ML20062J606
| ML20062J606 | |
| Person / Time | |
|---|---|
| Site: | 03019521 |
| Issue date: | 10/21/1993 |
| From: | Yuhas G NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION V) |
| To: | Mahn E KETCHIKAN GENERAL HOSP., KETCHIKAN, AK |
| References | |
| NUDOCS 9311090038 | |
| Download: ML20062J606 (3) | |
See also: IR 05000199/2013001
Text
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UNITED STATES
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NUCLEAR REGULATORY COMMISSION
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REGION V
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WALNUT CREEK, CALIFORNIA 94596-5368
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1450 MARIA LANE
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OCT 211993
Docket No.
030-19521
License No. 50-19913-01
Ketchikan General Hospital
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3100 Tongass Ave
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Ketchikan, Alaska 99901
Attention:
Ed Mahn
Hospital Administrator
Thank you for your letter dated October 4,1993, informing us of the steps
that you have taken to correct the items which we brought to your attention in
our letter dated September 14, 1993. Your corrective actions will be verified
during our next inspection.
In your response to violation C of our Notice of Violation dated September 14,
1993, you enclosed a new written policy and procedure (Attachments II and III)
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that you plan to use for credentialing visiting authorized users in your
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licensed program. We have two comments regarding the Attachment II procedure.
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First, the words: " broad license" should be added to Item 2, line 4 after
" Agreement State" to correspond with the requirement in 10 CFR 35.27(a)(2).
Second, we note the absence of any procedure in Attachment II for reviewing
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the license or permit naming the prospective visiting authorized user to
ensure that the named individual has been specifically authorized by that
license or permit for the medical procedures to be performed under Ketchikan
Hospital's NRC license, for compliance with 35.27(a)(3).
You should consider
revising the Attachment II procedure to address the above concerns.
Any
revision to the procedure that you plan to implement should be maintained on
file for review during our next inspection.
In addition, your letter did not include a response to our request for
information describing the administrative controls that will be established to
improve the management oversight of your overall licensed program to prevent
violations of NRC requirements (see page 2, paragraph 3 of our September 14th
letter).
Please submit the requested information within 30 days of the date
of this letter.
9311090038 931021
ADOCK 03019521
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Finally, in your response you requested that our inspectors evaluate whether
Ketchikan Hospital will ever be able to meet all NRC reqyirements for which it
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is held accountable. We expect that all licensees will devote sufficient
resources to meet all of the requirements imposed by NRC regulations and
license conditions.
If a licensee decides for any reason that-it cannot
comply with all NRC requirements then it should either obtain exemptions from
those requirements pursuant to 10 CFR 30.11, or cease operations and initiate
termination of its license.
If you have sny questions or comments on this matter, please contact the
undersigned 4t (510) 975-0226 or Mr. David D. Skov at (510) 975-0253.
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Sincerely,
,
b.
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Gregory P.
as, Chief
,
Radioactive Materials safety Branch
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Docket File '
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Inspection File
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G. Cook
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R. Huey
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B. Faulkenberry
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State of Alaska
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bec w/o eaclosure:
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M. Smith
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KETCHIKAN GENERAL HOSPITAL
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3100TONGASSAVE
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KETCHIKAN, ALASKA 99901-5794
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907-225:5171
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FAX # 907-225-2173
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October 4,
1993
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U.S. Nuclear Regulatory Commission
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Attn:
Document Control Desk
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Washington, D.C.
20555
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RE:
Ketchikan General Hospital
Docket No. - 030-19521
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License No. - 50-19913-01
This is the response to the Notice of Violation resulting from the
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inspection conducted by Mr. David D. Skov on August 17-19 and 24,
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1993 at Ketchikan General Hospital, Ketchikan, Alaska.
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A_
10 CFR 35.50 (b)(3) and (b) (4) require, in part, that a
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licensee test each dose calibrator upon installation for
linearity and for geometry dependence on the range of volume
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and volume configurations for which it will be used.
