Automated Immunodiagnostics (Autoimmune Testing)

Sources Sought The Government is conducting market research and identifying, as potential sources, companies that may possess the expertise, capabilities, and experience to meet the requirements of the follow-on contract for the Automated Immunodiagnostics (Autoimmune) Testing to be performed at the School of Aerospace Medicine (USAFSAM/PHE) at Wright-Patterson AFB, OH. CAUTION: This Sources Sought is issued solely for information and planning purposes. In accordance with Part 10 of the Federal Acquisition Regulation, the U.S. Government is conducting market research. The intended purpose is to identify potential sources that may possess the expertise, capabilities, and experience to meet USAFSAM/PHE requirements. It does not constitute a Request for Proposal (RFP) or a promise to issue an RFP in the future. Further, AFLCMC is not at this time seeking proposals, and will not accept unsolicited proposals. Responders are advised that the Government will not pay for any information or administrative costs incurred in response to this sources sought. Please be advised that all submissions become Government property and will not be returned. All costs associated with responding to this sources sought will be solely at the responding party's expense. Not responding to this Sources Sought[HSKGUAA1] does not preclude participation in any future RFP, if issued. In accordance with Federal Acquisition Regulation 15.201(e), responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. It is the responsibility of the interested parties to monitor this FedBizOps website for additional information pertaining to this sources sought notice. INSTRUCTIONS: The document below provides a description of the Automated Immunodiagnostics (Autoimmune) Testing and a Contractor Capability Survey, which allows you to provide your company's capabilities. If, after reviewing these documents, you desire to participate in the market research, please respond to the Contractor Capability Survey beginning on page 4 below to document your company's capabilities in meeting these requirements. Failure to provide a complete response may result in the government being unable to adequately assess your capabilities. If you lack sufficient experience in a particular area, please provide details explaining how you would overcome the lack of experience/capabilities in order to perform that portion of the requirement (i.e., teaming, subcontracting, etc.) Both large and small businesses are encouraged to participate in this Market Research. Joint ventures or teaming arrangements are encouraged. Questions relative to this market survey should be addressed via email to Robin Smith (AFLCMC/PZIOA), contact@example.gov. Verbal questions will NOT be accepted. PROGRAM DESCRIPTION: The Program is for reagents, consumables and support to perform testing, on the AFT2000, AFT3000, and Image Navigator. REQUIREMENTS: The United States Air Force School of Aerospace Medicine (USAFSAM/PHE) is seeking a fully automated, walk away, fully integrated, random access platform capable of high throughput. USAFSAM/PHE is seeking an Indefinite Delivery Indefinite Quantity (IDIQ) contract (base plus four options) for reagents, consumables and support to perform testing, on the AFT2000, AFT3000, and Image Navigator: 1. Antinuclear Antibody (ANA) Screen (screens for all antibodies listed below) using Indirect Immunofluorescence Assay (IFA) methodology 2. ANA Screen, IFA titer & pattern 3. Double Stranded (ds) DNA antibody, IFA 4. dsDNA IFA titer & pattern 5. Anti-SS-A (Ro) (SS-A52 and SS-A60) 6. Anti-SS-B (La) 7. Sm antibody 8. RNP antibody (RNP68/RNPA/U1RNP) 9. Centromere B antibody 10. SCL-70 antibody 11. JO-1 antibody 12. Anti-Mitochondrial Antibody 13. Anti-Smooth Muscle Antibody 14. Anti-Parietal Antibody - 1.1 Instrumentation minimum requirement: 1. Test kits and all reagents must be compatible with, the instrumentation currently in use, the AFT2000, AFT3000, and the Image Navigator from Immunoconcepts. Annual Workload Estimate: ANA, IFA screen 25,693 ANA titer & pattern 3,021 dsDNA, IFA 3,083 dsDNA titer & pattern 62 ENA confirmation, EIA 3,021 - o (La, Ro, Sm, RNP, SCL-70, JO-1) Anti-Mitochondrial Antibody 2187 Anti-Smooth Muscle Antibody 2187 Anti-Parietal Antibody 2187 2. Must have a bidirectional computer interface that is compatible with Composite Health Care System (CHCS). 3. Must sample directly from primary patient tube. 4. Must detect if primary patient sample has inadequate volume for required testing 5. Must have automatic clot detection 6. Must have automatic test reflex capability that are programmable by the user 7. Must perform the ANA screen, dsDNA, and titers by Indirect Immunofluorescence Assay (IFA) 8. Must be able to identify IFA patterns (speckled, homogeneous, centromere, and nucleolar) 9. Must be able to perform confirmation testing for the ENA antibodies La, Ro, Sm, RNP, SCL-70, and JO-1 10. Must be able to perform autoimmune testing by Indirect Immunofluorescence Assay (IFA) for Anti-Mitochondrial, Anti-Smooth Muscle, and Anti-parietal[HSKGUAA2] Antibodies. - 1.2 Instrument Install and Training Support: 1. Must provide instrument installation, to include calibration and test and system validation support (including assistance to find specimens for verification correlation). 