ML20054A471
| ML20054A471 | |
| Person / Time | |
|---|---|
| Site: | 07001470 |
| Issue date: | 12/21/1976 |
| From: | Book H, Zurakowski P NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION V) |
| To: | |
| Shared Package | |
| ML20049A151 | List:
|
| References | |
| FOIA-82-11 NUDOCS 8204150483 | |
| Download: ML20054A471 (16) | |
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DRAFT INSPECTION REPORT FORM 1.
Name and Address of Licensee 2.
Date of Inspection Sept. 29, 1976 Veterans Admin. Hospital Center Wilshire & Sawtelle Blvds.
3.
Type f Inspecti n Ann unced Los Angeles, California 90073 4
License Number (s). Docket N"mber(s). Number and Date of Last Ahendment for Each License - CateRory and Priority of Each Licensee 04-00181-04, Amendment 67, Aug. 6, 197G, Category
. Priority 2 SIM 1440, Amendment 1, May 27,1976, Category
, Priority 4 5.
Date of Previous Inspection Dec. 3,1974 (-04 license); Initial inspection f or MM-144U 6.
Proprietary Information flone 7.
Scope of Inspection if Other than Routine Routine 8.
Participants (Licensee Representatives & Titles, State Representatives. etc.)
1.
L. W. Wettereau, RSO, Physicist 2.
W. H. Blahd, M.D., Chief,fluclear Medicine Service 3.
Peggy Joe, Ph.D, Radiopharmacist 9.
Management Interview (Infornation Reauired for N/C Cases)
The management interview was held with the first two persons listed in paragraph 8.
10.
Action and Date - Letter to Licensee NRC-591 Clear X (for both licenses)
NRC-591 N/C 11.
Recommend Reincocction Date _Sgplember 1978 P. lR. Zurakowskin. ; ' /s l
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Inspector (s)
Date of Report (W
l Elf 743 Reviewer Date of Review IE:V Form 605 82041504m 820216 PDR FOIA NELSON 82-11 PDR
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. 13.
Inspection Summary The inspection of September 29, 1976 disclosed no items of noncompliance or health and safety significance. A clear form AEC-591 was issued for both licenses at the conclusion of the inspection to reflect these findings.
The last previous inspection also resulted in the issuance of a clear form AEC-591 for the -04 license.
This was an initial inspectin for the SNM license.
14.
Summary of Licensed Program The licensee continues to operate a rather large diversified program in Nuclear Medicine and Research under a broad license.
This involves substantial programs in diagnosis, therapy, research and education.
The Hospital now also employs a full time Nuclear Pharmacist.
During fiscal year 1976 there were 9246 patient visits, an increase of 17%;
39,387 images made, an increase of 56% and 18,106 tests, an increase of 43%.
There were only 15 therapy patients in this same time period, a decrease of 20%.
The Nuclear Medicine Radioimmunoassay Program has continued to expand performing more than 4,200 procedures quarterly'.
A brief description of some of the major research activities are included in the following listing.
Protocals & informed consent forms from patients were examined.
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I s a h/ Vg cc tion of Mvocardial Inf arc tion (Blahd)
Te hnetium-99m pyrophosphate has been used in more than 100 patients c
with suspected
- coronary artery occlusions to identify the presence The diagnostic id. plication of ~
or absence of myocardi,a1 infarction.,is being evaluated.
this technique in patient management Compton Scatter Tomocraphic Imaging (Blahd)
Compton scatter tocography is an imaging technique in which photons scattered out of a primary radiation beam are detected.
The system incorporates a conventional scintillation camera and its dedicated computer together with a specially designed gamma radiation source.
Phantom studies have demonstrated that the spatial resolution of this system is essentially equiv*alent to the inherent sc in tilla tion.
camera resolution, and its precise tomographic capabilities have been demonstrated.
The device was designed for brain imaging.
Human studies are now in prggres's.
Bone Imacine in Parathyroid Disease (Krishnamurthy)
Fif ty-three patients with parathyroid disease have been stud'ied by means of Tc-99=-pyrophosphate imaging procedures.
The results have been compared wi th skel.etal x-ra'y studies and indicate that. bone lesions are detected in these pa~tients by the imaging technique despite normal x-ray studies.
These studies are continuing.
Tc-99m and I-131-Labeled Metronidazole for Liver Scanning (Tubis)
These agents were designed to differentiate amebic hepatic abscesses from other space-occupying 1,esions of the liver.
One of the collabot rators in Brazil has reported successful imaging of liver abscesses using I-131-labeled bromometronidazole in. cases where the abscesses appeared as " cold" lesions using In-113m colloid.
Additional clinical studies are now in progress.
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. Radiolodinated Chlorpropamide foi Pancreas Studies (Tubis)
Chlorpropamide, an oral antidiabetic, has been trace-labeled with I-131 and its distribution studied in mice and rats.
