SOW - Histopathology.docx

Statement of Work

Histopathology Services to Support On-going Small Animal Product Efficacy Studies for Viruses with Pandemic Potential

The US Government has undertaken a broad effort to support the development of new products for use against viruses having the potential to cause future pandemics. As we saw during the SARS-CoV-2 pandemic rapid response requires the use of small rodent infection models in which to evaluate promising candidate vaccines and therapeutics. Because one of the hallmarks of several viral infections is overt pathologic changes to infected tissues, representative images and a complete evaluation of affected tissue sections are critical to study outcomes and are often a necessary and critical component of product efficacy evaluations. Preparing stained slides from infected tissues, evaluating slides, and generating a report of observations is labor-intensive and frequently exceeds the capacity of contractors conducting the efficacy studies. Therefore, there is a bona fide need to support these product efficacy studies by engaging professional histopathology services.

1. Scope: The Government seeks commercially available veterinary histopathology services to prepare H&E stained microscope slides from formalin-fixed tissue(s), evaluate and interpret the slides, capture photomicrographs of representative images, and generate reports to meet the requirements of product efficacy testing.

2. Testing Requirements:

A. From Tissues

i. The Contractor shall receive, and log shipments of mouse or hamster tissue(s) fixed in formalin provided by a third-party designated by the Government. Tissue(s) will be identified by study, treatment group number, and animal number.

ii. The Contractor shall perform routine tissue trimming, paraffin embedding, and sectioning to create slides (no more than 2 sections per slide).

iii. The Contractor shall stain slides with Hemotoxylin and Eosin (H&E).

B. From Prepared Slides The Contractor shall receive and log shipments of prepared slides provided by a third-party designated by the Government. Slides from each study will be identified by study, treatment group number, and animal number, tissue, and slide number (if multiple slides are created).

Anticipated volume: The typical number of animals (hamsters or mice) per study is fifty (50), however there are some studies that have a maximum study size of sixty (60). There will be up to four (4) slides or tissues per animal.

This acquisition is for a base award of eighteen (18) studies, one (1) option to extend the term of the contract for one year with the same eighteen (18) study requirement, and twelve (12) quantity options comprised of two (2) additional studies per option (e.g. a total of twenty-four (24) additional studies in increments of two).

The Contractor should assume that the target tissues may be lung, liver, spleen, or brain.

For the Base, the Contractor should assume that prepared slides will be provided for eight (8) studies and tissue(s) requiring processing to slides will be provided for ten (10) studies.

For the Options, the Contractor should assume that prepared slides will be provided for a total of six (6) options (i.e., twelve (12) studies) and tissue requiring processing to slides will be provided for a total of six (6) options (i.e., twelve (12) studies). For the Base period and Option Year, prepared slides will be provided for three (3) options and tissue requiring processing to slides will be provided for three (3) options each.

C. The Contractor shall conduct a microscopic evaluation of the slides, providing an interpretation of the observed histopathology of the stained tissues.

D. The Contractor shall create photomicrographs of representative cells, structures or lesions denoting pathologic changes.

E. The Contractor shall implement quality control and assurance standards to the interpretation and documentation of histopathological findings.

F. Contractor personnel performing the evaluations shall have the following credentials and experience:

i. Doctor of Veterinary Medicine from an accredited school of veterinary medicine (or similar if degreed from a foreign institution; must document equivalence of the degree requirements)

ii. Board certification in Veterinary Pathology through the American College of Veterinary Pathologists (or similar organization if degreed from a foreign institution; must document equivalence of the certifications)

iii. Documented experience in pathology associated with laboratory animal species (e.g., American College of Laboratory Animal Medicine (ACLAM) diploma)

iv. Documented experience with the following:

· Generating Good Laboratory Practice (GLP) quality pathology reports, including effective imaging of key physiological structures

· Identifying and describing histopathological features of respiratory infections

· High-throughput analysis of prepared slides

· Quality control and quality assurance standards and their successful implementation G. Contractor personnel preparing the slides shall have experience with routine preparation of stained slides, including tissue trimming, paraffin embedding, sectioning, and H&E staining.

3. Reporting requirements:

A. Content: The Contractor shall generate a pathology report for each study, that consists of:

i. Title page containing:

a. Third party provider of prepared slides

b. Study number

c. Date of final accepted report

ii. Description of the histopathological findings for each group and tissue; notable findings shall be identified by animal number and tissue.

iii. No more than 2 representative photomicrographs per tissue per treatment group, captioned and with the scale noted.

B. Style: The Contractor shall:

i. Use industry standard format, such as that generated with Provantis software (https://www.instem.com/solutions/provantis/#2) or similar.

ii. Develop the report with sufficient detail for inclusion in a GLP-level study report.

iii. Prepare the draft report in MS Word.

iv. Provide the final report in fully hyperlinked PDF format.

C. Review and revision: The Contractor shall:

i. Provide the draft report in MS Word electronically to NIAID for review.

ii. Make all requested revisions and return the amended report to NIAID for a final review within 1 week.

iii. Once authorized by NIAID, provide this final audited, signed report electronically to NIAID as a PDF along with all related documents e.g., scoring sheets.

iv. Once accepted, document any additions or corrections to an authorized final report as a formal addendum/amendment to the final report.

D. Delivery schedule:

i. The Contractor shall provide the draft audited report to NIAID for review no more than eight weeks after receipt of prepared slides or fixed tissues.

ii. The Contractor shall provide revisions to the draft report within one week of receipt of NIAID comments.

iii. The Contractor shall provide the final audited and signed report to NIAID no more than ten weeks after receipt of prepared slides or fixed tissues.

iv. The Contractor shall ship slides to the third party NIAID designate as directed by the COR.

E. Inspection and Acceptance

All deliverables will be inspected by the NIAID Contracting Officer’s Representative. Acceptance will occur when reports are successfully transferred to NIAID per the specifications of C. Reporting Requirements and D. Delivery Schedule listed above.