ML19250C489
| ML19250C489 | |
| Person / Time | |
|---|---|
| Site: | 07000074, 07000086 |
| Issue date: | 09/19/1979 |
| From: | Magrath C MINNESOTA, UNIV. OF, MINNEAPOLIS, MN |
| To: | Stello V NRC OFFICE OF INSPECTION & ENFORCEMENT (IE) |
| Shared Package | |
| ML19250C484 | List: |
| References | |
| NUDOCS 7911260381 | |
| Download: ML19250C489 (9) | |
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UNIVERSITY OF MINNESOTA office of the President 202 Mornli Hall 100 Church Street S.E Minneapolis, Minnesota 55455 Sephier 19, 1979 Mr. Victor Stallo, Jr., Director Office of Inspection and Enforcement Nuclear Regulatory Ocmnission Wash.ington, D.C.
Dear Mr. Stello:
I have received your letter citing violations of the Nuclear Regulatory Camission (NBC) regulations and assessing tM University of Minnesota civil penalties of $4,300 for items of nonocmpliance against License No. 22-00218-29, our Health Sciences Broad License, and License No. 22-00187-48MD, our Nuclear Pharmacy License. h University recognizes the seriousness of the violations and the legitimacy of the citations, and so does not propose to challenge the penalties assessed. We will pay the fines as levied, ackncwledging that the conditions at the time of the NBC inspection last Novmber 29, Deceber 1,1978 and January 8-12, 1979, were accurately evaluated.
A detailed respmse to the Notice of Violation prepared according to instruc-tions in Appendix A of your letter of Sephiser 4,1979 accupanies my letter.
I believe it twrrmtrates that we are taking the af.propriate measures, indi-cated in the attached letter, to remdy the deficiencies and to eliminate the likelihood of future nonccmpliance such as your inspection evidenced.
As you observe, we took inmediate action to rmedy the probles discovered at the time of the inspection, including steps to inprove oversight of the program. My March 1 letter to Dr. Keppler noted our intention to change the managment of the p1Tycw, and I want to inform you at this time that Dr.
Donald E. Barber, Professor and Director of Graduate Study in the School of Public Health (see attached resume), has been appointed to serve as Chair of the All-University Radiation Protection Advisory Ccmnittee.
Dr. Barber is a respected speinli=t in the field of radiological health with a Ph.D.
frun the University of Michigan. Further, he is not a major user of ralioisc W gs. With regard to the other management situation you referred to, the " Joint Venture Agreement" which brought into effect the splitting of the health physics responsibilities bet: ween two groups is being terminated effective on or before October 15, 1979. N University Raeliation Protection Program will then be the single enforement systen for radiation protection throughout the University. We have, of course, also taken steps to change the procedures so that the infractions and deficiencies noted in the Nuclear Phamacy will not recur. 'lhese aneliorative measures are wgted in our detailed response.
1390 099 REIURN RECEIPT lea >utsw 7
y en 260 ?
. Mr. Victor Stello, Jr.
Septsber 19, 1979 Page 'IWo I understand ard appreciate the importance of the NFC regulations and since.ely regret that the University has been rcrwyliant, and I believe
~.that we are taking proper precautions to assure future empliance. We are all intent upon providing the safest possible enviwinent. A check for
$4,300 frun the University of Minnesota payable to the Nuclear Regulatory Carmiission is enclosed.
Corrlially, i'
(.CCl"f,a C. Peter Magrath President CPd:kb Enc: Response to Septaber 4,1979 letter frun Victor Stello, Jr., to President Magrath fran Ralph O. Wollan and Jeram Staiger, Septaber 17, 1979 Resume, Donald E. AW, Ph.D., Professor and Director of Graduate l
Study, Envirormer.tal Health Check for $4,300 1390 100 e
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UNIVERSITY OF MINNESOTA Boynton Health Service TWIN CITIES 410 Church Street S.E.
Minneapoks, Minnesota 55455 September 17, 1979 C. Peter Magrath, President Office of the President 202 Morrill Hall University of Minnesota
Dear President Magrath:
We have received a copy of the September 4, 1979, letter to you from Victor Stello, Jr., Director of Enforcement and Inspection, U.S. Nuclear Regulatory Commission (NRC), which lists the results of the NRC inspection of NRC License No. 22-00218-29 and License No. 22-187-46MD.
