SOLICITATION NOTICE
66 -- Automated Open Platform Microbial Molecular Detection System with four (4) 1-year Post-Warranty Maintenance Option periods - Combined Synopsis/Solicitation
- Notice Date
- 4/19/2013
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 334516
— Analytical Laboratory Instrument Manufacturing
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001
- ZIP Code
- 20857-0001
- Solicitation Number
- FDA_13-223-SOL-1116246
- Archive Date
- 6/4/2013
- Point of Contact
- Yolanda T. Peer, Phone: 8705437479
- E-Mail Address
-
yolanda.peer@fda.hhs.gov
(yolanda.peer@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- Combined Synopsis/Solicitation for an Automated Open Platform Microbial Molecular Detection System with four (4) 1-year Post-Warranty Maintenance Option periods. Document Type: Combined Synopsis/Solicitation Solicitation Number: FDA_13-223-SOL-1116246 Posted Date: April 19, 2013 Response Date: May 19, 2013 Set Aside: Full and Open Competition NAICS Code: Small Business Size Standard: 334516 500 Employees Contracting Office Address FDA/OO/OFBA/OAGS/DAP National Center for Toxicological Research (NCTR) 3900 NCTR Road Jefferson, AR 72079 Description This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) Subpart 12.6 "Streamlined Procedures for Evaluation and Solicitation for Commercial Items", as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; offers are being requested, and a written solicitation document will not be issued. The Government intends to issue a Purchase Order in accordance with FAR Part 13.106 for the attached requirement using Simplified Acquisition Procedures. This solicitation number is FDA_13-223-SOL-1116246. This solicitation is issued as a Request for Quote (RFQ). Funds are not presently available for this requirement. Award will be subject to if/when appropriated funds are available. The solicitation document and incorporated provisions and clauses are those in effect through the Federal Acquisition Circular FAC 2005-66 dated April 1, 2013. The associated North American Industrial Classification System (NAICS) code for this procurement is 334516 - Analytical Laboratory Instrument Manufacturing; Small Business Size Standard is 500 employees. This combined synopsis/solicitation is a Full and Open Competition. The U.S. Food and Drug Administration (FDA) is seeking quotes that will provide the Office of Regulatory Affairs (ORA) with an Automated Open Platform Microbial Molecular Detection System with four (4) 1-year Post-Warranty Maintenance Option periods. Background The Southeast Regional Laboratory (SRL) requires a faster more efficient way to screen samples for pathogenic organisms. An automated microbial molecular detection system that utilizes target capture, transcription mediated amplification, and a hybridization protection assay to detect individual pathogens could be a faster and more efficient way of microbial detection. Intended Use of Product The instrument will be initially utilized in a single laboratory validation with a future intent of multi-lab validations for Salmonella and Listeria species. This instrument shall be capable (as delivered) to create customized analysis not readily available in kit form. The Contractor shall meet the following Specifications: Detailed Instrument Characteristics Power requirements for this instrument are as follows: Voltage: between 100-240. This system shall evaluate the analysis of samples for Listeria and Salmonella in multiple food and environmental matrices. This system, as delivered, also shall be fully capable of screening for Shigatoxigenic group of Escherichia coli (STEC). This system shall have an open platform allowing customer's development of new assays. System shall minimize operator hands-on time. System shall generate results for greater than 200 samples in an 8 hour period. Instrument shall have automated liquid level sensing and verifcation for onboard reagents. System shall provide automated tracking, barcoding, and storage of data for accountability and traceability. The instrument shall be fully automated from sample purification through detection and results. Ancillaries and Reagents Supplied Ancillaries - Vendor shall provide start Up kit reagents and ancillaries sufficient for 2,500 test validation. Reagents - Ten (10) Assay kits (2,500 tests) for customer validation. Training Provided Vendor shall provide Training - Four to five operators trained at the Customer's Site, Offereor responsible for associated travel and training related expenses (supplies, reagents, kits). General Duties / Description of Work The automated open platform microbial molecular detection System shall be capable of next day detection of Salmonella, STEC's and Listeria. Trade and Service Specifications 1. The automated open platform microbial molecular detection system shall be a newly manufactured unit, not used and refurbished or previously used for demonstration. The life cycle of this instrument is expected to be greater than ten years at full performance. 