4 20-02025 HMS Pathology services and diagnostics_SOW_2020 RFQ.pdf

Performance Work Statement

National Oceanic and Atmospheric Administration (NOAA) National Marine Fisheries Service (NMFS)

Hawaiian Monk Seal Research Program (HMSRP)

Veterinary Pathology services, ancillary diagnostics and consultation

BACKGROUND:

The NMFS Hawaiian Monk Seal Research Program (HMSRP) is procuring services for veterinary histopathology, ancillary diagnostics, and associated veterinary consultation in Hawaiian monk seals as part of its long-term population health monitoring and disease surveillance program for wild, free-ranging seals sampled during the course of research activities and stranding response.

The purpose of this requirement is to provide diagnostic testing and expertise in test interpretation of Hawaiian monk seal cases submitted by the National Marine Fisheries Service (NMFS) Pacific Island Fisheries Science Center (PIFSC) Hawaiian Monk Seal Research Program (HMSRP). This effort is especially important given the endangered status of Hawaiian monk seals, to inform researchers on the health, health trends, and diseases of monk seal populations, and to provide advice to management regarding circumstances or causes of morbidity and mortality for the species and is support of NOAA’s mandates for species’ recovery under the Endangered Species Act and Marine Mammal Protection Act.

TASKS:

Required Services:

A. Tissue and slide processing of formalin-fixed tissues including trimming of tissues, embedding of tissues, cutting slides, and H&E stains.

B. Pathologic interpretation in order to 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.

C. Ancillary diagnostics: Conduct in-house molecular analyses (PCR) when indicated by preliminary pathological findings, ability to develop in-house PCR tests as needed, for new pathogens of concern. When in-house tests are unavailable, capacity to send samples directly to the appropriate specialty laboratory, in coordination with the submitter. Complete in-house aerobic and anaerobic microbiological cultures and full susceptibility testing (MIC) for monk seal biomedical samples.

D. Provide consultation services on issues of population health and conservation concern that stem from or may be informed by histopathology data or other diagnostic results.

Consultation may include retrospective case review, collation of data on cases of interest, analyzing/summarizing trends in population health factors related to pathology findings, contributing to scientific report writing, providing expert guidance and support to patient management and research/enhancement efforts.

DELIVERABLES:

Consultation services shall be discussed with the pathologist and project point of contact and timelines agreed upon before work begins. Methods and controls used for histological assessment, special stains, or immunocytochemical assessment shall be provided upon request.

Final reports: Final reports must be written in a clear, explanatory manner such that all readers (ranging from educated lay persons to specialists) are able to comprehend the significance of the findings. Final Reports should be sent via email to the submitter and will consist of animal information including:

● Field ID and accession number for the laboratory, species, and sex

● Histologic descriptions

● Morphologic diagnosis

● Final diagnoses (indication of most significant findings)

● Comments

● Ancillary diagnostics (special stains, immunohistochemistry, culture, etc., as applicable)

● Digital images shall be provided as warranted

The exact duration of a particular analysis will be determined in consultation with the submitter and/or the project point of contact. In general, processing times required are as follows:

● Expedited cases: final report within 1-2 weeks of receipt

● Routine cases: final report within 2-4 weeks of receipt

● Low priority: final report within 3 months of receipt

Tissue Processing: Provide routine processing including trimming of tissues, embedding of tissues, cutting slides, normal H&E stains, special stains, and immunohistochemical stains.

Provide a standardized turnaround of submitted samples to include expedited, routine, and low priority cases.

Expert interpretation and consultation: Provide board certified pathologist interpretation of submitted tissues in a final histopathology report, in order to 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.

REQUIREMENTS:

The contractor and facility must fulfill the following requirements and have the following educational qualifications and expertise to provide the above services.

Qualification and Expertise:

● Board certified pathologist from the American College of Veterinary Pathologists (ACVP) in order to provide interpretation of submitted tissues, written histopathology report, 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. Expertise should encompass knowledge and experience in these areas that is specific to Hawaiian monk seals.

● PhD in comparative pathology, so as to consult on pathology results, integrate pathology findings with other diagnostic information, and provide expertise in interpreting their relevance to population health research, retrospectively and prospectively.

● At least 6 recent years of pathologic interpretation experience with Hawaiian monk seals and at least 15 years of experience with pinnipeds.

● Research expertise studying coccidian parasite infections in marine mammals, specific experience with Toxoplasma gondii infections in Hawaiian monk seals is preferred.

● At least 5 years of recent experience with the investigation of Marine Mammal Unusual Mortality Events (UMEs).

Facility and capability requirements:

● Capacity to conduct routine processing, including trimming of tissues, embedding of tissues, cutting slides, and H&E stains.

● Capacity to do immunohistochemistry and special stains in-house.

● In-house access to RNA scope to conduct in-situ hybridization studies.

● Capacity to do in-house molecular analyses (PCR) and to complete in-house PCR test development as needed, for new pathogens of concern. When in-house tests are unavailable, capacity to send samples directly to the appropriate specialty laboratory.

● Capacity to complete in-house aerobic and anaerobic microbiological cultures and full susceptibility testing (MIC) for monk seal biomedical samples.

● Ability to store Chain of Custody (COC) samples and COC forms in a controlled, limited access storage area for up to 1-2 years until returned to HMSRP or transferred to an archive facility.

Other requirements:

● Requests by pathologists for additional testing, in-house or by external laboratories, must be approved by the project point of contact before fee-for-service laboratory work begins.

● Upon request, wet tissues and paraffin blocks will be returned to the HMSRP or an archive facility designated by the project point of contact, unless the entire block of tissue has been exhausted (in such case, the HMSRP shall be notified). In certain circumstances, tissues or blocks may remain with the institution, but these cases will be specified.

● The contractor must comply with Chain of Custody standards (including storage of slides, paraffin blocks, wet or frozen tissues in limited access storage areas) for any legal or enforcement cases and provide data with interpretation and appropriate quality control information.

● Any genetic sequences obtained must be provided to appropriate genetic banking collections.

NMFS POC

TO BE PROVIDED AT TIME OF AWARD

PERIOD OF PERFORMANCE:

Base Period: July 15, 2020 through July 14, 2021 Option Period 1: July 15, 2021 through July 14, 2022 Option Period 2: July 15, 2022 through July 14, 2023 Option Period 3: July 15, 2023 through July 14, 2024 Option Period 4: July 15, 2024 through July 14, 2025

PERIOD OF PERFORMANCE: