Laser-Induced Flurescence Detector

This is a combined synopsis/solicitation for commercial items prepared in accordance with the Federal Acquisition Regulation (FAR) format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. The government intends to issue a Purchase Order in accordance with FAR PART 13.106 for the requirement under Simplified Acquisition Procedures. The solicitation number is 1113351 and this solicitation is issued as a Request for Quote (RFQ). RESPONSE DATE: 2/11/2013 The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2005-65 effective January 29, 2013. The associated North American Industry Classification System (NAICS) Code is 334516- Analytical Laboratory Instrument Manufacturing; FSC Code is 6640. Small Business Size Standard is 500 employees. Acquisition is unrestricted. Contract Type: Commercial Item-Firm Fixed Price. REQUIREMENTS: Part I: General Information A. Introduction Characterization of bio-conjugated nanoparticles and detection/quantification of oligonucleotides/proteins/peptides are crucial for development of ultrasensitive viral pathogen diagnostic methods for and the research of blood borne pathogens and emerging diseases. Recently the Food & Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER) acquired an Agilent 7100A Capillary Electrophoresis (CE) instrument equipped with an Agilent Ultraviolet-Diode Array Detector (UV-DAD) for use in this research work. The sensitivity of the UV-DAD detector is insufficient for identifying picomolar/femtomolar levels of samples. To further enhance the capability of the CE system, the FDA/CBER requires a Laser-Induced Fluorescence (LIF) Detector. B. Background The CE technique provides ultrahigh resolution and great separation speed for a broad range of complex biological samples found in life sciences such as nucleic acids, peptides, proteins, lipids, carbohydrates, pharmaceutical compounds, nanoparticles, viruses and cells. However, the sensitivity of the standard CE detector, UV-DAD, is insufficient for identifying samples with concentrations at or below picomolar levels, which greatly hinders efforts on the study of HIV, influenza and viruses from other emerging diseases, discovery of related biomarkers, and development of ultrasensitive diagnostic tools against the pathogens. A typical LIF detector, however, is up to 100,000 times more sensitive than UV detection. The significantly higher sensitivity of the LIF detector makes it highly desirable for sensitively and selectively detecting low-abundance analytes in complex biological matrixes, and thus greatly benefits the CE method development/validation, nanoparticle bio-conjugate characterization and general clinical research. C. Scope An ultrasensitive LIF detector is important to the CE study of pathogens and rapid identification of oligonucleotides, proteins, small compounds and nano/micrometer-sized particles. The LIF detector together with the existing Agilent 7100A CE system will be employed in the characterization of bio-conjugated nanoparticles, analysis of Polymerase Chain Reaction (PCR) products and peptides/proteins/antibodies from HIV/influenza or other viruses, as well as the discovery of nucleic acid/peptide/protein biomarkers for diagnosis of blood borne pathogens in existing and emerging diseases. Part II: Work Requirements A. Technical requirements: � Capabilities: ultrasensitive fluorescence detection and quantification of fluorescent-dye-labeled or natively fluorescent proteins, nucleic acids (DNA/RNA), polysacchoarides, small compounds, virus/bacterial particles and nanomaterials. Detection limit shall be achieved at picomolar to femtomolar levels. � Must be able to excite wavelength from 280-620 nm � Must be able to detect emission from 450-700 nm � Must be able to accept multiple laser sources in the detector � Must include 355 nm and 488 nm laser sources and necessary accessories (e.g. filter block, detection cell, power sources, etc.) � Adaptable to different capillary columns (Inner Dimension (ID)/Outer Dimension (OD): 50-200 �m /360-400 �m) � Ability to interface through dual-detector mode with downstream mass spectrometer required (for CE-LIF-MS setup). � Must be compatible with Agilent 7100A CE instrument � Inside delivery (to end-users laboratory) is required. � Equipment shall be furnished with all software, drivers, adapters, cassettes, converters, etc., required to seamlessly integrate with the existing Agilent 7100A CE instrument and Chemstation software (data acquisition and analysis); Contractor is responsible for turnkey solution. � Installation and testing are required to verify all aspects of the system are operating within manufacture's recommended calibration parameters. At a minimum, this will be accomplished by running an operational test followed by a performance qualification test (measuring the signal to noise ratio of a test solution and comparing it against the specifications). � Comprehensive on-site post warranty annual preventative maintenance for up to 3 option years, inclusive of all labor, parts, and travel. At a minimum, preventative maintenance shall include inspecting the detector, laser and power supply for defects and correct operation. The system and cell shall be cleaned, calibrated and operationally tested to ensure correct function. A quality performance qualification test shall be completed, requiring the measurement of the signal-to-noise ratio of a test solution to compare against the specifications. All maintenance and calibration of equipment must be conducted by factory certified technicians. � Unlimited Technical Support and Trouble Shooting Assistance by phone, email, live-chat Interface, etc. within 4 hours from initial contact. � Unlimited Software Updates and Firmware Updates. � Minimum of one (1) year warranty following Government acceptance. Part III: Supporting Information A. Security Delivery driver shall call Jikun Liu (301-827-0906) or Jiangqin Zhao (301-827-0797) from security guard desk for entry to B258 Nicholson Lane Research Center (NLRC) loading dock. B. Place of Performance Shall be delivered to, installed, tested and maintained at (FOB Destination Point): B258, 5516 Nicholson Lane, Kensington, MD 20895 301-827-0906 C. Period of Performance Delivery, to include installation and testing, expected within 10 weeks of award with up to 3 post-warranty annual preventative maintenance