Sole_Source_Justification_Redacted.pdf

U.S. DEPARTMENT OF COMMERCE

National Oceanic and Atmospheric Administration National Marine Fisheries Service Office of Protected Resources 1315 East West Highway Silver Spring, MD 20910

SINGLE SOURCE DETERMINATION

USING SIMPLIFIED ACQUISITION PROCEDURES (SAP)

FOR AN ACTION NOT EXCEEDING THE

SIMPLIFIED ACQUISITION THRESHOLD (AUTHORITY: FAR 13.106-1(b)(1))

1. Agency and contracting activity.

Department of Commerce, NOAA Acquisition and Grants Office (AGO), Western Acquisition Division and the NOAA Fisheries/Office of Protected Resources (OPR).

2. Description of supplies or services required to meet agency needs (including the estimated value).

This requirement is necessary to provide marine mammal diagnostic testing from cases submitted by the NMFS Marine Mammal Health and Stranding Response Program (MMHSRP) network members especially during and after Unusual Mortality Events (UMEs), and by researchers especially from live capture release health assessments. Data from these cases will further our understanding of health, health trends, and diseases of marine mammal populations in the wild and provide advice to management regarding circumstances or causes of morbidity and mortality in these marine animal populations.

The requirement is to provide specialized tissue sample processing (including trimming, embedding, cutting, H&E stains, immunohistochemical stains, etc.), histological evaluations, laboratory diagnostic pathogen testing (PCR, whole genome sequencing, etc.) and expert consultations. The contractor must provide veterinary diagnostic laboratory services with expertise in performing and developing assays for the detection of marine mammal pathogens including but not limited to Brucella ceti and pinnipedialis, morbillivirus antigen, viral RNA and DNA, virus isolation, and the ability to perform whole genome sequencing. The laboratory must be an operational diagnostic laboratory with rapid turn around and quality assurance standards, and the ability for surge capacity to assist with response during unusual mortality events or disease outbreaks. Morbillivirus and Brucella sp. testing by PCR and sequence confirmation of results must be conducted using validated tests using known dolphin morbillivirus and/or phocine /canine distemper virus and Brucella ceti and pinnipedialis control materials. The contractor must offer veterinary diagnostic pathology services by certified experts in veterinary pathology (Diplomates of the American College of Veterinary Pathologists or equivalent) that are qualified to perform a histologic evaluation of tissues and provide causes or contributors of morbidity or mortality, including infectious diseases, neoplasia, toxins, identification of injuries as antemortem, post mortem, or perimortem, and determine the impact of diseases or conditions on the individual. The contractor should have at least 10 years of experience working on and diagnosing samples collected from stranded marine mammals. The contractor shall have subject matter experts on staff that have background and expertise in the required diagnostic tests and can provide interpretation of test results and descriptions of test methodologies.

The contractor should have demonstrated expertise in test development for marine mammal pathogens of concern and in particular morbillivirus and Brucella sp.

This contract is important to inform the MMHSRP and researchers on the health, health trends, and diseases of marine mammal populations, and to provide advice to management regarding circumstances or causes of morbidity and mortality to support NOAA’s mandates for species conservation and recovery under the Endangered Species Act and Marine Mammal Protection Act.

143015-24-0049

3. Identification of the single source to be solicited.

University of Illinois College of Veterinary Medicine Zoological Pathology Program Dr. Katie Colegrove 3300 Golf Rd.

Brookfield, IL 60513

UEI: Y8CWNJRCNN91

4. Supporting rationale. Only one source or brand name is reasonably available as detailed below:

□ Other - Only one source is capable

The University of Illinois, College of Veterinary Medicine, Zoological Pathology Program works through a variety projects and initiatives to address complex health problems in zoological collections and wildlife. The program has earned an international reputation for excellence in diagnostic service, education of residents and veterinary students, contribution to worldwide conservation efforts, and original scholarship. The Zoological Pathology Program contributes to global conservation efforts through diagnosis and research into wildlife diseases which not only benefit species conservation programs but also enhance the health of domestic animals, humans, and the environment. The Zoological Pathology Program has faculty and staff members that are board certified (ACVP diplomats) by the American College of Veterinary Pathology and/or hold PhDs in veterinary medicine, wildlife disease, or other related disciplines. Dr. Kathleen Colegrove is the lead pathologist for marine mammal case review and has 15+ years of experience in marine mammal pathology.

