ML19250A036
| ML19250A036 | |
| Person / Time | |
|---|---|
| Issue date: | 09/06/1979 |
| From: | Nicholson N, Oberg C, Paul R NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION III) |
| To: | MINNESOTA, UNIV. OF, MINNEAPOLIS, MN |
| Shared Package | |
| ML19250A030 | List: |
| References | |
| 30-02174-78-01, 30-10989-78-01, 30-10989-78-1, 30-2174-78-1, NUDOCS 7910110513 | |
| Download: ML19250A036 (20) | |
Text
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h U.S. NUCLEAR REGULATORY COMMISSION OFFICE OF INSPECTION AND ENFORCEMENT REGION III Report No. 03010989/78-01; 03002174/78 01 Docket No. 03010989; 03002174 License No. 22-00187-48MD; 22-00218-29 Priority IV;III Category E; G(1)
Iicensee: University of Minnesota Minneapolis, MN Inspection Conducted: November 29, 30, December 1, 1978 and January 8-12, 1979
% lb Inspectors:
R. A. Paul
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N. A. Nicholson
/[. d y Mdv.%
C. T. Oberg
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f Approved By:
. Pap riello, Chief Materials Radiological Protection Section 1 Inspection Summary Inspection on November 29, 30, December 1, 1978 and January 8-12, 1979 (Report No. 03010989/78-01; 03002114/78-01)
Areas Inspected: Routine, unannounced inspection of radiation protection practices under a broad license and byproduct material distribution license including: organization, internal audits, employee training, radiation protection practices, receipt and transfer of byproduct material, instruments, equipment and facilities, external radiation monitoring, internal radiation monitoring, surveys, radioactive effluent to an unre-stricted area, waste disposal, shipping incidents, notification and reports, emergency preparedness, environmental monitoring and confirmatory measurements. The inspection involved 111 inspector hours onsite by three NRC inspectors.
Results: Of the 17 areas inspected, 14 items of noncompliance with NRC regulations were identified of which one was a violation (10 CFR 20.103(a)(1) thyroid uptakes in excess limits - Paragraph lej; twelve were infractions:
10 CFR 20.103(a)(3) no evaluations were made to determine compliance with 880 026 7910110f d
10 CFR 20.103(a) and (b) - Paragraph 10; 10 CFR 20.103(b)(2) failure to document and evaluate for case in excess of 40 MPC hours - Paragraph 10; 10 CFR 20.202(a) personnel exposure not measured to determine compliance with 10 CFR 20.101 - Paragraph 9; 10 CFR 20.106(a) airborne concentrations in unrestricted areas in excess of limits - Paragraph 12; 10 CFR 20.201(b) failure tu survey to determine compliance with 10 CFR 20.106 - Paragraph 12; 10 CFR 20.101(a) whole body exposure in excess of quarterly limits -
Paragraph 9; 10 CFR 20.205(b)(1)(v) required surveys of incoming packages not made - Paragraph 7; 10 CFR 20.207(b) BPM not under surveillance or constant control - Paragraph 7; License Condition 19, thyroid counts not performed at required frequencies - Paragraph 10; License Condition 19, authorized possession permit for user not current - Paragraph 7; License Condition 19, use of byproduct material procedures not followed -
Paragraph 6; 10 CFR 30.41(c) transfe r of byproduct material without adequately verifying transferee's 1:. cense is current - Paragraph 7; One is a deficiency:
License Condition 13, records of assays not made
- Paragraph 2.
880 W
DETAILS 1.
Persons Contacted
- Dr.
Lyle French, Vice-President for Medical Affairs
- Dr. A. J. Linck, Associate Vice-President for Academic Affairs
- Clint Johnson, Associate Vice-President for Finance, Treast.rer
- Sherrie Perinautter, Assistant Vice-President
- Dr. Merle Loken, Director of Nuclear Medicine
- Dr. Larry Williams, Associate Professor of Radiology and Radiation Physicist for Nuclear Medicine
- Dr.
Roger DeRoos, Associate Director of Boynton Health Service and the Director of the Department of Environmental Hcalth and Safety
- Ralph Wollan, Radiation Protection Officer and Assistant Professor
- Jerome Staiger, Senior Health Physicist Dr. Dennis Hoogland, Director, Health Pharmacy Dr. Anthony Faras, Professor of Microbiology James Tennison, Chief N:. clear Medicine Technician In addition,12 other persons were contacted and interviewad during the inspection.
- Denotes those present at the exit interview on December 1, 1978, and January 12, 1979.
- Denotes those present at management meeting on February 14, 1979.
2.
General The inspection comprised the review of the broad medical license No.
22-00218-29 and the Nuclear Pharmacy distribution license No.
22-00187-48MD.
The broad license encompassed the nuclear medicine and pharmacy departments as well as large academic research departments. Various aspects of the licensee's operations were reviewed including laboratory and clinical procedures, dosimetry, smear surveys and shipping records. A tour was made of the licensee's facilities. E.sphasis centered on the review of circumstances related to the iodine-125 uptakes repetted by the licensee on November 20, 1978 (Attachment 1).
a.
