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General
Information |
| Only
Authorized Users (AU) can order radioactive materials. All
individual users intending on receiving and using radioactive
materials ordered by the AU must be properly trained
and approved by the DRS.
There
are a variety of ways for Authorized Users to order and
purchase radioactive materials. Some have different procedures
that the AU must follow to expedite the ordering process.
To receive your radioactive material in a timely fashion,
please follow the procedures described below for the different
ordering processes carefully.
All
radioactive materials must be shipped to the Division of Radiation Safety (DRS) in building 21 for inspection and
repackaging prior to delivery to the Authorized User's
intended laboratory. When placing orders for radioactive
materials please advise your purchasing agent to request
the shipping address to be: |
|
Division of Radiation Safety
NATIONAL INSTITUTES OF HEALTH
BUILDING 21 ROOM 107
21 WILSON DRIVE
BETHESDA, MD 20892-6780 |
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| If
you receive a direct delivery of radioactive material, do
not attempt to open the material, call the DRS immediately
at 301-496-3277 to have material picked up and brought back
building 21 for inspection. For
some radioactive material ordering
processes, a properly completed Request
for Use and Purchase of Radioactive Material form (NIH
88-1) must be submitted to the DRS at the address
above one day prior to the expected arrival of the material.
The NIH 88-1 form must be signed Authorized User to be
accepted by the DRS. If it is signed by anyone other than
the Authorized User, the form will be rejected by the
DRS and your material will remain in storage until a properly
signed form is received. The NIH 88-1 form can be hand
delivered or mailed to the address above, faxed to (301)
480 - 9708, or submitted electronically through the Authorized
User Portal. In case of technical difficulties with
fax machines, the DRS recommends mailing a copy of the
form to assure its receipt. Also, retain a copy of the
form for your records.
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Activity
Control Policy |
| What
is it? |
| To
ensure Authorized Users are prepared to deal with the variety
of radionuclides used in biomedical and clinical research,
a tiered system of Authorization has been established -
effective October 13, 2003. This system separates out Authorized
Users who do not have previous experience working with radionuclides
that are not covered in our routine training or who have
not worked with larger amounts of the common nuclides. The
primary goal is therefore to ensure that Authorized Users
who wish to use unusual nuclides or larger amounts of radioactive
materials are properly prepared in all aspects of radiation
safety prior to their first use of such materials.
As
a result of this policy change, the daily receipt limit
for activity has been eliminated. Instead, an Authorized
User's aggregate total inventory, decay-corrected
in real time, will be used as the basis for both
general Division of Radiation Safety controls over work
with radioactive materials (including possible withholding
of radioactive packages) and the requirement for having
a Radiation Safety Protocol. If you were Authorized prior
to October 13, 2003, please be sure to read the "Persons
Authorized before October 13, 2003"
section after the description of the activity control
policy below to see how you might be affected by these
changes.
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| What
is it not? |
The
activity control system does not apply to clinical human
use, sealed source procurement, irradiator ownership, or
cyclotron production activities.
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| How
does it work? |
| Basic
Authorization
When you become Authorized, you will receive
permission to order and receive the following nuclides
(known as the common set): H-3, C-14, P-32, P-33, S-35,
Ca-45, Cr-51, Fe-55, and I-125. You will be allowed to
accumulate activity (decay corrected in real time) up
to the amount in the first column ("default ceiling
amount") of the "basic authorization" section
of the activity
control table without any intervention from Radiation
Safety. Should your workload cause you to exceed the ceiling
you are assigned for any given nuclide, further orders
of that nuclide will not be delivered to you until you:
-
Send in completed Utilization/Disposal sheets to close
out orders of that nuclide to reduce your inventory
total.
OR
- Consult
with your Area Health Physicist to raise your assigned
ceiling anywhere up to the amount in the second column
("max HP ceiling amount")
of the activity
control table. The
Area Health Physicist will verify that you and your
lab are adequately covered in all aspects of radiation
safety (e.g. dosimetry, shielding, monitoring capability,
etc.) for having a higher ceiling.
OR
- Submit
a Radiation Safety Protocol if your assigned ceiling is
already at the amount shown in the second column.