The method of labeling has been much improved and the final compound resembles the original drug.
Distribution studies showed a ratio of concentration in pancreas to liver of 1:2 to 1:3 but may be higher in larger animals.
Labeled chlorpropamide showed an insulin and glucagon release in an isolated rat pancreas preparation.
Further animal and later human studies will be carried out.
Clinical Measurement of Bowel Perfusion (Winston)
Studies of Xc-133 washout rates from bowel wall have been obtained in patients with mesenteric artery occlusion, both before and immediately af ter bypass of obstructed segment by means of surf ace radioactivity counting.
Comparison in patients without this disease indicates only a partial restoration of washout rates right af ter bypass.
Further clinical studies are in progress.
Treatment of Thyrotoxicosis in Graves' Disease (Blahd)
This is a prospective study to evaluate the therapeutic ef ficacy of a I-131 treatment protocol that attempts to deliver 5,000 rads to the thyroid gland of patients with Graves' disease.
A precise dosimetric technique is employed.
To date, 58 patients have been studied.
Radiolabeled Anti-CEA for External Detection of GI Tumors (Blahd)
In this study, a technique has been developed for labeing CEA with indium 111 by means of a conjugation method that employs transferrin.
The primary objective of the study is the use of the labeled antibody for the detection by means of radioisotope scanning of gastro-intestinal cancer.
Clinical studies are now in progress.
Body Composition Changes in Radiation Therapy of Malienancy (Blahd)
Body water and electrolyte studies are being carried out in patients undergoing radiation therapy for bronchogenic and ENT cancer.
In addition, blood from these patients is being examined for evidence of DNA repair by means of a tritiated thymidine labeling technique.
Detection of Multiple Sclerosis by Labeled Leukocytes (Winston)
Work'on isolation and labeling of leukocytes has continued, largely in tumor bearing experiment.a1 animals.
Labels such as Cr-57 and Tc-99m' have been tried in an attempt to study migration of leukocytes
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into a malignant tumor.
When techniques are perfected, it is planned to study human subjects to determine if such migration can be detected in tumors.
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5-Only one use of the SNM license has been made.
One patient has had a pacemaker implanted containing 160 mg of Pu-238.
Dr. R. A. Williams, Asst. Chief of the Cardiology Section has been named the Physician re-sponsible for the care of this patient.
The patient is seen routinely every six months for a physical examination.
On the basis of records
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1 examined, discussions with personnel and observations by the inspector, uses of licensed materials by both licensees appeared to be as i *"
authorized under the subject licenses.
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15.
Oroanization and Administration (An organizational chart has been included as Enclosure,TE) 1 l
There have been no changes in basic organizational structure since the last inspection.
There have been only a few personnel changes and research programs added.
Dr. J. Coburn has been named Head of the Renal Lab and has incorporated Na-22 and H-3 into his research program, i
A new tumor lipid lab under Dr. W. Baker has been formed.
The isotopes used by Dr. Baker are H-3 and C-14.
The Cerebral Circulation Lab under l
Dr. Oldendorf has shut down.
The last previous inspection report l
under the -04 license should be consulted for more detail.
Under the SNM license, Dr. R. A. Williams has been named to replace Dr. J. S. Carey l
as the person responsible for the one patient using a pacemaker con-taining Pu-238.._.
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. 16. Facilities The facilities used by both licensees have not changed since the last inspection.
The last previous -04 inspection report should be consulted for more detail.
However, the entire Nuclear Medicine Prcgram will be moved into the new Hospital Building (which has not been given a number yet) in the next few months.
17.
Equipment Because of the impending move to the new building, a detailed inventory of equipment was available to the inspector.
It is listed below:
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a.
Imaging Equipment - Cameras Searle, Pho/ Gamma Scintillation Camera System, Model HP,1972 Searle, Pho/ Gamma. IV Model 7407A Scintillation Camera,1975 Searle, Pho/ Gamma III Scintillation Camera System, Model 6403, 1969 - upgraded to HP Model, 1974 MDS, Basic Modumed Clinical Computer, 1975 Nuclear-Chicago M-09009 Dual Isotope Display, 1974 Riverside Bio-Engineering Camera (70 mm), Model 801, 1974 l
b.
Imaging Equipment - Scanners Picker Nuclear, Magnascanner II, 3" crystal, Model 6184-D,1964 Picker Nuclear, Magnascanner 500, 3" crystal, Model 2806-K,1970 l
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Picker 11uclear f4agnascanner III, 5" crystal,flodel 500, 1969 Picker riuclear Magnascanner 500, 5" crystal, Model 500, 1969 fluclear-Chicago, Pho/ Dot V, 5" crystal, Model 1775, 1973 Picker fluclear Magnascanner, Dual 5", Model M-1000,19'76 c.
