SOURCES SOUGHT
65 -- Immunodiagnostics Testing
- Notice Date
- 6/25/2015
- Notice Type
- Sources Sought
- NAICS
- 325413
— In-Vitro Diagnostic Substance Manufacturing
- Contracting Office
- Department of the Air Force, Air Force Materiel Command, AFLCMC/PZIO - WPAFB, 1940 ALLBROOK DRIVE, WRIGHT-PATTERSON AFB, Ohio, 45433-5309, United States
- ZIP Code
- 45433-5309
- Solicitation Number
- FA8601-15-R-0099
- Archive Date
- 7/25/2015
- Point of Contact
- Robin A. smith, Phone: 9375222277
- E-Mail Address
-
Robin.Smith.4@us.af.mil
(Robin.Smith.4@us.af.mil)
- Small Business Set-Aside
- N/A
- Description
- The Government is conducting market research to identify potential sources that possess the expertise, capabilities, and experience to meet the requirements for Immunodiagnostics Testing under a contemplated Blanket Purchase Agreement (BPA) that will cover one basic year plus four option years in support of the USAF School of Aerospace Medicine, Wright-Patterson AFB, OH. The Government is seeking potential sources that are capable of providing a fully automated, walk away, fully integrated, random access platform capable of high throughput that will include leasing of analyzers (instrumentation), maintenance of analyzers, reagents, consumables and training support. The reagents and consumables will be purchased on a cost-per-test basis. CAUTION: This Sources Sought Synopsis is issued solely for information and planning purposes. Please review this announcement in its entirety. In accordance with Federal Acquisition Regulation 15.201, this announcement does not constitute a Request for Proposal (RFP) or a promise to issue an RFP in the future. Responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Any information submitted by respondents to this sources sought synopsis is voluntary and will not be returned. The Government will not reimburse any costs incurred or associated with the submission of information in response to this notice. The decision to solicit for a contract shall be solely within the Government's discretion. The government reserves the right to consider a small business set-aside based upon responses hereto for any subsequent action. IMPORTANT: All interested contractors must be registered in SAM in order to be eligible for award of Government contracts. It is the responsibility of the interested parties to monitor this FedBizOpps website for additional information pertaining to this sources sought notice. INSTRUCTIONS: 1. The information below provides a "Program Description" and a "Contractor Capability Survey", which allows you to document your company's capabilities in meeting these requirements. 2. If after reviewing these documents you desire to participate in the market research, please complete and return the Contractor Capability Survey below. Response format and due date information is specified at the bottom portion of this notice. 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.) 3. Both large and small businesses are encouraged to participate in this Market Research. Joint ventures or teaming arrangements are encouraged. 4. 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. Questions relative to this market survey should be addressed via email to Ms. Robin Smith, AFLCMC/PZIOA, at robin.smith.4@us.af.mil. PROGRAM DESCRIPTION: The Government is seeking Autoimmune Testing that is a fully automated, walk away, fully integrated, random access platform capable of high throughput. This requirement includes leasing of analyzers (instrumentation), maintenance of analyzers, consumables, purchase of reagents, and support to perform testing on the AFT2000, AFT3000, and Image Navigator from Global Focus Market Distribution (GFMD), Immuno Concepts. 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 Instrumentation minimum requirements: 1. Must provide enough instrumentation, reagent and consumables to complete an average daily test load within a 24 hour window. (The daily workload can be estimated from the anticipated annual workload and factoring in TUE - FRI testing, except on federal holidays from 0730 to 1630). 2. Test kits and all reagents must be compatible with, the instrumentation currently in use, the AFT2000 and AFT3000 from Immuno Concepts. And will include an additional AFT3000 and the Image Navigator Microscope. Annual Workload Estimate: ANA, IFA screen 25,693 ANA titer & pattern3,021 dsDNA, IFA3,083 dsDNA titer & pattern62 ENA confirmation, EIA 3,021 (La, Ro, Sm, RNP, SCL-70, JO-1) Anti-Mitocondrial Antibody 2187 Anti-Smooth Muscle Antibody2187 Anti-Parietal Antibody2187 3. Must have a bidirectional computer interface that is compatible with Composite Health Care System (CHCS). 4. Must sample directly from primary patient tube. 5. Must detect if primary patient sample has inadequate volume for required testing 6. Must have automatic clot detection 7. Must have automatic test reflex capability that are programmable by the user 8. Must perform the ANA screen, dsDNA, and titers by Indirect Immunofluorescence Assay (IFA) 9. Must be able to identify IFA patterns (speckled, homogeneous, centromere, and nucleolar) 10. Must be able to perform confirmation testing for the ENA antibodies La, Ro, Sm, RNP, SCL-70, and JO-1 11. Must be able to perform autoimmune testing by Indirect Immunofluorescence Assay (IFA) for Anti-Mitochondrial, Anti-Smooth Muscle, and Antiparietal Antibodies. 