Scope of License No. 22-00218-29 Under the broad medical license, the licensee uses byproduct material for medical research, diagnosis, and therapy. The largest quantities of byproduct material are possessed and used for labeling and in the nuclear pharmacy. There are approxi-mately 330 authorized users under this license; each license user application is reviewed by the RSO prior to approval. A 880 028
review of the inventory use and receipt records indicated that licensed material possessed appears to be used in quantity and kind authorized, b.
Scope of License No. 22-00187-48MD This license authorized the distribution of licensed material to persons licensed pursuant to Section 35.14 and Sections 35.100 of 10 CFR 35 for Groups I, II, IV and V or under equivalent licenses of Agreement States. The inspection included a review of the licensee's manufacturing and distribution procedures which included administrative and operational procedures which were sent to the Division of Materials Licensing dated January 10, 1975, license verification procedures, authorization records, shipping and receipt records and the method of distribution to authorized licensees.
The results of this review indicate that with the exceptions listed below, the licensee is performing the scope of its operation in accordance with the conditions of the license.
A review of the licensee's molybdenum 99/ technetium-99m generator elution record.s showed that on November 17 and 20, 1978, December 20, 1978 and on several other occasions the molybdenum assay results were not recorded. This is an item of noncompliance with License Condition 13 in that Section IV(c)(6) of a letter dated Janua ry 10, 1975 to the Director of Licensing requires that records be maintained for molybdenum assays.
One item of noncompliance was identified.
3.
Organization a.
Structure The organizational structure for both licenses which provides for the delegation of authorized users is outlined in the
" University of Minnesota Manual of Policies and Procedures for Radiation Protection."
b.
Radiation Safety Committee The licensee has an "All University Radiation Protection Advisory Committee," a " Health Sources Radiation Sub Committee" (Human Use) and a " Campus Radioisotope Subcommittee" (Non Human Use).
Dr. Merle Loken, Head of the Nuclear Medicine Department, is the chairman of the first two committees mentioned above.
Committee meetings were held on four occasions during 1978, minutes of which were reviewed during the inspection.
Based on a review of the minutes and other correspondence between members 880 029
of the Department of Environmental Health and Safety, the Chairman of the committees and the Radiation Safety Officer appointed by Dr. M. Loken, it appears that the committees are functioning. However, the large number of items of noncom-pliance indicate that the management of the radiation protection program by the committees has not been effective. Furthe rmore,
it does not appear that all responsibilities delegated to the Department of Environmental Health and Safety and the Radiation Safety Office have been adequately discharged. The failure to take adequate air samples, the failure to perform thyroid counting as required and the failure to follow-up on missing film badges are examples.
4.
Licensee Audits 00218-29 and 22-00187-28MD The licensee does not have a formal internal audit system nor is one required by his license. Most of the health physics responsibility for the nuclear medicine and the nuclear pharmacy departments are under the direction of a Radiation Safety Officer (RS0) who is appointed by the Director of Nuclear Medicine. The RSO is responsible for reviewing the technician's handling records, taking monthly surveys, taking thyroid readings, training o certain personnel and reviewing film badge results. The responsib;'.ity for ensuring the use of approved procedures in nuclear medicine and the nuclear pharmacy on a daily basis is assigned to supervisory personnel.
The responsibility for ensuring the use of procedures in the research laboratories on a daily basis is assigned to the authorized users and their delegates.
No items of noncompliance or deviations were found.
5.
Employee Training, Retraining, and Instructions to Workers The licensee provides all personnel working with radioactive material with a four hour videotape training session. An examination turned in by the worker to the Radiation Safety Officer is used as documenta-tion that the videotape was viewed.
A special slide presentation concerning handling and lab procedures particular to radioiodine is being prepared and will be shown to radiciodine workers in addition to the four hour videotape requirements. Under the joint venture agreement between the Department of Environmental Health and Safety and the Nuclear hedicine Department and Nuclear Pharmacy, clinical and pharmacy workers must view the videotape and are also encouraged to attend lectures given by the Radiation Physicist of the Nuclear Medicine Department that specifically deal with topics concerning the handling and effects of radiopharmaceuticals. Each authorized user is given a copy of the laboratory use procedures and is required to show all laboratory workers what the use procedures are.
s 880 030
A review of the licensee's training records indicate that a number of individuals worked in the Nuclear Pharmacy for a considerable period of time before the above training was received. There are as follows:
Individual Start of Work Date of Training 1
December 9, 1976 July 20, 1978 2
September 6, 1977 August 31, 1978 3
September 29, 1977 July 21, 1978 4
October 1, 1977 July 25, 1978 5
December 21, 1977 June 13, 1978 The licensee's letter dated October 11, 1974, in response to a Nuclear Materials Licensing Branch question states that before recommending an application for possession and use of radioisotopes, the project director and the person involved with the radioisotope use are trained. This letter also includes an outline of a four hour training course to be taught to all employees working with radioisotopes. The letter does not specify the time by which such training is required however.
Training and instructions to nurses caring for patients receiving iodine-131 therapy is provided by the health physics personnel from the Department of Environmental Health and Safety. The training for those caring for the patients receiving therapy implants is provided by the Radiation Safety Officer assigned to the Nuclear Medicine Department.
