Serological & PCR Testing of Rodents

This is a Sources Sought notice. This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. Background. The Comparative Medicine Branch (CMB) maintains the animal facility for the National Institute of Environmental Health Sciences (NIEHS). The health of the 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 the diseases can be zoonotic (contagious to humans). Diagnosis of these animal diseases is very important in maintaining the quality of the NIEHS research animals as well as ensuring the safety of the researcher and animal care staff. The CMB oversees the care and use of these animals. The Quality Assurance Laboratory (QAL), a laboratory within CMB, is responsible for monitoring the health status of incoming and resident animal colonies and making appropriate decisions based on the results of this monitoring. The animals used as sentinels for colony health status are evaluated by the QAL staff. This evaluation may include, as appropriate, a complete necropsy, examination for ecto and endo parasites, bacterial cultures, Polymerase Chain Reaction (PCR) and/or serological assays. Animals which appear ill or die are also submitted to the QAL for diagnostic services. The QAL is responsible for reporting the health status of the animal or tissue specimens back to the appropriate veterinarian(s) and researchers. Purpose and Objective. The purpose of this acquisition is to obtain the services of a commercial laboratory for the serological analysis, PCR and related assay rodent sera, tissues, and fecal specimens used to monitor the health of NIEHS animal colonies. To provide a readily available source of Serology Assay Testing Services and PCR assays to meet the needs of the QAL and NIEHS. The overall objective is to provide serological testing and PCR assays for the diagnostic and health monitoring programs of the NIEHS. The specific objective is to have a Contractor receive serology samples, perform testing on these samples and report the positive and negative results. Project Requirements. (1) The scope of this requirement will be to perform the serology testing necessary to complete the animal health monitoring process. In addition to the serological testing, PCRs, may be requested to determine the presence of an agent in an animal facility or may be used in conjunction with serology as a method of health surveillance. Other assays, such as Western Blot or Immunofluorescent Antibody (IFA) may be requested to confirm initial positive serological results. (2) The Contractor shall perform serological testing and/or PCR testing in accordance with good laboratory practices, and state of the art microbiological procedures. The number of tests requested per sample will depend upon species and the animal's history. (3) Independently, and not as an agent of the Government, the Contractor shall furnish all necessary labor, materials, supplies, equipment, and services (except as otherwise specified herein) and perform the work set forth below. (4) Based on what we feel is in the best interest of the Government the PCR and Serological services may be awarded in either one or two contracts. The serological assays, such as Enzyme-Linked Immunosorbent Assay (ELISA), Multiplex Fluorescent Immunoassay (MFI), IFA, Hemagglutination Inhibition (HAI) and Western Blot, may be awarded separately from the PCR assays for the presence of viral antigens in cell cultures, tissues, feces, and swabs. (5) Serological Tests: (a) The Contractor shall, as a minimum, be prepared to perform serological assays by appropriate methods such as MFI, IFA, ELISA, and HAI, as appropriate. IFA and/or Western Blot methodology should be available for confirmatory testing. Should new testing technology become available or new pathogenic agents be discovered during the course of this offering, it will be incorporated through modification of the Contract. (b) Rodent sera shall be processed (diluted 1.5 and heat inactivated at 56'C for 30 minutes), frozen in 2 ml cryotubes labeled with the QAL's identification number and shipped in leak proof styrofoam containers with dry ice. The styrofoam container will be delivered to the Contractor by express overnight delivery service by NIEHS personnel. The Contractor shall receive the samples delivered by the express delivery service at the Contractor's own expense. Samples will be mailed by the Government on Wednesday afternoons at 4:00 p.m. with an anticipated arrival time and day of 10:00 a.m., Thursday of the following day of shipment. Sera shall be received at the Contractor's testing laboratory within twenty (20) hours following pickup. If the samples are not received within the designated timeframe the Contractor will contact the Government's Project Officer (PO) / Contracting Officer Technical Representative (COTR) by phone for further instructions. (c) The Contractor shall perform the appropriate tests requested by the QAL and provide the PO/COTR and the Contracting Officer (CO) with reports of the serological results within the following time periods: The Contractor shall provide to the PO/COTR and CO by email or fax at the Contractor's expense the serological results within 3 working days from the date of receipt of the sera and a final written report within 10 working days. (6) PCR Assays: (a) The Contractor shall be prepared to perform PCR assays for a variety of agents. Cell lines, tissues, fecal samples, and environmental swabs will be shipped in a leak proof, styrofoam container with dry ice. The styrofoam container will be delivered to the Contractor by express delivery service by NIEHS personnel. The Contractor shall receive the samples delivered by the express delivery service at the Contractor's own expense. Samples will be mailed by the government on Wednesday afternoons at 4:00 p.m. with an anticipated arrival time and day of 10:00 a.m., Thursday of the following day of shipment. Tissue, cells shall be received at the Contractor's testing laboratory within twenty (20) hours following pickup. If samples are not received within the designated timeframe, the Contractor will contact the PO/COTR by phone for further instructions. These further instructions shall be by email/fax from the PO/COTR. (b) The