ML19261A379
| ML19261A379 | |
| Person / Time | |
|---|---|
| Issue date: | 01/12/1979 |
| From: | James O'Reilly NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION II) |
| To: | CORNELL UNIV., ITHACA, NY |
| References | |
| NUDOCS 7901180008 | |
| Download: ML19261A379 (1) | |
Text
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- psh' "f Gug UNITED STATES o,
NUCLEAR REGULATORY COMMISSION 3g,(
REGION ll t
101 M ARIETT A STRE ET, N.W.
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ATLANTA, GEORGIA 303t2 o
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JAN 121979 CORNELL UNIVEESITy HADIATION SAFFTY OFFICE 512 E.
STATE STREET ITHACA NY 14e50 Gentlemen:
The enclosed IE Circular 79-01, is forvarded to you f or information.
If there are any questions related to your understanding of the sugEested actions, pleasa contact this office.
ang'\\ ( Y:
mes P. O'Reilly Di ector r
-losures:
1.
IE Circular No. 79 01 2.
List of IE Circulars Issued in 1976
~
790118000%
UNITD STATES NUCLEAR REUIAIORY COFMISSION OFFICE OF INSPTTION AND ENFORCEbETT KASHINGION, D.C.
20555 January 12, 1979 IE Circular No. 79-01 ADMINISTPATION OF USAUIHORIZED BYPRODUCT FRTERIAL 'IO 1D%55 Description of Circumstances:
Recently the U. S. Nuclear Pegulatory Cconission (NRC) has inwstigated two incidents in which reagent grade ccnpaunds containing byprodtrt material were adrtinistered as intravenous radiophanraceuticals to humans.
These ccmpounds had neither been mnufactured for use as radiopharra-ceuticals nor undergone terting for nu w) use.
In these incidents the byproduct m terials were in chemical forms otlier that the forms used in diagnostic studies and should not have been shipped by the supplier.
In one case Selenitra-75 labeled selenious acid was shippcd instead of Selenitrn-75 labeled selencmethionine.
In the other case Ytterbitzn-169 labeled chloride was shipped instead of Ytterbitn-169 labeled diethylenetriaminepentaacetic acid (DTPA).
The hospitals which received these mterials should not have accepted then since they were not authorized to possess then by their NRC license.
In addition, the hospital personnel preparing the patient doses should not have prepared these mterials for adattnistration to 2 patient since the labels, leaflets, ard brochures in each case identified the radioisotope and chemical form and incitded a warning that the radicactive mterial was not for use in hirans or clinical diagnosis.
Notice to Mcdical Licensees:
Medical licensees should have proccdures to be follouxi by persons preparing radiophanraceuticals for administration to htnans. The procedures should incltde the following steps:
ccnfinution that the ccnpound is a radiopharnaceutical intended for a.
htrun use, 1 of 2
IE Circular No. 79-01 b verification that the type, che=ical 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 radiopharms :eutical was manuf actured and distributed under a license issued by the NRC or and 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 radiopharnaceuticals to human patients.
No scitten response to this Circular is required.
If you require 2dditional information regarding this subject, please contact the Director of the appropriate NRC Regional Of fice.
IE Circular No. 79-01 January 12, 1979 LISTIN3 0F IE CIRC'JLAP.S ISSUD IN 1976 Circular Sutjeet rate Issuei Tc No.
of 2ssue 76-01 Loss of well Logging L/5/76 All E:1ders cf Sourc e Vell Logging Source Licenses 78-02 Proper Lubrimating 011 h/20/78 All Holders of for Terry Turbines Reactor OLs or cps 76-03 Packaging Greater Than 5/12/78 All Holders of Type A Quantities of Leactor OLs, cps, Low Specific Activity Fue. Cycle, Radioactive Material Priorit;. I Material for Transport and Waste Ois;; sal Licenses 75 Installation Error That 5/15/76 All Ho'ders cf Could Prevent Closing of Reactor OLs cr Fire Doors cps 75-05 Inadvertent Safety inje:tien 5/23/76 All Eciders of Reactor OLs or During Cooldovr.
CFs 75-06 Potential Co==:n Mode 5/23/76 All H:1ders er Flooding of ECCf Equip =ert Eeart:r OLs Or Boots at Bi? Fa:ilities CFs 7S-07 Damaged Components of a 5/31/78 All Holders of Peactor OLs er Be gen-Paterson Series cps 25000 Hydraulie Test St an d 75-DE Enviror.= ental Qualification 5/31/7E All E:1ders cf Fearter CLs or of Safety Felated Equip ent CFs at Nuclear Power Plants 76-0)
Arcing of Genera Electrie 6 / 5 "7 E All Eciders of CFs Corrany Size 2 Contact rs En:lesure Page 1 of 3
IE Circular No. 79-01 January 12, 1979 LISTING OF IE CIRCULARS ISSUED IN 1978 Circular Subj ect Date of Issued to No.
Issue 78-10 Control of Scaled 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 Stops BWR OLs or cps 78-12 HPCI Turbine Control 6/30/78 All Holders of Valve Lift Rod Bending BWR OLs or cps for plants with HPCI Terry Turbine 78-13 Inoperability of Multiple 7/10/78 All Holders of Service Water Pumps Reactor OLs and cps except for plants located in: AL, AK, CA, FL, GA, LA, MS, SC 78-14 HPCI Turbine Reversing 7/12/78 All Holders of BWR Chamber Hold Down Bolting OLs or cps for plants with a HPCI Terry Turbine excepting Duane Arnold and Monticello 78-15 Checkvalves Fail to 7/20/78 All Holders of Close In Vertical Reactor OLs or cps Fosition 78-16 Limitorque Valve 7/26/78 All Holders of Actuators Reactor OLs or cps 78-17 Inadequate Guard Training /
10/13/78 All Holders of Qualification and Falsified and applicants Training Records for Reactor OLs.
Enclosure Page 2 of 3
IE Circular Nc. 79-01 January 12, 1979 LISTING OF IL CIRCULARS ISSUED IN 1978 Circular Subject Date Issued To No.
of Issue 78-18 UL Fire Test 11/6/78 All Holders of Reactor OLs or cps 78-19 Manual Override (bypass) of 12/29/78 All Holders of Safety Actuation Signals Reactor cps