No items of noncompliance were found, 6.
Radiation Protection Procedures The Radiation Protection Program is committed to follow procedures found in the " University of Minnesota Manual of Policies and Procedures for Radiation Protection" which is referenced by the 22-00218-29 license application dated February 28, 1974, and also by a letter dated October 11, 1974, in response to the licensing branch request for information regarding radiation safety procedures.
These two documents set forth guidelines for film badge monitoring, bioassay, handling procedures for radioisotopes within laboratories, and training programs. A copy of the Proce. <res Manual is issued to all approved users. All of these topics wer eviewed by the inspector.
During the inspection of the week of Nove er 29, 1978, two individuals working in Laboratories No. 920-930 in the layo Building stated that they had pipetted radioactive materials by mouth. On January 12, 1979, the inspector observed an individual working in the above area pipetting a tritium solution by mouth. This is an item of noncom-pliance with License Condition 19 which references the " University 880 031
of Minnesota Manual of Policies and Procedures for Radiation Protection" which states in the procedures for radioisotope use, that mouth pipetting is prohibited.
One item of noacompliance was found.
7.
Receipt and Transfer of Material a.
Receipt of Materials - License No. 22-00218-29 The licensee's procedures for receipt of radioactive material for approved users for other than the Nuclear Pharmacy are described in the " University of Minnesota Manual of Policies and Procedures for Radiation Protection." Samples of isotope receipt records were reviewed and no problems were noted.
The receipt of byproduct material records for use in the Nuclear Pharmacy were reviewed and it was noted that smear surveys were not made on two separate packages containing 150 millicuries of iodine-131 each, received on November 16, 1978, and December 29, 1978. Employees stated that such surveys had not been conducted.
This is an item of noncompliance with 10 CFR 20.205(b)(1)(v) which requires that upon receipt of byproduct material a survey of external surfaces of packages containing radionuclides with half-lives of less than 30 days and containing more than 100 millieuries shall be made.
One item of noncompliance was found.
b.
Use Permit - Authorization Procedures - License No. 22-00218-29 The licensee's requirements for possession and use of radio-isotopes by individuals authorized under this broad license is described in the " University of Minnesota Manual of Policies and Procedures for Radiation Protection" manual. The section of the manual titled " Requirements for Possession and Use of Radioisotopes" states that permits issued by the Health Sciences Radiation Subcommittee are valid only for the time specified.
During a review of the authorized permit records it was noted that byproduct material has been used from June 1978 to the time of the inspection on a daily basis in the nuclear pharmacy and nuclear medicine under an authorization issued to the Director of Nuclear Medicine which had expired in June 1978.
This is an item of noncompliance with License Condition 19 which states that byproduct material will be used in accordance with the procedures in the " University of Minnesota Manual of Policies and Procedures for Radiation Protection" which requires that persons who are approved and receive authorized permits use the byproduct material for the time listed only in the permit.
One item of noncompliance was found.
880 032 c.
Transfer of Radioactive Materials - License No. 22-00187-48HD This license authorized distribution of byprodu t material repackaged in the Nuclear Pharmacy. A review of some of the licensee's distribution records showed that the prepared radio-pharmaceuticals, which were distributed to several authorized users in the St. Paul - Minneapolis, Minnesota area on a daily basis, had the required inserts and packaging labeling. The licensee's authorized user verification program consists of possessing a copy of the transferee's licenses and amendments.
Based on interviews with several persons in the Nuclear Pharmacy it appears there is no specific procedure for reviewiag each customer order against their file license. A review of all of the file licenses indicated that eight licenses were expired and the licensee had no records available to show otherwise.
The records show that on July 13, 1978, 7 mci of iodine-131 were sent to Bethesda Lutheran Hospital in St. Paul, Minnesota, whose license expiration date in the licensee's files was April 30, 1978. Also on August 15, 1978, 9 mci of I-131 and on October 11, 1978, 6 mci iodine-131 (capsules) were sent to the Fairview-Southfield Hospital in Minneapolis, Minnesota, whose license expiration date in the files was July 31, 1978. This is an item of noncompliance with 10 CFR 30.41(c) in that prior to transferring licensed material the licensee did not verify that the transferee's license which authorized the receipt of the type, form and quantity of byproduct material was current.
One item of noncompliance was found.
d.
Caution Signs, Labels, and Controls - License No. 22-00218-29 As noted on the tours made of the Nuclear Medicine Department, Nuclear Pharmacy, selected research laboratories and rooms and/or areas where radi Isotopes w re used for research or clinical purposes, the licensee's posting and labeling practices were found to be i;. accordance with 10 CFR 20.203.
e.
Storage and Control of Material - License No. 22 00218 29 The inspectors toured various departments and areas to determine compliance with 20.207, " Storage and Control of Licensed Materials in Unrestricted Areas."
