notification of use for human products

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UNIVERSITY OF TEXAS MEDICAL BRANCH
NOTIFICATION OF USE FOR
HUMAN PRODUCTS
NON-HUMAN PRIMATE PRODUCTS
DIRECTOR/PRINCIPAL INVESTIGATOR:
DEPARTMENT:
RT:
EXT:
ROOM#
LOCATION - BUILDING
1. Purpose:
Clinical lab
2. Type of submission:
New
3.
Type of products being used:
Tissue/bone
IRB Approval #:
Blood, serum, body fluids IRB Approval #:
Primary
Cell Cultures:
Established
Commercial
4.
Research lab
Renewal
Human
Concise description of work being performed:
5. Biological Safety Level:
BSL1
BSL2
6. Check the protective clothing or equipment used when:
Lab coat/ gloves (BSL2)
Scrubs, cover gown/booties/gloves (BSL3E)
PAPR (Racal/Max Air)
Eye protection
Safety Centrifuge/blender
Chemical Fume Hood
Room location:
Biological Safety Cabinet
Room location:
7. Bio-hazardous waste disposed through:
Placed in red bag for disposal.
Chemically disinfect, then placed in
regular trash.
Autoclaved, then packaged for
incineration. (BSL 3 & 4 only)
8.
Non-Human primate
IACUC Approval #
IACUC Approval #
BSL3
BSL3E
Cover gown/ gloves (BSL3)
Dover/ Delta suits (BSL4)
N95 respirator
Face Shield
Other specify:
BSL4
Surgical mask
Autoclaved, then placed in regular trash.
Chemical disinfection of bulk liquid then poured down sanitary
drain (BSL3) or effluent treatment system (BSL3E and BSL4).
Place in Yellow bag for incineration
List disinfectant used for decontamination and spill clean up:
9.
Personnel: provide name and description of laboratory experience for the P.I./Director and the
designated trainer (see example on reverse, attach additional sheet if necessary).
10. Have personnel received Standard precaution training (bloodborne pathogen training)?
If yes, Hepatitis B immunization is recommended and
Standard precaution training certificate for all personnel must be provided for all personnel
Revised 03-12
1
No
Yes
BSC Approval Date: _________
P.I./Director Signature
Date
Signature, BSC Chairman
Revised 03-12
2
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