Attachment_1_ STATEMENT OF WORK Sentinel testing4-12.docx

STATEMENT OF WORK

1.0 BACKGROUND:

1.1 A sentinel is “an animal that is placed in a given environment and then monitored to find out if an infectious disease or other harmful agent is present in that environment.” The San Francisco Veteran’s Affairs Medical Center (SFVAMC) Veterinary Medical Unit (VMU) houses approximately 3,000 cages of research mice and rats across two campuses, Fort Miley (4150 Clement Street) and Mission Bay (1700 Owens Street). These are maintained under Specific Pathogen Free conditions using a ventilated rack system and treated drinking water but must also be tested periodically for quality control. Sentinels are purchased from an approved vendor and before use are shown to be free of select agents by means of a Health Status Report accompanying the animals upon delivery. They are housed on every rack within the colonies and are used to monitor for the presence of pathogens which could jeopardize the health of the vivarium. The sentinels are periodically exposed in ways that will promote transmission of infectious and parasitic agents to evaluate the overall health status of all colonies used for research. After exposure, samples from sentinels are collected in the form of pelt swab, feces, and serology (blood), and are shipped out for testing as stated above.

1.2 More recently it has become possible to test for pathogens using bedding from existing research colony mice and rats, eliminating the need for sentinels. Sentinel-Free Soiled Bedding (SFSB) is a PCR-based Environmental Health Monitoring (EHM) testing approach to monitor the health status of rodent colonies without using sentinel animals. Environmental Health Monitoring methods are highly appealing because they align with the 3R’s in replacing the use of sentinel rodents for this purpose, but also have the added advantages of improved pathogen detection, having an overall decreased health monitoring program cost. SFSB provides a universal EHM approach for use with any rodent housing type. This process involves the transfer of soiled bedding from colony cages into a central testing cage that lacks animals but contains a collection substrate. Over the course of the health monitoring period, the substrate will bind pathogens, or their components, allowing detection by PCR testing and reveal health status of the colony rodents.

1.2.1 We have yet to try this new method, thus we will be requesting both the traditional sentinel method and the SFSB method of testing, with the goal of gradually switching to the new method.

1.3 When exporting/importing animals between our vivarium and any outside institution for collaborative purposes, testing for select agents on the animals being imported or exported is often required. This is for quality control purposes and to prevent infectious agents from invading an otherwise “Specific Pathogen Free” animal colony. Animals imported from outside institutions are initially placed into a quarantine unit and undergo testing before being housed in the main vivarium. In the past 4 years the SFVAMC VMU has averaged 8 imports a year and approximately as many exports, requiring some form of pathogen testing for each transaction. Samples are collected on request or per quarantine SOP and shipped out for testing as stated above.

2.0 General Scope:

The vendor shall provide all labor, materials and equipment to perform sample testing as required in 3.0 below.

3.0 SPECIFIC REQUIREMENTS:

3.1 The San Francisco VA Medical Center requires biological/environmental sample testing from blood, feces, fur swab (sentinel method), and/or sample substrate (SFSB method).

3.1.1 Sentinel (blood, feces, fur swab), or SFSB (sample substrate) samples are collected by VA VMU staff, animal caretakers, and shipped to the contractor for testing four times a year for sentinels or SFSB and on an “as needed” basis for animal imports/exports. Samples are processed within 3-5 days of receipt. The lab collects the DNA for PCR analysis using blood, fur swab, or fecal samples taken by VMU staff.

3.1.2 The vendor will test for the following rat and mouse pathogens using biological samples (blood, feces, fur swab collected by VMU staff) for serology antibody detection and/or PCR (polymerase chain reaction), or SFSB (substrate collected by VMU staff) for PCR detection:3.1.2.1 Ectromelia (sentinel blood serology profile or SFSB PCR)

3.1.2.2 EDIM (sentinel blood serology profile or SFSB PCR)

3.1.2.3 LCMV (sentinel blood serology profile or SFSB PCR)

3.1.2.4 Mycoplasma pulmonis (sentinel blood serology profile or SFSB PCR)

3.1.2.5 MHV (sentinel blood serology profile or SFSB PCR)

3.1.2.6 MNV (sentinel blood serology profile or SFSB PCR)

3.1.2.7 MPV (sentinel blood serology profile or SFSB PCR)

3.1.2.8 MVM (sentinel blood serology profile or SFSB PCR)

3.1.2.9 PVM (sentinel blood serology profile or SFSB PCR)

3.1.2.10 REO3 (sentinel blood serology profile or SFSB PCR)

3.1.2.11 TMEV (sentinel blood serology profile or SFSB PCR)

3.1.2.12 RCV/SDAV (sentinel blood serology profile or SFSB PCR)

3.1.2.13 NS-1 (sentinel blood serology profile or SFSB PCR)

3.1.2.14 RPV (sentinel blood serology profile or SFSB PCR)

3.1.2.15 RMV (sentinel blood serology profile or SFSB PCR)

3.1.2.16 KRV (sentinel blood serology profile or SFSB PCR)

3.1.2.17 H-1 (sentinel blood serology profile or SFSB PCR)

3.1.2.18 RTV (sentinel blood serology profile or SFSB PCR)

3.1.2.19 P. carinii (sentinel blood serology profile or SFSB PCR)

3.1.2.20 Sendai (sentinel blood serology profile or SFSB PCR)

3.1.2.21 Aspiculuris tetraptera, PINWORM (sentinel fecal, fur swab PCR panel or SFSB PCR)

3.1.2.22 Myocoptes, FURMITE (sentinel fecal, fur swab PCR panel or SFSB PCR)

3.1.2.23 Radfordia/Myobia, FURMITE (sentinel fecal, fur swab PCR panel or SFSB PCR)

3.1.2.24 Syphacia obvelata, PINWORM (sentinel fecal, fur swab PCR panel or SFSB PCR)

3.2 Testing Requirements

3.2.1 Serology Testing

3.2.1.1 Uses MFI2 serology sampling techniques, with secondary and tertiary testing performed by indirect fluorescent antibody (IFA) testing and Western blot (WB) analysis.

3.2.1.2 Provide dry blood sampling materials for serology testing, or other method similar which only require 25-30 µL of blood. This will reduce the need to pull larger amounts of blood, centrifuge and eliminates having to ship whole blood or serum on ice.

3.2.1.3 Results within 24-36 hrs.

3.2.2 SFSB testing:

3.2.2.1 Provide individually packages environmental testing material for SFSB and material that does not require extra containers or specialized equipment.

3.2.2.2 Provide 50 mL Conical tubs for submission.

3.2.2.3 Results within 72 hours

3.2.3 Endo And Ectoparasite Testing:

3.2.3.1 Provide sterile, dry flocked swabs for testing, and sterile sample tubing. Allow up to 5 swabs per sample if pooling samples.

3.2.3.2 Provide fecal collection tubes. Only require 3-6 fecal pellets per sample and allow to pool samples from several cages.

3.2.3.3 Results within 24-36 hrs.

3.3 Reports. Test reports are provided within one week of sample receipt, via email or online portal system through an account setup. Results include positive or negative for each pathogen.

3.4 Disposal of samples shall be per vendor SOP.

4.0 Additional information

4.1 Contractor Qualifications

4.1.1 Experience: A minimum of seven years experience with serology and PCR animal testing

4.1.2 Certification: Good Manufacturing Practices (GMP)

4.2 Period Of Performance: The estimated period of performance is 7/1/2024-6/30/2029.

4.3 ISSUANCE OF TASK ORDERS: Each Task Order shall have a separate Period of Performance. The performance period for each TO will be based on pricing located in the schedule at the time of issuance of the TO. Funds will only be obligated for each Task Order. Task Orders must contain the following:

(i) Contract number and order number.

(ii) Schedule of Services/Supplies based on schedule

(iii) Period of Performance

(iv) Name of Principal Investigator

(v) Obligation number/Purchase Order

4.4 Realistic estimate The following table represents the Government’s realistic estimate in accordance with FAR 52.216-21. This is not a guarantee that the Government will order these services or supplies and should only be considered an estimate of anticipated needs.