SS Attachment 1 - Draft SOW.pdf

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

DRAFT Statement of Work

7/24/2024

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 animal 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 reports detailing pathologic changes to affected tissues, 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.

I. Scope The Government seeks commercially available veterinary histopathology services to evaluate and interpret the H&E-stained slides, capture photomicrographs of representative images, and generate reports to meet the requirements of product efficacy testing.

II. Testing Requirements The Contractor shall receive, and log shipments of prepared slides provided by a Government-designated third-party. Slides from each study will be identified by study, treatment group number, and animal number, tissue, and slide number (if multiple slides are created). The typical number of animals per study is sixty (60), however some studies will have a maximum size of seventy (70). There will be up to four (4) slides or tissues per animal.

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

This acquisition is for:

Base - five (5) studies evaluating tissue pathology.

A. Options

1. One (1) option to extend the term of the contract for one year with the same five

(5)-study requirement.

2. One (1) quantity option comprised of one (1) additional study evaluating tissue pathology.

This option may be exercised ten (10) times during the base period for a total of ten (10) additional studies.

This option may be exercised ten (10) times during the term option period for a total of ten (10) additional studies.

3. One (1) quantity option comprised of one (1) additional study requiring the following in addition to evaluating tissue pathology:

a. The Contractor shall receive, and log shipments of formalin-fixed tissue(s) provided by a Government-designated third-party. Tissue(s) will be identified by study, treatment group, and animal number and be accompanied by documentation listing the same information.

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

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

This option may be exercised five (5) times during the base period for a total of five (5) additional studies.

This option may be exercised five (5) times during the term option period for a total of five (5) additional studies.

Contract Period # of Studies Starting with Prepared Slides

# of Studies Starting with Fixed Tissues

Base Period 5 0 Option A1 – Additional Qty (Base Period) 1 0 Option A2 – Additional Qty (Base Period) 1 0 Option A3 – Additional Qty (Base Period) 1 0 Option A4 – Additional Qty (Base Period) 1 0 Option A5 – Additional Qty (Base Period) 1 0 Option A6 – Additional Qty (Base Period) 1 0 Option A7 – Additional Qty (Base Period) 1 0 Option A8 – Additional Qty (Base Period) 1 0 Option A9 – Additional Qty (Base Period) 1 0

Option A10 – Additional Qty (Base Period) 1 0 Option A11 – Additional Qty (Base Period) 0 1 Option A12 – Additional Qty (Base Period) 0 1 Option A13 – Additional Qty (Base Period) 0 1 Option A14 – Additional Qty (Base Period) 0 1 Option A15 – Additional Qty (Base Period) 0 1 Option Period 1 – Additional Term 5 0 Option B1– Additional Qty (Option Period 1) 1 0 Option B2 – Additional Qty (Option Period 1) 1 0 Option B3 – Additional Qty (Option Period 1) 1 0 Option B4 – Additional Qty (Option Period 1) 1 0 Option B5 – Additional Qty (Option Period 1) 1 0 Option B6 – Additional Qty (Option Period 1) 1 0 Option B7 – Additional Qty (Option Period 1) 1 0 Option B8 – Additional Qty (Option Period 1) 1 0 Option B9 – Additional Qty (Option Period 1) 1 0 Option B10 – Additional Qty (Option Period 1) 1 0 Option B11 – Additional Qty (Option Period 1) 0 1 Option B12 – Additional Qty (Option Period 1) 0 1 Option B13 – Additional Qty (Option Period 1) 0 1 Option B14 – Additional Qty (Option Period 1) 0 1 Option B15 – Additional Qty (Option Period 1) 0 1 TOTAL # of Studies (Base + Options) 30 10

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

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

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

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

A. 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).

B. 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).

C. Documented experience in pathology associated with laboratory animal species

(e.g., American College of Laboratory Animal Medicine (ACLAM) diploma).

D. Documented experience with the following:

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

ii. Identifying and describing histopathological features of respiratory infections

iii. High-throughput analysis of prepared slides

iv. Quality control and quality assurance standards and their successful implementation

E. Contractor personnel preparing the slides shall have experience with routine preparation of stained slides, including tissue trimming, paraffin embedding, sectioning and H&E staining.

VII. Reporting requirements:

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

i. Title page containing:

Third party provider of prepared slides

Study number

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.

VIII. Delivery schedule:

A. 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.

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

C. 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.

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

IX. Evaluation factors:

The evaluation of quotes will be based on the demonstrated capabilities of the Offerors in relation to the requirements set forth in the Statement of Work with particular attention to:

A. The documented education, certification, and relevant experience of the proposed Contractor veterinary pathologist.

B. The documented experience and qualifications of Contractor personnel preparing the slides shall have experience with routine preparation of stained slides, including tissue trimming, paraffin embedding, sectioning and H&E staining.

C. The documented experience of the Contractor with generating high-quality pathology reports, including effective imaging of key physiological structures; identifying and describing histopathological features of respiratory infections; high-throughput analysis of prepared slides.

Some additional considerations:

The technical proposal will receive paramount consideration in the selection of the Contractors for this acquisition.

All evaluation factors, other than cost or price, when combined are significantly more important than cost or price.

Cost or price may become a critical factor in source selection in the event that two or more Offerors are determined to be essentially equal following the evaluation of all factors other than cost or price.

The Government reserves the right to make an award (or awards) to those Offerors whose proposals provides the best overall value to the Government.

X. 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 VIII. Reporting Requirements and IX. Delivery Schedule listed above.