SOURCES SOUGHT
65 -- Automated Immunodiagnostics Testing - questions and answers
- Notice Date
- 5/14/2015
- Notice Type
- Sources Sought
- NAICS
- 339113
— Surgical Appliance and Supplies 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-0042ss
- Archive Date
- 5/30/2015
- Point of Contact
- Emmeline J. Spaulding, Phone: 9375224565
- E-Mail Address
-
emmeline.spaulding@wpafb.af.mil
(emmeline.spaulding@wpafb.af.mil)
- Small Business Set-Aside
- N/A
- Description
- Answers from Government questions from industry Due to SAF/AQ small business policy, this sources sought, originally posted for 15 days from 22 April 2015 until 7 May 2015, is reposted for an additional 15 days (totalling 30) from 14 May 2015 until 29 May 2015. No additional action is required from contractors that responded initially. This is a Sources Sought Synopsis issued solely for information and planning purposes in seeking potential sources that may possess the expertise, capabilities, and experience to meet the requirements for an Automated Immunodiagnostics Testing to be used at the United States Air Force School of Aerospace Medicine (USAFSAM/PHE) at Wright-Patterson AFB, OH. T here is no solicitation available and requests for a solicitation will not receive a response. 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. CAUTION: Please review this announcement in its entirety. In accordance with Federal Acquisition Regulation 15.201, 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. T he Government will not reimburse any costs incurred or associated with the submission of information in response to this notice. NOTE: 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 Emmeline Spaulding, AFLCMC/PZIOA, at emmeline.spaulding@us.af.mil. PROGRAM DESCRIPTION and SALIENT CHARACTERISTICS 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 a one year Indefinite Delivery Indefinite Quantity (IDIQ) for instrumentation, reagents, consumables and support to perform, on a single platform: •· Vitamin D Total •· Antibodies to Hepatitis B Surface Antigen •· Testosterone Total •· Sex Hormone Binding Globulin (SHBG) •· Antibodies (IgM) to Hepatitis A Virus •· Antibodies (Total) to Hepatitis A Virus •· Antibodies (IgM) to Hepatitis B Core Antigen •· Antibodies (Total) to Hepatitis B Core Antigen •· Hepatitis B Surface Antigen •· Hepatitis B Surface Antigen Confirmation •· Antibodies (IgG) Hepatitis C Virus •· Antibodies to HIV type 1, Group O and/or type 2 •· HIV Ag/AB 4 th Gen Combo (added for use when available) •· Antibodies (IgG) to toxoplasma gondii •· Antibodies (IgM) to toxoplasma gondii Instrumentation minimum requirement: 1. Must be capable for high throughput of at least 240 tests per hour. The contractor will provide enough instrumentation, reagent and consumables to complete an average daily test load within a 16 hour window. (The daily workload can be estimated from the anticipated annual workload and factoring in TUE - FRI testing, except on federal holidays). Annual Workload Estimate •· Vitamin D Total 98,000 •· Antibodies to Hepatitis B Surface Antigen 94,800 •· Testosterone 25,000 •· Sex Hormone Binding Globulin (SHBG) 25,000 •· Antibodies (IgM) to Hepatitis A Virus 57,400 •· Antibodies (Total) to Hepatitis A Virus 21,700 •· Antibodies (IgM) to Hepatitis B Core Antigen 7,000 •· Antibodies (Total) to Hepatitis B Core Antigen 97,600 •· Hepatitis B Surface Antigen 144,400 •· Hepatitis B Surface Antigen Confirmation 600 •· Antibodies (IgG) Hepatitis C Virus 90,800 •· Antibodies to HIV type 1, Group O and/or type 2 (3 rd gen) 429,400 •· HIV Ag/AB 4 th Gen Combo (added for use when available) included in workload above •· Antibodies (IgG) to toxoplasma gondii 2,200 •· Antibodies (IgM) to toxoplasma gondii 1,600 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 have the capability of reloading sample, reagent and supplies without interruption from sample processing 5. Must detect if primary patient sample has inadequate volume for required testing 6. Must automatically dilute patient sample if initial testing is outside the reportable range. 7. Must have automatic clot detection 8. Must have continuous specimen loading capability 9. Must have automatic test reflex capability that are programmable by the user 10. Must have autoverification capabilities 11. Must have tiered pricing based on workload changes projected in future. Automation Minimum Requirements: 1. Sample bar code reading 2. Autodiscrimination (reads more than one bar code symbology) 3. Onboard test auto inventory 4. Preanalytic decapping of sample tube 5. Preanalytic evaluation of sample integrity 6. Postanalytic sealing/capping of sample tube 7. Postanalytic aliquoting and capping of secondary tube 8. Sorting samples base on ordered test to analyzer 9. Sort samples based on collection date and tube type 10. Preanyltic evaluation sorted to error holding lane for review 11. Capable of programmable rule base interface Instrument Install and Training Support: 1. Must provide instrument transportation, delivery, and installation, to include calibration and test and system validation support. 2. Must provide training to include: onsite training and vendor specific to cover training that is not covered at onsite training. Off site 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. 3. Must provide training and support for automation rules programming. 4. Installation will use current electrical and water supplies. No building modifications except for air compressor installation (at contractor's expense). 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 manufactures 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. Reagent Minimum 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 contractor will be the sole manufacturer and distributor of the test kits. 5. The contractor will provide assistance troubleshooting any issues that result from College of American Pathologist (CAP) proficiency test. 6. The contractor shall comply with all FDA regulations, and the College of American Pathologist (CAP) checklist, dated 21 April 2014, or the most current version. 7. The contractor has or is pursuing HIV Ag/AB 4 th Gen Combo and this test will be added for use as soon as it is available. 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: 334515, 500 employees, please circle 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 52.247-34, FOB Destination FAR 52.252-1, Solicitation Provisions Incorporated by Reference FAR 52.252-2, Clauses Incorporated by Reference FAR 52.252-5, Authorized Deviations in Provisions DFARS 252.225-7002, Qualifying Country Sources as Subcontractors DFARS 252.211-7003, Item Identification and Valuation AFFARS 5352.201-9101, Ombudsman 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 Airborne Cesium Magnetometer and Counter System, 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 "Automated Immunodiagonostics 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 25 pages and may be submitted electronically to the following email address: emmeline.spaulding@us.af.mil RESPONSE DUE DATE: Responses are due to email emmeline.spaulding@us.af.mil no later than 2:00 pm, EST, Friday, May 29th 2015.
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