573-15-1-901-0001-VMU Oversight and Support_Dr. Bose/Services

STATEMENT OF WORK

Objective:

The purpose of this contract is to establish continuing services for veterinary oversight and support to the Veterinary Medical Unit (VMU) and VA Research Investigators from 12/1/14 through 11/30/15. The Contractor will be responsible for providing professional, regulatory, and clinical veterinary services to Research Service at NF/SGVHS.



Location of Contract Performance and Hours of Service

Work is to be performed in the NF/SGVHS VMU at 1601 SW Archer Road Gainesville, Florida 32608. Contractor needs to be in close proximity to Gainesville, FL in order to provide immediate oversight and support.



Personnel Qualifications:

To fulfill the conditions of this contract the Contractor also known as Vendor will retain individuals that maintain good standing a DVM or equivalent licensure in Veterinary Medicine in at least one state in the United States. These individuals will serve as the Veterinary Medical Officer (VMO) and will have completed training in laboratory animal medicine.

Specific Tasks:

1) Per VHA Handbook 1200.07 Use of Animals in Research; directing the operations of the animal research facility to ensure compliance with current animal welfare laws, regulations, and policies and to support R&D Programs using animal subjects.

2) Provide advice and instruction concerning the design and operation of research and development programs using laboratory animals.

3) Provide recommendations as needed to VA management, animal facilities supervisors and principal investigators to ensure compliance with all relevant state, federal, and local animal welfare regulations.

4) Will assist in preparing for and maintaining full AALAC Accreditation.

5) Provide support as needed in the planning and execution of research projects.

6) Provide advice on the proper selection of animal models.

7) Participate on the VA Institutional Animal Care and Use Committees (IACUC/(s)

8) Provide oversight for ensuring compliance with Occupational Health,

Hazard, Containment, and Zoonosis control programs.

9) Provide oversight of surgical and post-surgical care programs.

10) Provide Animal Facility Management oversight.

11) Provide Clinical care and preventative medicine experts for the VA facility listed in this contract.

12) Provide guidance to investigators in regard to the selection of anesthetics and analgesics. In addition to proper post-surgical and euthanasia methodologies.

13) Provide animal care training to Research Service staff.

14) Provide on-site inspections of:

Animal facility to assess the health and well-being of all research animals.

A minimum of 2 visits per week are required to the Veterinary Medical Unit (VMU)

15) Is available for emergency coverage at the request of the VMU Coordinator.





Additional Tasks that will be performed:

1. The Contractor's Veterinary Medical Officer (VMO) or designee will provide the overall supervision and management of the Veterinary Medical Unit (VMU).

a. This management does not include management of currently employed VA employees.

2. Management will include the scheduling of employees in the evening, weekends and holidays that are not covered by current VA employees.

a. VA Employees shifts (2) are:

i. 6:30am to 3pm

ii. 8:30am to 5pm

b. In the event of illness, VA employees will call in to the ACOS/Research, who is their direct supervisor, or designee as assigned.

c. The ACOS/Research or designee will contact ACS for coverage of ill VA employee.

d. If over-time charges are incurred the Contractor will absorb those costs.

3. The VMO will move towards utilizing the standard operating procedures utilized at the University of Florida. Those changes will be approved by the IACUC and Research and Development Committee prior to implementation.

4. The Contractor, VMO, or designee, will be responsible for maintaining and providing necessary documentation and support as prescribed by the Guide for the Care and Use of Laboratory Animals, PHS Policy and VHA Handbook 1200.7 Use of Animals in Research and for maintaining accreditation by AAALAC-International.

5. The Contractor, VMO or designee will be responsible for additional training required for Animal Care Awareness.

6. The VMO, or designee, will take charge of the husbandry services to include:

a. Moving towards utilizing the same per diem rates at both the Contractor and the VA with the approval of the IACUC and VA Research and Development Committee.

b. Working with the VA for the billing of charges associated with specific grants.

c. Specialty Care services provided by the VA will be billed separately by the VA to the appropriate grant.

7. Will assist and maintain all documentation necessary for VA regulatory purposes outside of the IACUC responsibilities. The VA will maintain its own IACUC separate from the University of Florida.