2. The entire system shall be warranted for parts and labor for a minimum of 12 months from the date of FDA's formal acceptance of the system and supporting services. 3. Vendor shall install the instrument in a building whose access is as follows: Dimensions of doorways, hallway, and elevator inside of facility: Elevator - 48' WideX106 Deep' X82' high, doorway 82' height, hallway 60' wide, and lab doors-82'x48'. 4. Inside delivery and setup of the equipment and on-site operator familiarization training by the vendor is required. Vendor shall also be responsible for clean-up of area after installation. Post-Warranty Maintenance (Four 1-Year Option Periods): 1. Minimum of one planned preventive maintenance visit per year to include OEM-prescribed/recommended calibrations/recalibrations; 2. Unlimited corrective/remedial maintenance visits per year as necessary in cases when problems cannot be corrected via phone or online, to included OEM-prescribed/recommended calibrations/recalibrations, within 3 business days of service call; 3. All preventive and corrective/remedial maintenance shall be performed by OEM-certified technicians, following OEM specifications, manuals, and service bulletins, using OEM-certified tools and replacement parts, components, subassemblies, etc.; 4. Pricing for preventive and corrective/remedial maintenance shall be inclusive of all labor, travel, and parts, components, subassemblies, etc.; 5. Unlimited 24X7 Telephone Technical Support and Trouble Shooting Assistance; and 6. Unlimited Software and Firmware Updates Schedule of Items FOB Destination: To be delivered (inside delivery), installed, and on-site training conducted no later than 90 calendar days after receipt of order (ARO). Delivery of system and services will be the U.S. Food and Drug Administration, Office of Regulatory Affairs, Southeast Regional Laboratory, 60 8th Street NE, Atlanta, GA 30309. Contract Type: Firm Fixed-Price Base Period: CLIN DESCRIPTION QUANTITY UNIT UNIT PRICE AMOUNT 0001 Automated Open Platform Microbial Molecular Detection System* 1 EA $ $ Catalog/Item/Part No.: ______________________________ GSA Contract No. (if applicable):_____________________ 0002 Post-Warranty Maintenance** 0002AA Option Year 1 (immediately following expiration of system warranty) 12 MO $ $ Catalog/Item/Part No.: ______________________________ GSA Contract No. (if applicable):_____________________ 0002AB Option Year 2 (immediately following Option Year 1) 12 MO $ $ 0002AC Option Year 3 (immediately following Option Year 2) 12 MO $ $ 0002AD Option Year 4 (immediately following Option Year 3) 12 MO $ $ Total, CLINS 0001 and 0002 $ *Pricing shall be FOB Destination, inclusive of all shipping, handling, inside delivery, installation, set-up, and clean-up of area following installation and set-up **Proposed price increases beyond Option Year 1 shall be explained and supported in the offer. Actual dates will be established once the system is formally accepted by the FDA. Place of Delivery/Performance U.S. Food and Drug Administration Office of Regulatory Affairs Southeast Regional Laboratory 60 8th Street NE Atlanta, GA 30309 Clauses and Provisions: The full text of FAR and HHSAR provisions and clauses may be accessed electronically at http://acquisition.gov/far/index.html and http://www.hhs.gov/policies/hhsar/. Clauses The following clauses apply to this acquisition: FAR 52.212-4 Contract Terms and Conditions-Commercial Items (FEB 2012) The following FAR 52.212-4 addenda apply: FAR 52.204-4 Printed or Copied Double-Sided on Recycled Paper (MAY 2011) FAR 52.204-7 Central Contractor Registration (DEC 2012) FAR 52.217-9 Option to Extend the Term of the Contract (MAR 2000) (a) "...one (1) calendar day of contract expiration;.....30 calendar..." (c) "...four (4) years, exclusive of CLIN 0001." HHSAR 352.202-1 Definitions (JAN 2006) HHSAR 352.203-70 Anti-Lobbying (JAN 2006) HHSAR 352.222-70 Contractor Cooperation in Equal Employment Opportunity Investigations (JAN 2010) HHSAR 352.223-70 Safety and Health (JAN 2006) HHSAR 352.231-71 Pricing of Adjustments (JAN 2001) HHSAR 352.242-71 Tobacco-Free Facilities (JAN 2006) Invoice Submission Invoices shall be submitted to the address identified below and contain all necessary information per FAR 52.212-4 (g) in accordance with the following instructions. I. To constitute a proper invoice, the invoice shall be submitted on company letterhead and include each of the following: (i) Name and address of the contractor; (ii) Invoice date and invoice number; (iii) Purchase order/award number; (iv) description, quantity, unit of measure, unit price, and extended price supplies delivered or services performed, including: (a) period of performance for which costs are claimed; (b) itemized travel costs, including origin and destination; and (c) any other supporting information necessary to clarify questionable expenditures; (v) Shipping number and date of shipment, including the bill of lading number and weight of shipment if shipped on government bill of lading, if applicable; (vi) Terms of any discount for prompt payment offered, if applicable; (vii) Name and address of official to whom payment is to be sent (shall be the same as that in the purchase order/award, or in a proper notice of assignment) (viii) Name, title, and phone number of person to notify in event of defective invoice; (ix) Taxpayer identification number (TIN); (x) Electronic funds transfer (EFT) banking information, including routing transit number of the financial institution receiving payment and the number of the account into which funds are to be deposited; (xi) name and telephone number of the FDA contracting officer representative (COR) or other program center/office point of contact, as referenced on the purchase order; and (xii) Any other information or documentation required by the purchase order/award. II. An original and two (2) copies shall be submitted to: Yolanda Peer DHHS/FDA/OAGS/DAP/Field Operations Branch Jefferson Laboratories 3900 NCTR Road Bldg. 50, Room 420 Jefferson, AR 72079 An electronic invoice can be emailed to the following address: Yolanda.peer@fda.hhs.gov III. One copy to the Contracting Officer Representative (COR) or other program center/office designee, clearly marked "courtesy copy only": IV. Questions regarding invoice payments should be directed to the FDA payment office at (870) 543-7446 or (870) 543-7042 or electronically at nctrinvoices@fda.hhs.gov Contracting Officer's Representative (COR) The following COR will represent the Government for the purpose of this contract: (To be provided upon contract award) Name: Email Address: Phone: Mailing Address: The COR is responsible for: (1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) interpreting the specifications and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this contract; and (5) assisting in the resolution of technical problems encountered during performance. The Contracting Officer is the only person with authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to: (1) direct or negotiate any changes in the contract; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor any costs incurred during the performance of this contract; or (5) otherwise change any terms and conditions of this contract. The contact information for the Contracting Officer/ Contract Specialist: Contracting Officer Name: Jerry Martin Email Address: jerry.martin@fda.hhs.gov Phone: 870.543.7040 Mailing Address: DHHS/FDA/OAGS/DAP/Field Operations Branch Jefferson Laboratories 3900 NCTR Road Bldg. 50, Room 434 Jefferson, AR 72079 Contract Specialist Name: Yolanda Peer Email Address: Yolanda.peer@fda.hhs.gov Phone: 870.543.7479 Mailing Address: DHHS/FDA/OAGS/DAP/Field Operations Branch Jefferson Laboratories 3900 NCTR Road Bldg. 50, Room 420 Jefferson, AR 72079 The supplies and/or services delivered hereunder shall be inspected and accepted at destination by the COR. If the supplies or services are acceptable, the COR shall promptly forward a report of inspection and acceptance to the paying office. If the supplies or services are not acceptable, the COR shall document the nonconforming items/services and immediately notify the Contracting Officer. Service Records and Reports The Contractor shall, commensurate with the completion of each service call (inclusive of warranty service), provide the end-user of the equipment with a copy of a field service report/ticket identifying the equipment name, manufacturer, model number, and serial number of the equipment being serviced/repaired and detailing the reason for the service call, a detailed description of the work performed, the test instruments or other equipment used to affect the repair or otherwise perform the service, the name(s) and contact information of the technician who performed the repair/service, and for information purposes, the on-site hours expended and parts/components replaced. In addition, the Contractor shall provide a written report to the FDA COR and Contract Specialist, not later than the 5th work day following the end of each month, summarizing all maintenance and repair activities (including warranty work) each time service and/or repair activities for the previous month; negative reports are required. FAR 52.212-5 Contract Terms and Conditions Required to Implement Statues or Executive Orders (AUG 2012) The following FAR 52.212-5(b) clauses apply: 52.203-6 Alt I, 52.204-10, 52.209-6, 52.219-4, 52.219-8, 52.222-3, 52.222-19, 52.222-21, 52.222-26, 52.222-35, 52.222-36, 52.222-37, 52.222-40, 