1.
Reason for violation - The unit in question was on
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temporary loan from Health Physics Northwest.
An
assumption was made that calibration and testing done on
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the unit by Health Physics was adequate for the temporary
use of the unit.
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2 .-
Corrective steps taken - Not applicable as machine is no
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longer on site.
3.
Corrective steps to avoid future violations - A policy
and procedures has been written for the Nuclear Medicine
Department that addresses the need to have all dose
calibrators, new, used and rental units, tested for
linearity and geometry prior to use at the facility.
(See Attachment I).
4.
Date of compliance - September 30, 1993
B.
and (4),
35.59(d) and 35.59
(g)
require, in part, that a licensee retain records of dose
calibrator annual accuracy tests, quarterly linearity tests,
geometry dependence tests, sealed source leak tests,
and
sealed source inventories, respectively, and that the records
include,
in part, the signature of the Radiation Safety
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officer.
The lack of signature was an
1.
Reason for violation
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oversight when the review was done by the RSO.
T fjl 0 b W S -
SISTERS OF ST. JOSEPH OF PEACE
KH
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Sennng The Community Since 1923
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NRC Violation
Page 2 ......
Part B (cont.)
2.
Corrective steps taken - All signatures were put in place
during the Radiation Safety Committee meeting of Sept. 8,
1993.
3.
Corrective steps to avoid future violations - The review
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with accompanying signatures will take place at each
quarterly Radiation Safety Committee meeting so that more
than one person can ensure that signatures are in place.
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4.
Date of compliance - September 8,
1993.
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C.
10 CFR 35.27(a)(1) and (2) provides, in part, that a licensee
may permit any visiting authorized user to use licensed
material for medical use under the terms and condition of the
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licensee's license for sixty days each year if the licensee
has
the
prior written
permission
of
the
institution's
Radiation Safety Committee, and if ,the licensee has a copy of
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license issued by the Commission or an Agreement State or a
permit issued by a Commission or Agreement State broad
licensee that identifies the visiting authorized user by name
as the authorized user for medical use,
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Reason - for violation - There was a breakdown in the
credentialing process.
Information was faxed, however,
the copy was not legible and was discarded without
followup.
2.
Corrective action taken - The issue was discussed at the
Radiation Safety Committee on September 8,1993.
It was
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agreed to develop a 'more stringent credentialing process
in order to ensure that all proper documentation is in
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place.
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3.
Corrective steps to avoid future violations
-A
new
policy and procedure was written for the purpose of
credentialing locum tenens radiologists. The Diagnostic
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Radiology Privilege form was also revised to include a
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checklist to ensure that privileges are not granted
without proper documentation of NRC licensure.
(See
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Attachment II and Attachment III).
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4.
Date of compliance - September 30, 1993.
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D.
requires that a licensee survey with a
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radiation detection instrument at least once each week all
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areas where radiiopharmaceuticals or radiopharmaceutical waste
is stored.
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NRC Violation
Page 3.......
Section D (cont.)
1.
Reason for violation - The Nuclear Medicine Department
has
only
one
trained
technologist.
When
this
technologist is on vacation the nuclear medicine unit is
closed and no procedures are performed.
Weekly testing
was not performed due to unavailability of trained
personnel.
The hospital was not aware that testing had
to be completed even when the unit was closed.
2.
Corrective action taken - See #3.
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3.
Corrective
steps to avoid future violations
A
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technologist will
be
trained
to
conduct
radiation
detection testing for all applicable areas during the
absence of the nuclear medicine technologist.
This
person will be trained only to perform the tests under
the supervision of the Radiation Safety Officer.
4.
Date of compliance - Training will begin November 1,1993
and it is anticipated that it will be completed by May
30, 1994.
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10 CFR 35.70(e) requires that a licensee survey for removable
contamination
once
each
week _
all
areas
where
radiopharmaceuticals
are
routinely
prepared
for
use,
administered or stored.
