+--------------------------------+----------------------+-------------+
| BROOKHAVEN NATIONAL LABORATORY | GCRC POLICY: IC-13   | PAGE 1 OF 1 |
|                                |                      |             |
| ###  GENERAL C                 |                      |             |
| LINICAL RESEARCH CENTER POLICY |                      |             |
+--------------------------------+----------------------+-------------+
|                                | PREPARED BY: B.      |             |
|                                | Pyatt Infection      |             |
|                                | Control              |             |
+--------------------------------+----------------------+-------------+
|                                | REVIEWED BY: W.      |             |
|                                | Gunther GCRC Manager |             |
+--------------------------------+----------------------+-------------+
|                                | APPROVED BY: G. J.   |             |
|                                | Wang Medical Dept.   |             |
|                                | Chair                |             |
+--------------------------------+----------------------+-------------+
| SUBJECT: Animal Studies at     | EFFECTIVE DATE:      |             |
| Clinical Facilities            | 1-15-08              |             |
+--------------------------------+----------------------+-------------+
|                                | ##                   |             |
|                                |  REVISION HISTORY: 5 |             |
+--------------------------------+----------------------+-------------+

1.0 [PURPOSE AND SCOPE]{.underline}

This document defines the procedures that must be followed when
facilities which are primarily used for human research are also used for
animal studies, (see Attachment 1 for listing). The requirements apply
to all research personnel.

2.0 [APPLICABLE DOCUMENTS/DEFINITIONS]{.underline}

N/A

3.0 [GENERAL NOTES]{.underline}

The first priority for the use of Medical Department General Clinical
Research Center (GCRC) and GCRC Satellite facilities is for treatment or
clinical study of research subjects. However, these facilities may be
used by BNL researchers for animal studies, dosimetry and other physics
experiments, etc. In those studies, the researchers are guests of the
facilities, and after use they are responsible for returning the
facilities to their usual state of cleanliness and availability for the
next subjects. If this is not done by the researchers [to the
satisfaction of the facility operators]{.underline}, the privilege to
use the facilities may be revoked by the cognizant facility manager.
Special care must be taken by the researcher when studies with animals
are involved. It is imperative that cross-infection between animals and
people is prevented, especially as zoonotic transmission to humans and
allergic reactions of some subjects to animal hair and dander are
possible.

4.0 [MATERIALS]{.underline}

Cleaning supplies and checklist

5.0 [POLICIES AND PROCEDURES]{.underline}

The following procedure shall be followed by the researcher:

> 1\. Prior to beginning such work, an experimental review must be
> conducted by the ESH Committee.
>
> 2\. For animal studies the researcher shall obtain prior approval from
> the BNL Institutional Animal Care and Use Committee (IACUC).
>
> 3\. The researcher and his/her collaborators shall have completed all
> required training prior to the study.
>
> 4\. The researcher shall follow the Infection Control Protocol
> (Attachment 2) when animals are involved.
>
> 5\. A schedule of proposed animal studies shall be submitted to, and
> must be approved by, the Facility Supervisor/Manager or designee, at
> least 7 days before the study and shall be kept by the Infection
> Control Practitioner.
>
> 6\. An Infection Control Checklist (Attachment 3) documenting the
> required procedures, shall be used by the researcher in preparing for,
> and conducting, the study, and in the subsequent cleanup.
>
> a\. A copy of the completed checklist shall remain at the facility to
> be used by the operator to determine that the facility is ready for
> subject use.
>
> b\. If the operator determines that the facility is not left by the
> researcher in the appropriate condition for subject use, the operator
> shall immediately notify the Infection Control Practitioner.
>
> c\. The Infection Control Practitioner shall immediately contact the
> researcher to clean up the facility and, if necessary, coordinate the
> appropriate cleanup with the custodians and other personnel.
>
> 7\. Additional requirements imposed by Facility Supervisors may be
> included as additional attachments.

6.0 [RECORDS]{.underline}

The checklist to be maintained by the Principal Investigator/Facility
Supervisors in each facility and the Infection Control Practitioner.