During a tour of the Nuclear Medicine Department the inspector 1
observed that two areas specifically used for the preparation and administration of radioisotope doses were not under complete control of the licensee. The inspector saw the dcor of Room C232 of the Mayo Building (the Nuclear Medicine Preparation Area) open on several occasions during the inspection. The 880 033
door from the main corridor through the Nuclear Medicine Department is kept open at all times. Doses are stored and reassayed in Room C232 until used; most of the time a techniciar is not in the room. A desk in the main corridor of the Nuclear Medicine Department is used as a point to administer bone scan doses using technetium-99 to ambulatory patients. Doses are labeled and stored in a lead cannister prior to and after the administration.
The cannister and doses are not locked or secured in any way from the through traffic in the corridor.
This is an item of noncompliance with 10 CFR 20.f.07(b) in that licensed materials which are used in an unrestricted area are not under constant surveillance and immediate ccntrol of the licensee.
Except for tLe above example and the item discu' sed in Paragraph 15 all other material appeared to be under proper control.
One item of noncompliance was identified.
f.
Sealed Sources - License No. 22-00218-29 The review of the licensee's leak test records indicate that all required tests have been made and all were below the limits stated in License Condition No. 13.
No items of noncompliance were identified.
8.
Instruments, Equipment, Facilities and Materials a.
Survay Instruments and Dosimeters Radiation survey instruments are required to be available to all authorized users as a condition of receiving a use permit.
Calibration of these instruments is not required but is available as a service performed by the Health Physics section. All portable survey instruments used by the Health Physics section and the Department of Nuclear Medicine are calibrated at least semi-annually, records of which are maintained for the instru-ments which belong to the Department of Nuclear Medicine but not for the Health Physics section.
The Department of Environmental Health survey and monitoring L,.ipment is essentially the same as described in the license application dated February 28, 1974. A review of this equipment indicates it is available and in working order. During the inspection of certain of the approved investigators' laboratories, it was noted that portable survey devices were also available.
However, it was noted that in Laboratory 927 in the Mayo Building, the laboratory where iodine-125 iodinations are frequently performed and the area in which four persons were exposed to 880 034,
airbcrue concentrations in excess of Part 20 limits (Paragraph 11), the portable survey meter was a Geiger-Mueller type which does not have the detection sensitivity to detect low levels of iodine-125 loose contamination. A licensee health physicist is aware of this problem and is in the process of reviewing the instrument needs for all iodine-125 users.
This matter will be reviewed at the next inspection.
Personnel dosimetry as required by 10 CFR 20.202 is supplied by the Radiation Safety Office and includes film badges and e rmoluminescent (TLD) finger ring badges.
The licensee appeared to meet all requirements in this trea.
b.
Facilities A review of the licensee's process and fume hoods, generator elution facility, shielding, handling devices and ventilation systams in the Nuclear Pharmacy was made during t' e inspection.
w It was noted during the review that the air vent of the hood in which iodine-131 in theraputic quantities are opened and dis-pensed was partially blocked with equipment and waste. This reduced the flow rate at the face of the hood to 25 lineal feet per minute as measured, at the inspector's request, by a velometer reading taken by a member of the Department of Environmental Health and Safety. This situation was corrected on the day it was observed.
At the time of this inspection the hoods, in the Nuclear Pharmacy, Nuclear Medicine and in the research laboratories, which use iodine-131 or 125, did not have charcoal filtration.
While this is not required by the license, the lack of charcoal filters may have contributed to the excessive releases noted in Paragraph 12.
The licensee's facilities met his license commitments. No items of noncompliance were noted.
9.
Personnel Radiation Protection - External Film badge records were reviewed for workers in research labora-tories, the Nuclear Pharmacy, and Nuclear Medicine Department.
Only employees in the Nuclear Medicine and Pharmacy Departments wear TLD finger ring badges. The film badges are turned in monthly to the Radiation Safety Officer who forwards them to R. S. T.andauer, and Company. The highest extremity reading posted was for an employee in the Nuclear Pharmacy who received 14.400 rem for the third quarter of 1977. The highest whole body exposure was also for a Nuclear Pharmacy employee whose exposure was 1.840 rem during the fourth 10 -
880 035
quarter of 1978. This is an item of noncompliance with 10 CFR 20.101(a) in that this individual, for 'ihom no NRC Form 4 was completed, received i.n exposure in excess of 1.25 rems during a calendar quarter.
The licensee's whole body film badge reports showed that for one employee from the Nuclear Pharmacy there were no badge results recorded for the third quarter of 1977 and one month in the fourth quarter of 1977. This individual had recorded exposures of 170 mrem for the two months of the fourth quarter of 1977 and exposures of 290 mrem and 200 mrem respectively for the second and third quarters of 1978. The licensee had performed no evaluation of the individual's possible whole body dose for the period on missing badges.
A number of separate instances of employees with missing extremity dosimeters for one month or more were recorded for the Nuclear Pharmacy. The licensee's report from the dosimeter vendor shows the following data:
Average Monthly Doses Individual Period Missing from Available Reports A
4th/qtr 1977 228 mrems 1st/qtr 1978 B
1 month in 4th qtr 2101 mrems 1977 1 month in 1st qtr 19/o 2nd/qtr 1978 C
1 month 2nd/qtr 1977 2839 mrems 1 month 4th/qtr 1977 D
2 months 3rd/qtr 1977 1814 mrems 1 month 4th/qtr 1977 E
2 months 2nd/qtr 1977 81 nrems 1 month 3rd/qtr 1977 2nd/qtr 1978 F
1 month 4th/qtr 1977 1700 mremt G
1 month 4th/qtr 1977 844 mrems H
1 month 4th/qtr 1978 None available 10 CFR 20.202 requires personnel dosimetry to be provided and used if it is likely that an individual in a restricted area will receive an extremity dose in excess of 4,688 mrems/q w.ter.
