ML20052G962
| ML20052G962 | |
| Person / Time | |
|---|---|
| Issue date: | 04/29/1982 |
| From: | Riedlinger B NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION V) |
| To: | |
| Shared Package | |
| ML20052G957 | List: |
| References | |
| NUDOCS 8205190190 | |
| Download: ML20052G962 (8) | |
Text
._
Veterans A fninistration 'fospital bN The responses directed by this letter and the accomoanying '!otice are not subject to the clearance procedures of the Office of Management and nudget as required by the Paperwork Reduction Act of 1980, PL 96-511.
If you have any questions on this matter or concerning this inspection, please telephone R. Ried11nger on 415-943-3700.
Sincerely,
- Tis: m w u.c.,,
L L 5 fact.
George S. Spencer, Director Division of Radiological Safety and Safeguards Program
Enclosures:
'\\. *!otice of Violation 9
Federal Register !!atice 47 FR 9937 bcc:
DMB/ Document Control Desk (RIDS)
Distributed by RV:
State of CA RHE A. Johnson LFM3 8205190190 820429 NMS LIC30 04-00421-05 PDR
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W APPENDIX A
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"0TICE'0F VIOLATIOy Veterans Administration Hospital-License '30. 04-00421-05 42nd Avenue ?< Clement Street San Francisco, California 94121 As a result of the inspection conducted on April 6, 7 and 8, 1982, and in accordance with the 4RC Enforcement Policy (10 CFR Part 2, Appendix C),
47 FR 9987-(March 9, 1982),.the following violations were identified:
A; License Condition 20. states that the licensee shall possess and use licensed material in accordance with statements, representations, and procedures contained in the application dated March 8, 1978, and letters with attachments dated May 9, 1979 and July 6, 1979.
Item 3b. of Attachment 1
" Medical Isotope Committee," submitted with the letter dated May 9,1979, states that the Medical Isotope Committee "will' review and 9 rant permission for, or disapprove, all uses of radioactive byproduct material (both experimental and routine uses) within this institution in conformance with URC regulations, specific conditions of the institutional license and its amendments, and with regard to established hospital radiation safety procedures and guidelines."
In addition, Iten da. of Attachment 1, submitted with the letter dated
[
~ May 9,1979, states that the Medical. Isotope Committee requires a quorum of five members.
1 1.
Contrary to these requirements only the Radiation Safety Officer i~
and the Chairman of the Medical Isotope Committee have reviewed and approved or disapproved of research involving non-human use-4 studies conducted between October 11, 1979 and April 8, 1982.
2.
Contrary to these requirements, at the time of the inspection an unapproved hepatocyte research project was being conducted j
. using tritium. The Radiation. Safety Officer confirmed that the
. study was in progress and that no protocol had been submitted for approval.
- The above items constitute a #everity Level IV Violation _(Supplement VI).
l-1.
License Condition 20. states that the licensee shall possess and use
- licensed material in accordance with statements, representations,
' and procedures contained in the application dated March 8,1978, and f
letters with attachments dated May 9,1979 and July 6,1979.
- Section III., " Ordering and Receipt of Radioactive Material" of the Radiation Safety Manual submitted with the application ~ dated Starch 8, 1978 states:
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' "Due to affiliation of this instit'stion with the University of California there must exist two mechanisas for keeping the Radiation Safety Officer aware of the incoming radioisotope shipments to tHs institution.
For orders that are placed with non-V.A. funds, either a copy of the order must be sent to the h diation Safety Officer, or, written notification with the equivalent infomation must be sent to the Radiation Safety 9fficer at the time that the order is placed with the non-V.A. procurement Source.'
Contrary to these requirements, the following materials were ordered through the University of California at San Francisco and were delivered eiirectly to the Nephrology Laboratory without notification of the
%diation Safety Officer:
. Order Date Activity Material 6/1/81
?50 microcuries C-14 5/5/81 1 millicurie C-14 This is a Severity Level IV Violation (Supplement VI).
C.
License condition 20. states that the licensee shall possess and use licensed material in accordance with statements, representations, and procedures contained in the application dated March 8, 1973, and letters with attachments dated 'tay 9,1979 and July _6,1979.
Itern C., section VIII, " Instrument Calibration" of the hdiation Safety
'4anual states that the dose calibrator must be checked for geometrical variation at the time of the initial installation.
Item C. also states that " daily reference checks of a long-lived source yielding a reading Tccuracy of iST" are required. Also, " variation greater than 15%
dictates that recalibnation is necessary."
