for a bloassay, he would cause that individual to report or take immediate actions to prevent the individual f rom handling radioactive materials. The RSO told the inspector that no one on his staff tracked radioiodination activities to ascure compliance with the bioassay requirement nor did a system exist to do so on a timely basis. 1

16

10. Receipt and Disposal of Radioactive Material The inspector reviewed the licensee's procedures for the receipt of radioactive materials.

Individual users are responsible for orderin radioactive material. These orders are then processed by the WONJ'gs purchasing department. All purchase orders for the radioactive material are forwarde.d to the Radiation Safety Office for approval before being issued. Individual and institution radioactive material inventories are tracked against authorized possession Itaits thro h the use of a computerized tracking system. The inventory is u ated quarterly using radioactive material inventory reports from each f the authorized users. The only departments that order radioactive material directly are the UMDNJ and C*l Nuclear Medicine Departments. All shipments of radioactive material except radiopharmaceuticals for the two Nuclear Medicine Departments are received by the Radiation Safety Office. Receipt of radioactive material by the two Nuclear Medicine De Radiation Safety Office staff during weekly visits.partments is audited by Receipt surveys of radioactive material were observed being performed in the UMDNJ Nuclear Medicine Department and in the Radiation Safety Office. Individuals making the sut veys wore laboratory coats and gloves. These individuals were observed making the necessary direct radiation surveys and collecting samples for radioactive contamination surveys. The failure to report the results of the of radiocontamination surveys in units of activity was noted earlier as an apparent violation (see paragraph 9). The Radiation Safety Office collects all solid and liquid radioactive waste from the two Nuclear Medicine Departments and the various research areas on a weekly basis. Waste is segregated on the basis of the radioactive half life of the material. Waste which is made up of hypodermic needles is further segregated and is handled as radioactive material and as a biohazard. Short half-lived materials are held in l storage a minimum of ten half lives, surveyed to assure that radiation levels are below background, and then disposed of by incineration. l Long lived radioactive waste is drumed and transferred to a comercial waste broker for disposal. The UNDNJ does not permit individual authorized users to dispose of radioactive material to the sanitary sewer. The Radiation Safety staff does release radioactive material to the sanitary i sewer through a sink in the Radiation Safety Office. Review of radioactive waste disposal records indicates that all releases of radioactive material were less than regulatory limits. No violations of NRC rules, regulations, or license conditions were identified. 11. Notifications and Reports The Radiation Safety Officer stated that an administrative whole body exposure limit of 100 millirem per month had been established. Review of l \\

~ 0 17 records revealed that individuals were immediately notified and that the circumstances of the exposure were promptly investigated by the Radiation Safety Office. The exposed individual and their supervisor would then be advised of the results of the investigation. Records of these investigations were signed by the involved individual and their supervisor to indicate that they had been advised of reduce personnel radiation exposure. what measures were suggested to exposures in excess of NRC lialts were found.As noted above in paragraph 8, no No theft or loss of licensed radioactive material has reportedly occurred. No violations of NRC rules, regulations, or license conditions were identified.

12. Radioactive Material Handling Practices During the inspection at the UMONJ Hospital, portions of the administration of a diagnostic dose of 1 131 tagged monoclonal antibodies were observed.

The radiopharmaceutical is prepared at the CMI. Patient doses for diagnostic imaging procedures can range anywhere from 10 to 25 sci. Therapeutic doses may range up to 200 mci, the activity being limited by a 350 Rem dose to the patient's bone marrow. The material is transported on a hand cart to the UMONJ Nuclear Medicine Department. Diagnostic doses are then transferred to a plastic intrt, venous (IV)he Radiation Saf saline. The t#0NJ's procedures require that t bag containing ph stological i Officer make this transfer. i the IV bag in the Nuclear Medicine Department's dose calibrator.A nucle l The IV bag is then placed in a radiopharmaceutical transport case similar to those used by nuclear pharmacies and carried to the patient's room. The nuclear medicine physician or the Radiation Safety Officer will then hang the IV bag in the patient's room and assist with the infusion of the patient. Therapeutic doses are prepared in glass IV bottles. These are handled in a similar fashion except that the IV bottle is inserted into a lead shield to reduce personnel dose during the infusion procedure, item 7 of the radioactive material license appilcation dated April 20, 1983 states that the Radioisotope Comittee regulates the use of all radioactive material on the UMONJ campus. (latest revision dated November 5The C m l radiotherapy pr raa trotocol 1987 was ap > roved b Comittee. Item 7A of the Day 2 pr,ocedur)es of ttis prot col requires thatthe tedioisot no dose be administered without the presence of the attendino r5ysician, the Radiation Safety Officer and a quantities of radioactive malertal (person authorized to handle large the inspection a nuclear medicine physician). port container,to the IV bag intended for use during the pr At this point the procedure was delayed pending the completion of some additional, medical tests on the patient and the arrival of a attending physician. The RSO and the ins)ector then returned to the RSO's office to continue record review during tie interim. The RSO left Instructions that

18 he was to be called before the administration of radioactive material began. Later the RSO contacted a member of his staff to determine how much longer tbe procedure would be delayed. The RSO was then advised that the infusion of radioactive material had just been completed. The RSO and the inspector immediately went to the floor on which t te patient was being treated. The RSO confirmed the procedure had been completed. The RS0 asked the attending p sician why the procedure was carried without the RS0 being present. The p sician stated that he assumed that all the arrange-ments sad been comple for the procedure. The R$0 pointed out to the physician and to the inspector a form used to doc uent all such procedures which required the RSO's signature before administering radioactive mater-tal to a patient. The appropriate place for the R$0's signature on the form for this particular procedure was blank. The failure of the licensee to use radioactive material in accordance with the statements, representa-tions and procedures contained in the application dated April 20, 1983 is an apparent violation of License Condition 21. During tours of the nuclear medicine and research areas where is radioactive material used the inspector found no evidence of radiation workers or other persons e,ating, drinking, or smoking in these areas. While visiting an unoccupied laboratory where radioactive material is used and stored, the RSO was observed confiscating a coffee cup found in the immediate vicinity of a radioactive material use area. 13. Speci_al Tests and Physical Inventories 4 The licensee receives technetium 99m doses and is not required to perform m(olybdenum 9Tc 99m) for medical uses in u breakthrough assays prior to administration of the Tc 99m to patient A review of dose calibrator records revealed tha daily constancy checks and annubl calibrations of the dose calibrators in the LM)NJ and CMI Huclear Medicine Departments were performed as required, item 10 of the radioactive material license appilcation dated April 20, 1983, states that dose calibrators will be tested for linearity in accordance with the procedures contained in Appendix 0 of Regulatory Guide 10.8, ' Guide for the Prekaration of Applications for Medical Programs revision 1. Item E of t is appendix describes the test procedure thal is to be used to assure that the dose calibrator is responding linearly over the entire range of activities that it is used to assa. The linearity test is to use a vial of Tc-99m whose activity is e alent to the maximum anticipated activity to be assayed. Review of the Nuclear Medicine Department dose calibrator linearity test records revealed that linearity tests were performed with a maximum quantity oif about 10 millicuries of t Tc 99m. ?.s was noted above the dose calibrator is regularly used for the oC1.y oi 1 131 tagged monocional antibody therapy doses ranging up to 200 l assa ihe failure to test the dose calibrator for linearity with a quantity l l t ~ - - -, - - - -

e 19 of radioactive material equivalent to the maximum activity assayed is an apparent violation of License 21. Interview with the CMil Chief Nuclear Medicine Technologist indicated that he had written a new using a computer program to perform the calculations used to evaluate dose calibrator linearity. A review of the CMf! dose calibrator linearity tests records revealed that the data was not laid in a format where calculated values, measured values could be found so that the linearity test data c,ould be verified andand elapsed decay validated. The Chief Nuclear Medicine Technologist was unsuccessful in his attempts to exolain the test data to the inspector and to the RSO. The inspector advised the RSO that the failure to test the dose calibrator in accordance with the procedure in Iten E, Appendix 0 of Reg Guide 10.8 is an apparent violation of License Condition 21. The RSO was advised that the-licensee could submit an alternate dose calibrator linearity detersination method to the NRC for evaluation. A review of the LMDNJ records also revealed that the Nuclear Medicine Department dose calibrator linearity tests records for 1987 and the first quarter of 1988 were missing at the time of the inspection. The failure to maintain dese calibrator linearity tests records for 1987 and the second quarter of 19PS is an apparent violation of License Condition 21. Condition 12 of License 29 02957-13 requires that sealed sources possessed under the broad radioactive material license be tested for leakage and that the test for leakage be capable of detectina 0 removable activity. License Condition 12 also r.005 microcurie (uti) of equires that the results of these leak tests be recorded in units of uti. A review of sealed source leak tests records revealed that there was no documentation to show that the leak test performed on sealed sources was capable of detecting 0.005 uti of removable activity. recorded in units of cpm. Results of sealed source leak tests were these results were less than 0.005 uti.No evaluation had been performed to assure that The failure to conduct sealed source leak tests as required is an apparent violation of License Condition 12. Condition 13 of License 29 02957 14 requires that irradiator scaled sources be tested for leakage and that the test for leakage be capable of detecting 0.05 microcurie requires that the(uti) of removable activity. License Condition 12 also results of these leak tests be recorded in units of uCf. A review of irradiator sealed source leak tests records revealed that there was no documentation to show that the leak test performed on the irradiator Results of sealed source leak tests were recorded in units o No evaluation had been performed to assure that these results were less than 0.05 uCt. The failure to conduct irradiator sealed source led tests as required is an appcrent violation of License Condition 13.