option periods. Schedule of Items Equipment (to include in-side delivery, installation and set-up) $____________ Option Year 1, Post-Warranty Preventative Maintenance $____________ Option Year 2, Post-Warranty Preventative Maintenance $____________ Option Year 3, Post-Warranty Preventative Maintenance $____________ Total $____________ The provision at FAR 52.212-1, Instructions to Offerors- Commercial Items (FEB 2012) applies to this solicitation. Addendums to this provision are as follows: Award will be made to the lowest-priced, technically acceptable offer. Offerors shall provide sufficient descriptive information to show the proposed products meet the Government's technical requirements. Types of descriptive material include, but are not limited to, technical specifications, product literature, brochures, and any other information corresponding to each minimum requirement stated above. The Government is not responsible for locating or securing any information on the proposed products not identified in the offer. Proprietary information shall be clearly marked. The Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. Addendum to Paragraph (b)(8) Representations and Certifications- In addition to completing the representations and certifications at FAR 52.212-3(b), the Contractor's quote shall also clearly show that the Contractor has selected the appropriate certification under FAR 52.222-48 as provided in full text below. Note: This solicitation is being issued under the premise that the Contractor 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, 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 WD 05-2035 (Rev.-13): http://www.wdol.gov/wdol/scafiles/std/05-2035.txt?v=13 FAR 52.222-48 - Exemption From Application Of The Service Contract 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 Provision at FAR 52.212-3, Offeror's Representations and Certifications-Commercial Items (APR 2012), applies to this acquisition. The clause at 52.212-4, Contract Terms and Conditions - Commercial Items (FEB 2012), applies to this acquisition. Addendums to this clause are as follows: The supplies and/or services delivered hereunder shall be inspected and accepted at destination by the contracting officer's representative (COR) specified at award. 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. Other Terms and Conditions FAR and HHSAR Clauses and Provisions incorporated by reference may be obtained at: https://www.acquisition.gov/far/ http://www.dhhs.gov/asfr/ogapa/acquisition/acquisitionpolicies.html 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, summarizing all maintenance and repair activities (including warranty work) each time service and/or repair is performed. Invoice Submission Payment terms net 15 days after government acceptance of the supplies/services. Invoices shall be submitted to the attention of the designated Contract Specialist identified below and contain all necessary information per FAR 52.212-4 (g) in accordance with the following instructions. I. An original and two (2) copies shall be submitted to: FDA/OC/OA/OFO/OFS Attn: Division of Payment Services 3900 NCTR Road, HFT-324 Building 50, 6th floor, suite 616 Jefferson, AR 72079 Phone: (870) 543-7446 Fax 870-543-7224 An electronic invoice can be emailed to the following address: nctrinvoices@fda.hhs.gov II. One copy to the Contracting Officer Representative (COR) or other program center/office designee, clearly marked "courtesy copy only": Questions regarding invoice payments should be directed to the FDA payment office at phone or email reference provided above. Questions relating to when payment will be received should be directed to the FDA payment office at the email below or at (870) 543-7446 or (870) 543-7042. nctrinvoices@fda.hhs.gov. The following clauses are incorporated by reference: � FAR 52.217-9, Option to Extend the Term of the Contract is applicable, (a) "...by written notice to the Contractor within one (1) day of contract expiration; ...preliminary written notice of its intent to extend at least 30 days before the contract expires." (b) "...shall not exceed 3 years beyond the warranty expiration." � FAR 52.232-99, Providing Accelerated Payment to Small Business Subcontractors (DEVIATION) is applicable. � HHSAR Clauses: 352.222-70, 352.231-71 352.242-71 are applicable to this solicitation. The clause at FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders - Commercial Items (JAN 2013), applies to this acquisition. The following additional FAR clauses cited in this clause are applicable: (b) 52.204-10, 52.209-6, 52.219-4, 52.219-28, 52.222-3, 52.222-19, 52.222-21, 52.222-26, 52.222-36, 52.223-18, 52.225-3 with Alt II, 52.225-13 and 52.232-33 (c) 52.222-51 Additional Information Site visits will be granted if necessary. Contact Crystal G. McCoskey at the email address or phone number below to schedule an appointment prior to 9:00 am on February 5, 2013. Failure to inspect the site will not relive the successful offeror from fully meeting the requirements of the resulting contract at the price offered. It is the offeror's responsibility to monitor the internet site for the release of any information related to this combined synopsis/solicitation. Offerors are responsible for delivery in person, by e-mail, fax, mail or other delivery method their complete proposal and any additional documents before 2:00 pm (Central Standard Time - Local Prevailing Time in Jefferson, Arkansas) on February 11, 2013 to crystal.mccoskey@fda.hhs.gov, Fax (870) 543-7990, or mail to the U. S. Food and Drug Administration, FDA/OO/OFBA/OAGS/DAP, Attention of Crystal G. McCoskey, 3900 NCTR Road, Building 50, Room 426 Jefferson, AR 72079-9502. When appropriate, offerors should consult with delivery providers to determine whether their documents will be delivered prior to the scheduled time. For information regarding this solicitation, please contact Crystal G. McCoskey by e-mail at crystal.mccoskey@fda.hhs.gov. Questions regarding this solicitation will be accepted only via email and shall be submitted no later than 07:00 AM CST on February 5, 2013. Please reference solicitation number 1113351 in subject line of all correspondence. PLEASE NOTE - The above contact information is for the Contracting Office and not necessarily the delivery address. The delivery address is indicated in the Place of Performance section above.