36C26025Q0427.docx

Sources Sought Notice Sources Sought Notice

GENERAL INFORMATION

SET-ASIDE

ATTN: V4CONT

1601 E. Fourth Plain Blvd Bldg.17, Suite B428 Vancouver WA 98661

POINT OF CONTACT*

Contract Officer Amy Kuczajda Amy.Kuczajda@va.gov 208-429-2018

PLACE OF PERFORMANCE

VA Portland Health Care System

Research and Development Department

3710 SW US Veterans Hospital Road

Portland OR

ADDITIONAL INFORMATION

AGENCY’S URL

URL DESCRIPTION

AGENCY CONTACT’S EMAIL ADDRESS

EMAIL DESCRIPTION

DESCRIPTION

This is a SOURCES SOUGHT SYNOPSIS and is for informational / market research purposes only. THIS IS NOT A REQUEST FOR PROPOSAL, QUOTATION OR BID, NOR A SYNOPSIS OF A PROPOSED CONTRACT ACTION UNDER FAR SUBPART 5.2. No reimbursement will be made for any costs associated with providing information in response to this synopsis or on any follow up information. NO SOLICITATION IS CURRENTLY AVAILABLE.

The purpose for this synopsis is to conduct market research to help identify capable, potential sources and to establish if this requirement can be set-aside for small business or other socio-economic programs.

NAICS Code: 541940 – Disease Testing services, veterinary Small Business Size Standard: $10M PSC/FSC: R416 – Support – Professional: Veterinary/animal care

GENERAL INFORMATION:

The Department of Veterans Affairs Portland Research and Development department intends to procure services for a Rodent Health Surveillance monitoring and testing program. Under Federal guidance, the Rodent Health Surveillance Monitoring Program sets out to diagnose, treat, and control disease by testing sentinel animals identified within the Surveillance Program for viral, bacterial, and parasitic infections to protect and maintain the health and well-being of the animal colony and provide reliable research outcomes to Principal Investigators.

See attached Statement of Work for details.

INSTRUCTIONS TO RESPOND TO SOURCES SOUGHT SYNOPSIS:

Any vendor interested and capable of meeting this requirement should provide a written statement to the Contracting Officer. Vendor response must include at a minimum:

· Point of Contact

· Business size

· Short Description of Capabilities

· VetCert certification (if applicable)

· SAM registration (https://sam.gov)

· Unique Entity ID (UEI#)

Any response to this notice must show clear and convincing evidence of the Vendor’s capability of meeting this requirement. Please note, responses will be shared within the Government and project team, but otherwise will be held in strict confidence.

Interested firms shall respond to this synopsis no later than 7:00 PM Mountain Time on 04/09/2025. All responses shall be submitted electronically to amy.kuczajda@va.gov

STATEMENT OF WORK (SOW)

1. Contract Title. Rodent Health Surveillance Monitoring & Testing

2. Background.

The Veterinary Medical Unit (VMU) at VA Portland Health Care System (VAPORHCS) Research and Development Service is a flagship core service serving over 100 Principal Investigators operating 150 approved Institutional Animal Care and Use (IACUC) research protocols. The VMU operates under an Assurance with Public Health Service (PHS #A374501) and is Fully Accredited by AAALAC, International (Unit Number is VA-060; most recent site visit was 18 June 2019).

The VMU also complies with the Animal Welfare Act and is licensed with the United States Department of Agriculture (USDA License Number 92-V0001, Customer Number 1321). The VMU provides animal models (Rodent Species, Mus musculus, Rattus norvegicus, and Microtus ochragaster) in full compliance and accreditation with the above regulatory and auditing agencies. In order to operate within the guidelines (The Guide for the Care and Use of Laboratory Animals, Eighth Edition, National Research Council of the National Academies; AVMA Guidelines on Euthanasia, 2013 edition; USDA 2011 Animal Care Policies; VA Handbook 1200.7 ) set forth by these agencies, the VMU is mandated to have an IACUC-approved Rodent Health Surveillance Monitoring Program (IACUC Approval #2767, #2768-18) which oversees the health and well-being of all the research animals within the colony. In other words, this work is driven and required by Federal policy.

The Rodent Health and Surveillance Program requires testing of sentinel animals on a quarterly basis and in the event a disease outbreak occurs. This Program has been in existence since the basic science research facility was established in 1986 and has evolved over that time with improvements in animal testing and disease diagnosis. During this time, the VMU has maintained a healthy research colony providing Principal Investigators with predictable and reliable animal models creating reproducible research outcomes. It has also been able to diagnose accurately in a thorough and timely manner disease conditions or states of individual animals with the assistance of certified laboratory animal veterinary pathologists and with certified laboratory testing equipment producing reliable results.

3. Scope.

Under Federal guidance, the Rodent Health Surveillance Monitoring Program sets out to diagnose, treat, and control disease by testing sentinel animals identified within the Surveillance Program for viral, bacterial, and parasitic infections to protect and maintain the health and well-being of the animal colony and provide reliable research outcomes to Principal Investigators.

This also tests for any zoonotic illnesses that may infect veterinary and research technicians working on those animals. There are animal research colonies housed in three vivarium at three different buildings at the VA Portland Health Care System.

To monitor disease surveillance in these animal colonies, tissue samples and live sentinel animals are collected and sent to an outside, certified animal diagnostic laboratory with PHS Approval and AAALAC, International Full Accreditation. The VMU then receives these test results quarterly and is required (by Federal Law and internal policy) to post the results for Principal Investigators to review. Furthermore, these test results are then shared with receiving institutions (there are irreplaceable strains of animals within the VMU research animal colony that have been selectively-bred or genetically-modified and shipped all over the world to research collaborators). For those collaborators to receive these animals, the VMU is required to provide Rodent Health Surveillance Monitoring Quarterly Test Results to the receiving institutions prior to shipment, and these test results must be from an outside, certified laboratory.

For the past ten years, the VMU has coordinated with its academic affiliate (Oregon Health & Science University, OHSU) to use the same laboratory and conduct the same tests on the animals to facilitate the shipment and/or transfer of the animals between the institutions, saving researcher’s and taxpayer’s money and time by not running duplicate tests or, prolonging the quarantining animals between institutions.

The selected contractor shall provide testing that is applicable and unique to the research program at Veterinary Medical Unit at VAPORHCS for diseases that are specific or endemic to this area and to this colony. Likewise, with the decrease in research funding, there has been a significant increase in collaborations all over the world; this requires shipment of genetically modified animals, and to do so, the shipping institution must guarantee the health of the animals within that colony for the collaboration and transfer to proceed. For the past twenty-eight years, the Rodent Health and Surveillance Monitoring Program has been in operation and has evolved over this time with newer and more sophisticated and improved testing processes. The latest development in these testing procedures utilizes PRIA (PCR (Polymerase Chain Reaction) Rodent Infectious Agents) testing on the animals.

Contractor must test for all viruses, bacteria, and parasites that are of particular importance to this facility; this includes but is not limited to the following: Mouse Parvo Virus, Mouse Noro Virus, Lymphocytic Choriomeningitis Virus, Mouse Hepatitis Virus, Sendai Virus, Epizootic Diarrhea of Infant Mouse (EDIM) Virus, Tyzzer’s Disease, Helicobacter, Car bacillus, Mycolpasmosis, Corynebacterium, Dermatomycosis, Myobia musculi, Mycoptes musculinis, Radfordia affinis,Radfordia ensifera, Syphacia obvelata, Syphacia muris, and Oxyuriasis. Any of these diseases are devastating to a research animal colony and can halt animal transfers between institutions. In order to maintain a Specific Pathogen Free (SPF) colony, the VMU is required to test for these (and more) diseases, have those tests be performed by a certified, AAALAC-International accredited laboratory, that provides consistent, accurate, and timely test results.