20 Review of records revealed that the licensee performs $ysical inventories of sealed sources at the required frequency and that tle records of these inventories listed all necessary information.

14. Misadministrations A misadministration of Tc 99m was reported at the LSOU hospital on Febru-ary 26, 1988.

A physician ordered a bone scan for the wrong patient. In patient received th(HOP)llowing doses:accordance Tc 99#oxidronate a skeletal As a result, the e fo Body Organ Dose (rads)* Bladder Wall 4.8 (assuming 2.6 hour void) 2.6 Gonads (male) 0.22(assuming 4.8 hour void) Bone Marrow 0.56 Whole Body 0.13 These doses were calculated using information provided in the radiopharma-ceutical manufacturer's package insert. Previous to this occurrence, the technologists would proceed with pre-scribed studies after reviewing the procedure requisitW cly. The licensee modified the Nuclear Medicine Department procedura to require that the Nuclear Medicine Technologists review a patient's chart prior to physician has entered written orders for the study into the pa

chart, if the patient's chart does not have written orders the technol-ogists are instructed not to proceed with any nuclear medic}ne

)rocedure until the attending physician has been cor+ acted and the chart ias been amended. be complete.The licensee's investigation and corrective actions were found to No violations of NRC rules, regulations, or license conditions were identified. 15. Posting and Other Requirements Copies of Forn NRC 3, Notice to Employees', and a notice detailing where copies of 10 CFR Parts 19 and 20 the radioactive material license, and other relevant documents were ava,ilable for review were posted at all the licensee's facilities. .i list of the names and telephone numbers of persons to be contacted he event of an incident involving radioactive material was posted in are-wiere radioactive saterial is stored and used, i

21 No violations of NRC rules, regulations, or license conditions were identified. 16. Exit Interview at the conclusion of the inspection on June 2,1988.The inspect findings of the inspection were susunarized. The scope and 1 i l l t

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vus essent No.. AR A coos i 2 01 29-02957-13

4. INDIVIDU AL USE RS Plan sade'#was =^* =>ll we or erecur E R ADI ATION SAFETY OFFICER (RSO)(Neme e/ person arspiens

,,oer,., a e reo a.cu,e menne. cswa n swoomats A eas a ,,,a.ere u er, erra, or ena e, m asa, m.,, n r r per ear > eer, ewe ) me of enn,as aw asoeren a e V: aAI This application is for renewal of a Type B Specific License of Mr. George Govelitz Broad Scope. 6A R ADtOACTIVE MATERIAL FOR MEDICAL USE M A XIMUM M A Rl( M AXIMUM ITEMS POSSE S$10N ITEMS POSSE SSION ADDITIONAL ITEMS: De sir g o U MITS A.AOIDACTIVE M ATE RI A L DESIRED LIMir$ LiS TE D iN: ,~x~ tin mu.cu ent ~x" fra nutt><vresi r IODINE.131 AS 60DIDE FOR TRE ATMENT to CFR 31.11 FOR IN VITRO STUDIES OF HYPERTHYROIDISV to CFR 2100. SCHEDULE A, GROUP I AS NEE DE D PHOSPHORUS.32 AS sot.UBLE PHOSPH ATE FOR TRE ATMENT OF POLYCYTHEMIA 10 CF R 2100. SCHEDULE A. GROUP 11 AS NEE DED PHOSPHORUS 32 AS COLLOIDAL CHROMIC PHQ$PH ATE FOR INTRACAVITARY THE AT. 10 CF R 3100, SCHE DULI A. GROUP 111 MENT OF MALIGN ANT E FFUSIONS GOLD 198 AS COLLOID FOR INTPLA. sf0Ns 10 CF R 35.100,5CHE DUL1 A GROUP IV AS NEEDE D gpp CDINE.131 AS lODIDE FOR TRE ATMENT 10 CF R 31b.100 SCHEDUL1 A. GROUP V ASNEEDED OF THYRotD CARCINOMA X E NON 133 AS C AS OR C AS IN S ALINE FOR 10 CF R 5.100 SCHEDULI A. GROUP VI SLOOO FLOW STUDIES AND PULMONARY FUNCTION STUDtES 6 b. R ADIOA CTIVE MATERIAL FOR U$ES NOT LISTED IN ITEM 6.a. Isandseanna w = 2.< =<sor eer.sc,,,e oas re e,e.ar nanovos are e.uner.r** uader s*< sea 2s utos, to cra ran 25. *w utto uor or us rioJ r CH E MIC A L M A XIMUM NUMat R E La MEN 3 AND uaSS Nte.astR ,JNj'(ca 0,7,M,lgCgsj of SCRioE puRPOst or uSE y, See attached application for radioac.ive material possession l imits listed in Items 6. n. and 6.b. 8706020060 670227 REG 1 LIC30 29-02957-13 POR I I ov a C 8 C " W 313 W ..n cJ n o r f hin n 'A'$ p. le ssi ) fvvu

l lNF )ATION REQUIRED FOR ITEMS 7 THROI h Fce itams 7 theough 23 check the appr priate box (es) and mbmit a detailed description of all the requested informati n. Begin each.t ern on a seperate sheet. Identrf y the item number and the date cf the application in the lower right corner tf each page. If you reicate that an appendix to the medical licensing guide will be followed, do not mbml} the pages, but specif y the rev' ion s number and date of the referenced guide: Reguistory Guide 10.8 , R ev. Date:

15. GENER AL RULES FOR THE SAFE USE OF 7 MEDICAL ISOTOPES COMMITTEE R ADIOACTIVE MATERI AL (Check Onel mmes and Specialties Attached; and X

Appendix G Rules Followed;or x Duties es in Appendia B; or Equivalent Rules Attached X (Check One) Eauivalent Duties Attachd

16. EMERGENCY PROCEDURES (Check Onel Appendix H Procedures Followed; or

8. TR AINING AND EXPERIEN::E x

Supplemerits A & S Attached for Each Individual User; Equivalent Procedures Attached Supplement A Attached for RSO.

17. AREA SURVEY PROCEDURES (Check Onel

9. INSTRUMENTATION (Check One)

Appendix I Procedures Followed;or Appendix C Form Attached;or Equivelsnt Procedures Attached List by Name and Model Number

18. WASTE DISPOSAL (Check Onel

10. C.All8R ATION OF INSTRUMENTS Appendix J Form Attached;or X

Appendiz D Proctdures Followed for Survey Equivalent Information Attached x instru ments; or /Cheet 0.v/ HARMCEWICm EauNalent Procedures Attached;and 19. x (Check Onel Appendix D Frocedures Folic.wed 6r Dose Appendix K Procefures Followed;or x Calitrator ; or x (Check O.v) Equivalent Proccdures Attached Equivalent Proceduras Attached

11. F ACILITIES AND EQUIPMENT

20. THERAPEUTIC USE OF SEALED SOURCES 1

Desoiption and Diagrem Attached Detailed information Attached;and X

12. PE RSONNEL TRAINING PROGR AM X

Appendix L Procedures Followed;or (Check One) Description of Trehh Attached Equivalent Procedures Attached 13' PROCE JURES FOR ORDERING AND REC 51VING PROCEDURES AND PRECAUTIONS FOR USE OF RADIO ACTIVE MATERI AL Ila R ADIO ACTIVE GASES te.g., Xenon - 133) { Detalleiinformebon Attached X Detailed information Attached g PROCED'JRES FOR SAFELY OPENING PACKAGES

22. PROCEDURES AND PRECAUTIONS FOR USE OF 14.

CON TAINING RADIOACTIVE MATERIALS RADIOACTIVE MATERIAL IN ANIMALS (Check Owl Detailed information Attached X PROCEDURES AND PRECAUTIONS FOR USE OF Appendia F Procedsres Followed;o'

23. RADIOACTIVE MATERIAL SPECIFIED IN ITEM 6 b Equivalent Procedures Attached Detailed info'mation Attached ev a c 8 C a u 213u l

ts en Page2

1

24. PE R50NNE L MONITORING OEVICES Tvrt sue 9 LIE R EXCHANGE FREQUENCY ICsot a aco'co* * *** I x

Siemens Gammasonics Inc. Each month

e. vnaoL E soov of ut a tsseo41 FILW

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x Siemens Gammasonics Inc. Each month oTMta13arofr/ PILW c wml5T TL D of mt n Ispeci41

6. oTH E R 150et/vl Wallet TLD cards are supplied to support personnel and are exchanged yearly or whenever personal exposure is suspected.