For monthly 880 0%
- 2' -
monitoring periods this amounts to an average of 1563 mrems/ month.
The above data show that the Nuclear Pharmacy is a restricted area in which it is likely that an individual will receive an extremity dose in excess of 4,688 mrems/ quarter.
In particular individuals B, 2, D and F above for the periods they were monitored had measured extremity doses which exceeded the level at which personnel monitoring is required.
Individual C was missing a dosimeter reading foe one month in a quarter in which the 2 month recorded dose was 10,140 mrems, a value well over the level at which monitoring must be provided.
In the above cases, discussions with licensee representa-tives indicated that personnel dosimeters were provided for extremity monitoring but were either lost or not returned to the RSO for readout. Furthermore, the licensee failed to follow up on lost or missing dosimeters and failed to determine what the extremity dose might have been for the periods missing.
This failure to use personnel dosimeters when extremity doses were likely to exceed 25 percent of the limits in 10 CFR 20.101 is an item of noncompliance with 20.202.
A review of extremity dose records for persons working in the Nuclear Pharmacy indicated that one employee has a consistently higher extremity dose than other Nuclear Pharmacy workers. On the basis of these elevated extremity doses the licensee was requested to make an evaluation of this person's exposure to determine what action can be taken to reduce these doses. Further, the licensee was requested to make an evaluation to determine that whole body badges worn by the Nuclear Pharmacy personnel are worn such that they will reflect the most representative dose which is yielded frcm a variety of work functions. These matters will be reviewed during a future inspection.
Two items of noncompliaace were identified.
10.
Personnel Radiation Protection - Internal - License No. 22-00218-29 The licensee has established a formal system for internal dose monitoring for iodine-125, iodine-131 and tritium which is outlined in License Condition No. 15 and a letter directed to the Director of Licensing, Nuclear Regulatory Commission, dated February 25, 1975.
This requires that bioassay urinalyses be performed for persons who use 10 millicuries or more of tritium labeled organic compounds and that the analysis will be performed within one week following single operations and on a weekly interval for continuing operations.
Furth.-- it requires that for individuals who use iodine-131 and/or iodine-125 in procedures where volctil..:ation is likely, thyroid counts will be performed within one week for single operations involving one millicurie or more of iodine-131 and 0.5 millicuries or more of iodine-125. For continuing operations monthly thyroid counts will be made of personnel. 880 037
a.
Bioassay The inspectors reviewed the bioassay results for research workers using tritium and iodine-125 and persons in the Nuclesr Medici F clear Pharmacy using iodine-131 between March 1r 7 at Dsccs r 1978.
The resalts of this review indicated that no persons have used IP" Jillicuries of tritium since the last inspection. Therefore, Oioassay was re,uired.
For radioiodine, the inspector reviewed the licensee's -
oid Count Report Forms. The inspector noted the uptakes by five individuals working in Laboratory ~,27 in the Mayo Building.
In a letter dated November 20, 1978, the licensee reported that an incident apparently occurred in this laboratory during the first week in September. The licensee's Thyroid Count Report Forms showed the following data relating this incident:
Individual Date of Couat Thyroid Burden Date of Uptake (9/7/78)
V 10/20/78 0.494 uCi 1 uCi = 1.39 times MPC for I-125 W
10/21/78 1.61 uCi 3.49 uCi = 4.82 times MPC for I-125 11/29/78 0.84 uCi X
9/7/78 0.932 uCi
.932 uCi = 1.28 times MPC for 1-125 Y
10/27/78 0.319 uCi
.727 uCi = 1.004 times MPC for I-125
~
Z 10/6/78 0.282 uCi
.455 uCi =.63 times MPC for I-125 Individual W is the person for whom the li ensee submitted the letter dated November 20, 1978. The licensee in that letter stated that based on their analysis of the incident, they believed that Individual W had a thyroid uptake of about 3.94 microcuries on or about September 1, 1978. The licensee in that letter stated that four other indiviluals ia the laboratory had thyroid doses ranging from approximately 4 rems to 2 rems as a result of the incident.
A rurther investigation by the licensee failed to show any specific incident which caused these uptakes. Bioassay measurements made on and before September 1,1978, show little uptake. A measurement of individual X showed an uptake by September 7, 1978. The 880 038
licensee concluded that an incident or incidents occurred between September 1 and September 7, 1978, resulting in the above thyroid burdens for individuals working in this laborato ry.
The thyroid burden equivalent to the quarterly exposure limit is 0.725 uCi. This value is calculated from the maximum permis-sible concentrations for iodine-125, the total volume of inhaled air from footnote 3 to 10 CFR 20.103 and the models for assess-ment of individual intakes specified in footnote 5 to 10 CFR 20.103.