The Zoological Pathology Program has extensive experience in marine mammal diagnostic pathology and diagnostic pathogen testing.

NMFS Office of Protected Resources works throughout the United States and abroad to detect, investigate, and respond to marine animal health and emergency response issues. Specifically, the diagnostic capabilities of the Zoological Pathology Program will be used for health and disease investigations of stranded and live captured wild marine mammals including UMEs.

The Zoological Pathology Program is uniquely qualified to assist with the marine mammal diagnostic pathology and diagnostic testing for pathogens particularly morbillivirus and other viral pathogens, as well as with data interpretation and analysis. They have significant expertise and experience in viral pathogen testing in wildlife nationally and globally and have provided rapid turnaround diagnostic services for marine mammal pathogens routinely. At this time, this laboratory is the only veterinary diagnostic and surveillance laboratory that performs whole genome sequencing for dolphin morbillivirus in the United States. As a diagnostic marine mammal laboratory, Zoological Pathology Program performs the whole genome sequencing and PCR testing and provides preliminary results within the 15 days and final results by 60 days.

Currently, other research laboratories perform genome sequencing only as research and therefore do not provide data in a rapid manner. In addition, other laboratories do perform marine mammal pathogen PCR but do not currently perform full genome sequencing. The Zoological Pathology Program molecular lab also has developed rapid diagnostic PCR testing for marine mammal bacterial and fungal pathogens including Brucella

sp. Currently the Zoological Pathology Program is the only diagnostic service laboratory that offers PCR testing for marine mammal specific Brucella sp., including Brucella ceti and Brucella pinnipedialis. Current projects outside of various UME work with the MMHSRP include an extensive multi-institutional Brucella genetics investigation. The Zoological Pathology Program molecular laboratory also has the capability for diagnostic assay development, should the need arise.

The laboratory has the expertise and the experience in handling samples and swabs for morbillivirus and other viral pathogens from marine mammals and has been participating in various UME investigations for over the last 10+ years. The Zoological Pathology Program has experience with the sample tracking, chain of custody, and paperwork associated with the legal aspects of these services and understand the importance of these processes for law enforcement investigations and Natural Resource Damage Assessments. From both a scientific and legal perspective for future cases, it is critical that an experienced laboratory be used when testing marine mammal samples. The laboratory also has the expertise to summarize and analyze patterns of disease and evaluate risk factors for exposure to disease in marine mammals, and thus often participates as a member of the multidisciplinary teams that investigate UMEs as well as other diseases that affect marine mammal or other wildlife populations. Finally, this laboratory has recently worked as diagnostic support for four ongoing large whale UMEs and has provided rapid turnaround of PCR results to managers and responders.

If this contract could not be awarded to the Zoological Pathology Program then several investigations the MMHSRP is conducting on the health, health trends, and diseases of marine mammal populations would be impacted. This lack of diagnostic date would impact the ability of the MMHSRP to provide advice to management regarding causes of morbidity and mortality in marine mammal populations and support NOAA’s mandates for species conservation and recovery under the Endangered Species Act and Marine Mammal Protection Act.

5. Market Research.

As mentioned above the Zoological Pathology Program is the only veterinary diagnostic service laboratory in the United States that performs marine mammal specific Brucella sp. testing (Brucella ceti and Brucella pinnipedialis) as well as marine mammal viral whole genome sequencing for dolphin morbillivirus.

We could not identify any additional veterinary diagnostic service laboratories that offered these services.

Additionally, the Zoological Pathology Program has several existing sole-source contracts with both the NMFS Southeast Regional Office (SERO) and Pacific Islands Fisheries Science Center (PIFSC) to provide histopathology and pathogen testing for marine mammals.

Efforts to locate other possible vendors through the veterinary marine medicine industry and scientific publications have been unsuccessful.