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. Instrument Repair and Maintenance: At a minimum, the contractor will provide the following maintenance and repair services: 1. Must provide onsite maintenance (monthly, quarterly, annually, etc.) in accordance with manufacturer's guidelines. 2. Must provide all required tools, parts and labor as necessary to keep the instrument operational. 3. Must provide over the phone, instrument technical support during normal duty hours (0730 - 2200 EST) 4. The contractor will monitor equipment to ensure instrument downtime will not exceed 48 hours for a single occurrence. 5. In the event of an instrument failure, the contractor will provide onsite technical support with a response time of <24 hours. The contractor is responsible for all tools, parts, travel/lodging and labor that are necessary to bring the instrumentation back online in <48 hours from service call. 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 Immunodiagnostics 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: Please provide the following business information for your firm: Company/Institute Name: Address: Point of Contact: CAGE Code: Phone Number: Email Address: Web Page URL: Based on North American Industry Classification System (NAICS) code: 325413, 500 employees, please indicate Yes or No 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) Please provide a statement as to whether your company is domestically or foreign owned (if foreign, please indicate the country of ownership). Indicate if you are the manufacturer or provide the name and size of the manufacturer of the product(s) you will be supplying. Please provide a statement that the respondent will allow or will not allow the Government to release proprietary data. The Air Force will handle proprietary items in accordance with FAR 2.101 and 3.104. Please provide information about the firm's standard warranty. Please provide recent sales history to commercial companies in order to determine commerciality. Please provide a statement to acceptability of the following proposed provisions and clauses, as they are determined to be consistent with customary commercial practice. The Government anticipates utilizing the following non-commercial provisions/clauses in a resultant solicitation: FAR 52.203-3, Gratuities FAR 52.204-4, Printed or Copied Double-Sided on Recycled Paper FAR 52.229-3, Federal, State, and Local Taxes FAR 52.233-2, Service of Protest FAR 52.242-13, Bankruptcy FAR 52.247-34, FOB Destination FAR 52.252-1, Solicitation Provisions Incorporated by Reference FAR 52.252-2, Clauses Incorporated by Reference FAR 52.252-3, Alterations in Solicitation FAR 52.252-4, Alterations in Contract FAR 52.252-5, Authorized Deviations in Provisions FAR 52.252-6, Authorized Deviations in Clauses DFARS 252.225-7002, Qualifying Country Sources as Subcontractors AFFARS 5352.201-9101, Ombudsman AFFARS 5352.223-9000, Elimination of Use of Class I Ozone Depleting Substances 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 providing at least 50% of the entire scope of the Autoimmune Testing effort, 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. Name of Country where the item is manufactured. 2. 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. 3. Describe your company's past experience on previous projects similar in complexity to this requirement. Include contract number and date, a brief description, agency/organization supported, and point of contact name and telephone number. 4. Describe your company's capabilities for generating, handling, processing and storing technical reports and for storing classified material and data. 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 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. RESPONSE FORMAT INSTRUCTIONS: Be advised that all correspondence sent via e-mail shall contain a subject line that reads "FA8601-15-R-0099, Autoimmune Testing". If this subject line is not included, the e-mail may not get through e-mail filters at Wright-Patterson AFB. Filters are designed to delete emails without subject lines or with suspicious subject lines or contents. Attachments with files ending in.zip or.exe are not allowable and will be deleted. Ensure only.pdf,.doc, or.xls documents are attached to email. Responses are limited to 15 pages and may be submitted electronically to the following email address: robin.smith.4@us.af.mil RESPONSE DUE DATE: Please email responses to robin.smith.4@us.af.mil no later than 5:00 pm, EST, Monday, July 9th 2015.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/USAF/AFMC/88 CONS/FA8601-15-R-0099/listing.html)
- Place of Performance
- Address: WPAFB, Ohio, 45433, United States
- Zip Code: 45433
- Zip Code: 45433
- Record
- SN03776022-W 20150627/150625235156-96917cd0d0031a8062b15be51e571583 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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