Probes riuclear-Chicago Probe-Scaler Assembly, Model 820582, 1970 fluclear-Chicago Probe-Scaler Assembly, Model 8725, 1971 d.
Other Equipment Picker Renogram Assembly Dual Analyzer /Ratemeter, Model 620-085, 1966 fluclear-Chicago Auto /Garrina Spectrometer, flodel 1085, 1971 Packard Tri/Carb Liquid Scintillation Spectrometer, Model 3320, 1971 Kodak X-Omat Dry Film Processor, Model M6A-fi,1970 Kodak X-Omat Dry Film Processor, Model M6A-fi,1972 Technical Associates, Portable Analyzer-Scaler Model FS-7 AP,1976 Capintec Dose Calibrators, with CXC9 Dose Computers (2),1975 Picker fluclear Ultrasonoscope, Model 1020-2, 1972, with Dynamic Range Scan Converter, 1975
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Olivetti Desk Programmer, Model 101, 1969 Whole-body Counter (constructed in 1959) 5" steel chamber 4" x 8" crystal fluclear Data 512-channel Analyzer System, Series 2200, 1971
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_ Computerized System (1) Dedicated scintilation camera computer Medical Data Systems (MDS) l Unicam model, 1975 Purchase Cost:
$65,000 (2) The MDS Unicam computer is a software based system. As such, the software is an integral part of the unit and is included in the purchase cost.
l (3) Software capabilities:
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Acquisition in 64 x 64, or 128 matrices Light pen region of interest selection j
Curve generator programs i
Math analyzer programs Image enhancement Quality control (4)
Software is upgraded every six months by MDS and is an integral part of the contract cost.
18.
Radiological Safety Procedures The licensee has developed a Procedures Manual, May 1974 (Appendix D) and QC procedures.for counting instruments (Appendix E) both of which are considered Proprietary and are not to be released.
These 1
procedures were. developed in response to an AMA requirement for hospita,1 certification.
These procedures are available to all authorized users of licensed materials.
For the SilM license, the procedures used are those i
i submitted with the application for the current license.
fio changes have been made to any of the procedures without Licensing Review. All Part 19 requirements were being met by both licensees- (L. W. Wetterau is the RSO for both licenses.)
A very significant training program,is conducted for both professional and technical staff and for residents, interns and trainees.
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a.
Description of Residency Training The Nuclear Medicine Service has an AMA-approved residency program.
Physicians seeking eligibility for certification by the American Board of Nuclear Medicine take two years of residency training.
Formal, instructional activities include regularly scheduled lectures, laboratories, seminars, and conferences.
Residents receive instruction in the theoretical and practical aspects of diagnostic and ' therapeutic nuclear medicine.
I.nstruction includes lectures in relevant basic sciences such as nuclear physics, radiation biology, radiopharma-
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ceuticals, statistics, radiation protection, and instrunentation.
Residents spend about two-thirds of their time. participating in the Nuclear Medicine Service clinic activities uhich provides the oppor-tunity for direct patient care.
During FY 1976 three' physicians were trained in nuclear medicine.
One of the three is now board eligible in Nuclear M'edicine.
One resident who received training during FY 1975 took and passed the ABNM examination in September of 1975.
b.
Basic Scientists Nuclear Medicine scientific personnel offer the following courses:
13 hr/qrtr Radioisotope Handling and Safety Physical Aspects bf Nuclear Medicine -
12 hr (1 qtr/yr)
Radiopharmacy -
12 hr (1 qtr/yr) 12 hr (1.-qtr/yr)
Radiobiology 12 hr (1 qtr/yr)
Radioimmunoassay Nucicar Medicine Technologist Training
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The Nuclear Medicine Service conducts a one-year AMA-approved
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training program in Nuclear Medicine Technology.
Training includes didactics covering clinical applications of radio-n'uclides, in vitro testing, radiation safety, radiopharmacy, radiobiology, nucicar physics. and nuclear instrumentation.
In addition, trainees receive laboratory and clinic experiences.
Upon ccmpletion of the program, trainees are eligibic for the examination in Nuclear Medicine of f ered by the ARRT.
During each of the past two yqars, 4 trainees were in the program.
Pour trainees are currently enrolled.
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d.
. Radiopharmacy Training During the past six years the Nuclear Medicine Service and the University of Southern California School of Pharmacy have co-sponsored Radiopharmacy training.
The program culminates in a !! aster's degree in Radiopharmacy from the University of Southern California.
The training year has been divided into an academic portion (9 months) and internship (3 months).
Internship is provided within the Nucicar Medicine Service.
Beginning in FY 1977,' a stipend will be paid for the internship period only.
Three trainees are funded each year.
The RSO takes a very active part in the training which takes place in a college type atmosphere.
The fall schedule shows fir. Wetterau as one of the principle instructors.
