Loren Data's SAM Daily™

FBO DAILY ISSUE OF JUNE 27, 2012 FBO #3868
SOLICITATION NOTICE

66 -- Automatic Magnetic Cell Separator System

Notice Date

6/25/2012
 

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, Bldg 50 Room 422, Jefferson, Arkansas, 72079, United States
 

ZIP Code

72079
 

Solicitation Number

1104410
 

Archive Date

7/21/2012
 

Point of Contact

Nicholas E Sartain, Phone: 870-543-7370
 

E-Mail Address

nick.sartain@fda.hhs.gov
(nick.sartain@fda.hhs.gov)
 

Small Business Set-Aside

N/A
 

Description

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. This requirement is being issued in conjunction with FAR Part 13 Simplified Acquisition Procedures, as applicable. The solicitation number is 1104410. 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) 2005-58 dated May 18, 2012. The associated North American Industry Classification System (NAICS) Code is- 334516- Analytical Laboratory Instrument Manufacturing; Small Business Size Standard is 500 employees and is issued as full and open competition. The U.S. Food and Drug Administration (FDA), Laboratory for Emerging Pathogens (LEP), within the Center for Biologics Evaluation and Research (CBER) requires an automatic magnetic cell separator with post-warranty service/maintenance options inclusive of all parts, labor and travel for the entire system. The LEP performs FDA mission-oriented research in bioterrorism agents. Congress mandated that the FDA develop a counter terrorism program to address licensing of products to counter the threat of biological release of bioterrorism agents. To evaluate immune responses against bioterrorism pathogens, LEP needs to separate pure sub-populations of cells from heterogeneous populations. Due to the number of cell sub-populations needed to perform the FDA research (along with the need for reproducibility of results), LEP requires the use of an automated cell separator based on attachment of cells to magnetic beads. This technology has incredibly less impact on a cell than the larger, non bead separators currently on the market and positive and negative selection of cells without affecting cell viability is paramount. It is also necessary to isolate populations of leukocytes from whole blood without affecting the function of the cell. For this reason, the automatic cell separator based on magnetic beads is required to conduct experimentation in molecular biology, immunology, vaccine development, and diagnostics of bioterrorism agents. Due to space limitations within the lab, it is preferred that the system has a small profile and great flexibility to accommodate different formats such as large and small separation columns. The system must also perform cell separations in 3-10 minutes to maintain cell viability. Performance Requirements • Cell separator must be fully automated • Automatic Magnetic cell separation with bead technology • System must be equipped with preprogrammed isolation protocols. • Integrated high resolution screen and computer must be included. • Desired system should have a separation time of no greater than 10 minutes in order to maintain cell viability. • Must have automated system cleaning. • System must be capable of 99% depletion of cells. • System must be capable of isolating cells at a frequency of up to 10-8 cells in heterogeneous cell populations. • System installation and training. Post-Warranty Service Agreement The service agreement shall include, at a minimum, the following: • Minimum of one (1) Preventative Maintenance visit per contract year; • Unlimited on-site preventative maintenance, services, and repairs; • Unlimited Priority Telephone and Email Support; • Peak performance maintenance kits; • Software and firmware updates; • Preventative maintenance, services, and repairs performed by an OEM trained and certified technician; • Preventative maintenance, services, and repairs include all labor, travel, and new OEM factory-certified replacement parts, components, subassemblies, etc. (except consumables); • Phone support available from 8am to 5pm Eastern Time, Monday through Friday; • Priority scheduling for requests for service within 24 hrs; and • Absolute adherence to and conformity with OEM specifications, manuals, bulletins, etc. in performing all preventative maintenance, services, and repairs. • Service Records and Reports The Contractor shall, commensurate with the completion of each service call (inclusive of warranty service) or preventative maintenance visit, provide the end-user of the equipment and the Contracting Officer 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. FOB Point Destination. To be delivered, installed, and on-site training no later than 60 calendar days after receipt of order (ARO) FOB Point of Delivery for Services and Supplies will be the FDA/CBER located at 29 Lincoln Drive, Building 29, Room, 231 Bethesda, MD 20892. Payment terms net 30 days after government acceptance of the instrument. Period of Performance Note: Service period start/end dates is dependent on delivery, installation, on-site training and acceptance of the instrument. The estimated date could potentially be as follows: Award of contract- 8/1/12 Instrument delivered, installed, and on-site training conducted and accepted- 60 calendar days ARO 9/29/12. Initial 1-year warranty (minimum) ends on 9/29/13. Option year 1: September 30, 2013 through September 29, 2014. Option year 2: September 30, 2014 through September 29, 2015. Option year 3: September 30, 2015 through September 29, 2016. Option year 4: September 30, 2016 through September 29, 2017. Preventative maintenance and repair 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 Schedule of Items: 1. Automatic magnetic cell separator system which includes inside delivery, installation, on-site training as specified above, and a minimum of one year warranty for the fixed price of $____________. 2. Option Year 1:- Service maintenance agreement as described above for the aforementioned Automatic magnetic cell separator system. For the service agreement services that the Contractor shall provide, the Government will pay the contractor the fixed price of $___________. 3. Option Year 2:- Service maintenance agreement as described above for the aforementioned Automatic magnetic cell separator system. For the service agreement services that the Contractor shall provide, the Government will pay the contractor the fixed price of $___________. 4. Option Year 3:- Service maintenance agreement as described above for the aforementioned Automatic magnetic cell separator system. For the service agreement services that the Contractor shall provide, the Government will pay the contractor the fixed price of $___________. 5. Option Year 4:- Service maintenance agreement as described above for the aforementioned Automatic magnetic cell separator system. For the service agreement services that the Contractor shall provide, the Government will pay the contractor the fixed price of $___________. Contract clauses- The clause at 52.212-4, Contract Terms and Conditions-Commercial Items (FEB 2012), applies to this acquisition. The following addenda have been added to the clause. The following FAR and HHSAR clauses, incorporated by reference, and apply to this acquisition. FAR Clause 52.204-4 Printed or Copied Double-Sided on Recycled Paper.(MAY 2011) FAR Clause 52.204-7 Central Contractor Registration. (FEB 2012) FAR Clause 52.217-9 Option to Extend the Term of the Contract (MAR 2000) (a)... within 1 day of contract expiration;.... at least 15 days before the contract expires... (c)...shall not exceed the time stated in the schedule. HHSAR Clause 352.202-1 Definitions JAN 2006 HHSAR Clause 352.203-70 Anti-Lobbying JAN 2006 HHSAR Clause 352.222-70 Contractor Cooperation in Equal Employment Opportunity Investigations OCT 2009 HHSAR Clause 352.223-70 Safety and Health JAN 2006 HHSAR Clause 352.231-71 Pricing of Adjustments JAN 2001 HHSAR Clause 352.242-71 Tobacco-Free Facilities JAN 2006 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. Contract Administration a. Contracting Officer/Contract Administrator Nick Sartain, Contracting Officer 3900 NCTR Road HFT-320 Jefferson, AR 72079 Phone: 870-543-7370 Email: nick.sartain@fda.hhs.gov b. Contractor's Point of Contact (To be completed by the contractor) Name: Phone: Email: c. Technical Point of Contact-Contracting Officer's Representative The following COR will represent the Government for the purpose of this contact: (To be completed at time of award) Name: Phone: Email: 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 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. 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. 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 Fax 870-543-7224 An electronic invoice can be emailed to the following address: nctrinvoices@fda.hhs.gov II. Electronic invoices must be on company letterhead and must contain no ink changes and be legible for printing. Questions regarding invoice payments should be directed to the FDA payment office at (870) 543-7446 or (870) 543-7042. The clause at FAR 52.212-5, Contract Terms and Conditions Required to Implement Statues or Executive Orders-Commercial Items (MAY 2012) applies to this acquisition. The following additional FAR clauses cited in this clause are applicable: 52.203-6 alt I, 204-10, 209-6, 52.219-4, 52.219-8, 52.222-3, 52.222-19, 52.222-21, 52.222-26, 52.222-36, 52.222-51, 52.223-15, 52.223-16, 52.223-18, 52.225-3, 52.225-13, and 52.232-33. Solicitation provisions Contract Type: Commercial Item-Firm Fixed Price. The provision at FAR 52.212-1 Instructions to Offerors-Commercial Items (FEB 2012) applies to this solicitation. The following addenda have been added to this provision: Addendum Paragraph (c) Period for acceptance of offers. The offeror agrees to hold the prices in its offer firm until September 30, 2012. The provision at FAR 52.212-2 Evaluation-Commercial Items is applicable to this solicitation. 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 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 quotes: (i) Technical capability of the items/services offered to meet or exceed the Government's requirement. (ii) Price. Technical is significantly more important when compared to price in determining the best value to the government; however price remains a significant factor and must be affordable. Technical capability 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 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. Offeror shall address cell viability and functions with the use of the proposed system. Provide the following information of proposed system: 1. Ability to perform automated magnetic cell separation. 2. Column capacity and ability to bind cells. 3. Time needed to complete cell separation 4. Ability to isolate cells in heterogeneous cell populations 5. Percentage of successful depletion of unwanted cell types 6. Sample input volumes. 7. Negative and positive cell isolation 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. Include the firms DUNS number with quote. (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 government reserves the right to make an award without discussions. The Provision at FAR 52.212-3, Offeror Representations and Certifications-Commercial Items (APR 2012), applies to this acquisition. An offeror should complete only paragraph (b) of this provision if the offeror has completed the annual representations and certifications electronically at http://orca.bpn.gov. One or more of the items under this acquisition is subject to the World Trade Organization Government Procurement Agreement and Free Trade Agreements. FAR and HHSAR Clauses and Provisions incorporated by reference may be obtained at: FAR: https://www.acquisition.gov/far/ HHSAR: http://www.dhhs.gov/asfr/ogapa/acquisition/acquisitionpolicies.html 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. Offerors that fail to complete the required representations and certifications, or reject the terms and conditions of the solicitation, may be excluded from consideration. All responsible sources may submit an offer, which if timely received, shall be considered. The offer must reference solicitation number 1104410. The offers are due in person, by postal mail or email to the point of contact listed below on or before July 6, 2012 by 13:00 hours (Central Standard Time in Jefferson, Arkansas) at the Food and Drug Administration, FDA/OO/OFBA/OAGS/DAP, Attn: Nick Sartain, 3900 NCTR Road, HFT-320, Jefferson, AR 72079-9502. For information regarding this solicitation, please contact Nick Sartain at (870) 543-7370, FAX (870) 543-7990 or email nick.sartain@fda.hhs.gov.
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/NCTR/1104410/listing.html)
 

Place of Performance

Address: 29 Lincoln Drive, Building 29, Room, 231, Bethesda, Maryland, 20892, United States

Zip Code: 20892
 

Record

SN02785538-W 20120627/120625235523-16d414b40acefad1f1f28b42d3126a21 (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

---

| FSG Index  |  This Issue's Index  |  Today's FBO Daily Index Page |