8. The contractor will be responsible for maintaining adequate supplies within the VMU.



Plan for the supervision of VA employees:

1. The ACOS/Research or designee will coordinate with the Veterinary Medical Officer (VMO) to ensure that shifts are covered and that the monitoring of animal care is performed as described in the Veterans Health Administration Handbook, Guide for the Care and Use of Laboratory Animals, NRC (2010), and USDA regulations on the care and use of laboratory animals.

2. The ACOS/Research or designee will assist the technician with communications within the VMU program and the VMO.

3. All issues surrounding VA employees and communication will go through the ACOS/Research or designee and communicated with the VMO, Contractor supervisor, or other contractor management designee.

4. Any issue involving VA employee issues that could or have resulted in disciplinary action will be managed by the AOCS/Research or designee.

5. ACOS/Research or designee will coordinate schedules for time off with the technicians and ACS supervisor, or other ACS management designee for continuous coverage of the facility.





VA Responsibilities:

1. Building #11 currently known as the VMU, at the Malcom Randal VA Medical Center (Gainesville VA).

2. Movable and fixed equipment as well as Service Contracts for fixed equipment.

3. Replacement/restoration of aging finishes

4. Waste disposal costs

5. Monitoring and maintenance of environmental parameters in all animal housing rooms

6. VA will be responsible for all correspondence with OLAW.

7. Documentation of husbandry and veterinary care for IACUC

a. Preparation of USDA annual report

b. USDA registration

c. ACS will lead in preparation of the AAALAC Program Description, but the VA will be responsible for:

i. Organization chart

ii. Facility Plans

iii. Securing of HVAC data

iv. Annual usage forms

v. IACUC member lists

vi. IACUC Minutes

vii. IACUC Semi-annual report

viii. Blank IACUC protocol form

8. AAALAC annual report

9. PIV Sponsor and/ or COR Responsibilities

The VA PIV Sponsor and or COR is to ensure that all contractors are processed administratively prior to obtaining physical access to perform duties in the VMU; the contractor staff covered by the VA contract must:

o Have Fingerprints taken by VA Police Services

o Complete SF-85 for SAC for background investigation (will accept equivalent suitability clearance-UF)

o Obtain a VA ID Badge from VA Police Services (FIPS PUB 201-1)

Research Service Responsibilities: Ensure requirements are complete current

o VA Privacy and Information Security Awareness and Rules of Behavior

o Privacy and HIPAA Training (if you will use a VA computer)

o IACUC (s) and Biosafety CITI Training(s) (UF Training will be accepted)

o Animal Scope of Practice



Contractor Responsibilities:

1. Husbandry for all animals in the VA animal facility. The following are included in the per diems charged, anything not on the list below will be at an additional cost to the investigator:

a. Receiving, unpacking and housing of newly arrived animals

b. Environmental enrichment

c. Cage changing

d. Cage checking for animal health and welfare issues

e. Label cages when illness is detected

f. Observing and reporting of aberrant behavior

g. Quality assurance monitoring of mice and rats (sentinel program)

h. Animal room maintenance/sanitation

i. Veterinary consultation on animal care and use

j. Provision and sanitation of personal protective equipment for animal care staff, investigator and research staff

k. Census verification

l. Cage washing and room sanitation supplies

m. Repair or replacement of aging/damaged cages

n. Billing investigators accounts for services not covered as standard husbandry care

o. Investigator and animals resource staff training

2. All materials and supplies needed for standard husbandry care.

3. Additional caging and water bottles.

4. Prepare, update, maintain and provide necessary documentation and support of the IACUC program with all provisions applicable with the Animal Welfare Act and other Federal statutes and regulations relating to animals.

5. Quality assurance monitoring of animal facility.

6. Assist with preparation of AAALAC Annual Report to include other reporting requirements pertaining to the VMU and animal care issues.

7. All services and supplies not defined as "standard care" will be billed to investigators on a per service bases.

a. "Contractor's Standard of Care"

8. To obtain physical access and perform duties in the VMU; the contractor-supervisor must ensure that all its staff members covered by the VA contract:

Have Fingerprints taken by VA Police Services

o Complete SF-85 for SAC for background investigation (will accept equivalent suitability clearance-UF)

o Obtain a VA ID Badge from VA Police Services

o Complete VA Training and maintain current at all times

o Complete VA Animal Scope of Practice and maintain current at all times

o Wear VA ID badge at all times when on VA property

o Sign-in when entering the Animal Facility









Submission of Invoices will be on a quarterly basis.