Contractor shall perform the appropriate requested tests and provide the PO/COTR and CO with reports of the serological results within the following time periods: Results shall be reported by email or fax at Contractor's expense within 10 working days after receipt of specimens by the Contractor and a final written report within 5 working days after the fax or email report. (7) The Contractor's lab shall be fully equipped (laboratory and computer equipment) to provide serological testing and PCR assays prior to bidding on the solicitation. Equipment used in these serological and PCR testing procedures shall be maintained in good working order. Calibration of all devices and testing equipment shall be done with sufficient frequency as to ensure accurate results. (8) The PO/COTR may request expedited processing of specimens deemed critical by the PO/COTR at no cost to the Government. For these samples the Contractor shall process and report test results electronically by e-mail within three working days of receipt of the specimen. The PO/COTR may request expedited processing of PCR assays. These samples shall be processed by the Contractor and result data transmitted to the PO/COTR within 96 hours. (9) After completion of the serological and PCR assays the test sample (if sufficient sample remains) shall be stored for six months at - 70'C. During this period stored samples shall be returned to the PO/COTR (or authorized designee) if so requested. After six months the samples may be discarded. (10) In the event of an outbreak at the NIEHS of rodent disease caused by an unknown agent(s), the Contractor shall be able to perform or assist in research to help elucidate the cause, pathogenesis, and epidemiology of the causative agent as requested by the PO/COTR/CO. 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 three workdays of receipt of the sera samples and five workdays of receipt of the PCR samples by the Contractor from the Government. (11) The PO/COTR/CO may make an annual visit to the Contractor's place of work to inspect and review the serological testing and PCR procedures covered in the resultant contract. The PO/COTR and/or the CO shall tour the facility with a representative of the Contractor. The PO/COTR has the option to observe all of the procedures mentioned in the resultant contract while visiting the Contractor. (12)The PO/COTR may request that the Contractor send a representative to the NIEHS, Research Triangle Park, to make a presentation on this testing program and/or answer questions from the NIEHS user community. The requirement will not exceed one visit per year. (13) The Contractor shall maintain an electronic copy of this data for the life of the resultant contract. Anticipated period of performance is January 15, 2012 thru January 14, 2013 for the base year and January 15, 2013 thru January 14, 2017 (four 12 month option periods) if the Government exercises its options. Other Important Considerations. (a) All work under the resultant contract shall be monitored by the PO/COTR whose position will be defined in the resultant contract. (b) Samples must be properly maintained and handled by the Contractor to arrive at destination in an acceptable condition for determining accurate test results. (c) Shipping: Specimens for testing will be shipped in leak proof styrofoam containers with dry ice. NOTE: All Mycoplasma isolates on agar plates will be shipped in separate containers without dry ice. (d) If samples are not received within the designated timeframe, the Contractor will notify the PO/COTR and/or the CO by phone. The PO/COTR will provide instructions at that time in writing, based on the sensitivity of the sample, on how to proceed with testing. Capability Statement/Information Sought. Respondents must provide, as part of their responses a capability statement and information and answers to the following questions/issues: (1) Respondents' opinions about the difficulty and/or feasibility of the potential requirement or proposed acquisition, possible solutions and approaches that may currently exist in the marketplace, and information regarding innovative ideas or concepts; (2) Information regarding respondents': (a) staff expertise, including their availability, experience, and formal and other training; (b) current in-house capability and capacity to perform the work; (c) prior completed projects of a similar nature; (d) corporate experience and management capability; and (e) examples of prior completed Government contracts, reference, and other related information; (3) Respondents' DUNS number, organization name, address, point of contact, and size and type of business (e.g., 8(a), HUBZone, etc) pursuant to the applicable NAICS code; (4) Respondents' information should be outlined and the material should be organized (e.g., cover page, title, index of topics addressed, executive summary, etc.); (5) Page limit, if any, for the response and whether any page limit includes references, if requested; (6) Respondents' shall provide with their responses their technical and administrative points of contact, including names, titles, addresses, telephone and fax numbers, and e-mail addresses; (7) All responses to this notice shall be sent to Ms. Laura McGrew, Contracting Officer, at 530 Davis Dr., 1st floor, Cubicle 1049, Morrisville, NC 27560; Phone: (919) 541-3813, not later than 4pm local time on the 5th of December 2011; (8) 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 school 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) A Laboratory Supervisor who is responsible for supervising the personnel actually performing the assays. This may individual serve as the principal for the Project Officer and/or his/her designee. This individual shall have a minimum of a Bachelor's degree and one year's experience with rodent serologic testing in a supervisory capacity; and (9) Does the respondent provide these services to non-Government customers and/or to the general public? Yes ___ / No ___ Disclaimer and Important Notes. This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provided feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. Confidentiality. No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).