In response to your request we are providing the info mation required by the NRC. We followed the instructions outlined by Mr. Stello in Appendix A in the preparation of this report. The University acknowledges that items 1-14 listed in Appendix A are accurate assessments of the conditions at the time of the NRC inspection. Listed below arc the required responses in the order in which they appear in Appendix A:
l-a & b.
This item pertains to the exposure of three individuals within the University to 225I air concentration levels in excess of the 520 MPC-hr.
concentration limit during the third calendar quarter of 1978. The Univer-sity Radiation Protectic. Program had based the quarterly report criterion for these personnel on the quarterly thyroid dose limit rather than on the 520 MPC-br. limit.
Consequently, only one person was reported to the NRC as having exceeded the quarterly dose limit. Our November 20, 1978, letter to the NRC did indicate that the other two individuals in question received a thyroid dose, but that their dose was not in excess of the quarterly thyroid dose limit. The University Radiation Protection Program has corrected this misinterpretation of 10 CFR 20.103, and has established the 520 MFC-br. level as the report criterion on all future air concentra-tion exposure to p-rsonnel. Howc7er, it is felt by many professionals in the field of radiation protection that the report criteria for exposure of individuals as a result of internal deposition of radioactive materials should be based on radiation dose to the individuel. This would be consistent with the criteria for reporting external radiation exposures.
125 The exposure of the three individuals to airborne I concentrations in excess of the 520 MPC-br. limit resulted from an accidental release of 1251 in Room 925 Mayo. The radiation exposure to personnel in the laboratory was detected when they reported for a routine thyroid count.
An investigation was conducted to determine the cause of the personnel ex-posure. The results of this investigation and corrective actions to prevent a recurrence of this type of personnel exposure were outlined in the November 20, 1978, letter to the NRC. Subsequent to the receipt of the December 7,1978 Immediate Action Letter fron the RNC, all radioiodine use is required to be scheduled through the Radiation Protection Program.
1390 101
.C. Peter Magrath September 17, 1979 The Radiation Protection Program receives and holds all radiodine shipments until a schedule can be arranged with the individual user to perform sampling of the concentration of radioiodine in the breathing zone in the hood effluent.
According to our records full compliance with this require-ment was in effect as of the third week of January, 1979.
2-a & b.
It was not apparent from thyroid monitoring information that air sampling was required until the accidental radioiodine release which resulted in the previously mentioned thyroid quarterly overerposure.
Based on the immediate Action Letter received from the NRC on December 7, a moratorium was immediately established on volatile radioiodine use.
All volatile radioiodine use must be scheduled with the Radiation Protection Program and radiation protection personnel are always present to measure hood effluent release as well as operator breathing zone concentrations.
The air sampling is performed using activated charcoal traps which are counted in an auto-gamma counter to determine air concentration.
There have been no radioiodine conceatrations in excess of the MPC in either the effluent air release or into the general laboratory air when averaged over the last six months of use.
The Radiation Protection Program ensures that all personnel working with volatile radioiodine receive a thyroid count following each iodination pro-cedure.
All shipments of radioisotopes are received by the program and shipments are not delivered to the approved user until their thyroid has been counted in line with program requirements. We have established both the 40 NTC-hr. investigation limit and the 520 MPC-hr. report limit for the radioiodine thyroid monitoring program. Again, according to our records, we have been in full compliance with these requirements since the third week of January, 1979.
The University has approved the funding of a central radioiodination facility which, when completed, will provide centralized ' handling and use of all volatile radioiodine. Each approved user of these materials will do all of the iodination procedures in a hood provided with activated charcoal filtration of all effluent air release and continuous air moni-toring. All shipments will arrive at the central facility and all radio-iodine waste sill be collected at the facility. A Radiation Protection Program represantative will supervise all activities during radioiodine use and will monitor all procedures, personnel, and final labelled products.
3.
This item refers to the failure to conduct an appropriate investigation when an individual's thyroid burden exceeds a level corresponding to 40 MPC-hrs.
This incident occurred in the NuclearLPharmacy d ere the joint-venture agreement was in effect. Several letters were sent by the University Radiation Protection Program informing the Nuclear Pharmacy Staff of the need for evaluation of radioiodine thyroid burdens and the need for investi-gation of thyroid exposures received by personnel. However,.the 40 HPC-br.
level was not adopted as the investigation limit until the Immediate Action Letter of December,1978. Since the month of December,1978, we have been in full compliance with this requirement.