2. Must provide training to include: onsite training and vendor specific to cover training that is not covered at onsite training. Offsite training will be a minimum of two per instrument provided and will be available over the length of this contract. The contractor will provide, all expense to include but not limited to travel, lodging, meals and any additional expense that are training specific. 1.3 Minimum Reagent Requirements: - 1. All reagent kits must be FDA approved and will exhibit at least 95% sensitivity and 95% specificity. - 2. Upon request, sufficient reagents shall be provided by the vendor for in-house evaluation of each analyte. - 3. Following evaluation, each test kits shall exhibit at least 95% agreement with test kits currently in use in the Immuno Diagnostics Laboratory - 4. The vendor will be the sole manufacturer and distributor of the test kits - 5. The vendor shall comply with all FDA regulations, College of American Pathologist (CAP), and Clinical Laboratory Standards Institute (CLSI) recommendations. CONTRACTOR CAPABILITY SURVEY Part I. Business Information: [HSKGUAA3] Please provide the following business information for your company/institution and for any teaming or joint venture partners: Company/Institute Name: Address: Point of Contact: CAGE Code: Phone Number: Email Address: Web Page URL: Size of business pursuant to North American Industry Classification System (NAICS) code: 334517, 500 employees. Based on the above NAICS Code, please state whether your company is: Small Business (Yes / No) Small Disadvantaged Business (Yes / No) 8(a) Certified (Yes / No) HUBZone Certified (Yes / No) Veteran-Owned Small Business (Yes / No) Service-Disabled Veteran-Owned Small Business (Yes / No) Women-Owned (WO) (Yes / No) Economically Disadvantaged Women-Owned Small Business (Yes / No) *All interested contractors must be registered in SAM in order to be eligible for award of Government contracts. The government reserves the right to consider a small business set-aside based upon responses hereto for any subsequent action. A statement as to whether your company is domestically or foreign owned (if foreign, please indicate the country of ownership). Please provide a statement that the respondent will allow or will not allow the Government to release proprietary data. Please provide a statement to acceptability of the following proposed provisions and clauses, as they are determined to be consistent with customary commercial practice. Please provide information about the firm's standard warranty. Please provide recent sales history to commercial companies in order to determine commerciality. FAR 52.222-50, Combating Trafficking in Persons (FEB 2009) (22 U.S.C. 7104(g)). FAR 52.252-2-Clauses Incorporated by Reference FAR 52.252-5-Authorized Deviations in Provisions FAR 52.209-7-Information Regarding Responsibility Matters FAR 52.212-3-Offeror Representations and Certifications-Commercial Items with its Alternate I FAR 52.212-4-Contract Terms and Conditions-Commercial Items FAR 52.212-5-Contract Terms and Conditions Required to Implement Statutes Or Executive Orders-Commercial Items FAR 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns FAR 52.219-28 Post Award Small Business Program Representation FAR 52.222-3, Convict Labor FAR 52.222-19, Child Labor-Cooperation with Authorities and Remedies FAR 52.222-21, Prohibition of Segregated Facilities FAR 52.222-26, Equal Opportunity FAR 52.222-36, Affirmative Action for Workers With Disabilities FAR 52.222-50, Combating Trafficking in Persons FAR 52.223-18, Encouraging Contractor Policies to Ban Text Messaging while Driving FAR 52.232-33, Payment by Electronic Funds Transfer-Central Contractor Registration FAR 52.233-3, Protest After Award FAR 52.233-4, Applicable Law for Breach of Contract Claim FAR 52.225-13 - Restrictions on Certain Foreign Purchases (Jun 2008) (E.O.'s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury). FAR 52.232.40- Providing Accelerated Payments to Small Business Subcontractors DFARS 252.209-7993-Representations by Corporations Regarding an Unpaid Delinquent Tax Liability or a Felony Conviction under any Federal Law-Fiscal Year 2014 Appropriations (Deviation 2014-O0004). (OCTOBER 2013) DFARS 252.203-7000, Requirements Relating to Compensation of Former DoD Officials DFARS 252.225-7000, Buy American Statute - Balance of Payments Program Certificate DFARS 252.225-7001, Buy American Act and Balance of Payment Programs DFARS 252.232-7003, Electronic Submission of Payment Requests DFARS 252.232-7006, Wide Area Workflow Payment Instructions is incorporated into the solicitation and resulting contract. The fill-in portions of this clause will be complete in the award document. DFARS 252.232-7010, Levies on Contract Payments The following AFFARS provisions are incorporated into the solicitation: AFFARS 5352.201-9101, Ombudsman AFFARS 5352.223-9000, Elimination of Use of Class I Ozone Depleting Substances (ODS) ATTENTION small business respondents who are interested in submitting a proposal as the prime contractor for this effort: No set aside decision