SOLICITATION NOTICE
66 -- Upgrade Exactive Plus LC-MS System to Q Exactive Mass Spectrometry System
- Notice Date
- 6/26/2014
- 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, 3900 NCTR Road, HFT-320, Bldg 50 | Rm 421, Jefferson, Arkansas, 72079, United States
- ZIP Code
- 72079
- Solicitation Number
- 1130284
- Archive Date
- 7/18/2014
- Point of Contact
- Virginia C. House, Phone: 8705437405
- E-Mail Address
-
virginia.house@fda.hhs.gov
(virginia.house@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested and a written solicitation will not be issued. This requirement is being issued in conjunction with FAR Part 13 Simplified Acquisition Procedures and FAR 13.5 Test Program for Certain Commercial Items. The solicitation number is 1130284. This solicitation is issued as a Request for Quote (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2005-74 dated May 30, 2014. The associated North American Industry Classification System (NAICS) Code is- 334516-Analytical Laboratory Instrument Manufacturing; Small Business Size Standard is 500 employees. This RFQ is issued as full and open competition. SCHEDULE OF ITEMS Line Description Qty Unit Unit Price Extended Price Item 1 Base Requirement. Upgrade existing ExactivePlus LC-MS, system, Serial Number SNOP2092P to Q Exactive System in accordance with Statement of Work contained herein. 1 EA $______ $___________ 2 Option Year 1. Maintenance Agreement for Q Exactive System in accordance with Statement of Work contained herein. Period of Performance: 12 months 12 MO $______ $___________ 3 Option Year 2. Maintenance Agreement for Q Exactive System. Period of Performance: 12 months 12 MO $______ $___________ 4 Option Year 3. Maintenance Agreement for Q Exactive System. Period of Performance: 12 months 12 MO $_______ $____________ 5 Option Year 4. Maintenance Agreement for Q Exactive System. Period of Performance: 12 months 12 MO $_______ $_____________ Total Items 1-5 $_______________ Statement of Work Upgrade Exactive Plus System to Q Exactive Mass Spectrometry System Part I: General Information A. Introduction: The Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER) Facility for Biotechnology Resources (FBR) requires purchase of components and services required for upgrading/converting an existing Thermo Fisher ExactivePlus LC/MS System, Serial Number SNOP2092P to a Q Exactive Mass Spectrometry LC/MS/MS System or otherwise provide an alternative cost effective solution that would be able to satisfy requirements contained herein. B. Background: FBR provides an array of services, including the synthesis of oligonucleotides and peptides for scientists at CBER and the Center for Drug Evaluation and Research (CDER). Oligonucleotides and peptides are utilized in research ranging from gene amplification, DNA sequencing, studies of protein-protein interactions, etc. Crude oligonucleotides and peptides synthesized at FBR must be purified for most applications. A liquid chromatography-mass spectrometry (LC-MS) system (ExactivePlus of Thermo Scientific) is used to confirm the molecular weights of synthetic products. The system cannot however be utilized to provide proteomic service unless functions of ion isolation and ion fragmentation for an analyte are added. Scientists at CBER and CDER conduct cutting-edge molecular biological research and review products related to pathogen identification, disease mechanisms, vaccine development (e.g., influenza and other viruses), safety of blood products, or protocols involving cellular, tissue and gene therapies, etc. Often studies require synthetic peptides for biochemical characterizations and vaccine development. Experiments involving cell or animal models raises an important question of how cells or animals respond to a specific treatment or challenging, one tool for answering such a critical question is to examine the change of proteins in target cells or animals, an area of study referred as proteomics. To date, the most effective way to assess the protein profile change is by LC-MS (liquid chromatography-mass spectrometry). In this practice, proteins are digested into peptides and the peptides are subjected to electrospray ionization. The molecular weights (MW) of these peptide ions are determined, followed by fragmentation of ions to produce several daughter ions. Since the MWs of daughter ions are dependent on peptide sequences, through established software programs, it is possible to derive peptide sequences in a mixture, and to identify the proteins in the original sample where peptides are derived from. To be able to perform this highly sophisticate task, an LC-MS instrument has to be equipped with components needed for ion isolation and ion fragmentation, in addition to ion mass determination. Thus upgrading the existing LC-MS system (ExactivePlus) to a Q Exactive LC/MS/MS system is necessary, to provide proteomic service(s) and keep up with current trend in biological and biomedical investigation. C. Scope: The ExactivePlus LC-MS system requires upgrade to an instrument that is capable of MS1 and MS2 analyses. Standard Commercial Warranty and Options for Post Warranty Preventative and Corrective /Remedial Maintenance are required. Part II: Requirements A. Technical Requirements Upgrade existing Thermo ExactivePlus LC-MS system to Q Exactive system, enabling ion isolation and ion fragmentation to include the following features and changes. i) Hardware needed to enable MS2 function (ion isolation and fragmentation) capability from MS1 