1390 102
C. Peter Magrath September 17, 1979 4.
This item refers to the loss or non-return of personnel radiation dosimeters in the Nuclear Pharmacy. All personnel in the Nuclear Pharmacy are provided film badge and TLD ring dosimeters by the University Radia-tion Protection Program. The Nuclear Pharascy Staff were informed by letter on several occasions of the problem of lost dosimeters and of the need for corrective action to prevent a recurrenosof this problem. The problem has been essentially eliminated by requiring Nuclear Pharmacy staff to leave their dosimeters in a specially designated area before leaving the Nuclear Pharmacy Facility. Also, a medical physicist for the Nuclear Pharmacy has completed a review of all past Nuclear Pharmacy dosimetry records and has assigned a radiation dose to individuals during all periods when dosimeters were lost or not returned. These assigned doses are based on dose interpolation obtained from radiation dosimetry records for periods corresponding to the date of the lost dosimeters. The assigned radiation doses are on file with the Radiation Protection Program at this time. We are establishing a procedure which will require a review of all incidents where radiation dosimeters are lost or not returned. The procedure will require the assignment of a radiation dose to the individual for the period in question. If the individual continues to lose or misplace his/her dosineter, they will be required to appear before the University Connittee for remedial action.
l 5.
It is our opinion that no further information should be required relative to this item, because items 1 and 2 have explained the Univer-sity corrective action. There may be a question of duplication of penalty in that a previous penalty has covered the failure to provide these surveys.
6.
This item refers to the calculation of the I air concentration at the effluent discharge of the Nuclear Pharmacy radioisotope hood (discharge located on the penthouse roof of the VFW building). The concentration listed is based on the total 131 1 usage for the year 1978 with release activities per month based on air samples taken during December, 1978, and January, 1979. There was some discussion at the time of the inspection concerning the classification of the penthouse roof as an " unrestricted area."
Because the penthouse roof was accessed by a ladder, it was so classified.
If it were considered a " restricted area" the concentration listed would be within the limitation of 10 CFR 20.
We have had an opportunity to make measurements of the penthouse rooftop concentration during the use of 1311 and have found these concentrations to be within the limits specified in the 10 CFR 20 for an " unrestricted area."
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Also, the Nuclear Pharmacy terminated all receipt of liquid radiciodine as of the end of March, 1979, and presently rece1ves diagnostic and therapeutic 131I in capsule form.
7.
This item related to the exposure of a Nuclear Pharmacy technician during the fourth quarter of 1978, to a radiation dose in excess of the quarterly whole body dose limit of 1.25 rem.
The dosimetry report indicating this overexposure was received the second week of January, and a letter listing the results of the investigation were sent to the NRC on February 9, 1979. It was determined that the overexposure re-sulted from exposure to 131I radiation. Some individuals expressed a 1390 103
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C. Peter Magrath 4-3 September 17, 1979 N
concern that Ms. Wyatt's film badge may have beenfinte tionally exposed; however, no documentation of this could be obtaing the procedures Ms.
Wyatt followed in thehandling of a preparation of I ' vere reviewed and it was also recommended that she not be nasigned this task in the future, because she experienced some difficulty in handling the lead 131I con-tainers. All 1311 shipments are now received in capsule form and procedures have been developed which require a minimum' of transfer and handling of these capsules to prepare them for administration to patients.
8.
This item relates to the failure of the Nuclear Pharmacy to monitor 1311 shipments for possible radioactive contamination as required in 10 CFR 20.205. The Radiation Protection Program has conducted a complete review of the radioactive materials shipment survey procedures in the Nuclear Pharmacy. Based on this review, the Radiation Protection program has requested and employed, as of July, 1979, a full-time staff person to conduct the Radiation Protection surveys required in the Nuclear Pharmacy.
In addition, the Head of the Nuclear Pharmacy, and the Director of the Division of Nuclear Medicine have agreed to provide sufficient staff to assure radiation protection survey coverage during weekends, lunch breaks, etc., when the radiation protection staff person is not present.
9.
The Director of the Division of the Nuclear Medicine was informed by the NRC inspector and a memorandum has been sent to him from the Radiation Protection Program pointing out the regulations regarding the above men-tioned violations and the need for enforcement. He has assured us that the sample preparation room will be restricted by being attended, or will be locked when not attended.
There were technetium-99m doses on a table in the hall of the Division cf Nuclear Medicine. They were apparently set on the table preparatory to being administered to a patient. The hall, obviously not a restricted area, is no longer used to store, even temporarily, technetium-99m. The Director has indicated that this policy will be strictly enforced within the Nuclear Medicine Clinic.
10.