In summary, the Rodent Health Surveillance Monitoring Program is an on-going testing program of the laboratory animal research colony at VAPORHCS in Portland, OR. This testing program is required by federal law and outside auditing agencies. It assures the researchers that the animals are free of opportunistic infections that may interfere with research outcomes. It assures the workers that there are no zoonotic agents that may infect them and, it assures the public that the research animal colony is free of specific pathogens. The Surveillance Program allows animals to be transferred to other institutions locally and globally conserving animal lives and resources. Consistency of testing procedures and methodology is paramount in tracking diseases, monitoring animal health and in having confidence in results.

4. Specific Tasks.

According to the IACUC-approved VMU Standard Operating Procedures V.d.1 and V.d.9 and according to the IACUC-approved Sentinel Animal Program (Rodent), #2768- 18, the specific tasks required are as follows:

Task 1: Quarterly animal sentinel testing and test reporting and pathologist consultation as needed, whereby tissue samples are submitted to contractor for specific tests that are of specific importance and significance to the VMU mouse, rat, and prairie vole colonies:

Mus Musculus (mouse) and M. ochragaster (vole):

Quarter 1: PRIA Testing, Mouse Surveillance Plus; HM profile (voles) Quarter 2: PRIA Testing, Mouse Prevalent; HM profile (voles) Quarter 3: PRIA Testing, Mouse Surveillance Plus; HM profile (voles) Quarter 4: Serological Testing, Mouse Tracking Profile; HM profile (voles)

Task 2: Quarterly animal sentinel testing and test reporting and pathologist consultation as needed, whereby tissue samples are submitted to contractor for specific tests that are of specific importance and significance to the VMU mouse, rat, and prairie vole colonies:

Rattus norvegicus (rat):

Quarter 1: Assessment Plus Serology Quarter 2: Assessment Plus Serology Quarter 3: Assessment Plus Serology Quarter 4: Necropsy and Serology

Task 3: Quarterly testing and test reporting (and pathologist consultation as needed) of Thoren rack housing units and caging filter tops whereby HEPA filters are tested for genetic components of viral, bacterial, and parasitic diseases:

Housing Unit Plenums:

Quarter 1: PRIA Testing Quarter 2: PRIA Testing Quarter 3: PRIA Testing Quarter 4: PRIA Testing

Task 4: Contractor will provide the following supplies for sample submission:

1. Non-alginate oral swab

2. Body swab

3. Eppendorf tubes

4. Shipping containers

5. Microsampler (Neoteryx)

5. Performance Monitoring:

Contractor shall provide the POC, annually and on an as requested basis, the results of the following:

1. The accreditation status of AAALAC, International most recent site visit.

2. Quarterly sentinel results of their own animal colonies.

3. Good Laboratory Practice (GLP) certifications of all testing equipment.

Subtask—Quality Assurance: Contractor shall provide the VMU with their Quality Assurance outcome reports on an annual basis and as requested by the Veterinary Medical Officer (VMO) at VA Portland Health Care System (VAPORHCS). These reports include testing equipment certifications, disease outbreaks, and disease monitoring.

Subtask—Technical Support: Contractor shall provide expert technical support representatives to assist the assigned Veterinary Medical Officer and Unit Team in test outcomes, interpretation, and monitoring follow-up. The Technical Support Specialists are Doctors of Veterinary Medicine who are Board-Certified in Laboratory Animal Medicine and Veterinary Pathology.

Subtask—Contract Management:

1. The assigned VMO reviews testing procedures and results to assure investigators and the IACUC team of the health and well-being of the research animal colony. The assigned VMO responds to disease outbreaks as needed and implements disease containment measures, decontamination of facilities, treatment of animals, and on-going training of VMU staff.

2. The assigned Lead Veterinary Technician conducts all testing of sentinel rodents and ships samples to contractor. The assigned Lead Veterinary Technician receives the quarterly test results, reports any areas of concern to the VMO, and reviews test results. The assigned Lead Veterinary Technician consults with the contractor’s Technical Team on an as needed basis regarding sample submission, shipping, and reporting.

Task 2: Deliverables are Test Results: Test Results are delivered quarterly to VAPORHCS VMU following quarterly sample submission to contractor or delivered on an as needed basis to a particular test performed.

Diagnostic summary for quarterly sentinel results or specific test results from a particular sample submission; this includes gross necropsy and thirteen serologic test results along with a positive control test.

Diagnostic summary for quarterly sentinel results or specific test results from a particular sample submission including gross necropsy findings; this includes thirty-eight polymerase chain reaction (PCR) test results for viral, bacterial, and parasitic genomes.

Diseases tested for include:

MFIA SEND

MFIA PVM

MFIA MHV

MFIA MVM

MFIA MPV-1

MFIA MPV-2

MFIA NS-1 –

MFIA MNV

MFIA GDVII -

MFIA REO

MFIA EDIM (ROTA-A)

MFIA MPUL –

MFIA Anti-Ig

MAV 1 & 2 PCR -

PVM PCR -

RCV/SDAV PCR -

REO PCR -

RPV PCR -

RTV PCR -

SEND PCR -

SEO (Hantavirus) PCR - Beta Strep Grp B PCR + Beta Strep Grp C PCR - Beta Strep Grp G PCR - B. bronchiseptica PCR - Campylobacter Genus PCR - CAR Bacillus PCR - C. kutscheri PCR - C. piliforme PCR - Helicobacter genus - K. oxytoca PCR - K. pneumoniae PCR - M. pulmonis PCR – P. pneumotropica-Heyl PCR - P. pneumotropica-Jawetz PCR + P. mirabilis - Ps. aeruginosa PCR - Salmonella Genus PCR - S. aureus PCR - S. moniliformis PCR - S. pneumoniae PCR - Cryptosporidium PCR - Entamoeba PCR - Giardia PCR - Mite PCR - Pinworm PCR - Pneumocystis PCR - Spironucleus muris PCR

6. Security Requirements.

Contractor will have no access to VA Portland Health Care System VMU computer systems or databases, PHI/PII, or sensitive study information. No contractor employee shall have VMU access. VMU access is monitored monthly as well as randomly. The Veterinary Medical Officer oversees which individuals have access to this Bio-secure area.

7. Government-Furnished Equipment (GFE)/Government-Furnished Information (GFI).

No GFE or GFI is provided.

8. Other Pertinent Information or Special Considerations.

a. Identification of Possible Follow-on Work.

There is no follow-on work identified in this Statement of Work.

b. Identification of Potential Conflicts of Interest (COI).

There is no Conflict of Interest.

c. Inspection and Acceptance Criteria.

Along with Principal Investigators and the Veterinary Medical Officer (VMO), the test results will be forwarded to the POC or Research Department POC who will see that the work is being done as stated in the SOW. The POC will provide Monthly Account Status Reports to the VMO, and in these reports the POC will provide updates of the Testing Results.

VMU staff will keep accountability for contract burn rates, product or servicing needs being requested, and take measures to action any contract modifications – with the assigned POC according to the Federal Acquisition Regulations – for needs outside of the original award.

9. Risk Control All agents within the Veterinary Medical Unit are either Risk Group 2 or less and are under Animal Biosafety Level 2 or less. Standard donning of Personal Protective Equipment (PPE) is required to enter the VMU, and this measure protects both humans and animals from possible zoonotic infections. Allergen exposure is the greatest risk, and all work will be performed in a certified (annually) Animal Changing Station (NuAire) or biosafety cabinet.

Individuals working on the animals are enrolled in the Occupational Health and Safety Program and have annual medical evaluations performed by Employee Health specialists. Individuals are annually fit-tested with N-95 masks.

VMU staff will continue to meet VAMC Biosafety requirements with the [assigned] Research & Development Biosafety officer(s).

10. Place of Performance.

Tissue sample collection occurs within the VMU at VAPORHCS. Testing of samples will occur at the contractors laboratory.

11. Period of Performance.

Base Year: Date of Award – 08/31/26 Option Year 1: 09/01/26 – 08/31/27 Option Year 2: 09/01/27 – 08/31/28 Option Year 3: 09/01/28 – 08/31/29 Option Year 4: 09/01/29 – 08/31/30

12. Delivery Schedule:

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