Using the licensee's data and the above value one concludes that four of the five persons working the Laboratory 927 in the Mayo Building where iocine-125 iodinations were performed during the third quarter of 1978 showed iodine uptakes in excess of that which would result from iodine 125 for 40 hours4.62963e-4 days <br />0.0111 hours <br />6.613757e-5 weeks <br />1.522e-5 months <br /> per week for 13 weeks at uniform concentrations specified in 10 CFR Appendix B, Table 1, Column I.
This is an item of noncom-pliance with 10 CFR 20.103(a)(1) in that these four persons had th=;roid uptakes which were equivalent to being exposed to 1.39, 4.82, 1.28 and 1.004 times the maximum permissible concentrations in air for iodine-125.
It was also noted during a review of the iodine-125 iodination and iodine-131 dispensing and adminis-tration use records that individuals who had administered iodine-131 doses to patients on January 12, 1978, August 4 and 10, 1978, and several other occasions in quantities in excess of 75 millicuries did not receive thyroid readings within one week after the administration.
Thyroid counts were not performed on persons performing iodinations with iodine-125 in excess of 0.5 mci in Laboratory 927 of the Mayo Building within the specified one week period after the iodination. For Example, Individual W performed iodinations on March 21, 1978, July 31, 1978, September 7, 1978, and October 5, 1978 and did not receive a thyroid count until October 24, 1978.
Similarly, Individual X conducted iodinations on May 24, 1978, June 9, 1978, June 23, 1978, July 10, 1978, July 21, 1978, August 7, 1978, and August 9, 1978; the thyroid count for this period was taken on September 7, 1978.
Likewise, Individual Z performed iodinations on April 14, 1978, May 12, 1978, June 9, 1978, and June 26, 1978, and did not have a thyroid count until August 24, 1978. This is an item of noncompliance with License Condition 19 which references a letter dated February 25, 1975, which requires that for individuals who use iodine-125 and/or iodine-131 in procedures where volatilization is likely, (protein labeling, other experi-ments of similar potential), thyroid counts will be performed within one week for single operations involving one millicurie er more of iodine-131 or 0.5 millicuries or more of iodine-125.
880 039 This is a repeat item of noncompliance noted from the previous inspection.
In the Nuclear Pharmacy, the bioassay records are maintained by the Radiation Physicist for Nuclear Medicine. These records show that a person had a thyroid uptake of 0.17 microcuries of iodine-131. This was measured 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> after that person administered a therapeutic dose of iodine-131 to a patient.
This occurred during the week of August 25, 1977. The individual had been monitored the previous week and showed no uptake at
^
that time. The licensee had made no evaluation of the cause of the uptake. There was no records of action taken to assure against recurrence.
An exposure to an airborne concentration of iodine-131 at the maximum permissible concentration for a restricted area for 40 hours4.62963e-4 days <br />0.0111 hours <br />6.613757e-5 weeks <br />1.522e-5 months <br /> in seven consecutive days would result in a thyroid uptake of 0.100 microcuries.
Since the individual had an uptake greater than 0.100 microcuries in a period less than
'ven consecutive days and since the licensee failed to eval-cate this exposure and take action to prevent recurrence, this i.s an item of noncompliar~e with 10 CFR 20.103(b)(2) in that the licensee failed to make such evaluations and to take such actions which are necessary to assure against recurrence any time an individual exceeds that which would result from inhalation of such material for 40 hours4.62963e-4 days <br />0.0111 hours <br />6.613757e-5 weeks <br />1.522e-5 months <br /> at the uniform concen-trations specified in 10 CFR 20 Appendix B, Table I, Column I, and document the same in a form suitable for summary review and evaluation.
Three items of noncompliance were identified.
b.
Airborne Monitoring Required by 20.103(a)(3)
At the time of the November 30, 1978 inspection the licensee did not have a routine air monitoring program to measure airborne concentrations of radioiodine in restricted areas.
Bioassay results (Paragraph 10.a) showed the presence of airborne areas in both the Nuclear Pharmacy and Laboratory 927 in the Mayo Building. Furthermore, one individual working in laboratory 927 at that same time as thyroid measurements showed other persons in the areas had been overexposed, never had his thyroid counted until after the start of this inpsection.
This is an item of noncompliance with 10 CFR 20.103(a)(3) in that no airborne measurements were made, and for one individual bioassay measurement either, to determine comp 3iance with 10 CFR 20.103(a) and (b).
- 880 040
As a result of an Immediate Action Letter sent to the licensee by RIII on December 7, 1978, the licensee began taking air samples during each radioiodine labeling procedure in restricted areas to determine area concentrations. Also, all use of volatile radiciodine was restricted following receipt of the letter. Each user now must schedule radioiodinations with the Radiation Protection Officer. Thyroid counts are performed on all radioiodine users within one week of use.
For those who use radioiodine at a frequency greater than once each month, a thyroid count is given at least monthly.
One item of noncompliance was identified.
11.
Surveys - License No. 22-00218-29 Each authorized user is responsible for making adequate surveys and maintaining permanent records of the survey results as stated in the
" University of Minnesota Manual of Policies and Procedures for Radiation Protection" under Periodic surveys of Radioisotope Facilities.
The Department of Environmental Health and Safety recommends that surveys be made weekly but requires surveys every three months for the quarterly report. Research labs are surveyed quarterly or semi-annually by the Department of Environmental Health and Safety for the larger authorized users on campus but less frequently for other users. A review cf the Department of Environmental Health and Safety survey records indicate they were accomplished as required and no problems were noted.
The Nuclear Pharmacy is surveyed daily by clinical personnel and on a sporatic monthly basis by the acting Radiation Protection Officer
the Nuclear Medicine Department.
Surveys of the Nuclear Medicine separtment are performed quarterly by the members of the Department of Environmental Health and Safety and in addition they also take quarterly surveys of the Nuclear Pharmacy.
Survey records indicate that the surveys required by the Department of Environmental Health and Safety were taken quarterly and the surveys of the Nuclear Pharmacy taken daily and no significant problems were noted.
No items of noncompliance were identified.
12.
Airborne Eftluent Fume hoods used for the handling of radioactive material in both the Nuclear Pharmacy and in all radionuclide labeling areas vent to the unrestricted areas with no filtration for radioiodine. No evaluations or surveys were made by the licensee to determine compliar-
'.th 10 CFR 20.106(d) with respect to the concentration of radioact ty in unrestricted areas during 1978 until the latter part of December
,' 1978. This occurred in spite of the fact that thyroid bioassay data showed that airborne radioiodine was being generated in the hoods 880 04i.
which were being vented to unrestricted areas. This is an item of noncompliance with 10 CFR 20.201(b) which requires the licensee to make such evaluations or surveys.
On the basis of collectiag iodine-131 effluent samples from the radiopharmacy hood vent during separate dose dispensing operations on December 18, 20, 21 and 29, 1978, a determination was made of airborne concentrations released when working with less t!1an 50 mci, and the concentration released when working with greater than 50 3Ci.
Assuming the operations to be representative, and based on known dispensing operations during 1978, the licensee calculated for the year 1978 that the iodine-131 daily average release concentration 9
was 3.5 x 10 microcuries,pgr ml which exceeds the limit for iodine-131 which is 1 x 10 microcuries per ml when averaged over one year. This is an item of roncompliance with 10 CFR 20.106(a) which requires that byproduct material not be released to an unre-stricted area in concentrations which exceed Part 20 limits. The inspector brought to the licensee's attention at the close out meeting at the end of the inspection on Janaury 12, 1979, the fact that iodine-131 cannot be continued to be released to unrestricted areas in concentrations in excess of the unrestricted area MPC's.
Two items of noncompliance were identified.
13.
Waste Disposal - License No. 22-00218-29 Solid waste is discarded into labeled radioactive trash cans, usually fitted with a thick plastic disposable liner. The user notifies the Radiation Safety Officer when the can's capacity is reached and the Radiation Safety Officer arranges a time for pickup and disposal.
The solid waste is picked up and stored at the University's Rosemont facilities; it is later disposed by a contractor under the licensee's waste disposal License No. 22-00187-49 license. Radiation waste management procedures for solid and liquid waste are outlined in the
" University of Minnesota Manual of Policies and Procedures for Radiation Protection." The licensee is authorized to receive waste byproduct material from the customers who received the material under the 22-00187-48MD license. Radioactive waste records were not reviewed during this inspection but will be reviewed in the near future during an inspection of the licensee's nuclear waste disposal License No. 22-00187-49.
No items of noncompliance or deviations were identified.
- 14. Description of Facilities - License No. 22-00218-29 Laboratory Complex No. 920-930 Mayo Building - This microbiology researchlaboratoryisoneofthelaggesb2usef55 n camggs; the user's permit authorized the use of H,
P, I and S in millicurie amounts. The laboratory has approximately 1500 square 880 04.2
feet working area for 17 workers. One authorized iodination hood, having no charcoal filter at the time of inspection, is in this laboratory. The laboratory has a Geiger-Muller counter for surveying the areas.
Nuclear Pharmacy - The Nuclear Pharmacy is located in the basement of the Mayo Building. One working laboratory is used to prepare doses for distribution to 25 customers in the Minneapolis-St. Paul area in addition to the Nuclear Medicine Department of the University of Minnesota. An iodination hood is located in this room but did not have a charcoal filter at the time of inspection. Two radiophar-maceutical research laboratories are within the Nuclear Pharmacy across the hall from the preparation room. Two staggered shifts of employees reduce overcrowding in a limited area.
Nuclear Medicine Departnient - A corridor runs through the Nuclear Medicine Department which is used for through traffic of moderate volume of medical personnel and students. The laboratory, used for reassaying and storage of doses, opens onto this corridor and is kept open during the day, usually a technician is only in attendance while preparing doses. Bone scan doses are kept on a desk within the corridor without adequate security measures.
(See Paragraph 7.e)
Doses, except for radiciodine, are administered in the Nuclear Medicine Department. Facilities for brain, whole body, renal scans and xenon gas adminfetration were observed. This department also has a thyroid counter that is used for clinical purposes and thyroid bioassay of nuclear medicine technicians working with radioiodine.