The Radiation Safety Office maintains a variety of direct reading dosimeters for use by personnel using penetrating radiation.

25. FOR PRIVATE PRACTICE APPUCANTS ONLY

~ g MQ$PITAL AGatt:NG TO ACCEPT P ATt1NTS CONT AINING R AOiOACTIVE M A1141 AL % aut OF MosPIT AL tk A1T ACH A COPY OF THE AGREEMENT LETTE R SIGNE O SY THE HOSPITAL ADMINISTRATOR. " ' '

• O ^ D 0 "' 8 8

s. veutN REQUESTING THER APY PROCEOURES, ATT?CH A COPY OF R AOIATION SAFETY PRECAU-l8'A'E ltiPcoot flONS TO BE TAKEN AND LIST AVAILABLE cit v R ADI ATION DE TECTION INSTRUtdENTS.

26. CERTIFICATE (This irrm must be completed by applicart)

Two.pos.une sad eae of f.<*a esecutias this certificate on teheat of the sept.csat aemed m lesra le cwtity that the asetuten 6e propened sa seafo:mety onth inte 10, Coos of f ederel Regulations, Parto 30 W 35, and that sin saformeiea esatesmed heema, saceud.ag eay swoole< wets seg.ched hereto, e true and te*Mst to the best of ov' hW *ad beinf. b APPLI TOR RTIF YlNG OF FICI AL I!ar*4,*/

• )

e LiCEN54 FEE REQUIREO Me de-4'J t$re $rree 910 21,10 CFM 1101 s t, n a u g t rype.g p,,,,; % ErichHirschberg,Ph.D. ,i, LICE Nst # E E CAtE coRv Associate Dean, Office of License fee not required Recemh & Srensored Progrrri g QATE i;. LtCENSE #EE E%ClostD 8 Aprii pg_ 1993 Nmc # Omu 313V 19 818 p

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W Pb. 02 j Pursuan: to the Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974 (Public Law 93-438), and Tit I Code of Federal Regulations, Chapter 1, Parts 30,31,32,33,34,35. 40 and 70, and in reliance on statements and repres her:tofore rnade by the bcensee, a bcense is hereby issued si ',horizmg the licensee to receive, acquire, possess,and source, and special nuclear material designated below; to use such material for the purpose (s) snd at the place (s) design 1 i j l deliver or transfer such matenal to persons authonzed to receive it in accordance with the regulations of the appbcable Pa I Lcense shal! be deemed to contain the conditions specified m Section 183 of the Atomic Energy Act of 1954, as amended, an I i subject to s applicable rules, regulations and orders of the Nuclear Regulatory Commission now or hereafter in effe 'l conditions specified below. I s I Ucme In acuerdenen with letter detal Phry 25,1983 l.colleae of Medicine and I j

3. Ucense number 2>029511-14 is amended in l

Tentistry of New Jersey its entirety to rund as follows: l 12 0 - Feene Jersey Medical Sdcol f u oO ,.n t o Plenzt, ame Jersey 07103 l

4. Eipirnba'n dah Saf***'ar 30,192 l

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5. Docket or Reforence No.,7..

g si

6. Byproduct. source, and/or f', '

7. Chemical and/or physical I 8'. Muirnum enount that licenaec l

special nuclear material form may possess at any one tirne I under this licenae I ~ l A. tMe 137 A.

• WM:D % CPMi'4t. sealed A.

Che source of I ecnaree 400 an-ies I I 9. Auti 1 zed use 'I A. Por noe in an Isamlix casureta 704-1 irradiatar flor the irradiatico l of reteriale (except explosives and hichly flarmable retarials). I 'l CDqCaraars. s 10 Licensed Peterial aball be uned only at colloos of Medicine aM Dentistry of I ( ' lev Jerse/, t?T - rew Jersey Mor*1 cal edeel,, im kroen street, Nark, M Jersey. I l i 11. "be licensee are11 ctry1v with the provisicos of Title 10, ovqter 1, Ctde ~j of Feiocral Pemlatiere, Dart 19, "rbt. ices, Instzuctler6s aM pepcrts to i Nteerst Inspecticce" an* Part '20, *8 tan. tarde fcr Protectico h;minst Padiaticn." l il 12. 1.ioeneeo ruterial she11 re tusa* by, er urr'er the surcrvisico of, iniividuals -l desic rated h* the Mc'leisotew (trrdttee. I I l l l I I I I I I I I I I I I .I ll l t 2

$UPPLEMENT ARY SHEET 1 W 9>. W I l l l l 'czzrt t r==='l) l I me semise mus== essenesens' Geenssa esterial stall to tested Bar lanlage l 13. A 6 at 2Mhergets aut'es emaged ste %diment'Beh Jeemamme' < - l m t ame/ar et a sustiftsmes esem a W BM Wadi e tagreestgum guer '.- inttda mis sumate pier to ed tamander, a senlad essren 9theBee Gulen j I ' - yogas esmil est he gut late juur.=nen er ^ ^ - l .m. ~- .v I A ~. Sam tout heal to angete of N,_ _ _ - ef 94 g6seuemate * ( I stall to tafian ihan / red asutsutenkaan em ter des cualad asures la l of them "'^ ..e m,, A M :- er naise east I er I in antas of =d e asse ear i seemite ses11 to a.. es <3+ U l

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-r, , L cenne : l .-qye es - "" N,..a... c.y.-- -.- .. p ' c. ' 1f b ei test ' M of ESB adereuer$e 46 et giumpueble l ~ acutardnaticr4 'We '1 din 11 humediately @ the amat=d accree I er to be' I frem use and 'JDall emme4 46 he Amrw=**meredd'4rd A stall be I AtW of in accerthindh e 'M @*rmis. filed within 5 days of ttie test in tem,' l I piegim I, office of hopectlen ard Iktfbrumment, 631 Pad, m, King of Prussia, Pomerivania 1Mos, ammaihing e..pireent imetsed, the test i i results, me the -- r tve not.km h I i feets fcr lanhage ard/or ecritasilriettarzt em11 be par *wmad hy the licensee I " ,I D. __2 or bf other persons WhW aartterized W the Manim w an I, ( state to p % anut services. j 11sta stall be blioed I 14ritten irstnetims prairided by the espplier of the im 2 l n 14. and a copy of these inetmet.Lcre chall be rode available to.sech irdivi&al i using or having routcrmIbility fcr use of lin=naai metarial. Arty etengine in ,3 1. these irwtructicrw dall have the pr6cr approual cd the Mitarial Licensing il l f(! l Ba..1, Divisim of Fuel Cycle ard Ptrtarial Safety, U.S. Ibcdear Regniatory l !g ( Ocymimeien. j II 3! 5 'the licensee is authcrized to WL reintenance ard repair of the unit ddch 4 I I pupiaciment and M W ,[ 1. aces not imolve are.ure of the o.alea ocurce. or.e.se1.e d.u he m mw w specm aur th-i.ed l y s' ty en ocmsissim cr an igrosaare state to wL such services. ' l II t}

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Uv e h M M + o&* 4IvuJu APPENDIX g gg lbj Documentation Quality control checklist Where located