SCHEDULE 1976 FALL COURSE Dr. Mirell H story & Review Radiation Safety Dr. Mirell Oc t 7 i
14 Atomic Structure - Terminology Dr. Mirell 21 Radioactivity - Unita - Decay Schemes Dr. Mlrell 28 Interaction of Radiation with Matter Mr. Vetterau Nov 4 Detection of Radiation - Units of Measurement Dr. Gambino 11 Biological Effects of Radiation, I Mr. Vetterau 18 Principles of Radiation Safety Dr. Gambino Dec 2 Biological Ef f ects of Radiation, II 9 Control of Contamination, and Waste Disposal Mr. Wetterau Mr. Wetterau 16 Liquid Scintillation Counting - Principles Mr. Wetterau 23 Ca=ma Ray Spectrometry
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. 19.
Personnel Monitoring and Exposure to External Radiation Monthly film badges and TLD finger rings are supplied and evaluated by Radiation Detection Company of Sunnyvale. At the time of the inspection 72 badges and 22 finger rings were being used.
Exposures in general were
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quite low, the high quarterly exposure being about 50 mrem and the high finger ring exposure was approximately 400 mrem.
The one patient wearing a pacemaker does not use a film badge or TLD dosimeter.
20.
Exposure of Employees to Airborne Radioactive Materials There is no evidence that employees are exposed to airborne radioactive j
material.
All leak tests have been negative.
The health physics log disclosed no major spills where airborne material would be released.
21.
Effluents to Unrestricted Areas The RSO stated that th~ey do not release radioactive materials to unrestricted areas via effluents.
22.
Disposals The services of W. H. Hutchinson and Sons (Cal Salvage) are utilized for waste disposal.
Approximately 15-18 55 gallon drums per quarter are picked up by Cal Salvage.
Shipments average 19-100 mci per quarter.
Records of disposal are maintained.
No disposals of SNM have been made.
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. 23.
Mi_scellaneous Surveys, Evaluations and Reco_r_ds Routine area surveys are performed on a weekly basis by the RSO and or his assistant Mr. R. Bennett.
An examination of the health physics log disclosed no significant spills or related problems.
Routine whole body
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counts and urine assays for tritium or C-14 are also done by the RSO and/or his assistant.
An examination of the records disclosed no significant exposures in these areas.
Leak tests of a fli-63 chromatographic source, a Sr-90 eye applicator and a Co-60 scaled source were all negative.
These leak tests were performed and evaluated in a timely manner by the RSO.
24.
Special License Condition Condition 18 requires bioassay for H-3 when quantities greater than 100 mci are handled.
The RSO performs and evaluates these bioassays.
flo problems h6ve occurred'in this area.
25.
Posting and Labeling The posting and labeling observed during a tour of the facilities were '
in conformance with f4RC regulations.
The pacemaker patient carries identification with him at all times which identifies him as wearing a pacemaker containing Pu-238.
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Independent Measurements None 27.
Operations Observed The Radiopharmist was observed making up a diagnostic dose of I-131.
She appeared to use good health physics techniques to limit her exposure.
Both a shielded syringe and a lead glass barrier were used during the process.
The Radiopharmacist also was wearing a film badge and a TLD finger ring.
Afterwards she was questioned about the safety aspects of her job.
She appeared to be very knowledgeable in this area.
Her quarterly exposures have been quite low.
28.
Incidents, Overexposures, Theft or loss, Equipment Malfunction, h-The RS0 stated that no problems of this nature have occurred since the last inspection.
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UNITED STATES GOVERNMENT
] CMOYandum To
- U. S. Nuclear Regulatory Commission D NTE: Sept. 29, 1976 Region V Office FROM : L. W. Wetterau, Radiation Safety Of ficer VA Wadsworth Hospital Center
- SUDJ ECT: NRC License 04-00181-04, Hospital Radioisotope Inventory as of 9-29-76 Radioisotope Millicuries 3H - as labeled compounds 338.000 14C - as labeled compounds 31.200 22Na-as labeled compounds 0.500 32P - as labeled compounds 22.850 36Cl-as labeled compounds 0.200 45Ca-as labeled compounds 8.900 47Ca-as labeled compounds 0.250 SICr-as labeled compounds 1.000 54Mn-as labeled compounds 1.000 57Co-as labeled compounds 0.130 63Ni-as labeled compounds 0.100 99"Tc-as labeled compounds 375.000 1251 - as labeled compounds 21.305 1311 - as labeled compounds 20.500 137Cs-as labeled compouads 0.362 192 Ir-implant seeds 443.500 1251 - Norland sealed source 35.000 63Ni-Hewlett Packard G.C. source 15.000 k
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Sr - Ophthalmic Eye Therapy M-RA-1A 24.750 60Co - Calibration source MR-30 0.055 M
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