15.
Shipping Incidents - License No. 22-00187-48MD According to licensee records, and a report dated September 13, 1978, (Attachment 2) three doses of technecium 99, which were shipped from the Nuclear Pharmacy on August 2,1978, were lost on that date.
The doses, totalling 25 millicuries, were sealed in a lead tube and placed on the back truck bumper of a delivery car to be loaded for transport. The tube was left on the bumper and fell off the car onto the road during transit. The tube containing the three undamaged doses was found August 17, 1978, in Minneapolis. The Minnesota State Department of Health measured no detectable radiation and notified the University at 4:30 p.m.
The Radiation Protection Officer of the University was not notified of the loss until the doses were found on that date. At the time of the loss, a search was made by delivery personnel in the local area. These lost doses were " extras" not sch'duled for delivery but kept on hand in the car if a call were received from a hospital enroute that requested additional doses.
The delivery policy did not require at the time that extra packages be logged on a delivery sheet; consequently, the fate of the lost shipment was not recorded. The licensee has since changed its procedure for logging receipt of radioactive material that is shipped, but not delivered, to customers in the Minneapolis 880 043
area and returned tc the licensee. A review of these logs from the date of this incident indicate that the licensee has in fact recorded all return doses.
No items of noncompliance were identified.
- 16. Notification and Reports It was noted during the inspection that notices to workers were provided by the licensee as required by 10 CFR 20.405 and 10 CFR 19.13.
On November 1, 1978, the licensee submitted a report of thyroid dose exposures to four individuals who were exposed to iodine-125 airborne concentrations in excess of 10 CFR 20.103(a) limits during the third quarter 1978. This report was determined to have been submitted in a timely manner as required by 10 CFR 19.13(d).
No items of noncompliance were identified.
17.
Emergency Preparedness Program The licensee's Radiation Emergency Program is described in the "Univeriity of Minnesota Manual of Policies and Procedures for Radiation Protection." These procedures also include information and instructions for nurses in cases where radioactive spills occur during patient care. A specific review of the licensee's program was not made during this inspection.
No items of noncompliance or deviations were identified.
18.
Environmental Monitoring Program The licensee does not have any requirement to conduct a formal environmental monitoring program nor have they performed any environ-mental sampling through December 1978.
No items of noncompliance or deviations were identified.
~
19.
Confirmatory Measurements Independent direct area surveys taken in the Nuclear Pharmacy preparation room indicate radiation fields ranging from 1 to 4 mR/hr. Radiation fields in the hallway outside this area were less than 0.2 mR/hr.
No items of noncompliance or deviations were identified.
20.
Management Exit Interviews - Licenses No. 22-0218-29 and No.
22-00187-48MD Those subjects inspected during this inspection as outlined in the Details of this report were discussed with personnel denoted by an asterisk in Paragraph 1 during an exit interview on January 12, 1979. 880 044
The following items were specifically discussed at this meeting:
a.
The items of noncompliance.
b.
Licensee action with respect to previously identified enforcement matters.
c.
Extremity exposures of a nuclear pharmacy worker whose exposures are constantly higher than other workers.
^
d.
The results of discussions inspectors had with several workers concerning training.
e.
The licensee's response to the Immediate Action Letter sent to the licensee by RIII dated December 7, 1978.
f.
The inspectors request for evaluations to be made by the licensee concerning the following matters:
(1) To establish a bioassay program to determine phosphorus-32 intake levels for certain workers.
(2) That quarterly velometer readings be made of all hoods where radioiodine labeling and volatile radiation is used.
(3) To detemine if Nuclear Pharmacy personnel are wearing their whole body badges in a position that reflects the greatest wh'le body exposure.
g.
An outline of the various enforcement options available to the Commission.
h.
The effectiveness of the All University Radiation Protection Advisory Committee concerning management control.
i.
The request by RIII to meet with the President of the University to discuss the items of noncompliance, the licensee's corrective action, possible enforcement action and the role of the Radiation Protection Advisory Committee.
21.
Management Meeting - February 14, 1979 A management meeting was held on February 14, 1979, at the University of Minnesota to discuss the findings of this inspection and the management of the licensee's radiation protection program were the topics of discussion. The meeting was attended by licensee management representatives denoted in Paragraph 1.
Region III was represented by Mr. James G. Kepple, Director; Mr. A. B. Davis, Chief, Fuel Facility and Materials Safety Branch; Dr. C. J. Paperiello, Chief, Materials Radiological Protection Section 1; Mr. R. Paul, Radiation Specialist; and Dr. J. W. Cooper, Chief, Regional Licensing Branch. B80 045
t The NRC representatives stated the purpose of the meeting was to discuss the inspection findings, review the NRC regulatory program and the enforcement options available to the NRC and review the items of noncompliance with the licensee and obtain their assessment of their management control over the program.
At the request of the licensee, each item of noncompliance was discussed in detail and the licensee presented proposed corrective action for specific items.
With respect to changes in management control no definite proposals were made by the licensee.
An individual licensee representative noted that the size of the program in the Nuclear Pharmacy grew significantly in the past two years since the last inspection.
880 046
.