This item relates to the M1nre to perform thyroid counts on per-sonnel within the specified time period for persons performing radioiodine labelling. A problem of interpretation of intent; arose in this instance.
The February 25, 1975, letter goes on to say that, "For continuing opera-tions, monthly thyroid counts will be made of personnel." The Radiation Protection Program interpreted _this statement to mean that for persons who use radioiodine more than once a month, a monthly thyroid count would be required. However, if an individual conducted a single operation once every 3 months, or once every six months, a thyroid count would be conducted within one week of this use. The NRC inspection results disa-greed with this interpretation and indicated that a thyorid count should m
be conducted within one week of each usage even though more than one operation per month is conducted. It is unclear,Ivith this interpretation, when an operation becomes a " continuing operation" and why a single monthly thyroid count would suffice for such continuingUeperations when it does not for less frequent us6de during the same thly} period. As of
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C. Peter Magrath September 17, 1979 December,1978, the Radiation Protection Program has required a thyroid count following each single operation.
This is more easily enforced at present because each individual user must now schedule every radioiodine use through the Radiation Protection Program (see item 2). We have, however, requested an amendment from the NRC to change tne condition of a thyroid count within one week to "a thyroid count within two weeks of the date of use."
We have requested this amendment because of the difficulty of scheduling the thyroid count within one week in some instances, particularly over weekends, holidays, and vacations.
11.
A letter was sent to radioisotope users at the time to the NRC Closeout meeting in January,1979, officially informing them that the University policy clearly stipulates that there must be no mouth pipe-tting in radioisotope laboratories. Perscnnel in laboratory #920-930 have been instructed specifically that mouth pipetting is strictly for-bidden.
A notice has been placed in a recent issue of the University Department of Environmental Health and Safety newsletter relating to the fact that eating, drinking, smoking, and mouth pipetting are in violation of NRC and University Radiation Protection regulations.
At a meeting of the. All University Radiation Protection Advisory Commit-tee, shortly after the NRC inspection; the Committee made the following ruling regarding eating, smoking, drinking, and mouth pipetting in l
radioisotope laboratories:
If a project director fails to enforce these restrictions, he will be asked to come before the Committee and explain why the regulation is not enforced and what he will do to ensure compli-ance with the regulation.
be revoked.
If the violation persists, his license may All " Caution Radioactive Material" signs posted on University laborat-ories are now stamped with the notice:
No smoking, drinking, eating, or mouth pipetting allowed in this laboratory.
This is an extremely difficult regulation to enforce; however, a very real effort is being made to ensure enforcement.
12.
An application was made for a renewal of the expired use-permit and was approved by the Health Sciences Radiation Committee on February 28, 1979.
13.
This item relates to the failure of the Nuclear Pharmacy to maintain an updated license file in each hospital and institution that obtains radioactive materials from the Nuclear Pharmacy. This file has been completely updated, and is reviewed by the Radiation Protection staff Person now assigned to the Nuclear Pharmacy.
A copy of these records are also now kept on file in the Department of Environmental Health and Safety by the Radiation Protection Officer.
14.
This item pertains to the requirement to perform molybdenum-99 break-through assays on all 99 o/99mTc generator eluates.
M As of January, 1979, the Head of the Nuclear Pharmacy and the Director of the Division of Nuclear Medicine have agreed to record the results of molybdenum-99 break-through tests on all generator eluates.
Also, the Radiation Pro-tection staff person assigned to the Nuclear Pharmacy now reviews the records on these assays to assure that they are properly recorded.
!390 105
C. Peter Magrath September 17, 1979 As indicated in the letter from Mr. Stello, the NRC has expressed concern with the large number of items of nencompliance and their relationship to the University supervision of the overall program.
In the March 1, 1979, letter from the University to Mr. J. A. Keppier, several items were listed as proposed changes in the management of the program to ensure improved super-vision. Some of the proposed changes have been accomplished, such as the appointment of the revised committee with a new committee chairperson. In ad-dition, the stipulations were made that no major ionizing radiation user will be appointed chairperson of the Committee, and that no committee member' will vote on matters relating to his/her ionizing radiation usage.
A concern, however, still exists regarding the splitting of radiation protection responsibilities between the University Protection Program and the Department of Radiology. It is my opinion, which is substantiated by the number of items of noncompliance, that for a radiation protection program to operate effectively with overall continuity, it must have authority for direct surveillance and supervision. To fragment a program by allowing a department, particularly one which is a major user of sources of ionizing radiation, to operate their own radiation protection surveillance, hinders proper management and enforcement of radiation protection.