• lInsp l Conf l Draft lDraf t l Cover l l

Information h I Rept i Nov i Ltr IMemo 10ther i I i l i l l B.1. What was the requirement and, l l l J l l l if the requirement was l j j / / ll conditional, how were the l l l l l l conditions satisfied which made l l l l l l l l l l the requirement applicable? 1 I l l l l l l l l l l l 1 8.2. How the requirement was l j ll l jl l l l violated? 1 l l l l l 1 l 1 B.'3. When the requirement was /ll l l l l / ll l violated and what was the l l l-l l / l l l l duration of the violation? J l l l l J l 8.4. Who caused the violat!on? I l l l ] B.S. How and by whom (be specific) l [ l h l l l was the violation discovered? 1 l l 1 l l l 1 l l i l l l B.6. Was the violation required to l l l l l l l be reported and, if so, what l g l l l l l l was the applicable reporting l l l l l l l requirement? j i l l l l l l is so, when and by whom was it lj,1 I i l i I B.7. Was the violation reported and, I j l l l l l l l l l l l reported? 1 1 l l l l l B.8. If the violation was reported. l l l l l but the report was late, why was l l l l l l l the report late? ] l l l l l l B.9. Was the report complete and !l accurate? l l l I l l l l l l l l / ll / l B.10. Were there multiple examples l l of the violation? j 1 l l l l "Place an "X" in the appropriate column (s) or N/A if the issue is applicable to the case. When an issue is N/A'd, the supporting documentation will support the conclusion that the issue is not applicable.

e Where_ Located

• s.

lInsp l Conf l Draft lDraf t l Cover l l Information M l Rept l Nov i Ltr IMemo 10ther I I I l l l l B.11. What was the apparent root l l l l l l cause and contributing casual l l l l [1l / ll factors for the violation? l l 1 1 l l l i l i l l l B.12. Describe any facts and i l l l l l l,/ circumstances that address the l l l l l l l'M ll aspects of negligence, careless l l l l l l l disregard, w111 fulness and l l l l l lgj management involvement. J l l l l gj l 1 l I l I i i B.13. Was there economic or other l l l l l l fluj personal or corporate gain l l l l l l associated with the violation? J l l 1 l l dpp[l l i I I I I I B.14. What were the opportunities l /t l l l l l and when did they exist for l l l l licensee staff and management l l l l l l / ) y/ ll to be aware of the violation? I I l l l l l l l l l l l 1 l B.15. What were the circumstances l l l l l l l surrounding the violation, such l l l l fl l l as system configuration and l l l l ) j l l operational conditions for l l l' l l/ l l reactor cases, which effect the l l l l l l l significance of the viol: tion? I l l l 1 l l B.16. Is the violation indicative of l l l s/ ll /l f programmatic problems or is it l l l l an isolated case? l l J l 1 l l 1 l l 1 l l l l B.17. What short term corrective and l /l l l l l l remedial action was taken and l \\/ l l l l l l when was it taken? I i l l l l l 1 / I i l i i B.18. Did NRC have to intervene to l l l l accompitsh satisfactory short l l l l l [l l term correction and remedial l l l l l t/l l l action? I l l l l _ 1 l l l l l I l B.19. Were there previous similar NRC l .l l l l l l inspection or licensee audit l l l l l l l findings and, if so, should the l l l l l l l corrective actions from those l l l l l l l findings have prevented this l l l l l l l violation? 1 I I l l l l 2

Where Located

• Information

!!ns; l Conf l Draf tl Draft l Cover l l M _1 Rept l Nov I Ltr IMemo 10ther I i i l i j C.1. List the enforcement conference l l l l l -l W, yl D attendees from the NRC and l l l l l l '^ j g licensee. J l l l l l Ter I I I I I I l

• C.2.

Describe additions or l l l l l l l corrections to the factual l l l l l l l information in the inspection l l l l l l l report. 1 I I l l l l C.3. If the Itcensee takes issue with l l l l l @hN the violations, describe the l l l l l l v (f / licensee position. J l 1 1 I l Mf I i l l I l l C.4. Describe any additional l l l l l l l information which effects the l l l l regulatory or safety l l l l /,) d l l significance of each violation. ] l l l l l l l l l 1 1 I I I l l C.S. Describe any additional l l l l l l l information on correction and l l l l l J l remedial actions the licensee l l l l /l has implemented has committed l l l l t/ 1 fll l to implement. l J l l l l l l i i l i i i 3 D.1. A concise, clear statement of l l l l l l l the requirement appropriately l l l l l l l referenced, paraphrased or l l l l l l l quoted. J l 1 l 1 l l 1 1 I i l l l D.2. A brief statement of the l l l l l l l circumstances of the violation l l l l l l l including the dates of the violation and the facts necessaryll l l l l l l / ll l l l to demonstrate that one or more l l l l l l l l elements of the requirements werel l l l l l l not met. I l l l l l l l i i i 0.3 The severity level proposed for l l l l f lll [lll l the violation, l j l l l l D.4 The civil penalty proposed for the violation. l l l/ l l ] l l 1 /l l l l l l 1 /I I I E.1. When, where, and by whom an l l l l j j l l inspection was conducted. ] l l l l 1 l 3

Where located

• lInsp l Conf l Draft l Draft l Cover l l

Information JRept _l Rept l Nov I Ltr IMemo 10ther I i l i /l l l E.2. When and where an enforcement l l l l G ll l l conference was conducted and l l l l l l who were the lead NRC and l l l l l l l licensee representatives. J l l l l 1 l 1 1 I i l l l E.3 When reports of the inspection l l l l fl l l and enforcement conference l l l l / l l l results were provided to the l l l l l l l licensee. 1 I I l l l l l l l l l l l E.4 A description of the violations. l l l l l l l including who identified the l l l l l } l violations, and t5e apparent l l l l l l l root cause of the violations, l l l l 'l l l and any other major attributes ofl l l l l l l the violations necessary to l l l l l l l support the safety and regulatory l l l l l l l significance of the violations. J l l l l l l l l l l I I E.5. A statement of the results l l l l l l l which we expect to achieve l l l l l l l through issuance of the l l l l l l l proposed enfercement action l l l l / ll' l l focusing en correction of the l l l l l underlying problems disclosed l l l l l l l by the violation. l l l t l l l l l l 1 1 I I E.6. A description of the proposed l l l l l 1 l enforcement sanctions including l l l l /l l l severity level and civil penalty l l l lV l l l valve. J l l l l l l 1 l l l l l l E.7. An analysis of any factors which l l l l l l l caused the severity level to be l l l l l /{ l dif ferent from the normal l l l l l ylll l severity level for the type of I l l l l l involved violations, for example,l l l l l l programmatic aspects, or l l l l l l l willfulness. 1 l l l l 1 l l l l l l l E.8. An analysis of any factors which l l l' l caused the civil penalty valve l l l l /l l l l l l to be different than the base l l l l J l l l valve for that severity level l l l l l l l violation. J l l 1 l 1 l 1

Where Located

• lInsp l Conf l Draft lDraf t l Cover l l

l Information JRept Rept l Nov ' Ltr IMemo 10ther F.1. The Enforcement Action (EA) l l /h l l number. 1 l l 1 l l l l lVll l F.2. The referenced inspection l report numbers. 1 l l J l F.3. A summary of the nature of l l l h l l l the violation (s). l l l l F.4. A summary of the root l l l /l cause(s)/ problem area (s) l l l l l l represented by the violation (s). J l l l l l l 1 1 I I l l l F.5. A description of the regulatory l l l l l l l and Technical Safety significance l l l l l l l of the violation (s)/ problem l l l l l /ll l area (s), including l l l l l l considerations such as l l l l l / ll l l opnational configuration, l l l l l supervision / management l l l l l l l involvement and willfulness. l l l l l l 1 I I I l l l F.6. A description of the purpose of l l l l j lll /lll l the enforcement action and the l l l l l message we intend to send to the l l l l l licensee and industry. I l l l 1 l 1 1 I i l F.7. A description of the rationale l l j l l l l for the recommended severity l l l l l l l 1evel and grouping of the l l l l l /ll l violations including reference l l l 3 fl l to the relevant sections of the l l l l /l/ l l Enforcement Policy and OE l l l l l i l guidance and prior EA's. I l l l 1 l l 1 1 I i l l l F.8 A description of the rationale l l l l l l l for the recomended civil l l l l l l l penalty addressing all five l l l l l l l Enforcement Policy escalation and mitigation factors as well esl l l l j l l l t l l l l l l duration, willfulness, ability tol l 1 l l l l pay, and prior EA's which are l l l l l l l similar. J l l l l l 1 I l l 5