Advanced Authorization
For all nuclides not in the common set,
your ceiling is initially set at zero. The first time
you wish to work with a radionuclide outside the common
set, the Area Health Physicist will consult with you to
ensure your lab is adequately prepared to use that nuclide
(e.g. dosimetry, shielding, monitoring capability, etc.).
Once satisfied that work can proceed, the Health Physicist
will assign you a ceiling commensurate with your expected
workload. This value can be anywhere between the "default
ceiling" and the "max HP ceiling" values
in the columns under the "advanced authorization"
of the activity
control table. Should your future workload
then cause you to exceed your assigned ceiling, the procedure
for receiving future orders of that nuclide are the same
as for the basic authorization described above. If you
wish to work with a nuclide not in either table, it will
likely require a Radiation Safety Protocol. Contact your
Area Health Physicist (301-496-5774)
well in advance of ordering an unlisted nuclide.
Radiation Safety Protocols
Adittional Radiation Safety Protocols
may be required for any circumstances not listed above.
For more information refer to the guidelines in the Radiation
Safety Protocol section.
Persons Authorized before October
13, 2003
If you were authorized prior to this policy
change, you are subject to the new policy. However, you
will be assigned ceiling values for the common set that
raise your ceiling to the “default ceiling”
or lowered to the “max HP ceiling”, as appropriate
for the ceiling value you had prior to the policy change.
This is also true for any advanced nuclides you have worked
with previously. Note that a grandfathered Authorized
User wanting to use an advanced nuclide for the first
time in their NIH career will be subject to the new ceiling
amounts.
In all cases, if your future workload
were to exceed adjusted ceiling value, you would need
to follow the procedures described above to continue to
receive activity. If your workload exceeds the "max
HP ceiling" value
on the activity
control table for the appropriate nuclide,
you will have to submit a Radiation Safety Protocol to
receive the additional activity.
If
you are uncertain about what amount of activity you may
accumulate for any nuclide you work with, please contact
your Area Health Physicist (301-496-5774)!
Radioactive materials may not be delivered to you if your
decay-corrected inventories exceed your assigned ceiling
levels.
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Receiving
Radioactive Materials In the Laboratory |
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After
all the steps have been completed for each ordering process
the material will then be delivered to your laboratory.
Delivery of radioactive material to a lab requires a signature
from an approved individual in the lab that is an NIH
employee. Upon receipt of the material the individual's
NIH ID will be verified by the delivery technician. Lab
personnel should promptly verify contents of package according
to the Radioactive Material Utilization and Disposal Record
(NIH-8816) and label on the radioactive material vial.
Immediately notify DRS of any discrepancies with the material
or the NIH 88-16 record. Store material securely according
to its proper storage temperature until it is needed.
Radioactive materials source vials must be stored according
to the NIH Radioactive
Materials Source Vials Storage policy. Place utilization
and disposal records in a convenient location near where
the source vial is stored where individual users can conveniently
find them to fill them out when the radioactive materials
gets used.
In
order to expedite the processing of radioactive materials
packages, all outside packaging will be inspected for
contamination by the DRS or its contractor, but only certain
shipments will be opened and checked internally for possible
contamination. The contents of all packages are verified
against the NIH 88-1 for the correct material. Please
be sure to follow the DRS recommended procedures for opening
radioactive materials packages as describes below. |
| Recommended
Procedures for Opening Radioactive Materials Packages |
- Wear
proper protective clothing and gloves.
- Open
the outer package.
- Remove
item open inner packaging and verify the contents with
the order.
- Any
discrepancies with the order should be reported to the
Division of Radiation Safety.
- Check
to confirm there is no evidence of leakage of material
during transport.
- If
contamination is suspect, take appropriate precautions
and check with an
appropriate instrument or use smears to establish the
presence or absence of
contamination.
- If
the inner containers are intact and there is no evidence
of leakage, secure the
materials in storage or prepare for use.
- Monitor
packing materials and empty shipping containers to ensure
they are free of
radioactive contamination.
- Remove
or deface all warning labels before discarding contamination-free
materials
in regular trash containers.
- Discard
any contaminated materials into appropriate radioactive
waste container
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Ordering
Processes |
| Blanket
Orders |
|
Blanket
orders are multiple shipments of radioactive material
under one purchase order.
The Authorized User must know what material they will
be ordering, the amount of material, and the company where
the material will be purchased. Contact your purchasing
agent and ask for a market requisition. Send your market
requisition to the DRS for clearance.
Submit an NIH
88-1 form one day prior
to material arrival. The 88-1 form must indicate the number
of shipments and the activity of each shipment. A purchase
order number will be assigned by the purchasing agent
and DRS must be notified of the new purchase order number.
Call 301-496-3277 with the new purchasing number
|
| IMPAC/VISA
Purchase Card |
| Authorized
Users may now purchase radioactive materials using the IMPAC/VISA
purchase cards. Please review the requirements and restrictions
provided below before using the purchase cards to purchase
radioactive materials. Information concerning the change
to the NIH Policy Manual Internal Procedures for the Purchase
Card Program can be obtained from your purchasing agent
or administrative officer. All
Radiation Safety requirements for the purchase and delivery
of radioactive materials remain the same. In summary,
- the
vendor must deliver the radioactive material to Building
21, Room 107,
- the
packing slip must indicate the name of the Authorized
User and his/her DRS ID number, and
- submission
of a properly completed NIH
88-1 form is required and must be received by Radiation
Safety before the material will be released to the Authorized
User.
Please
note the following restrictions on the use of the IMPAC/VISA
purchase card.
- The
card may not be used for standing orders of radioactive
material.
- Do
not place a duplicate order for the same material in
the RAMOS system (or AMBIS) or place a duplicate Record
of Call against the vendor's Blanket Purchase Agreement
(BPA).
- Do
not include radioactive material and non-radioactive
supplies on the same VISA purchase card order. Place
separate orders for these supplies.
Authorized users are responsible
for ensuring that all aspects of the purchase and
use of radioactive material adhere to NIH radiation
safety program policies and procedures. Your cooperation
will ensure the continued success of the NIH radiation
safety program.
|
| Record
of Call |
| Records
of Call (ROC) orders are one time shipments of radioactive
material under a specific purchase order number.The Authorized
Investigator completes and signs a NIH
88-1 form
and sends the form to their Purchasing Agent. Your Purchasing
Agent will order your material and will submit your NIH
88-1 form to building 21 one day prior to your material
arrival. |
| No
Charge |
| No
Charge material is any material that is sent to you from
a manufacturer free of charge. Submit a NIH
88-1 form one day prior to material arrival. Material
must be delivered to building 21 for inspection by DRS. |
Transfers
of Radioactive Material |
| There
are two ways of transferring material on campus. Material
may be transferred from one Authorized Investigator to another
Authorized Investigator, or to the same Authorized User's
current lab location to their new location. If the Authorized
Investigator receiving the material is located off campus,
the material must be transferred through the DRS following
Department of Transportation and Nuclear Regulatory Commission
regulations. Contact the DRS at 301-496-3277 for all off
campus shipments. |
| Authorized
Investigator to Authorized Investigator |
The
Authorized Investigator receiving the material must properly
complete a NIH 88-1 form and
submit the form to building 21 DRS on day of transfer.
The original owner and user number should be listed as the
supplier.
The word "Transfer" should be written in the "Record
of Call or Purchase Order Number" box. The transferring
Authorized Investigator should complete their copy of the
Utilization and Disposal record that came initially with
the original order. The new Authorized Investigator receiving
the material will be sent a new Utilization and Disposal
record from the DRS. |
| Laboratory
Location Change |
|
Dispose
of all unneeded and decayed material into your radioactive
waste can and call the Radioactive Waste Services at 301-496-4451
for a waste pick up. Complete your Utilization and Disposal
records for all material disposed and fax records to 301-480-9708
for removal from your inventory. Contact the DRS
at 301-496-3277 and schedule a date and time for the transfer
and provide information on the amount of material in your
possession and storage requirements. A copy of your Utilization
and Disposal record for all items being transferred is
required at time of transfer. Your material will be stored
in building 21 until you notify the DRS of a delivery
date and location. |
Shipments |
| All
radioactive material to be shipped off campus must be shipped
by DRS. The DRS will properly package the shipment according
to Department of Transportation and Nuclear Regulatory Commission
regulations. If this is the first time you are shipping
through the DRS, or, if you are shipping to a new location
the DRS will need to be notified one week in advance. For
all other shipments, 24-hour advance notice is required.
If you have questions or would like to schedule a shipment,
call the DRS Materials Acquisition Unit at 301-496-3277.
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