It has been very difficult to ensure good radiation protection practio in a joint arrangement. Por this reason, the " Joint Venture Agreement" with the Department of Radiology will be terminated and the Radiation Protection Program will assume full responsibility for the program throughout the University.
Mr. Stello also indicated in his letter a concern for the proper radiation protection training of Nuclear Pharmacy Staff persons.
Since the January 12, 1979, close-out meeting with the NRC inspectors, the Director of the Division of Nuclear Medicine has agreed that no individuals will be allowed to begin work with radioactive materials until they have first completed the viewing of the required radiation protection training tapes. All of the present employees in the Nuclear Pharmacy have viewed these tapes. We have advised both the Head of the Nuclear Pharmacy and the Director of Nuclear Medicine that all employees of the Nuclear Pharmacy must also be trained in proper radiopharmaceutical dose handling and dose preparation procedures before they are allowed to handle radioactive materials.
In addition, the radiation protection staff is in the process of preparing a complete training manual and slide presentation for the Nuclear Pharmacy, instructing personnel in proper radiation protection surveys, dose preparation, shipment packaging, contaminstion surveys, personnel dosimetry, etc.
This manual is in the final stages of completion and each Nuclear Pharmacy staff person will be required to participate in the training sessions and will be required to sign a written statement agreeing to comply with all radiation rotection procedures.
I trust that this information will be of help to you in formulating your response to the Nuclear Regulatory Commission. Please call me if I can be of further assistance.
1390 106 Sincerely, Ralph O. Wollan RadiationyrotectionOfficer WtN R.
ML g -
3 er me W Staiger ROW & JWSec Senior Health Physicist Department of Environmental Health and Safety
RES U.'E DONALD E. BARBER, Ph.D.
Professor and Director of Graduate Study Environmental Health School of Public Health University of }dnnesota Hinneapolis, Minnesota 55455 Born in Harrisburg, Pennsylvania, April 1,1931. Received B.S. in Mathematics, Dickinson College, Carlisle, Pennsylvania,1953; M.P.H. in Environmental Health, University of Michigan,1959, and Ph.D. in Environmental Health, Uni-versity of Michigan,1961.
A.E.C. Fellow, Radiological Physics, University of Rochester, 1953-1954; Health Physicist, Electric Boat Division, General Dynamics Corporation,1954-1955; Health Physicist, U.S. Air Force, Wright-Patterson Air Force Base, Ohio, 1955-1958; U.S.P.H.S. Trainee in Radiological Health, University of Michigan, 1958-1961; Assistant Professor of Radiological Health, Departtent of Environ-nental Health, University of Michigan, 1961-1966; Associate Professor and Radiological Health Program Director, Environmental Health, fessor and Director of Graduate Study,1974-Present.
1966-1974; Pro-Experience has included: radiation protection program in the shipyard during construction and testing of the nuclear submarine Nautilus; writing and en-forcing radiation protection regulations for the U.S. Air Force, development of a personal monitoring program for the Air Force, preparation of an Air Force Specialty Code for Health Physicists, consultant to all Air Force bases on matters of radiation protection; teaching and research in radiological health at the University of Fuchigan, thesis research on the biological ef fects of microwaves and development of film badge performance standards through the National Sanitation Foundation; Board of Trustees, Findlay College; teaching, research and public service, University of Funnesota; consultant to industrial, medical and non profit organizations; nu=erous publications including the following subjects: biological effects of microwaves, radiation exposure in industry, monitoring of noble gases, film badge test procedures and standards, environmental monitoring, permissible concentrations for radioactivity, health physics administration, radiation protection in nuclear medicine, low energy radiation dosimetry, leukemia, and the radiological impact of burning coal.
Professional 1kmbersb4.ps: Health Physics Society (Charter lhmber), American
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Industrial Hygiene Ar ciation, Sigma Xi, Delta Omega.
Health Physics Society activities have included:
certification by examination, American Board of Health Physics, -1961; me=ber, Panel of Examiners, American Board of Health Physics, 1965-1968; a Society representative to the International Radiation Protection Association meeting,1970; organizer and first president, North Central Chapter,1969; member, Standards Cornittee and Comittee on
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Education and Training; chairman, technical session on the Environment, Health Physics Society Annual Meeting,1970; progran contributor at a nu=ber of Annual and Mid-Year meetings; ChairmanT Education and Training Committee, 1972-1974; Board Member, 1972-1975; Continuing Education Panel, American Board of Health Physics, 1976-1390 107 en