Where Located

• lInsp l Conf I Draft l Draft l Cover l l

Information LRepj l Rept l Nov l Ltr IMere 10ther e i l l l l l l F.9 An analysis of the licensee's l l l l l l l position on any aspect of the l l l l l l l violations or application of l l l l l l gy,IIl g y l the Enforcement Policy to l l l l l (e ; (,/[l,I those violations which is in l l l l l l substantial disagreement with l l l l l l the regional proposal. 1 l l l l 1 1 I I I l l l F.30 The Regional Counsel's view of l l l l l l,j. l the legal aspects and l l l l l l ris l l p., (jl!,' f, / risk associated with the l l l l l proposed action and the l l l l l l4 lj) g advisability of OGC review of l l l l l l ( gp! the proposed action. 1 l l l 1 o I i l i i l l F.11 Any other regulatory framework l l l l l l l factors that need to be l l l l l l l considered in review of the l l l l l l l case; such as, pending licensing l l l l l l l 1ssuance or renewal action, and l l l l l l l commission meetings. J l _l l l l ? i 5 (

L= = cm w e 29-02957-13 l MATERIALS LICENSE i i %,y, SUPPLEMENT ARY SHEET 030-09926 I l Amen &ent No.15 's{. (12. continued) CONDITIONS I gr I I l' (3) Notwithstanding the periodic leak test required by this condition, any I licensed sealed source or detector ceil is exempt from such leak tests i l when the source or detector cell contains 100 microcuries or less of beta i g and/or gama emitting materials or 10 microcuries or less of alpha 1 i emitting material. I d 1 I (4) Except for alpha sources, the periodic leak test required by this condi-j I tion does not apply to sealed sources that are stored and not being used, i l-Thesourcesexceptedfromthisitysti.3halNgtestedforleakagebefore i within 6 months before b(d'date of use or transfer.any use or transfer to an theY vers l e I l t' l Eachsealedsource%y g f., detector cell fabricated by theslicensee shall be l 1: B. l inspected and tested for construction defects, leakage..,and contamination p prior to use or.transfe,r as a sealed source or detector"cell. If the 3 a e inspection or test reveals. any construction defects or 0.005 microcurie i I or greater of contamina40n, the source shall not be used or transferred 8 I as a sealed source or detector cellauntil'it has been repaired, decontami-I [ nated and retested. $ %! / \\( l Each sealed source containNng 11Nnsed mater,ial, other than hydrogen 3, ~ C. 4 withahalf-lifegreaterthan.30fdaysandinanyformotherthangas 1 4l shall be tested fordeakage and/or conta:ntnation at intervals not to 8 i exceed 6 renths'excepthhat each' source designed for the', purpose of l y[t emitting alpha' particles shallytes*.ed at. intervals tjot to exceed 3 months. f E 0. The test shall be capable of detecting the presence of 0.005 microcurie F l of radioactive material on the test sample. The test sample shall be [i taken from the sealed

• source or detector cell or from the surfaces of the f

l device in which the sealed source or, detector cell is permanently or i l g! semipermanently inounted or stored on which one might expect contamination ) g I to accumulate. Records of leak test results shall be kept in units of I Il microcuries and maintained for inspection by the ConTeission. Records may I l I be disposed of following Comission inspection. ( E. If the test required by Subsection A. or C. of this condition reveals the [ I! presence of 0.005 microcurie or ciora of removable contamination, the I icensee shall imediately withdraw the sealed source or detector cell i ( I; fl rom use and shall cause it to be decontamir.ated and repaired or to be 3 t i 8 li disposed of in accordance with Comission regulations. A report shall be h filed within 5 days of the date the leak test result is known with the l' L. S. Nuclear Regulatory Comission, Region I, ATTN: Chief. Nuclear Il N terials Safety and Safeguards Branch, 631 Park Avenue, King of Prussia, i l lj Peinsylvania 19406, describing the equipment involved, the test results, I [ and the corrective action taken. j r I! M II I t; 1 41;Cryxi r2r w:g;7;r:iiv-{+Ecry.sv:,ww2r3vsv.tMMCO_ tin:+f w++1+W(( l l L

g. n a-r2.-a r=wrs a w rw rac. - - - - - = =... - - -...... .. m.., p"e,. n or, u s wuct:4a catuwoav ecumussia 6 6 ,m o, ,un Li iS ucco...w, MATERIALS LICENSE 9-02957-13 SUPPLEMENTARY SHEET O 09926 k Amendment No. 15 i 1 (Continued) CONDITIONS I l 21. Except as specifically provided otherwise in this license, the licensee shall conduct its program in accordance with the statements, representations, and ) procedures contained in the documents including any enclosures, listed below.

)

) l The Nuclear Regulatory Comission's regulations shall govern unless the state-I ments, representations and procedures in the licensee's application and corre-I spondence are more restrictive than the regulations. l I A. Application dated April 20, 1983 including ALARA Program l l B. Letter dated April 20,1983 - p* [{ { g (/,. t 31, 198,4 #- i C. Letter dated August F I 0. Letter dated July 24,'}986 P-I E. Letter dated September 24, 1986 } } F. Letter dated January 27, 1987 i G. Letter dated July 6,1987 i H. Letter dated September.9,1987 l 1. Letter dated October 8,1987 1, ,..g. I hY j 4a _s g. 1 y; j 7p y, - )$ ll]lh-f]I 1 N >d l i + j/ Fl N 1 el j 1 1 I h l' 1} Lf 1 [ t l 2 [ t 1 l For the U.S. Nuclear Regulatory Comission I I Original Sisned Py 2 N0V 1987 sy s a. m. v. n u.a. l I Date l Nuclear Materials Safety and I Safeguards Branch, Region 1 j king of Prussia Pennsylvania 19406 6meumum.mmum-m:< arm- -J

)

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C. Training of Houcokosping Perconnel Housekeeping personnel receive a radiation safety training lecture as part of their orientation session at the time of hiring. The training lecture includes the subjects listed below: I. Presentation of appropriate warning signs and labels and their meaning II. Special cleaning procedures in hot labs III. Federal anc State regulatory guides and institutional responsibilities. D. Training of Nursing Staf f It is a requirement that the Radiation Saf ety Of fice be notified a minimum of forty-eight hours prior to the start of a radiotherapy a procedure involving sealed or unsealed sources of byproduct material. At the time of notification, the Radiation Safety Office shall ascertain in wh'ich room the radioactive patient shall be kept and which nurses will be attending the patient. The Radiation Safety t Office shall then meet with these individuals and instruct them l as to specific hazards associated with the case and the use of ( personal monitoring devices. j I i E i i 2t-l i ,,,-,-,_,,,--,,,_,_,,__.n_ ,e -n ,-.c- -_,._.,-.--n

) ) Itcm 23 procGduros and precautions for Uco of Rcdioactiva Material Specified in Item 6.b In addition to the procedures and precautions described in Item 10 through Item 22 above, the following safety programs have also been implemented. Bionssay Individuals using millicurie quantities of unsealed sources of l radionuclides are required to submit urine specimens for analysis j of possible ingested radioactive material. The frequency of monitoring l conforms with the recommendations contained in NRC Division of Fuel Cycle and Material Safety publication dated October 19, 1979," l "Guidelines for Dioassay Requirements for Tritium", and Regulatory l l Guide 8.20, "Applications of Bionssay for Iodine-125 and Iodine-131". Glove Box Requirements All individuals' handling unsealed sources of volatile radionuclides (e.g. inorganic radioiodine) or radioactive gases are required i to handle the material in a glove-box located in the Radiation Safety Office. This unit is completely scaled and exhausts through an activated charcoal filter capable of removing greater than 99% of the radionuclides present and discharges independently into the atmosphere. All incoming packages of radioactive gases or volatile radionuclides are kept in the Radiation Safety Office, rather than transferred to the licensee, to ensure this safety procedure is followed. ) ) Itcm 7 Dascription of Rsdiation Safoty CommittGo The Radiation Safety Committee regulates the acquisition and use of all sources of ionizing radiation at the University of Medicine and Dentistry of New Jersey (UMDNJ), Newark campus. The Human Use Subcommitteu cf the Radiation Safety Committee reviews and acts on all applictb.ons for licensure to perform routine and non-routine human uan diagnostic, therapeutic and clinical research procedures. The Human Use Subcommittee must unanimously approve an application before it is presented to the full Radiation Safety Committee for review. Membership on the Radiation Safety Committee and the Human Use Sub-committee is by appointment through the Office of the Associate Dee.n for Research and Sponsored programs, UMDNJ-New Jersey Medical School. The Committee derives its authority through that Office from the Dean of the USIDNJ-NJMS and the president of UlfDNJ. The Radiation Saf. Committee is es'tablished in conformance with the provisions of 10 CFR 33.14(b). The Human Use Subcommittee is established in conformance with the provisions contained in 10 CFR 35.11(b) and 21 CFR 361.1(c). The Human Use Subcommittee is being registered as a "Radioactive.. rug Research Committee" with the Food and Drug Administration, Bureau of Drugs. r The duties of the Radiation Safety Committee conform with those detailed in Appendix B, Regulatory Guide 10.8, Revised October 1980.

CMMI RADIOIMMUNOTHERAPY PROGRAM Day Pdo - Theraf, injection 1. Check ?4.hr. Sterility test A. If no growth appears on plate or in tube record on sterility sheet arid proceed with injection. B. If growth is present have it identified. 1. Set up repeat test 2. If the grow *.h is only contamination, recora results on sterility sheet and proceed with injection. 3. If growth is other than contamination have bacteriology set up culture and I.D. growth. cancel therapy injection. 4. If labeled antibody dose shows. growth other than contamination by poor technique you must send patient home untreated or delay the injection by one day and prepare another dose if isotope and antibody are available. 2. Prepare Patients Room 1. Bed is moved to location as f ar away f rom door and the beds of patienta in other rooms as possible. 2. Trash Cans with lids are placed inside patient's room. A. Cans are labeled 1. Radiation Hazard 2. Our Lab Name 3. phone and Beeper l's 4. Person's name to call in case of emergenc). B. One Can is for Lines C. One Can is for Trash D. Remove all other trash cans f rom room. E. Af ter dose is given nothing leaves patient's (([iationOncolog*>'*Pyic1[Y.* 8" U 'b N F. Place I.V. pole with lead shielding in room.

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a CMMI - RADIOIMMUNOTHERAPY PROGRAM Protocol for Day One - 24 hrs. Prior to Injection 1. Call admission office. A. Make sure patient has arrived before you label the antibody. B. If patient wished to remain as outpatient for day 1, have him/her contact you as early as possible. C. Do not label any dose until you are sure patient is here. 2. Collect all Medical Records or other information patient may have hand carried or mailed to the office and place in patient chart. A. Make copies for our files 3. Have patient sign consent form and medical information release form for each dose given. A. I copy is placed in patient's chart and I copy for our file (of the consent form). B. Be sure to have both copies of the consent form signed by the physician., 4 Label Antibody for Therapy Dose. A. See Labeling procedure in manual. 5. 24 Hr. Sterility Test on Labeled Antibody A. See 24 hr Sterility Test in manual 6. 24 Br. Skin Test Ai Skin testing is required before each therapy dose. 6 Patient is skin tested with the following... 1. Normal Control - NACL 2. In HSA 1

CMMI - RADIO!MMUNOTHERAPY PROG.AM 3. lilo, 1:100, 1:1000 dilutions of (unlabeled) free antibody. 4. 0.03 al of labeled antibody. C. Or as otherwise instructed by Dr. Goldenberg 7. Check to make sure all Dxs are testing completed before therapy injection. A. CT, L/S/CxR and Blood testa must be done since patient is isolated after injection. B. No blood should be sent to the lab after the injection, because the radioactivity will mess up the electronics of the lab machines. 1. If medical emergency requires blood to be testad, be sure the lab is notified and the specimen is labeled with a Radioactive Ha: ard sticker or tape. 8. Draw Blood for Antibody Testing and Tumor Markers A. 10 cc in red top tube to be tested for sensitivity to our lab. B. 5 cc in purple top tube for CEA and HeG C. 5 cc in red top tube for ATP Note: physician has an ordered for tumor marker, ot.her than CEA as pre-admissions, test do not have a repeat done, CEA is always drawn whether ordered by physician or not. 9. Check with physician if the patient may leave on pass for that evening if he/she request. A. he/she can not leave until all tests are completed.

CMMI - RADIOIMMUNOTHERAPY PROGRAM G. Blood Pressure cuf f and thermometer. H. Plastic basin (in case pt. should vomit.) 3. Patient Ready A. Must wear hospital gown or P.J's in case contami-nation occurs. B. Have I.V. started C. Pre medicated if needed D. Patient in prone position on bed in case adverse reactions occurs. 4. Contact physician, Rad. Safety Of ficer, Radiation Oncology Physic.i.st an'd Person t'o draw dose with time injection to take place lLast final check). S. Supplies for therapy Injection A. 2-250 ml I.V. Bags of NACL for low Dose, 1. 1 bag is hung and ready 100 m1 in cylinder to replace I.V. started by nurse or physician that morning. 2. I bag is hung and ready (100 ml) to replace therapy I.V. if adverse reaction should occur to insure clean I.V. for neds if needed. B. Disposable chucks ("diapers") 1. One is placed under the arm of the patient where I.V. is sited. 2. One is placed over work area where therapy dose will be placed. C. 3.V. pole with lead shielding 1. Af ter dose has been delivered to I.V. Cylinder, the cylinder is then placed into the shielding.

CMMI - RADIOIMMUNOTHERAPY PROGRAM D. Blood pressure cuff is placed on pt. arm. E. Thermometer Plastic basin 1. Used in case pt. should vomit G. Etoh pads H. 10 cc syringes if blood is to be drawn I. 23 g l' needles

1. used to start I.V.

J. 20 g 1" needles to inject dose into cylinder K. gauze and paper tape L. Purple top tubes for blood M. Red top tubes for blood N. Therapy injection Sheet 1. Anounts are filled in af ter the dose has been drawn. ( 2. Dosimeter read out is stapled to back of labeling sheet. 3. All comments and reactions are recorded on this ~ sheet. l l l l P. Gallon jug (plastic) for 24 urine, on ice. 6. Measure Therapy Dose of Radiolabeled Antibody. A. Dose is drawn in disposable syringe with 20 q l' needle and peasured on dosimeter with print out. B. Place in lead shielding. C. Normally techs do not draw therapy doses. ~

CMMI - RADIOIMMUNOTHERAPY PROGRAM D. Tech should be present during this procedure to record volume and activity. E. Transport dose to patient's room. 1. Take extra precaution on elevators and hallways as not to expose children and pregnant women. 7. Therapy Injection A. No dose is administered without the presence of the attending physician, the Radiation Safety Officer, and person authorized to handle large amounts of radioactive ms.terial and the tech. B. Authorized person injects dose into 100 ml of Mc.L using sterile technique. + C. All other persons remaining in room must stand distance of 10 ft. from pt. D. Dose is administered over I hr.

• 1.

Physician may inject partial dose into patient via cath, or port if so decide. This type of injection is done as ' push' directly from the syringe

• .o the cath, or port.

2. Tech remains with pt., others may leave. E. After cylinder is empty of dose it is refilled with 100 ml NACL to Rinse. f. When rinse is emptied the needle is removed from pt.'s arm an I.V. equipment is placed in lead shielding along with ' hot' material and transported to proper disposal area. C. Take blood pressure and temperature. 1. If normal, remove needle, clean work area, and remove any ' cold' waste f rom room, af ter clearance as per paragraph 2.2 E. I A. Instruct pt. and Nurse on 24 urine collection. i

c.,

make sure nurse understands, this is not to be sent to the hospital lab, but is to remain in pt, room on ice until our lab claimr it. l t i

CMMI - RADIOIMMUNOTHERAPY PR00 RAM b. Label urine jug with pt, name, file 6, therapy 4, date and hour; Radiation Hazard Warning tape, and a *Do Not Remove from Patient Room" warning. c. Patient continues to take Lugol's. Check order shee-2. If patient should have adverse reaction ( blood pressure up or down, temperature up, chills, rash, fever, '/cmiting, dizziness, low back nn, or chang.e in respiration) call the nurse ca And the physician. a. switch therapy IV to NACL. 1 b. discontinue therapy at physician request only. 1 = a 1 1 f i 1 1 4

2 special Safety Inspection No. 87-001 Violation - Condition 21, License No. 29-02957 Failure to possess muy 7, 1987 and use licensed radioactive material in accordance with the statements, representations and procedures in the license application. (Failure to ensure that persons receiving licensed radioactive material have received approval from the Radioisotopes Committee. 'i Er forcement Letter dated J.1y 7, 1987. - :stine Safety Inspection A:. 86-01 Violation - 10 CFR 20.201(b) - Failure to make adequate survey (evaluation) to J.1y 18 and July 22, 1986 ensure compliance with 10 CFR 20.101. Violation - Item 8, License No. 29-02957 Failure to ensure that licensee inventory of radioactive material does not exceed license-specified limits. Violation Condition 12, License No. 29-02957 Failure to ensure that irradiator operators were 4Dproved by the Radioisotopes Committee. Violation - Condition 16 License No. 29-02957 Failure to possess and use licensed radioactive material in accordance with the statements, representations and procedures in the license application. (Failure to ensure users of radioactive material were i approved by the Radioisotopes Committee. Failure to perform thyroid bioasssys in accordance with Rvg Guide 8.20) Open item - Licensee committed to develop carbon-14 urinalysis action limits and guidance for researchers using C-14 labeled organic compounds. E 'orcement Letter dated h:. ember 4,1986. Telephone cc :3unication acknowledging l':ensee's reply and requesting ac:itional information on Ce: ember 17, 1956.