7.0 [ATTACHMENTS]{.underline}

1\. Facilities used for both human and animal research

> 2\. Infection Control Protocol for Animal Studies at Subject Treatment
> or Diagnostic Facilities
>
> 3\. Infection Control Checklist for Animal Studies at Subject
> Treatment or Diagnostic Facilities

The only official copy of this file is the one online at the Medical
Department website under "Clinical Research Center Policy Manual."
Before using a printed copy, verify that it is the most current version
by checking the document effective date on the website.

Attachment 1

IC-13/5

[List of facilities in which both human and animal research is
conducted:]{.underline}

12/07

PET

MRI

Attachment 2

IC-13/5

INFECTION CONTROL PROTOCOL FOR ANIMAL STUDIES

AT SUBJECT TREATMENT OR DIAGNOSTIC FACILITIES

The Medical Department is primarily devoted to research and therefore
animal studies will be periodically conducted in facilities used for
treating or studying subject/participants. Strict infection control
guidelines shall therefore be used:

> 1\. Only animal studies directly relevant to the IACUC research
> protocol requested, reviewed and approved shall be allowed.
>
> 2\. The studies shall be performed only in the facility identified in
> the IACUC protocol. All studies shall have the written approval of the
> facility supervisor or designee of the facility involved.
>
> 3\. Whenever possible, animal studies should be conducted
> [after]{.underline} subject/participants\' treatments or studies are
> completed. The researcher shall contact the person coordinating the
> work at each facility to schedule the non-subject/participant work.
>
> 4\. The studies shall be initiated and completed within an agreed upon
> time frame as identified in the protocol.
>
> 5\. A predetermined, precise route of transport of the animals from
> the Animal Facility to the site of experimentation and return shall be
> followed for each experiment.

6\. Researchers should don the appropriate personal protective equipment
for their experiment and also when working