1.
Contrary to these requirements, no geometric variation test had been performed on the Capintec CRC-104 dose calibrator with San Francisco V.A. Hospital Number 6625-5277, which was in use in the Nuclear !fedicine Department at the time of the inspection.
2.
Contrary to these requirements, daily reference checks disclosed readings outside the 15% accuracy range on 8/24/81, 8/25/81 and 8/26/81. Recalibration was not performed.
The above items constitute a Severity Level IV Violation (Supplement VI).
D.
License Condition 20. states that the licensee shall possess and use licensed material in accordance with statements, representations, and procedures contained in the application dated March 8, 1978, and letters with attachments dated '>!ay 9,1979 and July 6,1979.
.Section IX., ' Radioactive "aste Disposal"-of the Radiation Safety Manual submitted as part of the application dated March 8, 1978, states:
"No radioactive waste will be disposed of by conventional trash disposal
~
methods. All potentially contaminated materials are considered radioactive until and unless a survey by the Radiation Safety Officer o; his designee reveals that contamination levels are less than 0.1 mR/hr as measured with a G.fl. survey meter."
Contrary to this requirenent, at the time of the inspection, the inspector observed radioactive waste in a normal trash container in the !!uclear Medicine Laboratory. The waste was measured by the inspector at 0.8 mr/hr, using a G'1 survey meter (NRC #007907, E-520, calibrated on 3-9-82).
This item is a Severity Level IV Violation (Supplement VI).
E.
License Condition 20. states that the licensee shall possess and use licensed material in accordance with statements, representations, and procedures contained in the application dated March 8, 1978 and letters with attachments dated '4y 9,1979 and.luly 6,1979.
Section VI., " Contamination Surveys" of the Radi-ation Safety Manual sul,aitted with the application dated ' larch 8,1978 states, "All preparation, elution and injection areas will be surveyed daily with a G.P. survey neter and decontaminated if necessary. For daily surveys where no abnormal exposures are found, the entry into your survey record will include the date, identification of the person performing the survey and result of the survey (either neqative or specific positive results)."
Section VI also states that " laboratory areas where only small amounts of radioactive material are used (less than 100 microcurie) will be surveyed monthly.
Other radioactive areas will be surveyed weekly."
The weekly and monthly survey will consist of the following:
A measurement of radiation levels with a' survey meter sufficiently sensitive to detect 0.1 mR/hr. Laboratories utilizing only hydrogen-3 and/or carbon-14 are exempt from this requirement.
A series of wipe tests will be performed to measure contamination levels in the work areas of your laboratory.
The method for nerforming such tests will be sufficiently sensitive to detect 100 disintegrations per minute.
A permanent record will be kept of all survey results, including negative results.
1.
Contrary to these requirenents, at the time of the inspection, the preparation, elution, and injection areas were not being surveyed on a daily basis.
_j
2.
Contrary to these requirements, no surveys for removable radioactive contamination have been conducted in the Nuclear fledicine Laboratory areas for the past two years.
Each week molybdenum-technetium generators containing two curies of licensed naterial have been used in these areas.
Surveys for removable radioactive contamination were not made in the Nephrology Research Laboratory, Room 40C, between November 19, 1981 and April 7, 1982. At the time of the inspection, 1.5 mil 11 curies of hydrogen-3 and 3.0 millicuries of carbon-14 were possessed and used by this laboratory.
Surveys for removable radioactive contamination were not made in the G.I. Research Laboratory, Room IC-12, between February 3, 1982 and April 7, 1982. One millicurie of sulfur-35 and 20 millicuries of iodine-125 were possessed and used in this laboratory.
The above items constitute a Severity Level IV Violation (Supplement VI).
F.
License Condition 20. states that the licensee shall possess and use licensed material in accordance with statements, representations, and procedures contained in the application dated March 8, 1978, and letters with attachments dated May 9, 1979 aad July 6, 1979.
The memorandum dated '4 arch 14,1979, " Volatile Procedures Involving Radioisotopes" which was attached to the letter dated ' lay 9, 1979, states that " urinalysis will be done on all radioisotope workers employing at least microcurie amounts on a regular basis.
For those utilizing radioisotopes sporadically, urinalysis will be done immediately following any major procedure. Urinalysis is _ absolutely re giced following any multi-millicurie or volatile procedure." Also, the letter states that "all therapeutic quantities of 1-131 are shipped directly to Nuclear Medicine Service where they are processed as per procedures in'" Volatile Procedures Using Radioisotopes".
The Radioisotope is brought to the patient's room sealed in two lead containers. The patient is administered the dose orally and will remain in the room until exposure and contamination hazards have been reduced to an acceptable level.
All contaminated articles are disposed of as nuclear waste and urinalysis is performed as soon as possible to assay any uptake of I-131 by the technician.
1.
Contrary to these requirements, no urinalyses were performed on individuals who administered liquid iodine-131 to patients on the following dates:
11/03/81 150 millicuries 08/19/81 150 millicuries 07/15/80 150 millicuries 04/10/80 100 millicuries
2.
Contrary to these requirements, no urinalyses were performed on researchers who performed iodination procedures using 3 millicuries of iodine-1?5 on 9/2/31 and 1 millicurie of iodine-125 on 3/2/82..
The above itens constitutea Severity Level IV Violation (Supplement VI).
G.
License Condition 13.C. states that each sealed source containing licensed material, other than hydrogen-3, with a half-life greater than thirty days and in any form other than gas shall be tested for leakage and/or contamination at intervals not to exceed six months.
Contrary to this requirement, a 10 curie americium-241 source used in an x-ray fluorescence analyzer was leak tested on.luly 31, 1979 and was not leak tested again until April 15, 1980, a period in excess of eight months. After the leak test of April 15, 1980, the tource was not leak tested again until January 20, 1981, a period in excess of nine months. Subsequent to the January 20, 1981 leak test, the source was not tested again until August 31, 1981, a period in excess of seven months.
This item is a Severity level IV Violation (Supplement VI).
H.
An Order to all nedical licensees pertaining to the performance of molyhdenum 49 breakthrough tests was issued by the Nuclear Regulatory Commission on '4 arch 12,1079. The Order requires the following:
Beginninq as soon as feasible but within ten (10) days of the date of this Order, technetium-99,containing more than one (1) microcurie of molybdenum-99 per millicurie of technetium-90m or more than five (5) micrncuries of molybdenum-99 per dose of technetium-99m shall not be administered to patients. The limits for molybdenum-99 contamination represent maximum values and molybdenum-99 contamination should be kept as low as reasonably achievable below these limits.
Seeinning as soon as feasible but within ten (10) days of the date of this Order, the licensee shall establish written procedures for personnel performing molybdenum-99 breakthrouch tests including all necessary calculations and steps to be taken if quantities of molybdenum-99 in excess of the above specified limits are detected.
Personnel performing molybdenum-99 breakthrough tests shall be given specific training in performing these tests prior to conducting such tests.
The licensee shall maintain for inspection by the Nuclear Regulatory Comission records of the results of each molybdenum-99_ breakthrough test performed and records of training given to personnel performing the molybdenum-99 breakthrough tests.
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r 9 Records described above shall be maintained for two (2) years following performance of the tests.
1.
Contrary to these requirements, at the time of the inspection, written procedures for personnel performing molybdenum-99 breakthrough tests had not been prepared.
2.
Contrary to these requirements, at the time of the inspection, the 9enior 'luclear '1edicine technician who elutes the molybdenum-99 generator on a daily basis had never been given specific training by the V.A. Hospital in performing molybdenum-99 breakthrough tests.
3.
Contrary to these requirements, no records were maintained of the results of molybdenum-99 breakthrough tests that were performed on a daily basis between January 11, 1982 and April 8, 1982.
The above items constitute a Severity Level IV Violation (Supplement VI).
I.
10 CFR 20.201(b) states that each licensee shall make or cause to be made such evaluations as may be necessary for the licensee to comply with the regulations in 10 CFR Part 20.
Contrary to this requirement, no evaluations have been made since October 11, 1979 to assure that the sum of all materials disposed to the sanitary sewer did not exceed the limits specified in 10 CFR 20.303.
This item is a Severity Level IV Violation (Supplement IV).
1.
License Condition 20. states that the licensee shall possess and use licensed material in accordance with statements, representations, and procedures contained in the application dated March 8, 1978, and letters with attachments dated May 9, 1979 and July 6, 1979.
Item 7, page 34 of the Radiation Safety Manual submitted with the a? plication dated March 8, 1978 states, "Do not eat, drink, smoke or apply cosmetics in any area where radioactive material is stored or used.
Never store food in a radioisotope storage refrigerator or location."
Contrary to this requirement, the inspector observed licensee representatives eating and drinking in a laboratory where 1.5 millicuries of hydrogen-3 and 3.0 millicuries of carbon-14 are stored and used. The inspector-also observed food which was stored in the laboratory area and cigarette butts on the floor of the laboratory.
This item is a Severity Level V Violation (Supplement VI).
J '
K.
License Condition 20. states that the licensee shall possess and use licensed material in accordance with statements, representations, and procedures contained in the application dated March 8, 1978, and letters with attachments dated May 9, 1979 and July 6, 1979.
1.
Item 3a. of Attachment 1, " Medical Isotope Comittee," submitted with the letter dated May 9,1979 states that the Comittee "will ensure that the license is amended, when necessary, prior to any changes in facilities, equipment, policies, procedures and personnel."
Contrary to this requirement, the license was not amended when 4
the approval procedure for non-human use protocols was revised from that stated in the Radiation Safety Manual submitted with the application dated March 8, 1978, or when the dosage ranges for several nuclear medicine procedures were made less restrictive on April 28, 1981, or when the maximum amounts of radioactive materials that may be disposed to the sanitary sewer on a daily basis were increased on December 16, 1980, or when the new Radiation Safety *1anual was approved by the Medical isotopes Committee on April 28, 1981.
2.
Yter 4b. of Attachment 1, " Medical Isotope Comittee", submitted
+
with the letter dated "ay 9, 1979 states, "The Medical Isotope Committee will hold regular meetings once every calendar quarter."
Contrary to this requirement, the Medical isotope Comittee did
~
not hold regular meetings once every calendar quarter during the years 1980 Ond 1981. Meetings of the Isotope Corrnittee were held on the following dates:
4/15/80, 9/16/80, 12/16/80, 4/28/81 and 8/6/81.
The above items constitute a Severity Level V Violation (Supplenent VI).
L.
License Condition 20. states that the licensee shall possess and use licensed material in accordance with statements, representations, and procedures contained in the application dated March 8, 1978, and letters with atta:hments dated May 9, 1979 and' July 6, 1979.
The letter dated May 9,1979 states that "any new employee who shall be employed in or frequenting a " Radiation Area" is directed to the Radiation Safety Officer (RS0) ror orientation. The RSO outlines the Radiation Safety Program and presents a 45 minute coordinated slide and tape show covering
" Principles of. Ionizing Radiation and Basic Radiation. Protection" and " Prenatal Radiation Exposure". After the presentation the RSO makes coments applicable to the new employee's situation and answers any questions."
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, Contrary to this requirement, no training in radiation safety was given by the V.A. Pospital RSO to an employee who has worked for the V. A. lbspital since January 15, 1982. At the time of the inspection, the employee was using hydrogen-3 in a research project.
This item is a Severity Level V Violation (Supplement VI).
ti.
10 CFR 20.203(e) requires each area or room in which licensed material is used or stored and which contains any radioactive material (other than natural uranium or thorium) in an amount exceeding 10 times the quantity of such material specified in Appendix C of 10 CFR 20 to be conspicuously posted with a sign bearing the radiation caution be conspicuously posted with a sign bearing the radiation caution quantity of such material specified in Appendix C, pf 10 CFR 20, to be conspicuously posted with a sign bearing the. radiation caution symbol and the words, " Caution Radioactive Materials".
Contrary to this requirement, at the time of the inspection no " Caution Radioactive Material" postinq was present in the Mcphrology Research Laboratory, Room 100, where 3 millicuries of carbon-14 were stored and used: nor was there any such posting on the door to the Nuclear Waste Roon where 10 millicuries of iodine-125 were being stored.
This item is a Severity Level V Violation (Supplement IV).
N.
10 CFR 19.11(a) and (c) requires that each licensee shall post current copies of 10 CFR lo and 20, the license and supportinq documents, the operating procedures, and copies of Form NRC-3.
Contrary to these requirements, at the time of the inspection none of the required postin1s were present in the Nephrology Laboratory, Room 40C. Licensee representatives working with radioactive materials in Room 40C stated that they had never seen a Form NRC-3.
This item is a Severity Level V Violation (Supplement VI).
Pursuant to the provisions of 10 CFR 2.201, the Veterans Admin _istration
!!aspital, San Francisco, is hereby required to submit to this office within thirty days of the date of this Notice, a written statenent or explanation in reply, including:
- 1) the corrective steps which have been taken and the results achieved;
- 2) corrective steps which will be taken to. avoid further items of noncompliance; and (3) the date when full compliance will he achieved. Consideration may be given to extenrling your response time for good cause shown.
-dated B. R i ed l i ng er, 'RTdi a t'idii~STsifa lTst Radiological Safety Branch s