1.
Reason for violation - The Nuclear Medicine Department
has
only
one
trained
technologist.
When
this
technologist is on vacation the nuclear medicine unit is
closed
and
no
procedures
are
performed.
Radiopharmaceuticals are not prepared or administered.
Weekly testing was not performed due to unavailability of
trained personnel.
The hospital was not aware that
testing had to be completed even when the unit was
closed.
2.
Corrective action taken - See #3.
3.
Corrective
steps
to avoid
future violations -
A
technologist will
be trained
to
conduct
radiation
detection testing for all applicable areas during the
absence of the nuclear medicine technologist.
This
person will be trained only to perform the tests under
the supervision of the Radiation Safety Officer.
4.
Date of compliance - Training will begin November 1,1993
and it is anticipated that it will be completed by May
30, 1994.
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ITRC Violation
Page 4.......
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I hope that the violations have been addressed fully per the NRC
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requirements.
I would like to thank you for noting the significant
improvements we have made to comply with NRC regulations and
require.ments. We feel that we are making great strides toward full
compliance due to the direct supervision of Terry Lesko, M.D.
We
are a small facility in a remote location.
We provide nuclear
medicine procedures as a service to our community without any
anticipation of recoupment of resources. We are looking forward to
the early reinspection of our licensed program that Mr. Gregory
Yuhas referred to in his letter of September 14, 1993.
With this
in mind, we respectfully request that during the reinspection of
our licensed program that your inspectors evaluate whether we, as
a small institution, will ever be able to meet all the requirements
for which we are held accountable.
Since we operate this unit on
a.breakeven basis, further monetary violations, in. spite of good
intentions, could prove cost prohibitive in the future. Since the
cost of healthcare is of national interest, we may all feel that we
can better serve our patients in a.more cost effective manner by
not providing nuclear medicine procedures.
Thank you for yon consideration to our request.
Sincerely,
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Edward Mahn
Administrator
Attachments
cc:
U.S. Regulatory Commission
Region V
1450 Maria Lane *
Walnut Creek, CA
94596-5368
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ATTACHMENT I
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KETCHIKAN GENERAL HOSPITAL
POLICY AND PROCEDURE MANUAL
NUCLEAR MEDICINE DEPARTMENT
POLICY:
Dose calibrator " testing" procedure prior to
installation
APPROVAL:
Radiation Safety Officer
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EFFECTIVE DATE:
9/93
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PROCEDURE:
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Prior to any usage of any dose calibrator, whether it is new, used.
or rental unit,. it must be tested for both linearity and geometry
prior to its use in the Nuclear Medicine Department of Ketchikan
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General. Hospital..
This is in accordance with- Nuclear Regulatory
Cnmi ssion Regulation 10 CFR 35, 50 (B) (3) and (B) (4).
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The test results must be submitted to the Radiation Safety Officer
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for review and approval (signature required) . Thereafter, any test
results shall be presented to the next scheduled Radiation Safety
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Co=mittee for final approval.
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ATTACHMEi4T II
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POLICY AND PROCEDURE MANUAL
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ADMINISTRATION
POLICY:
Credentialing for Radiology Locum Tenens
APPROVAL:
Radiation Safety Officer
Administrator
EFFECTIVE DATE:
9/93
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PROCEDURE:
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a completed application form,
1.
The applicant will provide
privilege form and all other documentation required by all
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lecum tenens applicants.
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2.
In addition to the above, the applicant will provide a copy of
a. license issued by the Nuclear Regulatory Commission or an
Agreement State or a. permit issues by a Commission or an
Agreement State that identifies the visiting authorized user
by name as the authori::ed user for medical use.
3.
When the applicant's
file is complete with all proper
special meeting of the Radiation Safety
documentation, a
Committee will be called to review the credentials of the
applicant.