..... a 3 Routine Inspection No. 84-01 October 5,16, 23, and Violation - Condition 16 License November 8,1984 No. 29-02957 Failure, to possess and use licensed radioactive material in accordance with the statements, representations and procedures in the license application. Failure to test dose calibrator accura (cy in accordance with Reg Guide 10.8, Failure to conduct laboratory area contamin at required frequency.) ation surveys Enforcement Letter dated October 4,1984 99999999900006099999980009999999999999999999 99899$$$399990e999993333e333333333 8 6 ) ,i 6) t' k i I. c z [ gi E 6 1

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\\ veniso TATS 4 I t NUCLEAR REQULATZRY COMMISSION ' h. AsoHm 479 ALLEN 0 ALE ACAD KING OF PMuBS4A PtNtWYLVANIA 1 Met JA i 91984 Docket No. 070 01718 License No. S W-1531 Decket No. 070-01718 EA 88-188 Shadyside Hospital ATTN: David T. Martin Vice President. Diagnostic and Therapeutic Services 5230 Centre Avenue littsburgh, Pennsylvania 15232 Gentlemen:

Subject:

Special Inspection No. 070-01718/87-001 On April 15, 1967, Mr. Lester Tripp of this office conducted a special safety inspection at Shadyside Hospital of activities authorized by NRC License Hunter SNM-1531. The inspection was an examination of your licensed activities as they relate to radiation safety and to compliance with the Consnission's regulations and the license conditions. The inspection consisted of observations by the inspector, interviews with personnel, and a selective examination of representative records as detailed in the enclosed inspection The findings of the inspection were discussed with yourself, Messrs, repo rt. Ralph Caputo and Ronald Scala, and Ms. ?eggy Gavenda at the conclusion of the inspection. Subsequent to the inspection, the NRC's Office of Investigations conducted an investigation of the circuinstances surrounding an apparent false statement stade to the NRC by Shadyside Hospital in a letter received by NRC Region I on January 2,1986. A synopsis of the report of this investigation is included as Enclosure 2 to this letter. On July 19, 1968, Mr. James H. Joyner of this office contacted you by telephone to discuss the results of the inspection. During the discussion, Mr. Joyner informed you that the appaunt violations identified during this inspection will be discussed at an Enforcement Conference at our office in King of Prussia, Pennsylvania et 11:00 a.m., Jwly 29, 1988. We understand that you will attend this snecting with merrters of your staff. You should be prepared to discuss the causes of these apparent violations and your proposed corrective actions. Enforcement action for these violations will be considered by the hRC following the Conference. i The NRC Enforcesent Policy is described in Appendix C of 10 CFR Part 2, a copy of which is enclosed for your infomation. Directions to the Region ! office are also enclosed. y E u f W $ O N f'

Shadyside Hospital 2 Your cooperation with us is appreciated. Sincerely, M '%~ len L. Sjobl Acting Director Division of Radiation safety and Safeguards

Enclosure:

1. MRC Region 1 Inspection Report No. 070-01718/87-001 2. Synopsis Report of Investigation, Case No. 1-87-012 3. 10 CFR Part 2 4. Directions to NRC Region ! Office cc: Public %vrent Room (w/ concurrences) Muclear Safety Information Center (NSIC) Comonwealth of Pennsylvania Ralph M. Caputo, Chairman, Radiation Safety Ccmittee

U.S. NUCLEAR REGULATORY CODNISSION REGION ! Report No. 070-01718/87-001 Docket No. 070 01718 License No. SNM-1531 Priority 7 Ca tegory K Licensee: Shadyside Hospital 5230 centru Avenue Pittsburgh Pennsylvania ITFTl Faciluy Nane: Shadyside Hospital .l Inspection At: Pittsburgh, Pennsylvania inspection Conducted: April 15,1987 Inspectors: dik ._ % M Y/9h Lester M. Tripp, Health)Pfysicist date signed Approved by 7 ! '[ Ahn E. Glenn, Chief date signed [ Nuclear Materials Safety Section B Inspection Sumary: Special, announced inspection on April 15. 1987 (Inspection ho. 070-01718/87-001). Areas Inspected: Special announced inspection to review circumstances associated with the failure to remove and properly dispose of a plutonium-238 powered pacemaker from a deceased patient. Results: Three apparent violations were identified: failure to notify the hiic, within 24 hours of occurrence, of the death of a nuclear pacer.aker patient; failure to recover a nuclear pacemaker from an expired patient and properly dispose of the pacemaker; and f ailure to perfom weekly telephone renitoring of l 4 patient irplanted with a nuclear pacemaker. l l l \\ l w'9 - w

1 OETAILS 1. Persons Contacted

• David Martin, Hospital Administrator l
• Ralph M. Caputo, Chairman, Radiation Safety Comittee l
• Ronald Scala, Consultant Physicist
• Peggy Gavenda, Head Nurse. Heart Station David Rigo, Funeral Director, McCabe Brothers Funeral Home Dave Allias, Senior Deputy Coroner, Allegheny County Coroner's Office Jerry McCabe, McCabe Brothers Funeral Home Linda Whigham, fomer Cardiovascular Technologist at Shadyside Hospital Dr. William B. Tuttle Cardiologist
• indicates those present at exit interview

===2. Background=== On October 16, 1986, Region I received telephone notification from Ronald Scala, Consultant Physicist to Shadyside Hospital, that a plutonium-238 powered pacemaker apparently had been disposed in the nomal trash. Mr. Scala was infomed that a written report should be filed with Region 1. The events surrounding the disposal of the pacemaker were sumarized in the licensee's letter to Region I dated November 18, 1986 signed by Ralph Caputo Chaiman, Shadyside Hospital Radiation Safety Comittee. This letter states: The plutonium powered pacemaker was manufactured by Arco Medical Products and was implanted at Shadyside Hospital on March 4,1976. The patient expired on December 18, 1985 and the hospital was made aware of his death on Decenter 20, 1985 when they attempted to set up a routine transtelephonic pacer analysis. 14 An esployee of the hospital called the Coroner's Office requesting that the pacemaker be removed. The employee also called Arco Medical Products, Philadelphia, Pennsylvania the manufacturer of the pacemaker, and inforred them that the pacemaker was at McCabe Brothers funeral Hme, Pittsburgh, Pennsylvania and confimed with McCabe Brothers Funeral Home that they would return the pacemaker when they received a package from ARCO. In January 1986, David Rigo. Funeral Director of McCabe Brothers Funeral Home called a physician associated with the hospital, and requested that he accept the pacer.aker. His request was refused. JL The "transtelephone pacer analysis" is described in Paragraph 5.c.

3 The plutonium pacemaker was thrown in the normal trash on August 31, 1987 by the Funeral Home. The trash from the Funeral Home is taken to a local landfill. 3. Allegheny County Coroner's Office The inspector visited Dave Allias, Senior Deputy Coroner of the Allegheny County Coroner's Office, on April 14, 1987. Revtew of the coroner's report revealed that the deceased had gone to a local restaurant for breakfast shortly after 6:00 a.m. on Decad er 21, 1985. He expired about 6:15 a.m. and was pronounced dead at 6:30 a.m. at the restaurant. A supplemental coroner's (autopsy) report stated that on December 21,1985 at 10:20 a.m. Shadyside Hospital was contacted and asked to provide information on the deceased, but the Hospital provided none. The report does not state what infomation was requested or who made or answered the call, nor does it mention a nuclear pacemaker. The supplemental autopsy report states that the autopsy consisted of an external examination of the deceased and notes the presence of a pennanent subcutaneous pacemaker below the lateral portion of the right clavicle. The cause of death was deemed to be atherosclerotic cardiovascular disease and carotid atherosclerosis. The Senior Deputy Coroner stated that the pacemaker was not removed from the deceased. The coroner's report contained no mention of the pacemaker being nuclear powered. 4 Shadyside Hospital On April 15, 1987 the inspector interviewed the Chaiman of the Shadyside Hospital Radiation Safety Comittee, the Consultant Physicist and the Head Nurse of the Heart Station, and reviewed records associated with the pacemaker program. The information obtained during these interviews is sumarized in Paragraph 5. Dr. William B. Tuttle, Cardiologist, was responsible for follow-up of nuclear pacemaker patients. In April,1987 Ralph Caputo was responsible for Radiation Safety at Shadyside Hospital, 5. Interviews a. Chairman, Radiation Safety Comittee (RSC) The Chairman of the Radiation Safety Comittee stated that there had been several personnel changes involving persons who were invohed with the nuclear pacemaker progran at the time of the incident under review. Two Assistant Administrators and the Cardiovascular tSchnolo. gist who were invoked in the progran are no longer with the Hospital. 1