52.222-51, 52.223-15, 52.223-16, 52.223-18, 52.225-5, 52.225-13, 52.232-33 Provisions The following solicitation provisions apply to this acquisition: FAR 52.212-1 Instruction to Offerors-Commercial Items (FEB 2012) The following FAR 52.212-1 addenda apply: The offeror agrees to hold the prices firm until September 30, 2013. It is the offeror's responsibility to monitor the internet site for the release of an amendment to the combined synopsis/solicitation (if any). Offerors that fail to complete the required representations and certifications, or reject the terms and conditions of the solicitation, may be excluded from consideration. In accordance with the Debt Collection Improvement Act of 1996, in order to be considered for an award of a Federal contract, the contractor shall be registered in the System for Award Management (SAM), a free web site that encompasses the capabilities of the - Central Contractor Registry (CCR); Federal Agency Registration (Fedreg); Online Representations and Certifications Application (ORCA); Excluded Parties List System (EPLS); and the Catalog of Federal Domestic Assistance. The Contractor is responsible for the accuracy and completeness of the data within the SAM database, and for any liability resulting from the Government's reliance on inaccurate or incomplete data. To remain registered in the SAM database after the initial registration, the Contractor is required to review and update on an annual basis from the date of initial registration or subsequent updates its information in the SAM database to ensure it is current, accurate and complete. Updating information in the SAM does not alter the terms and conditions of this contract and is not a substitute for a properly executed contractual document. To access the SAM website go to: https://www.sam.gov/portal/public/SAM/ FAR 52.212-2 Evaluation-Commercial Items (JAN 1999) The Government will award the purchase order to the responsible offeror whose offer conforming to the solicitation will be the most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate offers: (i) Technical capability of the items/services offered to best meet or exceed the Government's requirement (ii) Past Performance (iii) Price Technical and past performance, when combined, are significantly more important when compared to price in determining the best value to the Government; however, price remains a significant factor. Technical capability will be determined and evaluated by review of information submitted by the offeror, which shall provide sufficient technical information necessary for the Government to conclusively determine that the offered instrument and components meet the technical requirements identified above. Offerors shall specifically address the specifications stated above as well as technical specifications, descriptive material, literature, brochures and other information which demonstrates the capabilities of the offeror. Past Performance will be evaluated on the basis of recent and relevant sales and support to federal, state, local government, or private parties for which the offeror has, in the past three (3) years, sold and supported the same system for use in same or similar applications. Provide client name and address; client point of contact name, telephone number, and email address; date of sale; price of sale; and description of sale and support provided to include inclusive dates. Prices shall be firm-fixed-price and shall not be subject to any further economic price increase beyond the initial price offered. Offers shall be supported by a full-breakout of all components, etc. making up the proposed system, identifying the manufacturer/contractor part number, nomenclature, quantity, unit price, and extended amounts. The Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. The Government may determine that an offer is unacceptable if the option prices are significantly unbalanced. Evaluation of options shall not obligate the Government to exercise the option(s). The Government is not responsible for locating or securing any information, which is not identified in the proposal, however the Government reserves the right to obtain information for use in the evaluation from any and all sources including sources outside of the Government. Offeror's shall include the firms DUNS number with quote. FAR 52.212-3 Offerors Rerepresentations and Certifications-Commercial Items (APR 2012). An offeror shall complete only paragraph (b) of this provision if the offeror has completed the annual representations and certifications electronically via http://www.acquisition.gov/. If an offeror has not completed the annual representations and certifications electronically at the ORCA website, the offeror shall complete only paragraphs (c) through (o) of this provision. This solicitation is being issued under the premise that the offeror will certify that the combination of equipment/service it will propose to fulfill this requirement is exempt from the Service Contract Act per the conditions set forth in FAR 52.222-48 & FAR 22.1003-4(c). If this is the case and the Contractor certifies that is exempt under the terms and conditions of 52.222-48 (provision is set forth below), then clause 52.222-51 will flow per usual from this solicitation to the resulting order. In the event that a Contractor does not make this certification, traditional Service Contract Act clauses 52.222-41, and 52.222-43 shall be included in the resulting order award as well as Wage Determination No. WD 05-2133, Revision No. (Rev.