4-
Upon approval of the Radiation Safety Committee, the Radiation
Safety Officer (who is also the Chief of Service) will sign att
the appropriate line.
5.
Following approval by the Radiation Safety Committee, the
credentialing file will be presented for approval to the Chief
of Staff (Chairman of the Executive Credentials Committee) and
the Administrator (Chairman of the Governing Board) .
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ATTACHMENT III
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KETCHIKAN GENERAL HOSPITAL
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Diagnostic Radiology Privileges
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Privileges in Diagnostic Radiology shall be based on adequate
documentation
of
training
and
experience
and
continuing
demonstration of adequate technical skill and appropriate patient
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care as evaluated day to day by peers and as evaluated periodically
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by the Medical Review Committee.
Initial each procedure for which
you are seeking privileges to perform.
General Diacnostic Radioloav
Plain film interpretation
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Performance of and interpretation of films
produced during UGI, BE, IVP, and other like
general contrast exams.
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Special Contrast Examinations
Arteriography head and neck
Arteriography visceral
Arteriography extremity
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Arteriography aorta
Venography extremity
Venography inferior vena cava.
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Venography superior vena cava
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Lymphangiography
Myelography lumbar and thoracic via lumbar
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puncture
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Myelography cervical via Cl-C2 puncture-
Sialography
Hysterosalpingography
Cystourethrography
Renal cyst puncture and injection
Percutaneous antegrade pyelography
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Percutaneous transhepatic cholangiography
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Arthregraphy TMJ
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Arthrography shoulder
Arthrography elbow
Arthrography wrist
Arthrography hip
Arthrography knee
Arthrography ankle
Arthrography vertebral facet joint
Bronchography
Cisternography
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Dacryocystography
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Diagnostic pneumoperitoneography
Other
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Special Interventional Procedures
Percutaneous abscess drainage
Percutaneous biopsy head and neck
(extracranial)
Percutaneous biopsy thorax
Percutaneous biopsy abdomen
Percutaneous biopsy retroperitoneum
Percutaneous biopsy pelvis
Percutaneous biopsy extremity
Percutaneous biopsy spine and other osseous
structures
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Percutaneous biliary drainage
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Percutaneous nephrostomy
Percutaneous gastrostomy
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Percutaneous thoracentesis, paracentesis,
amniocentesis
Introduction of intraluminal drainage tube
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(e.g., Miller-Abbott tube)
Other
Ultrasonoaraphy
Neonatal head
Neck thyroid
Neck carotid and vertebral
Heart M-mode
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Heart 2-D realtime
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Heart Doppler (pulsed. and. continuous. wave):
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Chest wall and pleural space
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Abdomen liver and pancreas
Abdomen kidneys
Abdomen great vessels
Pelvis
Gravid uterus and fetus
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Testicles
Abdominal wall and soft tissue of the extremity
other
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Nuclear Medicine Imaginq
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Brain
Cerebrospinal fluid spaces
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Thyroid and parathyroid
vascular flow
Lung perfusion
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Lung ventilation
Heart myocardial
Heart wall-motion
Liver-spleen reticuloendothelial system
Liver biliary scintigraphy
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Renal cortical
Renal GFR functioning
Isotopic cystography for v-u reflux detection
Bone scintigraphy
Marrow scintigraphy
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Skeletal muscle (thallium 201)
Adrenal
Abscess and/or tumor scintigraphy
Thrombosis scintigraphy
Other
Computerized Tomocraphy
Head brain
Head petrous pyramids
Head orbits, face, paranasal sinuses
Thorax
Abdomen and retroperitoneum
Pelvis
Spine
Extremity
Neck soft tissues
Other
Documentation of NRC Licensure (Please attacit to this form)
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Applicant's Signature:
Date
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Chief of Service Signature
Date
(Radiation Safety-Officer)
Chairman, Exec-Credentials Committee
Date
Chairman, Governing Board
Date
9/93
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