has been made; however, the Air Force is contemplating setting this acquisition aside for Small Businesses if there is sufficient demonstrated interest and capability. Note that a key factor in determining an acquisition to be a Small Business Set Aside is that two or more small business prime contractors must be capable of performing at least 50% of the entire scope of the Arthroscopic and Joint Replacement Procedures , as defined in Federal Acquisition Regulation (FAR) clause 52.219-14, Limitations on Subcontracting. The clause reads, in part, as follows: "Limitations on Subcontracting (Dec 1996) ... (b) By submission of an offer and execution of a contract, the Offeror/Contractor agrees that in performance of the contract in the case of a contract for - (1) Services (except construction). At least 50 percent of the cost of contract Performance incurred for personnel shall be expended for employees of the concern... ". Provide specific details and rationale as to how compliance with FAR clause 52.219-14 would be achieved, including specific details regarding teaming arrangements, etc. If subcontracts are to be used, provide anticipated percentage of effort to be subcontracted and whether small or large businesses will be used. Teaming and/or subcontracting arrangements should be clearly delineated and previous experience in teaming must be provided. ATTENTION All potential respondents: The acquisition strategy for this program has not been finalized. If this acquisition is not set aside for small business, it is anticipated that the contract may contain a small business utilization requirement. Please provide feedback on the requirement and what areas are likely candidates for SB subcontracting. Part II. Capability Survey Questions: - 1. Describe briefly the capabilities of your facility and the nature of the services you provide. Include a description of your staff composition and management structure. - 2. Describe your company's past experience on previous projects similar in complexity to this requirement. Include contract numbers, a brief description of the work performed, period of performance, agency/organization supported, and individual point of contact (Contracting Officer or Program Manager). - 3. Describe your company's capabilities for generating, handling, processing and storing classified material and data. - 4. Describe your company's capabilities for generating, handling, processing and storing technical reports. - 5. Describe your company's capabilities and experience in providing statistical, technical test & evaluation support to identified acquisition programs. Identify what software programs are utilized to generate these data products and what formats are available for delivered items. - 6. Are there specific requirements in the documentation that we provide that would currently preclude your product/service from being a viable solution to our requirement? - 7. Describe your capabilities and experience in managing website content projects and development of tracking databases, including subcontractor involvement. Include any experience in project planning, work breakdown structures, resource allocations, schedule tracking, risk analysis and cost management. - 8. Are there established market prices for our requirement? If you offer this product and/or service to both U.S. Government and commercial sources, is the same workforce used for both the U.S. Government and general public? Is our requirement offered to both under similar terms and conditions? Briefly describe any differences. - 9. Describe your standard warranty and return process for goods and services furnished to the government for items similar in nature to this requirement. If your company is interested, e-mail your responses to: contact@example.gov. E-mail responses should be received no later than: 21 October 2014. Direct and succinct responses are preferred. Marketing materials are considered an insufficient response. All responses must be UNCLASSIFIED; no classified material will be accepted or considered with this Sources Sought Synopsis. The response to Part I. Business Information should be single spaced, 12pt font. The response to Part II. Capabilities should be limited to no more than 20 pages (8.5x11 inches), single spaced, 12pt font. In addition, identify a representative to support further Government inquiries and requests for clarification of the information provided, if needed. Respondents should indicate which portions of their response are proprietary and should mark them accordingly. The Air Force will handle proprietary items in accordance with FAR 2.101 and 3.104. Responses to questions from interested parties will be promptly answered and posted on this FedBizOps website, unless some release of proprietary information is involved or the answer addresses a question peculiar to a company or that company's response. Information feedback sessions may be offered to respondents after the sources sought assessments are complete. An Industry Day (date to be determined) with one-on-one information sessions with respondents may be offered to clarify the Government's understanding of their submittal, capability ramifications, or to discuss their business approach.