Attachment 2 - SOW_Pathology Monitoring.pdf

Statement of Work - July 2024 Attachment 2

Statement of Work

Pathology Monitoring of Aged Rodent Colonies

1. Background

The National Institute on Aging (NIA) supports several colonies of aged rats and mice for use in research on aging. The purpose of this contract is to provide independent surveillance of the health status of NIA-supported, contractor-maintained colonies of aged rats and mice. This contract will provide monitoring which is independent of and in addition to the health monitoring that the colony contractor provides. The aim is to provide confirmation of results reported by the colony contractor, to serve as a research resource for resolution of questions on animal health, and to provide advice on animal health management practices. This project is not intended to provide a statistically significant sample of the colony population, but rather to provide a resource to the Contracting Officer Representative (COR) to monitor colony contractor performance and to provide an independent assessment of animal health when needed.

2. Objective

The objective of this project is to provide independent surveillance of the health status of rodents maintained in contractor facilities for the aged rodent colonies. The evaluation to be performed will include gross pathology, histopathology, microbiology, parasitology and serology. The COR will select animals from the colonies in a manner which samples the range of strains, ages and holding rooms that characterize the colonies.

The number of animals to be tested each year is dependent on the number of contract colonies in operation each year. There are two colonies to be covered by this contract: the multi-genotypic rat colony and the multi-genotypic mouse colony. Each rodent colony contract is a 10-year contract with the renewal contract for each colony beginning in year 7 of the original contract, with a 3-year overlap of the contracts to ensure constant supply of animals. The first year of each of the rodent colony contracts is devoted to re-derivation of strains, so there are no animals to be tested in that year. Years 2 through 10 represent the build-up and maintenance of the active colonies, when health monitoring is performed regularly.

3. Work To Be Performed

Independently, and not as an agent of the Government, the Contractor shall provide all the necessary services, qualified personnel, material, equipment, and services (except for those to be furnished by the Government as specified elsewhere in the contract agreement) to perform the work required by this statement of work. Specifically, the Contractor shall perform clinical evaluation of mice and rats selected by the COR from the NIA colonies and shipped at no cost to the Contractor. During the period of time between the receipt of the live animals and animal euthanasia, the Contractor must provide adequate housing and protection from contact with other animals, within the standards established for laboratory rodents by the Institute for Laboratory Animal Resources (ILAR) 2010 "Guide for the Care and Use of Laboratory Animals" (http://dels.nas.edu/Report/Guide-Care/12910?bname=ilar ).

Table 1 summarizes the maximum number of rats and mice to be tested each year. No more than 30 animals will be shipped in any one week. The contract colony and barrier/room from which the animals are shipped will be identified. Eighty percent of the animals will be evaluated with the basic profile (described below), and 20% of the animals will be evaluated with the comprehensive profile (described below).

TABLE 1

MAXIMUM Quantity of Tests

Year 1 Year 2 Year 3 Year 4 Year 5

TOTAL MICE 480 480 480 960 960

Basic Profile 384 384 384 768 768

Comprehensive Profile 96 96 96 192 192

TOTAL RATS 120 120 120 120 240

Basic Profile 96 96 96 96 192

Comprehensive Profile 24 24 24 24 48

MINIMUM Quantity of Tests

Year 1 Year 2 Year 3 Year 4 Year 5

TOTAL MICE 480 480 480 480 480

Basic Profile 384 384 384 384 384

Comprehensive Profile 96 96 48 72 48

TOTAL RATS 120 120 120 120 120

Basic Profile 96 96 96 96 96

Comprehensive Profile 24 24 24 24 24

(NOTE TO PROSPECTIVE OFFEROR(S): PLEASE USE THE ESTIMATED NUMBERS IN THE ABOVE TABLE 1

WHEN PROPOSING PRICES.)

In the event of an apparent outbreak of disease, or serious question regarding the health status of a group of animals, the Contractor shall contact the COR by email within four (4) hours.

As part of the assessment, the Contractor shall:

a. Describe general conditions of all animals, weight, and any visible lesions or symptoms.

b. Conduct a gross pathology examination on all animals using procedures that will maximize the chance for detection of the agents listed below.

c. Evaluate eighty percent (80%) of the animals with the Basic Profile (below) and the other twenty percent (20%) with the Comprehensive Profile (below), which includes the Basic Profile plus additional tests listed under Comprehensive Profile. All tests are applied to both rats and mice unless indicated specific to either rats (R) or mice (M).

d. Collect the data in a format approved by the COR.

Serology

Basic Profile: Comprehensive Profile:

MHV (M) Includes Basic Profile plus:

Ectromelia virus (M) Reovirus(es)

Mouse parvovirus(es) (M) Polyomavirus (M)

Theiler's (M) Adenoviruses

PVM LDV (M)

LCMV (M) TMEV (R)

Rotavirus (M) Hantavirus (R)

Sendai

Rat Parvoviruses (R)

Rat coronavirus (R)

Pneumocystis carinii (R)

Microbiology

Basic Profile: Comprehensive Profile:

Mycoplasma pulmonis Includes Basic Profile plus:

Corynebacterium kutscheri CAR bacillus (histopathology)

Streptococcus pneumoniae Pasteurella pneumotropica

Citrobacter freundii (4280) Bacillus piliformis (histopathology)

Pseudomonas sp. Helicobacter

Salmonella enteritidis

Parasitology

Basic Profile: Comprehensive Profile:

Spironucleus muris Same as Basic Profile

Giardia sp.

Cryptosporidium sp.

Syphacia sp.

Hymenolepis sp.

Mites

Histopathology

Basic Profile: Comprehensive Profile:

GI tract: Includes Basic Profile plus:

Small intestine Spleen

Cecum Thymus

Colon Heart

Respiratory tract: Kidney

Nasal passages Reproductive organs:

Middle ears Ovaries

Lungs Uterus

Trachea Testes

Liver Prepuce

Brain

Skin

Salivary gland

Harderian gland

4. Disposal of Tissue/Slides

Excess tissue can be disposed of upon completion of the analysis. Slides and embedded tissue blocks shall be held (archived in room temperature storage) for a period of one (1) year, after which they may be discarded unless otherwise specified by the COR. The Contractor shall be prepared to accept delivery of archived slides and tissue blocks from the previous contract and store them for the remainder of the one-year archival period. At the end of the contract period, the Contractor shall ship the archived slides and blocks to a new Contractor upon written direction from the COR. If the contract expires and the Government no longer requires these services, the tissues shall be discarded, and the slides shall be returned to the COR. However, if a contract is awarded continuing these services, the slides and tissues shall be sent to the new contractor.

5. Anticipated Period of Performance It is anticipated that an IDIQ with a 5-year ordering period will be awarded beginning on or about 3/1/2025.

6. Required Reports/Deliverables

a. Pathology Reports. The data generated from the evaluations will be gross pathology, histopathology, microbiology, parasitology, and serology data on each individual animal submitted for evaluation. Data shall be collected on forms supplied by the Contractor in a format approved by the COR. Copies of data forms for each animal, together with a summary report of findings and a Contractor's statement regarding the significance of these results in terms of the success of colony management practices and the health of colony animals, shall be delivered to the COR within sixty (60) calendar days of each animal shipment to the Contractor. The Contractor shall retain at least one copy of each raw data form for use in preparation of an annual report.

b. Annual Reports. The Annual Report shall be delivered to the CO and COR within ninety

(90) calendar days of the completion of each contract year. This report shall consist of a summary of the number of animals evaluated and a Contractor's statement regarding the significance of these results in terms of the success of colony management practices and the health of colony animals. An Annual Report shall not be due when the Final Report is due.

c. Final Report. The Final Report shall be delivered to the CO and COR. The Final Report shall consist of the work performed and results obtained for the entire contract period of performance. The Contractor shall submit, with the Final Report, a summary of salient results achieved during the performance of the contract. The Final Report shall be due on or before the contract expiration date.