STATEMENT OF WORK-2020.docx

7/24/2020

STATEMENT OF WORK

DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

I. Statement of Work

A. Background Information

The purpose of this acquisition is to obtain the services of a commercial laboratory for the serological analysis, PCR and related assays of rodent sera and tissues used to monitor the health of NIH animal colonies. The National Institutes of Health (NIH) has numerous facilities for maintaining research animals. The health of these animals is a critical factor in many research projects. Laboratory animals are susceptible to many different diseases, which may be symptomatic or subclinical but still have profound effects on research. Some of these diseases can be zoonotic (contagious to humans). Diagnosis of these animal diseases is very important in maintaining the quality of the NIH research animals as well as ensuring the safety of the researcher and animal care giver. NIH veterinarians oversee the care and use of these animals. They are responsible for monitoring the health status of the animal colonies and making appropriate decisions based on the results of this monitoring. The animals used as sentinels for colony health status are submitted to the Diagnostic and Research Services Branch (DRSB) of the Division of Veterinary Resources (DVR), ORS, OD for evaluation. This evaluation may include, as appropriate, a complete necropsy, examination for parasites, bacterial cultures as well as Polymerase Chain Reaction (PCR) and/or serological assays. Animals which appear ill or die are also submitted to DVR for diagnostic services. DVR is responsible for providing the results of health surveillance testing to the appropriate veterinarian(s), managers and researchers. The scope of this contract will be to perform health surveillance testing necessary to complete the animal health monitoring process. Serological and PCR testing will be requested primarily as the methods of health surveillance testing. PCR testing may also be requested for confirmation of an agent’s presence in an animal facility. Bacterial agent identification may be requested selectively for confirmation of bacterial culture results. Other assays, such as Western Blot or Immunofluorescent Antibody (IFA) may be requested to confirm initial equivocal serological results.

B. Objectives

The purpose of the proposed contract is to provide a readily available source of serology assay testing services, PCR and other assays to meet the needs of the DVR and the NIH. The overall objective is to provide serological testing and PCR assays for the diagnostic and health monitoring programs of the institutes at the NIH. The scope of the proposed contract is generally limited to the testing of lagomorphs, rodents and other small laboratory animals, such as zebrafish.

The specific objective is to have a Contractor receive serology samples, perform testing on these samples and report the results back within 3 workdays to the Contracting Officer’s Representative (COR). The COR will then disseminate the results to the appropriate veterinarian and animal facility manager. PCR assay submissions shall be tested and the results provided to the COR within 7 working days.

II. Services to Be Performed A. General Requirements

B. Specific Requirements

(1) The Contractor shall, as a minimum, perform serological assays by appropriate methods such as Multiplex Fluorescent Immunoassay (MFI), IFA, Enzyme-Linked Immunosorbent Assay (ELISA), Hemagglutination Inhibition (HAI), as appropriate. Western Blot methodology should be available for confirmatory testing. Should new testing technology become available during the course of this offering, it will be incorporated through modification of the Contract. The Contractor shall perform PCR assays for a variety of agents. Bacterial agent identification may be requested selectively for confirmation of bacterial culture results.

(2) The Contractor shall propose groupings of pathogens (hereafter referred to as panels) to facilitate the submission of sera for testing and to enable NIH users to develop a standard surveillance routine for their facilities. An NIH user, therefore, will request a specific panel rather than individually list all the pathogens. The Contractor shall propose the same panels as offered to the general public and may develop new panels specifically for the NIH. Once implemented, the COR must be given 60 days notice prior to any changes in the composition of these panels.

(3) The Contractor shall provide submission forms and instructions for preparation of serological and PCR samples and packaging of the same. The Contractor shall arrange to pick up the samples from a designated location as provided by the COR. The Contractor shall be responsible for transporting the samples to the testing laboratory and maintaining the samples at that location. The sample information shall be logged into a computerized database at the contract laboratory by the Contractor. The Contractor shall begin testing the samples no later than the next working day after the arrival of the samples in the Contractor’s laboratory. Results of testing shall be recorded in a database and reports generating these results shall be published in an electronic form to be delivered by e-mail or another electronic medium no later than 3 working days after receipt of the serology samples from the Government. The COR shall be notified by email or phone of all significant positive results as soon as they are available. The COR may request re-testing of any unexpected or equivocal results using either the original or a confirmatory procedure. The COR may also request that the questionable sample be sent to another laboratory for retesting at the Contractor’s expense. The Contractor shall perform all requested PCR assays and report the results within seven working days following the receipt of the specimen by the contracting laboratory.

(4) The Contractor’s lab shall be fully equipped (laboratory and computer equipment) to provide serological testing and PCR assays at the time of proposal submission. No instrumentation shall be purchased with the contract funds. Equipment used in these serological and PCR testing procedures shall be maintained in proper working condition. Calibration of all devices and testing equipment shall be performed with sufficient frequency as to ensure accurate results. Positive and negative controls should be routinely utilized as appropriate for all assays.

(5) The COR may request expedited processing of any specimens deemed critical by the COR. For these serology samples the Contractor shall process and report test results telephonically or electronically by e-mail within one workday of receipt of the specimen. The COR may request expedited processing of PCR assays. These samples shall be processed by the Contractor and result data transmitted to the COR within three workdays.

(6) After completion of the serological and PCR assays the test sample (if sufficient sample remains) shall be stored for six months at – 700C. During this period stored samples shall be returned to the COR (or authorized designee) or additional testing shall be performed if so requested. After six months the samples may be discarded.

(7) In the event of an outbreak at the NIH of rodent disease caused by an unknown agent(s), the Contractor shall perform or assist in research to help elucidate the cause, pathogenesis, and epidemiology of the causative agent as requested by the COR. In this event or in the event of an outbreak of a known rodent agent the Contractor may be requested to handle a greatly increased number of samples for that particular agent. The Contractor shall process these samples and report the results by email transmission within two workdays of receipt of the sera samples and three workdays of receipt of the PCR samples by the Contractor from the Government.

(8) The Contractor shall provide a training program for their employees involved with this contract. Employees shall be trained to perform the testing procedures indicated in this contract. Also, training shall be provided on new techniques which have been approved by the COR. The purpose of rodent health monitoring shall be explained to the employees. Information about rodent infectious agents and their impact on research shall be presented to the employees. A copy of the training program shall be furnished to the COR.

(9) The COR may visit the Contractor's place of work to inspect and review the serological testing and PCR procedures covered in this contract. The COR may tour the facility with a representative of the Contractor. The COR has the option to observe all of the procedures mentioned in this contract while visiting the Contractor.

(10) The government may require that the Contractor send a representative to the NIH Bethesda campus to make a presentation on this testing program and/or answer questions from the NIH user community. The requirement will not exceed one visit per year.

(11) It is anticipated that this contract will generate approximately 350,000 individual test results per annum. DVR maintains a database used to collate and disseminate these results to the various NIH facilities. The Contractor shall provide the results to DVR electronically in a form that can be easily downloaded into the DVR database. Historically, this has been accomplished by an e-mail with a downloadable file attached. Advances in IT technology may lead to alternative ways to accomplish this task. The Contractor shall have IT personnel available to work with NIH IT professionals to ensure that this critical interface is functional and efficient.

(12) The Contractor shall maintain an electronic copy of this data for the life of the contract.

(13) Key personnel designated by the Contractor shall include:

a. A Project Supervisor responsible for overseeing all serological and PCR testing related to the contract and personnel. This individual shall have a Ph.D. in microbiology or DVM/VMD from an accredited college of veterinary medicine and be board certified by the American College of Laboratory Animal Medicine. This individual shall have a minimum of five years in laboratory rodent serology testing and PCR assays.

b. The Laboratory Supervisors who are responsible for supervising the laboratory personnel performing the assays may also serve as the principal point of contact for the COR and/or his/her designee. These individuals shall have a minimum of a bachelor’s degree and one year’s supervisory experience with either rodent serologic or molecular diagnostics (PCR) testing.