4 b. Consultant Physicist The Consultant Physicist stated that he was not involved with the pacemaker program in December of 1985. He stated that the Chairman of the RSC, the Head Nurse of the Heart Station, and himself pieced together the sequence of events surrounding the disposal of the nuclear pacemaker from various notes in the patient's file. They approximated the date of death, resulting in an error in the report to the NRC. (The report places the date of death as Decem6er 18, 1985; the coroner's report states December 21, 1985 as the date of dea th). The physicist determined that the pacessker had been disposed to the normal trash through his discussions with personnel at McCabe Brothers Funeral Home. c. Head Nurse. Heart Station The Head Nurse of the Heart Station stated that the procedure for following nuclear pacemaker patients is to cortact the patient once per rionth. In addition she stated that every six renths the hospital sets up a transtelephonic pacer analysis. The transtelephonic pacer analysis is a procedure through which the hospital receives infonnation abeut the functioning of the pacemaker and an electrocardiogram of the patient through impulses transmitted via the telephone. The Head Erse further stated that an attempt was made about Decerter 20, 1985 to set up the routine seM-annual transtelephonic pacer aralysis with the pacemaker patient. She stated it was at this tire that the hospital became aware of the death of the patient. She was unsure exactly who at the telephone contact nunter infonned the hospital of the patient's death, because she was not present and notes are incomplete. Further she stated that if more infonnation were needed, to contact the Cardiovascular Technologist who was present at the time, d. Cardiovascular Technologist (C.V.T) The C.V.T., a former e@loyee of the licensee, was contacted on April 21,1987. She stated that the mortuary had contacted the hospital at the time the deceased was brought in and asked her what should be done with the pacenaker. She stated that she told the mortuary employee that the manufacturer of the cardiac pacemaker, Arco Medical Products, would be contacted and would forward special packaging and instructions to the mortuary for transport of the cardiac pacenaker to Arco. According to the former C.V.T., Arco was contacted at that time and requested to send, to the mortuary, packaging and instructions for transport of the cardiac pacemaker back to Arco. She stated that, to the best of her knowledge, no follcw up had been done to assure that the package was sent from Arco to the rortuary. i

e. Cardiologist The Cardiologist who was assigned to follow the progrsss of the patient was Interviewed by telephone on April 21, 1987. He stated that he did not recall being contacted by the Allegheny County Coroner's Office or the Funeral Home concerning the nuc' tar pacemaker patient. However he did recall being contacted by Arco Medical Products many months after the death of the patient, but he did not recall the exact date of the contact, f. Funeral Home Director McCabe Brothers Funeral Home is located at 5300 Penn Avenue Pittsburgh, Pennsylvania. The inspector interviewed Jerry McCabe of McCabe Brothers Funeral Home on April 14, 1987. He was unable to provide any informa-tion relative to the matter and deferred to David Rigo, the Director. Mr. Rigo was interviewed by telephone on April 20, 1987. He stated that he had personally handled the disposition of the deceased in Dececter of 1985. He also stated that they received the individual's remains, his personal f.ffects and (in a plastic bag) the explanted pacemaker from the coroner's office on er about December 21, 1985. He recalls contacting Shadyside Hospital on or about Deceeter 21, 1985 and was told that the hospital would contact Arco and tell Arco to send special packaging so that the funeral home could return the racemaker to Arco. The pacemaker was placed in a cabinet in the ectalming room of the mortuary until late August or early Septenter 1986, when Mr. Rigo personally placed it in the ncrmal trash.

Further, he stated that he never had any contact with Arce nor did he ever receive a package from Arco er the hospital.

l 7. Licensee Action on Previous inspection Finding i Inspection No. 85-001 on February 19, 1985: i (0 pen) Failure to notify NRC of loss of contact with a nuclear pacemaker patient. In response to the Notice of Violation enclosed in NRC letter dated March 14,1965, the licensee stated Oat they had made arrangeevnts to continuously monitor the nuclear pacsaker patient with whom they had lost contact. However, the licensee did not describe actions taken to assure that the NRC would be notified within ten days of loss of contact with a patient in the future. 8. Program Requirements The itcensee is required to notify the NRC, within 24 hours of occurrence, of the death of any patient in which a nuclear pacemaker Sas been implanted. However, the death of a nuclear pacemaker patient which occurred on Decerrber 21,1985 was not reported to the Ccmission cetil October 16, 1986.

6 l The failure to report to the NRC within 24 hours after notification the occurrence of the death of patient implanted with a nuclear pacemaktr is an apparent violation of Condition 13 of License No. 58M-1531. The licensee is further responsible for recovery of the nuclear pacemaker and return to the manufacturer for authorized disposal. However, the nuclear pacemaker was apparently removed by the Allegheny County Coroner's office. Subsequently, the explanted nuclear pacemaker was forwarded to a mortuary with the remains of the deceased. The pacemaker was then placed in a cabinet in the edalming room and in late August or early September, 1986, the mortuary disposed of the pacemaker to the normal trash. The failure to dispose of licensed material in an authorized manner is an apparent violation of 10 CFR 20.301 and Condition 15 of License No. $NM-1531. The licensee is required by Condition 16 of its license to monitor the functioning of the pacemaker weekly by telephone af ter the nineteenth week of irplantation. The inspector detennined that the periods between monitoring, after the nineteenth week of implantation, was greater than one week. At the time of the inspection, patients were being monitored at six month ini,ervals. The failure to monitor nuclear pacemakers by telephone at least once a week af ter the nineteenth week of implantation is an apparent violation of Condition 16 of License No. SNM-1531, 9. Exit Interview The inspector net with the licensee representatives identified in paragraph 1 at the close of the inspection. The inspector sunfarized the purpose and scope of the inspection and the findings. The licensee representatives expressed a desire to bring the program into full cog 11ance. I

'O, 4 J e Shadyside Hospital Inspection History May 21,1975 License No. SNM-1531 issued July 28 and 29,1976 (76-01) License No. SNM-1531 - No violations f License No. 37-02523-01 1. Violation: Radiation exposure in excess of regulatory limit. 2. Violation: Failure to report i radiation exposure in excess of regulatory limit. August 24, 1977 (77-01) License No. $NM-1531 - Not inspected 1 l License No. 37-02523 No violations October 26, 1978 (78-01) License No. SNM-1531 Inspection report notes a concern that licensee is not always following up on i patients with nuclear pacemakers. l L License No. 37-02523-01 j 1. Violation: Failure to use syringe shields. l t 2. Violation: Failure to wear i i gloves. I l May 7,1981 (81-01) License No. SNM-1531 - No violations 1 License No. 37-02523-01 l 1. Violation: Failure to survey (extremity dose) i i 2. Violation: Failure to survey (thyroid bioassay). l 3. Violation: Failure to survey areas l adjacent to room of patient who received iodine-131 therapy i I l i I - _ _ _., _,. _.. _ _,.... _ -.. - _ -. _ - -.. _ -, - ~ _ _ _ - - -----

2 4. Violation: Failure to survey trash prior to disposal as normal trash 5. Violation: Failure to use syringe shields. 6. Violation: Failure to use disposable gloves. 7. Violation: Failure to perform daily, quarterly and annual dose calibrator checks. B. Violation: Failure to institute audit program. 9. Violation: Failure to maintain negative pressure for room in which senon-133 procedures were performed. 10. Violation: Individual other than the l named individual acting as Radiation Protection Officer. 11. Violation: Clinical procedures other thai one specified in radiopharmaceutical packaging, hote: A meeting was held on June 16, 1981 at the Itcensee's facility with a Region I representative to discuss NRC's concern over lack of management control over licensed programs. September 19, 20 and 26,1984 (84-01) License No. 37-02523-01 { l. Violation: Failure to perform annual dose calibrator checks. 2. Violation: Inadequate survey of package containing radioactive material prior to opening. 3. Violation: Failure to perform daily surveys of het lab. 4. Violation: Inadequate survey (thyroid bioassay). 5. Violation: Failure to maintain waste disposal records.}}