> with animals. Gloves and long sleeved laboratory coats or work clothes
> should be worn while working with the baboons. While handling mice or
> rats heavy duty gloves should be worn as to prevent bites from
> occurring.
>
> 7\. As required, the animal(s) shall be prepared (i.e., anesthetized,
> where applicable, shaved, etc.) in the Animal Facility or
> researcher\'s laboratory and shall remain totally anesthetized during
> the transfer to the Subject Facility\'s experimentation site. Any
> initial surgery should be accomplished, whenever possible, before
> transfer to the experimentation site. The animals shall remain
> anesthetized during the course of the experimentation. If the
> experiment is to take place at a satellite facility, a BNL van shall
> be used to transfer the animals. Protective equipment shall be used in
> the van while animal is present. After the animal is removed the van
> needs to be disinfected. A scratch/bite kit is also provided in the
> van.
>
> 8\. Large animals shall be covered with a sheet or disposable paper
> during transportation to and from the Subject Facility. Smaller
> animals shall be transported in clean cages with clean bedding. These
> cages shall then be covered with a sheet so that the animal(s) shall
> not be visible to the public during the transport.
>
> 9\. Precautions shall be taken during the transport and experiment to
> prevent the loss of feces, urine, blood and secretions into the
> environment. Large animals shall be diapered to prevent loss of urine.
> In addition all procedures shall be carefully performed to minimize
> the creation of aerosols. Therefore, certified safety cabinets or
> other appropriate combinations of personal protection or physical
> containment devices, such as special protective clothing, respirators,
> centrifuge safety cups and sealed centrifuge rotors shall be used. The
> risk of infected aerosols from animals or their bedding can be reduced
> if animals are housed in partial containment caging, i.e., solid wall
> and bottom cages covered by filter bonnets. Larger animals especially
> primates need to be transported in covered/filtered transport cages.
>
> 10\. All equipment and facility surfaces which may come in contact
> with animals shall be completely covered with impermeable drapes
> during the studies.
>
> 11\. instruments and equipment that come into direct contact with the
> animal shall either be disposable or obtained from the Animal
> Facility. No equipment shall be utilized in the experiment(s) that
> will come directly in contact with a participant.
>
> 12\. Researchers and assistants shall follow all appropriate facility
> procedure requirements.
>
> 13\. Facility doors shall be left closed when any experiments are in
> progress.
>
> 14\. The researcher and assistants shall wear clean laboratory coats
> for the study. [Laboratory clothing worn in the Animal Facility shall
> not be worn in the subject area.]{.underline}
>
> 15\. After the studies are finished, follow IC-6.02 (Handling &
> Disposal of Regulated Medical Waste). It is the researcher\'s
> responsibility to leave the Facility in a clean condition and ready to
> receive subjects. All non-sharp disposables shall be placed in a
> leak-tight plastic bag or plastic lined ice cream container (ICC).
> This shall include all drapes, waste, disposable equipment, and other
> materials and drugs used during the course of the experimentation. The
> researcher shall seal the bag or cover the ICC and remove it from the
> Facility. The researcher shall place all sharps in a sharps container
> brought along for this purpose, and shall remove it from the Facility
> at the end of the study. Animal carcasses whether infectious or non
> are disposed of as regulated medical waste (RMW). They are stored in a
> freezer within the BLAF (Brookhaven Laboratory Animal Facility) in
> Room 11-118. (MO-375-BLAF). Radioactive carcasses (R-RMW) shall be
> stored in the appropriate freezer in the basement.
>
> 16\. The researcher shall wipe all surfaces used in the study with a
> freshly prepared disinfectant (Cidex, Metrex, Maxima or equivalent).
>
> a\. Work surfaces shall be cleaned from cleanest to dirtiest areas.
>
> i\. Clean from top to bottom.
>
> ii\. Remove loose dirt/debris before washing.
>
> b\. Damp dusting/washing shall be performed to avoid cleaning methods
> that generate dust aerosols.
>
> c\. Cleaning supplies or equipment shall not be stored in subject
> rooms.
>
> 17\. The researcher shall bring his own supplies for the study.
> However, disinfectant and disposable cleaning clothes may be available
> in the Subject Facility.
>
> 18\. Personnel shall wash their hands after handling the animals,
> before entering the Facility, and before leaving the Facility.
>
> 19\. Infection Control surveillance shall be done periodically by the
> Infection Control Practitioner and facility liaison operator to check
> for cleanliness after the study and before the next
> subject/participant is treated or studied. The Infection Control
> Practitioner shall use a review form that provides a record of the
> work practices and compliance with this procedure.
>
> a\. If the operator determines that the facility is not left by the
> researcher in the appropriate condition for subject use, he/she shall
> immediately notify the Infection Control Practitioner.
>
> b\. The Infection Control Practitioner shall immediately contact the
> researcher to clean up the facility and, if necessary, coordinate the
> appropriate cleanup with the custodians and other personnel.

Attachment 3

IC-13/5

INFECTION CONTROL CHECKLIST FOR ANIMAL STUDIES

AT SUBJECT TREATMENT OR DIAGNOSTIC FACILITIES

12/07

DATE: RESEARCHER: IACUC PROTOCOL NO.

ANIMAL SPECIES:

1\. Bring the following items with you to the Subject Facility:

A. Plastic lined ice cream containers and plastic bags

B. Sharps containers

C. Change of lab coats

D. Diapers

E. Disinfectant

F. Gloves

2\. Make sure animals are totally contained, shaved, anesthetized (where
applicable) and covered before transporting them to the Patient
Facility.

3\. Wash your hands after working with the animals in the Animal
Facility before entering the Subject Facility.

4\. Change your lab coat before entering Subject Facility.

5\. Make sure the door to the Facility is closed and [no]{.underline}
food or drink is brought into the Facility.

6\. Cover all surfaces in the Subject Facility in contact with the
animal.

7\. When leaving the Facility, disinfect all surfaces thoroughly and
take everything with you.

8.\_ Before leaving the Facility, make sure you wash your hands.

9.\_ If you are using the van, lay diapers down before placing animal/s
in the van. Make sure you disinfect the van after use. This disinfection
procedure is done when transporting baboons, mice, rats and other
animals.

The above procedures have been followed by the researcher and
assistants.

Researcher:

Assistants: