ML20207P169
| ML20207P169 | |
| Person / Time | |
|---|---|
| Site: | 07100623 |
| Issue date: | 12/19/1986 |
| From: | Anger R METHODIST HOSP. OF INDIANA, INC., INDIANAPOLIS, IN |
| To: | Gordon L NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| References | |
| 27740, NUDOCS 8701150152 | |
| Download: ML20207P169 (4) | |
Text
P 7/- DM3
.Metaodist RETURN TO 396-SS Hosaita_
1701 North Senate Boulevard Indiapapolis, IN 46202
()h
/9-I l.ogI___2h_#_E_?_4_________.
December 19, 1986 Remitter ____________________.
Check No. /o,3fA /_ _ _ _ _ _ _ _ _ _
y s;;>
A m :u n t _ _ _ WJ3. _ _ _ _ _ _ _ _ _ _ _
Tec CatcCary_ J O E __________
O MTMD2/$i RECENED g
o Otto Cor.:,.ted _ _ //Us]. _ _. {
g 3 gg*/ f
(
DOC m Y
DU - - - -
- "---'~
E 1, U.S. hUCLEAR REGULATORY l DSNRq 00y.msst0M 9'-
Leonard Gordon M&HS38# 8 3
g 5 I307.
42 f
Transportation Certification Branch
(
g/
g pg[hgg
/
U. S. Nuclear Regulatory Commission 4
7915 Eastern Avenue m=
QOggg 7
S co
Dear Mr. Gordon:
As we discussed over the telephone, I would like to submit for approval under our broad byproduct materials license no. 13-02063-01, the following QA program applicable to procurement, use, maintenance, and repair of packages designed to transport radiographic exposure devices. At the same time, I would like to request approval for use of a USA /5800/B overpack to transport a Cs-137 irradiator (AECL GC10) source assembly from Ann Arbor, Michigan to Indianapolis, Indiana.
Enclosed is a check for $150 to cover the cost of review / approval of our QA program.
10 CFR Part 71 QA Program 1.
As required for an institutional medical licensee, the radiation safety program is the responsibility of the Radiation Safety Officer, under the direction of the nadiation Safety Committee. The Vice President, Profes-sional Services, is a member of the Radiation Safety Committee. The Radiation Safety Officer will be the responsible individual for the Part 71 QA requirements, including overall administration of the program, training and certification, document control, auditing. The Radiation Safety Officer or his designee will be responsible for handling, storing, shipping, inspection, test and operating status and recordkeeping.
2.
The management of Methodist Hospital establishes and implements this QA program. Training, prior to engagement, for all QA functions is required according to written procedures. QA program revisions will be made according to written procedures with management approval.
The QA Program will ensure that all defined QC procedures, engineering procedures, and specific provisions of the package design approval are satisfied. The QA Program will emphasize control of the characteristics of the package which are critical to safety.
0701150152 861219 PDR ADOCK 071*****
~ _ _ _
C PDR m g.
lA i
L-N ~'~:-R h7ffb 1
y=
- e g
is Leonard Gordon December 19, 1986 Page 2-The Radiation Safety Officer shall assure that all radioactive material shipping packages are designed and manufactured under a QA Program approved by the Nuclear Regulatory Commission for all packages designed or fabricated after January 1, 1979. This requirement will be satisfied by receiving a certification to this effect from the manufacturer.
3.
All documents related to a specific shipping package will be controlled through'the use of written procedures. All document changes will be performed according to written procedures approved by management.
The Radiation Safety Officer shall insure that all QA functions are conducted in accordance with the latest applicable changes to these documents.
4.
Written safety procedures concerning the handling, storage, and shipping of packages for certain special form radioactive material will be followed.
Shipments will not be made unless all tests, certifications, acceptances, and final inspections have been completed. Work instructions will be provided for handling, storage, and shipping operations.
The Radiation Safety Officer or his designee shall perform the critical handling, storage, and shipping operations.
5.
Inspection, test, and operating status for certain special form radioactive material will be indicated and controlled by written procedures.
Status will be indicated by tag, label, marking, or log entry. Status of nonconforming parts or packages will be positively maintained by written procedures.
The Radiation Safety Officer or his designee shall perform the regulatory required inspections and tests in accordance with written procedures. The Radiation Safety Officer shall ensure that these functions are performed.
6.
Records of package approvals (including references and drawings),
procurement, inspections, tests, operating logs, audit results, personnel training and qualifications and records of shipments will be maintained.
Descriptions of equipment and written procedures will also be maintained.
These records will be maintained in accordance with written procedures.
The records will be identified and retrievable. A list of these records, with their storage locations, will be maintained by the Radiation Safety Officer.
7.
Established schedules of audits of the QA Program will be performed using written check lists. Results of audits will be maintained and reported to management. Audit reports will be evaluated and deficient areas corrected.
The audits will be dependent on the safety significance of the activity being audited, but each activity will be audited at least once per year.
Audit reports will be maintained as part of the quality assurance records.
Members of the audit team shall have no responsibility in the activity being audited.
o e
e.
Leonard Gordon December 19, 1986 Page 3 If you have any questions, please let me know.
Sincerely.
f /,
Robert T. Anger, Jr.
Radiation Safety Officer RTA/lm enclosure t
~7 m
h 4
e eh b ' i B
=
w.
cavum.
a_zz@
um, v=.
PG 84 u m r.cvu. _ _ _ 0 /. _ /. #_ _
47 reur_ _
e: -
FCAF l
c
.v g w mq TCTC Ct-o m / 2 7 u. A f k J