-11) dated 06/19/2012 available at the following locations: http://www.wdol.gov/wdol/scafiles/std/05-2133.txt?v=11 FAR 52.222-48, Exemption from Application of the Service Contract Act to Contracts for Maintenance, Calibration, or Repair of Certain Equipment Certification (Feb 2009) (a) The offeror shall check the following certification: CERTIFICATION The offeror does ___ does not ____ certify that- (1) The items of equipment to be serviced under this contract are used regularly for other than Government purposes, and are sold or traded by the offeror (or subcontractor in the case of an exempt subcontractor) in substantial quantities to the general public in the course of normal business operations; (2) The services will be furnished at prices which are, or are based on, established catalog or market prices for the maintenance, calibration, or repair of equipment. (i) An "established catalog price" is a price included in a catalog, price list, schedule, or other form that is regularly maintained by the manufacturer or the offeror, is either published or otherwise available for inspection by customers, and states prices at which sales currently, or were last, made to a significant number of buyers constituting the general public. (ii) An "established market price" is a current price, established in the usual course of trade between buyers and sellers free to bargain, which can be substantiated from sources independent of the manufacturer or offeror; and (3) The compensation (wage and fringe benefits) plan for all service employees performing work under the contract are the same as that used for these employees and equivalent employees servicing the same equipment of commercial customers. (b) Certification by the offeror as to its compliance with respect to the contract also constitutes its certification as to compliance by its subcontractor if it subcontracts out the exempt services. If the offeror certifies to the conditions in paragraph (a) of this provision, and the Contracting Officer determines in accordance with FAR 22.1003-4(c)(3) that the Service Contract Act- (1) Will not apply to this offeror, then the Service Contract Act of 1965 clause in this solicitation will not be included in any resultant contract to this offeror; or (2) Will apply to this offeror, then the clause at 52.222-51, Exemption from Application of the Service Contract Act to Contracts for Maintenance, Calibration, or Repair of Certain Equipment-Requirements, in this solicitation will not be included in any resultant contract awarded to this offeror, and the offeror may be provided an opportunity to submit a new offer on that basis. (c) If the offeror does not certify to the conditions in paragraph (a) of this provision- (1) The clause in this solicitation at 52.222-51, Exemption from Application of the Service Contract Act to Contracts for Maintenance, Calibration, or Repair of Certain Equipment-Requirements, will not be included in any resultant contract awarded to this offeror; and (2) The offeror shall notify the Contracting Officer as soon as possible, if the Contracting Officer did not attach a Service Contract Act wage determination to the solicitation. (d) The Contracting Officer may not make an award to the offeror, if the offeror fails to execute the certification in paragraph (a) of this provision or to contact the Contracting Officer as required in paragraph (c) of this provision. (End of provision) The offer shall reference solicitation FDA_13-223-SOL-1116246. Offers are due in person, by postal mail or email to the point of contact listed below on or before May 20, 2013 by 1:00 PM, (Local Time Jefferson, Arkansas) at the Food and Drug Administration, OO/OFBA/OAGS/DAP, Attn: Yolanda Peer, 3900 NCTR Road, HFT-320, Building 50 - Room 420, Jefferson, AR 72079-9502 or yolanda.peer@fda.hhs.gov. For information regarding this solicitation, please contact Yolanda Peer at yolanda.peer@fda.hhs.gov.
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- Place of Performance
- Address: FDA/SRL, 60 8th Street NE, Atlanta, Georgia, 30309, United States
- Zip Code: 30309
- Zip Code: 30309
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