function (ion mass determination). Replace Q1 rod with the hyperbolic quadrupoles inside the mass spectrometer. ii) Add advanced active beam guide to improve uptime and reduced noise, and increase robustness. iii) Provide Nanospray Flex Ion Source kit for ion generation under extreme low flow rate (nano flow). iv) Include all labor required and certification of the instrument. Deliverables: Site Upgrade - End Product- Thermo Scientific Exactive Mass Spectrometry LC/MS/MS System inclusive of system components/upgrade, installation, set-up, training, warranty and post warranty maintenance options B. Service Requirements: Not less than a 1-year Warranty including parts and labor. Yearly service agreement for preventative and corrective maintenance beyond warranty period with four (4) 1-year options is required. Contractor shall at a minimum: • Perform one (1) annual on-site planned preventative maintenance visit per contract year. • Provide unlimited on-site corrective /remedial maintenance visits within 3 business days • Shall include unlimited technical support, Mondays - Fridays (excluding Federal Holidays) between the hours of 7:00 AM - 5:00 pm Central Time, within 8 business hours of contact for assistance (e.g., telephone, email, live-chat, website). • Provide unlimited software and firmware updates and maintenance. • All maintenance and repair activities shall be performed by formally trained and certified technicians/engineers, following Original Equipment Manufacturer (OEM) specifications, manuals, and service bulletins, using OEM replacement parts, components, subassemblies, etc. • All maintenance pricing shall be inclusive of labor, travel, replacement parts, components, subassemblies, etc. The Contractor shall, upon completion of each service call, 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 each time service and/or repair is performed. Deliverables: Service Records and Reports Part III: Supporting Information A. Delivery/Performance Address: Center for Biologics Evaluation and Research U.S. Food and Drug Administration Rm 1152, Bldg 72/52 10903 New Hampshire Avenue Silver Spring, MD 20993 Vendor shall coordinate system upgrade, installation, set-up, training and subsequent maintenance requirements with the Technical Point of Contact (TPOC) (to be provided with order). B. Period of Performance Upgrade to the system is expected within 45 days after receipt of order. The period of performance for maintenance options shall commence after acceptance and subsequent warranty period. Each option period shall be for 12 months. End of Statement of Work The FAR Provision at 52.212-1, Instructions to Offerors-Commercial Items, applies to this acquisition. The following addenda apply: Addendum Paragraph (c) Period for acceptance of offers. The offeror agrees to hold the prices in its offer firm until September 30, 2014. Offerors are instructed to include a completed copy of the provision at 52.212-3, Offeror Representations and Certifications-Commercial Items with their offer. Specific attention is directed to the following sections: • "an offeror shall complete only paragraph (b) of the 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 System for Award Management (SAM) website, the offeror shall complete only paragraphs (c) through (o) of this provision". • Offeror shall complete the certifications as applicable in the provision at FAR Provision 52.212-3(k) or FAR 52.222-48 (see below) for the application of the Service Contract Act (SCA). The offeror must certify that the maintenance/service it will propose to fulfill this requirement is exempt from the Service Contract Act per conditions set forth in FAR 22.1003-4(c). If this positive certification is not provided the FAR Clauses at 52.222-41, 52.222-42 and 52.222-43 shall be incorporated and the applicable SCA wage determination at the delivery location shall become part in any resultant contract which is Wage Determination No. WD 2005-2035 (Rev.-14) dated 6/25/2013 which is located at http://www.wdol.gov/ FAR 52.222-48 Exemption from Application of the Service Contract Act to Contracts for Maintenance, Calibration, or Repair of Certain Equipment Certifications (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. • FAR and HHSAR Provisions incorporated by reference may be obtained at: http://www.acquisition.gov/far/ http://www.hhs.gov/regulations/hhsar/ • It is the offeror's responsibility to monitor FedBizOpps.Gov for the release of any information related to this acquisition, e.g., questions and answers, amendments, award notice, etc. • The offer must reference solicitation number 1130284. • The Government is not responsible for locating or securing any information which is not provided with the offer, 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. Include the firm's DUNS number with quote. The FAR Provision at 52.212-2, Evaluation-Commercial Items is applicable. The specific evaluation criteria to be included in paragraph (a) of that provision are as follows: The Government will award a contract resulting from this solicitation to the lowest priced, technically acceptable offeror. The lowest priced offer will be evaluated first. If the lowest priced offeror is not technically acceptable, the next lowest priced offer will be evaluated and so on until a technically acceptable offer is determined. The Government reserves the right to conduct discussions at any time. Technical acceptability will be determined by review of information submitted by the offeror which must provide sufficient technical information necessary for the Government to conclusively determine that the offered equipment and post warranty maintenance services or other proposed alternative meets or exceeds the requirements identified above. Offerors shall specifically address the Statement of Work requirements and support same with submitted technical specifications, descriptive material, literature, brochures, publications where proposed solution has been used for same or similar purposes, and other information which demonstrates the acceptability of the offered solution. Include technical competency, knowledge and access to OEM proprietary systems. (b) Options. 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). (c) A written notice of award or acceptance of an offer, mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer's specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award. The FAR Provision 52.212-3, Offeror Representations and Certifications-Commercial Items, applies to this acquisition. The FAR Clause at 52.212-4, Contract Terms and Conditions-Commercial Items, applies to this acquisition. The following addenda apply: • FAR and HHSAR Clauses incorporated by reference may be obtained at: http://www.acquisition.gov/far/ http://www.hhs.gov/regulations/hhsar/ Inspection: The equipment/supplies and/or services delivered hereunder shall be inspected and accepted at Destination by the Technical Point of Contact (POC) specified at award. If the supplies or services are acceptable, the POC shall promptly forward a report of inspection and acceptance to the paying office. If the supplies or services are not acceptable, the POC shall document the nonconforming items/services and immediately notify the contracting officer. Contract Administration a. Contracting Officer, Jerry Martin 3900 NCTR Road HFT-320, Bldg. 50, Room 434 Jefferson, AR 72079 Phone: 870-543-7040 Email: jerry.martin@fda.hhs.gov b. Contract Specialist, Virginia House 3900 NCTR Road HFT-320, Bldg. 50, Room 432 Jefferson, AR 72079 Phone: 870-543-7405 Email: Virginia.house@fda.hhs.gov c. Contractor's Point of Contact (To be completed by the contractor) Name: Phone: Email: d. Technical Point of Contact (TPOC)- The following TPOC will represent the Government for the purpose of this contact: (To be completed at time of award) Name: Phone: Email: The TPOC 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 statement of work 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 statement of work; (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. Maintenance visits shall not be scheduled during Federal Holidays or Federal Closures as determined by Executive Orders or WWW.OPM.GOV. Federal holidays are as follows: New Year's Day Martin Luther King, Jr. Washington's Birthday Memorial Day Independence Day Labor Day Columbus Day Veteran's Day Thanksgiving Day Christmas Day Payments. Payments for post-warranty maintenance services will not be paid more frequently than monthly in arrears. There shall be no advance payments. 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 must 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 (must 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; (xii) Company's DUNS number; and (xiii) Any other information or documentation required by the purchase order/award. II. An original and two (2) copies shall be submitted to: 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.gov III. One copy to the Contracting Officer Representative (COR) or other program center/office designee, clearly marked "courtesy copy only": Note: POC information will provided at time of award by Government. 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 HHSAR Clause 352.202-1 Definition HHSAR Clause 352.203-70 Anti-Lobbying HHSAR 352.222-70 Contractor Cooperation in Equal Employment Opportunity Investigations HHSAR 352.231-71 Pricing of Adjustments HHSAR 352.242-71 Tobacco-Free Facilities FAR Clause 52.203-17 Contractor Employee Whistleblower Rights and Requirement to Inform Employees of Whistleblower Rights FAR 52.204-4 Printed on Copied Double-Sided on Postconsumer Fiber Content Paper FAR Clause 52.217-9 Option to Extend the Term of the Contract (a) "... within 10 days of contract expiration;.... at least 30 days before the contract expires..." (c) "...shall not exceed four (4) years beyond system upgrade (or alternative solution) warranty expiration." FAR 52.232-40 Providing Accelerated Payments to Small Business Subcontractors FAR 52.233-4 Applicable Law for Breach of Contract Claim. The FAR Clause at 52.212-5, Contract Terms and Conditions Required To Implement Statutes or Executive Orders-Commercial Items, applies to this acquisition. The following additional FAR clauses cited in 52.212-5 apply: (b): 52.203-6 Alt I, 52.204-10, 52.209-6, 52.219-4, 52.219-8, 52.219-28, 52.222-3, 52.222-21, 52.222-26, 52.222-35, 52.222-36, 52.222-37, 52.222-40, 52.223-15, 52.223-18, 52.225-3, 52.225-5, 52.225-13, and 52.232-33. (c): 52.222-51. Quotes are due on or before the date and time specified in the FBO announcement by delivery in person, by postal mail or email to: Food and Drug Administration, FDA/OO/OFBA/OAGS/DAP, ATTN: Virginia House, Building 50, Room 432, 3900 NCTR Road, HFT-320, Jefferson, AR 72079-9502 or via email to virginia.house@fda.hhs.gov. The name and telephone number of the individual to contact for information regarding the solicitation is Virginia House at (870) 543-7405
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