ML20136A586
| ML20136A586 | |
| Person / Time | |
|---|---|
| Issue date: | 01/12/1979 |
| From: | Seyfrit K NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION IV) |
| To: | FITZSIMONS ARMY MEDICAL CENTER, AURORA, CO |
| Shared Package | |
| ML17354B291 | List:
|
| References | |
| FOIA-96-395 NUDOCS 7903060116 | |
| Download: ML20136A586 (6) | |
Text
,._ _
' of Mco, UNITED STATES f
o, NUCLEAR REGULATORY COMMISSION y,
l #
[ 'P-REGION IV
{,.,$
p 611 RYAN PL ATA DRIVE. SUITE 1000 n
g, g 4;
%, s. r p January 12, 1979 x
License No. 05-00046-13 l
Department of the Army Fitzsimons Army Medical Center Denver, Colorado l
Gentlemen :
- s. a The enclosed IE Circular 79-01, is forwarded to you for information.
If there are any questions related to your understanding of the suggested actions, please contact this office.
Sincerely, f
f EDW '
Karl V. Seyfr'it Director Enclosures :
1.
IE Circular No. 79-01 2.
List of IE Circulars Issued in 1978
'O
\\t k
0hkh $I
1
.s A,I '
l j.
i UNITED STATES i
-NUCLEAR REGULATORY COMMISSION 0FFICE OF INSPECTION AND ENFORCEMENT' i
WASHINGTON, D.C.
20555 i.I i
IE Circular No.'79-01 i
j January 12,1979
{
Page 1 of 2 i
l' ADMINISTRATION OF UNAUTHORIZED BYPRODUCT MATERIAL TO HUMANS i
l j
Description of Circumstances:
l-i Recently the U. S. Nuclear Regulatory Commission (NRC) has investigated two incidents in which reagent grade compounds containing byproduct material were administered as_ intravenous radiopharmaceuticals to humans.
These compounds had neither been manufactured for use as radiopharma-l ceuticals nor undergone testing for human use.-
In these incidents the byproduct materials were in chemical forms other i
than the forms used in diagnostic studies and should not have been shipped by the supplier.
In one case Selenium-75 labeled selenious 4
j acid was shipped instead of Selenium-75 labeled selenomethionine.
In the other case Ytterbium-169 labeled chloride was shipped instead of j-Ytterbium-169labeleddiethylenetriaminepentaaceticacid(DTPA).
The hospitals which received these materials should not have accepted them since they were not authrized to possess them by their NRC license.
In addition, the hospital personnel preparing the patient doses should not have prepared these materials for administration to a patient since the labels, leaflets, and brochures in each case identified the radioisotope and chemical form and included a warning that the radioactive material was not for use in humans or clinical diagnosis.
i Notice to Medical Licensees:
Medical licensees should have procedures to be followed by persons preparing radiopharmaceuticals for administration to humans.
The
- procedures should include the following steps:
1 a.
confirmation that the compound'is a radiopharmaceutical intended for human use, i
l e
4 r
,~
e
A w
4,
,)
IE Circular No. 79-01 January 12, 1979 Page 2 of 2 b.
verification that the type, chemical form and quantity of byproduct material is the correct one for the particular patient and the medical procedure being used, and c.
verification that the radiopharmaceutical was manufactured and distributed under a license issued by the NRC or an. Agreement State.
These confirmations and verifications can be accomplished by reviewing the labels, leaflets, and brochures enclosed in the package.
Medical licensees should instruct and require personnel to follow these procedures in preparing and administering radiopharmaceuticals to patients.
The contents of this Circular should be brought to the attention of all personnel who prepare and administer licensed radiopharmaceuticals to human patients.
No written response to this Circular is required.
If you require j
additional information regarding this subject, please contact the Director of the appropriate NRC Regional Office.
i 4
'I l IE Circular No. 79-01 January 12, 1979 LISTING 0F IE CIRCULARS ISSUED IN 1978 Circular Subject First Date Issued To No.
Of Issue 78-01 Loss of Well Logging 4/5/78 All Holders of Source Well Logging Source Licenses 78-02 Proper Lubricating 4/20/78 All Holders of Oil for Terry Reactor Operating Turbines Licenses (OL) or Construction Permits (CP) 78-03 Packaging Greater 5/12/78 All Holders of Than Type A Reactor Operator Quantities of Low Licenses (OL),
Specific Activity Construction Radioactive Material Permits (CP), Fuel for Transport Cycle, Priority I Material and Waste Disposal Licenses 78-04 Installation Error 5/15/78 All Holders of That Could Prevent Reactor Operating Closing of Fire Licenses (OL) or Doors Construction Permits (CP) 78-05 Inadvertent Safety 5/23/78 All Holders of
. Injection During Reactor Operating Cooldown Licenses (OL) or Construction Permits (CP) 78-06 Potential Common 5/25/78 All Holders of Mode Flooding of Reactor Operating ECCS Equipment Licenses.(OL)or Rooms at BWR Construction Facilities Permits (CP) 78-07 Damaged Components 5/31/78 All Holders of Of a Bergen-Paterson Reactor Operating Series 25000 Hydrau-Licenses (0L) or lic Test Stand Construction Permits (CP)
Enclosure Page 1 of 3
^
il IE Circular No.
79-01 January 12, 1979 78-08 Environmental Quali-5/31/78 All Holders of fication of Safety-Reactor Operating Related Equipment Licenses (OL) or at Nuclear Power Construction Plants Permits (CP) 78-09 Arcing of General 6/5/78 All Holders of Electric Company Reactor Operating Size 2 Contactors Licenses (0L) or Construction Permits (CP) 78-10 Control of Sealed 6/14/78 All Medical Sources Used in Licensees in Radiation Therapy Categories G and G1 78-11 Recirculation M-G 6/15/78 All Holders of Set Overspeed Stop BWR Operating Licenses (OL) or Construction Permits (CP) 78-12 HPCI Turbine Control.
6/30/78 All Holders of Valve Lift Rod BWR Operating Bending Licenses (OL) or Construction Permits (CP) with Similar HPCI Design 78-13 Inoperability of 7/10/78 All Holders of Service Water Pumps Reactor Operating Licenses (OL) or Construction Permits (CP)
)
except for plants located in: AL, AK, CA, FL, GA, LA, MS, SC
, Enclosure Page 2 of 3 1
~ _.
'r i
IE Circular No.
79-01 January-12, 1979
)
78-14 HPCI Turbine Reversing 7/12/78 All Holders of Chamber Hold Down BWR Operating Bolting Licenses (0L) or Construction Permits (CP) for plants with a HPCI Terry Turbine excepting Duane Arnold and
~
Monticello 78-15 Tilting Disc Check 7/20/78 All Holders of Valves Fail to Close Reactor Operating With Gravity in Licenses (OL) or i
Vertical Position Construction Permits (CP) 78-16 Limitorque Valve 7/26/78 All Holders of Actuators Reactor Operating Licenses (0L) or Construction Permits (CP) l 78-17 Inadequate Guard 10/13/78 All Holders of Training /Qualifica-and applicants tion and Falsified for Reactor Training Records Operating Licenses (OL) 78-18 Underwriters 11/6/78 All Holders of Laboratory Fire Reactor Operating Test Licenses (CL) or Construction Permits (CP) 1 78-19 Manual Override 12/29/78 All Holders of I
(Bypass) of Safety Reactor Construction Actuation Signals Permits (CP)
I i
Enclosure I
Page 3 of 3 I
i