SOW 7-30 (Updated).pdf

Statement of Work Histopathology Services to Support On-going

SARS-CoV-2 Small Animal Product Efficacy Studies

The rapid response to the COVID-19 pandemic required the establishment of animal models in which to evaluate promising candidate vaccines and therapeutics. Because one of the hallmarks of SARS-CoV-2 infection are cellular changes in tissues (especially lung), representative images and a complete evaluation of affected tissue sections are critical to study outcomes and necessary components of study reports, which are the primary deliverable for these task orders.

1. Scope: The Government seeks commercially available veterinary pathology services to complete the evaluation, interpretation, imaging and reporting to meet the requirements of product efficacy testing.

2. Testing Requirements:

A. 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).

(*the scope of this requirement does not include embedding, sectioning or H&E or IHC staining of tissues)

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 three (3) slides or tissues per animal.

This acquisition is for a base award of eighteen (18) studies and 10 quantity options comprised of three additional studies per option (e.g. a total of 30 additional studies in increments of three).

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

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

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

E. Contractor personnel performing the testing shall have the following credentials and experience:

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

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 electronically to NIAID for review.

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

iii. Once authorized by NIAID, provide this final audited, signed report electronically to

NIAID.

iv. Provide a Word file with the text of the report.

v. 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 final audited and signed report to NIAID no more than one month after receipt of the prepared slides.

ii. The Contractor shall return the slides to the third party NIAID designate.

https://www.instem.com/solutions/provantis/#2